Watching the Watchers

TGGP asks whether it would be better to have the FDA regulate surgeries instead of drugs.

Even if it were surgeries as well as drugs, I’d say the answer is ‘no’. Why?

Many people do not realize that the FDA doesn’t actually perform any testing of drugs. It merely examines the reported results of tests submitted to it. Who performs the studies of the drugs? Why, the pharmaceutical companies who developed and are hoping to market them, of course.

Does that strike you as a conflict of interest? It should.

The biggest problem with this arrangement is that there’s really nothing preventing the drug makers from only reporting positive results. Yes, there are rules against that, but without keeping tabs on what the companies are doing or granting the authority to discipline violators, they’re paper tigers.

If you go out and look for them, you’ll find that there have been many cases of a drug that appeared to be useful in the experiments submitted to the FDA that turned out to be nigh-useless in actual clinical use. Given a drug that doesn’t appear to be doing better than placebo, you can always just perform lots of tests and then keep the ones in which the drug happens to do better than the control. What about the scientific ethics of the researchers paid to perform the tests? If they get a reputation for being ‘troublesome’, they’re likely to be let go – and find it difficult to obtain employment elsewhere in the pharmaceutical industry. Drug makers can sit on the negative results and never let them see the light of day.

The problem isn’t so much that what the FDA does is bad, but that it’s inadequate and horrifyingly ineffectual – and that, by existing, it helps create the impression that drugs are being properly vetted. People presume that drugs that make it through the process are valuable, that in-all their benefits are substantial and outweigh their costs. That trust is misplaced.


2 Responses to “Watching the Watchers”

  1. I guess I wasn’t being clear in that, rather than asking the usual question of whether the FDA is goor or bad overall, I just wanted to know your relative opinion on them regulating surgery vs drugs. I guess it might be hard to do the same kinds of testing for surgery.

    • Not ‘hard’ so much as that none of the entities directly involved – except the patients themselves – have an interest in testing, and the patients are both too ignorant and too uninterested to demand it themselves.

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