1.Consent and refusal
9. Consent for anesthesia for procedures with special societal implications: psychosurgery and electroconvulsive therapy
A 20-year-old patient suffers from severe psychiatric disorders (agitation, hetero-aggressivity, threatened self-mutilation) for which he had been hospitalized almost continuously for 7 years. His condition is refractory to the usual psychiatric medication, and psychosurgery may reduce his potential for violence and make him less dangerous to himself and to others. The health care team thus hopes the intervention will provide more humane treatment than the prison-like incarceration to which he is currently subjected. However, given the history and grim connotation of lobotomy as well as its irreversibilty, it raises major issues of appropriate consultation and informed consent more than for any other treatment. These concerns continue to be at the forefront of ethical considerations in psychosurgical techniques and other functional psychiatric interventions, such as electroconvulsive therapy (ECT).
Psychosurgery has a controversial history, in which medical, moral, social, and political considerations intermingle. First described in 1936, and defined as a surgical ablation or destruction of nerve transmission pathways with the aim of modifying behavior, the conventional “lobotomy” of the 1940s and 1950s flourished. There was a strong desire to relieve over-population in asylums and hospitals, and lobotomy came to be seen as a means for calming down and even discharging an appreciable proportion of committed patients,1 or of at least of making caring for them easier. Little attention was paid to patient selection and consent. The unrestrained application of lobotomy makes it difficult to this day to gain an objective evaluation of its true efficacy.
Almost immediately after its introduction, lobotomy was noted to have severe collateral effects on the patient’s personality and their emotional experience of the world. Caregivers described them as listless, dull, apathetic, without drive or initiative, passive, preoccupied and dependent. A horror among the public developed that the operation actually excised free will.
In 1948, Norbert Wiener remarked,
Prefrontal lobotomy … has been recently been having a certain vogue, probably not unconnected with the fact that it makes the custodial care of many patients easier. Let me remark in passing that killing them makes their custodial care still easier.2
In 1950, physicians in the Soviet Union banned lobotomy, concluding that it was “contrary to the principles of humanity,” and that it “turned an insane person into an idiot.”3 Notorious outcomes involving lobotomy, both in real life (e.g. Rosemary Kennedy and Rose Williams, sister of Tennessee Williams), as well as in fiction (e.g. Ken Kesey’s One Flew Over the Cuckoo’s Nest) perpetuated a horror of psychosurgical techniques.
After neuroleptics and chlorpromazine were discovered in the 1950s, psychosurgery declined rapidly, although it continued to be used in cases viewed as otherwise refractory to treatment. Following spirited social controversy in the US, a Federal commission was convened in 1977, which discredited growing public allegations claiming that psychosurgery was used to control minorities, restrict individual rights, and that its undesirable effects were nonethical. The Chairman of National Committee for the Protection of Human Subjects of Biomedical and Behavioral Research, even went so far as to declare:
We have looked at the data and they did not support our prejudices. I, for one, did not expect to come out in favor of psychosurgery. But we saw that some very sick people had been helped by it … The operation should not be banned.4
Nevertheless, lobotomy was subsequently prohibited in a number of states in the US and in other countries such as Germany or Japan. Psychosurgery continues to be performed, but is strictly regulated and controlled in the US, Finland, Sweden, the UK, Spain, India, Belgium, and the Netherlands1.
Prefrontal leucotomy – or “standard” prefrontal lobotomy – and transorbital leucotomy destroyed parts of the frontal lobes or their connections to the limbic system. Significant “frontal lobe” syndrome was a common complication, characterized by permanent apathy or euphoria, inconsistency, puerility, boorishness, impaired judgment, and chaotic behavior. Harmful side effects included epileptic seizures or aggressiveness.
Earlier techniques have since been abandoned in favor of much more limited – although still destructive – procedures. Grouped under the heading of “psychosurgery,” these procedures based on a “functional” neurosurgical approach are:
(1) anterior capsulotomy – interrupting frontothalamic connections in the internal capsule
(2) cingulotomy – partial destruction of the cingulate gyrus, altering certain connections within the limbic system
(3) subcaudate tractotomy – acting on the lower portion of the frontal cortex to destroy the fibres which connect it to the hypothalamus and the head of the caudate nucleus and
(4) bilimbic leucotomy – combining cingulotomy and subcaudate tractotomy.
Results are generally considered effective, although this is on the basis of small case series due to the paucity of acceptable indications. The severe cognitive behavioral disorders experienced by early lobotomy patients are no longer observed. More recently, the administration of highly focused gamma radiation (“gamma-knife”) has produced clinical results similar to functional neurosurgical techniques, while being minimally invasive.
