Summary
U.S. Senator Charles Grassley has asked the Food and Drug Administration to explain why it has not yet gone public with an analysis of a large-scale study on the possibility that major arthritis painkillers cause heart attacks. The study was done, after all, by one of the agency's own scientists, Dr. David Graham. The FDA has not responded to the inquiry, which comes as officials are bracing for some high profile meetings about problems with the drugs.
Original source:
http://www.boston.com/business/articles/2005/02/12/senator_hits_fda_for_delay_of_study/
Details
- The Food and Drug Administration is preventing an agency scientist from presenting the largest, most up-to-date study of popular painkillers like Bextra, Celebrex and Vioxx during an FDA meeting next week on heart risks posed by the drugs, a US senator charged.
- The study, coauthored by FDA scientist David Graham, taps a large California Medicaid database to reveal heart risks posed by a comprehensive range of painkillers, including the controversial class known as Cox-2 drugs.
- This would be the third time in recent months the FDA was accused by Congress of rejecting analysis by its own scientists.
- In a letter to the agency, Senator Charles Grassley asked why the FDA didn't make review of the California Medicaid study a priority within the agency, ''given the urgent regulatory and drug safety issues."
- When Graham and his coauthor submitted a summary of the paper for a European conference on Feb. 2, FDA superiors forced Graham to remove his name from the paper.
- The panel was prompted by Merck & Co.'s decision to pull Vioxx from the market on Sept. 30 after long-term use showed the drug doubled the risk of heart attacks, compared with a placebo.
- According to Grassley's letter to the FDA, the agency killed Graham's presentation of the study because it was not vetted by the agency or published in a peer-reviewed journal.
- Yesterday's letter is the second time this week that Grassley, Senate Finance Committee chairman, took the FDA to task.
- Grassley also accused the FDA of trying to pressure Health Canada not to halt sales of Adderall, an amphetamine used to treat Attention Deficit Hyperactivity Disorder, due to worries the drug was linked to sudden deaths and strokes.
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