Conflict of interests loosely monitored at FDA: a report by HHS Inspector General

01/15/2009

Current FDA disclosure protocols and mechanisms to prevent conflicts of interest in research are not working.  A recent report by the U.S. Department of Health and Human Services Department of the Inspector General, and highlighted in a New York Times editorial, found that:

·        Only 1 percent of doctors involved in clinical trials reported a financial conflict of interest as reported in 118 marketing applications to the FDA by drug and device manufacturers in FY2007.  In contrast, a national survey of physician-industry relationships published in the New England Journal of Medicine found that more than one quarter (28%) of physicians received payments from industry for consulting, giving lectures, or enrolling patients in trials.

·        In 42 percent of the applications, the sponsoring company did not provide the required financial information of its investigators, potentially hiding conflicts of interest.