Cerebral stimulation techniques
New hopes are arising for new, nondestructive techniques based on stereotaxic neurostimulation. Initially used to treat severe Parkinson’s disease, they appear to be comparatively free of complications, as there is no permanent cerebral damage. They achieve psychomodulation, even the equivalent of a reversible anterior capsulotomy, by inducing radiofrquency stimulation to the brain in specific locations of the cerebral parenchyma via implanted electrodes. Although very different from surgery mutilating the cerebral parenchyma, these stimulation techniques will probably always remain less psychologically and socially acceptable than, for instance, cardiac electrical pacing. However, because the patient is free to interrupt the neurostimulation, the voluntariness of the patient’s submission to treatment is preserved. In fact, these new treatments share many points in common with behavioral modification induced by pharmaceutical treatment.
The present indications for psychosurgery, although exceptional, have not entirely disappeared. In 2001, a prominent specialist stated:
“However, despite the plethora of pharmacological agents that are available today, there remains a small but significant proportion of patients who suffer horribly from severe, disabling, intractable psychiatric illness. It is in these patients that surgery might still be appropriate if intervention is safe, reasonably effective, and without significant morbidity.”5
The main ethical issues connected to these interventions involve the scientific validity of the therapy and its evaluation, the validity of patient consent, and the possibility of conflict between the interests of the patient and those of society – particularly in the case of dangerous or violent individuals.
Accordingly, many questions remain to be answered. What are the indications? How are these techniques being evaluated and researched? What are the limits of informed consent? Are patients able to consent who have, in essence, lost a significant aspect of their freedom of judgment?
A primary indication for psychosurgery is obsessive-compulsive disorder (OCD). Treatment-refractory OCD is both tormenting and disabling. About 70% of psychosurgical procedures are currently performed for OCD, with notable objective improvement. Patient consent is not usually an issue, since patients are frequently aware of their disability, competent, and eager to pursue treatment.
Other possible indications include severe depression refractory to extreme pharmacologic therapy and sismotherapy (ECT), selected affective disorders such as treatment-refractory schizophrenic psychosis, and selected cases of aggressiveness to self or others.
In practical terms, pre-surgical evaluation to enable medical selection of patients applies solely to patients suffering from OCD. Selection criteria that are considered are: (1) an established diagnosis for at least 5 years; (2) significant suffering evidenced by validated clinical and social function scores; (3) failure of the usual medications to control the disorder, either singly or in combination when administered for at least 5 years, or inability to continue medication due to intolerable side effects; (4) appropriate treatment of an associated co-morbid disorder, and (5) a poor prognosis for the disorder in question. In all cases, it is necessary to inform the patient of the risks, prefer less intrusive stereotaxic techniques, and obtain patient consent.
The relationship between therapy and research procedures
For all other indications, the scientific demand for research is dominant, in view of the uncertainties veiling both the pathology and its presumed treatment. Although a degree of tension emerges whenever potentially irreversible cerebral manipulation is considered, obviously the actual reversibility of new techniques can only be formally established through research. It therefore seems ethically improper to oppose research which aims to examine reversibility of the effects produced. According to a report of the French Bioethics Advisory Commission on the subject of consent6:
The intricacy of the care and research relationship has become a major characteristic of “scientific medicine”. This should be a subject of pride. When it engages in research, medicine questions its own principles, corrects its mistakes, and progresses. Good research is not sufficient in itself to ensure quality health care, but it does contribute.
The concept of consent has very different implications depending on whether the perspective is medical, legal, philosophical, or ethical; whether it only concerns the individual in question; or whether it is given for the benefit of a third party. Consent remains a crucial issue in psychiatry, more than for any other medical discipline, and particularly so when psychosurgery is one of the options.
In the case of severe obsessive psychoses and OCD patients are fully conscious of the torment they endure and are often the first to call for the intervention. In the presence of this desire, physicians need to recognize the anguish created by the pathology, and consider whether they should accede to such requests. Understanding and sensitivity to the reality and intensity of the patient’s distress may bring the conviction that it non-ethical to deny such treatment to patients suffering from a disabling, chronic, and intractable disease. Furthermore, the risk of social, somatic and mental complications of non-treatment, including the risk of suicide cannot be discounted.
Consent may be easy to secure because some patients endure such suffering that they may be ready to accept, or for that matter demand, intrepid action. It is precisely this ease of securing consent that paradoxically raises ethical concerns. But an alternate, equally legitimate question is how long a patient can ethically be left to suffer medical therapeutic failure before offering the option of neurostimulation.
For patients suffering from aggressive delusional conditions (who may be dangerous for themselves or others), the question of consent is much more problematic. It is wishful thinking to imagine that the validity of consent (“free and informed”) does not bear scrutiny in cases where judgment is severely impaired. Nevertheless, all efforts must be made to secure the patient’s assent, even though this “consent” may be dubious in legal terms. Cerebral neurostimulation techniques may be appropriate in some particularly disabling treatment-refractory psychiatric pathologies. However, because neurostimulation for such patients is not established standard therapy and therefore is inextricably involved with research, a very specific concept of consent, validated by external appraisal, must be provided. For further discussion of consent for human subjects in research, see Chapter 27.
