FDA To Consider Selling Out To The ECT Lobby

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Advocates & Survivors To Speak At FDA Hearing

GAITHERSBURG, MD: The US Food & Drug Administration (FDA) is holding two days of public hearings on the question of whether or not to begin regulation of the electroshock device, used by psychiatrists to run electricity through the brain causing a convulsion. Your Deadline for Online Comments to US Government About Hearing: ** This Tuesday, 25 January 2011 ** [Update2 24 Jan 2011]

Loretta Wilson, electroshock survivor from Michigan, plans to testify.

Update2 24 January 2011: NY Times runs brief article about FDA hearings here.

Update1 23 January 2011: According to one of the speakers, the known scheduled speakers opposing ECT include, by last name:

• Breeding John
• Dundas Dorothy
• Fisher Dan
• Frank Leonard
• Posthauer Dianna
• Reynolds Carol
• Scogin Evelyn
• Tenney Lauren
• Wilson Loretta

19 January 2011 - Original alert

Updates About US Government Public Hearing on Electroshock

US Food & Drug Administration Holds Public Hearings Next Week:

Thursday, 27 January and Friday, 28 January 2011

Also, called "electroconvulsive therapy" or ECT, the controversial procedure has been done for 70 years in the USA, including at times involuntarily to this day, but was "grandfathered in" by the US government.

So the ECT device has never been tested or regulated for safety and effectiveness!

BELOW are brief updates about:

• ** how to comment to the US government online
• ** who MindFreedom has heard is attending the hearings, and how you may attend
• ** commentary on shock by dissident psychologist and author John Breeding
• ** how to get more information about the hearings and electroshock

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ACTION: COMMENT *SOON* ON US GOVERNMENT WEB SITE ABOUT ELECTROSHOCK!

The FDA is inviting public comment via its web site, but your deadline is this Tuesday, 25 January 2011. Your comments become part of the public record. Even registering a brief statement of concern shows there is public attention. If you can also make any specific points based on evidence or experience, that can help too. You may even comment on other comments.

You may register and comment for free on the FDA web site here:

http://www.regulations.gov/#!submitComment;D=FDA-2010-N-0585-0001

or use this link:

http://3.ly/FDACommentECT

Official FDA information about FDA ECT hearing is here:

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm234979.htm

or use this link:

http://3.ly/FDAHearingECT

FDA Docket No.: FDA-2010-N-0585

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ADVOCATES AND ELECTROSHOCK SURVIVORS TO ATTEND HEARING

MindFreedom is aware of a number of advocates, allies and electroshock survivors who are attending (note not all are shock survivors), including:

John Breeding, Dorothy Dundas, Dan Fisher, Leonard Roy Frank, Dianna Posthauer, Lauren Tenney, Loretta Wilson

Loretta Wilson (photo above) is an electroshock survivor who has helped start MindFreedom Michigan. You can hear her interview on MindFreedom Radio archive, here.

You may join these advocates, and attend the hearings for free on 27 & 28 January 2011, here:

Hilton Ballroom

620 Perry Pkwy.

Gaithersburg, MD

For information, contact FDA liaison James Engles at 1-301 796-7543.

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MINDFREEDOM "ZAPBACK INITIATIVE"

For 25 years, MindFreedom has helped coordinate a MindFreedom ZAPBACK initiative to challenge human rights violations related to electroshock. MindFreedom provides an e-mail list ZAPBACK to MindFreedom members to network those interested. Current MindFreedom members may sign up free here:

http://www.intenex.net/lists/listinfo/mindfreedom-zapback

Peacefully unite and.... Zap Back!

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BELOW is commentary supplied to ZAPBACK by a long-time MindFreedom member, psychologist and author John Breeding of Texas. (The author is responsible for content.)

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FDA and Electroshock

by John Breeding

January 2011

History

As always a bit of history is a good place to start; in this case, three bits.

First, my own. I have been active challenging electroshock for about 20 years. I was honored to serve on the advisory board of the World association of Electroshock Survivors, courtesy of heroine Diann'a Loper's invitation, back when she and that group were leading the charge in the Texas legislature that almost go shock banned in the state--did in fact for young people under age 16. My continuing personal opposition to electroshock comes as part of the Coalition for the Abolition of Electroshock in Texas, whose activities are described on our Web site, http://www.endofshock.com. As our name implies, we are an abolitionist group, and our intention is exactly that--to end the use of electroshock.

