Paddling Upstream . . . Figuring Out The Role Of TMS In The Treatment Of Major Depression

Whenever a new medication or new technology hits the market, there is always a learning curve for both the public and for practicing physicians.  Tempering the excitement about receiving/delivering help with a dose of skepticism is healthy.  It keeps the public and physicians from being bamboozled by snake oil salesmen.  That is the whole idea behind the concept of the Food and Drug Administration.  They have been charged with the task of impartially reviewing data on new products and medication and giving us some measure of reassurance that new options for treatment are beneficial and not harmful. They have had their own set of difficulties over the last ten years, but I am encouraged that their response to issues of questionable oversight has been to be a bit more rigorous.  Better for us.  My difficulty has not been with products or with patients, but with insurance companies and their “oversight” of healthcare delivery.  New options for patient care are typically not covered or are covered with expensive co-pays attached to them.  This can be annoying when it comes to medication options, but downright infuriating to me when it comes to Transcranial Magnetic Stimulation.

Living with Major Depression is, to say the least, difficult.  For both the patient and for the family involved.  Living with asthma, epilepsy, or a broken hip is difficult, too.  But nothing saps the JOY out of a household better than a family member with a significant depression.  Because of the insidious nature of the disorder and the potential social stigma, people have difficulty seeing it and difficulty responding to it.  It comes in the night like a thief and one day you wake up and life is different.  “Things” are missing in your life and it is difficult to know where they went or why.  And getting “them” back is a long, slow process.  A process that one must often do by themselves or with minimal support from those around them.  Coping with financially based insurance hurdles is the last thing that someone should have to do at that time in their life.

Most of the options for treating depression are cheap and easy.  Since most of the SSRIs have gone generic, there are good options for first line interventions for this disorder.  Most people don’t even enter the “Behavioral Health System” to get their treatment, choosing instead to talk to the family doctor.  Family docs account for the majority of first-time prescriptions of antidepressants (even tho they get like NO training in managing depression . . . but that is a subject for another time . . .).  But what if you don’t respond to your first antidepressant???  What then????  Switch to another antidepressant??  Which one?? And why???  It starts to get increasingly complicated.  The treatment of Major Depression that has been resistant to medication interventions is a very complicated and difficult subject.  Well beyond the scope of a family doc’s training.  And it has very important treatment and prognostic implications for the patient.  The longer a patient is depressed and the greater the number of treatment failures, the less likely you will get a positive outcome for the patient.  Since a good solid trial of an antidepressant might take months, it is easy for a patient to go a year or more trying and failing two or three medications.  That would never be tolerated in the management of any other illness, but is glossed over in the management of Depression.

In trying to figure out the role of Transcranial Magnetic Stimulation in the treatment of Major Depression, we do need to balance cost with need.  It will not take the place of a first line treatment when so many relatively inexpensive medication options are present.  But as patients fail medication trials and spend more and more time struggling with their symptoms, they should have the option of undergoing TMS.  The company-sponsored research was more than adequate at showing benefit for patients.  This research has been replicated by an independent study that was recently published in the Archives of General Psychiatry showing the benefits of TMS in the management of Major Depression.  Yet, when I try to get coverage for this treatment, I am told (in an impersonal letter that comes from who knows where) that TMS is “experimental” and the insurance companies do not cover “experimental” treatments.  . . . “EXPERIMENTAL??????”  I thought FDA approval was enough to consider a treatment non-experimental?  Apparently, I was wrong.  The result of this stonewalling by the insurance companies is that people are suffering.  Patients who should have this as a second or third treatment option for their depression are having to wait till they fail many, many medication trials and have to wait years longer than they should.  The cost of this in terms of life (suicide), productivity, and happiness (for the patient and for those around them) is immeasurable.  It is a plain fact that the longer you wait, the less likely you are to respond to an intervention.  The same is true of TMS.  Having the opportunity to get TMS early in the course of a Major Depressive episode is one of the most important interventions we can advocate for.  Better than getting Abilify (look at the list of potential short and long term side-effects).  Better than pharmacologic tricks (Lexapro is too similar to generic citalopram to be considered an innovation, and Prisiq is just Effexor . . . don’t be fooled!!!).  And better than the wave of non-FDA approved (hence “experimental”) options that I was recently told to try by an insurance company Medical Director during an appeal hearing.  I was asked (no kidding) if I have tried lithium augmentation, thyroid augmentation, Wellbutrin augmentation, nutritional supports, and SAMe.  I HAD tried all of the above (except SAMe) but I did note that the above recommendations were . . . EXPERIMENTAL AND NOT APPROVED BY THE FDA FOR THE TREATMENT OF MAJOR DEPRESSION.  The patient in question was DENIED approval for TMS . . . because this FDA approved treatment that has had subsequent peer-review evidence of effectiveness was still considered “experimental”.

Go figure.

I think it had something to do with money.

–Dan Hartman, MD

4 comments to Paddling Upstream . . . Figuring Out The Role Of TMS In The Treatment Of Major Depression

  • Phyllis

    Your sidewalk psychiatrist blogs are good. A lot of sound psychiatric advise, a place one can identify with and enough sharing of yourself which makes this “real”.
    Last Sept. 30th you wrote a blog on one suffering with depression and the hopelessness of family and/or friends.
    And often in this field a person needs to cling onto another family member, professional or friend(blog) despite the energy they know is required.
    Which brings me to hope. At one point when my world was in a downward spiral you returned my phone call and upped my ellavil. You also knew of my Catholic faith and beings it was Holy Week you said, “So what are your Holy Week plans.”
    “None” I replied and your response was “maybe you might want to think about making some.” Your words gave me the little bit of hope I needed to know I indeed needed to be involved in the Tridium. I stomped my feet a bit but then grabbed onto my faith/my all.
    Faith is a mystery to all who choose it and it comes in many forms,through words, actions, sadness and joy (to name just a few). It is not one particular religion it is just being in the moment waiting for or giving hope.
    Thank you for your love of God.

  • Phillis–Thank YOU for your comment. Your words today have inspired me and made my day better. God Bless!!

    –DH MD

  • joan

    I have treatment resistant depression. I’ve been treated with medications for the last 20 years. I have taken over 30 medications and multiple combinations. They either work short term or I can’t handle the side effects. I have two dyskinesias from Abilify which was working well but had to stop. I’ve had 10 sessions of TMS and just found out today my insurance company denied it because of studies out there over the years say its not effective and that they consider it experimental. Does FDA approve experimental treatments?

    • doctordan

      Joan–The denial of your TMS treatments is, of course, an administrative effort to limit financial exposure and hold down costs. TMS is FDA approved because multiple independent studies done (both before and after FDA approval) have shown it to be effective in a percentage of patients who get treated. Not everyone gets better with it . . . but how many people do you know who had back surgery and did not get better???? Why do the not consider back surgery experimental then!!! You have to go toe to toe with them, and your doc has to help you do it. Contact your state insurance regulators and file a grievance. Contact your elected representatives at both the state and federal level and get everyone you know to do the same. If enough people make enough noise . . . things will change. Good luck.

      –DH MD