Thursday, November 15, 2012
Ethics, personhood and the persistent vegetative state: New evidence new obligations?
Ethics, personhood and the persistent vegetative state: New evidence, new obligations?
A vegetative state is diagnosed according to the following criteria:
(1) no evidence of awareness of self or environment and an inability to interact with others;
(2) no evidence of sustained, reproducible, purposeful, or voluntary behavioral responses to visual, auditory, tactile, or noxious stimuli;
(3) no evidence of language comprehension or expression;
(4) intermittent wakefulness manifested by the presence of sleep-wake cycles;
(5) sufficiently preserved hypothalamic and brain-stem autonomic functions to permit survival with medical and nursing care;
(6) bowel and bladder incontinence; and
(7) variably preserved cranial-nerve reflexes (pupillary, oculocephalic, corneal, vestibulo-ocular, and gag) and spinal reflexes.
(Medical Aspects of the Persistent Vegetative State,The Multi-Society Task Force on PVS, N Engl J Med 1994; 330:1499-1508May 26, 1994DOI: 10.1056/NEJM199405263302107)
The diagnosis is not normally made until the patient has been in that state for at least three months. Hence: “persistent.”
In what follows I will try to lay out the arguments and the issues as clearly as I can. This may be bluntly put but we have to remember that the patients under discussion are real people with families who love and care for, and about, them.
The key ethical elements of this definition are lack of awareness of self or environment (we will return later to the relevance of “evidence.”) Many would argue that the key and essential element of what it is to be a “person” is that one has an awareness of one’s self as a self and an awareness of one’s self in distinction to one’s environment. That is, one knows or is aware of oneself as a thinking thing, an agent of consciousness that can imagine, hope, wish, fear, choose and so on. (This goes back at least to Descarte’s “cogito ergo sum” I think therefore I am.) In the context of a patient in a persistent vegetative state this idea is important for subsequent care. If the vegetative state persists, or more particularly if it is permanent, then that patient is not capable of the experience of being a person and will not recover that capacity. It may then be possible to withdraw artificial life-sustaining measures, without harming the person (because the person is in some sense, already gone.)
This is reflected in practice and in the things that families say about their loved ones and care teams say about their patients. If the person is no longer capable of experience and is no longer aware of him or herself as a person then he or she is already “gone” and all we are doing is caring for that person’s body. I should point out that this is a judgment from the outside and is importantly different from saying that the person concerned would not wish to live this way. Generally (although the law varies from jurisdiction to jurisdiction) the task of a substitute decision-maker is to make the decisions that he or she was instructed to make by the patient when that patient was capable of making decisions, or if there are no such instructions, the decisions the person concerned would have made had he or she been able to do so (that is, decisions in accordance with that person’s values). This is where statements like “She would not wish to live this way...” or “He was always really active and in control, he would hate to be like this..” become important. It is also worth noting that the exact state of the person’s consciousness or awareness under these conditions may not be a determining issue. A person could say: “The worst thing I could imagine would be to be aware and trapped inside my own body unable to do anything or communicate, I would hate to live that way.” Or, he or she could say: “If I was unaware and unconscious with no real prospect of a recovery I would hate to have my body kept alive like that...”
But, of course, people also say and believe things that lead in the opposite direction. Some people, particularly those with certain religiously grounded views (or in some cases as a result of personal choice), believe that the essential part of a person is that person’s “soul,” which is present in that person’s body until the time of death (or sometimes shortly thereafter.) From this perspective it might be appropriate to argue that, regardless of consciousness or awareness, the person’s body should be kept alive as long as possible.
What we should do in cases like these, who has the power and authority to make what decisions, what we, as a community, owe to persons in these states are all contested territory. Clearly, patients and their substitute decision-makers, as described above, are entitled to decline further care. But can physicians or health care teams decline to provide continued care, if in their professional medical opinions, such care would be “futile or inappropriate?” (See previous blog posts on “futility and inappropriate care.) Finally, what must we, as a community fund? Are we obliged to pay for care for a person’s body beyond the time when there is any reasonable prospect of a meaningful recovery? It is hoped that in Canada some direction on these issues will be provided by the Supreme Court when they hear the Rasouli case in December 2012.
So now to the potentially game-changing new evidence. Recent media reports have highlighted the work of Dr. Adrian Owen in London Ontario. Basically, his technique involves scanning the brains of patients in a fMRI. The patient is instructed to imagine performing a vigorous activity, such as playing tennis. If the patient is capable of understanding and responding to such a command his brain will show characteristic patterns of activity which start and stop in accordance with the command. By contrast the patient may be asked to imagine performing a more sedate activity such as moving from one room to another in his house. This too results in a characteristic pattern of activity. Those two activities can now be linked to yes and no, and act as the answers to yes/no questions. Dr. Owen’s research over the last few years has shown that about twenty per cent of the patients he has seen who have been diagnosed as being in a persistent vegetative state are able to answer yes/no questions of this type appropriately. The breakthrough reported recently involves a local patient who was able to respond to the question: “are you in pain?” (He indicated that he was not.)
The “game-changing” nature of this research is that it shows that some patients who were clinically determined to be in a persistent vegetative state, are, in fact, not in such a state at all, but rather are aware and “conscious.” The key components of the definition of a “vegetative state” were that there was no evidence of “awareness of self or environment.” Until now, “evidence” was taken to mean clinical evidence. Dr. Owen’s technique introduces a new way of providing evidence of awareness of self and environment.
So what are the ethical implications? First, there will be increased demand for the type of testing that Dr. Owen has employed. In media interviews Dr. Owen has stressed the highly complex and involved nature of his procedures and the very specific conditions that need to be met in order for the testing to be undertaken – including the medical stability of the patient and the possibility that the patient can travel to the fMRI. It is not clear how medical practitioners, and their funding agencies, will respond to increased demand for this procedure. Second, if it can be shown that patients who were thought to be unaware and therefore incapable of making decisions about their own medical care are in fact shown to be aware, then maybe they can be shown to be capable of making decisions about their care. In which case, if this technology became more readily available it could be a tool to empower patients to make their own decisions about care. Third, there is an important human dimension to all of these discussions. Families often say that they see signs of awareness in their loved ones that are not picked up by the medical professionals. Families often say that they believe their loved one is “still there” somehow trapped inside, despite medical evidence and belief to the contrary. Dr. Owen’s work shows that some of those families are right. And finally, what are the impacts on other areas of care? If there is increased demand for these procedures and increased demand for prolonged medical treatment what impact does that have on other areas of care – does the pot get bigger or do we simply redistribute what is already in the pot.
