Avandia Critic Claims FDA Smear Campaign

Prominent critic of the diabetes drug says the FDA tried to sully his name.

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.

'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."

Nissen calls the anonymous blogger's accusation an example of "the big lie." "The idea that I would somehow be selective in my criticism to those companies that don't bring clinical trials [to the Cleveland Clinic] is … extremely offensive … and absolutely untrue."

Nissen points to his outspoken criticism of Cox inhibitors including Celebrex -- a Pfizer product -- at the time he was the principal investigator for a Pfizer clinical trial.

'I'm Not Backing Down'

But Nissen said he is even more infuriated that a top FDA spokesman distributed articles including the blog disparaging his reputation and that of the Cleveland Clinic, instead of confronting the Avandia study itself.

"They're barking up the wrong tree," he said. "While I did spend a sleepless night about this, I'm not backing down. What counts here is the truth. What counts here is the health of our patients. And if they think they can intimidate me by doing this … they have another thing coming."

In the study, Nissen and his co-author report that diabetes patients who took Avandia were 43 percent more likely to have a heart attack than patients who took other medications or a placebo.The drug's manufacturer, GlaxoSmithKline, said it, "strongly disagrees with the conclusions" in Nissen's article, which the company contends "are based on incomplete evidence and a methodology that the author admits has significant limitations."

The FDA responded to the study by issuing a safety alert, recommending that physicians "continue to carefully make individualized treatment decisions" for diabetes patients who take Avandia. At least three congressional committees are planning to investigate Avandia -- and the FDA approval process -- in the coming weeks.