Institutional Ethics
And the Defense Department's
Anthrax Vaccine Immunization Program

Testimony to the Institute of Medicine
By Major Thomas L. Rempfer
April 18, 2001

Thank you for the opportunity to present testimony to the Institute of Medicine (IOM) as you evaluate the safety and effectiveness of Anthrax Vaccine Absorbed (AVA), in accordance with your charter by the United States Congress.

Today, I hope to discuss the concept of Institutional Ethics as it relates to the Department of Defense's (DoD's) conduct in the implementation and administration of the Anthrax Vaccine Immunization Program (AVIP). Some may question if an ethics discussion is an appropriate topic for a scientific body evaluating the safety and efficacy of AVA. The simple answer is that an ethical breakdown occurred within the institutions of the government that allowed a vaccine supported by a "paucity of science" ; in the IOM's own words, to be the foundation of a military immunization program mandatory for all United States Servicemembers. This breakdown, recognized by the United States Congress, necessitated the AVA safety and effectiveness study in which you are now engaged.

In addressing ethics, my goal is not to discuss personal ethics, but instead to concentrate on an organizational level, and the macro ethical issues essential to our democratic government of complex checks and balances. On the personal level, we all pledge oaths to medicine, or to the Constitution, or to both, and conduct ourselves on a micro basis with honor and integrity based on prescribed codes and values. But what happens when on an institutional level it becomes obvious that a branch of government, an agency of our government, a department as a whole, or at least in the implementation of a single program, is ethically corrupt? Even worse, what happens when several institutions or agencies of our government allow themselves to be corrupted by one department or agency through blind adherence to an ethically corrupt policy, while that entity cloaks itself in moral imperatives? What happens when the institutions of America's government are intimidated and used by this department that was intended by the Founding Fathers to be subordinate to all other implicated civilian agencies, branches, and institutions?

The case I will make to you documents such an institutional ethical lapse. The Defense Department is the culprit and the IOM is merely the latest in a long list of agencies or branches of government the DoD would hope to manipulate and intimidate with threat briefings, and their latest post-facto science, to justify the anthrax vaccination program. The question remains as to whether or not the Institute of Medicine will allow itself to be similarly 'used' and become the latest institution to aid in the DoD's rationalization of the punishments, discharges, imprisonments and illnesses inflicted upon our nation's Servicemembers? I respectfully remind you that the, "anthrax vaccine's manufacturing process is not validated" by the FDA to this day, and was never originally properly approved. Despite this fact, over 500 active duty Servicemembers, and over 300 Guard and Reserve members have been discharged during the earliest stages of the stagnated program. Additionally, almost two-dozen young enlisted men have served jail sentences as a direct result of this ethical dilemma - one where senior leaders cannot answer the legitimate safety, effectiveness and legal questions posed by the soldiers they are punishing.

Rather than reiterate the details of a multitude of reports published which chronicle the lack of truthfulness of the AVIP, I will instead reference the US Congress House Government Reform Committee Report, 106-556 , and hearing reports documenting the most recent Congressional analysis of this issue. Additionally, Connecticut's Attorney General submitted a letter to the Secretary of Defense documenting more recent revelations about the illegal nature of AVA. Finally, Citizen-Soldiers and Parents, dedicated to reversing the institutional deception embodied by the AVIP, have made their own research and information available which documents the integrity violations and inconsistencies inherent within the AVIP.

Regardless of the reasons behind the AVIP, the reality is the IOM is convened today because the original science did not support the glowing Orwellian "education" program embarked upon by the DoD, or at a minimum it was questionable. This quandary for Servicemembers ordered to submit to the vaccine is directly responsible for the citizens and soldiers who ask you today to put forth your greatest effort in honestly evaluating the new science presented to you with the greatest caution. Just as you wrote in your preliminary report on the AVA that there is a "paucity of science" documenting AVA's safety and efficacy, similar determinations have been reached by other government agencies, concluding that the mandatory AVIP is not being administered in accordance with FDA regulations based on AVA's investigational application. The AVIP also represents a violation of the law, 10 USC 1107, since only the President of the United States can mandate waivers of a Servicemember's prior consent.

