Bringing in the rule book

In the November 1 2000 JAMA Lisa Bero of UCSF published a study of UCSF’s response to conflict of interest issues over the last 20 years. She found that by 1999 a full 7.6% of UCSF faculty reported personal financial ties with industry sponsors of their research, and that a supervising committee recommended taking remedial action in 25% of these cases. The actions included sale of company stock, refusing additional payment for talks, resigning from a company management position, or naming a new principal investigator to a university research project.

UCSF’s committee tended to be lenient when an academic’s research was significantly different from that of the company supplying monetary rewards. But the inconsistency in applying these standards troubled Bero. "You need to look at individual cases, but it would be good if there were more definite rules so consistency was assured," she says. "Right now the whole thing is very ad hoc."

The situation only gets worse at the national level. In the same issue of JAMA Mildred Cho of Stanford University (Stanford, California) reported on the conflict of interest policies of the 100 US institutions with the most funding from the National Institutes of Health in 1998. The regulations varied widely, with only 19% specifying limits on the financial interests that researchers could have in the corporate sponsors of their research.

UCSF’s Scott is amongst those who are calling for national guidelines to improve this situation. Such guidelines are probably unlikely to be as strong as those at UCSF, which is one of the few institutions to ban researchers from conducting clinical trials for companies in which they hold any financial stake.

Northwestern’s Bennett, meanwhile, is looking at the reasons behind the bias. He has concluded that company-sponsored trials are often, if anything, of a higher quality than other trials. But academics without company ties share one characteristic. "We are more willing to generalize, and the generalizations may not be so optimistic," says Bennett.

Further distortions can arise when drug trials are analyzed in retrospect, because different researchers will analyze the same data with different questions in mind. "The companies ask, how much value did we find," says Bennett. "The academics ask, how bad was it."

Bennett’s solution is simple. "The way to fix it is to have prospective, comprehensive registrations of all trials," he says. That way all those trials with negative results cannot be hidden, and the aims of the trial must be declared before the data come in.

UCSF is all in favor of full disclosure before trials begin. Full disclosure might have saved the university from the wrangling that accompanied another study appearing in the November 1 2000 JAMA. The actors had changed since the earlier conflict over Synthroid: now UCSF researcher James Kahn played the part of Betty Dong, and the Immune Response Corp.(IRC; Carlsbad, California) the part of Boots/Knoll. But the subject of the conflict (this one direct, not a conflict of interest) remained the same — the right to publish.