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Name : Martin Stuart Cetron / [Cetron Martin] / [Martin Ceteron] / [Martin S Centron]
Birth Date : Feb 1956
Residence : 1994-2020 / 2514 Echo Dr Ne / Atlanta, Georgia, USA / 30345
Second Residence : 1997-2015 / 3401 Winding Oaks Dr / Longboat Key, Florida, USA / 34228
Third Residence : 1989-1998 / 1712 Ne 68th St / Seattle, Washington, USA / 98115
Fourth : 1994-1996 / 2606 Glenrose Hl / Atlanta, Georgia, USA / 30341
EVIDENCE TIMELINE
EVIDENCE TIMELINE
2000 (August 8) - NYTimes : "Clues to an Alien Virus; Scientists Begin to Crack the Mysteries of West Nile"
2000 (August 8) - NYTimes : "Clues to an Alien Virus; Scientists Begin to Crack the Mysteries of West Nile"
By Andrew C. Revkin / Aug. 8, 2000
2000-08-08-nytimes-clues-to-an-alien-virus-scientists-begin-to-crack-the-mysteries-of-west-nile.pdf
2000-08-08-nytimes-clues-to-an-alien-virus-scientists-begin-to-crack-the-mysteries-of-west-nile-img-f1.jpg
2000-08-08-nytimes-clues-to-an-alien-virus-scientists-begin-to-crack-the-mysteries-of-west-nile-img-f2
West Nile virus appears to be settling in for the long haul.
Almost one year after the Western Hemisphere debut of the virus sent 62 people to hospitals, eventually killing 7 of them with severe brain inflammation, the bird-carried, mosquito-transmitted disease has struck again, infecting a 78-year-old man from Staten Island.
The man, who became ill last month before New York City began this year's round of mosquito spraying, recovered, as the vast majority of infected people do.
But despite widespread spraying, many scientists expect that a scattering of such cases and a few deaths, mostly in the elderly or infirm, may well become the norm in years to come.
More slowly than expected, but steadily, the globe-hopping virus is dispersing from last year's focal point in northern Queens, leaving a trail of dead birds that so far extends north to Boston, west to Syracuse and south to Maryland.
According to virus experts, this pattern indicates that West Nile, which was first identified in Uganda in 1937 and flares up sporadically in Africa, Europe and the Middle East, appears ensconced in the New World.
Since last fall, dozens of scientists have been scrambling to understand West Nile's origin and destiny as it explores this continent and tests new hosts, decimating some, like crows, leaving others, like pigeons, untouched, and occasionally spilling over into people. Thousands of hours of sleuthing, testing and analysis are only now offering preliminary clues. The big questions are largely unresolved.
How did the virus get here? Where did it come from? What is its main animal reservoir -- the birds in which it can simmer in sufficient concentrations to be passed by mosquitoes from one host to another? How far will it spread?
Most important, will West Nile pose a major threat to public health in the United States? The answer to this question, at least so far, appears to be no.
Where there are answers, they are couched in caveats:
Though the virus was first identified in Uganda, the source of the outbreak here was probably Israel; the American strain is almost indistinguishable from a virulent strain found in a goose on an Israeli farm in 1998.
House sparrows -- ubiquitous, dust-colored, one-ounce crumb-snatchers -- are probably a principal reservoir here; new tests at federal laboratories show they can harbor the virus for five days or more at levels high enough to infect mosquitoes that bite them.
Beyond that, little is known.
Given the lack of knowledge about what conditions set off the virus's spread to people, spraying near spots where birds died, the major response so far, is akin to shooting at an assailant in the dark, many scientists say. ''But at least it gives you something to do,'' said Dr. Vincent Deubel, a virologist at the Pasteur Institute in Paris who has studied West Nile outbreaks for 15 years.
For now, scientists investigating West Nile say one thing is clear: surveillance and spraying can help cut the risk that people will be infected, but the virus is probably here to stay and will continue to spread.
''We're beyond containment now,'' said Robert G. McLean, a government biologist studying West Nile's effect on birds. ''We have to live with it and do the best we can.''
Virus's Arrival in U.S.
Virus's Arrival in U.S.
The closest thing to a fact in the investigation of the disease, scientists say, is that it is truly new in the Americas, arriving somewhere around New York City in the months before last summer's outbreak.
Blood tests in people and birds showed the kind of immune response typical when a body is freshly exposed to an infection, according to federal health officials. Mapping of test results for captured house sparrows -- which do not migrate -- show a hump in the exposure rate in and around Queens and nowhere else.
And crows, the most vulnerable birds, are almost nowhere to be seen in northern Queens this summer. The population there crashed 90 percent, federal scientists say, while in other areas the birds were hit less hard.
West Nile virus is closely related to several other mosquito-borne viruses found around the world, including Japanese encephalitis virus and St. Louis encephalitis, which has a similar cycle in birds and mosquitoes and occasionally strikes people across the South and Middle West.
One big difference is that St. Louis encephalitis is ''silent'' in birds, generally not killing them, scientists say, so there is usually no warning before a human case. For West Nile, at least the American strain, birds, and particularly crows, offer a hint of possible trouble to come.
The disease has caused epidemics in the past. In West Nile outbreaks in Israel in the 1950's, South Africa in 1974 and Romania in 1996, hundreds and sometimes thousands of people became ill, with 5 percent to 10 percent of those cases proving fatal.
But far greater numbers of people bitten by infected mosquitoes never know they have been exposed.
Over all, scientists say, human illness from the virus is likely to remain rare, a result of unusual confluences of mosquito-friendly weather, chance bird movements and other influences that cause the virus to ''amplify'' enough to pose a threat beyond its normal hosts.
Humans are always likely to remain what biologists call a ''dead-end host,'' one that can be infected, but whose immune system almost always prevents the virus from multiplying enough to be passed back to mosquitoes and then other hosts.
''It's horrible for the few individuals who've been terribly affected, but I don't see any way that it will cause more than a dribble of cases here,'' said Dr. Paul W. Ewald, an infectious disease expert at Amherst College.
Still, West Nile has already defied expectations here. So health officials want to be prepared, should it surprise them again.
Last fall, the surprise was pleasant. The federal Centers for Disease Control and Prevention issued an alert from New York to Texas, offering money to states to track what was expected to be a kind of rolling wave of dying birds as the annual southward migration took place and the virus tagged along.
But no southerly die-off was seen. And since then, the only new discoveries of birds with the virus have come to the north, not the south -- in Syracuse, and just outside of Boston.
In New York City, health officials put a particular focus on watching for the virus in northern Queens, which was the clear hot zone last summer. This summer, if anything, it appears that Queens is a cold zone.
Staten Island has been a hot spot, and in late July, West Nile popped up in the heart of Manhattan, forcing the abrupt cancellation of a New York Philharmonic concert in Central Park when some trapped mosquitoes were found with the virus.
Of growing concern to some biologists is the virus's potential effect on American wild birds, including species like whooping cranes, eagles and ravens, which seem susceptible.
The imported West Nile strain, and the Israeli strain it most resembles, are more dangerous to birds than other known strains of the virus, said Dr. McLean of the National Wildlife Health Center in Madison, Wis., which is run by the United States Geological Survey.
And the dead birds keep coming. In a telephone interview last Friday, Dr. McLean said a shipment of 25 bird carcasses had just come in from New York, ''and it's going to start picking up more and more.''
Retracing Virus's Journey
Retracing Virus's Journey
While trying to stay a step ahead of the virus, scientists are also looking back, trying to retrace how and why it finally found its way across the Atlantic Ocean now.
This could help change the way health officials guard against other so-called emerging diseases, said Dr. Martin Cetron, an epidemiologist in the federal centers' quarantine division in Atlanta, who is helping to direct the investigation.
A team based at the centers devised a mathematical model to test the probability of nearly every possibility -- ranging from a sick tourist returning from Tel Aviv to an infected goose to a mosquito confined eight or more hours in an airline cabin.
The team ended up with a top-10 list of probable sources, Dr. Cetron said, including mostly things like shipments of poultry or pet birds. Only one subset of people ranked in the top 10: travelers from Israel whose immune systems were weak enough to allow the virus to thrive long enough to be picked up by a New York mosquito and spread to birds and, eventually, back to people.
The research has not yet been published, so Dr. Cetron said he could not disclose details. But he did describe some remarkable statistics the team came upon, which show just how many possible carriers of the virus came to the New York region through the three major airports in the year leading up to the outbreak.
From July 1998 to June 1999, 5 million people arrived with the metropolitan region as their final destination. Of those, 2.1 million came from places where West Nile has been found.
There were shipments of imported birds, horses, even frogs, all of which can harbor the virus. More than one million live birds, mostly poultry, were imported in that span.
The numbers were only the beginning, Dr. Cetron said. The next step was winnowing the data for each suspect animal or human population based on two things: were they arriving from a place with the most similar strain of the virus, and what were the odds that they could have been harboring live virus in their blood when they got here?
Dr. Cetron stressed that the model was like a compass, pointing in a certain direction, but providing no firm answers.
Extent of the Threat
Extent of the Threat
Now that West Nile is here, what is it capable of? No one has found a formula predicting how it makes its leap to a human outbreak from the circumstances now seen in southern New York -- with a scattering of bird deaths, one human case and a few dozen samples of trapped mosquitoes carrying the virus.
But analysis of past outbreaks in temperate zones in its previous range shows some patterns. It is usually passed from birds to humans in late summer, in cities more than the countryside and in weather or in places that mosquitoes enjoy.
Some scientists say that conditions are not nearly as primed for a significant human outbreak as they were last year. They note that frequent downpours this summer in the New York metropolitan area are likely to have flushed storm drains that were stagnant last year because of a prolonged drought. Stagnant, nutrient-laden water is a welcome mat for Culex mosquitoes.
This year, too, many communities revived mosquito control efforts, including widespread use of larvicide, that had ended 10 or 20 years ago for lack of concern.
Even with all the surveillance and spraying and larviciding under way now, many scientists said, it is likely that when the disease spills into people, it will come as a surprise.
For St. Louis encephalitis, the infection rate in mosquitoes generally has to reach about 1 in 1,000 for the virus to become a threat to people, experts say, adding that a similar ratio is expected for West Nile. But it is almost impossible to trap enough mosquitoes to detect when this threshold has been reached in a particular place, they say.
And, ultimately, scientists just do not know whether West Nile, in its new terrain, will play by established rules. ''We don't have the luxury of a track record,'' said Roger S. Nasci, a mosquito expert in the disease-control centers' laboratories at Fort Collins, Colo.
On the front lines in New York, scientists are racing to keep up with a rising flow of dead birds. In his laboratory near Albany, Dr. Ward B. Stone, the state's wildlife pathologist, conducts triage on a steady flow of crows, herons, hawks, bluejays and other birds, quickly assessing which should be sent on for tests for the new virus and which were killed by conventional causes.
''From mid-August until after Labor Day, we're going to see this virus amplifying,'' Dr. Stone said.
He said that he had no doubt that the current frenzied focus on West Nile would eventually ebb, and that it would be added to the growing list of diseases on the fringe -- never as familiar as flu, rabies or meningitis, but something always to consider when a bird dies, or an elderly man spikes a fever in the summertime.
''It will become one of the diseases in America that we have to watch for,'' Dr. Stone said. ''And we should be getting ready for the next one.''
- Correction: Aug. 17, 2000; A chart in Science Times on Aug. 8 with an article about West Nile virus misstated the origins of the house sparrow, which can harbor the organism. The bird was introduced to America from Europe; it is not a native species.
2002 (May) - Research collaboration of Thomas Monath and Martin Cetron - "Prevention of yellow fever in persons traveling to the tropics (vol 34, pg 1369, 2002)"
2002 (May) - Research collaboration of Thomas Monath and Martin Cetron - "Prevention of yellow fever in persons traveling to the tropics (vol 34, pg 1369, 2002)"
https://academic.oup.com/cid/article/34/10/1369/327881
https://academic.oup.com/cid/article/34/10/1369/327881
July 2002
Clinical Infectious Diseases 35(1):110-110
Authors:
Article history
Received: 05 November 2001
Revision received: 03 January 2002
Published: 15 May 2002
2002-07-clinical-infectious-diseases-yellow-fever-prevention-monath-cetron.pdf
2002-07-clinical-infectious-diseases-yellow-fever-prevention-monath-cetron-img-pg-1369.jpg
Prevention of Yellow Fever in Persons Traveling to the Tropics Thomas P. Monath, Martin S. CetronClinical Infectious Diseases, Volume 34, Issue 10, 15 May 2002, Pages 1369–1378, https://doi.org/10.1086/340104Published: 15 May 2002 Article historyA correction has been published: Clinical Infectious Diseases, Volume 35, Issue 1, 1 July 2002, Page 110, https://doi.org/10.1086/341961pdfPDF Split View CitePermissions Icon Permissions Share AbstractYellow fever (YF) is a potentially lethal mosquito-borne viral hemorrhagic fever endemic in Africa and South America. Nine million tourists annually arrive in countries where YF is endemic, and fatal cases of YF have occurred recently in travelers. In this article, we review the risk factors for YF during travel and the use of YF 17D vaccine to prevent the disease. Although the vaccine is highly effective and has a long history of safe use, the occurrence of rare, fatal adverse events has raised new concerns. These events should not deter travelers to areas where YF is endemic from being immunized, because the risk of YF infection and illness may be high in rural areas and cannot be easily defined by existing surveillance. To avoid unnecessary vaccination, physicians should vaccinate persons at risk on the basis of knowledge of the epidemiology of the disease, reports of epidemic activity, season, and the likelihood of exposure to vector mosquitoes.
Topic: africaculicidaeimmunizationsouth americatravelvaccinationvaccinesyellow feverinfectionstravelerepidemicssurveillance, medicaladverse eventpreventionIssue Section: Invited ArticleYellow fever (YF), a mosquito-borne viral hemorrhagic fever, is one of the most lethal viral diseases. It is characterized by a rapid evolution and hepatitis, renal failure, hemorrhage, shock, and death; the mortality rate is 20%–50%. Because YF is maintained in nature by transmission between wild monkeys and mosquitoes, and because it cannot be eradicated, prevention and control of the disease requires continuous immunization of human populations at risk. In 1936, workers at the Rockefeller Foundation developed the 17D live attenuated vaccine by prolonged serial passage of wild-type YF virus in chicken embryo tissue [1]. This highly effective vaccine has been in routine use for 65 years, and, wherever high vaccine coverage rates have been achieved, there has been a dramatic decrease in the prevalence of disease in travelers and residents of countries where YF is endemic. Where the vaccine is underused, YF remains a public health problem of varying magnitude. In recent years, there has been an upsurge in the incidence of YF [2]; 13,236 cases and 3589 deaths have been officially reported to the World Health Organization (WHO) from 1990 through 1999. The true incidence, estimated to be ∼200,000 cases per year, far exceeds the reported incidence [2].
This review focuses on the threat of YF to travelers, on the proper use of YF 17D vaccine to prevent infection in travelers, and on new data pertaining to vaccine safety, tolerability, and efficacy. The prediction and control of epidemics, the clinical presentation and management of cases, and the transmission cycle are reviewed elsewhere [3, 4]. Further information about YF vaccine requirements for travel may be found on the Centers for Disease Control and Prevention (CDC) Web site (http://www.cdc.gov/travel).
Expansion of Travel to Areas Where Yf is EndemicIncreasing travel to the tropics, and adventure travel to remote areas in particular, has amplified exposure to YF. Each year, 9 million tourists from North America, Europe, and Asia travel to countries where YF is endemic [5]; the number of tourists who actually visit regions within these countries in which YF transmission occurs may exceed 3 million.
Risk of Acquiring Yf During TravelSince the advent of YF 17D vaccine, the disease has been uncommon in travelers and expatriates from developed nations, with only 11 reported cases since 1950 [6, 7]. YF is a zoonosis; it is transmitted from monkeys to humans by the agency of vector mosquitoes. The risk of a traveler acquiring YF is determined by immunization status, geographic location, season of travel, length of exposure, occupational and recreational activities partaken of while traveling, and the rate of YF virus transmission at the time. Although reported cases of human disease are the principal guide to the level of YF transmission, they may be absent (because of a high level of immunity in the population) or not detected (because of poor surveillance). Few YF cases are officially reported, because the disease occurs in remote areas that lack specific diagnostic facilities. For example, in an outbreak in The Gambia that spanned ∼6 months (1978–1979), the incidence of YF virus infection was 33% and the incidence of severe disease with jaundice was 4.4%, with a case-fatality rate of 19.4%. Only 30 cases were officially reported out of a probable 8400 cases and 1600 deaths [8]. Remarkably similar incidences of infection and disease have been recorded in many other YF outbreaks in Africa [6]. Presently, epidemic activity is ongoing in the Ivory Coast, Guinea, and Liberia. One may estimate that an unimmunized person entering an area of epidemic activity would have risks of YF illness and death of 1 : 267 and 1 : 1333, respectively, for a 2-week trip.
During interepidemic periods in Africa, the incidence of overt disease is less than the threshold of detection of existing means of surveillance. Interepidemic conditions may last years or even decades in specific countries or regions. “Epidemiological silence” may provide a sense of false security and lead to travel without the benefit of vaccination. Surveys in rural West Africa during “silent” periods indicate that the incidence of YF illness is 1.1–2.4 cases per 1000 persons and the incidence of death due to YF is 0.2–0.5 deaths per 1000 persons, which are less than the threshold of detection of the existing means of surveillance [9]. The risks of illness and of death due to YF in an unvaccinated traveler are estimated to be 1 : 1000 per month and 1 : 5000 per month, respectively (for a 2-week journey, the risks of illness and death are 1 : 2000 and 1 : 10,000, respectively), although the risks vary considerably according to season. In West Africa, the most dangerous time of the year is during the late rainy and early dry seasons (July–October). These estimates, which are based on risk to indigenous populations, may overestimate the risk to travelers who take precautions against getting bitten by mosquitoes and who have less outdoor exposure than do indigenous residents.
The incidence of YF in South America is lower than that in Africa, because virus transmission between monkeys and mosquitoes occurs in the canopy of the forest, isolated from human contact, and because vaccine coverage is high. The risks of illness and death are probably 10 times lower in South America (i.e., 1 : 20,000 for illness and 1 : 100,000 for death for a 2-week journey) than they are in rural West Africa, but the risks vary greatly according to specific location and season. As in Africa, virus transmission between mosquitoes and monkeys may be epidemiologically silent, although some monkey species succumb to infection. Virus transmission is highest during the rainy season (January–March) in Brazil. The low reported incidence of YF (generally a few hundred cases per year) has resulted in lulled concern among travelers. In Brazil, for example, where the majority of the population lives in coastal regions outside of the zone of endemicity, unimmunized recreational or vocational travelers to the interior of the country are the usual persons to be affected by YF. Three of the 4 patients from the United States and Europe who acquired YF in 1996–1999 were exposed in South America [7, 10, 11]. Although it is not as dramatic as the situation in Africa, the 1990s represented a period of increased enzootic and epizootic YF transmission in South America. Brazil and Peru are currently experiencing an expansion of YF virus activity, and the risk to travelers is higher than usual.
Geographic Characteristics of Yf and Comments on the International Health RegulationsBecause it is not possible to define the risk of exposure to YF on the basis of surveillance data, all persons traveling outside urban areas of countries where YF is endemic should be vaccinated. The zone of endemicity and areas that have sustained recent epidemics are shown in figure 1. Urban outbreaks have been reported from the Ivory Coast and Nigeria recently, and recommendations regarding rural versus urban travel need to be continuously reconsidered (as discussed in the next paragraph). Autochthonous cases of YF have also been reported in selected cities and periurban areas in Bolivia and Brazil. The threat of more-widespread urban YF in the Americas is a serious concern, which may change vaccination recommendations in the future.
Figure 1Regions of tropical South America and Africa where yellow fever (YF) is endemic (shaded). Areas shown in black represent intensified YF virus activity or epidemics that occurred during 1999–2001. Numbers denote officially notified cases reported during the period of 1990–1999.Open in new tabDownload slideRegions of tropical South America and Africa where yellow fever (YF) is endemic (shaded). Areas shown in black represent intensified YF virus activity or epidemics that occurred during 1999–2001. Numbers denote officially notified cases reported during the period of 1990–1999.
It is difficult to obtain specific information about the geographic characteristics of YF even from health professionals in their indigenous geographic areas. Moreover, the epidemiological status of YF is never static, and what is true one year may not be the next. For example, Iguazú Falls, a favorite tourist destination on the Brazil-Argentina border, is usually not a high-risk area, but it may be so during exceptional periods of epizootic expansions, such as those that occurred in 1966 and 2001. Travel to urban areas within the zone of endemicity, such as Iquitos (Peru), Manaus or Brasilia (Brazil), or Enugu (Nigeria), generally present a low risk, which, however, cannot be taken as zero risk. Because urban (Aedes aegypti–borne) YF occurs regularly in West Africa, vaccination is recommended for persons traveling to towns and inland cities within the zone of endemicity. Cases of YF are currently being reported within the city of Abidjan (Ivory Coast). Clearly, visitors to this urban region require vaccination.
Cases of Yf in Travelers and Expatriates Residing in Countries Where Yf is EndemicCases reported since 1970 are listed in table 1. These cases illustrate a number of points: (1) all patients traveled to remote, rural areas; (2) the duration of exposure was relatively brief in some cases; (3) there was no evidence of an ongoing epidemic in the location of exposure, although YF activity may have occurred in the recent past or in surrounding areas; (4) the disease was fatal in most cases, suggesting that there may have been other cases with mild or abortive infection that were missed; (5) there was a potential for introduction of YF to receptive areas and secondary spread by the urban vector, A. aegypti; and (6) most patients had not been vaccinated. It is possible that the cases that occurred among vaccinated travelers resulted from the use of vaccine that had deteriorated during storage. However, in various clinical trials of YF vaccines, 1%–5% of vaccine recipients have not responded to vaccine, as determined by a neutralization test; this suggests that primary vaccine failure may occur at a low incidence [6, 16].
Table 1Reported cases of yellow fever in travelers, 1970–2000.Open in new tabDownload slideReported cases of yellow fever in travelers, 1970–2000.
Yf VaccineThe live, attenuated YF 17D vaccine is delivered as a single subcutaneous inoculation of 0.5 mL. The vaccine induces neutralizing antibodies (the mediator of protection) in 90% of vaccine recipients within 10 days after inoculation and in 99% within 30 days after inoculation. Immunity is very durable and probably lifelong [17], although revaccination is recommended at 10-year intervals. No cases of secondary vaccine failure (i.e., YF occurring in an individual who had been shown to respond to the vaccine but who lost protective immunity over time) have been identified. The vaccine may be simultaneously administered with most other vaccines, including measles, BCG, inactivated and oral polio, diphtheria-pertussis-tetanus, meningococcus, hepatitis B, hepatitis A, oral cholera, oral typhoid, and parenteral typhoid vaccines [18–23]. If other live viral vaccines, such as the measles and the measles-mumps-rubella vaccines, are not administered simultaneously, administration should be separated by 1 month. There are no data on coadministration with Japanese encephalitis (JE) vaccine (another flavivirus), although interference is unlikely. Prior infection or immunization with JE does not interfere with YF vaccination [24, 25], but cross-protection due to prior dengue infection probably reduces the response to YF vaccine [26]. As new live, attenuated JE and dengue vaccines come into use, research will be needed on interactions between those vaccines and YF 17D.
YF 17D vaccine is well tolerated. In practice, a small proportion of subjects complain of injection site pain, inflammation, fever, mild headache, myalgia, and malaise. In clinical trials in which the subjects were directly questioned, local and systemic adverse events have been reported by ∼25% of vaccine recipients during the first 3–7 days after inoculation [3, 16, 19, but these events are mild and do not interfere with normal activities. Mild systemic reactions are probably mediated by cytokines. In persons who are vaccinated for the first time, mild viremia, not exceeding 102 pfu/mL, occurs for ⩾1 days between the third and seventh day after vaccination and is associated with elevations of IFN-α, TNF-α, and markers of T cell activation (i.e., neopterin and β2 microglobulin) [27–30]. Revaccination results in no viremia and a lower incidence of adverse reactions [16, 28, 30], because the vaccine inoculum is neutralized by preformed antibody.
Serious and severe adverse reactions are extremely rare. These fall into 3 major categories: (1) hypersensitivity reactions, (2) encephalitis caused by neuroinvasion of the 17D virus, and (3) pansystemic infection, including hepatitis, which is similar to wild-type YF.
Hypersensitivity reaction.. YF 17D vaccine is an extract of embryonated chicken eggs, and it is contraindicated for persons with a clear history of egg allergy (i.e., oral intolerance). In persons without egg allergy, systemic allergic reactions (e.g., anaphylaxis and urticaria) occur at an incidence of 1 case per 58,000–131,000 persons vaccinated [31], and the reactions may be caused by sensitivity to the hydrolyzed porcine gelatin used to stabilize the vaccine.
Postvaccinal encephaliti.. Although up to 400 million persons have received YF 17D vaccine, there have been only 21 patients with postvaccinal encephalitis described in the literature, of whom 20 recovered without sequelae and 1 died [6]. Unpublished postmarketing surveillance of adverse events confirms that encephalitis is very rare, occurring at a rate of <1 case per million doses. Because postmarketing surveillance is passive, the true incidence may be higher. Postvaccinal encephalitis occurs principally in very young infants. Eighteen of the 21 published cases of postvaccinal encephalitis occurred in children, of whom 16 were infants of ⩽7 months of age. Virus recovered from the brain of the single patient to have died contained 2 amino acid changes in the envelope glycoprotein gene and had increased neurovirulence in animals [32], which suggests that mutation of the vaccine virus during replication in the patient was responsible for the event.
Fever, jaundice, and multiple-organ failure associated with YF vaccinatio.. Ten cases (8 of which were fatal) of a syndrome resembling wild-type YF associated with YF 17D vaccination have recently been described. Of the 10 cases, 7 have been reported in the literature [33–35], 6 occurred in persons immunized for travel, and 4 occurred in persons living in a region of endemicity. Four cases in the United States occurred in elderly patients, had a diversified and complex clinical presentation, and were labeled “multi-organ failure,” which reflects the uncertainty regarding the role of YF17D in direct viral injury. In contrast, extensive virological evidence in the cases that occurred in Brazil and Australia support the conclusion that an overwhelming infection with 17D virus was responsible.
These adverse events were characterized by rapid onset of fever and malaise within 3–5 days after vaccination; jaundice, oliguria, cardiovascular instability, and hemorrhage; and midzonal necrosis of the liver noted at autopsy [34, 35]. Large amounts of YF viral antigen were found in the liver and in other affected organs. Similar cases have undoubtedly occurred throughout the history of use of YF 17D vaccines, but they were missed or misdiagnosed.
The actual incidence of the syndrome is unknown. Estimates from a retrospective review of events passively reported to the Vaccine Adverse Events Reporting System (VAERS) in the United States during 1990–1998 suggest a reported rate of 1 case per 400,000 persons [33], but the true incidence will remain uncertain until prospective surveillance is applied to large populations undergoing primary vaccination. Since the syndrome was first described in 1996, ∼190 million doses of YF vaccine have been distributed, and there have been 10 reported cases of this syndrome. The syndrome can probably occur only in patients who have undergone primary vaccination. Some of the patients from the United States developed very high titers of YF antibody, suggesting either prior exposure to a heterologous flavivirus or a response to abnormally high levels of YF 17D replication and antigen expression.
The syndrome is apparently not caused by mutations in the virus, but rather by the unusual susceptibility of the individual host. The virus strains recovered from patients with fatal cases failed to show mutations that could explain the unusual clinical presentation [35, 36]. The host factors for increased susceptibility are not yet identifiable. A genetic basis is likely, on the basis of observations of mice showing genetic control of susceptibility to flaviviruses [37].
Retrospective analysis of VAERS data in the United States revealed a higher incidence of severe adverse reactions in elderly persons: persons aged >75 years had a risk 12 times higher than that for young adults, which suggests that waning immunity with age may play a role [38]. However, elderly subjects who developed multiple–organ system failure in the study had robust immune responses to YF17D virus [35]. Although the 4 deaths in Brazil that occurred during 1999–2001 were in children and young adults, any predilection for severe reactions in the elderly population (observed in the United States) would not be apparent in Brazil, because older persons have been vaccinated in the past. In summary, no clearly identifiable risk factors related to age and immunological competence can be formulated at the present time.
Although there are no definitive data, it is likely that the vaccine may induce a milder form of hepatic injury without overt clinical signs. In a recent Phase III trial of 2 YF 17D vaccines manufactured in the United Kingdom and the United States (Arilvax [Evans Vaccines] and YF-Vax [Aventis-Pasteur], respectively), elevations in alanine and aspartate aminotransferase levels were noted in 3.5% of the subjects in both treatment groups 10 days after vaccination, with resolution thereafter [16]. Without a placebo group, it is uncertain whether the chemical hepatic dysfunction was caused by vaccine. If so, subclinical hepatic dysfunction is probably inconsequential, because persons who survive severe hepatitis due to wild-type YF have complete healing of the liver without postnecrotic cirrhosis.
Patients with an undiagnosed febrile illness that occurs within 10 days after vaccination should be investigated, and those with elevated liver enzyme levels should be hospitalized for observation. The examination should include collection of serial samples for quantitative viremia and antibody studies, preservation of frozen buffy coat cells for future genetic studies, reporting of the event to the VAERS (toll-free number, 1-800-822-7967), and consultation with the CDC (Division of Vector-Borne Infectious Diseases in Fort Collins, Colorado, 303-221-6400; CDC Division of Quarantine in Atlanta, 404-417-8000) [39].
Precautions for the Use of Yf 17D VaccinePhysicians faced with questions about allergy, immunosuppression, or other contraindications to YF vaccination should carefully consider the true risk of exposure on the basis of the regions to be visited. Unvaccinated subjects should be advised not to travel to a region affected by a YF epidemic or to very high-risk areas, such as rural West Africa or the Amazon forest.
Young ag.. Because of the increased risk of postvaccinal encephalitis, YF vaccine is not recommended for infants aged <9 months (or <6 months during epidemics), and vaccination is absolutely contraindicated for infants aged ⩽4 months.
Egg intoleranc.. Travelers with a history of egg allergy should undergo skin testing, proceeding from a scratch test to intradermal inoculation with increasing concentrations of the vaccine, as described in the vaccine package insert (YF-Vax; Aventis Pasteur) [40]. For patients who have a positive test result, the full dose should not be administered and a neutralization test should be performed >14 days later to determine whether seroconversion caused by the skin-test dose occurred. (For antibody testing, contact the Director of Laboratories, State Health Department, who may refer the request to the CDC, Fort Collins, CO.) Determination of neutralizing antibodies is the only useful test for immunity, and other less specific, less sensitive, or nonbiological assays (e.g., ELISA, hemagglutination-inhibition, and immunofluorescence) should not be used [41]. If seroconversion does not occur, desensitization before vaccination may be considered (as described in the product label), or, alternatively, personal protection against mosquito bites or avoidance of travel may be recommended.
Immunosuppression and malignanc.. On theoretical grounds, persons with immunodeficiency due to malignancy, HIV/AIDS, or receipt of immunosuppressive therapies should not be vaccinated, because prolonged viremia may increase the risk of neuroinvasion and encephalitis, and unrestrained virus replication could enhance damage to the liver and other visceral organs. However, there are no reports of adverse events in immunosuppressed individuals. No adverse events occurred in a small study of HIV-infected children with low CD4+ cell counts; however, such patients may not have been immunized effectively [42]. Asymptomatic HIV-infected travelers with CD4+ cell counts of >200 cells/mm3 who require vaccination for travel should be immunized. If possible, tests should be performed to determine whether they have developed neutralizing antibodies. Similar considerations apply to persons taking high-dose corticosteroids or antineoplastic drugs. Recommendations of the Immunization Practices Advisory Committee (ACIP) [43] specify that intra-articular or bursal treatment with corticosteroids, short-term treatment (i.e., for <2 weeks), or systemic doses of ⩽10 mg of prednisone or the equivalent are not significantly immunosuppressive and do not constitute a contraindication to vaccination.
Recently we had the opportunity to assist in the treatment of a patient with chronic lymphatic leukemia for whom active vaccination was contraindicated. Commercial lots of intravenous immunoglobulin (IVIG) contain high titers of YF neutralizing antibody [44], because 5%–10% of adult male donors in the United States were vaccinated during military service. The protective level of YF neutralizing antibody is accepted as a log neutralization index of 0.7 [45]. The patient with chronic lymphatic leukemia was treated with IVIG that had an log neutralization index of 3.0 to achieve a high initial passive titer and a protective level of antibody throughout several weeks of travel (R. McMullen, T. P. Monath, R. Nichols; unpublished data).
Pregnanc.. The safety of YF vaccination during pregnancy has not been established, and the vaccine should be given only if travel to an area of endemicity is unavoidable and if there is a high risk of exposure. Congenital infection of the fetus with YF 17D appears to occur at a low rate (probably 1%–2%) and has not been clearly associated with fetal abnormalities [4]. In a case-control study of YF 17D vaccination of women in the early stages of pregnancy, the relative risk of spontaneous abortion was 2.3, but this study lacked statistical power [46].
Pregnant women who have received the vaccine should be reassured that there is no risk to themselves and very low risk to the fetus. These women should be observed until parturition, and if fetal abnormality is noted, a cord blood sample should be obtained for IgM testing to determine whether congenital infection had occurred. Of interest, the immune response to YF vaccination during pregnancy is impaired, and revaccination is indicated after parturition [47]. If vaccination during pregnancy is required because of a high risk of exposure during travel, it is advisable to measure neutralizing antibodies >14 days after inoculation. If the patient is seronegative, revaccination should be considered.
Risks and BenefitsUntil the reports of multiple–organ system failure in 1996, YF 17D was widely accepted as an innocuous vaccine, with very rare complications that occur principally in persons with identifiable risk factors [2, 6]. The new serious adverse events that have occurred in persons without risk factors (except possibly advanced age) mandate closer attention to the risk-benefit equation. Until the incidence of the syndrome is quantified, it will be difficult to make clear recommendations. The estimated incidence of 1 case per 400,000 persons vaccinated [33], if accurate, may be compared with the 1 case per 750,000 risk of vaccine-associated paralytic poliomyelitis in primary vaccine recipients. Serious adverse event rates of this order of magnitude are high enough to restrict vaccination to persons who are truly at risk of exposure. As described in the section Risk of Acquiring YF during Travel, our conclusion is that the risk of wild-type YF exceeds the risk of vaccination for persons traveling to rural areas in the zone of endemicity, to inland towns and cities, or to urban areas sustaining YF outbreaks. The low incidence of recognized YF cases in travelers (table 1), despite a low vaccination coverage (discussed in the section Vaccine Coverage, below) suggests, however, that the overall risk of YF exposure may be overestimated. If there are 3 million unvaccinated travelers to regions of endemicity (as suggested in the section Vaccine Coverage, below), and the risk of death due to YF is 1 death per 10,000 infections, one would expect 300 deaths per year, whereas only 2 cases per year have been reported.
The problem is that there is no way to accurately assess the specific level of risk to the individual traveler, and the vagaries of YF virus activity in tropical jungles and forests defy prediction. The traveler and his or her physician will generally wish to accept a defined risk of adverse events due to vaccination rather than experience the fear and uncertainty associated with possible acquisition of a fatal illness during travel. However, unnecessary vaccination for travel to regions where YF is not endemic but that are within the zone of endemicity, such as coastal South America, should clearly now be avoided.
Means of Preventing Yf Other Than VaccineTravelers who must enter areas of possible YF activity without the benefit of vaccination should take precautions against exposure to vector mosquitoes. These vectors are principally daytime biters. The use of protective clothing and repellents applied to exposed skin and to thin clothing that is penetrable by mosquito mouthparts can reduce the risk of exposure. In rural wooded areas and in moist savanna regions of Africa, use of these measures should be a continuous ritual. Indoor living spaces should be sprayed with pyrethrin insecticides, and care should be taken to treat secluded spaces, such as closets.
Location of Vaccination Centers in the United StatesYF vaccine is available only at certified vaccination centers. The certification of YF vaccination centers is a responsibility that has been delegated to state health departments by CDC since 1977. In the United States, 3110 centers were available to the general public as of June 2001 (figure 2). These centers are concentrated in large metropolitan service areas. On a state-by-state basis, there is little variation in the density of centers. On average, each state has 1 certified center per 100,000 population, with a range of 1 center per 500,000 population in Tennessee to 1 center per 20,000 population in Alaska. Elsewhere, we have expressed concern that the urban distribution of centers represents an possible barrier to immunization in rural areas where driving distances to centers are long [48].
Figure 2Location of 3110 certified yellow fever vaccination centers and density by state per 100,000 population, as of June 2001. Light blue, 0.1–0.4 centers per 100,000 population (e.g., Nevada); medium blue, 0.5–0.9 centers per 100,000 population (e.g., California); dark blue, 1.0–2.4 centers per 100,000 population (e.g., Oregon); deep blue, 2.5–4.9 centers per 100,000 population (e.g., Wyoming). The map does not include centers operated by private industry or by the US Department of Defense.Open in new tabDownload slideLocation of 3110 certified yellow fever vaccination centers and density by state per 100,000 population, as of June 2001. Light blue, 0.1–0.4 centers per 100,000 population (e.g., Nevada); medium blue, 0.5–0.9 centers per 100,000 population (e.g., California); dark blue, 1.0–2.4 centers per 100,000 population (e.g., Oregon); deep blue, 2.5–4.9 centers per 100,000 population (e.g., Wyoming). The map does not include centers operated by private industry or by the US Department of Defense.
Vaccine CoverageAlthough the number of persons traveling from the United States to areas where YF is endemic may be as high as 3 million, only 150,000–300,000 civilian travelers are vaccinated annually. A recent attempt to estimate vaccination coverage used a mathematical model based on the number of annual US arrivals to countries where YF is endemic (published by the World Tourism Organization) and on the number of doses of YF vaccine doses sold to civilians in 1992–1998. Several assumptions were made in developing the model that limit the conclusions until they can be independently verified. We assumed, in each year, that a constant 99% of vaccine sold was administered to individuals traveling to a country in tropical South America or Africa where YF is endemic (we assumed 1% waste, either caused by the clinic refrigerator or because of administration of vaccine to persons traveling outside the countries where YF is endemic), and that 5% of the persons traveling to countries where YF is endemic had been immunized within the past 10 years. We calculated the size of the at-risk target population as follows: (1) with 33% risk, assuming that only 1 of every 3 travelers to countries of endemicity would go to a rural area of the country, and (2) with 100% risk, assuming all travelers to countries where YF is endemic are potentially at risk. Vaccination coverage for the 2 models is shown in figure 3. If only 1 in 3 travelers to countries where YF is endemic are considered, the coverage rate decreased steadily, from 64% in 1992 to 31% in 1998. If all travelers to countries where YF is endemic are considered, coverage decreased from 21% in 1992 to 10% in 1998. In both scenarios, the coverage decreases by >50% during the 7 years, largely because the rate of increase in travel to countries where YF is endemic vastly outstrips the amount of vaccine being given. The 2 recently imported cases of YF into the United States in 1996 and 1999 highlight the underuse of YF vaccine.
Figure 3Comparison of models for yellow fever (YF) vaccine coverage of persons traveling to countries where YF is endemic. Variables in the model are shown in the inset key. Five parameters were varied in the model. These variables, in left to right order in the inset, were vaccine waste (0% or 1%), the proportion of travelers who were revaccinated at the recommended 10-year interval (0% or 5%), the proportion of travelers who had already been vaccinated (0%, 5%, or 10%), and the proportion of travelers at risk of acquiring YF by virtue of travel to regions where YF is endemic in countries that have zones both inside and outside the region of endemicity (33% or 100%).Open in new tabDownload slideComparison of models for yellow fever (YF) vaccine coverage of persons traveling to countries where YF is endemic. Variables in the model are shown in the inset key. Five parameters were varied in the model. These variables, in left to right order in the inset, were vaccine waste (0% or 1%), the proportion of travelers who were revaccinated at the recommended 10-year interval (0% or 5%), the proportion of travelers who had already been vaccinated (0%, 5%, or 10%), and the proportion of travelers at risk of acquiring YF by virtue of travel to regions where YF is endemic in countries that have zones both inside and outside the region of endemicity (33% or 100%).
Barriers to Vaccination of TravelersTraditional barriers to vaccination, such as cost and access, are unlikely to explain the suspected underuse of YF vaccine among travelers. The cost of the vaccine (approximately $50 for a single-dose vial in the United States) is modest compared with the other costs associated with travel. Lack of awareness about YF among providers and travelers is common, especially during periods of epidemiologic silence, and it is probably the most important factor. Providers are often confused by the difference between a “recommendation” for vaccination, which is designed to protect the individual traveler, and the political “entry requirements” for proof of YF vaccination, which are designed to protect a host country from importation of the virus. This confusion results in both overvaccination and undervaccination. Disease risks associated with travel are not advertised by countries wishing to attract tourists, and travel agents are not motivated to disseminate information regarding health risk. Finally, periodic fluctuations in vaccine supply and distribution may contribute to undervaccination.
Risk of UrbanizationUnimmunized travelers represent the means by which YF may be introduced to receptive regions of the world. YF is currently not present in the United States, Central America (west of the Panama Canal), Mexico, the Caribbean, Australia, the Middle East, southern and northern Africa, or Asia. Countries in these regions are infested with A. aegypti and are susceptible to the introduction and spread of YF.
Virus is present in the blood during the incubation period and early stage of illness at levels capable of infecting blood-feeding A. aegypti. The recent appearance of West Nile virus in North America, which was possibly introduced by a viremic human, and of dengue in Hawaii illustrate the potential for the reemergence of urban YF, and the movement of YF-infected travelers is documented by recent imported cases (table 1). It is likely that secondary spread of YF virus in the United States would be identified rapidly, because of the dramatic clinical presentation of typical cases, and that it would be contained by vaccination and vector control. However, because full-blown cases of YF occur in only ∼1 of 7 persons infected with the virus [9], virus amplification would occur before detection.
Introduction and spread of YF in other areas of the world (India and Asia, in particular) has long been considered a significant threat. Logistical barriers are breaking down as air travel increases and areas of Africa and South America where YF is endemic become less remote. Cross-protective immunity to dengue appears to be a barrier to YF in these regions [6, 49]. Time will tell whether YF will recur outside of its present boundaries, but steps to mitigate this risk should be a goal of public health programs. One specific area of concern is the worldwide shortage of YF vaccine and barriers to use of vaccine that is manufactured elsewhere and not regulated by national health control authorities. In the event of an epidemic, the amount of vaccine required might exceed the national supply. Importation of vaccine from other manufacturers might be delayed, and such vaccine would be considered an investigational product, requiring delivery under a clinical protocol requiring informed consent. On a worldwide basis, there is currently a shortage of YF vaccine, such that regional needs are not being met.
acknowledgmentsWe wish to thank Leisa Weld, for her efforts with the mathematical modeling of vaccine coverage, and Julie Bettinger, for her efforts with the mapping and density distribution of YF vaccination centers in the United States. In addition, we thank Leisa, Julie, and Phyllis Kozarsky for their thoughtful comments in reviewing the manuscript. Russell McMullen kindly permitted mention of a patient of his who was treated by passive immunization.
Topic: africaculicidaeimmunizationsouth americatravelvaccinationvaccinesyellow feverinfectionstravelerepidemicssurveillance, medicaladverse eventpreventionIssue Section: Invited ArticleYellow fever (YF), a mosquito-borne viral hemorrhagic fever, is one of the most lethal viral diseases. It is characterized by a rapid evolution and hepatitis, renal failure, hemorrhage, shock, and death; the mortality rate is 20%–50%. Because YF is maintained in nature by transmission between wild monkeys and mosquitoes, and because it cannot be eradicated, prevention and control of the disease requires continuous immunization of human populations at risk. In 1936, workers at the Rockefeller Foundation developed the 17D live attenuated vaccine by prolonged serial passage of wild-type YF virus in chicken embryo tissue [1]. This highly effective vaccine has been in routine use for 65 years, and, wherever high vaccine coverage rates have been achieved, there has been a dramatic decrease in the prevalence of disease in travelers and residents of countries where YF is endemic. Where the vaccine is underused, YF remains a public health problem of varying magnitude. In recent years, there has been an upsurge in the incidence of YF [2]; 13,236 cases and 3589 deaths have been officially reported to the World Health Organization (WHO) from 1990 through 1999. The true incidence, estimated to be ∼200,000 cases per year, far exceeds the reported incidence [2].
This review focuses on the threat of YF to travelers, on the proper use of YF 17D vaccine to prevent infection in travelers, and on new data pertaining to vaccine safety, tolerability, and efficacy. The prediction and control of epidemics, the clinical presentation and management of cases, and the transmission cycle are reviewed elsewhere [3, 4]. Further information about YF vaccine requirements for travel may be found on the Centers for Disease Control and Prevention (CDC) Web site (http://www.cdc.gov/travel).
Expansion of Travel to Areas Where Yf is EndemicIncreasing travel to the tropics, and adventure travel to remote areas in particular, has amplified exposure to YF. Each year, 9 million tourists from North America, Europe, and Asia travel to countries where YF is endemic [5]; the number of tourists who actually visit regions within these countries in which YF transmission occurs may exceed 3 million.
Risk of Acquiring Yf During TravelSince the advent of YF 17D vaccine, the disease has been uncommon in travelers and expatriates from developed nations, with only 11 reported cases since 1950 [6, 7]. YF is a zoonosis; it is transmitted from monkeys to humans by the agency of vector mosquitoes. The risk of a traveler acquiring YF is determined by immunization status, geographic location, season of travel, length of exposure, occupational and recreational activities partaken of while traveling, and the rate of YF virus transmission at the time. Although reported cases of human disease are the principal guide to the level of YF transmission, they may be absent (because of a high level of immunity in the population) or not detected (because of poor surveillance). Few YF cases are officially reported, because the disease occurs in remote areas that lack specific diagnostic facilities. For example, in an outbreak in The Gambia that spanned ∼6 months (1978–1979), the incidence of YF virus infection was 33% and the incidence of severe disease with jaundice was 4.4%, with a case-fatality rate of 19.4%. Only 30 cases were officially reported out of a probable 8400 cases and 1600 deaths [8]. Remarkably similar incidences of infection and disease have been recorded in many other YF outbreaks in Africa [6]. Presently, epidemic activity is ongoing in the Ivory Coast, Guinea, and Liberia. One may estimate that an unimmunized person entering an area of epidemic activity would have risks of YF illness and death of 1 : 267 and 1 : 1333, respectively, for a 2-week trip.
