Overdosed America (24 page)

But there’s a hitch. Most of the information available to you (and your doctor) about the diagnosis and treatment of common medical problems comes from the drug and other medical companies themselves. The medical industry has finely honed its ability to mold public knowledge about the best medical care—slanting our beliefs in favor of the most profitable medical therapies. Its most obvious technique involves the nearly ubiquitous drug ads that pepper our television shows, newspapers, and magazines. More insidious—and, for that reason, potentially more influential—are the public relations campaigns that translate into seemingly unbiased news stories and nonprofit public awareness campaigns.

These marketing efforts are specifically designed to appear to inform the public about important health issues, but their real purpose is to serve their sponsors’ commercial interests. Health has little to do with the process, except that its singular importance, combined with recent advances in medical science and changes in medical insurance, has created what is probably the greatest marketing opportunity of all time. Whether the products actually improve our health is irrelevant. This may sound harsh, but just think back to hormone replacement therapy, or the pushing of Celebrex and Vioxx as safer arthritis remedies, or the exaggerations of the cholesterol guidelines.

Patients do indeed need to become medical consumers, but not just of drugs, doctors, and hospitals. We need to become critical consumers of medical knowledge itself. The first step is to understand where our medical information comes from.

For years the pharmaceutical industry was allowed to market its drugs only to doctors. It did this through medical journals, continuing medical education, sponsored events, sales calls, and junk mail. Then,
in 1981, the drug industry proposed
that the FDA allow advertising directly to consumers, arguing that the public should not be denied access to the “knowledge” that would be provided by such marketing. Four years later, the pharmaceutical industry got its foot in the door when the FDA agreed to allow “direct-to-consumer” (DTC) advertising. But the rules were strict, and the content of the ads was, therefore, limited: Drugs could be mentioned by name, but advertisements that discussed the treatment of specific conditions were required to include a lengthy list of side effects and contraindications (situations in which the drug should not be used). As a result, the ads were vague and unfocused, primarily brand-awareness campaigns designed to smooth the way at the doctor’s office.

Drug companies kept pressure on the FDA to loosen these restrictions. In 1997,
the FDA changed its rules
so that TV and radio ads could include the condition or conditions a drug was designed to treat without presenting all of the information previously required—only major side effects and contraindications had to appear in the ad itself (audiences could be directed to a magazine ad or website for more complete information). For example, in a recent TV ad, after Zoloft whisks away clouds of depression, the words “See our ad in
Shape
magazine” flash briefly on the screen. Few television viewers—least of all depressed ones—are likely to search newsstands for specific magazines to find out about the side effects of advertised antidepressants.

The 1997 change unleashed an unprecedented onslaught of commercials. By 1999, the average American was exposed to
nine prescription drug advertisements
on television every day. The number of television ads
increased 40-fold
between 1994 and 2000. Suddenly it became a normal part of our everyday experience to be confronted with the idea that we or a loved one might be suffering from ED (erectile dysfunction, for those not in the know), arthritis pain, high cholesterol, nasal congestion, osteoporosis, heartburn, or even the heartbreak of toenail fungus. In the “teachable moments” created by these skillfully raised concerns, consumers are “educated” about readily available drugs to solve the problem.

The explosion of drug ads in the 1990s was exquisitely coordinated with the transition of large numbers of Americans to health plans that covered the cost of prescription drugs. Drug companies could now “help” consumers realize that they had the power to request or demand expensive new brand-name drugs from their doctors (and their greedy insurance plans) for which they had to pay only a small fraction of the real cost. This became a nearly perfect system for maximizing demand, untempered by the usual discipline of cost in a well-functioning market.

