December 05, 2007

You can find experts without conflicts of interest

The FDA has been criticized for how many scientists with conflicts of interest that the agency allows to serve on its advisory committees. The FDA says it can't find conflict-free experts. But a study by the Integrity in Science Watch project of the Center for Science in the Public Interest (CSPI) suggests the FDA isn't looking hard enough.

CSPI reports:

"For each of the four advisory committees analyzed in the study, it would have taken a single FDA official just one week to replace all the advisers who had conflicts of interest with experts who do not have conflicts of interest. Moreover, the FDA would be able to choose from nearly two potential unconflicted experts for every open slot. And, based on the same criteria for the expertise of potential committee members used in the study, these easily identifiable unconflicted experts would be more qualified than the ones eventually chosen, whether they had conflicts of interest or not. ... Choosing well-qualified advisers without conflicts of interest instead of conflicted experts will strengthen the nation's food and drug safety system."

CSPI, along with other prominent science and consumer groups, urged the FDA "to adopt the conflict-of-interest guidelines the agency published last March. Those guidelines would ban anyone with greater than $50,000 a year in financial ties to industry from advisory committees and deny a vote to anyone with lesser conflicts."

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Meantime, read Maggie Mahar's blog for details on the FDA Science Board report, "FDA: Science and Mission At Risk." Some lowlights:

* “The Information Technology situation is problematic at best—and at worst it is dangerous.”
* “The FDA has substantial recruitment and retention issues”.
* “Critical data…including valuable clinical trial data...are sequestered in piles and piles of paper documents in large warehouses."
* “The FDA has an inadequate and ineffective program for scientist performance."
* "The FDA has inadequate funding for professional development to ensure that staff maintain scientific competence."

Posted by schwitz at December 5, 2007 07:42 AM | TrackBack
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