Avandia Critic Claims FDA Smear Campaign

May 30, 2007 — -- 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.

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.

"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."

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."