March 5, 2009

Viral Pandemic H5N1 flu threat: Baxter contaminates European labs by error

It could be a Hollywood Worst Case Thriller, but it is real: According to the scientific network PROMED, Baxter International Inc. in Austria "unintentionally contaminated samples with the bird flu virus that were used in laboratories in 3 neighboring countries, raising concern about the potential spread of the deadly disease". As PROMED reports, the contamination has been discovered when ferrets at a laboratory in the Czech Republic died after being inoculated with vaccine made from the samples early this month. "The material came from Deerfield, Illinois-based Baxter, which reported the incident to the Austrian Ministry of Health, Sigrid Rosenberger, a ministry spokeswoman, said today in a telephone interview", the network-alert-system is quoting. "This was infected with a bird flu virus," Rosenberger said. "There were some people from the company who handled it." There are severe signs that the long expected pandemic avian influenza could be on its way to conquer the world - even without Baxter's error driven help.

First deaths in Asia concern little children, which from virological point of view is a rather new aspect, and could be the evidence for a new spread. While scientists expect this pandemic to happen in the near future, the new President should also stay alert: A coming influenza pandemic would deteriorate the global economy even without financial crisis, recession - or Baxter.

Evidence for the global threat comes from China, where a 2 year old girl has been confirmed to be infected with bird flu in the northern Shanxi Province, as government officials said last Saturday. The child was found ill on 7th of January in the central Hunan province - the little patient still is in critical condition. According to the test result of the Chinese Center for Disease Control and Prevention, the girl had been tested positive for the H5N1 strain of avian influenza.

On the other site of the globe, the Ministry of Health and Population of Egypt announced a new human case of avian influenza A(H5N1) virus infection last week, the case being a 21 month old girl Kerdasa District.

“Infection with the H5N1 avian influenza virus was diagnosed by PCR at the Egyptian Central Public Health Laboratory and subsequently confirmed by the U. S. Naval Medical Research Unit No. 3 (NAMRU-3) laboratories”, reports the special wire PROMED. According to PROMED, investigations into the source of her infection indicate a recent history of contact with sick and dead poultry - 23 similar cases in Egypt have been fatal up to date.

Old Europe as leading research power?

Given such facts, Mr. Obama should follow European research policy: European research on vaccine development for pandemic influenza has been financed since 2001 by the European Union. Early projects worked to develop an egg-free vaccine, which is faster and safer to produce, along with innovative application techniques. Research is now underway with the objectives of fighting the disease at the source (infected birds) and protecting human populations through pandemic influenza vaccines. Future EU research will improve vaccine efficiency by adding adjuvants, substances that boost the body’s immune response to vaccine antigen. Additionally, research teams are currently focused on developing a universal flu vaccine that could provide a lifetime of protection from influenza.

Latest surveillance data coming through the European Centre for Disease Prevention and Control (ECDC) from virologists and clinicians indicates that the influenza A(H3N2) virus is the predominant strain in Europe so far this season (2008/2009). Based on the data published by ECDC the pharmaceutical company Roche confirms that the oral antiviral Tamiflu (oseltamivir) is fully active against influenza A(H3N2) and influenza B, which currently comprise 94 percent of circulating viruses in Europe this year. Tamiflu resistance reported in the 2008-2009 influenza seasons is confined to H1N1. No resistance has been seen with other circulating seasonal viruses - H3N2 and influenza B.

"Recent media reporting has elevated awareness of the H1N1 seasonal resistance seen this year in the United States and the Far East. However, in Europe the picture is different with H3N2 being the dominant strain so far. The circulating H3N2 viruses, which often cause a more severe illness than H1N1, are sensitive to oseltamivir, which means that oseltamivir will be active against the vast majority of influenza infections in Europe this season, if current trends continue," comments Prof Albert Osterhaus, Head of Virology, Erasmus Medical Centre, Rotterdam. "It is important that doctors understand that oseltamivir remains an effective treatment for patients across Europe."

Flu alert for the new President

However, the situation in the United States is more alerting, according to the Centers for Disease Control and Prevention (CDC). A new University of Colorado at Boulder study showed the resistance of the avian flu virus to a major class of antiviral drugs "is increasing through positive evolutionary selection, with researchers documenting the trend in more than 30 percent of the samples tested", as the scientists report. Even if the expected influenza pandemic did not start yet, there is no doubt about the comeback of the lethal virus: The first Pandemic Influenza occurred in three waves in the United States - exactly 90 years ago, between 1918 and 1919.

February 18, 2009

Inside USA's Biological Warfare Center

Inside USA's Biological Warfare Center;

Q. & A. With Citizen Activist Barry Kissin



One legacy of the Bush-Cheney administration is the grandiose expansion of our germ warfare research program. This was declared to be necessary because of the September-October 2001 anthrax letters’ attacks on Congress and the media---attacks the public is now being told came not from the Middle East but from within our own government’s facilities. As a result, developmental work is going forward with deadly and loathsome pathogens capable of triggering plagues and epidemics.

Legislation to finance this expansion rolled through Congress after the anthrax attacks killed five persons, sickened 17 others, caused more than 10 million Americans to go on very strong antibiotics, and cost hundreds of millions of dollars to clean up. Laboratories at hundreds of universities and corporations have expanded into biological warfare research centers. More than $50 billion has been lavished on this effort—an effort critics charge is in violation of the existing treaty against bioweapons development ratified by the United States in 1975. So much of the nation’s resources have been shifted into germ warfare research that 750 of our most celebrated scientists signed a petition protesting the adverse effect this is having on research into combating naturally occurring diseases.

The Government’s admission the anthrax attacks came not from the Middle East but from its own biowarfare research facilities signifies the anthrax letters constituted a “false flag” operation designed to whip up public sentiment for the “War On Terror.” One man who saw the expansion of the Government’s biological warfare research hub at Ft. Detrick under President Bush as a danger to his community and to the nation was Barry Kissin, a 57-year-old Brooklyn-born attorney who moved to Frederick, Md. in 1981. Kissin and his wife, Dr. Malgorzata Schmidt, make their home just a few miles from the main gate of Ft. Detrick. Kissin has found himself devoting ever more of his time to challenging the expansion of “biodefense” as well as the underlying rationale contained in our government’s mutating story about the anthrax letters.

Over the past six years, Kissin has become a leading citizen activist in the struggle to halt the expansion of our “biodefense” program. His work evidently came to the attention of the Homeland Security division of the Maryland State Police. The Washington Post of October 12, 2008, reported that this Homeland Security division had listed Kissin and 52 others as “terrorists,” and furthermore that authorities had acknowledged their wrongdoing and had agreed to purge the files. Kissin, an unsuccessful candidate for Congress in 2006, was in good company. The activists labeled as terrorists included two nuns, a man who challenges military recruiting in high schools, and critics of the Iraq war.

Following is my Q. and A. with this passionate opponent of a new biological arms race---a race once shut down by President Richard Nixon only to be stoked anew by the Bush regime.

Q: How did you happen to get interested in Ft. Detrick?

