Controversy – ECT machines and the FDA

Hello Friends,

Once again, ECT is being bullied and manhandled by stigma, using fear instead of science, to steer people away from a lifesaving treatment. In this instance, they are targeting the ECT machines as an angle to keep others from having access to treatment. Science and life example clearly states the efficacy and success rates with ECT. The machines, …really?

The best way to diminish stigma is to tell others your own story.

Tell others here:

RE: FDA ECT DEVICE RECLASSIFICATION

Please post your comments to the FDA website: http://www.regulations.gov , as soon as possible.

To post comments for the proposed rule:

http://www.regulations.gov/#!submitComment;D=FDA-2014-N-1210-0001

To post comments for the draft guidance document:

http://www.regulations.gov/#!submitComment;D=FDA-2014-D-1318-0002

_____________________

A colleague, whom I tremendously respect, responded to this elequently. I wanted to share it with the world. He has so many years of practice, a deep skill set in the art of medicine, and in these short paragraphs, captured much of the beast in ECT stigma. Thank you Dr. Guerra!

Electroconvulsive therapy is a treatment for potentially fatal illnesses including major depression, bipolar disorder (manic, depressed, mixed, rapid cycling), catatonia, and schizoaffective disorder. It has a remarkable rate of success. Many patients only remain well with continuation or maintenance ECT. In more than forty years of practice, I have seen hundreds of lives saved and hundreds of my patients restored to productive lives.
ECT remains the most rapidly effective form of treatment for those who have not responded to psychotherapy and/or medication. For the acutely suicidal or catatonic patient the risk of mortality may be equal to that of a ruptured aortic aneurysm.  
As we in psychiatry and medicine are trying to fight the stigmatization of the mentally ill, a few points demand attention:
Among the treatments for potentially fatal illnesses (chemotherapy, radiation, surgery), ECT has the highest rate of success with the least physical damage. In fact, while cognitive difficulties occur with ECT, they are generally short-lived and are not the result of physical damage to the brain. By contrast, treatments for other life-threatening conditions, like cancer, often leave patients permanently damaged in the service of saving lives. Treatments such as those for cancer are embarked upon (with consequent debilitating effects) even when the likelihood of remediation or cure is low. In all cases, clinical judgment and the consent of family and other stakeholders are involved before a decision to treat occurs. Such informed consent is the standard for the practice of ECT as well.

An agreement regarding the safety of ECT machines is reflected in the decision to change their classification. Restricting the clinician’s ability to apply his or her clinical skills and knowledge does not improve the safety of ECT machines. It only communicates that the safety of the ECT apparatus is of concern for some diagnostic categories by not of concern for others. Furthermore, restricting the ability of clinicians to apply treatments according to a set of guidelines does nothing the make the apparatus safer.
Having determined that the machines are safe for some, they must be safe for all. Their use must be left to the discretion of the treating physician.

The restrictions being imposed do not seem logical to me. They tie the hands of clinicians, promote stigma, and will foster diminished access to treatment for those most desperately in need.

Frank Guerra, MD, DLFAPA, FACA
Psychiatrist/Anesthesiologist
Medical Director
The Guerra Fisher Institute
Boulder, Colorado
Clinical Professor of Psychiatry and Anesthesiology
University of Colorado School of Medicine
Past President
Colorado Psychiatric Society

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