Written Testimony of Redmond H. Handy
Department of Defense Anthrax Vaccine Immunization Program (AVIP)
Thank you, Mr Chairman and Honorable Members of the Subcommittee, for this opportunity to testify. I would like to enlighten you as to how I believe the anthrax vaccine is being perceived by the vast and mostly silent majority of service members and explain my involvement with this issue. Last year, about this time, I had been newly promoted to the rank of full colonel in the Air Force Reserves and had done some research on this program, knowing it would affect me and many reservists I worked with for the past ten years.
Initially, I found disturbing information and soon discovered I would be unable to agree with or help enforce this policy as a senior officer, nor could I envision taking the shot myself. I became concerned for fellow service members I have known over the years that they would invite needless health risks while taking a questionably-efficacious vaccine against a mostly-theoretical threat. Subsequently, I co-sponsored a Reserve Officers Association resolution which recommended against using the current, mostly-quarantined anthrax vaccine stockpile. Additionally, I testified against this program in March.
Realizing an irreconcilable difference had occurred between my principles and this DOD policy, I retired in May of this year in protest of the program. Now instead of meeting my first Brigadier General Officer screening board this year, I elected to forego even the status of full Colonel and am now a retired Lieutenant Colonel and civilian using what time and resources I can to raise awareness of this policys ramifications and dangers. The major problem areas I see are listed below and are supported by the nearly 100 pages of backup material provided in this package. I encourage reading this material which will should make it apparent that the anthrax vaccine policy is putting the military on a course of self-destruction.
Impacts on Recruiting, Morale, Retention and Readiness
It was bound to happen sooner or later, but now there is the first reported incident of recruiting being affected by the AVIP. The following account from the Wall Street Journal just last week on September 23 should be both instructive and prophetic:
Later in the same article, another recruit mentions hes considering "his mothers $500 anti-enlistment bonus".
Another perspective on the recruiting dilemma comes from the NY Times, Sep 27 1999:
In a recent on-line article, military columnist David Hackworth thinks the recruiting problems go deeper, as well:
In this recruiting environment, the anthrax vaccine can by itself destroy a potential recruits interest in the military. The growing awareness from media sources of the problems with this policy is contributing to an increasingly negative image of military life and service. What other civilian career field requires as a condition of employment 24 vaccinations of just one type as an adult? Considering the additional 15 or so biological warfare (BW) vaccines under development in the budget and some 50 which could be researched, it is not inconceivable that a military career may soon involve 75 or more injections.
A forthcoming DOD study examines the health effects on lab researchers who have already taken between 150-300 shots in the past couple of decades (mentioned in written DOD Congressional testimony before the House National Security Subcommittee on July 21, 1999). Is this where were headed with BW defense? Making frontline soldiers the equivalent of laboratory worker pin-cushions? While a few brave (?) souls may be willing to give their bodies to science in this manner, it is inconceivable that the average recruit is going to sign up for such an experience with any career, military or otherwise, regardless of potential conclusions that dozens of untried vaccines are both safe and effective.
Have we progressed so far from the supportive environment for the veteran after WWII that now defense dollars need only support contractor needs regardless of how much those contracts might risk or hurt service member health? Where does such doctrinal lunacy come from, anyway?
Anthrax: Threat or Theory?
Before we plunge over this cliff, maybe we need to back up a minute and examine the prospect of an anthrax attack more closely.
Doubts by BW "Professionals" and Defense Analysts - The DOD says its the top biological warfare threat, but if thats so, why does a top former USSR BW official, Dr Ken Alibek, claim that plague and smallpox are the top threats? He was there producing the BW agents. Is his experience of no value to our policymakers? Also, a recent Washington Post article reported that the Sarin terrorist group in Japan had virtually unlimited funds and four years to infect victims with inhaled anthrax, but failed completely to produce even a single case of infection after 8 attempts. If its so easily weaponized as claimed by the DOD, why were they not successful?