A: I became a resident of Frederick, MD, home of Ft. Detrick, in 1981. I was aware Ft. Detrick was headquarters for our bio-warfare related programs ever since the first such program commenced in 1943. Before my move to Frederick, I was also conscious of the Silent Vigil that was maintained from July, 1959, until March, 1961, outside Detrick’s main gate that stood for the cessation of our bio-warfare program and the conversion of Detrick’s scientific facilities into a health research center. This Vigil, conceived by a Quaker named Lawrence Scott, is credited with laying the foundation for the decision by President Nixon in 1969 to terminate our offensive bio-warfare program. Two years later, Nixon came to Detrick and announced he was creating the National Cancer Institute (NCI) there which would utilize (and continues to utilize) former Army bio-warfare buildings, thus “sending a clear message that America could beat its swords into plowshares.” I might add that it has since become apparent that the CIA and its “Special Operations Division” at Detrick did not abide by the decision to terminate bio-weapons research. Various bio-warfare related programs continued to function in the 1970s, 1980s and 1990s.

During my formative years, I was very active in the movement against the Viet Nam War. Since then I have been very conscious of the terrible workings of our military-industrial-intelligence complex. Upon moving to Frederick, I quickly became aware of how the Army at Detrick manipulated the local community and local media. Ft. Detrick is the largest employer in Frederick County. Its unassailable position in the community is based on a mixture of messages about its contributions to the local economy and its patriotic role in defending against the enemy, once Communist, now terrorist.

Q: What steps did the Bush administration take to launch its biological warfare program?

A: Upon coming into power, the Bush Administration immediately exercised its strong preference for arms race over international arms control. In the realm of bio-warfare, it promptly withdrew from negotiations to strengthen the 1975 Biological Weapons Convention (BWC), the international treaty that bans the development of biological weapons. This made the United States practically the only country among 150 signatories to the Treaty opposed to a protocol for international inspections and verification. Thereafter, using the anthrax letters attacks of the fall of 2001 as a central pretext, the Bush Administration launched a massive expansion of our so-called “bio-defense” program, much of it at Ft. Detrick.

Q: Could you briefly describe the nature of the work going forward at Ft. Detrick and the names of agencies involved?

A: One of the programs at Ft. Detrick is under the auspices of the National Cancer Institute (NCI). My focus of course has been upon bio-warfare related activities, which, since termination of the overtly offensive program, have been conducted by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). USAMRIID is a part of the U.S. Army Medical Research and Material Command (USAMRMC) at Ft. Detrick, which also manages activities unrelated to bio-warfare, such as supplying medical materials for use by the Army.

The expansion underway at Ft. Detrick contemplates a “National Inter-agency Bio-defense Campus” (NIBC) which upon completion would occupy 200 acres there. The plan is for the NIBC to be the site of a new facility for USAMRIID, designed to measure more than one million square feet (approx. 25 acres of facility space), at a cost of $1 Billion (2005 cost estimate). Construction of two of the new NIBC facilities has already been completed (in 2008) – namely the “National Biodefense Analysis and Countermeasures Center” (NBACC) to be operated by the Department of Homeland Security (DHS), which measures 160,000 square feet, and the “Integrated Research Facility” (IRF) to be operated by the National Institute of Health (NIH), which also measures about 160,000 square feet. After the new USAMRIID facility is completed, the plan is to erect another new facility on the NIBC, to be operated by the Department of Agriculture (USDA). And the Center for Disease Control (CDC) has announced that it also wants to join this campus “confederation.”

Q: Please explain what BSL laboratories are and how they are graded. Also, could you describe some of the pathogens government scientists are working on in these labs?

A: BSL labs are biocontainment facilities designed for research, development, testing and evaluation (RDT&E) activities involving specific pathogens (germs), exposure to which would be hazardous to lab workers as well as the “outside environment.” BSL stands for Bio-Safety Level --- the higher the level, the more elaborate the safety and security measures, the more dangerous the germs. BSL-4 is for maximum containment. There are dozens of diseases viewed as potential agents for biological weapons. RDT&E upon diseases such as hepatitis A, B and C, influenza A, Lyme disease, dengue fever and salmonella takes place in BSL-2 labs. Anthrax, West Nile virus, Venezuelan equine encephalitis, Eastern equine encephalitis, SARS, tuberculosis, typhus, Coxiella burnetii, Rift Valley fever, Rocky Mountain spotted fever, and yellow fever are dealt with in BSL-3 labs. And Bolivian and Argentine hemorrhagic fevers, Marburg virus, Ebola virus, Lassa fever, and Crimean-Congo hemorrhagic fever are dealt with in BSL-4 labs.

The new DHS, NIH and Army facilities at Detrick alone will house approximately 60,000square feet of BSL-4 laboratory space, specifically designed to accommodate work with germs for which there is neither vaccine nor cure.

This amount of space is four times the total amount of BSL-4 space that existed in the entire country as of 2004.

Q: How have you attempted to slow or stop the expansion of these laboratories?

A: Since 2003, I and others in the community have been participating in proceedings under the National Environmental Protection Act (NEPA) designed to examine the environmental impacts posed by new bio-warfare related facilities at Ft. Detrick. Though NEPA treats as a priority the consideration of public input, our input has essentially been ignored as one facility after the other has been approved. I and others have also been conducting demonstrations in downtown Frederick against the expansion.

Q: In some ways the community’s activism has paid off, has it not?

A: In August, 2007, for the first time in history, an elected official, namely a Frederick County Commissioner, publicly expressed concerns about what was going on at Ft. Detrick. This opened a floodgate. Unprecedented columns and editorials in the local newspapers appeared questioning what was going on at Ft. Detrick. And in November, 2007, upon the occasion of a public meeting hosted by the County Commissioners, more than 150 members of the community filled Frederick City Hall to express their many concerns.

Under much pressure, both of Maryland’s U.S. Senators----Barbara Mikulski and Ben Cardin---got behind the demand for a review by the National Academy of Sciences (NAS) of the public health and environmental hazards posed by the new facilities being built at Ft. Detrick. Though the appropriation for this NAS review was passed by Congress in September, 2008, we continue to wait for the Army to fulfill its obligation to enter into a contract with the NAS for this review.

Q: Are you a member of any citizen groups concerned about research underway at Ft. Detrick?

A: Frederick Citizens for Bio-lab Safety; Frederick Progressive Action Coalition (FredPAC); Frederick County Peace Resource Center (PRC). There are also national organizations concerned about our national “biodefense” program, a central part of which is being implemented at Ft. Detrick. A most important example of such an organization was the “Sunshine Project” based in Austin, Texas. This non-profit organization was instrumental in procuring the Congressional hearing in October, 2007, regarding the alarming (if not reckless) proliferation of high-security bio-laboratories in the U.S. Unfortunately; the Sunshine Project has since ceased its operation for lack of funding.

Q: As I understand it, with most of the rest of the world on record as opposed to a new bioweapons arms race, the United States is setting a terrible example by its research at Ft. Detrick.

