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Ethical considerations in bipolar disorders
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Commentary
Ethical considerations in bipolar disorders S. Richa a,∗ , R. Chammay a , A. Dargél b,c,d , C. Henry b,e,f , M. Masson g,h a
Department of psychiatry, faculty of medicine, Saint-Joseph university, Pobox 17-5208 Beirut, Lebanon Unité perception et mémoire, Institut Pasteur, 25-28, rue du Docteur Roux, 75015 Paris, France c Unité mixte de recherche, centre national de la recherche scientifique, UMRS-CNRS 3571, 3, rue Michel Ange, 75016 Paris, France d Nightingale hospitals Paris-Clinique Bellevue-Meudon, 8, avenue du 11-Novembre-1918, 92190 Meudon, France e Université Paris-Est, UPEC, 61, avenue du Général-de-Gaulle, 94000 Créteil, France f Pôle de psychiatrie, hôpital H. Mondor–A. Chenevier, AP-HP, 31, rue du Parc, 94000 Créteil, France g Service-hospitalo universitaire, centre hospitalier Sainte-Anne, 1, rue Cabanis, 75014 Paris, France h Nightingale hospitals Paris-Clinique du Château, 11, bis rue de la Porte-Jaune, 92380 Garches, France b
a r t i c l e
i n f o
Article history: Received 14 October 2017 Accepted 11 December 2017 Available online xxx Keywords: Bipolar disorders Bioethics Stigmatisation
a b s t r a c t The implications of biomedical ethics principles extend to both medical care and biomedical research. They are particularly relevant for psychiatry in which pathologies are often chronic and disabling. Bipolar disorders impact the ability to make judgements and to take decisions during mood episodes and remain a stigmatised condition. Early interventions, even those in the prodromal phase, pose ethical questions for both clinicians and researchers. The degree of patients’ autonomy in their clinical care must also now be considered from a biomedical ethics perspective. ´ Paris. © 2018 L’Encephale,
1. Introduction
2. Stigmatisation
The Heideggerian principle of “solicitude without being substituted by others” is a founding principle of biomedical ethics [1]. How can we protect, guide and support patients rendered vulnerable by mental disorders? The burden of bipolar disorders, ranked among the ten most disabling diseases by the World Health Organization, attests to the extent of this vulnerability [2]. Bipolar disorders (BD), a recurrent mental disorder, is characterised by the occurence somewhat impredictably of acute symptomatic episodes (manic, hypomanic or depressive) during which the patient’s ability to make judgements may become severely impaired. Behavioural changes such as emotional hyperreactivity and psychomotor alterations may endanger patients and can leave them extremely vulnerable. Even during the phase between acute episodes (previously thought, incorrectly, to be a phase without impairment), bipolar patients are often subject to stigmatisation.
In a group of people, the stigmatisation process consists of several steps: after the identification of differences in relation to social constructs or representations considered undesirable, the stigmatised person is relegated to the margins of the group and excluded from the community. As a result, the social standing or status of the person is reduced and he or she is subject to stereotypes that reinforce inequalities [3]. Stigma exists when the following converge: people distinguish and label human differences; dominant cultural beliefs link labelled persons to undesirable characteristics that form the stereotype; labelled persons are seen as an out-group, as ‘them and not us’; and labelled persons experience status loss and discrimination that lead to unequal outcomes. The ‘stigma process’ comprises four stigma components and can be conceived of as being arranged in a logical order. This approach may start with the identification and labelling of ‘differentness’, ending with loss of status and discrimination [4]. In the study by Thomé et al., bipolar patients presented increased levels of perceived stigma (the feeling of stigmatisation) had lower levels of psychosocial functioning [5]. Thus, in addition to violating bipolar patient’s dignity, stigmatisation can hinder the recovery process. Stigmatisation is thought to affect close to 50% of those with BD, particularly in a professional context. Psychiatric hospitalisation is one of the most stigmatising factors (Nilsson et al., 2016). These authors have also shown that affective temperament and the
∗ Corresponding author. Department of psychiatry, faculty of medicine, SaintJoseph university, Pobox 17-5208 Beirut, Lebanon. E-mail address: [email protected] (S. Richa). https://doi.org/10.1016/j.encep.2017.12.005 ´ 0013-7006/© 2018 L’Encephale, Paris.
