Mary PENDERGAST (FDA):  As I indicated to you, it was not the type or quantity of information we would have hoped for.

SHAYS (R-CT): That’s an understatement.

PENDERGAST: It – it was.  We don’t disagree with you. This was war. This was the first time, and it didn’t work particularly well. We are in full agreement with you on that.

SHAYS: This isn’t the first time the military has conducted themselves this way. And as long as they know the FDA’s going to be a paper tiger with the military, they will continue to do this. They will continue to basically say, bug off. And . . . as far as I’m concerned, that’s what they’ve said, and that’s what you’ve accepted. . .

. . . And so we’re going to pursue this with the FDA, because in my judgment, the FDA allowed the military to do what they have to do in time of war, to have gotten a waiver from informed consent. They should have required that the troops technically, not just in spirit, be notified. And they should have made sure that it was being enforced . . . and [it’s] an outrage that it was not kept and data was not kept.

And the FDA has not, in fact, really overseen this . . . And frankly, if you had said to me, we really blew it, just like the military, I could accept it. But you’re defending it, so now we’re going to pursue it.

During the hearings on the Nixon impeachment, Senator Howard Baker (R-TN) asked the now famous question: “What did the President know and when did he know it?”[i] This same question is equally applicable to both FDA and DoD officials regarding the anthrax vaccine program. There has been a startling lack of candor and double-speak from both of these government agencies. While some of this could be attributed to normal bureaucrat-ese inside the Beltway, the level to which it has risen with this particular program goes so far beyond the “norm” as to be risible – and imputes far less honorable motives to those involved.

_______________________________________________________

In 1985, at the same time that the FDA’s panel was preparing its review on the anthrax vaccine, the Army had conducted its own review and sent out a Request for Proposals (RFP) for a contract to develop a new anthrax vaccine. The purpose of the RFP was to solicit manufacturers for their willingness to enter into a contract to create a new anthrax vaccine and the stated justification for fielding such a vaccine was that “[t]here is an operational requirement to develop a safe and effective product which will protect US troops against exposure from virulent strains of Bacillus anthracis.” This would seem to be a fairly straightforward proposition, but it immediately raises the question: why would the Army need a new vaccine, in light of the existing AVA? The Army RFP explains it quite simply:

There is no vaccine in current use which will safely and effectively protect military personnel against exposure to this hazardous bacterial agent.[ii]

In light of later DoD statements already examined and the ongoing program, it seems rather incredible that the Army announced in 1985, when there was only one existing license for anthrax vaccine (as there has been since the AVA was fist developed), that no vaccine in current use was safe or was effective – the two fundamental legal requirements for licensure by the FDA – safety and efficacy.

The RFP singles out MBPI’s anthrax vaccine, noting that there is “a licensed vaccine against anthrax, which appears to afford some protection from the disease . . . [but]  [t]he vaccine is . . . highly reactogenic, requires multiple boosters to maintain immunity, and may not be protective against all strains of the anthrax bacillus.”[iii] Now, contrast this with statements by Dr. Kathryn Zoon of the Center for Biologics Evaluation and Research (CBER), who claimed in Congressional testimony in 1999 of the same exact vaccine that “to our knowledge . . . the vaccine that we are using protects against all known natural strains of anthrax.”[iv] She is either completely misinformed or lying. Setting that aside for the moment, what is even more troubling – and revealing – about her statement is that Dr. Zoon, a member of the FDA, the agency that is supposed to regulate Biologics, refers to the vaccine as one that “we are using[!]” Dr. Zoon is a senior government official in the Division that is supposed to regulate the safety of vaccines and monitor compliance with Good Manufacturing Practices.

In this same hearing, Dr. Zoon dismissed the previous Notice of Intent to Revoke (NOIR) letter given to MBPI by her own Agency as if it were a minor matter. When asked directly “what the most serious problems are with the manufacturing of the vaccine and whether the manufacturer is taking steps to remedy those problems” Dr. Zoon replied that “. . . the manufacturer has had a notice of an intent to revoke. There were GMP deficiencies, and the manufacturer is currently engage in remedying those deficiencies.”[v] This is from the head of an agency that has found continuous and repeated cGMP violations, to such an extent that the Agency has called the manufacturing process “not validated,” had issued an NOIR which led to a “voluntary” shutdown of the entire facility just 20 months prior, had found that when the FDA was not notified that “[o]n 6/30/98, the firm installed a new reaction tank mixer on Tank (redacted).” Finally, one month after Dr. Zoon is telling Congress that this vaccine works against all known strains of anthrax, in November, 1999, the FDA inspectors would find again that “[t]he manufacturing process for Anthrax Vaccine Adsorbed is not validated.”[vi]

