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The Pharmaceutical Business With Disease: Indicting the Drug Industry's Practices

Indicting the Drug Industry's Practices
Posted on September 06, 2004
New York Times

Dr. Marcia Angell is a former editor in chief of The New England Journal of Medicine and spent two decades on the staff of that publication. If much of that time was devoted to reviewing papers on pharmacological research, it must have been spent in a state of near-apoplexy.

Her new book is a scorching indictment of drug companies and their research and business practices. "Despite all its excesses, this is an important industry that should be saved - mainly from itself," she writes.

This turns out to be one of her book's more forgiving pronouncements, since the rest of it is devoted to assertions of shady, misleading corporate behavior. If she is accurate in her assumptions about big drug companies' feistiness and tenacity, Dr. Angell is likely to be on the receiving end of angry rebuttals. She is sometimes vague enough to leave room for such attacks. ("I have heard that morale in some parts of the F.D.A. is extremely low, and I can certainly understand why it might be.")

But over all, Dr. Angell's case is tough, persuasive and troubling. Arguing that in 1980 drug manufacturing changed from a good business into "a stupendous one," thanks to changes in government regulations. She adds, "Of the many events that contributed to their sudden great and good fortune, none had to do with the quality of the drugs the companies were selling."

In the past, drug discoveries made through government research remained in the public domain. Beginning in 1980 those breakthroughs could be patented, even if their research was sponsored by the National Institutes of Health. As a consequence, Dr. Angell says, patent shenanigans have reshaped the drug business, as have the recent government regulations that expedite direct-to-consumer drug advertising. "Once upon a time, drug companies promoted drugs to treat diseases," Dr. Angell writes. "Now it is often the opposite. They promote diseases to fit their drugs."

Consider the consumer who exclaims, in Dr. Angell's words, "Omigosh, this Clarinex ad makes me realize I have hay fever!" According to her book, this individual is being snookered in several ways. First of all, there is the drug itself: she calls Schering-Plough's Clarinex a "me too" variant of the same company's popular allergy drug Claritin. But Claritin's patent expired in 2002, so the new version has been heavily marketed.

Dr. Angell maintains that while Claritin was approved as a hay fever remedy, Clarinex is an improvement only because it has been approved for the treatment of both indoor and outdoor allergies. "It was approved for the additional use only because the company decided to test it for that use," she says.

And why all the advertising? "If prescription drugs are so good, why do they need to be pushed so hard?" she asks, citing Nexium, Lipitor and Paxil as other me-too products with whopping ad campaigns. As for Nexium, the new purple heartburn pill meant to replace Prilosec (which went off patent in 2001), Dr. Angell proposes a "big bang theory of Mom's cooking." She invites the reader to imagine a single, protean meal that has spun off "a seemingly inexhaustible supply of leftovers" in the form of renamed and repackaged versions of established drugs. "It wouldn't have done to call it 'Half-o'-Prilosec,' but that is what it was," she says about Nexium.

"The big drug companies are competing not so much to find new drugs but for the limited number of drugs to license," she argues. The enormous research-and-development budgets that are invoked to justify high drug prices, she claims, also pay for questionable forms of education for doctors and all manner of barely concealed incentives for them to prescribe certain drugs. While much of this material is drawn from investigative reporting published in magazines and newspapers, Dr. Angell effectively heightens its impact by shaping it into one long, angry accusation.

"The Truth About the Drug Companies" is unrelenting enough to sound scoldy and pedantic at times. (Dr. Angell is now a senior lecturer at Harvard Medical School.) And the book repeats certain complaints in ways indicative of padding. But Dr. Angell's overall questions about drug companies' finances, their influence on government regulation and their methods of testing new medicines are enhanced by her dogged, contentious tone.

Though she proposes a list of changes at the book's end, in hopes of improving the way drug companies operate, her most-repeated suggestion is one of her most persuasive. Why, she asks, should new drugs be tested against placebos, and sometimes tested in such high doses that their effectiveness is guaranteed? Why shouldn't they be tested in equivalent doses against drugs that already exist - and already work?

While awaiting the storm of rebuttal sure to greet Dr. Angell's version of the facts, her readers will be galvanized to look at the drug industry with closer scrutiny. Is the new pink and lavender pill called Sarafem really just Prozac in a different casing? Has the Eli Lilly company really tested it on children (one way of extending an exclusive patent) yet sold it as a remedy for premenstrual problems? And is erectile dysfunction actually caused by watching the Super Bowl, on the evidence of so many Viagra, Levitra and Cialis ads? In a book as alarming as Dr. Angell's, the last thought is what passes for a joke.