Academic Freedom at Heart of Issue

Researchers studying an HIV drug say the drug's manufacturer tried to block publication of their results because they showed that it was an ineffective treatment. The drug, Remune, is a vaccine-like immune booster, designed to bolster the immune system's power to control HIV virus.

• Researchers studied 2,527 patients at 77 medical centers across the USA.

• They found that the drug provided no additional benefit over the drugs that patients were already taking.

The results were published in the November 1 issue of the Journal of the American Medical Association, over the objections of the study's sponsor, Immune Response Corp. (IRC) of Carlsbad, Calif, which also manufactures the drug.

IRC filed a complaint with an independent arbitrator, asserting that the study's conclusions would damage the company, and requesting $7 million to $10 million in compensatory damages. The University of California at San Francisco (UCSF), who conducted the study, has filed a counterclaim.

Lead investigator James Kahn says, "The study was well-conducted and answered an important question: Does (Remune) delay disease progression or death in HIV-infected people with a relatively intact immune system? The answer is no."

IRC officials maintain that researchers didn't include an analysis of crucial data from a subpopulation of more than 200 patients, who the company says showed benefit from the treatment

According to Steve Sternberg of the USA Today, "The dispute hinges on whether the lead researchers have the legal right to publish a study without the approval of the study's sponsor and their collaborators ... "

Zachary Hall, the university's vice chancellor for research, says there is a much larger issue at stake here. "What's at issue here is the right of academic investigators to publish their data, which for us, is a core value."

Journal of the American Medical Association November 1, 2000