Researchers led by University of California, San Francisco and Harvard School of Public Health are reporting the largest randomized trial among HIV-1 infected persons conducted during the 1990s. The compound tested in the trial, intended to boost the immune response of HIV patients, had no effect on slowing disease progression, the research team reports.
The researchers and their colleagues submitted their paper to JAMA, where it is published in the November 1 issue, despite the attempt by the company sponsoring the trial to block publication.
The company has filed an action with the American Arbitration Association against the University of California and lead author James O. Kahn, MD, UCSF associate professor of medicine in the Positive Health Program at San Francisco General Hospital Medical Center, to block publication. The study, established in 1995, was led by Kahn and senior author Stephen W. Lagakos, PhD, Professor of Biostatistics at the Harvard School of Public Health.
The company's action against the University of California and Kahn continues, and includes a demand for $7 million to $10 million from Kahn and the University, which the company contends would be the financial damage to the company from publication of the findings.
The University of California has filed a counterclaim, arguing that the agreements between the company and the University give the University the right to publish the data, and that the company has wrongfully withheld the final data from Kahn.
The decision to publish the study results affirms the University of California's right to publish unfavorable or neutral, industry-sponsored research findings.
The trial was sponsored and funded by a private pharmaceutical company which entered into agreements with UCSF (Kahn) and Harvard (Lagakos) in September 1995 to allow Kahn to act as the study chair and Lagakos to act as statistician for a nationwide team of investigators in evaluating the clinical benefi
Contact: Jennifer O'Brien
University of California - San Francisco