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 Officer’s 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 policy’s 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:

Recruiters are working harder than ever, often putting in 65-hour weeks. But they are chasing an ever-shrinking pool of high-school students willing even to consider a military career. The reasons are many: The economy is surging, so more attractive options abound. States have spent billions building up vast community-college systems, giving millions more high-school graduates access to post-secondary education. Many of today's parents never served or were alienated by the Vietnam War; thus their children have little or no emotional connection to the military. And as the Cold War and the Gulf War have given way to peacekeeping missions of uncertain duration in unattractive locales, a career in uniform has become a much harder sell. . .

For the first time since 1979, both the Air Force and the Army can't find enough people to fill the ranks. The Navy came up 7,000 recruits short of its target last year of about 55,000, so it decided to accept a larger number of recruits who didn't graduate from high school to meet this year's goals. Only the Marines, the smallest of the forces, is meeting its relatively modest goals without much trouble. Overall, the Department of Defense is 7% behind its recruitment goals this fiscal year -- the largest shortfall in years -- leaving it more than 9,000 recruits short and struggling to fulfill its missions with fewer and in some cases less-qualified troops. . .

Even the Pentagon's generous tuition plan -- up to $50,000 once recruits finish their initial four-year commitment -- has little impact. Three-quarters of all high-school seniors today say they have no interest in joining the military at all, up from about 55% in 1976. . .

When the month's final day arrives, Sgt. Cady (a recruiter) suffers one last blow: Devlin McGill, a community-college freshman who signed up in November 1998 for a September enlistment, tells the recruiter he's having grave doubts. He drops by the office for a meeting. Mr. McGill's parents, both college graduates, have flooded him with literature questioning the safety of the anthrax vaccine administered to almost all enlistees. They have pushed him to give community college one more try. "For someone who is going to waste four years of their life, the Air Force is a great adventure," Mr. McGill explains before visiting Sgt. Cady. "As much as I don't like the way my parents do things, I am starting to think I might be better off in college." Once inside the recruitment office, he tells Sgt. Cady he doesn't want to join the Air Force, citing concerns about the anthrax vaccine. "I can tell you that the secretary of defense had the anthrax shot," Sgt. Cady tells him. "The Air Force wouldn't require it if it weren't safe." The pitch goes nowhere. When Mr. McGill leaves, Sgt. Cady rubs his face. "I am dying," he says. . . That knocks Sgt. Cady down to zero recruits for the month. It is his worst month ever."

Later in the same article, another recruit mentions he’s considering "his mother’s $500 anti-enlistment bonus".

Another perspective on the recruiting dilemma comes from the NY Times, Sep 27 1999:

And in a striking break with tradition, the Army has sent hundreds of fresh young soldiers on recruiting assignments back to their hometowns in the hope that they can convince others like themselves to join. . . Pvt. Dennis L. Neal, who undertook such a mission recently in a tough neighborhood of the nation's capital, where he used to live, has barely been in the Army long enough to know if he likes it. His entire military experience so far has been a couple of months of basic training and truck-driving school. Now the Army has turned to him to do what veteran sergeants are hard pressed to accomplish these days: find new recruits.

"What I tell them," Neal, 21, said the other day as he stood with colleagues from one of Washington's two recruiting stations at a street music festival a few blocks from where he grew up, "is that it ain't so bad."

And yet even (Army Secretary) Caldera warned that the Army needed to reverse the waning interest in military service among the first generation of young people whose fathers came of age after the draft ended in 1973. "If unabated," he said, "it might not make a difference what kinds of resources you're plowing into recruiting."

As hip-hop music blared, though, the recruiters had little to do. Almost no one over the age of 10 paid much attention to the brochures neatly stacked on two rickety folding tables. Finally, after more than an hour, the first prospect appeared: Damall Kellem, a 17-year-old senior in the Class of 2000. He took a brochure, but he said most young people do not give military service much consideration. "It's not even in their vocabularies," he said with a shrug and walked off.

