- Email: [email protected]
Canada: To be or not to be
1212
competition was not due to start until after the Election, but the institutions have recognised that it is not in their interests to wait. London is in dire straits. Its teaching hospitals will not be as competitive on costs as the outlying general hospitals. The new funding procedures in which districts are allocated finance according to their populations has made the dilemma even more acute. Some teaching hospitals-University College Hospital, for example-are in districts with hardly any resident population. What Guy’s is doing makes sense for Guy’s, but makes a nonsense of national policy-making. The troubles of London are far too complex to be left to the whim of the market. What is needed is a strategic plan, based on the needs of patients rather than the needs of institutions. Successive ministers have run away from the problem, plagued as it is by health services spread across four regions, ten inner-London health districts, plus eight postgraduate teaching hospitals directly accountable to the Health Department. Thankfully, the King’s Fund has set up an independent commission which is due to publish its first working paper in the autumn. Ministers also have only themselves to blame for the rush with which they introduced the restructuring. Not only were none of the ideas tested out, but even the most basic requirements of a market system were not in place. Few hospitals have the computer systems to work out a proper pricing mechanism. And too little attention at the top was paid to the increased costs that markets introduceinfrastructure (billing clerks, data processors, accountants, and computers), advertising, extra labour costs, regulatory costs, and the "political bribes" needed to get hospitals to cooperate. The most serious indictment of the Government’s plans is provided by the handful of district health authorities that have been allowed to opt out as an entirety: the rationale of these districts was that this was the only way they could protect their vulnerable community services. Significantly, mental health was identified in one of the leaks from Guy’s as a service scheduled for the chop. Two years ago, when the Government’s plan was first published, ministers insisted that "core services" would be protected. An essential list of services, including mental health, was published at the same time. By the following year, however, core services had been diluted into designated services left for local councils to decide. One year later designated services seem to have
disappeared. The best hope at the end of the sixth week were developments in the Government’s education reforms. These preceded the health service restructuring by two years. In the past year, major changes have been made to the system of national tests at ages 7, 11, 14, and 16 years because the original proposals had proved unworkable. The best concession on health-properly tested pilot schemes in different regions-is, alas, no longer possible. GP practice budget holding, for example, is an interesting concept. It will certainly restore more power to the GPs, who treat 9 out of 10 patients who turn to the NHS, and could provide a welcome boost to primary care. But by introducing the changes nationwide-along with the other radical changes-ministers have made it much more difficult to measure the benefits of individual changes. Although pilot schemes are not on offer, there are other obvious concessions. These include delaying next year’s second wave of opted-out hospitals until the effects of this year’s wave is evaluated, restoring a core service list, and devising a proper strategy for London. Malcolm Dean
Round the World Canada: To be
or
not to be
The living will has become a hot topic. It is a "written document signed by an individual and witnessed, directing that if he is subsequently terminally ill and death is imminent and he is no longer able to express his wishes, then life-sustaining procedures should not be utilized to artificially prolong his life".1 In view of all that, the term "is a misnomer ... it is not a will and it deals with dying not living".1 It may also be styled a "rejectionist document".1 The Manitoba Law Commission has written a discussion paper on advance directives and durable powers of attorney for health careto consider "the situation of the individual who through age, illness or accident, loses the ability to communicate his or her wishes respecting medical treatment". The Commission also wants to ascertain how, if there is to be legal recognition of the wishes of the individual, the law would ensure that the wishes are made known and that they are not thwarted by others. The Commissioners indicate that all of these issues are underpinned by philosophical dilemmas: personal autonomy versus societal values and scarce health care dollars versus heroic extension of life. The discussion paper reflects issues and proposed legislation in other provincial jurisdictions, such as Ontario. A basic premise is that "Every person who understands the nature and consequences of proposed medical treatment has a right to consent to or refuse that treatment". The fact that a competent individual has the right to refuse beneficial treatment, and even die as a consequence, was recently reinforced in