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Epstein: Clinical Trials on Trial: How Should the FDA Do Its Job?

Given that the obvious answer, “Quit!”, won’t fly in the near future, Prof. Epstein toward the end suggests applying a strong exothermic reaction to the FDA.

Not perfect, but very good nonetheless, and provides info and reminds us of That Which is Too Often Unseen and Discounted. About an hour.

Uploaded on May 20, 2011

One of the major functions of the FDA is to check new drugs for their safety and effectiveness. The chief tool for doing this has been the double-blind clinical trial. Over the past 20 years ago, the requirements for these trials have become ever more stringent, reducing the probability that new chemical entities will be approved, delaying their onset into the market, and increasing their costs. The FDA claims that these stark measures are needed to discharge its chief function of consumer protection.

In this talk, Professor Epstein disputes that contention, to argue that many of the FDA standards are analytically unsound and socially counterproductive. The constant demand for compassionate exemptions on the one hand, and widespread off-label use of approved drugs are clear signs that the current system is out of whack and in need of serious recalibration.

https://www.youtube.com/watch?v=IEhzoh86N9M

3 Comments

  1. Paul Marks says:

    The FDA was less bad before the Senator K. Amendments of the early 1960s.

    However, reversing them would be as hard as getting rid of the FDA itself.

    So might as well go for the prize of getting rid of the FDA.

  2. Laird says:

    Simply eliminating the “effectiveness” test would go a long way toward fixing the problem. Safety is important, but the market can take care of effectiveness.

  3. Paul Marks says:

    Laird “health and safety” ALONE can mess things up.

    Mess them up in a massive way.

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