Maybe the publics first suspicions about the legitimacy of this program should have occurred when the Secretary of Defense announced the program by holding up a five pound bag of flour and saying if it was anthrax dispersed over Washington, D. C., half the areas population (3 million) would die. He left out important details as to how this scenario could actually occur, such as wind conditions, the existence of an effective dispenser system, or the complete failure of all radar systems in the area. Using the same information source as the SECDEF, others have calculated the amount of anthrax needed to saturate an area sufficiently to cause that many deaths is more like 880 cubic feet (tough to fit in a five pound bag of anything), something to be dispersed by several large aircraft making undetected passes numerous times over many square miles.
This pronouncement has been characterized by reputable BW experts as an extremist scare tactic. Other DOD officials have followed suit more directly by constantly saying, "Fear the disease, not the vaccine." Some in the military are saying in response, "Sorry, other service members have been there, done that, and got the side effects in the Gulf War."
Lethal Anthrax Dose - In June, Ken Bacon, DOD spokesman told reporters, "Exposure to anthrax is about 98 percent lethal." What he did not say is that anthrax is no more lethal today than it has been during the last thirty years the anthrax vaccine was available, but not used by DOD. He also didnt tell reporters that every major U.S. adversary since World War II has had weaponized anthrax just as deadly as that faced today. Additionally, he didnt distinguish between cutaneous, ingested and inhaled anthrax threats. Even with inhaled anthrax it depends on how many spores are inhaled as to what constitutes a lethal dose.
It has been reported that an Army officer briefed congressional staff members that it only takes 5-10 thousand spores to kill a person and claim no scientist would disagree with that fact. Fielding questions later in the briefing, that same officer said between it would take between 8-50 thousand spores to be lethal. A successor to that individual has even claimed it only takes 2-5,000 spores. But a California paper reported earlier this year that another biologist indicates it takes between 100,000 and 100,000,000 spores to kill a person. Does only the DOD have the corner on the truth market here? Probably not. Maybe the truly speculative nature of this "data" explains why there are so many inexplicable inconsistencies in this program.
Presidential Support - Quite disturbing to many in uniform and the public (if they know) would be the level of commitment the President appears to have to this program and his apparent fictional influence for BW concerns from reading a novel entitled The Cobra Event, according to a New York Times article last year. One gets a flavor of this phenomenon by reading excerpts from another New York Times article dated, January 22, 1999:
Taking the Presidents lead, a recent Medscape on line article by FDAs Kathryn Zoon titled Vaccines, Pharmaceutical Products, and Bioterrorism: Challenges for the U. S. Food and Drug Administration reveals the following plans: "In regards to bioterrorism, the goal of the FDA is to foster the development of vaccines, drugs and diagnostic products. . . Accelerating product development is important in many situations, including bioterrorism." The article goes on to mention the anthrax vaccine in particular without indicating in its 1985 review of the vaccine, the FDA recommended continuing its very narrow use against cutaneous exposure in mill workers, as well as resolving the 3 vs 6 initial dose dilemma. Additionally, the article admits that DOD is trying to establish the "quantitative relation of antiprotective antigen antibody to protection". . . meaning that even DOD doesnt like what it sees in terms of efficacy.
Anthrax Vaccine: Effective or Experimental?
So the Administration, the DOD and FDA are committed to going down the vaccine defense road, but again, the USSRs Dr Alibek (and others) cast grave new world doubts on whether vaccines will provide the desired protection. In his book, Biohazard, Dr Alibek offers the following observations:
The House Armed Services Committee has heard of this problem before. In fact more than 10 years ago, Jay Jacobsen, M. D., testified in a hearing on "Biologic Warfare Testing", May 3, 1988: "The plethora of real and constructable microbial pathogens, and the numerous ways in which exposure to them can occur, makes development of agent and route-specific defenses both foolish and futile."
And at the same hearing, Anthony Robbins, M. D.,: "One cannot overstate our inability to deal with novel agents . . . [for] unprepared public health authorities who know nothing of the weapons origins, its structure, its pathogenic mechanism and transmission, the task of producing a vaccine or drug and doing it very rapidly is almost impossible . . . Today the number of potential agents has multiplied to the point where it is no longer possible to plan or respond with defenses."
The foremost US BW expert, Bill Patrick, who ran the offensive biological warfare program in the 1960s, also says vaccines are not effective against biological agents.
