* Consumer Reports seeks rigorous upfront testing of devices
* Claims FDA fast-track approval process is too easy
* Devicemaker trade group: more regulation would be stifling
By Debra Sherman
CHICAGO, March 12 (Reuters) - Consumer Reports, the 76-year-old publication best known for its reviews of automobiles and refrigerators, is trying to galvanize the American public into protesting the way medical devices are approved by the U.S. Food and Drug Administration.
The past couple of years have seen a steady drumbeat of concerns by some lawmakers that health regulators are doing too little to protect consumers from hastily approved devices that can cause injury or even death.
“It’s a nightmare scenario,” Consumer Reports President Jim Guest wrote in an email blast to 1 million Americans earlier this year. “The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you.
“This isn’t science fiction. Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled - 700 different products a year. And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were ‘similar’ to products already on the market,” he wrote.
For decades, certain devices have been cleared by the FDA without the manufacturers ever having to test them in human beings in clinical trials, which take time and money.
The fast-track approval process is known in the industry as Pre-market Notification, or 510(k), named for the numbered section of the Food, Drug and Cosmetic Act.
Intended for low- and moderate-risk medical devices, such as blood pressure cuffs and hypodermic needles, too many high-risk devices, such as hip implants and heart valves, were cleared through the 510(k) process and later found to cause life-threatening incidents, according to Guest.
Consumer Reports, an independent nonprofit, publishes a monthly magazine, as well as newsletters focusing on health, money, travel, home and garden, weddings and other topics.
It has a total of 8 million subscribers to all of its publications and 800,000 for its On Health monthly newsletter, which was established in 1989. On Health maintains its own medical experts, but sometimes taps outside physicians.
Consumer Reports’ advocacy arm, Consumers Union, would not disclose how much money it is spending on efforts to change the medical device approval process, but says its campaign is a top priority. The campaign was launched late last year at its annual Patient Safety Summit.
The Institute of Medicine, a nongovernmental, nonprofit organization that provides medical advice to policy makers and the public, characterized the 510(k) approval process as “fatally flawed” and said it should be scrapped.
The FDA, for its part, believes that the current device-approval process could stand some improvement. Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said 510(k) should not be eliminated, but thought changes to the process were in order.
Lawmakers have the authority to change the way devices are approved. FDA cannot change the process, but it can change the way it classifies devices. Hip implants and heart valves, for example, are categorized as “moderate risk,” which allows them to go through the 510(k) process.
The medical device industry has argued for either leaving the 510(k) process as it is or further streamlining the approval process. Most new medical devices - about 4,000 in 2009 - are cleared through the accelerated program.
AdvaMed, the trade group representing medical device makers, warns that more regulation would stifle innovation and that streamlining the process is necessary to move the large volume of products awaiting approval through the system.
In one of the highest-profile cases, Johnson & Johnson in August 2010 recalled its ASR hip implants after they failed at a higher-than-expected rate, with some patients experiencing pain, joint dislocation and sometimes systemic damage to the central nervous system, thyroid and heart. Many patients have cobalt and chromium poisoning from the implant.
Surgical mesh - used to repair or reinforce soft tissue where there is weakness, for such procedures as pelvic organ prolapses - has also been a subject of major recalls, including products by Boston Scientific Corp and J&J. Almost every synthetic mesh device on the market today cleared through the 510(k) process was based on the ProteGen mesh, manufactured by Boston Scientific, even though it was recalled in 1999.
Jaye Nevarez, of Lakewood, Colorado, said she never would have had J&J’s Gynecare surgical mesh implanted in her body four years ago had she known how easy it was for products to gain approval and how severe the complications could be.
At age 50, Nevarez cannot walk because of nerve damage that she believes is a consequence of mesh erosion.
“I’m alive. I function, but I don’t function well. I’m in pain every day, all day long, day after day, and it doesn’t go away. It’s not worth it,” said Nevarez, who is suing J&J.
