SWAT TEAM WEIGHS IN ON ANTHRAX VACCINE

Faced with a difficult decision, federal health officials called upon the School's SWAT (Scientists Working to Address Terrorism) team to advise them on whether to offer the anthrax vaccine to 32,000 people exposed to the deadly bacteria through attacks in the mail. Five people have died from inhaling anthrax spores since the outbreak occurred in October. Health officials fear that nearly 10,000 people exposed to high levels of anthrax spores need protection beyond the initial 60-day antibiotic treatment. While antibiotics kill the bacteria, they do not kill the spores and it is not known if the remaining spores could germinate and cause a new infection. Research with animals suggests that anthrax spores can survive in the lungs for as long as 100 days after exposure. The decision to use the anthrax vaccine is controversial, because the vaccine is not approved by the Food and Drug Administration (FDA) for treating people already exposed to anthrax. The SWAT team was established by Dean Alfred Sommer, MD, MHS,'73, to tackle the complex scientific, social, and governmental issues raised by terrorism. In late December, several members of the team were asked to take part in a special forum held at the National Academy of Sciences. The meeting was convened by the Department of Health and Human Services (HHS), the Centers for Disease Control (CDC), and D.A. Henderson, MD, MPH, '60, the new director of the Office of Public Health Preparedness. Lynn Goldman, MD, MPH, '81, professor of environmental health sciences, Ron Brookmeyer, PhD, professor of biostatistics, and Cliff Mitchell, MD, MPH, '91, assistant professor of environmental health sciences, were among the team members who participated in the forum. During the weekend meeting, Thomas Inglesby, MD, deputy director of the School's Center for Civilian Biodefense Strategies, gave a presentation recommending that the vaccine be used to prevent the disease from recurring. While no one knows the full risks to those already exposed to anthrax, Dr. Inglesby noted that the disease remains hard to diagnose and develops very rapidly. Speaking for the Center for Civilian Biodefense Strategies, Dr. Inglesby recommended the vaccine be given to anyone who investigating health officials determined was exposed to anthrax spores. He advised against a strategy of waiting for symptoms to develop before recommending another round of treatment. He also said the anthrax vaccine is safe and effective for preventing anthrax, but acknowledged that it has never been used to prevent infection after anthrax exposure has already occurred. Ultimately, HHS decided to recommend two additional treatment options for anyone potentially exposed to anthrax. The first is to provide an additional 40-day treatment of antibiotics and continue to closely monitor for any signs of illness. The second option is to provide the anthrax vaccine along with an additional 40-day treatment of antibiotics. The vaccine requires three doses over a four-week period and is being given as an investigational treatment, but may provide additional protection from the bacteria. HHS further warns the vaccine has not been proven to prevent illness after exposure to anthrax and may cause adverse side effects. While many people on Capitol Hill have chosen to take the vaccine, District of Columbia health officials have advised against inoculation. They say it is not certain that further treatment is necessary and that the vaccine's effectiveness is unproven and the potential benefits do not outweigh the potential health risks. Dean Sommer agrees with the decision by HHS to offer multiple treatment options. "Modern medicine recognizes the important principle of patient autonomy," he explains. "Patients themselves should make decisions about their own treatment, after being fully informed about the potential benefits and risks of alternative courses of action, and after close discussion with their personal physician. When treatment involves an experimental drug or device, as in this case, the patient's informed consent is absolutely mandatory," adds Dean Sommer. "If I were faced with this decision, I would choose to get the vaccine, but people really need to evaluate the potential benefits—and risks—talk to their own doctors, and make a personal decision about this," said Dr. Goldman.

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