AIDS and Medical Aid in Dying - are there lessons to be learned?

Canadians debate currently where to draw the line in the sand in terms of eligibility criteria for medical aid in dying. The federal government is determined to push thru a bill that is uncontroversially unconstitutional by limiting access to terminally ill patients.

Today the Globe and Mail (a paper that supports our government's restrictive approach to medical aid in dying) published an unusually thoughtful commentary by Konrad Yakabuski in support (you won't be surprised to hear) of said restrictive approach.

Yakabuski and I have something in common, something important. We both lived thru the early years of the HIV/AIDS epidemic, we both lost loved ones to the disease. Yakabuski mentions that his brother and several friends of his died of the ravages of AIDS, 'with dignity, the old-fashioned way'. Yakakuski's main point (a very reasonable point) is that eventually treatments for HIV infection came about that permit HIV infected individuals today to live basically healthy lives. If medical aid in dying would have been available to them, some HIV infected patients may have chosen to end their lives prematurely, however, if they had decided to stick it out, they might have been able to hang on for long enough to benefit from the life preserving drug regimes that exist today. He then makes the same claim about anti-depressants (arguably he is terribly mistaken on that frontier, but that's unimportant for the purpose of his broader point, it doesn't rely on him being right on that count).

Well, I'm a gay man who has seen very many of his friends succumb to HIV infection in the same years that Yakabuski writes about, and I disagree entirely with his argument and his policy recommendations. You won't be able to see this response in the Globe and Mail, unfortunately, because the paper has been reduced to a propaganda vehicle for a restrictive assisted dying regime.

There has been some debate both among medical ethics people, but certainly also among HIV infected people about medical aid in dying, in the 1980s. One leading bioethics journal, the Hastings Center Report, published many years back a piece by my friend, the late Michael Callen, entitled 'If I have AIDS, then let me die now.' Michael had, of course, no intention whatsoever, to die on AIDS. In fact, years after he published his commentary he wrote a book called Surviving AIDS. Eventually he succumbed to the disease, shortly before life-preserving treatment regimes came onto the market. I have lost far too many friends like Michael.

But I digress, let's return to Yakabuski's commentary. Why would educated AIDS activists, like Michael, have written a commentary for a mainstream medical ethics journal in which they argued that they should be able to receive medical aid in dying when they thought their time had come? Simply put, it was about self-determination. Something maligned by Canadian anti-choice activists as 'autonomy fundamentalism' (not Yakabuski's words!). It was a choice for Michael to make for himself, not for me, not for government, it was his call to make.

The problem with timelines in this context is that we can never know whether, if at all, and when a successful treatment for a particular ailment comes onto the market. Yakabuski briefly mentions the horrible deterioration in health and quality of life HIV infected people in those days experienced. It was worse than that, they had seen friends and lovers wither away, they knew what was coming their way. It's all nice and well to describe this withering away as 'dignified and old-fashioned', but frankly, for many of these young people who died during those years there was nothing dignified about their dying, and no amount of hand-holding and caring would have made their disintegrating lives any more dignified. I am deeply troubled about the euphemisms Yakabuski deploys to describe what was actually happening in our community. I also have no doubt that that is how he subjectively experienced or remembers his brother's death. It is not an experience that is representative of how dying of HIV was experienced by many, if not most, of those who died in those years.

The question then, surely, is whether these patients were entitled to call it a day when they decided they had enough, or whether the state had any right (as the Liberal government's legislation proposes) to force them to stick around and deny them access to medical aid in dying on the ground that some drug might come about. My answer: Of course they were entitled to make those choices and see those choices respected and supported. That the state would think it has a role to play in forcing such patients to stick around no matter what, or commit suicide by some gruesome means, is just mind boggling.

HIV is different to depression, of course, in that it was actually an illness where death would have been reasonably foreseeable, so HIV patients arguably would have met the standard set out in the restrictive government draft legislation of bill C14.

I have published a year ago with Suzanne van de Vathorst a lengthy piece on treatment resistant depression and medical aid in dying. May be take a minute or two to read it. It's available here. The same link will also take you to published responses, including one or two making Yakabuski's case, as well as our considered response to those arguments. The article also supplies hard data on the actual large scale failure of available treatment modalities that Yakabuski glosses over in his piece. The argument here is the same as above, if a patient is competent at the time of decision-making and he or she does not consider their lives worth living, and available treatment options have been exhausted, we as a society have no right whatsoever to force such people to stick around in the hope that some treatment might come about during their lifetime. It's a decision only such patients can make for themselves. Whatever they decide, they deserve our support.