In 1989 the DoD actually defended its position that the (then)-current vaccines were not good enough for mass troop inoculation. A DoD letter to Senator John Glenn of the Senate Committee on Government Affairs from Assistant Secretary of Defense Robert Barker proffered that “[c]urrent vaccines, particularly the anthrax vaccine, do not readily lend themselves to use in mass troop immunization for a variety of reasons: the requirement in many cases for multiple immunizations to accomplish protective immunity, a higher than desirable rate of reactogenicity, and, in some cases, lack of strong enough efficacy against infection by the aerosol route of exposure.”[vii] This can be contrasted with Dr. Sue Bailey’s claims on behalf of the DoD in 1999 that “[t]he vaccine . . . is effective and has an incredibly safe record. The evidence of vaccine effectiveness against aerosol exposure to anthrax is very persuasive.”[viii] Dr. Bailey was the Assistant Secretary of Defense for Health Affairs. She also offered that “[w]e have a vaccine that can protect our troops from this deadly weapon. It would be irresponsible for us to deploy our servicemen and women without using this safe and efficacious vaccine.”[ix] Evidently, the same exact vaccine, which in the intervening ten years had failed almost every conceivable FDA inspection for sterility and purity and potency and quality, had managed to transform itself in the eyes of the DoD from being “highly reactogenic” in 1985 and again in 1989 and lacking in “effectiveness against aerosol exposure” to being an essential force protection measure against anthrax. The only comparable transformation for a liquid involves water, wine, and a Jewish carpenter.

In March of 1990, two Army doctors, Col. Takafuji, of the Army Surgeon General office and Col. Philip K. Russell of Fort Detrick, Maryland, describe the anthrax vaccine as a “limited use vaccine  . . . unlicensed experimental vaccine.”[x] This is interesting because in the same year that two prominent Army doctors were calling the anthrax vaccine “unlicensed” and “experimental”, the DoD was arguing to the FDA that it didn’t need a Rule 50.23(d) waiver for anthrax – or any other drugs, actually, regardless of their status. This medical admission, however, appears to have been an aberration in the DoD’s medical community, or at least in its messaging. The more consistent opinion, from senior Army physicians was actually that the vaccine was unlicensed and potentially hazardous. In 1994, Major General Ronal Blanck, later the Army’s Surgeon General, testified before the Senate Armed Services Committee about the anthrax vaccine as a possible cause of Gulf War Illness.

Although anthrax vaccine had been considered approved prior to the Persian Gulf War, it was rarely used. Therefore, its safety, particularly when given to thousands of soldiers in conjunction with other vaccines, is not well established. Anthrax vaccine should continue to be considered as a potential cause for undiagnosed illnesses in Persian Gulf military personnel because many of the support troops received anthrax vaccine, and because the DoD believes that the incidence of undiagnosed illnesses in support troops may be higher than that in combat troops.[xi]

This position was reiterated by Colonel Arthur Friedlander, the Army’s Chief anthrax vaccine researcher, in a chapter in a medical textbook, Plotkin’s Vaccines, stating that the anthrax vaccine was “unsatisfactory for several reasons.”[xii] Among these reasons were the high adverse reactions and the unknown “degree of purity” of the vaccine. The Senate Committee on Veterans’ Affairs, after hearing Major General Blanck’s testimony and many others, found in its 1994 report that “the vaccine’s effectiveness against inhaled anthrax is unknown. Unfortunately, when anthrax is used as a biological weapon, it is likely to be aerosolized and thus inhaled. Therefore, the efficacy of the vaccine against biological warfare is unknown. . . . The vaccine should therefore be considered investigational when used as a protection against biological warfare.”[xiii]

By 1995, the DoD had, it appears, two plans in place to gain licensure for the anthrax vaccine as a pretreatment for a biological warfare attack. The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) had “developed a new recombinant protective antigen vaccine against anthrax. This vaccine was successfully tested in experiments using animals but has not been tested on humans.”[xiv] USAMRIID officials stated that the testing on this new vaccine “would take about 3 years, and FDA approval of the manufacturing of the vaccine could take years longer.”[xv] Either this dissuaded the DoD from pursuing this approach or the DoD had a concurrent plan to approach MDPH to see what kind of arrangement could be made with respect to the existing vaccine. In light of the previous DoD articles, responses, letters and statements, it appears that the length of time to bring an updated, recombinant vaccine through the FDA approval process was unacceptable and the project was abandoned.[1] A House Committee attributed the DoD’s abandonment of the new generation vaccine to the time it would take to complete FDA approval, perhaps 6 to 8 years.[xvi] In 1999, the “DOD consider[ed] further development of this [new] vaccine candidate an unfunded requirement.”[xvii] One has to wonder if this new vaccine’s status had anything to do with fear of undermining the new anthrax program that was announced in 1997. The GAO and Congress both criticized the DoD for focusing “almost exclusively on the older, FDA approved vaccine, to the exclusion of development work on newer, recombinant vaccine formulations.”[xviii] Whatever the reasons,[2] in 1995, the DoD shifted its focus from developing a newer, better vaccine to amending the license for the existing vaccine.

