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Pharma gets slapped

Slap, slap, slap.

That could be the soundtrack to a U.S. Senate Finance Committee report last week that blisters GlaxoSmithKline PLC for what it calls "an orchestrated plan to silence" a critic over the diabetic drug Avandia, charges the company strongly disputes.

Back in 1999, John Buse, a University of North Carolina medical professor, suggested that the drug carried cardiovascular risk. In e-mails, executives of the company called Buse an "Avandia renegade" and considered suing him. One executive called Buse's department chairman to complain about him, the report said.

Buse wrote back to the company, saying "Please call off the dogs. I cannot remain civilized much longer under this kind of heat." He later sought money from the company for a continuing medical education program about Avandia.

The report documents that key e-mails about efforts to influence Buse were copied to GlaxoSmithKline CEO J.P. Garnier. In a July interview with The Inquirer, Garnier denied that he knew anything about the campaign to influence Buse.

Now, the company says executives are correcting errors by a researcher during the critical launch period of Avandia. "Could we have handled the tone of the conversation better? Perhaps yes," said spokeswoman Nancy Pekarek. "We apologized, and everybody moved on. There was no attempt to silence him. There was an attempt that we got the accurate information out there."

In August, the FDA put a black box warning on Avandia for heart failure. Last week, the FDA put another black box warning on the drug, saying it might cause chest pain and heart attacks but that there still wasn't enough evidence to ban it.

Speaking on the Senate floor last week, Sen. Charles Grassley (R, Ia.) said one important lesson from Avandia was not to chill the researchers. "Scientists should feel free to contact my office if a pharmaceutical company threatens their career or attacks their reputation when they raise the alarm about a possibly dangerous drug," he said.

- Karl Stark

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