Ann MacDonald

Deep brain stimulation: Experts raise alarms about aggressive marketing

A paper published in the February issue of Health Affairs—discussed at length in an article in the New York Times —contains the sort of blunt, plain-spoken language you seldom read in academic journals. The authors, who include some of the most prominent neuroscientists and ethicists in the world, warn that manufacturers are misusing the FDA’s humanitarian device exemption to promote deep brain stimulation as a “treatment” for obsessive compulsive disorder (OCD).

In fact, they make clear that deep brain stimulation is very much an experimental procedure. Research is still at an early stage, and the risks to patients are not well defined. When suffering is severe and no other treatment has provided relief, there is value in making available an intervention like deep brain stimulation. But misleading or biased information, no matter where it comes from, certainly undermines patients’ ability to calculate benefits and risks.

To enable deep brain stimulation, a surgeon must first implant electrodes in the brain and connect them to a pair of small electrical generators underneath the collarbone. Deep brain stimulation uses electricity to affect how brain signals are transmitted in particular areas of the brain. The image to the right, from the National Institute of Mental Health, shows how deep brain stimulation depends on the implantation of pulse generators below the collarbone and electrodes in the brain.

Among the concerns raised by the article in Health Affairs (and in our own article on this topic last year in the Harvard Mental Health Letter):

  • Inadequate research. Although deep brain stimulation is sometimes described as a “pacemaker for the brain,” that is an oversimplification. Cardiac pacemakers monitor heart rhythm and trigger a heartbeat when necessary. While cardiac pacemakers have an established track record of success and clear guidelines for use, deep brain stimulation does not. (Among other things, when OCD symptoms do improve after deep brain stimulation, we still don’t know exactly how or why the electrical stimulation helps.) Only about 100 people in the world have undergone deep brain stimulation for OCD—only some of the results have been published—altogether too small a number to standardize the procedure.
  • Safety. Implantation of a deep brain stimulation device involves boring small holes into the skull (for the electrodes) and surgery on the chest (for the battery). Possible complications—as for any surgery—are infection and bleeding. The wires may break. And the device’s batteries can run out, sometimes without warning—causing rapid mood deterioration or behavior changes.

Furthermore, many alternatives exist. Deep brain stimulation is only appropriate for people who suffer severe and incapacitating symptoms and have exhausted every other treatment alternative. Fortunately, most people with OCD have other—and more proven—options. These include behavioral treatments, drug treatment, or some combination of the two. You can read more about treatment options in an article in the March 2009 Harvard Mental Health Letter.

Comments:

  1. Brainwave entrainment com

    Brainwave entrainment is a powerful but relatively unknown technology that uses an external stimulus to synchronize your brain to a certain brain wave frequency. …Brainwave Entrainment

  2. david b.

    My doctors at the Medical University of South Carolina gave me the Reclaim DBS for OCD. My psychiatrist was my doctor for 15 years. He knew of my bipolar, body dysmorphic, personaltiy disorder and at the time of the operation had me addicted to 90mg of oxycodone per day on top of ambien, klonopin, thiaridazine, mirtazapine and risperdal. I had never been treated for OCD. We did no more than talk about it for a couple of hours over a 15 year period. He gave me a pamphlet,prior to the surgery that did not include the the comorbid mental disorders warning or warn of drug dependence. My life has been hell since the operation in Aug. of 2010. My doctor did high amplitude settings, causing mania and wide pulse width settings causing me to want to kill myself. When I called and emailed him telling him I would not live another day he refused to see me. I had to go to the hospital and make him redo the settings. The device makes suicide seem very easy and the rational thing to do. I have called and emailed every doctor and facility in America to have this device removed and not one doctor will see or talk to me. It is a very dangerous device and everyone should know that no other doctor will undo what the original doctor has implanted. I can give doctor names and hospital names. I think anyone already knows the names of the most well known hospitals in America. They all refused to see or treat me. Be very careful of the Deep Brain Stimulator. Once it is in you life could become the hell I live through daily.
    If there is any doctor out there that will see me please fax me at 843-553-7003. I am begging you. I will sign any release you need and I will travel to you to be evaluated and have this device removed. It has affected my heart, I have lost 15% of body weight, I have chest pains, I sleep only 3 to 4 hours a night, my medical records have been falsified and the doctors at MUSC have not treated me in about 11 months. They have also influenced the other doctors to not see me. There are many more complications but I will stop here.

  3. Andrew Ludlam

    This is an interesting article. I have had OCD for many years unfortunately. Medication has made it a lot easier to cope with. That said, I don’t think I would like to undergo this kind of treatment.

