YouTube Medical Ads Feel the Heat
According to an advocacy group, ads on the video Web site YouTube for medical devices sold by Abbott Laboratories, Medtronic Inc. and Stryker Corp. violate federal rules because they don’t contain required warnings and disclosures.
On December 3, 2008, the Prescription Project petitioned the FDA to update its advertising rules specifically to address such Internet marketing. As the Web has grown as a source for health information, doctors and others have raised concerns that online promotions lack sufficient oversight to ensure patients can make informed decisions on what treatments to pursue.
“Patients can come in asking for things that may or may not be appropriate based on a biased ad they saw,” said Kevin Bozic, an orthopedic surgeon in San Francisco, who testified in September before the Senate Special Committee on Aging about direct-to-consumer ads.
Federal rules require drug and medical-device ads to include information about potential side effects. An FDA spokeswoman, who declined to comment on the group’s petition, said agency rules apply across all media, including the Internet.
In September, the FDA sent a letter to Shire Pharmaceuticals, a unit of Britain’s Shire PLC, asking it to pull a YouTube video for Adderall XR that the agency said overstated the hyperactivity drug’s effectiveness and omitted risk information. The company said it didn’t intend to post the video on the site and, upon learning of the posting in May 2007, promptly removed it.
But Allan Coukell, director of policy at the Prescription Project in Boston, said the agency hadn’t warned any medical-device makers, and it needed to update rules to take advantage of the Internet’s ability to link to and provide complete information about a product’s possible side effects.
A spokesman for YouTube, a unit of Google Inc., said in a statement that videos uploaded to the site “must comply with local laws and regulations, as well as our own policies.” He said YouTube reviews its guidelines regularly and works with video producers and government agencies “to keep them current and effective.”
In its complaints to the FDA, the Prescription Project, whose backers include the Pew Charitable Trusts, cited ads for Abbott’s Xience V, a drug-coated stent; Medtronic’s Prestige Cervical Disc, a spinal implant; and Stryker’s Cormet hip-resurfacing system.
Stryker said it wouldn’t comment because the issue was before the FDA. Medtronic said it is committed to adhering to FDA guidelines for direct-to-consumer advertising. The company said the video in question had been taken down.
An Abbott spokesman said the company posted a link to Adderall XR’s safety and risk information next to its YouTube video, but will from now on embed safety and risk information in such videos.
