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EXECUTIVE SUMMARY
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Electroconvulsive Therapy (ECT) is a procedure that continues to be
the subject of serious controversy and disagreement, even within the
psychiatric profession. ECT entails sending an electrical current
into the brain of a patient to produce a grand mal epileptic seizure.
It has been used for many years to treat certain types of mental
illnesses, primarily as a last resort when all other treatment
modalities failed. More recently, the New York State Office of
Mental Health has encouraged the use of ECT as an initial or
mid-level treatment option.
The New York State Assembly's most recent examination of the issue
of ECT began in February, 2001. On February 14, 2001 at a public
hearing in Syracuse, New York regarding the proposed closing of the
Hutchings Psychiatric Center , a presenter discussed the case of
Paul Henri Thomas, then a patient at Pilgrim Psychiatric Center who
had been receiving ECT against his will. The Assembly subsequently
became aware of the case of Adam S., another patient at Pilgrim P.C.
who was a recipient of ECT therapy against his wishes and those of
his family.
Since the State Legislature had not conducted a formal review of
ECT use in New York State since the mid-1970s, the Assembly scheduled
hearings in New York City on May 18, 2001 and in Albany on July 18,
2001. The purpose of the first hearing was to determine the
incidence of ECT use in the State, its efficacy, benefits and
risks, and to examine issues related to informed consent and
involuntary court ordered ECT. The second hearing was held to
obtain feedback on the initial series of proposed legislation
addressing ECT introduced by the Assembly.
It was clear from testimony received that there was a wide
variation of opinion related to the use of ECT. Proponents
claimed that ECT is a safe, effective procedure with no permanent
adverse side effects and cited a figure of 1 in 10,000 deaths
related to ECT to document its safety. In contrast, opponents
maintained that ECT causes brain damage, can result in permanent
memory loss and, in some cases death, and asserted that the death
rate related to ECT was closer to 1 in 200. Opponents expressed
additional concerns about the utilization of ECT on children, the
elderly, other vulnerable populations and possible use as a behavior
modifying, non-therapeutic intervention for mentally retarded
individuals.
Currently, there is no regulation of ECT protocols by the State or
federal governments. However, the federal Food and Drug
Administration (FDA), which has regulatory authority over ECT
devices, considers ECT machinery to be experimental, Class III
devices. Such a classification is used for pre-market approval for
medical devices that show an unreasonable risk of illness or
injury. Although the FDA has never completed testing of ECT
devices to determine its safety, ECT has been in use since the
1930's.
In addition to the public hearings, New York State Assembly
Mental Health Committee Chairman, Martin A. Luster, and Committee
staff met with proponents and opponents of ECT, as well as
representatives from the State Office of Mental Health (OMH),
Office of Mental Retardation and Developmental Disabilities
(OMRDD), Commission on Quality of Care for the Mentally Disabled
(CQC), and the Mental Hygiene Legal Service (MHLS). Committee
staff also reviewed extensive literature regarding ECT.
The Committee sought information regarding the prevalence of
ECT use within the State and found there were no available
statistics. The Committee requested the CQC complete a survey
of ECT use in State operated psychiatric centers. The CQC found
that protocols varied at the five State-operated psychiatric centers
that perform ECT. CQC recommended that OMH establish a Blue Ribbon
Task Force to develop procedures for consistent application
throughout State facilities administering ECT use, while
simultaneously promoting the application of best practices
and strict adherence to statutory and regulatory standards
for safeguarding patient rights. The Committee has requested
the CQC complete another survey of ECT use in non-state operated
facilities. The results of this survey are not yet complete.
Moreover, the Committee requested the MHLS provide statewide
statistics on applications for court orders authorizing ECT. In
April 2001, the MHLS reported a 73% increase in such applications
between 1999 and 2000. On May 17, 2001, in a written response to
the Committee's initial public hearing notice, the MHLS identified
concerns with respect to the current practices for obtaining consent
for ECT.
The Committee also reviewed the American Psychiatric Association's
(APA) 2001 Task Force report, The Practice of Electroconvulsive
Therapy, Recommendations for Treatment, Training, and Privileging,
Second Edition, which delineated issues related to the education and
training of ECT practitioners, procedures for obtaining informed
consent, standards for ECT administration and safety of ECT
equipment. The Task Force report further identified certain
equipment that should no longer be used to provide ECT and
expressed concern that ECT facilities be properly equipped and
staffed with personnel to manage potential clinical emergencies.
During its review, the Committee uncovered instances where ECT had
been administered with equipment that the APA stated should no longer
be used and on an outpatient basis in physician offices where
emergency equipment and staff were unavailable.
Article VII of the New York State Constitution states that the aid,
care and support of the needy are public concerns (Section One),
that the protection and promotion of the health of the State's
inhabitants are also matters of public concern (Section Three)
and that the care and treatment of persons suffering from a mental
disorder or defect, as well as the protection of the mental health
of inhabitants may be provided by State and local authorities in
such manner as the Legislature may from time to time determine
(Section Four).
In an effort to mitigate identifiable areas of concern,
the Assembly has introduced five legislative proposals to
ensure proper use and administration of ECT:
- Resolution 2097 - Resolution calling upon the United
States Congress to require the FDA to determine safety of ECT
equipment and to pass legislation establishing proper protocols
and administration of use.
- A.9081 - Defines capacity as well as procedures for
assessing a patient's mental capacity in supplying consent
for ECT treatment. Requires written disclosure of benefits,
risk and alternatives as a component of authorized
(i.e. signed) informed consent.
- A. 9082 - Creates a temporary advisory
council on ECT to address associated issues, including
but not limited to education and training of ECT
practitioners on standards for administration and
equipment safety.
- A. 9083 - Requires mandatory reporting of
information regarding ECT use to enable the OMH
Commissioner to better regulate its application and
help ensure that the Legislature effectively exercise
its constitutional oversight function.
- A. 9084 - Mandates all
facilities practicing ECT to provide accessible
emergency treatment.
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INTRODUCTION
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In order to better understand the issues related to the efficacy
and use of Electroconvulsive Therapy (ECT), Committee staff
conducted extensive research. Individuals with a working knowledge
of ECT were interviewed, including ECT recipients, proponents,
opponents, researchers, medical and mental health professionals
and human rights advocates. Staff reviewed numerous documents to
gain insight regarding ECT's historical basis, its efficacy related
to certain mental health diagnoses, evolution of equipment and
protocols, and potential risks and benefits. Public hearings were
held in New York City on May 18, 2001 and in Albany on July 18, 2001
to receive input regarding the efficacy of ECT, to identify possible
legislative actions, and to receive feedback on proposed legislation.
This report is intended to summarize the Committee's findings and
provide a basis for legislative action regarding ECT.
This report is organized in the following manner to assist the
reader in understanding the issues, controversies and recommended
legislative actions: Introduction, Background, Incidence of Use,
Safety, Protocols, Special Populations, Informed Consent, Cases of
ECT and Conclusion.
The Committee selected eight documents for inclusion in this
report, as well as testimony from its public hearings on ECT and
excerpts of communications received or distributed. The documents
referred to throughout the report include, but are not limited to
the following:
- "Electroconvulsive Therapy. National Institutes of
Health, Consensus Development Conference Statement," June 1985.
- New York State Protection and Advocacy for Individuals
with Mental Illness Advisory Council (PAIMI), Resolution,
March 15, 1996.
- "ECT Practices in the Community, an unpublished
report," J. Prudic, M. Olfson, and H.A. Sackeim.
- The Practice of Electroconvulsive Therapy, Recommendations
for Treatment, Training, and Privileging, Second Edition, Task
Force Report of the American Psychiatric Association, 2001.
- Written Comments to the Committee regarding ECT by the
Mental Hygiene Legal Services (MHLS), May 17, 2001.
- "Information about ECT," Office of Mental
Health, July 2001.
- "Survey of the Provision of Electro-Convulsive Therapy
(ECT) at New York State Psychiatric Centers," Commission on
Quality of Care for the Mentally Disabled, August 7, 2001.
- "ECT: Sham Statistics, the Myth of Convulsive Therapy,
and the Case for Consumer Misinformation," Douglas Cameron,
The Journal of Mind and Behavior, Winter and Spring 1994,
Volume 15, Numbers 1 and 2.
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BACKGROUND
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The use of Electroconvulsive Therapy (ECT) has been a subject of
controversy since it was first introduced in 1938. The process of
sending an electrical shock into a person's brain in order to produce
an epileptic grand mal seizure does not appear as a safe process to
many people, including health care professionals and mental health
experts. Further, the fact that mental health experts do not fully
understand how ECT works, coupled with its indiscriminate use to
treat a variety of mental illnesses following the first few decades
of its introduction, have contributed to the ongoing controversy.
The lack of federal testing of ECT devices, as well as an absence of
federal or state regulation of ECT protocols and demographic and
statistical data related to ECT use, have also contributed to the
longstanding controversy surrounding its safety and efficacy.
The following reflects opinions from well known established
organizations addressing mental health concerns in New York State
and nationwide:
NATIONAL INSTITUTES OF HEALTH CONSENSUS STATEMENT,
JUNE, 1985
In June 1985, the National Institutes of Health (NIH) published a
Consensus Statement regarding ECT. NIH Consensus Statements are
prepared by a non-advocate, non-federal panel of experts and reflect
the panel's assessment of medical knowledge available at the time the
statement was written. Following are excerpts from the NIH
statement.
Electroconvulsive therapy is the most controversial treatment in
psychiatry. The nature of the treatment itself, its history of abuse,
unfavorable media presentations, compelling testimony of former
patients, special attention by the legal system, uneven distribution
of ECT use among practitioners and facilities, and uneven access by
patients all contribute to the controversial context in which the
consensus panel has approached its task...To prevent misapplication
and abuse, it is essential that appropriate mechanisms be established
to ensure proper standards and monitoring of ECT (NIH, pgs. 11-12).
Electroconvulsive Therapy (ECT) is a treatment for severe mental
illness in which a brief application of electrical stimulus is used
to produce a generalized seizure. In the United States in the 1940s
and 1950s, the treatment was often administered to the most severely
disturbed patients residing in large mental institutions. As often
occurs with new therapies, ECT was used for a variety of disorders,
frequently in high doses and for long periods. Many of these efforts
proved ineffective and some even harmful. Moreover, its use as a
means of managing unruly patients, for whom other treatments were
not then available, contributed to the perception of ECT as an
abusive instrument of behavioral control for patients in mental
institutions for the chronically mentally ill, (NIH, p. 2).
