1999 West Nile Virus scare / OraVax development (Yes , discovered in the Bronx Zoo by Tracey McNamara .. who had worked with Annelisa Kilbourn)
BioPort anthrax vaccine challenges
VaxGen anthrax vaccine
SARS 2003 kickoff - Sep 11 2002
Mid October US congress testimony
anthrax letter, key dates
old anthrax vaccine funding ; refusal of some US military to take it (perceived as too dangerous)
https://www.newspapers.com/image/534719640/?match=1&terms=bioterrorism
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PDF : [HG00JF][GDrive]
https://www.newspapers.com/image/111073022/?terms=cheney%20lederberg&match=1
1994-03-27-the-courier-journal-louisville-kentucky-pg-e-4
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(Intro quote by Joshua Lederberg)
https://www.newspapers.com/image/583910203/?match=1&terms=bioterror
https://www.newspapers.com/image/752019815/?match=1&terms=bioterrorism
Presenting - Dr. Margaret Ann Liu (born 1956)
Mentioned - William A. Haseltine
https://en.wikipedia.org/wiki/The_Cobra_Event
Note the Wikipedia is wrong (says 1998 release)
AMAZON description -
by Richard Preston (Author)
The Cobra Event is the story of a secret counter-terror operation. It is set in motion one spring morning in New York City when a seventeen-year-old student wakes up feeling vaguely ill. She seems to be coming down with a cold. Hours later she is having violent seizures, blood is pouring out of her nose, and she has begun a hideous process of self-cannibalization. Soon, other gruesome deaths of a similar nature have been discovered, and the Centers for Disease Control in Atlanta sends a forensic pathologist. an expert in epidemiology, to investigate. What she finds precipitates a federal crisis.
The details of this story are fictional, but they are based on a scrupulously thorough inquiry into the history of biological weapons and their use by civilian and military terrorists. "The creation of advanced biological weapons using methods of genetic engineering and biotechnology is sometimes known as 'black biology,'" Richard Preston writes. The extent to which the products of black biology are available nearly everywhere in the world is shocking. Preston's sources for his story include members of the FBI and the United States military, public health officials, intelligence officers in foreign governments, and scientists who have been involved in the development and testing of strategic bioweapons. The stories of what they have seen and what they expect to happen and how they plan to deal with it are chilling.
The Cobra Event is not science fiction. It is a dramatic, heart-stopping account of a very real threat, told with the skill and authority that made Richard Preston's The Hot Zone an internationally acclaimed bestseller
Release date : June 19, 1998
NOTE : The 1998 X-Files film uses phrasing from Cooper (e.g. "Silent Weapons for Quiet Wars") and features the name Cooper in apparent homage.[10]https://profiles.nlm.nih.gov/spotlight/bb/catalog/nlm:nlmuid-101584906X12251-img
1998-04-10-profiles-nlm-nih-gov-white-house-roundtable-on-biological-warfare-preparation.jpgInfo:
See : Jesse Gelsinger (born 1981) / Vical Incorporated /
see https://www.nature.com/articles/nm0200_118 (Published Feb 2000 ) ...
"The notoriously fickle biotechnology company investment community has hedged its bets on the issue of gene therapy. Following the death last fall of Arizona teenager Jesse Gelsinger and the ensuing federal investigation into this experimental technique, (Nature Med. 6, 6; 2000), stocks in companies using non-viral vectors, such as San Diego-based Vical, have risen substantially, whereas the share price of firms testing viral vectors has remained steady."
"The attractiveness of non-viral vectors is easy to understand in light of Gelsinger's death due to adenovirus toxicity. And the stability of viral vector investments could be based on the notion that industry is confident no further legislation will be imposed on its activities. Or it may be the calm before the storm. Richard Selden, president and CEO of Transkaryotic Therapies, Massachusetts, which conducts ex vivo gene therapy research, speculates, “It is still too early for investors to decide, since the scientific community has yet to come to any solid conclusions about what went wrong.” "
PDF version (with OCR... but bad OCR) : [HN02B4][GDrive] / Text file : [HN02B5][GDrive]
Mentioned : Jeanne (Wolford) McKelvey (born 1947) / Francis Nicholas "Nick" Jacobs (born 1947) / Windber Medical Center (2001) /
WINDBER - Thanks to a dream of a local cancer survivor, the [Windber Medical Center (2001)] will enter into a breast cancer risk assessment, treatment and research partnership with Walter Reed Army Hospital in Washington D.C.
U.S. Rep. John Murtha, announced on Thursday, that a portion of the $7 .5 million dollar grant from the Department of Defense will be used to establish a facility at Windber Medical Center with all research, diagnostic and treatment modalities needed to mirror screenings set up by Walter Reed.
Murtha said that the funds became a reality because of the strong views of local breast cancer survivors, including [Jeanne (Wolford) McKelvey (born 1947)], Windber Medical Center treasurer.
"I am convinced that we will be able to find a cure and ultimately be. able to prevent breast cancer and that's why I've been in the forefront in directing over $S00 million of defense funding into breast cancer research and related programs in recent years," Murtha said. "It makes economic sense and defense sense to focus on breast cancer research and treatment for our servicewomen, especially when these programs can simultaneously benefit every women and the families of every women in America who faces breast cancer.'
[Jeanne (Wolford) McKelvey (born 1947)] spoke on the role she played in seeing the [Windber Medical Center (2001)] become part of such an important program.
McKelvey said that having gone through the treatment, she knew there had to be a better way. Since she and her husband are friends with the Congressman and his wife, McKelvey said concern was always expressed for her well being . "When we ran into them at a social event, the Congressman asked about my experience and what he could do for the women in this area who may be going through the same thing."
"You would be able to talk to others who have gone through the same thing because people who have been through the experience can help others. It would really be sort of a home away from home."
After listening to McKelvey, the Congressman asked where she would suggest such a center be located and she answered, the Windber Medical Center. Murtha issued McKelvey a challenge to put together a proposal for such a center, within ten days. McKelvey called [Francis Nicholas "Nick" Jacobs (born 1947)], CEO of Windber Medical Center, who had just returned from a trip to Bosnia, and the proposal was prepared within three days, she said.
Jacobs commended McKelvey for her work on the project. He said, "through programs to prevent breast center, we will be able to prevent breast cancer." Jacobs said that the new facility will be located near the $8 million dollar medical arts buildings and will be called the Joyce Murtha Breast Care Center. "I think this is the first public facility in the area to be identified with Mrs. Murtha."
The Windber Medical Center's new breast care center will operate as an effective research screening facility to test Department of Defense beneficiaries of the genetic mutation that causes breast cancer in women. If the studies show women are prone to cancer through genetics, research will determine the proper protocols to be used army-wide to prevent the onslaught of breast cancer in both women in the military and Department of Defense dependents.
See National Nanotechnology Initiative (NNI)
Also present : Dr. David Baltimore (born 1938) /
Mentioned : Francis Nicholas "Nick" Jacobs (born 1947) / Windber Medical Center (2001)
Mentioned : Francis Nicholas "Nick" Jacobs (born 1947) / Windber Medical Center (2001) / Col. Craig David Shriver, MD (born 1958) / Richard Idem Somiari (born 1968(est.)) / Multiple Peptide Systems
Find sources: "Operation Dark Winter" – news · newspapers · books · scholar · JSTOR (November 2010) (Learn how and when to remove this message)
Operation Dark Winter
Location Andrews Air Force Base, Maryland, U.S.
Date June 22, 2001 – June 23, 2001
Operation Dark Winter was the code name for a senior-level bio-terrorist attack simulation conducted on June 22–23, 2001.[1][2][3][4] It was designed to carry out a mock version of a covert and widespread smallpox attack on the United States. Tara O'Toole and Tom Inglesby of the Johns Hopkins Center for Civilian Biodefense Strategies (CCBS) / Center for Strategic and International Studies (CSIS), and Randy Larsen and Mark DeMier of Analytic Services were the principal designers, authors, and controllers of the Dark Winter project.
August 2001 / Infection and Immunity 69(7):4509-15 / DOI:10.1128/IAI.69.7.4509-4515.2001 / PDF saved as: [HP00E8][GDrive]
Authors:
Article available in other US newspapers : https://www.newspapers.com/image/740804190/?match=1&terms=%22judith%20miller%22
Sept. 4, 2001 / This article was reported and written by Judith Miller, Stephen Engelberg and William J. Broad.
NYTimes article : https://www.nytimes.com/2001/09/04/world/us-germ-warfare-research-pushes-treaty-limits.html
2001-09-04-nytimes-us-germ-warfare-research-pushes-treaty-limits.pdf
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Over the past several years, the United States has embarked on a program of secret research on biological weapons that, some officials say, tests the limits of the global treaty banning such weapons.
The 1972 treaty forbids nations from developing or acquiring weapons that spread disease, but it allows work on vaccines and other protective measures. Government officials said the secret research, which mimicked the major steps a state or terrorist would take to create a biological arsenal, was aimed at better understanding the threat.
The projects, which have not been previously disclosed, were begun under President Clinton and have been embraced by the Bush administration, which intends to expand them.
Earlier this year, administration officials said, the Pentagon drew up plans to engineer genetically a potentially more potent variant of the bacterium that causes anthrax, a deadly disease ideal for germ warfare.
The experiment has been devised to assess whether the vaccine now being given to millions of American soldiers is effective against such a superbug, which was first created by Russian scientists. A Bush administration official said the National Security Council is expected to give the final go-ahead later this month.
Two other projects completed during the Clinton administration focused on the mechanics of making germ weapons.
In a program code-named Clear Vision, the Central Intelligence Agency built and tested a model of a Soviet-designed germ bomb that agency officials feared was being sold on the international market. The C.I.A. device lacked a fuse and other parts that would make it a working bomb, intelligence officials said.
At about the same time, Pentagon experts assembled a germ factory in the Nevada desert from commercially available materials. Pentagon officials said the project demonstrated the ease with which a terrorist or rogue nation could build a plant that could produce pounds of the deadly germs.
Both the mock bomb and the factory were tested with simulants -- benign substances with characteristics similar to the germs used in weapons, officials said.
A senior Bush administration official said all the projects were ''fully consistent'' with the treaty banning biological weapons and were needed to protect Americans against a growing danger. ''This administration will pursue defenses against the full spectrum of biological threats,'' the official said.
The treaty, another administration official said, allows the United States to conduct research on both microbes and germ munitions for ''protective or defensive purposes.''
Some Clinton administration officials worried, however, that the project violated the pact. And others expressed concern that the experiments, if disclosed, might be misunderstood as a clandestine effort to resume work on a class of weapons that President Nixon had relinquished in 1969.
Simultaneous experiments involving a model of a germ bomb, a factory to make biological agents and the developoment of more potent anthrax, these officials said, would draw vociferous protests from Washington if conducted by a country the United States viewed as suspect.
Administration officials said the need to keep such projects secret was a significant reason behind President Bush's recent rejection of a draft agreement to strengthen the germ-weapons treaty, which has been signed by 143 nations.
The draft would require those countries to disclose where they are conducting defensive research involving gene-splicing or germs likely to be used in weapons. The sites would then be subject to international inspections.
Many national security officials in both the Clinton and Bush administrations opposed the draft, arguing that it would give potential adversaries a road map to what the United States considers its most serious vulnerabilities.
Among the facilities likely to be open to inspection under the draft agreement would be the West Jefferson, Ohio, laboratory of the Battelle Memorial Institute, a military contractor that has been selected to create the genetically altered anthrax.
Several officials who served in senior posts in the Clinton administration acknowledged that the secretive efforts were so poorly coordinated that even the White House was unaware of their full scope.
The Pentagon's project to build a germ factory was not reported to the White House, they said. President Clinton, who developed an intense interest in germ weapons, was never briefed on the programs under way or contemplated, the officials said.
