No New Drugs

This is Megan McArdle, writing in The Atlantic:

The number of clinical trials required to support a new-drug application has more than doubled since 1980, while the number of patients needed in each trial has almost tripled. As a result of these and many other factors, the clinical-trial stage now costs more than four times as much, even after adjusting for inflation…

Because of their astronomical expense, one drug with a huge market is more commercially desirable than 25 drugs that each treat a less common disease, because only one set of trials is necessary. If you’re targeting a disease that affects relatively few people, one of two things will happen: the drug will be very expensive, or the drug will be shelved because it’s unlikely to earn back its R&D investment.

Allergic reactions to penicillin kill a higher percentage of its takers than Vioxx ever did, while the gastrointestinal bleeding produced by aspirin means it probably would have flunked while still in animal testing.

Comments (5)

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  1. Devon Herrick says:

    This article is one of the best that I’ve read on the economics of drug discovery. It explains why drug makers are so fixated on blockbuster drugs.

    Critics of the drug industry are fond of claiming the only drugs that drug makers create are “me too” drugs. This article explains that it is actually much harder to get drugs approved to treat conditions for which there are already good drug therapies because you have to prove your drug is as good or better. It’s a harder case to prove than merely showing your drug works better than a placebo — which is about all you need for the first new drug to treat a condition.

  2. Virginia says:

    This is pretty fascinating. Imagine if we had just now discovered aspirin. The bottle that costs $3.50 at Tom Thumb would be $400 via prescription-only. We’d all be taking percocet for our headaches because it was cheaper.

  3. Bruce says:

    Bottom line: we are going to get fewer new drugs.

  4. Bruce says:

    Also, if you don’t think the FDA is killing people, read again the passages about how we would not have access to aspirin and penicillin if these drugs had to get FDA approval today.

  5. Larry C. says:

    Has anyone ever considered that one way to hold health care costs down is to make it almost impossible to produce any new drugs?