Saturday, February 21, 2009

Lilly the FDA and Intellectual Bias

Here's an interesting article in the blog - Hooked: Ethics, Medicine, and Pharma 
by Dr. Howard Brody

The article is very much in line with what some of our regular friends on PharmaLittle have been telling us of the inner workings of the FDA. In this case they got caught. 


  1. Where is Joshua Sharfstein?

  2. Hi Nancy - I'm not sure what you mean by your question. As far as I know, he hasn't been appointed Commish, has he?

    Regarding "intellectual bias," the Howard B's piece is a good one, and especially the link to an earlier reflection of his.

  3. Hi Justice. I'll rephrase my question: What is causing the delay in appointing Joshua Sharfstein to the FDA Commissioner position? In my view, he is the best individual for the job.

  4. This case demonstrates again the need for a sea change in FDA’s ethical environment. This kind of change cannot be achieved without consistent, sustained, and strong leadership.

    In his paper Tough Challenges at the FDA John Calfee said, “In the eleven years and eleven months since David Kessler, the first Senate-confirmed commissioner, resigned in February 1997, the FDA has been presided over by acting commissioners more than half the time. The four interim periods without a confirmed commissioner averaged 18.5 months, and none was shorter than fifteen months [,pubID.29235/pub_detail.asp].”

    I am confident that the new administration will get this party started [Senate confirmation] ASAP.

  5. The fix is in. Those charged with safeguarding our health are using their insider advantage to enrich themselves.

    The FDA has become a bed of corruption and needs to be completely overhauled or abolished.

  6. Hi Nancy,

    I have assumed the FDA Commish delay reflects the HHS Secretary delay since the Secretary is the "bigger boss." This only surmise.

  7. Good point, Justice.


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