Scientist to withhold painkiller data
FDA worker said he was pressured to forego presentation
WASHINGTON (Reuters) -- A veteran scientist at the Food and Drug Administration said Monday he had decided against presenting new data on the heart risk of pain relievers at a highly anticipated meeting later this week, saying he felt intimidated by FDA officials.
David Graham, associate director for science and medicine at the FDA's Office of Drug Safety, had planned to present the as-yet-unpublished information to a panel of health experts who will discuss safety issues with pain relievers like Merck & Co. Inc.'s now withdrawn Vioxx.
The FDA called for the public meeting after several studies showed a link between some of the drugs and heart attacks or strokes. The experts will also discuss whether Pfizer Inc.'s Celebrex and Bextra, drugs similar to Vioxx, should remain on the market.
But Graham told Reuters in an interview that an e-mail from his supervisor Paul Seligman said that if he continued to press for inclusion of the new data he would be doing so at his own risk.
"The tone of it is (that) I'm being insubordinate," he said.
An FDA spokeswoman said agency officials told Graham it was his choice as to whether he wanted to present. "We just prefer that published literature be presented," she said.
But Graham said it was not a real choice. "Because I feel so threatened by management, it's not worth taking the risk," he said he told his supervisors.
The study in question examined data from California's Medicaid program, called Medi-Cal, and is larger than any previous related study and looked at more than 15,000 heart attack patients, Graham said.
"Our findings are important to the safety of a number of marketed pain relievers," he said.
Senator: Mixed messages from FDA
The pain medicines, a type of non-steroidal anti-inflammatory drug (NSAID), are part of a class known as Cox-2 inhibitors.
At a congressional hearing in November, Graham testified about his worries over the agency's handling of drug safety.
His testimony, which included warnings about other drugs he considered unsafe, caused the FDA to defend its drug approval process and raised concerns of public interest groups and others about whether the 20-year agency veteran would be fired or reassigned.
"This is an instant replay," said Graham, who is scheduled to speak on the second day of the three-day meeting due to start on Wednesday.
Graham said managers had not "spoken to me to say 'your perception is wrong"' about the risk to his job or to encourage him to present the new findings.
Sen. Charles Grassley, chairman of the Senate Finance Committee that held the November hearing, said the FDA first told Graham he could not present the study but later, in Seligman's e-mail, said it was Graham's decision to make.
In part of the e-mail quoted by Grassley, Seligman said, "I think we've already articulated our preference that your talk cover the key studies in the published literature. Clearly, you would like to cover more than this which is your call."
Grassley said Graham was "being sent mixed messages."
"Dr. Seligman is clearly saying to Dr. Graham proceed at your own risk," the Iowa Republican wrote in a letter to FDA Acting Commissioner Lester Crawford sent late Monday.
Grassley also questioned the FDA's defense that only published studies should be presented, noting that Graham was reportedly asked to present information from an unpublished Merck study.
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