Inability of nih, fda, to identify conflict of interest, Operation Research

Inability of NIH, FDA, to Identify Conflict of Interest

While federal regulations require that researchers receiving NIH grants remain free of financial conflicts of interest, NIH relies on the academic institutions to gather financial information from grant investigators and to manage or eliminate conflicts of interest, but does not require universities to provide information about the conflicts or how they are resolved. Indeed, a report of the inspector general of the Department of Health and Human Services concedes NIH does not know the number or nature of conflicts of interest and does not track how universities and other institutions resolved them. The FDA may be faring no better than NIH. The Office of Inspector General of the U.S. Department of Health and Human Services audited the financial disclosures made by researchers in "all 118 marketing applications approved by the FDA in the 2007 fiscal year," determined that "[o]nly 1 percent of clinical investigators disclosed a financial interest in the products they studied," and concluded that "[c]linical investigators may not be disclosing all financial interests." As noted above, the Harvard University survey of U.S. doctors determined that 28% of doctors were paid for consulting, giving lectures, or signing up patients for clinical trials, and the AMA survey determined that 27% of medical school department heads worked as paid consultants. Most universities rely on their professors to report financial information, but lack the wherewithal to verify the information they submit. Only a handful of states and the District of Columbia require some level of disclosure of pharmaceutical company payments to physicians. There is no database which universities can use to check the disclosures made by physicians to their academic institutions or which informs the public of the fees paid by drug companies to physicians for consulting, speeches, and clinical trials. 

Posted Date: 2/26/2013 6:35:18 AM | Location : United States

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