Monday, November 6, 2000
While it surely is not unusual for researchers to disagree over the interpretation of data, those disputes generally don't become public. But such a dispute did break into the open last week between The Immune Response Corp. and the University of California at San Francisco, raising questions about how data should be published when the parties involved disagree. Perhaps even more important, the dispute raises the issue of corporate influence over the analysis of clinical data, as the company's interpretation is more positive than the UCSF researchers' interpretation.
UCSF researchers and colleagues published in the Journal of the American Medical Association results of IMNR's 2,527-patient Phase III trial of Remune, a gp120-depleted HIV-1 immunogen. That trial was halted early on the recommendation of an independent data safety monitoring board due to a lack of significance for Remune compared to placebo on the study's primary end point, which was clinical progression to AIDS-defining conditions or death (see BioCentury, May 24, 1999).