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Date: Wed, 19 Jan 2011 11:21:09 -0800
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MFINews: FDA Electroshock Hearing, Public Comment
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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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~~~~~~~~~~~~
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~~~~~~~~
End
of MindFreedom-News Digest, Vol 283, Issue
1
************************************************
