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Avandia Critic Claims FDA Smear Campaign

Cardiologist 'Not Backing Down' After Alleged Media Attack by an FDA Spokesman

The prominent cardiologist sounding alarms about the diabetes drug Avandia claims he is the target of a smear campaign organized by a top Food and Drug Administration (FDA) spokesman.

Avandia
A new study on the safety of the diabetes drug Avandia may lead to more questions than answers, experts fear.

Dr. Steven Nissen, chairman of Cardiovascular Medicine at the Cleveland Clinic, showed ABC News an e-mail sent to several health reporters by Douglas Arbesfeld, a senior communications consultant to the FDA.

In the e-mail, entitled "What are St. Steven's feet made of? Clay, perhaps?," Arbesfeld forwarded to reporters a critical news article which included an anonymous blog accusing Nissen of playing favorites among drug companies.

Nissen, who co-authored a recent study in the New England Journal of Medicine suggesting that Avandia may increase the risk of heart attacks, was visibly upset about what he considers a direct attack on his personal integrity and professional reputation.

'An Outrage'

"I'm a pretty tough guy," Nissen told ABC News, "but I'll tell you, having this kind of an e-mail that questions my motives, broadcast to the major journalists with whom I work and have established a reputation, is -- it's an outrage. Using taxpayer dollars, a federal agency's press office, rather than responding to the scientific questions that I raised, attempting to smear me individually. It's unacceptable."

Arbesfeld, who is among the FDA's top spokesmen, acknowledged sending the e-mail to a handful of reporters but denied he was attempting to impugn Nissen's reputation.

Arbesfeld joined the FDA as a full-time communications consultant after serving as a spokesman for Johnson & Johnson's pharmaceutical division. In a statement, the FDA told ABC News, "The content of the e-mail from an FDA consultant was his own words and does not represent an FDA position."

'The Big Lie'

Arbesfeld included in his e-mail a comment on a blog posting, originally published in the Wall Street Journal, that accuses Nissen of primarily criticizing manufacturers that do not support drug trials at the Cleveland Clinic: "Wake up, pharmaceutical companies … if you don't hire the Cleveland Clinic for your big trials then you face the firing squad from Nissen and Company." The comment's author is identified only as "Brian A."

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