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Nissen: Plainspeaking In The Plain-Dealer

Dr. Steven Nissen
Source: my.clevelandclinic.org
Dr. Steven Nissen

Dr. Steven Nissen, the cardiology chief at the Cleveland Clinic, reportedly remains on the shortlist to possibly become the next FDA Commissioner.

Some analysts believe if Dr. Nissen gets the nod there could be a negative knee-jerk reaction in the big pharma sector stocks. He's a safety watchdog and many in the industry consider him to be an outspoken adversary.

I am not campaigning for or endorsing him or anyone else for the job. But I can tell you I've heard Dr. Nissen come down on both sides. For example, before torcetrapib--the once-promising experimental Pfizer drug that appeared to lower bad cholesterol and raise the good kind--blew up over heart safety issues, Dr. Nissen was effusively touting the medicine as potentially the greatest thing since sliced bread. On the flip side, over the past year when questions were raised about the efficacy of Vytorin from Merck and Schering-Plough he, at one point, called for a "moratorium" among doctors prescribing that cholesterol drug. He also did the controversial study questioning the safety of GlaxoSmithKline's diabetes drug Avandia.

As the not-so-subtle campaigns continue for the FDA job, Dr. Nissen is speaking out in at least two publications this week. In the scientific journal "Nature" he writes that the next FDA commish "should serve a fixed six-year term to insulate the agency from political influence. Moreover, the system by which pharmaceuticals companies fund a major portion of the FDA's budget through user fees requires re-evaluation." He calls for more government funding.

Dr. Nissen goes on to say, "The current voluntary mechanism for adverse-event reporting is relatively ineffective....The approaches used to approve drugs needs attention."

Simultaneously, Dr. Nissen gave a lengthy interview to his hometown paper. Reporter Sarah Jane Tribble asked Nissen, "Have you ever felt pressured by a drug company to publish results more positive than you came across?" Nissen replied, "All the time. The pharmaceutical industry is a for-profit enterprise. When they do research, they want that research to support their product. We have to be tough and independent."

As for what's holding up the appointment of a new FDA kahuna and when we can expect to hear who it's gonna be, Nissen said, "I think it's a very challenging appointment. We have a failed agency that desperately needs a new direction and a very powerful industry sitting on the sidelines with lots at stake. I am confident that the Obama administration, with a very thoughtful transition team, will do what's right for the country. And by having a campaign which was free of lobbyists' contributions, I'm confident that they will make an independent decision based upon what they believe is right for the country."

As I had blogged several times during the campaign, though, the drug companies gave Obama more money than any other candidate — Democrat or Republican.

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