About

Michael Callahan is a physician scientist boarded in medicine, ID, tropical medicine (DTM&H), Mass Casualty Care (DMC) and Rescue Medicine Command MD#17. Dr. Callahan's clinical appointments are at MGH/Harvard Medical School, and Visiting Professor at King Chulalongkorn Medical Center in Bangkok, Kaduna, Nigeria and Panama City, PN. His focus is emergency clinical trials for catastrophic infectious diseases such as Ebola, H5N1, MERS, Zika Virus, Chikungunya and complex dengue viral disease. He has developed drugs in market and expedited Phase 2 trials to support Animal Rule decisions including EUA-OLU trials for H5N1 (Jakarta), H7N9 (Nanjing), cutaneous anthrax (Gombe) burkholderia (Phnom Penh), Ebola (Isiro, Monrovia) and Lassa (Kaduna, Kano). From 2005-2012 he led DARPA's $270M biodefense therapeutics program where he developed multiple drugs in clinic and launched Prophecy, a international physician-to-foreign government clinical trials network to support regulatory decisions for zoonotic and biodefense therapies. In 2010 he was awarded the DARPA Achievement Award, the highest award in the Agency. Biotechnology achievements include: CRP-liposomal amphotericin (Ambisome; Gilead); cPG (Pfizer) MIMIC (Sanofi), pH1N1 vaccine, Nicotinia-expressed Ebola therapies (Leaf/Mapp); 2 vaccines from FSU BW programs and inception, development and funding of DARPA's Accelerated Pharmaceuticals Programs (AMP; 7 INDs; 3 NDAs), 7-Day Biodefense (4 INDs), the MIMIC platform, Rapid Altitude & Hypoxia Acclimatization (ENO; Phase 2),: Prophecy (7 international trial sites) and CLIO (licensing agreement disclosed under CDA). In 2012 Dr. Callahan was recruited as President of Unither Virology a United Therapeutics company (UTHR), leading a R&D team executing a $45M NIH contract to accelerate a antiviral from lead to Phase 2 for dengue and flu, and to develop next-generation antivirals against RSV, Zika, Chikungunya and transplant-associated viral indications

Experience

• United Therapeutics 

  • • President, UT Division of Cellular Therapeutics  (  Oct 2012 - Present  (8 years 11 months )  /   Silver Spring MD  )

      • • Oversight of international team devoted to discovery, pre-clinical development, translation and accelerated clinical trials to develop novel cellular therapeutics and synthetic immune therapies directed against high consequence and high-burden diseases. This effort leverages an 8-year, $U.S. 266M Defense Advanced Research Projects Agency (DARPA) portfolio which set industry records in pre-clincal development, translation and accelerated clinical trials in both the ASEAN, the US and the EU. Examples of profitable products include immunogenomics for cancer and vaccine efficacy, micro-dose Phase 1/2 trials in Singapore; Sanofi's MIMIC, and prophetic ex-vivo prediction of AEs in clinical trials, use of proxy drug avatars for de-risking IND packages, ex-vivo individualized patient studies, and clinical investigator appointments in foreign clinical trials centers, all to reduce risk and shorten path to successful Phase 2/3.

    • U.S. Government and United Nations Foreign Service

      • • Support and source selection authority on DTRA, DARPA, and WHO efforts in infectious disease countermeasures and outbreak response, emergency trials and recovery. Specifically, implemented use real-time, on-location clinical teams to improve accuracy of Animal Rule-based approvals with Phase 2 trials, while building sustainable medical response for high burden diseases such as cancer and infectious diseases outbreaks (H5N1, Ebola, Marburg, MERS-2014, SARS-2003, Drug resistant organism outbreaks in foreign hospitals and support of host nation IRBs to protect vulnerable populations.

• Massachusetts General Hospital/ U.S. Dept of Defense

  • • Medical Director, Prophecy/One Health Global Clinical Surveillance (DARPA/DTRA)   ( Jan 2005 - Present  /  16 years 8 months    /  Washington DC  )

      • • Disease Outbreak Alert:  Leadership of DTRA and DARPA funded program for the creation, management and reporting of novel, emerging and highly dangerous pathogen outbreaks in Sub-Saharan Africa and developing Asia using a physician-referral network of 960 Western trained, foreign clinicians and regional health care referral networks. Prophecy was the first network to report pandemic H1N1 precursor (double re-assortment predecessor to California/07, in Northern Panama and Costa Rica (Nov 2008), Mokano Ebola in J.F.K hospital in Monrovia (April 2014) and multiple H5N1 outbreaks in central Siberia, Indonesia and Kowloon (2004-date).

        • Outbreak Response:  Responsibilities include mass-infection care decisions of foreign physician officers, coordination of U.S. disaster response operations, procurement of specialized diagnostics and mass casualty care medical equipment and staffing with experienced, respected physician leaders in the biological threat

        • Highly Dangerous Pathogen Clinical Trials :  Design, IRB approval and clinical investigation of off-label use (OLU) therapies for clinically futile diseases under host-country concurrence and informed consent to include boosted neuraminidase and COX2 treatment of H5N1 and H7N9, use of sequential antibiotics for anthrax toxemia, and rational use for supportive therapies of Ebola viral disease and Marburg viral disease.

        • Public Release Approved/Distribution Unlimited :   Defense Advanced Research Projects Agency

    • Clinical Associate Physician, Division of Infectious Diseases, Dept of Medicine  (  Sep 2001 - Present20 years  /  Boston, MA )

      • • Support development of institution-generated therapeutic products to IND, and for translation to industry and/or U.S. Government-sponsored clinical trials

        • Support hypothesis-generated research and secure federal funding from DARPA, DTRA, DHS and HHS/NIH and NCID

        • Teach physicians in training in general medicine, infectious disease, mass casualty care and overseas refugee and disaster medicine

        • Support institution collaborative engagements with international partners in Asia and S. America.

• DARPA

  • • Director, Biodefense Medical Countermeasures  (  2005 - 2012   /  7 years   /   Arlington, VA   )

      • • Served 4 DARPA Directors (Tether, Lehany, Dugan, Prabhaker) as one of the longest running Program Manager for Defense Science Offices. From 2005-2012, led Biological Defense, Accelerated Insertion of Therapeutics and Peak Soldier Performance medical programs; Conceived, procured funding and led interagency source selection and management of over $280M biodefense and therapeutic portfolio including:

          1. • 2005: Rapid Vaccine Assessment (MIMIC); Accelerated Manufacture of Pharmaceuticals; Biological Inspired Sensors; Unconventional Pathogen Countermeasures (cPG)

             • 2006: Rapid Altitude and Hypoxia Acclimatization

             • 2007: 7-Day Biodefense

             • 2008: Chronicle of Lineage Indicative of Origin (CLIO)

             • 2009: Prophecy; Rapid Monoclonals; Blue Angel ($110M Emergency Appropriation)

        • FDA Approval: Led Critical Path approval programs for FDA/CBER INDs for DARPA generated medical therapeutics (BLAs) and executed industry or interagency transitions of therapeutics and regulatory technologies generated in above programs (2007-2012; **exception: Blue Angel pH1N1 SUV)

        • U.S. Government Committees

        • Served on interagency committees lead by HHS/BARDA; HHS/ASPR; NIAID; FDA; DHS

        • Committee Member: Biological Threat Net Assessment (BNA), Homeland Security Counsel/National Security Counsel

        • Multiple subcommittees of the U.S. Dept of Defense, Dept of Homeland Security, American Academy for Advancement of Science, National Academy of Science, American Society of Microbiology

• USAID

  • • Country Health Director, Nigeria  ( 1999 - 2003  /  4 years  )

Education

• London School of Hygiene and Tropical Medicine, U. of London

  1. • DTM&H (UK)International Public Health/International Health  ( 2000 - 2001 )

• University of Alabama School of Medicine

  1. • MDTinsley R. Harrson Physician Scholar 1991-1995

       1. • Activities and Societies: Founded Alabama Center for Envenomation/ Children's Hospital of Alabama Tinsley R. Harrison clinical research society Medical Student Research Society

• University of Alabama School of Public Health

  1. • MSPHInternational health and biostatistics   ( 1988 - 1990 )

• University of Massachusetts, Amherst

  1. • Bachelor of Science (BSc)Microbiology and Immunology  ( 1980 - 1984 )

Michael V. Callahan, M.D., DTM&H (U.K.), M.S.P.H., doesn't wear a military uniform, but he plays a crucial role in keeping Americans safe by beefing up the nation's defenses against disease.

