Consumer safety proponents press for tougher standards while firms want faster approvals.
Minnesota resident Steven Baker says the FDA-approved prosthetic elbow implanted in his arm has never worked properly and continues to cause excruciating pain. Records show that the part of the prosthesis that malfunctioned in Baker’s arm had been the subject of two recalls in Canada and an “adverse event report” of the U.S. Food and Drug Administration.
WASHINGTON - Steven Baker's artificial elbow locked up as he was going through a metal detector at a Senate office building recently. The malfunctioning FDA-approved joint left the 56-year-old Minnesota millwright in a world of hurt.
Not unlike the consumer movement he represents.
As victims of faulty medical devices press for tougher standards, the focus of the debate in Congress has shifted from consumer safety to quickening the approval process for new devices. Critics and proponents alike agree that the medical device industry, which has deep roots in Minnesota, has successfully pushed a D.C. agenda that seeks to simplify federal oversight of product development.
"Well-funded lobbyists are skewing the vision," said Baker, who came to Capitol Hill as part of an effort by the Consumers Union Safe Patient Project to show what happens when medical devices fail.
Despite such efforts, the device industry's political momentum is building along a number of fronts. Among them:
•A bill in the U.S. House aims to change the mission statement of the Food and Drug Administration to include "job creation" as well as safety.
•Another bill, introduced by Rep. Erik Paulsen, R-Minn., gives outside reviewers expanded authority in the approval process for some life-sustaining and permanently implanted medical devices.
•In the Senate, Minnesota Democrat Amy Klobuchar introduced legislation that, in part, loosens conflict-of-interest rules for those who review the safety of medical devices.
•An FDA-funded report by the Institute of Medicine has gone nowhere, despite strongly concluding that a program allowing certain devices to go to market without testing was not in the public's best interest. In fact, the device industry so effectively countered concerns raised by the institute that one congressman suggested the FDA seek a refund.
Meanwhile, rules to create an identification system for medical devices to help recall unsafe products remains stalled, several months after they should have been published. The medical device industry has called the ID system burdensome. A high-ranking FDA official said he cannot say if the administration will release the rules this year.
Steve Ubl, who helps represent the interests of the medical device industry, acknowledges that policy discussions among Congress and federal regulators have broadened and become less acrimonious over the past year.
"Today, we're discussing the role of FDA regulation in the context of innovation, investment, economic growth and global competitiveness," said Ubl, president of AdvaMed, which bills itself "the world's largest medical technology association."
Officials with Medtronic, the world's largest device maker, say they like the direction of policy proposals in Washington.
"We look forward to continuing to work with FDA to strengthen the process and assure that safe and effective technologies get to market in the U.S. in an appropriately timely manner," said Amy von Walter, spokeswoman for Medtronic, which is based in Minnesota.
Boston Scientific, which also has a huge Minnesota presence, agreed:
"Boston Scientific's first priority is patient safety," said Denise Kaigler, senior vice president of corporate communications. "The FDA routinely requires the submission of extensive testing results and scientific data."
Balancing speed and safety
Regulators, businesses, politicians and patients have battled for years over whether America's public health is better served by avoiding risks or by faster innovations in the medical device industry.
For people like Baker, who received a device that doesn't work properly, the fast-track process frustrates and confuses. For Minnesota's 400 medical technology companies and their 35,000 employees, changes to the system could be time-consuming and costly.
Experts agree that roughly 1 percent of medical devices introduced in the U.S. get recalled. Where they struggle is reaching consensus over whether that is a positive outcome.
Industry representatives and some patient groups say time is the problem. They say inefficient device approval procedures keep Americans from getting cures or pain relief as fast as patients in many other countries, especially the European Union.
The medical device industry "is behaving as they are supposed to," said Eric Campbell, director of research at the Mongan Institute for Health Policy at Harvard Medical School. "The first thing people have to realize is that they make a product to sell a product."
What consumers need, Campbell said, is "a policy champion who is an elected official." Otherwise, no one addresses situations like Baker, who lives with excruciating pain from an FDA-approved medical device that he says never worked right.
Baker met with staff members in the offices of Paulsen, Klobuchar and Sen. Al Franken. In statements after the meetings, the Minnesota trio affirmed their commitments to patient safety while emphasizing the need for faster device approval.
"We need to ensure patients have access to safe, lifesaving treatments and services," Klobuchar said. "This includes preventing regulatory burdens from getting in the way of delivering lifesaving products to patients who need them, while still ensuring the highest level of patient safety."
Patients share their stories
Dr. Jeff Shuren, the physician who directs the FDA's section on medical devices, said the agency is "not moving away from patient safety." He defended the current device approval system as "safe and effective."
"All devices have risks," he said. "What we look for is where are there problems. We don't have to make a major overhaul."
Lisa McGiffert, director of the Consumers Union Safe Patient Project, says it's critical that patient advocates demonstrate the serious consequences when a medical device fails.
"Statistics are one thing," she said. "Real people have a much stronger impact and are harder to ignore."
Medical device victims like Baker and Jim Shull of Browns Mill, N.J., hope so.
On a recent day, Shull shifted awkwardly from sitting to standing as he waited to testify before a House subcommittee. Shull lives with constant nerve pain and a long, disfiguring scar that marks the removal of a malfunctioning piece of FDA-approved surgical mesh implanted during a hernia operation.
Most of the testimony concerned getting medical devices to market faster. There was little talk about protecting patients.
"For me to get their attention," Shull mused, "I would need to take every one of these committee members into a back room, drop my drawers and show them what happened."
Jim Spencer • 202-408-2752 Jim Walsh • 612-673-7428