NEED FOR DEBATE

Center for Advocacy in Mental Health
A research center of Bapu Trust, Pune, India

INTRODUCTION
The World Health Report, 2001 of the WHO is the most recent among a line of reports and documents suggesting the tremendous increase in the burden of mental disorders in developing regions. Several researchers (for example Patel, 1999) have underscored the "social determinants model" of mental health, where poor social and economic development is linked with increased risk for mental ill health. The poor and vulnerable groups are seen as being at high risk for common mental disorders (CMD). The research of the last decade on gender and mental health has also shown the greater vulnerability of men and women to substance abuse and depression respectively (Davar, 1999; 2001).

Incommensurate with the emerging epidemiological and social science data bases in mental health today, and the increasing awareness in society about mental disorder, there is a large gap in service provision and quality of care research or advocacy. When it comes to service provision, "cost effectiveness", "risk benefit analysis", etc. has led to some questionable arguments and conclusions, because of the lack of public debate. Only partisan views prevail in this area and the debate is polarized between medical professionals and human rights groups in mental health.

Two significant arguments made on the basis of cost effectiveness are the following:
(1) That direct ECT (Electro Convulsive Therapy) is the cheapest and most effective form of treatment (Andrade, 2003a, b; Tharyan, et. al. 1993) and

(2) That anti-depressants are better (cheaper and more effective) than placebo or psychological counseling in the treatment of depression (Patel et al 2003).

Both these arguments boost the prominent bio-medical profile and future of mental health provision in India. With a view to starting a public debate on community alternatives and quality of care in mental health service provision, in this paper, we take a position regarding the recent advocacy promoting the use of direct ECT (i.e. shock treatment without anesthesia), as the cheapest, and most effective form of treatment for mental disorders (Andrade, 2003a, b; Tharyan, et. al. 1993).

We argue that direct ECT is a controversial, hazardous and traumatizing procedure. There is no contemporary evidence base for the use of the procedure. There is an uncommon degree of death, injury, terror and trauma caused by the procedure. And finally, there is a high potential for abusing it as a form of punishment. These factors, we conclude, makes direct ECT an instrument of torture, rather than of treatment. The use of the procedure must be brought within human rights jurisprudence and should be the subject of consumer action and litigation. Regulatory bodies such as the IECs, Medical Research Council and the Psychiatric Society should stop further research on direct ECT.

We do admit that families may have obtained beneficial results from use of the ECT when administered well. However, we agree with Pathare (2003) who writes that people friendly, psychotherapeutic and community-based options must be developed instead of routinely prescribing ECT on the basis of the "poor country" argument. The topic of ECT in general and its relevance in community mental health must be more widely debated.

1. ELECTRO-CONVULSIVE THERAPY (ECT): OUT OF THE CLOSET
Finally, the subject is out of the closet. Shock treatment has always been a taboo subject in India. It has been an esoteric topic discussed in medical forums, but never brought up before for public debate. Recently, in the wake of the Supreme Court approval of the procedure, a prominent psychiatrist has written making a case for direct ECT (Andrade, 2003a, b). This article follows in a line of other articles advocating direct ECT in recent times (Tharyan, et al 1993). This resurgence of direct ECT is risky in mental health service provision in India.

1.1 What is ECT?
In ECT, an electrical current of between 70 to 170 volts is passed for between 0.5 and 1.5 seconds. In direct ECT, the body is thrown into frank epilepsy like seizures. While the patient is conscious in the beginning, he or she is rendered unconscious when the grand mal seizure starts. He is held down physically by staff to prevent fractures and internal injuries. The risk of injury is high. As the procedure is usually given in series, this hazard is experienced again and again. In an ideal text book situation, the procedure is repeated between 6 to 10 times. But continuous dosing of up to 20 times or more is neither unknown nor uncommon in India.

In its "modern" or "modified" form (Modified ECT), text book practice suggests that the patient should not eat or drink for four hours or more before the procedure, to reduce the risk of vomiting and incontinence. Medication may be given to reduce the mouth secretions. Muscle relaxants and anesthesia are given to reduce the overt epileptic / muscular convulsions. The muscle relaxant paralyzes all the muscles of the body, including those of the respiratory system. Anxiety may be caused to the patient due to a sense of suffocation and anesthesia is given to prevent the anxiety. General anesthesia is given intravenously to make the patient unconscious. A "crash cart" is kept nearby, with a variety of life-saving devices and medications, including a defibrillator for kick starting the heart in case of a cardiac arrest. The brain is subjected to seizure activity induced by the electrical current, as it is believed that seizure is the essentially curative. The causal mechanism by which the treatment works is not known. Endocrinological, neurotransmitter and other changes have drawn a blank (Kiloh, et al 1988). It is believed that electricity itself and the seizure activity it produces is the curing element.

To get a picture of the procedure, read below, a full narrative of the experience of modified ECT, reported by doctors in 1988:

"In a generalized seizure (grand mal) the patient loses consciousness immediately and the whole musculature goes into a powerful tonic spasm. The upper limbs are held close to the body with flexion of the wrists and fingers, while the lower limbs extend with inversion of the feet and flexion of the toes. The trunk muscles contract and as the extensor muscles are the more powerful the spine tends to become hyperextended. The respiratory muscles are involved so that respiration ceases. The pupils dilate and become inactive and the eyes are insensitive to touch. There is an increase in heart rate and a rise in both systolic and diastolic blood pressure. If the bladder or bowel are distended at the time of the fit, either or both may be evacuated. The tonic phase usually lasts some 10-30 s followed by a partial, brief relaxation of muscles and a swift return of the spasm. Violent jerks then convulse the body in rapid succession and blood-stained froth may exude from the mouth. The clonic jerkings continue, the intervals between them lengthening, until with a final jerk the clonic stage terminates. At this point a degree of cyanosis is usual but after a brief period of flaccidity breathing is re-established. Often as consciousness begins to return, the patient passes into a deep sleep. If this does not occur the patient shows evidence of confusion with disorientation and may talk in a rambling and disjointed manner sometimes with paraphasias. The patient is likely to be restless and may show excited behaviour perhaps becoming irritable, angry and even violent" (Kiloh, et. al. 1988: p. 189).