I have also had the privilege of working with a lot of courageous electroshock survivors, many as fellow activists challenging the procedure, a few as counseling clients. I have personally witnessed the profound damage, most apparent in terms of memory loss and learning disability. I have seen again and again, electroshock's contribution to the disability epidemic chronicled by Robert Whitaker in his book, Anatomy of an Epidemic. I have gotten personally close to three individuals who suffer from permanent seizure disorders, as an effect of electroshock. I am angry.

Second, the beginning of electroshock. As an electroshock abolitionist, I am in surprising company. Italian psychiatrist Ugo Cerletti created electroshock in 1938 after observing its use to stun pigs in a slaughterhouse before killing them. After witnessing his first ECT experiment on a human being, wrote, "When I saw the patient's reaction, I thought to myself: This ought to be abolished."

Another witness to that event, German-born psychiatrist Lothar Kalinowsky, emigrated to the United States, where he became a leading ECT specialist. Kalinowsky said many years later, "According to my wife--because I don't remember it exactly--she claims that when I came home I was very pale and said, 'I saw something terrible today--I never want to see that again!'"

If these two shock doctors had been true to their initial experiences, we would have avoided the plague of brain damage and ruined lives caused by ECT. Instead, they spawned what has become a multibillion-dollar industry, with an estimated 100,000 Americans and as many as 2 million victims worldwide electroshocked every year.

At recent public demonstrations, our array of signs has included "Electroshock Is a Crime Against Humanity" and "ECT = Electro Convulsive Torture." Clearly our coalition sees electroshock as a violation of human rights and dares to call it torture.

Third, the history of FDA involvement. I cannot recommend highly enough Linda Andre's 2009 book, Doctors of Deception: What They Don't Want You To Know about Shock Treatment. It is a tour de force and will tell you everything you need to know about the practice and the research (or lack of). A very brief synopsis is that psychiatric industry public relations has thus far won out over science in the effort to sell electroshock as a medical procedure.

Get the details from Doctors of Deception; the short story is that the FDA's involvement with electroshock is another sordid example of government agency catering to industry and doing everything they can to deny and obfuscate the evidence. Prior to 1976 there was no federal regulation of medical devices. The Medical Devices Amendment of 1976 put the FDA in charge of classifying devices on the basis of safety and effectiveness. Class II devices are considered low-risk; class III is the high-risk classification for devices in which "benefits have not been shown to outweigh risks," and which present "a potential unreasonable risk of injury or illness."

Due to intense effort lead by psychiatric survivors Marilyn Rice and Linda Andre and their Committee on Truth in Psychiatry, electroshock machines have remained in Class III even though the FDA repeatedly ignored large parts of the law it was supposed to carry out, and allowed the electroshock device industry to flagrantly ignore FDA mandates to meet the standards on premarket approval (PMA) of medical devices.

Due to ongoing activism, electroshock machines remain in Class III despite the FDA's express intention since the early 1980s to reclassify them as safe--not with legitimate PMA research, but contingent only on the development of a performance standard. Incredibly, when the industry succeeded in pressuring Congress to lower the standards for reclassification of medical devices to "special controls"--loosely defined guidelines and recommendations--the manufacturers still ignored the mandatory call to submit evidence, and there were no consequences. The FDA was again not willing to enforce the law. In fact, they took on the manufacturers' task and decided they would do their own studies of the literature. Andre reveals the systematic bias of this effort.

The industry continues to electroshock large numbers, but our resistance has thus far foiled its efforts to get the machines reclassified as safe. So now we come to another round of hearings. Please do weigh in:

James Engles 1-301 796-7543

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm234979.htm Docket No. FDA-2010-N-0585

Safety

** Death - As Leonard Roy Frank shows in his article on "Electroshock and Death," estimates of ECT death rates range from 1 in 10,000 to as low as 1 in 4 among the very elderly (http://www.endofshock.com/101i%20brochure%20on%20deaths%203-29.doc ).

