Device Firms Go Direct To Consumers Amid Physician Skepticism
This article is reprinted from "The Gray Sheet" – December 17, 2007
Device firms are increasing investments in television advertising for their implantable products, but some physicians are skeptical that safety information about complex devices can be adequately conveyed in direct-to-consumer ads.
A television ad campaign for Johnson & Johnson/Cordis' Cypher sirolimus-eluting stent was launched on Thanksgiving Day, the first effort to market a stent directly to patients in that medium.
"Drug-eluting stents are complex devices that offer tremendous patient benefits, but also carry certain risks," commented Gregg W. Stone, an interventional cardiologist with Columbia University Medical Center and vice chairman of the Cardiovascular Research Foundation. "This complex message has been difficult to accurately communicate through traditional media, especially given our constantly evolving understanding as new studies emerge."
Drug and device companies frequently do not adequately convey safety information in ads, says William E. Boden, cardiologist and professor of medicine at State University of New York at Buffalo. Boden says the Cypher ad campaign is particularly problematic because it omits important adverse event information included in Cypher's patient information brochures.
Cypher Pitch: "Life Wide Open"
Cordis' 60-second "Life Wide Open" commercial features athletic adults, mostly older and male, and flashes slogans such as: "When your arteries narrow, so does your life."
The firm launched the campaign in early October with a new Web site, 1www.cypherusa.com. Full-page ads in the Wall Street Journal, New York Times and USA Today and the TV commercial followed soon after.
The television ad ends with a statement about risk and directs patients to consult with their doctor and visit the Web site for more safety information. But Boden says the contents of the site are "totally incomplete" and "grossly misleading."
"Everyone will have an opinion on whether or not this is the right thing to do," Cordis spokeswoman Carol Goodrich said. "The physicians we've talked to have been supportive, but obviously there are physicians that feel otherwise."
Cordis says the ad campaign's main purpose is general patient education about percutaneous intervention, as part of an industry-wide attempt to combat safety concerns about late thrombosis.
"As a result of some of the data that's been published over the course of the last year, there was a lot of patient confusion and even fear about the safety of drug-eluting stents," Goodrich said. Despite emerging data that indicate drug-eluting stents may be as safe as bare-metal stents, people are still wary, she said (2"The Gray Sheet" Oct. 29, 2007, p. 3).
"This is an effort to educate patients about coronary artery disease, about the different treatment options available to them - including diet, exercise and other treatment options - as well as Cypher," Goodrich said. Of course, "the goal is two-fold, obviously. It is still a branded Cypher campaign."
DTC Push May Alienate Doctors, Ad Agency Says
J&J/DePuy has run television ads for its knee replacements since 2004. Its latest commercial has been on air since early 2007, and shows an actual patient discussing her knee pain and treatment decision, the company said.
In January, Medtronic launched a $100 million ad campaign for its implantable cardioverter defibrillators, including print, TV and online ads (3"The Gray Sheet" Jan. 22, 2007, p. 18). Allergan is also running TV ads for its Lap-Band gastric banding device.
There is a clear trend toward more direct-to-consumer device ads, says Colette Kuhnsman of Jocoto Advertising, a California-based firm specializing in medical device promotions.
But Kuhnsman cautions device makers not to alienate physicians by targeting the public too quickly.
"Maybe [the physician] hasn't seen the clinical data, he hasn't been prepped or he's not familiar with it. At the end of the day, doctors don't like their patient dictating to them. The patient doesn't always know what they're asking for."
Done properly, TV ads could provide yet another vehicle for patient education, Columbia Medical Center's Stone suggests. "I'm in favor of alternative means of communication that prompt patients to request more information from their doctors, as long as they don't imply that the device or drug is a panacea without potential complications," he wrote in an email.
Food, Drug and Device lawyer Robert A. Dormer of Hyman, Phelps & McNamara questions how much influence an ad has on whether a patient gets a J&J stent over one made by Boston Scientific, Medtronic or Abbott.
"It's making people, including health care providers, aware of the existence of the product and its benefits, but I don't know to what extent it really influences consumer behavior," Dormer said.
FDA Issues Still In Flux
Aside from consulting with doctors, the company shared the TV commercial and print ads with FDA prior to running them, Goodrich said.
FDA says it expects materials to present a "fair balance" between risk and benefit information, but risk statement requirements are "far more minimal" for devices compared to drugs, says Jocoto's Kuhnsman.
Drug TV ads have been the target of complaints like those lodged by Boden for years. Congress recently gave FDA new authority to fine drug companies for false and misleading ads.
CDRH oversight of DTC ads, limited to "restricted" devices including many implantables, is still in early evolution compared to the drug sector.
The Office of Compliance has recently signaled efforts to strengthen its own enforcement of promotion activities including DTC (4"The Gray Sheet" Sept. 24, 2007, p. 15).
Industry, meanwhile, has asked for more guidance on putting together so-called "brief statements" of intended use and risk that are both compliant and accessible to consumers (5"The Gray Sheet" Nov. 7, 2005, p. 10).
- Jessica Bylander
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