A veteran journalist explains why it’s so tough to inform the public about medical devices — and what can be done about it

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Mary Chris Jaklevic is a freelance health care reporter who will be joining the HealthNewsReview.org team as a full time staff contributor in January 2018. She tweets as @mcjaklevic.

Millions of Americans are implanted with medical devices every year, yet surprisingly little is known about whether those devices help or harm them.

medical devices

While Walmart tracks every head of lettuce on its shelves, no one “can say how many people are dying because of implanted medical devices. It’s a black hole,” veteran journalist Jeanne Lenzer, a former associate editor at The BMJ, writes in a new book, “The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It.”

News stories seldom call attention to this data gap. While critical news coverage of the pharmaceutical industry and its products has made the public more wary of drugmakers, Lenzer asserts that “the same skepticism is largely lacking about implantable devices.”

“The public and doctors often perceive these devices as advanced products of cutting-edge technology that are inert and so, unlike drugs, don’t have serious side effects,” she writes. “Nothing could be further from the truth.”

Unlike drug companies, device makers often do not have to prove their products benefit patients and frequently get away without submitting safety data, according to Lenzer’s research. Also unlike drugs, devices such as pacemakers and artificial joints are often implanted via surgery and aren’t simple to remove.

‘Industry is good at concealing bad outcomes’

Further, she writes, devices can cause side effects such as bleeding and organ perforation, can be subject to hacking, and, if they are metallic, pose a risk of injury if a patient undergoes an MRI. Their manufacturers are also shielded from lawsuits when something goes wrong.

Jeanne Lenzer

In an interview with HealthNewsReview.org, Lenzer said she’s observed an “ocean of bad reporting” on medical devices–stories that regurgitate news releases, hold out rosy patient anecdotes in place of scientific evidence, fail to mention potential harms, and employ “wiggle words” such as “promising” or “appears to.”

She believes journalists should refrain from covering medical devices unless they have the time and expertise to take a deep dive and ask informed questions about the quality of evidence.

“Industry is good at concealing bad outcomes,” Lenzer said. “It takes a lot of time and effort to suss out what’s true and what’s not.”

That means knowing your way around the FDA review process, reaching out to independent experts, and learning about statistics and research methodology, she said.

“If you’re not an investigative journalist, you’re contributing to the problem rather than the solution” she said.

Profits over patient welfare

Lenzer spent years researching her book, which chronicles the device industry’s lack of accountability through the story of one epilepsy patient who nearly died when a vagus nerve stimulator implanted in his chest repeatedly stopped his heart.

The book is worth reading for anyone who wants to understand how government, medicine and academia became enmeshed in a medical-industrial complex that puts profits over patient welfare, and what policy steps might lead to better patient protections.

In 2017, the FDA issued a “safety alert” for roughly 465,000 radio frequency-enabled pacemakers that were already placed in U.S. patients.

The FDA can’t determine the rate of harmful events caused by a particular device because it doesn’t track the number of devices in use, Lenzer writes. Moreover, “only a tiny fraction of adverse events and deaths related to medical devices is ever reported.” While manufacturers and hospitals are required to alert the FDA when patients are harmed, it’s rarely enforced.

Reporting about medical devices is also difficult because the FDA’s evidence bar is lower for devices than it is for drugs, as described in HealthNewsReview.org’s tips for analyzing claims about medical devices.

Lenzer said it can be tough to find independent sources who have time to read through the available record and point out deficiencies in the data. Meanwhile, journalists often don’t have the time or expertise to do it themselves.

“Journalists take their cues from the scientific community, and if the scientific community is selling these things as doing good, it’s very hard to dig for contrary information,” she said.

Journalists must step up scrutiny

Often, reporters don’t know what questions to ask, which results in credulous reporting.

Take a recent story in the Newport News, Va., Daily Press, To treat depression without drugs, go electromagnetic. It touts the use of “deep transcranial magnetic stimulation” to treat depression, using the story of one patient as evidence of a benefit and giving no research data. The story also repeats a common industry assertion that devices can allow patients to give up their medications without offering evidence.

Uncritical coverage that encourages patients to seek out unproven devices is just part of the problem, as Lenzer sees it: We also need “much, much more” investigative reporting.

Lenzer wonders how many patients might have been spared from cardiac stents if journalists two decades ago had examined the quality of evidence for using stents to unblock arteries. Both doctors and the public assumed that common procedure saved lives and relieved chest pain in stable patients until more rigorous studies showed otherwise.

Examples of strong reporting

She also points to some effective reporting, such as the Minneapolis Star-Tribune’s probe of Medtronic’s cover-up of complications from its bone-fusion product; Consumer Reports’ Dangerous Medical Implants and Devices; Mad in America’s Adverse Effects: The Perils of Deep Brain Stimulation for Depression; and Street Sweeper’s investigation into deaths and injuries from the vagus nerve stimulator.

“Forces are arrayed against journalists, but there are courageous reporters who have turned the tide,” Lenzer said.

She said journalists should be prepared to ask pointed questions about research methodology. Some of her recommendations are included in HealthNewsReview.org’s toolkit for medical devices.

Among her key recommendations:

  • Call out the use of surrogate markers, which is rampant in device studies.
  • Consult with statisticians and learn about concepts such as “regression to the mean,” which is the tendency for symptoms to improve naturally during clinical trials since patients enroll in studies when their symptoms are most severe.
  • Report whether devices were tested against both “sham” devices and existing drug interventions. Both comparisons are needed for completely new devices.
  • Ask whether a device has been given conditional approval, meaning it was allowed on the market before it was proven safe.
  • Tap this list of independent medical experts, and reach out to sponsors of the list or the National Center for Health Research.

Lenzer believes systemic changes are also in order to shift resources to more meaningful reporting. “We need to change our media system, which is very much beholden to industry,” she said.

Investigations into devices can be “hugely time consuming” and therefore beyond the resources of many newsrooms, she said. We need more support for investigative journalism.”

Loosening FDA regulations could put more patients at risk

The need for journalistic scrutiny could increase under FDA Commissioner Scott Gottlieb, M.D., who has announced plans to “modernize” the device review process in early 2018 in an effort to hasten new technology to market.

Gottlieb said new procedures will aim to ease burdens on industry and give patients quicker access to new treatments. But critics including Lenzer say the proposed reforms could allow more unproven products on the market.

Lenzer said it’s a “big lie” that shifting evidence-gathering to the period after a device is on the market will help patients. In fact, it could put them at risk, she said. “The FDA has not disciplined companies for not doing their post-approval studies,” she said.

As Lenzer’s book documents, promised follow-up studies to confirm that a device is safe once it’s been allowed on the market often aren’t submitted to the FDA, or don’t contain relevant data. In the case of the vagus nerve stimulator, five safety studies were reported but incredibly, none measured how many patients died using the device, Lenzer found.

Another emerging concern is that the FDA has launched a precertification program for digital health products, allowing tech companies like Fitbit to sell wearable devices that track conditions such as irregular heart rhythms.

Lenzer agrees with those who have expressed concern that a proliferation of loosely regulated health trackers could do more harm than good by generating false positives that lead people to seek unnecessary and risky treatments.

But there’s no way for the public to know about such pitfalls, Lenzer said, unless journalists step up and “hammer away” at the missing science.

“If they do their homework well enough and persist over time, journalists can make a difference.”

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