The FDA Cannot Handle Personalized Medicine

The current regime was built during a time of pervasive ignorance when the best we could do was throw a drug and a placebo against a randomized population and then count noses. Randomized controlled trials are critical, of course, but in a world of limited resources they fail when confronted by the curse of dimensionality. Patients are heterogeneous and so are diseases. Each patient is a unique, dynamic system and at the molecular level diseases are heterogeneous even when symptoms are not. In just the last few years we have expanded breast cancer into first four and now ten different types of cancer and the subdivision is likely to continue as knowledge expands. Match heterogeneous patients against heterogeneous diseases and the result is a high dimension system that cannot be well navigated with expensive, randomized controlled trials. As a result, the FDA ends up throwing out many drugs that could do good.

Alex Tabarrok on Peter Huber. See our previous posts on personalized medicine here and here.

Comments (11)

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  1. Devon Herrick says:

    There is a recent initiative to match the chemical entities and the receptors they bind with and record in a database. This would make it easier to identify other conditions that an old drug might treat.

    • Craig says:

      What would be the cost difference for that system in comparison to the status quo where randomized controlled trials are prevalent?

      • Evan says:

        It would probably be substantially cheaper, just because of the costly nature of randomized trials.

  2. Jeff says:

    The FDA is already incentivized not to approve product as a result of previous law suits. The government needs to reform the FDA and it’s drug approval policies.

    • Nigel says:

      How are they incentivized not to approve drugs?

      • Jeff says:

        Because if they approve a drug and someone has a negative reaction to it and sue the FDA they lose a lot of money, so they already have a disincentive to approve things as often because they could be harmed, which leads to a lot of drugs that could possibly help people are rejected.

  3. Craig says:

    I wonder if the cure for cancer has been recently impossible to create because all forms of cancer are heterogeneous and completely different so you would thousands of specific drugs or processes to fix it.

    • Nigel says:

      That is probably an accurate assessment, but I wonder if all of the forms of cancer have and common denominator or factor that one medication could neutralize, therefore killing cancer.

  4. Gabriel says:

    This is why the FDA should be abolished.