A former senior official in the Clinton White House conceded that in retrospect, someone should have been responsible for reviewing the projects to ensure that they were not only effective in defending the United States, but consistent with the nation's arms-control pledges.
The C.I.A.'s tests on the bomb model touched off a dispute among government experts after the tests were concluded in 2000, with some officials arguing that they violated the germ treaty's prohibition against developing weapons.
Intelligence officials said lawyers at the agency and the White House concluded that the work was defensive, and therefore allowed. But even officials who supported the effort acknowledged that it brought the United States closer to what was forbidden.
''It was pressing how far you go before you do something illegal or immoral,'' recalled one senior official who was briefed on the program.
Public disclosure of the research is likely to complicate the position of the United States, which has long been in the forefront of efforts to enforce the ban on germ weapons.
The Bush administration's willingness to abandon the 1972 Antiballistic Missile treaty has already drawn criticism around the world. And the administration's stance on the draft agreement for the germ treaty has put Washington at odds with many of its allies, including Japan and Britain.
During the cold war, both the United States and the Soviet Union produced vast quantities of germ weapons, enough to kill everyone on earth.
Eager to halt the spread of what many called the poor man's atom bomb, the United States unilaterally gave up germ arms and helped lead the global campaign to abolish them. By 1975, most of the world's nations had signed the convention.
In doing so, they agreed not to develop, produce, acquire or stockpile quantities or types of germs that had no ''prophylactic, protective or other peaceful purposes.'' They also pledged not to develop or obtain weapons or other equipment ''designed to use such agents or toxins for hostile purposes or in armed conflict.''
There were at least two significant loopholes: The pact did not define ''defensive'' research or say what studies might be prohibited, if any. And it provided no means of catching cheaters.
In the following decades, several countries did cheat, some on a huge scale. The Soviet Union built entire cities devoted to developing germ weapons, employing tens of thousands of people and turning anthrax, smallpox and bubonic plague into weapons of war. In the late 1980's, Iraq began a crash program to produce its own germ arsenal.
Both countries insisted that their programs were for defensive purposes.
American intelligence officials had suspected that Baghdad and Moscow were clandestinely producing germ weapons. But the full picture of their efforts did not become clear until the 1990's, after several Iraqi and Soviet officials defected.
Fears about the spread of biological weapons were deepened by the rise of terrorism against Americans, the great strides in genetic engineering and the collapse of the Soviet Union, which left thousands of scientists skilled in biological warfare unemployed, penniless and vulnerable to recruitment.
The threat disclosed a quandary: While the United States spent billions of dollars a year to assess enemy military forces and to defend against bullets, tanks, bombs and jet fighters, it knew relatively little about the working of exotic arms it had relinquished long ago.
In the mid-1990's, the C.I.A. and other intelligence agencies stepped up their search for information about other nations' biological research programs, focusing on the former Soviet Union, Iran, Iraq and Libya, among others. Much of the initial emphasis was on the germs that enemies might use in an attack, officials said.
But in 1997, the agency embarked on Clear Vision, which focused on weapons systems that would deliver the germs.
Intelligence officials said the project was led by Gene Johnson, a senior C.I.A. scientist who had long worked with some of the world's deadliest viruses. Dr. Johnson was eager to understand the damage that Soviet miniature bombs -- bomblets, in military parlance -- might inflict.
The agency asked its spies to find or buy a Soviet bomblet, which releases germs in a fine mist. That search proved unsuccessful, and the agency approved a proposal to build a replica and study how well it could disperse its lethal cargo.
The agency's lawyers concluded that such a project was permitted by the treaty because the intent was defensive. Intelligence officials said the C.I.A. had reports that at least one nation was trying to buy the Soviet-made bomblets.
A model was constructed and the agency conducted two sets of tests at Battelle, the military contractor. The experiments measured dissemination characteristics and how the model performed under different atmospheric conditions, intelligence officials said. They emphasized that the device was a ''portion'' of a bomb that could not have been used as a weapon.
The experiments caused concern at the White House, which learned about the project after it was under way. Some aides to President Clinton worried that the benefits did not justify the risks. But a White House lawyer led a joint assessment by several departments that concluded that the program did not violate the treaty, and it went ahead.
The questions were debated anew after the project was completed, this time without consensus. A State Department official argued for a strict reading of the treaty: the ban on acquiring or developing ''weapons'' barred states from building even a partial model of a germ bomb, no matter what the rationale.
''A bomb is a bomb is a bomb,'' another official said at the time.
The C.I.A. continued to insist that it had the legal authority to conduct such tests and, intelligence officials said, the agency was prepared to reopen the fight over how to interpret the treaty. But even so, the agency ended the Clear Vision project in the last year of the Clinton administration, intelligence officials said.
Bill Harlow, the C.I.A. spokesman, acknowledged that the agency had conducted ''laboratory or experimental'' work to assess the intelligence it had gathered about biological warfare.
''Everything we have done in this respect was entirely appropriate, necessary, consistent with U.S. treaty obligations and was briefed to the National Security Council staff and appropriate Congressional oversight committees,'' Mr. Harlow said.
In the 1990's, government officials also grew increasingly worried about the possibility that scientists could use the widely available techniques of gene-splicing to create even more deadly weapons.
Those concerns deepened in 1995, when Russian scientists disclosed at a scientific conference in Britain that they had implanted genes from Bacillus cereus, an organism that causes food poisoning, into the anthrax microbe.
The scientists said later that the experiments were peaceful; the two microbes can be found side-by-side in nature and, the Russians said, they wanted to see what happened if they cross-bred.
A published account of the experiment, which appeared in a scientific journal in late 1997, alarmed the Pentagon, which had just decided to require that American soldiers be vaccinated against anthrax. According to the article, the new strain was resistant to Russia's anthrax vaccine, at least in hamsters.
American officials tried to obtain a sample from Russia through a scientific exchange program to see whether the Russians had really created such a hybrid. The Americans also wanted to test whether the microbe could defeat the American vaccine, which is different from that used by Russia.
Despite repeated promises, the bacteria were never provided.
Eventually the C.I.A. drew up plans to replicate the strain, but intelligence officials said the agency hesitated because there was no specific report that an adversary was attempting to turn the superbug into a weapon.
This year, officials said, the project was taken over by the Pentagon's intelligence arm, the Defense Intelligence Agency. Pentagon lawyers reviewed the proposal and said it complied with the treaty. Officials said the research would be part of Project Jefferson, yet another government effort to track the dangers posed by germ weapons.
A spokesman for Defense Intelligence, Lt. Cmdr. James Brooks, declined comment. Asked about the precautions at Battelle, which is to create the enhanced anthrax, Commander Brooks said security was ''entirely suitable for all work already conducted and planned for Project Jefferson.''
While several officials in both the Clinton and Bush administrations called this and other research long overdue, they expressed concern about the lack of a central system for vetting such proposals.
And a former American diplomat questioned the wisdom of keeping them secret.
James F. Leonard, head of the delegation that negotiated the germ treaty, said research on microbes or munitions could be justified, depending on the specifics.
But he said such experiments should be done openly, exposed to the scrutiny of scientists and the public. Public disclosure, he said, is important evidence that the United States is proceeding with a ''clean heart.''
''It's very important to be open,'' he said. ''If we're not open, who's going to be open?''
Mr. Leonard said the fine distinctions drawn by government lawyers were frequently ignored when a secret program was exposed. Then, he said, others offer the harshest possible interpretations -- a ''vulgarization of what has been done.''
But he concluded that the secret germ research, as described to him, was ''foolish, but not illegal.''
The authors have reported on biological weapons for The New York Times and based this article on material gathered for their book, ''Germs: Biological Weapons and America's Secret War,'' which is being published this month by Simon & Schuster Inc.
Also see : Joseph "Joe" Robinette Biden Jr. (born 1942)
https://www.govinfo.gov/content/pkg/CHRG-107shrg75040/html/CHRG-107shrg75040.htm
2001-09-05-usa-committee-foreign-relations-bioterrorism-threat-s-hrg-107-124.pdf
https://drive.google.com/file/d/1IPxDmPQmCje9mAZM9QQp-zD9sSXi2Xqr/view?usp=sharing
S. Hrg. 107-124
THE THREAT OF BIOTERRORISM AND THE SPREAD OF INFECTIOUS DISEASES
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON FOREIGN RELATIONS
UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
__________
SEPTEMBER 5, 2001
__________
Printed for the use of the Committee on Foreign Relations
2001-09-05-usa-committee-foreign-relations-s-hrg-107-124.pdf
https://www.newspapers.com/image/203026347/?match=1&terms=%22judith%20miller%22
Also see - 2001 anthrax attacks on the United States
https://www.newspapers.com/image/408661701/?match=1&terms=%22judith%20miller%22
Saved as PDF : [HE00A9][GDrive] / See Dr. Darrell Ray Galloway (born 1946) /
COLUMBUS, Ohio - Researchers here have shown that mice injected with fragments of DNA from anthrax bacteria can be immunized against the disease. In traditional vaccine approaches, researchers have used live, weakened or dead pathogens - or proteins produced by the organisms - to produce an immune response.
This new approach represents a new -- and perhaps, safer -- way to produce vaccines against highly contagious diseases.
This latest study, published in a recent issue of the journal Infection and Immunity, improves on earlier work that suggested that DNA-based vaccines might be effective. By using combinations of two gene products produced by the bacteria responsible for causing anthrax -Bacillus anthracis - the researchers were able to successfully immunize mice against the disease.
The work was headed by Darrell Galloway, associate professor of microbiology at Ohio State University, and colleagues at the National Institute of Dental and Craniofacial Research and the Biological Defense Research Directorate program at the Naval Medical Research Center in Silver Spring, MD.
Anthrax is a lethal disease if not detected shortly after exposure to bacterial spores. Antibiotics are effective in halting it if given soon after exposure before any symptoms develop. It is one of the leading potential agents discussed for use in biological terrorist attacks.
"The current work is a strong argument for the feasibility of using a DNA-based immunization strategy against anthrax."
Once anthrax spores are inhaled, they are pulled deep into the lungs where they usually are consumed by macrophages - white cells that scavenge the body for pathogens and other components that may lead to disease.
"Unfortunately," Galloway says, "the macrophages seem to be uniquely sensitive to this bacteria and are essentially targeted." Once inside the macrophages, the spores germinate producing bacterial cells that multiply until their numbers literally burst the cells, spreading infection. The bacterial cells produce and release toxin components that specifically attack additional macrophages, ultimately leading to death. This, in turn, releases massive amounts of cytokines - critical chemical components of the immune response that cause physiologic effects throughout the system.
"Ultimately, the destruction of the macrophages, and the dumping into the bloodstream of the large amounts of cytokines produced by these cells, causes the patient to go into shock which ultimately kills him," Galloway says.
His team focused on using the genes responsible for producing the bacterial toxin. These genes normally secrete three gene products - protective antigen (PA), lethal factor (LF) and edema factor (EF). The protective antigen combines with the lethal factor to form a molecule known as lethal toxin, which can invade the cell and claim credit for the fatal potential of anthrax.
"Without PA," Galloway said, "neither of the remaining two toxin components would be effective."
To construct their vaccine, the researchers assembled groups of mice and injected them three times at two-week intervals with plasmids - circular DNA molecules that are widely used for the cloning and expression of genes and their products - containing fragments of PA and LF.
Some mice received PA plasmids only, some LF plasmids only and some received a combination of both. A control group received plasmids lacking PA or LF genes. Two weeks after the last injection, researchers measured the groups' antibody response to both gene products. Mice receiving gene-laden plasmids developed strong immune responses to the gene product they were exposed to.
"Significantly," the researchers wrote, "titers (measures) of antibody to the LF antigen appeared to be about twice those of antibody to the PA. This suggests that the LF antigen induces a greater response."
