The Ethics of Evidence-Based Psychiatry Mona Gupta MD CM, MA, FRCPC Departments of Psychiatry, University of Toronto & Women’s College Hospital Lakefield Conference on Ethics & Mental Health July 6, 2007 Mona Gupta MD CM, MA, FRCPC Departments of Psychiatry, University of Toronto & Women’s College Hospital Lakefield Conference on Ethics & Mental Health July 6, 2007

Acknowledgements I would like to acknowledge, with gratitude, 1) the generous support of the people of Canada, through the Canadian Institutes of Health Research which funded this research 2) my doctoral thesis committee: Ross Upshur (supervisor), Bill Harvey, Lynne Lohfeld, and Lawrie Reznek 3) Dr J Maher I would like to acknowledge, with gratitude, 1) the generous support of the people of Canada, through the Canadian Institutes of Health Research which funded this research 2) my doctoral thesis committee: Ross Upshur (supervisor), Bill Harvey, Lynne Lohfeld, and Lawrie Reznek 3) Dr J Maher

Context ‘Today, no therapeutic method will be fully accepted unless supported by randomized controlled trials. In other words, understanding disease and treating patients increasingly are dominated by an evidence-based approach.’ Paris (2000) CJP, Vol 45, p.34 ‘…the only ethical practice in [child] psychiatry is one that uses the principles of evidence-based medicine.’ Szatmari (2003) EBMH, Vol 6, p.1 ‘Today, no therapeutic method will be fully accepted unless supported by randomized controlled trials. In other words, understanding disease and treating patients increasingly are dominated by an evidence-based approach.’ Paris (2000) CJP, Vol 45, p.34 ‘…the only ethical practice in [child] psychiatry is one that uses the principles of evidence-based medicine.’ Szatmari (2003) EBMH, Vol 6, p.1

Key Question Does evidence-based medicine (EBM) provide psychiatry with the ethical support it seeks?

Contents I. What is evidence-based medicine (EBM)? II. The ethics of EBM/EBP III. The ethical debate about psychiatry IV. What ethical issues are unresolved, or created, by EBM/EBP? V. EBP & Spirituality VI. Conclusions I. What is evidence-based medicine (EBM)? II. The ethics of EBM/EBP III. The ethical debate about psychiatry IV. What ethical issues are unresolved, or created, by EBM/EBP? V. EBP & Spirituality VI. Conclusions

I. What is EBM?

Definition Evidence-based medicine requires the integration of best research evidence with our clinical expertise and our patient’s unique values and circumstances. Straus et al, 2005, 1 Evidence-based medicine requires the integration of best research evidence with our clinical expertise and our patient’s unique values and circumstances. Straus et al, 2005, 1

EBM describes itself in various ways : EBM is...a ‘philosophy of medical practice based on knowledge and understanding of the medical literature supporting each clinical decision.’ ‘...a practice whose goal is forming a diagnostic and therapeutic alliance between doctor and patient as a means of optimizing clinical outcomes and quality of life.’ (Straus et al, 2005) EBM is...a ‘philosophy of medical practice based on knowledge and understanding of the medical literature supporting each clinical decision.’ ‘...a practice whose goal is forming a diagnostic and therapeutic alliance between doctor and patient as a means of optimizing clinical outcomes and quality of life.’ (Straus et al, 2005)

EBM describes itself in various ways EBM is about ‘clinical decision-making,’ EBM is about ‘solving clinical problems.’ ‘…the goal is to be aware of the evidence on which one’s practice is based, the soundness of the evidence, and the strength of inference that evidence permits.’ Guyatt et al 2002 EBM is about ‘clinical decision-making,’ EBM is about ‘solving clinical problems.’ ‘…the goal is to be aware of the evidence on which one’s practice is based, the soundness of the evidence, and the strength of inference that evidence permits.’ Guyatt et al 2002

What is evidence? ‘best research evidence’: ‘… we mean valid and clinically relevant research, often from the basic sciences of medicine, but especially from patient-centered clinical research…’ Strauss et al 2005, p. 1 ‘best research evidence’: ‘… we mean valid and clinically relevant research, often from the basic sciences of medicine, but especially from patient-centered clinical research…’ Strauss et al 2005, p. 1

What is evidence? ‘…any empirical observation about the apparent relation between events.’ Guyatt and Rennie, 2002, p.6 ‘…any empirical observation about the apparent relation between events.’ Guyatt and Rennie, 2002, p.6