"Call it junior year abroad," he said. But Rep. Steve Buyer, the Indiana Republican who is chairman of the House's subcommittee on military personnel, said the problem was the missions themselves -- a complaint echoed by the leading Republican presidential candidate, Gov. George W. Bush of Texas, in a speech last week.

"We're fooling ourselves if we believe we can solve the problem with more GED programs or more money for ads," Buyer said. "What we need is a change in foreign policy."

In a recent on-line article, military columnist David Hackworth thinks the recruiting problems go deeper, as well:

These factors are part of the problem:

A booming economy, which makes tooling down Mainstreet USA in a new set of wheels more attractive than playing RoboCop in one of Clinton's global villages.

College fun and games over close order drill and war games in the rain.

Too many harebrained missions such as Kosovo that are stretching our forces to the breaking point and causing the troops to ask, "Why go to the Balkans to be shot at for nothing?"

Relatives and friends who because of a recent bad military trip or broken promises, such as reduced medical, hospital and other retirement benefits, are telling young people, "Don't join up. You'll just get used and abused like I did."

Generation Y-ers without the same patriotic fever or motivation that their fathers and grandfathers mustered when they faced the Imperial Japanese, Nazi Germany or Cold War communists who, in their time, were all major threats to our security.

And senior brass -- both politicians and military leaders -- who talk a good game of caring for the troops, but rarely put their efforts or money where their mouths are. Few, for example, have challenged the poor pay and near-ghetto housing. . .

Many solutions are being kicked around. Unfortunately, most have to do with "dumbing down" the Army by further lowering standards instead of smart moves like immediately fixing the pay, cleaning up the lousy living conditions and taking the teen-age summer camp out of basic training. Secretary of the Army Louis Caldera has proposed accepting more high-school dropouts. Caldera, a West Point graduate, should eyeball the lessons of Vietnam. During that cruel war, Project 100,000 was implemented to produce more grunts for the killing fields of Vietnam. It took unfit recruits -- classified as Category IVs -- from the bottom of the barrel and rushed them to Vietnam. The result was human applesauce. Cat IVs sustained the highest casualties of any group and caused such massive discipline problems -- fraggings, drug use, racial strife -- that by 1973 the Army had been virtually brought to its knees.

Ten smart-and-fit soldiers are better than 100 out-of-shape dummies. From a decade of combat experience as a soldier and war reporter, I'm convinced that the brighter the soldier, the higher his chances of making it through the nightmare of combat.

We're back to the quantity over quality system that produced Lt. William Calley of My Lai shame and filled so many body bags in Vietnam.

In this recruiting environment, the anthrax vaccine can by itself destroy a potential recruit’s 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 we’re 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 it’s the top biological warfare threat, but if that’s 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 it’s so easily weaponized as claimed by the DOD, why were they not successful?

Maybe the public’s 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 area’s 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 didn’t 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 didn’t 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:

Clinton's personal interest in the threat, aides agree, has become a powerful force behind a series of secret Federal meetings, actions and directives meant to bolster the nation's anti-terrorism work and to counter what they describe as a growing danger to civilians. . . Clinton said he hoped that a major legacy of his Presidency would be to stave off unconventional attacks. He said he would be delighted if, decades later, Americans looked back on any such threat as "the dog that didn't bark."

Elaborating on some of the initiatives he intends to unveil . . ., Clinton said he is weighing a proposal from the Defense Department to establish a commander in chief for the defense of the continental United States, a step that civil liberties groups strongly resist. Such a step would go far beyond the civil defense measures and bomb shelters that marked the cold war, setting up instead a military leadership to help fight chaos and disarray if an attack occurred. The Pentagon has commanders overseeing regions around the globe, but none for the continental United States. Critics fear such moves could open the door to rising military influence and a loss of individual rights, but Clinton insisted that such erosions would never occur, even while acknowledging the danger. "We've got to preserve civil liberties, resolve all doubt in favor of that, and if there's a question, bring it to me," Clinton said, while acknowledging there were specific concerns in areas like computer security. He did not offer details on how he would insure protection.

