Healthy Skepticism Library item: 14743

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: news

Japsen B.
Abbott to add safety information in YouTube ads after group complains
The Chicago Tribune 2008 Dec 3
http://www.chicagotribune.com/business/chi-081203abbott-youtube,0,1919085.story

Full text:

North Chicago-based Abbott Laboratories said it will embed safety information about its Xience heart device into a YouTube video spot, a disclosure made hours after a consumer group complained the spots ran afoul of U.S. Food and Drug Administration rules on product marketing.

“Abbott’s practice is to comply with all regulatory requirements and to provide patients and consumers with accurate and complete product information,” Abbott said in a statement to the Tribune on Wednesday. “All Abbott’s Xience V videos on YouTube were posted in July 2008 with prominent links to the ‘Brief Summary of Instructions for Use,’ which details the product’s risk and safety information. To avoid any problems in the future, we will embed safety and risk information in the videos moving forward.”

Boston-based Prescription Project, long a critic of drug and medical device industry marketing, said Wednesday that such videos showing medical device maker’s products should be regulated by the FDA and include safety warnings like other health industry products marketed in other venues.

The FDA could not be reached for comment.

The Prescription Project said the YouTube video does not have safety warnings like drug ads on television. The Prescription Project also cited videos of devices made by other companies, urging them to withdraw the YouTube videos for medical devices used in heart, hip and neck surgeries, the group said.

“The four Abbott videos currently available on YouTube promote use of the company’s Xience V drug coated stent for use in coronary angioplasty but contain none of the federally-mandated warnings or provisions required of medical device advertisements,” The Prescription Project said in a statement.

Abbott said the videos are linked to safety information, but a spokesman said the company was in the process of embedding the information into the videos. Abbott said it had done nothing wrong.

The FDA approved Xience for marketing in July. Analysts believe Xience will become the leader in a U.S. drug-coated-stent market projected to generate nearly $2 billion in annual sales this year.

Xience is thinner and more flexible than the first drug-coated stents, tiny metal scaffold-like devices used to keep arteries open that came on the market in 2003. By 2010, analysts say Xience could generate more than $500 million in annual sales, surpassing the current market leader, Taxus, which is sold by Boston Scientific Corp. Taxus was approved by the FDA in 2003.