Evidence Hierarchy (for studies of therapeutics) N of 1 randomized controlled trial Systematic review of randomized trials Single randomized trial Systematic review of observational studies addressing patient-important outcomes Single observational study addressing patient important outcomes Physiologic studies Unsystematic clinical observations Guyatt and Rennie, 2002, p.7 N of 1 randomized controlled trial Systematic review of randomized trials Single randomized trial Systematic review of observational studies addressing patient-important outcomes Single observational study addressing patient important outcomes Physiologic studies Unsystematic clinical observations Guyatt and Rennie, 2002, p.7

II. The Ethics of EBM/EBP

Why should we practice EBM? There is no scientific answer to this question. EBM’s/EBP’s scientific superiority and therefore, greater effectiveness in improving patients’ health are assumed to be true. Valid, quantitative data = evidence  Increased certainty about healthcare interventions  Improved health outcomes There is no scientific answer to this question. EBM’s/EBP’s scientific superiority and therefore, greater effectiveness in improving patients’ health are assumed to be true. Valid, quantitative data = evidence  Increased certainty about healthcare interventions  Improved health outcomes

The “Bottom Line” of EBM Assumption of EBM If we pursue EBM we arrive at the most effective means of achieving the best health outcomes + Values of EBM We ought to pursue the most effective means of achieving the best health outcomes = Ethical conclusion We SHOULD adopt EBM because it is the most effective means of achieving the best health outcomes. Assumption of EBM If we pursue EBM we arrive at the most effective means of achieving the best health outcomes + Values of EBM We ought to pursue the most effective means of achieving the best health outcomes = Ethical conclusion We SHOULD adopt EBM because it is the most effective means of achieving the best health outcomes.

What is morally relevant to EBM? Three specific consequences: improved health decreased harm improved cost-effectiveness (‘convenience’ is also mentioned but I don’t consider this to be a moral consequence) Three specific consequences: improved health decreased harm improved cost-effectiveness (‘convenience’ is also mentioned but I don’t consider this to be a moral consequence)

Ethical Critiques of EBM EITHER question the exclusivity of EBM’s ethical goals OR accept the goals, but challenge EBM’s ability to achieve them

Critiques challenging EBM’s ability to meet its ethical goals: Scientific (methodological) Philosophical (related to the logic of RCTs, or concept of evidence) Sociological (e.g. source-of-funding bias) Scientific (methodological) Philosophical (related to the logic of RCTs, or concept of evidence) Sociological (e.g. source-of-funding bias)

Are there critiques specific to psychiatry? Mildest argument “Many studies are inapplicable to real clinical (psychiatric) practice.” Moderate argument “EBP is useful for some psychiatric interventions (medications) but not for others (social or psychotherapeutic interventions).” Strongest argument EBP is not applicable to psychiatry because of the unique features of psychiatric disorders Mildest argument “Many studies are inapplicable to real clinical (psychiatric) practice.” Moderate argument “EBP is useful for some psychiatric interventions (medications) but not for others (social or psychotherapeutic interventions).” Strongest argument EBP is not applicable to psychiatry because of the unique features of psychiatric disorders

Does EBM apply to psychiatry? Prognostic Homogeneity Not possible in psychiatry because of the criteria-based method of diagnosing psychiatric disorders Randomization cannot solve this problem since the group is not uniform Quantification of Outcomes Can numerical ratings capture/convey meaning? Prognostic Homogeneity Not possible in psychiatry because of the criteria-based method of diagnosing psychiatric disorders Randomization cannot solve this problem since the group is not uniform Quantification of Outcomes Can numerical ratings capture/convey meaning?

EBM/EBP could lead to inappropriate reduction of patient/practitioner choice EBM/EBP has the potential to lead to unjust cost-cutting EBM/EBP favours the authority of the research community over other communities EBM/EBP could lead to inappropriate reduction of patient/practitioner choice EBM/EBP has the potential to lead to unjust cost-cutting EBM/EBP favours the authority of the research community over other communities Critiques of EBM/EBP: questioning the ethical goals

III. The ethical debate about psychiatry

Psychiatric classification (or diagnosis) a) inappropriately pathologizes human differences b) facilitates the social control of deviance a) inappropriately pathologizes human differences b) facilitates the social control of deviance

Psychiatric treatments a) even if well-intentioned and/or scientifically-based, do not help, or even do more harm than good b) are inappropriately imposed involuntarily c) are malevolently imposed involuntarily a) even if well-intentioned and/or scientifically-based, do not help, or even do more harm than good b) are inappropriately imposed involuntarily c) are malevolently imposed involuntarily

How does EBP enter the ethical debate about psychiatry? 1. Improve health: EBP tries to improve mental health by determining what treatments work better. 2. Decrease harm: EBP tries to decrease harm by identifying which treatments don’t work as well. 1. Improve health: EBP tries to improve mental health by determining what treatments work better. 2. Decrease harm: EBP tries to decrease harm by identifying which treatments don’t work as well.