1.2 Use of ECT in India
Only a few scattered articles exist in India, mostly published in the official journal of the Indian Psychiatric Society (Indian Journal of Psychiatry), on direct ECT practice. Vahia et al's early study (1974) reported that in Bombay, 10580 patients out of 12,540 were given direct ECT, a large proportion of the help seeking population. Davar (1999) reviewing secondary literature wrote that, unlike the trend in the west, the use of ECT increased 20-fold in a hospital in Mumbai over a decade. Agarwal, Andrade and Reddy (1992) reported that direct ECT is widely practiced in India as a form of psychiatric treatment. Sharma and Chadda's (1990) review of hospital facilities also showed that a majority of Indian mental hospitals used direct ECT.
Agarwal and Andrade (1997) studied the attitudes of psychiatrists towards ECT. Of 263 respondents 2.7% strongly objected to the procedure and another 9.5% generally opposed. Another 5.3% had no feelings one way or another. 64.3% were generally favourable, another 12.5% were decidedly favourable. 80% of doctors felt that ECT is the safest, cheapest and most effective form of treatment. A fair majority disagreed that ECT should be used when all else failed. The researchers are "reassured that most felt positive towards ECT".

Professionals claim that patients are overwhelmingly happy about the effects of ECT (Andrade, 2003b). However, there is no experiential or quantified consumer satisfaction research to back this up. Not surprisingly, patient views on ECT are completely missing in the literature. Experiential accounts of staff or doctors, who have administered the procedure, are not available. There are problems, as we will see, about doing such studies. One study done during the direct ECT era (Verghese, Gupta & Prabhu, 1968) reported that not a single patient out of 36, voluntarily opted for ECT. 26 passively submitted, 8 had apprehensions and 2 strongly objected. This study reported memory loss and marked disorientation following the treatment. This is the only consent study we have found reported in literature.

1.3 SC interest in direct ECT
As readers of EPW may be aware, direct ECT has been placed as a controversial and contested issue before the Supreme Court recently. In the month of August, 2001, 28 people labeled with mental illness perished in a fire tragedy in Ramanathapuram district of Tamil Nadu. The manager of the private shelter in Erwadi had kept them tied to their cots, and so, escape was impossible. The SC took suo moto action and ordered all State Governments to file affidavits on a continuing basis, tabling information on the following topics: the availability of services within the state for mental disorders; whether the Mental Health Act has been implemented; the functioning of the State Mental Health Authority (SMHA); information on religious healing sites and whether mentally ill persons have been kept in chains in any part of the state. The SC appointed an amicus curiae to make recommendations, to field relevant information to the court and to process related petitions that may be filed by the public.

Direct ECT is considered a most contested and controversial procedure in the treatment of mental disorders. Saarthak, an NGO working for persons with mental illness in New Delhi, filed a petition before the SC appealing mainly the following: limitations on physical restraint, an unconditional ban on direct ECT and removal of Section (81.2) of the Mental Health Act, which allows proxy consent for research on persons with mental illness (Writ Petition No. 562/2001 in Saarthak vs. Union of India). While noting that ECT is not the top question for discussion in mental health today, Pathare (2003) has written responding to the Saarthak petition: "This debate [direct vs. modified] is a non-starter: it is accepted the world over that ECT must be administered in a modified form. It has been argued that there is a special case for permitting direct ECT in India because of the lack of facilities for anesthesia and to reduce the costs of treatment. Both these arguments are spurious. ECT is a major procedure and must be carried out under reasonably safe medical conditions" (p. 11). Not many professionals have written in response to the SC intervention.

The response of the state and the judiciary to use of direct ECT has however been ambivalent. In response to the SC orders, many states have reported that direct ECT is being phased out and that as per modern practice, only modified ECT is being used. Some states have given a justification for continuing the use of direct ECT, while also certifying that in their State this practice is not being followed.

In their final judgment, the apex court noted that "ECT remains effective in several major mental disorders". It is "life saving" and reduces the "risk of suicide". It further states, notoriously, that direct ECT is safer than modified ECT, as in the latter the risk of use of anesthesia and muscle relaxants is added. Dr. D. Mohan, Psychiatrist, AIIMS advised the apex court, in this instance. The doctor observes a mortality rate of "only 0.03%" in direct ECT, considered clinically insignificant, where as with modified ECT risks of use of anesthesia are to be added. Dr Gauri Devi, erstwhile director of NIMHANS, wrote observing mainly that modified ECT is a non-issue in the treatment of certain mental disorders. But she did not frontally address the issue of direct ECT, the central topic of the Saarthak litigation.

The Supreme Court judgment in this regard raises several questions about the interphase between law and science, the responsibility of medical professionals when giving testimony or scientific evidence, and the collective responsibility of the sciences and the judiciary, towards establishing certain standards of quality health care. The AIIMS professional did not give the background database about direct ECT, or explore the controversy surrounding it, even as a matter of informing the court. Instead of treating this as a quality of care issue and as an investigative matter, he "certified" the procedure as safe, raising the concern about questionable authorisation. The court, on its part, considered the certification given by a couple of psychiatrists as sufficient for making a decision. The Saarthak petition with respect to ECT was not treated with the respect that it deserved by the judiciary or by the professional community.

Around the world, in well-developed legal or policy formulations on involuntary commitments for mental illness, there are provisions and sanctions on the use of (modified) ECT. In India, legal or policy instruments in mental health do not address the procedure of ECT. The Mental Health Act, 1987, is about the institutionalization of persons with mental illness through commitment procedures. The Act was formulated in the context of involuntary commitment of persons labelled with mental illness - a reality in mental health care. Involuntary commitment ill automatically cancels the constitutional right of liberty (Dhanda, 2001) and a further law was required to allow this to happen within the law. However, the Act makes no mention at all of ECT, the top notch instrument of involuntary treatment in mental health care.
A few premier mental health institutions in the country have internal guidelines for the practice of ECT within their institution. At a National workshop on ECT in NIMHANS in 1990, members of the Indian Psychiatric Society recommended the use of modified ECT, in the presence of a qualified anesthetist as the norm for clinical practice. In a meeting of the State Health Secretaries in Bangalore in June, 1999, organized by NIMHANS, modified ECT has been recommended. Regulation of direct ECT has happened in some states of India mainly by High Court interventions. The Bombay High Court recommended against the use of direct ECT way back in 1989, following the Mahajan Committee Recommendations. In Goa too, due to legal advocacy and the proactive role of psychiatrists there, direct ECT has been banned (WP (Civil) No. 257, 1998, Collossa vs. State of Goa in the High Court of Mumbai). In Japan, ECT is used, just as in India, without anesthesia (Minkowitz, 2002), often as a type of punishment for political prisoners. Some countries in the Central and South of America continue to use direct ECT, and international human rights organizations are involved in challenging and reforming the practice.