A: In 2004, Milton Leitenberg, Senior Research Scholar at the University of Maryland, James Leonard, head of the U.S. delegation that negotiated the international arms control treaty known as the Biological Weapons Convention (BWC) that bans the development of bio-weapons, and Richard Spertzel, former deputy Commander of USAMRIID and Senior Biologist on the United Nations inspection team in Iraq, co-authored a commentary containing the following statements:
“The rapidity of elaboration of American biodefense programs, their ambition and administrative aggressiveness, and the degree to which they push against the prohibitions of the Biological Weapons Convention (BWC), are startling. . . . [The Deputy Director of DHS’s NBACC himself] noted that one NBACC objective, the creation of genetically engineered agents, might raise BWC compliance questions. . . Reportedly, the US intelligence community is under orders to carry out studies. . . . Surely, the ‘intelligence community’ is the least appropriate place in the US government to ‘carry out’ such work — and the most likely to lack adequate oversight.”

Q: According to some critics, “biodefense” activity at Ft. Detrick will violate Federal criminal law, is that correct?

A: In 2007, International Law Professor Francis Boyle, who drafted the “Biological Weapons Anti-Terrorism Act of 1989” that criminalizes violations of the BWC, stated:

“The proposed construction and operation of new facilities at Fort Detrick is an integral part of the program that is referred to as ‘Biodefense for the 21st Century’ in Homeland Security Presidential Directive - HSPD-10, released on April 28, 2004. In my expert opinion, said program constitutes clear violations of the [BWC]. . . . [This] so-called ‘biodefense’ program . . . [has the] unmistakable hallmarks of an offensive weapons program. . . . In my expert opinion, participants in this so-called ‘biodefense’ program are subject to criminal liability [under the Act that I drafted.]”

Q: Have you been inside Ft. Detrick?

A: Numerous times. As an attorney, I have represented before the Magistrate’s Court at Ft. Detrick individuals charged with misdemeanors committed on post. More to the point, I have attended various “community meetings” on post hosted by the Army for the purpose of answering questions about the expansion. Furthermore, on March 5, 2008, I personally was given a three-hour-long tour of the USAMRIID facility by then USAMRIID Commander Colonel George W. Korch, which included an inspection (through windows) of the “biological containment” laboratories [like the ones portrayed in the Dustin Hoffman film, “Outbreak” (1995)].

Q: How many acres does Ft. Detrick cover and what’s it like?

A: Ft. Detrick comprises 1200 acres, (about 10% of the total land area of the City of Frederick, population 60,000). “Area A” contains all of the buildings for the activities summarized above, as well as a substantial number of recently-constructed single-family homes for Army families, a very large gymnasium, commissary, etc. (Though remarkably it still has places in it that would be easy to penetrate), the perimeter fencing has recently been bolstered, which critics describe as contributing to a militaristic presence in the middle of a densely populated community.

Q: What is going on in “Area B?”

A: “Area B” is about 400 acres and is separated from “Area A,” and has livestock on it used in testing by USAMRIID. Area B was a landfill site. Though questions were raised beginning in the 1970’s about possible leakage from Detrick dumping, it was not until the early 1990’s that monitoring wells were installed that revealed in the ground water the presence of TCE and PCE, both cancer-causing chemicals, at levels between 1,000 and 5,000 times the levels determined to be safe by the EPA. It became clear that the water supplies of nearby residents had been severely contaminated. On July 1, 2003, the local Frederick News-Post published a front-page article “Cancer questions: Residents point finger at Detrick,” based on the statements of many of Detrick’s neighbors about the high incidence of cancer in their families.

Q: How have Ft. Detrick authorities and the Army responded?

A: The clean-up has dragged along ever since the early 1990s. Two thousand metric tons of hazardous waste have been unearthed. In 2003, sanitation crews were shocked to find vials containing live germs. The discarded biological agents included anthrax, Brucella melitensis, which causes the virulent flu-like disease brucellosis, and klebsiella, a cause of pneumonia. (On May 28, 2003, The Guardian, a prominent English newspaper, published an article entitled “US finds evidence of WMD at last -- buried in a field in Maryland.”)

Q: Surely, public officials would raise questions about this situation.

A: On November 13, 2008, both of Maryland’s U.S. Senators, ordinarily quite protective with respect to Ft. Detrick, stated in a letter to then President-elect Obama: “[W]e write to draw your attention to the Department of Defense’s (DOD) position that it is not subject to the Environmental Protection Agency’s (EPA) authority to administer federal environmental protection statutes. The Department of Defense has been in flagrant and repeated violation of these statutes at installations in Maryland and around the country. . . . [A]dmitting flaws in its characterization of contamination at Ft. Detrick Maryland as well as the handling of the clean-up there, Secretary Davis promised that the Army would not oppose EPA’s decision to list Area B at Fort Detrick Maryland on the National Priorities List. Yet, we now have a clear sign that DOD appears to be shirking its responsibilities and legal obligations to protect the health and welfare of our constituents, particularly . . . neighbors outside the gate. As recently as November 3, 2008, Secretary Davis wrote to the EPA asking that the Agency refrain from placing Ft. Detrick on the Superfund list in spite of the fact that the site meets all the listing criteria.”

Q: Wow. Have there been any injuries or deaths as a result of the biological research at Ft. Detrick? I understand some of its streets are named after fallen employees.

A: In general, secrecy in the name of “national security” has concealed the consequences of biological research at Ft. Detrick.

According to the official account, three people have died as the result of contracting diseases being cultivated at Ft. Detrick, all before the overtly offensive program was terminated in 1969. A microbiologist and an electrician died from anthrax, and an animal caretaker died from the Machupo virus. The official account does not acknowledge what has come to light about one of the anthrax cases, namely that, at first, the victim was placed by his personal physician in a Frederick hospital, and that “bronchial pneumonia” was listed on his death certificate.

Q: Sounds like a cover-up.

A: One must study Pulitzer Prize-winning Seymour Hersh’s seminal work, Chemical & Biological Warfare: America’s Hidden Arsenal (Doubleday & Company, 1969) to discover the case of an enlisted laboratory technician at Detrick contracting pneumonic plague. In a memo classified as secret, Detrick officials cautioned that this lab technician was also a life guard at a public swimming pool in the community. But no attempt was made to inform Frederick residents of the danger, or to provide preventative antibiotic treatment. There was also a case of an enlisted man residing off base who contracted meningitis, which can be highly contagious. The Frederick County Health Commissioner was not informed of this case until weeks after it was discovered. Regarding the plague case, this Health Commissioner told Hersh: “I co-operated with [Ft. Detrick officials]. I had an obligation to them – I had a secret clearance. They told me not to report the case [because] we didn’t want to alarm anyone.” Referring to “funny cases” related to Ft. Detrick, this Commissioner also told Hersh about questionable incidents involving typhoid fever and tuberculosis.

