Publications
Disputes with Investigators over Publication of Clinical Trial Data
Below are just two examples of the ongoing conflict between the research community’s need to publish and the pharmaceutical/biotechnology industry’s need to maintain the confidentiality of the studies it sponsors during drug development.
Immune Response Corporation (“IR”) recently entered into arbitration in a dispute with the University of California at San Francisco and a member of its faculty, Dr. James Kahn, requesting that the arbitrators order UCSF to pay up to $10 million in damages for violation of its confidentiality obligations. The dispute centers on Dr. Kahn’s publication of clinical data from a clinical trial of IR’s HIV drug, Remune, over IR’s objections. At issue is whether a 250 patient sub-analysis should have been included in the results of the 2,527 patient study. IR believes that failure to include the additional analysis was scientific misconduct, while Dr. Kahn believes that the additional analysis was misleading. After several months of IR refusing to provide all the study data to Kahn and the other researchers, and Kahn refusing to include the sub-analysis, IR filed a request to have the dispute settled by a panel of arbitrators, as provided in the agreement between the parties.
Despite IR’s attempts to prevent the study’s publication, the researchers submitted the results to the Journal of the American Medical Association, which published them on November 1. Following publication, IR saw a 25% one day drop in its stock’s value. IR is now looking to a panel of arbitrators to order the University and Kahn to pay up to $10 million in damages and prohibit Kahn from using the data in the future.
While the arbitrator’s outcome is uncertain, it is apparent that despite an agreement to the contrary, Immune Response was unable to prevent publication of its study results.
Boots Pharmaceuticals, Inc.’s Synthroid Bioequivalence Study
Several years before the Remune dispute, the University of California at San Francisco was involved in a strikingly similar dispute. In 1987, UCSF researcher Dr. Betty Dong entered into a collaboration with Boots Pharmaceuticals, Inc. to study whether rival thyroid replacement drugs were bioequivalent to Boot’s market leading Synthroid. Based on the results of the study, Dr. Dong concluded that the rival products were bioequivalent to Synthroid. In 1995, Boots prevented Dr. Dong from publishing her results and conclusion based on the standard contract Dr. Dong had signed that prevented her from publishing without Boot’s consent. When Boots and Dr. Dong were unable to reach agreement on data interpretation, UCSF, faced with the likelihood of a breach of contract action and the possibility of significant damages, urged Dr. Dong to comply with the publishing rights clause, or litigate with Boots without the support of UCSF. Dr. Dong withdrew her article from publication in the Journal of the American Medical Association. Boots later published a repudiation of Dr. Dong’s unpublished work, citing numerous flaws in the study methodology that made bioequivalence conclusions impossible. Under pressure from the FDA, Boots eventually entered into negotiations with UCSF to allow publication of Dr. Dong’s article, despite Boot’s continued stance that the conclusions from the study were not supported by the data.