Although ECT has been in use for more than 45 years, there is
continuing controversy concerning the mental disorders for which
ECT is indicated, its efficacy in their treatment, the optimal
methods of administration, possible complications, and the extent
of its usage in various settings. These issues have contributed to
concerns about the potential for misuse and abuse of ECT and the
desire to ensure the protection of patient's rights. At the same
time, there is concern that the curtailment of ECT use in response
to public opinion and regulation may deprive certain patients of a
potentially effective treatment (NIH, p. 2). To maximize the
benefits of ECT and minimize the risks, it is essential that the
patient's illness be correctly diagnosed, that ECT be administered
only for appropriate indications, and that the risks and adverse
effects be weighed against the risks of alternative treatments
(NIH, p.5).
NEW YORK STATE PROTECTION AND ADVOCACY FOR INDIVIDUALS
WITH MENTAL ILLNESS ADVISORY COUNCIL (PAIMI), MARCH 15, 1996
RESOLUTION
The Protection and Advocacy for Individuals with Mental
Illness Amendments Act of 1991 (Public Law 100-509) provides legal
advocacy supports for individuals who have been diagnosed as mentally
ill and who reside in any residential facility which provides care and
treatment, or who are in the process of being admitted or recently
discharged from such facility. The PAIMI system investigates
complaints about abuse, neglect and violation of rights, and provides
both legal and non-legal advocacy on behalf of individuals. On
March 15, 1996, PAIMI, a federally funded arm of the New York
State Commission on Quality of Care for the Mentally Disabled,
issued a resolution requesting that New York State consider
development of legislation that would provide for monitoring of
the provisions of ECT, as well as for informed consent of ECT
recipients. According to PAIMI:
- Electroconvulsive therapy (ECT) is a
procedure that continues to be the subject of serious
controversy and disagreement, even within the psychiatric
profession.
- There is a growing body of evidence that there
is substantial potential for irreversible brain damage and
permanent memory loss.
- No standards exist which pertain to the mechanical
safety of equipment used to administer ECT or to the
certification of the operators of such equipment.
- No State regulation or policy exists which
governs the manner in which ECT is administered.
- No safeguard exists which assures truly informed
consent.
When contacted by Committee staff prior to the first public
hearing on ECT, PAIMI reaffirmed its support of its 1996resolution.
ECT PRACTICES IN THE COMMUNITY (an unpublished report)
In a 1997 study, funded in part by the National Institute of
Mental Health, the New York State Psychiatric Institute and Columbia
University conducted a survey of 86 facilities in the greater
New York Metropolitan area that used ECT. Responses were received
from nearly 70% (59) of these facilities.
The survey revealed that facilities varied considerably in many
aspects of ECT practice, including frequent departures from field
standards. It further found that the more intensive the form of ECT
used at the facilities, the less likely cognitive status was assessed
following the course of treatment. The survey concluded that,
"the marked departures from the field standards of care and
the wide variability in how ECT is conducted, undoubtedly raise
public health concerns." (Prudic, Olfson and Sackeim,
p. 8)
TASK FORCE REPORT OF THE AMERICAN PSYCHIATRIC
ASSOCIATION, 2001
The Practice of Electroconvulsive Therapy, Recommendations
for Treatment, Training, and Privileging, Second Edition is a
Task Force report of the American Psychiatric Association.
Following are some key excerpts:
- The decision to recommend the use of ECT
derives from a risk/benefit analysis for the specific
patient.
- ECT should not be reserved for use only as a
last resort.
- The likely speed and efficacy of ECT are factors
that influence its use as a primary intervention.
Additional considerations for the first line use of ECT
relate to the patient's medical status, treatment history
and treatment preference.
- ECT is most often used in patients who have
not responded to other treatments.
- There are no diagnoses that should automatically
lead to treatment with ECT.
- To some extent, medical adverse events can be
anticipated.
- Continuation therapy has become the rule in
contemporary practice…the risk of relapse after ECT is very
high, particularly during the first few months…the need for
aggressive continuation therapy…is compelling and should be
instituted as soon as possible.
- After ECT, concern over recurrence of illness
is so great…that maintenance therapy should be initiated
for virtually all patients receiving continuation therapy.
At present, no applicable data indicate how long maintenance
therapy should be sustained after ECT.
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INCIDENCE OF USE
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Information regarding the incidence of ECT use in New York State
is currently not required by the State. Information regarding
equipment type, a provider registry (by classification), protocols
utilized, consent procedures and demographic statistics need to
be collected and reported in order to ensure that patient rights,
safety protective measures and efficacy are comprehensively examined
on an ongoing basis with regard to the administration, use, oversight
and outcomes of ECT treatment in New York State.
When the issue of ECT was brought to the Committee's attention,
efforts were made by Committee staff to ascertain the prevalence
of ECT use in New York State. It soon became apparent that such
information was not available. The Committee requested the Office
of Mental Health, Commission on Quality of Care for the Mentally
Disabled and Mental Hygiene Legal Services, collect specified
information. The Committee also reviewed an unpublished joint
report by the New York State Psychiatric Institute and Columbia
University, which summarized the results of a 1997 survey of ECT
use in the greater New York Metropolitan area. In lieu of
comprehensive statewide information regarding ECT, the Committee
has compiled anecdotal information that provides a snapshot of ECT
use in the State.
NIH CONSENSUS STATEMENT, JUNE, 1985
The panel is concerned that there are only limited data on
the manner and extent of ECT administration in the United States
and on the training of personnel involved in it. A national
survey should be undertaken to assemble basic facts about the
status of ECT treatment (NIH, p. 10).
ECT PRACTICES IN THE COMMUNITY (an unpublished report)
The 1997 study, completed by the Departments of Biological
Psychiatry and Clinical and Genetic Epidemiology at the NYS
Psychiatric Institute and Departments of Psychiatry and Radiology,
College of Physicians and Surgeons, Columbia University, stated that
ECT is utilized in the U.S. far more in private and academic medical
facilities than in public sector hospitals. The report elaborates
that "Age, income and race are powerful predictors of ECT
utilization in the U.S., which is higher among older, more affluent,
and white patients…The greater utilization in older patients has
been attributed to the high presentation in this group of medical
intolerance…The greater use of ECT in non-minority populations and
those of higher income is unexplained" (p. 3). In addition, the
report found that:
- Nine of the 59 reporting facilities treated 58% of the
patients receiving ECT in the Greater Metropolitan New York City
area.
- The majority of patients were greater than 60 years
of age.
- No facility reported treating children under age 13 and
ECT use among adolescents from ages 13-18 years was extremely
rare.
- The great bulk of ECT was performed exclusively on an
inpatient basis.
- The high volume ECT facilities were more likely to
utilize outpatient ECT.
- On average, 46.2% of patients had cognitive impairment
following ECT.
- Recent literature suggests that relapse rates in the year
following ECT may be 60% and higher. The facilities estimated
that the relapse rate is only 20.2%, a striking contrast.
Dr. Harold Sackeim, Chief of Biological Psychiatry at the New
York State Psychiatric Institute, member of the APA's Task Force
Committee on Electroconvulsive Therapy, and co-author of the Task
Force report and more than 200 other publications relating to ECT,
testified at the May 2001 public hearing. Dr. Sackeim stated there
are no known statistics on the use of ECT in NYS. However, based
upon the 1997 survey, he surmised that the 59 respondent facilities
average 51 patients annually for ECT treatment (which totals 3,009
individuals). Dr. Sackeim advised, given his best estimate, that
approximately 100,000 patients receive ECT per year in the U.S.,
and proportionately nearly 7,000 NYS residents receive such treatment
annually. Dr. Sackeim cautioned that his figures are likely to be
conservative given higher rates associated with ECT use concentrated
in metropolitan areas.
On April 12, 2001, the MHLS, at the request of the Committee,
reported on the collection of statewide statistics on applications
for court orders authorizing ECT. While stating there may be a few
cases not captured due to minor variations at the field staff level
in the coding of treatment proceedings, the MHLS noted a 73%
increase in applications in 1999 to 2000, from 59 to 97. Since
1997, applications for court orders authorizing ECT increased by
125% (43 to 97). The MHLS stated that more often than not, ECT is
administered without court involvement. Additionally, MHLS advised
it is not routinely notified when a patient does not object or when
the ECT is performed per the patient's consent or in instances when
someone other than the patient grants consent on their behalf without
judicial intervention.
On June 1, 2001, OMH provided the Committee with limited
demographic information regarding ECT use. The Committee requested
additional information, which was received in June 2001 and
summarized below:
- Five of OMH's 27 facilities currently provide ECT on
site and 12 facilities used offsite providers in
calendar year 2000.
- The five OMH operated facilities, which
provide ECT on site, are in compliance with APA guidelines.
- A total of 134 inpatients received ECT during
calendar year 2000 (CY2000).
- Of the 134 individuals in OMH facilities receiving
ECT in CY2000, 26% were court ordered. Since 1998, the number
of court ordered ECT procedures increased by 52%.
- During (1998-2000), the distribution by gender was
45% male and 55% female.
- By age, the distribution was 33% for persons
18-44 years; 43% for ages 45-64 and 24% for recipients
65 and older.
- In CY2000 there was one patient, age 17 years
and 8 months, in a children's facility who received ECT.
- According to SPARCS data from the New York State
Department of Health, the rate of ECT was 1.8% (1,822 individuals)
of the total number of persons served in non-OMH facilities
in CY2000.
SURVEY OF THE PROVISION OF ELECTRO-CONVULSIVE THERAPY AT NEW YORK STATE
PSYCHIATRIC CENTERS, COMMISSION ON QUALITY OF CARE, AUGUST 7, 2001
On October 2, 2001, the CQC forwarded the Committee its
report, "Survey of the Provision of Electro-Convulsive
Therapy at New York State Psychiatric Centers." dated
August 7, 2001, which reflected its findings from the most
recent survey conducted on the provision of ECT at New York
psychiatric centers. Following are report excerpts:
The purpose of this survey was to obtain information about the
frequency of administration of this treatment; facilities'
management of such, and the patients who undergo this treatment,
but not to evaluate its efficacy. As a result, the Commission
obtained information about facility-specific procedures
governing the use of ECT; protocols for privileging physicians
to administer the procedure; and demographic information
regarding age, gender, diagnosis and capacity to consent for
those persons receiving ECT in state psychiatric centers between
June 1, 1999 and May 31, 2001...ECT is currently administered in
Manhattan Psychiatric Center, Creedmoor Psychiatric Center, Pilgrim
Psychiatric Center, the Psychiatric Institute (PI), and Rockland
Psychiatric Center (p. 1).
