American Journal of Law & Medicine

Informed consent in the military: fighting a losing battle against the anthrax vaccine .

In civilian life, an individual has the right to refuse medical treatment in almost any circumstance. While a patient who refuses treatment may face adverse consequences such as prolonged illness, our society recognizes the importance of individual choice in health matters. Members of the military, however, enjoy no such right. Service members are required to submit to certain medical treatments as a part of their employment contract. Refusing such treatments is disobeying an order, and the service member then faces the prospect of a dishonorable or "other than honorable" discharge, and even imprisonment. (1) Disobeying an order to receive treatment can thus result in the equivalent of a felony conviction on the individual's employment history forever. (2)

The lack of a right to refuse treatment in the military has become public in recent years because of the anthrax vaccine controversy. In 1998, well before the recent civilian cases of anthrax, the Department of Defense (DOD or Pentagon) ordered that all 2.4 million active duty and reserve service members be vaccinated against anthrax. (3) While the vaccine was approved by the National Institutes of Health (NIH) for general use in 1970, (4) concerns over potential side effects, primarily sterility, arose among the soldiers, and significant numbers of them began refusing the vaccine. (5) Some soldiers recently may have eased their stance on the vaccine because of the new reality of the anthrax threat. However, the question of whether a member of the armed forces can decide which drugs and biological agents enter his body has not lost its significance.

Service members argue that the right and the duty to refuse the vaccine arises from the armed forces' policy that service members must disobey "illegal or immoral orders." (6) Air Force reservist Thomas Rempfer claims that "professional standards justify disobedience" when an order is "militarily absurd," and that the vaccine is such an order. (7) Therefore, Rempfer asserts that punishment of such disobedience through courts-martial is inappropriate. (8)

To support this argument, members of the military claim that the vaccine is in fact an investigational drug. (9) Even the military must obtain informed consent from research subjects. Therefore, if the vaccine is actually experimental, the DOD is violating not just its own regulations, but also international principles of human dignity. (10)

Several issues thus arise from the anthrax vaccine order. (11) First, can the military require its forces to give up their right to refuse treatment? Is this a valid employment contract? The answer to both of these questions is most assuredly yes. Those joining the military voluntarily give up many of their freedoms and rights for the good of the country. Second, can members of the military succeed with the argument that the order to receive the anthrax vaccine is immoral or illegal because of the possible health risks, and thus that they have the right, and even the duty, to refuse the order? Because the reasons behind such refusal are based on personal fears and not on larger moral issues or goals, and because a reasonable person in the situation would not view this order as illegal, service members are unlikely to succeed with this argument. Finally, should the anthrax vaccine be considered experimental for the purpose of protecting combatants against germ warfare? If so, soldiers could refuse the vaccine as a violation of national and international law. While the vaccine is not approved for this very narrow purpose, a broad interpretation of its labeling will allow the vaccine to be legally used to protect susceptible populations from airborne anthrax. Thus, the military has the right to require that its service members receive the anthrax vaccine, and resignation from the service is the only recourse for a soldier who does not wish to take it.

Part I of this Note will discuss the history of the anthrax vaccine and the concerns of the soldiers, which are based in rumors of side effects as well as distrust of the Pentagon's health-related decisions. Part II will briefly examine the history of informed consent and the right to refuse treatment generally. Part III will examine the military employment contract and the purposes behind it. Part IV will examine the potential charges against those who refuse the vaccine. In Part V, this Note will discuss the defense of refusing to obey an illegal order, as specifically applied to the health concerns of the soldiers, concluding that this defense cannot succeed. This section will further examine the soldiers' arguments that the military's use of the vaccine is experimental, concluding that this defense should not be accepted. Furthermore, even if the vaccine were determined to be experimental, the President could potentially grant a waiver, allowing the DOD to continue to require the vaccine, as discussed briefly at the end of Part V.