So one might conclude that not only is the threat arbitrarily magnified (as noted in DoD documents in the backup material), but the effectiveness of the anthrax vaccine is highly questionable. This being the case, every taxpayer dollar spent on this program is a wasted expenditure, and because of the measurable health disadvantages constitutes a cruel and unusual program.
Medical Morality and Soldier Safety
One of the greatest and most inexcusable travesties of this program is that service members are being denied adequate medical care because the medical "professionals" are obsessed with policy enforcement rather than open-minded investigations into possible vaccine reactions. House National Security Subcommittee testimony in July revealed that military physicians are continually downplaying side effects of the anthrax vaccine and neglecting or even outright refusing to file Vaccine Adverse Event Reporting System (VAERS) forms with the FDA because of arbitrarily-established filtering conditions such as loss of 24 hours of duty, when the package insert clearly makes no reference to such criteria.
Shots are even being given even after a systemic reaction in some cases because the military medical community has no specific guidance to discontinue shots after such an event, even though the package insert directs such cessation. An atmosphere of fear surrounds concerned service members who want more assurance or express opposition to the program. The military medical system is not simply broken, it is actively subverting its own principles and destroying military member health over this program world-wide. Refer to the five pages in the beginning of the supplement section on just the experience at one military installation where shot reactions are just beginning to be tracked more closely.
Actively tracking the shots administered, but not the consequences seems counter to the primary principle of medicine - first do no harm. The Nuremberg Code was established to prevent medical abuses. In that regard, the Association of American Physicians and Surgeons (AAPS), a voice for private physicians since 1943, issued the following statements regarding the AVIP: "The Nuremberg Code was promulgated by four American judges acting under the authority of the U.S. military, following American rules of procedure. The key principle is the requirement for informed, voluntary consent by the individual subject of experimentation. The Code makes no exceptions for members of the military or the exigencies of war. . . Although U.S. law has not made authoritative use of the Nuremberg Code, the guidelines adopted by the National Institutes of Health in the mid-1950s were based on the "ten commandments" of Nuremberg, and provided that "[e]very volunteer must give his full consent to any test, and he must be told exactly what it involves."
The reason this statement on the Nuremberg Code is relevant to the anthrax vaccine is because although it is FDA-approved, it has also been in Investigational New Drug (IND or experimental) status since 1996 because of the desire of the DOD to provide better evidence of inhalation efficacy and a reduced dosage regimen. On the one hand, DOD says its effective. On the other, its not yet proven effective. This is administration and DOD doublespeak. Which is it? It cant be both. If its in IND status, informed consent should be required.
The AAPS statement goes on to say:
What would be the thoughts of the half million American casualties in WWII, many of whom paid the ultimate sacrifice for the principles of human decency, respect and liberty, if they saw this DOD flirting and skirting with the abominable medical practices of their enemy in that war?
OTHER MAJOR ISSUES AND OBJECTIONS
Specific information and sources on other issues are provided in the backup material, but a quick list of those issues includes:
- Actual systemic reaction rates are up to 100,000 times higher than reported earlier this year
- Vaccine Adverse Event Reporting System (VAERS) shows nearly 50 different reactions--
many outside the scope of the manufacturers anticipation. Why is it still on the market?
- GAO report NSIAD-99-5: vaccine may contain a non-FDA-approved adjuvant called squalene
- FDA wrote a scathing 98 report on this vaccine84 quality control & procedure violations!
- Supplemental testing of lots to pass FDA inspection deemed useless by both DOD and GAO
- 4/29/99 hearing--program reviewer had no anthrax expertise; made marketing suggestions
- Disturbing Similarities of Anthrax Vaccine to Government Swine Flu Vaccine Mistakes in 70s
- Three surveys show no public support for the program; average of 80+% against
- Large 1998 Army mice and guinea pig studies show up to 90% failure rate for the vaccine
- DOD Defense Threat Reduction Agency and State Department -- VOLUNTARY SHOTS!
