January 7, 2010

To: Food and Drug
Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Docket Number FDA-2009-N-0392

To whom it may
concern:

As a survivor and
opponent of electroshock (ECT, electroconvulsive “treatment”)
who, over the years, has communicated with hundreds of other survivors
of the procedure and has studied the subject and written extensively about
it, I am responding to the Food and Drug Administration’s call for
information and comments regarding the current classification of the ECT
devices. I urge the FDA not to reclassify these devices from Class III
(high risk) to Class II (low risk) because the procedure continues to
be, as it has been since its introduction in 1938, an extremely harmful
method used on persons diagnosed as “mentally ill.”

Here, in summary
form, is my case against ECT:

1. Electroshock is
a brutal, dehumanizing, memory-destroying, intelligence-lowering, brain-damaging,
brainwashing, and life-threatening technique. ECT robs people of their
memories, their personality and their humanity. It reduces their capacity
to lead full, meaningful lives; it crushes their spirits. Put simply,
electroshock is a method for gutting the brain in order to control and
punish people who fall or step out of line, and intimidate others who
are on the verge of doing so.

2. Brain damage is
the most ruinous effect of ECT and lies at the root of most of ECT’s
other harmful effects. It is also the 800-pound gorilla in the living
room whose existence electroshock psychiatrists refuse to acknowledge,
at least publicly. Nowhere is this more clearly illustrated than in the
American Psychiatric Association’s Practice of Electroconvulsive
Therapy, which states that “in light of the accumulated body
of data dealing with structural effects of ECT, ‘brain damage’
should not be included [in the ECT consent form] as a potential risk of
treatment” (2001, p. 102). The exclusion of brain damage as a risk
of ECT makes a sham of the entire ECT informed-consent process and turns
what is ostensibly a medical procedure into an act of criminal assault.
The following statements and reports, all by psychiatrists or neurologists,
refute the APA’s position on the risk of brain damage from ECT.

A. “The importance
of the [foregoing autopsied] case lies in that it offers a clear demonstration
of the fact that electrical convulsion treatment is followed at times
by structural damage of the brain” (Alpers and Hughes, 1942).

B. “This brings
us for a moment to a discussion of the brain damage produced by electroshock….
Is a certain amount of brain damage not necessary in this type of treatment?
Frontal lobotomy indicates that improvement takes place by a definite
damage of certain parts of the brain” (Hoch, 1948). Paul H. Hoch,
a Hungarian-born U.S. psychiatrist, had been commissioner of the New
York State Department of Mental Hygiene.

C. In a report
“based on the study of 214 electroshock fatalities reported in
the literature and 40 fatalities heretofore unpublished, made available
through the kindness of the members of the Eastern Psychiatric Research
Association,” David Impastato found that 66 ECT patients had died
from “cerebral” causes among the 235 patients for whom the
cause of death had been stated (Impastato, 1957). Impastato, a Sicilian-born
U.S. psychiatrist, was a leading figure in the early history of ECT
in the United States.

D. An extensive
American Psychiatric Association membership survey found that 41 percent
of the respondents agreed with the statement, “It is likely that
ECT produces slight or subtle brain damage”; 26 percent disagreed
with the statement (American Psychiatric Association, 1978).

E. “Electroshock
‘works’ by damaging the brain…. [T]he changes one sees when
electroshock is administered are completely consistent with any acute
brain injury, such as a blow to the head with a hammer” (Coleman,
1978).

F. “The principal
complications of EST are death, brain damage, memory impairment, and
spontaneous seizures. These complications are similar to those seen
after head trauma, with which EST has been compared” (Fink, 1978).
Eleven years later, Fink was quoted in a magazine article as saying,
“I can’t prove there’s no brain damage [from ECT]. I
can’t prove there are no other sentient beings in the universe,
either. But scientists have been trying for thirty years to find both,
and so far they haven’t come up with a thing” (Rymer, 1989).
Max Fink, an Austrian-born U.S. psychiatrist, is the world’s leading
proponent of ECT.

G. “After
a few sessions of ECT the symptoms are those of moderate cerebral contusion,
and further enthusiastic use of ECT may result in the patient functioning
at a subhuman level. Electroconvulsive therapy in effect may be defined
as a controlled type of brain damage produced by electrical means….
In all cases the ECT “response” is due to the concussion type,
or more serious, effect of ECT. The patient “forgets” his
symptoms because the brain damage destroys memory traces in the brain,
and the patient has to pay for this by a reduction in mental capacity
of varying degree” (Sament, 1983).

