Tuesday, June 2, 2009


Sweeping Changes in Store

It happens in small steps, but every day we learn another bit about the changes the Hamburg/Sharfstein team are bringing to an FDA saddled in dysfunction, corruption, and incapacity. Most recently, they have announced a program that would bring much more transparency to decisons on NDAs and applications for new indications that could unearth material on drugs and devices that are normally not surfaced except in litigation. Read about it in the New York Times:


After years of having to put up with an FDA leadership that wanted mostly to hide under rocks or their jockey shorts of their benefactors, it is almost difficult to believe we are seeing this much change. I still wonder how many dead-enders there are who will offer pockets of resistance--and maybe more--as reform goes on. Old and corrupt regimes die hard, as the last eight years have taught us, even at their most grotesque.

One interesting tidbit I didn't know. After the scam around the CLASS study was uncovered, and JAMA learned that it had been given the only part of the data set, the journal explicitly disowned the article. Neverthless, detailers continued to use it to sell Celebrex. I never get tired of quoting what Bob Temple said at the time: That the hype from the JAMA article will always have greater impact than our labeling does.


  1. How sad that the FDA found it necessary to hide facts that, if known, could have prevented suffering and saved lives. Per the link, they had to forgo their duty to protect the public health because,

    “Agency confidentiality decisions are governed by several interconnected laws, including the Federal Trade Secrets Act.”

    “For years, the Food and Drug Administration has withheld information about drugs and medical devices from the public when their makers cite trade secrecy.”


    “Avandia…made by GlaxoSmithKline, increased the risk of heart attack by 42 percent. The data Dr. Nissen used was made public because of a lawsuit, but the agency had known of the possible risk for nearly two years.”

    Lawsuits protect the public.

    Hamburg and Sharfstein must be successful, for the sake of all of us.

  2. How much crap is this? I doubt that the intent of trade legislation was to compromise public safety. Again, pharma has twisted the law to serve pharma.

    The (other) mob also has trade secrets; they don’t disclose who they whack, either.

  3. madoff used secrecy and collusion with the feds to run his 50 billion ponzi scheme. big pharma the same methods and bet you they will bring out the big guns for this one. controlling info is too important to their marketing machines. until now the FDA have accepted this, and if not, pharma sends a threatening letter to scare them. interesting to see if the new administration can make some necessary changes, not superficial.

  4. Please read the corrections to that article. The CLASS study was never retracted.

    Marilyn Mann

  5. Thanks, Marilynn. What you say fits my own memory. There was noise about it, but no retraction (what would that mean, actually?)

  6. The article would no longer appear on the journal's website. If you searched for it, you would find the title with a notation saying it had been retracted.



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