OK, so the title is a little provocative; on the other hand, this is my take on a legitimate treatment for depression that was just approved by the FDA only last week. A company called Flow Neuroscience is marketing the newly approved FL-100 device for treatment of depression and their website definitely has their marketing skills down. And I definitely was reminded of a TV commercial about removing your own appendix.
That’s my smartass joke, but hang on, there’s more to it than jokes. I had to search around a while to find actual FDA web evidence that they actually did approve the FL-100, but I was saved by the reliable and trustworthy Psychiatric Times article about the FL-100 with references that I could verified the FDA’s approval.
So, I’m a retired psychiatrist and I was a clinician educator type doctor, not a neuroscientist, but I can read the FDA approval document section XV. Conclusions Drawn from Preclinical and Clinical Studies (starts on page 12). It boils down to, yeah, this device’s probable benefits outweigh its probable risks.
The Effectiveness Conclusions subsection on effectiveness outcomes at Week 10 contains what sounds like realistic answers: “The medical literature lacks consensus regarding what constitutes a clinically significant or meaningful between-group difference in HDRS-17 scores. As such, the clinical significance or meaningfulness of the between-group difference of -2.3 points on the HDRS-17 scale has not been established. Nevertheless, the 2.3 point between-group difference helps support the view that FL-100 provides probable benefit.”
I’m not familiar with the EQ-5D-3L scale of health-related quality of life but the summary says:
“The EQ-5D-3L measures a person’s health-related quality of life by assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There was no between-group statistical difference in EQ5D-3L scores at Week 10. The EQ-5D-3L frequently fails to detect mild depressive symptoms, as individuals with subclinical depression often select “no problems” on the anxiety/depression dimension. The insensitivity of EQ-5D-3L is documented in the literature.”
I happen to think that comparison of medical treatments with psychotherapy is a good idea but: “Data were not provided regarding FL-100 used adjunctively with psychotherapy or with psychotherapy and antidepressants.”
The device has no recommendation for use with patients with treatment-resistant depression:
“Patients who previously had an inadequate clinical response to two or more antidepressants at an adequate dose and duration were excluded from the study, limiting the evidence for use of the FL-100 in a more treatment resistant population.”
The potential risks are first degree skin burns if you’re not careful with the electrodes, headaches, and scalp pain. The benefit is modest but outweighs the risk.
You can use the device at home under the supervision of a clinician—they don’t do house calls so you’d presumably do this by zoom call. You can also get advice through an app on your device, which may or may not be a monotonal AI. You pay $500-800 and there won’t be any answers to questions about insurance coverage until at least next spring. But it’s being used by tens of thousands of people in Europe and beyond.
So go ahead, take your own appendix out (just kidding; put that jack knife away!). Did you know that at least one guy actually did that? A Russian surgeon, Dr. Leonid Rogozov managed it in 1961 while he was stranded in Antarctica.
It’s just my opinion, but the headset could be more stylish.
