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Electroconvulsive Therapy Device, Docket No. FDA–2009–N–0392, December 2009

December 16, 2009

The Honorable Margaret Hamburg, M.D.
Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Commissioner Hamburg:

The American Association for Geriatric Psychiatry is a national association representing and serving its members and the field of geriatric psychiatry. It is dedicated to promoting the mental health and well being of older people and improving the care of those with late-life mental disorders. AAGP’s mission is to enhance the knowledge base and standard of practice in geriatric psychiatry through education and research and to advocate for meeting the mental health needs of older Americans.

As an organization, we are writing to urge the Food and Drug Administration (FDA) to reclassify electroconvulsive therapy (ECT) devices as a Class II device based on the strong evidence of ECT’s safety and efficacy.

ECT is a highly sophisticated medical treatment administered by physicians who are specially trained and credentialed by their facility to do so. Its effectiveness in treating severe mental illnesses is recognized by the American Psychiatric Association, the American Medical Association, the National Institute of Mental Health, the U.S. Surgeon General’s office, and similar organizations in Canada, Great Britain and many other countries.

Many studies since the 1940s have demonstrated ECT's effectiveness. ECT is generally used with severely ill patients when other forms of treatment – such as medications or psychotherapy – h ave not been effective, cannot be tolerated, or (when rapid, definitive response is medically urgent) will not help the patient quickly enough. ECT is the most effective and most rapidly acting treatment available for severe major depression. Clinical evidence indicates that for uncomplicated cases of severe major depression, ECT will produce a substantial improvement or remission in at least 80 percent of patients.1 ECT is also used effectively in patients with a major depressive episodes who do not respond to other forms of treatment, and in patients with other disorders (including catatonia, schizophrenia, mania, neuroleptic malignant syndrome, and some cases of Parkinson’s Disease and related movement disorders) not responding to other treatments. The American Psychiatric Association has published comprehensive recommendations for ECT administration and supports the use of ECT to treat severe, disabling mental disorders.2

The medical risks associated with ECT are well characterized, relatively modest even in medically ill elderly patients, and are weighed carefully before a physician prescribes ECT. The risks of brief general anesthesia, which is needed for ECT, are similar to other procedures such as minor surgeries and colonoscopy. For some patients these risks may be less dangerous than extended treatment with medications, and they are almost always less than the risk of severe, untreated depression and related disorders. The effects of ECT on memory, while impacted by patient and treatment variables, are, following a brief recovery period, largely limited to possible patchy gaps in memory for some events in the weeks to months prior to the treatment series. These must be balanced against the consequences of ineffectively treated severe psychiatric disorders. Researchers have found no evidence that ECT damages the brain. The safety of ECT with properly administered general anesthesia and medical management of seizures is well documented in the scientific literature.

Most of the recent increase in the use of ECT has been in the elderly. This is likely due to the fact that older patients may be more likely to present with particularly severe forms of depression, or have depression associated with certain brain changes or medical conditions, that may lower the likelihood of successful treatment with medications but not with ECT. Although response to ECT for appropriate indications is very high in all age groups, recent research has suggested that older age is actually a positive predictor of response to ECT.

In light of the device’s longstanding history of safety and effectiveness, AAGP would like to express its strong support for revising ECT’s classification to a Class II device and urge FDA to take the necessary steps to complete reclassification. The absence of ECT as a treatment option would have a devastating impact on the mental and physical health of the most severely ill patients, and this is particularly true of the elderly population which members of AAGP serve.

Sincerely,

Christine M. deVries
Chief Executive Officer/Executive Vice President

REFERENCES:

1. Husain MM, Rush AJ, Fink M, Knapp R, Petrides G, Rummans T, Biggs MM, O'Connor K, Rasmussen K, Litle M, Zhao W, Bernstein HJ, Smith G, Mueller M, McClintock SM, Bailine SH, Kellner CH. Speed of response and remission in major depressive disorder with acute electroconvulsive therapy (ECT): a Consortium for Research in ECT (CORE) report. J Clin Psychiatry. 2004 Apr;65(4):485-91.

2. American Psychiatric Association. Task Force on Electroconvulsive Therapy: The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training, and Privileging. Washington, DC, American Psychiatric Association, 2001

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