ECT MACHINES NOT SAFE

Read the statement by the Coalition Against Psychiatric Assault (CAPA)’s statement that ECT machines are not safe: CAPA is based in Toronto, Ontario, Canada. Website:

http://capa.oise.utoronto.ca

COALITION AGAINST PSYCHIATRIC ASSAULT
December 15, 2009
Food and Drug Administration
Dockets Management Branch (HFA-305
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Docket Number FDA-2009-N-0392
CAPA Statement re Shock Machines

The Coalition Against Psychiatric Assault (CAPA) strongly opposes the FDA’s intention to reclassify shock (“ECT”) machines from Class-III (high-risk) to Class-II (low-risk). CAPA is a grassroots, political action organization of electroshock survivors, psychiatric survivors, health professionals, academics, social justice and antipsychiatry activists; it plans and organizes strategic actions against electroshock and psychiatric drugs – its two priorities. We wish to point out that several CAPA members have undergone electroshock and suffered permanent memory loss and brain damage from this allegedly “safe and effective treatment”. Since its founding over five years ago, CAPA has spoken out against electroshock, organized educational events such as public forums, free public lectures, and nonviolent public protests. CAPA has repeatedly and publicly called for an immediate ban.

CAPA’s continuing resistance to electroshock is based on several scientific facts and the personal testimony of many shock survivors:

  • Shock machines deliver up to 400 volts of electricity (Cameron, 1994)
  • It has been established to a point of statistical significance that all forms of ‘ECT’ cause brain damage.
  • The FDA has never tested shock machines for medical safety and therapeutic effectiveness. (Andre, 2009)
  • During the shock treatment, electrodes are placed above the temporal lobes, the site of memory function in the brain
  • Every shock treatment causes a grand-mal epileptic seizure. convulsion and coma (Breggin, 1997,1998)
  • Shock treatments cause many devastating effects – particularly brain damage, permanent memory loss, problems in concentration and learning, loss of creativity, and sometimes death. It has destroyed the careers and lives of many (Friedberg, 1977; Breggin, 1998, 2008; Frank, 1990, 2006; Sterling, 2002; Funk, 1998; Report of the Panel, 2005)
  • Thirty years ago in a report on medical devices, the FDA officially listed 8 “risks to health” including brain damage and memory loss (Federal Register,1979; Andre, 2009)
  • Women and the elderly are very vulnerable and suffer the most severe memory loss and brain damage (Sackeim, 2007); elderly women are the most vulnerable (Burstow, 2006; Weitz, 1997)
  • 2 to 3 times more women than men are electroshocked; women experience electroshock as a form of violence against women (Burstow, 2006a, 2006b)
  • Shock treatments shorten the life of elderly patients (Black et al, 1989; Breggin, 1997, 2008; Kroessler & Fogel, 1993; Weitz, 1997)
  • Since psychiatrists and other physicians frequently violate the patient’s right to informed consent, shock treatments are generally coercive (Breeding, 2000; Report of the Panel, 2005)
  • Electroshock triggers terror and trauma in most patients. (Breggin, 1998; Report of the Panel, 2005)

Given these facts, we conclude that shock machines pose unacceptably high risks to the health and lives of hundreds of thousands of people. We urge the FDA not to be pressured by the American Psychiatric Association, which is currently lobbying to reclassify them in Class-II. Until they are banned, all shock machines should remain in Class-III. We also recommend that the FDA start testing shock machines for their medical safety; we are confident they will be proved medically unsafe. As engines of destruction, shock machines have no place in the health care system of the United States and all other countries. They should have been banned long ago.

Dr. Bonnie Burstow, Chair
Dianne Moore
Don Weitz
Executive Committee, Coalition Against Psychiatric Assault (CAPA)

References

Andre, L. (2009). Doctors of Deception: What They Don’t Want You To Know About Shock Treatment. New Brunswick, NJ: Rutgers University Press.

Black, D.W., Winokur, G., Mohandoss, E., Woolson, R.F. and Nasrallah, A. (1989) “Does treatment influence mortality in depressives? A follow-up of 1076 patients with major affective disorders.” Annals of Clinical Psychiatry, 1(3), 165-173.

