Info Tech, Law, The Economy

Let me start with a personal revelation: I have toenail fungus. It is a very common problem, one that can easily be cured with a pill. The problem? People have died of liver complications after taking the pill. Great — the FDA issued a warning — but why is the drug still on the market after 13 people died (as of March, 2001)? My foot doctor didn’t even tell me about these deaths. I only became suspicious because he had me get a blood test to check my liver. He suggested it was just a precaution” and that complications could only occur if I had a damaged” liver. Although it is less effective (and more expensive in the long-run), one can take a topical treatment, which is what I chose to do. I’m glad I did, especially after seeing last-night’s Frontline about the all-too-cozy relationship between the FDA and the industry they are supposed to be regulating. What is the problem?

The pharmaceutical industry’s influence gets exerted in a number of ways. One, starting 10 years ago [with the Prescription Drug User Fee Act (PDUFA)], the influence was exerted by their directly funding, paying cash right up front, for FDA review. So in many ways, the FDA started looking upon the industry as their client, instead of the public and the public health, which should be the client.

How does this effect the quality of FDA reports?

I was told very explicitly, Don’t write in your review that you’re recommending against approval. Write that the data is unclear, you could go either way.” So it was quite explicit. … It was pretty typical that, at the start of a review, the division director would say, You know, I don’t really see any issues with this drug. Some small things may come up in the course of your reviews. You have to do a careful review, but I don’t see any roadblocks on the way to approval.” That would set an overall tone for the review, where potential problems were really de-emphasized in the meetings to discuss the data.

There was just an overall expectation from the top that it would be approved. You knew that if you found a problem and wanted to pursue it, it would take a lot of extra effort, a lot of extra meetings, a lot of extra justification for why something wouldn’t be approved. Whereas, if you felt the drug was safe and effective, very rarely would someone challenge you on that.

As a result of this very unprofessional climate, there has been a tremendous increase in the number of drugs approved by the FDA — and the number of drugs later removed from the market because of safety concerns. (i.e. People die or get sick from side effects of the drugs which have been approved.)

So — before you take any prescription medication, first do some research on your own!