Among other new considerations, Clinton said he was weighing a proposal to give anthrax vaccinations to police, fire, public health and other emergency officials in cities throughout the country. That would be in addition to the current drive to vaccinate more than two million soldiers.

Among the programs he will highlight on Friday are developing new vaccines, stockpiling antibiotics, setting up emergency medical teams in major cities and a corps of computer experts who could respond quickly to electronic attacks.

Clinton asserted that "a lot of what we've done already," some of it secret, "has delayed" foreign efforts to develop and deploy chemical, biological or nuclear weapons. He said that ultimately, America's best defense against unconventional warfare and bioterrorism in particular would be scientific strides in deciphering the genetic material in microbes and humans, so that vaccines could be tailored for quick response to an attack. This, he said, would allow defense to stay ahead of the offense. His hope, he said, was that America would use "each new wave of technology to close the gap between offense and defense."

He said he wanted Americans "not to be afraid or asleep. I think that's the trick."

Clinton said that of all the new threats, the one that "keeps me awake at night" is the possibility of germ attack. "A chemical attack would be horrible, but it would be finite," he said, adding that it would not spread. But a biological attack could spread, he added, "kind of like the gift that keeps on giving."

Taking the President’s lead, a recent Medscape on line article by FDA’s 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 doesn’t 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 USSR’s 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:

It is easier to make a biological weapon than to create an effective system of biological defense. Base on our current level of knowledge, at least seventy different types of bacteria, viruses, rickettsiae, and fungi can be weaponized. We can reliably treat no more than 20 to 30 percent of the diseases they cause.

Donna Shalala, the Secretary of Health, (referring to the $1.4 billion in the FY2000 budget to respond to BW threats including vaccine stockpiling). . . "This is the first time in American history in which the public health system has been integrated directly into the national security system." The President warned Americans not to panic. He insisted that new intelligence needs would not infringe on civil liberties.

America has done more than any other nation to protect civilians from biological weapons. But it is not clear, for all of its efforts, that its citizens are any safer.

The American plan to stockpile and develop vaccines against known agents is the most comprehensive of its kind in the world. Yet as parts of that plan have been implemented, its limitations have become clear. . . Injecting soldiers against dozens of diseases would not protect them from the agents we don’t know about, or from those for which there are no vaccines.

They (vaccines) can trigger significant changes in the blood and endocrine system. Some have been known to affect the functioning of the heart, lungs, kidneys, and other organs. It is not medically advisable to combine too many different courses of vaccination.

The anthrax vaccine used in the United States has to be administered six times before it becomes effective with annual boosters thereafter. . . scientists generally agree that excessive vaccination can create complications in the immune system, leading in rare cases to the formation of tumors.

Repeated vaccinations have been known to trigger or aggravate allergies. Thirty minutes after I received my last vaccination against anthrax in 1987, my face became swollen, and I developed a rash and had trouble breathing. I knew this was a sign that I was genetically susceptible to large quantities of specific foreign proteins, and that my immune system had been stretched to its limit. I received my first anthrax vaccination in 1979 and began a course of annual vaccinations in 1982. . . the chronic allergies I have suffered throughout my adult life are a direct consequence of repeated exposure to live vaccines, and to other biological substances I worked with.

Vaccines provide excellent protection against specific diseases, but the characteristic that made them so effective -- that specificity -- is also the source of their limitations. . . A vaccine works against a single pathogen, or occasionally several similar ones, but an all-purpose antidote does not exist.

I am not suggesting we should drop vaccines from our biodefense plan, only that we should keep their effectiveness in perspective. Even if we could afford the expensive and lengthy process of development, testing, and approval currently required for the introduction of new vaccines in the United States and most Western countries, the continued advances in weapons-making knowledge will always put us a step behind.

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 weapon’s 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 it’s effective. On the other, it’s not yet proven effective. This is administration and DOD doublespeak. Which is it? It can’t be both. If it’s in IND status, informed consent should be required.

