Sidebar: A Case for Anonymity
. . . the only prudent and ethical course of action is an immediate termination of the mandatory anthrax vaccination policy—or at the very least, program suspension . . .
I have grave concerns about the Department of Defense policy of mandatory anthrax vaccination of all 2.4 million military personnel. My research shows this to be a complex issue, shrouded in controversy and permeated by half-truths and conflicting information. In my opinion, the questionable policy decisions to date threaten the health, welfare, and morale of all military service members, as well as the rigor of America's all-volunteer forces and the sanctity of our national security.
I would not object to receiving an anthrax vaccine that has been tested successfully for its intended purpose, proven effective against the potential threat (airborne anthrax biological warfare agents), certified as safe by competent health-care professionals, and produced in accordance with Food and Drug Administration (FDA) requirements for purity and potency. However, this does not appear to be the case with regard to the current anthrax vaccine. Here are my major concerns:
- Adverse reactions to anthrax vaccine. Rates of reaction are extremely high (e.g., 70% in women), far exceeding expectations outlined on the vaccine package insert. Published reports state that numerous vaccine recipients have been sick for months at a time, and many remain incapacitated today. According to Congressional testimony, 12 previously healthy members of the 9th Airlift Squadron at Dover AFB have unusual or disabling illnesses that developed from "unknown causes" after receiving the Anthrax vaccine. Illnesses include external and internal cysts (including cysts around the heart), liver damage, thyroid damage, auto-immune disorders, tuberculosis of the bones, crippling bone/joint pain, seizures, memory loss, vertigo, and inability to concentrate. Reactions similar to the Gulf War Syndrome also have occurred (e.g., at Dover Air Force Base where 20-25 persons have contracted a similar illness, resulting in more than a 50% loss of function, compared to their pre-vaccination state). According to the vaccine insert, no studies have been conducted to determine fertility or carcinogenic effects of the vaccine. Questions also have been raised about anthrax vaccine contamination and serum purity, because the production facility—Bioport—has a history of FDA violations, as reported by the Government Accounting Office in April 1999. Whatever the cause, many normally healthy vaccine recipients are experiencing serious long-term health problems.
- Distorted reporting of adverse vaccine reaction. A very small number of Vaccine Adverse Event Reporting System (VAERS) reports have been filed by medical personnel (e.g., of 600 service members vaccinated at Tripler Army Medical Center, 120 developed a systemic reaction requiring medical attention, with only four VAERS reports filed). Reasons vary for the low reporting rates, ranging from physicians' reluctance to report (or medical policies to not report) "non-traditional reaction symptoms," to patients' reluctance to report adverse reactions that might preclude deployments and thus harm career prospects, to concerns by reserve aviators that a VAERS report could terminate their civilian employment. In any event, VAERS reporting fails to show accurately the frequency and severity of adverse vaccine reactions.
- Efficacy of vaccine. In 1970, the FDA approved an anthrax vaccine for use against topical (skin) exposure to anthrax that might occur through handling contaminated animal products (bones, hides, or carcasses). However, it is most likely that anthrax biological-warfare agents would be inhaled. The vaccine package insert does not address the question of protection from airborne agents. Instead, it states that candidates for immunization include persons who "may come in contact with animal products" contaminated with anthrax spores, and that "routine immunization" is not recommended. To date, no comprehensive or conclusive inhalation testing has been accomplished to determine the vaccine's efficacy and safety for human beings, or its efficacy against the full spectrum of anthrax strains that could be developed for use as biological-warfare agents.
- Department of Defense misinformation. Numerous DoD press releases and informational brochures have been proven inaccurate. Examples include assertions that the vaccine is "widely used" by veterinarians, when in fact the Centers for Disease Control states that veterinarians do not routinely take the anthrax vaccine because of their low risk of exposure. Statements by military health-care representatives imply that the vaccine has received FDA approval for protection against airborne anthrax spores, even though such use has never has been tested clinically; protection is only presumed. Finally, DoD's "independent review" of the anthrax immunization program was conducted by Dr. Gerard Burrow, an obstetrics and gynecology specialist. Dr. Burrow has acknowledged in writing that he had "no expertise in anthrax," and had made recommendations only about the mechanics of administering the program.
