HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Friday, April 7, 2006

Harm v. Benefit

The blog, TigerHawk, has an interesting article on how the FDA and our regulatory system views the harms that drugs cause as compared to the benefits that those same drugs may achieve.  The article is entitled, "The FDA, the Tysabri conundrum, and our cultural incapacity for single payor healthcare.  The article quotes extensively from a piece in today's Wall Street Journal concerning the FDA and MS that requires a paid subcription.  The blog writer states,

One of the biggest problems with our system for regulating pharmaceuticals is that we carefully measure all the harm a drug may have done, but do not weigh against it all the good it certainly can do. This asymmetry between sins of commission, which both the FDA and the tort system consider grave, and sins of omission, which neither take into account in any systematic way, means that it is very difficult to gain the approval of drugs that may do tremendous good for virtually all patients, but grievous harm to a tiny percentage of the people who take them. The risk to the tiny percentage overwhelms the benefits to the millions in the minds of risk averse bureaucrats, and the FDA prevents or delays the approval of the drug.

An example of this is the FDA's hanky-twisting over the multiple sclerosis drug Tysabri, which is orders of magnitude more effective against that nerve-killing disease than existing therapies. Unfortunately, Tysabri has been "linked" -- tenuously, at best -- with a rare brain infection in fewer than five patients out of the many thousands who have taken it. The FDA pressured Biogen and Elan to pull the drug last year, and it has not cleared the drug for relaunch notwithstanding the unanimous recommendation of a non-binding expert advisory panel. Why? Because it fears the quick death of one or two people more than it values the lifespans of hundreds of thousands of people.

I found the article very interesting and highly recommend it. Thanks to Ezra Klein for the cite.  Ezra Klein also has some thoughts about the article.  [bm]

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