Lots of questions... What do you think?
Thursday, March 31, 2011
A little more on Baby Joseph
The current development on this story is that Baby Joseph has been transferred to a US hospital where a tracheotomy has been performed. The longer term objective is to transfer him home to die. So what should we say – or think about this outcome. If the procedure could be performed in the US why was it not performed here? Well, none of us were in the room when these questions were discussed but the course of events could have gone something like this:
The Canadian health care team believed that performing a tracheotomy with the sole purpose of sending the patient home to die was a cruel and unnecessary treatment. They believed that the patient would be harmed by the procedure which would bring no benefit to the patient. They believed that they have a commitment to the patient not to cause harm, in particular not to cause unnecessary harm. They understood that the parents wished to take baby Joseph home but they were not prepared to harm their patient in order to enable that to happen.
But if that is so how could another medical team come to the exactly opposite conclusion? How could they be prepared to perform the procedure? First, I think we need to assume that the baby’s medical condition has not changed, that is, the US health care team also believed that the purpose of the tracheotomy was to enable the child to return home. They would have to believe that the procedure could be performed without harming the patient and also that if that could be done it would be worthwhile doing it to benefit not the patient – but the patient’s family. I think they probably made a decision to perform the procedure on the child for the benefit of the family, believing that that could be done without harming the child.
How does that sound? Some commentators have accepted precisely that view. They have argued that if the procedure could be performed without causing suffering or discomfort to the child then why not perform the procedure to allow the parents’ the closure they so fervently desire. Why not “treat” the patient to heal the family?
What do you think?
I do think there is still something more to say. Even if the procedure causes no further suffering or discomfort I still have grave worries that it should be performed. “Treating” the patient to heal the family entails using that patient, that person, as a means to someone else’s objectives. It means using that person as a thing – an object to be, in this case, cut, to benefit someone else. I think, in practice, this is not uncommon. Think of the times an elderly patient is resuscitated, at the demand of the family, only to languish for days or weeks on life support in the ICU, only to die without ever having regained consciousness. All too often this is done – without there being any prospect of benefit for the patient just so the family can say – and feel “We did everything...” I think we can do better. I think we can make it far clearer that we have “Done everything” and that often merely keeping a person’s body alive – even if we have the technology to do so brings no real benefit. I think it is possible for good and loving families to work with their health care teams to do everything that might benefit the patient – but nothing that doesn’t.
What do you think?
The Canadian health care team believed that performing a tracheotomy with the sole purpose of sending the patient home to die was a cruel and unnecessary treatment. They believed that the patient would be harmed by the procedure which would bring no benefit to the patient. They believed that they have a commitment to the patient not to cause harm, in particular not to cause unnecessary harm. They understood that the parents wished to take baby Joseph home but they were not prepared to harm their patient in order to enable that to happen.
But if that is so how could another medical team come to the exactly opposite conclusion? How could they be prepared to perform the procedure? First, I think we need to assume that the baby’s medical condition has not changed, that is, the US health care team also believed that the purpose of the tracheotomy was to enable the child to return home. They would have to believe that the procedure could be performed without harming the patient and also that if that could be done it would be worthwhile doing it to benefit not the patient – but the patient’s family. I think they probably made a decision to perform the procedure on the child for the benefit of the family, believing that that could be done without harming the child.
How does that sound? Some commentators have accepted precisely that view. They have argued that if the procedure could be performed without causing suffering or discomfort to the child then why not perform the procedure to allow the parents’ the closure they so fervently desire. Why not “treat” the patient to heal the family?
What do you think?
I do think there is still something more to say. Even if the procedure causes no further suffering or discomfort I still have grave worries that it should be performed. “Treating” the patient to heal the family entails using that patient, that person, as a means to someone else’s objectives. It means using that person as a thing – an object to be, in this case, cut, to benefit someone else. I think, in practice, this is not uncommon. Think of the times an elderly patient is resuscitated, at the demand of the family, only to languish for days or weeks on life support in the ICU, only to die without ever having regained consciousness. All too often this is done – without there being any prospect of benefit for the patient just so the family can say – and feel “We did everything...” I think we can do better. I think we can make it far clearer that we have “Done everything” and that often merely keeping a person’s body alive – even if we have the technology to do so brings no real benefit. I think it is possible for good and loving families to work with their health care teams to do everything that might benefit the patient – but nothing that doesn’t.
What do you think?
Wednesday, February 23, 2011
Navigating Tragedy(ies): The sad story of Joseph Maraachli
Navigating tragedy(ies)
The sad story of baby Joseph Maraachli and his family has captured headlines in Canada and throughout North America. The publicly available information is as follows: he was born in January 2010 and appeared healthy. In May of last year he suffered seizures and spent a month in a children’s hospital in Detroit. Then, last October he stopped breathing and was admitted to the Children’s Hospital in London where he remains. He has been diagnosed with a progressive neurological disorder and is described as being in a vegetative state. His medical team does not hold out any prospect of recovery.
The first tragedy, of course, is the tragedy of this little boy and his family. It is easy to imagine that they went through this pregnancy with all the hopes, dreams (and fears) that most parents have as they prepare to bring a new life into the world. You can imagine their joy as they took their little one home – prepared to welcome this new member of their family. But then – every parent’s worst fear, something turns out to be wrong – seriously and disastrously wrong with their little baby. What are parents supposed to do – and feel when faced with the tragic prospect that their baby is sick, so sick he will not recover , so sick he will inevitably die, so sick that the very best medical experts we can find with all the power of contemporary technology are helpless to make this little one better? How does a parent wrap his or her head – and heart around that message. What would you (or I) or any parent do? Deny? “It can’t be true, there must be a mistake, what about another opinion? What about something else, what about another doctor another hospital, another treatment... What about..? “ How does a parent make the awful realization that now the best he or she can do for that beloved child is provide care and comfort as he dies?
