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FDA Misdiagnosing Research Conflicts

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The Associated Press

Published: January 12, 2009

WASHINGTON - Missing information, loopholes and weak oversight hamper efforts to uncover financial conflicts by researchers who test experimental drugs before companies seek government approval, an internal watchdog finds.

As a result, the Food and Drug Administration's screening system is unreliable, the Health and Human Services inspector general's office said in a report being released today.

"We found a number of limitations in FDA's oversight, leaving FDA unable to determine whether drug companies submit financial information for all clinical investigators," the report said

Because scientists can be tempted by profits, the government requires disclosure of possible conflicts involving clinical researchers who review medications before companies seek FDA approval.

The agency acknowledged the need for improvements while disagreeing with some of the findings and recommendations.

Drug companies hire outside scientists and doctors to test the safety and effectiveness of medications under development. Such tests provide raw data for the FDA to later decide whether to approve a drug. The process, which uses human patients as medical guinea pigs, is supposed to be governed by strict scientific and ethical rules, including financial disclosure.

The issue is not scientists' compensation for supervising drug development tests, but the conflicts that could arise from rewards such as honoraria, grants and stock.
Disclosure requirements were put in place after the 1999 death of a teenager in an experimental gene therapy trial. Among other problems with that clinical trial, it turned out that many of the scientists had financial ties to the drug company.

The report traced some of the problems to a loophole in the disclosure requirements. Companies are supposed to gather financial information from their researchers and submit it to the FDA. They do not have to submit any information if they certify they used "due diligence" and were unable to collect it.

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