Your Depression Should be Over Already.
The true story of a massive study on one of the most effective treatments that you've never heard of.
This article is about the data that demonstrate a depression treatment that works is here —now— and is wildly more effective than the standard of care. I spent about five years of my life contributing to this publication. I have a massive emotional and financial conflict of interest in the following essay (and not because it made me wealthy):
Being a co-author on the largest data set ever published on one of the most effective treatments for depression? It could be a cause for celebration. However, much like the reality of getting depression to remission that major healthcare payers routinely block, it’s a bit of a hollow victory. This real-world follow-up of an FDA-cleared treatment in 1351 patients demonstrated the most likely outcome of dTMS treatment with the “H1” stimulator—a medical device—was remission. This remarkable. It’s also a challenge to the popular discourse around an intractable “mental health crisis.”
The paper has the following title:
Deep TMS H1 Coil treatment for depression: Results from a large post-marketing data analysis: Deep TMS post-marketing analysis
It's like a marketing firm was hired by science to make sure that everybody falls asleep before learning anything relevant.
First, the most important takeaway:
65% of patients with treatment-resistant depression will no longer be depressed in a month.
Because the treatment works. Even in people for whom oral medicines have not been helpful. This is post-marketing data—it was not a randomized controlled trial. Those have been done already. Many, many times over. This is a study of what happens when you take an already approved treatment and deploy it in the real world, and you see if it works as well as it did in a tightly controlled research setting. You include only real patients with real problems under real constraints in the real world. I treated hundreds of the patients represented by the data in that paper. Many more were treated under my supervision in a clinical setting in which I was a founder. Others were treated at a variety of other real-world sites without my iron fist in control over data collection.
I'm going to put this paper into context, and given that I'm a co-author on that paper, I know many of the humans whose suffering was ameliorated, as documented. That is what “remission” means—the end of a depressive episode. Over. Done. Maybe not forever, no.
Depression isn't always a chronic illness. It's not “hard to treat.” We have treated it with interventions that don't work as well as they need to.
It is as if we spent decades gassing up our cars with water and then dedicated ourselves to talking about the crisis of mobility. You can call these cars disordered. You could call it a really difficult problem to solve! People could talk about how important mobility is. It could have a month dedicated to its awareness. All of those things would be a waste of everyone's time because cars don't run on water.
Ineffective interventions do not a mental health crisis make. And our inability to call a spade a spade might as well be the actual crisis.
Deep transcranial magnetic stimulation is a procedure that I've been applying in my practice as a psychiatrist since 2017. This is not a secret. This is not new science. This has been FDA-cleared since 2012. The treatment works as well now as it did then. It's not a secret. It's even been in the news. I'll cite the tiny local Brooklyn newspaper that wrote a great article about me back in 2017 when I started treating patients:
The technology — patented by the U.S. and developed by a company called Brainsway — works by creating a magnetic field in the area of the brain where the mental disorder lives and fixing the rhythm of the local neurons that have gone slightly wrong.
Depression is caused by hypoactive — or slow — neurons in the left dorsolateral prefrontal cortex. When Muir puts the deep TMS helmet on one of his patients, tips it forward and turns it on, it creates an electrical field that changes when those neurons fire up.
It is not a secret. One of my first TMS technicians summed it up in the 2017 article thusly:
“It’s magic,” said Casey Wilen, a medical technician at Brooklyn Minds. “It’s science, but it’s magic.”
Now we have data and a scale in keeping with the largest studies in psychiatry, and larger than most.
The largest prospective depression study is STAR*D (sequenced treatment alternatives to relieve depression) is an NIMH-funded trial on depression, clocking in at 2,876 total patients. Comparing apples to apples and only looking at treatment-resistant patients, who would meet insurance criteria to get the deep TMS treatment described in the paper I am writing about, is as follows (for years, insurance companies required 4 failed medication trials in the current episode of depression, which is what STAR*D examined in sequence):
The data looks like the following for remission (not “response” —which would be like assessing is has worked for cars if the engineer it turned over once but never got you home):
And if we look again at the durability of remission in the above massive study:
Oral antidepressants prescribed as dictated by “fail first” insurance plans prevent patients from getting the most effective treatments we have. They routinely fail to help patients end their depressive episodes, and relapse is the most likely outcome with those “successful” treatments.
As my colleagues recently pointed out in an assessment of the “mismatch” between treatment guidelines related to TMS and insurance coverage policy when compared to the actual efficacy, this is a grave error:
In the US, the incremental cost-effectiveness ratio (ICER) is deemed cost-effective, and of good value, when the ICER is < $50,000/QALY gained.41 A recent analysis examining cost-effectiveness of rTMS after only 1 failed pharmacotherapy trial demonstrated that initiation of rTMS in younger (mid 20s) and older (mid 50s) patients yielded an incremental cost per QALY less than $50,000.42 Another study demonstrated that rTMS leads to higher QALYs and lower cost in TRD at both 3 and 5 years when compared to antidepressant treatment alone.43 This was shown even with conservative estimates of 37.5% response and 21.5% remission for rTMS. Another interesting coverage policy point is that there are at least 2 Medicare local carriers, Novitas Solutions (policy number L34998)44 and Noridian Healthcare Solutions (policy number L37086),45 that do cover the use of rTMS after treatment failure of at least 1 psychopharmacologic agent. Why other Medicare carriers and private insurers do not cover the use of rTMS after 1 trial is concerning, and it creates an access issue to a proven therapy.
Keep in mind the above assessment uses a permission rate that is 21.5%, and the above data presented in the paper I co-authored on the H-1 coil in depression is, at worst, 65%. This is a better, safer, and more cost-effective treatment than oral medications for most depression.
By the way, what are the side effects? They include improved cognition:
Your depression should be over already. The lack of an appropriate payment model from your insurance plan is getting in the way. Given the vastly reduced cost and better outcomes, there is little explanation for this other than a breach of fiduciary duty on the part of plan sponsors going forward.
—Owen Scott Muir, M.D.