State of Affairs: Canada's Medical Aid in Dying Legislation

I have explained on this blog (just see the entry below) how Canada's Liberal government's draft legislation aims to deprive Canadians who are not terminally ill, but who are eligible for medical aid in dying, of their Charter rights. A fairly large number of constitutional law experts, including the lead counsel in the Carter case that led to the Supreme Court judgment, warned the federal government that its legislation would be contested in the courts and would eventually be thrown out by the Supreme Court. Government apparently thought it could thumb its nose at the judgement by redefining clear Supreme Court of Canada criteria and pretending that black is kinda white. Since then two Canadian courts have heard cases where competent patients who are not terminally ill appealed to receive medical aid in dying. Government lawyers in both cases were sent packing and told in no uncertain terms that their insistence on the eligibility standards expressed in the draft legislation is unacceptable because these standards are unconstitutional

Yesterday the Canadian Senate weighed in and removed the terminal illness threshold the Liberals were so keen on, precisely because the majority of Senators realised that the legislation proposed by the federal government is unconstitutional. Our Justice Minister meanwhile insists that her (unconstitutional) 'balance' is just right, and waffles a bit about not further defined 'vulnerable' people that would be best 'protected' if her government's proposed restrictive regime was passed by the Senate. It's only mildly amusing that she deploys the same vacuous rhetoric here that the previous Conservative government deployed.

The question is why the Liberals would engage in that sort of thing. There are persistent rumours that there are a fairly large number of religious conservatives in the Liberal caucus who care more about their religious beliefs then about Canadians' constitutional rights. This in turn forced the Trudeau government to try to legislate hard-right on this issue, to the dismay of virtually every relevant legal expert in the country. What does surprise is that these folks seem to think that their personal beliefs somehow trump their obligation to legislate in line with our Charter of Rights and Freedoms and in line with the criteria the Supreme Court spelled out.

How Canada's new Liberal government plans to deprive Canadians of their Charter rights

It is becoming clearer by the day that our newly elected federal government has an insatiable appetite for talking progressive while governing conservative. I suspect this will be our new normal until election time. The behaviour pattern is obvious. I doubt Mr Trudeau's feel-good activism on that frontier will carry the Liberals much longer. Canadians are catching on to them.

Anyhow, as a quick reminder, the Canadian Supreme Court declared that parts of the Criminal Code that criminalize assisted dying are unconstitutional.

Canada's Liberal government introduced its legislation on assisted dying in parliament.  It is being debated in committee today.

Here's the legislative draft proposal

A person has a grievous and irremediable medical condition if

(a) they have a serious and incurable illness, disease or disability;

(b) they are in an advanced state of irreversible decline in capability;

(c) that illness, disease or disability or that state of decline causes them enduring physical or psychological suffering that is intolerable to them and that cannot be relieved under conditions that they consider acceptable; and

(d) their natural death has become reasonably foreseeable, taking into account all of their medical circumstances, without a prognosis necessarily having been made as to the specific length of time that they have remaining.

Compare that to the Supreme Court's criteria:

'‘competent adult person who (1) clearly consents to the termination of life and (2) has a grievous and irremediable medical condition (including an illness, disease or disability) that causes enduring suffering that is intolerable to the individual in the circumstances of his or her condition.'

Ii is trivially true that 'd' in the legislative draft is too restrictive, given the criteria the Court has set. Terminal illness is not a defensible threshold condition for access. Patients do not have to be in an advanced state of irreversible decline in capability either. Excluding not terminally ill patients from access who meet the above mentioned Supreme Court criteria would clearly violate Canadians' Charter rights. 

Government released today its rationale for the proposed policy.  

Here we go,

Restricting access to only those individuals whose death is reasonably foreseeable allows them to choose a peaceful, medically assisted death where their medical circumstances are such that the dying process would otherwise be painful, distressing, frightening, prolonged or otherwise lacking dignity from their perspective. This approach respects autonomy during the passage to death, while otherwise prioritizing respect for human life and the equality of all people regardless of illness, disability or age. It also furthers the objective of suicide prevention and the protection of the vulnerable. Recognizing the complexity of the legal and social issues associated with medical assistance in dying, this approach strikes an appropriate balance between the competing rights, interests and values. 

