Back in 1981 Ira, a journalist who had been suffering from arthritis of the hips for many years, saw the first television ad for a pharmaceutical. At the time Ira, who is now my patient, had no inkling that he was witness to the inception of an insidious process that in twenty years' time would threaten to undermine the fabric of medical discourse between doctor and patient. This first ad glamorized Motrin, one of the original arthritis drugs, and Ira became one of many who asked his physician at the time, Dr. Peter Berczeller, to prescribe it.
"It helped me," Ira says now. "But I thought it was supposed to cure me."
"When I was in practice, these ads weren't really in vogue yet," says Dr. Berczeller, retired professor of medicine at New York University. "But I was worried that they would remove the doctor as a filter, an essential provider of information. Prescribing drugs was intended to be a medical function, not a capitalistic stratagem. It's wrong for us to be pressured to prescribe by a patient dazzled by a slick ad."
It's not only wrong, it's unnecessarily inflating medical costs. In February the New England Journal of Medicine published a study showing that direct-to-consumer advertising was 16 percent of drug promotion spending. At the same time the National Institute for Health Care Management released a study showing that 2001 drug costs were up 17.1 percent from the year before, with most of the increases in four heavily advertised categories: arthritis, cholesterol, depression and allergy.
The Kaiser Family Foundation has demonstrated an association between consumer advertising expenditures and drugs that are growing the fastest. Pfizer has practically monopolized the cholesterol market over the past few years by heavily promoting Lipitor to the public as the drug to lower cholesterol and somehow bring about a healthier lifestyle. The result is a $3-billion-a-year drug. This advertising strategy is now being copied by an even more expensive drug, Zocor (Merck), which is less potent at the same dose. Meanwhile, another drug that may have fewer side effects, Pravachol (Bristol-Myers Squibb), is overlooked.
In 1983 the Food and Drug Administration, sensing a controversy, requested a voluntary moratorium on all drug ads until it could determine its position. This moratorium was lifted in 1985. At first, drug companies were hamstrung by the need for an extensive summary of side effects whenever brand names were mentioned. Many manufacturers tried to get around this by resorting to ads that increased consumer awareness of target medical conditions without mentioning brand names. The few drug ads on television that did mention specific products included a prohibitively long trailer of side effects. In 1996 an ad for Depo-Provera, a gynecological medicine, ran almost three minutes and contained almost two minutes of warnings.
But in 1997 the FDA issued a series of limited guidelines that essentially allowed TV ads with only a brief mention of side effects. The drug companies refer to this as "liberation day." The FDA now receives approximately 32,000 notifications of pending product advertisements a year, but generally deals with these over the telephone or with brief correspondences within an eight-week period before the ad is to appear. The actual ad is not seen prior to its appearance on television or in print, and the FDA almost never demands a correction or issues a reprimand. Bob Ehrlich, chairman of Rx Insight, a company that advises drug companies on direct-to-consumer advertising, administers a yearly survey course to drug representatives. He admits, "Like it or not, direct-to-consumer advertising has come to symbolize a drug industry hungry for sales and profits at a time when drug access and affordability are key social and political issues."
Over the past five years the drug companies have struggled to create name recognition using extensive television and magazine ads. The major effect of this full-court press has been to raise drug prices and overall costs as patients pressure doctors to prescribe drugs that often aren't needed. Doctors find themselves compelled to respond to ad-driven questions rather than those of fundamental medical importance. A report from UCLA last year concluded that doctor/patient roles may be damaged. "We will have a world of aggressive, distrustful and only partially informed patients and cowed physicians," it says. Surveys by the FDA in 1999 and by Kaiser in 2001 showed that between 20 and 30 percent of consumers, or more than 50 million people, responded to these ads by questioning their doctors. But the same two studies revealed that almost 60 percent of consumers felt that the warnings of potential side effects communicated by these ads were inadequate. It's no wonder that advertising of prescription drugs directly to the consumer is banned in every country in the world except the United States and New Zealand.
Into the 1990s Ira continued to suffer from arthritis of the hips, and he came to me for his medical care when Dr. Berczeller retired. Ira became caught in the aftermath of a billion-dollar struggle between Pfizer and Merck over two almost identical drugs for arthritis, Vioxx and Celebrex. This mini-drama played itself out in my office. Ira is a reasonable patient who readily follows a doctor's advice, yet the advertising wars over prescription drugs confused him. He asked to switch from Motrin to Vioxx as the result of a TV ad, and I accommodated him not because I thought it was better but because Motrin had to be taken several times a day to be effective and Vioxx only once. I reassured Ira when Vioxx's competitors ran fallacious campaigns to discredit it, first by wrongly claiming an association between Vioxx and heart disease, later by magnifying the extremely rare cases of meningitis that might be associated with its use. Finally, I sent Ira to Dr. Edwin Richter, associate clinical director at the Rusk Institute of Rehabilitation Medicine. Dr. Richter prescribed physical therapy but also switched Ira from Vioxx to Celebrex. I asked Richter why. "They're basically the same drug," he said. "But some people do better with one, some with the other. Usually it depends which one they've seen more of on TV."
"Do you think both drugs are necessary and should be available at every pharmacy?"
"No," he said. "Absolutely not."
In fact, Ira found he did better with Vioxx, and soon switched back. But most of all, he said, it was the physical therapy that helped him. "I would have gone for it years ago," he said, "if I hadn't been so busy trying to find a magic pill."
Ira is not my only patient who is unwittingly caught in the corporate struggles between drug companies. This year, several of my patients with acid reflux disease have been affected because the patent on Prilosec (AstraZeneca)--recently the number-one-selling prescription drug in the United States--is being challenged by generic equivalents. AstraZeneca is mightily promoting Nexium (an almost identical drug) to take its place. Of course the generic Prilosec will be a lot cheaper than the brand Nexium, and as far as I can tell, having tried both, just as good. Certainly most patients responding to the flashy Nexium ad wouldn't be able to tell the difference between the drugs, except in terms of the price.
Perhaps the most blatant advertising war is occurring in the world of allergy. After years of sniffling miserably, most of my patients have settled on Claritin (Schering-Plough) as the antihistamine that provides the most relief without making them drowsy. But the patent on Claritin is expiring this year, and it is also about to go over the counter at one-third the price, two major defeats for Schering after it spent a fortune successfully marketing this drug and turning it into a $3-billion-a-year product. Monopolizing the over-the-counter market for antihistamines might be a consolation, but Johnson & Johnson has already applied for approval of its generic product and is beating Schering to the punch. So Schering has now developed Clarinex, a more potent drug it claims doesn't make patients any sleepier than Claritin (patients who have tried the new drug tend to disagree). Schering--desperately attempting to hold on to its customers--has just entered Clarinex into a multimedia advertising face-off with Zyrtec (Pfizer) and Allegra (Aventis), a several-hundred-million-dollar exchange the likes of which may never before have graced the airwaves.
Meanwhile, drug prices skyrocket, transferring the costs of these massive advertising wars over almost identical drugs to the consumer. Last year the AMA protested impotently that the ads did nothing to educate either patients or physicians. Consumer advocacy groups and even HMOs lobby Congress, but the drug-company lobbyists outnumber their opposition eleven to one. The FDA turns a blind eye.
"I saw an ad for an antidepressant during halftime of the Super Bowl," Ira says. "It showed a beautiful person smiling, saying how much the medicine helped. Soon you'll have people asking you for the drug who aren't even depressed."
"Until they find out it affects their sex lives, which they don't bother to say on TV."
Ira thinks this over. "So then they'll ask you for another billion-dollar drug, Viagra, to compensate," he says, catching on to how the whole process works.