Our patients' lives are worth fighting for and electroconvulsive therapy (ect) saves lives: A compendium of the evidence

TY - JOUR

T1 - Our patients' lives are worth fighting for and electroconvulsive therapy (ect) saves lives

T2 - A compendium of the evidence

AU - Rosedale, Mary

N1 - Funding Information: Rosedale Mary New York University, New York, NY, USA, [email protected] 5-06 2011 17 3 209 211 © The Author(s) 2011 2011 The Author(s) electroconvulsive therapy depression advocacy for patients sagemeta-type Other cover-date May/June 2011 search-text 209 Commentary Our Patients’ Lives Are Worth Fighting for and Electroconvulsive Therapy (ECT) Saves Lives: A Compendium of the Evidence SAGE Publications, Inc. 201110.1177/1078390311407668 © The Author(s) 2011 2011 The Author(s) MaryRosedale New York University, New York, NY, USA, [email protected] Corresponding Author: Mary Rosedale, College of Nursing, 726 Broadway, 10th Floor, New York University, New York, NY 10003, USA electroconvulsive therapy depression advocacy for patients On January 27 and 28, 2011, the Neurological Devices Panel, a federal advisory body to the Food and Drug Administration (FDA), examined the reclassification of electroconvulsive therapy (ECT) devices. In their unoffi- cial vote, they concluded that ECT should remain in Class III (high risk) for all indications for use with the exception of catatonia. For depression (unipolar and bipolar), the indication for use for which ECT is most frequently and urgently used, the panel was sharply divided. Ultimately, it voted in favor of retaining ECT in Class III by a slim mar- gin (10 to 8), with several panelists indicating that they did not want their Class III vote to restrict availability of ECT. The following commentary describes the background of the recent FDA hearings, why the American Psychiatric Nurses Association (APNA) position statement on ECT is so important, issues and concerns with the hearings, key points and evidence-based discussion from interdisciplin- ary experts in ECT, and a patient’s narrative about having undergone ECT. Advocacy by APNA and the dissemina- tion of knowledge through this special commentary of the Journal of the American Psychiatric Nurses Association has the potential to influence final FDA decision making. Context for the recent FDA hearings is provided by the 1976 Medical Device Amendments to the federal Food Drug and Cosmetic Act, which asserted that medical devices needed to be proven safe and effective in clinical trials before they were reviewed for FDA approval. Before 1976, ECT equipment—along with 100 additional devices—were in use and were therefore “grandfathered in” with a Class III (premarket approval) designation. Since that time, the FDA has evaluated most of these devices and assigned them to final status into Class I, II, or III under section 510(k) of its regulations. In April 2009, the FDA issued an order to require manufacturers of devices that had not been formally reviewed (including ECT devices) to submit clinical data to support the products’ efficacy and safety. Of note, “high-risk, Class III” devices, although classified as having “a potential unreasonable risk of illness or injury,” include many that are life sustaining (e.g., implantable cardiac pacemakers or heart valves). Typically, premarket clinical trials are needed to establish safety and efficacy and subse- quent FDA approval. “Moderate-risk, Class II” devices (equipment such as X-ray machines) do not require such evidence. Rather, they are subject to general and special controls (to ensure safety and effectiveness), such as spe- cial labeling requirements, standardized informed con- sents, mandatory performance standards, and postmarket surveillance. In a notice published in the Federal Register on September 10, 2009, the FDA opened a docket to obtain public com- ments on how ECT devices should be classified. Although a number of nurses, physicians, psychologists, and patients provided public comment about ECT as lifesaving, there were also a number of entries opposing ECT and generally professing considerable antagonism toward psychiatry. At the end of the year, the FDA decided to hold hearings on ECT (separate from the other premarket approval devices), and the hearings were scheduled for January 27 and January 28, 2011. The fact that ECT devices could become subject to new requirements and restrictions on their use was a sig- nificant concern. If the FDA decided that devices should remain in Class III, the two small ECT device companies would likely have to conduct large-scale clinical trials to prove safety and efficacy. These trials could be prohibi- tively expensive, causing them to discontinue manufactur- ing the devices. Of great concern, the ability to provide ECT to severely ill patients who did not respond to any of our other treatment options could be lost. 210 On December 6, 2010, I wrote a letter to President Farley-Toombs highlighting the fact that the FDA’s decision could significantly affect access to this lifesaving treatment for our most acutely ill, vulnerable, and frail patients and drafting a position statement for our organization. Balancing the time-sensitive nature of the issue with the need for a process that allowed opportunity to gather viewpoints across the spectrum of our membership, the APNA Board reviewed this request and vetted the proposed position statement through Member’s Bridge. It was very exciting to see that APNA’s strength in leadership, membership numbers, and organizational infrastructure offered the ideal platform for deliberating over and asserting our professional position that advocated for the continued availability of ECT. APNA’s position statement was finalized, approved by the Board of Directors, submitted to the FDA, distributed to all mem- bers, posted on our website, and released to the press. Significantly, a new process for the development of posi- tion papers concerning issues of paramount importance to psychiatric mental health nursing and patient care was established. Moreover, APNA’s leadership was noted and appreciated around the world, with the Australian College of Mental Health Nurses fully endorsing the APNA’s posi- tion statement on ECT. Illustrating the international need for psychiatric-mental health nursing leadership, they sub- mitted a statement to the FDA underscoring the essential need for people with mental health conditions to have access to evidence-based treatments such as ECT. On the first day of the