Then there was the case of Frank Olson, whose death back in 1953 was attributed by officials to suicide. Largely as the result of ongoing efforts by one of Frank Olson’s sons, Eric, it has come to light that Dr. Olson was actually in charge of the CIA’s “Special Operations” at Ft. Detrick, that he was gradually becoming more and more disturbed by the CIA’s secret programs at Ft. Detrick, and that after he expressed some of his misgivings and shortly before his death, he was given LSD by CIA agents. In 1994, Dr. Olson’s son Eric retained Dr. James Starrs, a noted forensic pathologist at the George Washington University Medical Center, to assemble a team of experts to conduct an exhumation and autopsy on Frank Olson. After months of tests and investigation, Dr. Starrs concluded that the circumstances of Dr. Olson’s death had been deliberately covered up by the CIA, and that his death was the result of “homicide deft, deliberate, and diabolical.” (Dr. Olson’s son Eric has also uncovered documents that establish that Dick Cheney became personally involved in this cover-up – see Eric’s website,

Q: Are there any other examples of deaths or injuries at Ft. Detrick?

A: With regard to injuries resulting from biological research at Ft. Detrick, it is instructive to consider an article written by several medical doctors who work at USAMRIID entitled “Experience in the Medical Management of Potential Laboratory Exposures to Agents of Bioterrorism at USAMRIID” that appeared in the Journal of Occupational and Environmental Medicine: Volume 46(8), August 2004, pp. 801-811:
“The large number of exposure incidents reported . . . serves as a reminder that work in a laboratory of this type is inherently hazardous. . . . [W]e recognize that work in containment laboratories is inherently hazardous because of the need to work with sharp objects (ie, needles) and animals, which can be unpredictable. In addition, personal protective equipment may inadvertently increase the potential for incidents by limiting the field of vision, tactile sensation, and communication. . . . A laboratory worker was evaluated for a potential ocular exposure to orthopox viruses resulting from a splash of condensate. . . [A]ll 17 persons involved in the [anthrax] letter handling were considered at potentially significant risk for exposure due to the readily aerosolizable spores. . . . The route of exposure [in another case] was probably inhalational as the result of a malfunction (leak) of the filter in the bio-safety cabinet that was subsequently discovered. . . . As research on the agents of bioterrorism becomes more widespread, an increase in occupational exposures to bioterrorist agents may be expected . . .

“Much of our knowledge about biosafety has come from investigations into the mechanisms and activities that caused workers to become infected . . . However, historically the majority of individuals, over 80% in one report, diagnosed with laboratory-acquired infections, could not identify a known incident or breach in laboratory policy responsible for their infection. . . There were 77 individuals evaluated for potential exposures to 107 viral agents . . . [N]o vaccine existed for many of [these] viral agents. . . .” This Journal article also refers to instance after instance of the failure of existent vaccines to prevent infection.

The experience of one USAMRIID scientist who accidentally contracted a disease called “glanders” was described in the article as follows: “The individual, after a diagnostic liver biopsy, subsequently went into respiratory failure, necessitating intubation, [followed by] a 6-month course of treatment.” There is explicit acknowledgement in this article of “the risk of introducing communicable illnesses into the community at large.”

Also relevant to this question about death and injuries is the apparent incidence of cancer afflicting neighbors of Ft. Detrick due to water contamination, as outlined in my answer to a previous question. Also, there is the matter of the anthrax letters of 2001. It bears pointing out that according to the official account, the anthrax in the letters was developed at Ft. Detrick.

Q: Do you know what the budget is for biological research programs?

A: Spending on so-called “bio-defense” research greatly increased immediately after the anthrax letters. In the seven fiscal years following the anthrax letters, $48 billion was spent on “bio-defense.” There is another $9 billion budgeted in fiscal year 2009. Much of this is for the stockpiling of pharmaceuticals -- vaccines and remedies such as Cipro for anthrax.

The General Accounting Office and scientists like Richard Ebright of Rutgers University have suggested that the spending on research since 2001 has actually made this country less safe by vastly increasing the number of researchers and labs authorized to handle bacteria and viruses of bioterrorism concern, known as “select agents.”

Ebright estimates that the number of labs so engaged has increased 20-fold since 2001. Today, there are about 1,400 public and private labs and about 14,000 scientists known to be involved.

Q: Arms control expert Milton Leitenberg has said there is no evidence of biowarfare capability on the part of any terrorist group. What do you make of that?

A: I have read two books by Mr. Leitenberg that pertain to the bioterrorism threat, and I have spoken to him several times about his work. Mr. Leitenberg is a conservative academic. In Assessing the Biological Weapons and Bioterrorism Threat, Mr. Leitenberg demonstrates that billions of federal expenditures have been appropriated in the absence of virtually any real threat analysis, and that the risk and imminence of the use of biological agents by non-state actors/terrorist organizations has been “systematically and deliberately exaggerated” by our government. It is noteworthy that this book was published in December, 2005, by none other than the Strategic Studies Institute of the U.S. Army War College. On its title page can be found the following statement: “This publication is a work of the United States Government . . .”

Q: Turning to the anthrax letters, what is Amerithrax?

A: Amerithrax is the FBI’s name for its investigation into the anthrax letters attacks of September-October, 2001. This investigation has become a cover-up and a fraud, a systematic and deliberate fraud that now attempts to pin exclusive responsibility for the attacks upon a USAMRIID immunologist named Bruce Ivins. After months of intense harassment by the FBI, Ivins died in July, 2008, it appears by suicide.

Q: Do you believe the anthrax attacks on Congress and the media in 2001 emanated from Ft. Detrick?

A: The anthrax in the letters was of a particularly pernicious strain called the “Ames strain” of anthrax. After being discovered in a dead cow from Texas in 1981, the Ames strain made its way to Ft. Detrick, where it was originally cultivated as a potential bio-weapon. Bruce Ivins worked with the Ames strain at Ft. Detrick in the course of his efforts to derive an effective vaccine. According to the FBI’s genetic analysis, the anthrax in the letters was of a specific genotype designated RMR-1029. RMR-1029 was created by Bruce Ivins in 1997. Thereafter, Dr. Ivins was called upon to send RMR-1029 to various laboratories, including those at the Army’s Dugway Proving Ground in Utah, as well as those in Ohio owned and operated by the company named Battelle. So, it is likely that the anthrax came from Ft. Detrick. But the attacks “emanated” from either Battelle or Dugway, where the anthrax was converted from the “wet slurry” form it was in at Detrick to the powdered weaponized form found in the letters addressed to the Senators.

Since the FBI announced that Dr. Ivins was the lone culprit, two articles of mine have been published on the internet that set forth the strong evidence that the real source of the anthrax letters was one of our own secret anthrax weaponization projects being conducted by the CIA and the DIA at Battelle’s labs in Ohio and at the Army’s labs in Utah. “FBI Sweeps Anthrax Under the Rug” can be accessed at

“Amerithrax Hoax” can be accessed at
or at

Q: The anthrax letters had “Death to Israel,” “Death to America” and “Allah is Great” printed in them. This seems like a crude propaganda plant to make the public believe the letters were sent by persons from the Middle East or their sympathizers. I’ve also heard it said the Bush Administration leaked information at the time of the anthrax attacks that the letters came from the Muslim world. What do you make of that?

