Medical Community Debates Overseas Drug Testing

The Washington Post today profiles the ethical issues surrounding the use of placebos in HIV clinical trials in Thailand, its last report in a series on overseas drug trials. "Long-standing" research methods, such as the use of placebos, have "become more complicated and controversial" as treatment levels advance in some countries but not in others, the Post reports. Scientists have "clashed sharply" over whether researchers are obligated to provide the best treatment available in wealthy countries or whether they should be free to give "the best local care available," which could be far less advanced. This "angry debate" has taken hold in Thailand, where some "chafe at a system that allows Western researchers to present foreign test subjects with choices that provide less care and protection than those same researchers would be obliged to give subjects back in their own countries," the Post reports. Ever since the World Health Organization in 1991 declared Thailand to be a country "ripe" for AIDS vaccine testing, numerous drug trials have been conducted there. The Post reports that many U.S. researchers, however, have only provided the best local care available to their trial subjects, and many have used tests with a higher number of placebos than they would have in the United States.

VaxGen Testing
The issue was highlighted when the drug company VaxGen decided to conduct its AIDSVAX HIV vaccine trials in Thailand. The company recruited 2,500 intravenous drug users for the studies and "bargained tough" with the Thai government, which questioned whether the company would provide care for participants who became infected with HIV during the trials. For the trials, VaxGen vaccinated half of the Thai participants with the vaccine and the other half with a dummy vaccine. However, in its American AIDSVAX trials, VaxGen gave two-thirds of the participants the vaccine. Giving American volunteers an increased chance of receiving the vaccine was thought to be a possible "motivational factor for American gay groups to participate" in the trials, VaxGen's Senior Vice President for Medical Affairs John Curd said. Curd added that U.S. HIV infection rates are lower than Thai infection rates, so "a larger pool of subjects receiving the vaccine meant researchers would reach enough people exposed to the virus." But VaxGen "refused" to guarantee that the vaccine, if proven to be effective, would be sold at a discount to the Thais. However, VaxGen has said that if the vaccine is found to be effective and is approved by the FDA, all volunteers who received placebos in the trials will be vaccinated for free.

Ethical Debate
Medical ethicists have argued over the commitments drug companies and researchers should have to their foreign participants' health. Some have defended researchers' right to provide only the level of treatment available in the country. But Leroy Walters, a Georgetown University bioethicist, said, "If you have a safe and effective treatment anywhere in the world for a life-threatening condition, from that point on you cannot ethically conduct a clinical trial that gives some people placebo." This fall when the World Medical Association met to revise the 1964 Declaration of Helsinki, a set of principles that guides human clinical research around the world, the opposing viewpoints "clashed sharply." Participants from 45 countries voted to "clarify language on the use of placebos, making it unethical to use dummy medicines on some subjects in trials where proven treatments may be available," the Post reports. Although it is not a legal document in the United States, the revised declaration "wields considerable moral clout." However, the U.S. National Bioethics Advisory Commission, a presidentially appointed panel of experts, is drafting guidelines on this issue (Flaherty/Struck, Washington Post, 12/22).