Zantac

Generation Rx: How Prescription Drugs Are Altering American Lives, Minds, and Bodies By Greg Critser Houghton Mifflin, $24.95

Sometime in the late '80s, the CEO of the drug company Glaxo-SmithKline realized he had a problem. Glaxo's lead drug at the time was Zantac, which accounted for one-third of the company's bottom line and was also the world's bestselling ulcer medicine. Zantac had to stay the world's bestselling ulcer medicine for another few years while Glaxo scientists searched for replacements because the drug was slated to lose its patent protection in 1997. The problem was, evidence had been accumulating for several years suggesting that ulcers are not caused by an excess of stomach acid, which Zantac was really good at suppressing, but rather by a bacterium known as Helicobacter pylori. "The implication, hopeful for patients," as author Greg Critser puts it, "was also dismal for Glaxo." Scientists from Glaxo and other companies pooh-poohed the bacterial theory, but by the early 1990s, clinical trials had shown that antibiotics could, in fact, effectively clear up ulcers, leaving Glaxo and Zantac in search of a new market.

The company's salvation lay just north of the stomach, with the condition Gastroesophageal Reflux Disease, or GERD. GERD occurs when the esophageal sphincter, the ring of muscle at the top of the stomach, allows acid to creep up the esophagus. Basically, GERD is chronic heartburn--heart-burn so bad it can eventually damage the cells lining the esophagus. Zantac was great at treating GERD, too, but there was just one problem: GERD isn't common. Heartburn, on the other hand, is; but, unfortunately for Glaxo, most people considered heartburn nothing more than one of the wages of overindulgence, treatable with an over-the-counter remedy or a little more self-control at the dinner table--not with a prescription drug. What Glaxo needed to do was persuade people that ordinary heartburn was an early-warning sign of GERD.

So, Glaxo and its marketing team set about popularizing GERD and its potentially dire consequences through a marketing technique that is now used routinely by drug makers, and which came to be known as "condition branding," or selling a disease along with a drug. To brand GERD, Glaxo launched a public relations campaign called "Heartburn Across America." The campaign used the graphic of an erupting volcano to illustrate to consumers the severity of GERD. The company also set up the Glaxo Institute for Digestive Health, which funded research as a way to reach out to physicians. It enlisted the help of the American College of Gastroenterology, the professional organization for doctors who specialize in treating diseases of the stomach and gut, a campaign that deliberately and effectively conflated GERD, which is serious, and heartburn, which is not, in the minds of both consumers and doctors.

The rest, as they say, is history. Zantac sales skyrocketed, hitting $2 billion a year at its peak, two-thirds of which was for GERD. Physicians began to view Glaxo as a leader in the field of gastroenterology; consumers started worrying that their heartburn was potentially dangerous. Condition branding was soon being used by other drug makers to sell everything from high-cholesterol medications to Viagra.

And, as writer Greg Critser argues in this fascinating, often funny but ultimately flawed book, the drug industry's brilliant marketing techniques also helped turn Americans into a nation of pill poppers, or "Generation Rx." The book's first half is devoted to a detailed and compellingly told history of the transformation of the pharmaceutical industry from a group of conservative companies, focused on research and development, into marketing powerhouses. Drawing on his decade as a pharmaceutical business reporter, Critser, who is also the author of Fatland: How Americans Became the Fattest People in the World, chronicles the rise of DTC, or direct to consumer advertising. Before the 1980s, the idea of advertising directly to consumers seemed unethical to most drug companies, an attitude that was on display in a remarkable set of letters written to Congress in 1982 by pharmaceutical executives. In one letter, Charles Hagan, vice president and general counsel of American Home Products, wrote, "[Direct to consumer] advertising would make [patients] extraordinarily susceptible to product promises." The head of Smith, Kline & French wrote that "advertising would have the objective of driving patients to their doctors' office," while the head of Abbott Laboratories worried that advertising to consumers would lead them to pressure their doctors to prescribe drugs "that may not be needed." Drug company executives would change their minds about DTC advertising over the course of the 1980s and 1990s, once a few maverick marketers used DTC ads to drive up sales. A series of Supreme Court cases, brought by consumer groups and the advertising industry, eroded the boundary between commercial speech and individual free speech, and forced the Food and Drug Administration, which oversees drug industry marketing, to change its rules. New, liberalized regulations issued in 1997 sent drug sales through the roof, ironically bringing about many of the pharmaceutical executives' predictions.