For the past seven years, Callahan, a 1995 School of Medicine graduate, has been a program manager for the Defense Advanced Research Projects Agency (DARPA), the American military’s secretive R&D center. Callahan was recruited while working overseas “to work on fast-paced solutions to health threats,” he says. His biggest mission: Create a government-funded drug research and production capability focused strictly on national priorities, such as defense and pandemic preparedness, rather than profits. The Department of Defense had no idea how to make drugs, but they knew they had to learn, Callahan recalls.

Rush Request

“The military is most concerned about diseases of the tropics and diseases of bioterrorism, but these are rare globally,” Callahan says. “Though you might have 170,000 deaths per year from yellow fever, that’s not going to be a money maker for a drug company, so they aren’t interested.”

Callahan’s solution involved a special forces approach. His team identified promising work in U.S. labs, offering researchers the funding and equipment they needed to turn their discoveries into patient-ready treatments. In 28 months, DARPA-funded projects created six new vaccines, leveraging taxpayer dollars into economic payback at a ratio of up to 11:1. “It’s been wildly successful,” Callahan says.

Callahan also developed a “twinning” strategy, searching for treatment approaches for related diseases that would interest the military or government (such as bird flu, with its potential to cause a pandemic) as well as drug companies and venture capitalists (the regular flu). These players could then help fund development costs needed to bring the products to market.

Out with the Eggs

Another major goal was replacing the traditional egg-based methods of producing vaccines, which can take “eight years to forever” to develop and six months or more to produce. Callahan’s team launched the Accelerated Manufacturing of Pharmaceuticals project, which found a solution in tobacco plants. Grown in “bug-free hydroponic facilities,” the plants can be easily and rapidly altered to express the needed vaccine products in a matter of weeks. “One 2,000-square-foot chamber consisting of 12 trays can produce up to three million doses of flu vaccine” in a month’s time, Callahan says.

Faster, Higher, Farther

A lifelong mountain climber, Callahan is using a “twinning” approach to help acclimatize mountaineers to high-altitude conditions rapidly. A therapy using an inhalable gas—similar to an albuterol asthma inhaler, Callahan says—is currently in clinical trials on Tanzania’s Mount Kilimanjaro.

The military implications are obvious. “Our soldiers in Afghanistan have to chase bad guys uphill at anywhere from 14,000 to 18,000 feet,” Callahan says. “At the moment, it takes 24 to 46 days to truly acclimatize to those conditions, especially since most of our troops are coming from U.S. bases at or near sea level.” But, he adds, the same treatment “could also treat pulmonary arterial hypertension or chronic hypoxia from lung disease,” which affect millions of civilians worldwide.

Meanwhile, the Prophecy program seeks to predict emerging virus threats and develop vaccines or other treatments to contain them. Working in small teams with foreign governments, DARPA has established an early warning system that can rapidly collect and share information across borders.

“In a perfect world, doctors would see a new virus, sequence it, and e-mail us the genetic information,” Callahan says. Within a matter of days, Callahan’s team can identify the virus and its mechanism of action, letting health workers know if there is an existing vaccine that will help. If not, Callahan says, “we can create a new one and produce between 30 and 160 million doses within a month.”

Path to Birmingham

The Boston native started traveling overseas on relief missions in the early 1980s; in 1988, he founded a charter organization that provided emergency medical evacuation and refugee medical care in developing countries.

He determined to pursue a career in infectious diseases, receiving a master’s degree focusing on international health from the UAB School of Public Health. Soon afterward, he entered the School of Medicine, where he says he had “great training.” Today, Callahan continues to work with UAB colleagues including David Freedman, M.D., in the Division of Infectious Diseases, and several members of the Division of Pulmonary, Allergy, and Critical Care Medicine.

Forward Thinking

Now Callahan says he is ready for new adventures. In fall 2012, he returned to Massachusetts General Hospital, where he has worked for three months each year in the Division of Infectious Diseases, to run a new disease surveillance and antiviral clinical trials program in Africa and southeast Asia. He hasn’t relinquished his defense role, however. “I still have federal responsibilities to the White House for pandemic preparedness and exotic disease outbreaks, which will continue for the near future,” he says.

Meanwhile, Callahan is excited to see how techniques and strategies he initiated at DARPA can be adapted far beyond infectious diseases. The White House and the National Institutes of Health are both interested in the models, Callahan says. “The technology is cool,” he says, “but the experimental business strategy they allowed me to try will have implications across government.”

When 80 motivated and innovative students from five universities work together, novel ideas will emerge. The first [U] Invent produced 12 solutions to combat the spread of the Zika virus through educational and conceptual solutions. More than $4,000 in award funds and an opportunity for two students from a winning team to meet with the Centers for Disease Control and Prevention (CDC) was presented to the students.

Innovate Against Zika is the first [U] Invent program implementing the highly successful Aggies Invent model which gives students 48 hours to collaborate in teams solving identified design challenges related to a specific topic. The students have complete access to the Engineering Innovation Center (EIC) and topic experts throughout the innovation competition. 

“It was great having other universities participate in the first [U] Invent,” said Rodney Boehm, associate professor of practice.  “All of the students blended into tight teams and it allowed us to show how we innovate at Texas A&M University.”

The Texas A&M University College of Engineering and The Zika Foundation partnered to host Innovate Against Zika with the goal of applying new discoveries about the Zika mosquito using trans-discipline expertise to halt the spread of the Zika virus through the rapid development and implementation of low-cost, sustainable solutions. Student teams chose from one of three tracks for their needs statement: vector (mosquito) control, immune households or community resiliency and sustainability.

“This weekend opened my eyes to the ability for people to pull themselves together for a common cause,” said Garrett Harmon. “It’s really motivating to me to think more about my education and what I’m doing now so I can have a great effect of people in the future.”

Innovate Against Zika was stacked with 20 of the brightest researchers in the fields of public health, entomology, chemistry, architecture, engineering and biotechnology to guide and advise the students throughout the weekend. Some of the mentors and presenters included Dr. R. Ulrich Bernier, the acting national program leader and research chemist with the USDA’s Agricultural Research Service, whose efforts are focused on surveillance and control of the vector(s) responsible for pathogen transmission; [Dr. Michael Vincent Callahan (born 1962)], a physician scientist board certified in internal medicine, infectious disease, tropical medicine (DTM&H) and mass casualty care and a clinical and research faculty member at Massachusetts General Hospital/Harvard Medical School; and Josue Young, a researcher in the Medical Entomology Department at the Gorgas Memorial Institute in Panama City, Panama.

“Control of Zika is a problem-rich issue,” said [Dr. Michael Vincent Callahan (born 1962)]. “We therefore are compelled to bring this challenge to a solution-rich setting where new answers can be identified. This is the first time engineers, architects and urban planners have been given complete access to Zika-mosquito experts. We believe this event has identified new solutions to this growing global problem.”

