Senator Hits FDA for Delay of Study

posted on:
February 12, 2004

author:
Staff

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 U.S. 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 each instance, the work of the silenced FDA scientists was later confirmed by other researchers.

In a letter to the agency, Senator Charles Grassley asked why the FDA didn't make a review of the California Medicaid study a priority within the agency, "given the urgent regulatory and drug safety issues."

The Iowa Republican's letter, sent to FDA acting commissioner Lester Crawford last night, demands a formal reply no later than Wednesday.

The FDA did not immediately respond to requests for comment.

According to Grassley's letter, the FDA has done little with Graham's study since receiving the data on January 19, When Graham and his coauthor submitted a summary of the paper for a European conference on February 2, FDA superiors forced Graham to remove his name from the paper. And the agency refuses to let Graham present the new study when federal advisers meet next week for three days to weigh the risks, benefits, and future of the controversial class of painkillers.

Federal advisers will sift through hundreds of pages of studies, including previously unpublished data, to decide whether heart risks posed by painkillers like Arcoxia, Bextra, Celebrex, and Prexige outweigh their use by millions of Americans.

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.

The Medicaid study was the first to look at popular painkillers that have received scant safety analysis, such as Bextra, ibuprofen, naproxen, Mobic, and Motrin, making safety comparisons at low and high doses.

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.

Graham, in an interview, said he doesn't believe that explanation. "I personally think it has to do with the nature of the findings," Graham said. "Based on this study, there are pain relievers that are safe, and there are pain relievers that are less safe."

Graham and coauthor Dr. Gurkirpal Singh, a Stanford University adjunct medical professor, are attempting to publish the work in an academic journal. Neither would discuss their findings in detail, citing journal practices that preclude such discussions, apart from scientific gatherings.

The researchers did say the study includes data about painkillers used by thousands of California Medicaid patients who suffered heart attacks through Sept. 2004.

"It is the largest study done so far and it's the study that is most current," Singh said. "It will finally answer the question what happens with other painkillers."

Graham appeared before a Senate committee in November to express concern about painkillers.

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. Whistle-blowers within the agency told Grassley that FDA employees asked Canadian counterparts not to suspend Adderall sales. "There was concern that FDA could not handle another ‘drug safety crisis,' " according to Grassley.

"It is my sincere hope that the FDA continues to act with complete scientific integrity and with FDA's primary mission in mind-the health and safety of Americans," Grassley wrote. "If true, the aforementioned allegations do not suggest that this is the case."

Health Canada suspended sales of the drug, sold as Adderall XR in Canada, on Wednesday. The FDA kept the drug on the market and, in a statement, said no immediate label changes were warranted. Shire Pharmaceuticals Group, the drug's manufacturer, said it was surprised by Health Canada's actions.

 

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