In situations where both therapy and research are involved, consent takes on a new dimension. A physician must inform his patient of the consequences of the expected therapeutic effects, and also of the value of the research activity. Although it is clear that consent may be defective for patients suffering from psychiatric disorders, every effort must nevertheless be made to obtain agreement prior to treatment. Even though a particular patient’s “intervals of lucidity” may be very rare, assent should still be sought persistently to try to assure whenever possible that the patient has been able to understand, at least to some degree, the medical expectations and their consequences.
Confronted with a mentally disabled individual whose condition may risk violence to self or to others, society has a duty to protect the vulnerable, but while doing so, must also respect and protect the sick individual – who is also vulnerable. In the clinical setting as well as in biomedical research, pains should always be taken to do as much good and as little harm as possible, while respecting the freedom of decision of those one seeks to help. Even though duty calls for a constant effort to combine and reconcile these two principles, there often conflict between beneficence and autonomy. For example, the French Code of Ethics of the medical profession states:7
Consent from the person under examination or care must always be sought …. when the patient is in a fit state to express his/her wishes, and rejects the investigation or treatment offered, the physician must respect that rejection, after having informed the patient of the consequences. If the patient is unable to express his/her wishes, the physician may not take action unless next of kin have been warned or informed, unless that is an impossibility or urgent action is required.
Therefore, the issue of “being or not being fit to express a wish” is the crux of the matter. Further detailed instruction in the Code of Ethics on this difficult matter is unambiguous:
Consent from a mentally sick patient to treatment offered is most advisable and, if necessary, attempts to secure it may be insistent ; however, in case of refusal, the physician and the family must, in certain cases, ignore the patient’s wishes. When mental aberration is clearly established, or if the patient is dangerous, commitment by certification or voluntarily to a mental hospital or institution becomes necessary. The law dated June 27, 19908 on the commitment of the mentally ill, allows for the wishes of the patient to be ignored in certain cases, both as regards admission to a public hospital and administering treatment. When neurotic disorders or affective disturbances, even of a spectacular nature, do not alter the patient’s personality nor prevent reasonable decision, no treatment may be applied without the patient’s consent.
While the advisory and, in some cases, authoritative role of family members in providing consent for mentally disabled patients is recognized in Europe, such is not universally true elsewhere. In the US, where psychosurgical techniques and psychiatric interventions have been associated in public perception with manipulation or obliteration of free will, restrictions have been placed on consent for psychosurgical procedures and ECT. In some of the US, such treatments can be obtained for decisionally incompetent patients only by court order.
In many cases, a casuistic approach, based on a case-by-case discussion, is needed. In fact, the Madrid Declaration of the World Psychiatric Association states:
Ethical behavior is based on the psychiatrist’s individual sense of responsibility towards the patient and their judgment in determining what is correct and appropriate conduct. External standards and influences such as professional codes of conduct, the study of ethics, or the rule of law by themselves will not guarantee the ethical practice of medicine.9
One solution might be the formation of a formal committee tasked with establishing decision-making procedures for the purpose of providing support and protection to such patients. In the presence of severe psychotic conditions, it may not be best to accept a surrogate consent between the attending physician, the expert, and the family or legal representative. Rather, a committee including non-medical personnel as well as individuals capable of evaluating both the handicaps and misery endured by the patient, the family, and the entourage, might attenuate the pain and anxiety of making such decisions.
For procedures that involve considerations of research and care, every protocol should be approved by a special committee, according to criteria which define: (1) conditions for approaching potential candidates; (2) criteria for patient selection such as severity, chronicity, gravity and failures of prior medical treatment; (3) validity of consent; and (4) mode of evaluation of results.
In view of new issues arising out of the emergence of experimental therapy, the committee’s task would be to preserve the integrity of suffering human beings and safeguard respect for their autonomy, as well as to consider what alternative objective help can be given to them. On the subject of psychosurgery, a working group of the Steering Committee on Bioethics of the Council of Europe stated:
where States continue to sanction the use of it, the consent of the patient should be an absolute prerequisite for its use. Furthermore, the decision to use psychosurgery should in every case be confirmed by a committee which is not exclusively composed of psychiatric experts.10
Electroconvulsive therapy (ECT) is a procedure performed under general anesthesia during which a seizure is induced by application of electricity through electrodes applied on the head. After its introduction in the 1940s, as with psychosurgery, excesses involving its use in the 1960s and 1970s led to sharp criticisms questioning its very necessity. As with psychosurgery, negative associations of its use in public perceptions, both real (e.g., Frances Farmer and Ernest Hemingway) and fictional (e.g., Robert Pirsig’s Zen and the Art of Motorcycle Maintenance) perpetuate suspicion regarding ECT. It nevertheless remains widely used throughout the world. Current indications for ECT are severe psychiatric disorders (severe depressions, melancholia) with a tangible risk of suicide. It is also used in cases of documented resistance to medical therapies for severe depressions and in selected patients suffering from maniac-depressive psychosis or severe schizophrenic disorders.
