Healthy Skepticism Library item: 14568

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: Journal Article

Mitka M.
Direct-to-Consumer Advertising of Medical Devices Under Scrutiny
JAMA 2008 Nov 5; 300:(17):1985-1986.
http://jama.ama-assn.org/cgi/content/extract/300/17/1985?etoc

Abstract:

The increasing use of direct-to-consumer advertising of medical devices is making some physicians and legislators uneasy.

They question whether the public can truly comprehend, based on 60-second television commercials, ad pages in newspapers and popular magazines, or Internet pages, the benefits and risks of such device-based medical interventions as a total hip replacement or the use of stents in a percutaneous coronary intervention. They also are raising questions about how the US Food and Drug Administration (FDA) will handle its regulatory role over device advertising.

These concerns were highlighted in a Senate Special Committee on Aging hearing on September 17 called by committee chairman Sen Herb Kohl (D, Wis). Kohl has convened a series of oversight hearings exploring medical device and pharmaceutical marketing. “As with direct-to-consumer drug ads, the FDA has raised concerns about advertising restricted [not over-the-counter] medical devices; specifically, about whether appropriate risk and safety information . . .