It's plain for everyone to see that the Rationale is not actually a rationale as it does not explain at all why terminal illness is introduced as an eligibility threshold. 

The Justice department's briefing acknowledges the problem, it states,

This could impact the section 7 Charter rights of those who are suffering intolerably as a result of a serious and incurable condition, but whose natural death is not reasonably foreseeable. This could include individuals suffering only from a mental illness, and individuals with physical disabilities who lack the physical capacity to end their own lives. Persons with mental illness or disabilities would only have access to medical assistance in dying if they meet all of the eligibility criteria.

And yet, our government (lacking a rationale to actually respond to this concern), pushes ahead anyway. I trust you will savour the Catholic language introduced in the rationale, where government prioritizes 'respect for human life' over our Charter right to make decisions about our continuing existence based on competent, autonomous choice and our actual quality of life. Intractable human suffering is apparently of no concern to the Liberals. Go figure. Truly, this is legislation the Harper Conservatives could have drafted. 

Bioethicists taking on questionable publishers ... in ethics

Stefan Eriksson at Uppsala University and his colleague Gert Helgesson at the Karolinska Institute have undertaken the commendable job of creating two lists of English language bioethics journals, one featuring journals published by reputable publishers and another one featuring journals associated with other publishing outfits. Each of their critical choices is accompanied by links providing evidence in support of their concerns about the journals/publishers in question. It is doubtful that some of the questionable journals actually qualify as journals in any meaningful way. There is one such journal, for instance, that published a full one article in its three years of existence. The wonders of fee-for-upload open access publishing...

The list created by Ericsson and Helgesson should prove to be tremendously useful as a guide for junior faculty who wonder where to submit their first academic outputs for peer review, but it's also helpful to those of us who have been around for longer and are asked to provide sound publishing advice that goes beyond guessing the quality of particular journals.

Not unexpectedly, the list isn't quite complete, even as far as English language journals are concerned (e.g. the superb Indian Journal of Medical Ethics is missing in action), but it's a great start, and undoubtedly future iterations of the list will move closer to comprehensiveness. The list also does not aim to include journals other than English language journals. It's probably a fair enough approach as it would be a mammoth task indeed to check whether particular journal titles in other languages fall into one or the other category of publications.

Liberal Government ignores Supreme Court's eligibility criteria on assisted dying

Canada's Liberal government introduced its legislation on assisted dying in parliament. There's a lot to talk about there, but let me focus on the government's most brazen ignoring of the eligibility criteria the Court has established.

Here's the legislative draft proposal

A person has a grievous and irremediable medical condition if

(a) they have a serious and incurable illness, disease or disability;

(b) they are in an advanced state of irreversible decline in capability;

(c) that illness, disease or disability or that state of decline causes them enduring physical or psychological suffering that is intolerable to them and that cannot be relieved under conditions that they consider acceptable; and

(d) their natural death has become reasonably foreseeable, taking into account all of their medical circumstances, without a prognosis necessarily having been made as to the specific length of time that they have remaining.

Compare that to the Supreme Court's criteria:

'‘competent adult person who (1) clearly consents to the termination of life and (2) has a grievous and irremediable medical condition (including an illness, disease or disability) that causes enduring suffering that is intolerable to the individual in the circumstances of his or her condition.'

I'm sure even lay persons appreciate that 'd' in the legislative draft is simply too restrictive, given the criteria the Court has set. Terminal illness is not a defensible threshold condition for access. Patients do not have to be in an advanced state of irreversible decline in capability either. Excluding not terminally ill patients from access who meet the above mentioned Supreme Court criteria would clearly violate Canadians' Charter rights. Apparently that is of no concern to our government.

To cut a long story short, if this becomes law, a Charter challenge will occur sooner rather than later, and the matter will be fixed in the Court. It is shocking that a Liberal government would continue the Harper government's tradition of trying to subvert Supreme Court decisions.

Catching up in person?

I will be on the road a bit during the next few weeks, giving various talks in various places. In case you happen to be around, say 'hi' :).

I will be in Charleston, SC between April 6-8 to give a talk on the Ethics of Catastrophically Ill Patients Access to Unregistered Medical Interventions as part of the Thomas Pitts Memorial Lectureship in Medical Ethics at the Medical University of South Carolina.