The researchers also found that mice that had received both PA and LF had nearly twice the immune response of mice receiving either agent alone. This is extremely important for researchers striving to produce the most effective vaccine.
The groups of mice were then injected with five times the lethal dose of the anthrax bacterial toxin. All mice that had received the plasmid injections were immune while all animals in the control group died within several hours.
Galloway says that the results are important enough to suggest that an effective vaccine might be possible that focuses on using additional Bacillus anthracis antigens, including a mutated form of the lethal factor antigen. This point is important since earlier vaccine studies were focused on using the PA antigen alone.
"The LF antigen appears to be much more immunogenic and produces an immune response lasting much longer than the response to the PA antigen," he said.
The researchers believe their current work is a strong argument for the feasibility of using a "DNA-based immunization strategy against anthrax" and that any future vaccines should incorporate a mutated version of the LF antigen.
In a recent, as-yet unpublished study, the Ohio State University research team, in collaboration with scientists from Battelle, has demonstrated that the vaccine can protect against a significant aerosol challenge more than a year following the last inoculation.
By LAURA ROZEN / PUBLISHED OCTOBER 15, 2001 12:22AM (EDT) / PDF Saved as : [HM00EW][GDrive]
[Housatonic Notes : This story must have taken months to write. And it just happens to be reported now, on October 15?]
Mentioned : BioPort Corporation / Yahia Fuad El-Hibri (born 1958) / DynPort Vaccine Company, LLC / Dr. Zsolt Paul Harsanyi (born 1944) /
With each new confirmed anthrax infection raising fears of a wider bioterror attack in the U.S., pressure is mounting on the Defense Department and the Food and Drug Administration (FDA) to give the green light to Michigan-based [BioPort Corporation], the nation's lone anthrax-vaccine manufacturer, to ship new lots of the vaccine to the Pentagon.
Anthrax vaccine shipments from BioPort have been suspended by the FDA since 1998 because of questions about the facility's quality control, forcing the Pentagon to dramatically reduce its program to vaccinate all 2.4 million U.S. soldiers and reservists against anthrax. Now the lack of the vaccine threatens to become a scandal, as the U.S. is sending thousands of soldiers overseas and calling up reserves, and as the public is clamoring for access to protection from the deadly bacterium.
After three years of getting bailed out by the Defense Department, BioPort could be poised to make a fortune -- as its CEO [Yahia Fuad El-Hibri (born 1958)] did working with the British seller of anthrax vaccine, Porton International, during the Gulf War a decade ago. But only if the FDA approves the company's renovated plant, as expected, sometime in the next week. The decision could open the door for BioPort to market the drug to a worried public, as new anthrax scares are reported daily.
The story of the troubled U.S. anthrax-vaccine program is a tangled saga of science, politics, private-sector deal-making and national security. There have been persistent questions about the vaccine's safety and effectiveness. Critics say Defense Department studies have never proven the vaccine works against the more dangerous inhaled form of anthrax, only against cutaneous, or skin anthrax. Some military personnel have complained of mysterious illnesses after taking the vaccine, and at least 400 have been disciplined for refusing the mandatory inoculation. But the Pentagon insists the vaccine is both effective and safe. Even now, some researchers say the vaccine is seriously outdated, as BioPort gears up to ship more.
Then there are questions about BioPort's role as the nation's only anthrax-vaccine maker. How did Fuad El-Hibri, 43, a German-born entrepreneur and former director of British vaccine-maker Porton Products, come to have so much control over the West's supply of anthrax vaccine? Why didn't the Pentagon turn to a larger, more established drug maker for the crucial anti-biowarfare weapon? And how could it let BioPort remain the sole maker of the vaccine after it failed repeatedly to gain FDA approval for its renovated facility?
"It speaks to DoD culture more than anything else," says a congressional staff aide who asked not to be named. "The Pentagon just does not have a corporate culture. Once they decided to go with this program (BioPort), they stuck with it, even though oversight indicated they had built their biodefense program on a foundation of sand, and they had an unreliable producer. The DoD is simply incapable of admitting a mistake. They genetically just can't back out."
The Pentagon and BioPort deny they made a mistake, of course, and they believe their problems will be solved, perhaps next week. Government sources close to the process say as early as Monday, the FDA will approve BioPort's renovated facility, and enable it to resume shipments of the vaccine it has been stockpiling since 1999.
A government official who asked not to be named says while BioPort is "70 percent on the way there" in terms of improvements in quality control demanded by the FDA, political pressure due to the terrorism scare is playing more of a role than quality control in expediting FDA approval. But BioPort officials say FDA approval for their renovated facility is long overdue.
"We have heard the process will be speeded up, and it has taken an incredibly long time," said Jay Coupe, a longtime aide to Adm. William Crowe, who with Fuad El-Hibri serves as one of BioPort's owners, and who served as chairman of the Joints Chiefs of Staff during the Reagan administration. (Fuad's father, Ibrahim El-Hibri, also well-connected to the defense establishment, is a third partner in the venture.) "While BioPort certainly supports the FDA, and doesn't want any special consideration and wants a safe and effective vaccine, the approval process has gone on for a very long time for most vaccine manufacturers. This is one of the reasons people are getting out of the vaccine business."
"We have been manufacturing vaccine," BioPort spokeswoman Kim Brennan Root said. "As we submit final documentation for approval from the FDA, we have been manufacturing vaccine and contributing it to the stockpile so when approval comes we can be in a position to release the vaccine."
But critics of BioPort say that repeated FDA inspections have shown the company has failed to prove it can produce the same dose of vaccine twice.
"The most fundamental problem has to do with the quality of the process of vaccine manufacture," a congressional aide, who asked not to be named, told Salon. "They cannot show they can produce the same vaccine of the same potency and consistency twice in a row. The quality of the process is not validated. That means they don't have the data to show that, within this process, within this heat range, this process produces this vaccine. They are trying to retrofit a modern inspection and validation process on an old system."
"BioPort has tried to say it didn't know how much it would cost to bring the company to 2001 FDA standards," another congressional staffer told Salon. "But that is kind of a hard pill to swallow. They consistently showed deviations from good manufacturing practices. Some of the FDA complaints are substantive. There were contaminants in the lot. There were some deficiencies in packaging. There were problems with paperwork and record keeping. There was an inability to show consistency from one lot to the next."
"They have come a long way," he added, "at significant taxpayer support."
Even if BioPort gets FDA approval to resume vaccine sales, anthrax vaccine will be available only to the military, not to the general public. That is, unless BioPort can step up production, and get the Defense Department to agree to sales to federal health agencies. If the current anthrax scare in New York and Florida grows, some members of the public are certain to pressure their political leaders for access to the vaccine.
"I will tell you right now, I wish I had access to the vaccine myself, I can tell you," says [Dr. Zsolt Paul Harsanyi (born 1944)],, a former business partner of Fuad and Ibrahim El-Hibri who is president of the Washington office of Porton International.
BioPort's Kim Brennan Root would not disclose how much vaccine the company had stockpiled while awaiting FDA approval for their renovated facility since renovation was completed in 1999. But a congressional aide who has researched the matter estimates that approximately 5 million doses are stockpiled. Vaccination requires six doses over 18 months, and a yearly booster shot.
In testimony to congressional committees, BioPort CEO Fuad El-Hibri has indicated BioPort's viability depends on being able to sell anthrax vaccine to a much larger market than to just the Defense Department, which he said is getting "rock-bottom prices."
"It has become clear to us that the prices paid by the Department of Defense for anthrax vaccine are significantly below BioPort's costs for producing anthrax vaccine," El-Hibri told the House Government Reform Committee in June 1999, a year after he purchased the Defense Department's former anthrax vaccine supplier. "Traditionally vaccine manufacturers have been able to offer lower prices to the government by recovering a substantial portion of their costs through commercial sales. Because of the current unavailability of product, the commercial sales market has not materialized as anticipated. Without a second market, the government cannot expect the rock-bottom pricing it enjoys with some of the other vaccines it purchases."
"As a commercial entity," el-Hibri added, "BioPort cannot continue to subsidize the DoD."
Critics of BioPort are outraged at El-Hibri's contention that BioPort has subsidized the Defense Department. Chief among them is U.S. Rep. Walter Jones, R-N.C., who sits on the House Armed Services Committee. Jones estimates that the Pentagon has paid BioPort almost $150 million since BioPort purchased the state-owned Michigan Biologics Products Institute (MBPI) in 1998, giving it the exclusive U.S. license to make anthrax vaccine -- with no new shipped vaccine to show for the money.
"My whole concern has been that this company cannot meet FDA requirements to produce the product," Jones told Salon Thursday. "So how long does the government continue to put taxpayers' money into a company that cannot produce the product?"
"Since former Secretary of Defense Bill Cohen raised the concern about the possibility of anthrax being used on the military or civilians," Jones added, "the Clinton administration made the decision to go with BioPort."
As his comment suggests, partisan politics may at least initially have played a part in Jones' troubles with BioPort, and its co-founder, Adm. Crowe. Alone among top military brass, particularly those who served Republican administrations, Adm. Crowe endorsed the election of "draft-dodger" Bill Clinton, who was widely despised by the Republican-leaning military establishment. Clinton rewarded Crowe for his endorsement, Jones suggests, with a plumb ambassadorship to England from 1994 to 1997.
And England in the years during and after the Gulf War is key to understanding the close links between the half dozen people who have come to dominate the sale of vaccines against deadly bioweapons in the U.S. and the U.K. Only two countries, the U.S. and Britain, make anthrax vaccine, and El-Hibri has been involved in both, first at Porton International in Britain during the Gulf War, and now with BioPort in the U.S., as the world faces a new terrorism scare. Sources say El-Hibri remained involved with Porton International up until the firm partnered with defense contractor DynCorps in 1997 to get a new Defense Department contract to make a second generation of vaccines against bioweapons. The new company is named [DynPort Vaccine Company, LLC], and its license to make second generation vaccines to protect against small pox, anthrax and other bioweapons was publicly announced Thursday, although the contract appears to date from 1997.
It was in Britain that Ambassador Crowe resumed his acquaintance with an old family friend, Ibrahim El-Hibri, a wealthy Venezuelan citizen of Sunni Lebanese descent, and his son Fuad. Ibrahim El Hibri had made a fortune in the telecom business with Phillips Company, working in the Gulf states.
Crowe and Ibrahim el-Hibri were first introduced decades ago by a U.S. Naval Academy classmate of the admiral who, like Ibrahim El-Hibri, lived in Venezuela. They had stayed in close contact during the 1970s when Adm. Crowe was posted to head the U.S. Central Command in Qatar, in the Middle East, where Ibrahim El-Hibri was active in his businesses. And in England during his ambassadorship, they met again.
The mania for privatization in Margaret Thatcher's England made it a great place for entrepreneurs like El-Hibri. In the 1980s, an El-Hibri acquaintance named [Dr. Zsolt Paul Harsanyi (born 1944)],, an American Ph.D. in genetics who had spearheaded an early report on biotechnology for the U.S. Office of Technology Assessment, became involved in what would become in its time the largest private biotechnology firm in the world, Porton International. Porton got the rights to sell vaccines and other products developed by the U.K.-government run laboratory, the Centre for Applied Microbiology and Research (CAMR), on commercial markets. CAMR had done the early research into products like botulinum toxin, or botox, a bacterium that can be injected to stop spasms (as well as prevent wrinkles, its most popular use in the U.S., at least until now) and anthrax vaccine.
The marketing relationship between Porton and CAMR ended in the 1990s, Dr. Harsyani said, and CAMR now markets its own products.
