Healthy Skepticism Library item: 16833

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Publication type: news

Harris G
Academic Researchers’ Conflicts of Interest Go Unreported
The New York Times 2009 Nov 18
http://www.nytimes.com/2009/11/19/health/policy/19nih.html

Full text:

Few universities make required reports to the government about the financial conflicts of their researchers, and even when such conflicts are reported, university administrators rarely require those researchers to eliminate or reduce these conflicts, government investigators found.

In a report expected to be made public on Thursday, Daniel R. Levinson, the inspector general of the Department of Health and Human Services, said 90 percent of universities relied solely on the researchers themselves to decide whether the money they made in consulting and other relationships with drug and device makers was relevant to their government-financed research.

And half of universities do not ask their faculty members to disclose the amount of money or stock they make from drug and device makers, so the potential for extensive conflicts with their government-financed research is often known only to the researchers themselves, the report concluded.

The report is the latest in a series of investigations that have found that conflicts of interest in academic research are at best lightly supervised. Federal rules require that researchers report to their universities any outside income that may conflict with government-financed research, much of which comes from the National Institutes of Health. Those rules also require universities to manage those conflicts in ways that protect patients and the integrity of research.

But a long-running investigation by Senator Charles E. Grassley, Republican of Iowa, has found that the enforcement of these rules is based on an honor system that is often violated.

Sally J. Rockey, the N.I.H.’s acting deputy director for extramural research, said that the agency announced in May that it was considering changes to its rules governing conflicts of interest and that Mr. Levinson’s recommendations would be considered as part of that process.

“N.I.H. strongly believes that it is vital that all research be conducted with the highest scientific and ethical standards,” Dr. Rockey said. “The introduction of bias in the conduct of N.I.H.-supported research is antithetical to these principles and will not be tolerated.”

Eric G. Campbell, an associate professor at the Institute for Health Policy at Harvard Medical School, said universities had no interest in putting real limits on the incomes of their star researchers for fear that those researchers would leave for institutions with fewer restrictions.

“This report clearly raises the question of whether these institutions are capable of managing these conflicts themselves,” Dr. Campbell said.

In 2006, 41 universities reported to N.I.H. that 165 researchers who had received grants from the agency had potential financial conflicts. Hundreds of universities receive such grants, and surveys show that about half of academic researchers report having financial relationships with drug makers. So the reported conflicts probably represent just a fraction of the actual number of conflicts.

Most of the reported conflicts involved equity ownership in companies that could be affected by the results of government-financed research. In only a third of the cases did the universities specify to the government the size of the financial conflict and, among those, six had equity stakes valued at greater than $100,000. But in only 29 of the cases did the universities require researchers to reduce or eliminate their stakes. In most cases, the universities deemed that some sort of the disclosure of the conflict was enough to manage it.