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Cypher Stent Ad Criticized

May 15, 2008 | Parker Waichman LLP

A 60-second television ad for the Cypher drug coated stent—made by the Cordis subsidiary of Johnson & Johnson—is under fire.  It seems the ad failed to fully warn consumers about the potential dangers of receiving a stent, according to an article published by The New England Journal of Medicine.  The Journal says the ad promotes the Cypher stent’s potential benefits but minimizes its risks and this may be deceptive and should be reviewed by federal regulators.

The ad uses the tag line “life wide open,” a play on words. Stents are an important element in heart-disease treatment.  Tiny wire-mesh tubes, stents prop open arteries once doctors clear them of blockages.  Stents are implanted to maintain arterial blood flow and there is long, ongoing debate over drug-coated versus bare metal stent use.

“We believe that the Food & Drug Administration (FDA) 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.  The article also questioned the validity of advertising such high-risk procedures directly to the public.

Cordis defended the ad, saying its content and message had been reviewed by the FDA prior to the ad’s release last Thanksgiving Day, during a popular NFL 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,” Cordis said.  Cordis spokesman Christopher Allman, said the ad was no longer running nationally but was being broadcast in Baltimore.

The article comes as pressure mounts on the FDA to limit consumer medical advertising or at least increase its oversight.  The US is one of the few industrialized countries that permit such advertising.  Tomorrow, an FDA advisory committee plans to discuss whether TV ads for prescription drugs should include a statement encouraging consumers to report negative side effects to a toll-free number operated by the FDA, a requirement currently in effect for print ads. There is no such requirement for medical devices ads, which are not as closely monitored.

During a Congressional hearing last week on drug advertising, the chairman of the House Energy and Commerce Committee, John D. Dingell (Democrat-Michigan), pressed several drug company representatives on whether they would support the proposed ads.  “They said they couldn’t tell us, so we’re communicating with the CEOs of the companies,” said Dingell who also said he supported the requirement, “But understand one thing, it might not be enough.”  Dingell said the committee 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 FDA 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.


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