-- These departments are even more at risk; Congress wants answers to this lack of logic
- Vaccine policy erodes 1972 Biological Weapons Convention; encourages biological arms race
- Allies dont use or had bad experience with this vaccine
- Reservists cant afford vaccine health risks, jeopardizes civilian income; cant get treatment
- Between 25-100% of pilots (nearly 600 now) in Guard/Reserve units will avoid the shot
- Women concerned about delaying a family or passing something to nursing babies/future kids
- Everyone is given the vaccine regardless of important medical conditions or drug interactions
- No religion, except self-destructive cults, would approve injecting such questionable substances
- WSJ reports vaccine market potential increased with recent tax, patent and litigation changes
- Administration BW vaccine stockpiling planning included those who would gain financially
- Insider trading in sale of supplier to Bioport (Adm Crowe); lawsuit dismissed, facts undisputed
- Newer/better vaccines and drugs often not developed quickly because they are less profitable
- Other substances (rotavirus, redux, phen-fen) already off market for far less serious reactions
- 10/20/95 DOD meeting admitted all major vaccine efficacy & safety shortfalls listed here!
- Taxpayer money via Army coffers pays for manufacturers super-expensive insurance policy
-- Indemnification document portrays ineffective vaccine; may cause severe reactions!
Program Administration and Precedent for a "Time Out"
Recommendations from a book about the swine flu vaccine debacle of the 1970s should prove instructive for this anthrax vaccine program. The parallels from that episode in public policy (also evident in Harvards JFK School of Government Case Study) are disturbing indeed: the necessity to use antibiotics (swine flu complications) was de-emphasized; probability and severity of occurrence could not be predicted, the government changed incalculable risk to "not if, but when"--100% probability; no serious side effects anticipated, even though neither vaccine adequately tested; field trials yielded depressing efficacy results and many adverse reactions. The book, entitled Pure Politics and Impure Science states these principles for a vaccine policy should be followed:
Additionally, another recent Congressional development is instructive regarding the use of PB tablets. El Paso Times, August 24, 1999, reports:
Given the plethora of program questions and its divisive nature, the above wisdom on vaccines and the evidence that the anthrax vaccine is in all reality experimental, Congress could invoke the following language yet in the FY2000 Defense Appropriations Bill:
Section ______. None of the funds appropriated by this Act or any predecessor Act may be used to inoculate service members, DOD civilians, or contractors with the anthrax vaccine; or to initiate, process or conclude any adverse personnel actions, including but not limited to, discharge, court-martial, nonjudicial punishment or recall to active duty from Palace Chase or similar programs, against any member of the active military forces or any Reserve component for declining to submit to involuntary inoculation with the anthrax vaccine until all interested Congressional Committees conclude hearings on the DODs Anthrax Vaccination Immunization Program (AVIP) and vote on anthrax vaccine legislative measures.
Section ______. None of the funds appropriated by this Act or any predecessor Act may be used to inoculate service members, DOD civilians, or contractors with the anthrax vaccine; or to initiate, process, or conclude adverse personnel actions, including but not limited to, discharge, court-martial, nonjudicial punishment, or recall to active duty from Palace Chase or similar programs, against any member of the active military forces or any Reserve component for declining to submit to involuntary inoculation with the anthrax vaccine until Congress is satisfied:
As I see it, a Gulf War FDA/DOD Memorandum of Understanding allowed the involuntary use of unapproved or questionable substances in the name of chemical and biological force protection. Because no one has been held accountable for the related health consequences of that action, the nation is now reaping a harvest of crushed military morale, resignations, rebellion and legitimate fear from the renewed use of a poorly proven vaccine that is still considered a potential cause of Gulf War-type illnesses. This situation could become a national defense nightmare as readiness ratings plummet with the growing exodus from military service over this issue combined with recruiting challenges not faced by the services in the past two decades. The DOD is pursuing this mandatory vaccine regardless of its criminal effect (as characterized at the Congressional press conference on HR2548 and HR 2543 which both place restrictions on the AVIP). This policy must be abandoned, and the nation must adopt a correct, logical and responsible biowarfare defense policy.
"The willingness with which our young people are likely to serve in any war, no matter how justified, shall be directly proportional as to how they perceive the veterans of earlier wars were treated and appreciated by their nation." -- Author Unknown