FDA

Many people may have seen last night's Frontline re-run about the U.S. Food and Drug Administration (FDA) approval process for new drugs. It is not unusual for regulatory agencies to be captured by the industries they regulate. Unfortunately, this has happened with the FDA. Under the present administration, it has happened throughout the federal government, but in fairness, the problems at the FDA began during the Clinton administration.

The Frontline piece focused on the Fen-Phen diet drug combination and some smaller scale debacles, but of course the big news lately, which came too late for that show, is the Vioxx catastrophe. Possibly the companies are starting to recognize that putting greed ahead of honesty may be a counterproductive policy in the long run.

In any case, this is a complicated problem to parse. In the days ahead, I hope to take up most of the pieces one at a time. They fit together, ultimately, but it's a complex diagram. Here's at least a partial list:

-- The value of drug patents and the specifics of the intellectual property laws;
-- The broader economics of drug development and manufacturing;
-- The randomized controlled trial and the broader theory of knowledge underlying medical practice;
-- The hard science of drug development and the current state of biomedical research;
-- Marketing of drugs to doctors;
-- Direct to consumer advertising and other marketing techniques directed at consumers;
-- How doctors talk to patients (or don't) about their prescriptions;
-- How patients talk to doctors (or don't) about their prescriptions;
-- What people expect from medicine, vs. what they are likely to get;
-- How doctors think about risks and benefits, vs. how people in general think about them.

Yeah it's a lot of territory. But it's important for us all to think about all of these issues as citizens, patients, and providers.