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Needle Exchange Study to Be Reviewed by the National Institutes of Health


November 1996

On October 17, the National Institutes of Health (NIH) said it will review a needle exchange study after critics charged that the research was unethical (John Schwartz, "NIH to Review Needle Exchange Study Criticized for Possible Health Risk," Washington Post, October 18, 1996, p. A25; Warren E. Leary, "Questions on Ethics Lead to Review of Needle-Exchange Study," New York Times, October 18, 1996, p. A22).

The three-year, $2.7 million study is designed to determine the effectiveness of needle exchange programs in reducing the transmission of HIV, hepatitis and other deadly diseases. The study would divide 600 intravenous drug users in the Anchorage, Alaska area into two groups: half could receive sterile needles in exchange for their used needles, and the other 300 participants could not. Dr. Dennis G. Fisher, a professor of psychology who is conducting the study, said the second control group would be instructed on where to go for needles and how to get them.

Sidney Wolfe, MD, director of Public Citizen's Health Research Group, and Peter Lurie, MD, a researcher at the University of California at San Francisco, sent a letter to NIH Director Harold E. Varmus asking the NIH to withdraw its support. In the letter, they argue that the study unnecessarily puts half of the participants at medical risk. "It is simply unconscionable for the NIH ... to fund a project that so clearly violates basic research ethics in a manner that the researchers themselves admit in their grant proposal 'represents the withholding of a potentially lifesaving device.'"

NIH spokeswoman Anne Thomas said that Varmus had decided to review the proposed study because of the objections, even though it already had been reviewed and approved. A new review committee will look at the ethics and science of the study and will probably complete its findings quickly, she said. The study was scheduled to begin in December.

Since 1988, Congress has forbidden federal funding for needle-exchange programs, but the Surgeon General can lift the ban if he or she determines that such efforts reduce disease transmission without encouraging drug use. "This is the study to prove it," said Dr. Fisher. Dr. Lurie and Dr. Wolfe said studies by the National Commission on AIDS, the federal Centers for Disease Control and Prevention, and the National Academy of Sciences have already concluded that needle-exchange programs reduce disease transmissions by intravenous drug user, and do not increase illegal drug use.