The Commission identified 164 patients that had received ECT
during the timeline within 1999-2001 as outlined above.
Excluding PI, where all ECT patients are voluntary participants
in a research protocol, approximately 40% are receiving ECT
pursuant to court orders. The CQC found that ECT was not
administered to children at state psychiatric centers and was
given to women (62%) more often than men (38%).
HILLSIDE HOSPITAL
On June 26, 2001, the Committee requested OMH conduct a formal
investigation of the use of ECT at Hillside Hospital in Queens.
This request followed articles appearing in the New York Post
alleging that patients at Hillside Hospital were being given ECT
as a behavioral modification mechanism and that patients had been
coerced to agree to ECT.
On February 8, 2002, OMH staff verbally reported the findings
of this investigation to Committee staff. During the period
of January 1999 through July 2001, a total of 360 inpatients
received ECT, of which one person was retarded, another autistic
and one other diagnosed with delirium. Moreover, 10 of the 360
inpatients were adolescent recipients of ECT between the ages of
14 -17. While OMH did not find evidence to support the allegations
reported in the New York Post, it is continuing its review of ECT
practices at Hillside in response to questions raised by
Committee staff at the February 8, 2002 briefing.
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SAFETY
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There is a great deal of controversy regarding the safety of
ECT equipment, its use, and its long-term impacts, including
permanent memory loss and death. The safety of ECT devices
will remain a contentious issue until appropriate testing of
all types of ECT devices is completed. The Committee received
testimony and reviewed written materials regarding the efficacy
of ECT and its safety.
ECT PROPONENTS AND OPPONENTS
Proponents assert that ECT is a relatively safe procedure with
minimal long-term cognitive effects on memory and further cite a
death rate of 1 in 10,000 to document safety.
Dr. Richard Weiner, Professor of the Department of Psychiatry
at Duke University Medical Center, Chairperson of the APA's Task
Force Committee on Electroconvulsive Therapy, and co-author of
the Task Force report, appeared before the Committee at its May
18, 2001 public hearing on behalf of the APA. Dr. Weiner outlined
that ECT is a highly effective and rapid treatment for individuals
with certain defined severe mental illnesses.
At the same hearing, Dr. Sackeim, another APA representative and
colleague on the Task Force, stated in his written testimony:
The efficacy of ECT in specific psychiatric conditions is
amongst the most well established of any treatment in all of
medicine…The beneficial effects of ECT are not expected to
last unless other biological treatments are used as maintenance
treatments…The medical morbidity and mortality rates with ECT
are low. Despite some media statements to the contrary, a fair
estimate is that death associated with ECT occurs in approximately
1 in 10,000 patients, approximately the same as receiving general
anesthesia alone. This is particularly noteworthy since ECT is
often used in patients with serious medical complications….A
limiting factor in the use of ECT is its cognitive effects…the
negative effects of ECT on cognition involve two types of deficits.
During and following ECT, patients will show rapid forgetting of
newly learned information. This is termed anterograde amnesia…All
available information, from scores of studies, indicates that this
deficit disappears within days to a few weeks following the end
of ECT. ECT also results in a loss of memory for events that
occurred prior to the receipt of the treatment. This type
of memory loss is termed retrograde amnesia…All recent
published surveys of patients who have received ECT have
shown that the vast majority report that this form of memory
loss is a small price to pay for the therapeutic effects of
the treatment. As with all medical treatments, there are
individual differences, and some very rare patients may manifest
more extensive memory loss....There is no firm estimate on this
incidence…but my estimate would be on the order of 1 in 500
patients. Careful scientific study has shown that ECT does not
cause brain damage (cellular death)…To the contrary, all
antidepressant treatments promote the development of new
neurons (brain cells), a recently discovered fact. ECT is
the most effective in this regard.
The Committee also received testimony and letters from
recipients of ECT. One representative letter stated, "I
suffer from chronic depressive disorder recurrent and received
ECT two years ago… ECT has allowed me to function again. I will
be eternally grateful that ECT was available to me and hope
that it will continue to be available in the future"
(undated letter received June 2001).
Opponents, on the other hand, paint a very different picture.
Dr. Peter Sterling, a neuroscientist at the University of
Pennsylvania testified on July 18, 2001 regarding the effects
of ECT on the brain. He stated:
ECT unquestionably damages the brain, and there are a variety
of mechanisms that lead to this damage. In the first place,
the electroshock delivered to the skull is basically similar to
what you would get out of an electrical wall outlet, except that
there is a transformer in the ECT machine that steps up the
voltage…when this is done two or three times a week for weeks,
it's just completely obvious that this is going to eventually
cause some kind of brain damage…Now the second point, source of
brain damage for ECT is that it causes…grand mal epileptic
seizures…and this causes an acute rise in blood pressure, well
into the hypertensive range…And it frequently causes small…hemorrhages
in the brain. And wherever a hemorrhage occurs in the brain,
nerve cells die, and they are not replaced. And so one can
accumulate these hemorrhages over a period of treatments leading to
brain damage. A third thing that ECT does is to rupture the blood
brain barrier. This barrier normally protects the brain from
potentially damaging substances in the blood….breaching this barrier
exposes nerve cells in the brain to chemical insults that can kill
them…also leads…to swelling of the brain…swelling leads to local
arrest of blood supply, to loss of oxygen…and to death of neurons.
The fourth thing…is that ECT…causes neurons to release large
quantities of …glutamate. Glutamate excites further neuronal
activity…and this becomes a vicious cycle…Neurons literally…kill
themselves from over activity….the key manifestation of this brain
damage is retrograde memory loss….the tide seems to have turned.
And one of the most important proponents of ECT, Dr. Harold Sackeim
now acknowledges that memory and cognitive losses are real…excerpt
from Dr. Sackeim's recent editorial in the Journal of ECT…Virtually
all patients experience some degree of persistent and, likely,
permanent retrograde amnesia. A series of recent studies
demonstrates that the retrograde amnesia is persistent, and
that this long-term memory loss is substantially greater with
bilateral than right unilateral ECT.
ECT adversaries also state that the death rate is much higher
than 1 in 10,000 and more likely is 1 in 200 for elderly persons
undergoing ECT. Opponents cite data collected in Texas, the only
state presently requiring reporting of the incidence of ECT. Mr.
William Sullivan, Executive Director of the Mental Health Association
of Essex County, testified that deaths do occur from the procedure,
whether from the insult to the brain, a result of anesthesia, or
muscle relaxants used. Mr. Sullivan called for objective research
to determine the risks.
Again, the Committee received information and testimony from ECT
recipients, as well as from family members regarding the adverse
and/or permanent effects of ECT use on loved ones. The testimony
of Linda Andre, Director of the Committee for Truth in Psychiatry,
at the May 18th hearing, supplied the Committee with insight from a
"survivor's" perspective:
I am a survivor of ECT. I had involuntary ECT, though not
court-ordered ECT, and I had a fairly typical experience with it.
By that I refer to the fact that I lost five years of my life, which
were erased as if they had never happened…I have documented brain
damage, including 38 points off my IQ, and I live with daily memory
disability and cognitive disability that made it impossible for me
to return to my career.
EQUIPMENT
The safety of the devices used to administer ECT has been an
issue of longstanding contention among professionals and advocacy
bodies. In 1976, Congress enacted legislation granting the federal
Food and Drug Administration (FDA) authority to regulate certain
medical devices, including machines used to administer ECT. However,
the FDA was given only limited jurisdiction regarding ECT equipment
due to a grandfather clause that allowed continued use absent FDA
testing. Subsequently, in 1979, the FDA designated and classified
ECT devices as Class III medical devices. A Class III designation
is used for pre-market approval for devices that show an unreasonable
risk of illness or injury. Yet, no formal tests were conducted by
the FDA to determine the safety of such devices.
The APA, in its 2001 ECT Task Force report, identified certain
devices that should no longer be used, including sine wave, constant
voltage and constant energy devices, due to their negative impacts
on post ECT cognitive functioning of patients. The APA recommended
the use of brief pulse devices that would be safer. However, the
extent to which older ECT devices, no longer justified according to
the APA, continue to be used is unknown. Though difficult to track,
given existing oversight mechanisms, it appears likely that
such devices will remain in the marketplace to some degree
throughout the country and within New York State.
As an addendum to Ms. Andre's testimony was an article, "ECT:
Sham Statistics, the Myth of Convulsive Therapy, and the Case for
Misinformation," by Douglas Cameron, of the World
Association of Electroshock Survivors:
It has now become fashionable to declare brain damage from ECT
a thing of the past because of "new refinements" in
the procedure and in the machines…The implication that the sine
wave device of old has been replaced by the brief pulse device of
present lurks behind much of the continued use of ECT….Modern
day BP devices are not "lower current" machines, as most proponents
claim. Through electrical compensation, they equal SW devices in
every respect, and emit far greater energy….Most experts agree that
current, not convulsion…is responsible for long term memory loss
and severe cognitive dysfunction….Manufacturers may have parted
from the convulsion theory exemplified by just above seizure
threshold devices of the past, to what might be just above damage
threshold devices of the present, and if not forced to stop and
prove the safety of their devices (allowing for even more powerful
machines), might be embarking upon just above agnosognosic threshold
appliances of the future.
In summary, modern electric shock machine companies are
attempting to redefine safety from the original convulsion
concept of "just above seizure threshold" to "safer
wave form." The Food and Drug Administration must
rescrutinize today's SW and BP devices, withdrawing their
"grandfathered in" status under compulsive therapy
devices. Because they utilize an entirely different principle,…all
modern EST device manufacturers must be required to prove machine
safety to the Food and Drug Administration, prior to further
utilization of new machines.
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PROTOCOLS
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There are no minimal, federally approved standards governing the
education, training and privileging of medical practitioners of ECT.
