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Monday, May 2, 2016

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 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.
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, 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 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 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.”

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