"At the time of Mrs. Thatcher, there was a philosophy in the U.K. supporting taking public works to the private sector," Harsyani told Salon. The spirit of public-private partnership that existed in Thatcher's England in the 1980s then moved to the States, Harsyani explained. "A lot of U.S. government and military research was not commercialized because there was no mechanism for it. One of the things that has changed in the United States in the last 20 years is that intellectual property that came out could in fact be owned by the institution where the researchers worked. The U.S. has now taken steps towards that kind of privatization."
In 1989-1990, with Persian Gulf tensions heating up and the U.S. and Britain preparing to lead a war against Saddam Hussein's invasion of Kuwait, El-Hibri became a principal silent investor in Porton, while his Yale and Stanford-educated son Fuad was installed as director of a Porton subsidiary, Porton Products. Their Middle East connections were put to use, as Porton sold tens of millions of dollars worth of anthrax vaccine to Saudi Arabia and other countries -- deals all approved by the British Ministry of Defense.
(A U.S. government investigator says Porton sold vaccine to Saudi Arabia at the insanely high price of $300-$500 per dose -- some 30 to 50 times what the U.S. Defense Department agreed to pay BioPort per dose.)
The Gulf War was a boon to businesses like Porton, as well as its officers, the el Hibris and Dr. Harsyani. Increasingly, they started to look for similar business opportunities in the U.S., particularly in areas that revolved around biodefense. They gravitated to opportunities where the government-run defense industry meets the private sector.
After the Gulf War, with concerns mounting in the U.S. about reports of Iraq's production of anthrax, Adm. Crowe was posted as ambassador to England. There, he resumed his friendship with the El-Hibris. About the same time, the El-Hibri family was hearing that the U.S.'s lone anthrax vaccine manufacturer, the state-owned Michigan Biologics Products Institute (MBPI), was financially troubled and looking for a buyer.
In 1970, the Michigan lab had received the only U.S. license to make anthrax vaccine, but its facility was antiquated. By the late 1980s, according to Judith Miller's "Germs," Michigan's Biologic Products Institute was making small batches of the vaccine -- 15,000 to 17,000 doses -- every four years, and selling them mostly commercially, to people in the animal hides business who came into contact with anthrax. But in 1988, the U.S. Army went to the lab and signed a contract to buy 300,000 doses in five years. The order was ambitious. By the time Gulf War troops assembled in early 1991, there was only enough vaccine to protect 150,000 of the half million troops assembled there, and none for civilians or allies, though the Saudis were able to buy some from the U.K.'s Porton International.
After the war, as worry increased over Iraq's biowarfare capacity, some in the Pentagon proposed that the military build its own vaccine factory, but officials thought it best left to the private sector. By 1996, however, concerns were mounting that the Michigan facility, already inadequate to the challenge of producing enough vaccine for the entire military, was having new problems. After several years of troubling inspections, the FDA threatened to close the lab in 1997, citing problems with sterility and equipment maintenance as well as scientific procedure. The only other facility producing a vaccine, Britain's CAMR, which at one time had a marketing relationship with Porton, now terminated, was using a different anthrax strain, and wasn't licensed for U.S. use anyway.
The el-Hibris and Crowe came up with the idea for BioPort, which they thought could do in the U.S. what Porton had done in Britain: bring private-sector methods (and profits) to a public research lab. As Fuad el-Hibri testified to Congress in 1999, "When BioPort was originally conceived, we believed that Admiral Crowe's background would be important in ensuring that we did everything correctly in establishing a company that would best serve DoD's needs."
El-Hibri and Crowe also partnered with two former managers of the state-owned facility, Robert Myers, who serves as BioPort's COO, and Rob van Ravenswaay -- a deal former Michigan state Sen. Linng Brewer, a Lansing Democrat, has long charged was ethically suspect, because Myers and Ravenswaay as employees of MBPI "knew the identities of at least two bidders (El-Hibri and Crowe) and the substance of their bids, information not made available to the general public. It appears they used information not available to others to enhance their financial position relative to the other bidders, a clear violation." The BioPort partners have long denied the charges.
In June 1998, BioPort's $24 million bid for MBPI -- $17 million upfront and the rest in loans to be paid over five years -- beat out competitors, including a $16.6 million bid endorsed by the Defense Department by Gruppo Marcucci, that involved no debt. Some expressed concern about selling the sensitive national security facility to a foreign company. (Brewer says the Marcucci bid lost out because it had failed to partner with managers of the Institute, but he has been unable to bring his ethical violations against Myers and Ravenswaay to court.)
A former Porton employee who asked not to be named says the company was looking to make a fortune on the Pentagon contract. "When El-Hibri bought the Michigan plant, he thought they would make a killing. The lab was already knocking out this product. The vaccine was already FDA approved. It's an essential business but no one wanted to talk about bioweapons back then, even though they knew Iraq and other countries had anthrax."
But it didn't turn out to be so easy.
Despite El-Hibri's experience marketing anthrax vaccine at Porton, Crowe's strong ties with the defense establishment, and growing interest from the Pentagon in protecting troops from anthrax, BioPort's problems quickly mounted after it acquired the MBPI facility.
Troubles seemed unlikely, because in May 1998, shortly before BioPort's bid for MBPI was finalized, Defense Secretary William Cohen announced plans to require all 2.4 million U.S. soldiers and reservists to be inoculated against anthrax, which looked like a windfall for the new venture.
In testimony to Congress, Adm. Crowe has adamantly denied that he had any insider knowledge that led to his purchase of the anthrax vaccine facility. "It has on occasion been rumored that the decision to inoculate all service personnel was made to benefit BioPort Corporation and indirectly me, presumably because of my past associations with the military and the administration," Crowe told the House Committee on Government Reform in October 1999. "If this charge were not so ridiculous, it would be offensive. It outrageously exaggerates my influence. Let me be completely clear. I never, repeat never, solicited any official of this administration to install or promote a mandatory inoculation program."
Despite the Pentagon's decision to require anthrax vaccination for all troops, which clearly could have been lucrative for the new firm, BioPort was struggling. Only three months after their acquisition of MBPI, El-Hibri and Crowe were prevented from shipping any new vaccine, by a scathing FDA inspection that found over 40 items wrong with the plant, the vaccine, its consistency, the firm's accounting, and other problems. Indeed, by September 1999, BioPort was already appealing to the DoD for relief from a contract requesting BioPort's delivery of some 8 million doses of anthrax vaccine. It simply could not deliver, and certainly not at that price.
A Defense Department audit from July 12, 2000, shows that shortly after BioPort bought MBPI, the DoD awarded it a $29.4 million contract to supply 8.7 million doses of anthrax vaccine at the price of $4.36 a dose. But a year later, unable to ship product, BioPort requested and the DoD granted $24.1 million in relief to BioPort, reduced the number of doses demanded from 7.9 million to 4.6 million, and agreed to raise the price per dose from $4.36 to $10.36.
Even after a full-scale yearlong renovation of its manufacturing facilities, and significant efforts to meet FDA requirements to get its new facility reapproved, BioPort continues to wait for FDA approval to ship doses of the vaccine it has been manufacturing all this time. Problems have been found not simply with BioPort's process, but with the doses of the anthrax vaccine already produced. FDA tests found a lack of consistency in dosage and other problems with the finished product.
The delay has prevented the Pentagon from vaccinating all but the troops it is currently sending abroad, and has forced some soldiers to actually suspend vaccination mid-process.
"Now we're in a situation with the terrorist attack that we still have this company that has still not met FDA approval," Rep. Walter Jones says, "and we're spending almost $3 million per month on this company that is still months away from having FDA approval."
So why did the DoD stick with BioPort all these years of their failing to get final FDA approval -- until now, when the U.S. faces a real anthrax crisis?
"I blame everybody," says a congressional staffer well versed in the BioPort controversy. "The buyer -- the Pentagon -- kept BioPort alive. The DoD should have pulled the plug on this outfit a long time ago."
To be fair to the Pentagon and BioPort, however, it's not as if major pharmaceutical companies have been clamoring for the contract. A reliable anthrax vaccine has proven hard to make, and questions about its safety have likely scared off other manufacturers (although the Defense Department agreed to protect BioPort against lawsuits by military personnel.)
Even now, just as BioPort seems set to perhaps overcome its long regulatory and financial difficulties, many in the industry and government are coming to consensus that the anthrax vaccine BioPort produces is outdated.
Increasingly, the government is also supporting research into a second generation of vaccines that can protect against multiple bacteria -- perhaps all in one shot. The government has also turned to the well-connected defense contractor, DynCorps, known for its involvement in the drug war in Colombia, and sending retired U.S. cops to Bosnia and Kosovo to serve as U.N. police, to subcontract vaccine research. (DynCorps was implicated in the accidental killing of an American Baptist missionary and her infant daughter by the Peruvian military earlier this year.) In 1997, DynCorps partnered with the El-Hibris' old company Porton International, to form [DynPort Vaccine Company, LLC] (DVC), just in time to beat out four other bids for a $322 million, 10-year contract.
Under the award, "DVC acts as a prime system contractor for the management of the existing stockpile of biological defense vaccines (except anthrax vaccine) and the advanced development, testing, production, FDA licensure, and storage of up to 18 new biological defense vaccines, including new vaccines against anthrax, small pox, plague, botulism and tularemia," according to Pentagon spokesman Jim Turner.
Why did the Pentagon turn to the unknown DynPort over more established companies? Some in the industry say not a whole lot of pharmaceutical companies want to get into bioweapons vaccine research, because the capital costs to build a dedicated lab safe from airborne toxins are so high, and the market -- at least until now -- has been so small, primarily just the Pentagon.
"No one else wants these contracts," insists Ron Rader, who leads an industry research firm called BioPharm.com. "Spore-forming microorganisms, because of FDA regulations, require totally separate facilities. Botulinim toxin, anthrax -- the facilities have to be dedicated. No one wants to have a dedicated, one-product facility. The trend now is to have multiple suites, and/or large manufacturing facilities. That way, you can switch from product to product every few months. No one wants to deal with spore-forming organisms.
"Also back then, anthrax vaccine was just not an attractive product. It's associated with biological warfare -- and that's not a positive thing. It's not the kind of thing you want to put in your brochure. Mainstream pharmaceutical companies had no interest. And you're also talking about being absolutely dependent on one customer. Very few companies are willing to take that risk. Any day, the Defense Department could just walk away." But P.W. Singer, a scholar at the Brookings Institution who has studied private military companies such as DynCorps and Military Professional Resources Inc., says the Pentagon seems to be treating bioweapons vaccines as just another weapons system they want to outsource to a trusted private-sector insider.
"The Pentagon is in search of two things: efficiency, and expediency," Singer said. "They either think they can get a better product in terms of quality or price or rapidity, or for expedient reasons. DynCorps provides a disconnection, when they would rather not have the government involved in some activity."
"My concern," he added, "is that the company in Michigan [BioPort] is actually a government lab that was privatized. It strikes me that for something so important for societal security, that you don't want to leave it in private hands. There are just some things that are too important."
And indeed, for BioPort CEO Fuad El-Hibri, BioPort is not an exclusive priority. El-Hibri, who became a U.S. citizen around the time of the BioPort purchase of MBPI, does not work out of the Michigan company, but out of the Rockville, Md., offices of his company East West Resources Management. His secretary there, Sheila Glick, says BioPort is one of 15 different companies El-Hibri runs, including some mobile phone operators in El Salvador, Venezuela and Jamaica. El-Hibri did not respond to numerous requests by Salon for an interview, and his secretary later referred questions to back to BioPort.
[Dr. Zsolt Paul Harsanyi (born 1944)], president of Porton International, which has now been bought by the French pharmaceutical company Ipsen, and who is now involved in the DynPort vaccine contract with the Defense Department, said there is nothing sinister about the way the El-Hibris have approached the business of anthrax vaccine -- as a business opportunity.
