Approving Drugs

Instapundit has a post wondering if the FDA is getting too cautious about approving new drugs.

IS THE FDA getting too cautious in drug approvals? If it is, people will die who shouldn't. But it's less likely to get blamed.

Years ago, I think it was John Campbell who proposed that we license quacks. (Um... "Practitioners of Alternative Medicine".)

Anyone who had an unapproved medical treatment could hang out a shingle and treat people, provided:

1) The licensed quack could only claim to be licensed as a quack – he could not claim any legitimacy for this treatment, or any sort of sanction except that the Medical Establishment knew this person was practicing.

1A) Above all else, there was no guarantee that the treatment offered by the licensed quack would improve whatever condition was being treated. Indeed, it could even make things worse. That's the risk you take by going to a quack.

2) Licensed quacks were required to keep careful records of all patients they treated, and the outcomes of treatment. These records would be made available to medical researchers on request, with reasonable restrictions intended to safeguard patient privacy. (Though sacrificing privacy might well be another cost of going to a quack.)

The reason for provision 2 was that if a new and unapproved treatment turned out to work, the evidence would be in the practitioner's records. True, without a control group, it might not be as solid as we'd like, but if Witch Hazel cures 50% of her cancer patients, and the national average cure rate for the same cancer is only 30%, that would be enough to attract researchers willing to set up a proper study.

Maybe a similar thing could be done with drugs.

The FDA could institute several levels of approval. The highest level would be the standard adhered to nowadays: the FDA guarantees the drug is at least as safe as doing nothing, and more effective than a placebo, and (apparently) no side-effects that could prompt litigation.

Lower levels of approval could be implemented, with higher levels of possible risk, down to "licensed snake oil" which has no guarantees except it does contain oil from snakes, and that if it turns out to work, whoever's selling it has been required to keep records that will show that fact.

So cancer patients could buy FDA approved shark cartilege, or FDA approved laetrille, or FDA approved whatever else is being offered. Because all of these would be licensed as "snake oil", there would be no guarantee that any of these things would actually work, or even be safe to ingest. They would contain real, certified laetrille, shark cartilege, or whatever, but whether they do anything is not the FDA's problem at that level.

Just a thought.