Direct to Consumer Advertising of Cypher Stent Draws Heavy Criticism and Points to Need for Legislation

For several years the U.S. Food and Drug Administration has been reviewing a set of guidelines proposed in 2004 for advertising medical devices. Now, a television advertisement for a heart stent, metal mesh devices that are used to prop open arteries after they have been cleared of blockages, has been scrutinized and attacked in an op-ed article for failing to adequately warn consumers about the potential dangers of receiving a stent, including a ruptured coronary artery. The ad does warn of heart attack and stroke.

The ad for the Cypher stent, made by the Cordis subsidiary of Johnson & Johnson, was the first to market a stent directly to consumers on television and uses the tag line life wide open. Similar ad campaigns have promoted hip and knee implants, including one featuring the golfer Jack Nicklaus, who undrwent a hip replacement in 1999 using a device made by Stryker.

According to the article by cardiologists Dr. William E. Boden and Dr. George A. Diamond published by The New England Journal of Medicine, the advertisement promotes the products potential benefits but seems to play down the medical risks and should be reviewed by federal regulators.

The ad does, however, mention some adverse events that can occur after a stent implant, including heart attack and stroke. 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. In 2007 ad spending for medical devices was $200 million, according to TNS Media Intelligence, an advertising research firm.

The United States is one of the few industrialized countries that permit such advertising directly to consumers, although recent law and developments indicate that such advertising is about to be more closely monitored. During a recent Congressional hearing on drug advertising, the chairman of the House Energy and Commerce Committee, John D. Dingell, said the committee had found some ads appear to be misleading and others deceptive. The chairman of the House subcommittee investigating drug advertising, Representative Bart Stupak, said that Congress should consider banning drug ads aimed directly at consumers.

Section 906 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which went into effect on March 25, 2008, mandates that published direct-to-consumer advertisements for prescription drugs include the following statement printed in conspicuous text: “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.” There is no such requirement for television ads or for ads for medical devices.

The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) employs reviewers who have responsibility for reviewing prescription drug advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading.

One would hope that the FDA is more honest about enforcing its mission than the U.S. Federal Aviation Administration (FAA) is, as evidenced in recent accusations that the airlines and not the traveling public were considered the FAAs customers.

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