Please cite this article in press as: Richa S, et al. Ethical considerations in bipolar disorders. Encéphale (2017), https://doi.org/10.1016/j.encep.2017.12.005
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ARTICLE IN PRESS S. Richa et al. / L’Encéphale xxx (2017) xxx–xxx
2
practice of a cycle of psychoeducation were two factors implicated in the perception of stigmatisation [6]. 3. Difficulties in decision-making during episodes and consequences for research During acute symptomatic episodes, the ability to make judgements and to take decisions can be severely impaired. To maintain autonomy in the inter-episode period, the designation by the patient of a confidant, to whom the rules of medical confidentiality do not apply, can be of assistance. Integrating this confidant into the treatment plan and action plan, particularly at the time of an acute episode constitutes a considerable challenge for early intervention for relapsing patients [7]. In 2002, the World Psychiatry Association (WPA) announced the Madrid Declaration on Ethical Standards for Psychiatric Practice [8]. This included the following statements: “Because psychiatric patients constitute a particularly vulnerable research population, extra caution should be taken to assess their competence to participate as research subjects and to safeguard their autonomy and their mental and physical integrity. Ethical standards should also be applied in the selection of population groups, in all types of research including epidemiological and sociological studies and in collaborative research involving other disciplines or several investigating centres” [9]. In the context of BD, research protocols need to include an evaluation of a patient’s capacity to consent to participating in a research project [10]. In the event of an acute, mood episode, such as mania or severe depression, the validity of such consent is contested [11]. Thus, the motivations of a bipolar patient for participating in a research project need to be carefully assessed. Nugent et al. propose that with sufficient methodological and ethical precautionary measures, bipolar patients could participate in a placebo-controlled study, or in a study involving discontinuation of drug therapy [12]. It is worth mentioning that, in epilepsy research, new molecules are evaluated first in combination (as an add on) with a known and effective antiepileptic drug in order to evaluate the efficacy gain as compared with a monotherapy, or of an association between an antiepileptic and a placebo, as a means to avoid convulsive seizures. By investigating different therapeutic strategies used in epilepsy research protocols to reduce withdrawal seizures, Kaufman described a comparative bioethics in BD and epilepsy research [13]. 4. Ethical prevention The implication of genetic factors in the pathophysiology of BD, as with other brain diseases, enable us to identify those at elevated risk of developing the disease through family history. Bipolar patients, particularly those who are young mothers, are often acutely aware of any changes in mood or behaviour in their children. Despite recent advances, the identification and definition of early onset symptoms are not without problems [14]. These symptoms are often non-specific and are not always predictive of an acute mood episode characteristic of BD. This brings an additional ethical dimension related to the prescription of medication based solely on prodromal phase symptoms, or of prophylactic measures based on lifestyle factors for which the validity has not yet been clearly demonstrated.
Hafeman and colleagues [15] have recently developed a tool, which is able to estimate the risk of a youth with parents who suffer from BD of developing the same condition. In these highrisk adolescents, the dimensions of mania, anxiety-depression and emotional instability, as well as early development of bipolar disorder in the parent appear to be correlated with the evolution of disease towards BD. In a recent literature review, Rathseeh et al call for a risk-benefit analysis of preventive approaches in high-risk subjects [16]. This would consider management of early cognitive deficits, treatment of early symptoms, and lifestyle factors, while avoiding confining high-risk subjects to stigmatising and traumatic situations. 5. Conclusion The implications of biomedical ethics principles extend to both medical care and biomedical research. They are particularly relevant for psychiatry in which pathologies are often chronic and disabling. Bipolar disorder impacts the ability to make judgements and to take decisions during mood episodes and remains a stigmatised condition. Early interventions, even those in the prodromal phase, pose ethical questions for both clinicians and researchers. The degree of patients’ autonomy in their clinical care must also now be considered from a biomedical ethics perspective. Declaration of interests The authors declare that they have no competing interest. References [1] Heidegger M. (trad. Rudolf Boehm et Alphonse De Waelhens). In: L’être et le temps. Paris: Gallimard; 1972. p. 324. [2] Link BG, Struening EL, Neese-Todd S, et al. Stigma as a barrier