Our Review Summary
We would have questioned the decision to write about a device with so little evidence to back up its use, but with a huge health insurer considering whether to back this device as a panic attack treatment, it makes a lot of sense to examine it from multiple angles. The reporter does just that. Nearly across the board the story covers the important bases. Costs, availability, alternatives, the quality of the evidence, what independent experts think. The two big drawbacks on the piece are the lack of hard numbers (instead of percentages) to explain the purported benefits of the treatment and the lack of any discussion of the risks of using this treatment versus better known alternatives.
Why This Matters
As the article states, several million people in the U.S. have panic disorder, and millions more experience panic attacks that bring them to the emergency room or for a visit to a doctor. The disorder may significantly limit people’s lives. It is very treatable, although treatment can be time consuming (meeting 2-3 times/week for 3-4 months with a therapist) and fairly expensive. It usually includes the use of drugs as well entailing visits to a psychiatrist.
This device trains people with panic attacks to slow their breathing, and early evidence indicates that this results in a sustained decrease in panic symptoms. It’s unclear from the article though if studies were randomized controlled trials and/or were all sponsored by the manufacturer–always helpful info to know. This training may take less time and be less expensive than traditional courses of cognitive behavioral therapy.
Criteria
Satisfactory
Not only does the story discuss the costs, it explains that “no other insurance companies are covering Freespira’s $500-a-month price tag, a barrier to widespread use.”
The story could have gone even further by explaining that if people can train themselves at home to use this device, it would save visits (time and money) to psychologists and psychiatrists.
Satisfactory
We’re giving this a pass here because the story does discuss what limited evidence there is for the benefits of the device. Our one wish — and it’s a big one — is that the story would have talked about the benefits in absolute terms. Here’s a chief example: one “multicenter trail” involved just 69 patients. Only 48 of them completed the treatment. Then the story says that 69% of those 48 people had a “significant reduction in severity of panic disorder symptoms.” It’s hard for readers (including the reviewers) to get their heads around that. Why not just say that 33 of the 48 patients had the reductions (and explain what is meant by “significant”)? It’s easier for people to understand, and it emphasizes the small nature of the study.
Not Satisfactory
There is no explanation of the harms, and we think this is a troubling omission. Take the same example of the 69-person trial. If 21 people dropped out, why? And did this happen in other trials, too? We’re talking about a real mental health need that is not being met by current treatments, so the stakes are high enough that risks must be explained.
Satisfactory
The very first reference to the device says that it “suggests” that breathing slowly and shallowly might be better for panic attacks. It goes on to underscore why it uses that word. It’s because so much of the evidence is weak, and the story shows that.
Of course, we always see room for improvement, and in this case we think the story could have pointed out the lack of peer review of the multicenter study mentioned. It’s also important to know if any of the studies were randomized and controlled, and if the ones mentioned were sponsored by the manufacturer, which would skew towards a positive result.
Many people too don’t realize the exceedingly low standard for device clearance by the FDA. This clearance says little if anything about whether the device actually works or not or is safe. So the FDA stamp here, while it sounds good, really says nothing about the product’s effectiveness or safety — and the story could have been more clear about that.
Satisfactory
The story does not engage in disease mongering, and we very much appreciated how it waited until deep into the piece before bringing in an anecdotal success story. No editor will allow a newspaper story like this to run without a patient experience being included. And so we very much appreciated how hard it must have been to go through so much more context and detail in the scientific debate around this device before bringing in a patient.
Satisfactory
The story does a nice job exploring a wide range of opinions about the device and includes one potentially telling piece of context. The reporter tried to contact the scientist who led the studies that led to the device being given FDA approval. “She declined to discuss the company or her research for the article.”
That being said, we think it would have been helpful to clarify whether the studies noted were sponsored by manufacturer. And it seems possible that one of the sources, who is analyzing the (unpublished) multi-center trial, could be a company consultant (call us paranoid). We can’t be sure about either of these things so we’ll give the benefit of the doubt here.
Satisfactory
The story talks a lot about the alternatives to this treatment, although we think it’s a stretch to say that the results are “similar to results for cognitive behavioral therapy.” If a decent-sized randomized controlled trial showed that the two were equivalent, then we’d be more supportive. But it’s not clear that any of these studies were randomized, controlled, peer-reviewed, or even published.
Satisfactory
The story noted that the treatment is not widely available, including the fact that in the Inquirer’s readership area, “only Marvin Berman, a neurofeedback therapist…offers the device to patients.”
Satisfactory
The story did address the novelty question and showed how the question of retraining people’s breathing patterns is a longstanding issue that researchers have been trying to address multiple ways.
Satisfactory
The story did not rely on a news release.
Total Score: 9 of 10 Satisfactory
Comments (1)
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Debra Reisenthel
December 9, 2015 at 10:23 pmI want to address the questions about whether there was an RCT conducted, reasons for the drop out rates, was there any harm caused by using this protocol/ device and if the studies were company sponsored. Also, I want to correct your statement that FDA did not weigh in on safety and effectiveness. A non-company sponsored, NIH and VA funded, randomized controlled trial was published in 2008 by Meuret from Stanford (and other participating centers) that used a waitlist group as the control, as is done in many behavioral health studies. Meuret stated that attrition was very low, with no dropouts during treatment and most drop outs were due to the inability to schedule follow up for patients who moved. Dropouts in the Tolin (et al) Multi Center Freespira trial were primarily related to patients who were unable or unwilling to meet the time requirements of the study, including doing 2 sessions of 17 min a day. Research for the Multi Center study was sponsored by the company, but investigators were not paid consultants. The FDA clearance letter for the Freespira product/protocol and the 510(k) Summary are on the FDA website . The Summary states: “Findings of these empirical studies have shown that completing the …training led to long-lasting reductions in panic attack frequency and severity, anxiety symptoms, avoidance behaviors, along with improvements in mood and quality of life in the majority of patients. Respiratory training using the … protocol is safe, and no adverse events associated with the use of the device have been reported. “. In the Meuret trial, at 12 months post treatment (this is only a 4 week treatment), 68% of patients remained panic attack free and 96% were either “much improved” or “very much improved”.
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