"Mr. Ibrahim El-Hibri is a wonderful gentleman," Harsyani said Friday. "He started a charity for orphans." A scan of the Internet shows Mr. El-Hibri on the board of a Beirut-based Sunni charity, Dar Al Aytam Al Islamyah, that provides relief to orphans and widows, and espouses "commitment to the humanitarian principles of Islam such as justice, tolerance, and abhorrence of confessionalism or sectarianism."
[Dr. Zsolt Paul Harsanyi (born 1944)] said he had not spoken with Ibrahim El-Hibri in over a year, but that the two parted on good terms. The El-Hibris divested from Porton International about three years ago, about the time when DynPort got the Pentagon contract to begin work on a second generation of bioweapon vaccines.
The former Porton employee, who asked not to be named, says the El-Hibris should be viewed as defense contractors, and their relationship with the Pentagon is not unique. "You have to realize: BioPort and now DynPort, these are arms dealers. They are part absolutely of the military industrial complex. This is their business. They are selling to a captive audience: the Defense Department. That's all-American. All these defense contracts -- they are boondoggles -- and that's the American way, to make as much money as possible. There's not that much unique about BioPort."
Mentioned : Dr. Darrell Ray Galloway (born 1946)
[NOTE : As of May 2025, this news article is only available on newspapers.com in Candaa, not the USA. It appears that similar articles have been deleted or de-indexed in the USA]
Serena Gordon / FRIDAY, Oct. 19, 2001 / PDF saved at : [HW00DY][GDrive]
Mentioned : Dr. Stephen Albert Johnston (born 1948) / Dr. Darrell Ray Galloway (born 1946)
A new anthrax vaccine that uses pieces of the bacteria's DNA seems to work -- at least in mice, say researchers at Ohio State University.
The vaccine has successfully protected mice against anthrax, according to a recently published study in Infection and Immunity. And the study's lead author, [Dr. Darrell Ray Galloway (born 1946)], an associate professor of microbiology at Ohio State, says the researchers have had success with other animals as well.
But despite all that, Galloway adds, don't look for the vaccine any time soon. The earliest human trials are still at least 18 months away.
Galloway's research comes amid heightened concern. Officials are scurrying to find more ways to counter the disease as increasing incidents of anthrax exposure are reported. The only approved vaccine, made by only one factory, is earmarked for the military and must be taken over many months.
Anxiety over anthrax has swept across the United States since a Florida photo editor died from it two weeks ago. A number of his co-workers were found to have spores on them; 31 people on Capitol Hill in Washington, D.C., have tested positive for exposure; two aides to network news anchors Tom Brokaw and Dan Rather and a U.S. postal worker have tested positive for skin anthrax,; and spores were found in the New York governor's Manhattan office complex. The finely powdered form of anthrax most have confronted appears to have been delivered through the mail.
Anthrax is caused by the bacteria Bacillus anthracis. Once the bacteria enter the bloodstream, it produces three toxins. When these toxins combine with each other, they can then enter human cells and cause the cells to die. Untreated, anthrax can be fatal.
Traditional vaccines use the actual pathogens or proteins produced by the disease and can be made in several ways: by crippling the disease organism so it can't cause the full-blown disease but it can trigger the body's immune system; by using only the part of the organism that causes an immune response; or by using a weakened or aged disease organism.
Unlike those vaccines, Galloway's research used fragments of DNA from anthrax toxins. This approach is also known as genetic immunization. The researchers focused on two of the toxins -- protective antigen (PA) and lethal factor (LF).
They injected some mice with PA fragments, others with LF fragments, and still more with both. A control group received none. Each animal received three vaccines over a two-week period and then was exposed to five times the lethal dose of anthrax.
The mice in the control group died within hours of exposure, but all the vaccinated animals survived. Those who were co-immunized with both PA and LF showed the strongest immunity against the disease.
"If we co-immunized, we got a better response than if we immunized with either alone," Galloway says.
Galloway adds that a DNA-based vaccine offers definite advantages over traditional vaccines. DNA-based vaccines produce a stronger immune response. They are easier and less costly to produce. They require no cold storage, and they are very stable compounds with a long shelf life. And because DNA-based vaccines are so specifically targeted, there is less chance of side effects, he says.
Like the current anthrax vaccine, Galloway says the DNA-based vaccine would also probably require a series of shots. "I would envision that it will probably be a two- to three-dose situation," he says.
[Dr. Stephen Albert Johnston (born 1948)], director of the Center for Biomedical Inventions at the University of Texas Southwestern Medical Center in Dallas, worked on the original development of genetic vaccines and says this was a good test of the anthrax vaccine. The mice were, in fact, protected against the disease, he adds.
"Genetic vaccines are attractive to use against bio-threats because they are very easy to produce and rapidly scale up," he says.
Galloway thinks it could eventually be possible to immunize against three or four bio-threat agents in one vaccine. No DNA-based vaccines have yet been approved for use in humans, however.
SOURCES: Interviews with Darrell Galloway, Ph.D., associate professor of microbiology, Ohio State University, Columbus; [Dr. Stephen Albert Johnston (born 1948)], director, Center for Biomedical Inventions, University of Texas Southwestern Medical Center, Dallas; July 2001 Infection and Immunity
BY THOMAS H. MAUGH II / OCT. 29, 2001 12 AM PT / Saved text into PDF : [HN028F][GDrive]
Mentioned : Dr. Darrell Ray Galloway (born 1946) / Dr. Thomas Patrick Monath (born 1940) / Meryl Jae Nass, MD (born 1951) / Dr. Donald Ainslie Henderson (born 1928) / VaxGen, Incorporated /
As anthrax exposures continue and the specter of smallpox has loomed on the horizon, many officials have begun discussing widespread vaccination against the two diseases in an effort to reduce public concern about terrorist threats.
But the vaccines now in use present a number of problems--ranging from lack of manufacturing capacity to side effects--that render large-scale vaccination programs problematic.
Medical researchers have been working on efforts to produce safer vaccines. But until now, drug companies have put relatively little money into what has been considered a low-margin, low-priority part of the business.
For both anthrax and smallpox, the side effects of the vaccines are serious enough that widespread vaccination could cause more damage than the diseases themselves unless the vaccines are used only after a major outbreak has begun.
Anthrax vaccination of soldiers has produced reports of severe side effects, such as bleeding and thyroid malfunction, and has been linked to six deaths.
Just what degree of risk there is from the vaccine, however, is unclear. Many medical authorities say it is safe, but some doctors have suggested it could be one of the causes of the mysterious Gulf War syndrome, which some troops sent to the Persian Gulf in the early 1990s have said they suffer from
Fear of the vaccine is perhaps greater than fear of anthrax. As many as 400 members of the U.S. military have been court-martialed or have resigned rather than submit to the vaccination because of the perceived risks. Some physicians share their misgivings.
“You won’t see me getting in line for the vaccine,” says [Meryl Jae Nass, MD (born 1951)], a longtime critic.
The vaccine is produced by only one manufacturer, BioPort Corp. of Lansing, Mich., and the technology is nearly 40 years old. Although the company is currently producing the vaccine, the Food and Drug Administration will not allow it to be shipped because of various deficiencies in quality control and manufacturing at the plant.
The vaccine is unusual in that it is not targeted at the bacterium itself, as are most vaccines, but at the toxin produced by the bacteria as they grow. That toxin produces the cellular damage that can lead to death from an anthrax infection.
The toxin has three major components: protective antigen, lethal factor and edema factor. When the toxin is released in the body, individual molecules of the protective antigen clump together on the surface of target cells to form a doughnut-shaped pore. This pore is then used by the other two components to enter the cell, where they are lethal.
The vaccine is designed to stimulate antibodies to the protective antigen, preventing it from attaching to cells. In theory, if the action of the toxin is blocked, then the immune system can eradicate the bacteria or they can be killed with antibiotics.
“We buy the individual some time to fight off the infection,” said microbiologist [Dr. Darrell Ray Galloway (born 1946)] of Ohio State University.
BioPort grows a strain of Bacillus anthracis that secretes only protective antigen. The bacterial culture is filtered--in a process much like making coffee in a filter pot--to collect the antigen along with any other materials that are secreted by the bacterium. The material that drips through the filter becomes the vaccine. It contains no bacteria, either dead or alive.
But the antigen does not stimulate a strong immune response. To get good immunity, six doses of the vaccine must be given at two-week intervals.
Critics fear that the other bacterial components collected along with the antigen may cause side effects, so research has focused on eliminating them.
“The interest is in more highly defined vaccines so one knows precisely what one is being immunized with,” Galloway said.
The Army has been working with the National Institutes of Health to use genetic engineering techniques to produce a pure antigen. Although both the military and the NIH have consistently refused to talk about their work, other experts say that human tests will begin early next year. That vaccine will also require multiple doses.
In his research, [Dr. Darrell Ray Galloway (born 1946)] also is targeting the toxin. But instead of using the antigen protein itself, he is injecting mice with the gene that causes the body to produce the protein. Researchers have been producing such DNA vaccines against a variety of diseases, and they are generally thought to produce a more powerful immune response and fewer side effects than standard protein vaccines.
He also uses the gene for the lethal factor in his vaccine. “We get a greater response with both than with one alone,” he said. Preliminary results in mice reported earlier this year indicate that the DNA vaccine can blunt anthrax infections, but Galloway must conduct many more tests, including vaccination of primates, before use of the vaccine in humans can be considered
The most optimistic estimate would be 18 to 24 months before clinical trials could begin, he said.
The smallpox vaccine produces a different set of problems. Like the anthrax vaccine, it employs old technology--dating back to experiments by Edward Jenner, the pioneer of vaccines, in 1796.
Smallpox is produced by a virus called variola, but researchers do not use it to produce the vaccine. Instead, they use a related virus called vaccinia, which produces a disease called cowpox.
The normally mild infection produced in humans by the live vaccinia provides very good protection against smallpox--so good that the disease has been eradicated from nature. Today, variola is known to exist only in one laboratory each in the United States and Russia, although U.S. officials suspect that Iraq and perhaps other nations may also possess some virus stocks.
“The risk of its being used as a weapon is not very high, but it’s there,” said [Dr. Donald Ainslie Henderson (born 1928)] of Johns Hopkins University, who ran the global smallpox eradication campaign. “And if you got an outbreak, it would be a terrible global catastrophe.”
Existing stocks of the smallpox vaccine were grown in calf cells, collected and freeze-dried more than 30 years ago.
The vaccines are believed to still be effective, but they are contaminated with proteins and other materials from the cow cells that may produce adverse reactions in some individuals.
The FDA no longer allows vaccines to be grown in animal cells. The new contracts for vaccine production recently signed with several companies require that vaccinia be grown in human cells. That process is straightforward and should not introduce difficulties, and manufacturers assume that the new vaccine will be as effective as the old one.
“There are no technical hurdles here,” said Lance Gordon, chief executive of vaccine manufacturer [VaxGen, Incorporated]. “Everything that has to be done to make a state-of-the-art smallpox vaccine is technology already in use.”
But critics caution that a smallpox vaccine grown in human cells has never been tested and that assumptions don’t always hold up.
Vaccinia, moreover, can itself produce problems ranging from open sores all over the body to death.
The death rate is estimated to be as high as 2 in a million cases, meaning that if the entire U.S. population were vaccinated, about 600 people would die of the vaccine.
Inadvertent contamination of the eye--caused perhaps by touching the vaccination site and then the eye--can produce severe problems, including blindness.
Vaccinia itself is infectious. That’s a valuable trait in a vaccination program because it provides protection to people who weren’t directly vaccinated.
But in a modern society with large numbers of people whose immune systems have been damaged, by HIV infections or as a result of drugs taken for organ transplants, that contagion could be a major problem that likely would lead to additional deaths.