During interepidemic periods in Africa, the incidence of overt disease is less than the threshold of detection of existing means of surveillance. Interepidemic conditions may last years or even decades in specific countries or regions. “Epidemiological silence” may provide a sense of false security and lead to travel without the benefit of vaccination. Surveys in rural West Africa during “silent” periods indicate that the incidence of YF illness is 1.1–2.4 cases per 1000 persons and the incidence of death due to YF is 0.2–0.5 deaths per 1000 persons, which are less than the threshold of detection of the existing means of surveillance [9]. The risks of illness and of death due to YF in an unvaccinated traveler are estimated to be 1 : 1000 per month and 1 : 5000 per month, respectively (for a 2-week journey, the risks of illness and death are 1 : 2000 and 1 : 10,000, respectively), although the risks vary considerably according to season. In West Africa, the most dangerous time of the year is during the late rainy and early dry seasons (July–October). These estimates, which are based on risk to indigenous populations, may overestimate the risk to travelers who take precautions against getting bitten by mosquitoes and who have less outdoor exposure than do indigenous residents.
The incidence of YF in South America is lower than that in Africa, because virus transmission between monkeys and mosquitoes occurs in the canopy of the forest, isolated from human contact, and because vaccine coverage is high. The risks of illness and death are probably 10 times lower in South America (i.e., 1 : 20,000 for illness and 1 : 100,000 for death for a 2-week journey) than they are in rural West Africa, but the risks vary greatly according to specific location and season. As in Africa, virus transmission between mosquitoes and monkeys may be epidemiologically silent, although some monkey species succumb to infection. Virus transmission is highest during the rainy season (January–March) in Brazil. The low reported incidence of YF (generally a few hundred cases per year) has resulted in lulled concern among travelers. In Brazil, for example, where the majority of the population lives in coastal regions outside of the zone of endemicity, unimmunized recreational or vocational travelers to the interior of the country are the usual persons to be affected by YF. Three of the 4 patients from the United States and Europe who acquired YF in 1996–1999 were exposed in South America [7, 10, 11]. Although it is not as dramatic as the situation in Africa, the 1990s represented a period of increased enzootic and epizootic YF transmission in South America. Brazil and Peru are currently experiencing an expansion of YF virus activity, and the risk to travelers is higher than usual.
Geographic Characteristics of Yf and Comments on the International Health RegulationsBecause it is not possible to define the risk of exposure to YF on the basis of surveillance data, all persons traveling outside urban areas of countries where YF is endemic should be vaccinated. The zone of endemicity and areas that have sustained recent epidemics are shown in figure 1. Urban outbreaks have been reported from the Ivory Coast and Nigeria recently, and recommendations regarding rural versus urban travel need to be continuously reconsidered (as discussed in the next paragraph). Autochthonous cases of YF have also been reported in selected cities and periurban areas in Bolivia and Brazil. The threat of more-widespread urban YF in the Americas is a serious concern, which may change vaccination recommendations in the future.
Figure 1Regions of tropical South America and Africa where yellow fever (YF) is endemic (shaded). Areas shown in black represent intensified YF virus activity or epidemics that occurred during 1999–2001. Numbers denote officially notified cases reported during the period of 1990–1999.Open in new tabDownload slideRegions of tropical South America and Africa where yellow fever (YF) is endemic (shaded). Areas shown in black represent intensified YF virus activity or epidemics that occurred during 1999–2001. Numbers denote officially notified cases reported during the period of 1990–1999.
It is difficult to obtain specific information about the geographic characteristics of YF even from health professionals in their indigenous geographic areas. Moreover, the epidemiological status of YF is never static, and what is true one year may not be the next. For example, Iguazú Falls, a favorite tourist destination on the Brazil-Argentina border, is usually not a high-risk area, but it may be so during exceptional periods of epizootic expansions, such as those that occurred in 1966 and 2001. Travel to urban areas within the zone of endemicity, such as Iquitos (Peru), Manaus or Brasilia (Brazil), or Enugu (Nigeria), generally present a low risk, which, however, cannot be taken as zero risk. Because urban (Aedes aegypti–borne) YF occurs regularly in West Africa, vaccination is recommended for persons traveling to towns and inland cities within the zone of endemicity. Cases of YF are currently being reported within the city of Abidjan (Ivory Coast). Clearly, visitors to this urban region require vaccination.
Cases of Yf in Travelers and Expatriates Residing in Countries Where Yf is EndemicCases reported since 1970 are listed in table 1. These cases illustrate a number of points: (1) all patients traveled to remote, rural areas; (2) the duration of exposure was relatively brief in some cases; (3) there was no evidence of an ongoing epidemic in the location of exposure, although YF activity may have occurred in the recent past or in surrounding areas; (4) the disease was fatal in most cases, suggesting that there may have been other cases with mild or abortive infection that were missed; (5) there was a potential for introduction of YF to receptive areas and secondary spread by the urban vector, A. aegypti; and (6) most patients had not been vaccinated. It is possible that the cases that occurred among vaccinated travelers resulted from the use of vaccine that had deteriorated during storage. However, in various clinical trials of YF vaccines, 1%–5% of vaccine recipients have not responded to vaccine, as determined by a neutralization test; this suggests that primary vaccine failure may occur at a low incidence [6, 16].
Table 1Reported cases of yellow fever in travelers, 1970–2000.Open in new tabDownload slideReported cases of yellow fever in travelers, 1970–2000.
Yf VaccineThe live, attenuated YF 17D vaccine is delivered as a single subcutaneous inoculation of 0.5 mL. The vaccine induces neutralizing antibodies (the mediator of protection) in 90% of vaccine recipients within 10 days after inoculation and in 99% within 30 days after inoculation. Immunity is very durable and probably lifelong [17], although revaccination is recommended at 10-year intervals. No cases of secondary vaccine failure (i.e., YF occurring in an individual who had been shown to respond to the vaccine but who lost protective immunity over time) have been identified. The vaccine may be simultaneously administered with most other vaccines, including measles, BCG, inactivated and oral polio, diphtheria-pertussis-tetanus, meningococcus, hepatitis B, hepatitis A, oral cholera, oral typhoid, and parenteral typhoid vaccines [18–23]. If other live viral vaccines, such as the measles and the measles-mumps-rubella vaccines, are not administered simultaneously, administration should be separated by 1 month. There are no data on coadministration with Japanese encephalitis (JE) vaccine (another flavivirus), although interference is unlikely. Prior infection or immunization with JE does not interfere with YF vaccination [24, 25], but cross-protection due to prior dengue infection probably reduces the response to YF vaccine [26]. As new live, attenuated JE and dengue vaccines come into use, research will be needed on interactions between those vaccines and YF 17D.
YF 17D vaccine is well tolerated. In practice, a small proportion of subjects complain of injection site pain, inflammation, fever, mild headache, myalgia, and malaise. In clinical trials in which the subjects were directly questioned, local and systemic adverse events have been reported by ∼25% of vaccine recipients during the first 3–7 days after inoculation [3, 16, 19, but these events are mild and do not interfere with normal activities. Mild systemic reactions are probably mediated by cytokines. In persons who are vaccinated for the first time, mild viremia, not exceeding 102 pfu/mL, occurs for ⩾1 days between the third and seventh day after vaccination and is associated with elevations of IFN-α, TNF-α, and markers of T cell activation (i.e., neopterin and β2 microglobulin) [27–30]. Revaccination results in no viremia and a lower incidence of adverse reactions [16, 28, 30], because the vaccine inoculum is neutralized by preformed antibody.
Serious and severe adverse reactions are extremely rare. These fall into 3 major categories: (1) hypersensitivity reactions, (2) encephalitis caused by neuroinvasion of the 17D virus, and (3) pansystemic infection, including hepatitis, which is similar to wild-type YF.
Hypersensitivity reaction.. YF 17D vaccine is an extract of embryonated chicken eggs, and it is contraindicated for persons with a clear history of egg allergy (i.e., oral intolerance). In persons without egg allergy, systemic allergic reactions (e.g., anaphylaxis and urticaria) occur at an incidence of 1 case per 58,000–131,000 persons vaccinated [31], and the reactions may be caused by sensitivity to the hydrolyzed porcine gelatin used to stabilize the vaccine.
Postvaccinal encephaliti.. Although up to 400 million persons have received YF 17D vaccine, there have been only 21 patients with postvaccinal encephalitis described in the literature, of whom 20 recovered without sequelae and 1 died [6]. Unpublished postmarketing surveillance of adverse events confirms that encephalitis is very rare, occurring at a rate of <1 case per million doses. Because postmarketing surveillance is passive, the true incidence may be higher. Postvaccinal encephalitis occurs principally in very young infants. Eighteen of the 21 published cases of postvaccinal encephalitis occurred in children, of whom 16 were infants of ⩽7 months of age. Virus recovered from the brain of the single patient to have died contained 2 amino acid changes in the envelope glycoprotein gene and had increased neurovirulence in animals [32], which suggests that mutation of the vaccine virus during replication in the patient was responsible for the event.
Fever, jaundice, and multiple-organ failure associated with YF vaccinatio.. Ten cases (8 of which were fatal) of a syndrome resembling wild-type YF associated with YF 17D vaccination have recently been described. Of the 10 cases, 7 have been reported in the literature [33–35], 6 occurred in persons immunized for travel, and 4 occurred in persons living in a region of endemicity. Four cases in the United States occurred in elderly patients, had a diversified and complex clinical presentation, and were labeled “multi-organ failure,” which reflects the uncertainty regarding the role of YF17D in direct viral injury. In contrast, extensive virological evidence in the cases that occurred in Brazil and Australia support the conclusion that an overwhelming infection with 17D virus was responsible.
These adverse events were characterized by rapid onset of fever and malaise within 3–5 days after vaccination; jaundice, oliguria, cardiovascular instability, and hemorrhage; and midzonal necrosis of the liver noted at autopsy [34, 35]. Large amounts of YF viral antigen were found in the liver and in other affected organs. Similar cases have undoubtedly occurred throughout the history of use of YF 17D vaccines, but they were missed or misdiagnosed.
The actual incidence of the syndrome is unknown. Estimates from a retrospective review of events passively reported to the Vaccine Adverse Events Reporting System (VAERS) in the United States during 1990–1998 suggest a reported rate of 1 case per 400,000 persons [33], but the true incidence will remain uncertain until prospective surveillance is applied to large populations undergoing primary vaccination. Since the syndrome was first described in 1996, ∼190 million doses of YF vaccine have been distributed, and there have been 10 reported cases of this syndrome. The syndrome can probably occur only in patients who have undergone primary vaccination. Some of the patients from the United States developed very high titers of YF antibody, suggesting either prior exposure to a heterologous flavivirus or a response to abnormally high levels of YF 17D replication and antigen expression.
The syndrome is apparently not caused by mutations in the virus, but rather by the unusual susceptibility of the individual host. The virus strains recovered from patients with fatal cases failed to show mutations that could explain the unusual clinical presentation [35, 36]. The host factors for increased susceptibility are not yet identifiable. A genetic basis is likely, on the basis of observations of mice showing genetic control of susceptibility to flaviviruses [37].
Retrospective analysis of VAERS data in the United States revealed a higher incidence of severe adverse reactions in elderly persons: persons aged >75 years had a risk 12 times higher than that for young adults, which suggests that waning immunity with age may play a role [38]. However, elderly subjects who developed multiple–organ system failure in the study had robust immune responses to YF17D virus [35]. Although the 4 deaths in Brazil that occurred during 1999–2001 were in children and young adults, any predilection for severe reactions in the elderly population (observed in the United States) would not be apparent in Brazil, because older persons have been vaccinated in the past. In summary, no clearly identifiable risk factors related to age and immunological competence can be formulated at the present time.
Although there are no definitive data, it is likely that the vaccine may induce a milder form of hepatic injury without overt clinical signs. In a recent Phase III trial of 2 YF 17D vaccines manufactured in the United Kingdom and the United States (Arilvax [Evans Vaccines] and YF-Vax [Aventis-Pasteur], respectively), elevations in alanine and aspartate aminotransferase levels were noted in 3.5% of the subjects in both treatment groups 10 days after vaccination, with resolution thereafter [16]. Without a placebo group, it is uncertain whether the chemical hepatic dysfunction was caused by vaccine. If so, subclinical hepatic dysfunction is probably inconsequential, because persons who survive severe hepatitis due to wild-type YF have complete healing of the liver without postnecrotic cirrhosis.
Patients with an undiagnosed febrile illness that occurs within 10 days after vaccination should be investigated, and those with elevated liver enzyme levels should be hospitalized for observation. The examination should include collection of serial samples for quantitative viremia and antibody studies, preservation of frozen buffy coat cells for future genetic studies, reporting of the event to the VAERS (toll-free number, 1-800-822-7967), and consultation with the CDC (Division of Vector-Borne Infectious Diseases in Fort Collins, Colorado, 303-221-6400; CDC Division of Quarantine in Atlanta, 404-417-8000) [39].
Precautions for the Use of Yf 17D VaccinePhysicians faced with questions about allergy, immunosuppression, or other contraindications to YF vaccination should carefully consider the true risk of exposure on the basis of the regions to be visited. Unvaccinated subjects should be advised not to travel to a region affected by a YF epidemic or to very high-risk areas, such as rural West Africa or the Amazon forest.
Young ag.. Because of the increased risk of postvaccinal encephalitis, YF vaccine is not recommended for infants aged <9 months (or <6 months during epidemics), and vaccination is absolutely contraindicated for infants aged ⩽4 months.
Egg intoleranc.. Travelers with a history of egg allergy should undergo skin testing, proceeding from a scratch test to intradermal inoculation with increasing concentrations of the vaccine, as described in the vaccine package insert (YF-Vax; Aventis Pasteur) [40]. For patients who have a positive test result, the full dose should not be administered and a neutralization test should be performed >14 days later to determine whether seroconversion caused by the skin-test dose occurred. (For antibody testing, contact the Director of Laboratories, State Health Department, who may refer the request to the CDC, Fort Collins, CO.) Determination of neutralizing antibodies is the only useful test for immunity, and other less specific, less sensitive, or nonbiological assays (e.g., ELISA, hemagglutination-inhibition, and immunofluorescence) should not be used [41]. If seroconversion does not occur, desensitization before vaccination may be considered (as described in the product label), or, alternatively, personal protection against mosquito bites or avoidance of travel may be recommended.
Immunosuppression and malignanc.. On theoretical grounds, persons with immunodeficiency due to malignancy, HIV/AIDS, or receipt of immunosuppressive therapies should not be vaccinated, because prolonged viremia may increase the risk of neuroinvasion and encephalitis, and unrestrained virus replication could enhance damage to the liver and other visceral organs. However, there are no reports of adverse events in immunosuppressed individuals. No adverse events occurred in a small study of HIV-infected children with low CD4+ cell counts; however, such patients may not have been immunized effectively [42]. Asymptomatic HIV-infected travelers with CD4+ cell counts of >200 cells/mm3 who require vaccination for travel should be immunized. If possible, tests should be performed to determine whether they have developed neutralizing antibodies. Similar considerations apply to persons taking high-dose corticosteroids or antineoplastic drugs. Recommendations of the Immunization Practices Advisory Committee (ACIP) [43] specify that intra-articular or bursal treatment with corticosteroids, short-term treatment (i.e., for <2 weeks), or systemic doses of ⩽10 mg of prednisone or the equivalent are not significantly immunosuppressive and do not constitute a contraindication to vaccination.
Recently we had the opportunity to assist in the treatment of a patient with chronic lymphatic leukemia for whom active vaccination was contraindicated. Commercial lots of intravenous immunoglobulin (IVIG) contain high titers of YF neutralizing antibody [44], because 5%–10% of adult male donors in the United States were vaccinated during military service. The protective level of YF neutralizing antibody is accepted as a log neutralization index of 0.7 [45]. The patient with chronic lymphatic leukemia was treated with IVIG that had an log neutralization index of 3.0 to achieve a high initial passive titer and a protective level of antibody throughout several weeks of travel (R. McMullen, T. P. Monath, R. Nichols; unpublished data).
Pregnanc.. The safety of YF vaccination during pregnancy has not been established, and the vaccine should be given only if travel to an area of endemicity is unavoidable and if there is a high risk of exposure. Congenital infection of the fetus with YF 17D appears to occur at a low rate (probably 1%–2%) and has not been clearly associated with fetal abnormalities [4]. In a case-control study of YF 17D vaccination of women in the early stages of pregnancy, the relative risk of spontaneous abortion was 2.3, but this study lacked statistical power [46].
Pregnant women who have received the vaccine should be reassured that there is no risk to themselves and very low risk to the fetus. These women should be observed until parturition, and if fetal abnormality is noted, a cord blood sample should be obtained for IgM testing to determine whether congenital infection had occurred. Of interest, the immune response to YF vaccination during pregnancy is impaired, and revaccination is indicated after parturition [47]. If vaccination during pregnancy is required because of a high risk of exposure during travel, it is advisable to measure neutralizing antibodies >14 days after inoculation. If the patient is seronegative, revaccination should be considered.
Risks and BenefitsUntil the reports of multiple–organ system failure in 1996, YF 17D was widely accepted as an innocuous vaccine, with very rare complications that occur principally in persons with identifiable risk factors [2, 6]. The new serious adverse events that have occurred in persons without risk factors (except possibly advanced age) mandate closer attention to the risk-benefit equation. Until the incidence of the syndrome is quantified, it will be difficult to make clear recommendations. The estimated incidence of 1 case per 400,000 persons vaccinated [33], if accurate, may be compared with the 1 case per 750,000 risk of vaccine-associated paralytic poliomyelitis in primary vaccine recipients. Serious adverse event rates of this order of magnitude are high enough to restrict vaccination to persons who are truly at risk of exposure. As described in the section Risk of Acquiring YF during Travel, our conclusion is that the risk of wild-type YF exceeds the risk of vaccination for persons traveling to rural areas in the zone of endemicity, to inland towns and cities, or to urban areas sustaining YF outbreaks. The low incidence of recognized YF cases in travelers (table 1), despite a low vaccination coverage (discussed in the section Vaccine Coverage, below) suggests, however, that the overall risk of YF exposure may be overestimated. If there are 3 million unvaccinated travelers to regions of endemicity (as suggested in the section Vaccine Coverage, below), and the risk of death due to YF is 1 death per 10,000 infections, one would expect 300 deaths per year, whereas only 2 cases per year have been reported.
The problem is that there is no way to accurately assess the specific level of risk to the individual traveler, and the vagaries of YF virus activity in tropical jungles and forests defy prediction. The traveler and his or her physician will generally wish to accept a defined risk of adverse events due to vaccination rather than experience the fear and uncertainty associated with possible acquisition of a fatal illness during travel. However, unnecessary vaccination for travel to regions where YF is not endemic but that are within the zone of endemicity, such as coastal South America, should clearly now be avoided.
Means of Preventing Yf Other Than VaccineTravelers who must enter areas of possible YF activity without the benefit of vaccination should take precautions against exposure to vector mosquitoes. These vectors are principally daytime biters. The use of protective clothing and repellents applied to exposed skin and to thin clothing that is penetrable by mosquito mouthparts can reduce the risk of exposure. In rural wooded areas and in moist savanna regions of Africa, use of these measures should be a continuous ritual. Indoor living spaces should be sprayed with pyrethrin insecticides, and care should be taken to treat secluded spaces, such as closets.
Location of Vaccination Centers in the United StatesYF vaccine is available only at certified vaccination centers. The certification of YF vaccination centers is a responsibility that has been delegated to state health departments by CDC since 1977. In the United States, 3110 centers were available to the general public as of June 2001 (figure 2). These centers are concentrated in large metropolitan service areas. On a state-by-state basis, there is little variation in the density of centers. On average, each state has 1 certified center per 100,000 population, with a range of 1 center per 500,000 population in Tennessee to 1 center per 20,000 population in Alaska. Elsewhere, we have expressed concern that the urban distribution of centers represents an possible barrier to immunization in rural areas where driving distances to centers are long [48].
Figure 2Location of 3110 certified yellow fever vaccination centers and density by state per 100,000 population, as of June 2001. Light blue, 0.1–0.4 centers per 100,000 population (e.g., Nevada); medium blue, 0.5–0.9 centers per 100,000 population (e.g., California); dark blue, 1.0–2.4 centers per 100,000 population (e.g., Oregon); deep blue, 2.5–4.9 centers per 100,000 population (e.g., Wyoming). The map does not include centers operated by private industry or by the US Department of Defense.Open in new tabDownload slideLocation of 3110 certified yellow fever vaccination centers and density by state per 100,000 population, as of June 2001. Light blue, 0.1–0.4 centers per 100,000 population (e.g., Nevada); medium blue, 0.5–0.9 centers per 100,000 population (e.g., California); dark blue, 1.0–2.4 centers per 100,000 population (e.g., Oregon); deep blue, 2.5–4.9 centers per 100,000 population (e.g., Wyoming). The map does not include centers operated by private industry or by the US Department of Defense.
Vaccine CoverageAlthough the number of persons traveling from the United States to areas where YF is endemic may be as high as 3 million, only 150,000–300,000 civilian travelers are vaccinated annually. A recent attempt to estimate vaccination coverage used a mathematical model based on the number of annual US arrivals to countries where YF is endemic (published by the World Tourism Organization) and on the number of doses of YF vaccine doses sold to civilians in 1992–1998. Several assumptions were made in developing the model that limit the conclusions until they can be independently verified. We assumed, in each year, that a constant 99% of vaccine sold was administered to individuals traveling to a country in tropical South America or Africa where YF is endemic (we assumed 1% waste, either caused by the clinic refrigerator or because of administration of vaccine to persons traveling outside the countries where YF is endemic), and that 5% of the persons traveling to countries where YF is endemic had been immunized within the past 10 years. We calculated the size of the at-risk target population as follows: (1) with 33% risk, assuming that only 1 of every 3 travelers to countries of endemicity would go to a rural area of the country, and (2) with 100% risk, assuming all travelers to countries where YF is endemic are potentially at risk. Vaccination coverage for the 2 models is shown in figure 3. If only 1 in 3 travelers to countries where YF is endemic are considered, the coverage rate decreased steadily, from 64% in 1992 to 31% in 1998. If all travelers to countries where YF is endemic are considered, coverage decreased from 21% in 1992 to 10% in 1998. In both scenarios, the coverage decreases by >50% during the 7 years, largely because the rate of increase in travel to countries where YF is endemic vastly outstrips the amount of vaccine being given. The 2 recently imported cases of YF into the United States in 1996 and 1999 highlight the underuse of YF vaccine.
Figure 3Comparison of models for yellow fever (YF) vaccine coverage of persons traveling to countries where YF is endemic. Variables in the model are shown in the inset key. Five parameters were varied in the model. These variables, in left to right order in the inset, were vaccine waste (0% or 1%), the proportion of travelers who were revaccinated at the recommended 10-year interval (0% or 5%), the proportion of travelers who had already been vaccinated (0%, 5%, or 10%), and the proportion of travelers at risk of acquiring YF by virtue of travel to regions where YF is endemic in countries that have zones both inside and outside the region of endemicity (33% or 100%).Open in new tabDownload slideComparison of models for yellow fever (YF) vaccine coverage of persons traveling to countries where YF is endemic. Variables in the model are shown in the inset key. Five parameters were varied in the model. These variables, in left to right order in the inset, were vaccine waste (0% or 1%), the proportion of travelers who were revaccinated at the recommended 10-year interval (0% or 5%), the proportion of travelers who had already been vaccinated (0%, 5%, or 10%), and the proportion of travelers at risk of acquiring YF by virtue of travel to regions where YF is endemic in countries that have zones both inside and outside the region of endemicity (33% or 100%).
Barriers to Vaccination of TravelersTraditional barriers to vaccination, such as cost and access, are unlikely to explain the suspected underuse of YF vaccine among travelers. The cost of the vaccine (approximately $50 for a single-dose vial in the United States) is modest compared with the other costs associated with travel. Lack of awareness about YF among providers and travelers is common, especially during periods of epidemiologic silence, and it is probably the most important factor. Providers are often confused by the difference between a “recommendation” for vaccination, which is designed to protect the individual traveler, and the political “entry requirements” for proof of YF vaccination, which are designed to protect a host country from importation of the virus. This confusion results in both overvaccination and undervaccination. Disease risks associated with travel are not advertised by countries wishing to attract tourists, and travel agents are not motivated to disseminate information regarding health risk. Finally, periodic fluctuations in vaccine supply and distribution may contribute to undervaccination.
Risk of UrbanizationUnimmunized travelers represent the means by which YF may be introduced to receptive regions of the world. YF is currently not present in the United States, Central America (west of the Panama Canal), Mexico, the Caribbean, Australia, the Middle East, southern and northern Africa, or Asia. Countries in these regions are infested with A. aegypti and are susceptible to the introduction and spread of YF.
Virus is present in the blood during the incubation period and early stage of illness at levels capable of infecting blood-feeding A. aegypti. The recent appearance of West Nile virus in North America, which was possibly introduced by a viremic human, and of dengue in Hawaii illustrate the potential for the reemergence of urban YF, and the movement of YF-infected travelers is documented by recent imported cases (table 1). It is likely that secondary spread of YF virus in the United States would be identified rapidly, because of the dramatic clinical presentation of typical cases, and that it would be contained by vaccination and vector control. However, because full-blown cases of YF occur in only ∼1 of 7 persons infected with the virus [9], virus amplification would occur before detection.
Introduction and spread of YF in other areas of the world (India and Asia, in particular) has long been considered a significant threat. Logistical barriers are breaking down as air travel increases and areas of Africa and South America where YF is endemic become less remote. Cross-protective immunity to dengue appears to be a barrier to YF in these regions [6, 49]. Time will tell whether YF will recur outside of its present boundaries, but steps to mitigate this risk should be a goal of public health programs. One specific area of concern is the worldwide shortage of YF vaccine and barriers to use of vaccine that is manufactured elsewhere and not regulated by national health control authorities. In the event of an epidemic, the amount of vaccine required might exceed the national supply. Importation of vaccine from other manufacturers might be delayed, and such vaccine would be considered an investigational product, requiring delivery under a clinical protocol requiring informed consent. On a worldwide basis, there is currently a shortage of YF vaccine, such that regional needs are not being met.
acknowledgmentsWe wish to thank Leisa Weld, for her efforts with the mathematical modeling of vaccine coverage, and Julie Bettinger, for her efforts with the mapping and density distribution of YF vaccination centers in the United States. In addition, we thank Leisa, Julie, and Phyllis Kozarsky for their thoughtful comments in reviewing the manuscript. Russell McMullen kindly permitted mention of a patient of his who was treated by passive immunization.
JUNE 5, 2003
JUNE 5, 2003
Airline Cabin Air Quality
Airline Cabin Air Quality
Health and airline officials testified about aircraft cabin environments and air quality standards in commercial airlines. Among the topics they addressed were potential transmission of infectious diseases, occupational health concerns for airline crews, and the recent global outbreak of Severe Acute Respiratory Syndrome (SARS). close
https://www.c-span.org/video/?176910-1/airline-cabin-air-quality
Deputy Director
National Center of Infectious Diseases->Migration and Quarentine
2003 (Dec 09) - NYTimes : "If SARS Hits U.S., Quarantine Could Too"
2003 (Dec 09) - NYTimes : "If SARS Hits U.S., Quarantine Could Too"
By David Tuller / Dec. 9, 2003
2003-12-09-nytimes-if-sars-hits-us-quarantine-could-too.pdf
As the health officer of Alameda County, Dr. Anthony Iton is prepared to make tough choices if SARS re-emerges this winter or spring, as many infectious disease experts fear.
The county, just across the bay from here, has identified two large buildings where, if voluntary steps to quell an epidemic were to fail, the authorities could sequester not just people who were sick but also people who might have been exposed to the SARS virus, Dr. Iton said.
The buildings, he said, could house up to 100 people and could be guarded to keep anyone from leaving.
''It's a virtual certainty that sometime in the near future we will see a SARS-like event in the United States, a highly communicable infectious disease that will require mass quarantine or isolation,'' Dr. Iton said.
Since last spring's outbreak of SARS, or severe acute respiratory syndrome, public health officials across the country have been spending extraordinary amounts of time and energy preparing for the prospect that the disease -- or pandemic flu, smallpox or something as yet unknown -- could require them to order a quarantine, a once common public health measure virtually abandoned for most of the past century.
In a draft SARS preparedness plan released this fall, the Centers for Disease Control and Prevention advises states and communities to impose restrictions on people's movements based on the severity of an outbreak. In the event of a quarantine, the plan envisions extensive tracing of contacts of SARS patients, combined with a largely home-based, voluntary regime.
The plan, however, also calls for health authorities to cooperate closely with law enforcement, and to consider in extreme cases ''electronic forms of monitoring,'' ''detention facilities'' and the establishment of heavily guarded quarantine ''zones.'' It also calls for respecting civil liberties and keeping the public informed.
Patrick Libbey, executive director of the National Association of County and City Health Officials, said the health authorities in many jurisdictions had been identifying possible buildings and preparing for possible outbreaks.
''People are taking this question absolutely seriously,'' Mr. Libbey said. ''With the SARS outbreak, it really sharpened the focus on nuts-and-bolts planning.''
Some issues facing health officials, Mr. Libbey added, concern legal processes for imposing quarantines, ways to house people and manage their needs, and the financing of such undertakings.
In New York City, the authorities have revised the health code to make sure they can legally quarantine people not just for known diseases but for suddenly emerging ones that present a major health threat, said [Dr. Marcelle C. Layton (born 1958)], who is the city's assistant commissioner of communicable disease at the Department of Health and Mental Hygiene.
Dr. Layton and officials in other cities and states are discussing how they would provide food, medical care and psychological support to people placed under quarantine, whether at home or in a government-monitored building.
''Our preference would be for people to stay at home,'' Dr. Layton said, echoing Dr. Iton of Alameda. ''But we need alternatives in case people aren't compliant, and we've had teams identifying the kinds of facilities we might use.''
Until the advent of advances like antibiotics and routine vaccinations, quarantine was a widely used -- and sometimes abused -- method of controlling the spread of infectious diseases. While often effective, it was also applied disproportionately against immigrants, racial minorities and people in lower socioeconomic groups. And the word itself can still summon images of medieval plagues and of people abandoned to their fate on boats and islands and in fenced-off parts of a town.
Today's public health authorities remain intensely aware of the historical baggage. ''You've got to own up to all of the demons, the fears that have evolved from quarantine's misuse,'' said Dr. Martin Cetron, a quarantine specialist at the disease control agency. ''We're talking about a balance between a public health tool and a limitation on individual rights.
''The key is to get that balance as delicately aligned as possible, so that you have a minimum infringement on civil liberties but the maximum effect in quenching or preventing an epidemic.''
These days, public health officials clearly distinguish between what they call isolation, reserved for those already found to have the disease in question and who are under care, and quarantine, which involves restricting the movement of people who have been exposed to an infected individual and may -- or may not -- become sick themselves. The authorities say they will never lump together those who are ill and others only thought to be exposed, as happened frequently in past quarantines.
If those under quarantine were to remain free of symptoms until the end of the incubation period, they would be free to go. If they were to develop symptoms, they would be treated and isolated from those remaining in quarantine to minimize the possibility of infecting others.
Many health authorities credit the use of both isolation and quarantine -- mostly at home or at health care complexes -- with preventing an even worse epidemic of SARS this year in places like Singapore, Hong Kong, Taiwan and Canada.
In Toronto, the epicenter of the Canadian epidemic, thousands of asymptomatic people were asked to remain at home for about 10 days, the generally accepted incubation period for SARS. Almost all agreed, and health officials, who telephoned regularly to monitor their compliance and medical condition, were forced to issue formal quarantine orders in only a few cases.
Because SARS is considered transmissible only once someone has developed symptoms, the families of those quarantined at home were not considered to be at risk.
''The human cost of doing this was obviously large,'' said Dr. Paul Gully, a senior director general at Health Canada, the main agency overseeing health care. ''People basically couldn't go to work, they couldn't go to school, they couldn't socialize. It stopped their lives for 10 days. But people were very concerned about the spread of this disease, so they were willing to accept it.''
But in Singapore, with its more authoritarian traditions, the state installed video cameras in quarantined people's homes and threatened to clamp on electronic bracelets if they did not show their faces at regular intervals.
Some people express alarm at talk of government-imposed quarantines, especially given current political tensions over civil liberties. While critics say they generally trust public health officials, they fear that political leaders and law enforcement authorities may actually call the shots if a quarantine is imposed.
''The existence of emergency powers in the hands of the government just makes it more likely that the government is going to overreact,'' said Dr. George Annas, chairman of the health law department at Boston University.
Few dispute the state's authority to isolate people with an infectious disease like tuberculosis. In the United States, the small clusters of diagnosed and suspected cases of SARS were mostly kept isolated, sometimes against their will.
But the quarantine of suspected contacts, who may or may not become ill themselves, is much more contentious. Federal health officials say the largely voluntary compliance in Canada and other countries suggests that American will comply, but others are not so sure.
For one thing, critics say that an illness that is more virulent or has a longer incubation period than SARS will require a more severe form of quarantine.
''I think Americans will be more skeptical about quarantine proposals than Canadians are, and probably more anxious to exercise their legal rights,'' said Barry Steinhardt, director of the American Civil Liberties Union's Program on Technology and Liberty. ''I think they will by and large cooperate, but we're going to want some proof that there's a genuine threat.''
States and some cities have the authority to impose emergency public health measures like quarantine. The federal government retains the power to police the nation's borders against disease and to act to prevent transmission between states. In April, President Bush signed an order adding SARS to the list of ''quarantinable'' diseases.
With guidance from a model statute proposed by the disease-control centers two years ago, many states have revised antiquated public health laws. They have both clarified their authority to take emergency measures and improved provisions that allow people to protest quarantine orders.
Mr. Steinhardt and other civil libertarians say that these due process protections are far from ironclad. But the problem, public health authorities argue, is that a framework must be flexible enough to be deployed against a spectrum of known and unknown diseases, each with its own treatment regimen, incubation period, mode of transmission and degree of infectiousness.
''One of the challenging policy aspects is what steps do you take, particularly steps that infringe on a person's rights, with a syndrome that is totally new or not clearly defined,'' Mr. Libbey said. ''The earlier the intervention, the fewer the subsequent infections.
''But how much information is enough to act on, short of an absolute and complete causal connection, before you get to the point at which it may be too late to intervene effectively and stop transmission?''
2005 (Oct) - YALE JOURNAL OF BIOLOGY AND MEDICINE 78 (2005), pp.325-330. : "SYMPOSIUM: Public Health and Ethical Considerations in Planning for Quarantine"
2005 (Oct) - YALE JOURNAL OF BIOLOGY AND MEDICINE 78 (2005), pp.325-330. : "SYMPOSIUM: Public Health and Ethical Considerations in Planning for Quarantine"
PMCID: PMC2259156
Copyright © 2005. All rights reserved.
Martin Cetrona and Julius Landwirthb
Division of Global Migration and Quarantine, Centers for Disease Control, and Yale Interdisciplinary Center for Bioethics and Donaghue Initiative in Biomedical and Behavioral Research Ethics
Note the aexction on SOCIAL DISTANCING / SCHOOL CLOSURES .. Modeled in part on Larry Gostin's work ...
BULLET #5 - 5. Center for Law and the Public’s Health at Georgetown and Johns Hopkins Universities. The Model State Emergency Health Powers Act. Prepared by the Center for Law and the Public’s Health at Georgetown and Johns Hopkins Universities. Washington, DC; December 21, 2001. Available at http://www.publichealthlaw.net/MSEHPA/MSEHPA2.pdf
- Quarantine is one of the oldest, most effective, most feared, and most misunderstood methods of controlling communicable disease outbreaks. Its etymological roots are traceable to 14th century public health practices requiring ships arriving in Venice from plague-infected ports to sit at anchor for 40 days (hence, quar-antine) before disembarking their surviving passengers. While in recent times the use of quarantine has been more humane and scientifically based, the historical association with exile and death and the morally negative connotation of sacrifice of a few for the benefit of others remains as an undercurrent of public apprehension. Nevertheless, quarantine was recently implemented successfully in several countries as a socially acceptable measure during the SARS epidemic in 2003 [1]. It is an important component of the Department of Health and Human Services (HHS)† Pandemic Influenza Plan issued in November 2005 [2].‡
- The purpose of this article is to review the modern public health approach to quarantine, outline highlights of current plans for its implementation in the event of an avian influenza pandemic, and consider the ethical principles that should be considered.
DEFINITIONS
- Quarantine is the restriction of persons who are presumed to have been exposed to a contagious disease but are not ill. It may be applied at the individual, group, or community level and usually involves restriction to the home or designated facility. Quarantine may be voluntary or mandatory.
- Isolation is the separation of ill persons with contagious diseases. It may be applied at the individual, group, or community level.
- Quarantine of groups refers to quarantine of people who have been exposed to the same source of illness (e.g., at public gatherings, airline, school, workplace).
- Working quarantine refers to persons who are at occupational risk of influenza infection, such as health care workers, who may be restricted to their homes or designated facilities during offduty hours.
- Community-wide quarantine refers to closing of community borders or the erection of a real or virtual barrier around a geographic area (cordon sanitaire).
- Modern public health places quarantine within a broader spectrum of interventions generally referred to as “social distancing.”
- The effect of successful measures to increase social distance is to convert a dynamic of exponentiation in the spread of an infectious agent to one of suppression in which the number of secondary cases from exposed persons is reduced to a manageable level. Time is the key variable in the success or failure of social distancing strategies, including the duration of communicability, whether or not communicability occurs before onset of symptoms, the number of resulting contacts, and the efficiency of or delays in contact tracing.
- Globalization of travel and trade and decreased travel time between distant places have further complicated these relationships. There are several hundred international ports of entry airports in the United States. Fortunately, 25 of these airports account for approximately 85 percent of international arrivals. Detailed recommendations for travel-related containment measures can be found in the full HHS report and will not be further elaborated here.
PRINCIPLES OF MODERN QUARANTINE
- In the months before adequate supplies of vaccines and antiviral agents are expected to be available, quarantine and isolation are likely to be the mainstays of containment strategies.
- The HHS plan states that: The goal of quarantine is to protect the public by separating those exposed to dangerous communicable disease from the general population. It represents collective action for the common good that is predicated on aiding individuals who are already infected or exposed and protecting others from inadvertent exposure [3].
- Principles of modern quarantine and social distancing limit their use to situations involving highly dangerous and contagious diseases and when resources are reliably available to implement and maintain the measures. It encompasses a wide range of strategies to reduce transmission that may be implemented along a continuum based on phase and intensity of an outbreak.
- For example, at a stage when transmission of a novel influenza virus is still limited, either abroad or in the area, and local cases are either imported or have clear epidemiological links to other cases, individual quarantine of close contacts may be effective. At a more advanced phase of the pandemic, however, when virus transmission in the area is sustained and epidemiological links to other known cases is unclear, limiting quarantine to exposed individuals may be ineffective, and the strategy may need to expand to include community-based interventions that increase social distance. These include school closings, cancellation of public gatherings, encouraging non-essential workers to stay home, and reduced holiday transportation schedules. If these measures are believed to be ineffective, community-wide quarantine may need to be implemented.
- The HHS guidelines cite two important principles designed to help ensure that those in quarantine are not placed at increased risk. First, quarantined individuals will be closely monitored, with daily visits as needed, in order to detect earliest onset of symptoms and separation from those who are well. Second, persons in isolation will be among the first to receive any disease-prevention interventions. In addition, the HHS plan recommends that they should be provided with all needed support services, including psychological support, food and water, and household and medical supplies.
- Home quarantine is the preferred method of separation, whenever possible. Designated quarantine facilities may have to be identified for potentially affected persons who do not have access to an appropriate home environment, such as persons living in dormitories, travelers, the homeless, or if the configuration of the home is not suitable for the protection of the potentially infected person and other occupants.
- Voluntary quarantine is the preferred first option before resorting to mandatory orders or surveillance devices. In this connection, it is noteworthy that quarantine does not require 100 percent compliance to be effective. Toronto Public Health officials reported only 22 orders for mandatory detainment among the approximately 30,000 persons who were quarantined [4].
LEGAL AND ETHICAL CONSIDERATIONS
- Primary responsibility for public health matters within their borders rests with state and local governments. This includes isolation and quarantine. Applicable state laws, regulations and procedures vary widely. A recently developed Model State Emergency Health Powers Act attempts to promote greater inter-state consistency in response to emergency public health situations [5]. In the section on isolation and quarantine, the Model Act covers the principles and conditions governing implementation of quarantine; authorization of public health authorities to impose temporary quarantine by directive, with rights of appeal within 10 days; imposition of quarantine with notice following a public health authority court petition and hearing; and legal procedures for release from quarantine or relief from violations of conditions of quarantine. Although it has been criticized by some as being overly broad in its coercive powers [6, 7] the Model Act has been adopted in whole or part in a number of jurisdictions.
- The federal Public Health Service Act [8] gives the HHS secretary responsibility for preventing introduction, transmission, and spread of communicable diseases from foreign countries into the United States and within the United States and its territories/possessions. This authority is delegated to the Centers for Disease Control and Prevention (CDC), which are empowered to detain, medically examine, or conditionally release individuals reasonably believed to be carrying a communicable disease. The Public Health Service Act also provides that the list of diseases for which quarantine is authorized must first be specified in an executive order of the president, on recommendation of the HHS secretary. On April 5, 2005, influenza caused by a novel or reemergent strain that is causing or has the potential to cause a pandemic was added to that list [9].
- Although the discipline of public health has its origins several centuries ago, it is only relatively recently that ethical principles and codes to guide public health practice and policy have been formulated. The ethical principles at the heart of the more fully developed fields of medical and research ethics are grounded in the primacy of individual autonomy in clinical decision- making in the therapeutic setting and in consent for participation in the setting of human subjects research. They are guided by a fundamental moral axiom that individual persons are valued as ends in themselves and should never be used merely as means to another’s ends. Public health, on the other hand, emphasizes collective action for the good of the community.
- The Principles of the Ethical Practice of Public Health, issued by the Public Health Leadership Society in 2002 [10], states that community health should be achieved in a way that respects the rights of individuals and the community. Accompanying notes are instructive:
- This principle identifies the common need in public health to weigh the concerns of both the individual and the community. There is no ethical principle that can provide a solution to this perennial tension in public health. We can highlight, however, that the interest of the community is part of the equation, and for public health it is the starting place in the equation; it is the primary interest of public health. Still, there remains the need to pay attention to the rights of individuals when exercising the police powers of public health [10].
- To address this potential dichotomy, the principles require ensuring opportunity for informed community participation in the development of policies, programs, and priorities, accessibility to basic resources and conditions necessary for health, and protection of confidentiality.
- Principles of practice, law and ethics in the containment of outbreaks of infectious disease, especially use of quarantine, confront a common underlying concern, namely,
- The individual fear and community panic associated with infectious diseases often leads to rapid, emotionally driven decision making about public health policies needed to protect the community that may be in conflict with current bioethical principles regarding care of individual patients [11].
- In November 2005, the Council on Ethical and Judicial Affairs of the American Medical Association issued recommendations for the medical profession in the use of quarantine and isolation as public health interventions.Again, the tensions between the ethical imperatives of therapeutic medicine and public health are reflected in the following excerpts:
- Quarantine and isolation to protect the population’s health potentially conflict with the individual rights of liberty and self-determination. The medical profession, in collaboration with public health colleagues, must take an active role in ensuring that those interventions are based on science and are applied according to certain ethical considerations … Individual physicians should participate in the implementation of appropriate quarantine and isolation measures as part of their obligation to provide medical care during epidemics … In doing so, advocacy for their individual patients’ interests remain paramount [12].
- An important rationale for acknowledging and attempting to ameliorate this tension in pandemic preparedness planning, including quarantine measures, is to reduce the potential for unfair distribution of burdens and benefits among various segments of society [13]. In an important contribution, Nancy Kass has developed a six-step framework for ethical analysis specifically for public health [14]. The application of this general framework to quarantine is discussed in detail elsewhere in these proceedings.
- Ross Upshur has outlined four principles that must be met to justify quarantine [15]:
- First, under the harm principle there must be clear scientific evidence of person-to-person spread of the disease and the necessity of quarantine as a containment measure. Second, the least restrictive means should be implemented. Third, upholding the principle of reciprocity points to the community’s obligation to provide necessary support services for those in quarantine. Fourth, the obligation of public health authorities is to communicate the reasons for their actions and to allow for a process of appeal. In November 2004, theWorld Health Organization issued a checklist for influenza pandemic preparedness. It encourages planners to “consider the ethical issues related to limiting personal freedom, such as may occur with isolation and quarantine [16].
- An instructive example of how ethical considerations can be incorporated into pandemic preparedness plans can be found in the Ontario Health Plan for an Influenza Pandemic [17]. The development of this plan included a collaboration with the Toronto Joint Centre for Bioethics, which produced a 15-point ethical guide for decision making for a pandemic [18]. The guide identified four key ethical issues in pandemic preparedness planning, one of which was “restricting liberty in the interest of public health by measures such as quarantine. ” The guide describes the following substantive and procedural ethical values at stake in addressing this issue:
- 1. Individual liberty: Isolation and quarantine should be proportional, necessary, relevant, equitably applied, and done by least restrictive means.
- 2. Protection of public from harm: Officials must weigh the imperative for compliance and review decisions.
- 3. Proportionality: Restrictive interventions should be limited to the actual level of risk to community.
- 4. Privacy: There must be a necessity for overriding the public’s protection.
- 5. Reciprocity: Support is needed for those facing a disproportionate burden in protecting public health, individual liberty (proportional, necessary, relevant, least restrictive means, equitably applied), protection of public from harm (weigh the imperative for compliance, review decisions), proportionality (restrictive interventions limited to actual level of risk to community), privacy (necessity for overriding for public’s protection), and reciprocity (support for those facing disproportionate burden in protecting public health).
- Procedures should be reasonable, with reasons for decisions shared with stakeholders; open and transparent; inclusive, with stakeholder participation; responsive, subject to review and revision with experience; and accountable.
- Based on these principles, the guide recommended that:
- 1. Governments and the health care sector should ensure that pandemic influenza response plans include a comprehensive and transparent protocol for the implementation of restrictive measures. The protocol should be founded upon the principles of proportionality and least restrictive means, should balance individual liberties with protection of public from harm, and should build safeguards such as the right of appeal.