Further, there are no federally approved standards for required
protocols to ensure the safety and efficacy of ECT. In effect,
this has resulted in the implementation of a patchwork of protocols
across the nation. The efficacy of ECT and the impacts on patient
safety can be significant if certain equipment, protocols and
procedures are used. Yet, the 1985 NIH Consensus Statement
regarding ECT did not include specific recommendations for ECT
protocols, nor does the APA's 2001 Task Force report outline or
advocate for mandatory safeguard requirements. On the contrary,
the APA's report, identifies suggested protocols for voluntary
implementation, which does not provide the assurance necessary to
protect the health and safety of ECT patients.
NIH CONSENSUS STATEMENT, JUNE, 1985
An area location should be designated for the
treatment of ECT and for supervised medical recovery from
the treatment. This area should have appropriate health care
professionals available and include equipment and other medications
that could be used in the event of cardiopulmonary or other
complications resulting from the procedure (NIH, p. 9).
2001 APA TASK FORCE REPORT
- ECT is a complex procedure that requires a well-trained,
competent staff of professionals if it is to be administered in a
safe and effective fashion.
- ECT training in residency programs in the United
States ranges from excellent to totally absent. In many
cases, training is no more than minimal.
- No national accrediting body presently provides assurance of
competence in ECT. Accordingly, clinical competency of practitioners
is presently ensured through local privileging.
- Each member of the ETC team should be clinically
privileged to practice his or her respective ECT duties or be
otherwise authorized by law to do so.
- It is clear that general privileging in psychiatry
will not suffice and that specific clinical privileges to
administer ECT should be required.
- It is incumbent on facilities using ECT to implement
and monitor compliance with reasonable and appropriate policies
and procedures.
- ECT facilities should be appropriately equipped and
staffed with personnel to manage potential clinical emergencies.
- A variety of devices to administer ECT are in use.
- There is evidence that disruption of the EEG is more
profound with sine wave stimulation. Consequently, the
continued use of sine wave stimulation in ECT is not justified.
- ECT devices also differ in whether they operate on
principles of constant current, constant voltage or constant
energy.
- No conceptual justification exists for the
use of a constant voltage device in ECT.
- There is no conceptual justification for the use of a
constant energy device in ECT.
- Device manufacturers should provide detailed descriptions
of testing procedures and preventative maintenance instructions.
- As with other medical devices, a regular schedule of
retesting or recalibration by biomedical engineers or other
qualified professionals should be implemented.
- Electrode placement affects the breadth, severity and
duration of cognitive side effects. Bilateral ECT produces
more short and long term adverse cognitive effects than right
unilateral ECT.
- The extent to which practitioners use unilateral or
bilateral ECT varies considerably.
- The choice of stimulus dosing strategy should
consider that initial seizure threshold may vary widely
among patients and generally increases over the treatment
course.
- The choice of stimulus dosing strategy should also
consider that therapeutic and adverse effects might vary
depending upon the extent to which the stimulus intensity
exceeds the seizure threshold.
- Before the muscle relaxant is administered, a blood
pressure cuff should be inflated. Use of the cuff procedure
allows for timing of unmodified convulsive movements without
risk to the patient.
- At a minimum, one channel of EEG activity should be
monitored with a paper record or auditory output.
INFORMATION ABOUT ECT, OFFICE OF MENTAL HEALTH, 2001
In July 2001, OMH submitted written information to the Committee
regarding ECT. This OMH document states:
In order to maximize effectiveness and minimize side-effects,
OMH is committed to ensuring that practitioners administering
ECT in New York State follow the latest (second edition, 2001)
guidelines published by the American Psychiatric Association
(APA) Task Force on ECT. OMH psychiatric centers which provide
ECT adhere to the APA's Guidelines regarding its
administration.
Two of the guidelines cited in this document were:
- Procedures for obtaining written consent for the
administration of ECT for patients who possess the capacity
to consent
- Staff requirements, including medical disciplines,
privileging, training and specific treatment responsibilities
While OMH acknowledges that APA suggested guidelines are
worthy of adherence and assert they are being abided by OMH
psychiatric centers, unless OMH establishes stringent mandates
requiring such conformity, providers of ECT treatment will not
consistently apply the use of these parameters statewide. Again,
the APA's guidelines are recommendations, not required mandates.
ECT PRACTICES IN THE COMMUNITY (an unpublished report)
The 59 facilities surveyed varied considerably in many
aspects of ECT practice: stimulus waveform, electrode placement,
stimulus dosing, primary anesthetic agent, physiological monitoring,
frequency of cognitive assessment, and so on….In a number of instances,
the practices reported by the facilities clearly departed
from the 'standards' in the field….Finally, this study
did not audit actual practices, but relied on the report of the
Directors of ECT Services. Concerned about the correspondence
between the reports and actual patterns of practice, we also
reviewed the medical charts …When discrepancies were found between
the survey results and the review of the medical records, they were
consistently in the direction of… the reports by the ECT service
directors being more in line with guideline recommendations than
actual practices of the facilities (pgs. 8-9).
The report found:
- The forms of ECT administered varied widely.
- EEG monitoring was not used in 14% of the facilities.
- Monitoring of the motor seizure with the cuff technique
was not conducted in 53% of the facilities.
- Approximately 11% of patients received sine wave stimulation.
- Approximately 75% of patients were treated with bilateral ECT.
- The primary strategy was fixed dosages at 11 facilities.
- Nine facilities reported some use of multiple-monitored ECT, in
which more than one seizure is evoked in a session.
SURVEY OF THE PROVISION OF ELECTRO-CONVULSIVE THERAPY
(ECT) AT NEW YORK STATE PSYCHIATRIC CENTERS BY THE COMMISSION
ON QUALITY OF CARE, AUGUST 7, 2001
The CQC survey determined that protocols varied in detail
regarding the procedure itself, as well as in issues such as
physician privileging and determining capacity to consent.
The CQC report stated, "While all facilities have policies
and procedures in place governing the use of ECT, policies
regarding the credentialing of physicians and addressing
informed consent varied widely" (pg. 5).
The CQC recommended that OMH establish a Blue Ribbon Task Force
charged with the responsibility of developing ECT protocols that
can be consistently applied in state facilities administering ECT
and which promote the application of best practices while ensuring
strict adherence to statutory and regulatory standards for
safeguarding patient rights. In response, OMH stated that,
in January 2001, the Office began reviewing an ECT checklist
that had been used by State psychiatric centers administering
ECT for the prior two-year period. OMH also stated it had drafted
guidelines for consistent ECT administration and was planning to
submit these guidelines to the APA and HANYS (Health Association
of NYS) for review.
On October 11, 2001 Assembly Mental Health Committee Chair,
Martin Luster, wrote to OMH Commissioner Stone. Chairman Luster's
correspondence requested specifics including the following:
In chairing two public hearings on ECT, I have come to recognize
the wide range of opinions regarding the efficacy and best practices
relative to the administration of ECT. I am interested to know what
measures you have taken to ensure OMH's in-house review will address
the broad scope of issues that exist and include the varying opinions
that a blue ribbon task force would be charged with addressing. Could
you please provide me with an update on your progress with regard to
OMH's in-house review of ECT policies and a copy of OMH's draft
guidelines for state facilities administering ECT, with a list of
individuals consulted in the drafting of these guidelines?
A complete understanding of your goals, how you intend to
achieve these goals, and your progress in this task will be
helpful to me in determining whether an independent task force,
such as suggested by the CQC, remains necessary.
On November 6, 2001, OMH Commissioner James Stone responded.
He stated:
OMH's review found that equipment and administration of ECT in
our state-operated hospitals complies fully with these APA
guidelines. One area where further refinement was recommended
concerned informed consent and procedures….Concerning ECT
administration on the community side, my staff…have developed
draft guidelines…The most representative means of reviewing
these guidelines will be to submit them to the Mental Health
Services Council for review and comment…Once the Council has had
the chance to review these draft guidelines, I will be happy to
share them with you, along with a list of the committee members
who developed this document.
While the Committee recognizes that OMH is conducting an
in-house review of applicable guidelines, it is apparent based
upon the Commissioner's response that such review will not
include all of the issues identified by the Committee. Furthermore,
though OMH's planned process will help foster and facilitate a
timely discussion and review of protocols by a knowledgeable
advisory body, it appears it will be depending largely upon input
from an organization lacking the requisite expertise regarding
issues relating to ECT. More specifically, the Committee
acknowledges the Mental Health Services Council's contributions
to the field as an organization representing a diversified mental
health constituency. However, MHSC is not a professionally based
entity comprised of persons with specific expertise on medical
consent and/or in the establishment of medical related guidelines.
Therefore, it is recommended that OMH expand its review process to
ensure it comprehensively examines the issues and concerns raised
by the Committee, and solicits feedback from varying constituencies
with expertise in the areas under consideration.
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SPECIAL POPULATIONS
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The use of ECT on special populations needs careful review.
In the case of human research, the federal government recognizes
that particular populations need extra protections. These populations
include children, pregnant women and the mentally disabled. It
is the Committee's opinion that these same populations should be
entitled to extra protections with issues involving ECT. The
Committee further asserts that such safeguards should apply to
older persons who often fall under the designation of "specialized
populations" and require much needed protections.
In the case of children, ECT can adversely impact brain
development. Similarly, protection of the fetus needs to be a
top priority when pregnant women are recommended for ECT.
Additionally, there needs to be a mechanism for ensuring that
mentally retarded and developmentally disabled individuals truly
understand the need for ECT and the associated benefits and risks,
prior to furnishing informed consent. Currently, the integrity
of the consent protocol is questionable given the mental capacity
of some disabled individuals. Moreover, the possible use of ECT,
not as a therapeutic intervention, but to control behavior among
this population can also not be discounted. Particular care and
special protections need to be secured to assure that the rights of
the mentally retarded and developmentally disabled are not
violated.
Use of ECT on the elderly is also in need of thorough examination.
Currently, older adults number almost 35 million or about 12.7% of
the population within the United States. Considering that by the
year 2030, the "baby-boom" generation will be fully
retired, it is estimated that persons over 65 will represent
about 20% of the U.S. population. (U.S. Census Bureau, 2000
Census Estimates and Hobbs, FB & Damon, BL (1996) 65+ in the
United States, U.S. Census Bureau, Economics and Statistics
Administration Publication #P23-190.) Given that older persons
are more apt to receive ECT than any other age group, are more
resistant to medications and, in many cases, need higher electrical
stimulation to produce the required seizure, there is increasing
concern when contemplating the potential impact of such use on a
significant percentage of the nation's population. In many cases,
due to the temporary benefits of ECT, continued ECT treatments are
often necessary over extended periods of time. This may increase
the risks of permanent cognitive deficits, which can often serve to
exacerbate some memory loss or other retention related issues that
can begin to present in persons entering the latter stages of life.
