Sunday, 8 December 2019

Values underpinning "therapeutic necessity" in mental health legislation

Why is there disagreement over “therapeutic necessity” in mental health law?

Introduction

In Herczegfalvy v Austriathe European Court of Human Rights ruled that imposed psychiatric treatment without consent did not breach Article 3 of the European Convention of Human Rights (freedom from torture and inhuman or degrading treatment) in situations of medicalor therapeutic necessity(Bartlett, 2011: p. 525). In order to grant this warrant to override the usual ethical position of respecting patient autonomy it is necessary to define what medical ortherapeutic necessityis. Bartlett, a legal expert, suggested therapeutic necessity should involve “treating the underlying disorder or improving outcomes” in situations of severity (Bartlett, 2011: p. 525). The courts on medical matters tend to take the view of medical experts in their field of expertise. 
I will argue that therapeutic necessityis a conjunction of two terms – what is therapeuticand what is necessity.Therapeuticinvolves a broad series of potential therapeutic goals such as preventing occurrence of negatively perceived outcomes or relieving distress (Sackett et al, 1991: 189) rather than Bartlett’s narrow definition but these goals ostensibly are supposed to be based on patient values not imposed medical values (Sackett et al, 1991). Necessityinvolves judgements by clinicians as to the current severity and risk of adverse outcomes. These judgments involve values and the decision as to whether they justify compulsion also involves value judgements.
Although much work on enforced detention and treatment is centred on autonomy even if this issue is resolved satisfactorily these ethical warrants for therapeutic necessitystill heavily involve value judgements. In particular people may value autonomy differently versus other rights such as the right to life the disputes over this issue are unlikely to be resolved.

When is enforced psychiatric treatment legally justifiable?

“A characteristic feature of mental health legislation … is the provision which is made for waiving, in certain cases, that respect for patients’ autonomy, their right not to be treated without their explicit consent, … regarded as a requirement in most fields of medicine.” (Mathews, 2000: p.59)
Psychiatric detention and treatment without consent may be regarded by some as breaching Articles 3 (freedom for torture and inhuman/ degrading treatment),  5 (liberty and security of the person) and 8 (respect for private and family life) of the European Convention of Human Rights (Bartlett, 2012:  352). On the specific issue of enforced treatment without consent the case of Herczegfalvyv Austria is “key” in establishing under which circumstances Article 3 has not been breached (Bartlett, 2011). 

Mr Herczegfalvy was detained and treated for “paranoia querulans” – essentially a diagnosis used for people who are suspicious and excessively questioning - (after transfer from prison where he was violent) which involved use of prolonged physical restraints, use of restraint to administer antipsychotic medication which involved him suffering broken bones and lost teeth and being force fed. (Curtice, 2008). The European Court of Human Rights ruled Article 3 rights were not contravened and in paragraph 82 outlined their thinking on enforced psychiatric treatment and Article 3.
“82. … the position of inferiority and powerlessness
which is typical of patients confined in psychiatric hospitals calls for
increased vigilance in reviewing whether the Convention has been complied
with. While it is for the medical authorities to decide, on the basis of
the recognised rules of medical science, on the therapeutic methods to be
used, if necessary by force, to preserve the physical and mental health of
patients who are entirely incapable of deciding for themselves and for
whom they are therefore responsible, such patients nevertheless remain
under the protection of Article 3…

The established principles of medicine are admittedly in principle decisive
in such cases; as a general rule, a measure which is a therapeutic
necessity cannot be regarded as inhuman or degrading. The Court must
nevertheless satisfy itself that the medical necessity has been convincingly
shown to exist.” (Bartlett, 2012: p.365)

An article by Curtice summarised several of the crucial issues:

Margin of appreciation Domestic states have different accepted clinical practices and standards... Consequently, clinical decisions that are proportional, therapeutically necessary and in keeping with accepted clinical practice are very unlikely to be outside this margin…
Proportionality Clinical intervention needs to balance the severity of the effect of the intervention with the severity of the presenting clinical problem, i.e. be a proportionate response to a clinical scenario.
Threshold of severity to engage Article 3 Ill-treatment must attain a minimum level of severity; assessment of this minimum is relative. ...” (Curtice, 2008: p. 390)

Specific advice has been given firstly for necessity(Article 18) and what constitutes therapeutic(Article 19).