Concerns of the troops faced with the mandatory AVIP created the impetus for these reports. Legislators, and their staffers, willing to listen and look beyond the DoD hype and rhetoric, researched the AVA discovering a stark dichotomy when you compare what the DoD says today to the methodical scientific research documented in medical journals and government documents prior to the implementation of the AVIP. The conclusion in advance is inevitable: Servicemembers are only pointing out today what the DoD and the FDA said in the years past, such as the following key examples represent:
  1. 1985: DoD - Request for Proposal for a vaccine that was safe and effective.
  2. 1989: Senate testimony by DoD concerning the limitations of AVA.
  3. 1994: DoD's Col. Friedlander acknowledged that AVA is "unsatisfactory."
  4. 1994: Senate Report 103-97 deeming DoD's use of AVA "investigational."
  5. 1995: DoD Documents acknowledging AVA is "not licensed" properly.
  6. 1997-1999: FDA inspections rendering AVA's manufacturer "not validated."

As your Congressionally chartered IOM study contemplates its place in this debate, I implore you to reflect on these previous facts, extracted from Department of Defense letterhead, from DoD's testimony to Congress, from Congress' 1994 review of the vaccine, and from FDA's own continued lack of validation of the manufacturing process for the product your are researching. Just as the United States Congress carved its own place in the 'Threat of Communism' debates of the McCarthyism Era decades ago, the IOM is required to draw conclusions that will decide the debate on AVA one once and for all. Your Institution must either chose to go with the inertia against any who would be soft on bio-warfare or bio-terrorism, just as the Sen. McCarthy attacked all who would be soft on communism, or to take pause just as many Servicemembers, Parents, Legislators and Staffers have done in the past three years after reflective study. Many lives and careers were destroyed by McCarthyism groupthink, and the AVIP debacle is no different.

The IOM has an important choice to make in this chapter of the book on institutional ethics. Will you validate new studies and data of an old vaccine, extrapolated by organizations with a vested interest in their success, to justify a three-year-old vaccination policy? Will you validate future vaccinations with a product recognized previously as inadequate? Does the new science presented by the DoD warrant an endorsement for AVA and the AVIP, or will pre-1997 medical evaluations of an old vaccine and the FDA non-validation stand? Will the IOM allow the science to be rewritten, similar to the American Public Health Association's most recent Manual on Communicable Diseases, or will they not allow individuals on the micro level to affect their institutional integrity on a macro level.

These are important questions conjured up only through time and experience, but they're ones you will be required to answer as an institution chartered by and responsible to the Congress of the United States. If this were about science you probably would not be analyzing these issues in April of 2001. If this were about the "threat" than the Defense Secretary should make this case to the President of the United States so he can analyze the facts and make a determination if mass vaccination with AVA warrants the AVIP. If he determined this in the affirmative, our President could waive Servicemember's prior consent rights under the law, and mandate force-wide inoculations. So if this study and this policy are not about the science and not about the threat than I ask you what this debate is all about?

That's why I ask you to consider institutional ethics, and respectfully request you to ponder the rightful birthplace and role of the DoD within our government. Hopefully 'food for thought' on institutional ethics helps to highlight the dangerous precedent created when the DoD misleads our Congress, misrepresents the truth to their Commanders, and falsely educates their own troops. A democracy must take notice of these events and the institutions in our government charged with the authority and responsibility to oversee DoD's conduct must have the courage to do so while enforcing the laws that have been circumvented. Those institutions must analyze whether or not the DoD's role is to justify antiquated medicine of their own invention, or to manipulate and lobby other organizations of our government with less than accurate information. The DoD is an instrument of government, nothing more.

I thank you for the opportunity to present my thoughts based on my experiences to you today. Important issues and concepts are at stake and my sincere hope is that you consider the possibility that this debate is really not about the threat of anthrax, or the anthrax vaccine at all. Instead, I believe it's about the kind of military our democracy requires to protect and serve our nation.

Major Thomas L. "Buzz" Rempfer
3811 Phelps Road
West Suffield, CT 06093
TRempfer@aol.com
Home: 1-860-668-1512
Fax: 1-860-668-1513