Medical-Device Executives Support Comparative Effectiveness

Top executives in the medical-device industry said Wednesday they support research comparing the effectiveness of medical treatments so long as it doesn't force patients toward a single treatment based on cost.

"We can't afford a cheapest-at-best approach to medicine," said Bill Hawkins, chairman and chief executive of device maker Medtronic Inc. (MDT). "Cheapest in the short run is not necessarily the best value for patients over the long term."

The recently passed economic-stimulus bill includes $1.1 billion for research comparing which drugs and medical devices work best for certain ailments. Press reports said lobbyists for the drug and medical-device industries had tried to gut the provision, but Hawkins stressed the sector supports the research.

Executives from Edwards Lifesciences Corp. (EW), Becton Dickinson & Co. (BDX), Advanced Medical Optics Inc. (EYE) and Medtronic and other companies said they want to make sure the industry's concerns are considered in the dbeate on health-care overhaul.

Stephen Ubl, president of AdvaMed, the device sector's Washington-based association, said the industry is concerned that all the focus on reducing health-care costs will end up stifling medical innovation.

"We must guard against an innovation blind spot," Ubl said, adding that if comparative-effectiveness research is based on cost decisions it could "put an arbitrary dollar amount on an extra year of life."

Edward J. Ludwig, chief executive of Becton Dickinson, Franklin Lakes, N.J., said the industry supports boosted funding for federal health agencies, including the National Institutes of Health and Food and Drug Administration.

The FDA has been underfunded in the last several years, and critics say the shortage of resources makes it difficult for the agency to operate properly. Ludwig said the sector would like to see the agency get more funds to hire additional scientists to review medical-device approval applications.

Ludwig said the medical-device industry has provided the FDA with about $140 million through user fees, which the agency charges the industry to review medical-device applications.

The FDA's oversight of the medical-device industry has been under scrutiny recently. A group of scientists within the FDA's device division wrote to President Barack Obama and members of Congress about how managers in the agency have forced them to manipulate data to get devices approved.

The Government Accountability Office, the investigative arm of Congress, issued a report last month saying some of the most risky medical devices weren't carefully reviewed by the FDA before they went on the market.

The increased scrutiny of the FDA's oversight of the medical-device industry suggests the industry may face more intense criticism. Hawkins expects more federal oversight of how the FDA and device industry keep tabs on potential problems with their devices after they hit the market.

-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; [e-mail]