Over at the Adventures in Ethics and Science Blog, Janet Stemwedel (aka, Dr. Free-Ride) has an interesting piece on Greg Critser’s Generation Rx , a book I’ve been meaning to read for some time. I think, with Janet’s inspiration, now I will.
Critser starts off by dropping us into the regulatory environment in the U.S. in the early 1970s, walking us through the multifarious forces that started to change that environment. Some of the changes seem welcome and important — for example, removing the requirement that companies wishing to market generic versions of FDA approved drugs … produce additional studies demonstrating the compounds to be safe and effective rather than being able to point to the existing studies … Direct to consumer marketing (or DTC) was supported by Ralph Nader and his crowd as a way to put more information in the hands of the people… They seemed like reasonable ideas at the time.
But these seemingly sensible shifts keep sliding. We see faster approval of a bevy of drugs that aren’t necessarily more effective than the available drugs … We watch the business-minded pharmaceutical honchos consider the active properties of the compounds their scientists have created and cook up diseases that these compounds might be approved to treat. (Luckily, the advertising wizards creating the DTC campaigns turn out to be adept at whipping up “awareness” of new diseases, generating “needs” that might not even have been wants in the absence of the marketing.)
We see the FDA recast as a “partner” of the pharmaceutical industry, helping to speed clinical trials by requiring fewer of them, and cheerfully accepting promissory notes for further data on possible adverse reactions but not actually pressing to receive this data. And we see physicians increasingly prescribing new drugs “off label”, putting them to therapeutic uses for which there is little supporting evidence — save the exhortations of the drug company representative.
Just another reminder, in case you needed it: We must take back the FDA from Big Pharma and return it to being the true watchdog that it once was.30