The Recommendation of the Committee of Ministers to Member Statesconcerning the protection of the human rights and dignity of persons with mental disorder, Rec(2004)10,.. sets out different criteria for involuntary treatment and involuntary detention. The substantive recommendations concerning involuntary treatment are as follows: Article 18 – Criteria for involuntary treatment A person may be subject to involuntary treatment only if all the following conditions are met: i. the person has a mental disorder; ii. the person’s condition represents a significant risk of serious harm to his or her health or to other persons; iii. no less intrusive means of providing appropriate care are available; iv. the opinion of the person concerned has been taken into consideration. Article 19 – Principles concerning involuntary treatment 1. Involuntary treatment should: i. address specific clinical signs and symptoms;ii. be proportionate to the person’s state of health; iii. form part of a written treatment plan; iv. be documented; v. where appropriate, aim to enable the use of treatment acceptable to the person as soon as possible.” (Bartlett, 2012: p.374)
Legal justification for enforced psychiatric treatment without consent relies on the condition of therapeutic necessity and split into two further conditions – what is therapeuticintervention and what is necessity.  In the next two sections I will discuss what therapeutic means in  medical practice and what may be considered necessity, how values complicate both matters and how these values will prevent agreement in all parties involved in such discussions of the legal justification of enforced treatment – clinicians, patients, carers and lawyers. It is important to be clear what therapeutic necessity refers to before the issuing of ethical warrants for doctors to breach their usual convention of respecting patient autonomy.

What is Therapeutic?

What does therapeuticmean in this context? The Recommendation of the Committee of (EU) Ministers to Member States defined therapeuticas having an intention to “address specific clinical signs and symptoms” (Bartlett, 2012: p.374). Bartlett, a legal academic defines therapeuticas “treatments may appropriately be prescribed which are not therapeutically necessary. Treatments which attack the symptoms of a disorder but not the underlying disease are an obvious example” (Bartlett, 2011: p. 533) as well as “treating the underlying disorder or improving outcomes” (Bartlett, 2011: p. 531). The Code of Practice of the Mental Health Act (1983) requires that appropriate treatment “must be treatment which is for the purpose of alleviating or preventing a worsening of the patient’s mental disorder or its symptoms or manifestations” (Bartlett, 2011: p.533). So whereas Bartlett does not regard lessening symptoms as part of therapeutic necessity – only those treatments that target “underlying disease” or improve outcomes (but not outcomes such as improving symptoms) – the official viewpoints such as the Code of Practice are that improving or preventing deterioration of symptoms may count as therapeutic. These are legal and statutory viewpoints. What is the medical opinion which is the key factor (Bartlett, 2012: p.365)?
Critical psychiatrists offer two models of prescribing – one a “disease-centred model” where medication reverses hypothesised mechanisms of disease producing the symptoms (similar to Bartlett’s definition) or a “drug-centred model” where a drug is regarded as always harmful and producing many effects of which some may be regarded by the patient as beneficial such as blunting of painful emotions (Yeomans et al, 2015). A more sophisticated view of therapeuticregards medical interventions as having three potential goals:

 “alleviation of symptoms without affecting the disease course; prevention of progression, but not curative …; and curative or preventive …” (Lieberman et al, 2019: p.794

Sackett - one of the prime movers behind the “Evidence Based Medicine movement” - along with his co-authors outlined a list of objectives of treatments to be decided with the patient (Sackett et al, 1991: p. 189). I have listed them below with my suggested modifications and additions in italics.
“1.           Cure
2.              Prevent recurrence/occurrence
3.              Limit structural or functional deterioration
4.              Prevent later complication
5.              Relieve current distress/reduce symptoms
6.              Deliver appropriatereassurance
7.              Allow to die with comfort and dignity/avoid overzealous treatment”(Huda, 2019; p. 79) adapted from Sackett et al, 1991; p. 189)