In September 1995, the DoD contracted with Science Applications International Corporation (SAIC) to develop a plan to obtain FDA approval for use of the existing anthrax vaccine as a pretreatment for aerosol exposure to anthrax in a Biological Warfare (BW) environment. SAIC conducted an analysis and presented a plan to the Army that explained that there would be a significant informed consent obstacle to implementing this change in order to meet the regulatory requirements of the FDA and CBER. Dr. Anna Johnson-Winegar (U.S. Army) explained the legal status of the vaccine to Dr. Robert Myers (MDPH) in quite simple terms:

“This vaccine is not licensed for aerosol exposure expected in a biological warfare environment.”[xix]

Here is incontrovertible evidence that DoD officials at significant levels were acutely aware of the legal status of the anthrax vaccine at least two years before the anthrax program was commenced. While this is damning, it is only so because of the subsequent DoD actions. At the time, however, it appeared that DoD was preparing to comply with the regulatory requirements for obtaining a change to the existing license in order to get an indication for use against inhalational (aerosol) anthrax exposure expected in the BW environment.

In October 1995, the Joint Program Office for Biological Defense (JPOBD) held a meeting to develop a plan for obtaining the necessary FDA approval for amending the existing AVA license. The minutes from that meeting indicate that the Army knew it had two big problems in obtaining FDA approval of a new licensed indication for inhalation anthrax. First, the efficacy tests used to license the vaccine were for a different vaccine, the Merck vaccine used by the Brachman study rather than the MDPH vaccine. Second, there was no scientific data (the necessary two “well-controlled human studies”) to support this change by FDA. [xx] A meeting was held on 20 Oct 1995 to discuss the process for modifying the MDPH anthrax vaccine license for several purposes: to indicate a reduced number of injections, to include a different route of administration (intramuscularly as opposed to subcutaneous), and to expand the indication to include protection against aerosol challenge of spores. Col. Arthur Friedlander said that “the original series of 6 doses was established in the 1950’s for an anthrax vaccine similar to but not identical with the MDPH vaccine.”[xxi] The minutes also noted what had been commented on by the 1985 FDA panel review of the AVA: “Studies of vaccine (not MDPH product) effectiveness in humans working in tanneries showed protection against cutaneous disease, but there was insufficient data to demonstrate protection against inhalation disease.”[xxii]

This meeting also portended the beginning of the public relations campaign for the anthrax vaccine. Prior to that, however, Brigadier General Busby, the Joint Program Manager for Biological Defense, stated that: “the DoD’s position is ‘soldiers are citizens first’ and whatever studies are formulated, they have to be done with this concept in mind. Soldiers have the same Constitutional rights as other citizens.” These comments may have been addressing one of the SAIC briefing slides at that meeting. The slide is entitled “Volunteer Considerations” and is a comparison of two groups for use in any studies to amend the license for the vaccine. It depicts two rows: on one side is “At-Risk Forces” and on the other is “Normal Volunteers.” There are bulleted points on either side, indicating pros and cons of using the two groups. The At-Risk Forces have in their favor, it would appear, that using them would serve “Dual Purpose[s]” – “Immunized (??) force” and “Study needs.”  However, on the down side, At-Risk forces have “Informed consent complications,” which include record keeping and “assignment issues,” probably referring to the frequent rotation of service members. “Normal” volunteers have the problem of availability, but once you have them, there is better “access for study needs and record keeping”. They also come with a “cost” and using them “doesn’t support immediate readiness needs.” Finally, the last point against using soldiers points out the DoD’s concerns with public relations from the beginning: “Soldier ‘guinea pigs’ criticism.”[xxiii] Whether BGen Busby had his mind changed on soldier’s rights by the brief or not, he made an odd pronouncement at a meeting on the license amendment for the vaccine. According to the minutes, he “addressed the need to make the case that anthrax is currently the principal biological warfare threat. By protecting against anthrax and other BW threats, the vaccines serve as a deterrent.”[xxiv] We do not have transcipts of those meetings and we don’t know how exactly he “addressed” this supposed “need,” but it is troubling on many levels because it is a sweeping statement justifying the use of vaccines against an invisible, perhaps even non-existent, threat. A cynical person might reasonably infer that the General is suggesting running a PR campaign on the American people to justify knowingly using an unlicensed vaccine. It is also odd because this is not a meeting of operational planners discussing the terrorist threat to U.S. Forces. These are doctors mostly, discussing how to get a license amendment for the anthrax vaccine and suddenly a one-star starts talking about the need to make a case for the vaccine as a BW deterrent. There is no discussion about the intelligence or evidentiary basis for such a conclusion, nor an explanation as to why military doctors would need to ‘make the case.’ One can imagine the hushed silence or, perhaps worse, the nodding heads, after the General makes that statement. Was this an implication that informed consent was to be side-stepped and patients were to be told that this was a great deterrent to anthrax attack? Was this to begin some media campaign to justify the use of this vaccine off-label?  Whatever it was, the idea of soldiers having the same rights as other citizens did not ultimately win out.

