Armed Services Smallpox Vaccination: Medical Research and Military Necessity

Vol. 30 No. 2

By

Thomas May is associate professor of bioethics and director of the graduate program in bioethics at the Medical College of Wisconsin. He has published two books and numerous articles in peer-reviewed journals.

The Bush administration's decisions regarding smallpox vaccination of military personnel, health workers, and the general public have raised a number of human rights issues. Smallpox vaccination is a relatively dangerous and invasive therapy that, although offering protection against one of history's most devastating contagious diseases, poses significant risks and side effects. Potential complications include encephalitis, death, and a number of side effects serious enough to require a doctor's care in one of every 10,000 cases.

Smallpox vaccination was discontinued in the United States in the 1970s because its benefits no longer warranted exposing individuals to its serious risks. Today these potential risks are exacerbated by the fact that the vaccine for this program is either "old" vaccine that has been in storage for more than thirty years, or "new" vaccine manufactured through cell culturing and considered experimental. Studies of the safety and efficacy of the old vaccine in dilute doses, conducted during the past year primarily on healthy college-student volunteers, resulted in about one-third of the vaccine recipients becoming sick enough to miss work or school as a result of the vaccine. No deaths occurred. Since January 2003, approximately 350,000 military personnel have also been vaccinated with the old vaccine. Although only about 3 percent of vaccine recipients have required sick leave, there have been fourteen cases of myocarditis ranging from mild to severe (an incidence rate of one in 20,000) and a number of other side effects, including two reported deaths.

Vaccination of armed services personnel raises a serious human rights concern. Although vaccination of health workers and the general public involves voluntary, individual decisions (at least as of this writing), smallpox vaccination of armed services personnel is mandatory absent a medical exemption. Those who do not qualify for medical exemptions may be disciplined if they refuse vaccination. Such punishment can be serious: service members who refused anthrax vaccination during the 1990s were sometimes court-martialed or discharged. The problem posed by mandatory vaccination is basic: military service does not negate humanity and basic human rights.

Most important in this context, however, is that the vaccination program has aspects that are research oriented. As outlined in the Nuremberg Code, participation in medical research must be voluntary and military personnel are not excepted, even in times of combat. Pentagon rules against nonvoluntary medical research have been explicitly in place since at least 1925. Military personnel often risk their lives to protect the nation's security; however, this risk should not be unlimited, and individual human rights must be upheld. And, although the current military vaccination program is not primarily medical research, a society that seriously values human rights should take care to recognize the research implications of the program and be aware of potential conflicts of interests.

Rationales

Smallpox vaccination of armed forces personnel has a sound military rationale. Of course, soldiers and those who support them must be able to function even if attacked by chemical or biological weapons. Contagious disease among troops has been influential in many wars and battles. The United States suffered more casualties from disease during World War II than from combat.

The use of biological weapons also has a long military history. After the Iraqi invasion of Kuwait in 1990, recognition of a new era in possible biological warfare led the Department of Defense to request an exemption from normal FDA informed-consent requirements, for combat situations in which consent is "not feasible." This exemption was granted on a drug-by-drug basis in FDA Rule 23(d) during the first Gulf War. Most recently, command officers in Iraq expressed significant fears that biological or chemical weapons would be employed in the conflict, although there were no chemical assaults as of early May 2003. Protective suits providing immunity from chemical and biological agents were found in Iraqi positions, indicating a possible plot to use them.

Noncompliance by military personnel to the smallpox vaccination program could pose a number of problems. The most obvious is widespread contraction of the disease during a biological attack, which could require significant medical attention and resources. Even in the absence of biological attack, unvaccinated troops pose logistical problems: those who are vaccinated with the live vaccine can spread the infection or might require separate quarters from unvaccinated troops.