Describing these in order, cure should be applied to circumstances such as a reversal of disease process but in layman terms often refers to situations where the symptoms are eliminated or a disease mechanism is compensated for (such as when pharmaceutical insulin is prescribed to replace the body’s own insulin). Prevent recurrence refers to situations where treatment is aimed at preventing a return of the medical condition (or maintenance antipsychotics in schizophrenia) and I expanded it to interventions are given to prevent a first occurrence of a condition (such as vaccination to prevent infections). Limiting deterioration are where interventions are given to prevent further problems such as the use of plasters and surgical fixation to prevent displacement of fractures. Many medical conditions are treated to prevent known complications associated with the condition such as the use of antihypertensives in high blood pressure to prevent cardiovascular disease. Relieving distress or symptoms is an important therapeutic goal as it is often distress or other unpleasant experiences labelled as symptoms that bring people to seek out medical help. Examples include painkillers for pain or antidepressants in depression. Sometimes patients they are worried their symptoms may be caused by a dangerous medical condition but the results of tests are negative so doctors offer reassurance as the intervention. Finally, good medical practice in certain situations is not to carry out intensive interventions with little chance of success as well as to allow someone to have a ‘good death’ according to their wishes. 

This list of therapeutic objectives is broad not all could be regarded as justifying compulsory treatment (for example providing reassurance) and avoiding overzealous treatment by definition is not an imposed treatment without consent. Sackett et al emphasise the importance of patient choice for these treatment objectives.

“Since any decision about the ultimate objective of treatment is made for the sake of the patient, most clinicians involve, and even defer to, the patient’s wishes (or those of an impaired patient’s family) in this decision. And when assessing the risks and benefits (especially as they involve trade-offs between the quantity and quality of life) may not only be useful but crucial (Sackett et al, 1991: p. 188).”

Values clearly have a role in deciding which treatment objectives are valid and which should be chosen in specific circumstances. Bartlett’s own values are at a minimum highly sceptical about psychiatric treatments. He puts forwards his own view that  “benefits of psychiatric medication are not necessarily clear-cut, and the risks can be significant” (Bartlett, 2011: p.517) and contrary to his own claim to want a “balanced reflection” (Bartlett 2011; p. 517) barely mentions any benefits but instead discusses at length adverse effects including a claim that antipsychotics kills more people that it saves which is contradicted by the research evidence that antipsychotics reduce mortality (Tiihonen et al, 2009). This illustrates the perils of relying on balanced accurate evidence from someone advocating a legal argument. As for effectiveness of psychiatric treatments there is an overlap in effectiveness between medication used in psychiatry and general medicine in achieving therapeutic objectives (Leucht et al, 2012 and Leucht et al, 2015). 

Bartlett further reveals his attitudinal values towards psychiatric medication by describing them as “mind-altering drugs” (Bartlett, 2011: p.535) – a highly value-laden term that makes the medication sound frightening but just highlights conceptual confusion. After all, psychiatric medication is used to benefit people with mental health conditions whom are regarded as having unpleasant, distressing or impaired functioning of mind– hence the therapeutic aim would to be alter the state of mind in a beneficial way surely? Which begs the question what does Bartlett think psychiatric treatment should alter? The feet? These values may inform Bartlett’s views that only reversing the underlying causes of the condition or better (unspecified) outcomes but not reducing symptoms should be regarded as valid therapeutic necessity to justify enforced treatment. However, given most psychiatric treatments are justified on clinical grounds for reducing symptoms and does not reverse underlying mechanisms of mental disorders (many of which are unknown) (see Huda, 2019: p. 258-304 which also contains a discussion of how many general medical medications do not reverse underlying mechanisms either) Bartlett’s proposals -perhaps influenced by his values towards psychiatric treatment - would rule out of bounds most psychiatric treatments as fulfilling therapeutic necessitycriteria.

