Healthy Skepticism Library item: 12527

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Cohen R.
Critics troubled by ads pitching medical devices
The Star Ledger 2008 Jan 22
http://www.nj.com/news/ledger/index.ssf?/base/news-12/1200980109327621.xml&coll=1

Full text:

Richard J. Scott, an orthopedic surgeon from Red Bank, said patients have begun asking for specific brands of artificial hip and knee replacements after seeing advertisements on television, in print and on the Internet.

While the doctor said he thinks a full discussion of treatment options is a good idea, he is no fan of direct-to-consumer ads for medical devices.

“The advertisements substitute Madison Avenue for science, and talk to consumers who don’t understand that every new device is not necessarily better,” said Scott, who serves as president of the Medical Society of New Jersey.

Consumers have grown accustomed to TV, print and online ads promoting cholesterol-lowering drugs, sleeping pills, anti-impotence medications and heartburn remedies. Now, a new marketing trend is emerging: direct-to-consumer pitches that tout surgically implanted devices such as prosthetic hips and artery stents.

Since the late 1990s, prescription drugmakers have flooded the airwaves, newspapers, magazines and now the Internet with ads, spending more than $5 billion annually on direct-to-consumer marketing. Industry critics have complained the ads don’t provide adequate warnings and have unnecessarily increased drug usage.

Some critics find the ads for implanted medical devices even more troubling.

“You would think they were talking about buying candy when it involves serious surgery,” said Diana Zuckerman, head of the nonprofit National Research Center for Women and Families.

Echoing long-standing complaints about pharmaceutical advertising, Zuckerman said the medical device ads tend to “have a lot of personal storytelling but very little information about the risks.”

The ad campaign comes at a time when the medical device industry is under scrutiny by the U.S. Justice Department over how it markets to doctors, and by the Food and Drug Administration about its manufacturing practices. Just last week, the FDA cited Stryker, a leading maker of knee and hip replacements, for manufacturing problems at a plant in Mahwah, N.J.

The television and Internet video ads, featuring upbeat music and happy people, include Cordis Corp.‘s Cypher drug-coated, or “drug-eluting,” heart stent; Biomet’s partial knee replacement, starring Olympic gold medal gymnast Mary Lou Retton; and DePuy Orthopaedic’s knee replacement, the only one to “bend and rotate.” Commercials for hip replacements, defibrillators and weight-reducing stomach lap bands also have been aired.

CRITICS SPEAK OUT

The device ads first began appearing a few years ago, with manufacturers hoping to generate product awareness, create new demand and fatten their bottom lines. But as the ads have proliferated, criticism has been growing among doctors who find them inappropriate and consumer groups concerned the risks of device-related surgeries are not being adequately disclosed.

Consumers Union last month petitioned the Food and Drug Administration requesting that medical device ads include warnings about the dangers of infections from surgeries and the expected life span and possible failure of the products, “both of which can and do cause death or serious morbidity and expense.”

The FDA proposed advertising standards for device makers in 2004 that have never been finalized.

An FDA spokeswoman said the agency does not require device companies to submit ads for review prior to dissemination and has no staff devoted solely to device promotions. As a general principle, she said, the agency requires that ads be “truthful and not misleading,” and include “relevant warnings.” The FDA has yet to respond to the Consumers Union petition.

Carol Goodrich, a spokeswoman for Cordis, a Johnson & Johnson subsidiary, said her company launched its “Life Wide Open” drug-eluting stent television, print and Web campaign in November after a major study published in the medical journal Lancet provided new safety data. Stents are wire metal mesh tubes used to prop open arteries after blockages have been cleared.

Goodrich said earlier studies had questioned the safety of drug-eluting stents when compared with bare metal versions, and created fear and confusion. Frost and Sullivan financial analyst Benkat Rajan said sales of drug-eluting stents dropped from a high of about $3 billion in 2005 to $1.8 billion last year because of safety concerns.

“The genesis of our campaign was to provide some clarity about what the most recent data showed for drug-eluting stents and provide some important information to patients about heart disease and treatment options including Cypher,” Goodrich said.

She said the company shared its advertisements with the FDA before they were launched, and believes they are “appropriate and accurate.”

Aaron Kwittken, a spokesman for Stryker Orthopaedics, said the company has run national hip replacement television commercials featuring golfing legend Jack Nicklaus, and, more recently, has sponsored TV ads for joint replacement devices in a variety of local markets.

He said the ads, combined with online sites and other educational programs, are designed to “create a new dialogue between surgeons and patients” and help patients find “the right option to get back to an active lifestyle.”

Eric Bolesh, research team leader at Cutting Edge Information, a business research and consulting firm, said there is no public data available on how much is being spent by the device companies on advertising or whether the campaigns have been effective.

“But if you are seeing ads on television, which is not cheap, you know companies are expecting a return,” Bolesh said.

NOT CONVINCED

Scott, the orthopedic surgeon, said he has implanted hundreds of knee and hip replacement devices. He said he is leery about newly promoted products that have no track record.

“If there was one knee replacement statistically better and safer that lasted longer than the rest, you know which one every surgeon would use,” said Scott.

Colette Kuhnsman, a principal of Jocoto Advertising, a health care advertising agency, said medical device ads are “obviously picking up after the success in the pharmaceutical arena.” She said the television and print promotions create awareness and drive people to the Internet, chat groups and into discussions with their doctors.

“In some cases doctors resent patients coming in asking for specific devices, but the next time a sales representative comes in, it could possibly open some doors,” Kuhnsman said.

The debate over consumer ads for medical devices comes as the Justice Department last year reached a $311 million settlement with the nation’s five largest makers of knee and hip implants. The agreement followed a two-year probe into allegations the companies paid millions of dollars in kickbacks to orthopedic surgeons who used or promoted their products.