Thursday, December 15, 2005

Unprivatize Drug Testing

There's a myth common in our society that the private sector can do everything better than the government, and that as we should privatize as many government activities as possible. In reality, however, greed may be good for profits, but it's bad for public safety.

On Tuesday the Wall St. Journal wrote described how medical journal articles are often written by ghostwriters who work for pharmaceutical companies who then shop around for prominent academics to sign onto them as authors.

And last week, the New England Journal of Medicine accused Merck, the maker of Vioxx, of not reporting three deaths in the trial that led to the approval of the pain reliever which was later removed from the market for causing heart attacks.

To the rescue comes Merrill Goozner,
director of the Integrity in Science project at the Center for Science in the Public Interest and author of the blog GoozNews. Goozner analyzed the problem and came up with some solutions in an op-ed that appeared in the Chicago Tribune.

The main problem: "When industry has exclusive control over studies of its new drugs and medical devices, the most important questions usually do not get asked."

The result is that drug companies use studies to prove that their product is effective, rather than proving that it may or may not be more effective than drugs already on the market. It also leads to situations where they control the studies and they control the interpretation of the results. When Merck compared Vioxx with naproxin, they found that the heart attack rate was higher in those taking Vioxx.

So, did they say "holy shit," and send Vioxx back to the drawing board? No, they concluded that Vioxx was just fine, but naproxin was some kind of miracle drug that lowers the incidence of heart attacks. Imagine their surprise when people taking Vioxx started dropping dead.

That's what you get when you let companies test their own drugs.

The solution, according to Goozner?
The way to get better science in front of regulators and physicians (who rely on the medical literature) is to have an independent body take control of FDA registration trials. The drug and medical device industries already pay user fees to the FDA to hasten reviews of their new product applications. The user fee law is up for renewal next year. Why not expand those fees to include paying the government to conduct the final product registration trials?
Sounds good to me.