or Meryl Nass, MD, IMMEDIATELY, at
mnass@netquarters.netLetter 1 to Secretary of Defense regarding Anthrax Vaccine"
Letter 2 to Secretary of Defense regarding Anthrax Vaccine"
Michigan Biologics Shuts Down (Anthrax Plant)
Re: USS Independence - Anthrax Inoculations
Dear Secretary Cohen:
I represent several of the United States military personnel currently serving onboard the aircraft carrier USS Independence who have already refused, intend to refuse or hold reservations regarding, administration of the anthrax vaccine. As you know, despite Defense Department efforts, serious questions continue to be publicly raised regarding the efficacy, safety and necessity of the inoculations. My clients, their families and, indeed, the American public, are growing increasingly fearful of this vaccine and the health problems that may result from its administration.
The purpose of this letter is to establish a working relationship to promptly address these issues and obtain full and accurate disclosure of the situation. Therefore, I would respectfully request a meeting, preferably Tuesday or Wednesday, with your representative(s) as soon as possible to allay concerns and suspend the imposition of further punishments. This, it would appear, would serve the mutual best interests of both my clients and the Department of Defense. It serves neither our military personnel, the Defense Department or the nation to impose discipline on servicemen who otherwise hold unblemished records and who have honorably served our country.
While we certainly recognize the need to preserve the lawful chain of authority within the military command structure, we are also cognizant of the inherent international human and Constitutional rights afforded to every United States serviceman, particularly where it concerns matters of privacy and informed consent. No matter whether these servicemen ultimately seek to challenge the implementation of the inoculation program or if the anthrax vaccine has long been approved by the FDA, given the heightened confusion surrounding the origins of Gulf War Syndrome, the public perception continues to view this matter with trepidation and suspicion.
The Defense Department must strive to better address these public concerns. When the military-wide anthrax immunization plan was first announced last December, you specified that four conditions would be met before the vaccinations would be administered. The conditions were:
1. Supplemental testing, consistent with Food and Drug Administration (FDA) standards, to assure sterility, potency and purity of the vaccine.
2. Implementation of a system to fully track personnel who receive the anthrax vaccination.
3. Approval of appropriate operational plans to administer the immunizations and communications plans to inform military personnel of the overall program.
4. Review of health and medical issues of the program by an independent expert.
It has been alleged that the U.S. Central Command has met each of these conditions. However, no public disclosure confirming this fact has occurred. It is imperative that such information is made available to us to ensure all precautions have been taken. Furthermore, it would be most helpful if the Department of Defense could provide immediate responses to the following questions:
1. What is the official Department of Defense position regarding the protections afforded by and the intended use of the existing anthrax vaccine?
2. Does the existing anthrax vaccine provide protection against inhaled exposure?
3. What is the chemical composition of the vaccine presently being administered, and is it being administered standing alone or in combination with other compounds?
4. Have any studies been conducted regarding the long-term health effects of the vaccine? If so, can copies been disclosed?
We are necessarily exploring all available options to prevent any potential harm from occurring to my clients and all United States servicemen who are risking their lives daily in order to defend our country from foreign aggressors. In order to provide proper counsel, however, it is imperative that the facts be known to justify or allay the increasing fears that have emerged. Mr. Secretary, it is in the best interests of all to ensure that full disclosure is made and the hysteria that is developing is addressed immediately.
I look forward to hearing from your representative. Please have someone contact me by COB Tuesday, 14 April 1998, as time is clearly of the essence. Thank you for your cooperation.
Sincerely,
Mark S. Zaid
Honorable William S. Cohen
Secretary of Defense
The Pentagon
Washington, D.C. 20301
Re: USS Independence - Anthrax Inoculations
Dear Secretary Cohen:
This is a follow-up to my previous letter of 13 April 1998 of which I have still not received any response. Although I understand a response is forthcoming, I must express my disappointment in the length of time that was permitted to elapse and particularly that my request for a meeting for an appropriate official was ignored.
As you are aware, eight sailors on the USS Independence refused to accept the second inoculation of the anthrax vaccine last week. I understand that only Erik T. Julius, a 22-year-old aviation boatswain's mate third class, whose refusal was for the first time, was disciplined at Captain’s Mast. I commend the Department of Defense for hesitating to discipline the other seven servicemen and implore you to resolve this matter in a manner that would serve everyone’s best interests. For the time being, I remain committed to working with the Department to achieve a just and fair resolution. However, I continue to be contacted by U.S. military personnel and their families throughout the United States who are expressing their fears and concerns regarding this vaccine and desire direct action to be taken.
With this in mind, and as I await response to my letter from the Department’s Office of Medical Affairs, disturbing information has been discovered that merits your immediate response. In the 1990 article “Military Immunizations: Past, Present, and Future Prospects, which appeared in volume 4, issue 1, of Infectious Disease Clinics of North America, the following pronouncement was made on page 156:
"Limited use vaccines and products are defined as those unlicensed experimental vaccines, toxoids, and immunoglobulins that have been developed against specific military threats associated with high morbidity. These products would be used in specific contingency situations. Some of the limited use vaccines could be considered to be experimental deployment vaccines since they are directed against serious region-specific endemic diseases. Limited use vaccines include ... anthrax. (emphasis added)"
The significance of this assertion can not be underestimated particularly as its authors were Drs. Ernest T. Takafuji and Philip K. Russell. In 1990, Dr. Russell was the Commander of the U.S. Army Medical Research and Development Command at Fort Detrick in Frederick, Maryland. Dr. Takafuji, then with the Office of the Surgeon General, U.S. Army, is now, as I understand, the current Commander at Fort Detrick.
What, Mr. Secretary, has taken place since 1990 to have caused leading U.S. Army medical personnel to modify their view that the anthrax vaccine is no longer an unlicensed experimental vaccine? The official position of the Department of Defense has continually been that the vaccine is not experimental because of FDA approval in 1970. Yet the Department has thus far failed to identify any tests or studies conducted after 1990 regarding the vaccine that could legitimately led to such a drastic alteration of this assertion. Furthermore, the article also indicates that controversial issues on immunization are referred to the Armed Forces Epidemiological Board for review? Has such a referral ever taken place with respect to the anthrax vaccine? If so, the results should be disclosed.
Mr. Secretary, the decision to inoculate U.S. military personnel with the anthrax vaccine remains an issue that will only continue to escalate into public controversy unless full disclosure is forthcoming from the Department of Defense. Fear, whether founded or not, is running rampant throughout the military system and future refusals of the vaccine are to be expected. I implore you to immediately intervene in this matter and halt the inoculation process until all concerns can be adequately addressed.
I reiterate my request for a meeting with your designated representatives to fully explore this situation and devise an appropriate resolution. Your response to this letter would be appreciated by Monday, April 27, 1998. I await to hear from your office regarding the above concerns and requests.
Sincerely,
Mark S. Zaid
Defense Secretary William Cohen's plan to vaccinate all U.S. troops against the bioweapon anthrax has hit a snag. The Pentagon's sole producer of anthrax vaccine, Michigan's Biologic Products Institute, shut down after the Food and Drug Administration cited the facility for multiple quality control violations. In March 1998, the FDA issued a "notice of intent to revoke" the plant's manufacturing license and quietly warned DoD to test BPI's vaccine before using it. Pentagon sources say that enough of the stockpile has now been cleared (by and independent contractor) to begin vaccinating troops in the Persian Gulf, who are judged at highest risk. But BPI's anthrax production line closed down in January. Renovations at the plant will cost at least $100 million. Michigan, unwilling to foot the bill, has put the plant up for sale. So far, there are no takers.