FDA to Review Safety of Electroshock Devices

Monday, 24 January 2011

"Despite ongoing controversy, there has never been a large-scale, prospective study of the cognitive effects of electroconvulsive therapy (ECT)." Dr. Harold Sackeim, et al, 2007.

The classification of Electroshock  machines will be the focus of an FDA advisory committee hearing this Thursday and Friday, Jan. 26 & 27.

As noted by The New York Times (sent out earlier today - Vince) the hearing has reignited a contentious 50 year + debate about ECT's safety and efficacy.

In 1979, the FDA designated ECT devices as Class III, recognizing that its use posed serious risks--including permanent amnesia and brain damage. Despite the risks, FDA has allowed ECT devices to be used on patients--without requiring manufacturers to conduct safety tests, and without establishing any standards for the application of electric current to their brain. What's more, patients are not informed about the risks--so they have been unwitting human subjects of a vast uncontrolled experiment.

Once again, the powerful psychiatric lobby will join Electroshock device manufacturers in their effort to reclassify ECT machines from Class III, to Class II (benign risk)--in order to thwart a requirement for tests to determine whether ECT devices are safe for human application. 

The catalyst for this hearing is a Government Accountability Office recommendation in 2009 that high risk medical devices--such as electroshock machines, pacemaker electrodes, implanted blood access devices that had not undergone a stringent approval process-- should undergo proper safety tests, or--if deemed appropriate--should be reclassified as medium or low risk.     

The ECT literature is almost entirely corrupted by conflicts of interest--those who claim that ECT is "safe and effective" are the authors of self-serving, biased reports.

ECT proponents have indisputable financial stakes that collide with patients' best interest.   Device manufacturers have steadfastly refused all these years to put their machines to rigorous safety tests and ECT practitioners--who also have a financial stake in the ECT business, including close financial ties to ECT manufacturers. Practitioners have been applying varrying electric currents to the brains of patients without adhering to any standards of practice.   Indeed, the findings of the first large, prospective, federally funded study conducted by ECT’s most prominent researcher,  Dr. Harold Sackeim and colleagues at Columbia University, confirms its harm-producing results. Cognitive Effects of Electroconvulsive Therapy in Community Setting, Neuropsychopharmacology, 32:244-254 (2007): “ This study provides the first evidence in a large, prospective sample that the adverse cognitive effects can persist for an extended period, and that they characterize routine treatment with ECT in community settings.” The study confirmed ECT-induced long-term memory loss and other cognitive problems--especially for women, who are the majority of persons who undergo ECT--and the study confirmed that electroshock methods, including electrode placement and electric voltage, varied widely among practitioners. “It’s all trial and error — it’s all experimental," said Vera Hassner Sharav, president of the Alliance for Human Research Protection, an advocacy group in New York. "All the years it’s been controversial and there have not been clinical trials. Why not?”  

ECT practitioners operate in an unregulated, Devil-May-Care culture--psychiatry has the dubious distinction of disregarding the harm its "treatments" cause patients. 

Proponents of ECT proponents--i.e., device manufacturers, practitioners and organized psychiatry--dismissively deride patient testimonies, as if their first-hand experience isn't valid.  But in reallity, the most compelling testimony in opposition to ECT is the testimony of the eye witnesses--the patients whose memory and cognitive function has been damaged.

The Times also cites a very recent critical study, The Effectiveness of Electroconvulsive Therapy: Literature Review by John Read (New Zealand) and Richard Bentall (the UK) (both clinical psychologists with many years experience of working with severely distressed patients) published in the peer reviewed journal, Epidemiologia e Psichiatria Sociale. They reviewed "all relevant studies over 60 years" and found: "only very minimal evidence for improvement during the treatment period and no evidence for improvement afterward....no evidence that ECT prevents suicide." "strong evidence" for "persistent and, for some, permanent brain dysfunction." They concluded that "the cost-benefit analysis for ECT is so poor that its use cannot be scientifically justified." They further stated, "The continued use of ECT therefore represents a failure to introduce the ideals of evidence-based medicine into psychiatry." For the FDA to consider reclassifying ECT devices to Class II--the FDA would have to assert that ECT's safety can be assured by specified safeguards which would include the mandatory maintenance of records on the devices, labeling, performance standards or practice guidelines for use, and post-market surveillance such as patient registries.  

by Vera Hassner Sharav

                                                                    

                All ECT and all ECT machines      

    should be banned for use in human beings

 

                 

 

      

FRED A. BAUGHMAN, JR. M.D.*

NEUROLOGY AND CHILD NEUROLOGY (Board Certified)

FELLOW, AMERICAN ACADEMY OF NEUROLOGY

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1303 HIDDEN MOUNTAIN DRIVE

EL CAJON, CA 92019

Tele:(619) 440-8236 Fax: (619) 442-1932

James Engles January 14, 2011

Division of Dockets ManagementFood and Drug Administration5630 Fishers Lane, Room 1061Rockville, MD 20852

Docket Number FDA-2010-N-0585

RE: Are Electroshock Machines Safe and Effective?

