Blog

While many factors can influence an individual’s decision to leave the military, surveyed Guard and Reserve pilots and aircrew members cited the anthrax immunization as a key reason for leaving or otherwise changing their military status. Since September 1998, an estimated 25 percent of the pilots and aircrew members of the Guard and Reserve in this population transferred to another unit (primarily in a non-flying position), left the military, or moved to inactive status. While several reasons influenced their decision, when asked to rank the one most important factor, the anthrax immunization was the highest, followed by other employment opportunities, and family reasons. Further, about one in five (18 percent) left before qualifying for military retirement benefits. Additionally, 18 percent of those still participating in or assigned to a unit reported their intentions to leave within the next 6 months. These individuals also ranked the anthrax immunization as the most important factor for their decision to leave, followed by unit workload and family reasons. Each of these groups—those who have left and those who plan to do so–had accumulated an average of more than 3,000 flight hours, which symbolizes a seasoned and experienced workforce.[i]

The impact of the anthrax program on the Armed Services was substantial. DoD representatives continued to assert that the impact was negligible and that the refusals and courts-martial were only a misinformed minority. This is because the Armed Forces have to answer to Congress for recruiting goals and retention and how money is being spent. Even if the DoD doesn’t have to answer to servicemembers, it does have to answer to Congress for end-strength and staffing. If the anthrax vaccine program was a significant cause of members leaving the service, Congress could quash the program on those grounds alone. Thus, when asking the DoD about the AVIP’s effect on retention and recruiting, the answer was always “minimal”.[ii]

Both anecdotal and empirical evidence, however, show exactly the opposite.

Servicemembers left both active duty and reserve forces because of the anthrax vaccine program. Those who had no other alternative were refusing the vaccine outright and suffering the consequences. Unfortunately, the DoD did not want to know how bad the statistics were and as of October 2000, they still were not tracking refusal numbers or reasons people left the service. When the GAO recommended that exit surveys include a question about whether or not the anthrax vaccine was a factor in their decision to leave, the DoD objected to the question as being “leading” and that it would result in survey bias.[iii] In the study conducted on National Guard and Reserve aircrew, the GAO found significant numbers of people who cited the anthrax vaccine as the number one reason for either transferring to a new unit or for leaving the Guard or Reserve.[iv] As the GAO noted, “[t]hese components [Reserve and Guard forces] provide essential support to critical defense operations on a worldwide basis. They provide strategic and tactical airlift, aerial refueling, aeromedical evacuation, and augment DOD’s overall fighter force.”[v] Not noted in these reports, but important to understand, is that most Reserve and Guard aircrew are made up of former active duty servicemembers. While it is not definitive, neither is it a stretch to opine that the views of this particular segment of Guard and Reserve society is closely reflective of the views of their brethren on active duty. The numbers reveal two disturbing trends.

First, pilots and aircrew left or transferred in significant numbers because of the anthrax vaccine: to the tune of one out of every four (1/4). Of the remaining members, another 18% (about one out of five) indicated that they were leaving within the next 6 months (the survey was conducted from May to September 2000) and they listed the anthrax vaccine as the number one reason. This means that if a unit started with some baseline number of aircrew, it initially lost 25% citing the AVIP as the number one reason. Therefore, the unit is (setting aside new acquisitions for the moment) at 75% of its prior strength. At the same time, one fifth of the remainder will leave within six months. That cuts the unit down to 65% of original strength. The most disturbing aspect of this trend is that new acquisitions will not return the unit to its former functioning as the members leaving had an average experience level of 3000 flight hours, a fairly significant experience level.[1]

Second, adverse reactions were being massively underreported. The GAO survey of 1253 Guard and Reserve aircrew found that of the forty-two (42) percent who had received one or more shots

86 percent reported experiencing side effects or adverse reactions. About 60 percent indicated that they had not discussed any side effect to the anthrax vaccine with military health care personnel or their supervisors—some (49 percent) citing as their reasons fear of losing their flight status, adverse effects on their military or civilian careers, and ridicule. Seventy-one percent reported that they were unaware of the Food and Drug Administration’s Vaccine Adverse Events Reporting System. Slightly less than 6 percent of those who had a reaction reported to this system.[vi]

Here is proof that the VAERS system, upon which the DoD bases its .007 percent adverse reaction rate, is only being reported by 6% of those having adverse reactions. Perhaps it would be better to say that adverse reaction reports are being underreported by a factor of just under 20 (approximately 17). These numbers, as well as the anecdotal evidence, seem to correspond more closely to the AVA package insert’s serious adverse reaction rate of .2 percent.

