Marginal Revolution: The Golden Age of Medical Innovation

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The Golden Age of Medical Innovation

Writing in The American John Calfee surveys the recent history of medical innovation. I was especially struck by Lucentis, a new drug that Science magazine ranked sixth in its ten breakthroughs of the year (number one was the solution to Poincare's conjecture). Lucentis has had stunning success in treating age-related macular degeneration, the leading cause of blindness in seniors.

What makes Lucentis, as Calfee notes, especially interesting is that Lucentis is what industry critics call a "me-too" drug, a simple twist on another drug. Moreover, it's a twist on a drug originally approved to to treat cancer but subsequently used off-label to treat AMD.

Posted by Alex Tabarrok on April 9, 2007 at 07:10 AM in Economics, Medicine | Permalink

Comments

Question?
When the FDA approves a drug it states two things.
1. They have not found significant adverse side effects.
2. They have significant evidence that it works as claimed for a specific disease.

Does the fact that the FDA certifies that a drug does not have adverse side effects have a significant impact on doctors willingness to experiment with the drug for other purposes then the approved disease?

In other words, is the off-label use of drugs highly dependent on the FDA
approval and that without it doctors would be reluctant to experiment with
many drugs because of the fear of unknown side effects?

I do not know the answer to this. Does anyone have any data on this question?

Posted by: spencer at Apr 9, 2007 9:50:24 AM

Bear in mind that approval does *not* mean that a drug does not have significant adverse effects. At best, it means that in the FDAs judgment the adverse effects are not outweighed by the benefits the drug may have for some patients. At worst, it means simply that no significant adverse effects were found at the sample sizes used in the trials. A drug that kills 1 in 5000 is unlikely to be discovered in a trial of 5000 (which would be a large, expensive trial).

Thus, there is some information in the FDAs approval decision but not as much as one might think at first glance. In addition to the FDA doctors draw on the medical literature, other countries, and the experience of other physicians. My paper with Dan Klein has more on these processes but more research is needed.

http://mason.gmu.edu/~atabarro/DoOffLabel18.pdf

Posted by: Alex Tabarrok at Apr 9, 2007 10:59:24 AM

So you do not know the answer either?

I would think the answer would have a significant impact on any cost-benefit
calculations of drug regulation.

Posted by: spencer at Apr 9, 2007 1:06:23 PM

To Spencer:

I believe that it would be dependent on the doctor's perception of the FDA. Im sure most of this countrie's elite doctors probably use alternative methods for attaining knowledge about new drugs outside of what the FDA says. In many instances , doctors have a far different perception of drugs then what the FDA has legislated.

Posted by: John Pertz at Apr 9, 2007 1:17:13 PM

What I am talking about is experimenting with a drug for a different disease.

The question is simple, will doctors be more willing to to experiment with an off-label drug then with a drug that has not been approved by the FDA?

Isn't this just a plain simple factual question that someone should have conducted a survey about?

Posted by: spencer at Apr 9, 2007 4:43:43 PM

A survey? Jeez.

Doctors are pretty nervous about doing anything that can be argued to be "below the standard of care" because they get sued for that. Asking them about using a new drug not FDA-approved and not checked for basic toxicity is like asking them how they would feel about Russian roulette.

Now if there were alternative sources of information about safety--such as widespread use of the drug in another country--then you might get meaningful adoption, absent legal constraints. But those legal constraints bind pretty tightly, I think.

Posted by: srp at Apr 9, 2007 8:39:33 PM

It is utterly important to not to neglect the legal aspect of medical innovations. Nowadays, you can not exploit the medical resources (even in time of emergencies) unless you protect yourself legally. For example, if your child is being cared for by someone else (e.g friends or relatives) and your child required immediate/urgent surgery for some reason, the people caring for your child have to have the legal authorization from you to proceed with the surgery. This can save a child's life. These

legal forms

can be obtained anywhere online.

Posted by: elsa at Apr 12, 2007 11:53:21 AM

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