Medical journal’s article questions TV ads for heart stent
May 15th, 2008
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A television advertisement for a heart stent that promotes the products potential benefits but seems to play down the medical risks may deceive the public and should be reviewed by U.S. regulators, according to an op-ed article published on Wednesday by a leading medicaljournal.
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 ofMedicine.
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 wideopen.”
“We believe that the 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 journals article said. It also questioned the validity of advertising such high-risk procedures directly to thepublic.
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 gamebroadcast.
“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 statementsaid.
A spokesman, Christopher Allman, said the television ad was no longer running nationally but was being broadcast in Baltimore. Allman would not explain why the ad was running in one localmarket.
The journal article, by the cardiologists Dr. William Boden of the medical school at the State University of New York at Buffalo and Dr. George Diamond of Cedars-Sinai Medical Center in Los Angeles, comes as pressure mounts on the FDA to limit consumer medical advertising or at least to increase oversight ofit.
The United States is one of the few industrialized countries that permit such advertising. On Friday, an FDA 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 drugads.
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 theFDA.
During a congressional hearing last week on drug advertising, the chairman of the House Energy and Commerce Committee, John Dingell, pressed several drug company representatives on whether they would support encouraging television viewers to call the 1-800 number to report adverseevents.
“They said they couldnt tell us, so were communicating with the CEOs of the companies,” Dingell said in a telephone interview on Wednesday. Dingell, a Democrat from Michigan, said he supported the requirement. “But understand one thing,” he said. “It might not beenough.”
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,” Dingellsaid.
The chairman of the House subcommittee investigating drug advertising, Representative Bart Stupak, said that Congress should consider banning drug ads aimed directly atconsumers.
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, includingstents.
For several years the agency has been reviewing a set of guidelines proposed in 2004 for advertising medical devices. Karen Riley, an FDA spokeswoman, said the agency would have no comment on the articles call for a review of the Cypher stentadvertising.
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 byStryker.
In 2007 ad spending for medical devices was $200 million, according to TNS Media Intelligence, an advertising researchfirm.
Dr. Boden, one author of the journals 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-secondspot.
“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 aboutrisks.
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