ANTHRAX VACCINE IMMUNIZATION PROGRAM
Jane M. Orient, M.D.
April 1, 1999
in response to hearings 3/24/99
The Association of American Physicians and Surgeons respects the need of our military forces to maintain order and discipline as well as to protect our troops to the best of their ability and judgment. We also recognize the threat of biological warfare.
Because of this threat, the U.S. military plans to vaccinate 2.4 million personnel against anthrax, including more than a million "citizen-soldiers" who are members of the National Guard and Reserves. A number of soldiers are risking court martial rather than accept the vaccine because of concerns about safety. Some believe it may be related to the Gulf War Syndrome.
On the other hand, some civilians are asking questions about how to obtain the vaccine because they wish to protect themselves against a highly fatal disease, which has unquestionably been weaponized by many possible antagonists.
As scientists, we are concerned with limited testing before approval of vaccine and the lack of subsequent clinical trials, the limited efficacy of the vaccine and the adverse effects on patients, both systemic and localized.
For the purposes of this statement, we will focus on the ethical implications of these concerns. The question of mandatory vaccination of all forces against anthrax raises a number of questions of medical ethics and constitutional rights:
NUREMBERG CODE IS BASED ON INFORMED CONSENT
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 2. 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."
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).
ANTHRAX VACCINE: TREATMENT OR EXPERIMENTATION?
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).
SAFETY OF VACCINE IN QUESTION
The safety of the vaccine is in dispute. One issue is reported serious deficiencies in the manufacturing process or in the "updating" of expired lots. The systemic reaction rates reported in the government's own data have been as high as 1.33%. Consider that a risk of 1 in 100,000 is considered to be of regulatory concern for "involuntary" (public) risk and 1 in10,000 for "voluntary" (occupational) risk. (The risk of systemic vaccine reaction, for comparison, is 1,330 in 10,000, or 13,300 in 100,000, or 133,300 in 1 million.)
It has also been alleged by witnesses before this committee that adverse reactions are underreported. Long-term risk is unknown: appropriate studies have not been performed, and record-keeping has been inadequate.
INFORMED CONSENT MUST BE OBSERVED EVEN BY MILITARY
No consent can be informed if the information is based on science that violates fundamental precepts of honesty and integrity and lacks a proper research design that can disprove the hypothesis of safety if indeed there are significant adverse effects.
As pointed out by Grodin and Annas (authors of an article on legacies of Nuremberg for medical ethics and human rights, published in JAMA in 1996 [276:1682-1683]), the entire point of informed consent in combat is "not to prevent soldiers from obtaining whatever protection may be afforded them by an investigational agent that has not been adequately tested, but rather, it is to give them the choice of whether they think the 'protection' is worth the risks of adverse effects" (Grodin MA, Annas GJ: JAMA 277:712-713, 1997).
While the spotlight is on the military, we would also like to draw the committee's attention to the increasing demands for mandatory vaccination of civilians, even without the exigencies of war or the demands of military discipline. At a time when "patient's rights" are the focus of so much concern, we must not lose sight of the right to refuse a medical treatment as well as to refuse to participate in an experiment (or the functional equivalent thereof). Access to information necessary to reach a truly informed, independent judgment is also essential.
The military and scientific community should give consideration to the development and use of a newer, more effective vaccine. Several are in late-stage development which are more effective than the current vaccine but do not cause toxicity as reported by the Army's own Bacteriology Division at the Army Medical Research Institute of Infectious Diseases at Ft. Detrick, Maryland (Journal of Biological Chemistry, 264:19103-7, 1989).
A careful examination of the nation's vaccine policies, with respect to both military and civilian populations, is overdue. Some issues are scientific, to be sure, but basic constitutional rights and fundamental premises of medical ethics are also at stake.
The Association of American Physicians and Surgeons stands ready to work with this committee to help ensure the safety and well-being of our citizens and soldiers.