As
Christopher Lasch wrote in 1979
, long before the advent of advertising prescription drugs to the public, “Advertising serves not so much to advertise products as to promote consumption as a way of life.” Beyond promoting specific drugs, these expertly crafted commercial messages carry strong but unspoken themes that make prescription drug use seem like a routine part of life. First, the ads create the impression not only that can health and happiness be achieved by using the right drugs, but that drugs are
necessary
for health and happiness. Then the ads evoke a positive emotional connection to the drug, and finally challenge the viewer to take action. Viewers are encouraged to discuss the drug with their doctor (in the office, “discuss” usually morphs into “request” or “demand”), a suggestion that taps into every viewer’s desire to take charge of his or her health. Meanwhile, this powerful commercial message, the alleged purpose of which is to help improve health and enjoyment of life, diverts attention from the healthy life habits that usually play a far greater role than advertised drugs in preventing illness and achieving happiness.

Claritin, a formerly prescription antihistamine used to control allergic symptoms, was far and away the
most heavily advertised prescription drug in the two years
following the FDA’s 1997 rules change. And indeed, the unprecedented advertising blitz for Claritin was an unparalleled success. It certainly convinced many of my patients that they needed not just
any
allergy medicine, but Claritin and only Claritin. They resisted the idea that there were equally good and perhaps even better ways to relieve their allergy symptoms than a new (and therefore less well tested) drug. Moreover, they were unconcerned about Claritin’s cost (more than $2.10 per day): most had prescription drug coverage as part of their health insurance. With an
advertising budget greater than that of Budweiser beer or Coca-Cola
, Claritin took off: sales grew from $1.4 billion in 1997 to $2.6 billion in 2000.

One question was not addressed in the advertising campaign: How well does Claritin relieve allergy symptoms?

In a well-researched article about Claritin in the
New York Times Magazine
in 2001, writer Stephen Hall reported that the FDA medical officer assigned to review the application for Claritin concluded that the dose approved by the FDA, 10 mg, was only “minimally effective versus placebo.” The company’s own tests had shown that Claritin relieved allergy symptoms only 11 percent better than the placebo (that is, 11 percent better than nothing). The FDA officer further noted that 40 mg was the “minimum effective dose” for Claritin and requested that Schering-Plough, the manufacturer, perform tests on a higher dose. According to a former FDA official, Schering-Plough resisted. Its reason? At the higher dose, Schering-Plough would risk losing the all-important right to claim that its drug was “nonsedating.” Drowsiness can be an annoying side effect of the older and far less expensive allergy pills. With the primary focus of the marketing campaign for Claritin being that it did not cause drowsiness, marketing a more effective dose that could no longer be sold as “nonsedating” just wouldn’t do.

It is hard to make the argument that the $2.6 billion spent on a minimally effective drug for what is usually a relatively minor affliction was the best use of the nation’s health resources. In fact, while we were spending billions on Claritin, an experienced researcher could not get a relative pittance in funding to determine if a fraction of an $0.08 pill called chlorpheniramine (brand-name Chlor-Trimeton, sold without a prescription) would be as effective as, or more effective than, Claritin, without causing sedation. As the patent to Claritin expired, it was made available without prescription, and Schering-Plough’s marketing support for the drug decreased precipitously. The first drug to come of age in the new era of drug advertising was the first to fade away—it no longer made business sense for its manufacturer to sustain the huge advertising budget.

Understanding how drug patents work
can be difficult because the drug companies use so many legal ploys to extend their valuable exclusive rights to manufacture and sell drugs like Claritin. Drug patents are supposed to last for 20 years from the date the patent application is filed. As the drug companies reasonably argue, the patent clock is ticking while the drug is being studied and going through the FDA approval process. According to PhRMA, the effective life of patents after drugs come on the market is about 11 to 12 years.
Schering-Plough was unsuccessful
in its final attempt to extend its patent on Claritin. The manufacturer’s argument went like this: it still owned the patent on the chemical into which Claritin is metabolized after being taken (sold as Clarinex). Therefore, Schering-Plough argued, its patent would be infringed if people were allowed to swallow a generic form of Claritin and metabolize it into a chemical on which Schering-Plough still held the patent. The U.S. Court of Appeals for the federal circuit did not agree.