1.4 Status of Direct ECT in the developed world
If we were to ask, "what is the evidence base which will validate the use of direct ECT" it is difficult to find the answer. It is difficult to find materials on direct ECT in world academic journals of the last 30 years. The only "evidence base" cited is the one or two studies done in India itself, Tharyan, et. al.'s eleven year study (1993) being a very significant one. Indian professionals advocating direct ECT will not find international academic journals, which will publish their articles, and so such articles are published in the obscure Indian Journal of Psychiatry. The world professional community considers the procedure of shock treatment without anesthesia, as barbaric and obsolete.
Many European countries including Holland have phased out even modified ECT, with other countries drastically reducing usage. In the US, use of ECT came down by 46% following consumer action between 1975 and 1980. As awareness about quality care and patient self-determination grows in mental health, every "forced ECT" (i.e. modified ECT where patient has not consented) in any part of the US elicits immediate activism, direct consumer action and patient litigation. In the words of LR Frank, who is called the "Gandhi" of mental health activism in the US, "ECT is a brutal, dehumanizing, memory-destroying, intelligence-lowering, brain-damaging, brain-washing, life threatening technique. ECT robs people of their memories, their personality and their humanity. It is a method for gutting the brain in order to control and punish people who fall or step out of line, and intimate others who are on the verge of doing so" (Frank, 2003: p. 17). Several efforts are on to ban the use of even modified ECT, some of them with partial success. The American Psychiatric Association survey of 1978 showed that only 16% of psychiatrists in the US gave ECT. Consumer groups in mental health maintain "Shock Doctor Rosters", registering and shaming in public all doctors who indiscriminately prescribe shock treatments, and who do not offer a whole range of other psychotherapeutic opportunities.

This is why Dr Andrade's recent article (2203a), which has set off a recent controversy in Issues in Medical Ethics, is incredibly astonishing and terribly disappointing. The paper does not even place an exclamation mark in making a case for direct ECT. To make a case for direct ECT in today's context establishes a fresh, new low for psychiatric ethics in India. So, instead of debating the issue of 'whether or not ECT at all', and what other people and user-friendly alternatives we can create in mental health, we are placed in this ridiculous situation of debating direct ECT.

2. IMPACT OF DIRECT ECT
Any discussion on direct ECT, as mentioned above, has to draw from literature that is dated by atleast three decades. It is important to ask, why did the developed world ban the practice? Two major effects of direct ECT led to the phasing out of this procedure in the west-- One, relating to the death and injury, and second, relating to the terror and the trauma, caused by the procedure on patients. We discuss these two aspects in this section and the next.

2.1 Injury caused by direct ECT
Direct ECT was invented in curious circumstances. The Italian, Ugo Cerletti, was inspired by the fact that electricity was used in preparing pigs for slaughter in an abattoir. They were rendered unconscious by bilateral placement of electrodes and passing current. Convulsions preceded the loss of consciousness. Following much experimentation on the pigs, he and his colleague, Lucio Bini invented the ECT procedure in 1938 when they first induced an artificial convulsion in a man (Kiloh, et. al., 1988). The man in question was a wandering mentally ill person. In 1940s and 1950s ECT use greatly increased, with experimental research on direct ECT holding sway.

Soon the data on death and injury, which started emerging on direct ECT, was alarming enough to lead to a ban on the procedure. 0.5% to 20% reportedly experienced vertebral fractures in use of direct ECT (Wiseman, pp. 118-119). In the UK, what stopped direct ECT was a well-known case, Bolam v. Friern Barnet Hospital Management Committee, when the patient sustained pelvic fracture. The US army forbade use of ECT during World War II in the early days, but with the increasing role of psychiatrists in the military during this time, it was reintroduced in 1943. The "Young Turks" of the nascent American Psychiatric Society railed against the "promiscuous and indiscriminate use of ECT" in 1947.

Professionals claim (Andrade 2000; 2003a; Tharyan et al 1993) that direct ECT is risk free. Infact, the world experience shows that direct ECT is not safe. As Andrade (2003a) himself mentions, reviewing previous research done in the 40s and 50s, direct ECT is associated with risk of vertebral / thoracic fractures, dislocation of various joints, muscle or ligament tears, cardiac arrhythmias, fluid secretion into the respiratory tract, internal tears, haemorrhages and blood letting, other than fear and anxiety. Risks are greater in males, older subjects, pregnant women and those with osteoporosis. Their own study (Andrade et al 2000) had found that "only 2%" of patients (i.e. 1 out of every 50 patients) experienced "an adverse musculoskeletal event with unmodified ECT". Tharyan, et al (1993) enlist the risks involved in direct ECT: fractures of the spine, femur, humerus, acetabulum, scapula; dislocations of the arm, jaw and hip; rupture of abdominal muscles; fat embolism; rupture or bleeding of internal organs or viscera and increased apprehension. They do not mention cardiac complications and death, both of which their own study reported.

For "evidence base", Andrade (2003a) cites the earlier study by Tharyan, et al. (1993), advocating direct ECT. First, a single study is not "an evidence base". Secondly, this study itself needs careful examination. Andrade writes that in this study, only 12 patients experienced fractures out of a total of 1835 patients receiving 13,597 treatments. In the way the data from this study has been re-presented, it sounds as if a few of the patients walked out of the ECT table with a slight twisting of the middle finger. Andrade fails to mention all the relevant data from this study. The fractures that patients had during this study were thoracic / vertebral fractures involving almost a third of the body vertebrae. The sudden onset of convulsions has a crushing impact on the bones. The neurological disabilities and other orthopaedic consequences of these spinal injuries are unknown. Andrade also fails to mention that in this study, there was one reported death due to cardiac arrest (i.e. one patient out of 1835 died), a good percentage experienced body aches, both local and generalised, and another one percent of the patients had cardiac complications. These data, especially the high rate of spinal injury and mortality rate, which from the patient point of view seem horrific, are not considered "clinically significant" by the authors of this study. Absent, the professional standards for refusing any practice in psychiatry, there does not seem any other way of contesting this data except by throwing up your hands in horror.