hearings, the FDA presented infor- mation about regulatory background and the clinical and regulatory history of ECT. Importantly, the APNA position statement on ECT was entered into testimony along with that of the American Psychiatric Association and the International Society for ECT and Neurostimulation. Not surprisingly, interdisciplinary experts in the treatment and care of ECT patients who are especially familiar with the lifesaving aspects of ECT treatment and the dangers of limiting its access provided consistent position statements. The panel also heard some personal experiences from patients who had received ECT. Several patients spoke about how ECT had saved their lives. Julie Hersh poignantly described how ECT saved her from suicidal depression; the following is a link to her testimony: http://www.psychologytoday. com/blog/struck-living/201101/conflict-common-sense. Amy Lutz, whose testimony can be found at http://www.tms- nurses.org/?p=255, spoke about her son’s therapeutic and life-changing experience of ECT. Kitty Dukakis, a long- standing advocate and recipient of ECT treatment, declared memorably: “I would not be alive today if not for ECT.” Other patients reported distress that primarily con- cerned memory loss, but it was not clear how long ago patients received treatment or the type of treatment (includ- ing anesthesia) they received. ECT has been in existence for 70 years, and advances in electrode placement, pulse width, and anesthetic practice have substantially changed the procedure. Certainly, we would not compare a myot- omy from decades ago with its modern rebirth as a laparo- scopic procedure. Similarly, contemporary ECT treatment has evolved with advances in science and technology and continues to be an extremely safe, effective, and urgently needed treatment option for severely ill patients. On the second day of hearings, an FDA-appointed panel presented data about the safety and efficacy of ECT. Surprisingly, neither American Psychiatric Association (2001) treatment guidelines nor long-term data from the Consortium for Research on ECT sponsored by the National Institutes of Health were presented. Moreover, data concerning altered brain-derived neurotropic factor associated with neurogenesis (and a proposed mechanism of antidepressant response) were confusingly presented as neuropathological changes. Although brain changes sug- gest the therapeutic effect of ECT, the presentation made it seem as though the effects were negative and pathological. Ultimately, however, the panel agreed that existing data did not provide evidence of neuropathological changes. They did recommend special labeling requirements and clinical performance standards, including the monitoring of cognitive functioning and the use of a comprehensive checklist to strengthen the informed consent process. The panel additionally called for more qualitative research to assure that patients’ experiences were thoughtfully consid- ered as part of informed decision making. In this special Journal of the American Psychiatric Nurses Association commentary, we introduce interdisciplinary ECT experts who provide evidence addressing key issues that arose at the hearings. Weiner and Falcone review ECT efficacy in the treatment of depression. In a key contri- bution to the literature, they summarize the empirical evi- dence and point out areas for needed additional research. McClintock and Husein provide state of the evidence find- ings about the cognitive effects of ECT and concerns about brain damage. Cohen-Fetterman and Ying describe key issues in the informed consent process and underscore the need for sensitive and thorough dialogue with patients and their families who often feel that they have few remain- ing treatment options. Nahas and Anderson provide a review of brain stimulation therapies for mood disorders and exam- ine the continued necessity of ECT. We conclude with the experience of Broger, a patient who is also a psychiatrist, describing his progression to a severe, suicidal depression and his treatment with ECT. This narrative illuminates the key issues addressed at the hearings. More than that, it reminds us that even persons who knowledgably guide oth- ers through psychiatric illness can find themselves suddenly disrupted by severe depression. With great courage and attentive detail, Broger prompts us to reflect on the lived experience of our patients and to appreciate our privilege of entering their lives at crucial and vulnerable moments and our responsibility to affirm them as whole human beings. 211 This compendium of interdisciplinary contributions and patient narrative may be used to help our col- leagues, students, and the public examine the nature of what it means to suffer from refractory depression and how portrayals of ECT misinform and frighten patients and the public. Moreover, it can be used to stimulate discussion about how scientific advances in treatment that help our most vulnerable patients can be misunder- stood and misrepresented. As the FDA deliberates on its final decision, it is vitally important that psychiatric nurses work with our interdisciplinary colleagues to educate the public and strongly advocate for the preser- vation of ECT. ECT is a life-preserving, evidence-based treatment and often the only means to transport patients back to their full lives as family members, colleagues, and professionals. Our patients’ lives are worth fighting for, and ECT saves lives. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Funding The author(s) received no financial support for the research, authorship, and/or publication of this article. Reference American Psychiatric Association. (2001). The practice of electroconvulsive therapy: Recommendations for treatment, training and privileging. Washington, DC: Author. American Psychiatric Association. ( 2001 ). The practice of electroconvulsive therapy: Recommendations for treatment, training and privileging . Washington, DC : Author .

PY - 2011/5

Y1 - 2011/5

KW - advocacy for patients

KW - depression

KW - electroconvulsive therapy

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UR - http://www.scopus.com/inward/citedby.url?scp=79957789586&partnerID=8YFLogxK

U2 - 10.1177/1078390311407668

DO - 10.1177/1078390311407668

M3 - Article

C2 - 21653489

AN - SCOPUS:79957789586

SN - 1078-3903

VL - 17

SP - 209

EP - 211

JO - Journal of the American Psychiatric Nurses Association

JF - Journal of the American Psychiatric Nurses Association

IS - 3

ER -