In accordance with one of the decision tree slides from the 1995 briefing, the U.S. Army was supposed to help MDPH prepare an Investigational New Drug Application in an effort to amend the license for three reasons: (1) a new route of administration, (2) a reduced shot schedule (from 6 to 3), and (3) to obtain an indication against aerosolized anthrax. This IND application was pending with the FDA at the time of all of the courts-martials mentioned in the prior chapters. The importance of this application cannot be overstated. By law, that application becomes effective thirty days after it is submitted for the purposes set forth therein. This means that if someone administers the drug in accordance with the IND submission protocol, by definition and by law it is an investigational use of the drug. That IND was not withdrawn, modified, or otherwise dismissed by the FDA.

If the above wasn’t enough to demonstrate conclusively the absurdity of the DoD position, consider this: the clinical protocol for this IND was being conducted at Fort Detrick, Maryland, a U.S. Army base; it was being run by DoD doctors and administrators; and the volunteers were U.S. Army soldiers. Amazingly, in the coup de gras, the soldiers in that study were given information about the anthrax vaccine, filled out and signed consent forms, and they were using the exact same vaccine that DoD was concurrently compelling regular troops to take under threat of court martial. The IND application was submitted following an Army, Joint Staff, and OSD staff process in which there was concurrence that it was necessary to obtain FDA approval of a new licensed indication for inhalation anthrax before DoD could start mass anthrax vaccinations.[xxv]

For whatever reason, this consensus was reversed within a month of William Cohen’s confirmation in January of 1997 as Secretary of Defense. This followed significant DoD pressure on the FDA, much like in 1990 prior to the Gulf War, to get permission to begin use of the anthrax vaccine for inhalation anthrax without obtaining a new licensed indication or completing the scientific investigation proposed by the Army in the IND application.[xxvi] There were phone calls made, including one by Admiral Ed Martin, a U.S. Navy doctor and the Deputy Assistant Secretary of Defense for Health Affairs, looking for a new interpretation of the anthrax vaccine license, one different than the DoD’s long-standing position that the vaccine was not licensed for inhalational anthrax.

Now (in 1997) the DoD wanted the FDA to say that the anthrax vaccine was licensed for such a use. On March 4, 1997, four days after the retirement of long-time FDA commissioner Dr. David Kessler, the man who had negotiated and required DoD to get a Rule 23(d) waiver on the verge of the Gulf War, Dr. Stephen Joseph, the Assistant Secretary of Defense for Health Affairs, wrote to the acting FDA commissioner and stated that the “DoD has long interpreted the scope of the license to include inhalation exposure, including that which would occur in a biological warfare context.”[xxvii] Given what was already on the record by DoD officials, that statement cannot be spun any other way than as a bald-faced lie. In addition, Dr. Joseph asked “whether FDA has any objection to our interpretation of the scope of the licensure for the anthrax vaccine.” If Joseph’s assertion regarding the DoD’s position on the anthrax vaccine was correct and this belief was “long-standing”, then why would the DoD need to join in a clinical protocol and get an indication against aerosolized anthrax? Why did they even need to address that indication with the manufacturers? And why would the holder of the license, the maker of the vaccine, who presumably knows something about its own licenses and products, ask for an amendment to get the vaccine indicated for inhalational anthrax?  The answer is quite simple and mandated by the Food, Drug, and Cosmetic Act: it is because the AVA was never licensed for use against an aerosolized biological warfare attack.

On March 13, 1997, acting FDA commissioner Dr. David Friedman abandoned the FDA’s regulatory role. He offered that “[w]hile there is a paucity of data regarding the effectiveness of Anthrax Vaccine for prevention of inhalation anthrax, the current package insert does not preclude this use . . . Therefore, I believe your interpretation is not inconsistent with the current label.”[xxviii] Notice that Friedman has now completely turned the law and FDA regulations – and the English language – completely on its head. The DoD now (apparently) had the green light it wanted and needed to go forward claiming that the vaccine was “FDA approved” for inhalational anthrax… Almost.