The first-place team, awarded $1,000, was SWATeam. The team developed an app that engages young people in games to find mosquito areas, provides education and allows the community to learn more about Zika. The team consisted of two Texas A&M students — Kendra Mack, from biomedical sciences and Ankita Brahmaroutu from the college of medicine — and five University of Texas students —Jason He, electrical engineering; Annabel Wang, Ishani Chakravarty, and Justin Zhong, chemical engineering; and Zhra Biabani, economics.

The Bucket List team took second place and was awarded  $750. This team developed a Zika protection kit that is contained in a mosquito trap to form a multi-dimensional solution. The members of this team included Kedar Balakrishna, Diego Garcia, Austin Lu, Liana Polikaitis and Ashley Tucker, biomedical engineering; Jessica Lee, biomedical science; and Megan Rodriguez, nuclear engineering.

The third-place team, awarded $500, developed an education program in a pictogram that would be attached to rain barrels currently being distributed by non-governmental organizations worldwide. The Persistent Pictogram team consisted of three Texas A&M students, Mo Adesanmi, chemical engineering, Clare Elizondo, biomedical science and Jane Frederick, biomedical engineering; two Wichita State University students, Hannah Hund, biomedical engineering and LaRissa Lawrie, strategic communications; and Stephanie Strong, chemistry and biology from East Carolina University.

[...]  The CDC showed its interest in Innovate Against Zika by offering to bring two members from the winning team to Atlanta to present the team’s innovation to the Zika response team, speak with its technology transfer experts and tour its insectary.   [...]

Dr. Michael Callahan is CEO and co-founder of the Zika Foundation. He is a highly respected “physician scientist”,  who is board-certified in internal medicine, infectious disease, tropical medicine and mass casualty care, and is on both the clinical and research faculty at Massachusetts General Hospital/Harvard Medical School.

Dr. Callahan has clinical appointments globally, including in Thailand, Indonesia, Panama, and Nigeria. From 2005-2012, Dr. Callahan established Prophecy, the first rapid deployment clinical research capability for catastrophic infectious diseases outbreaks, such as Ebola.

Dr. Callahan has served as special advisor on infectious disease to two presidents, the Secretaries of Defense and of Health and Human Services, and  the Office of the Commissioner of the FDA. Dr. Callahan has been deployed to 7 mass casualty disease outbreaks, including Ebola, Marburg, H5N1 and H7N9 bird flu, and MERS. He used his experience with dengue to launch the Zika Foundation, where he is accelerating sustainable and low-cost interventions to protect women and men from Aedes mosquitos, which transmit dengue, chikungunya and the Zika virus.  His mission is to ensure that the 64 million pregnancies that occur every year in the tropical Americas are kept safe from Zika, and to prevent the epidemic of paralytic Guillain-Barre Syndrome that may well occur in southern nations over the next five years.

The interview that you're about to see challenges our basic understanding of the Zika virus. Dr. Callahan reveals, for example, that new research clearly demonstrates that Zika virus can have long-term neurological effects in adults. He discusses how the aerial spraying efforts, so common in South Florida, are actually ineffective and inappropriate for targeting the specific mosquito that transmits the virus.

However, Dr. Callahan does provide us with some very important, and actionable, tools for reducing our risk of contracting Zika, both in terms of what we can do to reduce the prevalence of the Aedes mosquito and also how we can protect ourselves day-to-day.

It's clear that we have to rewrite the book as it pertains to our understanding of mosquitoes, specifically as it relates to the Aedes mosquito that serves as the carrier of the Zika virus. Unlike what we’re used to, this mosquito lives indoors, and, according to Dr. Callahan, is actually able to watch our eyes to determine when is the best time to inflict its bite.

Dr. Callahan explores the effectiveness of various insect repellents and even touches upon his research dealing with genetically modified male mosquitoes in an attempt to limit the reproduction of the mosquito that carries this threatening virus.

"Michael V. Callahan MD, DTM&H, MSPH, Director, Clinical Translation, Vaccine & Immunotherapy Center (VIC), Massachusetts General Hospital, Harvard Medical School; President & Chief Medical Officer, United Therapeutics Corporation

Michael Callahan is physician scientist boarded in internal medicine, infectious diseases, and tropical medicine and is adjunct clinical faculty and Director, Clinical Translation at the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital. From 2004 to 2013, Dr. Callahan led the Defense Advanced Research Project Agency (DARPA) medical countermeasure program which had generated 19 INDs and 6 NDA/BLAs, including several multibillion dollar companies and a return on taxpayer investment of 56:1. While in the federal government, Dr. Callahan staffed both U.S. and Asian regulatory meetings to ensure parody and adherence to Common Rule and Best Practices across international regulatory agencies, including the Expert Clinical Safety Community to disclose severe-adverse events in cytokine modulation, monoclonal immunotherapy and cellular immunotherapy. Following federal service, Dr. Callahan consulted for the FDA, McKinsey Consultants, Monitor Consulting, Vertex, Sanofi-Pasteur, Nantkwest, Genentech/Roche, and J.P Morgan. Since 2012, Dr. Callahan has served as President and Chief Medical Officer of Cellular Therapies at United Therapeutics Corporation and interim CMO of Northern Therapeutics in Ontario, Canada, where he oversees multicenter trials for engineered autologous and allogeneic cellular therapies."

The fast-growing list of possible treatments for the novel coronavirus includes an unlikely candidate: famotidine, the active compound in the over-the-counter heartburn drug Pepcid. On 7 April, the first COVID-19 patients at Northwell Health in the New York City area began to receive famotidine intravenously, at nine times the heartburn dose. Unlike other drugs the 23-hospital system is testing, including Regeneron’s sarilumab and Gilead Sciences’s remdesivir, Northwell kept the famotidine study under wraps to secure a research stockpile before other hospitals, or even the federal government, started to buy it. “If we talked about this to the wrong people or too soon, the drug supply would be gone,” says Kevin Tracey, a former neurosurgeon in charge of the hospital system’s research.

As of Saturday, 187 COVID-19 patients in critical status, including many on ventilators, have been enrolled in the trial, which aims for a total of 1174 people. Reports from China and molecular modeling results suggest the drug, which seems to bind to a key enzyme in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), could make a difference. But the hype surrounding hydroxychloroquine and chloroquine—the unproven antimalarial drugs touted by President Donald Trump and some physicians and scientists—has made Tracey wary of sparking premature enthusiasm. He is tight-lipped about famotidine’s prospects, at least until interim results from the first 391 patients are in. “If it does work, we’ll know in a few weeks,” he says.

A globe-trotting infectious disease doctor named [Dr. Michael Vincent Callahan (born 1962)] was the first to call attention to the drug in the United States. Callahan, who is based at Massachusetts General Hospital and has extensive connections in the biodefense world, has spent time in disease hot zones around the world, including the 2003 outbreak of another coronavirus disease, SARS, in Hong Kong. In mid-January, he was in Nanjing, China, working on an avian flu project. As the COVID-19 epidemic began to explode in Wuhan, he followed his Chinese colleagues to the increasingly desperate city.

The virus was killing as many as one out of five patients older than 80. Patients of all ages with hypertension and chronic obstructive pulmonary disease were faring poorly. Callahan and his Chinese colleagues got curious about why many of the survivors tended to be poor. “Why are these elderly peasants not dying?” he asks.

In reviewing 6212 COVID-19 patient records, the doctors noticed that many survivors had been suffering from chronic heartburn and were on famotidine rather than more-expensive omeprazole (Prilosec), the medicine of choice both in the United States and among wealthier Chinese. Hospitalized COVID-19 patients on famotidine appeared to be dying at a rate of about 14% compared with 27% for those not on the drug, although the analysis was crude and the result was not statistically significant.

