Book review: Generation Rx.

I recently finished reading Greg Critser's Generation Rx: How Prescription Drugs Are Altering American Lives, Minds, and Bodies.

Frankly, I don't feel so well.

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 (once the patents had expired on those drugs) produce additional studies demonstrating the compounds to be safe and effective rather than being able to point to the existing studies (of the same compounds) that already make that case. Other changes seem to have at least some sensible patient-centered rationale. Given the length of time it took the FDA reviewers to work through new drug applications, user fees seemed like a creative strategy to get the review process moving faster (although the legislation implementing user fees didn't allocate additional funds for the safety surveillance of the drugs that would now be making it to market faster). 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, potentially expanding the patient's ability to exercise autonomy about his or her own health care rather than being at the whim of a paternalistic doctor.

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 (which are also less expensive) -- the supporting research, after all, needs only to show that they are better than placebos. 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. The first 110 pages of the book are so dense with details that it's hard to keep all the players straight, but they leave the reader with a palpable sense of speeding down a steep (and well-oiled) incline.

Critser draws on the words of a number of players in the pharmaceutical industry, from heads of companies to the drug reps pounding the pavement. It's not surprising that the people running these companies see speeding the pipeline that brings new drugs to market as an issue of corporate growth and profitability rather than primarily as a matter of getting better, safer drugs to the patient -- they have to answer to their shareholders, after all. But it is striking how unselfconscious they are about seeing patients primarily as walking wallets. As one pharmaceutical company president puts it, "There are still a profound number of patients who don't know they should be our patients!"

Of course, this means companies are hiring firms to research ways to reach those potential patients -- and the cost of all that research (which has nothing to do with the safety or efficacy of the pills the companies are trying to sell) gets passed on to the consumer.

One of the truly frightening elements of the landscape Critser explores in this book is just how tuned in to the frailties of the American psyche the folks charged with selling the pills seem to be. Not only can ad campaigns present medical complaints in such a way as to make us see them in our own bodies (even when they are, in fact, remarkably rare), but the presentation of new drugs has made them seem utterly necessary for our modern lifestyles, where there isn't time to eat properly or exercise because we might get downsized, and we can't afford to fall asleep at work or not to fall asleep in the few hours we have at home at night before going back to the office, and our managed health care won't let us access psychotherapy for our depression or anxiety until after we've tried to fix it with the pills. The advertisers have our number. They play into our resignation that capitalism in early 21st century America is going to get even more intense, leaving us more overworked and stressed out, and offer us pills to fix what this does to our body. Of course, the capitalist logic driving the pharmaceutical marketing means that we should expect to keep taking those pills, maybe forever, and hope that our livers (and hearts, lungs, and stomachs) can handle the long-term effects.

The players in this story who frustrate me most are the prescribing physicians, the ones who seem so willing to take at face value the "suggestive studies" the pharmaceutical reps bring them (with the free pens) to bolster off-label prescription of new drugs. It is true, in the age of managed care, that physicians are as overworked as their patients, pressured to see more patients in less office time and to address their complaints efficiently. In this crush to keep the pace, keeping up on the literature is daunting (as is fitting in the required continuing medical education -- of which, by the way, pharmaceutical companies subsidize a huge percentage). So leaning on the studies the drug company guy is putting in your hand seems to save time. But, doesn't it seem dangerous to rely uncritically on information from the people trying to sell the pills? Why let yourself be transformed to a pill-dispensing machine for patients who come in after seeing a slick commercial and self-diagnosing? (Isn't this part of how we got anti-biotic overuse?) Even if the imperative of the drug companies is to sell, the imperative of the physician should still be to heal, or at least to do no harm, shouldn't it?

Critser sees room for physicians to resist playing a supporting role in the hard sell, and he points to hopeful signs that physicians are starting to resist more actively. He also notes ways that the regulatory pendulum might swing back from the extreme of big pharma free-for-all. Finally, he suggests that American consumers and patients probably need to take a hard look at their relationship with prescription drugs and their own health, to stop being such willing consumers and start taking more responsibility for the long term care of their own bodies.