September 18, 2008
Experts Push For Regulation Of Medical Device Ads
On Wednesday, medical experts told lawmakers that new television advertisements for medical devices pose even greater risks to patients than ads for drugs, which have been scrutinized for years.
The Senate Aging Committee hearing was focused on whether new restrictions are needed on consumer-directed advertisements for artificial knees, heart devices and other medical implants.
Pharmaceutical marketers have taken advantage of magazine and TV spots for over a decade, with the industry spending over $5 billion on such efforts last year. While spending by the device industry is minuscule by comparison, several of the biggest players are adapting similar high-profile tactics.
Duke University basketball coach Mike Krzyzewski can be seen in TV advertisements promoting Johnson & Johnson's orthopedic hips. Biomet has promoted its competing products with spokeswoman Mary Lou Retton, an Olympic gymnastics champion.
Medical device spots are not required to give equal balance to risks and benefits of their products unlike ads from pharmaceutical companies.
"Because of that, they can create unrealistic expectations among patients and lead to overutilization of inappropriate and costly, unproven technologies," said Kevin Bozic, a board director of the American Association of Orthopedic Surgeons.
But some disagree. AdvaMed, which represents industry leaders like Medtronic and Boston Scientific Corp, argue that marketing "is a powerful education tool" that helps patients learn about important new treatment options.
Committee Chairman Sen. Herb Kohl, D-Wis., asked AdvaMed President Stephen Ubl whether some advertisements overstate the benefits of devices.
After playing the J&J advertisement featuring Krzyzewski - which shows a number of people playing various sports - Kohl asked, "Is it typical for hip replacement patients to be able to jump rope, surf and swim?"
Ubl declined to comment on the advertisement.
Device advertisements are more deserving of restrictions than those for drugs because the implants often involve greater risks, experts told lawmakers.
Dr. William Boden, a professor at the University of Buffalo, said that while all drugs have side effects, taking a pill for insomnia or impotence is nowhere near as risky as having a medical device surgically implanted.
A recent ad for Johnson & Johnson's Cypher stent, which he said "crossed the line" in touting the benefits of a device to millions without mentioning the sometimes fatal complications of surgery, Boden pointed out. Stents are mesh-wire tubes used to prop open arteries after they have been cleared of fatty plaque deposits.
He recommends a ban on advertisements for medical devices for at least two years after they are approved. Democrats have pushed for similar restrictions on the drug industry, but without much success.
He may consider proposing similar restrictions for medical device makers, Kohl said, and on Wednesday he pressed a Food and Drug Administration official on whether the agency needs more resources and authority to oversee device marketing.
We hope actions by Congress would improve public health and not just create more regulations, said Daniel Schultz, who runs the FDA's device center.
"There are a lot of things that could be done, the question is what should be done to get the ultimate outcome of improved public health," Schultz said.
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