  4. marksspencer

    The study of the brain and how it works has borne unbelievable fruits and led to amazing breakthroughs that were thought impossible in the past. By 2002 medical scientists and doctors were fully convinced that the same could be used to help Parkinson’s disease patients. This was also another victory and it was now clear that a lot more could still be achieved. In 2003 it was approved for treating Dystonia making it one of the most amazing breakthroughs in the world of science.

  5. Jevaughn Brown

    I haven’t heard of this procedure before or imagined something like this was in use, but I guess that’s not surprising given how few people have undergone the procedure to date. I wonder though; has there been any research and clinical use of Brainwave Entrainment technology in treating OCD? From what I understand of it, I would think that regular use of brainwave entrainment compositions – if specially designed for it – would provide enough “brain stimulation” to be of some benefit for OCD. Provided it’s made by a real expert in the field. I personally continue to get a lot of benefit from using brainwave entrainment audios with isochronic and monaural tones (not those weak binaurals) – but I certainly don’t have medical-grade OCD. I don’t know if it is an established enough method to be used medically.

    Anyway, drilling holes in the skull and implanting electrodes seems like an excessively invasive approach to deal with a mental disorder to me. Surgical procedures always seem to be bandied about as wonder treatments above all else…

    Jevaughn Brown
    [URL removed by moderator]

    • aziz

      Dear Jevaughn
      I read your letter with interest as I am a patient of dystonia and contemplating to have DBS.Let me hear from you whether my decision is rightor not.
      with thanks
      aziz

  6. sanmay

    nice article… thanks for sharing..

  7. Michael Curry

    Thanks for this informative post, I learned alot while reading it.

  8. Stretching For Sciatica Tips

    Surgery isn’t always necessary in order to treat sciatica. In many cases daily stretching exercises can bring relief from the pain that comes with sciatica. When these stretching and strengthening exercises are employed, pressure is taken off the sciatic nerve, thus reducing the pain. These exercises are easy to do and you can set your own pace.

    [URL removed by moderator]

  9. Anonymous

    My kind of being does favor this kind of academical interrelation in regards to the source in question with certainty. We can be delighted with that to experience this discourse. That’s like a let down I have to do offline work recently. The Individuals on this blog could be fun to confer and debate with sometimes. All the best

  10. Nathan Leavitt

    Thanks for the good information. It is interesting to learn about this brain stimulation and how it is being used to help people’s health.

  11. Jane

    Thanks for letting us know about this. This topic is really a must read to everyone. It’s very informative and educational as well. Thanks for sharing and looking forward to the next one!!!

    • Jane, not the one that wrote the top note to you.

      I agree with the person who had the DBS surgery and is not happy with it. Can we talk about this in private please? Thank you very much. E-mail me on this page and I’ll check back with you.

  12. jerry vanhorn

    Deep brain stimulation (DBS) in adults is a one- or two-stage procedure under both local and general anesthesia. Deep brain stimulation in children is usually performed under general anesthesia. In adults, the first stage begins with application of a stereotactic frame using sedation and local anesthesia. A stereotactic MRI scan is then performed to identify the deep brain target (this takes about 30 minutes). Coordinates are determined for the electrode and a safe trajectory down to the target is identified. The patient is taken back to the operating room and placed comfortably on the operating room table. The patient is monitored by the anesthesia service. After the hair and stereotactic frame are prepared, a small scalp shave is performed. The skin is numbed with local anesthetic and a small incision is made. A 14mm hole is made in the skull bone. The dura (covering of the brain) is opened and a tiny area of the brain is exposed. The probe is then passed down toward the deep brain structures.

  13. Jeremy Wilkerson

    Ann,
    This is another issue that the FDA is struggling with to close all the loopholes in clinical trials process. The FDA has a lot on their plate right now including an open letter to congress from FDA staffers who state that “the FDA is broken”. This along with multiple pressures from business, politicians and advocacy groups has really slowed the FDA down in recent years. As a Harvard Alumni and owner of a Clinical Trials service organization and a husband of a severe OCD spouse, I appreciate your advocacy on this subject and hope that it gains traction at the FDA.

    [URL removed by a moderator.]

  14. Abbie K.

    Hello, Ann

    Thanks for your fast and thoughtful reply. Re the aggressive marketing of DBS systems for OCD and its promise as an effective therapy, I’ll ask my psychiatrist about this, as he is a highly respected expert in treating OCD patients.

    Also, I appreciate the opportunity to share my clincial trial, DBS surgery, and post-surgery experiences with you. I’ll update you via email and you can decide what may be interesting and useful for your readers.

    Meanwhile, I sit here in my living room, waiting, flooded by the most intense hopelessness I’ve yet experienced. But, I’m using my very strong left brain and medications to fight it.

    I’ve been told that the FDA is close to approving expansion to the West Coast of the DBS clinical trials for which I’m registered. Anticipating this approval is approximately 1,000,000 times more intense than how a four-year-old feels waiting for Christmas.