to recovery: the consequences of stigma for the self-esteem of people with mental illnesses. Psychiatr Serv 2001;52:1621–6. [3] Angermeyer MC, Matschinger H. The stigma of mental illness in Germany: a trend analysis. Int J Soc Psychiatry 2005;51:276–84. [4] Link BG, Phelan JC. Conceptualizing stigma. Annual Rev Sociol 2001;27:363–85. [5] Thomé E, Dargel A, Migliavacca., et al. Stigma experiences in bipolar patients: the impact upon functioning. J Psychiatr Ment Health Nurs 2012;19:665–71. [6] Nilsson K, Kugathasan P, Straarup K, et al. Characteristics, correlates and outcome of perceived stigmatization in bipolar disorder patients. J Affect Disord 2016;194:196–201. [7] Gergel T, Owen GS. Fluctuating capacity and advance decision-making in bipolar affective disorder. Self-binding directives and self-determination. Int J Law Psychiatry 2015;40:92–101. [8] World Psychiatric, Association. Madrid declaration on Ethical Standards for Psychiatric Practice. Available on www.wpanet.org. [9] Okasha A. The declaration of Madrid and its implementation. World Psychiatry 2002;1:125–6. [10] Misra S, Socherman R, Park B, et al. Influence of mood state on capacity to consent to research in patients with bipolar disorders. Bipolar Disord 2008;10:303–9. [11] Misra S, Rosenstein D, Socherman R, et al. Bipolar mania and capacity to consent: recommandations for investigators adn IRBs. IRB 2010;32:7–15. [12] Nugent A, Miller F, Henter ID, et al. The ethics of clinical trials in severe mood disorders. Bioethics 2017;31:443–53. [13] Kaufman KR. Comparative bioethics in bipolar and epilepsy research. Seizure 2002;11:51–6. [14] Hafeman DM, Merranko J, Axelson D, et al. Toward the definition of bipolar prodrome: dimensional predictors of bipolar spectrum disorders in at-risk youths. Am J Psychiatry 2016;173:695–704. [15] Hafeman DM, Merranko J, Goldstein TR, et al. Assessment of a person-level risk calculator to predict new-onset bipolar spectrum disorder in youth at familial risk. JAMA Psychiatry 2017;74:841–7. [16] Ratheesh A, Cotton S, Davey C, et al. Ethical considerations in preventive interventions for bipolar disorders. Early Interv Psychiatry 2017;11:104–12.
Please cite this article in press as: Richa S, et al. Ethical considerations in bipolar disorders. Encéphale (2017), https://doi.org/10.1016/j.encep.2017.12.005
ARTICLE IN PRESS
ENCEP-1053; No. of Pages 2
L’Encéphale xxx (2017) xxx–xxx
Disponible en ligne sur
ScienceDirect www.sciencedirect.com
Commentary
Ethical considerations in bipolar disorders S. Richa a,∗ , R. Chammay a , A. Dargél b,c,d , C. Henry b,e,f , M. Masson g,h a
Department of psychiatry, faculty of medicine, Saint-Joseph university, Pobox 17-5208 Beirut, Lebanon Unité perception et mémoire, Institut Pasteur, 25-28, rue du Docteur Roux, 75015 Paris, France c Unité mixte de recherche, centre national de la recherche scientifique, UMRS-CNRS 3571, 3, rue Michel Ange, 75016 Paris, France d Nightingale hospitals Paris-Clinique Bellevue-Meudon, 8, avenue du 11-Novembre-1918, 92190 Meudon, France e Université Paris-Est, UPEC, 61, avenue du Général-de-Gaulle, 94000 Créteil, France f Pôle de psychiatrie, hôpital H. Mondor–A. Chenevier, AP-HP, 31, rue du Parc, 94000 Créteil, France g Service-hospitalo universitaire, centre hospitalier Sainte-Anne, 1, rue Cabanis, 75014 Paris, France h Nightingale hospitals Paris-Clinique du Château, 11, bis rue de la Porte-Jaune, 92380 Garches, France b
a r t i c l e
i n f o
Article history: Received 14 October 2017 Accepted 11 December 2017 Available online xxx Keywords: Bipolar disorders Bioethics Stigmatisation
a b s t r a c t The implications of biomedical ethics principles extend to both medical care and biomedical research. They are particularly relevant for psychiatry in which pathologies are often chronic and disabling. Bipolar disorders impact the ability to make judgements and to take decisions during mood episodes and remain a stigmatised condition. Early interventions, even those in the prodromal phase, pose ethical questions for both clinicians and researchers. The degree of patients’ autonomy in their clinical care must also now be considered from a biomedical ethics perspective. ´ Paris. © 2018 L’Encephale,
1. Introduction
2. Stigmatisation
The Heideggerian principle of “solicitude without being substituted by others” is a founding principle of biomedical ethics [1]. How can we protect, guide and support patients rendered vulnerable by mental disorders? The burden of bipolar disorders, ranked among the ten most disabling diseases by the World Health Organization, attests to the extent of this vulnerability [2]. Bipolar disorders (BD), a recurrent mental disorder, is characterised by the occurence somewhat impredictably of acute symptomatic episodes (manic, hypomanic or depressive) during which the patient’s ability to make judgements may become severely impaired. Behavioural changes such as emotional hyperreactivity and psychomotor alterations may endanger patients and can leave them extremely vulnerable. Even during the phase between acute episodes (previously thought, incorrectly, to be a phase without impairment), bipolar patients are often subject to stigmatisation.
