Excerpt from Generation Rx by Greg Critser, plus links to reviews, author biography & more

Some, if not most, of pharma's immediate crisis was of its own making, although this was not something most drug CEOs would admit. As a group and individually, they had simply failed to invest in new drug sciences and drug development. Instead, they had relied on (and indeed encouraged) the FDA's lack of a generic-drug approval process, giving pharmaceutical companies de facto monopolies — and huge profit margins — on many widely used drugs. This state of affairs had provoked a legal backlash of its own; district courts from New York to California were actively contemplating, and in some cases ruling, that many traditional pharmaceutical patents were invalid. The Supreme Court itself had grown hostile to the very notion of patents. In the pharma executive suite of the time, there was only one word for that: shock.

Yet some pharma problems were largely out of the industry's direct control. America in the late 1970s and early 1980s was going through one of its cyclical periods of what might be dubbed pharmaceutical stoicism. As a percentage of annual health expenditures, the Rx share was actually shrinking. And while cocaine might be hip, prescription drugs were uncool on a number of levels. On the cultural plane, drug makers were the domain of the blue-chip world, with which the baby boom had yet to fall in love. The growing alternative-medicine movement, with its reliance on herbs and vitamins, appealed to a generation concerned with what was natural. The movie version of One Flew Over the Cuckoo's Nest rekindled old suspicions about psychiatric medications, one of the industry's most profitable monopolies. News stories about abuse of Valium, one of the most profitable postwar drugs, led to its reclassification as a controlled substance in 1978, making it harder to prescribe. There were scares over new heart medications and horror stories about pharmaceutical industry negligence, and a new generation of ambitious politicians had no qualms about capitalizing on such fears. When a young congressman named Albert Gore learned from a staffer that a Pfizer attorney had made an off-the-cuff remark about how expensive it was to monitor the adverse events of one of his products ("What, are we supposed to schlep all over the world just to track down one goddamn side effect?" the attorney had sputtered), Gore promptly publicized the incident. Abroad and in D.C., big pharma was, more than ever, big fair game.

Worse from the point of view of pharmaceutical CEOs were attitudes and trends among young physicians and medical students. Many of them were deeply suspicious of the business end of medicine. Some of their attitudes grew from social activism by med students in the early 1970s, who were concerned with overmedication and polypharmacy. (Overmedication is the unnecessary use of medications in general; polypharmacy is the simultaneous use of several medications to treat one or more conditions.) The concern was deepest among young psychiatrists. "In our day, it was almost an aesthetic thing to be against polypharmacy," recalls one. "It was more beautiful if you could do it with just one or two pills." Many believed that growing rates of polypharmacy were fueled by pharma promotional activities, like giving out free samples and stethoscopes. "At national meetings, the idea we talked about was to reject the goodies," recalls Dr. Terry Kupers, who was head of the Medical Committee for Human Rights in the 1970s. "[Pharma sales representatives] would show up at grand rounds, and we would confront them and turn down the goodies. We also went to our intern meetings within our institutions and told our supervisors that we did not want [the reps] on grand rounds. It was happening at enlightened medical schools around the country. We did it as a statement."

Copyright © 2005 by Greg Critser. Reprinted by permission of Houghton Mifflin Company.