Clinical Trial Causes University-Corporation Tribulations
A dispute between university-based researchers and the corporation that funded their study is threatening to erupt into a $7 million to $10 million binding arbitration proceeding. Over the objections of the pharmaceutical company, the researchers published the results of a large clinical trial of an immune system booster to treat HIV-infected people this week. The report suggests that the drug isn't effective; the pharmaceutical company that developed the drug says the researchers should have included its analysis of a subset of the data that suggests it might help some people.
The study in question is believed to be the largest randomized clinical trial among HIV-infected persons in the last decade. The 3-year, double-blind study of 2527 people at 77 U.S. sites tested a drug called Remune, developed by Immune Response Corp. of Carlsbad, California. Immune Response and the University of California, San Francisco (UCSF), Center for AIDS Research funded the research.
The trial ended in May 1999 when an independent safety monitoring board decided the drug showed no clinical benefit and was unlikely to do so. AIDS researcher James Kahn of UCSF, biostatistician Stephen Lagakos, and three other researchers obtained what they say is 95% of the study's data from the safety board. The company refused to provide the final data unless the researchers agreed to include the company's analysis of viral load in a subset of the study population, and the company insisted on approving the final publication. The researchers refused and published their results in the 1 November issue of the Journal of the American Medical Association (JAMA).
Immune Response claims one subset of the data, focusing on 252 patients whose viral loads were monitored more closely than those of other patients, shows that the treatment can decrease the amount of HIV in the bloodstream, according to Ronald Moss, Immune Response's vice president for medical and scientific affairs. "All we've tried to do is be balanced and ensure all the information is included," he says. Kahn counters that the company's analysis of the data in this subset was flawed and inappropriate, and he says his team had a right and an obligation to publish its analysis of the results.
After the authors shared a copy of the manuscript with the company in July, Immune Response invoked a contract clause asking for legally binding arbitration. They claim that the research agreement does not give the researchers access to data beyond that generated by the UCSF site. UCSF has filed a counterclaim asking for the complete data set and maintaining the right to publish further analyses of the data. Moss says the full story will be out soon; another research team involved in the clinical trial will publish another analysis, with the disputed figure, possibly in January.