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Physician calls for more rigorous standards for drugs up for FDA approval
Date:3/9/2010

nt standard for approval that a drug not just outperform placebo, but that it also undergo direct comparison with at least one treatment considered the standard of care. In this way we can ensure that new, less effective treatments do not replace older, more effective and cheaper ones. Requiring new drugs to be compared with established treatments before drug approval would also decrease the amount of federally funded comparative effectiveness research required down the road."

O'Connor began studying issues related to drug approval a few years ago, when he began a meta-analysis of the effectiveness of approved medications to treat severe nerve pain, known as neuropathic pain. With the help of colleagues, he was able to unearth a great deal of information from unpublished studies available deep within the FDA web site. Oftentimes these studies contained negative data about new medications information that was largely unknown in the medical community.

In his commentary, O'Connor calls for revisions to the Code of Federal Regulations, which spells out the guidelines FDA uses to evaluate new medications. O'Connor notes that Congress, not FDA, sets the guidelines that FDA follows.

Last year O'Connor published another commentary in JAMA drawing attention to the availability of information about new drugs through FDA and suggesting ways to make the data easier to find for physicians and others.

"The FDA has its own statisticians who analyze data and arrive at their own conclusions regarding studies," said O'Connor. "They have no financial conflict of interest, and there is no pressure to produce favorable results for a drug. Such an independent analysis is a gold mine for researchers and physicians seeking information about the safety and efficacy of a medication that has recently been approved.

"I have a huge amount of respect for FDA. The amount of time and effort the agency puts into each new drug review is incredibl
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Contact: Tom Rickey
tom_rickey@urmc.rochester.edu
585-275-7954
University of Rochester Medical Center
Source:Eurekalert

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