There are obvious problems with these type of back-door, inter-office memos serving as policy statements of an agency: they circumvent the entire regulatory process. One person does not simply wave a magic wand and make a vaccine or drug licensed. Fortunately, enough people were apparently cognizant of the fact that outside entities might place undue reliance on the private informal opinion of FDA staff that the FDA drafted strict requirements for what it refers to as “advisory opinions” that might bind or commit the agency. 21 C.F.R. § 10.85(k) specifically states:

a statement made or advice provided by an FDA employee constitutes an advisory opinion only if it is issued in writing under this Section. A statement or advice given by an FDA employee orally, or given in writing but not under this Section or §10.90 is an informal communication that represents the best judgment of that employee at that time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.[3]

The above-mentioned “Friedman letter,” while consistently and extensively relied upon by the DoD as “proof” that the AVA was not an Investigational New Drug, was not issued under either of the required C.F.R sections. Accordingly, the letter is nothing more than an “informal communication” that has absolutely no legal effect. As such, the letter cannot modify the clearly defined legal status of the AVA that results from filing of the IND application by MBPI. What is even more bizarre about the DoD trying to solicit a favorable opinion about the AVA from the brand-new head of the FDA is that they are not even the manufacturer: they are a third party that wants to use it, but in no way does DoD have any ‘standing’ to do this where the company that makes the drug did not seek the FDA’s opinion on the vaccine’s status. This would be like Dow Chemical or Merck having an IND application for a drug pending before the FDA and then the American Medical Association steps in to ask the FDA to announce that the drug is actually not an IND, but licensed for the exact purpose that the drug’s own manufacturer is running a clinical testing protocol.

The second reason that the letter is of no legal effect is that the Supreme Court had recently decided a similar case, Christensen, et al v. Harris Country, et al.[xxix] The Supreme Court specifically found that agency “personal opinion” letters are not entitled to deference by the Court, but only to “respect” – and then only to the extent that the letter’s interpretations are persuasive.[xxx] In this case, in light of the FDA regulations, Dr. Friedman’s letter is completely illogical because it rewrites the entire FDA regulatory scheme. His letter states that the DoD’s interpretation is “not inconsistent” with the approved labeling. This is nonsensical because drugs are designed, tested, and licensed for a specific purpose, not licensed for what’s on their label AND anything not inconsistent with that label. How could such be the case with the requirements for showing efficacy through two well-controlled human studies? In short, Dr. Friedman’s letter was worth little more than the combined total of the ink and paper with which it was written. Indeed, there could be no other result, given the fact that the letter is totally at odds with the IND application language of the manufacturer. It makes absolutely no sense to believe that an FDA official writing in his personal capacity can single-handedly invalidate the regulatory scheme adopted by the FDA to prevent the licensing and interstate movement of Investigational New Drugs at the request of some third party.

What is truly mind-boggling about Dr. Friedman’s response is that just one week later, on March 20, 1997, CBER, the sub-agency of the FDA responsible for monitoring and inspecting the vaccine’s manufacturer, would issue the Notice of Intent to Revoke (NOIR) letter. To emphasize the recurring problems FDA had found at the manufacturer’s plant, the FDA letter stated:

While these deviations were documented in the most recent inspection, we note that significant deviations have been documented during previous FDA inspections of May 4 through May 7,1993; May 31 through June 3, 1994; and April 24 through May 5, 1995. The seriousness of these deficiencies was emphasized to you in a letter dated December 22, 1993, and a Warning Letter dated August 31, 1995.[xxxi]

To sum up, at the exact moment that the DoD is soliciting a favorable opinion/back-door approval from the head of the FDA for the AVA, the manufacturer is about to have its entire manufacturing process invalidated and threatened with having its license to manufacture the vaccine pulled by the results of FDA inspections. In an interview with the Canadian newspaper The Province, Mark Elengold, the Deputy Director for Operations at CBER, explained the significance of an NOIR letter. “. . . In the three years I have been in this job, I have done it about three times,” said Elengold. “It is a very serious tool. We view it . . . to be equivalent to an injunction . . . where we get a court to order compliance.”[xxxii] While the legal effect of Dr. Friedman’s letter is nil, it does make for great Public Relations and that’s exactly how the DoD would use the letter in seeking to win the PR battle that was about to begin. A number of interesting initiatives, press briefings, and press releases began not long after Dr. Joseph’s letter and Dr. Friedman’s response in March 1997.

In retrospect, an overall pattern starts to emerge. There were several fronts on which the Secretary of Defense and the DoD tried to outdistance criticism of the program. The first claim was that the vaccine was “licensed.” This category had several sub-claims, such as long-term safety, use on veterinarians, and proven effectiveness of the AVA. The problem with these statements is, of course, their lack of completeness and/or their outright falsity. Some of these statements were well-beyond being just “spin.” As another example, at a background briefing on December 15, 1997, two senior defense officials laid out the upcoming anthrax vaccine immunization program (AVIP), noting that it was still six months away. There reporters asked some questions.

