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Submission to the Standing Committee on Community Services
Bill 31: Mental Health Amendment Act
I'm very concerned about the "unintentional consequences" of Bill
31.
In terms of my special interest area, the collateral damage is very likely going
to include an increase of
both chemical and physical restraints, instead of adequate and appropriate care,
for elderly persons
whose dementia results in inconvenient or risky behaviours. This will become
increasingly obvious with
the current shift of care for seniors with chronic illness and impairment into
the community.
I'm going to begin this submission with a brief summary of my own experience
in this regard. For a dozen
years my mother suffered increasing cognitive impairment classed as "psychogeriatric
illness" as a
result of a series of "little" strokes. Her judgment and behaviour were seriously
affected. Not one of the
various antipsychotic drugs or cocktails of drugs prescribed by all the doctors,
including psychiatrists and
geriatric specialists, relieved her distress; indeed, most simply added to the
problems, increasing
agitation, confusion and fear.1
The favorite drug, Risperdal (Risperidone), is recognized as increasing the
risk of further strokes2
so we'll never know whether the continuing strokes were indeed caused by,
or
aggravated by, the prescribed cure.
One of the few studies attempting to justify the increased use of Risperidone
(and, by implication,
other atypical antipsychotics) for this purpose was published in 20043.
Without once mentioning
the considerable health risks or quality-of-life consequences of Risperidone,
or whether the use
was justified by medical diagnoses and licensed use of the drug, it concluded
that use was
justified because it "reduced the nursing burden".
Risperidone is manufactured by Janssen Pharmaceutica, and its products include
Haldol and
other atypical antipsychotic drugs. Funding for the "nursing burden" study was
provided by
Janssen Medical Affairs; one of the authors was an employee of Janssen, one
was a consultant
to Janssen, and the others were on contract with Janssen.
1 The Quality of Antipsychotic Drug Prescribing in Nursing Homes; Briesacher
et al, Arch Intern Med.
2005;165:1280-1285; http://archinte.ama-assn.org/cgi/reprint/165/11/1280.pdf
"Conclusions: This study detected the highest level of antipsychotic use
in (nursing homes) in over a
decade. Most atypicals were prescribed outside the prescribing guidelines
and for doses and
indications without strong clinical evidence. Failure to detect positive
relationships between
behavioral symptoms and antipsychotic therapy raises questions about the
appropriateness of
prescribing."
2 Risperidone (Risperdal): increased rate of cerebrovascular events in dementia
trials
CMAJ · NOV. 26, 2002; 167 (11): "The burden of dementia is staggering --
over 8% of the population
over the age of 65 is affected -- and behavioural disturbances that often
accompany dementia
(including physical aggression, hallucinations, wandering, yelling, throwing
and vocalizations) are
distressing for caregivers and patients alike. . . However, a recent analysis
by the drug's manufacturer
of trials involving patients with dementia suggests that the use of risperidone
may be associated
with increased rates of cerebrovascular adverse events, including stroke
and transient ischemic
attacks, when compared with placebo." (emphasis added)
3 The Effect of Risperidone on Nursing Burden Associated with Caring for Patients
with Dementia, Frank
et al, Journal of the American Geriatrics Society, JAGS 52:14491455, 2004
"The quality of care for cognitively impaired residents in long-term care
is a matter of great concern to
families, staff, and policy makers. Staff burden is one key factor among
the multiple factors identified
that may affect care quality. . In this trial, risperidone treatment for
residents with dementia reduced
some of the burden nursing staff perceive in caring for such individuals.
Any improvements that can
positively affect nursing staff in their performance of their job are likely
to ultimately improve the care
individuals with dementia receive."
Risperidone (Risperdal) is an atypical antipsychotic, developed and licensed to treat
schizophrenia and bipolar disorder, and tested in otherwise healthy persons (not including seniors
with multiple medical diagnoses). It has been the subject of both FDA4 and Health Canada5
warnings about use of risperidone in elderly dementia patients. The most recent concerns
involve the increased risk of strokes and related events.
Yes, some of these drugs did sedate Mom sufficiently so that the behaviours which were the
symptoms of her distress weren't quite so inconvenient for others. They also caused increased
confusion and anxiety, agitation, dysphagia, weakness, and coordination problems. She died,
eventually, of yet another "cerebrovascular accident". I can't prove that her "treatment" hastened
her death, but I know all too well that it damaged both our lives.