- 2. Governments and the health care sector should ensure that the public is aware of a) the rationale for restrictive measures, b) the benefits of compliance, and c) the consequences of non-compliance.
- 3. Governments and the health sector should include measures in their pandemic influenza preparedness plans to protect against stigmatization and to safeguard the privacy of individuals and/or communities affected by quarantine or other restrictive measures.
- 4. Governments and the health care sector should institute measures and processes to guarantee provisions and support services to individuals and/or communities affected by restrictive measures, such as quarantine orders during a pandemic influenza emergency. Plans should state in advance what backup support will be available to help those who are quarantined (e.g., who will do their shopping, pay the bills, and provide financial support in lieu of lost income). Governments should have public discussions of appropriate levels of compensation in advance, including who is responsible for compensation.
- Past experience has shown that voluntary cooperation and public trust are key ingredients of successful response to a public health emergency. They may be important antidotes to individual fear and community panic that may be engendered by infectious disease outbreaks. Careful attention to the ethical values at stake in public health decision making can help foster voluntary cooperation and public trust and should be a part of state and federal pandemic preparedness planning.
Note .. in the Same issue ... (* https://www.ncbi.nlm.nih.gov/pmc/issues/161862/ )
Robert A. Cook
Yale J Biol Med. 2005 Oct; 78(5): 343–353.
PMCID: PMC2259160
2005 (October 11) - First use of term "social distancing in any US newspaper " ... in terms of quarantines ... and descried by Martin Cetron
2005 (October 11) - First use of term "social distancing in any US newspaper " ... in terms of quarantines ... and descried by Martin Cetron
A1 : https://www.newspapers.com/image/660593906/
2005-10-11-the-fresno-bee-pg-a1
A10 : https://www.newspapers.com/image/660593912/?terms=%22social%20distancing%22&match=1
2005-10-11-the-fresno-bee-pg-a9
2005-10-11-the-fresno-bee-pg-a9-clip-quarantines.jpg
2005 (Nov 23) - NYTimes : "C.D.C. Proposes New Rules in Effort to Prevent Disease Outbreak"
2005 (Nov 23) - NYTimes : "C.D.C. Proposes New Rules in Effort to Prevent Disease Outbreak"
2005-11-23-nytimes-cdc-proposes-new-rules-in-effort-to-prevent-disease-outbreak.pdf
By Lawrence K. Altman / Nov. 23, 2005
Federal officials yesterday proposed the first significant changes in quarantine rules in 25 years in an effort to broaden the definition of reportable illnesses, to centralize their reporting to the federal government and to require the airline and shipping industries to keep passenger manifests electronically for 60 days.
The proposals would also clarify the appeals process for people subjected to quarantines to allow for administrative due process and give health officials explicit authority to offer vaccination, drugs and other appropriate means of prevention on a voluntary basis to those in quarantine.
The proposals could cost the beleaguered airline industry hundreds of millions of dollars, officials of the Centers for Disease Control and Prevention said. The officials are inviting public comment on the proposals, which are to be published in the Federal Register on Nov. 30, they told reporters in a telephone news conference.
The proposals are part of a broader Bush administration plan to improve the response to current and potential communicable disease threats that may arise anywhere in the world.
If adopted, the new regulations "will allow the C.D.C. to move more swiftly" when it needs to control outbreaks, said Dr. Martin Cetron, who directs the agency's division of global migration and quarantine.
The outbreak of severe acute respiratory syndrome (SARS) in 2003 underscored how fast a disease could spread through the world and the need to modernize and strengthen quarantine measures by pointing out gaps in health workers' ability to respond quickly and effectively, Dr. Cetron said.
As the C.D.C. joined with cooperative airlines to meet flights and later collect information about passengers who had contact with others who developed SARS, the epidemiologists had to compile and process by hand data collected from flight manifests, customs declarations and other sources.
But manifests contained only the name and seat number; customs declarations were illegible, and when readable, the names did not match those on the manifests.
"The time required to track passengers was routinely longer than the incubation period," which was two to 10 days for SARS, Dr. Cetron said.
"That was really quite shocking," Dr. Cetron said.
One proposed change would require airline and ship manifests to be kept electronically for 60 days and made available to the C.D.C. within 12 hours when ill passengers arrive on international and domestic flights. The proposed changes include provisions for maintaining confidentiality and privacy of health information.
The outbreak of SARS was stopped in part because of quarantines imposed in some affected countries.
Quarantine restricts the movement of a healthy person exposed to someone who has a communicable disease. The quarantine period is determined by the usual length of time that passes from exposure to an infectious agent to the onset of illness.
An executive order of the president limits quarantine to nine diseases: cholera, diphtheria, infectious tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers like Ebola, SARS and influenza caused by new strains that could cause a pandemic.
Another proposed change would expand the definition of illnesses to include respiratory ailments like influenza. An ill person would be defined as having a temperature of 100.4 degrees or greater, accompanied by one or more of the following: rash, swollen lymph nodes, headache with neck stiffness (a sign of possible meningitis), and changes in level of consciousness or cognitive function.
Also, the definition of illness would include diarrhea , a fever that has persisted more than 48 hours, severe bleeding, jaundice, severe persistent cough, or respiratory distress.
Captains of airplanes and ships are now required to notify local health officials about an ill passenger or crew at the next port of call and take such measures as local officials direct.
The new proposals call for captains to bypass local health officials and report instead to the director of the C.D.C. through quarantine officials or e-mail messages. The C.D.C., in turn, would notify local health officials.
The proposals would allow airline officials flexibility in establishing a system that would include a written plan to ensure the reporting of ill passengers and deaths on board flights and submit it to the director within 90 days of the final publication of the rule. The airline would be given an additional 90 day period to put the plan into effect. Airlines would be required to have periodic drills to make sure the plans work.
With roughly half the domestic airline industry in bankruptcy and losses exceeding $30 billion in recent years, carriers certainly are not looking for another expense to take on. But they can hardly say no to the government's effort to prevent a flu outbreak.
Some industry analysts consider avian flu to be a threat to airlines equal to any conceivable terrorism episode. Airlines' costs are heavily fixed, and even in good times they operate on thin profit margins, meaning that any significant falloff in flying by the public is ruinous to the financial condition of the industry.
The airlines' trade group, the Air Transport Association, issued a statement late yesterday on the C.D.C. proposal: "There no doubt is a need to update the current regulations to ensure the absolute safety of our passengers and employees. To what extent changes need to be made to existing practices will be done cooperatively with the C.D.C. through this proposed rule making." The group declined to elaborate.
A spokeswoman for Delta Air Lines said of the association, "They speak for us." Other carriers could not be reached or would not immediately comment.
2007 (Feb 1) - "HHS ties pandemic mitigation advice to severity"
2007 (Feb 1) - "HHS ties pandemic mitigation advice to severity"
https://www.cidrap.umn.edu/news-perspective/2007/02/hhs-ties-pandemic-mitigation-advice-severity
Filed Under: Influenza, General; Pandemic Influenza; Public Health
By: Robert Roos and Lisa Schnirring | Feb 01, 2007
Feb 1, 2007 (CIDRAP News) Federal officials today unveiled recommendations for nonpharmaceutical steps to battle pandemic influenza, tying them to a new "Pandemic Severity Index" (PSI), similar to the system for categorizing hurricanes.
Officials predicted that the early, coordinated use of "community mitigation measures" such as isolating patients, sending students home, and canceling public gatherings could make a significant difference in the course of an epidemic.
Relatively disruptive steps such as dismissing classes, changing work schedules, and canceling meetings should be reserved for moderate and severe pandemics, says the 108-page report released by the Department of Health and Human Services (HHS).
In a mild pandemic, the only community mitigation measure recommended is isolating sick people at home, along with using antiviral treatment as available.
In discussing the HHS guidance document today, Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention (CDC), called the five-level PSI "an important and new concept." She said the planners designed the index to mimic hurricane classifications. With recent memories of the Category 5 Hurricane Katrina, "We have embedded in our minds different levels of severity," she said.
Severity level is initially based on case-fatality ratio (CFR), a single criterion that will likely be known even early in a pandemic when small clusters and outbreaks are occurring, the report says. Other measures, such as excess mortality, could be factored in later. Two events would prompt the CDC director to designate a pandemic category: the World Health Organization (WHO) declaring a phase 6 pandemic level and the US government declaring a stage 3, 4, or 5 alert.
The pandemic severity index levels are:
Category 1, CFR of less than 0.1%
Category 2, CFR 0.1% to 0.5%
Category 3, CFR 0.5% to 1%
Category 4, CFR 1% to 2%
Category 5, CFR 2% or higher
The PSI "has been a missing aspect to pandemic preparedness," said Dr. Marty Cetron, director of the CDC's Division of Global Migration and Quarantine.
The pandemics of 1957 and 1968 both fit into Category 2, whereas the severe pandemic of 1918-19 qualified as a Category 5, according to Cetron and Gerberding.
The new report, titled "Interim Pre-Pandemic Planning Guidance: Community Strategy for Pandemic Influenza Mitigation in the United StatesEarly, Targeted, Layered Use of Nonpharmaceutical Interventions," is the product of months of work by government agencies and many other stakeholders, officials said.
The current federal pandemic plan contains some general information on community prevention measures, but state and local public health agencies and other groups had asked for more specifics, the CDC has said.
"This was an effort that reflected a huge army of people behind it," said Cetron. "The 9 months or more we spent on it was akin to birthing a child."
In preparing the recommendations, planners looked at the history of the last three pandemics, examined mathematical models, studied seasonal flu transmission, consulted experts from many fields, and conducted citizen focus groups, Gerberding said.
"One important conclusion is the earlier you initiate an intervention, the more likely it is to make a big impact," she said.
The report describes four types of measures for battling a pandemic:
Isolation and treatment of people who have suspected or confirmed cases of pandemic influenza in their homes or in healthcare settings, depending on illness severity and medical capacity
Voluntary home quarantine of household contacts of those with suspected or confirmed pandemic influenza, along with prophylactic antiviral medication use, if available
Dismissing school classes and closing daycare centers, along with other social distancing measures for young people
Social distancing for adults through actions such as changing work schedules and environments and canceling large public gatherings
For Category 4 and 5 pandemics, the CDC recommends that all four interventions be used and that school classes be suspended for up to 12 weeks. Category 2 or 3 pandemics would warrant voluntary isolation of sick people, though other measures may be added or modified depending on the recommendations of local health authorities; for example, schools could be closed for 4 weeks instead of 12 weeks.
Regarding school closures, Cetron said one idea under discussion is that while students would be sent home, buildings could be kept open for certain pruposes, such as preparing food for delivery to children depending on the federal school lunch program.
The goals of community interventions are to slow the pandemic in order to buy time for producing an effective vaccine and to lower both the peak number of cases and total cases, the report says. Achieving those things would lighten the burden on hospitals and improve the ability to maintain society in general, Gerberding noted.
Cetron voiced hope that nondrug measures could make a real difference in a pandemic.
In looking at the results of mathematical models, he said, "There was a remarkable confluence around common themes: Earlier is better than later, and second, though a series of partially effective measures might not be effective in and of themselves, when these are layered on top of one another, they have a real additive effect." He added that the common themes emerging from different studies "are reasons for optimism."
The report says the modeling studies indicate that multiple nondrug interventions "may decrease transmission substantially and that even greater reductions may be achieved when such measures are combined with the targeted use of antiviral medications for treatment and prophylaxis."
In response to a question about the use of breathing masks, Gerberding said the CDC would be releasing some updated guidance on citizen use of masks and respirators, though she couldn't predict when. For now, she said it would make sense in a pandemic for people to use simple surgical masks to prevent their own coughing from infecting others.
Gerberding stressed that the new document is not considered final. "We fully expect that as we learn more we're going to have to update our planning tool."
Cetron acknowledged that the recommended interventions will be difficult to plan and carry out. "What we're talking about here is not going to be easy to implement. But it would be much more difficult to try to come up with a solution on the fly in the midst of a pandemic."
CDC officials also announced today the launching of public service announcements designed to educate the public about the threat of a pandemic and how to respond. But they gave no details about where or how often the advertisements will run.
2007 (June 1) - With Julie Gerberding , in a press conference ...
2007 (June 1) - With Julie Gerberding , in a press conference ...
https://www.cdc.gov/media/transcripts/2007/t070601.htm
Update on CDC investigation into people potentially exposed to patient with extensively drug-resistant TB
Update on CDC investigation into people potentially exposed to patient with extensively drug-resistant TB
Friday June 1, 2007, 2:15 pm
Friday June 1, 2007, 2:15 pm
TOM SKINNER, PUBLIC AFFAIRS OFFICER, CDC: Hi. My name is Tom Skinner, and I´m a public affairs officer here at CDC, and I want to thank you today for joining us - excuse me - for this update on CDC´s investigation into people potentially exposed to a patient with XDR TB.
Joining us today is the director of the CDC, Dr. Julie Gerberding. Also with us is Dr. Marty Cetron, the director of the Division of Global Migration and Quarantine, and Dr. Ken Castro, the director of the Division of Tuberculosis Elimination.
We´ll begin by having Dr. Gerberding provide a very brief opening statement, providing an update on our public health investigation, and then we´ll move to Q&A - Dr. Gerberding.
DR. JULIE GERBERDING, DIRECTOR, CDC: Thank you, everyone, for joining today. I recognize that I´m on a difficult line, and if it becomes unsuccessful, I will ask Dr. Castro and Dr. Cetron to step in for me and continue.
I´m going to provide a very brief update today on the situation involving the patient with XDR TB.
First, let me mention a couple of things about the patient. We know that the patient is receiving excellent care at the National Jewish Hospital in Denver, and while it´s certainly been a difficult time for him and his wife and his family, we are hoping, all of us at CDC, that he will have a fast and successful recovery.
We know that the early evidence at the hospital indicates that the patient still does not appear to be highly infectious, and we´re thankful for that. It - we have no indication that his infectiousness has changed at all in the last few months.
.....
2008 (April 11) - Germ Warfare and Contagious Diseases : A panel discussion was held by legal, scientific, and counterterrorism experts on whether certain responses to a major epidemic or
2008 (April 11) - Germ Warfare and Contagious Diseases : A panel discussion was held by legal, scientific, and counterterrorism experts on whether certain responses to a major epidemic or
https://www.c-span.org/video/?204834-1/germ-warfare-contagious-diseases
Martin "Marty" S. Cetron M.D. : Director / Centers for Disease Control and Prevention->Global Migration and Quarantine Div.
Michael Chertoff : Secretary / Department of Homeland Security
Christopher F. Chyba : Professor / Princeton University->International Affairs
Michael Greenberger : Founding Director / University of Maryland, Baltimore->Center for Health and Homeland Security
[Dr. Margaret Ann "Peggy" Hamburg (born 1955)] : [ : Senior Scientist / Nuclear Threat Initiative
Pamela S. Karlan : Professor / Stanford University->Law School
Jeffrey W. Runge M.D. : Chief Medical Officer (Former) / Department of Homeland Security
Kathleen M. Sullivan : Founding Director / Stanford University->Constitutional Law Center
Robert Weisberg : Professor / Stanford University->Law School
2014 (September 3) - Panel .. "Ebola Epidemic"
2014 (September 3) - Panel .. "Ebola Epidemic"
Ebola - Cetron and Gostin ...
https://www.c-span.org/video/?321282-1/discussion-combating-ebola-epidemic
Panelists talked about treating the Ebola epidemic in western Africa and steps to prevent future outbreaks. They discussed the magnitude of this Ebola outbreak and how it differed from previous ones. Dr. Cetron said that the virus was winning and that the resources available were not sufficient to contain it. Topics included current vaccines, what the role of the U.S. should be, and the possibility of military involvement.
William "Bill" M. Treanor : Dean / Georgetown University Law CenterMartin "Marty" S. Cetron M.D. : Director / Centers for Disease Control and Prevention->Global Migration and Quarantine Div.
G. "Kevin" Kevin Donovan M.D. : Director / Georgetown University Medical Center->Center for Clinical Bioethics
[Lawrence Oglethorpe Gostin (born 1949)] : Director / O'Neill Institute for National and Global Health Law at Georgetown University
[Dr. Daniel Richard Lucey (born 1955)] : Adjunct Professor / Georgetown University Medical Center->Microbiology and Immunology
John Monahan : Global Heath Adviser / Georgetown University->Office of the President
J. "Steve" Stephen Morrison : Senior Vice President and Director / Center for Strategic and International Studies->Global Health Policy Center
The O’Neill Institute Colloquium “The West African Ebola Epidemic: How Can It be Contained and How Can We Prevent the Next One?” was held at Georgetown University Law Center.
2014 (Dec)
2014 (Dec)
https://www.youtube.com/watch?v=l5Xuch-F5j8
One-on-One Interview: CDC's Doctor Marty Cetron
One-on-One Interview: CDC's Doctor Marty Cetron
415 viewsDec 4, 2014
2017 (April 01) - Video : "Disease outbreaks"
2017 (April 01) - Video : "Disease outbreaks"
https://www.youtube.com/watch?v=I5Siq6Vb7i4
Science On Screen
Science On Screen® brings you to the Michigan Theatre in Ann Arbor, MI for a screening of Contagion.
About the Speaker
Howard Markel, MD, PhD, is a physician, author, editor, professor, and medical historian. Dr. Markel is the George E. Wantz Distinguished Professor of the History of Medicine at the University of Michigan and director of the University of Michigan's Center for the History of Medicine. He is also professor of psychiatry, health management and policy, history, and pediatrics and communicable diseases. Dr. Markel writes extensively on major topics and figures in the history of medicine and public health, is a best-selling author, and is editor-in-chief of the health care policy journal The Milbank Quarterly.
Captain Martin Cetron, MD, is director of the Division of Global Migration and Quarantine (DGMQ) at the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID). He previously served as director of DGMQ when it was within the National Center for Preparedness, Detection, and Control of Infectious Diseases. DGMQ's mission is to prevent the introduction and spread of infectious diseases into the United States and to prevent morbidity and mortality among immigrants, refugees, migrant workers, and international travelers. Dr. Cetron's primary research interest is international health and global migration, with a focus on emerging infections, tropical diseases, and vaccine-preventable diseases in mobile populations.
2020 (Jan 21 / 8:48PM Eastern Standard Time) - CNN : "First US case of Wuhan coronavirus confirmed by CDC"
2020 (Jan 21 / 8:48PM Eastern Standard Time) - CNN : "First US case of Wuhan coronavirus confirmed by CDC"
By Elizabeth Cohen, CNN Senior Medical Correspondent
Link - PDF at [HM001R][GDrive] / Video on page, recording - [HM001S][GDrive]
Mentioned : Dr. Martin Stuart Cetron (born 1959) / COVID-19 Pandemic (USA's "Snohomish County Man" patient zero narrative) /
The United States has its first confirmed case of a new virus that appeared in Wuhan, China, last month, the US Centers for Disease Control and Prevention announced Tuesday. The coronavirus has already sickened hundreds and killed six people in Asia.
CDC officials said the United States will be more strict about health screenings of airplane passengers arriving from Wuhan.
The patient, who is not being named, is in isolation at Providence Regional Medical Center in Everett, Washington. He is in his 30s and lives in Snohomish County, Washington, just north of Seattle. He had recently returned from Wuhan.
He arrived at Seattle-Tacoma International Airport on January 15, before any health screenings for the Wuhan coronavirus began at US airports. He sought medical care on January 19. The CDC and Washington state are now tracing the people he was in contact with to see if he might have spread the disease to someone else.
"We believe the risk to the public is low," said John Wiesman, secretary of health for the state of Washington.
The patient became ill four days after arriving in the United States and sought care. Based on the patient's symptoms and travel history, doctors suspected the novel Wuhan coronavirus and sent specimens to the CDC in Atlanta, where tests Monday confirmed the virus.
The patient is faring well but is still being kept in isolation out of an abundance of caution, health officials said.
Health screenings at more US airports
Health screenings at more US airports
Soon, passengers from Wuhan to the United States, whether on direct or indirect flights, will only be allowed to land at one of the five US airports doing health screenings. Screenings include a temperature check and observation for symptoms such as a cough and trouble breathing.
Last weekend, the CDC started health screenings for Wuhan passengers arriving at John F. Kennedy International Airport in New York, Los Angeles International Airport and San Francisco International Airport.
Starting this week, Wuhan passengers will also be screened at Hartsfield-Jackson Atlanta International Airport and Chicago O'Hare International Airport.
The CDC raised its travel notice for Wuhan, China, from level 1 to level 2 of three possible levels, according to its website. As of Tuesday afternoon, the agency advised travelers to "practice enhanced precautions." The highest level, "Warning - Level 3," advises travelers to "avoid nonessential travel."
Person-to-person transmission of Wuhan virus
Person-to-person transmission of Wuhan virus
The Wuhan coronavirus is in the same family as severe acute respiratory syndrome, or SARS, which killed more than 700 people in 2002 and 2003, and Middle East respiratory syndrome, or MERS.
To date, the Wuhan coronavirus has infected more than 300 people and killed six in an outbreak that has struck China, Thailand, South Korea, Japan and now the US.
It's not known how many of the cases became infected from animals and how many from another person.
On Tuesday, the CDC activated its emergency response system in response to the Wuhan coronavirus. The CDC activates this system on a temporary basis to centralize how the agency monitors, prepares for and responds to public health threats.
The outbreak started in late December at an animal market in Wuhan, about 700 miles south of Beijing. The virus can jump from animals to people.
While there's much to learn about how easily the virus can be transmitted human-to-human, health officials said it appears that it's not spread as easily as some other viruses.
"This isn't anywhere near in the same category as measles or the flu," [Dr. Martin Stuart Cetron (born 1959)], director of CDC's division of global migration and quarantine, told CNN.
2020 (Jan 22)
2020 (Jan 22)
World Health Organization discusses the novel coronavirus | USA TODAY
World Health Organization discusses the novel coronavirus | USA TODAY
https://www.youtube.com/watch?v=Ikf50jPC-kQ
The World Health Organization's emergency committee will recommend whether or not the outbreak constitutes a public health emergency of international concern – a PHEIC.
The WHO director-general, Tedros Adhanom Ghebreyesus, has the final say on declaring a PHEIC. If he does, he would then issue recommendations to countries to combat the new virus, although WHO has no enforcement power.
The U.S. representative at the meeting is Martin Cetron, who heads the division of Global Migration and Quarantine at the Centers for Disease Control and Prevention. The first U.S. case, reported Tuesday, involves a Washington state resident in his 30s who first displayed symptoms Sunday. He was listed in good condition at Providence Regional Medical Center in Snohomish County north of Seattle.
The WHO director-general, Tedros Adhanom Ghebreyesus, has the final say on declaring a PHEIC. If he does, he would then issue recommendations to countries to combat the new virus, although WHO has no enforcement power.
The U.S. representative at the meeting is Martin Cetron, who heads the division of Global Migration and Quarantine at the Centers for Disease Control and Prevention. The first U.S. case, reported Tuesday, involves a Washington state resident in his 30s who first displayed symptoms Sunday. He was listed in good condition at Providence Regional Medical Center in Snohomish County north of Seattle.
2020 (Jan22) - Los Angeles Times : "Chinese coronavirus outbreak has reached U.S. shores, CDC says"
2020 (Jan22) - Los Angeles Times : "Chinese coronavirus outbreak has reached U.S. shores, CDC says"
BY EMILY BAUMGAERTNER / JAN. 21, 2020 8:10 PM PT / PDF of source : HN027C][GDrive]
Mentioned : Dr. Rebecca Lynn Katz (born 1973) / Dr. Martin Stuart Cetron (born 1959) / Dr. Nancy Messonnier (born 1965) / COVID-19 Pandemic (USA's "Snohomish County Man" patient zero narrative) /
A man in Washington state has been sickened by the new coronavirus spreading through Asia, marking the first confirmed case in the United States, experts from the Centers for Disease Control and Prevention announced Tuesday.
The patient, a resident of Snohomish County, Wash., recently returned to the United States after visiting the region around Wuhan, China, the epicenter of the outbreak. Once inside the U.S., he began to experience pneumonia-like symptoms and notified his doctor about his travel history. Test results for the virus returned positive over the weekend.
The man, who is in his 30s, was transported to Providence Regional Medical Center in Everett, where he is being monitored and is good condition, officials said.
Chinese officials said that at least 440 cases had been reported as of early Wednesday, most of them in Wuhan and surrounding Hubei province, where nine have died. Officials have also identified 21 cases in Beijing, Shanghai and southern Guangdong province.
Additional cases of infected patients have been confirmed in South Korea, Japan and Thailand, according to the Chinese government. And Taiwan’s disease surveillance officials said Tuesday that one traveler to Wuhan has returned sickened with the virus.
The patient in Everett is the only known case outside of Asia, and he represents the farthest spread of the novel coronavirus.
“We do expect additional cases in the U.S. and globally,” said [Dr. Nancy Messonnier (born 1965)], director of the CDC’s National Center for Immunization and Respiratory Diseases.
At the same time, public heath officials emphasized that the virus poses a low risk to the American public, and that it’s unlikely to spread widely here.
Chinese health officials initially said that most patients infected with the virus in Wuhan were exposed to live animals in a large seafood market, suggesting that the virus jumped from another species into humans and may not spread directly from person to person. But the Washington state patient, along with several others, said he had not visited the market.
On Monday, Zhong Nanshan, a Chinese government scientist, announced on Chinese state television that the virus can be transmitted between humans.
Even before that development, public health officials were concerned that the virus would spread more widely as travel picks up for the Lunar New Year.
Airline passengers arriving from the outbreak region are already being screened for the virus’ pneumonia-like symptoms at Los Angeles International Airport, San Francisco International Airport and John F. Kennedy International Airport in New York. The CDC said it would begin monitoring travelers at Chicago’s O’Hare International Airport and Hartsfield-Jackson Atlanta International Airport this week.
The Washington state patient entered the country before any of those screenings were implemented. But even if they had been in place, he would not have been detected because he was asymptomatic at the time, experts said.
“Leave no doubt: Entry screening is just one part of a multilayered system,” said [Dr. Martin Stuart Cetron (born 1959)], the head of the CDC’s Division of Global Migration and Quarantine. “Individuals are empowered to make good decisions if they’re informed.”
Outside experts cautioned that the increased airport screenings will be expensive, and that it will take some time to get answers to basic questions like what animal was the source of this virus and what makes some people more susceptible to infection than others.
“Basic epidemiology questions remain unanswered,” said [Dr. Rebecca Lynn Katz (born 1973)], the director of the Center for Global Health Science and Security at Georgetown University. “The CDC is the best of the best, and we should have faith in their leadership.”
Officials have begun to trace the Washington man’s contacts from China to his home in the United States in order to identify other people who may be infected, said Dr. Scott Lindquist, a communicable disease epidemiologist at the Washington State Department of Health.
2020 (May 09) - USA Today : "CDC scientists overruled in White House push to restart airport fever screenings for COVID-19"
2020 (May 09) - USA Today : "CDC scientists overruled in White House push to restart airport fever screenings for COVID-19"
Brett Murphy, Letitia Stein : USA TODAY / updated jan 26 2021
2020-05-09-usatoday-com-white-house-push-airport-fever-screenings-overrules-cdc-scientists.pdf
2020-05-09-usatoday-com-white-house-push-airport-fever-screenings-overrules-cdc-scientists-img-1.jpg
The White House is pushing a return to a failed strategy of relying on temperature screening of air travelers to detect coronavirus despite vehement objections from the nation's top public health agency, internal documents obtained by USA TODAY show.
The discord underscores the diminished standing of the Centers for Disease Control and Prevention as local governments, businesses and community leaders seek direction on how to reopen safely.
Emails show CDC scientists, who have begun to own up to initial missteps in the federal response, trying to persuade the administration to reconsider.
The White House directive to check travelers in 20 U.S. airports for fever comes after earlier efforts by the CDC to screen travelers returning from China failed to stop the global pandemic from reaching the USA.
“Thermal scanning as proposed is a poorly designed control and detection strategy as we have learned very clearly,” Dr. Martin Cetron, the CDC’s director of global mitigation and quarantine, wrote in an email to Department of Homeland Security officials Thursday. “We should be concentrating our CDC resources where there is impact and a probability of mission success.”
Cetron questioned his agency’s legal authority to execute the airport plan, ending the email: “Please kindly strike out CDC from this role.”
2020-05-09-usatoday-com-white-house-push-airport-fever-screenings-overrules-cdc-scientists-img-2.jpg
White House chief of staff Mark Meadows pressed ahead anyway, directing the DHS to announce the airport screenings, which would be visible and aimed at instilling confidence in travelers, according to meeting notes.
Passengers with fever, Meadows said, would be referred to the CDC for clearance. The full plan has not been finalized.
The exchange follows two weeks of internal skirmishes between the CDC and the Office of Management and Budget over how to safely reopen the nation’s schools, restaurants and churches.
Separate emails show the public health agency’s recommendations that bars install sneeze shields and teachers space student desks 6 feet apart were dismissed as overly prescriptive.
As a result, detailed plans – which CDC Director Robert Redfield personally approved – have idled in administration officials’ email inboxes since late April. The Associated Press has reported on the draft guidelines since last Tuesday, but an official plan has not been released.
At the height of restrictions in late March and early April, more than 310 million Americans were under directives ranging from “shelter in place” to “stay at home.” Governors across the USA are rolling out a patchwork of plans to relax social distancing restrictions.
“The number one public health agency is completely ineffective in the most important of moments,” said Ashish Jha, director of the Harvard Global Health Institute. “It’s so absurd.”
CDC spokesman Benjamin Haynes said in a statement that Redfield has had a seat at the table throughout the crisis.
The agency’s public health expertise is “helping shape our nation’s response, as well as the response by our state and local health department partners who continue to be on the front line fighting this war,” Haynes said.
He said the CDC is revising its reopening guidance, based on White House feedback, but did not address the records that show the agency sparring with administration officials over the airport screenings, referring questions to the White House.
White House spokesman Judd Deere downplayed any discord, noting the administration has been “encouraging all Americans to follow the CDC guidelines from the very beginning of this pandemic.”
He said the that the CDC never cleared the reopening instructions it wanted to issue and that standardized guidance would be inappropriate across all states. Deere did not answer questions about the airport screening proposal.
In an Oval Office meeting last week, President Donald Trump signaled support for some form of increased health screenings, which airlines hope will convince travelers it's safe to fly again.
This week, the chief executive officer of Southwest Airlines said the Transportation Security Administration should add temperature scans to airport security checkpoints, and discount carrier Frontier announced plans to screen passengers before they board with touchless thermometers, beginning June 1.
The White House Coronavirus Task Force requested evidence of results from the screenings after the president restricted travel from China early in the U.S. outbreak in late January, emails show.
Scientists, including those at the CDC, have repeatedly insisted that those measures miss the large percentage of people infected with COVID-19 who display no symptoms or can infect others before or without spiking a fever. And fever can be a sign of a wide range of illnesses.
In Nevada, public health officials struggled to get basic details from the CDC about contact information for the early travelers it was supposed to track, according to records obtained by USA TODAY under a public records request.
The head of the state’s Department of Health and Human Services sent an alarmed letter to Redfield on Feb. 11.
“I am concerned about the breakdown between the communication the states have received from the CDC,” Nevada public health director Richard Whitley wrote. “The lack of communication in this circumstance created frustration and confusion for all those involved."
CDC spokesman Haynes said issues were addressed "as quickly and efficiently as possible," calling the airport screenings in January unprecedented.
Taking stock of failures and disease spread
Taking stock of failures and disease spread
The CDC has begun a public and private reckoning of its early mistakes, putting it at odds with a White House that has steadfastly defended the federal response.
An internal CDC memo, commissioned at the request of Health and Human Services Secretary Alex Azar and obtained by USA TODAY, reviews how the federal government missed early warning signs as the virus spread undetected around Washington state and California as early as late January.
The agency published a report last week highlighting the role of travel and large gatherings such as Mardi Gras, a professional conference in Boston and a small-town funeral in contributing to the early spread. The analysis was intended to help public health officials better prepare for another outbreak and not repeat mistakes.
The federal government’s coronavirus failures may have started with the first case documented in the USA, the CDC acknowledged in the internal memo documenting the disease’s spread.
Viral genetic sequencing suggests a link from the first case detected in late January in Washington state, involving a man who had traveled to China, to a chain of about 300 infections, although numbers vary widely.
The same viral line circulated on a Grand Princess cruise ship that departed several weeks later out of California, the first in a set of voyages that ended with the evacuation and quarantine of passengers.
That explosion of infections occurred despite the CDC’s leadership of a vigorous public health response. The Washington state resident’s close contacts were carefully tracked and monitored.
In the internal memo, the agency speculated that its efforts could have missed people who were infectious but only later, or never, showed symptoms. Large numbers of those infected with the virus are known to be asymptomatic, although at the time that had not been fully recognized.
“The virus could have spread from this case, despite the thorough investigation and response,” the CDC memo says, adding a concerning conclusion for a country facing a likely second wave of the virus: The origin of the Washington cluster “will probably always be unknown.”
The agency’s internal accounting of how the virus spread recognizes another shortcoming in the testing in the early stages of the outbreak. Critical weeks elapsed in February when there was minimal testing capacity after the CDC botched the development of what was then the nation’s only coronavirus test.
In the memo, the CDC says early transmission occurred during a period of “limited availability of testing.” Instead of highlighting its own delays in developing a reliable test, the agency described a Food and Drug Administration policy that blocked the scaling up of testing through commercial laboratories until late February.
Consequences of testing delays still coming to light
Consequences of testing delays still coming to light
Public health officials in Santa Clara County, California, learned from autopsies that two people who died in their homes in early and mid-February were infected with the new coronavirus – suggesting the virus was spreading locally much earlier than recognized.
These deaths occurred “when very limited testing was available only through the CDC,” the California health officials said in a news release, noting that the agency’s guidance on testing then excluded people without a travel history or specific symptoms.
The CDC’s internal memo minimizes the agency’s authority in those situations.
“CDC guidelines emphasized that they were just that – ‘guidelines’ – and that decisions about testing needed to be made on a case-by-case basis,” the document says, adding that the discoveries in Santa Clara County, which the agency confirmed in late April, were still “preliminary and could easily change.”
Haynes, the CDC spokesman, confirmed the government made decisions in January and February based on available data of likely exposures by those who had traveled to Wuhan, China. He said, "CDC guidance has always allowed for clinical discretion on who should be tested.”
Dr. Alison Roxby, a University of Washington epidemiologist who has been testing nursing home patients in the Seattle area, said she has been consistently let down by the federal response. She compared her experiences – vying for testing supplies daily with little clear direction from the federal government – to her time working in developing African countries.
“The leadership vacuum is tremendous,” Roxby said, noting that inconsistent public health messages have contributed to people mistakenly believing the crisis has passed.
“It’s not over,” Roxby said. “It’s the eye of the hurricane.”
2022 (May 02) - U.S. HOUSE OF REPRESENTATIVES WASHINGTON, D.C. INTERVIEW OF: MARTIN CETRON, M.D (Redacted!)
2022 (May 02) - U.S. HOUSE OF REPRESENTATIVES WASHINGTON, D.C. INTERVIEW OF: MARTIN CETRON, M.D (Redacted!)
2022-05-02-usa-gov-congress-house-of-rep-interview-martin-c-cetron-redacted.pdf
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2022-05-02-usa-gov-congress-house-of-rep-interview-martin-c-cetron-redacted-text.txt
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U.S. HOUSE OF REPRESENTATIVES WASHINGTON, D.C. INTERVIEW OF: MARTIN CETRON, M.D. MONDAY, MAY 2, 2022 The Interview Commenced at 9:10 a.m.
U.S. HOUSE OF REPRESENTATIVESWASHINGTON, D.C.
INTERVIEW OF: MARTIN CETRON, M.D.MONDAY, MAY 2, 2022
The Interview Commenced at 9:10 a.m.APPEARANCES:FOR THE MAJORITY:[Redacted] [Redacted][Redacted] [Redacted]
FOR THE MINORITY:[Redacted][Redacted][Redacted][Redacted]
FOR HHS:Kevin BarstowJenn SchmalzJoAnn Martinez
FOR CDC:Elyssa MalinErica Portman
INTERVIEW OF: MARTIN CETRON, M.D.MONDAY, MAY 2, 2022
The Interview Commenced at 9:10 a.m.APPEARANCES:FOR THE MAJORITY:[Redacted] [Redacted][Redacted] [Redacted]
FOR THE MINORITY:[Redacted][Redacted][Redacted][Redacted]
FOR HHS:Kevin BarstowJenn SchmalzJoAnn Martinez
FOR CDC:Elyssa MalinErica Portman
- P R O C E E D I N G S
- [Majority Counsel]. Let's go on the record. The time is now 9:10 a.m. It is May 2, 2022. This is a transcribed interview of Dr. Martin Cetron conducted by the House Select Subcommittee on the Coronavirus Crisis. This interview was requested by Chairman James Clyburn as part of th Committee's oversight of the federal government's response to the coronavirus pandemic. I'd like to ask the witness to state his full name and last name for the record, and please spell your last name.
- The Witness. Martin Stewart Cetron. Last name is Cetron, C-e-t-r-o-n.
- [Majority Counsel]. Good morning, Dr. Cetron. Again, my name is [Redacted]. I'm majority counsel for the Select Subcommittee. I want to thank you for appearing virtuallytoday. We recognize that you're here voluntarily, and we appreciate you taking time away from your duties at the CDC. I'll just lay out the ground rules and ask you a few questions. Under the Committee's rules, you're allowed to have an attorney present to advise you during this interview. Do you have an attorney representing you in a personal capacity present with you today?
- The Witness. I do not.
- [Majority Counsel]. Is there agency counsel present?
- The Witness. Yes.
- [Majority Counsel]. Would agency counsel please identify themselves for the record?
- Mr. Barstow. Kevin Barstow, senior counsel at HHS.
- [Majority Counsel]. And could additional agency staff in the room please introduce themselves for the record.
- We don't have anyone else?
- Ms. Martinez. Jo Ann Martinez, HHS.
- Ms. Schmalz. Jen Schmalz, HHS.
- Ms. Portman. Erica Portman, CDC.
- Ms. Malin. Elyssa Malin, CDC.
- [Majority Counsel]. And our colleagues in the minority, could you please identify yourselves for the record.
- [Minority Counsel]. [Redacted] with the Republican staff.
- [Minority Counsel]. [Redacted] with the Republican staff.
- [Minority Counsel]. [Redacted] of the Republican staff.
- [Minority Counsel]. [Redacted] with the Republican staff.
- [Majority Counsel]. And my colleagues on the majority, I'd ask you to introduce yourselves as well.
- [Majority Counsel]. [Redacted] for the majority.
- [Majority Counsel]. [Redacted] for the majority.
- [Majority Counsel]. [Redacted] with the majority as well.
- [Majority Counsel]. Okay. I'd like to go over the ground rules for this interview, and first is the scope. As previously agreed by majority staff and the HHS staff, the scope of this interview is the federal government's response to the coronavirus pandemic from December 1, 2019, through January 20, 2021. The way this interview will proceed is as follows: The majority and minority staffs will alternate asking you questions, one hour per side per round until each side is finished with their questioning. The majority staff will begin and proceed for an hour; the minority staff will then have an hour to ask questions. We'll alternate back and forth in this manner until both sides have no more questions. We've agreed that if we're in the middle of a line of questioning, we may end a few minutes before or go a few minutes past an hour just to wrap up a particular topic. In this interview, while one member of staff may lead questioning, additional staff may ask questions from time to time. There is a court reporter taking down everything I say and everything you say to make a written record of the interview. For the record to be clear, please wait until I finish each question before you begin your answer, and I will wait until you continue your response before asking you the next question. The court reporter cannot read nonverbal answers such as shaking your head, so it is important that you answer each question with an audible verbal answer. Do you understand that?
- The Witness. I do.
- ---
- Q And although you're here voluntarily and we will not swear you in, you are required by law to answer questions truthfully. This applies to questions posed by congressional staff in an interview. Do you understand?
- A I do.
- Q If at any time you knowingly make false statements, you could be subject to criminal prosecution. Do you understand?
- A I do.
- [...]
- Q We really appreciate you being here. We've wanted to sit down with you for some time. We've been looking forward to this. I don't know if you feel the same. But I'd like to start with talking a little bit about your background at the CDC. Can you tell us, walk us through your career path.
- A Sure. I came to the CDC in 1992 as a commissioned officer in the U.S. Public Health Service. Prior to that, I had 12 years of academic training in internal medicine and residency in infectious disease training. That was Tufts Medical School, University of Virginia internal medicine, and University of Washington in infectious disease. And I joined through the Epidemic Intelligence Service in 1992 in the Division of Parasitic Diseases. Two years after that, I was a staff person in the Division of Bacterial Respiratory Diseases, and in 1996 I joined the Division of Global Migration and Quarantine, and I have been in the Division of Global Migration and Quarantine for the last 26 years. And I have -- I am currently the director of the Division of Global Migration and Quarantine.
- Q And beginning in January of 2020, were you also serving as director of the Division of Global Migration and Quarantine at that time?
- A Yes. I have been the director of Global Migration and Quarantine for most of the 26 years of my service in the division.
- Q Who did you report to at that time?
- A Prior to the -- my position in the division as director of global migration and quarantine reports to the center director, the National Center for Emerging and Zoonotic Infectious Diseases, NCEZID. That has been Rima Khabbaz in the time you asked about, January 2020. In addition, the COVID Response Activated Emergency Operations Center, and I've been part of the COVID Emergency Response continuously and nonstop since January of 2020, and that has its own incident command structure as well. There's an incident manager who oversees the response activities. That incident manager position has rotated over the course of the two and a half years of the response, so the person in the incident manager position of the COVID response has varied over the course of -- since January 2020 to the present. So I have a dual reporting responsibility.
- Q And who reported to you at that time?
- A There are members -- there's a task force in the incident response on global -- the global migration task force, and so that task force reports up through the task force lead, and the task force lead reports to me. In addition, the entire staff of the Division of Global Migration and Quarantine reports up through me. Particularly there are a number of branch chiefs in program on leads that report to the division director. Then inside the office of the director in the Division of Global Migration and Quarantine, there's a deputy director, policy lead, each of the program branch chiefs response lead. There are several direct reports, up to 10 or so.
- Q In general terms, can you tell us what your responsibilities were before the emergency response?
- A Before the emergency response and for the duration of most of my 26 years in the Division of Global Migration and Quarantine, we have the broad responsibility of preventing importation and spread of communicable diseases into the United States. We have a responsibility on the medical side of screening immigrant refugee and migrant health, and we have responsibility for the issuance of guidelines on safe travel. We have a quarantine and border health services branch. We have a U.S.-Mexico unit. We have a travelers health branch. And then we have a number of offices, regulatory and policy, and IMIT -- I think I mentioned that we can provide you the organogram document, but we have fairly broad responsibility which includes overseeing and implementing directly or through partners the regulatory programs of the Division of Global Migration and Quarantine and responsibilities that are delegated through the HHS secretary, the CDC director, and the director of global migration and quarantine regarding a number of different parts of 42CFR parts 70 and 71 on the quarantine regulations and part 34 on the immigration health screening regulations.
- Q Sticking with this period in January 2020, who were you regularly interacting with, aside from your direct reports, but sort of in the leadership structure of CDC?
- A Well, with the leadership structure at CDC, including the incident management structure and multiple task force across the response, there were regular interactions with the CDC director as well, particularly on a number of the regulatory issues that are -- that there are delegated responsibilities to the division director of global migration and quarantine from the office of the director, and those would be the intramural CDC interactions. In addition, the position interacts regularly with HHS staff of response and otherwise. And in the interagency, there are regular interactions with the other departments and agencies in the response structure and through the National Security Council.
- Q And when did you first learn of the novel coronavirus circulating in Wuhan?
- A Very late in December of 2019, I started getting some incoming signals from my international collaborators and folks about concerns of unexplained severe respiratory illness in Wuhan, China. It would be in the sort of very -- sort of the penultimate days of December. I had been on leave at the time and returned immediately, based on hearing those concerns, to Atlanta, earlier from leave than had been scheduled, and began engaging immediately on return. Prior to the institution of the -- stepping up the emergency response structure, the EOC incident command structure, we had begun engaging in information gathering, fact-finding confirmation events, sort of discussions, planning and so on right from -- I think it was about January 4th across the interagency leadership -- I mean, the inter-CDC leadership with the director of the National Center of Immunization and Respiratory Diseases, with our own national center, and as well as the CDC director at the time. And then the incident command structure was initiated shortly thereafter. I don't remember the exact date in January. And then everything folded into the emergency operation center incident command structure for interactions and coordination.
- Q It seems like cutting your leave short is a significant step. Why -- what about what you were hearing told you that you needed to immediately get to work back at CDC?
- A Well, as indicated, I'd been at CDC 30 years, and most of that career has been involved in doing a number of emergency response activities regarding potential global threats. I've participated in nearly all of those infectious disease responses that the agency has been involved in since -- certainly since '96 and some prior to that. And there are features and characteristics which raise red flags, areas of concern which need to be vigorously addressed, fact finding, data gathering. Some of the things that I had heard that were concerning was the type of cases, the severe respiratory cases, the fact that there were healthcare workers also falling ill, the occurrence of deaths, the speed at which the cases may have been changing, so the rate, the type of questions about the route of spread and transmission. And usually these kinds of situations are ones to take very seriously. So we gathered. As soon as we got information, we began -- what we would normally do is try to get as much ground truthing and source of information as possible from multiple sources. I'm also regularly a member of the WHO emergency committee's roster, so I have a number of colleagues and coordinations and collaborations at the World Health Organization, and we began reaching out and trying to get some additional sources of information. But these kinds of situations it's always better to be alert and ready and track things down very vigorously and aggressively rather than waiting for information to passively come to you to -- that was the nature of the engagement.
- Q You mentioned your international collaborators earlier and you mentioned the WHO. But who else were you talking with in this --
- A Well, we have CDC staff deployed internationally and around the world. In particular, there are some CDC staff in China, and so we were reaching out to get information from CDC China office as well as what they could filter through the embassy. And this is the kind of thing where your tentacles go up and you try to get triangulated and get multiple sources of input and get a sense of ground truth around the key -- the key kinds of questions: Who's getting sick, how sick, what's the route of spread, how fast is the trajectory of change, are healthcare workers involved, what is the response system, what are the potential sources, what are the natures -- what are the potential natures of the pathogen, is anything known about -- you know, the etiologic agent or the cause of clusters, and piecing together all that kind of material. So multiple inputs. People that are involved and engaged are all reaching out to their own networks, and then we're meeting multiple times a day to coordinate and information share and exchange and try to develop a common operating picture.