Enforced treatment without consent contrasts with the typical situation in medicine where therapeutic goals are supposed to be chosen at least in conjunction at the least if not actually led by the patient and their values (Sackett et al, 1991: p. 188). Here the clinician’s values (usually the doctor’s but recent changes to the Mental Health Act have allowed other clinicians to have this power) has the ultimate power in deciding the therapeuticgoals; the Code of Practice may reinforce the importance of consultation and taking on board patient views and values but the clinician’s values have the golden vote. 

Several examples of clashes of values will now be discussed. The first obvious one is the allocation of states of mind and behaviour to the category of ‘mental disorder’ by the clinician. Whilst evaluative processes are involved in both physical and mental disease concepts these are more so in mental disorder (Fulford et al (1993): 806-807) as values underlying designation of states as physical disease are more commonly shared and thus less problematic for physical illness compared to mental disorder (Fulford in Boch & Chodoff (1991): 80-82). As a corollary, deciding that certain states of mind and behaviours are ‘symptoms’ that need ‘reduced’ is an evaluative judgement that may not be shared between clinician and patient.

A patient in an elated manic state may wish to continue in this state (though there are often periods of mixed moods including depressed mood) and not see any problem with spending large amounts of money or reckless impulsive decisions that may cause problems such as sexual activity with people other than their spouse. The clinician may decide that the priority is to reduce the manic symptoms which should also have the benefit of preventing complications in the person’s life by their disinhibited behaviour. (One patient told me “you spoilt my fun” when I had reduced their manic symptoms). The clinician is making the value judgement that these therapeutic goals are sufficiently desirable to have the chance (not certainty) of achieving them by having treatment imposed despite the negatives such as enforcing treatment and potential side effects. A depressed patient who is suicidal may not agree with the doctor for starting treatment with the therapeutic goal of reducing symptoms and preventing occurrence of suicide for several reasons: they may believe they deserve to suffer and die because of guilt, they may think treatment is pointless because of depressive pessimism, they may prioritise harm avoidance of treatment side-effects rather than taking a chance on feeling less depressed or they may think the treatment is intended to punish them because the doctor dislikes them.  A patient with what the doctor regards as delusions or hallucinations may believe in the truth of what the doctor describes as psychotic symptoms. They may want to have any associated distress reduced but in consonant with their beliefs/ hallucinations (such as the persecution ending from persecutors). They may not therefore agree with taking medication for psychosis they do not believe they have, they may worry the medication can sedate them making them vulnerable to attack or they may think the medication is part of the persecution to discredit them or even poison them.

Clinicians may be choosing therapeutic aims that are similar to those in medicine as a whole but in enforced treatment against consent, the values that “doctor knows best” trumps the patient’s values in an “authoritarian” model of physician-patient relationship and given the role of state authorised enforced treatment some may regard it as an “instrumental” model in which the physician is acting as the instrument of the authorities (Emanuel & Emanuel, 1992). These value differences persist regardless of the question of impaired autonomy. One can argue that these value clashes are state-dependent and will change when they are not in such mental states but as Bartlett describes there are mixed views on compulsion as a whole afterwards (including presumably the question of enforced treatment) after the detention ends (Bartlett, 2011:p.520) which suggests that even if autonomy was impaired then after restoration of autonomy the clashes in values about the decision can persist.  

What is Necessity?

