The Dangers of Consumer-Driven Medicine

Medical device makers are taking direct-to-consumer (DTC) advertising to a perilous new level. In a piece titled "Crossing the Line in Consumer Education?" that appeared in the May 22 issue of The New England Journal of Medicine (NEJM), Drs. William E. Boden, and George A. Diamond tackle the issue, arguing that a new campaign to peddle medical devices directly to patients warrants close scrutiny. Manufacturers are inviting consumers to decide not only what is best for them, but what is best for their surgeons. This is "consumer-driven medicine" at its most dangerous.

Boden and Diamond focus on a 60-second television spot for Johnson & Johnson's drug-eluting coronary stent, "the Cypher," which debuted during last year's Thanksgiving match-up between the Dallas Cowboys and the New York Jets. (Click here to view the advertisement in question).

The commercial has all of the hallmarks of the drug industry's highly polished DTC advertising: First, we're introduced to "the tough guy" -- a once-powerful man who now is "cornered by chest pains" and sits slumped in his arm chair. Then, we are shown how he can reclaim his life in a montage of joyous physical activity accompanied by upbeat music. Of course, "this product isn't for everyone," we're told. But "life is wide open. It all depends on what you've got inside."

In the campaign to put the health care "consumer" in the driver's seat, where he can have "control" and "choice," J&J is breaking new ground. This ad isn't for a pill that you buy in a pharmacy but rather for a coronary stent, a wire mesh device that is placed in an artery which has been blocked by fatty deposits. Doctors first thread a tiny balloon into the artery and inflate it to clear the blockage; then they insert a stent into the artery, and a second balloon expands the stent to keep the newly cleared blood vessel wide open.

"Unlike a drug," Boden and Diamond point out, "whose use merely requires an office visit to a physician and a prescription the patient can fill at a pharmacy, a specialized medical device such as a stent can be selected and implanted only by someone with a very sophisticated medical understanding that no member of the lay public could realistically expect to gain from a DTCA campaign."

This is an important point. It's bad enough that some patients are now sold drugs via a sound-bite, but it is even more pernicious to pretend that the pros and cons of a medical device can be condensed into a 30-second spot. In this case you're not just popping a pill that you can decide to stop taking if you don't like the way it makes you feel. Medical devices are literally installed in our bodies. Even if short-term results look promising, the reality of medical devices is that they stay in our bodies; and so complications often do not become evident until well after their installation.

Moreover, it's imperative that a surgeon is comfortable with the device he is using. In Money-Driven Medicine George Cipoletti, co-founder of Apex Surgical, a company that focuses on joint replacement products, explains that, when it comes to devices, "90 percent of success is determined not by the device itself but, by how good the surgeon is at implanting that particular device -- how much experience he has with it."

John Cherf, a Chicago knee surgeon, adds that surgical technique accounts for "80 to 85 percent" of a successful operation. "Think of it this way," said Cherf. "If you gave Tiger Woods 20-year old golf clubs, and gave me the newest clubs, he'd still kick my butt."

This is another reason why Boden and Diamond find it "almost unimaginable that a patient would challenge an interventional cardiologist's judgment about the use of a particular stent or that a cardiologist would accede to a patient's request for a particular stent on the basis of the information gleaned from a television ad. Indeed, the notion that television viewers, inspired by such an ad, would go to their physicians and request not only a stent but a specific brand and model of stent is frightening, if not utterly absurd."