H. “A vast
medical literature provides strong evidence that electroconvulsive therapy
causes permanent brain damage, including loss of memory and catastrophic
deterioration of personality” (Polk, 1993).

I. “There
is an extensive animal research literature confirming brain damage from
ECT. The damage is demonstrated in many large animal studies, human
autopsy studies, brain wave studies, and an occasional CT scan study.
Animal and human autopsy studies show that ECT routinely causes widespread
pinpoint hemorrhages and scattered cell death. While the damage can
be found throughout the brain, it is often worst in the region beneath
the electrodes. Since at least one electrode always lies over the frontal
lobe, it is no exaggeration to call ECT an electrical lobotomy”
(Breggin, 1998).

3. The most immediate,
obvious, and distressing effect of electroshock is amnesia. In her book
Doctors of Deception: What They Don’t Want You to Know About Shock
Treatment, electroshock survivor Linda Andre described what that is
like: “The memory ‘loss’ that happens with shock treatment
is really memory erasure. A period of time is wiped out as if it never
happened. Unlike memory loss associated with other conditions, such as
Alzheimer’s, which come on gradually and allow patients and families
to anticipate and prepare for the loss to some extent, the amnesia associated
with… ECT is sudden, violent, and unexpected. Your life is essentially
unlived…. You didn’t just lose your suitcase; you can’t say
where you got it, what it looks like, what you packed in it, what trips
you’ve taken it on. You don’t know that you ever had it”
(Andre, 2009).

4. Electroshock’s
harmful effects can be long-lasting. Electroshock psychologist Harold
A. Sackeim and colleagues concluded their recent study with this statement:
“[T]his 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”
(Sackeim, 2007).

5. Electroshock causes
a significant number of deaths. A 1995 report from the Texas Mental Health
Department (Smith, 1995) revealed that there were eight deaths among approximately
1,600 patients (1 in 200 cases) who had undergone ECT in Texas over a
then recent 15-month period, a rate 50 times higher than the death rate
(“about 1 in 10,000 patients”) given in the consent-form sample
in the American Psychiatric Association’s Practice of Electroconvulsive
Therapy (2001, p. 320). Reports in the professional literature give
further evidence that the ECT death rate is much higher than the rate
claimed by ECT proponents (Frank, 2007).

6. There are no scientifically
sound studies showing that ECT is an effective method of suicide prevention.
The authors of a large study published in the Annals of Clinical Psychiatry
(Black, 1989) reported there was no significant difference in the suicide
rate for depressed patients treated with ECT, anti-depressants, and neither
of these treatments.

7. Unlike its harmful
effects, electroshock’s supposedly “therapeutic” effects
are brief at best. No study shows that these effects persist for more
than at most a few months following the last treatment. One study indicates
the relapse rate for ECT patients is up to 50 percent within six months
following treatment, “even though antidepressant drugs are continued”
(Fink, 1999). Another study of patients diagnosed with “unipolar
major depression” concluded “that without active treatment virtually
all remitted patients [i.e., patients whose symptoms diminished following
ECT] relapse within 6 months of stopping ECT” (Sackeim, 2001). From
this, it is clear that an ECT patient with a diagnosis of depression or
manic-depression runs the serious risk of becoming a permanent outpatient
which usually entails ongoing drug treatment, “maintenance”
ECT, and/or occasional inpatient stays.

8. Contrary to claims
by ECT defenders, newer technique modifications have made electroshock
more harmful than ever. For example, the drugs accompanying ECT to reduce
certain risks, including bone fractures, raise seizure threshold so that
more electrical current is required to induce the convulsion (Saltzman,
1955): the more current applied, the greater is risk of brain damage and
amnesia. Moreover, whereas formerly ECT specialists tried to induce seizures
with minimal current, suprathreshold amounts of electricity are commonly
administered today in the belief that they are more effective.

9. Not only does
the federal government stand by passively as psychiatrists continue to
use electroshock, it also actively supports ECT through the licensing
and funding of hospitals where the procedure is used, by covering ECT
costs in its insurance programs (including Medicare), and by financing
ECT research, including some of the most damaging ECT techniques ever
devised. One study provides an example of such research. This ECT experiment
was conducted at Wake Forest University School of Medicine/North Carolina
Baptist Hospital, Winston-Salem, between 1995 and 1998. It involved the
application of electric current at up to 12 times the individual’s
convulsive threshold on 36 depressed patients. This reckless disregard
for the safety of ECT subjects was supported by grants from the National
Institute of Mental Health (McCall, 2000).