Dear Dr. Engles, et al,

The brain is our one organ of learning and adaptability. No ‘treatment’ of the brain that damages it can be presumed to do anything but lessen that persons ability to learn, adapt and adjust, or to recover from anything called a mental illness (none proved to be actual physical abnormalities, illnesses, sicknesses, disorders diseases).

It is difficult to understand why psychiatry so infrequently takes advantage of this fact to try to return their patients to full functional capacity in their homes, families, communities, and workplaces by the maximal utilization of non-medical, non-injurious, physical treatments such as talk therapies, education and rehabilitation, but elects, instead, electrical, surgical and chemical treatments all of which undoubtedly damage the previously normal brains of troubled and/or troublesome, physically normal persons diagnosed with psychiatric conditions--none proven-prior to treatment--to have a physical/organic abnormality/disorder/disease of the brain. Might it be that the marketplace pursuit of the disease/disorder/chemical imbalance model and prescriptions of electro-shock therapy and the unending plethora of psychiatric drugs is far more profitable and easier to maintain—politically and in the marketplace.

As a neurological resident at Mt. Sinai Hospital in New York City we—neurology attending and resident physicians--were called upon by members of the department of psychiatry to assist in the administration of ECT. We had no part in the psychiatric evaluation of such patients. This seemed to me an anomalous and unhappy duty.

Siezures—whether drug-suppressed or not—were produced by every such treatment, in every such patient—clear, irrefutable evidence of brain damage being caused, clear evidence that any psychiatric or mental status change was the result of brain damage induced by the ECT treatment.

Throughout the more than 3 decades of my neurological practice I have encountered patients treated with ECT who had permanent erasures of parts of their memory. Think of the extent of memory loss not immediately evident in these and in all patients. For their own selfish reasons, psychiatrists may wish to call ECT and such end-results ‘therapeutic’ but they never achieve anything but to diminish adaptability in the broadest sense and cannot be called ‘therapeutic or medically justifiable.

Moreover the Psychopharmacologic Drug Advisory Committee and all committess of the FDA must cease, once and for all calling psychiatric conditions/diagnoses—those of the DSM—disorders and diseases, assuming that physical abnormalities of the brain are present which such “treatments” normalize or return in part to normal, when such has never been proved to be the case.

 

In fact, recently Health Canada and at least one agent of the FDA (Dobbs) have stated that no psychiatric diagnosis/’disorder’ is an actual disease, having as it must a gross, microscopic or chemical abnormality by which to diagnose/confirm its presence--one ‘patient’ at a time

The Nov 10, 2008, letter from Health Canada to Mr. Brian Verbeek, father of a multiply “diagnosed,” “drugged,” 12 year-old boy, reads:

“For mental/psychiatric disorders in general, including depression, anxiety, schizophrenia and ADHD, there are no confirmatory gross, microscopic or chemical abnormalities that have been validated for objective physical diagnosis.On 3/12/09 Donald Dobbs, Consumer Safety Officer, Division of Drug Information, Center for Drug Evaluation and Research of the FDA, wrote: 

 

I consulted with the FDA new drug review division responsible for approving psychiatric drug products and they concurred with the response you enclosed from Health Canada. Psychiatric disorders (as Health Canada refers) are diagnosed based on a patient's presentation of symptoms that the larger psychiatric community has come to accept as real and responsive to treatment. We have nothing more to add to Health Canada's response.

All ECT and all ECT machines should be banned for use in human beings. They are nothing but instruments of knowing, willful abuse and control of fellow human beings—for profit.

Sincerely,

Fred A. Baughman Jr., MD, Fellow, AA

“This is why we never ask:  What existential cost do we inflict on the person whose moral agency we withdraw?   What existential price do we, as a society, pay for empowering a group of professionals to deprive persons of their status as moral agents and for treating certain psychiatrically identified persons as if they were not moral agents?  These questions- and with them the very possibility of debating the potential conflicts between moral agency, medical care, the safety of society, and other values – are now deeply buried under the rhetoric of mental illness and psychiatric paternalism.”

Thomas Szasz

“This is why we never ask:  What existential cost do we inflict on the person whose moral agency we withdraw?   What existential price do we, as a society, pay for empowering a group of professionals to deprive persons of their status as moral agents and for treating certain psychiatrically identified persons as if they were not moral agents?  These questions- and with them the very possibility of debating the potential conflicts between moral agency, medical care, the safety of society, and other values – are now deeply buried under the rhetoric of mental illness and psychiatric paternalism.”

Thomas Szasz

Mahon clinic offers free mental health assessment

By Jennifer Hough

Monday, January 10, 2011

 A COMMUNITY medical clinic in Mahon is offering free mental health assessments as part of a campaign to promote well-being and good mental health.

The Dean Clinic, Cork, is part of community clinics run by St Patrick’s University Hospital, Dublin — the Mahon centre being its only regional clinic with another to follow in Galway in the next few months.