HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Monday, September 22, 2008

Consumer Ads for Medical Devices Subject of Senate Panel

The New York Times reports that some lawmakers and medical groups are calling for restrictions on advertisements for medical devices like artificial knees and heart stents, claiming they mislead patients.  Barry Meier writes,

Television_adsAs makers of medical devices like artificial knees and heart stents increasingly pitch their products directly to consumers, some lawmakers, medical groups and others are calling for restrictions on such advertisements, claiming they mislead patients.

The amount of medical device advertising directed to consumers on television or over the Internet — an estimated $193 million last year — represents just a small fraction of the volume of consumer advertising for prescription drugs, according to TNS Media Intelligence, a consulting firm.

But some experts maintain that the advertising of a medical device can have more of an impact on a patient’s well-being than a drug, because devices often require surgery to implant and may remain inside the body for years.

“The results are irreversible because you are kind of stuck with a device,” said Dr. Kevin J. Bozic, a professor of orthopedics at the University of California, San Francisco.

On Wednesday, the Senate Special Committee on Aging plans to hold a hearing about direct-to-consumer promotions of medical devices. Dr. Bozic, who was an author of a recent medical journal article critical of consumer advertising, is among those scheduled to testify.

In a statement, the committee’s chairman, Herb Kohl, Democrat of Wisconsin, said he was holding the hearing because he thought that the Food and Drug Administration might have to increase its scrutiny of medical device promotions, much as it had done for pharmaceutical advertisements.

“The medical device industry is just beginning to get into the game,” Mr. Kohl said.

David Nexon, a senior official at the Advanced Medical Technology Association, a trade group in Washington that represents medical device makers, said the organization thought that current F.D.A. rules governing direct-to-consumer advertising were adequate.

He added that while an advertisement might stimulate a patient to ask a doctor about a device, the process of receiving one involves a discussion of its benefits and risks.

“You may take a pill because it doesn’t involve very much,” Mr. Nexon said. “But you don’t undergo surgery unless you think you have a serious need for it.”

In 2007, spending by medical device makers on direct-to-consumer advertising was nearly double the amount in 2005, according to data provided to the Congressional Research Service by TNS.

Over the last three years, a variety of device makers have started ad campaigns. Stryker, for instance, has run ads for a ceramic replacement hip, a device that some patients have since complained squeaks loudly enough to be heard while they walk.

Another orthopedics maker, Zimmer Holdings, has advertised a replacement knee created for women, and Medtronic, a maker of heart devices, has run consumer promotions about heart defibrillators.

At the hearing on Wednesday, an official of Consumers Union, the publisher of Consumer Reports magazine, is expected to testify that current rules requiring consumer drug advertisements to provide balance between a medication’s benefits and risks should be extended to cover medical devices.

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