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NIH Director Approves Disputed Needle-Exchange Research


January 1997

Following the advice of an review panel, the National Institutes of Health (NIH) said in a December 19, 1996 memorandum that researchers could begin a disputed syringe-exchange study in Anchorage, Alaska (John Schwartz, "Study of Anti-AIDS 'Needle-Exchange' Programs is Ethical, NIH Panel Concludes," Washington Post, December 13, 1996, p. A3; Warren E. Leary, "Disputed Study on Clean Needles for Drug Addicts Gets Approval," New York Times, December 20, 1996, p. A20; Associated Press, "NIH Director Endorses Needle Exchange Research," Washington Post, December 20, 1996, p. A13).

The $2.4 million research project, led by Dennis Fisher of the University of Alaska, is designed to determine which method of obtaining sterile needles most effectively reduces the transmission of AIDS, hepatitis and other dangerous diseases: counseling and needle-exchange or counseling and buying inexpensive needles through a pharmacy. The three-year study will also address whether good results from prior needle-exchange studies is attributable to better living habits of participants in the studies. In the Alaska study, 600 intravenous drug users and 500 former intravenous drug users will be divided into two groups: half with access to a syringe-exchange program, and the other without. All 1,100 participants will be tested for hepatitis B, hepatitis C and AIDS at the beginning and end of the study. The research is scheduled to begin in January.

According to the Washington Post, "Almost all studies of needle-exchange programs, which allow intravenous drug users to get sterile hypodermics, have found the programs reduce the spread of blood-borne diseases such as hepatitis and HIV." In 1988, Congress banned federal funding for syringe exchange programs, unless it can be proven that they reduce disease transmission and do not encourage illegal drug use.

In October 1996, Peter M. Lurie, MD, of the University of California in San Francisco and Sidney M. Wolfe, MD, of Public Citizen's Health Research Group criticized the proposed research as "immoral and unethical." They charged that it unnecessarily puts half of its participants at risk of infection with dangerous diseases. In fact, Lurie and Wolfe claimed that contraction of dangerous diseases is the standard used to measure the results of the study. In addition, Wolfe said, "Other studies show that people do better in needle-exchange programs and this new study only asks question that have already been answered." The two researchers asked NIH director Harold E. Varmus, MD, to revoke funding for the Alaska study. Varmus postponed the study, which was to begin on December 1, and asked a panel of scientists and ethicists to review it (See "Needle Exchange Study to Be Reviewed by the National Insitutes of Health," NewsBriefs, November 1996).

Robert J. Levine, a professor of medicine at Yale University and chair of the review panel, presented the panel's 17-page report to Varmus' advisory committee on December 12. Levine said the proposed research was "scientifically and ethically appropriate," and should go forward, because participants in the study would have ready access to syringes sold inexpensively in pharmacies. Varmus accepted the conclusions of the advisory panel.

However, Varmus said the study could only proceed if participants in the study were offered vouchers for a hepatitis B vaccine shot. He instructed the NIH to provide Fisher with additional funds to cover the expense of offering the vouchers to participants who request the inoculation and who are not covered by federal health programs or priate insurance. The advisory panel had concluded that offering a hepatitis vaccine to subjects in the study would exceed the standard of care in the area and in other studies.

Wolfe criticized the review panel's report as "an inside job" because many of its authors and researchers must go through the NIH grant approval-process for their own research and therefore were reluctant to be critical. He said drug abusers in the study would have trouble buying needles in pharmacies because of local ordinances. "This is not over," Wolfe added.