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.

Studies show that...

Pharmaceutical companies are constantly pushing the envelope on drug development and testing, because each new product proven safe and effective means more cash flow. So is it really surprising to anyone that industry-funded, published studies are 55% more likely to provide positive results than non-industry funded ones?

There are two things at work here. First, the pharmaceutical companies are less likely to want to publish unfavorable results. They're scientists with an agenda and that agenda is selling more product. Publishing studies that showed deleterious side effects or no therapeutic effect at all aren't worth the time to put the study to print.

Second, pharmaceutical-funded studies are also half as likely to use a control group to test their drugs. This is a major science no-no. A control group is necessary to ensure that your intervention - drug or otherwise - is not simply inducing the placebo effect. This still-not-understood effect often shows healing results in people who merely think they are receiving therapy, even if they just ingest sugar pills. Two-thirds of the drug companies' studies eschew the control group - and any change of ruling out the placebo effect.

What does this mean? Next time you see a commercial for Havidol touting how "studies show miraculous effects," just remember who paid the scientist.


Note: I also recall a fascinating tidbit about statistical significance in scientific studies. There are a disproportionate number of studies published with findings that are just over the threshold of statistical significance (here's a link to an analysis of political science studies). The study of peer-reviewed journals revealed a slight bias in scientific publications toward publishing findings that could "prove" something, although a little bit of mathematical tinkering is often the only barrier between "just significant" and "insignificant." This may be why 54% of all pharmaceutical studies found positive results instead of just half.