Friday, September 10, 2010

The Drug Pipeline and the FDA

No RefillsBy Megan McArdle

Over time, critics say, high-profile disasters like Fen-Phen and Vioxx, which killed or seriously harmed some of the people who took them, have encouraged ever-more-stringent review. 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.

...

This means that clinical trials have unwanted side effects. 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.


Tougher safety and efficacy standards may also be keeping good drugs out of the public’s hands. Most people agree that today’s FDA would not have approved aspirin; even penicillin, the miracle drug that helped dramatically extend the human lifespan when introduced in the early 1940s, is questionable. 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.


Interesting stuff. We are killing ourselves with regulation.

Here is Milton Friedman on the FDA:



TAKE IT TO THE LIMITS: Milton Friedman on Libertarianism

DRUG-STALL COWBOYS

ROBINSON The Food and Drug Administration which regulates everything from the drugs that pharmaceutical companies may put on the market to the ingredients in items we purchase off the grocery store shelves. Let me give you an example- Thalidomide [FRIEDMAN Everybody's favorite example...] Well I may be leading with my chin on this one but I'm going to lead with it anyway. 50's and 60's it is marketed in Europe as a drug to help women get through the nausea that they sometimes experience during pregnancy. The Food and Drug Administration said it had been inadequately tested in the United States and forbade it to be marketed in this country with the result that thousands of children were born with horrible birth defects in Europe to mothers who had used Thalidomide but that didn't happen to American children, because the FDA had intervened and kept that drug off the market. Thank god for the FDA, right?

FRIEDMAN Wrong [ROBINSON Alright, why?] this is a case in which they did save lives, this was a good case, but suppose they are equally slow in adopting a drug which turns out to be very good and beneficial. How would you ever see the lives that are lost because of that? You're an FDA official, you have a question of whether to approve or disapprove a new drug. If you approve it and it turns out to be a bad drug like Thalidomide, you're in the soup, your name is going to be on every front page [ROBINSON cost me my job, I get hauled up to Congress to testify..] right. On the other hand if you disapprove it, but it turns out to be good, well then later on you approve it four or five years later, nobody's going to complain about the fact that you didn't approve it earlier except those greedy pharmaceutical companies that want make profits at the expense of the public, as everybody will say. So the result is that the pressure on the FDA is always to be late in approving. And there's enormous evidence that they have caused more deaths by late approvals than they have saved by early approval.

ROBINSON So your view is abolish the FDA..

FRIEDMAN Absolutely [ROBINSON And what comes up in its place?] what comes up? It's in the self-interest of pharmaceutical companies not to have these bad things. Do you think the manufacturer of Thalidomide made a profit out of Thalidomide or lost? [ROBINSON I see, ok.] And you have to have..people should be responsible for harm that they do. It should've been possible...[ROBINSON So tort law takes care of a lot of this.] Absolutely, absolutely..
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1 comment:

Anonymous said...

I like this blog. I actually read Something where fanatical thinkers wanted to abolish psychiatry. Let their liscence expire and tell them to go do something else. WTF? Where is the common sense in that?