Health News Review

I’ve documented a track record in my local Star Tribune newspaper of cheerleading for local medical device companies.  This undoubtedly happens across the US in other local papers but I live in Minnesota and we have a lot of medical device companies here and this is what I see most often.

And today the paper provides a fresh, classic example of what I mean when I talk about cheerleading.

Page One of today’s paper displays the story, “Sleep apnea trials favor Minnesota device.”

As I’ve opined about past Star Tribune page one health stories, I doubt this story would have appeared in the paper at all – much less on page 1 – if it had come from a company in neighboring Wisconsin, Iowa, Illinois, or the Dakotas.

It was based on a paper in the New England Journal of Medicine this week about a local company’s device that requires surgical implantation in the chest along with “two wires: one that senses when a patient’s lungs begin inhaling and another that stimulates the nerves of the tongue. The electric pulse makes the tongue move out of the airway each time the patient inhales.”

Now of the big three (out of many) things we look for in a story – benefits, harms, costs – the Star Tribune unsurprisingly focused on benefits.  Harms and costs were touched on but almost as an afterthought, and buried deep in the story.

Check out how the story was framed.

“Results of clinical trials were so positive that experts predict the technology may become a viable alternative for patients who can’t tolerate continuous airway pressure (CPAP) machines…. the trial results appear likely to persuade U.S. regulators to approve the device for a sleep apnea market expected to hit $7 billion by 2017.”

Note:  there was no independent expert perspective in the story.  Only the company president and one of the study principal investigators were quoted. Predicting imminent FDA approval is a crap shoot.  You might be right.  Often you’re wrong. Journalism should stick to the facts and not play the crystal ball game.

Here’s the one mention of potential harms:

“(One patient) had her device implanted in July 2011 and was soon wondering if she had made a mistake in getting rid of her CPAP. Soon after her surgery, the incision became inflamed and painful. “It was like I had a basketball under my chin,” she said. Anti-inflammatory medications and an attentive medical team helped, she said. After several weeks, the pain and inflammation were gone.”

OK, it’s good that was mentioned.  But the story didn’t provide any data on how often that happened, or what else happened that might bother patients.  The study itself reports:

Two participants had a serious device-related adverse event requiring repositioning and fixation of the neurostimulator to resolve discomfort. A total of 33 serious adverse events not considered to be related to the implantation procedure or implanted devices were reported. Most of nonserious adverse events related to the procedure (88%) occurred within 30 days after implantation and were expected postsurgical events, including sore throat from intubation, pain at the incision site, and muscle soreness.

A total of 18% of the participants had temporary tongue weakness after surgery, which resolved over a period of days to weeks. No permanent tongue weakness was reported during the study. Among device-related events that were not considered to be serious, 40% of the participants reported some discomfort associated with stimulation, and 21% reported tongue soreness, including abrasion on the lower side of the tongue. These events were related to the functional stimulation of the tongue muscles and the resulting tongue motion over the lower teeth. Most of these events resolved after the participants acclimated to the upper-airway stimulation therapy or after the device was reprogrammed to adjust the stimulation variables. In nine participants, a tooth guard was used to resolve tongue soreness or abrasion related to the device.”

So the only patient profiled, and the only harm mentioned – one that left the patient wondering if she had made a mistake in her decision to have this done – was categorized by the researchers as a “non-serious” problem.  And, while the researchers reported that only 2% of patients had device-related serious adverse events, more than half had “procedure-related non-serious” problems such as the woman quoted.  And more than half had “device-related non-serious” problems. Not surprising, given that this is a surgical procedure.  But none of this was in the newspaper. It’s not difficult to find these numbers when you put more emphasis on reading the study than on merely listening to company presidents and principal investigators.

Finally, the device’s projected cost was mentioned, but only after the jump to another page deeper in the paper, and only in the second last sentence of a 900-word story.

“the Inspire technology is more expensive than CPAP — up to an estimated $30,000, including surgical and recovery costs, vs. $1,000 for a CPAP”

30-to-1 cost increases are kind of important in most industries. Gee, maybe this is one contributing factor to explain why the “sleep apnea market (is) expected to hit $7 billion by 2017″ and something that just might deserve a little bit more discussion, including from independent voices (who were not heard from in this story).

Summary:  this may turn out to be a very useful technology that will help many people.  That’s not in question here.  We question the framing of health care stories – what they emphasize and what they minimize or ignore.

This one is another classic case of cheerleading trumping journalism.

And don’t think that readers don’t notice.  See some of the comments left on the Star Tribune’s website, such as:

  • “Sorry, I will keep my CPAP. Less invasive and I haven’t had one problem since the day I started using it.”
  • “Pretty awesome, but $30,000 vs. $1,000? Please remind me again why insurance is so expensive.”
  • “I can’t imagine choosing this invasive procedure over CPAP.”

 

Addendum on January 10: Another news story this week, “Medtronic’s Renal Denervation System Fails,” should serve as a lesson to those who write giddy stories about early research findings.  Medtronic’s Symplicity device had been touted as a high blood pressure treatment after earlier, smaller study results.  But in a larger study, it failed to meet its study goal, and now the company has stopped enrolling new patients.   Researchers said they were “dumbfounded,” that “this is a very surprising result, entirely unexpected,” a “huge disappointment,” and that the major lesson of the trial was: “If the data are too good to be true, they usually are!” These are all lessons for journalists who write about new medical technologies, and for the public who reads their stuff.

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