All told, vaccinating all Americans against smallpox could cause 3,000 severe adverse reactions and a much larger number of lesser problems, according to [Dr. Thomas Patrick Monath (born 1940)], an executive at British vaccine manufacturer Acambis.
If a terrorist group actually launched a smallpox attack, however, “we don’t have any choice as a society” other than to use the vaccinia vaccine, said [Dr. Darrell Ray Galloway (born 1946)].
The U.S. population now is almost entirely unvaccinated--the effect of the vaccine largely wears off after about 20 years, so most people who received the vaccine as children are no longer immune. An unprotected outbreak of smallpox potentially could kill millions of people, experts say.
A small number of researchers have been exploring the possibility of using a different type of vaccine, a killed-virus vaccine, which would eliminate the danger to immunosuppressed individuals.
But development of such a vaccine, like that for anthrax, has been hindered by lack of a market, and any product is still at least a couple of years from human tests.
For that reason, officials have pushed for a major expansion of the current smallpox vaccine supply. Right now, the country has about 15 million doses, not nearly enough to contain a major outbreak.
The World Health Organization once had 200 million doses in storage in Switzerland, but the international body ran out of money to keep them, and they were destroyed after President Reagan reduced U.S. payments to the United Nations. ‘
https://dbb.defense.gov/Members/Michael-Bayer/
2021-05-21-dbb-defense-gov-michael-bayer.pdf
The highest levels of government have frequently called upon Michael for his thoughtful analysis and sound advice. In 2019, Michael led the Navy’s Cybersecurity Readiness Review which illuminated organizational and management gaps that exposed the Navy’s and other Military Services’ most crucial capabilities to cyber threats. In 2018, after the tragic loss of life in the collisions of U.S.S. Fitzgerald and later, the U.S.S. McCain, Michael led the Navy’s Strategic Readiness Review which identified the leadership and institutional changes necessary to prevent future tragedies. In 2001, following the terrorists attacks of 9/11, Secretary Donald Rumsfeld asked Michael and Noble Prize winner Joshua Lederberg to lead a classified investigation named “Red Nuff” to identify future vectors of global terrorism. In 1991, after the downing of PanAm Flight 103 over Lockerbie Scotland, President Bush asked Michael to lead the staff of a Congressionally created Commission to investigate causality. The findings of that report fundamentally changed the Nation’s and the Industry’s approach to aviation security and counterterrorism. In 1990, President George H.W. Bush appointed Michael as Federal Inspector of the Alaska Natural Gas Transportation System where he concluded the project to be economically infeasible and terminated it and his office. In 1986, President Ronald Reagan appointed Michael as the Assistant to the Secretary of Energy for Legislative Affairs, after as Associate Deputy Secretary of Commerce, and later still as a Member of the Board of Visitors to the U.S. Military Academy.
... this explains a mentioning of lederberg and rumsfeld in the same article in oct/nov 2001 - https://www.nytimes.com/2001/10/28/magazine/the-way-we-live-now-10-28-01-on-language-coordinates.html
https://en.wikipedia.org/wiki/Milton_William_Cooper
[NOTE: This article does not mention any particular Battelle at Columbus, Ohio employee names, but one of them likely was Dr. Darrell Ray Galloway (born 1946) was working at Ohio State in Colmbus, under a Battelle contract, to test new DNA vaccines against genetically modified anthrax in 2001. Although Project Jefferson is specific to testing genetically modified anthrax against the "existing" anthrax vaccine, which would be the one available form Michigan / BioPort in the late 1990s up to 2001.]
Mentioned : Dr. Barbara Hatch Rosenberg (born 1930) / David R. Franz /
[NOTE: This article does not mention any particular Battelle at Columbus, Ohio employee names, but one of them likely was Dr. Darrell Ray Galloway (born 1946) was working at Ohio State in Colmbus, under a Battelle contract, to test new DNA vaccines against genetically modified anthrax in 2001. Although Project Jefferson is specific to testing genetically modified anthrax against the "existing" anthrax vaccine, which would be the one available form Michigan / BioPort in the late 1990s up to 2001.]
By Laura Rozen / Published January 26, 2002 11:19PM (EST)
See : Ayaad Assaad (born 1948)
https://www.salon.com/2002/01/26/assaad/
2002-01-26-salon-assaad.pdf
2002-01-26-salon-assaad-img-1.jpg
Note - Assaad mentioned in US newspapers as early as Oct 17 : (pg 1) https://www.newspapers.com/image/378131497/ ... (Pg 11) https://www.newspapers.com/image/378131601/?match=1&terms=%22Ayaad%20Assaad%22
Dec 19 : https://www.newspapers.com/image/257006904/?match=1&terms=%22Ayaad%20Assaad%22 / https://www.newspapers.com/image/257006942/
NOTE: Ayaad Assaad has co-authored with Sina A Bavari (born 1959) at USAMRIID (see Ayaad Assaad (born 1948) ) (evidence - https://gulflink.health.mil/library/randrep/mr1018.5.bib.pdf )
On Oct. 2, [Ayaad Assaad (born 1948)], a U.S. government scientist and former biowarfare researcher, received a call from an FBI agent asking him to come in for a talk. It was well before anthrax panic gripped the nation -- in fact, it was the same day that photo editor Robert Stevens, 63, was admitted to a Florida hospital. It wasn't until the next day that Stevens was diagnosed with inhalation anthrax, and another two days later, on Oct. 5, when he would become the first of five eventual fatalities caused by the apparent bioterrorist attack.
The day after hearing from the FBI, Assaad met with special agents J. Gregory Lelyegian and Mark Buie in the FBI's Washington field office, along with Assaad's attorney, Rosemary McDermott. They showed Assaad a detailed, unsigned, computer-typed letter with a startling accusation: that the 53-year-old Assaad, an Environmental Protection Agency scientist who filed an age discrimination suit against the U.S. Army for dismissing him from a biowarfare lab, might be a bioterrorist.
"Dr. Assaad is a potential biological terrorist," the letter stated, according to Assaad and McDermott. The letter was received by the FBI in Quantico, Va., but Assaad did not learn from the FBI where it had been mailed from. "I have worked with Dr. Assaad," the letter continued, "and I heard him say that he has a vendetta against the U.S. government and that if anything happens to him, he told his sons to carry on."
According to [Ayaad Assaad (born 1948)], "The letter-writer clearly knew my entire background, my training in both chemical and biological agents, my security clearance, what floor where I work now, that I have two sons, what train I take to work, and where I live.
"The letter warned the FBI to stop me," he said.
After their meeting, Assad was thanked by the FBI agents, who have not contacted him since. The bureau says it cleared Assaad of the anonymous allegations against him.
"We received an anonymous letter with certain allegations about Dr. Assaad," Chris Murray, an FBI spokesman, told Salon Thursday. "Our investigation has determined those allegations are unfounded. Our investigation is complete. Period." But Assaad believes there is a possible link between the person who sent the unsigned letter to the FBI and the terrorist who sent anthrax to Democratic politicians and prominent members of the media. Whoever it was seemed to display eerie foreknowledge of the biological attacks, since the letter was sent to the FBI well before any anthrax terror attacks were known to the public.
And there is also the fact that Assaad used to work at the U.S. Army's Medical Research Institute for Infectious Diseases (USAMRIID), in Fort Detrick, Md., a biowarfare lab many critics believe might have been the source of the stolen anthrax. According to internal Army documents in Assaad's own possession (and first reported about in the Hartford Courant), 27 specimens, including anthrax, Ebola and the hantavirus were lost in the early 1990s from the lab. The documents paint a chaotic picture of a poorly managed lab.
[Ayaad Assaad (born 1948)] had his own unhappy experience at the lab: Before he was dismissed, he had run-ins with colleagues, once filing a racial discrimination complaint against some of them. And he believes that if the letter-writer was someone who at one point worked at the lab, it would explain why he knew so much about Assaad and would think that Assaad would make an easy target to frame.
"I'm the perfect scapegoat," Dr. Assaad explained. "I'm Arab-American. I'm a scientist who knows about biological and chemical agents. I'm suing the U.S. Army," he said. "Whoever did this clearly wants revenge."
There is no proof that former colleagues of Assaad at the Fort Detrick facility were behind the attempt to frame him or the anthrax mailings. But there is no doubt that security at the lab was notoriously sloppy. And government investigators hunting for the anthrax mail terrorist are reportedly looking at the lab as a possible source of the toxin.
Assaad worked for eight years, from 1989-97, at the Army-run lab, where civilian and military scientists with top security clearances handle the most lethal biological agents known. Assaad's tenure at the lab was not a particularly happy one. He was ultimately dismissed from the lab in 1997, along with six other older scientists, when the lab announced it needed to downsize because of budget restrictions. But Assaad disputes that reason in his age discrimination suit, which is still pending. He shared with Salon copies of Army internal documents, obtained under the Freedom of Information Act by Assaad's attorney, that are from the Army's own investigation into allegations of racial discrimination brought by Assaad.
But he is not alone in his concerns about his former colleagues. Another scientist who worked at the lab at the time -- and who admits to having been part of a group in the lab that called itself the "Camel Club," organized as a kind of drinking club that on the side ridiculed the Egyptian-born Assaad -- said he also believes that the anthrax in the recent terror scare came from Fort Detrick's USAMRIID.
"As soon as it came out" about the anthrax letters, "the first thing that came to my mind was Fort Detrick," said the scientist, who requested anonymity and is now employed in academia. "I don't know how many labs are utilizing anthrax from Detrick. Detrick represents a repository of many organisms, and they would send it out to various other labs. A lot of people who were working on anthrax in this country got their anthrax from Fort Detrick."
The scientist also claimed that he understood DNA analysis being performed by a private lab in Rockville, Md., had already determined that the source of the anthrax in the letter sent to Vermont Sen. Patrick Leahy was from Detrick. However, the private lab has told journalists that it will be another two weeks to a month before they publicly reveal their results.
According to interviews with [Ayaad Assaad (born 1948)] and this scientist, along with additional Army investigative transcripts obtained by Salon, the Army's biowarfare research lab in the early 1990s was an organizational disaster area. A big problem at the lab, which apparently contributed to specimens going missing, was that after the Gulf War, USAMRIID decided to phase out work some scientists had been doing on projects that the Army lab no longer considered crucial to their core mission of researching vaccines against bioweapons. Many scientists who had been engaged in other projects, such as Lt. Col. Phil Zack, who had been researching the simian immunodeficiency virus (SIV), were eager to continue working on projects USAMRIID said they should stop. What followed, the documents reveal, were scientists sneaking into the Army biowarfare lab to work on pet projects after-hours and on weekends, former workers like Zack, who left in 1991, still being let in to do lab work, pressure applied to technicians to help out, documents going missing, and deliberate mislabeling of specimens among other efforts to hide unsanctioned lab work.
Lt. Col. Michael Langford, an Army scientist who became head of the USAMRIID experimental pathology division in February 1992, was interviewed by a USAMRIID investigator in the spring of 1992. The transcripts of that and other interviews reveal shocking lapses of security and resistance to oversight by USAMRIID lab scientists, including some of the same ones who engaged in harassment of Assaad.
"At the time I took over the Experimental Pathology branch on the 3rd of February [1992] it was obvious to me that there was little or no organization of that group and little or no accountability of many things," Langford told the Army investigator, Col. Thomas J. Taylor.
Langford describes walking in to work one morning and seeing a group of lab scientists and technicians huddled behind closed doors in the room that houses an electron microscope. What Langford concluded was that certain scientists were covertly working on projects at night and on weekends that had been ordered halted by their division chief. He further concluded that employees were desperately trying to find old specimens of biological agents, including anthrax, they could "re-label" to cover up specimens that had gone missing in the chaos of prohibited, after-hours lab work.