- Q I want to ask you about the CDC staff -- CDC staff in China. Actually, there's been reporting about that and sort of the resources that CDC had. What's your view, given your expertise, in terms of how CDC was resourced in terms of people in China at that time?
- A This would be secondhand. I don't have the exact date on the numbers of staff over time, but it has been my best understanding that there had been a reduction in the total number of staff in the recent period leading up to that. And, of course, in an event where there's an emergency, you always feel like there's never enough people to get everything you need to know and done. We had some key people still there. I think one could determine, you know, more specifically and factually the numbers of staff over time and -- in the years leading in. There were residual excellent staff there. Whether we would have been better served by having a larger footprint in the CDC China office or not, it's easy to speculate in retrospect but hard to know for sure.
- Q Do you have a view in terms of that, given what you do?
- A Given what I do, I think CDC's footprint globally is incredibly important. Its relationships with post governments and ministries of health are incredibly important, and the kinds of networking that are often needed to assess the risk, the nature of the threat to ground truth and to understand what's going on, it is always better to be prepared with a broader footprint than to be working short-staffed. That's a general principle that I would say. And sometimes you never know where and when things are going to happen, but when they do, you really want a competent staff on the ground to be having established relationships and be able to get information and network effectively as quickly as possible.
- Q What's your assessment of the relationships with your counterparts on the ground at that time when this was first detected?
- A My relationship to the CDC with my counterparts at CDC on the ground?
- Q Your assessment of CDC's relationships with their counterparts on the ground at that time.
- A I probably am not the best one to answer specifically about what the nature of the CDC staff's relationship with host government are or were at that time. And what I can say is it's very important that the communication, you know, be robust and trusted and valuable and information sources be both credible and accurate to the extent that it's possible in the midst of a confusing emerging event.
- Q And let's take this and move forward a little bit to -- you said January 4 is really when things got organized. The incident management structure, I think, was set up on January 7. Can you broadly explain how your responsibilities changed once that structure was set up.
- A Well, the incident management structures -- we were organized in a smaller group of a smaller number of the sort of key principals that usually get involved in these types of events for risk assessment, data gathering and so on. As an emergency activation occurs and the EOC has stood up, a more formal structure has come into play, and there are usually more components and folks brought to bear in that regard. And so you would begin to get an additional bench of resources, and the kinds of things, you know, that need to get done are benefited by a broader group of coordination, and different parts of the agency get brought to bear. The incident managers are identified and sort of the regular flow of what we call the rhythm of activities, the scheduling of events, the coordination meetings, the establishment of task force MDs, all of those things happen very broadly from an agency-wide activation approach.
- Q Can you just tell us maybe about the teams working on global migration quarantine issues? What are the immediate priorities once that is --
- A The GMTF, the global migration task force, has been a regular fixture in numerous responses over -- as I said, over the last three decades of my time and 26 years in GFMQ, leading activities in DGMQ. And we have some typical types of responsibilities of understanding the scope, the spread, the speed, the nature of the risk, the symptom profile, et cetera. So we were -- at sort of in the opening act of an emerging threat, in addition to characterizing it as quickly as possible, we begin to look at what types of measures would be done to prevent importation and spread or slow the spread. Sometimes prevention of a distribution of a disease is -- in terms of the globalization is not possible, and the idea of looking at the transnational border issues is about trying to buy time to slow spread, think about what could be done. We have a number of plans and exercises around what occurs in the sort of opening act, depending on what the global distribution of disease is, borders, you know, screening, whether they were going to use temperature checking system, questionnaires, risk factors, exposure risks. Mapping out the movement of traffic from potential source or multiple sources into the United States, understanding the ports of entry that might be where there might be direct contact, in this case, with China, Wuhan, or in Wuhan province -- excuse me – Hubei province, the province that Wuhan is in. And so we began doing all of that work. The transportation network infrastructure mapping was one part of our key responsibility. In the pandemic planning back in the early aughts, in, '05 through '07, there was intensive pandemic planning around community mitigation strategies in which our division had a principal role in the use of the community mitigation toolbox: Isolation, quarantine, social distancing, school issues, testing, screening, surveillance, all of that stuff. So we began -- GMTF was a part, although in this type of response there were some dedicated components that were being established on domestic issues. We would also look at some of the interstate spread in addition to international introduction. That's another part of the -- part of our remit is international arrivals and interstate movement. So these were the things we were working on. We quickly mapped some of the air traffic and some of the other means. We would be looking at the context of movements and flows out of the source area where the original cases were being reported. It was notable that Chinese New Year was coming up and there would be a potential travel nexus from, you know, Wuhan to other parts of China, so then we would look at the additional transportation networks that were beyond the nearest -- the closest international airport. Those were some of our key priorities, and very early on, I believe by discussions and then plans for standing up airport entry screening at the three major airports that have direct connections to Wuhan, we were beginning to engage. It always takes a while from getting the green light to go to actually establishing sufficient people to distribute to our quarantine station networks. At first three airports, and then this continued to scale over the course of the next several -- several weeks by looking at both -- not only the direct flights to those -- you know, into the country but also the indirect and transit points. We were also engaging with international partners to see what types of screening and approaches might be taken. Again, the pandemic plan looks at some of these border approaches from the perspective for highly communicable respiratory disease of buying time, not from, you know, stopping the spread, but a lot of that needs to be characterized by understanding exactly what the modes of transmission are, how contagious something would be, and what's the symptom profile that you might look for, what tools do you have to detect that. So those would be some of the main things that we were gearing into -- sort of kicking into somewhat standard, you know, roles and responsibilities that follow playbooks as well as that have been exercised from prior events like Ebola in West Africa, Zika, monkey pox. You know, the number of events like this that we've been involved in since '96 are extensive.
- Q We'll circle back to airport screens in a little bit more detail later. I want to ask you as part of this process and you mentioned the plan involved in the early aughts, 2005. I want to ask you about the interagency processes and when those got started and who were you working with across agencies early on.
- A Yeah. The interagency process started very quickly. As I'm sure you know, CDC had significant concerns about this emerging threat, and we had been involved in a number of these kinds of things and understand very well the importance of interagency coordination. Especially with the global migration task force, we were intimately involved in the intersections with the Department of Homeland Security, with the Department of Transportation, clearly, obviously, with HHS and its component agencies, including ASPR. So all of the relationships exercised planning of prior events, all of this lead into a rhythm and a tempo that kicks us into familiar space. Sometimes the names of the people occupying the different roles have changed as administrations turn over, but the importance of the coordination is always the same. It always needs to happen early, and in many times there are preexisting agreements that allow things to transcend the individuals who are occupying the specific rolls.
- Q For the task force you were overseeing, who was doing that coordinating across agencies? And I'm thinking about the period probably before the standup of the White House task force, so throughout January.
- A I'm not sure I really understand the question. Who was responsible for coordinating --
- Q Who was leading the interagency interactions? Who was setting the meetings? Who was driving the agenda? What was happening in that period leading up to the creation of the task force?
- A Again, there are familiar roles. The department has, you know, a standing role in coordination of the interagency meeting, other departments and agencies at various levels, and those coordinations not only occur at the top where they happen out of multiple places, but also then staff become connected, agency-to-agency staff, and we -- you know, the counterparts are assigned to task forces and we begin meeting and, you know, developing shared information, common operating picture, discussing response plans and then policies. We move filters up again and those discussions are happening. So multiple levels of interconnectivity occur, and they are ongoing and they make a part of that rhythm of the emergency operation response, the response structure. So they're scheduled, again, at multiple layers. It's a web. It's not like a single -- it's a very complicated, interdependent web with a lot of information moving at multiple levels, filtering up and down, but also especially across.
- Q Okay.
- A That's the way this unfolds.
- Q Are you able to say who was sort of leading that web and who --
- A Well, at different -- different departments and agencies, those might be different people. But the roles -- for example, the incident manager at CDC would have a major role in sort of coordination. Then there would be, you know, department-wide coordination that involves, you know, agency leads, and plus the people that they want to bring into some of the conversations, so CDC director, other, you know, agency leads and directors. And those would often be coordinated, you know, by HHS setting the schedule for those kinds of things. And then the interagency meetings would have coordination. Very -- I mean, this was the kind of event that very quickly the level of coordination was high in the U.S. government. So there was -- you know, those groups and everything brought together by the HHS secretary's office and other places. And then the interagency meetings would have a coordination, very -- I mean, this was the kind of event that very quickly, the level of coordination was high in the U.S. government. So it was, you know, those groups are being brought together by department, by the HHS secretary's office and other places. But it was quite clear we were going to be dealing with a complex scenario. We had issues to think about -- I mean that "we" collectively -- on American citizens in Wuhan and issues to struggle with around repatriation, and those would involve multiple departments and agencies, state departments, DOD, DHS, of course, CDC HHS. So that network grows very quickly as the number of issues that have to be taken into account arises.
- Q When did your team start engaging with the White House?
- A I don't remember the specific date, but very early on through the secretary's office. The secretary of HHS has a lead coordinating responsibility for COVID in the very early days. And the secretary of HHS would bring together the interagency and structuring agendas. I'm not sure what you mean by when the White House task force started. You know, the White House engagement was coordinated initially through the HHS secretary before it was handed over. That would have been sometime in February. But there was engagement with the White House folks very early on, early in January.
- Q Who at the White House? In what roles?
- A Different roles. The folks that -- usually there was the senior official from all the cabinets and then senior folks that were identified from the White House. And the secretary, as I said, in the very early days in January, was coordinating -- was responsible for the White House Task Force on COVID. Then that position shifted to White House leadership. But there was -- there were numerous regular meetings in order to bring the entire U.S. government operation together and discuss situational awareness and systems and sort of policies and options, things like that.
- Q I want to talk about sort of the formal establishment of the White House task force. That was on January 29. The secretary of HHS was to chair it. Did that change your responsibilities in any way in terms of who you were reporting up to or who you were briefing?
- A Well, the CDC director was part of that task force, and the CDC would often ask me to participate in those meetings as a plus-one subject matter expert, you know, with the CDC director. If that's the question you're asking. I'm not sure exactly what you're asking.
- Q Sure, that's what I'm asking. I guess around that time, the decisions about travel were starting to be made. I'm wondering if we can first discuss the January 28 advisory to avoid all nonessential travel to China and your involvement in that decision.
- A So our -- the Division of Global Migration and Quarantine, in addition to the GMTF task force, traditionally has responsibilities to help advise and guide on safe and healthy travel. Our traveler health branch issues routinely peacetime and emergency response time guidance about safe and healthy travel with the best information that we're able to glean.And so we have a series of scaled level of travel advisories that assess risk and appropriate proportionate mitigation measures, and we update that on a constant basis as we better understand the risk assessment -- that is, the scope, the geographic scope, the magnitude, the intensity. So that would be a very standard place for the GMQ to get involved. That is a lot about what recommendations we would make regarding safe and healthy travel from an outbound perspective. People who would be going to, coming -- or American citizens that would be living in those locations, what was the risk assessment of CDC and what were the mitigation recommendations, what legal of concern we had. And they are tiered to four levels, tiered, you know, concerns in terms of risk assessment. So we definitely would be involved in that. That is also an activity where it's peacetime or emergency response time that gets coordinated through the interagency. We get regularly channels of communication involved with the Department of State and all across the interagency in that regard.So those would be the kind of things that the CDC director would rely on our program to do.I want to highlight that distinction between the guidance recommendations around outbound travel or the guidance and recommendations for American citizens in country, the expatriate communities where the risk might be from divisions that get made on the inbound side on the mode of preventing importation is spread clearly.There's an overlap, but they are slightly different and the tools in the tool kit are slightly different, whether the focus is incoming or whether the focus is keeping people who travel healthy and safe on the outbound side. So they are two important parts of a similar piece, but there are different tools available in different ways to approach those questions. We're getting involved in both.So the border screening kinds of activities that I mentioned earlier, the maximum benefits occur from doing exit screening at the source of where the threat is: Having an emergency response plan for illness that might occur intransit, whether it's by air, land, or sea, but the in-transit component; and then the -- sort of the last concentric ring would be what type of border screening might be considered on the arrival side.So you can see the most powerful and impactful way to approach this is understanding clearly where the source or more than one source are; try to get exit screening in place for people that are infected, sick, or exposed are not being put into international or other travel in the first place; and then, you know, a response plan with regard to the conveyances that move, and then, finally, another layer, outer concentric layer of screening on arrival.The reason the efficiency is maximum source control may be obvious. It goes much broader than just controlling direct travel risks to the U.S. But importantly, more often than not there's a lot of indirect movements, and those indirect points of transit are mixed in places in which it's hard to understand -- you know, as opposed to getting a direct flight that's full of 200 passengers right from the international airport, you know, near Wuhan to LAX, for example, or JFK, the more indirect ways people can come, the more sort of diluted and challenging it is to sort out who has actually been in a risk area or not.
- Q And I guess we can -- in terms of the way you described it, the January 28 advisory was outbound? It was avoiding all nonessential travel into China; is that right?
- A Yes.
- Q Why was that recommendation made at that time?
- A The threat picture that was emerging was a serious respiratory illness, like moving pretty quickly, growing quickly in numbers, as we started to get that data from the first several weeks, and it was clear that it was impacting health in ways that could not easily be circumscribed or defined. And that often at the beginning of a situation like this, where there's a lot of confusion and chaos and the risks are not always exactly clear that somebody can take, you know, one measure to protect themselves, whether it's a vaccine or prevention -- preventive medication or something else that would alleviate their risk and there was community spread and widespread transmission, the best advice we can give until there's much more clarity is for people to avoid an area like that. There was also strain on healthcare systems and hospital delivery. And so it was the combination of the severe threat, the widespread nature, the rapid spread, and the potential impact on healthcare system and delivery that -- what would be the options for an American citizen or other persons leaving from the U.S. traveling to the area, if they got sick, in terms of their ability to access care. Those are all the kinds of factors that lead into a decision like that.
- Q Do you think that decision should have been made sooner?
- A We had been providing, you know -- like I said, there are tiers of that, so that avoid all nonessential travel, that's the higher tier short of actually mandating restrictions and closures at the border. So that's a level of guidance.
- And I'd have to go back and check the record, but I believe we sort of tier through with some geographic specificity before we get to that fourth tier.
- And certainly, we had concerns earlier, we were setting up our screening, we were setting up surveillance systems, we were gathering data on the nature of the cases, whether it was strong evidence for person-to-person spread, what the incubation period, what the nature of the pathogens would be and whether there were countermeasures known -- that is, treatments -- already, you know, known.
- So I think by the end of January, we had a reasonable idea that this was a coronavirus in that SARS or MERS family. There were certain things that had been, you know, deduced about that just by the original genomics. I think by the end of January, the emergency committee at WHO had already met at least once, if not more than once in January,
- HVC122550 PAGE 32
- to my recollection, that I participated in.
- So I think as the information was rapidly being acquired, it was clearly a step that needed to be taken.
- Q Were you advocating for it earlier or was anyone at CDC wanting to do it before the January 28 date?
- A You know, I can't remember the specifics about that. There was a lot going on in the last two and a half years. I don't remember the specific of dates.
- But we were -- I can tell you that I and my team and others at CDC were very concerned about this pathogen from very early in January.
- Q I think what you described was ratcheted up three days later. Secretary Azar announced public health emergency and then the presidential proclamation that entry from China was suspended and the additional screening and quarantine. So that's a ratcheting up in three days. Can you tell us what goes into that and sort of mobilizing the airport screenings and the authority of quarantine?
- A Yes. So I can say just on the airport screenings, based on what I was hearing in the first week of January, I was making the recommendation we should start doing that even before knowing about all the characteristics of the virus, that heightening surveillance in trying to find cases was going to be important, even if it was only a way to create a better awareness or if we identified cases early in January, whether we had specimens in our hands in the U.S. to be able to begin characterization of the virus. So I'm thinking that by -- I mean, it takes a while to set up and coordinate and get those operations going, but we were doing that in a matter of days rather than -- you know, sometimes it can take longer to mobilize funding and all these other things, get people, discussed at the appropriate perch, develop questionnaires. We wanted to be asking about potential exposures in addition to symptoms, in addition to a temperature screening, and then having the protocol for how to handle those that flip the switch positive. So I'm vaguely recollecting that we had started in the three largest volume hubs receiving direct flights by the middle of January, maybe the second week or toward the end of the second week in January. I'd have to go back and check that record for specifics. And as we characterized the travel network as we learned more about what was going on in terms of travel out of the central locations, the specific hot zone in Wuhan, to other parts of China, and as we were defining the transit hubs and the indirect things, we were expanding that airport program. That, as I said, we were well aware was not designed to prevent importation of a highly contagious respiratory disease. These are about buying time to get better understanding of the risk assessment and what tools are needed, develop diagnostics, develop response plans, characterize things to really understand what's going on. Some of these types of highly contagious respiratory viruses are not going to be stopped by any entry screening program or any, you know, travel bans and all that. It's just not the way it works. Were it true, I would be very happy about that, but that is not the reality of my experience over three decades of doing this kind of work. But it does give you an opportunity to heighten the level of concern. I was hearing from colleagues in the surrounding countries to China that their screening programs were detecting introduced cases. And it's very important to be able to assess whether what's being done at the source is sufficient to prevent exportation and to gear up what type of things could be done at the source to really contain something as close as possible with the source or even, you know, slow it with maximal impact. But I was hearing from colleagues at -- both international colleagues as well as directly from CDC field colleagues in various countries that they were having -- they were detecting imported cases through the airport screening programs, and that allowed another path to characterizing the nature of the illness and to understand that things were moving beyond the boundaries of Wuhan and Hubei province as they characterized the itinerary from which the cases are defined. So we began to do that very early, as I said, prior to the end-of-January announcements that you're talking about.
- Q I think we can take a look at an MMWR by one of your colleagues -- it's Exhibit 1 -- that goes into some of these details very briefly.
- [Exhibit 1, marked for identification.]
- A Is this the one that --
- Q It's by --
- A -- and others --
- Q Dr. Patel and Dr. Jernigan.
- A Dr. Patel and Dr. Jernigan, yeah. So I definitely, you know, participated in providing information into this piece as a member of the response team. And it goes through a little bit of trying to crystallize the level of concern that we had.
- Q Yes. It seems like your memory is actually pretty good that the enhanced screening started on January 17. I wanted to turn your attention to the first paragraph on page 3, which is also page 142.
- A Okay. The first -- the initiating paragraph on January 24?
- Q Yeah. I guess we can start on the bottom. I want to ask you about as of February 1, 2020, and the numbers. Sort of -- it's in the middle of that cut-off paragraph.
- A Right. "As of 1 February 2020, 3,000 persons on 437 flights were screened and then we referred these five symptomatic travelers." Right?
- Q Right. Why do you think there was such a low number of positive cases detected from the screenings at that time?
- A I think probably there was some combination. What ultimately we learned more in retrospect than what we knew clearly at this time was that this -- in contrast to the SARS 1 coronavirus and certainly in contrast to MERS, there was a high amount of contagiousness and infectiousness very early in the incubation period, and transmission was occurring from -- and I'm saying this with clarity in hindsight. Transmission could easily occur and was occurring from both presymptomatic and asymptomatic cases. Our screening tools were really -- and our temperature checks and all those things were really focused on looking for febrile cases and people that had active symptoms. And that became very clear early on that we were -- that this program of entry screening that was focused on symptoms and fevers was not going to be very effective in dealing with the asymptomatic or presymptomatic early infection, high viral load, high-risk cases. That probably was the major reason the yield was less than we expected. We did a lot of screening, a tremendous amount of intensity of effort, and it just wasn't panning out the way it should have. That doesn't mean that doing it at the time wasn't something we should do, because, like I said, a lot of this information was gleaned in retrospect. The other possibility -- there was a number of possibilities for why that screening is less efficient than it would be. Some of them include containment at the source, and we have seen that there were some very heavy control measures being put in place first in Wuhan lockdowns and then subsequently in lockdowns in Hubei province. So we're really thinking about that part is the most effective part at filtering. But we were still seeing kind of volume stragglers, but they may not have been coming from areas where they were as exposed to that. That was another explanation. It's possible that the things you're looking for are not consistently positive over the course of an incubation period from exposure to symptom onset if there are going to be symptoms. That is, there's sort of peaks and troughs. It's also possible that people mask symptoms with medication that reduces fever or medication, or they don't directly report. And so it depends on our actual encounter assessment to detect them rather than having people voluntarily acknowledge, well, I don't have a symptom now, but yesterday I had a fever. Now I'm on Tylenol or something. So I think there's a lot of explanations, but it was not lost on me that the yield was low. And as we began to get further into this, I began to gather more information from the WHO emergency committee, reports directly out of China in terms of what they were finding. I became more and more skeptical that our initial border screening protocols would be able to have the kind of yield in preventing importation and spread and the need to move beyond that was becoming clear. I think that's -- you don't know that until you do all the screenings, and part of it is actually doing that to gather the exact data on how much exportation there will be and whether the protocols and tools are working. I will say in contrast, for example, that, things like Ebola, which are maximally contagious late in the illness, in fact, even after death, when some people are just too sick to travel. So this is a totally different scenario. Respiratory nature makes it different in that regard as well. So there's a lot to learn. We decided that we wanted to add the understanding of what would happen for those folks that came in who were not symptomatic or not detected at the airport but still had a 14-day rule -- it was emerging as a 14-day incubation period, how we would be able to follow those contacts after arrival and make sure that as soon as someone was identified, they had a way to report to public health during the 14 days after arrival. So contact information, contact tracing, the ability to alert the entire U.S. public health system to travel-related importation, since we weren't getting the yield on airport-based screening that I had hoped, would also be an important component. And incubation period post-arrival surveillance is always important, because not everybody is going to manifest at the time of travel. In fact, most often, for many infectious diseases, there are more retrospectively identified cases in people who had already traveled during the incubation than the ones you would find at the snapshot and point of time at the point of entry. So this has got to be a multilayered, multiple approach to addressing that. There's no one component that's going to solve this. And I think, you know, that's sometimes hard to convey. People want there to be a magic bullet. You know, you get everything as you walk through a thermal scanner or a temperature check. But it isn't like that, and the type of pathogens you're dealing with when people are contagious, if they get symptoms, if they get fever, all play a really important role in terms of how we can all be responsible.
- Q I want to ask you given what CDC learned later and published its findings about importations from Europe, do you think that screenings should have been expanded to passengers from Europe at this time? Do you think that would have made a difference?
- A I think -- look: The truth is this has been a rapidly inpatient evolving global pandemic with a pathogen that's got a high reproductive rate. It's highly contagious. It causes symptoms to move quickly. The kinds of roles that we had talked about for airport screening, if you think about pandemic in sort of phases, almost like the Queen's Gambit story or a chess match, you've got an opening act when the pathogen is first emerging and the number of source countries involved could be very narrow, and you've got a lot of focus in that. You've got a point in time at which many countries get involved and there's regional spread or even beyond regional, multi-regions of the globe are having active cases and epidemics. That's a long, long middle game while you have globalization but before you have full characterization of medical countermeasures, treatments, vaccines, all sorts of things. And there's a long period of time of relying on public health measures and community-based mitigation and control, what we call the sort of flattening of the curve. And our group led a lot of this analysis in the 2005 pandemic planning -- influenza planning plan, and our planning documents, we published that in '07. But this pandemic moved through regions very, very quickly, both spread in China, regional spread, and into Europe, particularly Italy. And the pandemic moved in some ways faster regionally than others; for example, large West African Ebola pandemic, for a number of reasons: Different pathogen, different mode of transmission, different communicability, different symptom profile, different ebola and Europe became quickly involved, other Asian countries and so on. The U.S. was actually very quickly involved because of our hub connectivity to some locations. Would we have been able to derive some benefit from getting screening in various measures done earlier from Europe? Undoubtedly yes. It would not necessarily, as I said, have been the things that stopped the globalization of a pandemic like this, but we may have gotten more cases, because movement was more open. There wasn't as much lockdown as there was in China. That may have allowed us to get specimens from people who were infected earlier to understand the introduction, distribution earlier, get tests developed -- all sorts of things that are really critical about characterizing the virus when it's on your own soil: Incubation period, symptom profile, whether people can spread before they get symptoms. All of that it's easier to acquire directly from your own early cases than it is to acquire by derivative, or trying to understand what another country's epidemiologic capacity is or exchange. So I think we could have moved much more quickly had we been able to expand those types of engagements. But it's one thing to have a certain response, you know, toward China and another thing to acknowledge how quickly things are moving from a global perspective.
- Q Is that something you or your team was advocating? Can you elaborate on that?
- A Yes. It was clear to those of us who had been doing this a long time that we needed a more aggressive posture, and we were advocating that in a variety of settings. And we were also advocating for, you know, different approaches to the screening. We were advocating for the need to do follow-on of the travel-related contacts. We needed good information to do that. We still didn't have, you know, a very reliable, sensitive, and specific diagnostic test, which, you know, hampered the ability -- when you're talking about a common set of respiratory symptoms, as you're moving into typical respiratory virus season, particularly flu season, you have the problem of a -- you know, a pretty common thing with a lot of volume and a lot of movement and trying to actually find the thing you're really looking for in order to better characterize it. But the only way to do it is -- these things move fast, and if you wait for systems to sort of, everyone to get on board and feel like things have to be done, the pathogen is always chasing you and likely to bite you in the back rather than you being in front of it in an anticipatory way. And I think it was very challenging to get that level of attention and seriousness about what we were dealing with and the likelihood -- I mean, it's clear to many of us that this was going to be an emerging pandemic very, very early by the nature of how it behaved at the source and in a few other places.
- [...]
- [Recess]
- By [MINORITY COUNSEL].
- Q My name is [Redacted]. I'm on the Republican staff of the Committee on Oversight Reform. I have a few questions for you. You testified in the first hour that your title is the director of global migration and quarantine. How long have you held that position?
- A I came to the division in '96 initially as a surveillance and epidemiology branch chief. I believe in 2000 I became the deputy director, and I don't remember the exact year that I became the director, maybe in 2003 or thereabouts. Roughly been in the role for about 20 years or just shy of that.
- Q I think you might have said this before. Is part of that job -- does part of that job involve public health for migration, bringing migration into the United States?
- A Part of the job involves the Part 34 regulations around medical screening for those applying for lawful permanent residence, and part of our public -- so on the regulatory side, and part of our job involves the public health approaches to general migration-related issues. So in the LPR side, that includes refugee migration and immigrant applicants. In the public health side, like I said, we're often asked to consult on migration-related public health issues.
- Q Were you involved in the drafting, execution, or implementation of the CDC March 20, 2020, order suspending introduction of certain persons from countries where communicable disease exists issued under Title 42?
- A Not substantially, no.
- Q It was reported that you refused to support issuing that order. Is that report wrong, then?
- A You asked if I was involved in the drafting, writing, and implementation. Did I misunderstand the question?
- Q So what was your involvement in the March 20 order, then?
- A Very little direct involvement.
- Q All right.
- A I was consulted by the CDC director about issuing that order, and as has been the case, I provided my advice to the director, public health advice about the approaches that should be done to reduce the public health risk. What was asked was specifically to construct the order as it was stipulated, not about what public health measures and risks should be done? I told the director, respectfully, I thought there were very important alternative public health measures. So that's -- I think that's what you're getting at.
- Q So is that report, then, overstated? If you weren't involved in the drafting or execution, there wasn't a question of whether or not it was your final pen on the check box?
- A No. I don't know how more clear I can be, because maybe I'm not sure exactly what you're saying. It's not like we rewrote it. I wrote it with my team and we -- you know, I refused to sign it. First of all, these delegations of authorities include the director for these regulatory authorities as well as the CDC director as well as the DGMQ director. But the specific ask about that public health tool that was posed that the director indicated that was what was wanted, the director and I, you know, had some conversations and it was decided that that tool and that use and that order would be drafted outside of my lane.
- Q Would it have normally been drafted within your division?
- A It might have been. Not necessarily, because, like I said, there's a lot of engagement and involvement around that. But -- and that was somewhat an unprecedented order in its scope and magnitude and approach. So it wouldn't necessarily have been directed by the CDC director -- I mean, the DGMQ director. In fact, there hasn't been anything quite like it in a long time, so I can't tell you what normative might have been for such a precedent.
- Q Did you -- as part of working with Director Redfield, on that, did you travel to the border?
- A I did not. This really was handled out of the director's office and with others, and I can't speak to various components.
- [Minority Counsel]. Okay. I think that's all we have for this hour. Thank you.
- [Minority Counsel]. I actually have a few.
- By [MINORITY COUNSEL]:
- Q You mentioned there you thought there were various alternatives to the order that you were discussing with my colleague, [Redacted]. What were some of those alternatives?
- A As I indicated before, often border measures, hard core border closures, can be considered, you know, in appealing or a quick first reach, but often they don't really work as intended. And the things that are most needed in terms of the public health readiness are issues around cohorting -- you know, isolation, quarantine,
- Q I guess I don't understand the distinction. So can you break it down? Like you support -- I guess maybe I missed it in the last hour. Did you --
- A Infection control, identifying cases through symptoms and cohorting groups where possible.
- Q So you favor keeping travel going but having more robust screening? Is that what I'm understanding you to say?
- A Some aspects of it are related to screening. Some aspects of it are really focusing on the risk, and some of the most important things are improving the basic hygiene circumstances that -- the -- the circumstances that promote transmission are really important to get at early on and to try to do, rather than having the impression that somehow you could actually prevent something from arriving through a border closure when that's less likely, and also looking at the relative balance of where is the infection pressure at the moment and so on. And we've had very good success with a number of tools that really mitigate the pressure of transmission, and some of it's related to age groups and other kinds of things. So I think that there are public health harms that also occur when some of the things that were, you know, being proposed.
- Q Okay. So we stopped travel from China; correct? Do you remember when the president did that?
- A I do. I do remember when the president did that in the end of January.
- Q So Dr. Fauci testified before our Committee that he supported that travel ban, for lack of a better way to put it, and that he thought that that saved lives. Do you agree with that or not?
- A I think, as I mentioned in my prior testimony, that there are tools that are appropriate at the onset or the opening acts of an emerging potential pandemic when there's single-source involvement, like a concentrated epidemic in Wuhan. And that as those things change and the sources become multiple and, to varying degree, globalized, it's really important to understand where the pathogen is and where the threat is and where it's not as you design strategies, and that matters. And so by March of 2020, we weren't in the situation that we were in January of 2020 with concentrated cases in China. There were cases in a number of places. There were notably very hot spots in the globe, of which the U.S. was already one of them, and there were notably places in the globe that did not have that many cases. And so it's really important to understand how you match the tools you're going to use with the locus, location of the source of the movement. And so that goes into that factor as well.
- Q So we were slow to, I think, ban travel from Europe. In my recollection, Italy was experiencing a large amount of cases in the spring of 2020. Would you or did you recommend stopping travel from Europe sooner than it was actually done?
- A I want to be conscious about your term "banning travel." There weren't hard outright travel bans. There were selected population. There was still large amounts of returning travel from Europe even when the 212 proclamations were put into place, if that's what you're asking about. And then, again, it's one thing to use a travel ban in January with a single focus of infection. The continuation of the use of travel bans as a tool once there's widespread, you know, infection in the U.S. starts to become diminished, and the shift in the approach of basically screening, assessment, isolation, quarantine, infection control, masking, basic hygiene circumstances becomes more paramount and more important from the perspective of preventing importation and spread. So the tools we take out of a tool kit need to vary by what the nature of the geographic distribution and scope of the pandemic is. It's not always going to be appropriate and sometimes more harm than good will come out of trying to put into place travel bans, which also have collateral damage, including the movement of goods and services, control and preventing the pandemic, the supply chains, many other things that come into play. So every situation needs to be evaluated for the context of the dynamism of the pandemic.
- Q Okay. So I want to just try to summarize really quickly. It sounds like, and is it fair to say, that you think that impediments to travel, we'll call them, should be based on -- should be timely and targeted to certain geographies based on where we're seeing the cases? Is that a fair summary? And it is a summary.
- A I think there's a difference between border closures and travel bans in one category, and I don't know what you mean by the term "impediments to travel," like safe and healthy travel advice, testing, eliminating, isolation of people that are sick, those kinds of things. I don't know whether you consider -- are you referring to those as impediments to travel? Because there's a real distinction between an outright border closure attempt and the level of collateral damage from a set of public health infection control measures that could be used to mitigate the impact of the transmission and spread. So if you mean impediments to travel, all those things, that's sort of one approach, but if you're actually talking about border closures and travel bans, that's a different question.
- Q Well, let's talk about what was your recommendation back in -- so most things in America, I think we would agree, shut down around March 12, 13, in there. What was your recommendation going back to that time, March 2020? What was your recommendation vis-a-vis travel, air travel from foreign countries? Was it based on geography and where infections were popping up?
- A I think what happens is that the focus on broad border closure measures becomes much, much less effective, and the need to pivot to a set of community mitigation strategies becomes much more paramount in having an effect. Because if you think about it, once the virus is already here, the real risk is the amplification of our community spread more than what is contributed by introduced cases. The volume of travel that was still coming into the country even under 212, you know, modified border permissions, which was limited to people who had been in a certain place within 14 days prior -- it wasn't an outright travel ban -- but certainly all of the vast -- a huge volume of that travel was ongoing. But the pressure of expanding the pandemic in was much more intrinsically focused and needed to be dealt with the community mitigation plans that we developed in 2005, published with full interagency engagement in 2007, and those infection control practices needed to be the backbone in this real structure and that there was a certain amount of false security that would come from focusing on the border closure aspect as opposed to what we needed to be doing domestically to get into mitigation.
- Q So, then, is it fair to say that you don't support travel bans at all, ever?
- A I don't think I said that. I think I was very clear that there's an opening act and a place where there's some uncertainty, where if we have no cases and there's a single nidus of infection, we're figuring out how to manage that volume through a whole variety of things, limited on the volume but also, you know, screening efforts and awareness. But, you know, three months into that process in a different point in the pandemic with a different status of the epidemic in the United States actually demands an ability to pivot the focus and the intensity and the concentration of the resources around control, mitigation, rather than this idea that it would be contained and you would stop the cases, because we already had a large number of U.S. cases at that point. And then you have to look at what are the collateral public health consequences of the border closures and how might they make the situation worse, both globally and domestically, by where the various, you know, people would be going, the relocation process of introducing new virus earlier into limited and constrained resource settings and great vulnerability. So there is not one really simple sound bite that is a perfect fit for all those circumstances.
- Q Did you agree with any of the border closures or travel bans that resulted from this ongoing pandemic?
- A I'm not sure there was another border closure. I'm not sure which border closure you're speaking of other than --
- Q Well, let me go back to my question about Dr. Fauci. Can you just give me a yes or no to that: Did you agree or disagree with Dr. Fauci's statement that he thought that closing off travel from China saved lives?
- A In the opening days where the epidemic was intensely concentrated in a particular city, I think that taking measures to stem, most importantly, the exit and then consequently the other things that we could do on entry around leakage, was very important in both buying time and saving some lives in that earliest phase where we didn't know so much about the virus. I think by March of 2020, we had a lot more understanding of the global distribution of the virus, the intensity of the spread, and the pivot away from geographically-based border closures. Like I said, 212 Act was not a border closure, unlike the Title 42 specific aspects were. The other things that need to be done and need to be front and center and foremost in terms of the protection of all the populations in the U.S. need to be pivoted away from border closure. I don't know how to say it more clearly. I do agree with the comment that Dr. Fauci made as they were appropriate to the context and the situation in early January. I think the situation was very different by March.
- Q So we acted too slowly? Did we act too slowly in the early days? Should we have banned travel from China earlier?
- A Well, I don't know that we knew the situation. I mean, I think things moved very quickly once data was being uncovered. I can't really speak to the specifics of that timing.
- Q Let's move on.
- A This was unfolding in a -- you know, the situation in January was very different from the situation in March in so many ways.
- Q Okay. So you said -- testified earlier that you came back early from vacation back to work at the CDC. Would that have been January of 2020?
- A Yeah. I think I was back, you know, engaging by January 4.
- Q Were you coming to the office every day?
- A Yes.
- Q Do you think it's important that CDC personnel come to the office during public health emergencies?
- A Do you mean as a blanket statement, or do you mean on January 4 of 2020?
- Q Well, January -- I mean, we were in a public health emergency; would you agree?
- A The declaration of public health emergency came later. There was a lot unknown, and in January 4 it was important for me and my team to be able to convene and clarify and get as much information to characterize the risk, the nature of the threat, the speed and mode of transmission. So that necessitated -- necessitated us being on site.
- Q And you and your team were on site in January of 2020?
- A Yeah, and except for the team -- I mean, I had a large footprint of people that also work at the airports around the country and some regional international folks. Those people were at their duty stations.
- Q Okay. And did you think that that was -- that was prudent to have your team on site?
- A In January of 2020, the people that were doing the job that needed to be done were at the duty stations where they needed to be as we characterized what was going on.
- Q Was that in the emergency response center? And we won't talk about where it is, Kevin. Were you at the emergency response center at CDC? -- which we don't know where that is. Is that where you were, or were you at your desk?
- Mr. Barstow. We'd ask that be struck and ask that be redacted from the transcript. I think we've said the location multiple times in these forums, actually.
- By [MINORITY COUNSEL]:
- Q Were you working out of the emergency response center?
- A In January of 2020, and except for the people that were working in their duty stations in the field were working out of the emergency response center deployed out of their -- that's where we were.
- Q Thank you.
- Doctor; is that correct?
- A That is correct.
- Q Do you consider yourself a virologist or no?
- A I'm not a -- specifically a virologist, no.
- Q Do you have any opinions that you want to share with us on the origins of the virus?
- A Outside of my expertise, really, to comment.
- Q That's what I thought you might say. You commented on the reduction in CDC China staff earlier. You just noted that there was a reduction. Do you have any understanding of why there was a reduction?
- A I do not.
- Q Okay. During the prior pandemics that you've worked on, do you recall recommending any travel-related measures?
- A Travel-related measures like --
- Q SARS or MERS or H1N1? I don't know -- was H1N1 a pandemic? I'm not sure.
- A That's 2009. Yes. So I think that maybe I need to understand better what you mean by "travel-related measures." When I mentioned at the opening that our travelers help branch provides guidance for American citizens traveling internationally or American citizens living abroad based on their assessment of the infectious disease health risks and scalable, sometimes it would be no recommendations and guidance about it, sometimes it would be at a level 1, sometimes at a level 4. Sometimes it would be focused on specific populations. For example, in Zika, there was a focus on recommendations for how to stay healthy if you were traveling during, if you were a pregnant woman is one example. And all of those things. So if that's included in what you're asking me about as a travel health measure, yes, it's important to be able to provide global situation awareness of threats and mitigation, you know, mitigation strategies. Those risks escalate and change, and the mitigations that we recommend are proportionate to the nature of the threat or focused on the population that's particularly at risk.
- Q What prior pandemic would you say most closely, now that you have hindsight, mirrors COVID-19?
- A None.
- Q So it's just completely extraordinary?
- A The last time we had anything like this was over 100 years ago. And this scale, scope, magnitude, speed of transmission, nature of all of society types of impacts -- I've been doing this, as I said, for almost 30 years and studying infectious threats for many years prior to the CDC. This is truly -- has been, in my experience, an unprecedented event. I studied in depth the history of the 1918 pandemic and published extensively on the lessons and the tools and approach, looking at the impact of the 1918 pandemic across 43 cities in the United States in a different context of movement. That's about as close as I can imagine. But I did not live through that other than reading the historical record and analyzing the details of data. This has truly been an unprecedented event for over 100 years.
- [Minority Counsel]. Okay. I don't have any other questions.
- [Redacted], do you?
- [Minority Counsel]. I've got one or two clarifying ones.
- By [MINORITY COUNSEL]:
- Q So just to be clear, I asked you if you ever traveled to the southern border during the scope of this interview, and you said no; correct?
- A I don't know if you asked if I had ever traveled at any time to the southern border. I think you asked if I traveled to the southern border as a part of this pandemic response. Is that --
- Q Yes. Whatever the scope is today, December 2019 to whatever. So no, you've never traveled for this pandemic?
- A That is correct. I did not go to the border directly. I have a -- you know, that's correct.
- Q Did anyone from DGMQ go to the border during the pandemic?
- A Yes. I have a U.S.-Mexico unit office that's based out of San Diego, and there are staff, you know, in our quarantine station at Texas, and there are folks from my team in Atlanta that visited the border periodically during the pandemic --
- Q Did anyone --
- A -- at headquarters.
- Q Did -- was one of the purposes to examine the practicality of Title 42 expulsion?
- A We traveled there before the Title 42 conversations, and, in fact, before the pandemic started in terms of recommendations to mitigate the impacts of other migration experiences on the border and the risk of infectious disease outbreaks and have made recommendations on these infection control approaches in the past.
- Q Was there any memo or report generated based on those travels through the pandemic specific to Title 42?
- A Specific to Title 42. I don't recall. I mean, we traveled at the request of the -- the team traveled at the request of the CDC director to assess the kinds of recommendations that we have been made -- making for border facilities for many, many months in terms of infection control changes and ability to use traditional public health measures. And those -- that advice was provided back to the CDC director internally.
- Q Dr. Anne Schuchat, the former deputy director of the CDC, testified that it was your view in March 2020 that "the facts on the ground didn't call for this from a public health perspective." Do you think that was characterized accurately?
- A Did you say my view or her view?
- Q Your view.
- A My view -- that does characterize my view, which is that there were a number of things that were more important -- just as I talk about the pivot, there are much more important things that needed to be done that we had been, you know, talking about that were going to be critical regardless. And that the collateral public health damage that might occur through the approach that was being -- at least as it was being explained to me from the CDC director, potentially could do more harm than good. And it was important to not be distracted by some of the views with which that concept would come across without realizing what the failure to address the infection control situation might ultimately create. So that was my view.
- Q Did you -- how did you communicate those facts to the CDC director? Did you just call Dr. Redfield and have a meeting with Dr. Redfield? Did it escalate to Secretary Azar? Did it escalate to the White House?
- A Yeah. I mean, I don't want to speak to specific deliberations or, you know, there was an -- what's now, but my views were communicated internally when asked.
- Q Dr. Schuchat continued that you thought Title 42 was being initiated for "other purposes." Could you expound on what those other purposes were, in your mind?
- A I don't know specifically what all the other purposes were. My concerns were that the proportionality and the approach of using a public health authority at a time when we have a lot of intrinsic disease in the U.S. and the reported threat that was being, quote/unquote, addressed to prevent importation in that approach was not consistent, and it potentially risked the misuse of a public health authority that was not going to actually control or be used in place of the public health tools that we knew were important to do. And, you know, pandemics can be difficult times, and, you know, sometimes the epidemic of disease can be followed by an epidemic -- an inappropriate epidemic of stigma and misrepresentation of where the problem is. And we had the problem to be addressed internally that was very important and that needed to be specifically handled over the perception that a border closure at that time when we had so much disease was actually going to, you know, solve the problem and would not actually create other problems that were consequential.
- Q So it was reported that Stephen Miller at the time, who was a senior advisor to President Trump, was pushing for Title 42 on March 17, 2022. A month ago, former CDC director Robert Redfield testified to us under oath that he's not aware of any involvement by Mr. Miller in Title 42. Did you have any communications with Stephen Miller regarding Title 42?
- A I was on phone calls in which he was speaking.
- Q Okay. Specific to Title 42?
- A I'm not going to discuss the content of the internal deliberations.
- Q Okay. Current DHS secretary Alejandro Mayorkas said about Title 42, "We're doing this to identify a public health need, not an immigration policy." Do you disagree?
- Mr. Barstow. It's outside the scope of the interview, [Redacted].
- By [MINORITY COUNSEL].
- Q I'll say it. If we're doing Title 42 out of a public health and not an immigration policy, do you agree with me?
- A What? I don't understand what you just asked.
- Mr. Barstow. If you want to ask about during the time period from December 1, 2019, through January 20, 2021, about the use of Title 42, you may do so. But you can answer the question.
- By [MINORITY COUNSEL].
- Q Are you aware that the Biden administration has been in court defending Title 42 up until last month?
- Mr. Barstow. That's outside the scope of the interview, [Redacted].
- By [MINORITY COUNSEL].
- Q On February 17, 2021, the Biden administration filed a legal brief in federal court opposing an effort to end Title 42. Were you involved in any way with assisting or advising on that brief?
- Mr. Barstow. That's also outside the scope of the interview.
- By [MINORITY COUNSEL].
- Q On August 2, 2021, the Biden administration filed another brief defending Title 42 with accompanying declarations. Were you involved in any way in assisting or advising on that brief?
- Mr. Barstow. That's outside the scope of the interview.
- By [MINORITY COUNSEL]:
- Q That particular brief notes record and strained DHS operations and caused border facilities to be filled beyond their normal operating capacity, impacting their ability to
- HVC122550 PAGE 67
- employ social distancing in congregate settings.
- From a public health perspective, does COVID-19 transmit indoor in non-socially-distanced or congregate settings?
- A I didn't catch the opening piece. You're asking me the general question, is COVID-19 -- is the risk of transmission in congregate settings greater than in noncongregate settings --
- Q Yes.
- A -- that have cohorting and social distancing?
- Q Yes.
- A Yes, especially unmitigated, but are there ways to mitigate, and CDC has made recommendations on mitigating risks in various settings.
- Q That brief also asserts that DHS lacks sufficient capacity to safely hold and process all individuals seeking to enter the United States during the global pandemic. If the U.S. government were restricted in its ability to implement the CDC order, again, from a public health perspective -- not commenting on Title 42 itself -- does COVID-19 transmit more to individuals in any congregate setting for a longer period of time than they have for mitigation?
- A When you say "that brief," what are you referring to? You opened it by saying "that brief." I don't know what brief you're talking about.
- Q There was a brief submitted by Biden administration on August 2, 2021, to a federal court defending the use of Title 42.
- A Now what's your question? Does COVID-19 transmit in congregate settings more easily if unmitigated? The answer is yes.
- Q Okay. The same brief says "DHS would effectively need to release a growing number of families in the border communities, which risks overwhelming the local testing, isolation, and quarantine infrastructure DHS has worked to create and will thus burden local healthcare systems and strain healthcare resources." Is straining healthcare resources and overwhelming hospitals a public health concern with COVID-19?