General anesthesia including muscle relaxants is mandatory to prevent musculoskeletal complications of seizures. Preoperative clinical evaluation allows recognitions of classic contraindications such as certain arrhythmias, or intracranial hypertension complicating some neurological disorders. ECT might even, in selected patients, have less morbidity than certain antidepressants.
The main controversy surrounding ECT involves the fear of psychiatric pathologies and their therapies. An important symbolic question also raised by ECT is the issue of dignity, which is deeply embedded in the concept of free will. Accordingly, the aim of safeguarding the patient’s freedom is central to the official declarations of psychiatric associations regarding patient rights. The World Health Organization recently condemned the abuses and violation of the human rights of people with mental disorders and Dr Jong-Wook Lee, former Director General of WHO urged:
countries, international organizations, academia, the healthcare and legal sectors and others to take a hard look at the conditions of people with mental disorders and take action to promote and protect their rights.11
The question of how to best preserve the interests of the patient while having effecting human behavior, is key to this subject. The use of ECT should be performed in a non-passionate and dramatic way, and in cooperation with the patient. When obtaining consent, the clinician must believe that the treatment is performed in what he/she thinks is in the patient’s best interests, yet always keep open the possibility of patient refusal.
• Special societal implications of psychosurgery and ECT lead us to reconsider the hierarchy of cardinal ethical principles.
• Because of the investigational nature of more recent, less invasive and potentially reversible techniques, research and patient care cannot always be disengaged from one another.
• When considering Autonomy, Beneficence, Non-Maleficence and Distributive Justice, the physician has a moral obligation to respect the common good, with a fair balance between beneficence and the autonomy of the patient.
• Psychosurgery raises fundamental questions, such as those linked to the definition of person and free will, concepts of dignity, integrity, and the validity of true consent.
• In the quest for authentic harmony in the relationships between the health care provider and the patient, tensions between means and ends should be recognized, as well as the understanding of contextual influences, such as economic, political, scientific, and social perceptions, that may alter the consent process.
• Ultimately, decisions regarding psychosurgical interventions and ECT must be made on a case-by-case basis, taking into account patient suffering and disability, and balancing these considerations with patient autonomy.
• Decisions regarding involuntary treatments may benefit from the input of established committees including non-medical personnel and representatives of the patient and their entourage.
1* Feldman, R.P. and Goodrich, J.T. (2001). Psychosurgery: a historical overview. Neurosurgery, 48, 647–59.
2 Wiener, N. (1948). Cybernetics, The MIT Press.
3 Laurence, W.L. (1953). Lobotomy banned in soviet as cruel. New York Times, p. 13.
4 Cullinton, B.J. (1976). Psychosurgery; National Commission issues surprisingly favorable report – news and comment. Science, 194, 299–301.
5 Cosgrove, G.R. (2001). Neurosurgery, 48, 657–8.
6 CCNE, Opinion n° 58, Informed consent of and information provided to persons accepting care or research procedures. Text available at http://www.comite-ethique.fr.
7 Article 36 of the Code de Déontologie.
8 Law n° 90–527 June 27 1990 (J.O. June 30, 1990) ; art. L.326 – L.355 of the code de la santé publique.
9 Madrid Declaration of World Psychiatric Association, Approved by the General Assembly on August 25, 1996. Text available at http://www.wpanet.org/generalinfo/ethic1.html.
10 “White paper” on the protection of the human rights and dignity of people suffering from mental disorder, in particular those placed as involuntary patients in a psychiatric establishment. Council of Europe, January 3, 2000.
11 News Release WHO/68, 7 December 2005 : “End Human Rights violations against people with mental health disorders”. Text available at http://whqlibdoc.who.int/press_release/2005/PR_68.pdf.
Bell, E., Mathieu, G., and Racine, E. (2009). Preparing the ethical future of deep brain stimulation. Surg Neurol, 72(6), 577–86.
Comité Consultatif National d’Éthique. CCNE, Opinion n° 71, Functional neurosurgery for severe psychiatric disorders. Text available at http://www.comite-ethique.fr.
Walter G, and McDonald A. (2004) About to have ECT? Fine, but don’t watch it in the movies: the sorry portrayal of ECT in film. Psychiatric Times; 21(7) http://www.psychiatrictimes.com/.