"I walked in and the lights were on, the scope was off, and they were intensely looking for these blocks [of anthrax]," Langford described. "What was indicated to me was that perhaps these specimens were bootleg so to speak, they were going to cover them with old specimens, and when the old specimens disappeared, they were going to take these old anthrax blocks and substitute them. Well, when those were unavailable then these new blocks [of anthrax] mysteriously disappeared. So of course the probability is high that there was a problem there."
Langford also described to the investigator strong resistance from his underlings and other scientists to his efforts to manage the group. Among those Langford considered management problems were Marian Rippy, a researcher in the experimental pathology division. (Zack and Rippy had also been reprimanded by the Army for harassing Assaad.) Langford said he considered a number of those on his staff to be "extremely difficult to deal with, would volunteer almost nothing, nearly almost always had to be given a written request to get a response, were very defiant, were very obstructive, and I also heard rumors that ... Marian [Rippy] had made comments to the people in that lab basically to undermine me, you know, when I was coming in there," according to Langford.
"We were not to continue any work; in fact I was aware that [Pathology division commander Lt. Col. Nancy Jaax] had secured the SIV materials and people because again it appeared from many sources that Phil Zack was asking people to work basically covertly and continue his SIV work against obvious clear mandates and directives of the division chief," Langford told the investigator. (In an interesting side note, Jaax, whom Langford refers to, is the protagonist of the Richard Preston book "The Hot Zone," about an Ebola outbreak in lab monkeys in Reston, Va., in 1989. The real-life events were also the basis of the movie "Outbreak," starring Dustin Hoffman.)
It was during this period, from 1990 to early 1992, when scientists apparently pursued projects covertly at the lab, that the Army facility appears to have lost track of 27 specimens, including anthrax, Ebola and hantavirus. USAMRIID told media this week that any specimens that went missing were rendered harmless by various preservation and radiation processes -- a contention Assaad says is not true. He says the specimens leave behind a residue that could be reactivated.
Assaad's personal experience at that lab makes him particularly skeptical. He complains of behavior from colleagues that, while certainly not necessarily that of potential terrorists, does seem like symptoms of a poorly managed lab that was out of control.
In particular, [Ayaad Assaad (born 1948)], who is Egyptian-American, was the target of the group of USAMRIID scientists and lab technicians who called themselves the Camel Club. Among his antagonists were colleagues in Fort Detrick lab's experimental pathology division, Zack and Rippy.
Using a stuffed camel as a kind of mascot, the Camel Club composed a poem, "The Rhyme of the Ancient Camellier," with the apparent purpose of humiliating Assaad. It begins:
"Ayaad Assaad was the start,
with a reputation for not having heart
A 'skimmer' without equal
We hope there's no sequel
In his honor we created this beast
It represents life lower than yeast
Whoever is voted this sucker,
you can't duck her, You must accept blame,
And bear all the shame Unlike Assaad,
that first motherfucker"
The poem continues for five typewritten rhyming pages, ending with:
Well it's time for the camel to pass.
So let's all reach and raise up a glass.
Let's give'm the credit,
the one who will get it,
the poor bastard we're gonna harass.
Assaad theorizes that the Camel Club and the racial discrimination he experienced were at least partly an outgrowth of a dispute he had with Zack and Rippy over the authorship of a scientific paper for which he says he had done the research. Rippy and Zack, Assaad says, had done only minor work, but wanted to put their names on the research paper, and he says he felt they didn't deserve it. Assaad says the dispute escalated, with Rippy and Zack threatening to be disruptive and humiliate him at a scientific conference where he delivered his paper's findings. Then, he says, their harassment took an ethnic cast, because of his Arabic heritage.
[Ayaad Assaad (born 1948)] said he filed a formal complaint with the Army after his supervisor ignored him. The commander of the U.S. Army lab investigated the complaint and found in Assaad's favor, and singled out Zack and Rippy for criticism for being at the center of the Camel Club. (The Army investigation documents further revealed that the two, both married, were also having an affair.)
"Based upon your complaint, I directed that an informal investigation be conducted," USAMRIID's then-commander, Col. Ronald Williams, wrote Assaad in a memo in August 1992. "The investigation revealed that Lieutenant Colonel Zack and Dr. Rippy had participated in discriminatory behavior.
"On behalf of the United States of America, the Army, and this Institute, I wish to genuinely and humbly apologize for this behavior," Williams' memo continued.
Before the investigation ended, both Zack and Rippy were reprimanded. Then Zack left USAMRIID in December 1991, first heading to the Army's Walter Reed Institute, then going to the private pharmaceutical company Eli Lilly, and then to a company in Colorado acquired by St. Louis' Nexstar Financial Management. Several calls by Salon to his last known phone number and address in Boulder, Colo., went unreturned, and Nexstar says it no longer has any record of Zack. Rippy, who left USAMRIID shortly after Zack, in February 1992, worked for a while at Eli Lilly, but could not be located by Salon.
Assaad is puzzled that after clearing him of the accusation that he could be a bioterrorist, the FBI showed no interest in talking with him about his days at Fort Detrick. "The whole world wants to talk to me, except the FBI," he said, as his lawyer's phones rang nonstop this week, with media organizations seeking interviews with him. "Something's wrong here."
But while the FBI may not be interested in talking with Assaad further, federal authorities increasingly seem to believe that the anthrax letters were sent by a U.S. government scientist -- and not by the Iraqis or al-Qaida, as some hawks have continued to insist over the past few months, while hundreds of Islamic and Arab-born immigrants have been questioned and detained by the FBI and INS.
"I can tell you there are scientists out there who do have military connections that we are focusing on, at least that connection," Kevin Donovan, FBI special agent in charge of the Newark bureau, said at a press conference Wednesday.
For his part, Assaad says, "I want people to know the truth," and wants to show the American people that Arab-Americans are not the enemy. Should the FBI trace the anthrax attacks back to his former lab, Assaad may have gone a long way toward his goal.
https://www.salon.com/2002/02/08/anthrax_19/
2002-02-08-salon-com-anthrax-19.pdf
2002-02-08-salon-com-anthrax-19-img-1.jpg
When Arthur O. Anderson, chief of clinical pathology at the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID), saw the anthrax sent to Sen. Tom Daschle, D-S.D., last October, he was amazed.
"There was nothing there except spores," he told Salon. "Normally, if you take a crude preparation of anthrax spores, you see parts of degenerated bacteria. But this stuff was highly refined."
Another former Army lab scientist characterized the sample as "very, very good."
"Only a very small group of people could have made this," said David Franz, a former U.N. weapons inspector in Iraq and biodefense scientist at USAMRIID, who now works for the Southern Research Institute, a defense contractor. "If you look at the sample from the standpoint of biology, it tells me this person [who made the anthrax] was very good at what they do. And this wasn't the first batch they've made. They've done this for years. The concentration was a trillion spores [on anthrax] per gram. That's incredibly concentrated."
Anderson and Franz aren't drawing conclusions about where the anthrax came from -- perhaps in part because the subject is deeply sensitive at the U.S. Army's own biodefense lab, which could find itself at the center of the investigation. But conversations with dozens of scientists and experienced biodefense hands reveal a growing belief that last fall's anthrax letter culprit is most likely an experienced bioweapons scientist. And while Franz and others note that there are Iraqi and Russian scientists with the skills to pull off the complex anthrax-mail attack, many experts now believe the culprit worked at a U.S. bioweapons facility.
Only a few dozen individuals in the U.S. possess the expertise to produce the sophisticated anthrax specimen sent to Daschle, Vermont Sen. Patrick Leahy and at least three media outlets last fall. There may be as many as 200 Russian scientists capable of such work, and perhaps 10 Iraqis. But certain clues have convinced many -- though not all -- bioweapons experts who've followed the FBI investigation closely that the anthrax in the letters most likely came from a U.S. lab. That's chiefly because Ames strain anthrax, the type used in the letters, has been distributed by USAMRIID to about 20 U.S labs since 1981. Of those, only four facilities are believed to have the ability to produce the highly lethal, dry powder form of the Ames strain anthrax the lethal letters contained.
But despite signs that this should narrow the list of anthrax suspects to a few dozen people, the FBI appears to be casting a wider net in its investigation, which seems to have made fairly limited progress since the first victim, American Media Inc. photo editor Bob Stevens, died of anthrax inhalation four months ago.
Just two weeks ago, for instance, the FBI blanketed New Jersey, where at least four of the anthrax letters were mailed from, with fliers asking anyone who might have any knowledge of the culprit to contact the Bureau. This week, a University of Illinois law professor said that his university was one of dozens that recently received FBI subpoenas demanding that they turn over all documents relating to anthrax. And last week, the American Society for Microbiology in Washington announced that, at the request of the FBI, it had e-mailed its 40,000 members asking for possible clues.
A spokesman for the group said that while they happily complied, they found the FBI request a bit perplexing. "As we understand, it's not just microbiology needed to create [the anthrax that was in the letters]," said the microbiology society's spokesman, who asked not to be named. "You need the microbiology skills to grow it, but to process it, you need a totally different set of skills," such as advanced chemical engineering training, he said.
The wide net cast by the FBI also baffles many scientists and other weapons nonproliferation experts familiar with the anthrax investigation, who think federal authorities could make more progress identifying the anthrax attacker by focusing on a much narrower group.
"If you want to see the intersection of the two talents -- the microbiologic ability to obtain and safely grow lots of anthrax, and the industrial ability to turn it into a dry powder -- then that would suggest to me that the person did indeed have some experience with the biological warfare program," says C.J. Peters, who, as a doctor specializing in hemorrhagic fevers such as Ebola, worked at USAMRIID from 1977 to 1990, and later at the Centers for Disease Control and Prevention. He now heads a new center for biodefense at the University of Texas at Galveston.
"Frankly, I find it puzzling," says Elisa D. Harris, who served as director of nonproliferation issues at the National Security Council from 1993 until 2001, and is currently a resident scholar at the University of Maryland. "Given what's been reported about the nature and quality of the anthrax material in the Daschle and Leahy letters, that the material itself almost certainly originated in the U.S. biological weapons program, they ought to be able to narrow the investigation to a fairly limited number of facilities. That number is certainly less than 20. So I find it puzzling that the FBI has approached all 40,000 members of the American Society of Microbiologists. I don't understand why they seem to be casting the net so widely."
The FBI says it is pursuing all avenues.
"We are continuing to investigate the source of the anthrax, and who might be responsible for sending it," an FBI spokesman told Salon. "That investigation is very thorough and very exhaustive and we have not ruled anything out. We have pursued thousands of leads."
Perhaps responding to a growing chorus of criticism, on Thursday unnamed FBI sources were quoted telling the Wall Street Journal that they are in fact zeroing in on U.S. weapons labs in their anthrax investigation. But the article also revealed a startling fact: The FBI has not yet subpoenaed employee records of the labs where Ames strain anthrax is worked with.
Barbara Hatch Rosenberg, a biological arms control expert at the State University of New York at Purchase and chair of a bioweapons working group at the independent Federation of American Scientists, believes the FBI has intentionally dragged its heels on the weapons-lab angle, most likely for political reasons.
"For more than three months now the FBI has known that the perpetrator of the anthrax attacks is American," Rosenberg wrote to Salon on Tuesday. "This conclusion must have been based on the perpetrator's evident connection to the U.S. biodefense program."
Rosenberg has become convinced that the FBI knows who sent out the anthrax letters, but isn't arresting him, because he has been involved in secret biological weapons research that the U.S. does not want revealed.
"This guy knows too much, and knows things the U.S. isn't very anxious to publicize," Rosenberg said in an interview. "Therefore, they don't want to get too close."
Other experts aren't ready to make that leap. Some suggest that the FBI may just be moving slowly and carefully to gather incriminating evidence that can stand up in court. Some blame simple incompetence.