Table - Effects and risks of direct ECT

Source: Kiloh, et. al. (1988: pp.254-266) "True side effects" refers to inevitable events that always accompany ECT; "Complications" refers to infrequent but not rare events accompanying ECT; "risks" refers to unlikely events accompanying ECT; and "complaints" refers to the physical or somatic complaints associated with ECT. It must be highlighted that with modified ECT, such events are "less likely" but not completely ruled out.

2.2 Death due to ECT
The recent APA Task Force on ECT (2001) notes that contrary to earlier evidence, they have to now acknowledge that mortality rates with ECT (modified) may be as high as 1 in 10,000 patients. Consumers (Frank, 2002) say that mortality rates may be as high as 1% with modified ECT. The mortality rates are probably higher among the elderly. The Task Force report also notes that 1 in 200 will experience irretrievable memory loss, a fact hitherto dismissed as irrelevant by the medical fraternity.

Death in the case of ECT is usually due to cardio-vascular or cerebral-vascular complications, followed by respiratory failure. Shukla (1985), in discussing a case report of death following modified ECT, reviews the mortality data associated with the procedure. Rates between 0.8% and 0.003% have been reported in the western literature. Shukla, finding it a curious fact that deaths have not been reported at all in the Indian professional literature, observes that fatalities are not always publicly reported, particularly in India, but every psychiatrist would have experienced such cases in his practice.

3. DIRECT ECT AS TRAUMA
Leo Frank, an ex-patient subjected to many years of insulin treatment and direct ECT, says, "Why is it that 10v of electricity applied to a political prisoner's private parts is seen as torture, while 10 or 15 times that amount applied to the brain is called "treatment"?" (2002, p. 19). Many human rights instruments around the world cover the area of the psychiatric system also, as medical coercion and violence, the loss of liberty, political abuse and being incarcerated through misuse of the criminal justice system is high in this health care sector. Involuntary commitment, patient consent, restraint and limits to coercive treatment are covered in human rights jurisprudence because of the fact that this constituency is particularly at risk for loss of constitutional rights. The UN Principles of 1991 also enlists fundamental rights and freedoms of psychiatric patients, and right to quality health care, as such explicit protection is seen as necessary for this vulnerable population. The Council of Europe came out with a White Paper (2000) on "protection of rights" of mentally ill patients and the Convention for Prevention of Torture (2002) also covers involuntary commitment. The ICCPR also covers the rights of institutionalized patients. As the label of mental disorder literally deletes personhood, such human rights safe guards are seen as necessary.

In India, we do not have human rights instruments covering the fundamental rights and freedoms of psychiatric patients. (The Mental Health Act, even though it has a human rights chapter, makes some general statements on such rights such as "no cruelty"). Such instruments are necessary because such patients are the most vulnerable within the community and risk abuse and civil rights violation on a daily basis (Dhanda, 2001).

In developing this instrument, use of direct ECT must be enlisted as a type of torture and as a human rights violation, as found in other world conventions. The European CPT (Convention for the Prevention of Torture) 2002 prohibits the use of direct ECT as a form of torture. The Convention says: "The CPT is particularly concerned when it encounters the administration of ECT in its unmodified form; this method can no longer be considered as acceptable in modern psychiatric practice. ECT should always be administered in a modified form" (Chapter VI, Section 39). One of the reasons cited by the CPT for prohibition on direct ECT is the terror experienced by patients during and after the procedure. The White paper (2000) on the "Protection of the human rights and dignity of people suffering from mental disorder, especially those placed in a psychiatric establishment" drafted by the Working Party of the Steering Committee on Bio Ethics (CDBI), Council of Europe, also prohibits the use of direct ECT.

3.1 Mental effects of direct ECT
Nearly all patients suffer amnesia about the period around which they were given ECT. People given ECT do not remember the experience itself and are not able to report on what it felt like to be given an ECT. In fact, this is a good reason why getting patient experiences of ECT is near impossible: As in trauma, the memories about the experience itself are not available to the conscious mind. Why does memory get wiped out, is a question that all concerned people have been grappling with for a long time. Earlier, professionals used to actually believe that brain damage is curative. We have also heard the cliché that "why would patients want to remember painful memories about mental disorder", mistakenly suggesting that such memories were wiped out selectively. Advocates against the procedure argue that since it traumatizes the brain, memories are wiped out.

Direct ECT, as a treatment procedure, causes several disruptive psychological effects (Wiseman, 1995). Patient stories show that loss of memory and concentration are common. This affects personal lives (loss of cherished memories), and job performance (technical or mathematical memory, which can be the basic skill for engineers, lawyers or accountants can be lost). Artistic abilities can be lost. Because of this, there is the risk of having to do mechanical unskilled jobs, be unemployed, lose relationships, etc. Confusion, self-doubt due to the loss of memory, uncertainty, increased helplessness, loss of ability to learn and unlearn, lethargy, loss of ability in cognitive subjects will be experienced by many. Suicide and increased violence has also been associated following the use of ECT.

It is common experience in India, too, that patients are terrified of ECT. Within institutional settings, taking someone for ECT is experienced as a punishment by the patients. There is an undercurrent of humilation, shaming and punitive action in the use of the procedure within institutional contexts. Few patients, even those who actually find it beneficial, escape the sense of rage and humiliation that the procedure evokes. As direct ECT is very much like what is crudely shown on bollywood films, the fear and apprehension is quite understandable.

Direct ECT, in the medical narratives, comes across as any other stimulus, which freezes a person in terror, fear and pain. The terror associated with the procedure is a sign of trauma, and not a sign of insanity. As Breggin writes, ECT evokes raw survival fears to the fore. Even the highest experts on ECT (Abrams, et al pp. 130-131) have written that organic brain syndrome to varying degrees is common following all ECTs. ECT may affect all aspects of the brain system including thoughts, feelings and behaviours. EEG abnormalities may not go away for several months or years following ECT, indicating continuing brain seizure activities and possible brain damage. Other psychiatric experts write: "What cannot be denied is that transient forms of brain dysfunction, sometimes of considerable severity, occur with the Cerletti-Bini technique [direct ECT] particularly in elderly patients" (Kiloh, et. al., 1988: p. 190). The most evident effect of ECT on the brain was the vegetativeness of the patient, and reduction in his motor abilities. In fact, psychiatrists of yore believed that temporary brain damage effects the "cure" of mental illness (p. 213).