The second tragedy faces the medical team that cares for that little boy. They all came into health care because they care, they wanted to spend their working lives helping make people whole and well. They chose paediatrics for the joy that comes from caring from – and curing little ones, young people who can then move on to lives full of rich promise. But sometimes they can’t. Sometimes with all the skill and knowledge – and all the technology in the world they can’t fix, all they can do – just like the parents is care and comfort as the little patient dies.
So now the stage is set for the third tragedy. What we all seek in health care is agreement. We want patients and care giving teams to agree on and understand the diagnosis, the prognosis, the course of treatment and the expected outcomes of that treatment. All the actors in this tragedy want the same thing. Everyone wants what is best for little Joseph. Our third tragedy is disagreement about what would be best for him. The care giving team believes, in effect, that it would be best to let nature take its course. They believe that we should stop intervening to prolong the suffering of this little one and that he should be allowed to die peacefully; well cared for, and comfortable. The family believes something different. Perhaps they believe that all of the treatment options have not been exhausted. Perhaps they believe that he could be better cared for elsewhere. They want further surgical interventions; surgeries the care giving team believe would be not only pointless but actually harmful to the little patient, the little person, the son who is the centre of all this care.
And so this private family heartbreak becomes public. The disagreement switches to a public agency, the Provincial Consent and Capacity Board, and subsequently the courts to arbitrate what is best for little Joseph. This tragedy appears to make opponents of parties who all seek the same thing – what’s best for Joseph. But there are no opponents here, and there are certainly no winners or losers. There are only different views, different views on what would be best for this little boy given his diagnosis, his prognosis, possible courses of treatment and their effects and consequences. The Consent and Capacity Board, is a neutral, independent body charged with the protection of the most vulnerable members of our society who are not able to speak for, or protect themselves. It, and subsequently the Court, heard those different views and determined that the course of action being proposed by the medical team was in the best interests of Joseph.
Is this a “good” outcome? What on earth does “good” mean here? This is a tragic story with consequences that will haunt those involved for the rest of their lives and the rest of their careers. Everyone would have loved it had Joseph got better and went home. But that did not happen. Everyone wants what is best for him, and everyone would love to get to that place by agreement. But we have not managed that yet – so we are stuck with playing things out through the Consent and Capacity Board and the Courts. It is imperfect, and it cannot relieve the heartbreak, but it does keep Joseph and his interests at the very centre of the discussion and the decision-making. And that might well be the best we can manage.
The sad story of baby Joseph Maraachli and his family has captured headlines in Canada and throughout North America. The publicly available information is as follows: he was born in January 2010 and appeared healthy. In May of last year he suffered seizures and spent a month in a children’s hospital in Detroit. Then, last October he stopped breathing and was admitted to the Children’s Hospital in London where he remains. He has been diagnosed with a progressive neurological disorder and is described as being in a vegetative state. His medical team does not hold out any prospect of recovery.
The first tragedy, of course, is the tragedy of this little boy and his family. It is easy to imagine that they went through this pregnancy with all the hopes, dreams (and fears) that most parents have as they prepare to bring a new life into the world. You can imagine their joy as they took their little one home – prepared to welcome this new member of their family. But then – every parent’s worst fear, something turns out to be wrong – seriously and disastrously wrong with their little baby. What are parents supposed to do – and feel when faced with the tragic prospect that their baby is sick, so sick he will not recover , so sick he will inevitably die, so sick that the very best medical experts we can find with all the power of contemporary technology are helpless to make this little one better? How does a parent wrap his or her head – and heart around that message. What would you (or I) or any parent do? Deny? “It can’t be true, there must be a mistake, what about another opinion? What about something else, what about another doctor another hospital, another treatment... What about..? “ How does a parent make the awful realization that now the best he or she can do for that beloved child is provide care and comfort as he dies?
The second tragedy faces the medical team that cares for that little boy. They all came into health care because they care, they wanted to spend their working lives helping make people whole and well. They chose paediatrics for the joy that comes from caring from – and curing little ones, young people who can then move on to lives full of rich promise. But sometimes they can’t. Sometimes with all the skill and knowledge – and all the technology in the world they can’t fix, all they can do – just like the parents is care and comfort as the little patient dies.
So now the stage is set for the third tragedy. What we all seek in health care is agreement. We want patients and care giving teams to agree on and understand the diagnosis, the prognosis, the course of treatment and the expected outcomes of that treatment. All the actors in this tragedy want the same thing. Everyone wants what is best for little Joseph. Our third tragedy is disagreement about what would be best for him. The care giving team believes, in effect, that it would be best to let nature take its course. They believe that we should stop intervening to prolong the suffering of this little one and that he should be allowed to die peacefully; well cared for, and comfortable. The family believes something different. Perhaps they believe that all of the treatment options have not been exhausted. Perhaps they believe that he could be better cared for elsewhere. They want further surgical interventions; surgeries the care giving team believe would be not only pointless but actually harmful to the little patient, the little person, the son who is the centre of all this care.
And so this private family heartbreak becomes public. The disagreement switches to a public agency, the Provincial Consent and Capacity Board, and subsequently the courts to arbitrate what is best for little Joseph. This tragedy appears to make opponents of parties who all seek the same thing – what’s best for Joseph. But there are no opponents here, and there are certainly no winners or losers. There are only different views, different views on what would be best for this little boy given his diagnosis, his prognosis, possible courses of treatment and their effects and consequences. The Consent and Capacity Board, is a neutral, independent body charged with the protection of the most vulnerable members of our society who are not able to speak for, or protect themselves. It, and subsequently the Court, heard those different views and determined that the course of action being proposed by the medical team was in the best interests of Joseph.
Is this a “good” outcome? What on earth does “good” mean here? This is a tragic story with consequences that will haunt those involved for the rest of their lives and the rest of their careers. Everyone would have loved it had Joseph got better and went home. But that did not happen. Everyone wants what is best for him, and everyone would love to get to that place by agreement. But we have not managed that yet – so we are stuck with playing things out through the Consent and Capacity Board and the Courts. It is imperfect, and it cannot relieve the heartbreak, but it does keep Joseph and his interests at the very centre of the discussion and the decision-making. And that might well be the best we can manage.
