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The Food and Drug Administration does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects, government investigators are reporting.
Moreover, the investigators say, agency officials told them that trying to protect patients from such conflicts was not worth the effort.
In 42 percent of clinical trials, the agency did not receive forms disclosing doctors’ financial conflicts and did nothing about the problem, according to the investigation, which was conducted by the inspector general of the Department of Health and Human Services and whose results were scheduled to be made public Monday.
In 31 percent of the trials in which the agency did receive the required forms, agency reviewers did not document that they looked at the information. And in 20 percent of the cases in which doctors revealed significant financial conflicts, neither the F.D.A. nor the sponsoring companies took any action to deal with the conflicts, the investigators found.
Karen Riley, a spokeswoman for the F.D.A, said the agency opposed reviewing doctors’ financial conflicts before trials because they...
Moreover, the investigators say, agency officials told them that trying to protect patients from such conflicts was not worth the effort.
In 42 percent of clinical trials, the agency did not receive forms disclosing doctors’ financial conflicts and did nothing about the problem, according to the investigation, which was conducted by the inspector general of the Department of Health and Human Services and whose results were scheduled to be made public Monday.
In 31 percent of the trials in which the agency did receive the required forms, agency reviewers did not document that they looked at the information. And in 20 percent of the cases in which doctors revealed significant financial conflicts, neither the F.D.A. nor the sponsoring companies took any action to deal with the conflicts, the investigators found.
Karen Riley, a spokeswoman for the F.D.A, said the agency opposed reviewing doctors’ financial conflicts before trials because they...