A: This aspect of the anthrax letters is what makes the anthrax letters a “false flag” operation. A “false flag” operation is one wherein a country stages an attack made to look like an attack by an enemy, so as to justify an (aggressive) attack upon that enemy. Clearly, elements in the Bush administration and in the media, for as long as they could get away with it, pretended that the anthrax letters came from Iraq. This played an unmistakable role in gathering support for the invasion of Iraq.

Q: What do you believe was the motivation for the anthrax attacks?

A: The practice of inventing or exaggerating an attack or a threat in order to stimulate demand for military build-up and war has been in place forever. (The Gulf of Tonkin incident and the fabrication of Iraqi soldiers throwing Kuwaiti babies out of incubators before the first Gulf War are important, relatively recent examples.) In his 1961 Farewell Address, President Eisenhower warned about the "unwarranted influence" and “misplaced power” of the “military-industrial complex.” Before that, General Douglas MacArthur declaimed: “Our country is now geared to an arms economy bred in an artificially induced psychosis of war hysteria and an incessant propaganda of fear.” And before that, General Smedley Butler: “War is a racket. It always has been. It is possibly the oldest, easily the most profitable, surely the most vicious.” And while we are at it, let’s also heed James Madison, the primary author of our Constitution: “The means of defense against foreign danger historically have become the instruments of tyranny at home.” And: “If Tyranny and Oppression come to this land, it will be in the guise of fighting a foreign enemy.”

Q: Are you saying the motivation traces back to the profit motive of the military-industrial complex?

A: For many involved in this practice of inventing/exaggerating threat, this is part of an effort to maximize profits. Others are believers in the need for a military build-up, and justify the invention/exaggeration as necessary to establish priority among competing demands for appropriations. No matter the quality of the motivation, the practice is fraudulent, and is directly responsible for the ignored phenomenon that the U.S. spends more on its military than all of the other countries in the world combined.

Q: And is the world’s No. 1 arms merchant as well, plus the U.S. has ringed the globe with 700-800 military installations, all for “defense” of course but, taken together, giving the appearance very much of an aggressive posture, the stance of an imperialist superpower.

A: The neocons who controlled policy under Bush were of course very closely connected to the “defense” sector of our economy, and the profits made in that sector have of course skyrocketed during the past eight years. What distinguished the neocons in this context was that they did not only rely upon inventing/exaggerating threat, they also explicitly espoused “full-spectrum dominance” for the sake of the ascendance of American empire.

Q: So where do the anthrax letters fit in?

A: The anthrax letters must be viewed in this historical context. In the case of the anthrax letters, the invention/exaggeration of threat took the perverse form of an inside job. The Bush Administration has had to officially acknowledge that the anthrax letters were an inside job. But in order to minimize the implications of this fact, the official account resorts to the flimsy claim that the insider was a lone nut named Bruce Ivins, peculiarly driven to stimulate demand for his anthrax vaccine.

The obvious cover-up in Amerithrax, which depends on the complicity of not only our FBI and Department of Justice, but also of our mainstream media, demonstrates how economically and politically powerful are our military-industrial-intelligence forces. Remarkably, despite the admission of inside job, the anthrax letters continue to serve their dual purpose of generating profits and of achieving dominance in the ghastly realm of bioweapons.

Q: Thank you, Barry Kissin.

(Sherwood Ross is a Miami-based public relations consultant who formerly reported for the Chicago Daily News and wire services. He is the author of the article, “America The Beautiful’s Germ Warfare Rash” published in The Humanist magazine. Reach him at Reach Kissin at

Barry Kissin leads a march in downtown Frederick to protest plans for the new “biodefense” campus at Fort Detrick. A variety of peace groups came together to express concerns that this campus will threaten local health and safety as well as international arms control.

February 17, 2009

UK Researchers Create Anthrax Vaccine Pill

UK Researchers Create Anthrax Vaccine Pill
Tests on mice have been very promising

Up to this point in time, administering anthrax vaccines has only been possible through needles. In other words, an eatable pill has been impossible to manufacture, simply because the acidic gastric liquids in the stomach would have disintegrated the vaccine molecules within a matter of seconds, and all its efficacy would have been lost. But now, researchers in the United Kingdom have managed to devise a new way of getting the cure through the stomach, and namely by “packing” it inside small bacteria.

These types of organisms are very common and can be found in products such as milk and cheese. Mice tests have shown minimal damage to the structure of the vaccine, meaning that, in their new “transport” vessel, the precious molecules have safely endured the hardships of the acids each human has in his or her stomach.

“Using 'food grade' lactic acid bacteria as a vehicle provides a safe way of getting the vaccine into the small intestine without losing any of the drug's efficacy,” US researcher Todd Klaenhammer, from North Carolina State University, who has been the co-author of the current study, says.

Finding a cure for anthrax is paramount, at least in America, where terrorists threats have people and authorities on their toes. The bacteria usually causes only minor skin lesions, which can be easily treated. However, if spores are inhaled, they rapidly and silently take hold of people's inner organs, and, by the time they start showing symptoms, it's usually too late for antibiotics to take effect and reverse the contamination.

The only current way to fight this pathogen is through injections, but because the vaccine is made of proteins, multiple shots must be administered, and not all have the desired effect on the body. However, the UK-US team has managed to disguise the proteins of the vaccine into regular bacteria, which can withstand the rigors of passing through a highly-acidic environment.

“Can we make these generally recognized as safe lactic bacteria into a premier delivery system for vaccines and biotherapeutics? That's the question we are now trying to answer,” Klaenhammer opines. The team is currently concentrating its efforts on finding out if other such organisms can carry other types of cures. If so, we could soon see a wide range of antibiotics delivered in the form of pills, and not through injections.

The results of the current research have been published in a recent edition of the journal Proceedings of the National Academy of Sciences. The US Army Medical Research of Infectious Diseases has also participated in the new study.

Court still undecided on report of anthrax testing on soldiers

NOTE:(Most vaccinated Israeli soldiers received US anthrax vaccine)

The Jerusalem Post Internet Edition

Court still undecided on report of anthrax testing on soldiers

Feb. 17, 2009
Judy Siegel-Itzkovich , THE JERUSALEM POST

The High Court of Justice once again deferred a decision Tuesday on whether to allow the publication of a report prepared by an Israel Medical Association committee investigating the giving of anthrax vaccine to over 700 soldiers who served as "guinea pigs" to determine side effects.

The story was initially disclosed by Ilana Dayan's Uvda TV program in 2007 after she received complaints from soldiers who claimed to suffer from side effects that affected various systems in their bodies.

The IDF's then-surgeon general, Dr. Chezy Levy, asked Prof. Avinoam Reches, then head of the IMA's ethics bureau, to set up a voluntary committee of experts to study the matter. Levy is today deputy director-general in charge of medical services at the Health Ministry, which has not taken any action regarding the vaccinations.

The IMA committee was chaired by Prof. Reuven Porat, chief of internal medicine at Tel Aviv Sourasky Medical Center (Ichilov). The committee members heard testimony from hundreds of soldiers who had been vaccinated, allegedly without being warned about possible side effects.

Although the report is ready for publication, the Defense Ministry's office in charge of state security petitioned the High Court to prevent its publication, arguing that its release would "endanger public security."

