When the Food and Drug Administration (FDA) drafted a new ruling and reclassification of the medical device treatment, Electroconvulsive Therapy (ECT), at the close of last year, it sparked renewed debate and outcry from many professionals in the field of psychiatry.
The FDA had refrained from ruling on ECT, despite historical controversy over the treatment, until 2011 when an advisory committee designated ECT Class III, or Premarket Approval (PMA). This classification indicates ECT as “high risk” for all patients and for all conditions.5 The new ruling moves ECT to Class II for adults with severe major depressive episodes associated with major depressive disorder and bipolar disorder, indicating “moderate risk.” The outcry from ECT advocates, many of them psychiatrists, stems from the exclusion of other conditions from this reclassification. For patients under 18, the treatment remains Class III “high risk” for all psychiatric conditions. ECT also remains Class III “high risk” for adults with psychiatric disorders not listed above as well as ECT as a maintenance therapy.
According to a research summary prepared by the FDA in preparation for their draft ruling, ECT benefits nearly 80% of patients and between 70 and 90% of patients enter remission.1 The treatment has been proven effective in schizophrenia, mania associated with bipolar disorder, and catatonia.1 Recent reports suggest its indication and potential for success in children with severe Autism Spectrum Disorder.2 Importantly, ECT is never supposed to be the first line of treatment for any psychiatric patient. According to FDA recommendations, ECT should be considered when the clinically recommended medication and/or psychotherapy options have been exhausted. This proves especially true for cases involving children. As one mother put it, “This is not for kids with moderate autism who are talking but have difficulty socializing; this is for kids who are going to be dead if they’re not restrained.”2
As with most medical treatments, there are certainly risks and side effects associated with ECT. Many ECT patients remain on maintenance treatment for a long period of time or indefinitely, and the long-term safety of ECT use in children and adolescents is not established. Perhaps the most concerning side effect of ECT is memory loss, although there is some discrepancy over how extensive and how frequently this occurs. Reports have stated that the effect is short-lived and generally affects only memories surrounding the procedure. There are reports of longer-term amnesia, but many psychiatrists claim this is rare.1 Other reports claim that over one-third of ECT patients experience memory loss that lasts 6 months or longer.6 For some, this experience of amnesia is enough to advocate for a ban of the treatment. For others, their improved psychological state outweighs even extensive memory loss— often memory loss associated with some of their darkest, most trying moments.1
Much of the fear surrounding ECT and the persistent negative public perception of the treatment can be traced back to its historical use and appearances in popular culture. Before the 1950s, ECT was performed while patients were awake and conscious, and side effects were extensive physical injuries, frequently including multiple, severely broken bones. Since the 1950s, patients receive anesthesia and muscle relaxants before the ECT procedures. However, the American media tends to depict patients strapped down and essentially tortured. A 2001 systematic study of American film and ECT concluded “the portrayal of ECT in American movies has become progressively more negative, leaving the impression of a brutal, harmful, and abusive maneuver with no therapeutic benefit. [It] bears little relationship to the modern practice of ECT, showing the treatment how it may have been performed in a worst-case scenario in the 1940s and 1950s.”3 A major ethical concern revealed in these films— one that remains relevant today— is the informed consent of the patient. The level of coerciveness and abuse by the medical community in treating those with mental illnesses historically remains a concern to patients and patient rights advocates today. Medical professionals should be especially sensitive to this concern and especially careful in obtaining informed consent from their patients or their decision makers.
In addition to the use of anesthesia and muscle relaxants, progress has also been made in terms of electrode placement and voltage of electricity delivered, significantly minimizing cognitive side effects. While concerns over memory loss are founded, concerns over “brain damage” have little basis. In fact, the current scientific literature supports the theory that ECT works by stimulating brain cell growth.4
The proven efficacy of ECT makes a substantial enough case for the continued use of ECT as a last-chance treatment. The case for ECT is further supported by the professional opinion of the American Psychiatric Association (APA) and National Alliance on Mental Illness (NAMI),1 and the testimony of many patients and their loved ones. There certainly exists an ethical issue regarding the proportionality of such a treatment, given certain safety concerns; however, outspoken opponents of the FDA ruling highlight its predicted, limiting consequence for access to treatment. By ruling that the efficacy of ECT in children/adolescents, for those diagnosed with bipolar disorder, schizophrenia, and even as maintenance therapy is unfounded — all there is a very serious risk that insurance companies will refuse to cover the treatment. The FDA ruling does not protect patients. The FDA ruling prevents certain groups of patients from being able to access a last-chance treatment.
References:
Graham, J. (2016, April 6). Psychiatric shock therapy, long controversial, may face fresh restrictions. Retrieved November 14, 2016, from https://www.statnews.com/2016/04/06/shock-therapy-restrictions/
Mandavill, A. (2016, October 27). How ‘Shock Therapy’ Is Saving Some Children With Autism. Retrieved November 14, 2016, from http://www.theatlantic.com/health/archive/2016/10/how-shock-therapy-is-saving-some-children-with-autism/505448/
Mcdonald, A., & Walter, G. (2001, October 1). The Portrayal of ECT in American Movies. The Journal of ECT, 17(4), 264-274. doi:10.1097/00124509-200112000-00006
Ongür, D. (2007, March 6). Electroconvulsive seizures stimulate glial proliferation and reduce expression of Sprouty2 within the prefrontal cortex of rats. Biol Psychiatry. doi:10.1016/j.biopsych.2006.11.014
Regulatory Controls. (2014, June 26). Retrieved November 20, 2016, from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm2005378.htm
Rose, D., & Fleischmann, P. (2003, June 19). Patients' perspectives on electroconvulsive therapy: Systematic review. BMJ. http://dx.doi.org/10.1136/bmj.326.7403.1363