Last year, Pharmalot spent a full day with Steve Nissen and filed a lengthy piece about the controversial doc. This is how it began:

To the pharmaceutical industry, he is increasingly troublesome, scuttling potential blockbuster medicines by raising red flags about safety. To some patient advocates, he’s an ally, who has shown more backbone than the FDA when it comes to monitoring prescription drugs.

Others accuse him of having it both ways, crusading on safety while accepting money from drugmakers to run their clinical trials. Nissen, who is chief of cardiovascular medicine at the renowned Cleveland Clinic and the prez of the American College of Cardiology, says he would rather be known for helping patients and setting standards for the nation’s 28,000 heart doctors.

“Honestly, the safety thing is not how I want to be known,” the studiously upbeat Nissen told Pharmalot last year, as he drove back to his office after taping a public-radio show about drug safety. “I understand how people may think that. But being an industry critic is not who I am. The most exciting thing I do is bring medicines to patients.”

Well, that may still be true. But Nissen has just extended his unbeatable streak of taking down blockbuster drugs or dashing the hopes of drugmakers who thought a forthcoming med was a sure thing. Today, of course, he made headlines with his piece in The New England Journal of Medicine, examining the heart risks associated with the Avandia diabetes drug.

But check out his track record:

- He first found himself in the spotlight in 2001, when he co-authored a paper in the Journal of the American Medical Association questioning the safety of Vioxx and Celebrex, three years before Vixox was withdrawn over links to heart attacks and strokes.

- Two years ago, he criticized the way Natrecor, a Johnson & Johnson heart drug, was used in hospitals and clinics, claiming it was marketed inappropriately and lacked sufficient safety studies. Though he sat on an FDA panel that endorsed the drug, his criticism focused national attention on the issue.

- He’s also helped squelch drugs before they landed in pharmacies. In 2004, he convinced other members of an FDA panel not to endorse Exanta, an AstraZeneca blood thinner. And the next yearl, he co-authored a withering critique of Pargluva, a Bristol-Myers Squibb diabetes pill up for FDA approval. The drug was dropped last year.

- Early last year, Nissen sparked a debate that stunned doctors and parents nationwide. As a member of an FDA drug-safety panel reviewing several popular attention-deficit disorder pills, he raised questions about heart risks. This prompted the panel to recommend a severe warning, although the FDA hasn’t issued one

[tags]Avandia, Steve Nissen[/tags]