** Brain Damage - The average electroshock procedure as administered today typically induces a level of electricity approximately two and one-half times greater than what is needed to induce a convulsion. Systematic brain damage is unavoidable, a fact that is documented in a number of brain scan studies and other reports. Even some electroshock advocates are finally acknowledging this. In an article in the journal Neuropsychopharmacology in January 2007, longtime ECT proponent and prominent researcher Harold Sackeim of Columbia University and colleagues, acknowledged ECT causes permanent amnesia and permanent deficits in cognitive abilities, which affect individuals' ability to function. The article notes, "This study provides the first evidence in a large, prospective sample that adverse cognitive effects can persist for an extended period, and that they characterize routine treatment with ECT in community settings." (http://www.nature.com/npp/journal/v32/n1/pdf/1301180a.pdf).

** Memory Loss - This sine qua non of brain damage is extremely well-documented. Sackeim admits in his 2001 editorial in The Journal of ECT that "...virtually all patients experience some degree of persistent and, likely, permanent retrograde amnesia." The only question is how much.

** Cardiovascular Complications - Well-documented.

** Extra risks on all three categories above for the elderly, who are the primary target population; about half of those undergoing ECT are 60 years of age and older.

** Seizures and Epilepsy - At least two members of our own local coalition have seizure disorders as a result of electroshock.

** Negative emotional effects of electroshock include terror, shame, helplessness and hopelessness.

** See the CAEST website at www.endofshock.com for documentation of the above information.

Efficacy

Electroshock directly violate the Hippocratic oath to first do no harm, the practice has never been proven effective. There are no lasting beneficial effects of electroshock; sham-electroshock (anesthesia but no electroshock) has the same short-term outcomes as electroshock (see Ross, C.A. , 2006, "The sham ECT literature: Implications for consent to ECT," Ethical Human Psychology and Psychiatry, vol. 8).

Let me reference Harold Sackeim one final time, from an article he wrote with several colleagues in 2001 in the Journal of the American Medical Association, titled, "Continuation Pharmacotherapy in the Prevention of Relapse Following Electroconvulsive Therapy." They state in their conclusion, "Our study indicates that without active treatment, virtually all remitted patients relapse within 6 months of stopping ECT." (Italics mine)

I have worked with scores of electroshock survivors, and I can tell you the damage is consistent and terrible. I can also tell you as a psychologist that there are methods so much gentler, safer and more effective to help people with depression. The United Kingdom has a better regulatory agency than our FDA. They banned many of the psychiatric drugs for children. Regarding electroshock, they went and pulled together all the reports they could find from the people who actually received electroshock. Unsurprising to us, they found memory loss as the dominant theme of all the literature. Their National Institute for Clinical Excellence (NICE) concluded that the use of electroshock should be limited, especially due to cognitive impairment "often lasting to such a degree that it outweighed any perception of benefit..."

In sum, psychiatric electroshock is very harmful and dangerous, and is not even effective. There is no excuse to relax FDA approval standards regarding ECT devices.

Tell the FDA to do the right thing and at the very least require a complete Pre-Market Approval submission on these machines, and not let public relations substitute for facts.

Contact James Engles at 1-301 796-7543.

Submit electronic testimony on Docket No. FDA-2010-N-0585 at:

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm234979.htm

I think it is our duty to make sure they are not allowed to deny the damages perpetrated on our citizens by electroshock.

Thanks for your help!

- John Breeding

(-end of Breeding essay-)

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MORE INFORMATION BY MFI ABOUT ELECTROSHOCK

Throughout the world -- including throughout the USA -- some individuals get electroshock involuntarily over their expressed wishes, such as guest Ray Sandford of Minnesota. For info about MindFreedom's campaign to stop Ray's forced court-ordered outpatient shock see http://www.mindfreedom.org/ray

Truly, the electroshock device is the unregulated "Bernie Madoff" of USA mental health, today. A new rubber glove for doctors is regulated. Not electroshock.

You may order Linda Andre's book "Doctors of Deception" about electroshock in MindFreedom's Mad Market here:

http://www.madmarket.org

Search for author name -- Andre.

Or go directly to here to order her book.

http://3.ly/AndreElectroshock

You may download an Irish Times about recent academic review of electroshock here:

http://3.ly/IrishTimesECT

You may download a PDF of Read & Bentall's new 15-page review here:

http://3.ly/ReadBentallECT

More info on electroshock at MindFreedom web site:

http://www.mindfreedom.org/kb/mental-health-abuse/electroshock

Thank You Mindfreedom and Dr. Breeding