It is a fundamental tenet of research ethics that when the community of experts has concluded that an intervention is effective in improving health outcomes, randomized trials that exclude many people from the benefits of the intervention are no longer ethical. Despite the consensus described above, the NIH-funded researchers propose to randomize 600 IDUs to NEPs or a comparison condition. The study examines whether those assigned to attend the NEP develop hepatitis B at a rate greater or less than those assigned to the comparison condition. In fact, there was already evidence that NEPs decrease the risk of acquiring hepatitis by the time Dr. Fisher submitted his grant proposal to the NIH in December 1995. Reduced risk of hepatitis B and hepatitis C among injection drug users in the Tacoma syringe exchange program.
Abundant data suggests otherwise.
First, all the non-randomized controlled studies on the effect of NEPs on IDUs' risk behaviors implicitly compare syringe availability through NEPs with syringe availability through pharmacies and diverted sources. Thus, the control group proposed by the researchers has already been demonstrated to be inferior. Second, the researchers argue that the study is ethical because Alaska has no requirement for a medical prescription in order to purchase a syringe. Again the data, conveniently excluded from their research proposal, do not support them. Compton W, Cottler L, Decker S, Mager D, Stringfellow R. Legal needle buying in St. Louis.