Journal op-ed questions Cypher stent ad
May 15th, 2008 joshua
An editorial in the New England Journal of Medicine says regulators should take a close look at a 60-second ad for the Cypher heart stent, made by Cordis, a subsidiary of Johnson & Johnson.
The author of the article says the ad doesn’t do much to highlight the potentially serious health risks posed with the Cypher heart stent.
“We believe the FDA should perform a critical post-release review of the ‘Life Wide Open’ campaign to asses whether it meets the basic regulatory requirements for non-descriptive advertising,” the article said.
Cordis began running the ad on Thanksgiving Day, during a national National Football League. Nationally, the ads have stopped running, but it continues appearing on in the Baltimore market.
The FDA is under increasing pressure to regulate the direct-to-consumer advertising for high-risk medical devices.
That would definitely include the drug-eluting heart stent market, which has been plagued with lawsuits brought on by injured patients who developed blood clots at the site of the surgery.