- A COVID-19 has shown us the potential to strain healthcare resources, and in the settings in which that has occurred have been -- as I indicated before, have been due to the COVID transmission that's already occurring inside our borders and communities in that regard. And those circumstances, you know, are important to mitigate, as CDC has recommended.
- Q So you agree with all three assertions from the Biden administration's brief that Title 42, in fact, had public health benefits?
- A That's not what I said at all. You asked me very specifically about COVID-19 under a set of assumptions that were articulated by the secretary of DHS, not articulated by me. You asked me about the principles of can we and should we be addressing COVID-19's risk for straining healthcare settings and what can be done about that. And that's what you asked. And yes, those are risks. Those were risks in our pandemic planning. They involved the community mitigation strategies that I talked about to flatten the curve. And those community mitigation strategies to flatten the curve that we talked about do not include border closures. So I don't know how to be more clear of the distinction and the intensity of the times in which COVID-19 has stressed healthcare resources in this country being very specific to different phases of the internal domestic situation with COVID-19, omicron and delta responses being some examples. So it feels like you're trying to make some link and make extensions to a policy about border closure, and that's not what I'm saying here.
- Q So you actually disagree with the Biden administration's stance that Title 42 is a public health benefit?
- Mr. Barstow. Outside the scope of the interview,
- [Redacted].
- Q Again, on September 17, 2021, for the fourth time the Biden administration filed another appeal on a motion to stay a lower court order to keep Title 42 in place. Were you involved in drafting or advising that order at all?
- Mr. Barstow. That's outside the scope.
- Q On October 21, 2021, the Biden administration filed another legal brief in federal appeals court arguing that the court should keep Title 42 order in place. Were you involved in that at all?
- Mr. Barstow. That is also outside the scope.
- Q On November 29, 2021, the Biden administration filed another brief in federal appeals court arguing the Court should keep Title 42 in place. Were you involved in that?
- Mr. Barstow. That's also outside of the scope of the interview.
- Q On January 19, 2022, the Biden administration sent government attorneys to argue in front of the Federal Appeals Court that the court should keep Title 42 in place. Were you involved in that at all?
- Mr. Barstow. That's outside the scope.
- Q So when the Trump administration put Title 42 in place, you said you voiced your displeasure with CDC director Redfield. The Biden administration has been in court for 15 months arguing Title 42 should stay in place. Did you voice your displeasure?
- Mr. Barstow. That's outside the scope of your interview.
- Q Do you continue to disagree that -- or do you continue to -- is it your continued stance that Title 42 is not a public health measure?
- Mr. Barstow. That's outside the scope of the interview.
- Q Dr. Cetron, if HHS counsel was not objecting to all these questions, would you be willing to voluntarily answer them?
- A The supposition doesn't apply.
- Q Minority party didn't agree to the scope of these interviews. I'm asking if we were to call an interview with a different scope, would you be willing to answer the questions that I'm asking you?
- A I don't know. It depends on the questions.
- Q I just asked them.
- A I can't answer that at this time.
- [Minority Counsel]. Okay. Thank you. That's all we have.
- [Majority Counsel]. I think we can take a five-minute break and start back up at 11:05.
- [Recess]
- [Majority Counsel]. Back on the record.
- By [MAJORITY COUNSEL]:
- Q Dr. Cetron, I wanted to follow up and return your attention to this period around the -- I guess it was the first proclamation, January 31 when entry from China was suspended. You mentioned a number of the tools that were being used to enhance screening, and part of that was also contact tracing for people who came in. I'm wondering if you could tell us what tools you had and what the government had at its disposal to conduct contact tracing at that time.
- A We were more limited in the ability to do -- to get accurate, complete, reliable, and timely information regarding especially air travelers' contact information, and have been. And this has been a gap that I have been dealing with and working on and trying to get closed for a number of years, going back to SARS 2003, SARS 1 and others. And that's because the data systems have been constrained. And, you know, we need -- we need to know the who, what, when, where in a very quick way to be moved through digital means for an infection that can move rapidly and spread rapidly so it could be traced and followed, either retrospectively or if we were told about an infectious case that was in the travel corridor while infectious or in order to follow proactively infectious cases through an incubation period after arrival so that information can be rapidly acted on by public health officials and used to mitigate around cases -- you know, the case finding, the contact notifications, the isolation of a case, the implementation of mitigation strategies, quarantine household contacts and so on. And you need to do that quickly before the generation times pass and a disease like SARS-CoV-2, which has a high reproductive rate, every generation that goes by that you can't effectively contact trace is missed opportunities for a rapidly amplifying spread. And those data are not -- as I said, it needs to be timely, accurate, complete, and, you know, readily available. It's not something that you have to go back and forth and extract and it comes two weeks later when, you know, it gets out -- the horse is out of the barn.
- Q Was this something you were pushing for at that time, additional data?
- A Prior.
- Q Prior. Okay.
- A Beginning of January, I began raising this and just said, you know, looking at the potential volume, we really need you to get this in place. I don't remember the specific dates, but we had -- I had found the struggle to be problematic in prior epidemics. I also found that when it could be obtained in the course of Ebola, which couldn't be done with the advance notification or collection of the information that was necessary for public health purposes, we had to deploy large numbers of people to actually capture that information literally at the points of arrival and get it into digital systems immediately. But it was used to do -- and this was -- you know, Ebola was a slower-moving disease, nonrespiratory spread, more contact, droplet, fewer people were able to travel when they were highly contagious because it was an airborne illness. And it was a longer incubation period, 21 days. And -- but during the large West African Ebola outbreak, the public health system was -- and, again, the numbers were smaller. It was arrivals from the three countries affected in West Africa. They were around 35,000 a year, much different in a number constraint. But proactive following of people who had arrived from a risk area could be done in the public health systems, but we had to capture all that relevant information by setting up an infrastructure at the airport and then moving that data flow from the collection point into state and local public health departments in this pure manner. For a rapidly interpreting respiratory viral disease with the characteristics of this virus, that type of system would not -- would not work. So in -- I forget the specific days in January, we had an interim final rule on the contact data fields and had issued an order to airlines identifying the data requirements.
- Q And did you get that data from the airlines that you requested?
- A We asked for it before the regulatory process could keep up. It was a struggle. The quality of information wasn't where it needed to be in terms of complete, accurate, and timely and in a digital format, and we continued to try to close the gap on those things.
- Q Did you get it? I'm asking specifically about sort of the basic contact information -- cell phone, address --
- A So the basic steps -- there are a number of data elements that are collected by DHS and others in the system, but the information that's needed to do the job of public health contact tracing included these additional data elements. That's the only way to actually do that. It has to be up to date, timely, accurate, and complete and move digitally in order to move at the speed of the pandemic, and we weren't getting -- you know, we weren't getting those kind of things. And we kept pushing on them. They involved systemwide kinds of changes in order to do that.
- Q Two follow-ups. Who were you pushing? And what were you told about why you weren't getting it?
- A I think we were making the plea in general. I was having meetings with airlines in general about the need and why and how and the processes that they required to get -- you know, the regulatory processes that they required to go to work. We were trying to move through on the regulatory processes as well. Ultimately, we got these emergency orders, and then the systems would come into place and then we would evaluate the quality of the information. But, you know, all the different obstacles that would come up, the pressure points that we would use to try to make sure all these different pieces could get rolling logistically, regulatory, operationally, et cetera, et cetera. I think the speed and urgency of this issue had been identified. We had directions from many prior events. It just really -- we really wanted it to be moving, moving very fast with great intent.
- Q It seems like certain agencies like DHS, FAA have that data. And -- is that accurate?
- A I think there's a distinction. There are data that are available in AFIS and other systems and there's some data that are available in airlines, such as frequent flyer systems. But often the kinds of data that we need are not readily available in preexisting systems or require cumbersome intersectivity in mapping and manual, you know, bridge building in order to get them linked, in order for them to be current. Just as an example, an airline might have a phone number or an email address from a frequent flyer data set that was set up 10 or 15 years ago and it actually would not be accurate, reliable information to be used in the moment. That's the kind of thing where a legacy data system -- some fields were generally not captured in those systems or in multiple places in different systems. And some fields needed to be updated, and many fields needed to be moved into an electronic format so that they are available in an emergency without having to, you know, reconstruct and build and create new databases that don't happen in the time frame that are needed for response.
- Q Once the regulatory process started, was there any pushback from within government?
- A I don't recall, really, where all the different delays were, and I'm not even sure I'm characterizing it as pushback or delays or whatever. But in an emergency, it's just not the time to try to get the kinds of momentum that are needed on processes, and the amnesia that occurs after an emergency sometimes isn't enough to close the gap. And this has been a frustration and a problem from my perspective on the readiness side for a while.
- Q Did your request for that data have the support of the White House?
- A I don't recall all the specifics about where the support or where the barriers were on that. I think it was -- it ended up being a bigger and harder problem to solve, but most people who were involved at the moment appreciated it. And having the continuity of three decades of public health experience around this issue and then reeducating it every time there's an administration change about the urgency of that is difficult. I'm not -- Yeah. And then obviously there are privacy issues that come up around it and who is going to have access to the data and how it's going to be protected and how do we make sure it's used only for the intended purposes. So a lot of that stuff turns over anew in every sitting, whether it's departments and agencies or whether it's, you know, administrations, you know, at the White House level. But these are hard problems to solve. They're important problems to solve. And we need to not go through these cycles about looking at the same problems over and over again in the middle of a crisis, but just have a commitment that is part of readiness and a response that would solve these sort of basic public health gaps.
- Q I want to --
- A The arguments are familiar that you mentioned, and they happen often. We need to solve them.
- Q I want to take us forward into February and the decision-making that led to further proclamations and restrictions and focus our attention on Europe. So maybe you can take us to February and just generally walk us through what you were working on as it relates to travel from Europe.
- A Yeah. Well, the epicenters of the pandemic were shifting, certainly, by February, and more of what we were learning was being uncovered. And the ability to engage and deal with a variety of the issues as the epicenter was shifting became more challenging than sort of the single notice -- single locus and issues around the emergency in Wuhan and Hubei province in China. And whether it was putting up travel advisories, that is, the outbound recommendations, or getting the screening issues expanded or the 212F proclamations, as you were mentioning, on the expanding geographic scope and the utility on how that would work as opposed to other kinds of tools -- all of that became -- you know, the volume became a bigger deal. The nature of the engagements and the connectivity and the relationships between the Schengen zone in the U.S. all came into play. Those were hard. We saw the shift happening with the epicenter faster than -- the virus was moving faster in some places like that than we could navigate the change in approach.
- Q And when did you first start working on restrictions involving travelers from Europe?
- A Do you mean the advice to people traveling to Europe, or do you mean the issues around the 212F proclamation from the Schengen zone?
- Q The 212F proclamation that came later in March.
- A Yeah. I would say we were trying to gain traction for the concept that the pandemic was expanding in geographic scope in certain areas, and the kinds of tools that we would need, we would need to look at that volume and mitigation strategies that we needed to be putting in place. And, again, the things that I talked about earlier about moving from border and geography alone and the optimism that was had about portion border restrictions but not really border closures, but not having the kinds of other mitigation, both in regard to advice around travel, but especially around understanding the need to move into mitigation components. Since the border was being, perhaps, overly relied on at the expense of thinking about the level of domestic mitigation that was going to be necessary -- those were the kinds of things that we felt were really difficult, just the reality of what was going on, what we were going to be facing. This thing was becoming very, very clear by February.
- Q Can you give us a little bit of a practical explanation on what you mean by trying to gain traction on these ideas?
- A Lots of different things. So, you know, the work that I'd been involved in and I mentioned about the historical review of 1918 and the pandemic response plan that came out in '07, preparedness plan, the role of border restrictions versus mitigation and the need to look at what was necessary to flatten the curve, it was -- a couple things were quite, quite clear. One is that you wanted to change the shape of the curve. 2000 You didn't want the spikes to be very high where they overwhelmed healthcare systems. You didn't want them to happen so fast that you didn't have other systems ready. So goal one is to get the peaks down. Goal two was to shift the epidemic to the right to buy time so that you could come back with all the tools you needed to be ready, including rapid development of antivirals, vaccines, diagnostics, et cetera. And the third is you wanted the total area under that curve to be lower in sort of a more manageable way while you understood risk factors, who was at risk, while you focused on mitigation. The key part is that you had to intervene early, because once things begin an exponential escalation, that phase, you had to be there at that inflection point when things were starting to escalate, because they would move fast with a high reproductive rate. They were going to grow exponentially, not linearly, and you could quickly overwhelm. So the kinds of things that had to be done had to be done in advance, I would say in some ways earlier than most people would think is necessary, and they had to be sustained for slightly longer than most people thought they could handle. So it wasn't just about getting to the peak and at the first downturn you could lift those measures, but they had to be modulated and pulsed. That started early. Later there's multiple strategies that I have described in a Swiss cheese-like model, that any one layer was going to have some holes in it, but combined multiple mitigation strategies would be more robust and more protective, and they had to be sustained for periods of time in the pulse until you were in a comfortable place. And that overreliance on border measures alone as a single layer were not likely to get you that kind of impact. So although it was necessary to consider what that enhanced screening looked like, the contact tracing, case finding, all those kinds of things, you still, had to be able to prepare for testing, isolation, quarantine, cohorting, mask use, all of that other stuff. And as the epidemic started to quickly move in February, globalize and have big sort of pockets of waves, we could see some of that as being a herald of an event, and we looked at the volume of connectivity and the speed of connectivity by air from Europe and the outbreaks that were occurring there and anticipate by the arrival that it wasn't very long before those would be major sources of -- you know, of outbreaks across the United States. And we couldn't wait for them to happen in order to be prepared to manage them. It just felt like it was too hard to get that kind of anticipatory reality of what was unfolding through all of the navigating the policy processes, whether it was surveillance or expanding, you know, testing options, you know, distribution of masks, isolation, quarantine. All the kinds of things that were in that '07 playbook, you know, were -- in addition to how we could understand the movements at the border -- one, border closures alone wouldn't necessarily do it, and, two, the need to sort of have all these tools available and, you know, early detection of arrival was going to be critical. And that was hard.
- Q And who were you and your team making this case to at that point?
- A Well, it was my responsibility, sitting on a lot of the interagency things. But first internally making the case, you know, into the response structure and into what -- you know, in the conversations with the division director and in the meetings that we would have with HHS, just understanding the nature of what was going on. And then there are other forums to make those presentations, other settings in which to do that. And so there were multiple places where we could articulate this framing.
- Q Pointing you to the interagency settings, who were you making that argument to and how was it being received in this period? Because, you know, the restrictions didn't come into play until March 11 from these countries. So I'm wondering about this critical period.
- A Yeah. No. These -- you know, I think we were invited to attend and make presentations. CDC was the interagency, the task force. Just looking at some of the exhibits you sent with some agendas, I don't remember the details of the dates and stuff, but --
- Q Sure. Let's look at them. I think they're Exhibits 2, 3, and 4. 2, 3, and 4 --
- A There were meetings that were occurring in February as well while the HHS was still chairing the task force, and then there were meetings that were occurring when the task force -- we switched over from the HHS secretary to the White House directly. And we were at the table. CDC was at the table and presenting sort of the forecasting of the significance of the potential severity of this virus and its characteristics in particular.
- Q And looking at these agendas -- and you might not recall them specifically -- but Italy was on the agenda, the screening update from Italy. You and Dr. Cetron [sic] were briefing the task force. I'm wondering if you can characterize how your presentation of these concepts that you've been talking about was received at that point.
- A I think you mean Dr. Jernigan and I. If I'm correct in this, I think he was the incident manager of -- the incident lead of the response structure, and a lot of these components were in my area of expertise. And so Dan and I were presenting kind of regularly at some of these meetings. And I described basically, you know, as I'm saying in terms of the general content was that this is significant. Both Dr. Jernigan and -- he had been an NIH officer of mine many, many years ago in respiratory diseases. He had a lot of experience as well, and we could both see the writing on the wall here. There were a lot of red flags, and we were trying to, you know, demonstrate the trajectory of the case occurrence as they were being defined globally. And in particular Dr. Jernigan asked what the domestic situation was looking like. I would be asked to describe some of the travel issues and volume and the potential for, you know, what was being missed in the screening modes and how -- what was the importance of getting things ready for these waves that we had seen. It was pretty devastating, the other places where they had occurred. So I guess I would say that CDC had a much greater level of concern about what this -- how this pandemic would unfold. That's what we were -- that's what we were asked to express and brief on.
- Q And generally what was the reaction from meetings like this, the White House task force?
- A It varied, to be honest, depending on different perspectives. We were offering a science-based public health perspective. Others were offering, you know, different perspectives and process.
- Q Dr. Schuchat said that the CDC has been pushing for this restriction from the Schengen countries and it had been delayed for a period of time. Is that accurate?
- A That is fair.
- Q Okay. Can you talk about that delay and what caused that delay?
- A In general, it just was all the other parallel factors of concerns regarding the connectivity, impact, you know, on things other than the public health impact. Just the general -- you know, sort of the general tone. And as I said, you know, this concept of multilayered strategies and tools. We needed a multiple approach in here. It wasn't that the point was to rely exclusively on a 212F, which seemed to be one of the things the administration had seemed to value in that regard, but also to ready the domestic situation for, you know, preparing to be able to implement mitigation strategies that had been in the response plan and the seriousness of what we would likely be anticipating in a very short period of time. So, again, there was just this general overall concern that maybe public health was overplaying the concerns and the significance and that there were all these other factors that need to be brought to bear. I think that was the general.
- Q Who was expressing that, without getting into specific conversations?
- A No, no. I'm just trying to give you a flavor. I'm not going to go down the "who said what, when, and where" and stuff like that.
- Q Okay.
- A These were internal deliberations. I'm trying to give you a sense of where the balance of thinking was about this.
- Q Sure. Understood. Our colleagues mentioned that part of our interview with Director Redfield, and he described you as being extremely frustrated during this period. I can review what he said. "One of the areas that was particularly frustrating was the area you're bringing up about escalating the order of travel. At the time, CDC felt that travel alerts should be alerted. So if you ever bring in Marty Cetron -- I don't know if he's one of the people he interviewed -- I'm sure he'll go into this in enormous detail, because he was extremely frustrated." Tell us your frustrations.
- A Okay. I think Dr. Redfield's sentiment accurately describes my frustrations. Things weren't being taken seriously enough. They weren't moving quickly enough. It was being underplayed and perhaps at a risk of what I -- and not I alone, but I and others at CDC were seeing as the inevitable consequences of delay. I had been one to study this in detail in the lead-up to the U.S. response plan in 2005 to 2007. I had seen what happens when there are delays in implementing multiple measures at an appropriate time, how quickly things can get overwhelming, and I had done a lot of analytic work on the toll of the delays and the shape of the way the epidemic would occur. I've seen the comparisons between Philadelphia and St. Louis, and I knew that you could flatten the curve. I knew you could mitigate the impact. I knew you could alleviate the strain on healthcare systems. I knew you could save lives. And I just didn't feel like -- I just didn't feel like there was enough listening going on. So it was very frustrating, and that's a fair -- his comments are a fair characterization. It required bold responses earlier than might be tolerable, and I know that those responses wouldn't be easy and would have some of their own consequences to weigh, but it felt clear to me that the failure to act in a timely way could really be significant for the country.
- Q And I think you just articulated this, but it's been said and we've heard from witnesses that this period in February was a lost month where things should have been done that weren't. Would you agree with that assessment as well?
- A More should have and could have been done, and the CDC was really, really pushing for more. It would have -- I think it would have helped significantly alleviate a lot of -- a lot more suffering and death.
- Q I want to change gears and talk briefly about messaging to the public. And you, along with other leaders, participated in telebriefings, providing updates to the public. I think you spoke January 17, January 21, January 24, and January 31 in telebriefings with others. Can you talk about those communications in the general sense and the importance of that.
- A Well, I can say that having also having been part of a lot of epidemic and other pandemic responses, the technical expertise is necessary; that is, the CDC technical expertise is necessary but insufficient. And communication is a huge part of it. And a big part of the communication has to be about public trust and that in settings where -- even where there was technical expertise, if there was for whatever reason -- and those reasons vary across the globe and, you know, on rationale, but where there's a bankruptcy of public trust or a bankruptcy of trust in the various institutions that are involved, you can't get -- you can't get an effective public health response when there's not a lot of trust. And that trust comes from timely, honest, transparent, regular, repetitive communication, including honest uncertainties about what's ahead, what you know, what you don't know, what you're doing to fill in the gaps, when we'll come back and tell you more. And that has been sort of a mantra training process for all CDC leaders who are involved in public communication. And I think it's very much true today. And there are many factors that are involved that erode trust. But it is so important to getting effective response to a public health crisis in an emergency. It's absolutely critical. Even the best technical solutions and technical agencies or plans or know-hows will crumble under the lack of effective communication and trustability.
- Q Was that mantra followed in moving forward past January and February?
- A I think it – there was a lot left to be desired.
- Q Why?
- A You know, one of the things -- there were so many factors and reasons in why this all evolved the way it did. But a lot of the way in which CDC would normally be regularly out there communicating, whether it's the CDC director or the senior leaders who are involved in the response, you know, shifted between probably when Dr. Messonnier and I were no longer doing those briefings. There was sort of a shift in the level of the briefings occurring in different settings and spaces. So I don't know. Again, there's probably a lot of reasons. But there was -- that was somewhat atypical from the way CDC responses had previously been done, whether it was the Ebola response or other kinds of things.
- Q Can you describe that shift and what it meant in terms of public health?
- A I think there was a de-emphasizing of communication from CDC directly, and more of the communication around the pandemic was coming, you know, outside the realm of public health officials or the government communication was occurring in different settings. Not that it's not appropriate for there to be whole of government communication, but there was not the level of communication that CDC would normally participate in as a component of overall communication. That's my sense, but that's -- again, there are many factors.
- Q What about the -- do you have a view on the quality of the communications coming from those other places?
- A I didn't -- I didn't think it met our standards for scientific accuracy. But that's my opinion. The principles and the teachings about how to communicate in a public health emergency and a crisis, what do we know and what do we not know, what are we doing to find out, coming back regularly, what can you do in the interim until we know more, what is the sort of factual scientific credible, both risk assessment, things that can be done to attenuate risk, scope, and magnitude. Those would be normally the places which CDC would fill in the way that we're more accustomed to. I think that that role was being fulfilled in the same way when the communication sort of didn't include as much of the CDC perspective.
- Q Anything that stands out to you specifically in terms of not meeting those ideals and principles?
- A I think there's -- I think there's a number of examples about, you know, what therapeutics work and don't work, what the approach is, what the perspective was on the trajectory, how long things would be until everything was over, you know. There's a lot of different areas which I just don't think was consistent with the science of what we were actually seeing. I'm sure you've heard numerous aspects about this by communication experts.
- Q Sure. And I won't get into specifics, but I want to ask you about the impact, and you mentioned this bankruptcy of trust. How did those communications contribute to that idea?
- A Well, information -- misinformation or information that's not factually accurate really erodes that, because if there is disinformation, misinformation, whether by intent or by accident that is not true, people wonder, you know, if anything that is being said is true. So -- or if it's, you know, contrary to what people can see in their own lives or out their door and it doesn't jibe, it erodes the credibility of the government's response, and it calls into question all sorts of things. It calls into question motives and all sorts of other stuff. And it's just not a time where those things should be -- it's a time where that kind of trust building and communication integrity is so important in order for people to be well informed, in order for people to be able to take the right steps, in order for people to anticipate what the impact on their lives will be. So it's -- it was very difficult.
- Q What was the public health impact of sort of those failures, as you articulated them?
- A I think a lot of confusion is one of them. A lot of uncertainty, a lot of questioning sources of authority, a lot of questioning what's true and what's counterfactual, you know. Calling into question the kinds of measures that might be needed and in what ways. And that kind of, you know, inability to grasp the circumstances you're in and take the right steps and protect yourself and your family, protect the most vulnerable people in your communities. All of that gets thrown into confusion and chaos, and it becomes really difficult. And that void gets filled by a whole variety of folks that are talking with various degrees of expertise, of various degrees of agendas or intent that may be different from the Public Health Service concept. And so it just becomes really, really hard. And a lot of, you know, false narratives get created, a lot of excessive blame and stigma. All of those kind of things are consequences of the failure both to build trust and accurate, timely, and credible information delivery.
- Q Do you think that the president adding to that confusion contributed to those problems, as you articulated them?
- A I'll leave it to you and others to judge.
- Q Given your expertise -- and I know you've done extensive work on looking at nonpharmaceutical interventions in the past -- do you think communications around those measures would have changed what we saw transpire over this year?
- A I do. That middle game before you have medical countermeasures, good treatments and good vaccines, and even when you do, the virus has the ability to mutate and escape. And so overreliance on waiting for the magic bullet has been a repeated, you know, lesson observed. I wouldn't even call it lessons learned. And the importance and value of nonpharmaceutical interventions in flattening the curve have been very well demonstrated scientifically. And I think the inability to communicate, one, that we need multiple tools for a pandemic of this degree of seriousness, that this long middle game -- I talked about the opening act and the middle game when you don't really have the medical countermeasure tools and you have public health measures, pharmaceutical measures, they need to be conveyed really accurately. Because that's what is going to make a difference on whether we can avoid an overwhelming surge in the healthcare system where we can protect those that are most vulnerable. We understood that we were using those things like masks not just as a matter of personal protection, but as source control for, you know, an unseen virus that spreads very rapidly and can quickly, you know, take out a large portion of vulnerable populations. I think proper communication on the why and the how and the impact of those things could have had a tremendous difference in mitigating the pandemic. While we awaited some of our most powerful tools, which have been the vaccines and more recently the antivirals, but also acknowledging that the toolkit has got to be mixed, and it takes a while to develop immunity and the virus is -- you know, while we may be sick and tired of the virus, at times the virus was not tired of making us sick. And in that setting, the virus is mutating and changing, and it may render some of our medical countermeasures less effective than others, although by and large they are really powerful. They are super important. But I think that the failure to appreciate the seriousness of the threat and the intensity of the virus's capacity to constantly throw us curveballs kind of undermines our ability to reduce suffering and save lots and lots of lives.
- Q I'll close with this: Given your expertise in this area and the research that you've done on these measures, do you think consistent messaging on nonpharmaceutical interventions -- what do you think the difference would have been in terms of the impact that we saw from the virus in the first year?
- A Yeah. I think honest and accurate messaging about the potential impact and how to empower people to take care of themselves, their family, and their neighbors and their community could have had a huge impact in keeping the mask as a measure of hygiene and less as a political signal or statement. And I'm saddened by the way an instrument of hygiene, sanitation, you know, lost its real meaning as an instrument of, you know, some type of other agenda signaling. So that saddens me. "Consistency" is a difficult term to use in that setting. I mean, honest and transparent and accurate and up to date, because things change during a pandemic. We've learned more all the time, and it may be that, you know, the messaging deviates a little bit in terms of what we know and what we've learned, whether what type of mask and what settings and actual impact of transmission reduction, disease reduction and so on. But the general principles of being very up front in conveying the scientific information to the power of these nonpharmaceutical mitigations and how they can shape the experience of this pandemic in terms of suffering and death, you know, was -- is clearly -- was lacking, you know. And I think that hurt. That hurt all of us. It hurts all of us and our families. And there are people, you know, who are no longer with us that would have benefited from that kind of very clear messaging.
- Q One last question in this area, and it's, you know, you mentioned the times that you were out there in telebriefings in January. We didn't really hear from you that much after that. It was reported in CNN that CDC officials said they had been muzzled and that their agency's efforts to coordinate -- to mount a coordinated response were hamstrung by the White House. You're a subject matter expert. You were out there in front of the public. Did you feel muzzled?
- A It was clear -- there was clearly a change in February in terms of how the communication would go. That's all -- that's all I can say. I mean, I think it was unfortunate change in -- not saying that it should have been all one way or all another way or whether it should have been me or other folks from the agency, but I don't think CDC was able to effectively communicate its messaging, as had been sort of the more normal approach to responding to public health crises, and I think that ultimately undermined an effective response. It's not about me.
- [Majority Counsel]. I want to move forward to talk about -- well, actually, rather than opening another huge topic, I will cede my time to my colleagues, but ask you if you want a five-minute break.
- HVC122550 PAGE 100
- Mr. Barstow. [Redacted], it depends how long you're going to go here. If you know.
- [Minority Counsel]. I think we probably just have a few minutes. Are you ready, Dr. Cetron?
- By [MINORITY COUNSEL]:
- Q So my colleague [Redacted] asked you some questions about CDC telebriefings. Do you know how many were given under the Trump administration?
- A I don't. Do you mean how many CDC telebriefings? No, I don't.
- Q So it was 27 over the 12 months, January to -- 11 months, January to December. Do you know how many were given during the Biden administration?
- A I don't.
- Q Six over 17 months. You said the Trump administration messaging left a lot to be desired. There were 21 more CDC telebriefings. Does your statement apply to the Biden administration as well?
- Mr. Barstow. Outside the scope of the interview, [Redacted].
- Q You were also talking about disinformation and how it "erodes credibility in the CDC." President Biden said, "If you're vaccinated, you're not going to be hospitalized, you're not going to be in the ICU unit, and you're not going to die." Dr. Cetron, have vaccinated Americans been hospitalized for COVID-19?
- A Yes. Certainly different proportions, significantly different proportions.
- Q Okay. Have vaccinated Americans been in the ICU for COVID-19?
- A Yes, I believe so.
- Q Have vaccinated Americans died from COVID-19?
- [Majority Counsel]. Just one quick point. The vaccines were rolled out in January of 2021.
- [Minority Counsel]. [Redacted], I don't think it's your time. And we've objected to many majority questions before, and you won't entertain our objections, so I won't entertain yours.
- [Majority Counsel]. It's outside the scope.
- [Minority Counsel]. You said July 2, 2021. But I'm asking health-oriented questions, not specific to that statement.
- Mr. Barstow. What was your question, [Redacted]?
- [Minority Counsel]. I'll just start over.
- Q So I read you President Biden's statement. I want to ask you three yes-or-no questions. Have vaccinated Americans been hospitalized with COVID-19?
- A So --
- Q The question is a yes-or-no question.
- A What do you mean by vaccinated? A single dose or fully vaccinated or boosted. What do you mean by the term "vaccinated"?
- Q Fully vaccinated. People who were fully vaccinated by the time the statement was made.
- A Have there been people who are fully vaccinated that have been hospitalized?
- Q Yes, correct.
- A Not all fully vaccinated people respond.
- Q Have there been fully vaccinated people who have been in the ICU unit for COVID-19?
- A Probably with the same caveats, many fewer, but not everybody is responding the same way to the vaccine based on --
- Q And have many vaccinated people died from COVID-19?
- A Again, with the same caveats, depending on their ability to mount a response or be protected by vaccine and whether they have been boosted and how long it's been.
- Q So, generally speaking, if I say if you're vaccinated, you're not going to be hospitalized, you're not going to be in the ICU, and you're not going to die, is that a true statement?
- Mr. Barstow. [Redacted], you're trying to take that into the presidency and a lot of the context. We've allowed some questions here, but I'm going to instruct you not to answer the question.
- Q Okay. President Biden also said the vaccines "cover the highly transmissible delta variant" and "you're not going to get COVID if you have these vaccinations." Have people caught COVID while being vaccinated?
- Mr. Barstow. That's outside the scope. We've allowed some questions in this phase. I don't think we're going to get any further.
- [Minority Counsel]. How is it outside the scope? COVID has been around since October, November of 2019.
- Q So I'll ask you this question: The first vaccine rolled out in, what, early December of 2020? Have people caught the virus between December 2020 and January 20, 2021, that were vaccinated?
- A The question you're asking really has to do with what the purpose of the vaccine has been, and the purpose --
- Q No, that's not what I'm asking. I'm asking if a vaccinated person can catch COVID-19.
- A But the vaccines -- the purpose --
- Q It doesn't matter --
- A -- is not whether you're infected or not. It's designed to attenuate the severity of the infection, and this is an example where nuanced messaging matters. So the vaccinations, being fully vaccinated and boosted are some of the best protection possible to avert severe disease, hospitalization, ICU admission, and death, point blank, and all the data support that. It does not actually say that everyone and anyone who gets a vaccine won't catch COVID. That's not the way that it's worked.
- Q Okay. You said nuance matters. So if I say that you're not going to be hospitalized, you're not going to go into the ICU, and you're not going to die, that's not very nuanced.
- A What I'm saying is the end point of the vaccination depends on who's being vaccinated, how much vaccine has given since, the time since the last dose. The point of the message is will the vaccine make a significant impact on what events as they emerge, whether they will circumvent some of the protection of the vaccine. That is nuanced. So, again, I thought I was very clear about the word on consistency of messaging. It's not about consistency; it's about being able to clearly explain what we know and what we learn as we learn it and not always saying the same thing that applies at every state when the new variant emerges and it escapes some of the effect of the vaccine or an elderly person doesn't respond or someone on cancer chemotherapy whose immune system is damaged by both disease and treatment, you're not going to get the same response. But the point of the message is will the vaccine make a significant difference on the proportion of people that are hospitalized, that die of COVID. There is no doubt that that's a true statement. Could that be messaged more clearly and can that occur in the proper setting? Absolutely. But it's not about perfect consistency and simplicity; it's about the accuracy of the message. And it matters. And the truth about the power of the vaccine to change the shape and the trajectory of the pandemic are quite important. But it depends on how many doses, how they're used, in what populations, who's being exposed and who's not, and what variant is emerging. That's the honest truth, [Redacted]. That's the way it works.
- Q And I'm not disputing any of it.
- A It feels like a little bit of a "gotcha" game here, and I think it's a big --
- Q Dr. Cetron, I'm not disputing any of what you just said. I'm just saying you were asked in the last hour about disinformation. You were asked about consistency of messaging --
- A I think there's a difference between disinformation and --
- Q It's wrong information. It doesn't matter if you disagree with it.
- A No, there is a difference. There's a difference in whether it's about intent, about how off it is. Variations around the predominance of truth and acknowledged certain amount of uncertainty of variants is one thing than offering up a counterfactual. Those are different types of disinformation. One may be done innocently, and it may be done by intent. Those are different types of disinformation. They are not all the same thing. And I was speaking in general that things that are -- where the counterfactual is portrayed as equivalent to the facts themselves, not these minor variants, that matters. When people can equally believe a complete counterfactual rather than understanding that this is true in the majority of times with 5 percent uncertainty is not the same as saying that this is completely counterfactual to everything we know. Those are not equivalent. And I'm sorry it's not convenient, but that's the truth.
- Q All right. Then I'm going to ask these again and you can just give me yes or no. If I say if you're fully vaccinated you will not be hospitalized, am I lying?
- Mr. Barstow. [Redacted], he already answered these questions. He's not going to answer them again.
- The Witness. I'm not going to keep playing.
- [Minority Counsel]. We have no more questions then, thank you.
- [Majority Counsel]. Dr. Cetron, I wanted to check in with you if you wanted to take a break or if you wanted to keep going.
- The Witness. Yes. Is this the break we take for lunch, or is this a five-minute break?
- [Majority Counsel]. It can be either. If you discuss with Kevin what your preference would be, we'll decide amongst ourselves as well.
- [Discussion held off the record.]
- Mr. Barstow. I think a longer break now would be good and then we can power through.
- [Majority Counsel]. That's fine with me.
- Mr. Barstow. 12:35?
- [Majority Counsel]. Is that okay with you, [Redacted]?
- [Minority Counsel]. Yes.
- [Majority Counsel]. We'll be back on the record at 12:35.
- [Recess]
- By [MAJORITY COUNSEL]:
- Q All right. Back on the record. Dr. Cetron, I'd like to move to another topic that was occupying a lot of your time, and that's cruise ships. I want to discuss how your team handled decisions around the outbreaks on cruise ships in the February-March period going forward. Let's start -- can you tell us how you first came to learn about coronavirus outbreaks on cruise ships.
- A Sure. Our first exposure had to do with the Diamond Princess docked off the coast of Japan reporting an outbreak of cases, and trying to understand the circumstances in that situation. I mentioned to you that my group, Global Migration and Quarantine, has some international field staff. We had the head of our office program that was based out of Bangkok, Thailand, Dr. Barbara Knust, and both from requests that were coming in from different places, including from the embassy in Japan, from, you know, State Department, from a variety of interests, we were trying to get a better handle on what was happening, because there were a number of American citizens on the Diamond Princess when it was ultimately docked in the harbor in Japan. And Barbara Knust was closest to the area, so I had asked her to deploy in support of the U.S. interests in coordination with the Japanese, you know, public health authorities. That's how we were sort of started trying to understand the circumstances. Again, it was really early in the COVID experience, but it was very -- sort of heralding a scenario where you have a closed environment with a prolonged stay. So when you look at these things, we look at the person, place, time, and space as variables which impact the risk for an outbreak, whether the -- what people are on board and what their vulnerability or risk for getting sick would be if they become infected. Place, what's the nature of the location, what are sort of the environmental constructs of the situation, indoor/outdoor, enclosed, ventilated poorly, well ventilated. Those would be the sort of characteristics around place, location. Is it in the middle of a hot zone? Is it an emerging area? Is it pretty far from the presence of the virus. Person, place, time. How much time were people spending in a setting of risk. And then space, what is the nature of the actual space in the environment. A lot of it -- as one can imagine, a lot of cruise ships, you know, would be ticking a lot of those boxes as a risk environment for a respiratory virus that spreads efficiently and quickly from person to person. They tend to be very crowded, large populations, very mixed international populations. The passengers, in general, are skewed more toward the elderly and more toward vulnerable, although that is not uniformly true across all the ships and all the lines, but as a generalization. And they're served by a large number of crew, which tend to be younger and more international, from particular areas in the world that haven't had some early impact of the virus. The passengers rotate generally around a week and the crew tend to carry over from vessel to vessel. So, as you can tell from what I'm describing, it is not surprising, perhaps, that cruise ships became one of the early sources of an outbreak, given how confined they were. And this was a really important outbreak, not only because of the size and the magnitude of those people who quite vulnerable on board, the impact, but, in fact, it sort of was an opportunity of a passenger population to understand some of the characteristics of the virus by what the attack rate what is, what the submission period was. How things were being interpret. So it was a really critical time to understand COVID in a maritime setting.
- Q And in terms of what your team learned, what were some of the things that had to be done to prevent this from happening on other ships?
- A It was -- well, so there's a lot that we were trying to understand. One is how could those -- how could we mitigate the outbreak on board. What would be the impact of disembarking the passengers on the local port communities and the introduction and spread. The ship had some challenges finding the harbor. Once it was identified as a place of having an outbreak, how would we safely identify who on board was infected, who needed to be triaged and taken to a local hospital for medical care, what was the attack rate, how could we get testing done in that setting. How many people got sick relative to how many people got infected? Was there evidence of asymptomatic or presymptomatic spread? Was there clustering of infection by a cabin or by area on the ship. What would that tell us about the level of infectivity? What types of measures were being put into place? Was there surface contamination issues that represented a particular transmission risk, or was it all moving through air and droplets? It was a lot to try to understand. And then it was an international setting and the whole issues about repatriation of citizens from multiple countries came into play, how could that be done safely, how would you repatriate people from an intense outbreak epicenter. And so on. So it was an international incident, obviously, and at times early in the pandemic the cruise ship itself, Diamond Princess, became a place that had more reported and confirmed cases than many other places outside of China, per se. So it was sort of a herald event and in -- what we have come to learn as a high-risk event. We had an outbreak investigation SWAT team that was involved and much engagement, international-coordinated engagement. And then it informed things about CDC guidance and recommendations about maritime safety in that environment and what COVID would mean -- what challenges were faced and what COVID would mean to high-risk persons that might be joining other cruise ships. And ultimately we had developed a dedicated maritime unit separate from the global migration task force just because of the scale and magnitude of that problem, the number of ships, the number of ships that were demonstrating infection where outbreaks were occurring and escalating that were at sea in all regions, you know, of the world that were having challenges finding a port harbor and evacuation issues and many, many other things that were unfolding in relation to this. So it was not a one-off incident, and it was an incident with a lot of global significance and had a big intersection with the global sort of travel and trade components.
- Q It's been reported that the Diamond Princess and then the Grand Princess after that occupied a lot of time of the White House task force in terms of the decisions that had to be made around those two. Is that accurate? And what was your experience?
- A It is accurate, because, as I said, the Diamond Princess, as a herald event, barely unfolded and the circumstances that led to that event and the growing, more globalized nature of the presence of the virus as well as the fact that cruise ships served as large mixing vessels, if you will. That is to say that in the course of introducing even a single or small number of cases, given the prolonged stay the living quarters, that the transmission would amplify very quickly in that setting, and then people after that period would scatter globally and become seeds and sources of introduction. So it was pretty important to understand the niche of the cruise ship environment in not only its role that one would play if you tried to contain a specific outbreak on a specific vessel, but that this pattern would likely be repeated over and over again across multiple vessels at sea. And such was the case. We had our own essentially domestic experience with an international cruise ship infection with the Grand Princess that went, came in out of California. And so -- and they're large population bases. I think when you mix passengers and crew, you're talking about thousands of people on board that are living, eating, you know, recreating, vacating, vacationing, all sorts of things that are together in common indoor spaces, some of which are very poorly ventilated and could be very crowded. So they were like floating cities of populations that were intensely intermingling at close risk. And it did take a lot of time not only to figure out how to define the risk of introduction and then amplification, mitigate it on board, mitigate its impact when people were embarking and disembarking and its impact on port communities and their healthcare systems. The transportation -- once people come back to a port and they have to get on to other commercial transport in order to get to where they're going and what the risk that that would entail. So it was kind of a microcosm of understanding multiple factors in managing the COVID pandemic in a maritime environment as a source of not only introduction, amplification, but also distribution and seeding and setting up new loci of infection in other places along the trajectory of that movement. It would take a lot of time.
- Q Who was making the ultimate decisions on this in terms of the task force?
- A Again, I think, as I indicated to you earlier, there are multiple levels of decision-making around -- depending on the type of problem that was being solved. But they were significant because of the scale of which the number of ships at sea, the number of passengers, crew members, number of countries that are implicated by the itineraries, there were many complex issues and complex policy issues which elevated up and down the sort of layered chains of responsibility. So there were definitely engagements in the White House task force. There were engagements in the interagency. There were engagements with state and local communities. There were port communities. There was a lot going on. And, of course, there were economic interests outside of the specific -- the public health interest, stuff outside but nested inside and interdependent in terms of how to manage the risk.
- Q Was there opposition -- sticking with the Diamond Princess and I guess the first 14 passengers who arrived in the U.S. from Japan, was there opposition to that decision to repatriate the sick passengers?
- A Some of the sick passengers were disembarked and cared for locally in Japanese healthcare facilities. Some of them who were not too sick to travel could be repatriated. Some of them who were not yet sick but may have been incubating or exposed possibly were part of the cohort that was repatriated. I think the idea of whether to repatriate American citizens from the Diamond Princess was not as -- not controversial, per se, in that setting. How to do it, how to do it safely and how to do it in an international context, those were challenging problems to solve, but I don't think there was a debate about whether to do it.
- Q It was reported in the New York Times that the president was "furious" when those 14 passengers were flown into the U.S. Was that position something that was articulated down to you, and did that change any of the decisions going forward?
- A We were aware by the media reports of the comments that the president was making. I would say that I think -- I don't remember exactly what was on the schedule of people that were, you know, quite busy around this, but the decisions about to repatriate or not in advance of those decisions, I don't think got raised there, so I can't speak to the specifics of what the degree were.
- But the planning around repatriation proceeded and perhaps proceeded prior to his comments. I don't remember the specific details on timing.
- Q Did his comments affect these decisions going forward, moving on to the Grand Princess and other ships?
- A As opposed to the decision to repatriate from the Diamond Princess?
- Q Moving forward.
- A Yeah. It's hard to know. I think the problem was is that there were many, many thousands of Americans at sea on ships during COVID, and ships -- and the number of outbreaks on ships was increasing very regularly, both in scale and magnitude. Outbreaks that involved significant morbidity and mortality as well as global distribution, and it created some challenges in terms of how to manage them, how those cases would be counted, whether they're counted, you know, in some type of -- against some type of international setting or whether they would be counted as U.S. domestic cases based on their citizenship. There was a lot of confusion handling that. I tend to see those kind of questions come up pretty regularly in outbreaks in globally mobile settings. So it's hard. It complicates policy as what the ledger of the cases going to be. But really the issue is how do you safely manage those cases to reduce harms, hospitalizations and deaths, to reduce transmission, to reduce the trajectory of impact as -
- [Technical interruption]
- [Recess]
- The Witness. I think you were asking -- maybe if you can repeat your question, [Redacted]. Not from the beginning.
- Q You said something interesting about ledgers and the issue of case counting. I wanted to ask you about that and sort of what the discussions were about case counting when it came to the next cruise ship crisis, the Grand Princess.
- A I think that -- I think that it's always confusing when outbreaks are occurring among globally mobile populations and occurring in places that are outside of the nation's domestic territory. How those cases get attributed, whether it's by place of exposure, whether it's by place of diagnosis, whether it's - you know, if the state that the person is resident of or the state, you know, if the exposure occurred at work. These are not uncommon challenges. And so the surveillance issues, you know, came -- those cases are cases that happen on cruise ships, and that always gets defined a little bit. That's not an uncommon problem. The bigger problem from the public health perspective is how to actually contain an outbreak in a globally mobile or internationally mixed setting, especially one that happens, perhaps, in international waters. And how do you safely intervene in the outbreak, make recommendations. How do you get the people who need medical care that's beyond the capacity of the vessel to safely give medical care. How do you move all the other people who may be infected and exposed but don't know it or incubating and it's not clear, how do you get them safely home. Those are the kinds of things that Diamond Princess opened that can by showing us that this is going to be a problem moving forward. Grand Princess reaffirmed that this was not a single vessel type unique circumstance. And then as we stood up a maritime unit and began a surveillance system to track cases that were out at sea or, you know, among recently embarked or disembarked persons or in support communities at ports, we realized that we were having to deal with a whole gamut of these international microcosms of high-risk events, high-risk settings that could basically be sources of introduction, amplification and distribution and seeding. And that is a challenge of these kind of floating international cities that periodically visit multiple countries in port calls, et cetera. It's a unique, difficult situation to manage.
- Q I want to get into the substance of the actions that were taken, but I wanted to ask you one last question about this sort of ledger issue. The president said publicly on March 6, when he was actually at the CDC, and he was asked about the infected passengers on the Grand Princess, and he said, "I don't have" -- "I don't need to have the numbers doubled because of one ship." First question is: How did the president weighing in on these decisions affect your work on the ground?