Ontario, in the Malette v Shulman case, where the Court of Appeal upheld the right of a Jehovah’s Witness to refuse a life-saving blood transfusion. However, there are times when decisions of others might have to override the wishes of the patient-for example, the doctor’s when the patient is unconscious, or the State’s when the patient is suicidal. Furthermore, substitute decision-makers are required in law for certain groups, such as minors, mentally retarded people, and those who are incompetent. What is at stake with living wills is whether they will be honoured. The written statement-the advance directive-may lack specificity and thereby be difficult to interpret. The delegation of authority to another person-the "durable power of attorney"-is fine if that person is reliable. The form of living will that is gaining in popularity is the health care directive, which specifies management for named conditions; it is not rejectionist and can be combined with delegation of authority. The Commissioners outlined some of the potential difficulties that have to be taken into account in developing satisfactory legislation. The first is the liability of medical care-givers under civil and criminal law. If they are liable under these laws the tort of battery and the criminal liability for assault may be applied. Whether an "advance directive" is the same as informed consent has not been tested in Canada. The second difficulty is whether the Canadian Charter of Rights and Freedoms might be involved in defence of violation of any law on living walls. Where fear of the Criminal Code might lead physicians to flout living wills, the interpretation of the Charter might well do the opposite. How the courts will rule when decisions are influenced in this way has not been determined. If the principles of inviolability of the person and selfdetermination prevail, sections of the Criminal Code will be
1213
struck down because they do not comply with the charter. The third potential difficulty is that medicine is advancing all the time. The legislation has to be drafted so as to protect those who believe in medical technology but also those who are sceptical and think that it might lead to an undignified and painful exit. So, although a competent person may give advance direction for non-intervention, subsequent development of a superior technology might change things altogether. Another worry is that the living will might have been made while the subject was under the influence of someone with different values or religious beliefs or of a relative whose motives are less than altruistic. Legislation is going to be focused on points that will help people to construct clearly worded living wills. In addition, the scope of the statutes, their binding effect upon medical care-givers, the criteria defining who qualifies as principal, the obligations of the attorneys and witnesses, the validity of documents and their publication, and, finally, safeguards (including opportunity for revocation) must all be worked out. Many lawyers think that the resulting legislation will embody the requirements of advance direction, but, even so, each directive will have to be considered on its own merits. There will not be the same uniformity of interpretation of such directives as there is in properly drafted testamentary wills. The Commissioners will be examining responses to their paper until August. Their conclusions will be examined with interest in many English-speaking and common law
jurisdictions. M. R. Eastwood J. McCaffrey 1. Hoffstein E. Wills for Seniors. In: Seniors as a growing client base: today’s issues, Toronto: 1991. Law Society of Upper Canada. 2. Manitoba Law Reform Commission. Discussion Paper on Advance Directives and Durable Powers of Attorney for Health Care. 1990.
India: Defluoridation battle Fluorosis is a major public health problem in India, where about 25 million people suffer from the crippling effects of excess fluoride. Thirteen states in the country have been declared endemic for this disease. Fluoride levels in natural sources of drinking water in these states were so high that the National Technology Mission on Safe Drinking Water set up a sub-mission on control of fluorosis, which is undertaking defluoridation programmes on a large scale. The aim is also to minimise, or if possible eliminate, fluoride intake from sources other than water. Apart from pressing for a ban on the sale and advertisements of fluoridated toothpastes in areas endemic for fluorosis, the sub-mission also advocated that all packaging for fluoridated toothpastes should indicate exact fluoride content and a warning against their use by children below 7 years. The basis for this action on toothpastes is work at Madras Dental College showing that in man toothpaste, when applied even in small quantities, is quickly absorbed systemically. In 1987 the Indian Council of Medical Research (ICMR) advised the sub-mission that fluoride toothpaste should not be used by children below 6 years of age; the ICMR referred to a World Health Organisation publication, Appropriate Use of Fluoride in Human Health, which, while promoting the use of fluoridation, cautions against fluoride mouth rinses for children below age 6 years and recommends that the amount of toothpaste be restricted to the size of a small pea.