But that was enough for Callahan to pursue the issue back home. After returning from Wuhan [(when did he return?)], he briefed [Robert Peter Kadlec (born 1957)], assistant secretary for preparedness and response at the Department of Health and Human Services, then checked in with [Dr. Robert Wallace Malone (born 1959)], chief medical officer of Florida-based Alchem Laboratories, a contract manufacturing organization. Malone is part of a classified project called [DOMANE  ( "Discovery of Medical Countermeasures Against Novel Entities" , created by the Defense Threat Reduction Agency  in Dec of 2019 )] that uses computer simulations, artificial intelligence, and other methods to rapidly identify U.S. Food and Drug Administration (FDA)-approved drugs and other safe compounds that can be repurposed against threats such as new viruses.

[Dr. Robert Wallace Malone (born 1959)] had his eyes on a viral enzyme called the papainlike protease, which helps the pathogen replicate. To see whether famotidine binds to the protein, he would ordinarily need the enzyme’s 3D structure, but that would not be available for months. So Malone recruited computational chemist [Dr. Joshua Pottel (born 1989)], president of Montreal-based Molecular Forecaster, to predict it from two crystal structures of the protease from the 2003 SARS coronavirus, combined with the new coronavirus’ RNA sequence.

It was hardly plug-and-play. Among other things, they compared the gene sequences of the new and old proteases to rule out crucial differences in structure. [Dr. Joshua Pottel (born 1989)] then tested how 2600 different compounds interact with the new protease. The modeling yielded several dozen promising hits that pharmaceutical chemists and other experts narrowed to three. Famotidine was one. (The compound has not popped up in in vitro screens of existing drug libraries for antiviral activity, however.)

“If it does work, we’ll know in a few weeks,” says Northwell Health’s Kevin Tracey, who leads the famotidine study,

With both the tantalizing Chinese data and the modeling pointing toward famotidine, a low-cost, generally safe drug, Callahan contacted Tracey about running a double-blind randomized study. COVID-19 patients with decreased kidney function would be excluded because high doses of famotidine can cause heart problems in them.

After getting FDA approval, Northwell used its own funds to launch the effort. Just getting half of the needed famotidine in sterile vials took weeks, because the injectable version is not widely used. On 14 April, the U.S. Biomedical Advanced Research and Development Authority (BARDA), which operates under Kadlec, gave Alchem a $20.7 million contract for the trial, most of which paid Northwell’s costs.

The study’s draft protocol was aimed only at evaluating famotidine’s efficacy, but Trump’s “game-changer” antimalarial drug was rapidly becoming the standard of care for hospitalized COVID-19 patients. That meant investigators would only be able to recruit enough subjects for a trial that tested a combination of famotidine and hydroxychloroquine. Those patients would be compared with a hydroxychloroquine-only arm and a historic control arm made up of hundreds of patients treated earlier in the outbreak. “Is it good science? No,” Tracey says. “It’s the real world.”

Anecdotal evidence has encouraged the Northwell researchers. After speaking to Tracey, David Tuveson, director of the Cold Spring Harbor Laboratory Cancer Center, recommended famotidine to his 44-year-old sister, an engineer with New York City hospitals. She had tested positive for COVID-19 and developed a fever. Her lips became dark blue from hypoxia. She took her first megadose of oral famotidine on 28 March. The next morning, her fever broke and her oxygen saturation returned to a normal range. Five sick co-workers, including three with confirmed COVID-19, also showed dramatic improvements after taking over-the-counter versions of the drug, according a spreadsheet of case histories Tuveson shared with Science. Many COVID-19 patients recover with simple symptom-relieving medications, but Tuveson credits the heartburn drug. “I would say that was a penicillin effect,” he says.

After an email chain about Tuveson’s experience spread widely among doctors, Timothy Wang, head of gastroenterology at Columbia University Medical Center, saw more hints of famotidine’s promise in his own retrospective review of records from 1620 hospitalized COVID-19 patients. Last week, he shared the results with Tracey and Callahan, and he added them as a co-authors on a paper now under review at the Annals of Internal Medicine. All three researchers emphasize, though, that the real test is the trial now underway. “We still don’t know if it will work or not,” Tracey says.

Callahan has kept busy since his return from China. Kadlec deployed him on medical evacuation missions of Americans on two heavily infected cruise ships. Now back to doing patient rounds in Boston, he says the famotidine lead underscores the importance of science diplomacy in the face of an infectious disease that knows no borders. When it comes to experience with COVID-19, he says, “No amount of smart people at the [National Institutes of Health] or Harvard or Stanford can outclass an average doctor in Wuhan.”

[Dr. Michael Vincent Callahan (born 1962)] was given a leave of absence from his senior executive role at United Therapeutics (UTHR) in the wake of the COVID-19 outbreak in Wuhan, China; sent there to assist colleagues handling mass infections of the novel coronavirus under his joint appointment at a Chinese sister hospital of the Massachusetts General Hospital/Harvard Medical School, where he has maintained a faculty appointment since 2005.

Soon, Callahan would be pouring through thousands of case studies emerging from the epicenter of the outbreak in Wuhan, examining patients in Singapore and briefing U.S. officials on the location of the next likely outbreak, according to NatGeo. The doctor marveled at the “magnificent infectivity” of the disease, which sits “like a little silent smart bomb in your community”. 

The doctor’s strange fascination with viral infections and morbid titillation might well be attributed to the fact that he has dedicated his life to studying these microscopic killers. “Triple boarded” in internal medicine, infectious diseases and tropical medicine, Callahan, nevertheless also has a strong entrepreneurial streak, that drove him to launch no less than 11 companies and develop 8 patents. 

Callahan’s nose for business came into play early on in the pandemic. After studying data from over 6,000 patient records from Wuhan, he reportedly detected a pattern that could point to a possible treatment using a low-cost and widely available ingredient of an “over-the-counter histamine-2 receptor antagonist called Famotidine”, more commonly known as the brand name Pepcid.

Simultaneously in the U.S., it is claimed, an old colleague of Callahan’s [Dr. Robert Wallace Malone (born 1959)] had been conducting a study with U.S. government-sponsored research teams. Specifically, Malone was working alongside U.S. Defense Threat Reduction Agency (DTRA) consultants to carry out supercomputer-based analyses to identify existing FDA-approved drugs that may be useful against the novel coronavirus responsible for COVID-19. Per their analyses, famotidine turned out to be the “most attractive combination of safety, cost and pharmaceutical characteristics“.

Callahan, who by then had been recruited to be Special Adviser on COVID-19 to the Assistant Secretary of Preparedness and Response (ASPR), Robert Kadlec, was presented the joint findings of the U.S. DTRA and [Dr. Robert Wallace Malone (born 1959)]. Both Dr. Callahan and Malone claimed to be unaware of each other’s conclusions regarding the anti-acid, and despite agreeing to collaborate, each claims to have made the initial discovery. Malone offered a February post on LinkedIn as proof, where he asserts that he was “the first to take the drug to treat my own case” upon discovering the proper dose. Callahan, meanwhile, never provided any evidence of his ostensible breakthrough, though he claims to have told Dr. Malone himself about the discovery before the Virginia-based physician began running the sequences through DTRA computers. 

Quite a Resume, Mr. Bond

In 1988, Michael Callahan started his first company called Rescue Medicine. A National Institutes of Health (NIH) bio describes the company as a charter organization that provides “emergency air medical evacuation and refugee medical care in austere developing regions”. According to their website, Rescue Medicine supports “federal government and U.S. corporations operating in remote international environments”, becoming a “global leader in disaster medicine research”. 