This story is relevant to Bill 31 on four counts.
The first has to do with "informed consent".6 Not once in those dozen years did a doctor,
pharmacist or nurse advise us of the possible benefits and risks of the prescribed drugs. That I
had to learn by my own research in an attempt to explain the problems I saw. Not once was
either Mom or I asked if we consented to this treatment. Even after I had forbidden the use of
these drugs, or indeed of any medication I had not expressly approved, they remained on the
care facility list of drugs prescribed for Mom, and were on occasion administered without my
knowledge.
The second has to do with safety. None of the health care professionals or care staff involved
with my mother's care were aware of the possible side-effects, and none recognized or reported
the changes in her behaviour or health that resulted. Not once, even after I had identified the
signs of problems to the care staff or health professionals, did they initiate an effective monitoring
process for the documented possible side-effects. And, during several periods when I had
directed that the drug be discontinued, the well-established and documented procedures for
withdrawal of these dangerously addictive drugs were simply ignored. These drugs, and others,
are typically used as restraints. There is no doubt that the use of restraints, whether physical or
4 http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a694015.html
"Risperidone is not approved by the Food and Drug Administration (FDA) for the treatment of behavior
problems in older adults with dementia." http://www.fda.gov/cder "
5 Canadian Adverse Drug Reaction Newsletter, Volume 11, Number 4 October 2001, Health Canada
Therapeutic Products Directorate
Health Canada Health Products and Food Branch; Updated Safety Information for Risperdal*
(Risperidone) in Elderly Dementia Patients, Announced in Canada October 17, 2002
"Data were analyzed from four clinical studies in elderly, dementia patients. In two of these studies, a
higher proportion of patients taking RISPERDAL experienced strokes or related events than did those
who received placebo (sugar pill). Patients or their caregivers should immediately report to their
doctors any signs and symptoms of potential strokes such as sudden weakness or numbness
in the face, arms or legs, and speech or vision problems. Patients or their caregivers should
inform their doctors of their past and present medical history, including history of stroke or
stroke-like events, and should also consult their doctor prior to making any changes in their
medication." (emphasis added)
6 Accountability in Health Care and Legal Approaches, Ries and Caulfield, Canadian Policy Research
Networks, 2004; How do Current Common Law Principles Impede or Facilitate Change? Caulfield,
University of Alberta, Discussion Paper for the Commission on the Future of Health Care in Canada,
2002; Ethical Choices in Long-Term Care: What Does Justice Require? World Health Organization,
2002; Out of the Shadows at Last, Transforming Mental Health, Mental Illness and Addiction Services
in Canada; the Standing Senate Committee on Social Affairs, Science and Technology, 2006; The
Texas Medication Algorithm Project, at http://psychrights.org/Drugs/AllenJonesTMAPJanuary20.pdf
Submission to the Standing Committee on Community Services,
2
Bill 31: The Mental Health Amendment Act
chemical, is risky. The decreased use of physical restraints coincides with the increased use of
chemical restraints, which while less obvious and less visually distressing to the onlooker can
cause much more harm.
The third has to do with the "nursing burden".7 The emphasis for care has shifted, particularly
with mental illness, to controlling specific behavioural manifestations. This can be a critical
intervention, when there is a serious risk of imminent harm to self or others. But indeed, and
especially with dementia in elderly persons, there are more effective and safer options. These
options (appropriate physical facilities; adequate skilled nursing and personal care; attention to
issues of self-respect and self-worth; suitable activities and human contact) are, apparently, seen
as "too expensive". I would argue that any such assessment ignores the real costs of the harm
that is done to patients, their families, and the community.
The fourth has to do with choice. We value our right to make our own choices; theoretically, our
Government is concerned that we have choices.8 In the situation I described, there weren't any
choices other than suggestions that if I didn't like the care being provided, I could take Mom out
of care. This "choice" culminated, a month before her death and just after a particularly
devastating "little stroke", in an ultimatum that either I agree to the administration of an
antipsychotic or remove Mom from the facility, because they simply did not have enough staff (let
alone qualified staff) to provide alternative care. (I refused; my son and I spent at least 40 hours
a week caring for Mom, with very good effect for her and disastrous consequences for my own
health.)