This WHO advice was intended for areas where fluoride levels in water, food, and other sources are not high. In March last year, after mounting pressure from scientific circles and consumer protection organisations, the Ministry of Health and Family Welfare issued a Draft Gazette Notification, proposing that the Drugs and Cosmetic Rules, 1945, be amended so that: (i) the toothpaste shall not contain more than 1000 ppm fluoride and that the concentration has to be given on the packaging; and (ii) every tube and carton of the toothpaste shall caution against use by children below 7 years. The ICMR responded to the proposal by sending to the Health Ministry its Scientific Working Group recommendation to completely ban the use of fluoridated mouthwashes and mouthrinses in India. Some members of the Indian Dental Association (IDA) sent their objections to clause ii. These dentists’ letters were nearly identical in their content to a draft sent to all members by the convenor of IDA’s fluoride committee, urging them to "rise to the occasion and demonstrate solidarity" in objecting to the proposed amendment; WHO was cited as strongly recommending the topical application of fluorides to reduce dental caries, but no scientific studies from high fluoride areas were offered. Consumer protection organisations, scientists, and members of the general public welcomed the Draft Gazette Notification as a very positive step. On March 26, a year after the draft notification was issued, the Drug Controller of India invited, among others, representatives of ICMR, dentists, and the sub-mission on control of fluorosis, to discuss the comments received-in particular those from the dentists. This time both the dentists and ICMR were unhappy about clause ii. The bizzare turnaround by the ICMR was inexplicable, especially because it was ICMR’s recommendation in 1987 that prompted the Health Ministry to include clause ii. Both the dentists and ICMR were unable to offer sound scientific reasons for their call to drop clause ii, whereas Prof A. K. Susheela, national coordinator of the sub-mission on control of fluorosis, presented an array of research work published in reputed scientific journals to support the clause. The meeting ended in chaos, with no decision taken. The Final Gazette Notification will be issued after review and recommendation by the Health Ministry’s Drugs Technical Advisory Board. If the clause on statutory warning for children is dropped because of unscientific pressure from dentists, who have been promoting fluoride indiscriminately for several years now, it will be a big blow for the public, who will be deprived of the benefits of public-funded scientific research.
Bhupesh Mangla
Turkey: Placebo effect Ephesus is probably the most impressive archaeological site in modern Turkey. The Greeks founded the city about 10 BC and brought their goddess Artemis to Ephesus and built her large temple there. Artemis was the goddess of chastity, and a festival in her honour was held every spring. St Paul also visited Ephesus at least twice. The second time, in about AD 54, he stayed for over two years, until he had to leave after a riot that occurred because he preached that man-made gods were not real gods. The local silversmiths, who had made their fortune by selling statues of Artemis, stirred up the people against Paul to try and boost falling sales.
competition was not due to start until after the Election, but the institutions have recognised that it is not in their interests to wait. London is in dire straits. Its teaching hospitals will not be as competitive on costs as the outlying general hospitals. The new funding procedures in which districts are allocated finance according to their populations has made the dilemma even more acute. Some teaching hospitals-University College Hospital, for example-are in districts with hardly any resident population. What Guy’s is doing makes sense for Guy’s, but makes a nonsense of national policy-making. The troubles of London are far too complex to be left to the whim of the market. What is needed is a strategic plan, based on the needs of patients rather than the needs of institutions. Successive ministers have run away from the problem, plagued as it is by health services spread across four regions, ten inner-London health districts, plus eight postgraduate teaching hospitals directly accountable to the Health Department. Thankfully, the King’s Fund has set up an independent commission which is due to publish its first working paper in the autumn. Ministers also have only themselves to blame for the rush with which they introduced the restructuring. Not only were none of the ideas tested out, but even the most basic requirements of a market system were not in place. Few hospitals have the computer systems to work out a proper pricing mechanism. And too little attention at the top was paid to the increased costs that markets introduceinfrastructure (billing clerks, data processors, accountants, and computers), advertising, extra labour costs, regulatory costs, and the "political bribes" needed to get hospitals to cooperate. The most serious indictment of the Government’s plans is provided by the handful of district health authorities that have been allowed to opt out as an entirety: the rationale of these districts was that this was the only way they could protect their vulnerable community services. Significantly, mental health was identified in one of the leaks from Guy’s as a service scheduled for the chop. Two years ago, when the Government’s plan was first published, ministers insisted that "core services" would be protected. An essential list of services, including mental health, was published at the same time. By the following year, however, core services had been diluted into designated services left for local councils to decide. One year later designated services seem to have