The IMA denied this. No one knows what is in the 100-page report (plus documents) except for the judges, IMA committee members and Reches.

On Tuesday, Justice Asher Gronis, who headed the three-judge panel, said he read the report and did not get the impression that its publication might hurt national security, but that perhaps there was a legitimate reason for the Defense Ministry's objections. He dispatched thanks (via the IMA lawyers) for working hard to prepare the report.

The court did not issue an opinion or ruling, but apparently may decide to send the report again to the Defense Ministry's office in charge of state security for an additional examination.

February 7, 2009

U.S. Army Lab Freezes Research on Dangerous Pathogens
Proposed Law Would Make NIH Less "Open"

February 7, 2009

U.S. Army Lab Freezes Research on Dangerous Pathogens

The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has suspended research activities involving biological select agents and toxins. Army officials took the step on Friday after discovering apparent problems with the system of accounting for high-risk microbes and biomaterials at the Fort Detrick, Maryland, facility.

The lab has been under intense scrutiny since August, when the Federal Bureau of Investigation (FBI) named former USAMRIID researcher Bruce Ivins as the perpetrator of the 2001 anthrax letter attacks. Although the case never went to trial because of Ivins's suicide on 29 July 2008, FBI officials have claimed that the evidence against him is indisputable and that he carried out the mailings using anthrax stolen from a flask at USAMRIID.

Officials have begun a complete inventory of all select agents and toxins at the facility. All experiments using select agents will remain suspended until the accounting is finished, which could take several weeks. Several USAMRIID researchers have been grumbling about the decision, which seems to have caught them by surprise, according to a government official not connected to the lab.

The decision was announced by institute commander Col. John Skvorak in a 4 February memo to employees. The memo, which ScienceInsider has obtained, says the standard of accountability that USAMRIID had been applying to its select agents and toxins was not in line with the standard required by the Army and the Department of Defense. USAMRIID officials believed that a satisfactory accounting involved finding all the items listed on its database; the Army and DOD wanted the converse—that is, all select agents and toxins needed to be matched to the database.

According to the memo, any materials found without a corresponding record in the database must be reported to the Vice Chief of Staff of the Army. "I believe that the probability that there are additional vials of BSAT [biological select agents and toxins] not captured in our … database is high," Skvorak wrote.

A former USAMRIID scientist told ScienceInsider that in the past, inventorying of biological materials at the institute routinely turned up items that had not been listed on the database before. Those items would be added to the database without shutting down research.

—Yudhijit Bhattacharjee

January 23, 2009

Deadly Bio-Weaponry Build Up Comes to the Heart of the U.S.

Deadly Bio-Weaponry Build Up Comes to the Heart of the U.S.

(NaturalNews) The powers of the world are in a new arms race far more terrifying in its scope than the race for nuclear weapons. Bio-weaponry and bio-wars are now real threats to the future of the human race. What sounds like the stuff of futuristic science fiction is already a quiet reality. The recent announcement of the new site for the National Bio and Agro Defense Facility brings this reality to light, particularly as this site will house level 4 pathogens, some of which are zoonotic, meaning they can jump the species barrier and infect humans.

The new facility, to be built near Manhattan, Kansas will be classified as Biological Safety Level 4 (BSL-4), a designation that allows for the study of the most deadly, most contagious diseases known, diseases for which there are no cures. It will replace the Plum Island Animal Disease Center, located 100 miles northeast of New York City in the Long Island Sound, just six miles off the Connecticut coastline and accessible only by ferry or helicopter, a location where prevailing winds blow out to sea. That facility is closing under the rationale that it does not have the security in place for this higher level of usage. Plum Island carries a lesser BSL-3 classification.

Connecticut residents knowledgeable about what goes on at Plum objected to the creation of a new facility where the old one stands, fearing that lethal viruses could escape onto the mainland.

The Department of Agriculture ran the Plum Island lab until 2003, when it was turned over to the Homeland Security Department as part of the nation's biological defense program. The public's perception of the research at Plum Island, created by government public relations releases, has centered on its mandate to protect herds from hoof-and-mouth disease, a highly contagious virus that is deadly to animals. According to government PR, researchers at Plum work on detection of disease, epidemic control strategies, vaccines and drugs, tests of imported animals, and training of professionals.

A large body of evidence suggests there is much more than this going on at Plum. Circumstantial and factual data has presented the likelihood that Plum is responsible for a number of disease outbreaks that have proven to be national public health and agricultural nightmares. Many see Plum Island as responsible for the re-introduction of the hoof-and-mouth disease it now claims to control. Some point to bio-containment mechanisms at Plum that were allowed to deteriorate and remain non-functional for several years, and lax security that allowed accidents to happen. Others suspect more deliberate actions.

While the stated mission of the new site continues to be the control of such animal diseases, the location for the new facility in Kansas places it near 542,507 head of livestock, over three times the amount in the vicinity of other sites that were considered. An outbreak of hoof-and-mouth disease could require the destruction of tens of millions of farm animals and devastate the livestock industry.

The diseases being researched at Plum are not necessarily contained in glass viles. There are a number of infected live animals for study there with diseases having incubation periods extending for several days. This means it is very possible for a researcher to be infected on Friday, take the ferry home to Connecticut and spend the weekend spreading the infection before any signs of it are visible in him. The government maintains that there has never been a leak to the mainland, and apparently the first appearance of Lyme disease just 13 miles from the facility falls under the category of coincidence, as does the still unexplained initial U.S. appearance of West Nile virus in Long Island and New York.

Bio-weaponry in the U.S. is nothing new

The development of bio-weapons in the U.S. dates back at least to the 1930's when the U.S. Public Health Service conducted an experiment on 399 black men in the late stages of syphilis, called the Tuskegee Experiment. The experiment was designed to see how long it took for men to die from infection by the syphilis spirochete.

During the 1950s and 60s, bio-warfare attacks took place in many parts of America, the most noted being the six day attack on San Francisco during which potentially harmful bacteria were sprayed over the city. In this attack, reported in the September 17, 1979 Los Angeles Times, twelve people developed pneumonia and one man died.

In 1954, Plum scientists looked for ways to inflict bio-damage on Soviet livestock. According the Cuban government, in the 1960s and 70s bio-weapons developed at Plum were deployed against Cuban agriculture, targeting pork, tobacco and sugar cane.

During the Cold War years, thousands of U.S. citizens were used in radiation experiments conducted by the Atomic Energy Commission and other government agencies.

In 2001 the U.S. Department of Defense (DOD) issued a press release admitting it conducted over one hundred tests in which thousands of American servicemen were intentionally dosed with chemical and biological weapons during the period from 1962 to 1973. Dozens of harmful agents like VX, Sarin gas, E-coli bacteria and Bacillus globigii, a cousin to anthrax and bubonic plague, were used on completely unaware and unprotected men. The announcement by the DOD was strategically placed just two days after the mind-numbing 9/11 attacks, at a time when it was given little to no attention by the national media.