There is a difference between psychiatric illnesses like schizophrenia and Alzheimers, dementia illnesses
and stroke damage; someone who is mentally impaired or brain damaged and lives to grow old. We
need to recognize these differences and so do the medical professionals and health care workers and
respond appropriately to these differing needs for treatment and care.
As a society, we owe a duty of care to those who cannot care for themselves. While I believe this Bill was
initially drafted to enable care for psychiatric illness, it doesn't provide the protections or the treatment
options that recipients of this "care" should have. It's not good enough to rely on civil litigation, long after
the damage has been done, for redress.9 Perhaps we should take some time to understand and define
that duty of care.
7 Potentially inappropriate prescriptions for older patients in long-term care
BMC Geriatrics 2004, 4:9 doi:10.1186/1471-2318-4-9. Rancourt et al. (Note: 2 of the 6 researchers were
employed by Merck Frosst Canada at the time of the preparation of this article.)
"Inappropriate medication use is a major healthcare issue for the elderly population. This study explored
the prevalence of potentially inappropriate prescriptions (PIPs) in long-term care in metropolitan
Quebec. Conclusions: Inappropriate prescribing is highly prevalent in the elderly long-term care
population in metropolitan Quebec. The use of a explicit criteria list to identify PIPs is a first step
towards identifying most critical issues and implementing strategies to improve quality of care and
patient safety. Identifying predictors of PIPs may help to target problems and prioritize interventions
that are most needed in the rapidly expanding older population."
8 Caring and Responsibility, A Statement of Social Policy for Alberta 1988; A Framework for Reform,
Report of the Premier's Advisory Council on Health 2001; the Broda reports; Building a better public
health care system 2002; Alberta's Healthy Aging and Seniors Wellness Strategic Framework 2002
2012; Health Policy Framework 2006; Health Authority Accountability in Alberta's Health System,
Alberta Health and Wellness 2006; et cetera.
9 Muir v. The Queen in right of Alberta 132 D.L.R. (4th) 695 Court File No. 8903 20759 Edmonton
Alberta Court of Queen's Bench Veit J. January 25, 1996
Remarks of the Right Honorable Beverley McLachlin, P.C.; Medicine and the Law: the Challenges of
Mental Illness, February 17 and 18, 2005
http://www.scc-csc.gc.ca/aboutcourt/judges/speeches/medecine_law_e.asp
Competence and Human Reproduction, Institute of Law Research and Reform, Edmonton. 1989
Submission to the Standing Committee on Community Services,
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Bill 31: The Mental Health Amendment Act
The underlying problem is mainly the failure of "community support services". The closure of the mental
treatment facilities started nearly 50 years ago. The theory was fine: most folks with mental illness could
be better cared for in the community, rather than in institutions. The problem is not with the theory, but
the planning and implementation. There have never been enough resources, including professional and
caregiver workforce training, research, or funding. Society, not the unfortunate individuals affected by
mental illness, is responsible for the consequences of these failures. We need medical, legal, income
security, housing, personal care, and social, supports for persons who are mentally impaired, and for their
families. A traumatic illness doesn't just affect one person; the family is devastated as well. We've been
shifting far too much responsibility to the individual and their families and friends without providing them
with the resources to cope.
We do have one example of a project which attempts to improve community care for seniors, in the
CHOICE10 programs Capital Health has initiated. That is considered to be quite successful, in making
coordinated professional care, home care services, income subsidies, and social supports available to
individuals but it is very limited. That may be a model that can be adapted to minimize the need for "last
resort" measures like those proposed in Bill 31.
When the State, or an agency or person with delegated authority, assumes the right to force treatment on
its citizens, it has an obligation to ensure that this treatment is a last resort; it is the least risky of all the
options; the social benefit far outweighs potential individual harm; the individual is afforded every possible
protection and recourse to representation. Our history includes embarrassing examples of situations
where these precautions were not in place.11
http://www.law.ualberta.ca/alri/docs/fr52.pdf
Suits allege Lilly, Janssen kept risks of drugs quiet by James Goodwin
"St. Louis Business Journal - October 27, 2006
Dozens of people are suing Eli Lilly and Co. and Janssen LP in St. Louis Circuit Court, saying anti-
psychotic drugs the companies make carry risks that were previously unreported.
