December 3rd, 2008

Consumer Group Accuses Medical Device Makers of Misusing Online Video Promotions

By Matthew Perrone (AP)
Los Angeles Times

A consumer watchdog group on Wednesday questioned the legality of several advertisements for medical devices that appear on YouTube and called on regulators to crack down on the promotions.

Online videos from Abbott Laboratories, Medtronic Inc. and Stryker Corp. tout the benefits of their devices, but do not mention the risks, according to the Boston-based nonprofit group, Prescription Project.

The Food and Drug Administration requires television advertisements for drugs and medical devices to give a balanced picture of benefits and risks; however, it’s unclear whether that law also applies to Internet promotions, the group says.

“The videos raise serious questions about whether drug and device companies are using the Internet to skirt laws that safeguard consumers,” said Allan Coukell, director of policy for the Prescription Project.

In a petition submitted to the FDA, the group asks regulators to order the companies to remove the advertisements from the Web. The group also asks the agency to issue regulations specifying that online ads are subject to the same standards as television ads.

Among the ads cited in the petition are an advertisement for Medtronic’s artificial spine disk, Prestige.

The company suggested the material may have been posted online by “third parties” and said it has been removed.

“Any additional video produced by, or on behalf of, Medtronic that does not comply will be addressed immediately,” the company said in a statement.

Other promotions highlighted by the group include those for Abbott Laboratories’ Xience, the best-selling drug-coated stent on the market, which had sales of $383 million in the last quarter. Stents are wire-mesh tubes used to prop open arteries after they have been cleared of fatty plaque.

The videos feature animated graphics showing how Xience works and interviews with patients who have had the device implanted.

The group also took issue with a video for Stryker’s Cormet hip implant.

Abbott Laboratories spokesman Scott Stoffel said the Xience videos included links to the product’s risk and safety information, and that the company will embed safety and risk details in videos moving forward.

“Abbott’s practice is to comply with all regulatory requirements and to provide patients and consumers with accurate and complete product information,” Stoffel said.

A spokesman for Stryker was not immediately able to provide comment.

The FDA has roughly six months to respond to the petition.

Magazine and TV spots have been a staple of pharmaceutical marketing for over a decade, with the industry spending over $5 billion on such efforts last year. While spending by the device industry is minuscule by comparison, the largest industry players have begun ramping up advertisements directed at consumers.

Industry spending on TV ads rose 62 percent last year to $193 million, from $119 million in 2005, according to the Prescription Project.

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