A watchdog group, The Prescription Project, is alleging that device makers are illegally advertising on the popular video-sharing Website YouTube.com, says Pharmalot.com. According to the report, The Prescription Project has petitioned the U.S. Food and Drug Administration (FDA) to require three device makers—Abbott Labs, Medtronic, and Stryker—to withdraw their YouTube.com video ads. The group alleges that the spots advertise medical devices used in heart, hip, and neck surgeries in violation of some FDA requirements.
According to Pharmalot, The Prescription Project is alleging that Abbott is running four videos on YouTube.com advertising its XIENCE V drug-coated stent, which is used in coronary angioplasty surgery. Abbott does not include federally mandated warnings in its ads. Also running ads without federally mandated warnings are Medtronic, which is promoting its Prestige Cervical Disk used in degenerative disk disease surgery and Stryker, which is advertising its Cormet hip resurfacing technology, reports Pharmalot.
“The videos raise serious questions about whether drug and device companies are using the Internet to skirt laws that safeguard consumers,” Allan Coukell, director of policy for the Prescription Project, said in a statement quoted by Pharmalot. The Prescription Project notes in its press release that the FDA must ensure that direct-to-consumer (DTC) ads are neither misleading nor deceptive. The FDA requires drug and device advertisers to include specific “disclosures” that not only contain mention of the product’s usage directions, but also “any relevant warning, precautions, potential side effects, and contraindications,” the release said.
Pharmalot says that the watchdog group is urging the FDA: “To advise drug and device makers that online and Internet ads and promotions are subject to the same requirements pertaining to other media, and recommend they conduct compliance reviews.” The group, says Pharmalot, has also asked the FDA to issue procedures on DTC broadcast ads on the Internet.
The Prescription Project also pointed out that patients claiming injuries from medical devices are no longer able to sue device manufacturers for failing to warn them about known, but not disclosed risks, following a Supreme Court Decision earlier this year (Reigel v. Medtronic). A similar ruling may soon be found for prescription drugs and is pending the outcome of a case against Wyeth (Wyeth v. Levine).
The Prescription Project also reports that the medical device industry has just about doubled its advertising spending from $119 million in 2005 to $193 million in 2007. That prompted U.S. Senate Special Committee on Aging Chairman Herb Kohl (Democrat-Wisconsin) to hold hearings this fall to determine if DTC ads adequately explained any health risks associated with medical devices. According to The Prescription Project, Kevin J. Bozic, M.D., author of “The Impact of Director-to-Consumer Advertising in Orthopaedics,” testified that “78 percent of surgeon respondents surveyed believed their patients were ‘confused or misinformed about the appropriate treatment for their condition based on an advertisement,’ and 84 percent believed their patients had ‘unrealistic expectations regarding benefits’ of the devices.”
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