Why Patients Don't Hear About Failed Medical Devices Until It Is Too Late . . .

Media mystery: Why did journalists ignore an important study on a costly, harmful back pain procedure?

April 20, 2016 (FiDA highlight)

Kevin Lomangino is the managing editor of HealthNewsReview.org. He tweets as @KLomangino.

What qualifies as “news” in the topsy-turvy world of health care can be a real head-scratcher sometimes.

A few weeks ago, the New York Times reported in some depth about a two-week, 9-person study of bicyclists headlined, Chocolate Can Boost Your Workout. Really.

Really?

That kind of coverage is exasperating. Especially when you consider that last week, I could find no mainstream news coverage — nada, nothing — about a 10-year, award-winning study that, according to several knowledgeable experts, has tremendous clinical and financial implications for the treatment of back pain in the United States.

The study was titled, “Does provocative discography cause clinically important injury to the lumbar intervertebral disc? A 10-year matched cohort study.”

But that title apparently wasn’t provocative enough for journalists on the health care beat.

It’s a shame the researchers couldn’t find a way to work the word “chocolate” into their study.

High costs and potential for harm

“Provocative discography” is a diagnostic procedure that’s used up to 70,000 times a year in the United States at great cost to the health care system. It’s commonly performed on patients with so-called “degenerative disc disease” who are considering spinal fusion surgery — a $40 billion per year industry in the U.S. In an attempt to pinpoint the disc that’s causing problems, the surgeon will typically do a pressurized injection of the suspect disc and one or two non-degenerated control discs.

Experts say that provocative discography has no proven benefit for identifying symptomatic discs and has previously been shown on magnetic resonance imaging to be associated with faster degeneration of injected discs. The new study followed 75 patients who received the injections and compared them to 75 matched controls. The point of the new study was to see whether the disc degeneration seen on MRI would translate into clinically important back pain symptoms.

There was no significant history of back pain in either group when the study began. But the new 10-year data showed that there were more back pain surgeries (16 vs. 4); more frequent sciatica and back pain syndromes, and greater work loss and doctor visits for low back pain in the punctured discs compared to controls.

More pain. More surgery. More costs.

All with a procedure that’s still performed tens of thousands of times a year.

But no news coverage.

An expert asks: “Why would providers perform this test?”

James Rickert, MD, an orthopedic surgeon and contributor to HealthNewsReview.org, called it a “very important study.” The study has limitations, Rickert noted, including the fact that 40 out of the 150 patients were lost to follow-up during the 10-year study period.

“But readers should be aware that a trial of this sort with 10 years of follow up is very compelling evidence of discography’s potential problems,” Rickert says. “Such long term studies are rare,” he adds, and this one should tell readers: “Do not go undergo provocative discography.”

Patients looking for relief are subjected to all sorts of tests but provocative discography is the most invasive, and, typically, causes some insult to structures that are either normal or are not pain generators for the patient.  Add in the low diagnostic yield for patients, why would providers perform this test?

Similarly, Steven Atlas, MD, MPH, another HealthNewsReview.org contributor, likened the issue to a “house of cards” that’s finally beginning to topple. He noted that responses to provocative discography depend upon a variety of factors including the physician’s technique for performing the procedure.

So, not surprisingly, results are not very reliable. We also know that patients who have fusion based upon findings of provocative discography don’t do any better than individuals who have surgery but don’t undergo this test. We also know that patients can report more pain after the procedure, including pain they didn’t have before the procedure. And now we know that there are long-term risks associated with discography.

Mark Schoene, editor of The Back Letter as well as a HealthNewsReview.org contributor, emphasized that the study also threatens companies developing new biologic treatments that might help fix degenerated discs.

Most of these companies are planning to deliver those therapies via disc injection. The compounds they will inject, however, often have large-size molecules and will require large-bore needles—as large or larger than the needles employed in [these] studies. This suggests that these therapies may actually cause harm through the acceleration of disc degeneration.

Schoene said that companies producing these therapies are fearful that the studies may prompt the FDA to alter its safety standards regarding these injections—and order long-term human safety studies. Human studies of these injections would take a decade or more to perform and “could stop this new business in its tracks,” he said.

Few vested interests pushing reduction of unnecessary care

The news media weren’t entirely silent on the issue of back pain last week. The Minneapolis Star Tribune had a hard-hitting exposé on Medtronic’s Infuse bone graft device. It asked why more than a thousand adverse events associated with the device weren’t reported to the FDA.

A handful of stories (HealthDay, WebMD) also reported on a pair of New England Journal of Medicine studies (see here and here) looking at clinical outcomes for spinal fusion surgery. They reported that the more invasive and costly fusion surgery isn’t any better than a simpler surgery known as decompression for patients with pain resulting from spinal arthritis.

But the silence about provocative discography is provocative. With such huge implications, how can this critical study have received no mainstream media coverage? (The study was, after all, the subject of a news release put out by the North American Spine Society that should’ve pinged journalists’ radars.)

Rickert says it mainly comes down to who’s willing and able to invest in publicity for these studies.

“When a clinical trial shows positive results for a test/procedure, the manufacturer deploys an army of salesmen and media specialists and publicists to publicize the data,” Rickert notes. “That doesn’t happen with studies that call existing procedures/tests into question.”

Media Has Role in Exposing Unsafe Medical Devices!

Why the media must play a bigger role in policing unsafe medical devices

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.

http://www.healthnewsreview.org/2015/10/why-the-media-must-play-a-bigger-role-in-policing-unsafe-medical-devices/

FiDA comment

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