Trudy Lieberman October 27, 2015
Contributor Trudy Lieberman has been tracking the progress of industry-friendly regulatory legislation — the 21st Century Cures Act — through Congress. Here she examines how current medical device regulations are already allowing many faulty devices on the market — and how the media will need to be more vigilant if and when current regulations are further weakened under 21st Century Cures.
Last September, the Food and Drug Administration convened a panel of experts to publicly examine the safety of Essure, a birth control device sold to more than half a million women over the past 13 years. The device, a coil implanted in a woman’s fallopian tubes, was sold as a way to permanently prevent pregnancies without the need for abdominal surgery and general anesthesia. Despite the touted advantages, more than 5,000 women have reported complications to the FDA, including tubal perforations, allergic reactions, severe pain and bleeding resulting in hysterectomies and hundreds of unintended pregnancies. In the last few years those complaints have multiplied, and more than 20,000 women have turned to Facebook to share their experiences.
Through the years Essure has gotten its share of press, but media coverage has swelled in the past month thanks to the power of Facebook, the FDA’s expert panel meeting, and a study released this month in The BMJ, which concluded that Essure was not associated with a higher risk of unintended pregnancies but was associated with a substantially increased risk of additional operations to fix the complications arising from use of the device. Outlets such as Reuters, the Wall Street Journal, NBC, and the Philadelphia Inquirer ran stories. A New York Times editorial called for the FDA to consider suspending sales of Essure until better data is available.
In early September, a few weeks before the FDA hearing, came more troubling news about a different medical device–the C.R. Bard Recovery filter. The Bard Recovery filter is inserted into the body’s largest vein and is intended to prevent blood clots that form in the legs from traveling to the heart and lungs. In a two-part series, which moved beyond the usual safe topics of network news, NBC reported that the filter could migrate through the body, puncture the heart, and had caused 27 deaths and 300 non-fatal medical events. Neither the FDA nor the manufacturer C.R. Bard would talk about the device or NBC’s revelation that Bard may have forged the signature of its employee who refused to sign off on the FDA approval application because of unresolved safety issues. (They did issue statements — see here and here.) Although NBC pointed out that some 20,000 people were estimated to be walking around with the device implanted in their bodies as far back as 2006, it was disappointing that the story of the migrating heart filter received so little media traction except from trade pubs like Fierce Medical Devices and websites sponsored by law firms no doubt trolling for clients.
As good as the NBC story was, it may have gotten more attention had NBC noted that the FDA had sent Bard a warning letter in July which flagged violations of the Food, Drug, and Cosmetics Act. The FDA said Bard had manufactured and marketed its Recovery Cone Removal System, intended to remove Bard filters from the body, without the required clearance or approval from the agency. The warning letter also advised the company that its “complaint investigation procedures do not ensure product complaints are adequately evaluated.” One case was reported by the company as a malfunction of a medical device when it “should have been filed as a death;” others were filed as malfunctions when they should have been filed as “serious injuries,” the FDA said. Scary stuff the public might want to know! When I asked NBC about this omission, a PR official said the letter “was not germane to the heart of our report,” but noted the warning and other legal and regulatory issues facing Bard were discussed in an online piece. The brief online mention, however, hardly communicated the seriousness of the warning.
Media interest in medical devices is a hit or miss affair, and when there is coverage, it usually doesn’t mean that the device, no matter what harm it may have caused, will be pulled from the market. Such devices continue to be sold, potentially causing more harm. The FDA’s response is often to call for stronger warnings or restricted use rather than ask the manufacturer to recall the device. The rationale: It may still help some people. It also helps the seller’s bottom line. In Washington’s current regulatory climate regulated industries rule the roost.
Most devices are approved with very little evidence they work and are safe.
Bard’s Recovery filter, for example, was approved in 2003, but two years later the company took it off the market and swapped it for a different model. Modifications in the new device were intended to prevent complications that had occurred. Both devices were approved under what’s called the 510(k) approval process that allows manufacturers to avoid conducting safety studies if a device is substantially equivalent to another already on the market. Essure was approved in 2002 on the basis of two nonrandomized, nonblinded prospective studies that lacked a comparison group. Since then some post-marketing studies have found problems.
