Medical Device Industry Attacks Upcoming Safety Study

When scientific research is published that puts pressure on an industry, business often pushes back.

But as The New York Times reports, the medical device industry is taking an unusual tack: It is waging a campaign in Washington to discredit a report that isn’t even out yet.

The respected Institute of Medicine, part of the National Academy of Sciences, is scheduled to release a report Friday that could recommend a tougher approval process for devices ranging from hip implants to hospital pumps and external heart defibrillators.

The analysis, commissioned by the Food and Drug Administration, comes after several recent high-profile recalls of devices that have failed in thousands of patients, causing many injuries.

But even before the Institute of Medicine’s review panel finished its work, industry advocates began arguing that the report will be biased, and they have stepped up their criticism in recent weeks. Device producers also have released their own reports claiming that more regulation would hamper innovation, harm patients and cost jobs.

Leading the charge against the report is Ralph F. Hall, a University of Minnesota law professor and attorney for the device industry who said the criticism was intended to air legitimate concerns about how the review had been conducted.

Medical experts said the institute’s study is likely to have a significant impact on patient safety, device effectiveness and the speed at which new products reach the market.

With millions of dollars at stake, the experts said, it isn’t surprising that the device industry and others would want to derail what they fear will be new barriers to product sales. Still, some say, the lobbying has focused on economic issues rather than patient health.

“We are trying to get to good policies, and the spin game doesn’t help us,” said Dr. Harlan M. Krumholz, a Yale medical school professor who has served on a different Institute of Medicine panel.

Some devices undergo clinical trials in patients before they can be sold. But most medical devices, go through an easier approval process under which a producer needs to show only that a new device is “substantially equivalent” to one already sold.

The 12-member scientific panel included physicians, academics and two lawyers who had worked for device makers on regulatory issues. Another lawyer on the panel, Brian Wolfman, who once worked for the consumer advocacy group Public Citizen, has come under particular attack by business-affiliated groups.

CHRISTINE YOUNG

Related Post:
Safety Problems Spur Order for Follow-Up Studies on Artificial Hips

Print Print  

One comment to “Medical Device Industry Attacks Upcoming Safety Study”

  1. FaithfulServant

    Shame on Ralph F. Hall, at University of Minnesota for putting the love of money before the love of patients! I was used for an experimental surgery in the state of Minnesota with out my knowledge and consent with a faulty medical implant. My doctor also worked with the University of Minnesota and also his wife! Medtronics had faulty leads on their baby monitors in the mid 80′s and patients are also walking around with faulty leads in their hearts from Medtronics. They are literally walking time bombs and many being zapped. Where is the protection for the end consumer? My doctors medical records magically disappeared which hurt in my settlement with the manufacturer! Lawyers on the side of fraud and abuse will one day feel the torture and pain for eternity unlike the patient who looks for the day of a new life in heaven…pain free!

Leave a comment