Saturday, January 22, 2011

FDA Electroshock Hearing - Public Comment

Comment submitted to FDA (via web form)

January 22, 2011

Comment regarding forthcoming ECT devices safety hearing
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm234979.htm
http://3.ly/FDAHearingECT
Published deadline for public comment Jan 25, 2011
The comment page has been removed:
http://www.regulations.gov/#!submitComment;D=FDA-2010-N-0585-0001
http://3.ly/FDACommentECT

ECT should be abolished.  It is an outdated and barbaric form of torture under the guise of medicine and healing. Psychiatry, as it is currently practiced, is an altogether outdated field. Neuroscientific findings demonstrate unequivocally that meditation leads to improved, even optimum, mental health. Therefore, any device applying electric convulsive shocks to the brain, that causes mild to severe brain damage and disability, should not be approved for use on any living being.

Mild and gentle techniques for regulating CNS activity exist, such as acupuncture, which I recommend be implemented widely within psychiatry. NIH/NCCAM funded studies on acupuncture include:
Mechanism of action - Langevin et al. Evidence of connective tissue involvement in acupuncture, The FASEB Journal. 2002. 16:872-874; Depression - Allen, J.J.B. An acupuncture treatment study for unipolar depression. Psychological Science. 1998. 9:397-401.
My work is relevant: Weiss, J. et al. Integration of acupuncture in a psychiatry department, Alternative Therapies in Health and Medicine 2001 7: S35.
http://therealjannaweiss.blogspot.com/2010/12/janna-weiss-abstracts.html

I encourage you to consult with scientists from the following institutions regarding ECT device "safety":
Richard Davidson, University of Wisconsin
http://www.investigatinghealthyminds.org

James Doty, Stanford University
http://ccare.stanford.edu

Charles Raison, MD, Emory University
http://www.emoryhealthsciblog.com/?p=1281

I wish you the best success with your efforts, and that they contribute to ethical and compassionate medicine for all.

Sincerely,

Janna Weiss, PhD, LAc

___________________
Begin forwarded message:

Date: January 20, 2011 8:00:03 PM GMT+02:00
Subject: MindFreedom-News Digest, Vol 283, Issue 1


Today's Topics:

  1. MFINews: FDA Electroshock Hearing, Public Comment
     (News & alerts from www.MindFreedom.org)


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Message: 1
Date: Wed, 19 Jan 2011 11:21:09 -0800
From: "News & alerts from www.MindFreedom.org"
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Subject: MFINews: FDA Electroshock Hearing, Public Comment
To: mindfreedom-news@intenex.net
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MindFreedom International Update - 19 January 2011
25 Years United For Human Rights in Mental Health
http://www.mindfreedom.org - please forward
[To stop these free public alerts see bottom.]


Updates About US Government Public Hearing on ELECTROSHOCK

Your Deadline for Online Comments to US Government About Hearing :
** This Tuesday, 25 January 2011 **

US Food & Drug Administration Holds Public Hearings Next Week:
Thursday, 27 January and Friday, 28 January 2011

Next week, in 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.

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

These updates with links & photo can also be found at http://mindfreedom.org
 in MFI news section:

~~~~~~~~~~~

ACTION: COMMENT *SOON* ON USA 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

~~~~~~~~~~~

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

You may 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.

~~~~~~~~~~~

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

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.)

~~~~~~~~~~~

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

~~~~~~~~~~~

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 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

~~~~~~~~~~~~

This is the 25th Anniversary Year of MindFreedom International!

United. Independent. Activism.

For a peaceful revolution in mental health care!

MindFreedom International is one of the few totally-independent
nonprofit coalitions supporting the voice of survivors of psychiatric
human rights violations, with zero funding from the mental health
system, governments, drug companies or religions.

That means your membership donation is crucial to MindFreedom
International's campaigns for human rights and alternatives.

Join the MFI community and celebrate MFI's 25th Anniversary Year,
united!

Join or donate now here:

http://www.mindfreedom.org/join-donate

You may make a one-time annual donation there, or set up automatic
monthly donations to match your budget.

~~~~~~~~~~~~

Please forward these events to all who support human rights in mental
health.

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mindfreedom-news public e-mail alert system, please add your e-mail
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End of MindFreedom-News Digest, Vol 283, Issue 1
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