FDA’s panel of experts concluded “that additional research needs to be done” to prove the device is safe, and they called for its use to be limited. It’s not clear what action the FDA will eventually take.
“Once the device has been implanted and used, it’s hard to pull back because it has become the expected way of practicing medicine,” says Sanket Dhruva, a cardiologist and clinical scholar at Yale. “In the U.S. there’s no systematic reassessment of device safety and effectiveness years later.” And there’s no systematic, comprehensive, and uniform way of collecting complaints through product registries that other countries have which track problems with medical devices. Medical specialty organizations, the government, and even manufacturers sponsor registries in the U.S. Jeff Lerner, who heads ECRI, the independent organization that tests medical devices, drugs, and other healthcare technologies, told me, “A lot of information comes from registries outside the U.S.”
These shortcomings in policing unsafe medical devices argue for increased media scrutiny, including from social media. (Facebook acted as kind of a registry in the Essure controversy, but consumer complaints–as important as they may be–are no substitute for official registries with controls and rigorous data collection practices.) “The press is absolutely critical,” says Dr. Hooman Noorchashm, a cardiologist, who has spent the last few years trying to get a device called the power morcellator off the market. The device treats uterine fibroid tumors but can also spread hidden cancers throughout the body. Noorschashm and his wife, Amy Reed, also a physician who has cancer thought to have been spread by the morcellator, have been on something of a crusade to warn others and challenge the FDA. “Any success we’ve had is because a few Wall Street Journal reporters listened to us,” Noorchashm told me. So far one manufacturer has pulled the product, and the FDA has called for a black box warning, the strictest cautionary label a product can have. “They put out a black box warning and an advisory. That doesn’t protect patients,” he says. “Doctors still think it’s okay.” One Dallas gynecologist told the Wall Street Journal that he asks patients to sign an informed consent document describing the risks of the procedure, but he added: “We tell them verbally that we don’t think those numbers are correct.”
As the 21st Century Cures Act moves closer to becoming law, media vigilance over medical devices will be even more crucial. The Senate is now considering the bill, which passed the House in July, and the PR campaign to speed up passage is gaining momentum. Earlier this month the Manhattan Institute, a conservative think tank that has provided the intellectual ammunition for the legislation, bought a full-page ad in the New York Times arguing “a new era in science and medicine calls for a new approach at the federal Food and Drug Administration…every American has a stake in this change because everyone will be a patient someday.” The Act would make it easier for devices to pour into the market in this “new golden age of medicine” the ad proclaimed. As I wrote in a previous post, should 21st Century Cures become law, devices will get even less regulatory scrutiny than they get now. Of course, there can be studies after a device has been around for awhile, but research published this summer in JAMA found that post-market studies varied in quality and only about 13 percent were completed between three and five years after approval. That’s a lot of time during which a bad device can be causing harm to unsuspecting patients.
I asked one of the study’s authors, Dr. Joseph Ross, an associate professor of medicine at Yale, how media coverage of devices could be better. Too often, he said, reporters who do cover devices don’t go far enough. “When you stop at the bad event, it doesn’t illustrate the path that got us there.” The larger story is really about the FDA, America’s laissez-faire philosophy of regulation, its insatiable appetite for cures, and the clash of these elements with costs and safety. That story is much harder to tell.
Trudy Lieberman, thank you! The media is welcome to review the chronicle of the medical device industry unearned entitlements and the FDA lax enforcement of regulation that I have collected since 9/2010 when I was invited and attended FDA/CDRH Patient Representative training. OSHI (office of special health issues) never selected me for a panel because a) most (98%+) devices are grandfathered in by 510(k) process and b) they select the Patient Representative that has no opinion about the product. So, in effect, the harmed patients are not in the room when decisions are made. No wonder the profit flows along with the harm! My blog: FiDA Failed implant Device Alliance http://fida-advocate.blogspot.com