"Barbara says the FBI's been told to look for things, and they haven't," says Milton Leitenberg, a biological arms control expert at the University of Maryland. "I don't know. I think they [the FBI] are doing a half-assed job of it myself. But maybe other people would have done as bad a job, who knows."
But Jonathan A. King, a professor of microbiology at the Massachusetts Institute of Technology, says he, too, is suspicious of the government's handling of the investigation.
"The first place one would have looked for the anthrax perpetrator is at the U.S. facilities where people have grants from the government to do biological defense research," King said in an interview. "But for months, there was no statement from any federal authorities naming these laboratories as under suspicion. It's extraordinary."
Although Rosenberg goes further than most experts in criticizing the FBI's anthrax investigation, her analysis of the case has become must reading for scientists and congressional staffers concerned about biodefense issues. (An FBI spokesman contacted by phone Thursday says the agency, too, is reading her work, but won't comment on it.) A microbiologist by training, Rosenberg worked as a cancer researcher at Memorial Sloan-Kettering Cancer Center, and as a professor of biochemistry at Cornell Medical College. A decade ago, she founded the Federation of American Scientists' biological and chemical weapons program, which she now heads.
In her analysis of the details known about the anthrax attacks to date, she has built a persuasive and disturbing case that the anthrax culprit is a deep insider to the U.S. government's biological weapons program.
Her conclusion is based on a collection of facts that point to a smaller and smaller number of individuals who could have met all the criteria for producing, handling and sending out the anthrax letters. The perpetrator seemed to have advanced expertise and experience in biological weapons like anthrax, for instance, and access to the technology to produce and refine it. He or she (but most think it's a he) probably would have had to have access to the anthrax vaccine, which is not widely available, in order not to succumb to the disease himself -- which means records of anthrax vaccinations, which require a yearly booster shot, would be available to further help identify the person.
In addition, the perpetrator used a highly sophisticated, lethal powder form of the Ames strain of anthrax. Although the strain itself came into the possession of USAMRIID in 1981, and was distributed from there for research purposes to about 20 labs, only about four facilities in the U.S. are believed to have the capability for "weaponizing" dry anthrax -- which basically means refining or cultivating a pure sample whose spores are so tiny and uniform they can easily be inhaled into the lungs.
Even the FBI seems to acknowledge the anthrax suspect has technical expertise in biology. In the letter sent to the 40,000 members of the American Society for Microbiology, Van Harp, assistant director of the FBI's Washington field office, told recipients: "It is very likely that one or more of you know this individual. A review of the information to date in this matter leads investigators to believe that a single person is most likely responsible for these mailings. This person is experienced working in a laboratory. Based on his or her selection of the Ames strain of Bacillus anthracis, one would expect that this individual has or had legitimate access to select biological agents at some time.
"This person has the technical knowledge and/or expertise to produce a highly refined and deadly product," the letter continued. "This person has exhibited a clear, rational thought process and appears to be very organized in the production and mailing of these letters. The perpetrator might be described as 'stand-offish' and likely prefers to work in isolation as opposed to a group/team setting. It is possible this person used off-hours in a laboratory or may have even established an improvised or concealed facility comprised of sufficient equipment to produce the anthrax."
Rosenberg says the perpetrator has dangled plenty of clues in front of investigators. One of those clues, she says, is a letter sent to the military police at the Quantico, Va., Marine base (and forwarded to the FBI) in late September -- well before the public was aware that anthrax was being sent in the mail -- that tried to frame a former U.S. biowarfare researcher as a bioterrorist. That anonymous letter stated that the writer had worked with the man, Dr. Ayaad Assaad, and had details about him that only an insider would know (although some details in the letter turned out to be incorrect.) The FBI has cleared Assaad of any possible connection to the case, but Assaad himself has criticized the agency for not zeroing in on his accuser as a likely culprit, since that person seemed to have foreknowledge about the anthrax attacks.
"The perpetrator has left multiple, blatant clues, seemingly on purpose," Rosenberg writes. "Second letters, addressed similarly to the anthrax letters and containing [talc] powder ... The postal addresses and dates of these letters map out an itinerary of the perpetrator(s) ... which single out the perpetrator from the other likely suspects."
Rosenberg also says three senior U.S. biodefense officials have given the same name of a likely suspect to the FBI. She would not reveal that person's name, but said he is a former USAMRIID scientist, who she understands is working for a defense or CIA contractor in the Washington metropolitan area. Rosenberg says that the FBI has questioned the individual, along with many other former biodefense scientists.
Interestingly, William C. Patrick III, the founder of the U.S. military's biological weapons program, and the man who taught the folks at the Army's Dugway Proving Grounds in Utah how to make dry anthrax (using a harmless anthrax substitute, though), is no longer willing to talk to the press. Contacted by Salon Thursday, Patrick said that he has been misquoted in the media, and doesn't wish to comment on the investigation anymore. Rosenberg believes that the anthrax perpetrator may know Patrick, because the attack resembles a classified study that Patrick wrote for a CIA contractor a couple of years ago, which tried to predict how an anthrax attack through the mail would work.
Based on all the evidence, Rosenberg sums up her conclusions this way: The perpetrator, she believes, is "angry at some biodefense agency or component, and he is driven to demonstrate, in a spectacular way, his capabilities and the government's inability to respond. He is cocksure that he can get away with it. Does he know something that he believes to be sufficiently damaging to the United States to make him untouchable by the FBI?"
But C.J. Peters, the former USAMRIID and CDC doctor, says the FBI's dragnet to date is just standard operating procedure, and he doubts that it's been a ploy to hide secret weapons research.
"The FBI throws the net as wide as they possibly can," Peters said. "They put hundreds of people on this case and turn the crank and look for little clues and putting A and B together. I could imagine that maybe, just maybe, there might be someone in the Defense Department who says, I don't want this to be traced back to Dugway [the Army proving grounds in Utah]. I could imagine a person thinking that. But I couldn't imagine that the FBI would care if it were traced back to Dugway. The FBI guy's thinking, 'Hey, man, I got them. I am going to be famous now. We are going to be heroes, we found it.' I don't believe it's a grand government-wide conspiracy."
That said, Peters does have concerns about the FBI's ability to use the scientific information the physical anthrax provides.
"I'm not sure the FBI understands how to use the biological information," Peters added. "They think they are going to solve this the way they solve all other crimes. But it also seems possible to me they may be overlooking some helpful hints from the biology of the anthrax itself. I wonder if they are making full use of everything that's known about the biology."
And while few other scientists admit to sharing Rosenberg's dark conclusions about why the FBI has been slow to solve the anthrax case, some believe that casting the net widely served multiple political purposes for the Bush administration.
"From the moment one saw that it was highly concentrated Ames strain anthrax, the first lead candidate should have been a U.S. laboratory with a military contract," says MIT's Jonathan King. "Instead, we heard no such public admission. Immediately they were talking about Iraq and al-Qaida, when the largest such facilities are in the U.S. That leads me to think two things: the U.S. government is covering up the fact that the most likely source of the anthrax was not al-Qaida, was not foreign terrorists, but was a home-grown individual. And secondly, it was turned into part of the anti-terrorist propaganda."
Indeed, while in the early days of the anthrax letter scare, U.S. political leaders said they were actively looking to see if there was a connection between the anthrax and Iraq and al-Qaida, those views are now in the minority. On Dec. 17, White House spokesman Ari Fleischer said that it is "increasingly looking like it was a domestic source." On Jan. 13, Homeland Defense Director Thomas Ridge told media, "the primary direction of the investigation is turned inward." Two weeks ago, at a New Jersey press conference, an FBI official said the investigation was focusing on a U.S. government scientist.
It would be easier to dismiss Rosenberg's fears of a high-level U.S. coverup as cloak-and-dagger paranoia if it weren't for the fact that U.S. bioweapons programs are so secretive and mysterious. There is growing evidence that the programs, which are governed by international law and are supposed to be under congressional oversight, are more widespread and ambitious than officials have admitted.
Many experts are still angry that the U.S. walked out of the Biological Weapons Convention conference this past July in Geneva, after the Bush administration rejected language that would have subjected signatory nations, including the U.S., to inspections to make sure they're not engaging in any prohibited offensive bioweapons development.
"They [U.S. government officials] don't want the treaty to be tighter, and they don't want people coming here and investigating our facilities and stockpiles," says Meryl Nass, an MIT-trained physician who has long advocated for stricter arms control. "So it turns out that the U.S. did have this dry weaponized anthrax after all, and that was a big secret. But no one has really discussed the implications of this. They completely avoided the issue. But the rest of the biodefense establishment around the world knew exactly what it meant. They knew the U.S. had basically transgressed the weapons convention."
And even if the FBI isn't intentionally trying to protect bioweapons secrets from being revealed, some experts worry that the proliferation of bioweapons programs -- some of them still secret -- could be hampering the FBI's anthrax investigation.
"I think a number of us were surprised by some of the revelations" of secret bioweapons programs, says Elisa D. Harris, the former Clinton administration NSC official. Harris thinks it's possible the FBI itself is not aware of all of the biodefense work being contracted out by the U.S. government, because it is such a highly secretive and compartmentalized program.
Harris says she was shocked to read in the New York Times last September about biodefense research programs that she herself had not known about, although she had served for eight years in the White House as the point person for weapons of mass destruction nonproliferation issues.
On Sept. 4, 2001 -- just a week before the Sept. 11 attacks, the Times reported that from 1997-2000, the CIA conducted a program called Clear Vision, to build a model of a Soviet germ bomblet. The program was carried out at the West Jefferson, Ohio, labs of Battelle Memorial Institute, a defense and CIA contractor. In addition, the Times story reported, the Defense Intelligence Agency, the Pentagon's intelligence arm, hired Battelle last year to create a type of genetically enhanced version of anthrax, a "superbug," to see if the anthrax vaccine currently in use by the Pentagon was effective against it. A second Pentagon program, called Bacchus, involved building a germ factory in the Nevada desert from scratch, but reportedly did not use real germs, but simulants that mimic their dispersal.
"I was only aware of one of those three programs," Harris says. "I was never told by the Defense Department about the other two. I was also not aware that since the early 1990s, the U.S. Army has apparently been producing small quantities of dry, very potent Ames strain anthrax."
An FBI spokesman said he knew of no effort by other government agencies to hamper the bureau's investigation. But whatever is stalling the investigation -- the forensic complexity of the case, bureaucratic resistance to FBI scrutiny, or a darker scenario of the sort Rosenberg describes -- Harris and others say it's now clear the U.S. biodefense program lacks proper oversight. And some experts even think it could take a congressional investigation to get to the bottom of what has stalled the anthrax investigation -- especially to answer questions about why the FBI didn't beat a quicker path to U.S. bioweapons labs.
"If it turns out that the anthrax that killed 5 people and injured a dozen and resulted in tens of thousands of people having to take antibiotics, if that anthrax came from the U.S. biodefense program, that just underscores the importance of the Congress looking into this program and getting a really comprehensive picture about what has been taking place.
"There has been no real serious oversight of the U.S. biological defense program for a very long time," Harris added. "And I think this is a good moment, given the impact of the anthrax attacks, for Congress to take responsibility."
01/10/2002 by Bob Fitrakis / Download the Microsoft Doc file : [HM00EV][GDrive]
Mentioned : Project Jefferson / BioPort Corporation / Yahia Fuad El-Hibri (born 1958) /
[NOTE : Found on Google with search of : "battelle biobomblet" on May 12, 2025]
[NOTE: This article does not mention any particular Battelle or Columbus, Ohio employees. It is noteworthy that Dr. Darrell Ray Galloway (born 1946) was working at Ohio State in Colmbus, under a Battelle contract, to test new DNA vaccines against genetically modified anthrax in 2001. Although Project Jefferson is specific to testing genetically modified anthrax against the "existing" anthrax vaccine, which would be the one available form Michigan / BioPort in the late 1990s up to 2001.]