Dr. Nissen's Suggestions to President Obama -- A Very Good Start. . . .

As the Inaugural euphoria winds down, and the business of governing gets into high gear, it is high-time for our 44th President, Barack H. Obama, to pick an FDA Commissioner.

For months now, Dr. Steven Nissen, head of Cardiac Medicine at the prestigious Cleveland Clinic has been rumored to be near the top of the very short list. He served as an advisor to the President during his campaign. This week, it seems that Dr. Nissen's cogent thoughts are popping up, all over -- in print, nationwide. Over at Nature [Note: subscription $$ req'd], and in an interview with the Cleveland Plain-Dealer, to mention just a few. The below summary of his Nature essay is derived from this blog. Here is a snippet, but do go read it all [Photo at right taken on 1100 Pennsylvania Avenue, on Tuesday afternoon. And, a Double Bonus! -- Extra, Extra Credit goes to Marilyn Mann, loyal reader, for collecting all these salient Nissen links! -- Gracias!]:

. . . .Dr. Nissen’s suggestions include:

▲ The FDA Chief should serve a fixed six-year term to insulate the agency from political influence;

▲ The FDA needs better harmonization between its Office of Surveillance and Epidemiology, which monitors post-marketing safety, and its Office of New Drugs, which is responsible for post-marketing regulatory decisions;

▲ Partner with large healthcare providers to collect better adverse event reporting data;

▲ Rely less on "non-inferiority" and "bio-markers" trials [Think Schering's Vyotrin here!], as an indicia of FDA approvability;

▲ Similarly, FDA ought ot reduce reliance on "substantially equivalent" trials;

▲ Curtail direct-to-consumer advertising until after two years from first FDA approval;

▲ Increase inspection of foreign drug manufacturing and compounding facilities; and

▲ Quadruple the FDA’s current $2.3 billion budget. . . .

[And now, little bit from the Plain Dealer blog:]

. . . .The Plain Dealer: A report released earlier this month by the U.S. Department of Health and Human Services noted that in 42 percent of trials, the FDA failed to receive disclosure forms from the physicians conducting the trials. Are those disclosure forms important?

Nissen: Absolutely. First of all, it's all about transparency. If one has a personal financial interest in a product, it's very hard to be objective about that product, its safety and its efficacy. . . .

The Plain Dealer: Have you ever felt pressured by a drug company to publish results more positive than what you came across?

Nissen: All the time. When you do research with a company, they have their interest and we have our interest. 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.

My group will only engage in pharmaceutical trials if we name an academic steering committee that governs the trial. And the entire trial database has to be transferred to the Cleveland Clinic -- not tables and figures and derived data, but the whole raw data.

We also have the independent rights to publish the results if they're favorable or unfavorable.

The Plain Dealer: The position of FDA commissioner is one of the few top agency or Cabinet positions President-elect Barack Obama has not filled. Are your sources at the FDA and on Capitol Hill telling you why there is a delay and when can we expect an announcement?

Nissen: 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. . . .

Well-put.