IV. What ethical issues are unresolved or created by EBP?

Ethical Problems Unresolved EBM obscures the normative aspects of psychiatric diagnosis. e.g. it attempts to objectify both the description and measurement of psychiatric symptoms EBM obscures the normative aspects of treatment. e.g. it presumes agreement on basic values, like what constitutes ‘good mental health’ and how to achieve it EBM’s implicit moral mandate sidesteps the issue of the legitimacy of involuntary intervention EBM obscures the normative aspects of psychiatric diagnosis. e.g. it attempts to objectify both the description and measurement of psychiatric symptoms EBM obscures the normative aspects of treatment. e.g. it presumes agreement on basic values, like what constitutes ‘good mental health’ and how to achieve it EBM’s implicit moral mandate sidesteps the issue of the legitimacy of involuntary intervention

Ethical Problems Created 1. EBP is vulnerable to the same ethical critiques as EBM 2. More particularly for psychiatry, EBM is re- shaping which voices and problems our discipline privileges. (e.g.behaviours vs experiences meds vs non-pharmacological therapies) 1. EBP is vulnerable to the same ethical critiques as EBM 2. More particularly for psychiatry, EBM is re- shaping which voices and problems our discipline privileges. (e.g.behaviours vs experiences meds vs non-pharmacological therapies)

V. EBP & Spirituality

Is there a moral obligation to address spiritual needs of patients and their caregivers? Dr D Sulmasy, CBS, June “…Patients are not just bodies…Patients are first and foremost persons. Persons are oriented to ask transcendent questions. When ill or dying, persons ask, “What does this mean? What do I mean? Is there any meaning in my suffering?” When ill or dying, persons ask, “What is my value? Do I have any dignity or worth? Is my value to be found only in my social contribution, now limited by my bodily condition? Will I have value that perdures beyond the grave?” When ill or dying, persons ask, “How does this affect my relationships with others?… Will my relationships somehow continue when I am no longer living?”

Dr D Sulmasy, CBS, June cont’d “These are spiritual questions. They arise for people of all faiths and for people of no faith. Illness occasions such questions. And science cannot answer them. The better medical technology has become, the more alienated and frightened patients have become…. A medicine that fixes bodies like machines but ignores the transcendent questions that are integral to the personal experience of sickness and death is no longer a healing art.”

Can EBP address questions of spirituality? Not in a meaningful way. Why not? 1)spiritual questions cannot really be addressed through EBM-preferred research 2) even if you could do EBM-preferred research on interventions related to spirituality, what is the meaning of the data? e.g. imagine that an RCT demonstrates that attendance at weekly formal religious observance improves scores on a symptom rating scale in women with major depression. Not in a meaningful way. Why not? 1)spiritual questions cannot really be addressed through EBM-preferred research 2) even if you could do EBM-preferred research on interventions related to spirituality, what is the meaning of the data? e.g. imagine that an RCT demonstrates that attendance at weekly formal religious observance improves scores on a symptom rating scale in women with major depression.

VI. Conclusions 1. EBM/EBP is fundamentally and ultimately a value- laden enterprise, however much it sidelines this aspect of its practice. It justifies itself using an ethical argument. 2. Although some psychiatrists hope that EBM will lend scientific/ethical credibility to psychiatry, this is unlikely to happen because EBM’s foci are too narrow to provide either a sufficient scientific or ethical basis for psychiatry. 1. EBM/EBP is fundamentally and ultimately a value- laden enterprise, however much it sidelines this aspect of its practice. It justifies itself using an ethical argument. 2. Although some psychiatrists hope that EBM will lend scientific/ethical credibility to psychiatry, this is unlikely to happen because EBM’s foci are too narrow to provide either a sufficient scientific or ethical basis for psychiatry.

V. Conclusions cont’d 3. Psychiatry could address its ethical challenges using ethical arguments, rather than by substituting science or evidence for moral justification. 4. The same could be said for including a spiritual dimension to clinical care. It must be defended as a good in and of itself, regardless of its impact on health outcomes. Be wary of an ‘evidence-based spirituality.’ 3. Psychiatry could address its ethical challenges using ethical arguments, rather than by substituting science or evidence for moral justification. 4. The same could be said for including a spiritual dimension to clinical care. It must be defended as a good in and of itself, regardless of its impact on health outcomes. Be wary of an ‘evidence-based spirituality.’