- A We do what we have to do to define, characterize, control an outbreak, you know. We just have to move on.
- Q Did that desire to keep numbers down, was that articulated to you or your team at any point?
- A The problem that I've been describing was articulated. It didn't stop -- it didn't stop me from telling my team we need to do good surveillance. We need to count. How we count and label them as to where they occurred was less important to me than that we understood fully what the scope and magnitude and the extent of the problem was and how we would solve it.
- To say we just -- you know, our division has been dealing with cruise ship outbreaks of infectious diseases before COVID and after, and we'll continue to do what we need to do and let other people worry about whose ledger they sit on.
- Q I want to dive into the substance of the problem and what was proposed. So your team, your maritime team was tracking all of the Americans on cruise ships. Can you give us a sense of the scope of the problem as you found it?
- A Yeah, I think -- I don't want to misquote the actual numbers. Most of these are available in published reports. The kind of counting the number of ships that were involved in outbreaks, the size of the outbreaks, and we counted cases whether they were in American citizens or in crew members or in foreign nationals. We tried to define the scope and magnitude and the severity of an outbreak in the transmission settings independent of, as I said, what ledger you would count -- hold as to the accounting. They occurred on a ship. We did, you know, count the data, whether it was in crew members or passengers. We did look at the data based on severity and how many people were requiring infirmary visits or intensive support or maybe oxygen support on the small medical capabilities that are available in the infirmaries on ships. How many evacuations, those kinds of things that we were getting called in about that might need some assistance beyond the capacity of the ship? And then we would be looking at how fast the trajectory was, whether the carryover infections were occurring from new introductions in seeding, new passengers coming on board, or whether the existing crew members that stayed over week to week and continued to support a vessel, whether the infections in crew members were creating these carryover outbreaks, whether it was the same ship repeatedly involved. Those are the kinds of things that our maritime team was intensively engaged in. And from those experiences, we were realizing the scope and magnitude and the problem that COVID would place in a maritime environment at sea sometimes miles and miles away from land-based medical care were going to be quite significant and that these weren't one-off events that occurred sporadically, but that these were the types of environments that were uniquely, you know, at risk and needed specific management, attention, very, you know, complicated guidelines for control, screening, surveillance, testing before embarkation, how many days when, testing at embarkation, testing periodically passengers and crew during that, beefing up infirmary capabilities, you know, defining the level of medical support that was available compared to the number of passengers and crew on board and the vulnerabilities. Having emergency response evacuation plans, having agreements with port cities as to where people could be brought, disembarking persons who were infected and how to manage them for a period of isolation and their close contacts for quarantine periods, arranging private, safe travel for people that were infected and not very sick and need to go from the disembarking port to their homes, which would involve -- normally involve commercial travel and not wanting to exacerbate this infection spread along the entire travel corridor trajectory. So having a plan for private movement of infected people from one location to another. So it was -- these were very complicated problems, and there were multiple outbreaks like this, scores, if not more, of settings like this. And complicating that further, there were many countries which did not allow any of these ships to come into their ports or receive any assistance from the national authorities and those other governments. So we had to deal with all of those aspects of trying to deal with, you know, a highly transmissible respiratory pathogen in a setting that was uniquely risky. Accommodation of household-type risk factors with hoteling-like risk factors with -- in the restaurant services. All of those different settings that create the risk for transmission and spread are sort of cohabitating on the vessel in that regard. And all the transportation corridor risks were really a difficult problem, and it did occupy the full attention of a large team in the maritime unit for many, many weeks and months.
- Q It sounds like a massive and complex problem. Can you talk about some of the tools that you were talking about using and how that led to an emergency order.
- A Well, we brought to bear everything we knew about containing sort of a high-risk land-based outbreak and extended it within the context of how that might happen at sea, where resources were more constrained because they needed to be all available in situ at a distance. And so developing a safe plan for defining surveillance plan, a testing plan, a monitoring plan, the proper scaling of healthcare resources on board, the proper agreements that people would know in an emergency where very sick people would be evacuated to, what port would be able to be brought to bear by Coast Guard or other emergency services, how to achieve isolation and quarantine for passengers and crew. Meals, obviously, meal service, the congregate, aggregate setting kind of things. Those are the kinds of things that had to be worked out. We -- on the very front end, once we understood the risk in this setting, we tried to issue travel-related guidance, eventually looking at the ship as if it were a geographic destination and advising people not to travel on cruise ships because of the increased risk and the limited resources, much the way we would do if there was an outbreak in a particular country. We would alert people in advance to not engage in an activity where it was difficult to both prevent and respond. Our travel guidance was initially focused regionally where we saw the outbreaks, but as the epidemic and the pandemic spread geographically, the advisories involved in that engaging in cruise ship travel anywhere on the globe, not just in the southeast Asia area -- that transmission happened very quickly, but certainly our experience with the Grand Princess off California was clear about that. We learned for that carryover passengers and carryover crew, particularly the entertainment and other kind of crew, were responsible for breaching outbreaks sequentially on some of these vessels, so that's something that came to play. Eventually it was also clear that we were not going to get the kinds of COVID control that were needed by doing this sort of one vessel at a time and that the plans to really prevent, contain, prevent, respond to outbreaks was going to be very broad and somewhat industry-wide in these large population settings. And so that led to the recommendation to go beyond the travel-related guidance, which was actually insufficient to prevent embarkation and any vessels from taking off fully loaded. And so we were discussing the need until further notice to have a no-sail order, a no-sail order in order to get a better handle on how to contain these outbreaks and create a situation where hundreds of thousands of passengers were stranded at sea in high-risk settings in many ports around the globe. Many countries would not allow them the safety of harbor and disembarking and so on.
- Q And just set us in a time frame. When was the -- when was your team proposing the no-sail order? I guess the first one was on March 14, and on March 7 there was an announcement of a plan amongst the industry.
- A Yeah. So I think things were getting out of hand between Diamond Princess and Grand Princess by the end of January into February, and our surveillance team was just hearing about vessel after vessel, line after line that were being plagued by these outbreaks. We were having, you know, the discussions about this no-sail concept. It was obviously a big deal, and it was one of those kind of items which would escalate quickly into the entire interagency with the task force and certainly had the attention of senior administration officials. And the approach to issuing the order versus having an industry come up with its own plan and then running that plan by the public health -- our public health maritime unit to see if it was feasible, operational, implementable and all of those kind of -- so that was all going on in this time frame through February and into early March.
- Q Let's start with March 7. And then it is Vice President Pence, Director Redfield, a number of Florida politicians. They met with the cruise industry executives in Ft. Lauderdale. Did you participate in that meeting in Ft. Lauderdale?
- A I did not. I did not.
- Q Did you have discussions with Director Redfield about your position in terms of --
- A Director Redfield was representing CDC along with other members of the White House task force. He was briefed regularly on our team on the scope and magnitude and the challenges of the problem and was aware that we were going to need to elevate to regulatory actions, because we weren't able to control this with things short of that. Incrementality and the proportionality was insufficient to stem the scope of the problem.
- Q It seems like the -- at least at that announcement, it wasn't a regulatory action that was being rolled out; it was a plan that would be announced in 72 hours that the industry was proposing. Is that right?
- A That's what -- that's what -- I wasn't at the meeting, but my understanding is that's what was agreed to between the administration and the CEOs or whoever attended the meeting.
- Q Given what your team was seeing, was that adequate to deal with the problem as you measured it?
- A I was -- I would fairly characterize my assessment was, it was I was skeptical, because there wasn't sufficient public health expertise within the industry to actually understand the characteristics of the virus, the scope, the risks. And I was skeptical that they would have adequate and sufficient plans, but I agreed with -- or I went along with the decision that was reached. That wasn't my call to make. It was above me to make that call for them to submit plans. And the plans that were submitted were reviewed by our team, and some I would describe as overly aspirational and not feasible and not implementable and others were wholly inadequate in terms of really appreciating the scope and the magnitude. So plans were developed, they were submitted, they were reviewed, and I did not think that they would be able to address the problems. By aspirational, I mean they were assuming the availability of certain things that were pretty difficult to get, assuming a major scale-up in their on-board laboratory capacity or their medical capacity, all sorts of things they didn't necessarily include in these agreements for managing an acute response. Evacuation for port agreements. So they were missing a lot of components and they had a number of gaps. But I commend -- an issue for making that effort. I don't think it was their fault that they lacked the public health resources in order to fully comprehend and manage this kind of a problem. It was an unprecedented problem in scope and magnitude.
- Q And Vice President Pence at that meeting said publicly that Americans could travel on cruise ships safely. Did you agree with that assessment at that time based on what you were seeing?
- A I don't know what specific time frame he was referring to in that, whether that was in the future, whether that was in the moment, whether that was in the past. I'm not sure what he was specifically referring to. My experience leading to that meeting was there was not a safe, healthy way to continue to travel on cruise ships in that moment without trying to control the huge number of outbreaks that were already ongoing and, you know, literally hundreds of thousands of people that were kind of stranded at sea in the midst of outbreaks that had also to be sort of managed in that setting concurrently. So to me, the scope and the magnitude of the problem far exceeded what I would describe as safe and healthy cruise ship travel until a much better handle could be gotten on the problem, per se.
- Q Were you concerned about this delay in getting to a no-sail order and the impact --
- A I was definitely of the opinion that we needed to push, push in that direction, that given the amount of consultation that was being required of my team and the entire maritime unit, which stood up and needed emergency managing all of the incoming on the outbreaks and the problems and the challenges, I was quite, quite concerned that we needed to have a pause and we needed to deal with all of the folks. Like I said, in the course of time there were, you know, counting passengers and crew, there were an enormous number of people that were still out at sea that needed to be safely repatriated without creating an extension of the epidemic. And so, like I said before, on other things this is the kind of virus that's very unforgiving in the mode at which it spreads and the speed at which it spreads and its stealth nature at times. And I thought we needed stronger action earlier in order to be able to get a handle on it and get in front of it. It was not a situation in control.
- Q This has been reported. I'll just ask you: Did you call this situation unconscionable in the conversation with Dr. Schuchat?
- A I did.
- Q And why?
- A Because I did not think it was being addressed with the sense of urgency that was needed to protect people, to reduce morbidity, and reduce fatalities.
- Q It was also reported that this was a stressful time for you personally and that you had expressed your frustration and you were working around the clock. Is that accurate?
- A That's accurate.
- Q Can you describe -- I guess you sort of went into it, but in terms of getting this done, what was blocking you, blocking your team, from getting this done?
- A I think, like I've said about other things, this system wasn't either appropriately assessing the risk and the magnitude of the problem, nor acting with sufficient urgency in order to save lives, and that was tremendously frustrating to someone who's spent, you know, decades with that as a principal goal.
- Q Did the administration's relationship with the industry and that announcement add to your frustrations about the issue?
- A The slowness of reacting really augmented my frustration, yeah.
- Q Do you think Americans died as a result of that delay?
- A I think the delay had significant impact on the morbidity and mortality.
- Q I want to move to the first iteration of the order, and that's on March 14, and that's Exhibit Number 5.
- [Exhibit 5 was marked for identification.]
- Q I want to ask you about specific parts of this order. And starting the first part, Applicability, and it had a big exception, the exception that "this order shall not apply to any cruise ship that voluntarily suspends operations for the period of this order." Can you talk about how that came to be and why that exception was in this order?
- A I think that, as you've mentioned, there was some confidence by the industry and perhaps others in support of that confidence that they could manage this problem on their own and -- or that they would see voluntarily when they got the feedback from us on their proposed plans that they couldn't manage the problem, so they would voluntarily agree to suspend operations short of having the regulatory authority and impose some of those restrictions and operations. So I think what you see in there is the regulation would only apply if you didn't voluntarily suspend, and there was some cascading momentum among certain parts of the industry that they would suspend until they were able to get their planning in place and then they would see.
- Q It seems to me that this is not the most direct way of dealing with a massive problem in allowing industry to regulate itself when people are dying. What was your view in terms of the adequacy of doing it this way?
- A In the end, my biggest concern was that there was a suspension in operations, because we had to stop, you know, pouring gasoline on the fire of the outbreaks at sea, which was a lot of risk. And whether they agreed to voluntarily suspend or those that didn't were going to be suspended by regulation, we just needed to get this paused and we needed to have sort of a major rethinking about how safe and healthy travel could and if it could and how it would resume in setting up a COVID pandemic of this magnitude, which, as I said, cascaded well beyond the ship itself. It had impact and implications for really accelerating the pandemic across the globe and in many communities. So how we got there was less important to me than that it happened and it happened quickly.
- Q Did this order get us there?
- A It made a huge -- the order made a huge -- things, as you will note, need to be modified along the way, but, you know, taking the accelerant away by not embarking new passengers and beginning new cruises made a big difference. We still had to manage the existing multiple outbreaks at sea across tens, if not hundreds of thousands of persons that were impacted either directly or by contact. So the first step was stop adding fuel to the fire of the outbreak, and the second one was managing the existing outbreaks that were still ongoing. And that was my goal and our goal at CDC.
- Q And moving down in the order, I just want to point to the section that reads "Coordination efforts with the cruise ship industry." And in that section, it says "the federal government recognizes the enormity and importance of this action taken by CRIA" -- that's the Cruise Lines International Association -- "and the commitment it demonstrates in protecting the health of both cruise ship passengers and the public at large." Who drafted this order?
- A The initial draft of the order was originated at CDC with my team and our general counsel. The order circulated in the interagencies, as was common for anything of this magnitude. Went through OIRA and OMB and the various interagency partners of people at the White House as well as in DHS and other departments and agencies that are a part of it. And the language was refined and drafted and modified and edited and so on as it moved through those processes.
- Q Was this language amending the industry group part of the original CDC draft?
- A I can't remember the specifics.
- Q Okay. So as you described, this was stopping the accelerant. What about the ongoing fires, the ships that were already at sea?
- A Our maritime unit and team, together with DHS and Coast Guard and public health practitioners in port communities and many others, had to manage the safe evacuation from all of these ships down to a skeleton level of crew only to keep maintenance and other basic things going. And that took many weeks to months in order to safely get people home. That involved finding the ports to enter in the United States, evaluate, test sort of infected, exposed, from not involved, and working to have isolation quarantine locations and then safe means of getting non-U.S. nationals who were coming into the U.S. ports repatriated with the assistance of foreign governments, whether they were Canadians or other nationalities. And reciprocal, the other way, where American citizens who were at sea coming into a port in other countries would have to be equally evaluated, sorted, and safely repatriated to the U.S. without extending the infection or seeding new communities. And that took a long time. But that was occurring during the cessation, during the no-sail period, so that you weren't continuing adding the accelerant to the problem. But it took a lot of intense coordination and public health resources to mitigate the impact of the extraction of people that were infected that were still out there at large.
- Q And the CLIA plan, those that had voluntarily undertaken the plan, how was it addressing those issues, sort of in between --
- A As I mentioned, the CLIA plan alone was inadequate and insufficient, but the engagement between the CDC requirements that were put into place in the setting of no-sail and the recognition broadly of the need to relate, not just stop adding accelerant to the fire of these outbreaks, but actually to put the fires out in multiple settings around the world, you know, came about in this phase of the no-sail issuance. This was what was collectively necessary in order to really get it down to a level at which people weren't getting infected, amplifying it, getting severely ill or dying. And so that took a fair amount of time, but it happened under the pause of the no-sail order.
- Q And the -- it's been reported that the industry had -- the plan had included that the carriers would hire a global rescue team of special ops veterans who would extract passengers and bring them into medical facilities without burden on the U.S. government. Did that happen?
- A I can't -- I can't say. But generally the extraction process happened with the intense engagement of our team at USG. Whether some of the vessels had independently contracted with other means, I don't really -- I don't really know. I only know about the ones that we were intensely involved in, which was the U.S. government. And largely the ones that we were intensely involved in had to do with ships that were going to be permitted into U.S. ports for this process. Whether the industry, you know, got or didn't get the level of public health support from some of these other countries or whether they were navigating it through other procedures internationally, I can't really speak to that. But I know that there was just intensive involvement of the CDC, U.S. public health and some of the other interagency coordination and support in order to safely evacuate, I believe -- and don't hold me to the numbers, but somewhere in the range of 300,000 people were disembarked and then moved without accelerating the spread to the maximum extent possible through the CDC guidance and involvement and the assistance of the maritime unit.
- Q I want to show you Exhibit Number 6, which is an email that you sent during this period between the first no-sail and the -- I guess we'll call it the first extension.
- [Exhibit 6 was marked for identification.]
- A Okay. Got it.
- Q First, I guess, "BLUF" means bottom line up front; right?
- A Yes.
- Q Can you tell us what led you to write this email and what this represented at the time?
- A I knew that Dr. Redfield was preparing for a White House task force meeting in which this was going to be -- the order was going to be added to the agenda. I wanted to make sure that he was very well prepared with all the efforts that we were doing collectively and the rationale for the order, which was significant one, and make sure that he was prepared to answer any questions or articulate why this was necessary. This was my attempt to make sure the director was well informed to face that conversation or to be prepared for that conversation.
- Q I want to ask you about the fourth bullet that starts with "poor planning."
- A What would you like to know?
- Q What was your basis or finding there was “poor planning by the industry” and “failure to adhere to recommendations and unsafe transport”?
- A Just actual experience that the team was finding that, you know, the kinds of things -- it's one thing to have a set of guidance and provide that to industry, but a plan is insufficient unless it's actionable, and we had members of the maritime unit that were overseeing and monitoring the adherence to the plan. We were receiving emails, photos, other kinds of material from people on the vessels and describing situations which were not consistent with saying that there was adherence to the plan and were continuing to expose gaps in the ability to execute a plan, even though it was pretty clearly articulated. And, like I said, you asked earlier about the confidence I had in the industry to execute on a mission, a public health mission of this degree of complexity. I think it's not necessarily to the fault of an industry that has a different purpose to be able to execute a very complicated public health plan. But my feeling was that they had not had adequate assistance on -- they were indicating that they would be commissioning some private public health assistance to provide the kind of support they needed it, and it was not evident that that was sufficiently being executed. And so I did want Dr. Redfield to be aware that we were trying to do our best to have this happen in the absence of a regulatory order, which I knew was not very popular, and that we weren't getting where we needed to be, and I thought the order was quite important. And I wanted him to be able to articulate that if he was questioned in the White House task force meeting.
- Q And at this moment, what was the state of, just generally, outbreaks on the ships? You know, we had no new embarkations, but I guess the ships were still out there?
- A Yeah, they were out there. And, I mean, I think more than 100 ship capacities ran anywhere from 2,000 passengers and 2,000 crew. That wouldn't have been uncommon. So we're talking about thousands of people on at least 100 different vessels that were out there. At any one point in time, any number of them were experiencing large outbreaks or in the early parts of new outbreaks. So, again, this was a pretty big -- and that's with the idea that new embarkations had already -- were going to be able to be ceased and there was voluntary suspension of new additions. But there was still a really big problem to get the existing outbreaks under control.
- [Majority Counsel]. If I may.
- A moment ago, Dr. Cetron, you mentioned that the order wasn't popular. What did you mean by that? Who wasn't it popular with?
- The Witness. For sure it was very unpopular with the industry. They didn't want to be regulated and they didn't think it was necessary. And, you know, pretty confident among some of them that they had this ability to get this under control in their home. I think the industry had a very strong voice in its opposition and was using that voice quite loudly.
- By [MAJORITY COUNSEL]:
- Q I wanted to talk about the interagency process in this. And you wrote in the beginning of the email, "All interagency members of NSC, PCC are supportive." What was the interagency process?
- A I think I described -- so basically it's a CDC order. We formulated it, had written extensive -- both the rationale, the background, the existing status, the outbreaks, everything we could to make it very clear what the state of play was, and then we would move that up through CDC clearance process. We go to HHS for clearance and then it would move into the interagency. There would be discussions with the interagency through the -- the White House convening the National Security Council and other pieces of the policy process. And then regulators of these kinds of sorts would go. So there would be an informal play of providing inputs from the interagency, and then it would be more formally submitted up the wire, and then they would send it out for further clearance across the interagency. More edits and other things would come the way of the drafters and CDC, and we would try to achieve broad concurrence across the White House and the interagency. And then the order would be -- amended versions of the order would then be sent up to the CDC director for signature. So that would be the process by which this occurred.
- Q One quick question. What does PCC mean in this context?
- A Policy Coordinating Committee. Each administration has a different acronym or definition for what those processes would be. There's a place for the interagency, and all of those with equities in these decisions would have policy coordination.
- Q Do you recall any agencies with equities in this decision that were opposed to the order, refused to sign off?
- Mr. Barstow. What order are we talking about?
- [Majority Counsel]. We're talking about --
- Mr. Barstow. There's the March order and there's the April order. This email is in April.
- [Majority Counsel]. We're talking about the movement from the March 19 order to the April order. That's what I'm talking about. This particular period of time.
- Mr. Barstow. Okay.
- The Witness. As I described the process, there were -- the deliberations involved inputs and edits and all sorts of things and concerns to be addressed and so on. Is that what you're asking?
- Q Yes. I'll be more specific. So it's been reported that in the lead-up to this order, the -- and this was -- and I'm quoting an article in ProPublica -- Department of Homeland Security refused to sign off and that the Department of Homeland Security “disagreed with CDC's narrative describing the actions of the cruise line industry.”
- Is that an accurate report?
- A There were definitely discussions of the general nature you're describing as part of the interagency deliberative process.
- Q Do you recall what the disagreement was over the CDC's narrative of the actions of the cruise line industry?
- Mr. Barstow. [Redacted], I think that's deliberative, so I'm going to instruct Dr. Cetron not to answer that question.
- [Majority Counsel]. Okay. I'll just note for the record that I'm quoting a publicly available news article. This decision has been reported in the news. The specific point that the agency articulated was in the news, and its disagreement with CDC's narrative was reported publicly. Noting that objection for the record and asking that we perhaps revisit it at some point.
- Q Beyond what the agencies were saying, what was your position in this process? So moving from the order that was applicable to really a small subset and now moving to a full-scale order no-sail order.
- A I thought it was necessary. It was unclear what voluntary participation would mean in terms of full compliance. It was unclear whether those that were voluntarily participating believed they had a sufficient plan or not. And so I thought that we needed a more uniform, consistent, clear set of instructions on what public health meant in terms of things that had to be done, and that may or may not have been the things that all the lines were either equally wanting to do or equally able to do. So that's how the piece was sort of evolving to be more directive and more clear on what was necessary and more consistent across the board. And not subjected to either the variability or the decision to opt in for some days and then opt out for another and tracking all that. I think one of the problems was there needed to be a very clear set of public health expectations and objectives in order to continue this process safely.
- Q And the "why" question: Why in terms of what you were seeing that was happening?
- A I said was there variability in understanding and intent. There was variability in capacity or completeness. There was variability in the aspirational nature from what was actually executable. We were getting a number of reports of the groups that said we're in, we're voluntarily in, we don't need to be regulated, but on the sort of -- the checks of what was going on, we weren't seeing that level of effectuation of the intent plan.
- Q Before moving on to the next order, I think it's a good time for us to take our five-minute break and turn it over to our colleagues.
- [Minority Counsel]. We have no questions for the next hour, so when you come back, just roll.
- [Majority Counsel]. Thanks, [Redacted]. I'll just ask the witness and Kevin if you want to keep going or if you want to take a break.
- [Recess]
- [Majority Counsel]. So back on the record.
- By [MAJORITY COUNSEL]:
- Q So we were reviewing the lead-up to the April 9 order. Now I wanted to review the April 9 order with you, and it's Exhibit Number 7.
- [Exhibit 7 was marked for identification.]
- A Okay. I have it open.
- Q And moving to the Applicability section, I think this is on the second page, first paragraph, second page.
- It reads that "this order shall additionally apply to any cruise ship that was excluded from the March order."
- So is this what you were describing in the need to --
- A Yes.
- Q Okay. Why was this critical at this moment?
- A As I had said earlier, it's because there was insufficient clarity and understanding and expectations and execution of the -- and too much variability. And voluntary, temporary suspension with or without some of the things that were part of the CDC requirements for safe operation and disembarkation were incompletely practiced. So I just felt it needed to be very clear that this needed to be industry-wide.
- Q I want to move down to the section that reads "Critical need for further cooperation and response planning."
- A Can you tell me which page we're talking about?
- Q It is page 4.
- A Uh-huh. I think this is -- most of what I'm reading on page 4 comports with what I described to you, is that there was some combination of the industry coming together to create a response planning framework, CDC developing its own internal plans and expectations, and trying to tease out what was aspirational from what was feasible and what was -- no matter how it was stated, what was actually being practiced.
- That's what this "Critical need for further cooperation and response planning" means, essentially getting on the same page.
- Q Who drafted this section of the order?
- A I don't recall specifically. But I think it was intended to be, you know, some -- some clarity about why there was a need to go beyond a voluntary approach to getting into this. This clearly represented a perspective that the cruise industry was looking for, obviously.
- They were looking for more of an engagement in the process so that they could, you know, have their perspectives shared.
- How this -- the actual words came about, I can't remember the details at the time.
- HVC122550 PAGE 148
- Q What about --
- A But we obviously weren't on the same page, just speaking in generalities, and we had some things that needed to be done and some things that weren't being done, and there were perspectives, you know, from the industry on, you know, wanting to have a say in this stuff and -- so there you have it.
- Q Sure.
- A The details of who wrote what words and which group represented getting those words in or interests really escape me at the time. My goal was to get another order clearly done with -- again, we were really focused on outcome and not on blame. We were really trying to get what needed to be done get done and get approval and get the orders out and make sure there was absolute clarity on what was needed from a public health perspective.
- Q Sure.
- A That's -- that was the goal.
- Q I think -- and looking back, we were trying to assess process. And I want to ask you about --
- A This was not an easy process.
- Q What about the title? Was that the original title?
- A I really honestly -- I really honestly don't remember. I don't.
- Q Let me try to jog your memory. It was reported in ProPublica that this section was originally titled "Failure of cruise ship industry to develop and implement a response plan." Is that accurate?
- A I don't know. I never spoke to ProPublica. I don't know where they got their information. The document, as I told you about process was significantly revised, amended, and churned through a deliberative process in the interagency. And, you know, it's entirely possible that who said what to whom where in the deliberative process is really kind of beyond -- beyond my memory and beyond my goals, which is to get an effective public health response out. That's where we needed to be. It was not easy. It was a big order, and it involved an entire industry. That doesn't -- you know, that doesn't escape me. It doesn't escape me that there were people not happy about it, but --
- Q I'll ask one last question on this and we'll move on. Did that change in title from "Recognizing the failures" to "the need for cooperation," did that come from CDC?
- A Yeah. I really don't want to get into that in the speculation. All this stuff -- again, I read the ProPublica article. I had nothing to do with it. It's not the way I work. I think I've stated my position, basically. We needed to get something done that was important, and it was hard work, and there were a lot of perspectives on this problem. And I'm going to leave it there.
- Q Okay.
- [Majority Counsel]. I apologize. Kevin, to the extent that you're planning to make an objection, could you just put that on the record that -- I saw that you may have been providing direction to the witness.
- Mr. Barstow. We had a conversation, but I think it's Dr. Cetron's position that he doesn't want to get further into the process. If you'd like to, I'm happy to put an objection on the record that it was his decision that he didn't want to get into it further. But I won't speak for him.
- [Majority Counsel]. I do think that a clarification -- For the record, Dr. Cetron, are you refusing to answer the question on the basis of an instruction from agency counsel?
- The Witness. No. It's not refusing to answer the question on the basis of objection from agency counsel. It is the sense that I can't remember every detail, number one. I don't want to speculate about who drafted what words, and I really don't want to, you know, compromise what is a deliberative process and it needs to be one where there is lots of inputs. And my goal here is to try to explain what the public health problems were, what weren't being met by the voluntary program, why the need for an additional order was there. And, you know, that's my rationale. I don't want to go out there and I have no -- you know, have no intention here of trying to pass judgments other than giving my professional judgment that this was necessary, whatever was necessary to get the job done and accomplish our public health goals is what I was trying to achieve. And whether or not the idea was mine or somebody else's and whose it was and how it came to be, I totally respect that there's a need for a deliberative process and there are many points of view that come to bear in addressing the pandemic. It's not one that -- one perfect right answer, but we need to be pulling in the same direction and get the job done. That's how I feel. That's why I've chosen to answer that way.
- [Majority Counsel]. Thank you. I just wanted to make sure the record was clear, so I made that clarification. Thank you.
- Q Okay. I have another question like this, but focused on your words. It was reported that in this period and the delay that led to getting to the April order that you told Olivia Troye, a member of the vice president's staff, “we’re going to kill Americans.” Did you make that statement?
- A I believe -- I don't know if that's exactly the specific words, but I believe the sentiment and the frustration that I was feeling about the delays and not able to really get to things that needed to be done had consequences on the lives of Americans and others, people that were at sea.
- Q Do you think Americans died because of this delay?
- A I think, as I've said earlier, that pandemics of this nature that move quickly with big consequences that there's a necessity to take early and bold action on -- sometimes even unpopular action with other consequences. But it is necessary to save lives and not have regrets. And yes, I do think the delays or the frustration were some of the challenges that we had in getting to where we needed to in public health. I believe some of those things have cost lives, and I'm saddened by it.
- Q Moving forward, let's -- I'll just call it the second extension. We'll talk in terms of extensions. That's the July 16, 2020, order, and that's Exhibit 8.
- [Exhibit 8 was marked for identification.]
- Q Can you tell us the process that led to this extension in July?
- A So, first of all, the need for the order was ongoing because of the nature of the pandemic, the status of the pandemic. As I mentioned to you, there was -- after the order that prevented new embarkations from the U.S. ports, there was still an enormous challenge to deal with the ongoing outbreaks that were at sea that neither the COVID threat itself, the virus specifically, had been mitigated sufficiently to remove that threat, nor had the challenges of the ongoing outbreaks been sufficiently met to have a sort of a pause and a reset. And so the order needed to be extended. In addition, it was clear that the industry would need -- or it was our opinion that the industry may be engaging in expanding its own public health advice and authorities from an independent -- separate from the -- from CDC and that that work would be ongoing and that work would involve public health consultants, former CDC people and other public health consultants, to address a whole series of issues. And that would be an ongoing process through the summer. So I think that was some of the genesis. One, the threat hadn't mitigated sufficiently; two, we weren't in a position to resume normal sailing; three, there were inadequate, you know, controls still being put in place to mitigate the outbreaks that were already out there, that were still challenges of folks with COVID at sea, and there needed to be much more engagement in the planning process, you know, that would happen somewhat independently to the other mechanisms that we became aware of. So those were -- I think I'm just trying to remember this point in time and what was going on and why another extension was needed and that we couldn't go back to this idea of the industry alone can handle it on its own through voluntary processes and would have ample -- both experience, guidance, and paths to follow.
- Q And I wanted to ask you about the third paragraph and the information included there.
- A Yes. I think that's basically the very crisp summary of some of the data that supports what I just shared with you verbally.
- Q So this was --
- A This was an ongoing issue, and, quite honestly, those were just the ones we knew about where people were within a sufficient U.S. jurisdiction to have -- to actually be reporting, as was required in the no-sail order, to have a regular reporting frequency, but it would not necessarily account for all of the outbreaks that didn't involve vessels with a U.S.-based itinerary for port calls. So, you know, at the least, this is the kind of tip of the iceberg issue that we were seeing for what eventually got reported to the CDC maritime unit, but not necessarily the totality of the experience, which was likely larger. And I believe we have -- further, after this July date, I think we have a further series of summary publications that included, you know, broader assessments of the various magnitudes. We can make those available through Kevin at another time.
- Q Sure. And let's just talk about the scope of the problem at this point. It's at 38,000 hours managing outbreaks, almost 3,000 cases, 34 deaths. Can you tell us about how these things were happening? And we had basically the stop at embarkations and then the April order. What were you seeing at this point in July in terms of --
- A I think this is mostly focusing on that -- on that time period where even with the orders in place, without adding new people to the journeys, to the cruising journeys, the residual effect between March and July was that these outbreaks were continuing and amplifying and extending and it was, you know -- it was not under control. And it was not a time to lower the guard and roll back and resume normal cruising at this point in the pandemic, but rather, really significant processes need to be in place at -- quite honestly, a lot of this because of so many other things that were accelerating in the pandemic in its early time frame and well before the availability of vaccines, for example, and other medical countermeasures, CDC wasn't going to be in the capacity to provide all the consultative support alone that the industry would need to be able to handle these decisions in an unregulated environment. And I was encouraged by the fact that the recommendations that I was making is that they were going to need some independent public health experts that would be actively commissioned to get engaged. And such a panel, the healthy sail panel, was actually not just contemplated but created and led by a former HHS secretary, Levitt, with a number of former CDC publication health folks and other non-CDC public health folks that were really tasked or requested by the industry or at least two of the lines with some representation from other parts of the industry to help engage in some really deep and difficult and technical conversations about how to move into a potentially safe sailing space, what would be some of the requirements to do that before there could be resumption. And so that panel started, and that was important. I think part of this paragraph was intended to reflect that the problem was still very much ongoing and part of it was to reflect that the enormous challenge that was posed by the problem for CDC that was also dealing with a huge number of domestic outbreaks around the country at that scale. It was going to require that this other process that they really wanted to move into a "what's the future look like for safe and healthy sailing" was going to require a very deep engagement process with public health.
- Q And moving forward to the -- what we'll call the third extension. That's Exhibit 9. That's the September 20, 2020, order. bviously this one is different. Can you tell us about the process that led up to this order?
- [Exhibit 9 was marked for identification.]
- A Some of the things that were different were that summer healthy sail panel that was commissioned did intensive work. I think -- don't hold me to the dates, but roughly over that summer, a three-month period, you know, July, August, and moving into September, and they were coming up with a series of a more concrete, very specific set of plans and recommendations. CDC had two liaisons that were requested and cleared by our general counsel to sit as liaison members on the healthy sail panel that participated and listened in on some of the conversations and were available as a resource to answer questions in that regard to provide technical input or answer specific questions about the surveillance data or things that were being learned about the virus. And that process had been ongoing over that summer period. And it was chaired by, I believe, former Secretary Levitt. You're muted.
- Q In terms of the legal authorities, this was a conditional order as opposed to the prior orders. Do you recall why that was?
- A You're referring now to the --
- Q September 20, Exhibit 9.
- A Okay. So the discussion was, you know, you take one perspective and what sort of -- when are we going to be in a better place. The recommendations and the other kinds of inputs that were coming, and then the desire from the industry is what is it going to take in the future in order for us to resume the business and have safer sailing; right? And so the flavor here was, you know, whether we extended the no-sail order through the winter, it was a big winter sailing season that was upcoming and that how long it might take to get to a better place both in the perspective of the virus, the perspective of the planning, and the perspective of proof -- going beyond plans but proof of concept in a safe, iterative way. And that's how this piece evolved. And so rather than an outright no-sail order, what you see here is a conditional sail order that laid out a series of phases and that by achieving each phase successfully -- so it's not just having the plan for a phase but getting through it, having some oversight and documenting the ability to execute in that phase, take lessons learned from phase one, phase two, and phase three and incorporate them and incrementally scale up before full resumption of commercial passenger services could be done safely. That's where the framing of the conditional sail order came from. And the concept of what would it take, what conditions would need to be met, you know, from CDC in order to plan toward a future resumption of commercial sailing.
- Q Did you think the industry was going to comply and get to a position where people could sail again?
- A You know, I have not prognosticated with any certainty what this virus will do, what the curveball is going to look like. I know when we weren't there. I knew how hard it would be to get to that place. And I knew there would be a number of contingencies and uncertainties that, if fulfilled, might bring us closer. For example, there was beginning to be a lot of discussion about the eventual availability of an effective vaccine. That would be a potential game changer in the way we looked at the pandemic. I knew that there were evolutions in the types of testing that were available that we would gain that capacity and some of the other nonpharmaceutical and mitigation measures. The surveillance components, the portable -- you know, the rapid test would play into this picture. And the understanding would be not to pretend we knew the outcome with some certainty, but to have both a set of incremental measures in the phases and then documentation that those would actually work. And so that was the thinking behind it. I thought it was a very good sign that at least some of the lines had commissioned the healthy sail panel and they were beginning to develop a more earnest and realistic sense of the magnitude of the challenges that the virus was posing and imposing on their industry. I thought that there were people really coming to grips to how hard this problem was. I also thought that we were making potential progress on the pharmaceutical and nonpharmaceutical front. And this seemed to be a way to provide both what the government thought would be necessary to assure a safer pathway, a healthier pathway, in addition to providing some future clear direction to an industry. And so that's how this ended. And the recommendations coming out of the healthy sail panel were validating and aligning very well with CDC's perspective, so that that gap that I talked about earlier, the disconnect between an industry that was largely not getting independent public health input and not just saying "we got this, we can do it all on our own," which I felt was really unrealistic. And the kinds of input that they were getting from experts that were not regulators from the CDC side was a very encouraging process. That's how we ended up here in this new space.
- Q The public reporting has been that Director Redfield wanted to extend the order into the winter, as you discussed, but there was an intervention from the White House. Did you work with Director Redfield on this particular conditional order?
- A Yes.
- Q And he --
- A We basically -- the statement is true. Our initial draft was another extension. We didn't see the vaccine really for the other things we're discussing were going to happen. They wanted to be able to clearly forecast what to do, what to tell about passengers who were booking in the winter sailing season. It seemed unrealistically that full commercial sailing would be doable in a safe and healthy way until several more months, and progress on the vaccinations, progress on all the other fronts were needed. The healthy sail recommendations were a report, but not necessarily with demonstrable impact. So there were many ways to go, and this idea of creating a conditional sail with spelling out criteria on steps along the way was another way to get there.
- Q And can you describe what that intervention was sort of around the time that this order was expiring?
- A Which intervention are you talking about?
- Q From the White House that's been reported.
- A I don't know what specific reporting source you're using in that regard, but they were very engaged, as they had been in this topic all along since the beginning, as you're aware. And so I'm not sure. I'm not exactly sure what you're asking.
- Q Sure. And there's an exhibit, if you want to refer back to the reporting. I will just get the exhibit number. It is Exhibit 15.
- [Exhibit 15 was marked for identification.]
- A So I wasn't in the meetings that were being discussed in this New York Times piece by Sheila Kaplan. And, like I said, I don't talk to reporters on these kinds of topics, and this seems like a more appropriate question for Dr. Redfield, who is obviously here and quoted. I don't know what to say about that.
- Q We spoke to Dr. Redfield, and here's what he said about that. He said -- and I'm going to quote him from our interview: "In October they gave me an extension to October 31, and I wanted an extension to like March. And, to be honest, I was prepared to step down as CDC director if that issue got prevented, because I felt so strongly about the no-sail order. And I came through with the idea of a conditional sail order and we wrote that guidance, and that guidance -- actually, the rigor of the debate against me subsided after that." And he made the point that this conditional order was a compromise position that the industry wouldn't actually meet and it effectively served as a no-sail order. Is that accurate?
- A Well, all I can say is when Dr. Redfield came back from these meetings, what he said to me was “let's work on a conditional sail order that provided an incremental pathway.” I didn't -- he didn't give me all the things he just said to you, and I wasn't privy to this interview with the New York Times. But he said that's where we landed, and can you do everything possible to rewrite everything and make it work this way, and we set about doing that.
- Q And effectively, is that what happened? Did this, essentially, in effect, act as a de facto no-sail order?
- A Well, if you're asking the question did commercial sailing resume with full complement of passengers on board in October, November, or December or even January, you know, of 2020 and '21, the answer is no, it did not -- there were -- it did not resume. The answer is no, it didn't resume. And because the steps that were required to go through the phases of conditional sailing to demonstrate that there was the ability to effectively sail with this pandemic with the tools that were on hand had not been met, but it did provide a pathway toward what needed to be done. And then as we moved into '21 and vaccines started to become available, in addition to the stipulations that we had in our three phases of the conditional sail order. We then began to incorporate by amendment and modification criteria on the proportion of passengers and crew that would have to be fully vaccinated in addition to being tested to embark and tested at disembarking. So we had another tool in the tool kit which essentially made the difference. And it wasn't really until that vaccine tool was added to the tool kit did the contemplation of resuming commercial sailing take place. And that actually -- I don't remember exactly when that happened, but it was into -- closer to the summer sailing season of '21. I don't know exactly what you mean by -- it was basically trying to stipulate what would be required not only in the phases, but oversight and proof of concept. In sailing, for example, there were phases where you had to have a plan, where you had to certify the capacity, the number of tests, the various port agreements. Those were all built into the conditional phasing. And then there would be periods of essentially test sails that did not involve any commercial passengers. First crew would come back and resume without passengers at all. There would be simulated voyages in which they would be able to detect early and contain any COVID outbreaks, and these simulated voyages did not involve paying commercial passengers. And then there would be a scale-up in volume and so on. So that halfway process of getting there and then, in effect, really scaling up a safe and healthy sailing process also really became very contingent upon having a highly vaccinated cohort of passengers and crew, like over 95 percent. Ultimately, it was all of those things in the evolution really in the months of '21 that led to the resumption of commercial sailing voyages. And so I think we ended up with a very deliberative, calculated, measured, safer process. But in terms of -- if there would have been a no-sail order through the winter -- and the winter season always proves to be a little bit more challenging with COVID -- versus this approach, essentially commercial sailing would not have been resumed. So there you have it.
- Q Okay.
- A That's how it evolved.
- Q I wanted to move on from cruise ships and ask you generally and briefly about CDC's quarantine powers and in an emergency response, how they can be exercised. So maybe you can give us just a brief overview of how that works.
- A Yeah, that's a tall order. I'll just say in general the federal quarantine authorities come in with regard to preventing importation and spread of -- a series of communicable disease come into areas of scope and conditionality. So in terms of scope, the federal jurisdiction is international arrival, interstate movement. It includes the territories, for example, and whether that movement poses a risk, you know, air, land, and sea kind of thing, and whether it's the movement of people, animal, or inanimate things. So that's the general scope that derives from the Public Health Service Act of 1944. The authorities are then -- that statute has been clarified in regulations. Part 70 is usually what we call the domestic component, 71 the international component, and it specifies the circumstances under which the federal government would be able to -- the legal language in there is "detain, apprehend, and conditionally release" in that framing. And for human movement, the criteria is specified around a set of specific disease conditions that are enumerated, and the list of those unique conditions has been augmented and added over time as we face different epidemic and pandemic threats, whether it be SARS, Severe Acute Respiratory Disease, MERS, Middle East Respiratory Syndrome, and those kinds of conditions covered under SARS rubric, and so on and so on. Diseases have been added to the list of which human movement can be added to the apprehension, detention, and conditional release. With regard to inanimate products or animate or animals --
- Q Just --
- A -- it's more broad.
- Q -- for brevity, let's stick with human beings.
- A Okay. So that's the setting on the human aspects of it under the quarantine authorities. By statute, they go to the secretary, and I believe maybe in the older statutes the surgeon general before, the CDC, and then the HHS secretary, the secretary -- the director of the CDC and, by further delegation, to the director of global migration and quarantine. That's the general sense of where those sit. It is notable that there are a number of these jurisdictions which -- that is interstate movement transportation corridors, you know, surface transport as well as air and even sea transport have some specific mentions. And some of those jurisdictional authorities are overlapping. Particularly complicated are sort of airports and train and bus stations, which have interstate or international touch point as well as a local touch point. So there are places in which that happens in coordination with the state and local. That's basically the broad sense of that. And there are some specific measures that are mentioned and a general reference to other measures that are appropriate to control introductions.
- Q I'm going to look back to the interstate authorities later. But I would say that the exercise of these authorities has been a big part of your life's work; safe to say?
- A Yes. Both when I first came into the division in '96 and we looked at the existing authorities and determined an overhaul, what needed a modernization and regulatory change, as well as in pandemic planning process. And then particularly in the COVID response where we had a whole different scale in terms of the level of need, as I mentioned, a threat that we haven't seen in quite this magnitude in over 100 years. So yeah, that has been a huge part of my life's work.
- Q And you have probably -- and this is probably hard to agree with, but one of the foremost experts in the exercise of these authorities in the federal government?
- A I've spent a lot of time in deep assessment of these authorities, but historically in mathematical modeling and actual practice in over dozens of epidemics, local and global, over my 30-year career. So I'm heavily invested. I'm sure there are other very smart people as well.
- Q I wanted to ask you about the principles that should guide your use when it comes to human beings.
- A Well, I think my staff has heard me say and one of the things that I have tried to study and learn along the way is the importance of asking some really key questions in these kinds of settings and also learning from historical mistakes when some of the questions weren't asked. Frequently it's asked may we do it, can we do it, should we do it. And sometimes there's a short circuit between what we may do and what we can do, and sometimes that's a disconnect. Sometimes there's a disconnect between the most important question is what should we do, what's the right thing to do in terms of reducing morbidity and mortality and saving lives. I think it's important to ask that question first. And if we may or may not, I think it's important to look for if those authorities may be needed and if they need help in implementing capacity to look for other places. Implementing capacity is bigger and greater in certainly more operational positions of the U.S. government. So at the borders, there's CBP, there's DHS, et cetera, in terms of operation and implementation. And that kind of coordination that we have in the interagency is very important in that regard. When we get to the question of what should we do, I think there's a number of principles that are also very important to have in play. And that is in terms of equity and proportionality that the measures that are taken are proportionate to the risks and the threat, that they could be scaled if the threat escalates and the measures need to escalate, that we should attempt to provide the least restrictive means in accomplishing the same public health outcome. We shouldn't go to the most restrictive approach if lesser restrictive means that have fewer collateral consequences and damages and unintended consequences would suffice. And so those are some of the important principles. Proportionality, ethical considerations, the equity considerations, and frankly, the opportunity for appeal in terms of the process and opportunity to be heard and to limit the time. If we're in an assessment phase and we don't know or we have reason to believe that there's an infectious threat being represented that we have a conditional approach for a short period of time and reassess the evidence as more is needed and confirm whether that person is infected or not or there's a true exposure or not and then take kind of a stepwise approach. So those have been the framing principles in which I've tried to both respect and understand the magnitude of having these types of authorities where we balance the interests of the public good. And sometimes doing what we need to do, that if it meets all those criteria can be resource intensive and requires investing in order to meet the bar on all those things. That's kind of how I've approached my responsibilities with this job since being in this role since 1996.
