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The great debate on DTC advertising is heating up again. We're going to be hearing a lot about fair balance and risk communication and costs. But what about the patients?
What's that rattling of sabers we've been hearing for the past few weeks? Why, it's the enemies of direct-to-consumer pharmaceutical advertising, laying the groundwork for what's likely to be a full-fledged assault some time after the upcoming presidential election. From Congressman Bart Stupak's hearings before the House Subcommittee on Oversight and Investigations to the advertising limits laid out in Merck's recent $58 million, 29-state Vioxx settlement, it's clear that DTC is in more than a few gun sights.
That's a depressing thought—not because the US shouldn't engage in a debate over the merits and problems of drug advertis-ing, but because as a society we do a lousy job of debating such issues. Judging by what's gone before, the conversation over DTC could turn out to be a singularly discouraging example.
The problem is that when you listen to the various perspectives on DTC, they're almost all correct. The folks who say DTC encourages overprescribing? Almost certainly right. And they're right that overprescribing leads to increased costs and unnecessary risks. But if they're correct, so are the people who argue that DTC helps reduce underprescribing—which has its own risks and costs.
Does DTC send patients to their doctors, asking for treatment? You bet. And do most of them turn out to need treatment of some sort, though not necessarily what they requested? Yes again. Even the subtler critiques of drug advertising elicit this kind of ambivalence. I've heard Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, refer to the "meta-message" of DTC advertising—the fact that the mere presence of DTC in the marketplace tells consumers that drugs are just consumer products, with the same risk profile as consumer products. It's the strongest argument I know against DTC. But it has its own counterargument—that by bringing medicines down to earth, such ads can demystify and destigmatize many medical conditions.
Intellectually, the enterprise of DTC advertising is a mess. We've persuaded ourselves that it's a balanced scientific discussion of benefits and risks, leading to rational conversation with the physician, leading to an informed, compliant, and ultimately patients that are better-off. I'm sure it works that way from time to time—but probably not often. And it doesn't necessarily matter that the process isn't pretty. The fact is that our ideas about how communication with patients ought to work aren't nearly as important as what happens to the patient. You don't measure outcomes by counting words in an ad, or checking to see if a cartoon bee is waving his wings distractingly during the risk information. You do it empirically—by seeing who was driven to the doctor's office by an ad, who got a prescription, and whether or not that should have happened. That's what we as a society need to know about DTC advertising. Without that information, the debate is mostly hot air.
Educational researcher Hank Slotnick, who has taught us so much about how physicians learn and make decisions, once explained to me his goal when he advises companies on selling to physicians. "I want 100 percent market share when my product is the best one for the patient," he said. "And I want zero percent when it isn't."
Not an easy goal, but it's the right one. If everybody—the industry, the ad agencies, the docs, the patients, the regulators, the payers, even Bart Stupak—keeps it in mind, maybe we'll get an outcome all of us can live with.