This article reports on an Food and Drug Administration “marketing authorization” for a commercial magnetic pulse delivery device designed to temporarily reduce the symptoms of obsessive-compulsive disorder (OCD) by affecting neurochemical transmissions in the brain. The device is worn on the head and, through a coil, delivers noisy, often headache-inducing pulses to part of the brain. Treatments are needed on an ongoing basis in most cases, and are delivered in a clinical setting by health care specialists. This type of device was first approved by the FDA for use in major depression and some migraine conditions.
The text of the story only thinly describes the very limited clinical trial that informed the new FDA decision, and doesn’t go much beyond a news release from the company. The only quote is from an FDA official saying the device has “potential” to help people with OCD who have not responded to conventional therapy. An independent expert source would have likely made this story much stronger.
The underlying cause and reasons why some therapies work for OCD are not well understood; it would be helpful if news articles about novel treatments would include that context. It is also imperative that this reporting is informed by as much detail about the clinical effectiveness as possible.
The article does not say how much this treatment cost nor whether insurance covers the costs. Some estimates of TMS put the cost of four to six week courses of five-day-a-week, 20-minute treatments at between $5,000 to $15,000 and up.
The article does give data on the reduction of symptoms and how that reduction was measured and it does note that people in the intervention and control groups both continued to take OCD medications if they were on them to begin with.
The article uses information from an FDA news release to discuss side effects:
The most common side effect in the clinical trial was headache, which occurred in 37.5% of the treatment group and 35.3% of the sham treatment group. Other possible side effects were mild, and included temporary jaw or face pain, muscle spasms or twitching, and neck pain.
This is enough to rate Satisfactory, but there is certainly more that could be said about side effects. We easily found evidence of short-term memory loss and patient complaints of significant anxiety by doing a quick Google search.
As noted above, the article needed to say more about the design of the clinical trial, the participants’ range of symptoms, the facilities in which they were treated and to what degree the study group represents and reflects most people with OCD. Without that context, it’s hard to know really how valid the outcome data are. It’s not clear what the treatment consisted of in terms of duration and repetition of TMS.
The article is weakened by the absence of expert comment and attribution of claims made by the company and the FDA. Nor does the reader learn anything about whether those who conducted the clinical trial have or had any ties to Brainsway or other conflicts of interest.
Although the article mentions alternative treatments (psychotherapy and medications), it doesn’t compare them to outcomes claimed for TMS.
Readers will understand that the TMS device is now commercially available for OCD, although the article does not offer any information about facilities that offer the treatment.
The story makes it clear that TMS and TMS devices aren’t new, but this is the first time a TMS device can be marketed as an OCD treatment.
However, the story says “there’s no equivalent device already available to patients,” but that doesn’t appear to be accurate. There are several brands of TMS devices. Is there anything unique about this one for OCD, or was Brainsway simply the first to test it on OCD patients?
The story didn’t include anything significant that wasn’t in the FDA or Brainsway news releases. The only thing we spotted that diverged from the news releases was that BuzzFeed used numbers from the NIH on how many people have OCD.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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