The industry now spends on the order of $3 billion on DTC advertising, and sees $4.20 in return on every dollar invested in "driving patients to their doctors' offices." The result has been rapidly rising pharmaceutical drug use. In 1993, the average number of prescriptions filled per person per year was seven. In 2000, it was 11; it was 12 four years later. Some 27 percent of elderly Americans are on nine or more medications simultaneously, compared with 17 percent in 1997.

While our national prescription drug habit costs us nearly $200 billion a year, it isn't necessarily a bad thing if it's improving our health, which the pharmaceutical industry argues it is. Americans benefit from its products, says the industry, by living longer, suffering fewer symptoms of disease, and spending fewer days in the hospital. To be sure, pharma has been the source of many medical miracles--longer lives for people infected with HIV, thanks to anti-viral drugs, and less suffering from everything from migraines to mumps. That's not the issue here. The problem with the drug industry, as Critser and others see it, is that its marketing techniques are leading too many Americans to take one of the following: a risky drug for a relatively mild condition; a more expensive drug when a cheaper, equally effective one would do; a drug for a condition that would be better treated in other ways; or a potentially dangerous combination of drugs.

This state of affairs has come to pass, in Critser's views, in part through the medicalization of more and more aspects of ordinary life. Marketing has persuaded both doctors and patients that uncommon conditions, like GERD, are widespread, while insignificant or merely troublesome complaints are serious if not life-threatening, and need to be treated with a potentially dangerous drug. Many of us now demand drugs not only for serious illnesses, but also for everything from allergies to toenail fungus. Meanwhile, risk factors like high cholesterol and lower-than-average bone density are portrayed by the industry as diseases in and of themselves, and in need of treatment with drugs that can themselves cause life-threatening conditions.

Implicit but to a certain degree unexplored in Critser's analysis are the ways in which doctors have played a pivotal role in the overselling of prescription drugs. They often accede to patient demands for heavily-advertised brand name drugs even when no drug is needed, or a less expensive, less dangerous drug will do. They have also permitted the industry to commandeer continuing medical education, the courses doctors are required to take to maintain their licenses, the majority of which are now underwritten by pharma. Big pharma, and to a lesser degree biotech, now funds 57 percent of clinical trials, the scientific tests that are designed to probe the efficacy and safety of drugs. Providing the funds for this research has given the drug industry unprecedented leverage over what doctors and patients know--and don't know--about drugs, and allows it to systematically and deliberately manipulate data. Critser describes several examples of how the financial relationships between physicians and pharma have led to patient harm, but he seems to lay most of the blame at the feet of industry, which in many ways is simply doing its job making money for stockholders.

Critser's history of the rise of direct-to-consumer advertising is rich, insightful, often wry, and filled with enterprising reporting. He brilliantly exposes the mismatch between marketers' perception of drugs as just another consumer product, no different from cars or computers, and the fact that all drugs can have side effects, some of them more dangerous than others. In the second half of the book, he argues that taking multiple medicines simultaneously, as more and more Americans do, may be taxing our organs and making us ill. Many drugs are metabolized in the liver, which has only a limited capacity to process the pharmaceutical stew that many Americans consume each day. Liver toxicity is, in fact, one of the most common side-effects of prescription drugs, but while Critser's assertion that poly-pharmacy is harming large numbers of Americans seems plausible, it has not been fully documented in the scientific literature.

Despite its excellent history, I found Generation Rx ultimately frustrating largely because the book lapses into an insufferable flippancy in the final third that undermines the author's cultural critique of drug marketing's effect on our perception of disease. Here is Critser in the last chapter, where he offers readers tips on avoiding harm from drugs: "When you think about drugs, recite these mantras: Drugs are poisons--useful poisons, but poisons nonetheless.... Say it. Say it again." Industry is the bad guy for marketing its wares so adroitly, he seems to say; and Americans are chumps for believing it. Read Generation Rx for its history of drug marketing. Then sit down with OverdoSed in America, by Harvard doctor John Abramson, and with Selling Sickness, by Australian journalist Ray Moynihan and Canadian physician Alan Cassels, for a more complex analysis of how the industry's sales tactics are turning healthy people into patients. Together, these three books offer consumers ample reason to ask questions before filling a prescription, and to think twice before going to the doctor to demand a brand-name drug.

Shannon Brownlee is a Schwartz senior fellow at the New America Foundation.

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