Q:  The availability of the vaccine at this point, if you wanted to do a large program tomorrow, is there a stockpile of this vaccine available?

A:  There’s a stockpile right now of seven million shots, which is about 1.2 TED – troop equivalent doses – of six shots, if you will. So there’s a large stockpile.

A:  But that’s the stockpile . . .  We’re redoing the testing on it just to be absolutely certain before we go out. There’s been a great attention to safety in this.

Q:  You found no impurities in the stockpile…

A:  No.

This answer came six months after the process for manufacture had been invalidated by CBER.

The second area where the DoD attempted to promote the AVA harkens back to Brigadier General Busby’s statements at the meeting about the license amendment plan. There he talked about the need to “make the case” that anthrax was the number one biological threat. This was relatively easy to accomplish because anthrax is a real biological threat, but the DoD would engage in an unprecedented fear-mongering campaign in order to support the vaccine. Making it even easier were events in the headlines, such as Aum Shinryuko cult’s sarin gas attack on the Tokyo subway, and the U.S. members of the U.N. inspection teams being forbidden from participating in Iraqi weapons’ inspections by Saddam Hussein. DoD briefers never missed an opportunity to point to the possibility of a terrorist attack on U.S. soil or to exaggerate the lethality of anthrax.[xxxiii] This is not to say that it is not lethal, but DoD briefers constantly called it “100% lethal,” which is a bizarrely hyperbolic claim. What does “one-hundred percent lethal” even mean? Does that mean everyone who breathes in even a molecule of anthrax spores? The answer to that is unequivocally “No.” What amount constitutes a lethal dose then? One briefer referred to 10,000 spores, while other DoD information refers to the LD₅₀ as the number in thousands of spores that constitutes a lethal dose. The SecDef himself participated in this campaign with his then-famous quote during a live TV appearance with Cokie Roberts on ABC’s “This Week.” While holding a five pound bag of sugar, Cohen said that if “this was anthrax, it could wipe out half the population of Washington, D.C.”[xxxiv] One expert later called that “one of the most irresponsible statements ever made by a politician.”[xxxv] Additionally, Secretary of Defense Cohen gave several speeches about the proliferation of these weapons, exaggerating the number of countries capable of manufacturing and delivering such weapons. In three different speeches, Cohen put the number(s) of countries capable of weaponizing anthrax at 30, 25, and finally 10.[xxxvi]

The final area of this media campaign was a kind of rhetorical fallback position, which consisted of a series of statements that can be summarized as “what else are we supposed to do?” The old “if it saves even one life” play. A number of high-ranking DoD officials made statements to the effect that they would be “derelict” if they didn’t give this vaccine in light of the threat, or that they were “morally obligated” to vaccinate soldiers, or that “it’s the best response” or “it’s the only response” that we have. These statements frequently relied upon the record of the individual making the statement as a testimonial to the vaccine’s necessity.

The problem with all of this is that it ignores three critical aspects of immunizing people against their will. First, it ignores the law requiring informed consent. Second, it ignores the lack of efficacy for the claims being made in support of the anthrax vaccine. In other words, there had been no studies, and could never be ethically, proving the effectiveness of the vaccine against aerosolized anthrax. Even the animal studies, while promising, indicated a less than stellar performance against certain strains of the anthrax bacillus.[xxxvii] Finally, it completely elides the validity and viability of other (non-vaccine) treatments.

There existed at the time a highly effective, fully licensed antibiotic with studies showing excellent success rates against anthrax if taken right after exposure. This has been a common military method of response to a number of other chemical agents, so there didn’t seem to be any explanation as to why the DoD couldn’t use these already licensed antibiotics in the event of an anthrax attack.[4] An illustration of the DoD’s refusal to consider other treatments occurred at the December 15^th press briefing, when a reporter asked about other treatments against anthrax. The briefer’s answer:

With regard to those medical countermeasures, antibiotics. They’re effective in sustaining service members until antibodies are built. Provides immediate protection, but it has to be sustained over a period of time, until the antibodies are developed. There are limited minor side effects with the dosage required of the antibiotics. Antiserum is a very fast reacting, immediately protection capability, but again, it’s limited, and it has to be re-administered to sustain protection. It’s expensive and the same minor side effects are associated with it.

