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

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


Surgical CostsWhat 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.”

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Comments (8)

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Johanna Ryan

April 21, 2016 at 9:27 am

Thanks so much for sharing this. As a paralegal helping injured workers in the workers’ comp system, I see a lot of discograms. They have become the gold-standard “evidence” to justify a spinal fusion surgery … not only selecting the vertebrae to be fused, but “proving” the pain is disc-related. I think insurance companies more and more demand them, in an effort to cut costs. They don’t seem to be reducing the number of spinal fusions, really … and if these guys are right, they may be making the spinal-fusion business even more hazardous than it already is.

I often feel conflicted when I find myself fighting for a client’s right to get a fusion. The trouble is, the insurance companies don’t want to track our clients into “more appropriate care.” They want to keep them from getting any care at all. This is what happens when you trust a for-profit industry to be your cost and effectiveness watchdog. Definitely hiring the fox to guard the chicken coop.

Charles Mauldin

April 22, 2016 at 5:49 pm

As a ‘company doctor’ for 25 years, I’ve seen plenty of people have lumbar fusions for degenerative disc disease but I never saw any get better and some were worse. (In my state if the patient wants the procedure and any doctor recommends it, the ALJ will direct the insurance company to pay for it.) Regarding Johanna Ryan’s comment, I don’t think the disco gram would cause any harm whenever the discs are fused. But more to the point, she might consider passing on Gordon Waddell’s quote: ‘The advantage that people in third world countries with back pain over us is lack of access to health care.’

Jen Kane

April 23, 2016 at 8:22 am

Excellent article. I had one, pre-fusion and it seemed unnessary and irrelevant, simply confirming the doctor’s suspicions that the discs were damaged (something they were already able to acertain by looking at my MRI.) I think it had no effect whatsoever on my fusion’s outcome and mainly served as diagnostic overkill.

Also I wanted to add that I almost didn’t read this post to get to your excellent insights due to the “so-called “degenerative disc disease” lead in, which implies that DDD is somehow a made up condition. This comes off as poor in taste as someone starting an article about the “so-called ALS” or the “so called Parkinson’s.” I’d suggest leaving the “so called” and the quotes off if you want to woo any readers/supporters in the DDD community.

Marilyn

April 23, 2016 at 3:36 pm

If I understand correctly, Provocative Discography also has a large “subjective” component to it: the patient’s and observer subjectivity!:)

Graham Yates

April 24, 2016 at 2:54 am

Also there are now many studies showing DDD is very normal in an asymptomatic population.(80% DDD, 20% disc bulges or herniations)..
Prof Peter O Sullivan has a really good article on his http://www.pain-ed.com website (22 Sept) suggesting a lot of chronic back pain is iatrogenic , that is caused by a health system finding things wrong and creating very negative thinking with patients.There is one very large study showing the sooner you have an MRI for low back pain the worse your outcome- more disability,more time off work , more surgeries and medication use.
We are stuck in a Cartesian medicalised system that forgets to look at the fundamentals- how well are you sleeping, how stressed/depressed are you, how much exercise do you take, what is your diet like and what is your thinking around your pain.

Kevin Lomangino

April 25, 2016 at 7:54 am

Hi Jen,

I certainly did not mean to call into question the pain or suffering of anyone with back pain. My use of the term “so-called” was referring to the fact that DDD is an inaccurate term used to describe an unproven entity. For a more thorough explanation, I turned to Mark Schoene, editor of The Back Letter. Here is what he had to say:

From my perspective, “so-called degenerative disc disease” is a perfectly accurate phrase—and not one that should be offensive to people with chronic low back pain.

It is not an attempt to deny that these patients have low back pain. Rather, it reflects the fact that “degenerative disc disease” has never been validated as the cause of chronic low back pain—or as a proven indication for spinal fusion. The use of the qualifier “so-called” is not questioning the existence of chronic low back pain. It is questioning whether disc degeneration is the cause of their pain.

Put more simply, there is no “smoking gun” linking disc degeneration to chronic low back pain.

There is no diagnostic test, nor combination of diagnostic tests, that can prove that “degenerative disc disease” is the cause of a patient’s chronic low back pain. Disc degeneration is common among these patients. But it is almost as common among people without back pain. No form of imaging can distinguish symptomatic from asymptomatic individuals. No other common diagnostic test can do so either.

I have attached a review of diagnostic tests by Dutch surgeon Paul Willems that was published in The Spine Journal. It shows that none of the diagnostic tests they looked at—MRI, annular tears, high intensity zones, bracing, external fixation, discography, etc) could identify a subset of patients with degenerative disease who are good candidates for spinal fusion surgery. So, until there is better evidence, these are all patients with nonspecific chronic low back pain in the presence of disc degeneration.

Here is the evidence summary by the editors of The Spine Journal on page 2 of the Willems study:

Surgery for chronic low back pain (without neurological
impingement, instability, etc) is controversial at best.
There is no clear pathognomic or specific pathologic lesion,
yet the authors discovered that strong data predicts
clinically serious low back pain syndromes. Diagnostic
tests have proven to be nonspecific and their accuracy
poor in determining treatment success. Outcomes are
universally inferior to those expected for clinically
well-defined degenerative conditions (herniated nucleus
pulposus, stenosis, degenerative spondylolisthesis). Despite
a nearly 60-year concerted effort and the escalation
of complex surgical approaches, little clinically significant
progress has been made to improve the situation
for these patients.

As the HealthNewsReview.org commenter noted, it wouldn’t be accurate or tasteful to use the phrase “so-called ALS” or
“so-called Parkinson’s disease”, because ALS and Parkinson’s disease are proven disease entities—proven beyond doubt.

At this point, “degenerative disc disease” is still a hypothesis not a disease. This label is widely used in clinical spine care, but it shouldn’t be, as it is confusing to patients and physicians alike.

leonard pitt

April 25, 2016 at 8:47 am

You sir are a writer and do not see how deadly boring and unprovocative that article title is? Just reading it induces the snoring reflex.

Tim Gallivan

April 27, 2016 at 7:54 pm

Degenereative Disc Disease is a very over-used diagnosis when applied to simply looking at an MRI of a patient with back pain. If an mri was performed on every person over 40, it would show that 100% of us would have degenerative discs. It is like grey hair and wrinkles, we all get them. Functionality, not structural assessment is much more accurate.