Situations of necessityjustifying legal detention and enforced treatment of mental disorders require sufficient severity with sufficient risk to health of the patient or to others and where compulsion is still necessary despite consultation with the patient who is judged to lack decision-making capability at the time and the proposed measures are proportionate to the situation (Curtice, 2008: p. 390, Bartlett, 2012: p.365 and Bartlett, 2012: p.374).
This definition of necessityinvolves values – for example the concept of margin of appreciationrecognises that in different EU states different standards and judgements will apply as to what is acceptable clinical practice (Curtice, 2008: p. 390) and this must be due to different local values not merely what specific treatments are available. 
Severity of mental disorder usually involves subjective judgements based on interviews and observations rather than more objective biomarkers which contrasts with the common use of investigation results to underpin decisions in general medicine (see Huda, 2019: p.187-206 for further discussion) and a values-influenced statement of severity such as ‘moderate’. This obviously is prone to be affected by values at various levels from culture to the individual. In mental health severity judgements may be based using ‘anchoring’ observations of such as ability to fulfil occupational demands, self-harming behaviours or self -care – these may display inter-rater reliability but are affected by values. 
Judging the risk involved is also subjective, often involving the collection and weighing up of protective and risk factors and the history of the patient but still involving an element of personal judgement and allocation to a category such as ‘high risk’ which is inevitably affected by values. Psychiatric assessments of risk may not be particularly reliable or accurate (Hope, 2004: p.81) which means that the weightone places on them and in their construction inevitably involves values.
Let us assume these psychiatric assessments of risk ARE reliable and accurate. Say a person with depression is estimated to be at a risk for suicide of 1% in the next week. Personal values influence how we weigh this information up as to whether it justifies enforced treatment let alone detention. Those whose personally value autonomy greatly (not least the patient whose autonomy is being threatened) or those who have an antipathy to psychiatric services (sometimes with good reason due to bad personal experiences of “care”) will focus on the absolute nature of the figure – 99% will not commit suicide and point to the usual civil justice standard of ‘balance of probabilities’ i.e. greater than 50% chance needed. Others will prize autonomy so greatly they will demand a higher threshold or even accept no imposition on autonomy at all. Those whose values regard mental health problems as clinical problems that require treatment or place great emphasis on the right to life may focus on therelativeincrease in risk – in the nature of several thousand fold increase in risk for the average member of the population (assuming an annual suicide rate of 10:100,000) and several hundred fold for people with depression (assuming a lifetime risk of 5-10% for suicide that operates over several decades of a recurrent illness).This great relative increase in risk may need a further justification to convince those wavering between autonomy and right to life – such as the availability of treatment that has a chance to benefit (there are no guarantees in medicine but there can be a reasonable possibility of benefit) and if it is enforced without consent it has a reasonable chance to reduce the symptoms of depression and improve the patient’s quality of life and maybe reduce the risk of suicide. 
The occasions where patients with mental disorders may pose a risk to others might be regarded as being more likely to lead to shared agreement over justification to detention and enforced treatment without consent as people are more likely to agree that autonomy does not allow one to ham others. On the other hand concerns about the reliability and accuracy of risk to others still applies (Hope, 2004: p.81) and the use of preventative detention on the grounds of a health condition posing a risk to others is still a value choice to treat people with mental health problems differently from ‘ordinary criminals’ who pose a risk to the public (Hope, 2004 p.81) even if an argument can be made that mental illness causing somebody to be aggressive implies reduced responsibility as well as a possibility of reducing this aggression with suitable interventions which justifies this different ‘treatment’.  Those whose values justify detaining and enforcing treatment on the basis of health alone are relying on judgments of what constitutes health and illness based on values which are less likely to be shared in mental health conditions (Fulford et al (1993): 806-807and Fulford in Boch & Chodoff (1991): 80-82) and therefore less agreement with those who prioritise autonomy.
Judgements as to necessity involve value judgements – on deciding the level of severity and the level of risk. Further value judgements are involved in deciding whether severity and the associated risks justify breaching autonomy and often involve weighing up different rights such as autonomy and the right to life – these values differ amongst people hence their conclusions for the same clinical scenario will vary.

