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.
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?
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.
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?
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.
liqingchao 07年8月14日
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