Release Date: May 14, 2008
BUFFALO, N.Y. -- A "direct-to-consumer" advertising (DTCA) campaign shown on network television over the past six months touting the benefits of a specific stent device used to prop open clogged arteries should be viewed as "potentially deceptive," asserts a commentary co-authored by a University at Buffalo cardiologist in the current on-line issue of the New England Journal of Medicine.
The article, written by William E. Boden, M.D., professor of medicine and social and preventive medicine in the UB schools of Medicine and Biomedical Sciences and Public Health and Health Professions, and George A. Diamond, M.D., senior scientist in cardiology at Cedars-Sinai Medical Center/UCLA, calls for the FDA to conduct a critical review of the television ad campaign.
Originally scheduled to appear in the May 22 issue, the commentary, titled "DTCA for PTCA – Crossing the line in Consumer Health Education?" was posted this week to coincide with FDA hearings on direct-to-consumer advertising set for May 15. PTCA is the medical abbreviation for percutaneous transluminal coronary angioplasty.
The advertisement campaign, called "Life Wide Open," debuted during the heavily watched Dallas Cowboys-New York Jets football game on Thanksgiving Day 2007. The ad promotes a device called the Cypher stent, a tiny, wire-mesh tube that emits a dose of medication to prevent re-narrowing of a once-clogged artery.
This was the first time a branded medical device used during angioplasty was advertised to the general public, an event Boden and Diamond say marked the dawn of a new era in television marketing. Brand-name drugs, but not medical devices, have been advertised commercially for 10 years.
"In making the leap from pharmaceuticals to medical devices, the ad campaign raises important questions regarding the net societal benefit of medical advertising directly to the lay public," the authors write.
"Has industry crossed the line this time?" they question. "In the ad for the Cypher stent, a device is being promoted to millions of people who are ill-equipped to make judgments about the many clinically relevant, but subtle and complex, therapeutic issues even specialists continue to debate."
Discussing the larger picture of DTCA, the authors note that, unlike print advertisements, which are required by law to provide explicit information about associated risks, major side effects, contraindications and precautions of drugs, a 60-second TV commercial is required only to direct viewers to other sources that provide this more complete information.
"This lower standard for disclosure is of great concern to physician opponents of DTCA, as well as to congressional oversight committees, which have objected that DTCA plays down the risks of certain medications while promoting their [supposed] benefits," the authors state. "As such, there is a fundamental inequality between the more comprehensive and balanced content of print advertising (newspapers, magazines, etc.) and broadcast advertising, which is too brief to provide health consumers with important and relevant safety information.
"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...
"For the FDA, the acid test is the degree to which the Cypher stent ad promotes fair balance with respect to risks and benefits in terms that patients can and need to understand," the authors continue.
"The 'Life Wide Open' DTCA campaign may not meet these basic FDA regulatory requirements for non-deceptive prescription drug advertising, an issue that is likely to emerge in scheduled FDA Advisory Committee hearing this week in Washington, D.C.," say Boden and Diamond.
The University at Buffalo is a premier research-intensive public university, a flagship institution in the State University of New York system that is its largest and most comprehensive campus. UB's more than 28,000 students pursue their academic interests through more than 300 undergraduate, graduate and professional degree programs. Founded in 1846, the University at Buffalo is a member of the Association of American Universities.