Discussion

The ethical warrant to allow doctors to enforce detention and treatment without consent in situations of therapeutic necessitygoes against the usual position of respecting patient autonomy (Mathews, 2000 p.59) and much focus has been on trying to demonstrate patients subjected to these breaches of autonomy-based rights do not have ‘autonomy’ due to their mental disorder (for example, Mathews, 2000: p. 66-69) thus allowing the doctor to act as substitute decision maker. There seems an assumption that if this is demonstrated satisfactorily then this make such enforced detention and treatment without consent uncontroversial or at least a largely value-free action.
Unfortunately for this point of view values will continue to be a source of dispute even if it can be demonstrated that patient autonomy is always impaired by mental disorder in situations of enforced detention and treatment without consent justified by therapeutic necessity. This is because deciding what are the appropriate therapeuticobjectives – such as reducing symptoms or preventing occurrence of events such as suicide – involves value judgements from the clinicians - such as what experiences are symptoms, what is a mental disorder – trumping those of the patient who may not agree that they have a mental disorder or with the therapeutic objectives when the mental disorder has improved (Bartlett, 2011:p.520). Further, many people have values that object to many psychiatric treatments regarding them as “mind-altering” in a perjorative sense (Bartlett, 2011: p.535). Deciding what is necessity further involves the role of values in deciding how severe the mental disorder is and how great the risks are as well as a value judgement in do they justify detention and treatment without consent.
One obvious clash of values is how to weigh up competing demands of autonomy versus other rights such as those of a right to life and some people may regard the restoration to what they regard as health as a right. People weigh these different entitlements differently and some people will never accept breaches of autonomy in any circumstances. 
Enforced detention and treatment without consent will never be universally accepted due to differences in values between people.

References

Bartlett, P., 2012. Chapter 14 Rethinking Herczegfalvy: the Convention and the control of psychiatric treatment in Brems, E. ed., 2012. Diversity and European human rights: rewriting judgments of the ECHR. Cambridge University Press.
Bloch, S.E. and Chodoff, P.E., 1991. Psychiatric ethics. Oxford University Press
Curtice, M., 2008. Article 3 of the Human Rights Act 1998: implications for clinical practice. Advances in Psychiatric Treatment14(5), pp.389-397.
Emanuel, E.J. and Emanuel, L.L., 1992. Four models of the physician-patient relationship. Jama267(16), pp.2221-2226
Fulford, K.W.M., Smirnov, A.Y.U. and Snow, E., 1993. Concepts of disease and the abuse of psychiatry in the USSR. The British Journal of Psychiatry162(6), pp.801-810
Hope, T., 2004. A very short introduction to medical ethics.Oxford University Press, Oxford
Huda, A.S., 2019. The Medical Model in Mental Health: An Explanation and Evaluation.Oxford University Press, Oxford.
Lieberman, J.A., Small, S.A. and Girgis, R.R., 2019. Early detection and preventive intervention in schizophrenia: from fantasy to reality. American Journal of Psychiatry176, pp.794-810
Leucht, S., Hierl, S., Kissling, W., Dold, M. and Davis, J.M., 2012. Putting the efficacy of psychiatric and general medicine medication into perspective: review of meta-analyses. The British Journal of Psychiatry200(2), pp.97-106.
Leucht, S., Helfer, B., Gartlehner, G. and Davis, J.M., 2015. How effective are common medications: a perspective based on meta-analyses of major drugs. BMC medicine13(1), p.253.
Matthews, E., 2000. Autonomy and the psychiatric patient. Journal of applied philosophy, pp.59-70.
Sackett D.L., Haynes R.B., Guyatt G.H. & Tugwell P., 1991 Clinical Epidemiology: A Basic Science for Clinical Medicine (Second Edition)Boston/Toronto/London. Little, Brown and Company
Tiihonen, J., Lönnqvist, J., Wahlbeck, K., Klaukka, T., Niskanen, L., Tanskanen, A. and Haukka, J., 2009. 11-year follow-up of mortality in patients with schizophrenia: a population-based cohort study (FIN11 study). The Lancet374(9690), pp.620-627.
Yeomans, D., Moncrieff, J. and Huws, R., 2015. Drug-centred psychopharmacology: a non-diagnostic framework for drug treatment. BJPsych Advances21(4), pp.229-236.