Breeding, J. (2000). “Electroshock and Informed Consent.”
Journal of Humanistic Psychology, 40, 65-79.
Breggin, P. (1997). Brain-Disabling Treatments in Psychiatry. New York: Springer Publishing Company. Ch.8 “Electroshock for Depression”, 129-156.; 2nd edition, 2008.
Breggin, P. (1998). Electroshock: Scientific, Ethical, and Political Issues. International Journal of Risk and Safety in Medicine (11), 5-40.
Burstow, B. (2006a) “Electroshock As a Form of Violence Against Women”, Violence Against Women, vol.12 no.4. 372-392.
Burstow, B. (2006b). “Understanding and Ending ECT: A Feminist Imperative”. Canadian Woman Studies, vol. 25, numbers 1,2, 115-122.
Cameron, D.G. (1994). “ECT: Sham Statistics, the Myth of Convulsive Therapy, and the Case for Consumer Misinformation”, The Journal of Mind and Behavior, vol.15, numbers 1 and 2, 177-198 

Federal Register (November 28, 1979). “Classification of Electroconvulsive Therapy Devices”. Vol.43, No.220, 55729.
Frank, L. (1990). “Electroshock: death, brain damage, memory loss, and brainwashing”. Journal of Mind and Behavior, 11, 489-512.
Frank, L. (2006). The Electroshock Quotationary [online http://endofshock.com.]
Friedberg, J. (1977). Shock treatment, brain damage, and memory loss: a neurological perspective. American Journal of Psychiatry 134: 1010-1014.

Funk, W. (1998). “What DiffErenCe Does IT Make?”: Journey of a Soul Survivor. Cranbrook, B.C.: Wildflower Publishing Company [self-published].

Kroessler, D. and Fogel, B.S. (1993) “Electroconvulsive therapy for major depression in the oldest old”. The American Journal of Geriatric Psychiatry, 1(1), 30-37.

Sackeim, H.A et al (2007). “The Cognitive Effects of Electroconvulsive Therapy in Community Settings.” Neuropsychopharmacology, 32, 244-54.

Sterling, P. (October 2002). Comments on Brain Damage and Memory Loss From Electroconvulsive Shock. Dublin, Ireland: Wellbeing Foundation.
Weitz, D. (1997). “Electroshocking Elderly People: Another Psychiatric Abuse”.
Changes: International Journal of Psychology and Psychotherapy, vol.15 no.2

Shock Machine Company Pays Up!

MECTA is first to pay for brain damage

For the first time, a product liability suit against a shock machine manufacturer has resulted in a successful settlement for the plaintiffs. The suit was brought by Imogene Rohovit of Iowa City, Iowa, and her daughters, alleging that Mrs. Rohovit, a single mother and former nurse, has been brain damaged and rendered unable to work by shocks inflicted by the MECTA Model D machine in 1989.

MECTA Corp. and the Model D were also the subjects of the very first product liability lawsuit against a shock machine company in 1987. The suit claimed that MECTA’s machine was designed to produce and did routinely produce permanent memory and brain damage (not that the machine was defective in any way). A judge initially ruled against MECTA, which then offered a settlement of $105,000. The offer was rejected, but an appellate judge then ruled MECTA did not have to go to trial.

No shock machine has ever been pulled off the market, but even shock doctors now warn others not to use the powerful Model D. It was sold in the early 1980s and many are still used. However, self-proclaimed shock “expert” Harold Sackeim testified at trial that he does not use the Model D on human beings, but only on research animals. MECTA President Robin Nichol has testified that MECTA has never performed a single safety test on its machines.

MECTA insisted on a gag order, meaning that the exact amount of the settlement cannot be disclosed by the parties. It is believed to be higher than the first settlement offer, but the plaintiffs expect to see little of the money due to the high costs of bringing their case against Mrs. Rohovit’s doctors to trial. The trial lasted three weeks and the case was lost. Mrs. Rohovit’s attorney, Marc Humphrey of Des Moines, Iowa, cites recent attempts to limit or eliminate all types of product liability lawsuits as a factor in the settlement decision. But if these attempts fail, the Rohovit case could encourage other suits.

From Linda Andre, CTIP

If you would like to receive “Shockwaves,” the official newsletter of CTIP and get the news you won’t find anywhere else, contact CTIP at 212-NO JOLTS

Linda Andre wrote a book released recently in May 2009. Her book is called “Doctors of Deception –

What they don;t want you to know about electroshock” See the book outline at:

http://doctorsofdeception.com

Linda Andre is having book launches. See the website above for the dates.

barBlackwithdotsAnim

Here are some links re the ECT machines to be tested:

ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com

It may come as a shock to some of you; but, Electroshock machines have never
been tested for safety or efficacy.
They were “grandfathered” into the system when the FDA assumed jurisdiction
over medical devices in 1976.