10. The use of ECT
is increasing. More than 100,000 Americans are being electroshocked each
year; half are 60 and older, and two-thirds are women. Seventy percent
of all ECT is insurance-covered. ECT specialists on average have incomes
twice that of other psychiatrists. The cost for inpatient ECT ranges from
$50,000 to $75,000 per series (usually 8 to 12 individual sessions). Electroshock
is a multibillion-dollar-a-year industry.

11. Electroshock
is especially dangerous and life-threatening for elderly patients. One
Rhode Island study conducted between 1974 and 1983 divided 65 hospitalized
depressed patients, 80 years and older, into two groups. Thirty-seven
patients in one group were treated with ECT and the 28 in the other group
were treated with antidepressant drugs. The death rate after one year
for the ECT group was 7.5 times higher than that of the non-ECT group:
10 deaths among the 37 ECT patients (27%) compared with 1 death among
the 28 drug-treated patients (3.6%). The authors, 2 psychiatrists, reported
that “two patients had only 2 ECTs: one withdrew consent, and the
other developed CHF [congestive heart failure] and died before ECT could
be continued.” They also reported that there was “lasting recovery”
for 22% in the ECT group and 71% in the non-ECT group. The authors attributed
the poor outcomes of the ECT patients to “their advanced age and
physical illness” (Kroessler and Fogel, 1993). In his extensive study
of ECT deaths (referred to in paragraph 2C above), Impastato estimated
that the ECT death rate for patients over 60 is one in 200, or 5 times
greater than the death rate of 1 in 1,000 for ECT patients of all ages
(1957, p. 31).

12. As a destroyer
of memories and thoughts, electroshock is a direct, violent assault on
these hallmarks of American liberty: freedom of conscience, freedom of
belief, freedom of thought, freedom of religion, freedom of speech, freedom
from assault, and freedom from cruel and unusual punishment.

Tens of thousands
of people every year in the United States are deceived or coerced into
undergoing electroshock. The FDA should do everything in its power to
discourage the use of electroshock by:
keeping ECT’s Class III, high-risk rating;
insisting that electroshock psychiatrists, manufacturers of ECT devices,
and executives and administrators in hospitals where ECT is administered,
substantiate with scientific proof their claims that the procedure is
“safe and effective”;
and calling upon the Congress and the Department of Justice to investigate
the fraudulent and coercive use of this cruel and inhuman procedure.

References:

Alpers, B.J., Hughes,
J. (April 1942). “The Brain Changes in Electrically Induced Convulsions
in the Human,” Journal of Neuropathology and Experimental Neurology,
pp. 172-177.

American Psychiatric
Association. Electroconvulsive Therapy (Task Force Report 14).
(1978). Washington, DC: Author, p. 4.

American Psychiatric
Association (A Task Force Report). (2001). The Practice of Electroconvulsive
Therapy: Recommendations for Treatment, Training, and Privileging
(2nd Edition). Washington, DC: Author.

Andre, L. (2009).
Doctors of Deception: What They Don’t Want You to Know About Shock
Treatment. New Brunswick, New Jersey: Rutgers University Press, p.
2.

Black, D.W., Winokur,
G. et al. (September 1989). “Does Treatment Influence Mortality in
Depressives?: A Follow-up of 1076 Patients with Major Affective Disorders,”
Annals of Clinical Psychiatry, vol. 1, no. 3, pp. 165-173.

Breggin, P.R. (1998).
“Electroshock: Scientific, Ethical, and Political Issues,” International
Journal of Risk & Safety in Medicine, vol. 11, pp. 5-40.

Cameron, D.O. (Winter-Spring
1994). “ECT: Sham Statistics, the Myth of Convulsive Therapy, and
the Case for Consumer Misinformation,” Journal of Mind and Behavior,
vol. 15, no. 1-2, pp. 177-198.

Coleman, L. (1978).
Introduction to Frank, L.R. (Ed.), The History of Shock Treatment,
San Francisco: Author, p. xiii.

Fink, M. (January-February,
1978). “Efficacy and Safety of Induced Seizures (EST) in Man,”
Comprehensive Psychiatry, pp. 1-18.

