Buffalo, NY and Los Angeles, CA - The new direct-to-consumer television advertisement for Cordis's Cypher sirolimus stent is the subject of a critical Perspective published online May 15, 2008 in the New England Journal of Medicine [1].

The Perspective, to be published in the journal's May 22, 2008 issue, has been made available online a week early. One of the authors, Dr William Boden (University at Buffalo Schools of Medicine and Public Health, NY), told heartwire: "What accelerated the publication of this editorial by one week is the fact that an FDA advisory panel is holding hearings on the broad topic of direct-to-consumer advertising [DTCA] this Thursday, and the journal editors evidently felt that this paper might be timely and germane to the committee."

In the article, Boden and his coauthor, Dr George Diamond (Cedars Sinai Medical Center, Los Angeles, CA), say the 60-second "Life Wide Open" commercial represents the dawn of a new era in medical DTCA, which has for the past decade focused on brand-name pharmaceutical agents.

They add that in making the leap from pharmaceutical to medical devices, the ad campaign raises important questions regarding the net societal benefit of medical advertising directed at the lay public. "In the ad for Cypher, a device is being 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," Boden and Diamond state.

They note that because of time constraints, television ads for medical products, unlike print ads, do not have to include all information about side effects and risks. "This lower standard for disclosure is of great concern to physician opponents of DTCA, as well as to congressional oversight committees, which have objected that DTCA plays down the risk of certain medications while promoting their putative benefits," they write.

The current Cypher TV ad starts with a shot of a man slumped in a chair and asks, "How big is the world? Ask the tough guy cornered by chest pains." It then shows several other people enjoying various different physical activities and says: "When your arteries narrow, so does your life" and "It's time to open it up." Boden and Diamond say the advertisement implies that the stent provides more than just symptom relief, despite the fact that recent clinical trials have shown that angioplasty is not superior to medical therapy in reducing death or MI.

While the ad does mention some adverse effects that can occur after stent implantation (eg, MI and stroke), it does not include many other serious complications, and the webpage flagged to direct patients to "important safety information" also fails to adequately address safety concerns, the authors say.

They continue: "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. It seems 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 request for a particular stent on the basis of 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."

Boden and Diamond call for the FDA to perform a critical postrelease review of the "Life Wide Open" campaign to assess whether it meets the basic regulatory requirements for nondeceptive prescription-drug advertising. "Until such an evaluation is conducted, the campaign should be viewed as a 'device' of potentially deceptive advertising and a bold preliminary experiment in interventional psychology," they conclude.

In response to the perspective, Cordis issued a statement saying it was committed to educating physicians and patients about the benefits and risks of medical device treatment options for coronary artery disease in an accurate and balanced manner. It states: "The content, messaging, and fair balance of the ads were reviewed with the US FDA prior to airing. The fair-balance information was appropriate for a television ad and directed the viewer to other sources of more detailed information, including their doctors and a more extensive patient-information statement that was also reviewed with FDA."

The company continues: "The goal of the 'Life Wide Open' campaign is to foster an informed, balanced conversation between patients and physicians about treatment options for coronary artery disease, which kills millions of Americans each year. That discussion itself offers the opportunity for the physician to review the treatment options and for the doctor and patient together to decide on the option that is best for the patient. We believe this is a worthwhile goal, are pleased with the results thus far, and invite the public to view the ad in question."