Thursday, July 31, 2008

When will the NIH start enforcing its own conflict of interest regulations?

It looks as if the Food and Drug Administration is not the only federal agency in need of a Congress-initiated overhaul. The same Congressmen who recently vowed to strengthen the FDA's ability to levy fines against drug companies, order drug recalls and restrict drug industry advertising, according to The Wall Street Journal, are also investigating the failure of the National Institutes of Health (NIH) to monitor and take action against serious conflicts of interest among doctors who receive NIH funding for their research. Sen. Chuck Grassley, the ranking Republican on the Senate Finance Committee, recently issued a call for the NIH to revoke grants to academic scientists who fail to report financial conflicts of interest, according to The Chronicle of Higher Education.

The controversy attracting the most attention of late involves Dr. Alan Schatzberg, chair of psychiatry at Stanford University, who owns about $6 milion in stock in a company whose drug he is also studying. According to recent postings on Pharmalot and Health Care Renewal, Schatzberg failed to fully disclose the extent of his holdings in Corcept Therapeutics to either Stanford University or the NIH, which has been funding research by Schatzberg into the use of Corcept's drug, mifepristone (RU-486) for treating psychotic depression. While Stanford has defended its management of Schatzberg's conflict of interest by saying that the psychiatrist "has not been involved in managing or conducting any human subject research involving mifepristone," Dr. Bernard Carroll, writing in Health Care Renewal, points out that Schatzberg is the principal investigator of the mifepristone depression study and recently published a review extolling the effectiveness of the drug in treating depression. As Carroll says, "So here we have an NIH-funded principal investigator, with a clear conflict of interest, who supposedly remains at arm's length from the project, accessing the primary data files, running a new analysis himself, and publishing an exaggerated new efficacy result for his drug..."

Schatzberg, who is president-elect of the American Psychiatric Association, is also a buddy and long-time colleague of Dr. Martin Keller, the chief of psychiatry at Brown University, whose own conflicts of interest I expose in Side Effects: A Prosecutor, a Whistleblower and a Best-selling Antidepressant on Trial. Just like Schatzberg, Keller failed to fully disclose the extent of his financial conflicts to the NIH, which has awarded him millions of dollars in funding for research on depression. When I first wrote about Keller's conflicts in 1999 for The Boston Globe, the NIH said they would look into the matter. NIH officials took no action against Keller and now the question is: will the agency be similarly passive in the Schatzberg affair, even though its own grant policy from 1995 requires universities to disclose and avoid such financial conflicts? And will Congress step in if the NIH doesn't? Let's hope so.

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