Under the terms of the agreement to end the arbitration, IRC has provided the UCSF and Harvard School of Public Health researchers with the final data set from the study and with access to stored blood samples from patients who participated in the study. The study was the largest randomized controlled trial of a proposed treatment conducted among HIV-1 infected persons during the 1990s.
The parties have agreed that, upon verification of the data by the study team, IRC will drop its arbitration demand for $7 million to $10 million from the University of California and the lead author of the study, James O. Kahn, MD, UCSF associate professor of medicine in the Positive Health Program at San Francisco General Hospital Medical Center. IRC sought the monetary award for damages it claimed were caused by Kahn's disclosure of the study results. The University will drop its arbitration demand for the final data set. The University and Kahn will pay no money to the company.
The dispute arose out of publication of results of a study of the clinical effectiveness of HIV-1 Immunogen in 2,500 HIV-1 infected patients. The researchers reported in the Journal of the American Medical Association (November 1, 2000), that the study showed no evidence that HIV-1 Immunogen, also known as Remune, was effective in delaying progression to AIDS or death and had no effect on HIV-1 RNA levels.
Prior to publication, the company had refused to provide the final data to the study team unless the researchers agreed to the inclusion of additional analyses specified by the company. The company had also demanded the authority to approve all publications. Because these conditions were unacceptable to the team, the researchers prepared a paper based on their interim data analysis.
The University of California filed an arbitration counterclaim, arguing that the agreements between the company and the University gave the University the right to publish the data, and that the company had wrongfully withheld the final data from the researchers.
The current agreement provides that the parties will dismiss their respective arbitration claims but does not waive any of the party's rights under the research contract.
"We are happy to see the resolution of this dispute on terms that do not compromise the rights of university researches to publish sponsored research findings," said Zach Hall, PhD, UCSF executive vice chancellor. "Dr. Kahn and his research team can now move forward to analyze the full data set for this study."
"The final set of data includes information about how patients responded to different anti-retroviral therapies, and different doses of the medications. Therefore, the full data set could provide important information about the effectiveness of emerging and standard HIV treatments and could be very valuable as we plan other studies," said Kahn.
Stephen Lagakos, PhD, Professor of Biostatistics at the Harvard School of Public Health, and the senior author of the study, notes, " I am very pleased that this disagreement has been resolved, so that future publications arising from this study can be undertaken without delays or disruptions. This is a positive development for persons with HIV/AIDS and researchers working in this area."