Vaccines are the way to go. It takes time to develop the immunity, but the immunity lasts for a long time. Limited, minor side effects. I think the rate of those folks that we’ve vaccinated over the last five years associated with their jobs — either lab workers, workers in industry in the private sector, special operations forces, there’s been about a 96-97 percent rate of no reaction at all, and those that did have had limited topical reactions, minor swelling or redness, things like that.

It’s extremely difficult to circumvent a vaccine. This would ward against genetic engineering of other strains. Once that vaccine’s in, it takes a major effort for an unfriendly nation to try to develop another type of anthrax strain that we would have to dissect, if you will, figure out what it was and then rework our vaccine. But it is very effective. It provides the protection we need over the long haul.

The briefer acknowledges the immediate nature of antibiotics and the long time necessary to develop immunity for vaccines, but offers that “vaccines are the way to go.” Additionally, probably most surprising, are the briefer’s references to the “minor reactions” (with a negative implication – “you’ve still got those minor reactions”) and the incredible claim of “96-97 percent no reaction at all” with the AVA, something that had never been true of the AVA. The briefer’s claims that the vaccine “would ward against genetic engineering” of other strains also had no evidence to support it. This makes the briefing read rather like an unsubstantiated point-by-point denial of the criticisms that had been levelled against the program. Either the briefer was unaware of BioPort’s problems, the DoD’s own studies on the highly reactogenic nature of the AVA, badly informed, or he was straight-up lying. With the DoD and this program, it is difficult to know which one.

The DoD’s media campaign was fairly extensive, involving many briefings with the press in each of the above areas. For example, On April 16^th, 1997, two senior defense officials gave a briefing on the DoD’s role in helping to train and “enhance the capability of federal, state, and local emergency response agencies to prevent and respond to domestic terrorist incidents involving weapons of mass destruction.”[xxxviii] On April 25, 1997, a notice was sent to the press that the Marine Corps’ Chemical Biological Incident Response Force (CBIRF) would conduct “demonstrate its ability to effect consequence management following the simulated detonation of a chemical-biological terrorist device” in the Washington, D.C. area on April 30^th. On April 28^th, 1997, Secretary of Defense Cohen gave a speech at the University of Georgia, speaking at a conference on Terrorism, and told listeners that a rogue state attack using chemical-biological weapons was “not only plausible, it’s really quite real.”[xxxix] In fact, he told his audience that “about 30 countries now possess mature chemical and biological weapons programs with 12 having advanced missile capabilities.”[xl] Secretary Cohen emphasized a comprehensive response that included active and passive measures against such attacks. By November 1997, when U.S. members of the U.N. Inspection teams were not allowed by Saddam Hussein to participate in weapons’ inspections, anthrax and chemical-biological warfare (CBW) and weapons of mass destruction (WMD) were being talked about as imminent. There was November 14, 1997, briefing by a senior defense official on Iraq’s CBW capability.[xli] On related fronts, General Ronald Blanck, the Army’s Surgeon General, and Vice Admiral Dennis Blair, on November 6, 1997, were briefing the press on the DoD’s improved ability to track vaccine’s and medical health of service members.[xlii] This would of course be a crucial part of any DoD vaccine program because of its historically atrocious record (including in the Persian Gulf War), which has already been laid out in prior chapters.

In sum, the DoD’s position on the AVA went from an open acknowledgment of the vaccine’s scientific and legal limitations in light of the vaccine’s history, to one of hyperbolic and straight-up false statements about its biological safety and efficacy and its legal status. This cannot be explained by bureaucratic turnover, or loss of institutional knowledge, because in many cases it involved the exact same people and agencies reversing their position within weeks, or even days, in some cases.

Endnotes

[1] Ironically, had this approach been taken, by 2002 the DoD would have had a new generation anthrax vaccine, presumably more effective and less reactogenic than the current vaccine, but more importantly, one actually licensed for its intended use. The quick fix did not turn out that way. A Congressional committee reached the same conclusion in 2000. See House Committee on Government Reform, 106 H. Rpt. 556.

[2] I do offer some hypotheses and supporting evidence for them as to why the DoD changed courses in later chapters. It is for the reader to decide if that evidence is compelling enough to support those assertions.

[3] The informal and non-binding nature of such “advice” is also made clear in the IND regulations themselves.  21 C.F.R. § 312.41(c).  Moreover, it is noted that the communication did not even involve the IND applicant, Bioport, Inc.

[4] I address possible/likely reasons that the DoD insisted on this particular vaccine over all other possibilities in later chapters and let the reader decide.

[i] Congressional Impeachment hearings on Pres. Richard Nixon.

[ii] Request for Proposals (RFP) No. DAMD 17-85-R-0078, US Army Medical Research Acquisition Activity, Fort Detrick, Frederick, MD, 16 May 1985.

[iii] Id.