- Q Thank you for that context. One thing that you said -- and I'm now referring to the March 20 order commonly referred to as the Title 42 order that my colleagues in the minority asked you about. You called this order unprecedented, and I wanted to give you an opportunity to elaborate why.
- A That kind of wholesale border closure restriction and not only closure against admission, but also active deportation and the suspension of other types of rights that come -- that are protected under -- not under the public health side, I don't think, to my knowledge, have -- we have seen going back a very, very long way under our public health rationale. I'm not speaking to immigration authorities, Title 8 and all other kinds of authorities that exist in the front war on terrorism, whatever. I'm talking specifically about the responsibilities derived under the Public Health Service Act and the orders that would be -- the regulation and orders that would be generated under a specific public health threat. So it's unprecedented. It would require jumping directly to the most restrictive approach rather than looking at lesser restrictive approaches to whether they could achieve the same goals. And I think it also bypassed some very fundamental public health principles in terms of going to root cause of the public health concerns. I think I mentioned this in the beginning when we talked about this topic -- cohorting, testing, assessment, use of nonpharmaceutical interventions, masks, et cetera. Understanding that the threat that was being addressed was a real and present danger, so what is the risk of importation into a setting where the reported burden of the virus was very low in the groups that were being targeted but the amount of virus that was already present in the United States was substantial and the tools that would be in place to mitigate the threat, you know, domestically were available to be used. And so on balance, in looking at all of those things, I didn't feel that this approach met the responsibilities that we had taken on for using public health authorities appropriately, judiciously, most widely, and with the least public health collateral damage. I thought some of these kinds of consequences that were not being realized would end up having greater both COVID consequences and other public health damaging consequences. Leaving unaccompanied minor children in camps at the mercy of many other both diseases and other consequential health risks. So on balance, it didn't meet, you know, the thresholds for -- that we have -- you know, I've expressed and held in high regard, particularly at that March 2020 moment when this was being contemplated. You're muted.
- Q I want to follow up on a number of things you just articulated. Before I do that, I want to ask you about process in terms of how this particular order fit into the process, as you understood it, of exercising this kind of authority.
- A I'm not sure I really follow your question. Sorry.
- Q The idea for this order, where did it originate from? I'll start with that question.
- A It did not originate from CDC.
- Q Where did it originate? How did you first learn about it?
- A I was informed by the director that this was something that was being discussed. I had also been on a few conversations with the director in which this -- you know, interagency conversations in which this was actively being discussed. And as I told the director, he sought my advice and that I would offer him my advice as a career public health official. But ultimately this was a decision that was his to make, not mine to make. But I offered him my risk assessment, the factors that are aligned with the principles that I just described.
- Q Those interagency discussions have been reported on publicly. I wanted to ask you about the involvement of the president's senior advisor, Stephen Miller. Specifically, it's been reported that on March 17 there was a group call where Mr. Miller reportedly urged CDC to use its authorities to close the border immediately. Is that true?
- A I was on -- I was on calls at the request of the director, Tillerson, and heard some of those ideas mentioned. But I'm not at liberty to discuss who said what where.
- Q Sure. I want to ask you about what's publicly been released. Well, I'll start with did your team -- after these discussions, did your teams look at the public health rationale for such an order?
- A So we looked -- we looked at the rationale. As I said to you earlier, we had trips to the border prior to assess situations. We had -- my team have had requests and participated in trips to the border prior to COVID looking at, you know, influenza and other diseases, communicable diseases there, and made a number of recommendations on improving the sanitary conditions. This is, again, prior to COVID. And so if that answers your question, we looked at the rationale. We gathered data on the reported incidents of the disease in these populations. We scoured international available data. My team that works physically on the border, including the U.S.-Mexico unit and others with a lot of experience, we could not substantiate that the threat was, quote/unquote, being addressed by this for importation and spread was consistent with taking these kinds of unprecedented actions. And that there were other very important sanitary measures and changes in capacities and cohorting and other tools that can and should be used and had been recommended many times in the past around this. And so that was our assessment.
- Q That call in March where Mr. Miller discussed what I mentioned, who else was on that emergency call?
- A Yeah. I think that I'm not going to get into the "who said what when to whom."
- Q Not asking you about anything that was said.
- A Just representation?
- Q Exactly.
- A Department? There were many departments with the obvious ones that had equity in this issue, you know, that participated in a lot of these kinds of conversations.
- Q And so who was represented there?
- A Homeland Security has equities in this. Occasionally the CBP commissioner would be involved. Representatives from some of the component agencies of Homeland Security.
- Q Was this a call that was organized by the White House?
- A I don't recall definitively, but it wouldn't have been uncommon in that regard. And whether it was originating at the White House at some times or whether NSC separately or some of the departments and agencies -- there were, you know, a number of ways in which they could be initiated and CDC would be asked to participate.
- Q And who from CDC was on the call?
- A To my knowledge, it was Dr. Redfield and I. I don't know that there was anyone else. I can't be a hundred percent sure of that.
- Q Aside from Mr. Miller, was anyone else on the call representing the White House?
- A I don't know for sure, but my best recollection is probably so. But I really can't remember. These were -- one, it's a long time ago, and, two, you know, there were people that were on -- that might have been on or weren't announced or whatever. I don't really know all the participants.
- Q Was this a one-off call or a series of calls?
- A There were a number of deliberations about this topic, and to my knowledge, it was not a one-off call. Dr. Redfield was the normal -- would be the normal invitee from CDC. He had asked me to join him on occasion with some of these conversations, whether it was with the White House directly or folks from Homeland Security or a call with the CBP commissioner.
- Q And because you've -- your team looked into the rationale -- let me ask you: Do you recall any other specific names of people who were working on these issues?
- A I don't know, but if I did, that would be information -- sort of privileged information that I wouldn't be comfortable talking about.
- Q So what was discussed is -- may be privileged, but who participated is not privileged. We can check with Kevin, but that's our position.
- [Majority Counsel]. Kevin, if you'd like to put an objection on the record, please feel --
- Mr. Barstow. I think if Dr. Cetron remembers who was on the calls or some of these deliberations, he's allowed to say so. I think he's saying that he doesn't remember.
- The Witness. I don't remember specifically enough to call in or out specific individuals named by omission or commission. I just remember there were commissions around this that involved sort of the normal folks who have equities in these kind of policy deliberations. That's where I'm uncomfortable in terms of my memory of these topics.
- [Majority Counsel]. Just to be clear, have you limited any of your answers based on instruction from Kevin?
- The Witness. You mean just now?
- [Majority Counsel]. Yes.
- The Witness. No.
- [Majority Counsel]. Thank you.
- Q So following this discussion, the interagency discussion, your teams looked at this risk; is that right?
- A Yes. We made some assessment trying to gather data to look at the strength of -- argument about the risk of importing this from -- from some folks, migration, and didn't -- it did not jibe. And like I said, there were hot spots in the pandemic that were clearly very apparent, and there were hot spots in the U.S. that were much more powerfully overwhelming at the moment and some, as I also mentioned in terms of at sea, with repatriating, you know, American citizens. This was a -- this was out of proportion to the risk, and there were many sanitary measures and nonpharmaceutical interventions that needed to be done to improve those settings, you know, very much as a first step, and there were some significant collateral damages and consequences from a public health perspective. The problem doesn't go away simply because those people, you know, that have a legitimate fear of persecution from where they are or where they're staying and so on, COVID concerns wouldn't be addressed by these other settings on top of other public health risks that might be encountered. So that was our assessment.
- Q I want to ask you about the piece of paper itself, the order. It's been reported that a Department of Health and Human Services attorney sent your team the proposed order following a call with Mr. Miller; is that accurate?
- A The order -- the proposed order was not drafted by me or my team. And there was one handed to us. As I said, you know, my job was to advise Dr. Redfield. That's been my experience as a career public health official, and I offered that advice when that order came. I asked him if I could be excused from that process in that this was going to be a decision for the director and it should be handled by folks in the office of the director. And he respected that -- my position on that. And I don't know specifically who had first pen or edit or who was all involved in crafting it, but to the best of my knowledge and understanding right now, certainly it wasn't members of my team, and it came from outside the CDC subject matter experts. Where the inputs came and how it derived and all of those things, we were excused from that process, and it was managed between the CDC office of the director and other officials in the administration, the HHS or beyond.
- Q I'll get into some of the reactions of your team. They've been published in the press. And specifically I'm referring to the ProPublica article. According to that article, a team member working under you said that the proposed order included a “misrepresented and incomplete piece of data” to overstate the public health risk at the border. Is that accurate?
- A I don't know who said that or whatever. As I told you, I don't speak to reporters on these internal matters. And -- but what is accurate is the general sentiment that you're describing. It was not my feeling alone, but other members, other CDC folks in addition to members of my team, were concerned about that. We were concerned that that misrepresentation could create more harms than benefits, and there were many other things that should be prioritized in terms of addressing the COVID threat at the border. And that is notwithstanding operational -- you know, the issues around the policymaking authority and regulations and ability with respect to Homeland Security and mitigation and immigration notwithstanding. The issue here was whether this was warranted under a public health intervention.
- Q Were there efforts to overstate the risk that you were aware of?
- A I do feel that the risk assessment was overstated in comparison to all of the data that we had in terms of the infection rate that was -- and so on. So, yeah.
- [Majority Counsel]. Okay. I'm out of time, but I'll check in with you, Kevin and colleagues in the minority, if you have any questions. But we're getting closer to wrapping up.
- [Minority Counsel]. We'll have a few questions. Are you done with your hour?
- [Majority Counsel]. Yes. This makes sense in terms of the time to stop.
- [Minority Counsel]. If the witness is okay, the minority would like to request a five-minute break. Or four minutes, like 3:00.
- [Recess].
- BY Mr. Barstow.
- Q You said that the risk COVID 19 at the border was overstated. If you explained it, pardon my reiteration of the question, but can you explain that again, why it was overstated?
- A I think a lot of the argument was the -- made that there was a lot of COVID coming in and crossing the border and represented a risk for introduction and -- and spread. And based on all the data that we were sort of able to gather, that was the part that was overstated. And the other aspect of it was that COVID was well established in the United States, and there were a number of hot spots, and we were also learning about the types of tools that were available in terms of nonpharmaceutical interventions and hygiene. And, quite honestly, those were things that had been recommended before with regard to other lesser threats, and those were the kinds of things that we thought were appropriate for the context at the time and that there was not a commensurate rationale and that there were significant harms that would come of the proposed actions that were taken. So there was a lack of proportionality, there was a lack of legitimate threat coming in, and that there were other potential consequential harms in terms of both COVID and other public health consequences that would come with the manner in which was proposed to resolve the problem that was already well established in the United States.
- Q And I'm not a medical doctor, but with an exponential disease like COVID, does stopping even one case pose its benefits?
- A The benefits of stopping one case when you're already in exponential spread in widespread communities, you know, in different places across the U.S. has a differential impact, marginal impact relative to the risk of essentially repeated consequential exposures in that regard. So yeah, I don't think stopping one case is the same when your day one January 1, 2020, as it is when you're in March.
- Q Would that same logic apply to a testing requirement for Americans coming back from abroad that stopping one case isn't necessarily the end-all deal?
- A So the testing requirement for -- the predeparture testing requirement had -- it's not about -- it's not about one case. We're talking about sort of the millions in terms of volume. An idea of the predeparture testing requirement is to prevent its introduction in the travel corridor and not so it's creating a safe and healthy travel corridor so that the movements and the benefits of engaging in international travel, as stipulated in the international health recommendations, can be maintained, because there's a lot of important activity that occurs with regard to maintaining the international exchange of goods and services in the case of travel, for example, and not having, you know, airlines take down the conduit that can move reagents, supply chain items for vaccine development, medical ingredients for pharmaceutical production, all of those things. So the calculus is different in that regard; right? So I think that it's not about stopping every case or only one case. We know that there's a certain amount of leakiness being tolerated. We had a testing requirement for -- first none, then 72 hours in advance. Then it was, with Omicron it was moved closer to the time. So these are all tailored to the circumstances and the goals, and they're not amenable to -- by analogy, to simple, you know, generalizations, because the context matters in terms of the issues and the consequences.
- Q So the testing requirement to reenter the country, that same fear doesn't apply at ports of entry? I mean, I was at the border a month ago and saw miles long of people trying to walk across that, to me, poses a congregate setting similar to --
- A Right, but it is not quite the same. It's a different kind of engagement. So, for example, we don't have a testing requirement at the land crossing. We do have one in the international airspace. And it's for the very -- you know, some of that very reason, right, is that it's a different setting and so on. So we do have adapted COVID measures that are contingent on the specific context and looking at the collateral damages versus those kinds of things. So in order to maintain the movement of trucks that are bringing required goods for infrastructure, for medicines and all of those things and that kind of exchange, the testing requirement is not done in that setting. So all of these different settings are a little bit different in trying to balance those kinds of benefits, and that's why they aren't the same in that regard. Our requirements at sea are based on the unique environment of a cruise ship and what's available, and even with the vaccination requirement, when we had the vaccines that aren't necessarily working as well in that setting, we might have, you know, a testing requirement in that space when there's a structure to do that. So it's very, very much, you know, contextually derived.
- Q The assertions that you said that the COVID-19 threat at the border, was that overstated, is that based on your team's visits and, I imagine, briefings back to you?
- A There are a number of factors that came into place, including some of the team's visits, including some of the team's work with other organizations that had the ability to test and report on the incidence of infection that they were discovering and testing.
- BY [MINORITY COUNSEL].
- Q Did you have any data on this? Did you guys conduct any studies at the border? Were you testing -- like, you know, sampling and doing -- did you have any studies or data to back up all these assertions you're making?
- A Actually, let me just reframe. Partner organizations that have been involved in some of these locations did have data, as did community organizations that were involved in testing migrants in different settings. So yeah, there were data on this in regard to -- that informed that the COVID infection rates were not justified to try to, you know, stop an entire set of movements based on the COVID risk in that setting. And then there were other things that could be done that might be able to mitigate that or when the situation was more manageable, that illness could be assessed and cohorting could occur. There were different rates of COVID that were occurring in different -- it was a lot of different --
- Q Could you provide those studies to us? Of the third-party partners.
- A I don't know about how quickly or whether we can get that information to you.
- Q You're sort of comparing flights and people crossing at land ports of entry, and you're making judgments based on, you know, the values of burdening and not burdening travel through those two means. And I'm just wondering is that -- whose job is it to -- is it your job -- you know, is there some sort of HHS directive that says it's your job to make those value judgments, that it makes sense to test air -- people repatriating via air, but not people repatriating and sometimes migrating across land borders?
- A It's our job to bring the public health data that are available and the perspectives into these discussions and provide guidance and advice. It is the job of, you know, the folks that are appointed, that are in charge of various agencies to set and make policy based on the input that they're getting.
- Q Is that Dr. Redfield at the time?
- A The CDC director has the ultimate responsibility for deciding what the policy of the agency will be. And, as we indicated when I first met him, I would faithfully give him my best assessment, my best opinion based on career experience in this role. But I understood and accepted that the responsibility for making these decisions sat with him. And that's what I've been doing, no matter who is in the CDC director role, and that's just kind of how we work. I give the best data available for him to make those decisions.
- Q I think it's come up over the course of the interview that you disagreed at certain points with some of, you know, the direction that Dr. Redfield was going in, and you voiced that to him; is that correct?
- A I always gave Dr. Redfield my best and honest and nonpartisan advice based on the public health assessment of risk and the consequences of various approaches to mitigation. I've been committed to doing that with every CDC director since I've joined this agency and will continue to do so.
- Q Over the course of, you know -- I mean, the Select Subcommittee is conducting this investigation based on lots of media reports, and I think you've discussed some of those media reports with [Redacted]. There's a reporter named Dan Diamond who has written a series of articles on political interference at CDC. Are you familiar with Dan Diamond's work?
- A Not off the top of my head based on your question right now. But in general my policy is not to talk to reporters about these kind of things or do background or off the record or anything else. Everything -- every engagement with reporters that I would do is cleared through the channels with the director and HHS and others.
- Q Is there an HHS or CDC policy on engaging with reporters?
- A I don't know what the CDC policy is, but in general the practice of people like me when there's an outreach for any of that stuff is to tell the folks to talk to the people in public affairs and public relations, and they will scope it out and they will get the clearance that's necessary. I don't do that.
- Q There was a letter that one of the prior directors wrote to Dr. Redfield about -- criticizing some of his decisions, and I think that letter got leaked. Are you familiar with that letter?
- A Are you talking about the letter that Dr. Foege --
- Q Yes.
- A I was familiar with it after the fact. I was unfamiliar with it at the time.
- Q Are you concerned that there's lots of folks at CDC that talked to the media on or off the record, but anonymously? Does that concern you?
- A In general, I think what we do as career folks is dependent on having the integrity of a deliberative process and providing our best advice and respecting the privacy of those deliberative processes so people who are in charge of decision-making make the best informed decisions.
- And I wouldn't want to see anything that chilled that process. I don't think leaks or all these other things are healthy for the way we need to operate. And it's been my practice to avoid that at every setting unless I was asked and cleared to speak.
- Q Do you have any recommendations for going forward what the agency should do to sort of stop what some may view as insubordination through leaks to the press? Do you have any recommendation? Should there be a policy? I'm just asking based on your experience, your 20-plus years of experience.
- A No. I'm trying to understand exactly what you're asking me. I think you're asking whether I thought it was a good idea that people speak off the record or anonymously. I don't think it's a good idea and I don't do it. Are you asking me whether --
- Q I'm asking going forward like what could CDC do differently to prevent, you know, these leaks that I think chip away at the American public's trust in our public health officials. But that's my personal opinion. You may not believe that, and I wouldn't want -- I'm not putting words in your mouth. I'm just asking for recommendations for going forward.
- A I didn't actually -- I wasn't prepared to come here with a thoughtful answer to that question. I certainly can provide some thinking about that. It's probably not a straightforward question. I think there's all sorts of things that need to happen to improve the quality of communication, the integrity of communication, the protecting the deliberative process. You know, I don't think leaks serve our public health purposes in that regard. I'm -- you know, there may be people who have a different point of view on that, but you won't find me participating in that process, I can assure you of that.
- [Minority Counsel]. Okay. [Redacted], do you want to take over? I might have a few more, but go ahead.
- By [MINORITY COUNSEL].
- Q So you talked a little bit about -- and I agree with you it should be the goal to use the least restrictive means possible to achieve the desired end of -- in this case, as few deaths and hospitalizations in cases as possible. Were you involved in -- I'm asking you a question about deliberations after you just said you don't want to talk about deliberations, but were you involved in any other decisions to close businesses or close schools?
- A Yeah, that has generally not been the purview of my scope in this response. I had mentioned that, you know, in the development of planning, going back to the early aughts, we looked at what was in the purview of when and if border measures were appropriate and how and what would be the benefits and consequences and what point of time it would work and how much could they achieve, and then what were the benefits of looking at 1918 in models and contemporary experiences around the globe in flattening the curve. It turns -- as it's unfolded in the scale of this pandemic outside of the preparedness realm, the actual guidance and responsibilities about the areas you're asking were taking place in another set of the response, another task force in the response on the timing of those decisions on schools and businesses and so on. I believe that some of the decision or the preparedness work that we did informed that, but as was quite clear, multiple layers had different types of contribution. If you think of them as Swiss cheese, some have bigger holes than others. Some have more collateral consequences than others and have to be carefully selected and evaluated and looked at in that regard. So the simple answer was I wasn't involved.
- Q Considering your history in infectious disease, I'm going to ask you your opinion on it. Do you think there were less restrictive means to achieving the end than closing businesses?
- A Do you mean in January of 2020 to January of '21? Is that what you're saying? Or are you talking about a particular point in time? Are you talking about the March --
- Q I think the mid one was March 2020 until -- and I think some were still at least operating at marginal capacities until recently.
- A It would be hard for me to give you a really specific opinion. What I can say is while we're awaiting for the vaccine development and medical countermeasures, et cetera, a wholesale unmitigated pandemic would have really, really grave consequences. And I do not espouse to that philosophy of what some would call the sort of "let her rip." And I don't think that if you take the kind of zero COVID policies that we've seen in certain Asian countries and you keep things, you know, down and suppressed for a very long time that you maintain a totally susceptible population. But you're buying time with those types of policies, and you aren't prepared to come back with a very robust use of effective medical countermeasures when they're available. You're setting up a vulnerability. So the answer about where is the sweet spot in trying to attenuate the more severe impacts, once the healthcare system becomes overwhelmed, the collateral damage across broadly beyond COVID is enormous. And I think that that -- you know, attenuating those kind of severe spikes that you saw with Omicron in late fall and Thanksgiving through something like January, those can be devastating when the entire healthcare systems are brought to the brink and surgeries that are needed can't be performed and response, ICU for a car accident isn't available. Now you're really talking about serious consequences. You've got to find a sweet spot, and in some ways that depends on what's working in different settings. And it's not an easy thing to answer. This is why we spend so much time studying it in history, studying it in models and theories, studying it in practice, looking at the impacts of other countries as they took on different policies, and constantly trying to navigate and find effective approach. And that approach also changes over the course of the pandemic when the virus issues a curveball and mutates or when population immunity does build up in a less vulnerable group, so they constantly have to be looked at and reflected on. And I don't think there's a simple answer of all on or all off. I think it's actually neither of those two. It's much more delicate to figure out the right balance.
- Q Do you recall who ran -- or, first of all, what was the name of the task force within CDC that was in charge of that kind of stuff and who ran it?
- A I don't recall. It was a big issue, and it was broken up into a lot of different settings. There were some that focused a lot on schools and were gathering data on schools. There were some that were collecting data on the use of masks and what impact masks would use. We have modeling and forecasting group that's assessing these kinds of things theoretically and doing projections. So it's a pretty widespread set of responsibilities.
- Q You brought up how mitigation measures evolve and medical countermeasures evolve. As more vaccines have been brought to market, more antivirals have been brought to market, we've learned the efficacy or non-efficacy of various nonpharmaceutical interventions, has CDC altered public health policy to kind of flow with it?
- A If you're asking my opinion as not the person that's responsible --
- Q Yes.
- A -- I think there's been an evolution of CDC guidance and recommendations that are adapting to the stages of the pandemic and the availability of interventions. I think it would be pretty apparent if you looked at the course of our guidance over time and from that opening act to -- in early January to where we are now. Examples include the length of time for isolation and quarantine, availability of tests, types of use, availability of using masking both as personal protection and importantly, very importantly, source of control and the different settings of risk, yes, I think CDC has attempted to be adaptive.
- Q In your opinion -- so we've seen how effective vaccines can be and how effective the antivirals can be, how much we've learned from like early processes in hospital care, in at-home care, but unfortunately more likely to continue to see significant deaths, more people dying in 2021 when we have all these things in 2020. Why do you think that is?
- A First, I want to be sort of careful about the scope. We're talking about largely vaccines. The emergence and use of the vaccines have been after the scope of this conversation. That said, I would say that even that is not a fixed answer. I tried to give you that indication earlier when we talked about the power of vaccines. They're influenced by -4890 - one is how vaccinated somebody is, which vaccine is in use. We've seen dramatic differences between vaccine platforms in terms of their effectiveness. Looking at vaccines against what end point? Is it against infection? Is it against hospitalizations? Is it against death? How many vaccine doses have people had? Whether they've been boosted and are fully up to date or never boosted, and most importantly, the risk factors of who's most vulnerable and who's likely to die and also who's likely to benefit from vaccine. So even vaccine effectiveness varies across the age structure of the population, varies across a host of underlying conditions. I will say in principle -- and this is based on my experience for several decades -- pandemics and epidemics are really complicated interactions between a pathogen, the host, the type of host, and the milieu or the environment or the social context to structure the engagement, the policies, the behavior aspects, whether it's, you know -- and one setting differs so much from another, as we've seen sort of zero COVID policies in China with the Omicron. The high -- the complex circumstances of pathogen hosts and the environment can have the perception of one pathogen, similar pathogen having either low severity overall impact or having a high-severity impact, depending on that interaction. The truth is this is what keeps people who do this for a living constantly engaged because we're always trying to figure out what's the balance of that interaction between the pathogen we see as it evolves, host of the populations that are at risk and the policies, behaviors, and the milieu and the context and the population and the setting where it occurs. That is a pretty holy trinity principle in infectious disease, public health.
- Q Knowing a significant portion of the population is fully vaccinated and another significant portion is not and there's at least another portion that has some level of natural immunity, Dr. Fauci said on TV last week that we're nearing the end of the pandemic phase of the virus. He said it's pretty much moving to endemic. Do you agree?
- A Yeah, I think that's a little bit out of scope here. But the other, you know -- you know, thing about this is, I think there's a lot of misunderstanding about the various terminologies and so on.
- Q It's just --
- A I'm not going to -- I'm not going to share here and I think it's a much more complicated question than perhaps even you realize.
- [Minority Counsel]. [Redacted], do you have anything more?
- [Minority Counsel]. No. I just hope that we can get some of that data from the third parties that were testing people at the border in those land crossing areas that helped you solidify your opinion on, you know, the land crossings versus flights coming into America and, you know, those opinions.
- Mr. Barstow. As always, we're happy to consider any request that is made by the Committee.
- [Minority Counsel]. Thank you, Kevin.
- [Minority Counsel]. I think we're good for our hour, then.
- [Majority Counsel]. Dr. Cetron, do you want to take five minutes or do you want to keep going? I anticipate having less than an hour left.
- The Witness. Let's keep going. It's a long day. So --
- [Majority Counsel]. I appreciate that, and I appreciate your patience.
- By [MAJORITY COUNSEL].
- Q I wanted to circle back to our discussion and clarify a few things for the record. Where did this proposed order come from?
- A Which proposed order? Which order are you talking about?
- Q That March 20, what became the March 20 order.
- A I don't know, to be honest with you. I can't say definitively one place. You're talking about the written order, the draft?
- Q The draft, yes.
- A I can't say with any certainty. I can just say that neither I nor my team were involved in drafting it.
- Q Was CDC considering anything like that in terms of restrictions at the land border?
- A Do you mean the wholesale closure of the land border to a certain population? Is that what you're talking about?
- Q Right.
- A As opposed to the other kinds of things that I mentioned?
- Q Right.
- A I think that we -- you know, I think we've looked at the people that have talked about it. We've discussed how those types of border closures have worked or not worked or failed in the past and what were the goals and what would be the effective means of trying to address it. And if the circumstances changed, it's a different situation, but that was not -- it was not deemed to be the appropriate tool or the appropriate use of that authority for that purpose, given all of the totality of circumstances.
- Q I want to ask you about another quote that's in the ProPublica piece. And it comes from -- it's attributed to someone reporting to you, and it is an email where this person wrote, "I'm also not a fan of trying to make the case that Canada and Mexico represent a big risk on the land border based on what we believe" -- and "believe" is in quotes -- "is occurring versus what we know about the number of cases, which are far fewer than the number of cases in the U.S. now due to community spread." Is that an accurate assessment of the data as it was known at that time?
- A Yes, I can't speak to every single word of a quote that somebody else offered on my behalf. But I think, as you've heard me say, you know, a number of times, that comports with the assessment.
- Q Okay. The quote is -- starts with "I'm also not a fan of trying to make the case that Canada and Mexico represent a big risk on the land border." Was your team asked to make a case for the public health rationale?
- A I think that's what was -- I think that's what was being asked by this proposal that came to us, you know, to invoke that kind of authority is to, you know, see whether that was a justifiable public health action based on the circumstances at the time. I don't know if you would call that making the case. But, in any event...
- Q Sure. And you mentioned that you chose to excuse yourself from the ultimate decision to authorize the order. When did that happen?
- A I don't know. I think whenever Dr. Redfield said, you know, said to me, this is the decision that's being taken, and I said to him, I think, that there are potentially significant harms in that decision, and I would appreciate it, if that's your decision, if you guys handled it out of the office of the director, which he accepted. I'd given him my advice on the issue earlier, and from past experiences in other epidemics in other settings, that I thought it might propose a false sense of security about what really needed to be done and should be done first and foremost, and it could be much more effective in addressing this and that it was not a least restrictive means approach. It was not generated -- insufficient evidence that the nature of the threat would warrant it and that it might be misperceived as -- you know, really using a public health rationale for a different -- you know, a different type of a need. And I wasn't taking issue with the questions around the overall policies with regard to immigration. I was actually concerned that the public health order, as it was being proposed, was not the appropriate tool to deal with that problem.
- Q Had you ever excused yourself from a decision like this in the past?
- A I don't recall ever having to -- having to do that. But I felt pretty strongly about it, and I felt pretty strongly about the potential negative downstream consequences of -- of that.
- Q One of the consequences that you mentioned -- I guess it was in our second hour in response to [Redacted]'s question -- was stigma. Can you explain what you meant by that.
- A Well, you know, I've been part of a number of epidemic and pandemic responses over time, and I think it's fair to say that epidemics -- there's the epidemic of disease. There's an epidemic of fear in how to deal with the fear about that disease, and then there's often an epidemic of stigma in which there's scapegoating or blaming or assigning the problem of the epidemic, perhaps inappropriately assigning it to a particular group of individuals or particular settings. And this is not an uncommon phenomenon in epidemics. The epidemics of fear and stigma, the best vaccine against those epidemics is truth, honesty, education, information, maintaining integrity about the nature of what the threat is and isn't, and not treating victims as vectors and not assigning, you know, to individuals as vectors when there's -- you know, when there's not evidence that supports that. And that's what I was referring to with stigma. I think there's some significant harmful consequences to allowing stigmatization, and I think that there is -- it veers away from the principles that I articulated about transparency and integrity and clarifying and informing and then adapting and being -- using good scientific and public health principles to address things. And authorities, our public health authorities, are really important to have at hand and use them when they're totally appropriate. So if we don't take a very fair and balanced approach to using them in that way, then the trust that we've built up on our ability to use those public health authorities begins to erode. Those were some of the things I was very concerned about in addition to the negative public health conditions of misidentifying the source of the problem and not addressing things that were more important and more impactful.
- Q And I know you've studied this and the exercise of these authorities throughout history.
- What sort of impact has that stigma had in the past in American history?
- A I think we've seen a number of examples where, you know, individuals or groups of individuals were blamed for a problem as if that allowed for an explanation that marginalized the problem and kept it at bay or contributed to either a sense of denial -- as long as I listen to that individual or that person, the problem didn't -- wouldn't and didn't impact me, so on, that kind of thing.
- That creation of a concept of "other," and "other" is where the risk is and "other" is where the consequences would be. I think that not only has harms in terms of creating the stigma, but it allows for a false sense of security about what an individual may or may not be part of that group need to be doing in order to play a role both in protecting myself and in my responsibilities toward handling the problem. And there are many examples in history, you know, that would comport with that, whether it's HIV stigmatizations or, you know, internment camps or other kinds of things. So I think that there's a risk there, and the risk is creating a false narrative and therefore avoiding the kinds of things that we all need to be doing collectively to address the risk as opposed to trying to comfort ourselves by distancing us from the risk as long as we're not part of that stigmatized group.
- Q In explaining your decision to excuse yourself, it's been reported that you told colleagues, "I will not be part of this. It is just morally wrong, and to use public authority that has never, ever been used this way, it's to keep Hispanics out of the country and it's wrong." Did you say that?
- A Again, I can't account for every word as it was quoted in somebody else's secondhand and so on, but I think what I'm describing to you here today is that the tone and the sentiment of that quote is consistent with some of the concerns that I had. And that would be fair to say, but I can't attest to specifics of every word there. And I would have never actually -- as I had told you, I would not have made that direct quote to a reporter in the public -- in the public setting. So that is -- what you're quoting back is the source from another individual, and I can't attest to that.
- Q Sure. Did you believe that the authority was being used to keep Hispanics out of the country?
- A I can't -- I can't specifically say why all the decisions that have been made around these kinds of things are being done. That's not for me to say what the intentions always were. What I can say is that the evidence to use the authority did not seem to be sufficient or justifiable, that there were less restrictive means. There was a potential that misrepresenting the situation would create stigma and would create a distraction from doing some of the things that were more important and absolutely necessary and that might create additional public health harms and consequences. I can't make judgment on, you know, what's in the minds and hearts of other people who are promoting those priorities.
- Q Were you concerned that keeping Hispanics out of the country might be the rationale?
- A Was I concerned that there might be more than a public health agenda involved and I don't know all the aspects of it? Yes, I was concerned that there may be a motivation that was beyond the specific public health agenda. But, again, that is for other people who are proponents of the policy to, you know, articulate, not for me.
- Q Do you think -- and you can limit your answer to the period that we're talking about. Do you think that the order created stigma against certain groups?
- A Yeah, you know, again, I don't want to -- I don't want to speculate. There's all sorts of things that gets said and there's all sorts of information that's moving around, and how people receive that information and, you know, what it means, different people hear it, that's not for me to say. My concern is to, again, kind of try to stay very clear about what are the justifiable uses, what's the evidence in support of it, how do we weigh the risks and benefits, what could be done.
- Q It's clear that this was a moment that you took a moral stand. Do you have anything else you'd like to say about the decision?
- A No. I think it's very important to realize that this -- that responding to a pandemic is a whole of society response, and it is an interaction between the pathogen and the host and the context in the environment. And what we say and what we do and our actions should reflect, you know, our sense of honest, you know, concern and care for one another. The people whose movements are restricted, who are restricting movements for the good -- when individual liberties are restricted for the benefit of the whole, we should be thinking and be very grateful for those people who make that effort and we should try to support in all ways possible mitigating the impact, you know, on these folks, because they are making, you know, compromises. And the best way to instill that collective spirit in this sense is to actually try to always stay a little bit, you know, above the fray and create a sense of balanced decision-making that's grounded in good science and good practice and with a sense of dignity and honesty and so on. I've tried to adhere to that, you know, my entire career. It can be very challenging in a pandemic. But I think it gets back to what we really understood to do collectively in terms of battling these problems and not just consider what our own individual perspective is, but consider the perspective of all involved.
- Q I want to move on and ask you -- you mentioned that the authorities include interstate authorities. I'll first ask you: At any point during this period did CDC consider any other uses of that authority? I'll ask -- in terms of --
- A I'm not sure I understand. I'm not sure I understand the question.
- Q That's a bad question. I'll ask you specifically, it was reported that CDC was considering a mask requirement on public transportation. Were you involved in that discussion?
- A Absolutely, yes.
- Q Okay. And tell us a little bit about what the authorities are in this in terms of that requirement.
- A Again, there were a lot of conversations happening jointly in the interagency about how do we mitigate the impacts of the pandemic while minimizing the interference with travel and trade. How do we create safe travel and healthier travel experiences? How do we maintain the ability for international exchange of goods and services to continue in parts of the economy, you know, in that regard that are critical or important and to continue, how do we move supplies of vaccine and antivirals and critical supply chain reagents around. And there was a joint interagency effort discussing what's in our tool kit. As I indicated to you, there was a time which this concept of geographic 212F proclamations where we tried to, you know, shut the borders or ban movement. Could be that wasn't actually going to be sufficient and no longer had the same kind of place in the phasing of where the pandemic as it was globalizing would be, but would have a chilling effect on keeping, you know, flights going and international exchange. This is also in keeping with the spirit of the international health regulations to which the U.S. is a signatory member, something that I have worked on for a number of years. From 2005 -- you know, 2003 to 2005 when the charter was proposed and signed. We were looking at the tool kit and the idea of individualized risk assessment in trying to create a safe travel corridor by keeping infections out of the area of transportation space, by doing everything that we could to -- if infections were getting in, because this was a contagious virus that could be asymptomatic and sometimes even testing negative 72 hours in advance wouldn't guarantee an infected person might not be boarding. And the large-scale volume mixing and movement of the virus, that masks would actually be one of those very important layers of Swiss cheese that was a lot more cheese than hole and that, if used properly as source control and personal protection and it was a community-wide commitment that the travel corridor safety could be markedly improved by masks and that was there an agreement that there was appropriate federal authority to create a mask for international air travel. Again, things may need to be adapted in different settings about the transportation corridor could safely be markedly improved by having people wear masks. And there were obviously caveats and exceptions and age limits and all of those things. But the evidence was scientifically there. We modeled the issue in terms of the risk on its potential contribution, which was significant in risk reduction. And these things were -- you know, this idea was generated out of CDC but discussed in interagency deliberations, and I had talked about it with CDC director and so on. And there was a general support for that, and we began working on that problem beginning in that July time frame of 2020, and these conversations were ongoing over the course of the summer and the summer travel season in 2020. So -- and we drafted -- we drafted that -- that order. Yes, I think it was a potentially important tool in the tool kit that could make a big difference. I know Dr. Redfield was very supportive and has given testimony on the record the tremendous power of masks in reducing transmission, especially if worn properly and worn by everyone and that it wasn't just about what you were doing for yourself to protect yourself; it was also a way of controlling the unknown asymptomatic infection and containing it so that you weren't actively spreading that. So if everybody participated in these various settings of density and mixing and so on, it would have a tremendous reduction effect. And it was written into some of the guidance and recommendations in the document that FAA led on putting out -- called "the ramp to recovery" or something of that sort. The CDC section reflected a lot of this work as well.
- Q In general terms, in terms of the reduction, what were your models telling you?
- A Significant impact in reduction. And they were also being borne out by data that were gathered in other use of community masks used in indoor poorly ventilated and dense settings. So if you take that parameter as I was talking about where transmissions would go way up and you look at the person, place, time, and space, the use of masking in these settings, especially community-wide, both source control and personal protection, really attenuated all of the risks of having, for high-risk persons, for places in which risk, you know, would be amplified, the time that people were spending, the choice they had about their ability to leave such a place or space or not, the place, whether indoor or outdoor, were well ventilated or not. So all of those things were impacted significantly in terms of risk reduction by a general mask use. And there was some emergence of decisions around this that were much more patchwork. It could be a particular state or a particular jurisdiction or the risk of one airport versus another or one, you know, entity versus another creating a lot of confusion. And so this was a -- seemed to be a very good space for a coordinated, unified set of efforts that were guided by best practices in some of the scientific evidence and the public health evidence was emerging. That was our thinking in developing that order was in that spirit of getting a handle on control, especially in the pre-vaccine era, but not exclusively. Even beyond, it's very important.
- Q Can you give us the contours of the order? Where would it have applied, what were the enforcement mechanisms, and --
- A Interstate and international arrival transport corridors. That would include both the hubs, the airports as well as on the conveyances, for example; also surface transport with interstate linkages and movements. So which is the buses, terminals and the buses that moved, you had linkages that would be transporting interstate passengers. You know, that was one of the overall framing of this. And that there were carve-outs for places on the grounds that were either, you know, outdoors and well ventilated or wholly private nonpublic-facing and so on. They were framed in those regards. There were carve-outs for folks with certain disabilities that had medical authorization and inability to use a mask or children under a certain age that couldn't be expected to regularly, you know, use masks in that regard. But yeah, aside from the sort of carve-out issues, it was meant to be that jurisdictional space within the federal government where the federal government had interstate movement on the international level.
- Q You said your team drafted it in July?
- A We began the discussions and we began evolution of the drafts and interagency deliberations and building the argument and presenting the data. And then we were moving it up. We had, as I indicated, support of our director and the secretary, and it was being moved into those kinds of decision-making processes for White House task force and the interagency and so on.
- Q So what happened with that order?
- A Despite what seemed like a fairly broad consensus, ultimately that decision was made and we were told that there would be no such use of federal authority for masking in a transportation corridor, mask requirements in the transportation corridor, and that that would not happen.
- Q Were you given a reason why that wouldn't happen?
- A Not specifically. There was all sorts of speculation, but I don't care to speculate. But it wasn't -- it wasn't going to happen, and we needed to look for alternatives to being able to use that tool.
- Q It was reported in October of 2020 that the White House blocked that order. We have an article there that covers it. I think it's the last exhibit, but let me check. Hold on one second. Yes, Exhibit 16.
- [Exhibit 16 was marked for identification.]
- A Okay. What's your question?
- Q It says there that "the White House Coronavirus Task Force, led by Vice President Mike Pence, declined to even discuss it." Is that accurate?
- A I think that that's also a question for Dr. Redfield. It sounds like meetings that he was involved in that I wasn't at. But I think it sounds like Dr. Redfield, you know, interviewed with Sheila Kaplan on this article, and maybe you asked him the same question. I'm not sure.
- Q Do you think that -- and I think you went into this. Do you think that such an order would have been in the best interest of public health at the time?
- A I do.
- Q We saw a very deadly surge of the virus in the winter of 2020. Do you think that implementation of this order could have saved lives?
- A I think it would have helped. Just like I said, multiple layers implemented early effectively, you know, makes a difference. And I think this would have -- I'm not saying it would have stopped the surge or the waves. I think it would have affected the shape of the surge, along with many other things that needed to be done, and I think the risk of both importation and spread, I think especially the risks of spread, travel of the many waves that we've now seen over two and a half years has been tightly correlated with resurging waves. It's been correlated with the introduction of variants, and it's been correlated with the shape of surges. As travel volume has gone up, it has amplified and extended and accelerated the shape of those curves, and I think that, you know, masking in the transportation corridor could have made a significant contribution. And I was disappointed when we were unable to use that tool. And in my opinion, it was well within the scope of the federal public health authority that the CDC was given.
- Q Apart from the episodes that we've discussed, did CDC seek to institute any other orders in this time period that didn't happen?
- A I don't recall that off the top of my head in that regard. But I think this is one I was very much directly involved in. That probably is something that others may be able to ask. But we sought, you know, the testing components and the kinds of tools that we thought would really make a difference and we were looking for -- to use this to help mitigate the impact of the pandemic. These are some of the nonpharmaceutical tools that are really important in that jurisdiction.
- Q What I'd ask you also, the decision you took in regards to the March 20 order, were there any other incidents where you felt you had to take a moral stand in that way, any other decisions involving public health during this period?
- A I think if you're asking the question were there decisions that I felt were important to bring to the table around these types of issues, you know, I'd like to think that they inform and infuse aspects, as I've said before, the general principles. This was a, you know, the March '20 order was a clear space, but I think as I present the data, I try to present a set of principles, the science, the equity, the considerations, the balance and the tradeoff, and provide my best advice to -- whether it's the director who's asking or anybody else in an agency discussion. I think it's important to understand the larger picture at play. So I think we're responsible for all of the -- you know, the authorities and the advice that's given to us as leaders and to use it with a strong moral compass.
- Q Were there any other times where your moral compass was challenged in that way?
- A You know, this has been a difficult pandemic on so many grounds, and it has been challenging to make hard decisions in a lot of places. I think suffice it to say that, you know, I looked and tried to consult the framing of all the decision that I make that is infused by a set of principles. I've served -- you know, the integrity of the science, communication, honesty of process, the balance of the equities, the least restrictive means, the opportunity to appeal given the decisions, the proportionality. I don't know if you call that a collection of moral assumptions or just, you know, parts of trying to execute my job faithfully and with responsibility and integrity.
- Q There has been a great deal of public reporting about political interference in the CDC scientific work by Trump administration officials. Do you think political pressure was a problem for the CDC in 2020?
- A I think that, yes, I think it was a problem in various aspects. I think that's, you know, not much in dispute in that regard. You know, pandemics are whole of society events. They involve taking into perspectives the political, public health, private sector population. There's lots of perspectives that they should all be as part of what we need to do as whole of society is rather than seeing all these things as a battle and a fight and false dichotomies that it's either public health or, you know, a private interest or a population desire or, you know, a political interest, it's all of those things. If we constantly are finger-pointing and blaming somebody else for things, we lose the fact that the real enemy here was the virus and its ability to cause just a tremendous amount of suffering, harms, morbidity, mortality, death, mental health consequences, missed opportunity, and collateral damages across multiple sectors. We are all best served if we're going to battle pandemics if we can find a way for those things to not be in false dichotomy, but to find a win/win where it's not an either/or but it's a both/and. How do we comprehensively work together to battle the threat of this virus, because at stake here is risk to all of us, no matter which lens we're using to look at the problem. And I think we could have had a better outcome and continue to have a better outcome if we kind of avoid these false dichotomies and try to find, you know, collective solutions. I think the virus doesn't really care about our politics. It doesn't care about, you know, our business interests and our financial bottom lines. It's really doing what it does best. We needed to be our better selves if we're going to effectively battle the next pandemic.
- Q What impact do you think this political pressure had on CDC and its ability to control its mission?
- A I think when there's all these tensions, as I said, I think that technical expertise alone is not going to be -- it's essential but not sufficient, and doesn't guarantee success. And building an established bank account of trust in institutions and individuals and our collective interests that we trust one another to have each other's back and have the best interest of all of us at stake, we will be able to do better off. So I think the erosion of credibility and trust really harms the ability to persuade people to take sometimes difficult steps that's in our joint collective interest. That's tough. It's tough.
- Q What can be done to sort of reverse that bankruptcy of trust that you've talked about?
- A Never too late to start. Better communication, better listening, better understanding. You know, truth and honesty, quelling the act of disinformation, fair representation of the circumstances and situation at hand, acknowledging uncertainty, living in difficult spaces but knowing that there are better and less well paths forward and trying to find those solutions jointly.
- I think that will help restoring the integrity of our institutions and our leaders, but also having more collective responsibility for one another at the individual local level as well.
- Q One final question: Are there any policies or procedures that you wish had been in place and could have protected the CDC or could have protected the public?
- A I think that's a really long answer, and I think that we'll -- we'll need to sit back and take time and tease this apart and do, you know, a full dissection and we will come up with recommendations and interim actions. My only hope is that we can do that with a sense of collective fairness for what's at stake and respect for one another and that we deliberate around that with a sense of integrity rather than a sense of divisiveness, because there's a lot at stake if we don't. And I would like to see some of the lessons observed really turn into lessons learned in a very honest way, self-reflection and reflection on others. And too often I think there's lessons that are observed that are never really learned and mistakes that are repeated. I know that when I look back at the 1918 pandemic in detail, it feels like there were lessons there that were missed and ignored as we came into this pandemic, and I hope we can do a better job in that reflection in the future.
- Q Any specific lessons top of mind?
- A There are going to be many, and I'd hate to leave some out at the end of a very long day. Probably that will take some time, but I just hope we commit to honestly engaging in that instead of blaming, finger-pointing. I really hope that we actually can see our way collectively to looking at what worked and what didn't and what we might do differently and have some genuine conversation around that.
- Q Is there anything else that you'd like to put on the record before we close?
- A No.
- [Majority Counsel]. On behalf of the majority staff, I want to thank you for your decades of service to this country and particularly the sacrifices you've made over the last couple of years, and I want to thank you for taking the time to speak with us today.