Sunday, January 30, 2011
On "Rationing" in Health Care
For many years the Lung Association in conjunction with the Ontario Thoracic Society have featured debates as part of the format of their conferences. These debates are intended to be a serious and provocative look at a significant topic but presented in a way that is engaging and at least a little playful. I was involved in one of these debates over the weekend on the topic of “rationing” in universal health care. As it turns out I was charged with defending the view that “rationing” ought not to be a part of universal health care. The actual content of the debate – and the cut and thrust of the debate format are not really the focus of this post – but the underlying issues that rose to the surface are worth discussion.
There are some things that are clear. Demand for health care services is unlimited – and supply of those services – or the resources to meet the demand is limited. So there has to be some way of matching the supply with the demand, some way of allocating the scarce resource. On the rationing side of the debate it was argued that, from an economist’s perspective, anything other than a free market entails rationing (by definition) so, as we do not have a free market in health services there must be rationing. Unfortunately the debate got rather stalled at this point – it became a discussion of what the word or concept “rationing” might mean. I think it is quite possible to argue in ordinary language that “rationing” means something like equal shares or allotments but I don’t think this is the real issue – the issue that actually warrants discussion is what do we do when our unlimited demand for health care services outstrips our capacity to meet that demand?
There are several special features of health care (or perhaps more properly we should call it “sickness care”) that warrant our particular attention. In the first place one does not need “sickness care” until or unless one is sick. That is, “sickness care” responds to a need, perceived or actual. On our model of sickness care we are not required to allocate the resource to those who are not sick, to those who do not need it. Next, health or sickness care services can only be delivered by professionals with a highly regulated form of training. And finally, on our model of health care, those services are, more or less, only paid for by a single payer – the government.
Now we can ask the interesting, and difficult, questions. Who decides what health or sickness care services should be paid for by the government? And what sort of a decision is this? I think these questions are interesting and difficult because they require a wide range of different types of expertise to answer – and they do not fall cleanly into the decision-making jurisdiction of any neatly defined entity. So, the decision about what health needs should be funded is not simply a “medical” decision to be made by medical practitioners. Nor is it simply an economic decision to be made by health care economists, nor is it just a political decision to be made at the ballot box. Rather it is a question – or series of questions about what we, as a community, value – and how our values in health care stack up against other community values, like education, or security, or roads, or art – or indeed the ability of each of us to spend our own money as we wish. Let’s make this concrete – do we as a community wish to fund keeping a person’s body alive when there is no reasonable prospect of a meaningful recovery? Do we spend tens of thousands of dollars on a cancer drug that may extend life by a couple of months? What other things are we prepared to forego, including funding for prevention in health care, in order to make those expenditures? Who should make those types of decisions – and what should count as a reason one way or the other?
But there are more questions that are worth asking. What do we, should we, say about those health care services we, as a community, decide should not be funded? If we choose not to fund the cancer drug that may only bring a couple months of extended life, should we allow individuals to spend their own resources as they wish and purchase health or sickness care that the community is not prepared to fund?
I think these are the difficult choices that we currently face in health care. I think this discussion can easily get derailed by a focus on the concept of “rationing” which can obscure the real questions and distract us from the difficult task at hand. What do you think?
There are some things that are clear. Demand for health care services is unlimited – and supply of those services – or the resources to meet the demand is limited. So there has to be some way of matching the supply with the demand, some way of allocating the scarce resource. On the rationing side of the debate it was argued that, from an economist’s perspective, anything other than a free market entails rationing (by definition) so, as we do not have a free market in health services there must be rationing. Unfortunately the debate got rather stalled at this point – it became a discussion of what the word or concept “rationing” might mean. I think it is quite possible to argue in ordinary language that “rationing” means something like equal shares or allotments but I don’t think this is the real issue – the issue that actually warrants discussion is what do we do when our unlimited demand for health care services outstrips our capacity to meet that demand?
There are several special features of health care (or perhaps more properly we should call it “sickness care”) that warrant our particular attention. In the first place one does not need “sickness care” until or unless one is sick. That is, “sickness care” responds to a need, perceived or actual. On our model of sickness care we are not required to allocate the resource to those who are not sick, to those who do not need it. Next, health or sickness care services can only be delivered by professionals with a highly regulated form of training. And finally, on our model of health care, those services are, more or less, only paid for by a single payer – the government.
Now we can ask the interesting, and difficult, questions. Who decides what health or sickness care services should be paid for by the government? And what sort of a decision is this? I think these questions are interesting and difficult because they require a wide range of different types of expertise to answer – and they do not fall cleanly into the decision-making jurisdiction of any neatly defined entity. So, the decision about what health needs should be funded is not simply a “medical” decision to be made by medical practitioners. Nor is it simply an economic decision to be made by health care economists, nor is it just a political decision to be made at the ballot box. Rather it is a question – or series of questions about what we, as a community, value – and how our values in health care stack up against other community values, like education, or security, or roads, or art – or indeed the ability of each of us to spend our own money as we wish. Let’s make this concrete – do we as a community wish to fund keeping a person’s body alive when there is no reasonable prospect of a meaningful recovery? Do we spend tens of thousands of dollars on a cancer drug that may extend life by a couple of months? What other things are we prepared to forego, including funding for prevention in health care, in order to make those expenditures? Who should make those types of decisions – and what should count as a reason one way or the other?
But there are more questions that are worth asking. What do we, should we, say about those health care services we, as a community, decide should not be funded? If we choose not to fund the cancer drug that may only bring a couple months of extended life, should we allow individuals to spend their own resources as they wish and purchase health or sickness care that the community is not prepared to fund?
I think these are the difficult choices that we currently face in health care. I think this discussion can easily get derailed by a focus on the concept of “rationing” which can obscure the real questions and distract us from the difficult task at hand. What do you think?
Thursday, September 16, 2010
When safety and confidentiality collide
When safety and confidentiality collide.
How do we decide what to do?