Fink, M. (1999).
Electroshock: Restoring the Mind, New York: Oxford University Press,
p. 12.

Frank, L.R. (Ed.).
(1978). The History of Shock Treatment. San Francisco: Author.

Frank, L.R. (Spring
2002). “Electroshock: A Crime Against the Spirit,” Ethical
Human Sciences and Services, pp. 63-71.
http://www.endofshock.com/leonard.htm

Frank, L.R. (2006).
The Electroshock Quotationary (an e-book).
http://www.endofshock.com/102C_ECT.PDF

Frank, L.R. (Ed.).
(2007). “Electroshock and Death” (an internet posting).
http://endofshock.com/101i%20brochure%20on%20deaths%203-29.pdf

Hoch, P.H. (1948).
“Discussion and Concluding Remarks,” Journal of Personality,
vol. 17, p. 48.

Impastato, D.J. (July
1957). “Prevention of Fatalities in Electroshock Therapy,” Diseases
of the Nervous System, p. 31. This 42-page report of 254 deaths is
the largest and most detailed study of ECT deaths ever published. It is
rarely cited in the writings of ECT proponents.

Kroessler, D., Fogel,
B.S. (Winter 1993). “Electroconvulsive Therapy for Major Depression
in the Oldest Old,” American Journal of Geriatric Psychiatry,
pp. 30-37.

McCall, W.V., Reboussin,
D.M. et al. (May 2000). “Titrated Moderately Suprathreshold vs Fixed
High-Dose Right Unilateral Electroconvulsive Therapy,” Archives
of General Psychiatry, May 2000, pp. 438-444.

Morgan, R.F. (Ed.)
(1999). Electroshock: The Case Against. Mangilao, Guam: Morgan
Foundation Publishers.

Polk, H.L. (August
1, 1993). Letter to the editor, New York Times.

Rymer, R. (March-April
1989). “Electroshock,” Hippocrates, p. 71.

Sackeim, H.A., Haskett,
R.F. et al. (March 14, 2001). “Continuation Pharmacotherapy in the
Prevention of Relapse Following Electroconvulsive Therapy” (abstract),
Journal of the American Medical Association, pp. 1299-1307.

Sackeim, H.A., Prudic,
J. (January 2007). “The Cognitive Effects of Electroconvulsive Therapy
in Community Settings,” Neuropsychopharmacology, pp. 244-254.

Saltzman, C., Konikov,
W. et al. (May 1955). “Modification of Electroshock Therapy by Succinylcholine
Chloride,” Diseases of the Nervous System, p. 154.

Sament, S. (March
1983). Letter to the editor, Clinical Psychiatry News. p. 11.

Smith, M. (March
7, 1995). “Eight in Texas Die after Shock Therapy in 15-Month Period,”
Houston Chronicle, pp. 1A, 6A.

Autobiographical
Sketch:

Leonard Roy Frank,
a native of Brooklyn, graduated from the Wharton School of the University
of Pennsylvania in 1954. While committed to a private psychiatric facility
near San Francisco in 1963, he was forced to undergo 50 insulincoma and
35 electroconvulsive procedures, which caused him severe memory loss,
wiping out the preceding three-year-period and effectively destroying
his high school and college educations. Following years of study reeducating
himself, he became active in the psychiatric survivors movement first
by becoming a staff member of Madness Network News (1972) and then
co-founding Network Against Psychiatric Assault (1974), both based in
San Francisco and Berkeley and opposed to all forms of coercive, fraudulent
psychiatric interventions. In 1978 he edited and self-published The
History of Shock Treatment. Since 1995, he has edited Influencing
Minds: A Reader in Quotations (Los Angeles, Feral House), Random
House Webster’s Quotationary (New York, Random House, 1998), and 7
other collections of quotations for Random House. In 2006, he self-published
The Electroshock Quotationary, an e-book. A resident of San Francisco
since 1959, he is a member of MindFreedom International (Eugene, Oregon)
and The Coalition for the Abolition of Electroshock in Texas (Austin).
Here are two Internet links relevant to his work and his encounter with
psychiatry: The Electroshock Quotationary: http://www.endofshock.com/102C_ECT.PDF;
“The Journey of Transformation”: http://www.mindfreedom.org/kb/mental-health-abuse/force/journey-of-transformation/view?searchterm=%22leonard%20roy%20frank%22

Leonard Roy Frank