Direct ECT was described even in doctor's narratives as somewhat close to lobotomy, the surgical removal of a portion of the frontal brain. Early doctors who gave direct ECT expected "regression", a state when the patient was meek and submissive, wetting or soiling themselves, whimpering and crying easily, like a child. A writer in the Diseases of the Nervous System wrote, in 1951: "By the end of this intensive course of treatment practically all 52 patients showed profound disturbances. All showed incontinence of urine, and incontinence of feces was not uncommon. Most of them were underactive and did not talk spontaneously. Many failed to respond to questions but a few patients would obey simple requests. They appeared prostrated and apathetic. At the same time, most of them whined, whimpered and cried readily, and some were resistant and petulant in a child like way" (Wiseman, pp.118-119). The suggestion in literature is that ECT affects the limbic system of the brain, the same system that is affected by deep trauma.

In the UK, following the famous case against direct ECT, there was also a general consensus among professionals and policy makers that its unpleasant effects gave more scope for it to be used as a punishing tool, and several such stories did emerge until the 1980s. Case after case indicates that ECT is made as a choice of treatment in the case of "unmanageable" patients. ECT quiets the patients and remits agitation immediately, for unknown reasons. Within institutional contexts, therefore, the risk of abuse of the procedure is high. In India, although there is negligible documentation, direct ECT has been used as a punishment by families in collusion with psychiatrists against errant daughters and given to cure "naxalism" (Ramaswamy, 1999). For many years, the writer has suffered irretrievable memory loss. ECT has been given in India for all and sundry problems, including "curing" homosexuality. The use of direct ECT for dealing with political prisoners in Japan is also known (Minkowitz, 2002).

3.2 Use of sedation to allay fear
The fear associated with direct ECT is equal to the fear caused by any instrument of punishment and torture, and it is not a sign of insanity. It is the prejudicial attitude of professionals towards persons with mental illness, which allows them to interpret every response to their treatment as a symptom warranting further abusive treatment. With this logic, it will never be possible for a patient diagnosed with mental illness, to ever raise a question about the treatment they receive, for all such questions will risk being interpreted as a "psychiatric symptom". Infact, Peter Breggin (1993), an erstwhile psychiatrist who gave up the profession in disgust over its abusive practices, and joined the mental health consumer movement as a researcher and a social scientist, wrote that the most dangerous impact of ECT was that the patient is no longer in a position to protest the damage done to him (p. 240). This strategy of seeing patient refusal of a particular treatment, as symptomatic behaviour, is evident in Tharyan et al's study as well, which we discuss below. Such attitudes diminish the self determination of the patient in his or her own care.

In Tharyan et al's opinion fuelling study, too, a high percentage of patients (7.5%) reported fear and apprehension of the procedure, and 50 patients actually refused the treatment. On ordinary ethical conditions of doing human behavioural research, we assume that such subjects would have been allowed to drop out of the study. How did the researchers proceed with this frightened sample of 150 patients?

Well, they did so, by actually sedating them and getting them to comply. Quoting them in full: "A fifty of them [patients] refused further ECT due to this fear while in the remainder (100 patients) the fear was reduced by sedative premeditation enabling them to complete the course of ECT. In the earlier half of the decade under review, barbiturates, oral diazepam, parenteral haloperidol and even thiopentone were used to allay anxiety; in recent years, this has been effectively managed by pretreatment with 1 to 4 mg of lorazepam given orally". Further, it was interesting for these authors to observe that those who refused ECT were not among those who were sedated, that is, most of those sedated complied.

Such is the prejudicial approach to mentally ill patients, that refusal of a hazardous and life-threatening procedure is considered as a mere symptom, and further treated with sedatives to obtain patient compliance. We are of course aware of other power situations, such as rape or wife battery, when refusal is treated as consent. Tharyan et al's study also suggests that it is common practice to sedate patients who refuse ECT. Amazingly, in their list of recommendations, they recommend the use of sedatives to minimize the fear of ECT among the patients. Their political message seems to be that, if people refuse a hazardous treatment, or if they will not participate in research that involves study of such a treatment, then it is okay sedate them. Patient ethics fundamentally rests on the principle of autonomy, which is seriously violated with this approach.

The world data of three decades already exists to rule out the procedure as barbaric. No further research is necessary on direct ECT. And if over six decades of ECT research has come up with little hard data on the causal effects of its beneficence, except the vague claim that electricity itself causes the cure, then perhaps it is time to question the assumption of its value in mental health service provision. Andrade recommends systematic sampling and interviewing of patients who have received ECT, as "dissatisfied patients can be found for all treatments?" (pp. 44-45). This call for quantified survey data on patient experience of direct ECT is against the very basis of human rights jurisprudence, where a single case of violation is indeed representative.

Because of the physical and mental trauma caused by the procedure, patients given direct ECT must be considered as victims of torture and the perpetrators of this form of torture must be brought within human rights jurisprudence. Direct ECT research should not be allowed to happen in future, as this would be a clear human rights violation. Statutory authorities, institutional ethics committees and consumer bodies must ask explanations regarding the recent highly objectionable research done on direct ECT.

4. WHY DIRECT ECT
The main argument used by Tharyan, et al (1993), Andrade (2003) and others is that direct ECT is "cost-effective". The dogma among professionals is that direct ECT is the cheapest and safest form of treatment for mental disorder, as it does not require medical facilities and an anesthetist. It is argued that in a resource poor setting, we have to compare "existing alternatives", use the cheapest means available for cure, and not go for the most ideal (modified ECT). If the choice were between no ECT and direct ECT, then direct ECT is considered to be the more "ethical" alternative in the treatment of mental disorders. We question these arguments in this last section.

