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Small studies belie Boston Scientific’s claims about safety and effectiveness of spinal cord stimulation

Boston Scientific Receives U.S. FDA Approval for Spectra WaveWriter™ Spinal Cord Stimulator System

Our Review Summary

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Millions of Americans suffer from chronic pain. The primary non-opioid strategy for treating that problem are nonsteroidal anti-inflammatory drugs (NSAIDS), like aspirin, acetaminophen, ibuprofen, naproxen and celecoxib.

The alternative described here — electrical nerve stimulation —  uses a small generator to send electrical pulses to relevant nerves in an effort to interfere with the nerve impulses that create feelings of pain. The device, Spectra WaveWriter Spinal Cord Stimulator, has just received approval from the U.S. Food and Drug Administration, and this news release portrays it as the beginning of a new day. But the release lacks specifics, and readers have no way of judging whether this optimistic framing is justified. We worry that the release misses on a number of our evaluation criteria, including information about cost and details of both risks and benefits stemming from the small studies conducted to date.

 

Why This Matters

Chronic low back pain is a common, disabling condition for many individuals. For many, there is no cure, rather the goal is to manage pain and improve function. There are numerous treatments for chronic low back pain ranging from oral medicines, to physical treatments, behavioral therapy, injection drugs, various invasive procedures to treat presumed causes such as the disc between the spine bones, joints, nerves, arthritic changes that narrow the spinal canal and pinch nerves. Spinal cord stimulation is an invasive technique that doesn’t focus on the pain generator, but rather attempts to block nerve stimuli from the spine that travel to the brain. Spinal cord stimulation has been available for many years, but evidence supporting its use is limited.

Finally, a note about nerve stimulation being an advantage over opioid treatment for pain. The messaging about moving from an opioid to a non-opioid treatment strategy for chronic pain is an important one in a world awash in opioid over-use. Medical reporters and potential patients need to tread carefully.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Although the purpose of the news release is to signal federal approval of a treatment, cost does not make an appearance. For uninsured patients, typical out-of-pocket costs for spinal cord stimulation are $15,000- $50,000 or more.

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

Not Satisfactory

While the release touts the recent FDA approval of this spinal cord stimulator system, it offers no specific information about its impacts on participants in recent clinical studies on which that regulatory decision was based. The release encourages readers to infer that the device works, but we have no idea how successful it has been in diminishing chronic pain. This is a problem, as electrical nerve stimulators generally have a spotty record in clinical studies. Despite searching, our reviewers could not locate results from the Whisper study, one of two named in the release.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

Spinal cord stimulation requires surgical implantation of a device. One study published in a pain journal found that 38% of participants in clinical studies of the technique experienced device-related problems such pain, lead migration, hardware failure, and infections at the implantation site. Other minor issues include electromagnetic interference, such as from an MRI, and skin irritation. There is no mention that complications from the device are common. None of this makes it into the news release.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The text refers to “more than a decade of clinical research” and to two recent studies that go by the acronyms PROCO and WHISPER. The PROCO study enrolled just 33 patients, 10 of which did not respond to the treatment. Results from the WHISPER trial have not yet yet made their way into the peer-reviewed literature. That study planned to enroll up to 146 previously implanted patients.

Further, the release adds a “cautionary statement regarding forward-looking statements,” an increasingly common addition to news releases, which seeks to absolve the source, in this case Boston Scientific, from push back should future research or use of the device belie the positive statements in the release.

Does the news release commit disease-mongering?

Not Satisfactory

The release suggests that spinal cord stimulation will be an alternative to opioids, implying this could be used in millions of individuals. The potential harms and evidence suggest that’s premature, if not a dangerous position for which to advocate.

The release states that “100 million Americans suffer from chronic pain” but only a small subset may be candidates for treatment with nerve stimulators.

Chronic pain plagues many people and deserves medical attention. However, distinguishing between pain that can be managed with over-the-counter treatments and unmanageable pain that needs medical intervention is important, and the release offers no usable distinction for readers.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The release makes no statement on funding sources for the two studies.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release barely meets the standard on this criteria. It mentions the popularity of opioids for chronic pain treatment and heralds the spinal cord stimulator as a non-opioid alternative. And although given short shrift, it mentions other devices are available.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

No reference to eventual availability is offered. The FDA often approves devices in “pre-market” mode, so it is difficult to tell when this particular device will be in use.

Does the news release establish the true novelty of the approach?

Satisfactory

A source in the release references the “main advantage” of the device (integrates multiple therapies and offers individual control) over existing ones.

Total Score: 3 of 10 Satisfactory

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