I. HISTORY OF THE ANTHRAX VACCINE

A. ANTHRAX DISEASE

Anthrax is a naturally occurring disease of plant-eating animals and is common wherever livestock is raised. (12) Cutaneous anthrax occurs when a person with cuts or breaks in the skin comes into contact with an infected animal. (13) Cutaneous anthrax has a mortality rate of about 20%, if no treatment is given. (14) The anthrax vaccine was first developed to protect factory and veterinary workers from this form of the infection. (15) In contrast, inhalational anthrax, which is contracted by breathing anthrax spores, has a very high mortality rate. (16) If antibiotics are administered before symptoms appear, patients have some chance for survival. (17) However, once symptoms appear, inhalational anthrax is fatal in 80-90% of cases. (18) Finally, gastrointestinal anthrax, a very rare form of the disease, can result from eating infected meat. (19)

Anthrax is viewed as a preferred agent of biological warfare because it is highly lethal, has a low production cost and is easily converted for use in weapons. (20) Anthrax spores can also exist in the ground for decades and are extremely difficult to eliminate. (21) Additionally, the DOD is concerned because the United States has limited ability to detect the use of anthrax spores in battle. (22)

B. TESTING AND APPROVAL OF VACCINE

The first major test of the anthrax vaccine took place in 1957 among workers in goat hair processing plants who were at high risk for exposure to cutaneous anthrax. (23) The study participants received either the vaccine or a placebo, and workers who were ineligible for the vaccine because of previous contraction of anthrax or because of refusal were placed in an observational group. (24) In this study, no cases of inhalational anthrax occurred among those who had received the vaccine, while five cases occurred in the placebo and observational groups. (25) Three cases of cutaneous anthrax appeared among the vaccinated, while fifteen cases appeared among those who had not received the immunization. (26) These results demonstrated a success rate of 92.5% for the vaccine. (27)

After these experiments, the vaccine was changed in minor ways. (28) The manufacturing process was altered, a different anthrax strain was used to grow the vaccine and the ingredients were changed in order to increase the protection granted. (29) In 1966, the NIH granted the vaccine's manufacturer an Investigational New Drug (IND) permit for this new version of the vaccine, which constitutes governmental approval to begin testing for the safety and efficacy of a new drug or vaccine. (30) Researchers conducted additional testing on about seven thousand study participants with about 16,000 doses of the vaccine. (31) Nearly all of the reported side effects involved pain, inflammation or bruising at the site of the immunization, with only four cases of systemic reactions of transient body aches, fever, chills and nausea. (32) Over twelve years, twenty-seven cases of anthrax occurred in the U.S. population, but only three of these were in vaccinated individuals. (33) Furthermore, all three cases involved individuals who had not received the entire course of six injections over eighteen months, but had received only one or two vaccinations. (34) No cases of anthrax were reported among individuals who received the entire course of the vaccine. (35)

In 1970, the NIH Division of Biologic Standards approved the vaccine for general use based on the safety, efficacy and purity information determined in these experiments. (36) The approved labeling calls for an initial dose of 0.5 mL, followed by doses of the same amount after two weeks, four weeks, six months, twelve months and eighteen months, with yearly boosters following. (37) The approved labeling recommends the vaccine for:

 
   individuals who may come in contact with animal products that may be 
   contaminated with Bacillus anthracis spores; and for individuals 
   engaged in diagnostic or investigational activities which may bring 
   them in contact with Bacillus anthracis spores. It is also 
   recommended for persons at high risk, such as veterinarians and 
   others handling potentially infected animals. (38) 

In 1972, the Food and Drug Administration (FDA) gained authority over vaccine approvals. The agency reviewed the anthrax vaccine information and recommended in 1985 that the licenses be continued and that the vaccine be classified as a Category I product, signifying that it is safe, effective and not misbranded. (39) In so doing, the FDA noted that the "[a]nthrax vaccine poses no serious special problems other than the fact that its efficacy against inhalation anthrax is not well documented." (40)

The FDA also conducts post-approval research and has the authority to withdraw its approval of the vaccine. (41) From 1974 through 1989, the manufacturer reported distribution of approximately 68,000 doses of the vaccine. (42) Between 1990 and spring of 1999, approximately 1.5 million doses were distributed. (43) The FDA established its current reporting system for adverse drug events in 1990, and from this date until October of 1999, the FDA received 425 reports of adverse events related to the anthrax vaccine. (44) The majority of adverse events included swelling at the site of the vaccine, rash, headache and fever. (45) The FDA considered twenty-nine events to be serious. (46) These included diagnoses of aseptic meningitis, Guillain-Barr syndrome, bipolar disorder, lupus and other disorders shortly after receiving the vaccine. (47) However, of the twenty-nine serious events, only the seven cases of severe injection site reactions can be attributed with confidence to the vaccine itself; the other events may have some other cause. (48)

C. CONCERNS ABOUT THE VACCINE

Despite the FDA's confidence in the vaccine, the vaccine's critics cite several reasons for their protest. …

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