In 1990, Congress ordered the FDA to have shock machines tested. BothECT
manufacturers and the closely knit shock advocates–most of who have
significant financial interests in ECT–vehemently opposed safety tests. The
agency went along with the vested stakeholders and failed to comply with the
congressional order.

Electroshock–unlike other medical devices–is most often forced on
non-consenting patients such as, Ray Sandford of Minneapolis
http://www.mindfreedom.org/ray-sandford-minnesota. Ray, who is 54, has been
subjected to 40 shock treatments against his will by court order!! Though
Sandford is not charged with any crime, he has received over 40 such rounds
of shocks on an outpatient basis so far–even after his original mental
problems have long since subsided and he has repeatedly asked for the shocks
to stop.
http://twincities.indymedia.org/2009/mar/their-own-words-ect-survivor-advoca
tes-speak-out-against-continued-forced-electroshocks
Is it civilized to
force a human being to undergo brain damaging electroshock as punishment ?
What, if any crime has Ray Sanford committed?

The Wall Street Journal reports that the Government Accountability Office
criticized FDA’s delay in January. So, this week the FDA ordered the makers
of 25 different types of medical devices marketed before 1976, to submit
safety and effectiveness data within 120 days. Electroconvulsive therapy
devices are included.

The ECT makers must submit proof of safety and efficacy to the FDA by
August, 7, 2009. If the data submitted is not up to par, the FDA intends
require manufacturers to undergo the more-rigorous pre-market approval
process for their existing devices, as well as new ones.

A just published book “Doctors of Deception: What They Don’t Want You to
Know About Shock Treatment,” by Linda Andre (published by Rutgers University
Press, 2009) couldn’t be more timely! This is an insightful, extensively
documented history of electroshock, that examines the controversial
“treatment” in a social, legal, financial, medical and moral context. This
book sheds light, among other things, on the maneuvers used by organized
psychiatry and the makers of Shock machines to delay safety trials for 33
years. If Shock were “safe and effective” as its adherents claim–some even
proclaim electroshock to be as safe and effective as penicillin–why, then
has the profession avoided conducting scientifically valid, safety trials?
http://rutgerspress.rutgers.edu/acatalog/Doctors_of_Deception.html

Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974

————————————-

By KEITH J. WINSTEIN

The Food and Drug Administration asked several medical-device makers to justify their products’ safety and effectiveness, as part of a move to require tougher evidence standards before products can be sold.

The request covers automatic external heart defibrillators from Medtronic Inc.,Royal Philips Electronics NV and Zoll Medical Corp.; dialysis catheters fromCovidien Ltd.; hip joints from Zimmer Holdings Inc.; spinal screws from Medtronic and Johnson & Johnson; a heart pump from Abiomed Inc.; and several other categories of products.

The move presents the possibility that the companies will have to pay for expensive clinical trials for products already on the market, unless they can persuade the agency to reclassify them as less risky.

The agency’s request comes in response to a 1990 order from Congress that directed the FDA to gather rigorous evidence before a manufacturer can sell medical devices considered to be in the most risky category, known as Class 3.

But despite several attempts during the 1990s, the FDA hasn’t finished implementing the law. In the past five years, it allowed hundreds of new Class 3 devices to be sold based on a less rigorous showing — called a 510(k), after a section of federal law — that they are “substantially equivalent” to combinations of other products marketed before 1976. Such evidence often is collected in a laboratory, not with a clinical trial in patients.

The Government Accountability Office criticized the delay in January. The agency said it will issue regulations Thursday asking makers of high-risk medical devices who had been allowed under the easier process to submit evidence to the agency backing their products’ safety and effectiveness.

The FDA will then either reclassify the devices into a less-risky category in which the 510(k) process is routinely allowed, it said, or require manufacturers to undergo the more-rigorous premarket approval process for their existing devices, as well as new ones.

Mary Long, an agency spokeswoman, said it could take several years for the agency to finish the process. Manufacturers would be granted a grace period to submit enough evidence backing their devices under the more-rigorous standard. “It is a priority, but it will really depend on the kind and amount of information we get on each type,” she said.

Write to Keith J. Winstein at keith.winstein@wsj.com

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