In a group of people, the stigmatisation process consists of several steps: after the identification of differences in relation to social constructs or representations considered undesirable, the stigmatised person is relegated to the margins of the group and excluded from the community. As a result, the social standing or status of the person is reduced and he or she is subject to stereotypes that reinforce inequalities [3]. Stigma exists when the following converge: people distinguish and label human differences; dominant cultural beliefs link labelled persons to undesirable characteristics that form the stereotype; labelled persons are seen as an out-group, as ‘them and not us’; and labelled persons experience status loss and discrimination that lead to unequal outcomes. The ‘stigma process’ comprises four stigma components and can be conceived of as being arranged in a logical order. This approach may start with the identification and labelling of ‘differentness’, ending with loss of status and discrimination [4]. In the study by Thomé et al., bipolar patients presented increased levels of perceived stigma (the feeling of stigmatisation) had lower levels of psychosocial functioning [5]. Thus, in addition to violating bipolar patient’s dignity, stigmatisation can hinder the recovery process. Stigmatisation is thought to affect close to 50% of those with BD, particularly in a professional context. Psychiatric hospitalisation is one of the most stigmatising factors (Nilsson et al., 2016). These authors have also shown that affective temperament and the
∗ Corresponding author. Department of psychiatry, faculty of medicine, SaintJoseph university, Pobox 17-5208 Beirut, Lebanon. E-mail address: [email protected] (S. Richa). https://doi.org/10.1016/j.encep.2017.12.005 ´ 0013-7006/© 2018 L’Encephale, Paris.
Please cite this article in press as: Richa S, et al. Ethical considerations in bipolar disorders. Encéphale (2017), https://doi.org/10.1016/j.encep.2017.12.005
G Model ENCEP-1053; No. of Pages 2
ARTICLE IN PRESS S. Richa et al. / L’Encéphale xxx (2017) xxx–xxx
2
practice of a cycle of psychoeducation were two factors implicated in the perception of stigmatisation [6]. 3. Difficulties in decision-making during episodes and consequences for research During acute symptomatic episodes, the ability to make judgements and to take decisions can be severely impaired. To maintain autonomy in the inter-episode period, the designation by the patient of a confidant, to whom the rules of medical confidentiality do not apply, can be of assistance. Integrating this confidant into the treatment plan and action plan, particularly at the time of an acute episode constitutes a considerable challenge for early intervention for relapsing patients [7]. In 2002, the World Psychiatry Association (WPA) announced the Madrid Declaration on Ethical Standards for Psychiatric Practice [8]. This included the following statements: “Because psychiatric patients constitute a particularly vulnerable research population, extra caution should be taken to assess their competence to participate as research subjects and to safeguard their autonomy and their mental and physical integrity. Ethical standards should also be applied in the selection of population groups, in all types of research including epidemiological and sociological studies and in collaborative research involving other disciplines or several investigating centres” [9]. In the context of BD, research protocols need to include an evaluation of a patient’s capacity to consent to participating in a research project [10]. In the event of an acute, mood episode, such as mania or severe depression, the validity of such consent is contested [11]. Thus, the motivations of a bipolar patient for participating in a research project need to be carefully assessed. Nugent et al. propose that with sufficient methodological and ethical precautionary measures, bipolar patients could participate in a placebo-controlled study, or in a study involving discontinuation of drug therapy [12]. It is worth mentioning that, in epilepsy research, new molecules are evaluated first in combination (as an add on) with a known and effective antiepileptic drug in order to evaluate the efficacy gain as compared with a monotherapy, or of an association between an antiepileptic and a placebo, as a means to avoid convulsive seizures. By investigating different therapeutic strategies used in epilepsy research protocols to reduce withdrawal seizures, Kaufman described a comparative bioethics in BD and epilepsy research [13]. 4. Ethical prevention The implication of genetic factors in the pathophysiology of BD, as with other brain diseases, enable us to identify those at elevated risk of developing the disease through family history. Bipolar patients, particularly those who are young mothers, are often acutely aware of any changes in mood or behaviour in their children. Despite recent advances, the identification and definition of early onset symptoms are not without problems [14]. These symptoms are often non-specific and are not always predictive of an acute mood episode characteristic of BD. This brings an additional ethical dimension related to the prescription of medication based solely on prodromal phase symptoms, or of prophylactic measures based on lifestyle factors for which the validity has not yet been clearly demonstrated.
