Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
The Associated Press - Thursday, December 19, 1996 5:57 pm EST
Paul Recer, AP Science Writer
Dr. Harold Varmus, director of the NIH, said in a letter released Thursday that the $2.4 million study in Anchorage, Alaska, could proceed as long as intravenous drug users in the program were given vouchers to receive shots against hepatitis B.
The study will compare the effects of two methods of clean needle distribution on the rate of infectious disease among 600 intravenous drug users and 500 former IV drug users. Half in each group will be allowed to exchange dirty needles for free clean ones, while the other half will be told how and where to buy needles from Anchorage drugstores.
All 1,100 of the participants will be tested at the beginning and end of the study for hepatitis B, hepatitis C and HIV, all diseases that can be spread when drug users share needles.
Dr. Dennis G. Fisher of the University of Alaska Anchorage said the purpose of the study is to determine which method of clean needle distribution will result in the least number of new infections among current IV drug users. Among former users, it will determine if the availability of clean needles will prompt a relapse to drug use.
Dr. Sidney Wolfe, director of Public Citizen's Health Research Group in Washington, said all of the questions being studied in the research have already been answered by other studies. In addition, he said, the new project increases the disease risk among IV drug users because some will not be able to receive free clean needles.
He said it is already well known that free needle exchange programs dramatically reduce the number of IV drug users who contract HIV and hepatitis. Denying free clean needles to these users is assuring that some of them will get the infections, he said.
"These are very vulnerable people and they are being further victimized by an immoral experiment," said Wolfe. "This whole thing is immoral and unethical."
Fisher said his study is designed to settle a basic question: Do needle exchanges encourage drug use?
In 1988, Congress prohibited federal funding of needle exchanges until this question was answered. The Clinton administration has contended that the issue is still unsettled.
Wolfe, however, says that a number of studies in the United States and elsewhere have shown that needle exchange programs prevent disease.
Fisher's study proposal was approved routinely last fall after review by a series of committees at the NIH and the University of Alaska Anchorage. Following a protest by Wolfe and others, Varmus ordered a new evaluation by an advisory committee. The 10-member panel concluded the study was scientifically valuable and was ethically designed.
Varmus said in his letter that he considered comments and letters from both sides of the controversy and decided that Fisher should be told "to commence his study."
However, Varmus instructed the NIH to provide Fisher with money to cover the cost of offering vouchers to pay for hepatitis B vaccine for drug users who request the inoculations and who are not covered by federal health programs or private insurance.
Fisher said providing the vaccine will not affect the validity of the study.
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