The next drug to
take center stage in direct-to-consumer advertising was Vioxx
. Merck spent more than $160 million to advertise this new and supposedly “improved” arthritis drug to consumers in 2000—half again more than its closest rival and $20 million more than the previous record set by Claritin in 1999. Overcoming the lack of scientific evidence that Vioxx provides better relief or is safer for most patients than its less expensive competitors, sales of Vioxx grew more than any other drug in 2000, to $1.1 billion.

The real purpose of DTC advertising is revealed in the
drugs that patients most frequently request
. In 2001, these were Claritin, Viagra, Celebrex, Vioxx, and Allegra (another nonsedating prescription antihistamine)—not exactly the kind of drugs for which creating greater demand through advertising is going to improve health or head off disease at an early stage.

Nonetheless, the drug companies claim that their
ads provide an important educational service
. As explained by Alan Holmer, president of PhRMA, in a recent issue of JAMA, direct-to-consumer advertising “is an excellent way to meet the growing demand for medical information, empowering consumers by educating them about health conditions and possible treatments.”

Studies show, however, that drug ads usually stay away from the facts that count. Researchers from Dartmouth Medical School found that
only 13 percent of drug ads
in magazines used data to describe drug benefits; the remaining 87 percent relied on vague statements. Not a single ad in the study mentioned the cost of the drug. Only 27 percent of ads presented the cause of or risk factors for the disease, and only 9 percent clarified myths and misconceptions about the disease. The
positive effects of lifestyle change
were mentioned in less than 25 percent of the ads and fewer than three out of 10 acknowledged that other treatments were available. Two out of five ads attempted to medicalize ordinary life issues. (Routine hair loss or a runny nose, for example, became a medical problem requiring treatment with expensive prescription drugs.)

Widespread public misconceptions
about drug ads contribute to their effectiveness. An article in
Health Affairs
reported that half of all respondents in a survey conducted in Sacramento County, California, believed that the government approved each drug ad before it was shown to the public, and 43 percent believed that only “completely safe” drugs could be advertised. Neither belief is true. Moreover, Americans with less education find drug ads to be more credible than do those with more education. Perhaps most telling, the survey showed that the people who are most misinformed about drug ads are also the most supportive of direct-to-consumer drug advertising.

The
drug companies capitalize on the public’s naïveté
about their marketing techniques. Two-thirds of drug ads create a positive emotional association with the drug they represent. Recall for a moment the image of the former Olympic champion Dorothy Hamill lacing up her skates—a beautiful aging athlete smiling and renewed. Who wouldn’t want to feel like that? The ad indelibly links her moment of joy to the name Vioxx in every viewer’s mind. As Ernestine McCarren, general manager of Ehrenthal & Associates, an advertising agency specializing in direct-to-consumer ads, explained in an interview for a trade magazine,
“We want to identify the emotions
we can tap into to get that customer to take the desired course of action. If you can’t find that basic insight, you might as well forget everything else.”

Advertisers know that their challenge is to evoke emotional responses that are strong enough to override traditional doctor-patient relationships. Does it work? The facts speak for themselves: more often than not, doctors accede to patients’ requests. As my patients’ ideas about the best approach to their medical care became increasingly influenced by the drug ads, I would try to help them understand how this process serves the drug companies’ interests, not their health. Often I was successful, but once it became clear that a patient was unwilling or unable to reconsider, I often gave in (unless there was a real danger, such as a patient with a history of heart disease requesting Vioxx).

Working within tight time constraints, doctors are reluctant to be drawn into these difficult discussions and usually go along with their patients’ requests for advertised drugs. A study done by the FDA in 2002 showed that patients
receive prescriptions for requested drugs 50 percent
of the time. A study published in the
British Medical Journal
showed that doctors in Vancouver, British Columbia, and Sacramento, California,
prescribed requested drugs about three-quarters of the time
. (Canadian patients made these requests less than half as often as American patients. Direct-to-consumer advertising is not allowed in Canada, but some drug ads arrive in American magazines and over cable television.) A study done by
Prevention
magazine in 1999 showed that doctors prescribed requested prescription drugs 80 percent of the time.