- The Witness. Thank you. Thank you to all the members here.
- [Minority Counsel]. Thank you, Dr. Cetron.
- [Proceedings adjourned at 4:10 PM]
Interview (2016)
Interview (2016)
David J. Sencer CDC Museum, Global Health Chronicles
Samuel Robson, Interviewer | 2016.600.152.1
CDC Ebola Response Oral History Project
https://globalhealthchronicles.org/ohms-viewer/viewer.php?cachefile=MartyCetronXML.xml
Dr. Martin S. Cetron
CETRON: There were a number of emotionally laden memories about the response. It was a long response, one of the longest. I've been doing these responses with CDC [United States Centers for Disease Control and Prevention] for twenty-six years and this one was the toughest in a lot of ways. There were some really hard ones, SARS [severe acute respiratory syndrome], [influenza] pandemic,monkeypox, and MERS [Middle East respiratory syndrome]. There's a lot of them that were [challenging], but this was uniquely different and difficult and it was a big chunk of your life. It wasn't a three-month SARS thing where you get in, you sprint, and get out. You go through a whole series of [emotions]--it's a bit of an emotional rollercoaster. There are various points along that way where things stand out.
One of them which was a consolidating, almost a processing cathartic experience. In September of '15, I think that's probably right, I was asked to give an
hour-long--I'm Jewish, and that time of year is our New Year's celebration and Yom Kippur, kind of a holy day of the year. I was asked to try to explain and tell the Ebola story to a congregation, to a group of about one thousand non-technical people, as interpreted through certain kinds of teachings and Jewish text and make a linkage between the time of year. They call it a d'var. I had prepared for it for months and then given it in late September, early October of 2015. That was a pretty emotionally laden time.
There were many others. The various times of pleading with the WHO [World Health Organization] much earlier. I sit on the emergency committees of many big responses for WHO, and trying to argue the need for action sooner [in this outbreak] than they were ready and willing to act. Transporting the first people back here to Emory [University Hospital], to others, hearing about exposures of colleagues and safe extraction. I run a large program and have a set of responsibilities that is both international and domestic, and at the time duringEbola, our team size was four hundred-plus. We had one hundred people probably cumulatively working in the field. The October surprise and the October events
happened, and the '14 pre-election, and Thomas Duncan and all of those things. I was called back to set up the domestic program at our airports and spent the next several weeks living in five quarantine stations trying to stand up a program that we had been designing for pandemics of influenza and had never really implemented, but had created a lot of exercises and plans and strategies around. We said once the decision was made to operate an entry evaluation program, we would need three weeks to stand up and get functional, and the White House said you've got six days. [laughter] You've got six days to create a USG [United States government]-wide, second-layer safety net, because most of our [border effort] was concentrated on containment at the source. Coming back to
build a domestic firewall and trying to live in the old quarantine station at JFK [John F. Kennedy International Airport], sleeping in the exam [examination] rooms, finding all the old history. Some of those memories sunk in. Mostly the fear and stigma and the emotional heartache of wrenching with the situation where your instincts for self-protection are exactly the wrong thing. The violation that occurs between--the instincts you would normally use to cope to survive are the things that you have to completely let go of. To me, the biggestthing which I wrote this d'var about was that this epidemic showed what happens
when there's a "bankruptcy of trust." Trust everywhere: personal, familial, institutional, governmental, societal, international relations. It just was a fundamental bankruptcy of trust and it didn't matter how technically good our agencies or our collective skillsets were. In the absence, in the bankruptcy of trust, which is very hard to reestablish in the middle of a crisis, that was the single most significant driving factor that was extending the epidemic. That and a certain lack of humility which is reflected by a favorite quote of mine from Stephen Hawking which is, "The enemy of knowledge is not ignorance, it's the illusion of knowledge." There were a lot of illusory beliefs that got in the way
of the kind of open mindedness that's needed when you're facing a new emerging threat. You may think you're familiar with the pathogen, but it's not just about the pathogen, it's the pathogen, the person and the milieu as an intersection, and sometimes what you think you know just gets in the way of what you need to be open to, to find a better way out. If you had to boil down what I'll tell you in the next hour, it's bankruptcy of trust, humility, logistics.
I guess the other really key theme for me was the world was looking for control and the suffering victims of Ebola were looking for compassion. Control without compassion or care, however you want to look at that. It's not like people
didn't care. But if the priority was protecting everybody else to control the epidemic from spreading, which was critically important--doing that in which you didn't establish a right to care, my job as the director of the quarantine program is to constantly balance the line between protecting the public's good and interest while respecting and understanding the needs of the individuals who were victims of disease. That's what I've been doing for twenty years, trying to walk the tightrope. I think there's a lot of false dichotomies out there about those being "either/or." In the easiest sense, you can say either we protect the public or we engage and provide care to the victim, but you can't do both. Well, I fundamentally disagree with that. I think these are false dichotomies. There are ways to do public protection and compassionate care [while protecting]
individual rights. Treating people like victims and not vectors. But that's the tension: is it a victim or is it a vector, do we extend compassion or do we restrict and contain? And you can do both. It's an intensive process, and it may be in the front end more resource-intensive to find the least restrictive means and to thread that needle, but in the end the absence of doing that process creates an untenable seesaw between epidemic control and care, buy-in, and trust. You're building trust when you create the balance in that tension. I think those were the themes for me over two years. They were vividly illustrated, it was intense. I have never seen so many people committing so much of their time, energy and emotional blood, sweat, and tears to work on an
epidemic and yet feeling so helpless about that ability to control things.
Q: If it's okay, maybe during this interview we can talk about some of those experiences that you drew from to think of those themes, all of those little incidents that illustrated that.
CETRON: Some of those are in this little reflection. That opportunity to speak to a thousand strangers--not strangers, community non-public-health people--with a perspective about that, really provided--not only preparing it forced me to think through the themes, but also there was a certain amount of catharsis in
letting go of the trauma of the experience. Those were some of the bigger issues for me. On the other hand, it's quite a privilege to be in that space, as you see. I mean your job, you bear witness to story, and to bear witness to a storythat intense and emotional and raw, that's a pretty powerful thing.
Q: It's been a privilege in itself. Some people went through the most intense experiences that I can imagine here at CDC, and they just continue to work here at Roybal [Campus], or--
CETRON: No matter where you were, it was hard to be untouched by the power of it because it was an onslaught in the media, the images are compelling, everyone
could see themselves in the victims. And the inequities; the fact that the mortality rate is eighty percent if you're left there and twenty percent if you're here. There's so much you have to grapple with in that setting.
Q: No doubt.
[break]
Q: This is Sam Robson here with Dr. Marty Cetron. Today's date is January 10th, 2018, and we're in the audio recording studio at CDC's Roybal Campus in Atlanta, Georgia. I am interviewing Dr. Cetron today as part of our CDC Ebola Response Oral History project for the David J. Sencer CDC Museum. Dr. Cetron, thank you very much for being here.
CETRON: My pleasure.
Q: Could you please state, if you could, your full name and your current position with CDC?
CETRON: My name is Martin Stuart Cetron and I'm the director of [the Division of] Global Migration and Quarantine, and that's in the National Center for
Emerging and Zoonotic Infectious Disease. I've been in this job for more than twenty years.
Q: If you were to give someone an elevator speech, just a few-sentence description of what your role was in the Ebola epidemic, what would you say?
CETRON: As the director of the Global Migration and Quarantine program, our mission is to prevent international spread of infectious disease threats, protecting in particular the American public and American interests abroad, while also recognizing and dealing with the epidemic at its source in the context of the individual victims who are suffering from this. There's this duel responsibility of preventing importation and spread, containing things at the source, and being sure that the epidemic can be brought under control as quickly
as possible to minimize suffering and death.
Q: Could you tell me when and where you were born?
CETRON: I was born in Philadelphia, February 23rd, 1959.
Q: Did you grow up in Philadelphia?
CETRON: I grew up in Philadelphia for the early years, and then my family moved across the river to southern New Jersey for high school years.
Q: Can you tell me a little bit about those early years? What was your family like? Who made up your family?
CETRON: I'm from a small family of four. I was the oldest. I had a younger sister, two years younger. My dad and mom were both rural Pennsylvania born and raised, first ones of their families to go to college. My dad was from Lancaster, Pennsylvania; my mom from Scranton. My dad was a dentist and an endodontist after that, and he has his office in the basement of our house. We
grew up in an urban environment in a very, very supportive family.
Q: What precipitated the move to New Jersey?
CETRON: I think my dad was moving from a general practice dentistry to a specialty in essentially, what is the infectious disease equivalent of dentistry, which is endodontics or root canals, dealing with infected teeth that needed to be managed in more complicated settings. There was a practice he was going to join across the river.
Q: What kind of stuff did you find cool or interesting when you were a kid?
CETRON: Gosh, a lot of stuff. I always liked international opportunities, travel and exposure. I was sort of a geek for science and math, and the STEM [science technology, engineering, and mathematics] fields in general. I spent a lot of
time outdoors in the environment, and to the extent that was possible, I was always trying to get away and explore some other place, some other culture, some other group. Tremendous curiosity about humanity.
Q: Was there an early experience where you were exploring a group of people who were different from you that really stands out?
CETRON: There's a number of experiences. I was very fortunate to have these. As a young kid, I spent the summers working on a kibbutz in Israel doing agricultural work and living in a sort of communal setting with other, non-US kids, Israeli kids my age. We had a lot of raw hand, farm labor type experiences, but it was real interesting to see that society and culture where people of a similar age cohort live together, separated from their parents
except for weekends. But also the cross-cultural activities, the exposure. It was an interesting time. I think it was the late sixties, maybe early seventies. It was a time of a lot of tension. There was war in the Middle East very close to the place where I was working. My sensibilities about international engagement, international politics, how to reconcile arguments and disputes between people on big issues, land and background, peace, religion, all these kinds of things, were really prominent. I was quite fascinated by that sort of whole setting, the milieu of living and working in that environment. And it was a place where you have to confront some pretty stark differences between people who have lots of means and people who are living and struggling more in terms of
their socioeconomic status. A lot of the world's problems came closely into view for me and to my eyes, both from a religious perspective, a cultural perspective, a socioeconomic perspective. What was most apparent in all of that was that despite all these differences and contrasts which could be emotionally wrenching, it was easy to see a thread of common humanity in different spaces. By far, there were many more things that people shared in common than the differences that defined them.
Q: Given these formative experiences of witnessing disparities and conflict, did that influence what you wanted to do with your life? What were you thinking at that point in time?
CETRON: Oh, yeah. It was the combination of those experiences, my complete
intellectual fascination with the sciences and medicine and the way the human body worked. I had a pretty early, strong driver to go into medicine. I wanted to be a doctor from as early as I can remember, and that was crystalized further by an experience I had with my dad who became critically ill when I was quite young, I think in high school, after returning from a trip to Mexico. He got very sick and developed liver failure and was in the hospital for months at a time. We were told he was on death's door, and none of the really talented, bright, Western doctors from the University of Pennsylvania and all these high-powered academic institutions had any idea what was making him so sick,
what infection he got that made him so sick after simply taking a trip to our neighboring country. It was a complete medical mystery, but a very personal one. Unlike the medical mystery stories that I enjoyed reading, Berton Roueche solving all those kinds of things, this one really hit home. I think the combination of experiences I had leading up to that, and then that pretty powerful experience with my dad's illness, which gratefully he recovered from,and later was able to be diagnosed in retrospect, was probably the driver. Not only did I know I wanted to go into medicine, but I wanted to be an infectious disease specialist and I wanted to specialize in tropical medicine and understand the global picture and maybe have a better understanding and ability to intervene and control the global disease threats that had affected me so personally.
Q: It's a pretty mature career aspiration for a young kid. [laughs]
CETRON: Yeah, it was probably more rooted in fantasy than reality, but through the next thirty years I'm sort of probing for both affirming and disaffirming experiences around that. I think I was able to navigate a very circuitous and iterative path to test different aspects of that along the way.
Q: What did you do after high school?
CETRON: After high school, one of the things as I eluded to, I had this strong sense of adventure and a passion for the outdoors. I sort of drew a circle with a certain minimum distance that I needed to be from home to have a different experience and looked at schools that would be both intellectually challenging in that regard but also giving me a lot of opportunities to explore people that
were different from me and the wilderness. I was fortunate to be admitted to Dartmouth College in Hanover, New Hampshire, in the sort of rural parts of NewHampshire. It offered that environment, which I found probably transformative in terms of my ability to create more independent thoughts, to find and build community in a small environment, to enjoy the White and Green Mountains of New England on a regular basis, to participate in Outward Bound programs in the winters in college, but also the quarter system at that school offered me a chance to spend a lot of time off campus traveling internationally. Finally, the small size and the very close relationship between the faculty and the studentsenabled me to get involved with a mentor my freshman year. It was Bob [Robert H.] Gross' first year as a biology professor on campus and we struck up a
relationship in an early class I had, which continued for thirty-five years until his death. But he became an individual mentor for me and taught me molecular biology and science and genetics, and it was a really precious relationship that extended beyond Bob but to include his family as well.
Q: What happens after high school? What do you do then?
CETRON: After high school or after college?
Q: I'm sorry, after college at Dartmouth.
CETRON: After college, I'd had a number of international opportunities to study language abroad and do other kinds of things and travel extensively. The debate was Bob had always tried to convince me that really, physicians couldn't be scientists, and that I should pursue a science degree and get a PhD [doctorate of philosophy] instead of an MD [doctorate of medicine]. I think he thought if
you really want to do science, you should get a PhD. This was a time in the seventies, so my college years were the [late] seventies, like '77 to '81, wheremolecular biology was becoming the science, not the tool, of genetic study. He had encouraged me to look at job opportunities with Genentech and Biogen, two big startup genetic molecular biology tech [technology] engineering companies on both coasts, one in Cambridge, one in San Francisco. I went out and had job interviews, and I was weighing--the debate between, did I want to go intomedicine or science? Then I took a hard look at both my interests and my skillsets and I realized that I learned a lot in the lab [laboratory] with him over four years, but I wasn't particularly good at it. [laughter] I wanted to be
good at it. I worked hard but I kind of sucked. I had a number of experiences that he, in his patience, he put up with me in that regard. But as I thought back, they were telling signs that I was probably better in medicine than at the bench doing basic research, and in particular that the places that I wanted to interact were at the macro level and not the micro level. Part of what was challenging for me in the research lab was working with things I couldn't see,microliter quantities of materials and molecular interactions. I really appreciated them, I believed wholeheartedly they were there, but I couldn't interact with them with that degree of precision to be good at replicating my work and my experiments. On the other hand, big picture challenges, system challenges, interactions between people and populations, culture and society, all of those types of interactions were always much more appealing and
fascinating to me in that regard.
So I went to medical school. I went to Boston to medical school. I looked at programs that had strong infectious disease training opportunities and international training opportunities. While I was in medical school at Boston at Tufts [University], I spent a good part of my fourth year, the latter part of my fourth year studying in India, particularly in the south. These were through contacts of my mentors and teachers at Tufts who were tremendously influential people, infectious disease giants in their own right, but also had a significant amount of engagement in tropical medicine and "geographic medicine" as it was known at the time. The chance to go over and live and work and study medicine in a tropical environment like South India over several months was one of those
really affirming as opposed to the disaffirming experiences in the lab. The really affirming experience of living, working overseas in a population-based setting, looking at problems like leprosy and other tropical infectious disease issues, was tremendously influential and in some ways transformative.
Not only did I fall in love with tropical infectious disease and had a whole world of experiences to draw upon, I fell in love with Indian culture and tradition and rituals and practices and understandings. I left at the end of fourth year, graduated from Boston, and went to the University of Virginia to do internal medicine for three years of training. I think in my first rotation on
the wards, I met and fell in love with an Indian woman who I later married after a number of years, and we have sort of blended our cross-cultural backgrounds between her Indian story and my sort of Eastern European Jewish narrative into this Hind-Jew, we call it, [laughter] exposure. Maya, who's been significantlythe most important person in my life over the last close to thirty-five, forty years, has not only shared some of those interests and passions that I have, she was a nurse on the wards. I was on my first rotation, which was oncology. I had a really sick cancer patient. She was a specialist in nursing cancer patients, and I was a very green intern. I had just had all these months of experience processing my time in India, so not only did I fall in love with her beauty and
mystique, but she was an intellectual powerhouse and knew a lot more about whatshe was doing than I did at what I was doing. We combined to be a team, and she really taught me how to care for cancer patients beyond just the science of that. How to draw up and deliver chemotherapy, how to listen at the bedside, and a lot of her intuition, a lot of her skills, a lot of her cultural background that led her to be such a fantastic nurse were really formative.
At University of Virginia, I ended up staying in Charlottesville with her and in the program for three years of internal medicine, then a year of emergency medicine on the faculty, but continued to pursue my--and the University of
Virginia had a really, really strong tropical infectious disease program and wonderful mentors for me to draw on there. I had a chance to work and study and live abroad in Brazil for a number of years through the UVA [University of Virginia] program and began to meet other people with similar interests who had made careers that were about ten years senior to me. Really influential people: Dick [Richard L.] Guerrant, Dick [Richard D.] Pearson, many others on the geographic medicine department at UVA, had active work going on in leishmaniasis and diarrheal disease and all sorts of tropical infectious diseases. Again, another really strongly affirming experiencing, Brazil being very different from India in some respects, but understanding culture, community, population, engagement, circumstances, and falling in love with parasitic infectious
diseases. I spent a lot of time working with Leishmania and Chagas disease, two parasites that were spread through a variety of vectors. I became totally fascinated and enamored with that part of the science of medicine and the pathology and the interaction between pathogen and host and the environment, and that all three of those things, that sort of holy trinity of infectious disease, that really took a strong grip for me.
From there, I was looking to have deeper professional and specialty understanding of infectious disease, and I went to the University of Washington to do a fellowship in infectious disease and took my experience and contact and exposure in Brazil back into the lab again to do some basic immunology research
on Chagas disease, looking at the host immune response to this parasitic infection, to Trypanosoma cruzi, which once people were bitten by the reduviid bug and the parasite was injected into the body, it persisted there for life through some very clever interactions with the host's immune system, often in low level. But then it created an immune response in the host that was an autoimmune response that was destructive against host tissue, and our research project was to understand this concept of autoimmunity with regard to this parasitic infection. It turned out that we discovered an antigen on the flagellum of this parasite which mimics nervous tissue in humans. When the body developed an immune response to try to get rid of the parasite, it was also developing an immune response that attacked the nervous tissue in the heart, which makes the conduction system work, and the nervous system in the gut, which
makes the GI [gastrointestinal] tract work. As a consequence, patients with chronic Chagas disease go on to get cardiomyopathy, a heart problem, and their heart dilates and it doesn't pace properly, and they get megacolon or mega GI tract, and their intestine doesn't move and peristalsis doesn't work properly.
My role in all of this, the lab I was working in with Wes [Wesley C.] Van Voorhis at the University of Washington, was looking at the molecular interactions. As probably has become obvious by now, I was much more interested in the population-level interactions. I was working to set up a field program to find chronically infected Chagas patients, those that had heart disease, those that had GI disease, and those that had no apparent disease, and try to contrast what was different about them and their bodies and their bodies' response to the
parasite and see if we could sort out what drove some people to get heart problems and some to get GI problems and some to just keep everything in check with no apparent problems. We set up a research lab in northeastern Brazil, in Fortaleza, with the University of Fortaleza and some partners there, and enrolled people from all over the northeast that had chronic Chagas disease. We drew their blood, we separated their blood cells out to find their immune response, their immune cells, their lymphocytes and peripheral blood mononuclearcells, and we exposed them to different stimuli with some of the antigens that we were discovering in the laboratory at University of Washington and tried to assess in a Petri dish their immune cells' different responses to these antigens that we thought were triggering. That was sort of a four-year project between doing clinical medicine in Seattle. I would also do clinical ID [infectious
disease] ward rounds at the university hospital in Ceara. Sao Jose Hospital was the infectious disease hospital in Ceara, and several really influential clinical mentors taught me a lot about tropical infectious disease. Anastacio [de Quieroz Sousa], who I recall very fondly, ran the hospital of Sao Jose, and I would do ward rounds for him when we weren't doing the research work. I fell under a mentor from the University of Virginia who was a brilliant pediatrician that was working in diarrheal disease named Jay McAuliffe. He was the director of Project Hope. Later on when Jay's Project Hope tenure was over, I recruited Jay to CDC, to come here, and I lived with Jay and his wife, Bell, in their
house through the birth of both of their kids. I would live with those guys, see patients with Anastacio, and do research on Chagas disease. It was a pretty great life.
Q: It sounds incredible. What years were these again?
CETRON: I think '89 to '92.
Q: Okay, finishing up in 1992.
Q: That's when I had to decide, where was all this going? It was pretty clear to me that I liked clinical medicine, I enjoyed patient care, especially patient populations that were different from outside--either people who had traveled to those places and gotten sick with things that no one knew about, which harkened me all the way back to my childhood days and my father's experience, or working with the diaspora populations of immigrants and refugees who were born elsewhere and then had moved to the US to various places and needed someone who understood
the infectious disease issues in those communities. I was involved in working in, and in some cases, running the tropical infectious disease clinics at these other training places along the way. When I wasn't in Brazil doing tropical infectious disease onsite, I was doing it at the University of Washington in clinics there that dealt with travelers, immigrants, refugees, migrant workers,etcetera. Really, really rewarding. As a result of that, we often made diagnoses that were pretty rare in the US and many of which didn't have treatments that were readily approved or available in the US. They required orphan drugs, which weren't fully approved in FDA [Food and Drug Administration] because they didn't have a huge market here.
That's when I first had my interactions with CDC. I would call up the CDC Drug Service, which kept a supply for investigational use of these orphan drugs to
treat exotic infectious disease. I first met some people in the Division of Parasitic Disease through that process. Ralph Bryan was an early mentor of mine. He was a CDC medical epidemiologist who had gone through EIS [Epidemic Intelligence Service], and he was overseeing the clinical approval process for the Parasitic Disease Drug Service. I'd call up on a pretty regular basis and talk to Ralph and say, "I've got a patient with Chagas disease from here," or "I've got somebody with leishmaniasis cutaneous, mucocutaneous from Brazil," or "somebody with leish from India, and we need some consultation and support for treatment strategies." I was just blown away because I probably had naively thought that I knew something about these compared to some of my colleagues in
academia. [laughter] When you're in that setting and you've got that experience, people will turn to you as the expert on that problem. But in reality, my knowledge of this field could fit in a thimble compared to the people I was consulting with at CDC. I was pretty blown away by the depth of understanding, expertise, commitment, and the challenge and passion for what seemed to be a pretty narrow space of interest for most US physicians. But there was this whole program at CDC, the Division of Parasitic Diseases, which was filled with brilliant people of all sorts: PhDs, MDs, veterinarians, and they knew stuff about this that was just beyond the pale. It was fascinating, the depth ofunderstanding, the appreciation and commitment. As I said, I at times thought I
had a fair amount of experience, but nowhere near it. I was totally enamored with the interactions that I had here. Then one day, as my three years of fellowship training was ending, Ralph said, "What are you doing next year?" And I said, "I don't know. I'm interviewing for faculty positions, I'm interviewing for ID practice positions." But I said, "This is who I am. What I really like is population-based medicine in developing country settings, and I'm more of a big picture person than a bench scientist. I love clinical practice and patient care, but I really feel like I want to get at the root cause, the system baseroot cause of some of these issues." He said, "You belong at CDC, you belong here. You should come here. Have you heard of EIS?" I said, "No, what's that?" "Epidemic Intelligence Service." Boy, it had a great ring and appeal to it. Ralph convinced me to look into it, and the next thing I knew I was applying to
the EIS program and learning about how to be an epidemiologist. Because one of the challenges in typical medical education for me at that time was there weren't a lot of role models that I was aware of, or exposed to, that had actually studied the epidemiology of infectious disease and tropical medicine or the factors that go into driving an epidemic. There were a lot of people who did individual clinical patient care, and there were a lot of people who did bug-specific research at the bench in infectious disease. But there weren't nearly as many--and admittedly, this was thirty years ago or so--that really understood the epidemiology of infectious disease, that appreciated that interaction between pathogen, host, and environment, and could define it,
describe it, characterize it, and once having that appreciation, get involved in influencing the trajectory of epidemics or understanding the cause of epidemics. He convinced me pretty easily that EIS was the right next step, and I came to CDC in June of '92, and I've been here ever since.
Q: Did you place immediately in [the Division of] Migration and Quarantine, or what happened?
CETRON: There was no Migration and Quarantine then. It was a very interesting thing. I came actually thinking, somewhat naively, that I was just coming--if I could get into the program, I was just coming to work with Ralph. Then I realized as I learned more that EIS was a broad program. You interviewed and you went to a match and then you got to a program. Fortunately, in the end, I did end up with the Division of Parasitic Disease, and Ralph was my supervisor for those two years. But it was just the beginning of understanding things.
I did EIS '92 to '94. After that it was pretty clear that I wanted to stay. My wife was actually going to stay in Seattle at the time, she had a great job. She had switched over from critical care and hematology-oncology nursing and bone marrow transplants at the university to doing public health work at Seattle, King County. We had bought our first house, she was very settled, and she said, "You're going to go to do EIS for two years, you're going to be traveling all over the world, and there's not much for me, so I'm going to stay here." And I said, "Nah, we should try something together." We talked it through. She applied to Emory [University] to the MPH [master of public health] program, and she spent the two years getting a master's degree and I spent the two years in EIS. We kept our house in Seattle with the full intent of going back, but we both really fell in love with what CDC had to offer. I did parasitic disease for a
couple of years. At the end of that, my first child was born, and it was clear that we were going to stay. I was offered a job to deal with a new, emerging problem in antimicrobial resistance, and so I joined Rob [Robert F.] Breiman's group in Bacterial Respiratory Diseases. I worked on setting up the surveillance systems for drug resistant pneumococcal infections and other drug resistant bacterial infections. Another set of tremendous mentors--Rob Breiman, Anne Schuchat, Jay Wenger, Claire [V.] Broome--some of the CDC legends and greats that were available to learn from and learn with. It was a fantastic experience where I really cut my teeth doing both surveillance science and outbreak
control, outbreak investigation.
I did that for two years, and these years between '92 and '96, those four years, were a really seminal time in infectious disease at CDC because this whole concept of emerging infectious diseases was unfolding. The Institute of Medicine issued a report led by Joshua Lederberg in 1992 called "Emerging [Infections: Microbial Threats to Health in the United States]," and highlighted the major drivers of these sort of emerging and reemerging threats. Population growth, urbanization, climate change, travel and trade were a huge part of that; genetic evolution of microbes to become resistant was another part of that; conflict and civil war and strife and population displacement was a big part of that. All of
these really big ecologic issues that for me, harkened back to this holy trinity of pathogens, hosts, and environment being so critical to understanding the macro picture of what we were seeing in terms of epidemic control and infectiousdisease. To their brilliant credit and the brilliance of Josh Lederberg, Nobel laureate, really articulated and saw this big picture. By happenstance, Ralph Bryan, my EIS supervisor, was one of five people who the [National] Center for Infectious Disease director, Jim [James M.] Hughes, identified to write CDC's response to the IOM [Institute of Medicine] report. Through Ralph, I got to actually engage in that process of laying out, what should CDC's strategy and response to emerging infectious disease, how does that shape? What are we going to do? If this is the picture, what do the next ten, twenty years look like?
Together with Ruth Berkelman and Bob [Robert] Pinner and Ralph Bryan and Bob [Robert] Gaynes, those five really led the charge on this. Being an EIS officer with Ralph gave me the opportunity to weigh in and help add some ideas and contribute some thoughts to that process.
In '96, one of the bigger issues that we came up with in that CDC response was the creation of sentinel provider networks. Realizing that emerging infectious disease threats really had to call upon beyond just the public health community for a response--that the clinical community, the academic community, lots of people had to be woven together in tighter networks to create a more comprehensive knowledge base about what was going and where. This was right up
my bailiwick. Two of the four original sentinel provider networks that were proposed were ideas that I had. One was creating an international travel tropical medicine clinical network where we would basically recognize that international travelers and immigrants, refugees and migrants who were crossing geography, they were also crossing epidemiologic divides. They were coming from places where burden was high and science and diagnostics were lower, to places in the West where the burden was lower, but the capability for detect, prevent and respond was higher. The idea of this network was to weave that together to see travelers as sentinels for what might be going on in silence or hidden in other parts of the world. This was sort of a perfect fit--I had been working in
travel tropical medicine and migration clinics since I was a medical student, and I knew that each of our clinical experiences was rich and interesting, but the sample size was too small to actually weave that picture together. One of the first things I did when I came here in '92 was work at Emory with Phyllis [E.] Kozarsky in the travel and tropical medicine clinic there, as a result of this response of sentinel networks, that we really needed a sentinel network that could link clinics like Phyllis' clinic, like the clinics I worked in in Seattle and in Virginia and all these other places. The data from all those clinics should be tied, the diagnosis and the itinerary and the source of exposure and the timing should all be tied together into a global network. That network became GeoSentinel in 1996, was funded, and I was sort of building and
working and trying to craft that as a global surveillance network.
The other global surveillance sentinel provider network we talked about, again, harking back a little to my early childhood days and my dad's experience in Mexico, was the huge percentage of the foreign-born population in the US that was actually Mexican-born, and the world's busiest international border was the US-Mexico border. Our sister countries were tightly woven together epidemiologically, geographically, and in some regards, culturally as well. Yet there was still a big void on what surveillance happened across the border. Wecreated another network together with Jay McAuliffe, who now had been recruited to CDC; Steve [Stephen] Waterman, who was a state epi [epidemiologist] for California and a former EIS officer; and we created something called BIDS, the
Bi-national Infectious [Disease] Surveillance system, initially the Border Infectious Disease Surveillance system. We took advantage of local, city, state and federal partnerships in public health along the border zone to create a sort of shared epidemiologic unit and prioritize certain diseases with common case definitions for shared surveillance.
There were four sentinel provider networks that were proposed in CDC's response to emerging infectious diseases: an ER [emergency room] network; an IDSA [Infectious Disease Society of America] network, which Bob Pinner had sort of come up with and led on; and then the GeoSentinel global tropical medicine network and a BIDS network, which I had taken the lead on. These were maturing and being birthed around '96.
Then another one of these great, sort of fateful accidents happened. Jim Hughes, who was the director for the National Center for Infectious Disease, who I also
credit as being a critical mentor and a wise, prominent leader in infectious disease for me, had taken the somewhat defunct Foreign Quarantine Service that had been sitting in the Center for Preventive Services, another place where the TB [tuberculosis] program was, and it sat there pretty much dormant from 1967 when it came to CDC until about 1996. When David Sencer came over in the sixties and was consolidating, he pulled the Foreign Quarantine Service into the agency, but there's a famous surgeon general quote that said, "the war on infectious disease is over" in the late sixties, and that we don't need a Foreign Quarantine Service in that regard. We're eradicating smallpox, antibiotics are
being discovered rapidly and they still work, childhood immunization programs are taking off eradicating measles, mumps, rubella, etcetera, etcetera, and we're winning. We've got this one, it's a wrap--which might have been absolutely true in 1967, notably before the era of jet travel, before the era of [high-speed] planes and before all the drivers in emerging infections. The Foreign Quarantine Service was essentially dismantled in the late sixties, sat quietly with a handful--probably less than a dozen people. And in 1996, Jim Hughes had the Foreign Quarantine Service back in the National Center for Infectious Disease. He approached me and a couple of other people--Bob [Robert B.] Wainwright, who was a division director in the Artic Investigations Program. He knew that I was particularly interested in this space of international
migration, immigrant, refugee, migrant health, in setting up global tropical surveillance systems, tropical medicine clinics linked to shared data. And I was very attached and wed to the challenge and the problem of emerging infectious diseases. The opportunity came up to be part of the rebuilding of the ForeignQuarantine Service, which had a several hundred year history; to be reinvented as we went into the twenty-first century with a whole different set of threat pictures. Global migration became an entity that needed to be studied and characterized. The movement of people, animal and things was fundamentally different in every way: speed and volume, moving from sea-based travel to jet air travel, where people and pathogens and things could move around the globe shorter than the incubation period of most of those threats. Which meant that the idea of quarantine, which was established formally in the fourteenth century
during the Black Plague epidemic, was that you hold the ship out of port for forty days and by doing that the pathogen burns out. Whoever survived is lucky enough, they get let in and fumigated, and that's your defense against importation and spread. It worked in the fourteenth century through maybe perhaps the nineteenth and early twentieth century, but it wasn't going to work in the twenty-first century, and it needed to be fundamentally redesigned. That opportunity came up for me in '96 when I moved from the Division of Bacterial Diseases to a new Foreign Quarantine Service, which we reinvented and called the Division of Global Migration and Quarantine, and I've been there ever since.
Q: Gotcha. That's a brilliant little summation of where you guys came from.
CETRON: Perhaps not so little, but it is a summation. [laughter]
Q: True.
CETRON: It's been a great ride in that regard because it offered an opportunity to rethink on a level that I like to engage is big, system level thinking, looking at macro-level problems and trying to figure out what systems can be reengineered and designed for surveillance so that we can detect threats early for prevention, so that we can intervene. And for response so that we can more effectively respond in ways that are cognizant of this trinity of pathogen, host and environment and all those interactions.
Q: What kinds of progress did you make in the first few years?
CETRON: Well, we matured these systems like GeoSentinel and BIDS and successfully were able to get funding and grow them widely internationally. We had good surveillance systems. We started developing datasets that would define
the movement patterns. We started across government and non-governmental entities that had access to movement data. We needed to basically define the migration of people, animal, and things, and there were datasets out there, but they were locked away in a narrow silo of special interest space. I wanted to be able to get those datasets into public health awareness. So we worked with the airline industry and were able to capture International [Air] Transport Association, IATA, data of all the international air routes by airport. What volume was leaving from A and going to B. We were able to do similar things with the cargo and with animal shipments and with all sorts of exchange of trade. We started looking at the challenge of defining the epidemiology of movement, and we built out a number of systems to not only curate them and anchor them in time
and place and update them, but also to integrate them with other systems. We were developing surveillance systems for disease burden and looking at other projects that had mapped disease burden by geography. And then we were developing these movement databases by air, land and sea, border crossing datasets and airplane datasets and rail and cargo movement datasets and things like that. Looking into shipping records of what was coming in as imported animals, from where and what threats did they potentially represent as they were translocated across these epidemiologic divides.
We began a project that was conceived more than a decade ago called BioMosaic, which was a project of being able to look and integrate multiple big datasets that are all sharing a common factor of a GPS [global positioning system] location at the most granular level and a timestamp. If you had time and place,
which was just a fundamental epidemiologic principle, if you could get who, what, when and where linked together across these big datasets, you would suddenly have that picture and be better able to anticipate, if something emerged in A, was it likely to go somewhere? If it went somewhere, where would the next stop be? If it arrived at that next place, in whom would it bearriving? What type of person? If it arrived in that person, what's the likelihood of it finding fertile ground and soil in terms of spreading? That was the challenge that we were starting--we wanted to build out that picture. We wanted to be able to forecast around emerging infectious disease by moving back the clock. We wanted to understand what the risk of a threat, where something was likely to emerge based on these environmental factors, the overlap of pathogen, host, environment, temperature, vector, disease, those kinds of
things, social interactions, disruption, and then say, what would be the trajectory of that pathogen likely moving somewhere else? Where would it go? It turns out, although the US may not be the place that most things will emerge from, we don't have as many of the drivers exactly here for new emergence compared to say Southeast Asia or places on the Africa subcontinent because of the interactions between humans and animals, between the sort of contextual setting. Because we are so highly connected as a country, maybe the most highlyglobally connected country on the planet, we would likely be the next place it would be seen. And it's possible we would be the first place that it was diagnosed in terms of with the public health infrastructure and the tools and capacity we have.
This idea of building an international network, understanding movement of people, animals and things and travel and trade, protecting the homeland from a
classic quarantine regulatory mandate, but also understanding, what is actually going on in a shrinking globe, and where do we need to apply public health tools at the source? This really became the focal mission of our program. We just started adding--I think in '96 we had maybe a dozen people, the number of quarantine stations had been reduced dramatically in the late sixties as I mentioned, and we started adding them strategically. We elicited support from the Institute of Medicine with Jim Hughes fervently behind this rebuilding process in order to develop a more robust strategy for twenty-first century threats. This was driven by the recognition that there were potential threats not only from Mother Nature, but also man-made threats in terms of use of biologic weapons, potentially insecure stocks of dangerous pathogens like
smallpox as infrastructure was falling apart in certain places. Being able to do these types of anticipatory response plans really required thinking about this globalized picture, thinking about globalization and its contribution to theinfectious disease threat and the health security, not only of the US, but the health security of the globe. That became sort of our anchoring point, and we grew the program out of the dust shells of 1996 into a program that was more able to respond to the kinds of threats that we have seen since that time. Learning from the anthrax attacks and then SARS and then monkeypox introduced through this bizarre thing, which basically, giant Gambian pouched rats from one
place move into the exotic pet trade and are cohabitating with prairie dogs sucked up out of holes in their habitat in the [American] West and spreading monkeypox from pouched rats from Africa to domestic prairie dogs exported to Japan and to pet stores all across the US. That story is the story of emerging infectious disease in the twenty-first century, and our program was just beginning to be better poised to be able to define that problem. We were defining it horizontally while at the same time collaborating with and engaging heavily with this deep vertical expertise of programs that were pathogen-specific around the agency. We were looking at the populations and the movement and the trajectory and the interactions and the sort of social milieu, and Inger [K. Damon]'s group was looking at the specific high consequence pathogens, or somebody else's group was looking at the bug itself, and we were
bringing a better understanding of who the hosts were and what the environment of movement and exchange was. That, for me, was so satisfying: to be able to round out the deep vertical expertise and pathogen-specific expertise that exists at this agency almost unparalleled to anywhere in the world with this newly appreciated, almost socio-anthropological framework in which all of that was occurring. That was like, what I had been dreaming of since I was a kid.
Q: I really like that image that puts in my head of the horizontal and the vertical ways of understanding the spread of these diseases. Were there some early--was it always smooth when you were trying to integrate those?
CETRON: Never smooth.
Q: Never smooth?
CETRON: Never smooth, right. And not because--you know, the friction doesn't come necessarily from turf battles. There's the usual stuff of who's in whose
space. That's not so much of the things that leaded to rocky--to make the road a little rocky. Part of it is that some data is understood or known, but it's only known in a narrow context, and some of the horizontal stuff are data that needs to be acquired from a variety of sources, some of which are dated, some of which are updated. Some of which come with a large margin of error and uncertainty and sampling bias, and some of which are really systematically collected. Some of which are hard to get because people don't want to disclose things around national origin or census data, which richly has country of birth. Public health data is not always as richly informed around some of these variables because of the consequences of stigma or legality or status or these other things. It's really important for public health to have access to that information to be able
to define it epidemiologically, but it's really important to be able to use itappropriately as well. The challenge is really about building the horizontal warp on this in so many ways in the public health sphere from scratch. It really didn't exist. Finding quality transportation data was really hard initially. Now we've gone through the process of curating it, we have other systems to define it. Really identifying who's moving and how and in what time frame. Sometimes it's easier to know who comes in than who goes out of the country. These types of things. We were early when we were trying to do this in the mobile devicearena, which positioned people. Now we have better tools to define that mobility, but we still face these issues around the privacy struggles. How do you responsibly use identifiable mobile information, de-identified to protect it, but still identified enough to have an appreciation of who's moving from
where to where and when? Those are big social issues, big privacy issues, big considerations. The rockiness around this.
Also, updating the regulatory framework. When I came into the program in '96, the quarantine regulations hadn't been substantively revised in more than fifty years. We were still dealing with a whole set of stuff on the books that represented a threat picture from the eighteenth, nineteenth, and early twentieth century, but not a threat picture that was commensurate with the twenty-first century pathogen emergence. We had to go through this huge regulatory process to revise that. There were a lot of vested interests that were willing to--we had to do contact tracing on airplanes of people who were exposed to pathogens while they were on the move, but then quickly scattered. It wasn't always easy to get that information captured and find people, and you
have this narrow window. If you've got somebody exposed to SARS on a plane and it's got a high consequence of killing them, and when they get sick they are likely to spread it through respiratory means to other people, you need to find them quickly, be able to isolate them, identify their contacts, potentially monitor all the contacts and the tracings for a period for symptom onset, and offer something in exchange for cooperation in order to prevent spread. And youhave a narrow time window to do it. With something like a pandemic of influenza, you have an especially narrow time window where people can spread either twenty-four hours before they even manifest their first symptom, and by two days later, they're already fully contagious. That's an epidemic that will rapidly escalate. Being able to efficiently put together the datasets that are needed for this type of contact tracing, movement, monitoring, all that stuff, is
pretty challenging. It's not been smooth, but we've been deliberate and persistent and have taken advantage of the fact of these rapidly ensuing global emerging threats to not only make progress in dealing with that epidemic at that time in that setting, but take advantage of the lessons we have learned, the gaps that existed in trying to do that job and closing that gap before the next emerging pathogen comes along.
Q: I'm interested in some of these lessons that were learned from '96 up until the time of Ebola. What's particularly interesting to me is the idea of the vested interests and trying to get data from someone like an airline, for instance, on passenger data, when that airline might be reluctant to give up that passenger data. Or, I don't know, I'm sure that there are tons of other examples.
CETRON: Oh there are, yeah, lots of stories like this.
Q: Do you have any specific examples you could point to where you said, from this interaction, we learned this about dealing with interests?
CETRON: I would say from all these interactions, what I've learned is the importance of balancing the interests of containment and control with the interests of compassion and care and respect at the individual level. What I've learned is that these aren't dichotomies--they aren't either/or premises. If you go into these engagements with this idea of, I have the right and the power, and in order to control this, this is what we're going to do, and you have to give me that data and information, when the perspective on the other side is, I've got interests that need protecting, whether they are privacy interests around the individual, whether they are business interests, whatever those are, youneed to be able to respect that. No, in confrontation, I'm not going to give you
that. I'm going to look at all the legal means that I can withhold, and you're going to look at all the legal means that you can force it and compel it, and most of it ends in a standstill. Coming to truly appreciate that these are false dichotomies, that there are ways to find the overlap of those Venn circles, those Venn diagrams, there's a huge amount of overlap where it's in the individual's interest, it's in the company's interest or the private sector's interest, and it's in the public interest for us to be cooperating. That actually, everybody can win and that you don't have to have either control or care, you can have care and compassion and control and containment living in the same space. Most of it is about finding where that intersection is. And also, being mindful that you want to be playing in that intersecting space in the least restrictive means that you can in order to accomplish your objectives. If you can accomplish something with a voluntary request with ninety-eight percent
compliance and no need to bring in legal and law enforcement and all these other compelling approaches, but you can make an argument voluntarily, which also is in the interest of the individual, the victim, as well as in the interest of the community at large, then why issue an order and create a conflicting situation or a confrontational situation? If the disease can be contained with something short of one hundred percent compliance, don't have to go for one hundred percent compliance, go for voluntary and build goodwill, build trust. Because the building of the goodwill is going to go so much further than the bankruptcy of trust will. That lesson has played out for me over and over in so many ways, in so many times. I think that's really clearly true, avoid the sense of these false dichotomies.
When I look at the job--and the director of the quarantine program has the largest regulatory responsibility at CDC. It's atypical for this agency to have regulatory responsibility, it's often more a technical agency, but it inherited that when it inherited the quarantine service fifty years ago. The questions that come with those kinds of responsibilities for me, the ones that are obvious when you have regulatory program is about authority. What's my legal authority in this space? May I do this? Is it permitted? Another question that you come when you start thinking about that is, what's my capacity to implement these regulations? Do I actually have the resources and capacities? A lot of times, I think, regulatory programs get stuck on the may I and can I, and they don't ask the third question, which is the most important question, which is, should I do
this? Is this the right thing to do in the spirit of epidemic control? In which case, the regulation just becomes another tool for prevention in terms of looking at the epidemic. It's not the endpoint in and of itself. It's not simply having a regulation to have it or having an authority to enforce it, it's the, should I do this. Once you ask that question first--what should we be doing--then you can go back and say, do we have permission to do it and if not, is there a way to get it or does somebody else have permission that we can leverage to do it? If we don't have the capacity, but we need to be doing this, then what do we do to find partners to grow this capacity? How do we get that? By putting that question first, which I think is the fundamentally most important question, you get down to other aspects of should. If yes we should, and then we can figure out we may and we can, the next question is, how do we do this in the least restrictive means? How do we implement an ethical quarantine
program that respects individual rights while concurrently protecting the public at large? Every big epidemic that I've been involved in at CDC has been an epidemic of disease followed by an epidemic of fear and an epidemic of stigma. Any time we try to approach only one of those, we miss the opportunity for a healthy response. We have to be doing what we know technically to control the epidemic of disease, but if we miss the epidemic of fear that's going on among the non-affected and don't address those concerns, or we miss the epidemic of stigma that's turning victims into vectors and stigmatizing and marginalizing, we drive surveillance and reporting and cooperation and all the voluntary measures you need to get things under control, you drive that completely underground if you stigmatize and dismiss people and see them as vectors rather than victims. This balance, this tension of, how do you have an ethical and a
successful and effective isolation and quarantine program? How do you prevent against importation and spread while minimizing the impact on individual liberties, trade and travel, all of those things? Instead of seeing them as the dichotomy in which they are often presented, "we've got to build this, we've got to lock it down, we've got to have a full-on quarantine containment and that's the only way to do it," and that's usually not true. Usually, what's true is we need trust and cooperation, we need engagement, we need multiple partners, and we need to find the areas of the Venn diagram where the individual's interest overlap with the interest of society because they're there and they are substantial. Holding the "both/and" rather than the "either/or" in this process is just a paramount principle.
Q: I want to thank you. I think that we won't have enough time to get to Ebola if that's okay with you.
CETRON: Yeah.
Q: Would you be willing to come back if you had--
CETRON: Sure, we can talk about Ebola later.
Q: Okay, I know you have a crazy schedule.
CETRON: No, that's fine.
Q: But I think that actually is a brilliant place, that I think we've set the stage now to be talking about what happened in this one particular incident starting in 2014.
CETRON: Okay sure, it's been very enjoyable sharing these ideas with you.
Q: It's been very enjoyable listening.
CETRON: All right, I'll see you next time.
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