OT:Avandia Critic Claims FDA Smear Campaign

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Avandia Critic Claims FDA Smear Campaign

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

Spokesman

From Nightline

By CHRIS BURY and DAN MORRIS

http://abcnews.go.com/Nightline/story?id=3225419 & page=1

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. Nissen, chairman of Cardiovascular Medicine at the

Cleveland Clinic, showed ABC News an e-mail sent to several health

reporters by Arbesfeld, a senior communications consultant

to the FDA.

In the e-mail, entitled " What are St. '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 & '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 " 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 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, GlaxoKline, 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.