Hafeman and colleagues [15] have recently developed a tool, which is able to estimate the risk of a youth with parents who suffer from BD of developing the same condition. In these highrisk adolescents, the dimensions of mania, anxiety-depression and emotional instability, as well as early development of bipolar disorder in the parent appear to be correlated with the evolution of disease towards BD. In a recent literature review, Rathseeh et al call for a risk-benefit analysis of preventive approaches in high-risk subjects [16]. This would consider management of early cognitive deficits, treatment of early symptoms, and lifestyle factors, while avoiding confining high-risk subjects to stigmatising and traumatic situations. 5. Conclusion The implications of biomedical ethics principles extend to both medical care and biomedical research. They are particularly relevant for psychiatry in which pathologies are often chronic and disabling. Bipolar disorder impacts the ability to make judgements and to take decisions during mood episodes and remains a stigmatised condition. Early interventions, even those in the prodromal phase, pose ethical questions for both clinicians and researchers. The degree of patients’ autonomy in their clinical care must also now be considered from a biomedical ethics perspective. Declaration of interests The authors declare that they have no competing interest. References [1] Heidegger M. (trad. Rudolf Boehm et Alphonse De Waelhens). In: L’être et le temps. Paris: Gallimard; 1972. p. 324. [2] Link BG, Struening EL, Neese-Todd S, et al. Stigma as a barrier to recovery: the consequences of stigma for the self-esteem of people with mental illnesses. Psychiatr Serv 2001;52:1621–6. [3] Angermeyer MC, Matschinger H. The stigma of mental illness in Germany: a trend analysis. Int J Soc Psychiatry 2005;51:276–84. [4] Link BG, Phelan JC. Conceptualizing stigma. Annual Rev Sociol 2001;27:363–85. [5] Thomé E, Dargel A, Migliavacca., et al. Stigma experiences in bipolar patients: the impact upon functioning. J Psychiatr Ment Health Nurs 2012;19:665–71. [6] Nilsson K, Kugathasan P, Straarup K, et al. Characteristics, correlates and outcome of perceived stigmatization in bipolar disorder patients. J Affect Disord 2016;194:196–201. [7] Gergel T, Owen GS. Fluctuating capacity and advance decision-making in bipolar affective disorder. Self-binding directives and self-determination. Int J Law Psychiatry 2015;40:92–101. [8] World Psychiatric, Association. Madrid declaration on Ethical Standards for Psychiatric Practice. Available on www.wpanet.org. [9] Okasha A. The declaration of Madrid and its implementation. World Psychiatry 2002;1:125–6. [10] Misra S, Socherman R, Park B, et al. Influence of mood state on capacity to consent to research in patients with bipolar disorders. Bipolar Disord 2008;10:303–9. [11] Misra S, Rosenstein D, Socherman R, et al. Bipolar mania and capacity to consent: recommandations for investigators adn IRBs. IRB 2010;32:7–15. [12] Nugent A, Miller F, Henter ID, et al. The ethics of clinical trials in severe mood disorders. Bioethics 2017;31:443–53. [13] Kaufman KR. Comparative bioethics in bipolar and epilepsy research. Seizure 2002;11:51–6. [14] Hafeman DM, Merranko J, Axelson D, et al. Toward the definition of bipolar prodrome: dimensional predictors of bipolar spectrum disorders in at-risk youths. Am J Psychiatry 2016;173:695–704. [15] Hafeman DM, Merranko J, Goldstein TR, et al. Assessment of a person-level risk calculator to predict new-onset bipolar spectrum disorder in youth at familial risk. JAMA Psychiatry 2017;74:841–7. [16] Ratheesh A, Cotton S, Davey C, et al. Ethical considerations in preventive interventions for bipolar disorders. Early Interv Psychiatry 2017;11:104–12.
Please cite this article in press as: Richa S, et al. Ethical considerations in bipolar disorders. Encéphale (2017), https://doi.org/10.1016/j.encep.2017.12.005