The AAPS statement goes on to say:

"During the Persian Gulf War, the FDA granted a waiver permitting the use of pyridostigmine bromide and anti-botulinum vaccine, without consent. This was the first instance in which an official government agency officially sanctioned the direct violation of the Nuremberg Code (see Milner CA: "Gulf War guinea pigs: is informed consent optional during war?" Journal of Contemporary Health Law and Policy12:199-229, 1996).

A distinction must be made between treatment and experimentation. It may be asserted that anthrax vaccine (unlike pyridostigmine bromide as used in the Gulf War or anti-botulinum vaccine) constitutes "treatment," or that it is not experimental because of being declared safe and effective by the FDA.

In fact, the anthrax vaccine was licensed by the FDA before efficacy studies were required. Its efficacy against inhalational anthrax has been questioned. Moreover, it is likely that an adversary would use a strain (possibly genetically engineered) against which the vaccine is not effective (see Ivins BE, Welkos SL: "Recent advances in the development of an improved, human anthrax vaccine." European Journal of Epidemiology 4:12-19, 1998). British epidemiologists suggested that troops be publicly randomized to receive active vaccine or placebo, clearly implying that many consider the vaccine to be experimental (Ness AR, Harvey I, Gunnell D, Smith GD: "All troops sent to Gulf should be randomised to receive anthrax vaccination or placebo." British Medical Journal 316:1322, 1998).

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?


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 manufacturer’s 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 vaccine—84 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 don’t use or had bad experience with this vaccine

- Reservists can’t afford vaccine health risks, jeopardizes civilian income; can’t 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 manufacturer’s 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 Harvard’s 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:

1. The decision to produce vaccine should probably be separated from the decision to immunize. Each action should have its own well-defined triggers, such as the appearance of a specified number of outbreaks of a specified severity in certain geographic locations.

2. The final announcement to act and commitment of prestige of person or of office should be made at the lowest level of bureaucracy practicable, rather than at the highest. Perhaps Gerald Ford was right in 1976 in thinking that only the prestige of the presidency could assure successfu8l implementation of the swine flu immunization program. But in doing so, he severely limited the options of those below him in HEW to reconsider, and of those in Congress to question.

3. A mechanism should be built into such programs from the start which requires periodic reevaluation of the premises upon which decisions are made and reconsideration of those decisions based upon the latest available information. What appears imperative in February or March may no longer seem justified in August or September.

4. All predictions and timetables must be questioned and requestioned. Some specialists (preferably outsiders) must be assigned to think about the possible effect of Murphy’s law.

5. The professionals who recommend a future program should not be left ot manage it alone. they will most likely need the help of individuals with more practical experience in management, in production, in logistics, in law, and in other fields.

Additionally, another recent Congressional development is instructive regarding the use of PB tablets. El Paso Times, August 24, 1999, reports:

The military can no longer administer the pyridostigmine bromide pill and botulism toxoid vaccine unless the president approves their use," said David Evans, a spokesman for the Pentagon. Under a new law, the anti-nerve agent pill and vaccine are considered "investigational drugs," which means they are not approved by the federal Food and Drug Administration as safe and effective for

use on troops without their informed consent. The amendment by Sen. Robert Byrd, D-WV, was passed as part of the 1999 fiscal year Department of Defense Authorization Bill. In a prepared statement, Byrd said it was intended "to improve the oversight and approval process for granting waivers to use investigational drugs without the informed consent of the troops." . . . Another related law that Byrd got passed required the military to conduct research on the safety of the anti-nerve agent pill, the botulism toxoid vaccine and the anthrax vaccine.


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:

Option A

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 DOD’s Anthrax Vaccination Immunization Program (AVIP) and vote on anthrax vaccine legislative measures.

Option B

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:

a. The vaccine will not endanger the long-term health or the morale of military members

b. The vaccine is effective as proven by more than a few monkey or rabbit studies

c. The vaccine offers protection against multiple and combined inhaled anthrax strains


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