Neuronetics TMS at the mercy of FDA's PMS

Today just wasn’t a good day for Neuronetics.

After the long-awaited hearing date for FDA approval, Neuronetics’ TMS (transcranial magnetic stimulation) device got shut down. Hard.

As I’d previously mentioned, CLPsych immediately reported the outcome of the FDA hearing. A juicy quote from a report he linked to:

"The majority of the panel—made up of an engineer, several psychiatrists and neurologists, and a statistician—had no problem with rTMS’s risks. There are almost none. The biggest worry with it is that it might accidentally spark a seizure, but that did not happen even once out of the 155 patients treated. The problem was that Neuronetics couldn’t prove any benefit. Treated patients got a little better, but so did those patients that underwent a sham treatment."

Cool. Placebos work just as well as the cure.

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5 Comments

  1. Herb said,

    January 27, 2007 at 12:50 am

    “Whoa. I’d rather be dead. I’m afraid that stuff could mess up someone’s mind just as bad, if not worse than ECT. Just in different ways.
    Posted by: Marissa Miller | January 25, 2007 04:09 PM”
    Dear Ms. Miller,
    I certainly cannot speak for you or your experiences but as a very, very long-time support person and health care advocate for my spouse, she has known the pain, anguish and the depths of despair of MDD (Major Depressive Disorder) or the recently used terminology TRD (Treatment Resistant Depression) and in those years she had opted to try almost all the available therapy options so that she could overcome her brains malfunctioning and preference to be dead rather than alive. The malfunctioning of the brain, overrides one of natures most basic instincts in almost all species; survival.
    Maybe you simply have not reached the point of such despair and anguish that you’re willing to try anything to survive?
    Then again, what leads you to believe that long-term MDD or TRD has not already “mess up someone’s mind just as bad, if not worse than ECT. Just in different ways…?”
    I personally would rather not see you or anyone dead. There is a need to be educated and encouraged to remain hopeful and persistent especially when there are therapy options to be considered and discussed with one’s licensed physician(s) that may offer a percentage of patients a degree of efficacy and a reasonable QOL (Quality of Life).
    Then too, maybe you just haven’t had the education or exposure to those patients who are benefiting from those therapies.
    I extend my best wishes to you for continued wellness.
    Warmly,
    Herb
    VNSdepression.com
    .

  2. March 16, 2007 at 11:06 pm

    Herb,
    You posted this a while ago on my blog and I have been thinking about this comment and mulling it over nearly every day since. Here’s my response:
    I certainly am glad that your wife is able to get help through VNS. According to what I’ve read, VNS can have an effect on some patients, while other patients have no need for it. Your wife apparently isn’t in the latter case if she is TRD.
    “Maybe you simply have not reached the point of such despair and anguish that you’re willing to try anything to survive?”
    No, I have not. When I am in despair and anguish, I am willing to do anything to die, that is, remove myself from this world. In my world of pain and suffering, I don’t want to survive. I don’t want long, hard routes to make things better. I want my suffering to end swiftly.
    “Then again, what leads you to believe that long-term MDD or TRD has not already “mess up someone’s mind just as bad, if not worse than ECT. Just in different ways…?””
    Herb, I am extremely skeptical of devices implanted into the body to reduce or treat depression. Scientists, doctors, and researchers only HYPOTHESIZE about the correlation between the brain and mental illnesses. Many of the results and outcomes of research in this area are mainly guesses. Some make sense, some are feasible, some are not so feasible, and some are unbelievably whacked.
    I’m sure you’ve read Liz Spikol’s blog, “The Trouble With Spikol.” (trouble.philadelphiaweekly.com) She used to have ECT treatments, which left her with cognitive impairment among other things. From what I understand, VNS has few side effects, but the treatment is relatively new so no one knows the long-term implications of this treatment. VNS is used primarily for epileptics; I assume your wife had no luck with anticonvulsants?
    “Then too, maybe you just haven’t had the education or exposure to those patients who are benefiting from those therapies.”
    You’re absolutely right; I am open to being educated. I sincerely hope your wife’s condition improves no matter what the treatment.

  3. Eric Wheelman said,

    March 24, 2007 at 10:04 am

    Vagus nerve can be stimulated to some degree non-invasively with infrared. There may be also stimulation of the cardiac nerves which limits its’ usability somewhat.

  4. craig jones said,

    July 5, 2008 at 11:46 pm

    The F.D.A. is cruelly denying millions of people a better quality of life, by their feet dragging of the approval of T.M.S. They should be accountable to someone, and the public on their criteria. They have approved more invasive less predictable treatments in the past. Their rationale does not stand logic. They seem to be masochists of the first kind.

  5. craig jones said,

    July 5, 2008 at 11:59 pm

    The F.D.A. should stop dragging their feet and approve T.M.S. by delaying the approval for so long, they are doing nothing more than protecting the profits Drug companies would lose to this therapy. They had no trouble approving more expensive and invasive treatments such as V.N.S. They are playing God with peoples’ lives, and should be accountable for their rationale and decision making proces to a Public Agency. With their never ending delay of T.M.S. They seem to be nothing more than a bunch of greedy masochists.


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