Bio-warfare development intensified in the 1970's particularly in the areas of genetic engineering. Much of it was euphemistically referred to as cancer research. During this period cancer causing viruses began to jump from one species of animal to another, a characteristic that signals the viruses are man made. New immunodeficiency diseases were then seen in lab animals.

Although generally regarded as conspiracy theory, some AIDS researchers believe the Special Virus Cancer Program and its connection to bio-warfare development spawned an immunosuppressive virus that was seeded into the gay community via the government sponsored experimental hepatitis B vaccine drive.

The Washington Times, October 19, 1998 reported bio-warfare experiments that took place at Fort Detrick between 1954 and 1973, utilizing volunteers who were exposed to germs causing tularemia, malaria, anthrax, Rocky Mountain spotted fever, encephalitis, and other diseases. Prevention, diagnosis and vaccine development were cited as the reasons for the experiments.

The Los Angeles Times, March 9, 1977, reported other experiments during which the military sprayed bacteria in New York City subways, in a Washington D.C. airport, and on highways in Pennsylvania. Military bases in Virginia, Key West, and off the coasts of Southern California and Hawaii have used live bacteria tests on U.S. civilians.

In 1992, a strike at Plum of union engineers was responsible for a loss of essential support services such as decontamination, waste-water treatment, generator maintenance, and other maintenance and safety-oriented functions. For the duration of the strike, temporary workers were brought in to replace the sentinels and technicians of the infrastructure. The water pressure fell precipitously disabling decontamination facilities and the necropsy rooms where dead animals were examined. In the fifth month of the strike a power failure occurred during which a worker called a Hillary Clinton staffer to complain that the facility was completely out of hand. Without power, the air filtration systems were inoperable, and the decontamination procedures stopped. The seals in the pressurized airlock doors deflated, and workers reportedly tried to seal them with duct tape.

In 1999, the administrator of the Agriculture Research Service persuaded President Clinton to include Plum in his expanded bio-terrorism program based on the possibility of a biological attack on the nation's agricultural base.

In 2001 it was discovered that Plum was involved in an effort to develop vaccine resistant forms of anthrax. Two years later a virologist at St. Louis University announced he was creating a more lethal form of mousepox, a relative of smallpox, and intended to extend his work to cowpox which can infect humans. The problem with research of countermeasures is that they need the lethal measure to go against. Creating deadly bio-weapons to determine how well they can be thwarted gives rise to the potential of more potent plagues. The government's budget for chemical/biological warfare has recently doubled, with $10 billion allocated to bio-weaponry projects.

These incidents are a record of what has become known in spite of all attempts to retain security and secrecy. It is obviously not the full extent of the U.S. government's bio-warfare or bio-weapon testing on its citizens. The full extent of this involvement is hidden in classified documents or is reported to be unavailable.

The increase of new bizarre diseases and organisms raises questions

The appearance in the past several years of AIDS, Legionnaire's disease, hepatitis C, mad cow, hemorrhagic viruses, Lassa fever, chronic fatigue syndrome, Persian Gulf War illness and others have made people question their sources. Older diseases such as tuberculosis, malaria and cholera have re-emerged in more virulent forms that are drug resistant. A study published in the January 6, 1999 JAMA reported infectious disease mortality in the U.S. declined during the first eight decades of the 20th century. From 1981 to 1995, there was an increase in infectious disease mortality of fifty-eight percent. The researchers concluded that recent increases emphasize the dynamic nature of infectious diseases and the need for preparedness to address them.

The official list of excuses for this rising mortality rate makes no mention of the infectious material produced for biological warfare purposes. The anthrax mailings following the attacks of 9/11 have been the only wake-up call that has reached many Americans. It raised the level of public fear enough to spark congressional increase in spending on bio-defense, but it quickly faded from the public mind.

About the same time as this funding was increased, the West Nile virus was dismissed by a government report as not being bio-warfare, a move surprising many people given the government's long and documented history of bio-warfare experimentation on its own citizens.

Bio-weaponry is for sale to the highest bidder

Killer microbes have been for sale to any person or country having the buying power. While the U.S. was still friendly with Iraq, the Education Ministry bought 70 shipments of anthrax and other disease-causing organisms from the U.S. Officials here continued to supply Iraq with bio-warfare material during the prelude to the Gulf War according to the September 24, 2002 Seattle Post Intelligencer.

Was the West Nile virus lab created?

People wonder whether the West Nile virus could be the result of animal experimentation and the laboratory manipulation of the African virus. In September, 2002, the media reported that some West Nile patients exhibited signs and symptoms of polio, although that disease is caused by a different virus. They ask if this means the virus has been laboratory altered. West Nile is generally only fatal in the old and the sick, groups being eyed by the government for their use of entitlements.

Fiction often portrays life's greatest truths

The Poison Plum (2006) is a novelized historical treatise of the Lyme disease now sweeping across the U.S. Recorded incidence of this puzzling illness without a cure shows it to be the fastest spreading disease in America today. From the politics of disease to the agenda of the powerful, the book reveals the betrayal of the nation and its people by their own most trusted institutions. It is a dark portent of the pain and suffering to come as Lyme disease and the escalation of bio-warfare continue.

The book is a testimony to the veil of secrecy surrounding Lyme, a veil that took ten years for the author to penetrate before he finally received his own Lyme diagnosis. It is a mesmerizing and powerful tale that speaks of truths that are only palatable when presented in the form of a story. The connections between Lyme and Plum are probed, as well as the involvement of government laboratories in engineering germs for use in biological warfare. Other questions raised involve the possibility of massive government cover-ups to deny the true severity of Lyme disease and the fact that there is no cure, as well as the involvement of insurance companies denying the complexity of the disease to avoid liability for costly long term treatment protocols.


Barbara Minton, Deadly Animal Virus May Soon Come to U.S. Mainland,

Patricia Doyle, PhD., Plum Island Lab Moving to Kansas, Goes BSL-4,

Alan Cantwell, Jr., M.D., The New West Nile Virus Epidemic: Bioterrorism? Or Mother Nature (Again)?

Patricia Doyle PhD., The Deadly Fools of Plum Island,

Poisoned Plum, Primate Freedom, February 3, 2007.