The experience made him a shoe-in as the health director of USAID in Nigeria; a post he held for 4 years, carrying out research on pathogen infections in Africa, prospectively enrolling participants for cutaneous anthrax studies in Nigeria and monkey pox, as well as Ebola and Marburg virus in the Democratic Republic of the Congo and Angola. 

As was the case for several individuals within a certain, tight-knit group within infectious disease and biological weapons circles, 9/11 and the subsequent anthrax attacks changed the course of Callahan’s career, spurring his meteoric rise in both the public and the private sectors. Robert Danzig, Clinton’s Secretary of the Navy, credited Callahan with being “extremely good at connecting the military environment with mainstream public health“. Touted as one of Callahan’s “first high-level links to the military”, Danzig would only be one of many “high level” people the doctor would add to his rolodex over the next two decades.

His time with USAID would overlap with the start of his faculty appointments at Massachusetts General Hospital – appointments he maintains to this day – and his participation in biological terrorism working groups at the National Academies of Sciences, the Department of Defense, and the Department of Homeland Security. 

A year later, in 2002, Callahan would be tapped by the State Department’s director for the Bureau of International Security and Nonproliferation to serve as “clinical director for Cooperative Threat Reduction [CTR] programs” at six former Soviet Union Biological Weapons facilities as part of the Bioindustry Initiative (BII) program, where he was officially tasked with carrying out the stated goals of the mission, which entailed the “reconfiguration of former biological weapons production facilities” in the former Soviet Union and the acceleration of “drug and vaccine production”. More specifically, however, Callahan would be put in charge of gain-of-function programs for viral agents at these facilities. 

The CTR, better known as the Nunn-Lugar Act “to secure and dismantle weapons of mass destruction in states of the former Soviet Union and beyond” was co-authored and sponsored by Senator Sam Nunn, who was none other than the “president” in the bioterror attack simulation that preceded the 2001 anthrax attacks by a matter of months, Dark Winter, an exercise covered by Whitney Webb and this author in the investigative series, Engineering Contagion. A few months prior to the Dark Winter exercise, Nunn had co-founded the Nuclear Threat Initiative (NTI) with conservative reactionary media mogul, Ted Turner, serving as its CEO until 2017. The NTI would play a critical role in the repurposing the former Soviet bioweapons labs into “vaccine production facilities”, allocating millions of dollars to this end.

A full year before Callahan’s BII appointment, the Sam Nunn Policy Forum received a proposal from two Russian scientists working at the “Vector Institute” or State Research Center of Virology and Biotechnology in the Novosibirsk district of Siberia. The former Soviet bioweapons R&D center had been selected to serve as a model for the makeover of other former BW facilities into “open and fully transparent” laboratories after the collapse of the Soviet Union; a process that had been discussed “at length” with the U.S. Vector Evaluation Team that had visited the compound a few years earlier in 1998. 

The Russian scientists aimed to create a non-profit organization called the International Center for the Study of Emerging and Re-emerging Infectious Diseases (ICERID). ICERID was intended to perform research in areas related to diagnostics, vaccines and therapeutics. The project was presented to the Sam Nunn Policy Forum in 2001. While ICERID, itself, fell through, Vector would nonetheless receive a $600,000 grant from Nunn and Turner’s NTI soon thereafter. 

Callahan would follow shortly in tow, under the auspices of the U.S. State Department program, leading clinical research teams at Vector and several other important Soviet bioweapons labs to aid in their transformation into profitable ventures. Callahan was also given access to the infamous Institute of Highly Pure Biopreparations (IHPB) where Soviet microbiologist, Vladimir A. Pasechnik had worked before defecting to England in 1989 and kick-starting the dreams of the international bioweapons mafia detailed in the Engineering Contagion series.

Both IHPB and Vector were part of the five principal institutes of the “Biopreparat” – the broader Soviet BW program. The State Research Center for Applied Microbiology (SRCAM), The Kirov Institute, the Research Center of Molecular Diagnostics & Therapy (RCMDT), RIHOP and Berdsk round out the six labs where Callahan was formally leading clinical research teams; though in Congressional testimony, given together with another high profile Russian defector, Callahan claimed to have worked at “14” separate facilities.

The Russian IP Party

Throughout Callahan’s travels in the former Soviet Union, Massachusetts General Hospital (MGH) was sharing in the research and scientific innovation taking place in the former Soviet labs as part of the consortium of Massachusetts medical research institutions. In 2004, the “number 1 research hospital in the U.S.“, Mass General was taking part in the Bioindustry Initiative (BII) program, making use of the Russian technology their faculty member, Michael Callahan was in the process of discovering.

“We took a Russian delivery system, a rocket as it were, and put an American warhead on it”, said Jeffrey A. Gelfand, a colleague of Callahan’s and international director of MGH’s Center for Integration of Medicine & Innovative Technology, referring to a drug delivery system taken from the RCMDT, one of the former Soviet facilities then under the clinical directorship of Callahan. 

The RCMDT is described as a “small-molecule research facility that traditionally focused on entities the body generates, such as interferon and cytokines, to turn on or turn down the immune response system”. The former Soviet research center obtained a grant from the National Institutes of Health via BII “for a collaborative project on new approaches to disease research”. Another facility Callahan was working at, Vector, also received funding for a novel HIV vaccine and helped file patents “on the institute’s approach to hepatitis C and influenza”. The same institution obtained grants from BII for RNA-based antiviral research.

The task of transforming these former Soviet bioweapons labs into profitable ventures was hitting some cultural walls, according to the then director of the Center for Global Security Research at Lawrence Livermore National Laboratory and chairman of the board of BII precursor ISTC, Ronald F. Lehman II: “They have no experience with a market economy”, he alleged and claimed that they had to “work very hard” to make the Russians understand that intellectual property (IP) was an “economic good”.

Soon enough, the Russian scientists would be ushered into brokered meetings with Eli Lilly and Dow Chemical, among other large Western pharmaceutical companies, to commercialize their discoveries. Much of the groundwork for this had been laid by a sort of precursor of the BII, the International Science and Technology Center (ISTC) – a Moscow-based “intergovernmental” organization established in 1992 to serve as “clearinghouse for developing, approving, financing, and monitoring projects aimed at engaging weapons scientists, technicians, and engineers” from the former Soviet Union and other states that were once behind the Iron Curtain.

Lehman conceded that “any kind of economic, political, or social turmoil” would complicate the process or commercializing the scientific work being done in these Eastern bloc labs. But, in the meantime Callahan, along with “BII and its partners” was doing his best “to push as much science as possible from Russian lab benches into production.”

One of the main functions of the BII was “scouting out sites and planning for business development”. At the time of Callahan’s sojourn through Russia, one of the projects that resulted from this activity by the BII and its private NPO partner, the U.S. Civilian Research & Development Foundation (CRDF), had to do with a little-known vaccine plant in the former Soviet state of Georgia. 

According to James Wolfram, a senior scientist with the CRDF, the Georgia facility was “antiquated” and housed “dangerous pathogens”. The ostensible goal of converting the vaccine plant into a “feed mill” turned into an agreement between the DoD and the government of the Republic of Georgia officially titled “Cooperation in the field of prevention of the introduction of pathogenesis and experience related to biological weapons development”. That same year, construction began on the Richard Lugar Center for Public Health Research in Tbilisi, Georgia. The center was completed in 2011.

In 2017, the U.S. Department of Defense awarded a $6.5 million contract to a company called EcoHealth Alliance, Inc to carry out research on “the risk of bat-borne zoonotic disease emergence in Western Asia”. Journalist Dilyana Gaytandzhieva uncovered the Pentagon project, which focused on “genetic studies on coronaviruses in 5,000 bats collected in Georgia, Armenia, Azerbaijan, Turkey and Jordan”. 

