Whistleblower to Share New Pain Drug Data

Whistleblower to Share New Pain Drug Data
Wed Feb 16, 2005 05:37 PM ET



GAITHERSBURG, Md. (Reuters) - A veteran scientist at the U.S. Food and Drug Administration said on Wednesday he will present new, unpublished findings about heart risk associated with a number of pain drugs at a meeting to assess whether they are safe enough for patients.

David Graham, associate director for Science and medicine at the agency's Office of Drug Safety, said he decided to talk about the findings after FDA Acting Commissioner Lester Crawford sent a letter saying he could do so without fear of reprisal.

Graham had earlier said he would not present the data because he felt threatened by his FDA supervisors.

"I want to assure you that Dr. Graham is free to present from his Medi-Cal study ... without any concerns of retaliation from any FDA employee," Crawford wrote.

The letter, provided to Reuters, was sent to Senate Finance Committee Chairman Sen. Charles Grassley, an Iowa Republican who has defended Graham since holding a hearing on Merck's now-withdrawn Vioxx in November.

Graham said he was heartened by Crawford's letter, but added that FDA officials were not encouraging him to present the data. "I'm doing it because it's in the public interest," he said in an interview with Reuters.

Graham will unveil his findings before an expert panel Thursday morning during the second day of an unusual three-day meeting called by the FDA. The panelists will help the FDA decide whether the medicines offer enough benefits to stay on the market, if they need stronger warnings and what further research is needed.

The new study in question examined data from California's Medicaid program, called Medi-Cal, and looked at more than 15,000 heart attack patients, making it larger than any previous related study, Graham has said.

FDA officials have said they prefer only published data be presented.

© Reuters 2005. All Rights Reserved.

http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=7653350

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