Military Medical Research

The United States has an unfortunate history of using military personnel for medical research, such as Walter Reed's yellow fever research in the early 1900s. The most informative incident in the context of exposing military personnel to unknown risks involved the military's testing of troops after nuclear explosions in the 1950s. A test to measure psychological effects of atomic blasts required troop deployment near an A-bomb detonation. Although the Advisory Committee on Human Radiation Experiments concluded that the primary motive for troop deployment in this instance was training for combat readiness, the involvement of medical personnel throughout the exercise cast doubt about its purity of purpose. The motivation driving an exercise might itself be multidimensional.

The question of preemptive smallpox vaccination before a biological attack has been in flux. See Jon Cohen and Martin Enserik, SCIENCE MAGAZINE, vol. 298, no. 5602. In devising a pre-event smallpox vaccination strategy, the Bush administration received conflicting advice from groups with differing objectives. Significant public and media voices called for universal access to vaccination. However, the Advisory Committee on Immunization Practice (ACIP), a group charged with offering smallpox immunization recommendations to the DHHS and the CDC, initially recommended that at most 20,000 first responders be vaccinated prior to an actual bio-terror event using this agent, later expanding its recommendation to approximately 500,000 health workers. The Bush administration eventually settled on a sort of middle ground, three-phase plan, with immediate vaccination of 500,000 health workers and 500,000 military personnel in the first phase, vaccination of an additional 10 million emergency personnel (including police and firefighters) in the second phase, and eventually moving to a third phase in which vaccination would be available to the entire population.

The three-step plan has been hailed as a compromise that allows later decisions to be revised in light of information gathered in previous phases. See William Foege, Can Smallpox Be as Simple as 1-2-3?, WASH. POST, Dec. 27, 2002. The administration seems well aware of this: in late November 2002, senior aides to President Bush indicated that a final decision concerning universal vaccination would likely be delayed until more information about adverse reactions and the ability to treat them had been gathered from vaccination of health workers and military personnel.

In this regard, vaccination of military personnel has become a significant issue, given that objections to pre-event smallpox vaccination have been widespread among health workers and many hospitals have refused to vaccinate their employees. The health worker vaccination program thus is far behind schedule: although officials had hoped to vaccinate 500,000 health workers before March 1, 2003, by the deadline only 12,690 volunteers had come forward. See Ceci Connolly, Smallpox Vaccine Comes Full Circle, WASH. POST, Mar. 16, 2003. In contrast, the mandatory armed services vaccination program has moved along according to plan, as evidenced by the following statement from William Winkenwerder Jr., M.D., assistant secretary of defense for health affairs: "Our smallpox vaccination program expanded rapidly and effectively to include more than 350,000 people. The program continues to go well, and has been administered in a thorough, careful and professional manner. We continue to experience the types of reactions that we expected overall. Close monitoring has afforded these individuals prompt, effective care." Although the ACLU carefully monitored the administration's vaccination plan through the end of 2002 and advocated for protections for health workers who choose not to be vaccinated, it has remained largely silent concerning mandatory vaccination of military personnel.

Medical research clearly is one aspect of military smallpox vaccination, even if it is not necessarily a prime motive in its implementation. We would be negligent not to use information available from an actual sample to guide broader, general public vaccination policy. But it does present potential conflicts of interest that should be monitored by human rights organizations.

What evidence we have indicates that protection of troops and their combat readiness are the focus of the military's vaccination program. First, the DOD indicated that armed services personnel were given the old FDA-licensed vaccine rather than the experimental one. See Release, available at www. defenselink.mil/news/ Dec2002/b12132002_bt634-02.html. But if medical research relevant to broad public vaccination is indeed part of the plan, testing the new vaccine would have been included.

Second, the smallpox vaccination program is consistent with the world's general and the military's specific focus on biological and chemical weapon preparedness. Troops routinely are vaccinated for a variety of potential agents, many of which have no relevance to the public. Finally, of course, there are valid concerns about biological or chemical terrorist attacks following the war with Iraq. Given the sacrifices already made by armed services personnel, we owe to them a special concern to see that their basic human rights are respected.

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