4.1 ECT is not a cure

Andrade (2003b) argues that:

"From an emotional perspective, a seizure-inducing treatment could certainly seem barbaric. However, if ECT is barbaric or unattractive, so too are cardioversions, abortions, Caesarean sections, radical mastectomies, open heart surgeries, orthopaedic and neurosurgical interventions, and so where does one draw the line?" (p. 44)

It is misleading to compare ECT with major surgery in justifying usage. Surgery intends to cure. But ECT is palliative, not curative. This means that in practice, professionals use it repeatedly as and when they like as, palliative care being an ongoing need, unlike curative care. Infact, relapse rate has been reportedly high in the use of ECT for schizophrenia and patients have to go for ECT "like an addiction", in the words of someone who has experienced the treatment. Within the span of a week or two, mastectomies or open heart surgeries are not prescribed in series. It would incredibly impoverish families and patients, if this were so. The text book prescribes 6 to 10 sessions of ECT, unlike the case of surgery. If we wish to adopt the surgery metaphor, then, ideally, the procedure would be used as a last resort. However, ECT is used often as the first line of treatment for dealing with mental disorders in India. Over-prescription is the rule rather than the exception. In the cost-effectiveness argument, are such realities of practice taken into account?

Finally, the stout evidence base underlying surgery is simply not comparable to the very weak epistemological foundations of ECT. Mental sciences in general suffer from weak epistemologies (Davar and Bhat, 1995) when compared to the natural sciences. Professionals cannot say how ECT works. Neurotransmitter and endocrinological studies have drawn a blank (Kiloh, et al 1988), and all that can be said is that electricity itself cures.

4.2 Training for direct ECT
Tharyan, et al's study (1993) reassures the reader that in giving direct ECT, "trained" professionals were used to give direct ECT. What does "training" mean in the context of giving direct ECT? You just need some physically very strong people to tie down the patient in strategic points and to keep the jaw and joint areas from major injury. [If we were to include direct ECT in our community mental health, NGO training or volunteer training programs, what kind of programs will we have to run? Training Programs on "Accident management during ECT", "Bone setting and suturing course for ECT managers", "Martial arts and body techniques for CHWs giving direct ECTs", etc. seem appropriate titles.]

However that may be, in Tharyan et al's study (1993), the composition of the full "trained team" used to prevent injury were the following: four orderlies, three nurses, two postgraduate trainees and a consultant psychiatrist, that is, a total of 10 "trained" people! If cost-effectiveness is our preferred parameter for "ethically" choosing a particular option, wouldn't it be just cheaper to hire an anesthetist? It is unrealistic that in the actual settings where direct ECTs are going to be used, for example, the district hospital or the private clinic, there would be so many "trained" people to audit the ECT procedure. The research situation was an ideal situation, unlike the practice situation. Even here, with a full load of 10 people tying down a patient from the convulsions, the reported injury rate was not insignificant.

Another aspect of cost is highlighted by Kiloh, et. al. (1988) (who in general approve of ECT as a sound treatment in some cases). They cite studies of patients wherein, following ECT, the depressive symptoms remitted immediately, but they had to stay in the hospital for a week to clear their "confusion, memory loss, euphoria, lability of mood and affect, and impaired judgement" (p. 251). In the case of direct ECT, we can expect that the costs of injury, illhealth and disability are higher. We wonder if these costs have been factored into the dogma about the cost-effectiveness of direct ECT.

4.3 ECT is lucrative
While we question the faith that direct ECT is cost effective for the patient, we suspect that it is lucrative for the doctor. In the US (Wiseman, 1995; Kiloh et al 1988), ECT research is conducted by very few organizations. Large research, medical foundations and psychiatric learned societies do not fund ECT research. The medical fraternity looks down upon the procedure. The government does not fund ECT research, and it is not often used in the federal, and state hospitals. However, this trend may be changing with the recent American Psychiatric Association's approval of the procedure.

In India, ECT is lucrative business. It falls within specialist practice. In nearly every city in India, a majority of psychiatrists practice privately and give ECT in their private clinics. In Pune city for example, nearly 90% of psychiatrists are in private practice, with the public mental health system having become literally dysfunctional. They cater mainly to the middle class with fees ranging between 100 rupees to 500 rupees per consultation. A recent survey in western India showed that nearly 80% of private psychiatrists give ECT, costing anywhere between 500 to 1000 rupees per dosage. If we set the dosage at textbook level (i.e. 6 to 10 ECTs), the total cost would be anywhere between 3,000/= to 10,000/= rupees per series. Direct ECT is a money-spinner for many psychiatrists in the business. There are unscrupulous psychiatrists who ask the patient to first take an ECT before even consultation (Bapu workshop, 2002)!

4.4 Policy regulation absent
In India, ECT is given without restriction for anything and everything, often as first line of treatment, for even "curing" homosexuality. Andrade (2003a) writes that ECT is given to catatonic, suicidal, or otherwise "highly disturbed" patients. To say that "highly disturbed" patients can be given ECT allows too much ambiguity and scope for abuse of the procedure. In the direct ECT era, Shukla (1974) recommended use of direct ECT as a solution for passing a nasal tube to catatonic patients who refuse food: "At times it is very difficult to pass a tube even under sedation. I have tried the following in such patients with a 100% success: I give the patient direct ECT. (There are no problems as these patients are usually fasting and their stomach, bowel and bladder are empty). As soon as the convulsions stop and the patient is in a flaccid state, I pass the tube and it goes in very easily" (p. 95).

Policy guidelines and evidence base repeatedly comes up with only one diagnosis where ECT may be tried if other treatments fail- that is in the case of endogenous depression. Some documents do say that in this case, modified ECT can also be tried as first line of treatment, but enlist further conditions, including patient consent, an active audit program in each ECT department. The CPT 2002 also talks about patient consent and ECT audit, including a registry of ECT.

Reviews of research on the use of ECT in the case of schizophrenia upto the mid '80s, when ECT research was at its peak, shows that
1. It is not possible to be emphatic about the value of ECT in patients diagnosed with schizophrenia
2. ECT and neuroleptic drugs have the same outcomes statistically
3. The relapse rate is high in use of ECT, showing that it probably has short term benefits

On the basis of the review, Kiloh et al (1988) observe that "the question whether the long-term effects of neuroleptic drugs, notably tardive dyskinesia, are more or less disabling than the possible ill effects of long term ECT cannot be answered" (p. 244).

ECT guidelines do not exist in India, making it a huge ethical issue among patients and consumers. Indian psychiatrists recognize the cavalier use of ECT. Agarwal (1990) in his editorial notes remarkable deficiencies in the administration of ECT even in the West, writing, "the situation in India is bound to be more disappointing". ECT in India is often prescribed in series, without any review, the conditions for safe use and correct use are not specified, the staff giving ECT are often untrained, and physical pre-exam is often not done, as it is felt that ECT is safe for anyone and everyone ("virtually no contradictions", according to the psychiatric dogma).

