As many as 61,000 people may have checked out after popping the painkiller (and alleged people killer) Vioxx. Last Friday, the first of thousands of cases against drug giant Merck began to ask who is responsible. Courts will be sorting through the morass for years, but Congress, incredibly, has already found and tried its culprits: drug ads, and the poor suckers who believe them.
A push to regulate televised drug ads has been building quietly since the late '90s, but the withdrawal of Merck's Vioxx unleashed a torrent of anti-ad rhetoric. On July 1, Senate Majority Leader Bill Frist (R-Tenn.), fresh from declaring Terry Schiavo bright-eyed and unvegetated from the Senate floor, railed against the dangers of letting Americans self-diagnose on the basis of paltry information. Direct-to-consumer (DTC) advertising, he explained, is what happens when companies go "over the heads of doctors" and dare to market "directly to patients." "It's time for drug companies to clean up their act," he thundered, "If they don't, Congress will." (Frist also questioned a culture that "leaves parents…having to explain to their 10-year old children what erectile dysfunction is," forgetting, perhaps, that it was a prominent Republican whose unsavory confessions catapulted the term into the American vernacular.)
Had Merck not plunged millions into selling Vioxx, critics contend, far fewer people would have medicated their way to cardiac arrest. This is the kind of conclusion that only flies in the twisted universe of pharmaceutical regulation. When faulty Firestone tires sent 148 people spiraling to their deaths five years back, an angry public did not demand an end to tire or SUV ads. Instead, consumer groups rightly blamed Firestone for building tires with a tendency to explode.
Yet the withdrawal of Vioxx has rocked Madison Avenue and its burgeoning pharmaceutical clientele. In a frenzy to self-flagellate before Congress whips them into submission, drug companies have started imposing limits voluntarily. A penitent Bristol-Myers Squibb announced a yearlong ban on advertising new drugs; Pfizer promised to submit new ads to the FDA for prior approval. The hope is that if Big Pharma can look sorry enough for trying to sell its products, Congress will back off. Market leaders like Pfizer have the least to lose from a moratorium on advertising, and they're leading the retreat.
The prevailing criticisms of drug ads can be summed up in two words: They work. Since the FDA loosened its grip on the ads in 1997, they have exploded into a $4.5 billion industry. The number of prescriptions sold for the 50 most heavily plugged drugs leapt 25 percent between 1999 and 2000. Critics contend that helpless consumers are tricked into diagnosing ailments they don't have and—suddenly empowered—proceed to strongarm gutless physicians into writing prescriptions. Consumers have become "victims of Madison avenue," FDA safety researcher Dr. David Graham told an FDA advisory panel in February.
It's certainly true that patients carry taglines to the doctor's office. A 2001 Kaiser Family Foundation survey found that 30 percent of Americans had spoken to a physician about a medication they had seen advertised. What's unclear is why this is bad. A 2003 FDA survey found that most physicians agreed patients who had seen DTC ads asked more thoughtful questions and led to more fruitful discussions. The same survey found that among patients who visited doctors and asked about a prescription drug by brand name because of an ad, 88 percent actually had the condition the drug treats.
Patients are more informed about available treatments, but informed patients, doctors complain, are annoying. An article in the Journal of the American Medical Association frets that physicians "must devote increasing amounts of scarce time to dissuading patients from taking drugs." Writing in USA Today, medical blogger and professor of internal medicine Robert Centor comments, "In an ideal world, the physician could take all the time necessary to explain why the drug isn't right for that particular patient. But physicians have limited time." These are interesting objections from members of a profession whose gatekeeping power hinges on the premise that patients need to be educated by force. Curious patients force physicians to do their jobs; that may be reason to gripe if you're a doctor, but it's not a reason to ban ads if you're a legislator.
Media reports are also littered with accusations that drug advertising drives up prices. "Let there be no mistake," Frist explained, mistakenly, "drug advertisements fuel America's skyrocketing prescription drug costs." But the business of selling drugs is crucial to the business of making them. Advertising promotes price competition, and increased sales allow research and development costs to be distributed among a great number of buyers. To the extent that drug ads are costing Americans money, we can thank a certain 1.2 trillion dollar prescription drug handout that passed why back when both parties decided that the one thing they could agree on was the right to saddle future generations with untold debt. Now that it turns out seniors want the Viagra Congress agreed to pay for, Congress wants to stop telling them about it.
The FDA continues to hound drug companies for failing to follow its complex, onerous regulations for 15-second TV spots. In trying, and failing, to keep pharmaceuticals from "overselling" their drugs, the FDA only encourages consumers to trust ads and look to them for substantive information on side effects and contraindications. If the Vioxx debacle proves anything, it's that patients can't depend on Big Pharma to spoon-feed them data. Nor can they depend on their doctors. In an article in the Columbia Journalism Review, Trudy Lieberman points out that medical journals were publishing damning reports on Vioxx four years before the drug was pulled.
Like the proposed ad bans, the Vioxx trials are ultimately about control over information. To start throwing up walls between patients and knowledge about new treatments now would be as toxic a solution as heart valve-shredding Fen-Phen, cyanide-laced Tylenol, and heart-attack-inducing Vioxx combined. If Bill Frist wants to play doctor to the nation from the floor of the Senate, he might start by pushing his patients to read up rather than tune out.