Finally, there is concern among ECT opponents that this therapeutic
option can impact on the physical and emotional health of the
elderly and lead to premature death.
Following are some excerpts from the 2001 APA Task Force Report
regarding the elderly, pregnant women, and children/adolescents.
APA TASK FORCE: ELDERLY
- ECT has a special role in the treatment of late-life
depression and other psychiatric conditions in the elderly, who
as a group constitute a particularly high proportion of the patients
who receive ECT.
- It is suspected, but not well documented, that resistance to
the therapeutic effects of antidepressant medication is age related,
with depression in late life more likely to be medication
resistant.
- Administration of ECT in the elderly presents certain
age-related issues. Seizure threshold may rise with increasing
age, and effective seizures may be difficult to induce.
- Especially when treated with bilateral ECT, some elderly
patients may have seizure thresholds that exceed the maximum output
of current-generation ECT devices in the United States.
- Elderly patients may be at greater risk for more persistent
confusion and greater memory deficits during and after ECT
treatment.
APA TASK FORCE: PREGNANCY
- Recent case material supports the use of ECT as a
treatment with low risk and high efficacy in the management of
specific disorders in all three trimesters of pregnancy.
- The risks of ECT anesthetic agents to the fetus are
likely to be less than the risks of alternative pharmacologic
treatments for psychiatric disorders and also less than the risks
of untreated mental illness.
- When gestational age is more than 14-16 weeks, non-invasive
monitoring of fetal heart rate should be done before and after each
ECT treatment.
- If pregnancy is high risk or close to term, additional
monitoring may be indicated at the time of ECT administration.
- At facilities administering ECT to pregnant women,
resources for managing obstetric and neonatal emergencies
should be readily accessible.
APA TASK FORCE: CHILDREN AND ADOLESCENTS
- Few studies address the use of ECT among children
and adolescents.
- First-line use of ECT in children and adolescents is
particularly rare.
- ECT treatment should be provided with the concurrence of
two consultants experienced in treating psychiatric disorders of
children.
- The consent process, including discussion of the risks
and benefits of ECT should involve the parents or guardians of
the child.
- Stimulus dosing must take into account that seizure
thresholds in children and adolescents are likely to be considerably
lower than those in adults.
- Because of the possibility for increased likelihood of
prolonged seizures in children and adolescents, the treatment team
ought to be prepared to intervene with appropriate medication to
terminate the seizure.
- Comprehensive guidelines for the use of ECT in adolescents
are presently under development by the American Academy of Child
and Adolescent Psychiatry. (NOTE: When contacted on March 13,
2002, the Academy advised Committee staff that the draft
guidelines were still being reviewed.)
DEVELOPMENTALLY DISABLED
The Committee found little material relating to the use of ECT
on mentally retarded individuals. Committee staff contacted the
New York State Office of Mental Retardation and Developmental
Disabilities (OMRDD) regarding this matter. Subsequently, on June
25, 2001, the New York Post ran an article describing how ECT was
administered to a mentally retarded woman at Hillsdale Hospital in Queens.
The Committee requested the CQC to look into this matter. While the CQC
found the process followed by the facility to be appropriate, the
facility discontinued ECT.
In January 2002, Committee staff visited the Institute for Basic
Research, an OMRDD facility, and learned of at least two other mentally
retarded individuals that had or were currently receiving ECT. The
Committee requested information from OMRDD on the incidence of ECT
use on this population. In a letter dated January 15, 2002, OMRDD
Commissioner Tom Maul responded.
ECT is a &aquot;professional medical treatment" under 14
NYCRR 633.11. As such, informed consent is required by OMRDD
regulation…If the person lacks capacity to give informed consent….
then informed consent is obtained from a qualified
surrogate or court order.… OMRDD does not require that consumers
who access professional medical treatment such as ECT report
these instances. Rather, it is expected that our 633 regulation
governing informed consent is strictly adhered to, and that good
clinical practice is followed in diligently pursuing appropriate
medical treatments, and second opinions where warranted. Therefore,
I cannot give an absolute number of persons with mental retardation
and developmental disabilities who have received ECT to address
symptoms of mental illness.
At a meeting with Chairman Luster on March 4, 2002, the CQC
indicated it had identified at least 24 mentally retarded
individuals that had received ECT in 2000.
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INFORMED CONSENT
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The issue of informed consent is critical in enabling a patient
to make a decision regarding the use of any medical intervention.
The courts in New York State have consistently recognized and upheld
the right of every individual to make his or her own treatment
decisions. It is a firmly established principle of the common
law of New York that every individual "of adult years and sound
mind has a right to determine what shall be done with his body"
and control the course of his or her medical treatment.
(Schloendorff v. New York Hospital, 211 NY 129 (1905)).
Pursuant to Rivers v. Katz, 67 N.Y. 2d 485 (1986) the
patient's right to self-determination is deemed paramount to a
physician's obligation to provide medical treatment, as is a
competent patient's right of refusal for treatment.
There is a significant degree of variability among facilities
regarding information provided during the informed consent process,
including risks/benefits, the type of ECT device to be used, number
and specific placement of electrodes and the need for continuation
and maintenance of ECT for extended periods. The ability of a patient
to obtain appropriate information regarding ECT and the timeframe
in which s/he must evaluate the efficacy of the information, as it
relates to the patient, is crucial for the patient to make a reasoned
and informed decision
Steven Brock, a lawyer who once managed the Mental Health Law
Project for Nassau/Suffolk Law Services, under a grant funded by the
Office of Mental Health, and founder of the Mental Disability Law
Clinic at Touro Law School in New York, in written testimony
stated:
A commission should be established to manage independent
investigation of ECT risks and benefits and improve the current,
drastically inadequate procedures for informed consent….Given the
uncertainty as to the safety of ECT, consent procedures should
immediately be enhanced. A commission could be charged with
developing appropriately conservative requirements for disclosure
of the risks of ECT to insure that a reasonable range of information
on risks is provided to persons asked to consent to the procedure.
In order to make consent to treatment a real process, it must be made
independent of the treating psychiatrists. The current reality is
that persons who consent are deemed competent and persons who decline
to follow a psychiatrist's recommendation are at severe risk of
forced treatment. An independent decision maker, not the treating
psychiatrist, should decide competency to consent to ECT in the
first instance. And a decision on competency should be made before
consent is requested. Those found competent will decide for
themselves whether to consent to ECT. Those found not competent
will require court approval for ECT whether or not they
consent.
Ultimately, the determination of a person's competency to consent
to treatment is a legal question quite different from the technical
medical and scientific matters in which psychiatrists are trained.
Psychologists, on the other hand, receive training that makes them
well suited to address both the legal and medical issues involved in
determinations of competency. The current system grants the
treating physicians extreme power to determine the course of
treatment of persons in psychiatric institutions and override
their objections to treatment. And in those instances when there
is disagreement, the legal process casts the psychiatrist as the
adversary of the person he or she is treating, which can profoundly
and adversely affect the therapeutic relationship.
Dr. Laura Fochtmann, a psychiatrist and Director of the
Electroconvulsive Therapy Service at the State University at
Stony Brook, member of the APA's Task Force and co-author of
the APA's report and numerous other articles appearing on the
neurobiology of ECT, appeared before the Committee on May 18,
2001 to testify on behalf of the state and national American
Psychiatric Association. In relation to informed consent, Dr.
Fochtmann stated in her written testimony:
In choosing any medical intervention for a given individual,
the potential benefits of treatment must always be weighed against
the potential for adverse effects….Discussing alternative therapeutic
options, with their corresponding risks and benefits, is but one
aspect of the informed consent process with ECT. In fact, the APA
ECT practice recommendations on informed consent are extraordinarily
comprehensive and detailed…modeled after those used at the New York
State Psychiatric Institute, include a description of the standard
ECT procedure as well as statements that there is no guarantee of
the efficacy of ECT…and that consent is voluntary and can be
withdrawn at any time….The informed consent process does not
end with the initiation of the ECT course. Rather, consent
is an ongoing process in which the patient receives ongoing
feedback on clinical progress and on side effects and has continued
opportunities to have questions or concerns addressed.
Also crucial to the informed consent process is the assessment of
capacity to provide consent. Individuals with mental illness are
considered to have the capacity to consent to ECT unless the evidence
to the contrary is compelling….Under such circumstances, the patient's
underlying psychiatric disorder may alter their decision-making
capacity, impairing their ability to consent to ECT or other
treatments.
In these cases, ECT is sometimes the treatment of choice for
individuals who lack capacity to give a fully informed consent….
Nonetheless, a complex balance must be achieved between the rights
of an individual to autonomous self-determination and the moral and
legal obligations of facilities to provide needed treatment if
individuals are dangerous to themselves and others….Under the
ruling in Rivers v. Katz…the New York Court of Appeals delineated a
two step process in order to provide psychiatric treatment for a
non-consenting incapable patient. First, the proponent of the
treatment must establish by clear and convincing evidence that
the patient lacks capacity to make treatment decisions…the court
must then determine that clear and convincing evidence establishes
that "the proposed treatment is narrowly tailored to give
substantial effect to the patient's liberty interests, taking into
consideration all relevant circumstances, including the patient's
best interests, the benefits to be gained from the treatment, the
adverse side effects associated with the treatment and any less
intrusive alternative treatment."
We believe that the strict requirements for judicial approval for
court ordered treatment strikes a proper balance between protection
of individual autonomy and dignity and the right of all persons to
receive appropriate medical care and be free from unnecessary pain
and suffering…With regard to ECT…, relatively few requests are made
for court ordered treatment relative to the total number of patients
receiving ECT….APA and NYSPA strongly believe that the APA
recommended informed consent process and materials insure the
provision of informed consent and that additional regulatory efforts
in this area are unnecessary.
NIH CONSENSUS STATEMENT, JUNE, 1985
When a physician has determined that clinical indications justify
the administration of ECT, the law requires and medical ethics
demand, that the patient's freedom to accept or refuse treatment be
fully honored. An ongoing consultative process should take place…they
should discuss the character of the procedure, its possible risks and
benefits (including full acknowledgment of post treatment confusion,
memory dysfunction, and other attendant uncertainties), and the
alternative treatment options (including the option of no treatment
at all).
