News | November 2, 2000

Immune Response files suit against UCSF for publishing negative results

A lesson for researchers who accept private money for drug studies

Marcia Angell said there'd be days like this. Last May, as outgoing editor of the New England Journal of Medicine, Angell issued a scathing indictment of financial ties between academic research and private industry and called for stricter conflict of interest guidelines particularly for medical research (click here for that story).

And now, the University of California, San Francisco (UCSF) is facing a multi-million dollar lawsuit, filed by a company that tried (unsuccessfully) to block the publication of a paper with negative findings on one of its products.

James Kahn of UCSF directed a clinical study of a drug called HIV-1 Immunogen (trade name Remune) manufactured by the Immune Response Corp. (Carlsbad, CA). The study, which is published in the latest Journal of the American Medical Association, showed that 2,527 patients receiving the drug in combination with standard antiviral medication fared no better than those who received standard antiviral medications alone. In fact, the trial was halted in May of 1999 by an independent group of experts monitoring the study, because the drug wasn't helping patients live longer.

Immune Response contends that researchers omitted favorable data and skewed the results. A sub-study of 250 patients conducted by the company showed that the drug could reduce the amount of HIV in the bloodstream. Immune Response criticized Kahn for not including a favorable review of that study and for not sending copies of his findings before publishing to dozens of investigators who enrolled patients in the study.

The company had filed for binding arbitration in September, during which it tried to produce "a more balanced manuscript," according to Ronald Moss, the company's vice president of medical and scientific affairs. Instead, he claims the researchers violated their contractual agreement and published incomplete findings.

On the other hand, Kahn charges that the company withheld important data and then tried to suppress publication. The company denies both claims, and has demanded $7 to $10 million from Kahn and the university, claiming dissemination of the negative findings caused it financial harm. Immune Response shares fell as much as 36% after the UCSF researchers revealed that the company tried to block publication of the study.

The university stands by Kahn's right to publish his findings. As well, JAMA editor Catherine DeAngelis defended the journal's decision to publish. "This study stands on its own scientific merit," she told the Associated Press. "It was peer-reviewed as such."

By Laura DeFrancesco
Managing Editor, Bioresearch Online

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