Dear Dr. McClellan:

I am writing to express concern about the conduct of an on-going U.S. Army clinical trial of the BioPort anthrax vaccine that is targeted at Congressional staffers. I request that the Food and Drug Administration take immediate action to sanction the Army and BioPort Corporation for their mischaracterization of the safety and efficacy of this vaccine.

The Army appears to have violated the Food, Drug and Cosmetic Act when it placed an advertisement for civilian volunteers to participate in a clinical trial of the BioPort anthrax vaccine in the February 16, 2003 edition of a Capitol Hill newspaper, The Hill (a similar ad was also placed in Roll Call). The advertisement, titled "Volunteers Needed: For a Clinical Trial of Licensed Anthrax Vaccine", was placed by the Clinical Trials Center of the Walter Reed Army Institute of Research. The advertisement states that the "purpose is to see if using fewer shots given in the muscle will give a good immune response with fewer side effects." This advertisement is similar to one placed by the Army in the Washington Post on October 15, 1996, about which the FDA wrote the Army in a December 13, 1996 letter (attached). The FDA's failure to sanction those responsible in 1996 has clearly encouraged a repeat occurrence, wherein the Army's use of "licensed" in the ad infers "safe and effective." As the FDA noted in its 1996 letter to the Army:

"The Anthrax vaccine is approved for the indication of the labeling specified in the vaccine, but not for the indication currently under investigation...No claims should be made, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation."

Despite the FDA's clear admonition in 1996, the Army is once again falsely inferring that the BioPort anthrax vaccine is licensed for the purposes for which it is under clinical investigation. In fact, the proposed reduction in doses and intramuscular administration of the vaccine were two of the objectives of a September 20, 1996 Investigational New Drug application (IND 6847) that remains active today. Therefore, the vaccine remains investigational -- not licensed -- for the purposes of the Army's advertisement.

FDA Commissioner Dr. Mark B. McClellan - February 28, 2003 - page 2

Additionally, given the as-yet unresolved origin of the post-Sept 11th anthrax attacks, the Army's solicitation of Congressional staffers as participants in this study is ethically suspect, if not also a violation of the Food, Drug and Cosmetic Act. Commenting on the origins of the anthrax attacks, on December 18, 2001 then-Homeland Security Director Tom Ridge told Time Magazine: "There are multiple agencies within government that have for many years, for many reasons had access to this strain of anthrax.The connection [to the military] could very well exist. The fact is we have multiple leads." Given Secretary Ridge's ambiguous comments, the Army's targeting of Congressional staffers by advertising at ground-zero of the anthrax attacks may represent a violation of the prohibition on coercive recruiting of clinical trial participants. In any event, it definitely represents a cynical attempt to subtly influence staffers who assist Members of Congress in their Constitutional oversight of the military's use of the BioPort anthrax vaccine as well as other biodefense programs.

Equally important, the Army's continued clinical investigation under IND 6847 confirms that the first (i.e. primary) listed purpose of this IND application remains unresolved: specifically, an indication for inhalation anthrax. Despite continued assertions by the FDA and the Department of Defense that the anthrax vaccine is "fully licensed," a review by an FDA expert panel, published in the Federal Register on December 13, 1985, observed that the vaccine "has not been employed in a controlled field trial" and that "its efficacy for inhalation anthrax is not well documented." Both then and still today, the BioPort anthrax vaccine has never been proven efficacious in humans for any route of infection, especially inhalation anthrax. The 1950's Brachman study of a similar, but different vaccine, often used by FDA and DoD to infer efficacy, clearly stated that no conclusions could be drawn from the study about efficacy for inhalation anthrax.

In addition to the lack of demonstrated human efficacy, any assertion of efficacy based on animal studies is undercut by an April 23, 2002 meeting held by the FDA Center for Biologic Evaluation and Research. The transcript of presentations and comments by Army and other researchers makes clear that there exists no correlate of immunity between humans and animal models for anthrax infection - despite this having been an objective of IND 6847. Therefore, FDA's acceptance of the Army's repeated assertions of anthrax vaccine efficacy based on animal studies is neither scientifically valid, nor legally relevant. This means the BioPort anthrax vaccine has never met the efficacy requirements for licensure, and therefore must be considered experimental.

In contrast, the 1985 FDA expert review panel recommendations were part of a Proposed Rule by FDA to make the anthrax vaccine a Category I (safe, effective and not misbranded) product. The last meeting of the FDA expert panel was actually in February 1979. Despite the recommendations of FDA's expert panel, FDA has not acted to finalize the status of the anthrax vaccine license in over 24 years since receiving their expert panel's recommendation. On August 28, 2002, in response to a Citizen Petition (Docket # 01P-0471/CP1), FDA confirmed its failure to finalize the Proposed Rule for the anthrax vaccine license -- yet offered no explanation for their decades of inaction.

