Later On

A blog written for those whose interests more or less match mine.

FDA needs some serious work

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From The Scientist:

Just when you thought nobody could be worse than the National Institutes of Health at managing financial conflicts of interest among trial investigators…

The Inspector General of the Department of Health and Human Services released a report today that indicates a pretty severe lack of oversight over at the Food and Drug Administration. The report found that only one percent of the almost 27,000 clinical investigators contracted by the agency in 2007 disclosed a financial interest. In 42% of clinical trials, the FDA never even received the financial disclosure forms from participating investigators that the agency mandates. The FDA not only failed to address these shortcomings, in 20% of the trials where investigators did report a financial conflict, the FDA took no action. In 31% of trials where researchers did submit financial conflict documentation, FDA reviewers didn’t even indicate that they read the forms.

If this isn’t enough to make you smack your forehead and send your morning coffee spraying from one nostril, the FDA also apparently told the inspector general …

Continue reading.

UPDATE: And from the NY Times:

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…

Continue reading.

Written by Leisureguy

12 January 2009 at 10:02 am

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