Undisclosed industry ties of scientific authors undercut credibility.

The first extensive review of financial disclosure policies used by scientific and medical journals has revealed that scientists who publish their research findings rarely divulge financial ties to industry that are likely to affect the independence of the researchers' work. (Conflict of Interest Policies in Science and Medical Journals: Editorial Practices and Author Disclosures, 7 Sci. Engineering Ethics 205 (2001).)

The study suggests that one standard used by federal courts to determine the validity of proffered scientific testimony--peer review and publication of the expert's theory or technique by a reputable scientific journal--is not a reliable indicator that the testimony is based on independent, and thus presumably more credible, research.

The study, conducted by scientists at Tufts University and the University of California at Los Angeles, reviewed 61,134 articles published in 181 medical and scientific journals in 1997. Only half of 1 percent of the articles' authors disclosed financial ties to industry--including honoraria, patents, and stock holdings--that could have influenced their research.

While it is possible that the authors simply had nothing to report, it is unlikely, said Sheldon Krimsky, a professor of urban and environmental policy at Tufts and the study's lead author, because "earlier pilot studies have shown an increase in commercial entanglements of scientists and academic faculty. It's more likely a failure to comply with the journals' conflict-of-interest policies."

All the journals in the study have these policies, which require authors to disclose industry-related benefits, financial or otherwise, that they might derive from their work. Some journals require authors to answer specific questions regarding these benefits, but some disclosure policies are "vague," Krimsky said. "They might say something like, `Disclose anything that you consider a conflict of interest.' This gives authors a lot of leeway not to disclose. That helps explain why the rate of reporting might be low."

The study's results undercut an assumption that many courts make in weighing the credibility of expert testimony. For nearly a decade, federal judges have been acting as "gatekeepers," applying the criteria announced in the U.S. Supreme Court's 1993 decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., to determine the reliability of proffered testimony before a jury can consider it. "[A] pertinent consideration is whether the theory or technique has been subjected to peer review and publication," the Court wrote. (509 U.S. 579 (1993).)

And several courts--including the Ninth Circuit when it entertained Daubert on remand--have assumed that any expert who published his or her work before participating in litigation is more believable than an expert whose research has not been published.

"Experts whose findings flow from existing research are less likely to have been biased toward a particular conclusion by the promise of remuneration.... That the testimony proffered by an expert is based directly on legitimate, preexisting research unrelated to the litigation provides the most persuasive basis for concluding that the opinions he expresses were `derived by the scientific method,'" the Ninth Circuit concluded. (43 F.3d 1311 (9th Cir. 1995).)

"I've thought, said, and written for many years that the Ninth Circuit's decision in Daubert II was misguided," said Sheila Jasanoff, a professor of science and public policy at Harvard University and the author of Science at the Bar: Law, Science, and Technology in America. The Ninth Circuit's assumption that prelitigation research is disinterested is problematic and not necessarily warranted, she said.

Responding to increasing concerns about industry ties to scientific research, the nonprofit Center for Science in the Public Interest (CSPI) recently launched an Internet site that provides details about hundreds of scientists and their links to corporations (www.integrityinscience.org). The site also

gives information about corporate support received by several health- and science-related organizations.

"Corporations increasingly are funding academic scientists to conduct research, speak at press conferences, and provide advice," said CSPI Executive Director Michael Jacobson in a statement announcing the Web site's launch. "Too frequently, neither the scientists nor the corporations disclose that funding."

The lack of disclosure can have far-reaching consequences, Krimsky said. For example, he noted, a panel of experts assembled by the National Heart, Lung, and Blood Institute, which is part of the National Institutes of Health, recently announced new guidelines for the treatment of high blood cholesterol in adults.

"The panel's official report lists all the people involved in the report, but there is nothing that has anything about affiliations. But [the Journal of the American Medical Association (JAMA)] published an executive summary of the report, and it lists affiliations of members of the panel. The head of the committee, Scott Grundy, has received honoraria from several pharmaceutical companies. And others have had relationships as consultants. If it weren't for JAMA [which has a conflict-of-interest disclosure policy], we wouldn't know this, and it's not trivial.

"There are different ways to treat cholesterol, but they're talking about increasing [the number of] people on cholesterol-lowering drugs by 23 million adults. At $1,000 a year per person--which is what these drugs cost--that's an additional $23 billion that goes to pharmaceutical companies," Krimsky said.

The executive summary of the new guidelines, the Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, appears in the May 16, 2001, issue of JAMA. The report is available online at www.nhlbi.nih.gov/ guidelines/cholesterol.