One related outcome of the study points to the most serious flaw and consequence of the AVIP: the loss of trust in low-level military leadership. There is perhaps nothing more tenuous, and yet necessary and essential, to a military organization than the trust that flows from those being led to their leaders. Unfortunately, in an effort to quash dissent, senior military leaders adopted a leadership style that was characteristic of the Soviet bloc armed forces we stood against for some fifty years – leadership by fear and threat of punishment. In the long run it did not work for those countries and our country is even more ill-suited for that style because of the free-flow of information within the United States. Quite simply, whenever a senior officer makes some factual assertion or claim about the AVA, or the anthrax program, or the manufacturer, or the threat of anthrax, it is a short trip to the library, internet, or other source of information for a soldier to check the veracity of that statement.

The results of the GAO survey showed that while “[m]ost Guard and Reserve pilots and aircrew members support immunization programs in general . . . relatively few appear to support the anthrax program or future immunization programs for other biological warfare agents.”[vii] If the correlation between Reservists and active duty members is valid, servicemembers appeared to recognize what the DoD was not willing to discuss publicly; using vaccines against diseases like the public at large is entirely acceptable, but using vaccines as pretreatments for chemical-biological warfare is a different matter entirely and people are understandably hesitant to allow their bodies to become the future battleground, particularly with the DoD calling the shots. The hard data validates this conclusion.

Almost three out of four (74 percent) of the pilots and aircrew members of the Guard and Reserve believe that immunizations in general are moderately to very effective, and 60 percent believe that immunizations are moderately to very safe. On the other hand, 65 percent, or two out of three servicemembers, reported little or no support for the anthrax immunization.[viii]

This statistic is interesting also because it shows that the DoD’s extensive education campaign was entirely ineffective. The reason for this is, unfortunately, because as more facts were uncovered, it became increasingly clear that the program evolved from telling less than the whole truth, to spin, to (in many cases) outright fabrication. There is nothing more damaging to the trust from subordinates to seniors than for subordinates to believe that their senior leaders have lied and are continuing to lie to them. In fact, several Reserve officers filed a complaint against two senior military officers involved in the anthrax program from the very beginning.

One of the charges in the IG complaint alleges that Colonel Arthur Friedlander, an Army doctor, lied under oath at a Canadian court-martial. A Canadian soldier was being court-martialed for refusing to take the anthrax vaccine, the same one produced by Bioport. The prosecution in that case called Dr. Friedlander as one of its witnesses. On cross-examination, Dr. Friedlander was questioned regarding his knowledge of the 1996 Investigational New Drug license amendment submitted by MDPH, along with the Department of Defense.

Attorney: If I’m going to suggest to you, sir, that the drug was licenced for cutaneous anthrax only and that there has been a subsequent amendment for coverage for inhalation anthrax, would you agree with me or disagree with me?

Col Friedlander:  I’m not aware of that . . .

[Later]

Attorney: In particular, the fifth paragraph, it says that the office, and this is referring to the Joint Program Office for Biological Defense, quote: “‘managed and funded efforts leading to the submission of a Biologic Licensure Application amendment to the FDA,’ including data to support its proposal ‘to license the vaccine to provide protection against aerosol exposure to anthrax.’” Is that something you’re familiar with, sir, or would you disagree with that statement?

Col Friedlander: I’m not sure the details of this. I do know that there were questions that were raised, since there are no direct studies in humans with this vaccine, and that a statement was made by the FDA that the use of the vaccine in the Gulf War against the threat of aerosol use of spores was not inconsistent with the product licence. . . .

Attorney: If I was to suggest to you, sir, that we’ve heard evidence that the vaccine was licenced for cutaneous anthrax and that there was an application placing the drug into IND status with the FDA for three reasons: one, is to change for inhalational anthrax; two, was to change the route of administration; and, three, to change the scheduling of the drugs, would you agree with that or do you know?

Col Friedlander: I know that there have been studies dealing with trying to reduce the number of doses and to look at the route of administration.

Atty: So are you saying, sir, that you’re not familiar with what I’ve said, or you disagree with it?

Friedlander: No, no. I don’t know that ­­ I’d have to look back at the documents that you’re referring to.

Atty: Okay. So you’re not saying the drug is not in an IND status for those three variations?

