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Time is Now to Support the ECT Reclassification Effort

     

The FDA recently proposed a rule change that would reclassify electroconvulsive therapy (ECT) devices used for treating major depressive disorder from class III (high risk) to class II (low risk). The change would significantly improve access to an effective and potentially lifesaving treatment.

In 1976, the FDA became responsible for regulating medical devices and the FDA placed ECT machines in the Class III category. This was partially due to testimony from former patients, who stated that they suffered permanent memory loss and brain damage.

A similar reclassification proposal by the FDA in 2010 met significant resistance from anti-psychiatry groups and did not pass. That is why it is so important for psychiatrists to take the lead in expressing their views in regard to the role that ECT plays in clinical practice and in the treatment of major depressive disorder. For appropriate patients, ECT has been a lifesaver. It has given them an opportunity for a normal, functional life.

The FDA is currently requesting public comment on the safety and efficacy of this treatment. The American Psychiatric Association will be submitting a comment in support of this change in designation. The government does give importance to the number of letters or emails received, pro vs con, in its deliberations. With this in mind, APA has created a form letter that you can send to the FDA supporting the reclassification effort.

You can download that letter here. Another option is to submit comments electronically here. We urge our members to reach out to the FDA and support a class II designation for ECT devices.


What APA is Doing for You

This blog post is part of an occasional series highlighting how APA advocates on your behalf to support the profession of psychiatry and put our interests before key policymakers.

Post by Renée Binder M.D.

 

Renée Binder, M.D. is the president of APA. Read Dr. Binder's full biography.

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Post by Saul Levin M.D., M.P.A.

Saul M. Levin, M.D., M.P.A., is APA's CEO and Medical Director. Read Dr. Levin's full biography

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CEO BlogPresident BlogWhat APA is Doing for You

 

Comments (13) Add a Comment

  • Steven J. Strnad

    When considering the reclassification of ECT it is important to consider the input of patients and not just psychiatrists since you get two completely different stories and because their are innate limitations upon those who have not had to live with the consequences of the treatments. In 2011 I had only 6 bilateral shocks and I may never be able to work again. I lost at least 4 years of memories and many thinking abilities have been impaired until the present day. It is also important to acknowledge that shock therapy is still a controversial treatment largely due to the many patient testimonies as well as several scientific studies that have shown cognitive deterioration amongst patients who have received ECT as well as because it has not been shown to have any long-term protective effects on the suicide rate.

  • Thomas Meeks, MD

    I am writing to add my voice to those of many other mental health professionals (as well as patients) in support of the reclassification of ECT as a lower risk medical device/procedure. Much of public opinion about ECT is unfortunately informed by Hollywood dramatization and organizations whose identity derives in part from being "anti-ECT." Conscious patients who convulse and appear to be in pain or appear to be "lobotomized" after the procedure makes for better dramatic effect (and profit), but creates a widely inaccurate public perception of the treatment.The resulting stigma and fear does a disservice to those for whom other treatments for depression (and other disorders) fail. Regulatory decisions should be based on science, not fear-mongering. There are true potential adverse effects of ECT--as with any medical procedure for a serious condition, but the response rate is better than any other mental health treatment and the mortality rate is very, very low. Cognitive impairment is the most concerning side effect, but there are ways to mitigate this, and it does not persist at a clinically meaningful level for most patients. Severe depression (unipolar or bipolar) and catatonia cause much more death and disability than ECT and themselves are neurotoxic and cognitively impairing. For those with these conditions who do not die but do not respond to other treatments, they may suffer for years with a very poor quality of life, often worse quality of life than many other dreaded diseases such as cancer, Parkinson's disease, COPD, or HIV. There are always trade-offs, but many, many patients have their lives restored to a higher quality of life with less suffering because of ECT, including overall IMPROVED cognitive functioning. Re-classification, insofar as it could increase accessibility and decrease stigma, is the scientifically and ethically justified right decision. There are people who will have negative outcomes with any given treatment, and my heart goes out to them, but regulatory decisions must be driven by the greatest collective good, and not by fear, stigma, and stereotypes.

  • Samuel Williams, III, M.D.

    ECT has been a life-changing clinical interventions for a lot of patients. I have patients( adults and children) that have benefited from ECT with significant improvement in mood and overall life, particularly those with refractory depression and some cases of Bipolar Disorder. I fully support reclassification of ECT as a low risk procedure.