FDA Commissioner Dr. Mark B. McClellan - February 28, 2003 - page 3

FDA apparently has never acted to finalize its 1985 Proposed Rule because its bureaucrats know, but will not admit, that there is no provable scientific basis for making the anthrax vaccine a Category I vaccine. Yet, the FDA has allowed the Department of Defense to involuntarily mandate the BioPort anthrax vaccine as a "fully licensed" vaccine, without informed consent, on over 700,000 military servicemembers since the Gulf War. This is a violation of federal law for which FDA officials, not DoD, may be held accountable. DoD has stated it will with comply with whatever FDA decides.

FDA's refusal to enforce the law with respect the BioPort anthrax vaccine cannot be justified by the threat. If the military threat dictates, federal law allows DoD to use experimental or investigational drugs or vaccines on servicemembers, without informed consent, as long as the President signs a waiver of informed consent. Over the past six years, FDA has subverted the 1998 law (Title 10 U.S. Code, Section 1107) and the earlier 1990 Interim Rule, by allowing DoD and BioPort Corporation to falsely assert that their anthrax vaccine is "fully licensed." Since DoD can mandate the vaccine whether the product is categorized as "fully licensed", investigational, or experimental, the only rationale for FDA's failure to enforce the law is to protect the Commander-in-Chief from assuming the political liability of using an unproven vaccine on military servicemembers.

In contrast to FDA's inaction, on May 14, 2002 the Department of Veterans Affairs recognized the unique risks posed by this vaccine. DVA's general counsel issued a legal finding - solely for the anthrax vaccine -- that redefines and broadens the meaning of the word "injury" with respect to disabilities caused by the vaccine. No other vaccine used by the military has been so recognized. Notably, the DVA general counsel was not swayed by the March 2002 Institute of Medicine (IOM) report on anthrax vaccine that is contradicted by at least four previous IOM reports. The IOM relied on the Army's unpublished safety studies that FDA stated, in a January 7, 2002 letter, had "significant methodological limitations" and were "not randomized or well-controlled." Yet, the IOM - and FDA - have ignored at least three independent, peer-reviewed, published studies that found a positive association between anthrax vaccine and Gulf War Illness.

Why does FDA continue to allow DoD to assert the anthrax vaccine is as safe as other routine vaccines, and to administer the vaccine without providing servicemembers a copy of the FDA-approved package insert? The chronic illnesses that were the catalyst for the DVA legal finding are clearly documented in the anthrax vaccine package insert. These include deaths, birth defects, and chronic autoimmune disorders such as Lupus, multiple sclerosis, Lou Gehrig's disease (ALS), chronic fatigue syndrome and many other ailments that mirror Gulf War Illness. Not coincidently, the Army has collocated their so-called National Vaccine Healthcare Center with the Gulf War Illness treatment facility at Walter Reed Army Medical Center. Those injured by the anthrax vaccine receive the same treatment regimen as those with Gulf War Illness. Absent FDA intervention, it is unclear whether the Army and BioPort will provide information on chronic illnesses to Congressional staffers and other civilians who are recruited for their current clinical trial.

FDA Commissioner Dr. Mark B. McClellan - February 28, 2003 - page 4

FDA's continued willingness to ignore the facts about the BioPort anthrax vaccine is undermining servicemembers' morale and faith in a military chain of command that has neither the time nor expertise to decide regulatory issues. The result is that DoD is currently court-martialing, demoting, fining, giving bad conduct discharges to, and threatening forcible inoculation and jail terms of a year or more to loyal servicemembers who have recently refused the anthrax vaccine. These servicemembers know that when 10,000 Congressional staffers and postal workers were offered the vaccine with informed consent, only two percent of them accepted. The military refusals stem from FDA's failure to enforce the Food, Drug and Cosmetic Act with respect to the Pentagon's involuntary immunization program (AVIP). Servicemembers who refuse the vaccine object, on principle, to involuntarily taking an improperly licensed vaccine mandated in violation of the laws they have sworn an oath to defend.

America's military servicemembers are willing to go in harm's way to serve the nation in the war against terror. But they should not be forced to be participants in yet another Pentagon experiment on their own troops - such as Gulf War Illness, Agent Orange, Operation SHAD, and nuclear testing -- for which there will once again be no accountability. It is the FDA's responsibility to insure this does not happen. Unfortunately, FDA's recent designation of pyridostigmine bromide (PB) as "fully licensed" for nerve agent protection and your inaction with respect to anthrax vaccine indicates that FDA continues to place the Defense Department's political concerns ahead of the laws that are supposed to protect military servicemembers.

As our troops prepare for battle, the least the FDA can do is to ensure the Department of Defense complies with the protections for our military servicemembers mandated in federal law so there is political accountability for those injured by the anthrax vaccine. This means, first, forcing the Army and BioPort to conduct clinical trials in compliance with federal law, FDA regulations and widely accepted ethical standards for human subject protection. Second, it means that you and Secretary of Defense Rumsfeld must place the law before politics and seek a Presidential waiver of informed consent for the mandatory use of the experimental BioPort anthrax vaccine.

Steve Robinson

Executive Director NGWRC

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Last revised: March 2003