Friedlander: You know, I’m not clear what you’re saying in terms of ­­ I mean, I’m not quite clear what that means, in other words. There are studies that have been done, that I’m involved with, looking at reducing the number of doses and changing the route of administration.[ix]

Here, Colonel Friedlander repeatedly denies having knowledge about the license amendment for the anthrax vaccine or the vaccine’s investigational status. This is impossible because Colonel Friedlander was personally involved on three occasions in DoD meetings, during which he specifically briefed the three reasons for the IND application, including an FDA license amendment to add an indication for inhalation anthrax. For example, at the October 20, 1995, meeting of the Joint Program Office for Biological Defense (JPOBD) Colonel Friedlander presented a briefing “covering three topics: (1) evidence for a reduction in the number of doses of anthrax vaccine, (2) evidence for vaccine efficacy against an aerosol challenge, and (3) progress towards an in vitro correlate of immunity.” [x] At this same meeting, Dr. Friedlander acknowledged that “there was insufficient data to demonstrate protection against inhalation disease.”[xi]

At another meeting on Feb 9, 1996, which was a follow up to the October meeting, Colonel Friedlander presented another briefing titled “Research Plan to Support Reduction in Dosage of Licensed Anthrax Vaccine (AVA) and Indication for Aerosol Exposure”.[xii] The meeting minutes show that Friedlander discussed the need for the study to show a correlation between animal and human immune response to the vaccine – a recognition that the anthrax vaccine had never demonstrated efficacy for inhalation anthrax in humans.[xiii] This shows an intimate knowledge on Colonel Friedlander’s part about the FDA’s requirements for human studies to prove efficacy of the vaccine.

Finally, on November 10, 1997, Colonel Friedlander presented another briefing to DoD and contractor representatives entitled “Supplement to AVA License.” This was 14 months after the submission of the IND application by the manufacturer, which was submitted in September 1996. The briefing slides clearly show the three changes sought (including an indication for inhalation anthrax) and that Colonel Friedlander was responsible for the pre-clinical portions of these studies intended to obtain FDA approval for these changes.[xiv]

There are only two possible conclusions to be reached when re-reading Colonel Friedlander’s denials at the Canadian court, and neither is particularly favorable. In the best light, he completely forgot everything he knew about the anthrax program and his participation in it. In the worst light, he intentionally lied under oath. In either case, these types of inconsistent statements by senior military officers involved with the program break down the trust between service members and their leaders. This is not even close to being the only instance of this happening.

There was a separate complaint filed by 74 Guard and Reserve officers surrounding statements made by Major General Paul Weaver before Congress. The complaint cited testimony before the House Government Reform Committee’s Subcommittee on National Security, Veterans’ Affairs and International Relations. At a Sept. 29, 1999, hearing in front of the House, Weaver stated:

“So, when I hear all of these other figures about these mass resignations [due to members refusing the anthrax vaccine], and what not, they’re just not there. There are challenges with explaining, with discussing, as they all are, with the members of their unit, on the anthrax issue. But when it really gets down to it, we’ve had 10,700 people inoculated for anthrax in the Air National Guard, with one known refusal.”[xv]

The problem with this testimony is that months before his statement to that Committee, Weaver had been made aware of the resignations of pilots from both the Connecticut Air National Guard and Wisconsin ANG. In the case of the Connecticut pilots, a memo was forwarded to Weaver about the Connecticut resignations. Additionally, both the Wisconsin and Connecticut resignations received widespread media coverage, including the Connecticut resignations being referenced by former Pentagon spokesperson Kenneth Bacon on Jan. 21, 1999. While ultimately the DoD IG did not punish Major General Weaver, it did find that his statement “lacked the necessary element of ‘straightforwardness,’ and so was inconsistent with guidelines for honesty as set forth by the Joint Ethics Regulations (JER).”[xvi] Major General Weaver later qualified what he meant by a refusal, which he defined as a person who had a commitment to the ANG and could thus be subject to disciplinary action, as opposed to someone who could simply resign because their status allowed them to. There were some emails by staff members prior to the General’s testimony that confirm that this definition was being contemplated, but it is clear no such qualifiers were made in the broad statement made to Congress – only one “refusal”, period.

The sum total of these kinds of parsings, misrepresentations, or flat-out lies, is a disintegration in the trust between those being led and those who are supposed to be doing the leading. When 74 officers are filing a complaint because of a General officer’s mis-statements before Congress, there is a serious problem. The DoD’s refusal to acknowledge in sworn testimony before Congress that such a problem even exists, rather than making it go away, only exacerbates the problem and further erodes trust in senior leaders. The final example of this is the most disturbing because at best, it illustrates a severe disconnect between senior military leaders and those they lead and have led (i.e. veterans) and at worst, it is a case of an intentional coverup of experimentation on service members.