Many organizations, in Ontario in particular, are reviewing their policies to enhance patient and staff safety. Recent legislation has required health care organizations to rethink their attitudes to risk and to take positive steps to protect workers and patients from violence and other risks to health. At a recent ethics committee meeting at a small hospital in rural Ontario the patient safety co-ordinator brought forward two proposals for discussion.
The first concerned the spread of infection, in particular antibiotic resistant organisms. The proposal was to identify patients who had tested positive for MRSA, VRE or C. Difficile by highlighting their names on their identification wristband. (Alternatives had been suggested such as coloured wristbands, but the method of highlighting had been proposed as the least intrusive option.) Easy visual identification of a patient who had tested positive for these infections would allow the staff who came into contact with that patient to take additional precautions as required.
The second concerned patients who had a history of violence. The proposal here was to have such patients wear a white wristband. The reasoning here was the same: staff (and patients, volunteers and visitors?) would readily be able to identify a patient who was believed to have the potential for future violence and they would be able to take steps to protect themselves.
In each of these proposals there is a clear clash between the desire to promote safety and the rights of a patient to privacy and confidentiality. Under what circumstances should safety and the minimisation of risk trump a patient’s expectations of, or rights to, privacy?
What do you think?
How do we decide what to do?
Many organizations, in Ontario in particular, are reviewing their policies to enhance patient and staff safety. Recent legislation has required health care organizations to rethink their attitudes to risk and to take positive steps to protect workers and patients from violence and other risks to health. At a recent ethics committee meeting at a small hospital in rural Ontario the patient safety co-ordinator brought forward two proposals for discussion.
The first concerned the spread of infection, in particular antibiotic resistant organisms. The proposal was to identify patients who had tested positive for MRSA, VRE or C. Difficile by highlighting their names on their identification wristband. (Alternatives had been suggested such as coloured wristbands, but the method of highlighting had been proposed as the least intrusive option.) Easy visual identification of a patient who had tested positive for these infections would allow the staff who came into contact with that patient to take additional precautions as required.
The second concerned patients who had a history of violence. The proposal here was to have such patients wear a white wristband. The reasoning here was the same: staff (and patients, volunteers and visitors?) would readily be able to identify a patient who was believed to have the potential for future violence and they would be able to take steps to protect themselves.
In each of these proposals there is a clear clash between the desire to promote safety and the rights of a patient to privacy and confidentiality. Under what circumstances should safety and the minimisation of risk trump a patient’s expectations of, or rights to, privacy?
What do you think?
Friday, April 16, 2010
Evidence, Ethics and Responsible Care
A radically innovative “treatment” approach to MS has sparked worldwide interest and huge demand for a surgery that has not been “proven” to bring a benefit for MS sufferers. I will not go into the details of the proposed “treatment” here but rather look at the issues of ethics, evidence and responsibility that are raised by this situation and situations like it.
Evidence
In most (all) areas of human endeavour we do things for reasons. So, if I perform some action or another you could ask “Why?” and could reasonably expect a reply that would give my reasons. Typically those reasons would consist of something like an outcome I wished to achieve and some method for reaching that outcome. “Why did you go to the store?” “To buy curry powder.” “Why did you want curry powder?” “To make curry for dinner.” And so on. Indeed in health care one of the ways that a professional would evaluate a person’s capacity to make health care decisions would be on the basis of the person’s ability to undertake this sort of means-ends reasoning; identifying intelligible goals and appropriate methods of achieving those goals. In everyday life we accept quite a wide range of goals as intelligible and quite a wide range of types as reasons as possible methods of achieving those goals. In health care in general, however, and more specifically in medicine, the goals are more restricted – health or physical outcomes or states, and the reasons given have come to be called “evidence.” “Why did you prescribe that drug?” “Because it increases blood flow.” “Why did you want to increase blood flow?” “Because it will increase oxygen uptake which will ease the patient’s symptoms of shortness of breath, which will allow him to perform more of his everyday activities.” The key question here, however, is what would count as evidence for the claim that this drug, or other form of treatment, will have this outcome. What counts as evidence (or good evidence) that this “X” causes that “Y?”
It is worth reiterating that the standards of evidence in medicine (and indeed the standards of evidence in professional life generally) are quite different from the standards, or indeed what might even be counted as evidence, that might be acceptable in ordinary life. That is because the professional – in this case the physician or other health care professional stands in a special “fiduciary” relationship to the patient (or client.) Professionals – and let’s use the example of physicians, have undergone a specialised training and licensing process which confers on them an expert status. They have been trained in the methods of their profession and they are committed to practising within the professional guidelines and standards of that profession. In medicine the standards of professional practice require that medical decision-making be “evidence based.” A physician – as physician cannot prescribe a drug because he or she thinks the stars are in appropriate alignment, or because he or she had a dream which suggested this drug, or because the drug manufacturer has paid him or her to do so. The physician is bound by standards of good professional practice only to prescribe the drug or other treatment, which, on the evidence, is likely to cause the outcome which is desired.
So far so good. But what counts as evidence of the causal efficacy of a drug or other treatment? This is an area for some debate. The so called “gold standard” for evidence in medicine is a randomised clinical trial performed on a suitably large group of suitably diverse subjects for an appropriate length of time. The reason for randomised clinical trials is that this is the best method we have devised of isolating the causal effects of the drug or other intervention on the outcome we are measuring. The assumption is that randomisation, over sufficiently large numbers will even out the background noise of naturally occurring variation to allow the true causal effect to shine through. The idea is that with a well-designed clinical trial we will be able to say with a certain degree of confidence (typically 95%) that the effect “Y” is caused by the intervention “X.” (More precisely that the effect “Y” is not attributable to chance.) Perhaps we should add a word on confidence. Certainty, the absolute, cannot- be- wrong, kind that can be found in mathematics, is not to be found anywhere in medicine. The best we get are probabilities. Clinical trials are designed so that we can make causal statements with a high degree of probability. A clinical trial is designed so that we can make causal statements with a high degree of confidence that the effects we have observed are very unlikely to have been caused by chance. (Typically only a 1 in 20, 1 in 100 or 1 in a 1000 possibility that the observed effect was caused by chance and not the effect of the drug or intervention under study. )
The other significant component of a clinical trial in medicine is the search for possible side effects. Not only does the drug or intervention have to be effective, but its side effects must be sufficiently slight or unlikely that the anticipated benefit outweighs the possible negative side effects. Again, trials are designed to be able to maximise the chances of identifying possible negative side effects.