It is not easy to achieve this ideal of "informed consent"
in any aspect of medical practice and there are special difficulties
that arise regarding the administration of ECT. In particular, the
patients for whom this procedure is medically appropriate may be
suffering from a severe psychiatric illness that, although not
impairing their legal competency to consent, may nonetheless cloud
judgment in fully weighing all of the available options. Such
judgmental distortion does not justify disregarding the patient's
choices; rather, it makes it all the more important that the
physician strive to identify and clarify the options that the
patient alone is entitled to exercise.
The consent given by the patient at the outset of treatment should
not be the final exchange on this issue but should be reexamined
with the patient repeatedly throughout the course of treatment.
These periodic reviews should be initiated by the physician and
not depend on patient initiative to "rescind" consent.
There are several reasons for this repeated consenting procedure:
because of the rapid therapeutic effect of the procedure itself, the
patient, after initial treatments is likely to have enhanced judgmental
capacities; the risks of adverse effects increase with repeated
treatments, so that the question of continued treatment presents a
possibly changed risk/benefit assessment for the patient; and because
the short term memory deficits that accompany each administration of
ECT, the patient's recollection of the prior consenting transaction
might itself be impaired, so that repeated consultations reiterating
that patient's treatment options are important to protect the patient's
sense of autonomy throughout the treatment process. Moreover, if the
patient agrees, the family should be involved in each step of this
consultative process (NIH p. 8).
2001 APA TASK FORCE REPORT
- The patient should provide informed consent unless s/he
lacks capacity or as otherwise specified by law.
- There is no clear consensus about what constitutes the
capacity to consent.
- Capacity to consent should be assumed to be present
unless compelling evidence exists to the contrary. The occurrence
of psychotic ideation, irrational thought processes or involuntary
hospitalization does not, by themselves, constitute such
evidence.
- There may be concern that the attending physician is biased
toward finding that capacity to consent exists when the patient's
decision agrees with his or her own.
- Informed consent is defined as voluntary when the consenter's
ability to reach a decision is free from coercion or duress. In
practice, the line between "advocacy" and "coercion"
may be difficult to establish
MENTAL HYGIENE LEGAL SERVICES (MHLS)
On May 17, 2001, MHLS provided written comments to the Committee
regarding ECT. The MHLS represents patients on facility applications
to the courts for orders authorizing the administration of ECT. Under
current laws and regulation, the MHLS is not ordinarily notified of
cases in which consent for the procedure is obtained from the patient
or a surrogate, without court involvement. The MHLS identified a
number of concerns with respect to the current practices for
obtaining consent for ECT, including:
- OMH regulations do not contain adequate safeguards
for ensuring that the patient has been fully informed of the risks and
benefits of the procedure and is capable of giving informed consent.
In addition to calling for a written consent document that
becomes part of the patient record, including a written
disclosure of the risks and benefits, the MHLS maintained
that OMH should establish a protocol for assessing a person's
capacity to give or withhold informed consent to ECT. The MHLS
stated that, "It has been our experience, in both ECT and
other treatment cases, that all too often the determination of
capacity turns on whether or not the patient agrees with the
Doctor."
- In the case of non-objecting, incapacitated
patients, we question whether OMH has the power to vest relatives
with the authority to give surrogate consent to ECT. We also
question whether the OMH regulations on surrogate consent for
ECT comport with the current statutory framework.
The MHLS stated, "The question of who may give informed
consent on behalf of an incapacitated patient is a legislative
judgment…the Legislature has promulgated a statutory mechanism
for securing consent from the courts for ECT on behalf of
incapacitated persons…The Court may…authorize or deny a course
of treatment directly, without the appointment of a guardian.
The Legislature has authorized non-judicial surrogate consent for
other forms of treatment in very limited circumstances, but has not
empowered others to give surrogate consent for ECT for incapacitated
persons…In T.D. v. OMH , 228 AD 2nd 95, the Appellate Division
"specifically reject[ed]" OMH's assertion that MHL
Section 33.03 empowers OMH to promulgate surrogate consent
procedures."
- OMH regulations are inadequate with respect to the procedure
to be followed when surrogate consent for ECT is sought and
refused.
According to the MHLS, "Even if OMH has the authority to
empower third persons to give surrogate consent for ECT, Part 27
of the OMH regulations violates due process principles, as it
fails to require notice to the patient that he or she is
believed to be incapacitated and that surrogate consent for
ECT will be sought…In addition, we are aware of cases where
consent for ECT has been refused by a surrogate and the facility
has ignored the surrogate's refusal of consent and shopped the
OMH surrogate list for someone else who would agree. This
approach is not permissible under OMRDD regulations, which
establish a hierarchy of surrogates and require a court
application where the first available surrogate objects."
- The Legislature should consider amending Section 35
of the Judiciary Law to make it clear that independent
psychiatrists and psychologists may be appointed by the
courts in ECT and other cases in which judicial authorization
is sought for treatment.
According to MHLS, currently Section 35 of the Judiciary
Law expressly provides for the appointment of an independent
psychiatrist or psychologist to assist the courts only in
commitment and habeas corpus proceedings arising out of State
operated facilities.
INFORMATION ABOUT ECT, OFFICE OF MENTAL HEALTH
In regard to OMH's proposed consent procedure,
the July, 2001 OMH document states:
In New York State, persons treated by ECT must be given an
explanation of the proposed procedure and course of treatment,
including a discussion of the expected benefits, reasonable
foreseeable risks, and any reasonable alternative to the proposed
treatment. New York's law and regulations state that no patient
may be treated with ECT over his or her objection as long as s/he
retains the capacity to make a reasoned decision concerning
treatment.
SURVEY OF THE PROVISION OF ELECTRO-CONVULSIVE THERAPY
(ECT) AT NEW YORK STATE PSYCHIATRIC CENTERS BY THE COMMISSION ON
QUALITY OF CARE, AUGUST 7, 2001
At the request of Mental Health Committee Chairperson Luster,
the CQC agreed to conduct a survey of the provision of ECT at state
psychiatric centers. ECT is currently administered in Manhattan
Psychiatric Center, Creedmoor Psychiatric Center, Pilgrim Psychiatric
Center, the Psychiatric Institute (PI) and Rockland Psychiatric
Center. The results of this survey, received by the Committee on
October, 2, 2001 found that "protocols varied in detail
regarding the procedure itself, as well as in issues such as
physician privileging and determining capacity to consent."
(October 2, 2001 letter.)
Regarding informed consent, the CQC report states:
Obtaining a patient's informed consent for ECT… is the subject
matter of 14 NYCRR Section 27.9. Section 27.9 …has been
superceded, though only in part. Section 27.9…provides that if
the patient does not have the requisite capacity to consent to ECT
treatment but does object, the objection may be overridden
administratively by the hospital. However, this provision of
Section 27.9 has been superceded as a result of the Court of
Appeals' 1986 decision in Rivers v. Katz. OMH promulgated Section
527.8 to supercede this provision in order to clarify that an
incapacitated patient may be treated over objection only by a
court order.
Only Pilgrim's operational policy defines capacity to consent….For a
patient who has sufficient mental capacity to give informed consent to
ECT, according to policy at PI, Pilgrim and Creedmoor, only the
patient can give consent, and if the patient refuses to consent,
ECT will not be administered and the hospital will not go to court.
If ECT treatment is deemed necessary for a competent patient who
refuses ECT, Rockland and Manhattan policy allows them to go to court
to obtain an order for treatment over objection.
Policies generally define the length of time a consent is valid.
At PI, the informed consent is good for up to 25 treatments of a
single course of ECT…At Pilgrim, consent is good for 25 treatments or
three months, whichever comes first…Creedmoor requires new consent
every three months. Rockland requires that consent be updated every
six months. Manhattan has no written requirement for renewing
informed consent, but does require that MHLS be notified before
anyone, consenting or not, receives ECT. Policies at PI, Pilgrim,
Creedmoor indicate that legally designated surrogates or a court of
competent jurisdiction can give consent to ECT if the patient lacks
capacity…but does not object. Creedmoor mandates that two
psychiatrists, neither associated with the ECT unit, must certify
that a patient lacks capacity…and they must further certify that the
patient does not object. At Manhattan and Rockland, court orders are
required before ECT can be given to anyone who is determined to lack
capacity to give consent (pgs.6-7).
The impact of bias on the determination of capacity to consent
necessitates extensive review as part of the informed consent
process. While the APA Task Force Report identified the possibility
of bias by the attending physician regarding capacity when the patient
agrees with the attending physician's decision, it did not comment on
the possibility of bias when the patient does not agree with the
attending physician's decision to use ECT. Another instance of
possible bias may occur when the patient does not have capacity
and does not object to ECT. Great care needs to be taken to ensure
that the patient's diagnosis is the correct one. ECT has been shown
to be effective with certain diagnoses and not with others.
Misdiagnosis, either as the result of bias or human error, can
lead to faulty judgments regarding capacity to consent and validity
of information provided during the informed consent process. The
involvement of mental health professionals, such as clinical
psychologists, who have no involvement in ECT, will help to
ensure that patients are diagnosed correctly and that bias in
capacity determinations is minimized.
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CASES OF ECT
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Listed below is a synopsis of cases submitted to the
Committee regarding recipients of ECT therapy. Such cases
help to illustrate the issues related to determination of
capacity, informed consent, possible bias and implementation
of protocols at state psychiatric centers.
PAUL HENRI THOMAS
The Committee first became aware of the issue of ECT at a public
hearing held by the Committee in Syracuse on February 14, 2001
regarding the proposed closure of Hutchings Psychiatric Center by
the Governor. One of the individuals testifying that day brought up
the case of Paul Henri Thomas, then a patient at Pilgrim Psychiatric
Center who had been receiving ECT against his will. Subsequently,
members of both Houses of the Legislature were inundated with e-mails
regarding this matter. Mr. Thomas had apparently received over 60
ECT treatments over his objection since 1999.
Shortly after the Syracuse hearing, the Committee requested the CQC
look into the use of such therapies as ECT, patients' rights in such
matters, and any specifics the CQC might be able to share regarding
Mr. Thomas. On April 6, 2001, the CQC reported back to the Committee
stating its review found documentary evidence and expert medical
opinion that the treatment provided was an effective modality for
Mr. Thomas and that the facility was in substantial compliance with
applicable regulations of OMH regarding treatment over objection.