- Questions about Bioport. Michigan Biologic Products Institute (which became Bioport in September 1998) was cited in 1997 by the FDA for numerous and significant deviations from applicable federal drug production standards and requirements. Problems involved quality control, contamination, product consistency, sampling and testing, equipment sanitation, storage and handling, record keeping, and numerous other deviations. Similar FDA deficiencies were noted in four consecutive annual inspections between 1993 and 1996, and 30 problem areas were noted in a November 1999 recertification inspection. Some reports indicate existing stockpiles from the earlier years are being used to vaccinate military personnel, despite questionable purity. In addition, no independent, third-party oversight of anthrax vaccine production has occurred. Bioport's evaluation of its own vaccine for quality, potency, and purity is a clear conflict of interest, exacerbated by the company's history of FDA infractions. Further, the U.S. Army has agreed to indemnify Bioport against all litigation arising from administration of the vaccine, thus removing the company's legal responsibility for adverse reactions. Finally, DoD has recently agreed to double the price it pays for the vaccine to help ease Bioport's financial difficulties. Mid-1999 news reports of Bioport's near-bankruptcy also call into question the company's ability to adhere to quality-control standards and other requirements.
In light of the deeply troubling aspects surrounding this program, the only prudent and ethical course of action is an immediate termination of the mandatory anthrax vaccination policy—or at the very least, program suspension until a safe and effective vaccine can be developed, tested, and certified. This action is crucial to maintaining the integrity and readiness of America's armed forces, and to restoring the confidence of military personnel in our military and civilian leadership.
The Case for Anonymity
This is the proper time and the appropriate forum in which to publish concerns about the mandatory anthrax vaccination policy, and it is a terrible shame that they must be expressed under a cloak of anonymity. But the facts speak for themselves: as widely reported, military personnel refusing the anthrax immunization have been branded as malcontents, hypochondriacs, and renegades (despite, in many cases, exemplary records to the contrary)—and as a result, have been sentenced to jail, received bad-conduct discharges, issued punitive administrative letters, or administratively separated.
The Department of Defense's retribution against vocal critics and those refusing the vaccine has ended many promising careers and stifled even the most-adamant voices. Consequently, the concerns of military personnel about the mandatory anthrax vaccine program have never been fully aired. Some members are voting with their feet by leaving the services, rather than have substances of questionable value that could jeopardize their short- and long-term health injected into their bodies—where they and their families will bear the full risk. Among those who stay, the undercurrent of worry and fear about the vaccine intensifies, as authorities continue to compound the error rather than fix the problems. I have been a serving officer for more than 17 years. I am a graduate of a war college, hold a post-graduate degree, and have received numerous personal awards, including a national award by a professional military organization. The government will soon force me to choose between my health and my career. At present, there is not one document that definitively establishes the vaccine's efficacy against inhaled anthrax spores. Further, there is no greater testimony to the risk of the vaccine and the flawed nature of this policy than the health sacrifice of military men and women (such as those at Dover AFB) who now suffer from its results. Given what I know about the vaccine, I cannot currently endorse it to my troops. As a result, the morale of my family and myself has sunk to an all-time low. If I could retire today, I would.
As a military leader, I have always been taught to "take care of my people." I am deeply saddened and distressed by the DoD's lack of concern for its most important asset—its people. For some time, I have been tempted to remain silent (as DoD wishes), and hope that policy makers would do the right thing. Unfortunately, the hard reality is that decision makers have cloaked the mandatory vaccination policy under the guise of a "moral obligation" to protect forces from attack, despite unverified efficacy against the airborne anthrax threat. Further, despite apparent negative health impacts of the vaccine, policy makers have shown little inclination to act for the welfare and in the best interests of service members without severe pressure. It would be an unconscionable disservice to my troops and to all my fellow service members and their families to turn aside and allow this policy, which has the potential to gravely impact so many, to continue without challenge. I pray that my comments, despite their anonymity, will serve as a catalyst to promote a policy that respects the health and well-being of all men and women in our armed forces.
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