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Direct-to-Consumer Drugs and Devices

We're all pretty much accustomed by now to seeing TV ads for prescription drugs. They're a genre unto themselves: the healthy-looking folks who have benefited from some new medicine frolicking and gazing happily at one another, the serene music, the rapid-fire recitation of terrifying side effects in the spot's final seconds.

That genre actually has a name: direct-to-consumer advertising, or DTCA. Since the 1960s, the U.S. Food and Drug Administration (FDA) has regulated drug advertising; the rules are meant to ensure that viewers (and readers of print ads) get an accurate view of what the medication can do and a balanced view of the risks and benefits associated with the drug.

But DTCA has long raised questions about the wisdom and ethics of promoting drugs to consumers. While there's plenty of room in print ads to list every potential risk and side effect associated with a drug, those downsides often get short shrift in TV ads. Many in the medical community fear that consumers are misled into thinking advertised medications are safer than they really are.

The debate has intensified over the past decade, since the FDA relaxed its rules regarding drug ads on TV. The FDA's Risk Communication Advisory Committee met earlier this month to discuss DTCA and to consider requiring drug ads to include an 800 number for consumers to use to report adverse events they've experienced when using the advertised drug; print ads for drugs already have to include that information. Congress has also recently discussed DTCAs, which very few other countries allow at all.

A recent article in the New England Journal of Medicine extends the debate by noting the expansion of DTCA into the realm of medical devices, which can be even more complicated to understand than medicines. On Thanksgiving Day in 2007, the article says, the first ad in a new campaign of commercials for an artery-opening stent called Cypher was aired.

Authors William Boden and George Diamond think the ad leads down a slippery slope: "In the ad for Cypher," they write, "a device is bring promoted to millions of people who are ill-equipped to make judgments about the many clinically relevant but subtle and complex therapeutic issues that even specialists continue to debate." The authors further note that while the ad paints a rosy picture of people's lives dramatically improved by Cypher, recent studies show that devices like Cypher are no better than medicines at reducing risk of death or heart attack.

The authors acknowledge that DTCA may be helpful in raising people's awareness of certain medical conditions and getting them to talk to their doctors. And, of course, laypeople can't act on impulse after seeing an ad: No matter how enticing something like Cypher may look on TV, you can't just drive to CVS and pick up a stent.

One thing is clear: direct-to-consumer ads work (as this study from 2003 shows). Drug companies wouldn't keep making them if they didn't.

Perhaps I'm not in the target audience, but I haven't yet seen a drug ad that made me want to call my doctor for a prescription, let alone a medical device. Have you been swayed by a DTCA? How did your doctor react when you asked for the Rx?

And do you think the FDA is doing enough to protect consumers from misleading medical ads? Do you even think those ads should be allowed in the first place?

By Jennifer LaRue Huget  |  May 27, 2008; 7:00 AM ET
Categories:  The Business of Health  
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