Gaytandzhieva also detailed the multiple covert activities being carried out by the USG, such as American diplomats trafficking in blood and pathogens for a secret military program, as well as an instance in which a breakout of hemorrhagic fever in the area immediately surrounding the Center was traced back to experiments being carried out by Pentagon scientists on “tropical mosquitos and ticks“.

Not coincidentally, EcoHealth Alliance had previously received a $3.5 million grant from the National Institutes of Health (NIH) in 2014 to study coronaviruses in bats in Asia. This particular study was carried out in partnership with scientists at none other than the Wuhan Institute of Virology.

Master of the Dark Sciences

After a few years bouncing from one former Soviet lab to another, Michael Callahan would return to the United States with a head full of new ideas and a brand new job at the Pentagon’s Defense Advanced Research Projects Agency (DARPA) where he could put it all to use as director of the agency’s biodefense therapeutics portfolio.

In the space of just seven years, from 2005 to 2012, Callahan would expand DARPA’s biodefense portfolio from $61 million to $260 million per year and launch eight programs that would generate nine investigational new drugs (INDs) and three new drug applications with products in market, including the injectable fungal treatment, Ambisome (Gilead), which has generated over $6 billion since approval.

Two programs in particular developed by Callahan while at DARPA would later play a critical role in his future involvement in the broader story of the SARS-CoV-2, a.k.a. COVID-19 and the vilification of China, IP and the advancement of a global vaccine regime.

The Accelerated Manufacture of Pharmaceuticals (AMP) program was created by Michael Callahan in 2006, barely a year after he first came on board as DARPA’s portfolio manager. Its purpose was to find technologies that could “radically accelerate the manufacturing of protein vaccines and protein-based therapeutics”, with the goal of “revolutionizing protein therapeutics and vaccine manufacture” through the private sector.

The program’s mandate dovetailed with concurrent efforts to fundamentally transform the U.S. government’s approach to vaccine manufacture and (Medical Countermeasures) MCMs. Just as Callahan was soliciting proposals and handing millions of DARPA’s money to private companies, the agency was entering into a cooperative agreement (HR0011-07-2-0003) with the University of Pittsburgh Medical Center (UPMC) to look into the challenges of this endeavor.

The seminal 180-page report that resulted from the 2-year deep dive (2007-2009) into USG procurement and manufacturing methods for MCMs, titled “Ensuring Biologics Advanced Development and Manufacturing Capability for the United States Government: A Summary of Key Findings and Conclusions” was led by [Dr. Tara Jeanne O'Toole (born 1951)] and [Thomas Vincent Inglesby, Jr. (born 1957)], two key individuals in the Dark Winter exercise and perennial participants in the course of the policy and legislative changes, that have led to the establishment of an entrenched biotech mafia in the halls of government.

The central question that this cooperative effort between DARPA and the UPMC wanted to answer was how to incentivize the private sector to manufacture products that only had one buyer, the U.S. government. To this end, the researchers probed different areas such as barriers to entry, cost analysis and several types of manufacturing options. They included one case study to demonstrate what they believed would be the most effective strategy to follow. That case study looked at a company headquartered in Rockville, MD called Novavax, which recently received a $1.6 billion grant (the largest so far) from Trump’s Operation Warp Speed to manufacture a COVID-19 vaccine.

The paper lauded the company’s “single-use [bioreactors and bags] equipment bioprocessing facility for the development of their influenza virus-like particle vaccine” and concluded that, although not all biopharma companies would be willing to transition to single-use facilities, it was nonetheless in the government’s best interest to patronize single-use manufacturing processes for MCMs, as these would lower costs and cut down production time by two years.

Several USG incentive programs were cited as successfully removing barriers to entry for private sector participants. Among these were the Orphan Products Program (OPP), tax cuts for Big Pharma, subsidies and, significantly, the Pandemic and All-Hazards Preparedness Act (PAHPA) legislation, created by ASPR Robert Kadlec and which established BARDA, clearing the unique “governance” barrier faced by global pharmaceutical firms.

In 2005, just as he was getting ready to decorate his new office at DARPA, Michael Callahan testified before Congress together with Ken Alibek – former deputy director of the Soviet Biopreparat, who defected to the U.S. and became the darling of the bioterror alarmists in and out of government. In his prepared statement, Callahan concluded with a chilling statement that summarizes the general sentiment shared by many in his circle: 

“The dark science of biological weapon design and manufacture parallels that of the health sciences and the cross mixed disciplines of modern technology. Potential advances in biological weapon lethality will in part be the byproduct of peaceful scientific progress. So, until the time when there are no more terrorists, the U.S. Government and the American people will depend on the scientific leaders of their field to identify any potential dark side aspect to every achievement…”  Michael Callahan

Callahan would receive DARPA’s highest commendation, the DARPA Achievement Award, for his success with the Accelerated Manufacture of Pharmaceuticals (AMP) program. But, it would be another program of his creation that would prove prophetic.

Self-fulfilling Prophecy

Prophecy was another program created by Callahan at DARPA. It sought to “transform the vaccine and drug development enterprise from observational and reactive to predictive and preemptive” through algorithmic programming techniques. In layman’s terms, the program proposed that “viral mutations and outbreaks” could be predicted in advance to more rapidly counter the unknown disease with preemptive drug and vaccine development.

Among the grantees of Callahan’s program were at least two institutions where he himself held faculty positions. Harvard University, where he holds a clinical appointment, received a $19.6 million contract for a joint project with the Johns Hopkins University Applied Physics Laboratory, University of Pittsburg and others. Another institution with close ties to Callahan obtaining generous funding through the DARPA Prophecy program was the King Chulalongkorn Memorial Hospital in Bangkok, Thailand, which houses the King Chulalongkorn Medical University where Callahan is a visiting professor. 

In 2009, Callahan’s old employer USAID launched PREDICT, an early warning system for new and emerging diseases in 21 countries. Thailand, known for being a “hotbed of undiagnosed illnesses and viruses” among medical experts, was among those 21 nation and a doctor described as a “giant in the field of virus discovery worldwide” was tapped by the CIA cutout to lead the PREDICT program in that country. 

Dr. Supaporn “Chu” Wacharapluesadee, from the King Chulalongkorn Memorial and faculty of Medicine at Chulalongkorn University had been conducting research on viruses in bats for years and is considered one of the world’s leading experts on bat pathogens. ” We need more Dr. Supaporns of the world”, exclaimed Callahan in a 2016 interviewwith Vice. The doctor praised his Chulalongkorn University colleague, noting that “Chu” was “at the very top of [his] list” when it came to whom he chose to work with on “virologic expeditions”. 

Indeed, Callahan and DARPA had identified Wacharapluesadee as an asset in 2004 when she discovered the Nipah virus in bats, which can affect humans and pigs. Callahan and the Thai doctor worked together on several studies. One of these, funded by the USAID PREDICT project, titled “Diversity of coronavirus in bats from Eastern Thailand” was published in 2015 and carried out between 2008 and 2013, as well as a 2013 study on encephalitis funded by DARPA and the Thai government. 

Callahan is not shy about crediting Dr. Wacharapluesadee with allowing the U.S. government to work on “critically important global virology projects”. His compliments could be more than simple admiration, however. It was Dr. Wacharapluesadee, after all, who would find herself at the center of the narrative built around the coronavirus outbreak in Wuhan, China; namely that the People’s Republic of China (PRC) purposely withheld critical genomic information from the world at the outset of the pandemic in January, 2020. 