The suits allege that Indianapolis-based Lilly and Titusville, N.J.-based Janssen knew of but failed to warn
patients of possible links to hyperglycemia and diabetes. . . "
http://www.elwx.com/risperdal-class-action-lawsuit.html
"Johnson and Johnson is the maker of Risperdal, a drug linked to hyperglycemia, a prelude to
Ketoacidosis, coma and death. Not to mention anemia, diabetes and stroke, and sometimes Bipolar
episodes. This drug was originally approved by FDA as a treatment for schizophrenia, acute mania and
dementia , attention deficit disorder or behavioral disorders in the elderly. But it managed to reach the
innards of children with anxiety, depression and even autism. Other serious effects associated with
Risperdal include neuroleptic malignant syndrome, panreatitis, gynecomastia or growing breasts in
male and female children and adults, dizziness, rapid heart beat, fainting, seizures, problems
swallowing, painful penile erection, vision problems, suicidal thoughts and uncontrollable movements.
For every drug there are lawyers forming Risperdal class action lawsuits for redress in this new
business of drugs which are more ready to provide patients with more harm, if not more deadly
illnesses than they already suffer. If you are among such sufferers there are myriad of attorneys to be
found on the internet."
10 CHOICE (Comprehensive Home Option for Integrated Care of the Elderly) is a coordinated care
program for older people living at home. Full range of medical, social and supportive services
including: a day centre, medical monitoring and treatment, medication dispensing, rehabilitation,
transportation, 24 hour phone number, in home personal care assistance.
11 The Residential Schools; the sterilization of "mental defectives" in Alberta; the Canadian military and
Defence Research Board sponsored LSD tests at McGill University and studies of even more powerful
hallucinogens in secret experiments in rural Alberta (1960s)
See Hidden from History: The Canadian Holocaust by (Rev.) Kevin Annett; references to the 1946 Project
Paperclip, the 1928 Sexual Sterilization Act in Alberta.
http://canadiangenocide.nativeweb.org/intro2.html
Submission to the Standing Committee on Community Services,
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Bill 31: The Mental Health Amendment Act
I would rather not see this piece of legislation go down in history like the 1928 Sexual Sterilization Act and
the 1937 and 1942 amendments, which included persons with neurosyphillis, epilepsies with psychosis,
mental deterioration, and Huntington's disease. That legislation was proposed to reduce the growing
burden of taxpayers in caring for mentally disabled persons, and for the benefit of society. It did not
require the consent of the person or that person's family, it did not consider the harm it would cause, it did
not allow for any appeal. It had a particular impact on women and Aboriginal citizens. It took a change of
government in 1972 to get the Act repealed. We don't need to repeat the experiment.
It is distressing that this removal of citizen rights with government-mandated treatments and confinement
is not accompanied by any plan for adequate follow-up and reassessment of the consequences. There
have been major shifts in the government's "interpretation" of our shared responsibility to fund and
provide health care supports for affected individuals and families, particularly in the area of seniors' care
and mental health, in the last quarter century. There has never been a competent assessment of the
effectiveness of the new regime. In particular, assessments of the quality of clinical care, and the fate of
folks and their families who have fallen through the cracks, have not even been considered. The failure
of responsibility regarding hospital-acquired infection in our hospitals reached critical proportions before
getting attention; we should learn from that, as well.
I would hope that the Committee would research and consider the provisions and the experience with
similar legislation in other jurisdictions particularly whether the health outcomes of the treatments
ordered are successful, and the response of those concerned with civil and legal rights.
Once again, although I appreciate that the Committee has invited public presentations and posted
submissions with respect to this Bill, it's too little too late for any meaningful public discussion and for an
exploration of the alternatives to resolve an important problem. These amendments present significant
ethical implications12, which need to be thoroughly considered and decided by an informed public.
Reliance on "stakeholder" input has once again failed to represent many of the interests and concerns of
the public.13
Thank you for your consideration.
Carol Wodak
213 Village Close, Sherwood Park T8A 4Y2
(780) 417-1705; cwodak@techwcs.com
12 Review of Bill 31 ,the Provincial Health Ethics Network, September 2007: notes that their review did
not allow for participants in different discussions to have the benefits of reflecting on each other's
comments. The Committee has not made the comments of PHEN, or other consultants, available to
the public on the website related to consideration of Bill 31
13 My submission to the Standing Committee on Government Services, Bill 1, the Lobbyists Act,
September 28, 2007 discussed problems with the current public consultation process, despite the
minor improvements in process recently introduced.
Submission to the Standing Committee on Community Services,
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Bill 31: The Mental Health Amendment Act
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