Only minor issues relative to documentation of Pilgrim P.C.'s
adherence to procedural requirements were identified.
In the interim, on March 3, 2001, Newsday reported that OMH
officials had made activists feel unwelcome at a judicial hearing
regarding Mr. Thomas held on facility grounds.
On March 12, 2001 Newsday reported on a judicial proceeding
regarding Mr. Thomas, whereby he had originally been diagnosed
with a schizophrenic affective disorder. However, more recently,
he had been diagnosed with bipolar mania with psychotic features.
(Note: The National Institute of Health's 1985 Consensus Statement
indicated that the proper diagnosis was essential in determining the
efficacy of ECT on a particular patient.)
On March 16, 2001, Newsday reported that in June 1999, Mr. Thomas
had agreed to undergo ECT. At that time he was deemed competent to
provide his consent. After the third ECT treatment, Mr. Thomas
refused to undergo further ECT treatments. At that time, his doctors
determined that Mr. Thomas no longer had the capacity to make this
decision. According to Newsday, "The revelation of a kind of
Catch-22 --the strange circumstance that Thomas was fine when he
consented to the procedure but mentally incompetent when he refused
it -- took center stage at a hearing yesterday to determine whether
doctors may again shock Thomas against his will." Newsday also
reported that on February 1, 2001, Pilgrim P.C.'s Associate Medical
Director and Director of ECT had signed a form authorizing a court
order for additional ECT treatments without first examining Mr.
Thomas in violation of State regulations.
On March 28, 2001, Newsday also reported that Pilgrim P.C. had
issued a written order that all papers signed by Paul Henri Thomas
must be intercepted and inspected and that he was not allowed
unrestricted visitors unless they were family members or attorneys.
There was to be one to one supervision for non-family visitors.
In April 2001, the Committee learned of an allegation that an
OMH employee had been forced to resign because of advocacy on behalf
of Mr. Thomas. On May 1, 2001, the former employee, Anne Krauss,
e-mailed the Committee stating:
I am extremely concerned about possible violations in
regulation and procedure which I fear have occurred in relationship to
Mr. Thomas, and which may quite possibly occur in relationship to
other people in situations similar to his….Mr. Thomas' case sheds
light on serious erosion of the system of checks and balances which
should put limitations on the power of the treating psychiatrist in
ordering major medical procedures and treatment….As I stated in my
letter of resignation…I was especially troubled by my agency's
apparent failure to observe some of its own regulations and
procedures…Specifically, it appears that 14 NYCRR 527.8 (c)
(4) (ii) was violated:
- The treating physician failed to conduct a comprehensive
review of capacity.
- A second physician did not personally examine Mr. Thomas
before signing the application.
On May 23, 2001, the Committee requested CQC revisit the case
of Paul Henri Thomas enumerating a number of issues of concern.
On October 1, 2001 the CQC responded.
ISSUE: Visiting Restrictions
MHLS brought action that was subsequently settled. "It is our
understanding that supervision protocols put into place since the
settlement have not met with any allegations that claim infringement
of Mr. Thomas' rights."
ISSUE: Physician Actions
"The physician appointed to conduct the second review and
examination, completed and signed the application to the court for
authorization for administration of ECT over objection prior to his
personal examination of Mr. Thomas…he did fail to follow established
and required procedure…we are confident that such a procedural error
is not likely to occur in the future."
ISSUE: Former OMH Staff Person, Anne Krauss
Regarding Anne Krauss, "your questions pertain to personnel
issues within the internal control of the administration of OMH, so
this matter is outside the purview of the Commission."
ISSUE: Bilateral vs. Unilateral ECT
Regarding bilateral vs. unilateral ECT, Pilgrim policy clearly favors
the use of bifrontal bilateral electrode placement. According to
Pilgrim's Policy Manual, "Unless compelling considerations favor
unilateral ECT, bilateral ECT will be the recommended initial
treatment." Pilgrim's Director of ECT told ECT investigators
that much more stimulus was needed to obtain the same effect with
unilateral ECT.
In the interim, Newsday reported the following on September 21, 2001
that Paul Henri Thomas had been released after his condition improved
without the shocks.
Thomas got a court order in March (2001) barring
doctors from administering the procedure, which can cause
disorientation and memory loss, and which he described as a
form of "torture"….The state had been appealing the judge's
ruling barring shock treatments on Thomas, but both sides said the
appeal is now moot and will be dropped…a spokesman of the state
Office of Mental Health…said…"Any discharge is based on
clinical considerations."…The state Attorney General's office,
which represented Pilgrim in court, said… "That avenue
(shock treatments) had been blocked by the court and, obviously,
they had to go to Plan B, which was come up with a different
approach in terms of medication…And they happened to put together
an approach that Mr. Thomas responded to very positively."
Anne Krauss, a friend of Thomas, was ecstatic over his release.
"It shows they could recognize he had recovered and that
recovery took place without the electroshock that they previously
felt was necessary…And in that way it's excellent.
ADAM S.
On May 24, 2001, the Committee requested the CQC look into the
case of Adam S., a patient at Pilgrim P.C. Anna Szyszko, sister of
Adam S., appeared before the Committee at its May 18, 2001 public
hearing in New York City. She stated that Adam suffers from
schizophrenia. The facility obtained a court order authorizing
ECT in 2000. Adam had been determined to lack the capacity to make
an informed decision regarding ECT use. The family objected and
wanted alternative treatments. On July 18, 2001, the Szyszko family
appeared before the Committee at its second public hearing in Albany
again calling for alternative treatments for Adam. The family alleged
that Adam was being abused and wanted him transferred to
another facility. On September 13, 2001 the CQC submitted
its report to the Committee. The CQC overall finding was that
the recommendation that Adam S. receive ECT was appropriate.
However, the CQC found several problems with his care unrelated
to the administration of ECT, as well as documentation problems.
The report, dated July 31, 2001, stated:
- On August 7, 2000 an adverse event occurred involving a
physician…the physician exhibited very poor judgment and did not
appreciate the seriousness of her actions. The physician
resigned the next morning and it is our understanding that
Pilgrim reported her to the national physician data base.
- The second area of concern pertained to the failure
of nursing staff to adequately monitor Mr. Szyszko…The
physician orders that specified every fifteen minute vital
signs…were not carried out, nor was it documented that nursing
had notified the physician of the inability to carry out the
order.
- A number of documentation errors were identified.
On August 27, 2001 the Supreme Court of the State of New York,
Appellate Division: Second Judicial Department vacated the stay of
administration of ECT. However, to date, Pilgrim P.C. has not
proceeded with ECT on Adam S.
PAM S.
On May 24, 2001, the Committee requested the CQC review the case of
Pam S., a patient at Mid-Hudson P.C., who was appealing a decision to
give her ECT over her objections. The Committee received the CQC
report, dated July 3, 2001 on August 1, 2001. The report stated:
The facility petitioned the court for ECT over
objection…Two psychiatrists determined that (Pam S.) did not have
the capacity to consent to ECT. Although the court ordered the
treatment(s)…staff had difficulty arranging for the provision of
ECT treatments…In the interim, MHLS obtained a restraining
order (April, 2001). MHFPC requested to have the order lifted,
but was unsuccessful (May, 2001). The case is currently on appeal…In
summary, we determined that MHFPC is providing appropriate treatment…in
accordance with applicable regulations and policies. Further, the
plan to provide…ECT appears to be a reasonable clinical treatment
approach, considering the seriousness and intractability of her
illness.
On August 27, 2001, the Supreme Court of the State of New York:
Second Judicial Department denied the petition to proceed with ECT.
"…the petitioner failed to prove by clear and convincing
evidence that the patient lacked the capacity to make a reasoned
decision regarding her treatment, which was the sole basis argued
for the relief sought (see,Rivers v. Katz, supra)…In light of
this conclusion, we need not determine whether the petitioner
established by clear and convincing evidence that the proposed
treatment was narrowly tailored to preserve the patient's liberty
interest (see Rivers v. Katz, supra, at 497-498).
The Committee was concerned that the CQC found ECT appropriate in
all three cases, even though two of the cases were dismissed because
of the patient's recovery without ECT and because of the court's
finding that the patient had the capacity to refuse consent to ECT. The
CQC indicated that it does not evaluate the efficacy of the patients'
diagnoses. The CQC assumes the diagnoses to be correct. The CQC
ascertained the viability of ECT as an accepted treatment modality based
on the diagnoses recorded in the patients' records.
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CONCLUSION
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This report is the culmination of a one-year review of the practice
of ECT in the State of New York. Proponents and opponents of ECT
passionately debate and defend their perspectives. Literature can be
found supporting the contentions of both sides of this debate. The
Committee received testimony and written communications from
individuals who had benefited from ECT and from individuals who had
suffered permanent damage.
Based on its review, the Committee is not prepared to call for a
ban on ECT use in the State. However, the Committee identified
several issues of concern and has proposed legislation to address
these concerns. Much of the argument that swirls around ECT
relates to its safety. The federal Food and Drug Administration
(FDA), considers ECT devices to be experimental, Class III medical
devices. Such a classification is used for pre-market approval
for devices that show an unreasonable risk of illness or injury.
The FDA has never tested ECT devices to ensure their safety. The
American Psychiatric Association (APA) has identified certain
devices that should no longer be used for ECT, yet it is
apparent that these devices continue to be used. In order
to render the safety argument moot, the federal government
needs to test all ECT devices for safety and to promulgate
protocols that will maximize the benefits and minimize
associated risks. Accordingly, the Committee calls upon
the Legislature to pass a resolution urging the U.S. Congress
to require the FDA to test ECT equipment for safety
The lack of minimum federally approved standards and protocols
have exacerbated the problem. The American Psychiatric Association
(APA) has recognized and promulgated standards and protocols in 1990
and again in 2001. However, these are voluntary standards and are
not being implemented in all facilities that provide ECT. The
Committee's review found several instances in both state operated
and private sector facilities where protocols recommended by the
APA were not being followed. For this reason, the Committee also
calls on the Legislature to pass a resolution urging the U.S.
Congress to enact legislation establishing proper protocols for
the administration of ECT.
The Committee recognizes that the federal government may take
some time to act. In the interim, there are steps the Legislature
can take now to improve the safety of ECT use in the State.
