I disagree. The next commissioneer needs a mandate to clean up FDA and the savvy to be able to do it. Everything else he/she can have advisors for and will. It’s getting those good advisors.

As an insider it’s clear it’s clear to me that Von Eschenbach was very successful at what his job truly is. Yet he didn’t have most of those qualifications.

It’s the mandate and having someone with the ability to clean things up that’s important.

Salmon

My takeaway: “Pharma Industry Out of Touch with Their Customers When It Comes to Who They Favor for FDA Commissioner”

FDA critics like Steve Nissen and Peter Rost are the candidates of choice in the Pharma Marketing News survey that asked respondents to vote on who they think should be nominated as the next FDA Commissioner.

The survey included representatives from various stakeholders, including executives and staffers working within the pharmaceutical industry, agents and vendors to the industry, healthcare professionals, members of the general public, and staffers within government health agencies.

It is particularly interesting that former FDA Commissioner David Kessler is almost as popular as Janet Woodcock among pharmaceutical industry respondents.

Perhaps it is not surprising that the drug industry favors these “insiders” and not “change agent” outsiders like Nissen, Rost, or Susan Wood, who are favored by pharma’s customers: the general public and healthcare professionals.

It’s just another indication that the industry may not be ready for changes that their customers want to see.

You can get the complete results of the survey here: http://tinyurl.com/43o6o2

I believe there is a potential subtext for the active role Nissen (and his predescesor, topol) played in illuminating the safety issues surrounding Vioxx (and for avandia).

The Cleveland Clinic has become a critical site for major clinical trials for Pfizer and an active “academic detailing” for the virtues of the Pfizer blockbuster drugs (Celebrex, Lipitor, Norvasc, and the upcoming Torcetrapib). I also believe they do work for takeda the manufacturer of a avandia competitor.

It is also conceivable that the Nissen/Topol campaign to discredit Vioxx was in part motivated by the strong relationships between the Cardiology department and Pfizer and designed to promote the alternative use of Celebrex. I think their campaign perhaps to please Pfizer by diminishing sales of vioxx backfired because of the safety concerns that now surround the whole class of drugs including celebrex. None the less, Nissen’s complex relationships with industry may be rife with conflicts of interest and a developing fact pattern suggests he may be substantially biased by his active participation in the Pfizer promotion machine

It is noteworthy that to the best of my knowledge he has not criticized a Pfizer drug and is often quoted extolling the virtues of Pfizer products. To his credit he has been critical of Merck, J and J, and BMS compounds that have concerning safety profiles. Some have argued that his concerns were voiced after the knowledge was already public and may have been part of a tactic to bolster his own credibility.

Some key examples:

Nissen was the Principle Investigator (PI) for the major Pfizer funded Lipitor trial REVERSAL. This trial is a critical part of Pfizer’s strategy to convince FDA that intermediate endpoints like intravascular ultrasound (IVUS) findings should be accepted by FDA in lieu of hard endpoints like mortality. IVUS is an essential component of Pfizer’s plan to accelerate approval of their pipeline of new HDL increasing drugs. Nissen active role in Pfizer funded research, his advisory board appointment at FDA, and his availability to the press has served Pfizer and his career handsomely.

Nissen was also the PI for the Pfizer funded CAMELOT Norvasc study.

Nissen is the PI for the Pfizer funded Torcetrapib trial that will be a critical piece of evidence for the fda new drug application. This drug was pivotal to Pfizer’s financial future and already generated controversy for Pfizer’s decision to bundle it with Lipitor - we all know it crashed a burned.

Nissen is the PI for the new 100 million dollar Pfizer Celebrex trial. The trial is a public relations prize for Pfizer. It is designed to bolster sales while the results will be unavailable for years.

Nissen is an active participant is Pfizer funded national “educational program” for physicians including free continuing medical education programs. These programs include the National Lipid Education Council (www.lipidhealth.org) and the Emerging Science of Lipid Management (www.eslm.org). These highly funded programs promote aggressive use of statins (Pfizer’s Lipitor being the most highly prescribed one). Nissen does state that he does not receive industry speaking or consulting fees but this is merely a token gesture.

My questions are:

 How do researchers like Nissen at the Cleveland clinic benefit from running major clinical trials? Clearly prestige, promotion, but does the clinic factor the trial dollars into bonuses, promotions, profit sharing, raises etc. Medical groups have powerful reward structures for bringing in revenue especially highly profitable enterprises like industry funded clinical trials. The travel and expenses perks alone are extraordinary for industry funded trials. Do these potential conflicts compromise the design, analysis, and conclusions of these studies?

 What kind of revenue is the Cleveland clinic cardiology practice generating by popularizing IVUS and how does Nissen and Topol benefit from this personally. Does the clinic have any financial interests in the technology?
 Are Dr. Nissens financial relationships with Pfizer substantial enough to question his role in fda proceedings?

 Does Dr. Nissen participate in major pharmaceutical company funded educational programs other than Pfizer? If not does lend support to the theory that he is for practical purposes a member of the Pfizer sales team.

FDA deserves and desperately needs a reformer without the baggage that Dr. Nissen has.

I auppose the hook was so successful, I got hooked! Well done, John!

Anyway, it’s annointing one’s blog poll as determinative of the right or wrong choice that’s, to me, a little bizarre.

For a look at some of where Josh Sharfstein may be coming from, see these remarks of his father, former Prez of the APA. (Not that sons echo fathers, but lines of conviction are not uncommmon.)

http://pn.psychiatryonline.org/cgi/content/full/41/12/1-a

You betcha.