[iv] Congressional Hearings on the Anthrax Vaccination Program, Oct 12, 1999, NSVAIR (II), testimony of Dr. Kathryn Zoon, cited in H. Rep. 106-556, fn 22, “DoD AVIP: Unproven Force Protection.”

[v] Id.

[vi] FDA Form 483 Inspectional Observations, 25-23 November 1999.

[vii] Letter from former Assistant Secretary of Defense Robert B. Barker to former U.S. Sen. John Glenn, chairman of the Senate Governmental Affairs Committee, 24 Aug 1989, transcript of Senate Hearing 101-744. The letter and quotes from Barker to Glenn are on page 474 and 480.

[viii] Congressional Hearings on the Anthrax Vaccination Program, Oct 12, 1999, NSVAIR (II), testimony of Dr. Sue Bailey, cited in H. Rep. 106-556, fn 22, “DoD AVIP: Unproven Force Protection.”

[ix] Id.

[x] Infectious Disease Clinics of North America, 3/90, p. 156

[xi] Maj. Gen. Ronald Blanck, Commanding General, Walter Reed Army Hospital, to Committee staff, 414 Russell Senate Office Bldg., Washington, DC, 4 Feb 1994, from Senate Report 103-97, 8 Dec 94, page 35.

[xii] Plotkin’s Vaccines, ed. Stanley A. Plotkin, Walter A. Orenstein, Kathryn M. Edwards. See chapter by Dr. Arthur Friedlander on anthrax.

[xiii] Senate Veterans Affaires Committee staff report 103-97, 414 Russell Senate Office Bldg., Washington, DC, 4 Feb 1994, from Senate Report 103-97, 8 Dec 94, Note 61-63.

[xiv] GAO T-NSIAD-99-226, July 21, 1999 (p. 10)

[xv] Id.

[xvi] H. Rep. 106-556, p. 32.

[xvii] GAO report 99-226 p. 10

[xviii] H. Rep. 106-556

[xix] SAIC Corporation plan, 29 Sep 1995, enclosure to memorandum from Dr. Anna Johnson-Winegar (US Army) to Dr. Robert Myers (MDPH), US Army Medical Research and Material Command, Fort Detrick, Frederick, MD, 5 Oct 1995.

[xx] LTC David Danley, “Minutes of the Meeting on Changing the Food and Drug Administration License for the Michigan Department of Public Health (MDPH) Anthrax Vaccine to Meet Military Requirements”, held on 20 Oct 1995 meeting; Joint Program Office for Biological Defense memorandum, 13 Nov 1995.

[xxi] Id.

[xxii] Id.

[xxiii] Briefing slide from Anthrax Vaccine License Amendment Plan: Information Briefing for Joint Program Manager, DoD Biological Defense, page 18. Oct 19, 1995.

[xxiv] LTC David Danley, “Minutes of the Meeting on Changing the Food and Drug Administration License for the Michigan Department of Public Health (MDPH) Anthrax Vaccine to Meet Military Requirements,” held on 20 Oct 1995 meeting; Joint Program Office for Biological Defense memorandum, 13 Nov 1995.

[xxv] Id.

[xxvi] Dr. Stephen C. Joseph, DoD ASD/Health Affairs, letter to FDA Lead Deputy Commissioner Michael Friedman, 4 Mar 1997

[xxvii] Id.

[xxviii] Id.

[xxix] 120 S. Ct. 1655, 2000 U.S. LEXIS 3003 (May 1, 2000).

[xxx]  Christensen, 2000 U.S. LEXIS 3003 at 19-20.

[xxxi] FDA letter to MBPI, 20 Feb 1997.

[xxxii] Ann Rees, “Their Dangerous Dose,” The Province [Vancouver, Canada], 25 Jun 2000

[xxxiii] See, e.g., DoD Press Briefing, Dec. 15, 1997.

[xxxiv] SecDef William Cohen on “This Week” with Cokie Roberts, Nov. 1997.

[xxxv] Paul Richter, “Experts Assess Risk of ‘New Terrorism’ Threat,” Los Angeles Times, Feb. 7, 2000.

[xxxvi] Combating Weapons of Mass destruction, by Jim Garamone, AFPS, 4/30/97; William S. Cohen, “Preparing for a Grave New World”, Washington Post, Op Ed., July 26, 1999; William S. Cohen, “Force Protection is My Priority”, Army Times, July 31, 2000.

[xxxvii] See GAO Report T-NSIAD-99-148, FN 4, 5.

[xxxviii] DoD Background Briefing, Apr 6, 1997.

[xxxix] Combating Weapons of Mass destruction, by Jim Garamone, AFPS, 4/30/97

[xl] Id.

[xli] Nov 14, 1997, DoD background briefing

[xlii] DoD News Briefing, Nov 6, 1997.