Patient consent:
The community mental health program in India (NMHP, 1982) promises to take mental health services to the community. Unfortunately, in most parts of India, it has remained a drug and ECT dispensing service, with minimal understanding or engagement with the community. The advocacy for direct ECT is likely to increase misuse of ECT in private practice and in the community mental health programs. Lack of awareness among communities about this procedure is likely to be harvested by unscrupulous professionals. As people with mental illness are not considered fit to give consent, patient consent is rarely addressed. In many hospitals, patients and their families are only told that they are receiving an "injection", as it is argued that patients will not understand the procedure. Consent letters, if used at all, are signed on that basis. See, for example, the narrative below.

"In the beginning my husband did not benefit from the medicine, so he had to be given shots. And while giving shots also they take [the patient] with great love and affection, not that they tied and took him. They will lure you and take you. There are two or three employees. Those who try to run, they have to be stern with them. Even for shots… because there is a danger that perhaps they may die… attention has to be paid even to their teeth that they should not dislocate or fall. When shots are administered the teeth is clenched and it clatters… the entire jaw may even come out, so they put a big bandage inside. If it moves, the entire set both can come out in that bandage. They would tell you before hand that you keep either milk or tea ready."

Quality of care
The research cited in this paper advocating direct ECT was done under ideal treatment conditions. The institutions where the research was conducted (NIMHANS, CMC) were well funded public health institutions, with a promise of high quality care. Adequate staff were allocated for the research. Under ideal conditions, the injury rate is not insignificant, as we have argued above. What can we expect from less than ideal conditions? We give a case study below:

"Meena" was imprisoned in a Maharashtra jail for killing her sister. She suffered from "voices in the head" for several years. After the accident, she was arrested and then taken for treatment. Here we present a portion of her experiences with shock treatment without anesthesia:

"I was totally maddened by this time. The police arrested me and kept me in the lock-up. I felt very remorseful after that. They later took me to a nearby famous hospital. There they gave me shock treatments. 4 shocks they gave me with anaesthesia and three shocks they gave me without anaesthesia. I remember feeling those three shocks while I was awake. I had not fainted, and could feel the shocks. It was extremely painful. They used not to give me any tea in the morning either. I would not allow them to put the cloth in my mouth. It was extremely painful. I suffered an enormous amount. It was the most horrible pain in my head. I don't remember anything else about the time. I was also very rude with the doctors. The voices in my head stopped after that. I kept feeling remorseful about how I had killed my auntie's only child. My aunty came to visit me in hospital also. I asked her whether she had told the doctors to give me shocks. She didn't know anything about it. I was unconscious for 3 days after the shocks. It was very traumatic."

We have all experienced the mundane pain of needles poking at our elbow because the poorly trained staffer "could not find a vein". What are the effects of poorly administered direct ECT? The patient is rendered unconscious only when the grand mal seizure starts at a particular electrical threshold. Meena was probably given ECT without anesthesia at infra-threshold, so she did not become unconscious.

4.5 Other guidelines
Recently, in Utah, an ECT Bill passed by the House is being considered by the Senate in which consumer groups have had a large role to play. The proposed bill (www.le.state.ut.us/-2003/htmdoc/hbillhtm/HBO109S1.htm) does the following: It prohibits shock for children under the age of 14. It prohibits shock for individuals who are committed against their will. It prohibits a legal guardian to consent to shock for someone else. It requires a second medical opinion to shock someone over the age of 65. It requires that informed consent mentions that possible side effects of shock may include permanent memory loss, cardiac arrest and death. It requires a reporting system to show how many are shocked every year and if they suffer from any side effects within a certain amount of time. It requires that an autopsy be done if someone dies after shock, and that the autopsy look for brain damage by searching for destroyed small blood vessels. It allows free individuals over the age of 18 to receive shock after they get full informed consent.

The Royal College of Psychiatrists Commission Guidelines give conditions for anesthetic equipment, the ECT machine, staff requirements and treatment protocols. As direct ECT machines are obsolete, such machines would be ruled out by international standards. The FDA considers ECT machines as "Class III" devices, that is "hazardous".

There is a need to investigate the condition and commerce of existing ECT machines in India, who makes these machines, who approves them, what are the standards for the machines. In UK, an internationally recognized advocate of ECT, Dr Abrams, who wrote the very popular reference book, Electroconvulsive Therapy, was found to be one of the two member Board of Directors of Somatics, a commercial venture involving ECT machine manufacture and sale. Half his yearly income was drawn from Somatics. While not making allusions to possibility or ethics of the commercial interests of any professional in the practice, we are indeed suggesting that the commerce of ECT needs to be more thoroughly investigated.

The National Mental Health Association, the largest non-profit mental health organization in the US, issued a public statement on the 11th of June, 2000. The statement says that the NMHA recognizes that ECT is a controversial procedure and that although it may have beneficial results, it also involves serious risks. It has urged the increased, rigorous and objective research, as well as dissemination of such research, on ECT especially from the safety point of view. The organization also supported the position that ECT recipients must be informed of all the pros and cons and have access to all kinds of information to be able to make fully informed decisions. NMHA further recommends that "ECT be presented as an alternative with extreme caution, only after all other treatment approaches have either failed or have been seriously and thoroughly evaluated and rejected" (www.nmha.org/position/ps31.crm).

CONCLUSION: THE NEED FOR PUBLIC DEBATE
There must be a public debate on the issue of the use of ECT in India. Most world data bases of the last decade, culminating in WHO's World Health Report, 2001, have highlighted the phenomenal "increase" in the "burden" of mental disorders in developing countries. The spin-offs of globalisation and economic reform, (including debts, ethnic violence, poverty, homelessness, displacement and cultural loss) have resulted in the greater mental ill health of vulnerable groups. Poverty and mental disorder are being linked in a significant way in the literature. Meanwhile, there has been little challenge to the privatization of mental health and little is known about the influence of drug companies on the development of research, technology and service within the sector.