According to a PBS.org story, on January 8, a Thai woman returning from Wuhan was “pulled aside” at the airport over symptoms of a runny nose, sore throat and high temperature. “Supaporn Wacharapluesadee’s team”, as claimed, discovered that the woman was infected with a “new coronavirus”. Dr. Wacharapluesadee herself had allegedly succeeded in “partially” decoding the genetic sequence of the virus by the following day and reported it to the Thai government. 

That same day, a 61-year-old man became the first death in Wuhan after succumbing to a disease with a reportedly similar pathology. However, the Chinese government didn’t report it until two days later on January 11 along with the virus sequences from the Wuhan Institute of Virology and its own CDC, sparking accusations against the PRC that it was delaying information about the outbreak. Dr. Wacharapluesadee compared her sequence with the one later published by the Shanghai Public Health Clinical Center and “found it was a 100% match”, making it the first officially recorded case outside of China and effectively dropping the first domino, which would eventually lead to the WHO declaring a global pandemic two months later.

Callahan, himself, had been stoking the fires about China’s caginess regarding its lack of enthusiasm for scientific collaboration with the West as far back as 2018: “Jeopardizing U.S. access to foreign pathogens and therapies to counter them”, declared Callahan over reports that Chinese officials had “concealed” lab samples of H7N9 (type of bird flu), which he argued “undermines our nation’s ability to protect against infections which can spread globally within days”. 

A Close-Knit Cluster of Institutions

Michael Callahan would leave DARPA’s payroll and his official title of Program Manager for Biodefense and Mass-Casualty Care in 2012 and return to Massachusetts General Hospital to run a disease surveillance and antiviral clinical trials program in Africa. But, a man with Callahan’s background never quite leaves government, as he himself admitted in a UAB alumni profile: “I still have federal responsibilities to the White House for pandemic preparedness and exotic disease outbreaks,” said Callahan in 2013, “which will continue for the near future”.

Dennis Carroll, a former USAID director of emerging threats division who had led the U.S.’ response to Avian influenza (H5N1) in 2005, would go on to create PREDICT, which partnered with a non-profit called EcoHealth Alliance to carry out its 9-year effort to catalog hundreds of thousands of biological samples, “including over 10,000 bats“. The aforementioned PREDICT-funded 2015 study on “diversity of coronavirus in bats” by Wacharapluesadee and Callahan also included Peter Daszak, president of EcoHealth Alliance, among its participants. 

Daszak, a regular advisor to WHO on pathogen prioritization for R&D, Carroll and Joana Mazet – former global director for USAID’s PREDICT – all joined together in 2016 to form the Global Virome Project; a “10-year collaborative scientific initiative to discover unknown zoonotic viral threats and stop future pandemics”. Mazet was also co-director of UC Davis’ One Health program, which recruited Dr. Wacharapluesadee and her team in Thailand to conduct a multi-year research project on bats. They are joined by Edward Rubin of Metabiota Inc, a recipient of Callahan’s PROPHECY funds at DARPA and, notably, an $18.4 million DTRA contract award for scientific research and consulting work in Ukraine and the Lugar Center in the Republic of Georgia. Metabiota was accused by the Viral Hemorrhagic Fever Consortium in 2014 of violating their contract and engaging in dangerous blood culturing work at a lab in Africa, as well as misdiagnosing patients. 

EcoHealth’s Executive Vice President, William Karesh, links directly back to the very top of the U.S. biodefense establishment, as a member of ASPR Robert Kadlec’s original Blue Ribbon Panel on Biodefense along with Hudson Institute senior fellows Tevi Troy, Jonah Alexander and Scooter Libby, whose pivotal roles has been detailed in the Engineering Contagion series. EcoHealth Alliance is listed as a partner of the Wuhan Institute of Virology on archived pages of its website and was mentioned as a one of the institute’s “strategic partners” by the WIV’s Deputy Director General, Prof Yanyi Wang, in remarks during the visit of an official U.S. delegation to the institute in 2018.

What better way to show our @EcoHealthNYC Board members the work we do – visiting farmer Wei’s rat farm in Guilin China where @nycbat is giving us a sampling demo! Watch out for the big ‘chompers’ pic.twitter.com/ZzysQAc0tf— Peter Daszak (@PeterDaszak) October 17, 2019

The relationship between the WIV and the American Biodefense establishment was advanced by EcoHealth Alliance policy advisor, David R. Franz, former commander at U.S. bioweapons lab at Fort Detrick (USAMRIID). Franz was chief inspector on the three UN Special Commission biological warfare inspection tours in Iraq, which included a young Robert Kadlec as a member of the team on the ground, and currently advises Robert Kadlec as a member of HHS’ National Science Advisory Board for Biosecurity.

Significantly, Franz was also part of the first “U.S.-U.K.” teams that visited the former Soviet Union’s BW facilities in the early 90’s, which led to the creation of the ISCT and subsequent BII program in which Michael Callahan served as clinical director for multiple BW facilities prior to joining DARPA in 2005. 

During a visit to the Wuhan Institute of Virology in 2017 as part of the “Second China-U.S. Workshop on the Challenges of Emerging Infections, Laboratory Safety and Global Health Security“, Franz outlined “possible joint project ideas”, which included carrying out joint “table top exercises” or simulations of outbreaks (e.g. exercises similar to Dark Winter), decision-making surrounding “gain-of-function” research and “overcoming barriers to sharing strain collections and transport of pathogens”. The last point would play a crucial role in the narrative emerging about the ostensible origins of the virus, which has been claimed to be the WIV, itself.

A “renowned” bat coronavirus researcher at the Wuhan Institute of Virology, Shi Zhengli a.k,a “Batwoman”, was not only the first scientist to associate the novel coronavirus with bats, but is also the original source of the claim that the virus had escaped from the WIV, when she mused in a Scientific American article published in March that the thought had crossed her mind and hadn’t “slept a wink” in days worrying about it until the lab tests results came back showing that “none of the sequences matched those of the viruses her team had sampled from bat caves”. Zhengli has been at the center of a whirlwind of rumors, including that she had smuggled “hundreds of confidential documents” out of the country and was seeking asylum with her family in France. These rumors have since been denied by Zhengli herself. 

Like Thailand’s Dr. Wacharapluesadee, Dr. Zhengli has also worked with EcoHealth Alliance’s Peter Daszak on bat-related studies. As far back as 2005, Daszak and Zhengli were conducting research on SARS-like coronaviruses in bats. Several PREDICT-funded studies on SARS-like coronaviruses and Swine Flu count with both Zhengli’s and Daszak’s contributions. Perhaps the most noteworthy of these is a 2015 PREDICT and NIH-funded study she co-authored entitled: “A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence”. 

Predictable Outcomes

While Michael Callahan was roaming across Africa for the DoD-funded disease surveillance program at MGH in 2012, United Therapeutics came calling for his services. He joined the publicly-traded company to execute a $45 million NIH contract to develop “next-generation” antivirals and currently holds the position of President of their division of Cellular Therapeutics. True to his word, Callahan didn’t let his day job interfere with any mission the federal government might send him on.

In March 2020, Callahan was on board the U.S. Coast Guard cutter Pike on his way to a cruise ship off the coast of California to separate the sick from the healthy among the 3,500 passengers of the Grand Princess. In a few days, the WHO would officially declare the coronavirus to be a global pandemic and spur the lurch into a “new normal” where quarantines, masks and hand sanitizer would be peddled as unquestionable realities.

Days earlier, NIAID director, Anthony S. Fauci, had come on Face the Nation, in one of his first televised appearances to announce, among other things, the implementation of the 14-day quarantine for all Americans as news of infected U.S. citizens on board cruise ships was making the rounds on all mainstream media outlets. The State Department would issue a travel warning specifically for cruise ship passengers on March 8, barely three days before the WHO’s official pandemic declaration.

