The Associated Press - Thursday, 17 October 1996.
Lauran Neergaard, Associated Press Writer

The study would have recruited 600 intravenous drug users, but only allowed 300 of them to get free clean needles in a newly established needle-exchange program, said Dr. Sidney Wolfe of the consumer group Public Citizen.

The other 300 would be blocked from trading their used needles for clean ones, Wolfe wrote Thursday to director of the National Institutes of Health, Harold Varmus. They would be told to try to buy syringes from pharmacies. Then University of Alaska researchers would test members of each group to determine which became more infected with hepatitis B and the AIDS virus, diseases spread by dirty needles, Wolfe said.

But previous studies have found needle exchanges cut new cases of HIV infection by 33 percent in Connecticut and caused an eightfold drop in hepatitis in Washington.

"It is simply unconscionable for the NIH, the nation's leading health research institution, 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 service,'" Wolfe wrote.

By noon, Varmus had decided to review whether the study, scheduled to start in Anchorage in December, should proceed.

"This study, when it was conceived and designed, was recognized as ethically sensitive," said NIH spokeswoman Anne Thomas.

She noted that the study had been approved both by the University of Alaska's review board and the federal Office of Protection from Research Risks. But she could not immediately say why the two groups deemed the study appropriate.

University of Alaska lead researcher Dr. Dennis Fisher did not return a phone call.

The National Research Council and the Centers for Disease Control and Prevention have declared needle exchanges effective, but Congress in 1988 banned federally funded needle exchanges until the surgeon general declared they work. The Clinton administration has drawn the ire of AIDS activists for refusing to do that. Critics charge the exchanges could encourage drug use.

The scientific findings make it unethical for Alaska researchers to deny drug users the chance to use a needle exchange, Wolfe said. Most such studies compare disease rates between addicts who voluntarily use the nation's 55 privately funded needle exchanges with addicts who do not, he said.

Also, the Alaska study did not offer the addicts a highly effective vaccine against hepatitis B, he said.

About one-third of AIDS patients are infected through intravenous drug use.

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