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One woman’s account of spinal cord stimulator skips realities of medical device safety in U.S.

Rating

2 Star

Categories

Here’s how one woman used an implant to get some relief from chronic back pain

Our Review Summary

back painThis story summarized one woman’s account of getting a spinal cord stimulator to relieve her chronic back pain, as published in more detail in Popular Science. This is a review of the Washington Post’s abridged version.

To its credit, the story mentioned the high cost of the surgery to get the implant and does not portray the device as a total cure.

But it did glorify the device as a “next generation” implant that could serve as an alternative to opioids. It missed an opportunity to describe who could benefit, spell out what evidence exists of a benefit, and discuss the potential harms of getting this device inserted in your spine. The story also did not mention that the woman, Janet Jay, acknowledged being a paid “advocate” for pain patients, which could present a conflict of interest.

 

Why This Matters

News stories should approach stories about medical devices with an extra shot of caution, given that scant evidence is required to show they provide a benefit or are even safe for patients. Journalists should scrutinize the available evidence, point out shortcomings, and remember that anecdotes are much lower on the totem pole than clinical trials despite their emotional tug.

Low back pain is a common problem. Most individuals will experience low back pain at some point in their life. However, for most, symptoms are self-limited and improve over time. But for a small percent, probably between 7-12%, symptoms become persistent – either happening all the time, or recurring frequently. Though a small percentage, it represents millions of individuals with low back pain. How best to treat them is unclear.

Recent emphasis has been focused on the harms of opioids for chronic pain. But the question of what is the alternative for these individuals remains. This anecdotal piece argues for spinal cord stimulators. Though this one patient is satisfied with the results of this treatment, it hasn’t been a cure. Additional surgery has been done, her pain isn’t resolved, and there is no mention of how long it is expected to help her for.

We don’t know what other pain treatments she may be getting and the reader is provided no information on the risks of these devices that include high rates of device failures and the need to remove or replace them. There is also no mention of the alternative treatments to manage chronic pain including non-opioid medicines, exercise, physical therapy, yoga, acupuncture, Tai-chi, cognitive behavioral therapy, mind body relaxation, as well as other invasive procedures such as injections, ablations and surgical procedures.

In summary, for a reader with chronic pain, this piece offers little in the way of information about who may want to consider this, what the alternatives are and what are the likely risks and benefits.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story scrapes by on this one — it said the surgery is “expensive” and that Jay’s insurance “covered much of the six-figure bill for the procedure.” The story could have mentioned other costs associated with treating this condition.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

To its credit, the story offered a nuanced view of the benefits as seen through the eyes of this single patient:

“Even for me, the battle is not over,” Jay writes. “Since this surgery I’ve actually had another disc herniate, complicating everything. My spine isn’t cured, and I still hurt all the time. But the pain is far more controlled, and I can function much better at my current level of discomfort.”

Still, it didn’t give readers a picture of an idea of the scope of the benefits for all patients who have had this procedure. What percentage see improvements? And how much better are they? We aren’t told.

In essence, there is no information provided to say what the chance of the next person having this procedure is of achieving pain relief. Moreover, it isn’t clear how this may compare to other treatments. It is implied that this was the last step, but that is rarely the case.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

This was a big oversight. There was no mention of the risks involved with having surgery in the vicinity of the spine, which could include serious complications such as infection, as well as device failure. The story should have cautioned that medical devices are not required to undergo rigorous safety trials before they are allowed on the market, as we cover in our medical device primer.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story didn’t describe the evidence that these implants offer a benefit or explain that a single anecdote does not constitute reliable evidence.

In the column, Jay cited an observational study based on insurance claims data in which, she said, opioid-using patients who had the device implanted and then removed took more opioids on average that those who continued to use the device. But that type of study — which has no control group of patients — cannot show that removing the device increased the pain of those patients. It’s possible that patients who had the device removed had something else going. This study provides nothing to help the reader determine whether she or he would benefit in the same way as Jay. It isn’t clear what her issues were, what was previously tried, or even what she continues to do in addition to the stimulator to control her pain.

Medical devices are not required to show a proven medical benefit before they’re allowed on the market, which means that the quality of evidence of a benefit is often very weak.

Does the story commit disease-mongering?

Not Satisfactory

The statement that “an estimated 25.3 million Americans, or 11.2 percent of U.S. adults, experience chronic pain” suggests that there are millions of Americans who could be lifted out debilitating misery with this technology. The story should have attempted to give an accurate picture of how many people could actually benefit. 

The implication is that this procedure may be appropriate for many patients with chronic pain. Given that there is very little evidence to support this treatment as safe and effective, the thought of spending billions to place them in the millions of individuals mentioned is frankly scary.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

There were no independent sources quoted in the story, which was a weakness.

In the Popular Science column, Jay said she has a “new part-time job advocating for people in chronic pain,” but not disclose who is paying her. The Washington Post story did not mention that potential conflict of interest.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story referenced Jay’s use of “painkillers” and states that spinal stimulation “may become more popular” due to the opioid crisis. But it didn’t compare the effectiveness, safety, or cost of spinal stimulation with the array of treatments available for back pain. Those treatments include not just opioids but over-the-counter medications, movement, cognitive behavioral therapy, acupuncture, spinal manipulation, and steroid injections.

In general, patients contemplating this procedure have already undergone many other treatments. Moreover, there as other treatments that could be done as alternatives. These would include non-invasive treatments such as interdisciplinary rehab, yoga, non-opioid pain meds and invasive treatments such as surgery and injections. More on the range of treatment Jay tried and other she considered would have been helpful.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

It’s clear that these devices are available and in some cases covered by insurance. Though it may have been helpful to note that these devices are usually performed by specialists and particularly in rural areas, access to them may be harder to get.

Does the story establish the true novelty of the approach?

Satisfactory

Spinal cord stimulation appears to have been around for years, though the marketing of these devices appears to be on the upswing. One concern: The piece refers to her getting a “next generation stimulator. This implies that there is a prior generation one, and we’re not sure what the difference is.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story does not appear to rely on a news release.

Total Score: 4 of 10 Satisfactory

Comments (2)

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Mary Daye

September 20, 2018 at 9:16 am

It seems fairly useless to review someone’s rewrite of the original story. Many of your ‘objections’ are addressed in the actual story’s reporting.

Reply

    Joy Victory

    September 20, 2018 at 9:22 am

    Thanks for the comment, Mary. Because of how large the Post’s readership is, and because some or most readers may never click to read the other story, we felt the rewrite was worthy of review. Non-journalists won’t always understand the implications that a rewrite might contain less information and that the original story needs to be read to get a fuller sense of the risks/benefits of getting a spinal implant.

    Reply