Callahan, ever the disaster entrepreneur, had struck while the iron was still hot in February and put on his Rescue Medicine hat – the company he had founded in the 80’s – to assist “Japanese and U.S. health authorities” tend to the sick aboard the Diamond Princess, which was being held in the Japanese port of Yokohama, near Tokyo. “There was no way this wasn’t going to show up on a cruise ship first,” Callahan told the Miami Herald. “Cruise ships are the canary for disease outbreak that reveals these diseases on a grand scale”. 

But, it appears that Dr. Callahan did not need the cruise ships to alert him about the nature or scale of the problem. Already by January 4, 2020, four days before his esteemed colleague in Thailand, Dr. Wacharapluesadee, had run the genomic data and come up with a “partial” sequence and a full match had been determined after China and the WIV had released their sequences, Callahan had phoned his old friend [Dr. Robert Wallace Malone (born 1959)] in New York with news of a new emerging disease out of Wuhan, China. 

In March, ASPR Robert Kadlec, wrote to Northwell’s executive vice president of research encouraging him to draw up a contract proposal and a budget for the “Pepcid trial” with Callahan. The proposal that came back was about $20.75 million-short of what Dr. Malone, whose Alchem Laboratories Corporation would be getting the actual contract, apparently wanted.

“We stepped in to do it on behalf of Northwell (which) knows nothing about federal contracting”, Malone told AP. But, it seems that Callahan’s Pepcid brainstorm ruffled a few feathers at HHS. Former BARDA director, Rick Bright, cited the Pepcid fiasco as the prime example of how Kadlec “was inviting violations of federal procurement law” in his March 5th complaint.

For the moment, the Pepcid trials are on hold as Malone and Callahan work out who gets the credit for the “idea”. Robert Kadlec, meanwhile, remains the ASPR and – as far as we know – Michael Callahan is still advising him on matters pertaining to COVID-19. 

• Acknowledgements: Whitney Webb contributed with research for this article

• Correction:  A previous version of this article stated that Dr. Callahan had called Dr. Malone on January 4, 2020 to suggest the possible use of Famotidine as a treatment. Dr. Robert Malone clarified to Unlimited Hangout that Callahan had only alerted him about an outbreak of the virus on that date. We have revised this article accordingly and regret the error.

In early January, when the first hazy reports of the new coronavirus outbreak were emerging from Wuhan, China, one American doctor had already been taking notes. Michael Callahan, an infectious disease expert, was working with Chinese colleagues on a longstanding avian flu collaboration in November when they mentioned the appearance of a strange new virus. Soon, he was jetting off to Singapore to see patients there who presented with symptoms of the same mysterious germ.

Name a major disease outbreak anywhere in the world in the last 20 years—SARS, Ebola, Zika—and chances are Callahan, 57, was there (in his biocontainment suit, of course). A stint working in a refugee camp in the Democratic Republic of the Congo during the 1990s convinced him to pursue work as a frontline infectious disease doctor. Since then, he has worked in remote Ebola clinics in Africa, helped retrain Russian bioweapons experts as infectious disease researchers, and led multimillion-dollar Department of Defense programs looking for ways to predict and preempt emerging diseases. 

After Singapore, Callahan flew to Washington, D.C., where he briefed U.S. government officials on where the disease might occur next. By then, two cruise ships were stranded at sea with cases of coronavirus on board. Since Callahan was one of the few American doctors who’d seen the disease, the Department of Human and Health Services asked him to help evacuate American passengers from the Diamond Princess, off Yokohama, Japan, and the Grand Princess, off the coast of California.

Those missions completed, he returned to Boston—where he’s at based at Massachusetts General Hospital—and New York to help launch clinical trials and attend to Mass General’s own COVID-19 patients. “It’s an arms race between death and a cure,” he says. “Either the virus wins or our immune systems win.”

National Geographic caught up with Callahan while he was taking a break at his home in Boulder, Colorado. The following interview has been edited for length and clarity.

How did your background as a climbing bum at Yosemite prepare you for a life in infectious diseases?

I worked my way through college [at the University of Massachusetts Amherst] as a paramedic and got involved with mountain rescues, where I learned how to make the call when lives are at risk during emergencies. During medical school [at the University of Alabama], my interest shifted toward disaster operations overseas. I realized that it wasn’t the earthquake or tsunami that’s killing everybody, but it’s the malaria, the dengue, and waterborne diseases that come afterward. Infectious disease is a slow-rolling disaster. And it goes on forever.

Did you ever expect to see a pandemic like COVID-19 in your lifetime?

During planning exercises [at the Department of Health and Human Services] for outbreaks, we considered worst-case scenarios, but we always thought they were hypothetical. We were also certain that the next pandemic would be flu, even after the SARS outbreaks in 2002 and 2003. That was a bad virus, but it wasn’t that infectious. It goes to show how much humility you have to have.

What makes this new coronavirus so hard to fight?

Its magnificent infectivity. It sits there like a little silent smart bomb in your community, and then it finds a vulnerable person and just takes them out. I like to say the new coronavirus is all iceberg, no ice. It’s all beneath the surface of the water. We’re just mopping up the top of this thing right now.

How is this crisis changing the rules of medicine?

We have the most affluent, resource-rich medical system on the planet, but none of that richness is really helping us because our patients are dying at the same rates as they do in much less well-resourced nation. Our best weapon is knowledge.

Have you ever contracted an infectious disease in the field?

I consider it a professional failing to get infected. I’m supposed to be the best example. When we brought the disaster team [composed of doctors, nurse practitioners, nurses, and pharmacists sent by the DHHS] to the Diamond Princess cruise ship in Japan, they had never set foot in a hot zone in their entire life. These are earthquake people, hurricane people. They are learning new skills and we tell them the most important thing is to slow down if they are nervous or uncertain. If they get infected, the failure is on us, not them.

What keeps you returning to hot zones?

The last Americans to leave a hostile nation are doctors and nurses. We have a defective gene that makes us go to these outbreaks and put ourselves in harm’s way, because we are troubled by the inequality of health care access. During medical school, I volunteered at the Goma refugee camp on Congo’s border with Rwanda. I was back home when the genocide happened, but I became driven by the unfairness of it all. By going to these remote places and teaching one physician how to do something, I realized, I could affect a thousand lives and create lasting changes in a village or a community.

How do you think the coronavirus crisis will end?

The only way out of it is that everybody becomes immune because they’ve either got the infection or they got vaccinated. If I had to put my money down, one of the vaccines on the immediate horizon will give us transient immunity, and if it holds for four to six months, we’ll break the pandemic cycle. Then, we’ll do it again with another, better vaccine. So, we’ll live through it. We’re not going to knock it out of the park with the first vaccines.

Do you feel like there has been too much emphasis placed on the vaccine?

When you are faced with a mass casualty infection, there’s a priority list. First, protect the vulnerable. Second, break contagion. Third, treat the sick. And number four is make a vaccine, because it takes the longest and is the highest risk. But we haven’t broken contagion, quite obviously. And we’re not investing enough in coronavirus therapies. Developing a vaccine requires understanding the response of the human immune system to a virus we’ve never seen before. I would rather take the virus into the lab, and punch it out with a bunch of direct-acting antiviral drugs.

How can we prevent a pandemic like this from happening again?

Infectious disease outbreaks are becoming bigger, faster, and more frequent. Every Ebola outbreak [in Africa], people race to the capital cities, where there are direct flights to Europe and India and China. That means these diseases are instantly international, and we need to set aside politics and work together to fight them.