    My bag is packed and I’ll let you know when I’m notified that it’s’ a GO.

    Best,

    Abbie

  15. Abbie K.

    Hello, Ann.

    I have Treatment-resistant Major Depressive Disorder and severe Generalized Anxiety Disorder, with minor bouts of mania thrown in. Since 1997, I have had 60 changes of medications/doses for both of these brain diseases and the many commorbid conditions caused by them. There are no new drugs for my condition in the FDA pipeline.

    I am registered to participate in an FDA clinical trial of a second-generation deep-brain stimulation system. And I CANNOT WAIT TO HAVE THE DBS SURGERY!

    More than 75,000 people worldwide have undergone DBS surgery for a variety of serious and disabling diseases. I have researched and studied countless papers and articles on DBS surgeries for many conditions in addition to the ones from which I suffer. And I have yet to encounter aggressive marketing of these devices! I have not found the information I’ve read to be misleading or biased. Neither my doctors nor the device manufacturers I’ve talked with have attempted to market DBS systems to me. In fact, I was the one who found the clinical trial information and discussed it with my doctor, who agrees the surgery is ideal for me.

    Given my experience studying DBS systems and surgery, I’d appreciate you providing examples and proof of the aggressive marketing and misleading and biased information you have found.

    I am confident in the FDA’s Humanitarian Device Exemption program and thrilled that I can participate in a clinical trial to obtain relief from the awful suffering I’ve endured. My health has declined to the point where, without DBS surgery, my brain diseases WILL kill me by driving me to commit suicide.

    I’m happy to be a “pioneer” in helping a highly respected device manufacturer test and refine its systems for my benefit and that of seriously ill people all over the world.

    Please review this recent article from the Journal of Clinical Neurology (www.ncbi.nlm.nih.gov/pmc/articles/PMC3024521/) for the latest on DBS surgeries and outcomes. Perhaps it will change your mind about the value of HDE and DBS surgery.

    Thank You.

    P.S. You might also more deeply research the efficacy of current non-surgical treatments for severe OCD. I believe you’ll find a huge failure rate, just as there is with the current non-surgical treatments for the diseases affecting my brain.

    • Ann MacDonald
      Ann MacDonald

      Dear Abbie,

      First of all, I’m happy to hear that you are participating in a clinical trial of DBS. I really hope it helps provide some relief for you. It sounds as though you are exactly the type of person qualified for such a study – someone who has not responded to many drugs or other treatments. DBS in a research setting is absolutely appropriate, and I’m glad you’re working with your doctor to find a study that is right for you.

      But let’s be clear. DBS is still experimental for OCD – that’s why you’re gaining access to it through a clinical trial.

      The Health Affairs article I referenced in my blog was written by some of the leaders in the DBS field. They take issue with aggressive marketing by manufacturers. Here’s one example cited in the paper: On Feb. 19, 2009, Medtronic issued a press release announcing the FDA humanitarian exemption. They described their DBS system as “therapy for obsessive compulsive disorder.”

      As the authors of the Health Affairs paper write, “Such statements are in direct contravention of the regulations governing the humanitarian device exemption, which require specific labeling stating that the effectiveness of the device has not been demonstrated. At the time of the press release … only 26 patients with OCD had been studied for their response to deep brain stimulation.”

      I really do hope DBS works for you, as it has for other patients enrolled in carefully conducted clinical trials. But this is still at the research phase. Even when the device works well, the FDA advises patients that they will still struggle with some symptoms and will need some type of medication to aid their recovery.

      But I tell you what. You are about to undergo DBS in a clinical trial, and perhaps your experiences — if you are willing to share them — would be of interest to other readers. Let us know how you’re doing (again, only if you want to). You can either repost here or email me at mental_health@hms.harvard.edu.

      In any event, I do wish you the best and hope that you find a path to recovery.

      Thanks for writing.

      Ann

  16. Syra

    Can deep brain stimulation also help those poor patients that suffer from lesch-nyhan syndrome? I read a study where brain stimulation had helped patients with their symptoms of self mutilation.

    • Ann MacDonald
      Ann MacDonald

      Dear Syra,

      I was not familiar with Lesch-Nyhan syndrome, so I looked up some background material through the U.S. National Library of Medicine.

      This is obviously a tragic genetic condition. It appears there is no treatment.

      But I understand why you asked. Deep brain stimulation can help alleviate tremors, rigidity, and other movement problems caused by Parkinson’s disease. It’s not a cure, but it does alleviate some of the suffering caused by Parkinson’s.

      Perhaps research will identify a treatment for people with Lesch-Nyhan syndrome. I sure hope so!

      Thank you for writing.