The Corruptible Academic-Industry Partnership

The past decade has seen a ballooning in private industry support for biomedical research. While the federal government was once the major funder of medical research, corporations are now the primary sponsors. Much of this research still occurs in academic settings, but the increasing prevalence of industry funding and the growing phenomenon of universities taking out patents on technologies they develop has fundamentally altered the biomedical research environment.

Over the last several years, there have been a slew of examples of the dangers of these entanglements. In one, a researcher at the University of California, San Francisco was deserted by her university after the drug company that supported her research was unhappy with her findings and threatened a lawsuit if she published the results. In another, a researcher at the University of Toronto became the target of hate mail from one of her colleagues after she sought to publicize the adverse effects of a drug in a company-sponsored study she had conducted.

Up until now, there have been only limited quantitative data on this issue. Recently, a group of researchers at Duke University published the results of their study of medical schools in the U.S. They sought to describe the provisions in academic-industry agreements to ensure the integrity of the scientific research (New England Journal of Medicine, October 24, 2002, pp. 1335-41). In particular, they sought to establish whether the agreements in multicenter studies (those conducted at more than one institution) were in compliance with the 2001 International Committee of Medical Journal Editors (ICMJE) guidelines for scientists' involvement in study design, access to data and publication.

To put it mildly, the results were dismal. One provision of the ICMJE guidelines is that all investigators in multicenter studies, not just the coordinating institution, should have access to all the data. The universities reported that a median of 1 percent of their studies had provisions for such access. In one study that was not a focus of the report, even the principal investigator did not have unfettered access to the data, forcing him to publish a paper with only 90 percent of the data.

The agreements were often lacking other crucial elements. Only a median of 5 percent of studies addressed plans for data analysis and interpretation, opening the doors to industry mischief in the forms of data massaging or the reaching of conclusions with an eye on marketing rather than science. Extraordinarily, a median of 0 percent of study contracts required the data to be published. This allows industry to suppress unfavorable findings and report only results that are advantageous to its bottom line. The failure to publish makes a mockery of the research process; as far as the scientific community is concerned, studies that are not published in some form are studies that did not occur. Meanwhile, participants have been exposed to risk in their altruistic efforts to advance scientific knowledge.

A relatively simple solution to this morass would be for the Association of American Medical Colleges to draft a standard contract that could be modified as needed. Universities should be denied accreditation if they fail to develop such a contract; similarly the National Institutes of Health should refuse to fund institutions that have not implemented the contract. Medical journals should also refuse to publish articles unless the authors can certify that all of the elements of the ICMJE guidelines were in place. Finally, the ICMJE itself should also be conducting studies to determine to what extent its guidelines are being followed. Absent that, the guidelines will remain what they are now: well-intentioned ideas that may insulate the industry from government regulation but are barely followed.