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."

Yet why else would J&J spend millions on television advertising? The company's goal is to create demand -- a "buzz" that will cause patients to ask about the product, and that will make some hospitals and surgeons feel that they must use it.

This is what happened with another J&J product, a spinal device called "Charité." After being approved by the FDA in 2004, Charité was heavily promoted. By the fall of 2005, more than 3,000 of the spinal discs had been implanted -- even though only two of the nation's eight largest insurers had agreed to pay for the operation. Some surgeons were questioning the safety of the device, but patients who read favorable reports about Charité online or in the press were beginning to demand the operation.

As a result, some hospitals were willing to absorb the cost of the operation even though insurers wouldn't reimburse. Dr. John Brockvar, chief of neurosurgery at Wyckoff Heights Hospital in Brooklyn, told Dow Jones Newswires that his hospital gave him permission to implant the device "because it was important to be on the leading edge."

"Some doctors say they're worried they will lose business if they don't offer the Charité option to patients," The Wall Street Journal reported. "There's a feeling that it isn't adequately proven, but there's anxiety about being left behind." [my emphasis]

In an almost pure example of money-driven, consumer-driven medicine, manufacturers intent on profits pushed consumers to push doctors and hospitals to use a product that they were not convinced was safe. This is not how we want medical decisions to be made.

Today, Charité remains controversial. There are many questions about long-term complications, and last spring, Medicare announced that it would no longer cover Charité for patients over sixty.

J&J's stent, Cypher, also has its critics -- which may be one reason why the company is pumping up promotion via television advertising. In the past, drug-makers have poured money into television ads for the same reason that movie studios resort to expensive television advertising: the critics are panning the product. If a drug-maker is having a hard time selling its new product directly to physicians -- either because the reviews in the medical journal reviews are mixed, or because it is a "me-too "product that appears to offer little benefit over older, less expensive drugs -- manufacturers go directly to the consumer, who is less likely to be aware of what the critics are saying.

This may be what J&J is doing with Cypher, one of the new "drug-eluting stents" that, unlike older, less expensive "bare-metal stents" release drugs which are supposed to prevent arteries from re-clogging.

If you were to judge drug-eluting stents solely by the Cypher advertisement, you might think they're a remarkable sure-fire innovation. After all, as the commercial asserts, "when your arteries narrow, so does your life." Who wouldn't want to lead a better life thanks to a device that -- again, according to the advertisement -- is "studied," "trusted" and "proven"?

Unfortunately, while drug-eluting stents have been studied, they are far from "proven." In fact, there is much debate over whether or not they're good options for folks with clogged arteries. In a 2007 NEJMarticle, William Maisel of Harvard Medical School asserted that, since the FDA approval of drug-eluting stents in 2003, "concerns about an increased risk of late stent thrombosis [i.e. late onset blood clots] have arisen and have been exacerbated by insufficient and conflicting information in the public domain."

This is putting it diplomatically. According to Maisel, a major 2006 study found "that between 7 and 18 months after implantation, the rates of nonfatal myocardial infarction [i.e. heart attacks], death from cardiac causes, and ... stent thrombosis were higher with drug-eluting stents than with bare-metal stents [i.e. those that don't release drugs]."

Equally disconcerting is a 2003 Swedish study cited by NEJM in which doctors examined a computer registry of every Swedish stent patient for the years 2003 and 2004. This analysis of almost 20,000 people found that when drug-eluting stents were implanted, patients were slightly more likely to die than those who had old-fashioned bare-metal stents. Four years later a Columbia University study reported that the four-year rate of stent thrombosis was 1.2 percent amongst patients who had received the Cypher, as opposed to 0.6 percent for those who had received bare-metal stents -- double the proportion.

On the other hand, a more recent but smaller study of 6,552 cases published in the NEJM comparing bare metal to drug-eluting stents for so-called "off-label" use (use not specifically approved by the FDA), found a lower rate of complications and no increased risk of death or heart attack for the drug-coated stents. But in the same issue of the NEJM, a study suggested that if patients have more than one blocked artery, bypass surgery provides a lower risk of death and heart attacks than do procedures involving any type of stent.

Questions about when to use stents, and what kind of stent to use, are far from resolved. As Boden and Diamond point out, this underlines the absurdity of J&J's effort to sell Cypher "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."

But just how likely is it that surgeons really will respond to consumer demands?

Much to their chagrin, doctors are finding that pressure from patients does in fact change their behavior. In one of the most compelling analyses of this dynamic to date, a team led by the University of California had trained actors make 298 visits to 152 primary-care physicians, portraying patients with major depression or adjustment disorder. The actors presented doctors with three types of scenarios: requests for specific brands of medications, general requests for medications without naming brands, and no requests for medication.

For major depression, physicians prescribed antidepressants at a rate of 53 percent for brand-specific requests; 76 percent for general requests; and 31 percent for no requests. For adjustment disorder, physicians prescribed antidepressants at a rate of 55 percent for brand-specific requests; 39 percent for general requests; and 10 percent for no requests. In other words, people with identical conditions were prescribed drugs at dramatically different rates depending on what they asked for.

The Wall Street Journal's report that hospitals and doctors feel that they must experiment with J&J's spinal disc, Charité, suggests that this logic can carry over to medical devices. One can envision a spike in procedures and surgeries thanks to patient demand. But do we really want a system where knee-jerk patient response to 30-second commercials trumps medical expertise?

Patients want to be able to ask questions. They want their doctors to take the time to give them detailed answers. But the more DTC ads encourage patients to make demands of their doctors, the more doctors and patients are positioned as antagonists rather than collaborators.

That's a recipe for friction, not patient satisfaction. One last question: even if patients get the Cypher they want, what happens when they develop a blood clot? Who is responsible then?