So, the good clinician will only prescribe treatments or interventions for which there is good evidence.
Radical Innovations
But what happens when something new comes along? What happens when someone proposes or discovers a radically new way of thinking about – and approaching a disease or condition? In the first instance the demand will be for evidence. What are the reasons to believe that this proposed approach will bring about the effects that are intended? Why should we think this will work? In some cases the initial answer to this question is that the new approach builds on ways that the disease is understood, and works by extending or developing existing approaches. In cases like this the development is incremental, we would still need evidence in order to proceed, but the search for that evidence would typically fit into the research programmes that already exist. What happens when the approach is radically different and requires a new way of thinking about the disease and is treatment. This situation is far more difficult, because on top of the standard demands for evidence there is the added layer of what could be thought of as the sociology and psychology of medical and scientific practice. If you have spent your life and research efforts exploring a disease using one approach you may not be the best person to evaluate a radically new approach which basically undercuts your life’s work. That is not to impute bad faith to anyone – just to recognise that we approach problems from a particular perspective and within a particular framework or paradigm. Those working within that framework or paradigm may well find it extremely difficult to appreciate, understand, accept or evaluate an approach to the problem that employs a different framework or paradigm. On the flip side, those advocating the revolutionary approach may well – at this stage, be doing so without sufficient evidence to make the new paradigm or framework compelling. What plays out is a scientific (and sometimes small “p” political) debate and the search for more and better evidence. But that is the scientific debate. What about the physician – the practitioner who faces demands from her patients for an unproven therapy?
Responsible Practice
Responsible practice requires evidence. In the cases we are discussing, by hypothesis, the evidence is insufficient to warrant a change in the way in which care is standardly provided. That is, there is not a consensus on the standards of good practice that has changed the current approaches. In practical terms this means that the expert bodies in the relevant areas are not recommending a change in practice. The “evidence” for the new approach may be anecdotal or theoretical but is not yet validated or accepted. The good practitioner should monitor the evidence and the debate as it emerges and may well wish to participate in research and clinical trials to seek evidence one way or the other. The responsible practitioner recognises that standards of good care are community decisions – the community being the expert practitioners engaged in the collaborative enterprises that are science and medicine. Does this mean that sometimes individuals will be harmed because of the relatively slow adoption of new treatment approaches (that in fact turn out to be successful) as we wait for the evidence of effectiveness and safety to accumulate? Undoubtedly yes. But the flip side is that if we introduce new approaches too soon we will harm people either by performing treatments and interventions that are simply ineffective, or by causing side effects both known and unknown.
The patient’s perspective
So far we have looked at this issue from the perspective of the medical practitioner and the scientist behind that practice. The perspective of the patient may well be completely different. That is, if the disease I face is sufficiently debilitating it may well make sense to me to try anything that holds any prospect of success. It may well be rational for the drowning man to clutch at straws. If I am going to die I may (quite rationally) wish to try anything I think may save my life. And, if we go back to the point at which we started I am under no compulsion to have “evidence” for my belief or desired. I may wish to try shark’s cartilage, or grapes or I may wish to pray or bathe in a particular pool. I am entitled to have my own beliefs and my own reasons for those beliefs, and those beliefs or reasons do not need to fit within the canons of contemporary science. I may also be quite willing to undergo any risk of known or unknown side effects. And, if the treatment or intervention I seek is under the control of my medical practitioner – which it may well be (for instance if it is a drug or controlled substance or a surgical intervention) I may seek to pressure him or her to provide me with that treatment. What should the patient-focussed , caring practitioner do under those circumstances?
I think this question takes us right back to questions of responsible practice. I believe the physician or other medical practitioner practices within a community of good care and professional standards. I believe that community determines what constitutes good care, professional practice and appropriate types of evidence. Which leaves the practitioner in a really tough spot, having to say no to a desperate patient as he or she clutches at straws.
I realise that this leaves many things unsaid – we have not discussed the ways in which responsible researchers may choose, in effect on ethical grounds, to stop a clinical trial early (either because the results are especially good, or because the side effects appear unacceptably bad). Nor have we discussed the added pressures which arise within a publicly funded health care system. In such a system the medical practitioner has an additional commitment not to waste scarce resources (for instance by pursuing unproven or highly unlikely treatments.) But we will leave those topics for another time.
What do you think?
Evidence
In most (all) areas of human endeavour we do things for reasons. So, if I perform some action or another you could ask “Why?” and could reasonably expect a reply that would give my reasons. Typically those reasons would consist of something like an outcome I wished to achieve and some method for reaching that outcome. “Why did you go to the store?” “To buy curry powder.” “Why did you want curry powder?” “To make curry for dinner.” And so on. Indeed in health care one of the ways that a professional would evaluate a person’s capacity to make health care decisions would be on the basis of the person’s ability to undertake this sort of means-ends reasoning; identifying intelligible goals and appropriate methods of achieving those goals. In everyday life we accept quite a wide range of goals as intelligible and quite a wide range of types as reasons as possible methods of achieving those goals. In health care in general, however, and more specifically in medicine, the goals are more restricted – health or physical outcomes or states, and the reasons given have come to be called “evidence.” “Why did you prescribe that drug?” “Because it increases blood flow.” “Why did you want to increase blood flow?” “Because it will increase oxygen uptake which will ease the patient’s symptoms of shortness of breath, which will allow him to perform more of his everyday activities.” The key question here, however, is what would count as evidence for the claim that this drug, or other form of treatment, will have this outcome. What counts as evidence (or good evidence) that this “X” causes that “Y?”
It is worth reiterating that the standards of evidence in medicine (and indeed the standards of evidence in professional life generally) are quite different from the standards, or indeed what might even be counted as evidence, that might be acceptable in ordinary life. That is because the professional – in this case the physician or other health care professional stands in a special “fiduciary” relationship to the patient (or client.) Professionals – and let’s use the example of physicians, have undergone a specialised training and licensing process which confers on them an expert status. They have been trained in the methods of their profession and they are committed to practising within the professional guidelines and standards of that profession. In medicine the standards of professional practice require that medical decision-making be “evidence based.” A physician – as physician cannot prescribe a drug because he or she thinks the stars are in appropriate alignment, or because he or she had a dream which suggested this drug, or because the drug manufacturer has paid him or her to do so. The physician is bound by standards of good professional practice only to prescribe the drug or other treatment, which, on the evidence, is likely to cause the outcome which is desired.