Advocating direct ECT against the background of the Indian reality of a questionable mental health care quality can be risky. Andrade writes that "if the risk-benefit ratio favours the treatment, and if the treatment is better than existing alternatives, in the interest of the patient the treatment must survive" and that "unmodified ECT may be preferable to no ECT" (2000b:p.44). The fact of not having created interesting and humane alternatives in mental health has been the pathos of the Indian mental health service system. It is disappointing that this fact should lead to advocacy of direct ECT, instead of fuelling the creation of imaginative psycho-therapeutic and community models. On the basis of the argument that India is a "poor" country and the poor need quick alternatives, justifications have also existed for various invasive and undignified "treatments", such as mass sterilization, and hysterectomies, in the case of the mentally challenged girls.

Background to the paper
The ideas presented here are the result of several discussions in our Center by Aparna Waikar, Bhargavi Davar, Chandra Karhadkar, Darshana Bansode, Deepra Dandekar, Seema Kakade, Sonali Wayal, and Yogita Kulkarni. Bhargavi Davar did the research for this paper. Deepra Dandekar and Darshana Bansode submitted a case study from the "Archives" team of our Center, from their documentation of the plight of mentally ill women prisoners in Maharashtra. The community narrative on ECT as "injections" came from our "Needs Assessment Study of NGOs in mental health". Fieldwork was done by Lalita Joshi and Seema Kakade for this study. Our activities are funded by Sir Dorabji Trust and Action Aid India.

References:
.Ramaswamy, G. (2001) "Remembered Rage" in Speaking our Minds. Aaina, A mental health advocacy newsletter, Vol. 1(1), March, p. 17.
.Minkowitz, T. (2002) "Psychiatric Disability in the UN Disability Convention", Special Report-I, Aaina, Vol. 2 No. 3, November, p. 10
.Abrams, R., Essman WB (Eds) (1982) Electroconvulsive therapy: Biological Foundations and Clinical Applications. Lancaster: MTP Press Ltd.
.Agarwal, A.K. (1990) "ECT: A need for re-appraisal". Editorial. Indian Journal of Psychiatry, 32(4) pp.295-296.
.Agarwal, A.K. and Andrade, C. (1997) "Indian psychiatrists' attitudes towards electroconvulsive therapy". Indian Journal of Psychiatry, 39(1), pp. 54-60.
.Agarwal, A.K., Andrade, C. and Reddy, M.V. (1992) "The practice of ECT in India. Issues relating to the administration of ECT". Indian Journal of Psychiatry, 34(4), pp. 285-297.
.Andrade, C. (2003a) "Unmodified ECT: Ethical Issues", Issues in Medical Ethics, Vol. 11 Issue 1, pp. 9-10.
.Andrade, C. (2003b) "ECT: A measured defence", Issues in Medical Ethics, Vol. 11 Issue 2.
Andrade, C., Rele, K., Sutharshan, R., Shah, N. (2000) "Musculoskeletal morbidity with unmodified ECT may be less than earlier believed", Indian Journal of Psychiatry, 42, pp. 156-162.
.APA Task Force on ECT (2001)
.Breggin, P. (1993) Toxic Psychiatry: Drugs and ECT, The Truth and the Better Alternatives. Harper Collins.
.Clinical Resource and Audit Group (CRAG) Working Group on Mental Illness (1997) Electroconvulsive Therapy (ECT): A Good Practice Statement. Edinburgh: CRAG.
.CPT, (2002) European Committee for the Prevention of Torture and Inhuman or degrading treatment or punishment, CPT - 2002, Chapter VI- Involuntary Commitment, Section 39 - ECT. Council of Europe.
.Davar, BV (1999) Mental health of Indian women. A feminist agenda. Sage Publications, New Delhi.
.Davar, B.V. (2001) Mental health from a gender perspective. Sage: New Delhi.
.Davar, B.V. & Bhat, P.R. (1995) Psychoanalysis as a human science: Beyond foundationalism. Sage: New Delhi.
.Dhanda, A. (2001) Legal order, mental disorder. Sage Publications, New Delhi.
Frank, LR 2003, "Electroshock: A crime against the spirit", In a Nutshell, Fall/Winter 2002-2003, pp. 16-22.
.Kiloh, L.G., Smith, J.S., Johnson, G.F. (1988) Physical treatments in Psychiatry. Foreword by Sir Martin Roth. Blackwell.
.NIMHANS (1999) "Recommendations of national workshop for State Health Secretaries", June 7th, 8th, Bangalore.
.Patel, V. (1998) Culture and Common Mental Disorders in Sub-Saharan Africa. UK: Psychology Press.
.Patel, V., Chisholm, D., Rabe-Hesketh, S., Dias-Saxena, F., Andrew, G. and Mann, A. (2003) "Efficacy and cost-effectiveness of drug and psychological treatments for CMD in GHC in Goa, India: A randomized, controlled trial". Lancet, Vol. 361, pp.33-39.
.Pathare, S. (2003) "Beyond ECT". Issues in Medical Ethics, XI(1) Jan-Mar, pp. 11-12
Royal College of Psychiatrists (1995) The ECT Handbook (Second Report of the Royal College of Psychiatrists' Special Committee on ECT). Council Report CR39. London: Royal College of Psychiatrists.
.Shukla, G.D. (1985) "Death following ECT- A case report", Indian Journal of Psychiatry, Vol. 27, Issue 01, pp. 95-97.
.Task Force Reports (1978, 1990, 2001) on ECT. American Psychiatric Association, USA.
.Tharyan, P., Saju, P.J., Datta, S., John, J.K., Kuruvilla, K. (1993) "Physical morbidity with unmodified ECT: a decade of experience", Indian Journal of Psychiatry, 35, Issue 4, pp. 211-214.
.UN General Assembly Resolution No. 46/119, 17-12-1991. "Principles for the Protection of persons with Mental Illness", United Nations.
.Vahia et al's early study (1974)
.Verghese, Gupta & Prabhu, 1968)
.White paper (2000) on the "Protection of the human rights and dignity of people suffering from mental disorder, especially those placed in a psychiatric establishment" drafted by the Working Party of the Steering Committee on Bio Ethics (CDBI), Council of Europe.
.Wiseman, B. (1995) Psychiatry: The ultimate betrayal. Freedom Publishing Co. A Publication of Citizens Commission for Human Rights, LA, California.
.World Health Report, (2001) Mental Health. World Health Organisation, Geneva.
.WP (Civil) No. 257, 1998, Collossa vs. State of Goa in the High Court of Mumbai.
.Writ Petition No. 562/2001 in Saarthak vs. Union of India in the Supreme Court of India.