U.S. Uses Bio-Weapons on Their Own People,

January 22, 2009

Revisiting the anthrax attacks

Contact: Clare Collins
University of Pittsburgh Schools of the Health Sciences

Revisiting the anthrax attacks
PITTSBURGH, Jan. 22 – When anthrax was sent through the U.S. Postal Service in 2001, an overwhelming majority of postal workers elected not to be inoculated with the available vaccine because of confusion and distrust, according to a University of Pittsburgh Graduate School of Public Health study. Although the FBI officially closed the case on the attacks this year, lingering suspicion and uncertainty remain, say study authors, which could influence the public's reactions to future emergencies.
According to the report, reactions from postal workers were shaped partially by fears of being experimental "guinea pigs," disagreements among public health agencies about whether the vaccine should be recommended, physician advice, low perceived risk of infection and conflicting reports from national media organizations.
The study was based on interviews and focus groups conducted with 65 postal workers in Trenton, N.J., New York and Washington, and published in the December 2008 issue of Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science.
"The reaction of postal workers demonstrates the essential need to build trust and educate the public before the uncertainty, confusion and time pressures of a bioterrorism or pandemic emergency create major barriers for clear communication," said study author, Sandra Quinn, Ph.D., associate dean for Student Affairs and Education and associate professor at the University of Pittsburgh's Graduate School of Public Health. These concerns may be particularly relevant given that, in October 2008, the Department of Health and Human Services declared anthrax as a continuing bioterrorism threat through the end of 2015, she said.
During the 2001 anthrax attacks, which resulted in five deaths, 10,000 postal workers and others who were suspected or confirmed to have been exposed received a two-month dose of antibiotics. The Centers for Disease Control and Prevention (CDC) then recommended people who failed to complete the regimen or who were at high risk for exposure take antibiotics for an additional 40 days with or without a supplemental anthrax vaccine. Only 11.5 percent of postal workers who took the additional 40-day dose of antibiotics agreed to take the anthrax vaccine as a precautionary measure.
"Scientific knowledge about the effectiveness of the vaccine after exposure to anthrax was uncertain at the time, making it an almost impossible task to communicate precise and proper health information to postal workers and other affected groups, including Senate staff," said Dr. Quinn. "Given the evolving nature of the crisis, postal workers were unsure whose advice they should trust and as a result, many decided to do without the recommended vaccination," she said.
In 2004, with the passage of legislation to establish Project Bioshield, the federal government created a mechanism for declaring public health emergencies. This authority also allows the Food and Drug Administration to authorize the use of experimental or "off label" drugs to address bioterrorism or public health emergencies. According to Dr. Quinn, communication about the use of these counter measures will present significant challenges for public health authorities in the future.
To address these challenges, she suggests public health experts openly acknowledge disagreements between health agencies, develop partnerships with trusted community agencies and work with media partners to address inaccuracies, misconceptions or other issues that may arise in news reports.
"We need to engage and educate the public before an emergency occurs to prevent unnecessary risk, disease and even death. Only by doing this can individuals make informed decisions about accepting or rejecting counter measures," she said.

January 16, 2009

Litigants Argue U.S. Regulators Lacked Basis to OK Anthrax Vaccine

Global Security Newswire
National Journal Group
Jan. 16, 2009

Litigants Argue U.S. Regulators Lacked Basis to OK Anthrax Vaccine

Friday, Jan. 16, 2009
By Elaine M. Grossman

Global Security Newswire

WASHINGTON -- The Food and Drug Administration violated its own regulations three years ago in approving the anthrax vaccine to prevent infection by a "weaponized" form of the disease, attorneys for eight Defense Department employees alleged in a brief filed last week at the U.S. Court of Appeals (see GSN, March 3, 2008).

(Jan. 16) - The anthrax vaccine received approval in late 2005 as a protective measure against inhaled anthrax (Emergent BioSolutions photo).

The Pentagon began a vaccination program for more than 1 million service personnel in 1998, during the Clinton administration, and continued the effort under President George W. Bush. However, compulsory shots were suspended from late 2003 through early 2007, after a federal judge found the Pentagon lacked the legal authority to
compel inoculations for an unapproved use of the vaccine.

Critics have voiced concern that it is unclear how useful anthrax vaccine is in preventing the highly lethal disease from being contracted through inhalation, and have called attention to the possible risks associated with giving the inoculations to a large population.

The U.S. government recently moved to shield itself from liability in distributing the vaccine in the event of a bio-warfare attack, just as a key advisory panel to the Centers for Disease Control and Prevention approved extending the shots to emergency first-responders nationwide (see GSN, Oct. 17, 2008, and Oct. 23, 2008).

A December 2005 FDA ruling allowed a vaccine previously labeled for use solely in inhibiting anthrax contracted through the skin or the digestive system to also be administered to prevent acquiring the disease via the lungs.

The decision paved the way for the Defense Department to resume mandatory inoculations for service members whose assignments are believed to put them at increased risk of exposure to anthrax during a potential biological attack (see GSN, Sept. 5, 2007).

However, two attorneys who succeeded in temporarily shutting down the mandatory shots program in 2003 remain dissatisfied. They alleged in a second lawsuit, filed in December 2006, that the Food and Drug Administration had not followed its own standards for reviewing a vaccine for approval in issuing its 2005 go-ahead.

The result, they are alleging, is that the vaccine has not been shown to be safe and effective for preventing inhaled anthrax.

U.S. District Judge Rosemary Collyer last year ruled against the plaintiffs, saying the court "will not substitute its own judgment when the FDA made no clear error of judgment."

Plaintiff attorneys Mark Zaid and John Michels took their case to federal appeals court, and the 73-page brief filed last week constitutes their written argument.

"There are ... internal inconsistencies in the [FDA-reviewed] record showing that nobody believed this vaccine was adequate for preventing inhalation anthrax until the DOD decided they were going to conduct this mass inoculation, " Michels said in an interview yesterday. "The FDA's failure [in its 2005 action] to explain all of these contradictory statements [in] their own documents is a violation of the Administrative Procedures Act."

The 1946 federal law controls how government agencies draft and issue regulations.

A Defense Department spokesman praised the federal judge's decision.

"We owe it to our service members to give them every possible protection," Bryan Whitman said last year. "Force protection is the No. 1 priority in the Defense Department and the anthrax inoculation program is an important force-protection measure."

In their Jan. 7 brief to the U.S. Court of Appeals, though, Michels and Zaid took issue with the notion that the vaccine has been proven to protect humans from contracting inhaled anthrax.

If the court invalidates the FDA authorization for this use, the Defense Department could be required to obtain informed consent from any personnel receiving the five-shot series (see GSN, Dec. 22, 2008).

In the case, called Rempfer vs. von Eschenbach, the two lawyers are representing Thomas Rempfer and seven other Defense Department personnel ordered to take the vaccines. Defendants are led by FDA Commissioner Andrew von Eschenbach and include the health and human services and defense secretaries.

"The regulatory history of the [anthrax vaccine] was nothing if not convoluted and contradictory, " according to the plaintiffs' new court submission. "The main basis" for Collyer's decision to dismiss the case "was the FDA's reliance on a single human test of [the anthrax vaccine] that occurred more than 50 years ago, using an admittedly different vaccine," the complainants stated.

The district court judge's Feb. 29, 2008, decision "ignored the significant disparities" in vaccine testing as well as plaintiff allegations that "undercut" the key medical study's "validity and scientific basis," the brief reads.

"We are alleging," Michels told Global Security Newswire, "the FDA has not done its job."

Agency records show a "significant failure by FDA to follow its own procedures with regard to licensing of the current version of the vaccine using data from a vaccine that was manufactured using different standards, a different anthrax strain, and different methodology, " according to the brief. "The District Court's simple acceptance of the representations made by the government was improper and factually unsupportable. "

An FDA spokeswoman today declined to offer comment on the court case.

Pending a possible extension in due date, the government has 30 days to issue its own written brief for the appeals court. After that, the plaintiffs will have an opportunity to submit their response. The appeals panel may then request to hear oral arguments on the case before issuing its decision.