So far so good. But what counts as evidence of the causal efficacy of a drug or other treatment? This is an area for some debate. The so called “gold standard” for evidence in medicine is a randomised clinical trial performed on a suitably large group of suitably diverse subjects for an appropriate length of time. The reason for randomised clinical trials is that this is the best method we have devised of isolating the causal effects of the drug or other intervention on the outcome we are measuring. The assumption is that randomisation, over sufficiently large numbers will even out the background noise of naturally occurring variation to allow the true causal effect to shine through. The idea is that with a well-designed clinical trial we will be able to say with a certain degree of confidence (typically 95%) that the effect “Y” is caused by the intervention “X.” (More precisely that the effect “Y” is not attributable to chance.) Perhaps we should add a word on confidence. Certainty, the absolute, cannot- be- wrong, kind that can be found in mathematics, is not to be found anywhere in medicine. The best we get are probabilities. Clinical trials are designed so that we can make causal statements with a high degree of probability. A clinical trial is designed so that we can make causal statements with a high degree of confidence that the effects we have observed are very unlikely to have been caused by chance. (Typically only a 1 in 20, 1 in 100 or 1 in a 1000 possibility that the observed effect was caused by chance and not the effect of the drug or intervention under study. )
The other significant component of a clinical trial in medicine is the search for possible side effects. Not only does the drug or intervention have to be effective, but its side effects must be sufficiently slight or unlikely that the anticipated benefit outweighs the possible negative side effects. Again, trials are designed to be able to maximise the chances of identifying possible negative side effects.
So, the good clinician will only prescribe treatments or interventions for which there is good evidence.
Radical Innovations
But what happens when something new comes along? What happens when someone proposes or discovers a radically new way of thinking about – and approaching a disease or condition? In the first instance the demand will be for evidence. What are the reasons to believe that this proposed approach will bring about the effects that are intended? Why should we think this will work? In some cases the initial answer to this question is that the new approach builds on ways that the disease is understood, and works by extending or developing existing approaches. In cases like this the development is incremental, we would still need evidence in order to proceed, but the search for that evidence would typically fit into the research programmes that already exist. What happens when the approach is radically different and requires a new way of thinking about the disease and is treatment. This situation is far more difficult, because on top of the standard demands for evidence there is the added layer of what could be thought of as the sociology and psychology of medical and scientific practice. If you have spent your life and research efforts exploring a disease using one approach you may not be the best person to evaluate a radically new approach which basically undercuts your life’s work. That is not to impute bad faith to anyone – just to recognise that we approach problems from a particular perspective and within a particular framework or paradigm. Those working within that framework or paradigm may well find it extremely difficult to appreciate, understand, accept or evaluate an approach to the problem that employs a different framework or paradigm. On the flip side, those advocating the revolutionary approach may well – at this stage, be doing so without sufficient evidence to make the new paradigm or framework compelling. What plays out is a scientific (and sometimes small “p” political) debate and the search for more and better evidence. But that is the scientific debate. What about the physician – the practitioner who faces demands from her patients for an unproven therapy?
Responsible Practice
Responsible practice requires evidence. In the cases we are discussing, by hypothesis, the evidence is insufficient to warrant a change in the way in which care is standardly provided. That is, there is not a consensus on the standards of good practice that has changed the current approaches. In practical terms this means that the expert bodies in the relevant areas are not recommending a change in practice. The “evidence” for the new approach may be anecdotal or theoretical but is not yet validated or accepted. The good practitioner should monitor the evidence and the debate as it emerges and may well wish to participate in research and clinical trials to seek evidence one way or the other. The responsible practitioner recognises that standards of good care are community decisions – the community being the expert practitioners engaged in the collaborative enterprises that are science and medicine. Does this mean that sometimes individuals will be harmed because of the relatively slow adoption of new treatment approaches (that in fact turn out to be successful) as we wait for the evidence of effectiveness and safety to accumulate? Undoubtedly yes. But the flip side is that if we introduce new approaches too soon we will harm people either by performing treatments and interventions that are simply ineffective, or by causing side effects both known and unknown.
The patient’s perspective
So far we have looked at this issue from the perspective of the medical practitioner and the scientist behind that practice. The perspective of the patient may well be completely different. That is, if the disease I face is sufficiently debilitating it may well make sense to me to try anything that holds any prospect of success. It may well be rational for the drowning man to clutch at straws. If I am going to die I may (quite rationally) wish to try anything I think may save my life. And, if we go back to the point at which we started I am under no compulsion to have “evidence” for my belief or desired. I may wish to try shark’s cartilage, or grapes or I may wish to pray or bathe in a particular pool. I am entitled to have my own beliefs and my own reasons for those beliefs, and those beliefs or reasons do not need to fit within the canons of contemporary science. I may also be quite willing to undergo any risk of known or unknown side effects. And, if the treatment or intervention I seek is under the control of my medical practitioner – which it may well be (for instance if it is a drug or controlled substance or a surgical intervention) I may seek to pressure him or her to provide me with that treatment. What should the patient-focussed , caring practitioner do under those circumstances?
I think this question takes us right back to questions of responsible practice. I believe the physician or other medical practitioner practices within a community of good care and professional standards. I believe that community determines what constitutes good care, professional practice and appropriate types of evidence. Which leaves the practitioner in a really tough spot, having to say no to a desperate patient as he or she clutches at straws.
I realise that this leaves many things unsaid – we have not discussed the ways in which responsible researchers may choose, in effect on ethical grounds, to stop a clinical trial early (either because the results are especially good, or because the side effects appear unacceptably bad). Nor have we discussed the added pressures which arise within a publicly funded health care system. In such a system the medical practitioner has an additional commitment not to waste scarce resources (for instance by pursuing unproven or highly unlikely treatments.) But we will leave those topics for another time.
