How Can we Learn From
Our Mistakes
THE LEGACY OF THE ANTHRAX VACCINE
By Jennifer S. Bard, J.D., M.P.H.
Assistant Professor, University of Texas Medical Branch, Galveston
Member, Institute for Medical Humanities
S
ince September 11, 2001 the nation has been aware of the looming threat of bioterrorism. Experts
immediately expressed fears that mass exposure to smallpox, Ebola, or anthrax could paralyze the nation
with illness and death. It was still, however, a surprise how quickly this fear became a reality. Before the
fires at the World Trade Towers were extinguished, members of the media and the Congress began
receiving letters containing a white powder. The powder turned out to be anthrax spores and led to the
deaths of five individuals, including postal workers, who inhaled the powder. Whether a foreign or
domestic terrorist sent those letters, their existence marked a new era in biodefense.
The deaths of five civilians brought to public attention the shortcomings of the anthrax vaccine. By
the time the Government made anthrax vaccine available to civilians who might have been exposed, less
than one percent accepted. The troubles with the vaccine, however, were apparent to the military and
scientific community well before September 11, 2001. The story of how the anthrax vaccine was
developed in the early 1950’s, licensed in 1972, forgotten about until the mass military immunization
program before the Gulf War in 1990, and brought into focus by Secretary of Defense William Cohen’s
decision to initiate total forces immunization by 2003, is an interesting one. One important thread,
however, is how decisions were made at every level of the government to vaccinate U.S. Military
personnel with a substance that had never been proved safe or effective for the purpose of defense
against inhalation anthrax. As an ethical question, we must ask why the federal government reacted to
the exposure of serious questions about the anthrax vaccine with a slick public relations campaign
targeted at military personnel rather than further scientific study. In particular, given the repeated ethical
lapses in military medicine in such instances as LSD and radiation experimentation, this vaccine was given
without the informed consent of thousands of soldiers. These soldiers in essence became part of a giant
research that would not stand the scrutiny of any ethical test developed since the Nuremberg trials.
For example, the vaccine that was developed in the 1950’s and licensed in 1972 was sole source
produced by the Michigan Department of Public Health. A few years later, employees of the Michigan
Department of Public Health brought a lawsuit seeking compensation for the changes they had made
to the vaccine. Subsequent inquiry has found that there were notable differences in the manufacturing
process and content of the vaccine as it was licensed and as it was used after 1972. Yet although this
was common knowledge, most of the military personnel giving briefings on anthrax either did not know
or chose not to mention this difference. Even while prosecuting military personnel who refused to be
vaccinated, the department of defense acknowledged in a petition to the FDA that the current vaccine
was an investigational new drug.
The lessons of the anthrax vaccine must inform any further military drug testing. Tests must be
performed under the standards of science, not expedience. Negative information should be studied, not
ignored. Individuals claiming harm should be listened to, not prosecuted. The dangers of biological
warfare to the military and civilian populations are as exigent as ever. The task now is to develop defenses
that are consistent with our moral and ethical responsibilities.
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HEALTH LAW NEWS