In testimony to the Senate Armed Service’s Committee on 13 April 2000, then-Army Surgeon General Lieutenant General Ronald Blanck misrepresented the purpose of the Investigational New Drug application prepared by the Army for the manufacturer. The Senator who queried LTG Blanck was unfamiliar with the Food, Drug, and Cosmetic Act and accepted LTG Blanck’s testimony without question. This question goes directly to the heart of the legal status of the vaccine and the General either lied or was grossly misinformed. It is difficult to believe that the United States Army Surgeon General was not “in the know” about the DoD’s plan to amend MBPI (and then BioPort’s) license.

SEN. ROBERTS: General Blanck, the annual Congressionally mandated chemical and biological defense program report to Congress submitted on March 15, 2000, states: “The Department submitted data to the FDA last year to license the vaccine to provide protection against aerosol exposure to anthrax.” My question is why is the Department seeking a license for the vaccine when the license for the anthrax vaccine has existed since 1970?

GEN. BLANCK:  It is really for the facility, not for the vaccine per se.

SEN. ROBERTS: Oh, I see, okay. All right. That clears that up.

There is a big difference between seeking a license change for a new facility and getting a new indication for the vaccine itself. In light of emails later discovered regarding DoD’s people “on site” and the supplemental testing conducted by the DoD, even in a light most favorable to the General, if he wasn’t lying, then he was either completely misinformed by his subordinates about what was going on (which isn’t reassuring in any way) or completely misunderstood the FDA regulatory process, which doesn’t speak well for his knowledge as the Surgeon General. Furthermore, in 1994, General Blanck, when he was the Commanding General of Walter Reed Army Medical Center, briefed a Congressional committee that

Therefore, its [AVA’s] 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.[xvii]

Just a few years prior, General Blanck asserts that the DoD believes that the AVA should be considered a cause of Gulf War Illness. Yet after his promotion to Surgeon General of the Army and the launch of the AVIP, he tried to disavow these statements. It would be understandable if General Blanck’s change in position were due to some scientific evidence that proves that the AVA is or was not a potential cause of Gulf War Illness. Unfortunately, the evidence continued to mount that the AVA was a possible source of Gulf War Illness. The DoD consistently opposed any study that showed a link between vaccines or other medicines that were given to soldiers and Gulf War Illness. The evidence supporting this would eventually become conclusive and the VA would acknowledge pyridostigmine bromide pills as causal of GWI for VA benefit purposes.

The problem with the dissembling and misstatements by senior military leaders isn’t just the loss of trust from the junior servicemembers. When all of the dissembling continually concerns the anthrax vaccine, it only serves to make people more suspicious of the program. The DoD repeatedly complained that it was “internet misinformation” undermining the program, but the real culprit was the DoD’s own misinformation that served to erode all faith in this program. This pattern of deception was most evident when the issue of the anthrax vaccine and Gulf War Illness came up. The DoD showed just how far it would go to protect the AVA.

Endnotes

[1] In the Marine Corps, for example, someone with 3000 flight hours would most likely be a Major returning to a squadron for a second tour or already into a second tour.

[i] GAO 01-92T p.6

[ii] Statement of MajGen Paul Weaver, USAFR (see background brief).

[iii] GAO T-NSIAD-00-36 p.37

[iv] GAO 01-92T

[v] Id. p. 1.

[vi] GAO 01-92T p.5-6

[vii] GAO 0192T p.4

[viii] Id. p.4

[ix] Canadian court-martial trial transcript, Judge G.L. Brais, 30 Mar 2000, Office of the Chief Military Judge, Canadian Forces

[x] 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.

[xi] Id.

[xii] Col (Dr.) Arthur Friedlander, Minutes of the Anthrax License Amendment Issues Meeting, briefing titled “Research Plan to Support Reduction in Dosage of Licensed Anthrax Vaccine (AVA) and Indication for Aerosol Exposure”, 9 Feb 1996.

[xiii] Id.  Col (Dr.) Arthur Friedlander, Minutes of the Anthrax License Amendment Issues Meeting, briefing titled “Research Plan to Support Reduction in Dosage of Licensed Anthrax Vaccine (AVA) and Indication for Aerosol Exposure”, 9 Feb 1996.

[xiv] Col (Dr.) Arthur Friedlander, briefing titled “Supplement to AVA License” (slides), meeting attended by USAMRIID and contractor representatives, 10 Nov 1997

[xv] House Government Reform Committee’s Subcommittee on National Security, Veterans’ Affairs and International Relations.  Sept. 29, 1999

[xvi] Reported by Dave Eberart, Stars and Stripes, May 11, 2001, quoting from March IG Report.

[xvii] Senate Report 103-97, note 143