A J&J spokesman declined to comment.
Possible changes to medical device regulations are especially relevant this year, as Congress is reviewing the fees the industry pays to the FDA in exchange for speedier review times. Since fees from makers of drugs and medical devices provide more than a third of the FDA’s funding, the bill often serves as a vehicle for broader FDA-related changes.
Last month, U.S. congressmen Edward Markey (D-Massachusetts), Henry Waxman (D-California) and Jan Schakowsky (D-Illinois), introduced legislation - the Safety Of Untested and New Devices Act of 2012, dubbed SOUND Devices Act - that would give the FDA more authority to reject a manufacturer’s application for a new device if it was based on a similar product that was recalled.
Guest said any new law should also require rigorous testing of the devices upfront and a national registry that would track device performance over time. Raising manufacturers’ user fees that fund FDA could help fund a registry, he said.
Some 93,000 people have been implanted with DePuy’s ASR hip system worldwide and J&J faces more than 2,000 lawsuits in state and federal court.
“When clients call, they are livid when they find out how (the device) was approved. They say ‘I don’t understand how this was able to get on the market in the first place,’” said attorney Felecia Stern of Bernstein Liebhard LLP, a New York law firm handling more than 200 cases against J&J over the ASR hip. However, these patients, she said, are usually too overwhelmed by medical problems to get involved in activism.
Carol Kochhar-Bryant, a 62-year-old professor and senior associate dean at the Graduate School of Education and Human Development at George Washington University, was one recipient of the Consumer Reports’ email blast.
She had the ASR implanted in 2009. The joint failed after a couple of years and she said it left her with high chromium and cobalt levels in her bloodstream, a condition known as metallosis that some experts fear could cause cancer and other serious problems. She continued to have pain and recently underwent a second, more extensive surgery to scrape out metal shavings embedded in the surrounding tissues of her hip and replace the entire ball and socket with a new device.
“I was assuming there was a much more rigorous process,” she said, referring to the approval process of her hip replacement. “I did not quiz my doctors on how these things come to the market. They gave me a lot of pamphlets on it. I went back to look to see what adverse events were listed, but there’s nothing in there.”
Katie Ayers, 42, also had the ASR hip implanted when she was 36 years old. Blood tests revealed that she also had elevated levels of cobalt and chromium, and she decided to have the device replaced with a J&J ceramic implant.
Ayers is suing J&J and testified before Congress last year. Kochhar-Bryant said she has not yet decided on legal action.
AdvaMed cites a September 2010 study by Battalle, a research organization it commissioned to look at the issue, that found that Class 1 recalls, the most serious kind, accounted for only 77 out of 46,690 (0.16 percent) of the medical devices - including low risk devices - that were cleared through the 510(k) process between Jan. 1, 2005 and May 1, 2010.
But a more recent study of the same data had a far different result. The study by Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen, the high-profile cardiovascular medicine chair at Cleveland Clinic, was published in the peer-reviewed medical journal, Archives of Internal Medicine, in February 2011.
Zuckerman said Battalle understates the problem because many products are often recalled after they have been on the market for five years or more. In addition, she noted that the Battalle study only looked at raw numbers of device approvals and did not consider how many people were affected by recalls.
“If you care about public health, you look at how many devices were recalled and how many lives were put at risk,” said Zuckerman.
She said her study concluded that more than 70 percent of the high-risk recalls were for medical devices that the FDA categorized as “moderate risk” and therefore went through the 510(k) process for approval.
AdvaMed, however, said the real problem at FDA is growing delays and inconsistency in product reviews. AdvaMed Senior Vice President David Nexon said consumer groups often do not have a realistic understanding of risk.
“Consumer groups, which typically represent primarily people who are healthy, often have a very heavy emphasis on avoiding any risks,” Nexon said.
“Patient groups ... have an equally strong interest in the development of new treatment and cures, and they understand that there is always a balance between risk and benefit,” he added.