Healthy Skepticism Library item: 14966

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Publication type: news

Alonso-Zaldivar R.
Report: FDA screening of researchers is unreliable
The Associated Press 2009 Jan 12
http://www.statesman.com/search/content/news/stories/nation/01/12/0112fdaconflicts.html

Full text:

Missing information, loopholes and weak oversight hamper government 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 says in a report that is 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.

Investigators examined 118 new drug applications that were approved by the FDA in 2007.

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

In all, 42 percent of the applications lacked complete financial information and less than 1 percent of researchers disclosed possible conflicts. Such limitations “could result in FDA being unaware of a clinical investigator’s financial interest, and thus unable to gauge its potential bias on clinical trial results,” the report said.

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 decide whether to approve a drug. The process, which uses human patients as test subjects, 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 other rewards, such as honoraria, grants and stock options.