This post was written by Maggie Mahar and Niko Karvounis
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 will appear 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.
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
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 NEJM article,
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
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 Journals’ 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?