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Friday, April 04, 2008

Science and drug companies: follow the money

A new cholesterol drug, Zetia, was being studied in the past two years. It got FDA approval for lowering LDL (bad cholesterol) more than statins alone, but was being studied for its efficacy at reducing arterial plaque (the actual goal of a cholesterol drug).

The findings weren't what the company hoped for - despite hitting lower LDL targets, it turns out that it was no more effective than existing drugs.

So what was the big deal in the recent announcement?
  1. The lag time - the study was completed two years ago (April 2006), but the company only released preliminary data in fall 2007 under intense public pressure.
  2. The money factor - Merck/Schering-Plough made $5.2 billion off the drug last year. Why tell people it was no more effective than other drugs?
  3. The science issue - how can we trust the efficacy of our medicine when so many studies are funded by those with a financial interest in the outcome?
  4. The regulatory issue - the FDA approved the drug because it lowered LDL, but it turns out that's not sufficient to improve health. It's like approving teeth whitening toothpaste because it makes teeth look better, not because it makes teeth stronger or healthier. Should this practice continue?
In the end, no one's health was harmed by this company's action, though no doubt a lot of folks paid more for medicine that was no better than the alternative. Science was stymied by the company's financial interest, and the FDA gets egg on its face for fast-tracking approval of a drug that doesn't do much.

Sounds like free market health care is working great.


rick said...

devil's advocate: the questions are interesting, but setting them aside shouldn't we expect occasional instances in which the free market doesn't "work great"?

jff said...

The question to me is, do we simply shrug our shoulders when that happens or do we intervene in the market?

rick said...

if we believe the result to be unacceptable, then perhaps we should change the rules (or enforce the rules better, etc).

for example, a problem of misaligned market-driven incentives may not be best solved by a solution that eliminates market-driven incentives altogether.

(here i am taking your comment regarding the "free market" to refer to "market-driven incentives")

jff said...

I agree. I'm not saying we eliminate a market, but that the rules and incentives in the drug market must be changed to restructure the market.

For example, requiring all drug studies to publish their results immediately. (Though I'm not sure if that's a great idea.)