A television advertisement for a heart stent that promotes the product’s potential benefits but seems to play down the medical risks may deceive the public and should be reviewed by federal regulators, according to an op-ed article published on Wednesday by a leading medical journal.
The 60-second ad for the Cypher stent, made by the Cordis subsidiary of Johnson & Johnson, failed to adequately warn consumers about the potential dangers of receiving a stent, according to the article published by The New England Journal of Medicine.
Stents are metal mesh devices that are used to prop open arteries after they have been cleared of blockages. The ad uses the tag line “life wide open.”
“We believe that the F.D.A. should perform a critical post-release review of the ‘Life Wide Open’ campaign to assess whether it meets the basic regulatory requirements for non-deceptive advertising,” the journal’s article said. It also questioned the validity of advertising such high-risk procedures directly to the public.
Cordis defended the ad in a written statement, saying its content and message was reviewed by the Food and Drug Administration before it began running last Thanksgiving Day, starting with a National Football League game broadcast.
“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,” the statement said.
A spokesman, Christopher Allman, said the television ad was no longer running nationally but was being broadcast in Baltimore. Mr. Allman would not explain why the ad was running in one local market.
The journal article, by the cardiologists Dr. William E. Boden of the medical school at the State University of New York at Buffalo and Dr. George A. Diamond of Cedars-Sinai Medical Center in Los Angeles, comes as pressure mounts on the F.D.A. to limit consumer medical advertising or at least to increase oversight of it.
The United States is one of the few industrialized countries that permit such advertising. On Friday, an F.D.A. advisory committee plans to discuss whether television ads for prescription drugs should include a statement encouraging consumers to report negative side effects to a toll-free number operated by the agency. That is currently required for print prescription drug ads. There is no such requirement for ads for medical devices, which are not as closely monitored as drug ads.
The trade group representing pharmaceutical companies, Pharmaceutical Research and Manufacturers of America, said on Tuesday that it had not taken a position on the proposal being discussed by the F.D.A.
During a Congressional hearing last week on drug advertising, the chairman of the House Energy and Commerce Committee, John D. Dingell, pressed several drug company representatives on whether they would support encouraging television viewers to call the 1-800 number to report adverse events.
“They said they couldn’t tell us, so we’re communicating with the C.E.O.’s of the companies,” Mr. Dingell said in a telephone interview on Wednesday. Mr. Dingell, a Democrat from Michigan, said he supported the requirement. “But understand one thing,” he said. “It might not be enough.”
He said the committee had found systemic violations of advertising requirements by drug companies. “Some ads appear to be misleading and others appear to be downright deceptive,” Mr. Dingell said.
The chairman of the House subcommittee investigating drug advertising, Representative Bart Stupak, said that Congress should consider banning drug ads aimed directly at consumers.
Although the F.D.A. currently does not scrutinize advertising for medical devices as closely as for prescription drugs, it does regulate ads for so-called high-risk medical devices, including stents.
For several years the agency has been reviewing a set of guidelines proposed in 2004 for advertising medical devices. Karen Riley, an F.D.A. spokeswoman, said the agency would have no comment on the article’s call for a review of the Cypher stent advertising.
The Cypher ad, which says that “when your arteries narrow, so does your life,” was the first to market a stent directly to consumers on television. Similar ad campaigns, however, have promoted hip and knee implants, include one featuring the golfer Jack Nicklaus, who underwent a hip replacement in 1999 using a device made by Stryker.
In 2007 ad spending for medical devices was $200 million, according to TNS Media Intelligence, an advertising research firm.
Dr. Boden, one author of the journal’s article, said in a telephone interview on Wednesday that it was impossible to inform viewers adequately about the benefits and side effects of a stent operation in a 60-second spot.
“This involves very sophisticated technology, totally in my view beyond what any sophisticated lay consumer could possibly learn from a 30- to 60-second television ad,” he said, pointing out that print ads require more detailed disclosure about risks.
The ad gives the impression that the Cypher stent is going to improve life more than other brands would, Dr. Boden said. “It doesn’t say artery wide open,” he said “It says life wide open.”
In the article, Dr. Boden and Dr. Diamond observe, “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.”
The ad mentions some adverse events that can occur after a stent implant, including heart attack and stroke. But the doctors’ critique said the ad failed to warn explicitly of the risk of some other serious complications, including a ruptured coronary artery. The ad referred patients to a Web site, but the authors said it also did not adequately address the full range of potential complications.