What do you think?
Thursday, February 25, 2010
Public and Private Health Care, Freedom and Responsibility
When the Premier of Newfoundland, Danny Williams, opted to go to the US (Miami) for his heart surgery earlier this month he ignited a flurry of discussion about public and private health care and what should, and should not be available in Canada. All of the details are not available, but the main gist of the story is that Premier Danny Williams needed heart valve surgery that was not available in Newfoundland. He then opted to pay to have the surgery performed at a medical centre in Miami. He has subsequently claimed that the minimally invasive surgery was not available in Canada, a claim that has been strenuously denied by cardiologists across the country. “It’s my health, it’s my choice,” he is quoted as saying.
In many ways the exact details of the case are not the critical issue. What this situation serves to do – in a very high profile fashion, is highlight some of the debate about what should – and should not be available and what limitations on personal freedom should be permitted in a free and democratic society. Danny Williams was free to take his cheque book and buy his care in the US. After all it is indeed his health and his choice; however Danny Williams could not take his cheque book and buy his care in his own country. Canada is one of the very few countries in the world where there is no private health care. It is easy to see how this is a limitation on individual freedom. A Canadian is not permitted to take his or her own money and purchase a wide range of medical services in his or her own country. Conversely a Canadian medical practitioner is not allowed to set up shop and provide that same wide range of medical services. What is the public good that could justify these restrictions on individual freedom?
There are a variety of arguments in favour of the prohibition on private care, some of those arguments are practical – others are ideological. Let’s have a look at them. The principal practical argument against permitting private care is that somehow the existence of private care (a two-tiered system) would undermine or diminish the publicly funded system. This argument gets vigorously pursued in both directions. Thos who think that private care would undermine the public system argue that private care would siphon resources, facilities, talent, staff etc away from the public system. They also argue that those with the resources to afford private care (or private insurance for that private care) would then become demotivated to protect the public system. And, as those with the resources to afford private care or insurance, are those with the preponderance of political power, the public system would decline through lack of funding and political neglect. On the other side, however, proponents of private care argue that the influx of additional funds into health care as a whole cannot help but be a benefit. They argue that increased resources would increase facilities and personnel, and that the for-profit facilities would take people out of public health care waiting lists and so would result in better care for the entire community. It is difficult to know what evidence would settle this one way or the other. European countries mostly have a mix of public and private care and many observers agree that the French health system is amongst the world’s best, most comprehensive and affordable.
But there are ideological arguments too. Some would argue that permitting people to pay for health care embodies a fundamental inequality. They argue that each human life is inherently of the same value. However, if we allow people preferential, paid access to health care services, if we allow them to buy their way past queues, or to buy better treatment, even if those waiting in the queues are no worse off (in fact, on ideological grounds, even if they were better off) then we have created an inequality, we have manufactured an injustice, we have valued some people more than others – and we Canadians, don’t do that. But, of course, there is ideology on the other side too. As we noted earlier, preventing people from buying products or services from willing sellers is a restriction of personal freedom, which, those on this side of the argument would claim, is unwarranted by any public good that might accrue from the restriction. What do you think?
Finally, the debate about public and private and public health care leaves untouched the very wealthy, like Danny Williams, who can just take their cheque books and buy the services they want where they want. But Danny Williams isn’t just another rich guy; he’s the Premier of a Province in a country where the provinces have jurisdi ction over health care. I’ll leave it up to the reader to decide if special considerations should apply to political leaders... What do you think?
In many ways the exact details of the case are not the critical issue. What this situation serves to do – in a very high profile fashion, is highlight some of the debate about what should – and should not be available and what limitations on personal freedom should be permitted in a free and democratic society. Danny Williams was free to take his cheque book and buy his care in the US. After all it is indeed his health and his choice; however Danny Williams could not take his cheque book and buy his care in his own country. Canada is one of the very few countries in the world where there is no private health care. It is easy to see how this is a limitation on individual freedom. A Canadian is not permitted to take his or her own money and purchase a wide range of medical services in his or her own country. Conversely a Canadian medical practitioner is not allowed to set up shop and provide that same wide range of medical services. What is the public good that could justify these restrictions on individual freedom?
There are a variety of arguments in favour of the prohibition on private care, some of those arguments are practical – others are ideological. Let’s have a look at them. The principal practical argument against permitting private care is that somehow the existence of private care (a two-tiered system) would undermine or diminish the publicly funded system. This argument gets vigorously pursued in both directions. Thos who think that private care would undermine the public system argue that private care would siphon resources, facilities, talent, staff etc away from the public system. They also argue that those with the resources to afford private care (or private insurance for that private care) would then become demotivated to protect the public system. And, as those with the resources to afford private care or insurance, are those with the preponderance of political power, the public system would decline through lack of funding and political neglect. On the other side, however, proponents of private care argue that the influx of additional funds into health care as a whole cannot help but be a benefit. They argue that increased resources would increase facilities and personnel, and that the for-profit facilities would take people out of public health care waiting lists and so would result in better care for the entire community. It is difficult to know what evidence would settle this one way or the other. European countries mostly have a mix of public and private care and many observers agree that the French health system is amongst the world’s best, most comprehensive and affordable.
But there are ideological arguments too. Some would argue that permitting people to pay for health care embodies a fundamental inequality. They argue that each human life is inherently of the same value. However, if we allow people preferential, paid access to health care services, if we allow them to buy their way past queues, or to buy better treatment, even if those waiting in the queues are no worse off (in fact, on ideological grounds, even if they were better off) then we have created an inequality, we have manufactured an injustice, we have valued some people more than others – and we Canadians, don’t do that. But, of course, there is ideology on the other side too. As we noted earlier, preventing people from buying products or services from willing sellers is a restriction of personal freedom, which, those on this side of the argument would claim, is unwarranted by any public good that might accrue from the restriction. What do you think?
Finally, the debate about public and private and public health care leaves untouched the very wealthy, like Danny Williams, who can just take their cheque books and buy the services they want where they want. But Danny Williams isn’t just another rich guy; he’s the Premier of a Province in a country where the provinces have jurisdi ction over health care. I’ll leave it up to the reader to decide if special considerations should apply to political leaders... What do you think?
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