disappeared. The best hope at the end of the sixth week were developments in the Government’s education reforms. These preceded the health service restructuring by two years. In the past year, major changes have been made to the system of national tests at ages 7, 11, 14, and 16 years because the original proposals had proved unworkable. The best concession on health-properly tested pilot schemes in different regions-is, alas, no longer possible. GP practice budget holding, for example, is an interesting concept. It will certainly restore more power to the GPs, who treat 9 out of 10 patients who turn to the NHS, and could provide a welcome boost to primary care. But by introducing the changes nationwide-along with the other radical changes-ministers have made it much more difficult to measure the benefits of individual changes. Although pilot schemes are not on offer, there are other obvious concessions. These include delaying next year’s second wave of opted-out hospitals until the effects of this year’s wave is evaluated, restoring a core service list, and devising a proper strategy for London. Malcolm Dean
Round the World Canada: To be
or
not to be
The living will has become a hot topic. It is a "written document signed by an individual and witnessed, directing that if he is subsequently terminally ill and death is imminent and he is no longer able to express his wishes, then life-sustaining procedures should not be utilized to artificially prolong his life".1 In view of all that, the term "is a misnomer ... it is not a will and it deals with dying not living".1 It may also be styled a "rejectionist document".1 The Manitoba Law Commission has written a discussion paper on advance directives and durable powers of attorney for health careto consider "the situation of the individual who through age, illness or accident, loses the ability to communicate his or her wishes respecting medical treatment". The Commission also wants to ascertain how, if there is to be legal recognition of the wishes of the individual, the law would ensure that the wishes are made known and that they are not thwarted by others. The Commissioners indicate that all of these issues are underpinned by philosophical dilemmas: personal autonomy versus societal values and scarce health care dollars versus heroic extension of life. The discussion paper reflects issues and proposed legislation in other provincial jurisdictions, such as Ontario. A basic premise is that "Every person who understands the nature and consequences of proposed medical treatment has a right to consent to or refuse that treatment". The fact that a competent individual has the right to refuse beneficial treatment, and even die as a consequence, was recently reinforced in Ontario, in the Malette v Shulman case, where the Court of Appeal upheld the right of a Jehovah’s Witness to refuse a life-saving blood transfusion. However, there are times when decisions of others might have to override the wishes of the patient-for example, the doctor’s when the patient is unconscious, or the State’s when the patient is suicidal. Furthermore, substitute decision-makers are required in law for certain groups, such as minors, mentally retarded people, and those who are incompetent. What is at stake with living wills is whether they will be honoured. The written statement-the advance directive-may lack specificity and thereby be difficult to interpret. The delegation of authority to another person-the "durable power of attorney"-is fine if that person is reliable. The form of living will that is gaining in popularity is the health care directive, which specifies management for named conditions; it is not rejectionist and can be combined with delegation of authority. The Commissioners outlined some of the potential difficulties that have to be taken into account in developing satisfactory legislation. The first is the liability of medical care-givers under civil and criminal law. If they are liable under these laws the tort of battery and the criminal liability for assault may be applied. Whether an "advance directive" is the same as informed consent has not been tested in Canada. The second difficulty is whether the Canadian Charter of Rights and Freedoms might be involved in defence of violation of any law on living walls. Where fear of the Criminal Code might lead physicians to flout living wills, the interpretation of the Charter might well do the opposite. How the courts will rule when decisions are influenced in this way has not been determined. If the principles of inviolability of the person and selfdetermination prevail, sections of the Criminal Code will be
1213
struck down because they do not comply with the charter. The third potential difficulty is that medicine is advancing all the time. The legislation has to be drafted so as to protect those who believe in medical technology but also those who are sceptical and think that it might lead to an undignified and painful exit. So, although a competent person may give advance direction for non-intervention, subsequent development of a superior technology might change things altogether. Another worry is that the living will might have been made while the subject was under the influence of someone with different values or religious beliefs or of a relative whose motives are less than altruistic. Legislation is going to be focused on points that will help people to construct clearly worded living wills. In addition, the scope of the statutes, their binding effect upon medical care-givers, the criteria defining who qualifies as principal, the obligations of the attorneys and witnesses, the validity of documents and their publication, and, finally, safeguards (including opportunity for revocation) must all be worked out. Many lawyers think that the resulting legislation will embody the requirements of advance direction, but, even so, each directive will have to be considered on its own merits. There will not be the same uniformity of interpretation of such directives as there is in properly drafted testamentary wills. The Commissioners will be examining responses to their paper until August. Their conclusions will be examined with interest in many English-speaking and common law
jurisdictions. M. R. Eastwood J. McCaffrey 1. Hoffstein E. Wills for Seniors. In: Seniors as a growing client base: today’s issues, Toronto: 1991. Law Society of Upper Canada. 2. Manitoba Law Reform Commission. Discussion Paper on Advance Directives and Durable Powers of Attorney for Health Care. 1990.
