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Victory: FDA Panel Votes to Require Testing of ECT Device After Survivors Testify at FDA Electroshock Hearing

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GAITHERSBURG, MD: A panel for the US Food & Drug Administration voted to ask the FDA to require testing of the device used for electroshock. MindFreedom members testified at these public hearings on whether to regulate electroshock device.

Victory: FDA Panel Votes to Require Testing of ECT Device After Survivors Testify at FDA Electroshock Hearing

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

29 January 2011 

Victory: Food & Drug Administration to Electroshock Industry: Testing Required!

 

After holding two days of public hearings, the FDA panel on electroconvulsive therapy (ECT) yesterday voted to advise the FDA that "rigorous testing" is required, says the Washington Post.

The ECT device will therefore remain "Class Three" for now, which means its safety and efficacy are unproven. If FDA follows the panel's advice, which is often the case, then the FDA may finally require the same testing used on other new medical devices. 

This outcome is the opposite of what the electroshock industry requested. While not a total victory, this is a first-step victory for those concerned about electroshock hazards. 

Reports MindFreedom member Dorothy Dundas who attended the hearing and spoke, "It was only a recommendation but we feel some of the panelists heard what we said."

This month marked the 50th anniversary of Dorothy's own experience of forced electroshock. After she left the hearing via train, she texted the following personal impression to MindFreedom:

"I just got off the train to NYC and feel as though I have been in a foreign never-never land: the land where I was side by side with the doctors who give the very shocks that almost killed me. Very weird, indeed. They displayed an arrogance which filled the air. But we held our heads up high and  put our hearts and souls into our testimonies. And it felt very nice that, when they went around the table giving their votes, in the end 10 panelists heard our voices. It was a good first step to be followed by more."


Media cover hearing results:

 

The Washington Post reports about the hearings here. The article quoted MindFreedom member and Austin psychologist John Breeding, who testified at the hearing. He said: "It was the best possible outcome we could have gotten." 

Other media pointed out the FDA panel advisory vote was very close, and there were exceptions to the positive news: 

NY Times 29 Jan: Reporter Duff Wilson points out that FDA panel caved on one diagnosis. For diagnosis of "catatonic," FDA said it would consider shock device Class II. 

Huffington Post 28 Jan: Psychiatrist Peter Breggin adds that more people are diagnosed "catatonic" today because of the impact of neuroleptic drugs. He predicts that because of the electroshock reclassification, the frequency of a catatonic diagnosis will increase even more. 

By coincidence, the first day of the FDA hearing was the day Elizabeth Ellis of Minnesota says "no" to her forced outpatient electroshock, click here for more information.

 

Several MindFreedom members attended the FDA hearing, seeking to testify. Read testimony here:

Dorothy Dundas did succeed in testifying and you may download a PDF of her testimony. 

Leonard Roy Frank, electroshock survivor and author tried to testify, but his flight out of San Francisco was cancelled (probably due to the east coast snow storm). You may read the testimony he intended to read, and that he submitted, here].

 On 24 January 2011, the NY Times ran a brief background article about the FDA hearings here.

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

 

 BELOW is the original alert MindFreedom issued about the hearings, including a statement against electroshock by psychologist John Breeding. 

 

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


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Cookie Gant

Cookie (1949 - 2003) was a founder of MindFreedom International's coalition, and was a rolling coalition herself: African American lesbian disabled psychiatric survivor artist photographer! Cookie served on the MFI board for several years, and co-founded MindFreedom Michigan. (Photo by Tom Olin at an MFI international strategy conference.)
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