AIDS Team Publishes Article Despite Lawsuit

A team of AIDS researchers, including two Harvard biostatisticians, published an article in the Journal of the American Medical Association last week detailing the failures of an HIV vaccine, despite the protests of the study's sponsor.

The sponsor, Immune Response, filed a lawsuit in September for seven to ten million dollars immediately following the research team's refusal to include the company analysis of the study's results.

The suit specifically names the research team leader, James Kahn, a professor from the University of California at San Francisco (UCSF), and the UCSF regents.

While the firm maintains it should have a role in shaping the study's analysis, the scientists--whose findings indicated the HIV vaccine was a dud--said scientific freedom was their guiding principle.

Kahn headed the study along with Dr. Kenneth Mayer, an AIDS researcher at Brown, and two Harvard biostatisticians, Professor of Biostatistics Stephen Lagakos and Deborah Weng Cheng, a biostatistician in the Center for Biostatistics in AIDS Research.

Immune Response, a California-based biotech company, commissioned the study in 1995 to use 2,500 HIV patients as a test study for the HIV vaccine, Remune.

They tested the ability of Remune to boost the immune response of HIV-infected people by reducing the patient's viral load because "it showed some activity in the lab," Cheng said.

However, by May 1999 the patients receiving Remune in addition to standard HIV treatment were faring no better than the control group, causing the Data Safety Monitoring Board and Immune Response to agree to stop the study, Kahn said.

Upon presentation of their paper describing Remune's ineffectiveness, Kahn says it was clear they "did not present an analysis that the sponsor wanted."

"They wanted the right to review all manuscripts," Kahn said of Immune Response, which the researchers refused because it was "clear it was a way to delay publication."

Dr. Ronald B. Moss, vice president of medical and scientific affairs for Immune Response, refused to comment. Calls to the public relations office were not returned.

Both Kahn and Cheng stressed their duty to the patients who participated in the Remune study in publishing their negative data.

"Patients involved in research treatment should be involved with the outcome," Cheng said.

For the researchers, the Immune Response lawsuit endangers the larger issue of scientific freedom and places a conditional value on scientific research.

"They're sort of like bullies in a sandbox--they take their toys and escape," Kahn said of Immune Response.

But the scientists said they are not concerned about the future of scientific research.

"So far my colleagues have been very supportive," Kahn says, "I just hope that people will not wait for sanitized results."

Lagakos is currently in Japan and could not be reached for comment.