Medical-Device Executives Support Comparative Effectiveness
February 25 2009 - 4:54PM
Dow Jones News
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;
jared.favole@dowjones.com