  • Barbara Silver MD

    I fully support the downgrading of the risk category for ECT. In 2014, a patient of mine with a 30 year history of schizoaffective disorder began to decline. He appeared to have symptoms of dementia, with poor short term memory, no understanding of his medical conditions, difficulty w/ verbal expression and other symptoms. He was hospitalized, became catatonic, and had a G-tube placed. The hospital staff considered sending him to a long term care nursing facility, but at the recommendation of a consulting psychiatrist, ECT was performed. He improved dramatically, walked out of the hospital at the end of the ECT course, and now, enjoys life, attending concerts and sporting events with his family. His cognition has improved, he enjoys discussing current events, particularly the current Presidential race. I cannot imagine where he would be without ECT.

  • Je Ko

    First, there should be reclassification of the procedure no matter what. Surgery by definition has 100% chance of bleeding, but with advanced technology the amount of bleeding can be minimal. We go through invasive procedures because the benefit of the contrary (not doing the surgery) means accepting the risk of the underlying condition (death or permanent disablity/disfigurement). Suicide embodies the same types of risks as any diseases, perhaps more. ECT's re-classification is necessary to even for the sake of detailing what it means; does high risk mean high likelihood of a side effect, or just having any risk of a dire effect? Otherwise, we'd be effectually depriving the patients from making a well-informed choice, or worse, depriving them to even make any choice due to the irrevocable outcome of their irrational choice they made while under the influence of a deadly condition.

  • Earl N. Solon

    ECT has been a life-saving clinical intervention in those major depressive illnesses that had been otherwise therapeutically inaccessible.

  • Jamie Katz

    I write to support the reclassification of ECT, so that it may continue to be used as a therapy for patients with severe depression. My wife has suffered two major depressions and medications could not bring her out of her depressions in either instance--indeed, some medications made her worse. ECT, however, brought her out of her depression both times, in relatively short time. Yes, there were side-effects to ECT, but there were side-effects to the drugs she tried. She is alive because of ECT and functioning well. I do not believe that ECT will work with everyone--but then neither does any one drug. I do believe that ECT can be a very effective treatment that can work quickly and without major side effects for many people, based not only on my wife's experience but on the many people I've met who have experienced ECT as a result of the mental health advocacy work that my wife and I have taken on. Please ensure that this treatment modality remains available to patients--it can be a life-saving alternative for many.

  • 000000092328

    I fully support the reclassification of ECT as a low low risk procedure. With modern devices and when done under General Anestesia and Muscle relaxants, it is totally safe. It saves many suicidal patients with major depression. It is also very useful in acute mania. It shortens the duration of hospitasation.

  • Dr Séamus Ó Flaithbheartaigh

    I have seen clear benefits fro ECT in over 27 years of clinical psychiatric practice in the UK, Ireland and the USA. In refractory depression or depression that endangers wellbeing or survival it's still unmatched. I've led a modest revival of use in my area as the designated ECT consultant, though most centers in my area have passively stopped its use due to lack of designated resources. A recent example is a moribund 61 yo lady who could barely be interviewed - she returned to eating, conversing, etc, but I was told today she'll need continuation - we'll continue at perhaps once every 2-3 weeks. ECT almost definitely saved her life, though she was too ill to self- advocate, and was treated Involuntarily, for the first few sessions only. Séamus

  • James R. McCurdy, MD

    I support reclassification of ECT, since I have referred selected patients of mine for ECT. These patients had a diagnosis of Major Depression with suicidal thoughts and intent, and/or significantly disabled medically because they were eating poorly. All these patients had an impressive recovery after receiving an appropriate course of ECT treatments by a colleague experienced in and regularly providing ECT treatment.

  • Kim jones-fearing

    Please support downgrading the risk category for ECT. Compared to other industrialized nations, the U.S. Has an unacceptably low utilization rate for ECT. I can tell you a story of a patient who was treated with ECT which absolutely changed his life and marriage. I have current patients who are insured but have no access to ECT because there is no department or personnel dedicated to determining benefits , cost, or preferred location.

  • Dr Saleem Ahmed

    I fully support your efforts for ECT.It is very effective treatment in certain indications,but its usage without anesthesia is bringing fear,recent memory loss,severe body ache and sometimes dislocation of joints and even fracture in heavy muscular body.One should checkout for application of ECT where needless but only use as a tool. Ect administration by unauthorized personels we found in some private hospital in my city.Otherwise under Anesthesia it is excellent.

  • Phyllis R. Peterson, PA

    Yes support reclassification of ECT, it is massively underutilized, effective and cost effective, and even difficult to access for many patients who would benefit.

 

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