India: Defluoridation battle Fluorosis is a major public health problem in India, where about 25 million people suffer from the crippling effects of excess fluoride. Thirteen states in the country have been declared endemic for this disease. Fluoride levels in natural sources of drinking water in these states were so high that the National Technology Mission on Safe Drinking Water set up a sub-mission on control of fluorosis, which is undertaking defluoridation programmes on a large scale. The aim is also to minimise, or if possible eliminate, fluoride intake from sources other than water. Apart from pressing for a ban on the sale and advertisements of fluoridated toothpastes in areas endemic for fluorosis, the sub-mission also advocated that all packaging for fluoridated toothpastes should indicate exact fluoride content and a warning against their use by children below 7 years. The basis for this action on toothpastes is work at Madras Dental College showing that in man toothpaste, when applied even in small quantities, is quickly absorbed systemically. In 1987 the Indian Council of Medical Research (ICMR) advised the sub-mission that fluoride toothpaste should not be used by children below 6 years of age; the ICMR referred to a World Health Organisation publication, Appropriate Use of Fluoride in Human Health, which, while promoting the use of fluoridation, cautions against fluoride mouth rinses for children below age 6 years and recommends that the amount of toothpaste be restricted to the size of a small pea.
This WHO advice was intended for areas where fluoride levels in water, food, and other sources are not high. In March last year, after mounting pressure from scientific circles and consumer protection organisations, the Ministry of Health and Family Welfare issued a Draft Gazette Notification, proposing that the Drugs and Cosmetic Rules, 1945, be amended so that: (i) the toothpaste shall not contain more than 1000 ppm fluoride and that the concentration has to be given on the packaging; and (ii) every tube and carton of the toothpaste shall caution against use by children below 7 years. The ICMR responded to the proposal by sending to the Health Ministry its Scientific Working Group recommendation to completely ban the use of fluoridated mouthwashes and mouthrinses in India. Some members of the Indian Dental Association (IDA) sent their objections to clause ii. These dentists’ letters were nearly identical in their content to a draft sent to all members by the convenor of IDA’s fluoride committee, urging them to "rise to the occasion and demonstrate solidarity" in objecting to the proposed amendment; WHO was cited as strongly recommending the topical application of fluorides to reduce dental caries, but no scientific studies from high fluoride areas were offered. Consumer protection organisations, scientists, and members of the general public welcomed the Draft Gazette Notification as a very positive step. On March 26, a year after the draft notification was issued, the Drug Controller of India invited, among others, representatives of ICMR, dentists, and the sub-mission on control of fluorosis, to discuss the comments received-in particular those from the dentists. This time both the dentists and ICMR were unhappy about clause ii. The bizzare turnaround by the ICMR was inexplicable, especially because it was ICMR’s recommendation in 1987 that prompted the Health Ministry to include clause ii. Both the dentists and ICMR were unable to offer sound scientific reasons for their call to drop clause ii, whereas Prof A. K. Susheela, national coordinator of the sub-mission on control of fluorosis, presented an array of research work published in reputed scientific journals to support the clause. The meeting ended in chaos, with no decision taken. The Final Gazette Notification will be issued after review and recommendation by the Health Ministry’s Drugs Technical Advisory Board. If the clause on statutory warning for children is dropped because of unscientific pressure from dentists, who have been promoting fluoride indiscriminately for several years now, it will be a big blow for the public, who will be deprived of the benefits of public-funded scientific research.
Bhupesh Mangla
Turkey: Placebo effect Ephesus is probably the most impressive archaeological site in modern Turkey. The Greeks founded the city about 10 BC and brought their goddess Artemis to Ephesus and built her large temple there. Artemis was the goddess of chastity, and a festival in her honour was held every spring. St Paul also visited Ephesus at least twice. The second time, in about AD 54, he stayed for over two years, until he had to leave after a riot that occurred because he preached that man-made gods were not real gods. The local silversmiths, who had made their fortune by selling statues of Artemis, stirred up the people against Paul to try and boost falling sales.