Currently, there is no effective reporting mechanism regarding
ECT use in the State. The Committee finds there is little
information regarding how ECT is practiced in the State. Based
upon existing information, there is considerable variation in the
nature of ECT practices. Moreover, patients are being treated in a
fashion that markedly departs from professional standards of practice
recommended by the APA. Assembly bill A. 9083 requires mandatory
reporting of information regarding ECT to enable the OMH
Commissioner to better regulate the use of ECT and help ensure
that the Legislature can effectively exercise its constitutional
function. The report will include:
- The number of patients who receive ECT, both
inpatient and outpatient.
- The number of patients for whom a court order was
sought, including the results of such action.
- The age, sex, race and diagnosis of patients who
receive ECT.
- Injuries reported and autopsy findings if the patient
died within fourteen days of the administration of ECT.
Assembly bill A. 9082 establishes a temporary advisory
council to address issues related to ECT, including but not
limited to:
- Education and training of ECT practitioners and
standards for ECT administration
- Safety of equipment
- An analysis of the efficacy of ECT on special
populations
- Resources to be given to patients to help them learn
more about ECT
Assembly bill A. 9084 requires all facilities practicing
ECT be accessible to emergency treatment. As the NIH and the
APA have pointed out, ECT can have serious adverse physical
consequences. It is prudent to require such access in order
to avoid life-threatening situations that may be associated with
the use of ECT.
Protecting the mental health of the people of the state by
providing appropriate care and treatment to persons afflicted with
mental illness and ensuring that such persons are treated with
dignity and respect are matters of public concern. Protecting the
rights of patients and ensuring the appropriateness of medical
interventions are based on proper diagnoses and are therefore also
matters of public concern.
The Committee identified weaknesses regarding the determination of
the capacity of a patient to make an informed decision regarding the
use of ECT. The Committee also identified weaknesses in the informed
consent process. Assembly bill A. 9081 requires:
- In addition to the treating physician, a licensed
psychologist who is not an employee of the facility will provide
a written opinion regarding the patient's capacity to consent
to ECT.
- If a patient is determined to possess capacity to consent,
the patient will be:
- Given written disclosure of the benefits and risks,
and any less intrusive alternative treatments.
- Provided with a list of resources to learn more
about ECT.
- Given a minimum of five business days to decide
whether to consent.
- Asked to sign a consent to treatment form which, with
the written disclosure will be included in the patient's clinical
record.
- Informed, in writing, that the patient may withdraw
consent to the treatment at any time.
- If the patient is determined to lack capacity and
that ECT is appropriate, the clinical director may apply for
court authorization
- The determination of incapacity and the determination
that the proposed treatment is in the best interests of the
patient will be based on clear and convincing evidence. The
burden of proof will rest with the clinical director of the
facility.
The Legislature has a constitutional obligation to protect
and promote the health including, specifically, the mental
health of the residents of the State. The federal government
also has an obligation to protect and promote the health and
well being of its residents.
The Committee has identified areas of concern and proposed the
aforementioned legislative initiatives to address issues in need
of attention. The Committee recognizes that these legislative
initiatives will satisfy neither proponents nor opponents of ECT.
Proponents will argue that the legislation goes too far in
regulating the use of ECT and that voluntary compliance with
standards and protocols developed by the American Psychiatric
Association are sufficient. Opponents will argue the
legislation does not go far enough and have called for, at
the very least, a ban on involuntary, court ordered ECT.
Simply, adversaries would prefer a total ban on the use of
ECT.
The Committee finds that the proposed legislative initiatives
are prudent, given the present state of information regarding the
safety of ECT equipment, protocols, capacity and informed consent
determination procedures, and risks/benefits associated with ECT,
based on diagnoses, age and other factors.
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REFERENCES
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- "Electroconvulsive Therapy, National Institutes of
Health, Consensus Development Conference Statement,"
June 1985.
- Resolution, March 15, 1996 New York State Protection and
Advocacy for Individuals with Mental Illness Advisory Council
(PAIMI).
- "ECT Practices in the Community, an unpublished
report," J. Prudic, M. Olfson, and H.A. Sackeim.
- The Practice of Electroconvulsive Therapy,
Recommendations for Treatment, Training and Privileging,
Second Edition, A Task Force Report of the American Psychiatric
Association, 2001.
- The Practice of Electroconvulsive Therapy:
Recommendations for Treatment, Training and Privileging,
a comprehensive set of recommendations for the practice of
ECT, American Psychiatric Association, 1990.
- Written Comments to the Committee regarding ECT
by the Mental Hygiene Legal Services (MHLS), May 17, 2001.
- "Information About ECT," Office of Mental
Health (OMH), July 2001.
- "Survey of the Provision of Electro-Convulsive
Therapy (ECT) at New York State Psychiatric Centers"
by the Commission on Quality of Care for the Mentally Disabled,
August 7, 2001.
- "ECT: Sham Statistics, the Myth of Convulsive
Therapy, and the Case for Consumer Misinformation"
by Douglas Cameron, The Journal of Mind and Behavior, Winter
and Spring 1994, Volume 15, Numbers 1 and 2.
- Memorandum, Re: Applications for Court Ordered
Electroconvulsive Therapy (ECT), MHLS, April 12, 2001.
- Memorandum Re: ECT Data, Office of Mental Health,
June 1, 2001.
- Memorandum to OMH Re: ECT Data, Assembly Committee on
Mental Health, Mental Retardation and Developmental Disabilities,
June 26, 2001.
- Memorandum Re: ECT Data in response to Committee's
June 26, 2001 request for information, OMH, June 28, 2001.
- Testimony by Dr. Richard Weiner, New York State Assembly
Standing Committee on Mental Health, Mental Retardation and
Developmental Disabilities Public Hearing Regarding
Electroconvulsive Therapy, May 18, 2001.
- Testimony by Dr. Harold Sackeim, New York State Assembly
Standing Committee on Mental Health, Mental Retardation and
Developmental Disabilities Public Hearing Regarding
Electroconvulsive Therapy, May 18, 2001.
- Letter from former ECT patient received by the Committee
subsequent to May 18, 2001 Public Hearing Re: ECT.
- Testimony by William Sullivan, New York State Assembly
Standing Committee on Mental Health, Mental Retardation and
Developmental Disabilities Public Hearing Regarding
Electroconvulsive Therapy, May 18, 2001.
- 18. Testimony by Dr. Peter Sterling, New York State
Assembly Standing Committee on Mental Health, Mental Retardation
and Developmental Disabilities Public Hearing Regarding
Electroconvulsive Therapy, July 18, 2001.
- Testimony by Linda Andre, New York State Assembly
Standing Committee on Mental Health, Mental Retardation and
Developmental Disabilities Public Hearing Regarding
Electroconvulsive Therapy, May 18, 2001.
- Letter to James Stone, Commissioner, Office of
Mental Health from Martin A. Luster, Chair, Assembly Committee
on Mental Health, Mental Retardation and Developmental
Disabilities, October 11, 2001.
- Letter to Honorable Martin A. Luster from James
L. Stone, Commissioner Office of Mental Health, November 6,
2001.
- "Dad's Rights Zapped by the Shock Docs,"
New York Post, June 17, 2001.
- Letter to Gary O'Brien, Chairman, Commission on
Quality of Care for the Mentally Disabled (CQC) from Committee
Staff, June 18, 2001.
- Letter to Committee Staff from Mark P. Keegan,
Director, Quality Assurance and Investigations Bureau, CQC,
September 13, 2001.
- Letter to Committee Staff from Thomas A. Maul,
Commissioner Office of Mental Retardation and Developmental
Disabilities, January 15, 2002.
- Testimony by Steven Brock, New York State Assembly
Standing Committee on Mental Health, Mental Retardation and
Developmental Disabilities Public Hearing Regarding
Electroconvulsive Therapy, May 18, 2001.
- Testimony by Dr. Laura Fochtmann, New York State
Assembly Standing Committee on Mental Health, Mental
Retardation and Developmental Disabilities Public Hearing
Regarding Electroconvulsive Therapy, May 18, 2001.
- Testimony by Kevin Chatterson, New York State
Assembly Standing Committee on Mental Health, Mental
Retardation and Developmental Disabilities Public
Hearing Regarding the Proposed Closing of the Richard H.
Hutchings Psychiatric Center, February 14, 2001.
- Letter to Gary O'Brien, Chairman, CQC from Martin A.
Luster, Chair, Assembly Committee on Mental Health, Mental
Retardation and Developmental Disabilities, February 21,
2001.
- "His New Battle, Patient Takes Fight
Against Electric Shock Treatment to Court,"
Newsday, March 3, 2001.
- "Notes Say Shock Treatments Help Man,"
Newsday, March 12, 2001.
- "Mental Competence in Question/ Doctors:
Man Not Fit to Refuse Shock Treatment,"
Newsday, March 16, 2001.
- "Man Says More Rights Violated",
Newsday, March 28, 2001.
- Letter to Honorable Martin A. Luster from Gary
O'Brien, Chairman, CQC, April 6, 2001.
- E-Mail from Anne Krause to Committee Staff,
May 1, 2001.
- Letter to Gary O'Brien, Chairman, CQC from Martin A.
Luster, Chair, Assembly Committee on Mental Health, Mental
Retardation and Developmental Disabilities, May 23, 2001.
- "Shock Therapy Patient Released,"
Newsday, September 21, 2001.
- Letter to Hon. Martin A. Luster from Gary O'Brien,
Chairman, CQC, October 1, 2001.
- Letter to Gary O'Brien, Chairman CQC from Committee
staff, May 24, 2001.
- Testimony by Anne Krauss, New York State Assembly
Standing Committee on Mental Health, Mental Retardation and
Developmental Disabilities Public Hearing Regarding
Electroconvulsive Therapy, May 18, 2001.
- "Opinion and Order In the Matter of Adam S.,"
Supreme Court of the State of New York Appellate Division:
Second Judicial Department.
- Letter to Hon. Martin A. Luster from Gary O'Brien,
Chairman CQC, September 13, 2001.
- Letter to Gary O'Brien, Chairman CQC from
Committee Staff, May 24, 2001.
- Letter to Hon. Martin A. Luster from Gary O'Brien,
Chairman CQC, August 1, 2001.
- "Decision and Order In the Matter of Pamela S.,"
Supreme Court of the State of New York Appellate Division:
Second Judicial Department, August 27, 2001.
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