From April 11-13 I will be at Williams College, MA to give a talk on the Ethics of Catastrophically Ill Patients Access to Unregistered Medical Interventions in the context of the Ebola virus outbreak in West Africa in 2014/15. I will also run a seminar on intractable depression and assisted dying there.

From May 9-11 I will be at Erasmus University in the Netherlands, giving talks on the Ethics of Catastrophically Ill Patients Access to Unregistered Medical Interventions and on why I think there should be no conscientious objection accommodation for doctors in liberal democracies.

From May 12-14 I will be attending the Euthanasia 2016 congress in the Netherlands, offering a presentation on the current state of play in Canada (on a panel with Margaret Battin), as well as a presentation on intractable depression and assisted dying.

So, if you happen to be in the vicinity and you always meant to say 'hi', don' hesitate.

Why Canada's assisted dying regime must not be limited to the terminally ill

A kerfuffle has broken out in the Canadian news media about eligibility criteria for assisted dying. The Supreme Court of Canada in its decision is unequivocal that limiting access to include only people who are about to die would be violating the Charter rights of other patients. Here are the core criteria the Court set, an eligible person would be a ‘competent adult person who (1) clearly consents to the termination of life and (2) has a grievous and irremediable medical condition (including an illness, disease or disability) that causes enduring suffering that is intolerable to the individual in the circumstances of his or her condition.’ It is uncontroversial then that terminal illness cannot be a viable access threshold for the purpose of upcoming federal as well as provincial-territorial legislation. That hasn’t stopped constitutional ‘experts’ like Margaret Wente, a notorious columnist at the Globe and Mail to insist on just that. Experts celebrated in her piece include Harvey Chochinov, an anti-euthanasia activist appointed in the dying days of the Harper government to advise him on how to act on the Supreme Court judgment. Chochinov acted as a witness for the Harper government’s side during the trial. His evidence, obviously, did not convince the trial judge and her decision was upheld in what was a unanimous decision going against everything Chochinov argued for. It is no surprise that Wente, a writer not known for good judgment, celebrates Harper’s appointee on her Globe and Mail platform.

The Globe and Mail ran no less than at least three opinion pieces arguing that a parliamentary special joint committee as well as a provincial-territorial expert advisory group got it wrong when they included for instance people with intractable depression among those eligible for access to assisted dying. So, here’s a quick few notes on Wente. She writes that 110 psychiatric patients have been ‘euthanized’ in the Netherlands between 2011 and 2014.  The journal article she refers to actually notes that these were cases of euthanasia or assisted suicide, ie it is not the case that 110 patients were actually euthanized. Small difference in Ms Wente’s fantasy land.

Another highlight from Wente land, ‘The rationale [in the parliamentary committee report, U, Sch.] is that psychiatric patients should have the same rights as everybody else.’ Well, in Canada we have this little document called the Charter of Rights and Freedoms, and when we take a closer look at it, we will realise that competent psychiatric patients have the same rights as competent people who are not psychiatric patients. Labelling someone ‘psychiatric patient’ doesn’t miraculously do away with their Charter rights! Apparently the Globe and Mail does not have funding any longer for basic fact checking of the content the writers generate for its opinion columns.

Wente eventually claims that the numbers of psychiatric patients seeing their lives ended by assisted dying are growing fast. This is doubtful, given that the overwhelming majority of requests for assistance in dying from psychiatric patients are denied in the Netherlands. 2013 saw an increase in cases of euthanasia for patients with psychiatric illnesses. A total of 42 cases were reported—as is legally required—to the Dutch Euthanasia Review Committee. The 42 cases reported in 2013 compare against 12 in 2012. Of these 42 cases, 32 were investigated by the Committee in 2013 and the findings published. In 22 of these 32 cases, depression was mentioned as (one of the) the cause(s) of suffering. This brief, intermittent increase in cases is probably mostly due to the start of the ‘end-of-life’ clinic, an organisation that aims to grant euthanasia to all of, and only, those who fulfil the due care criteria in the Netherlands but who have been unable to obtain assisted dying from their physician. The start of this service in March 2012 led to a significant number of applications from patients who were determined to end their life by means of assisted dying, among them were a large number of patients with psychiatric illnesses (38% of applicants). Some 62% of these patients with psychiatric illnesses were refused an assisted death mostly because their death wish was judged to be more or less impulsive, and therefore did not meet the Dutch due care criteria. The Dutch Minister of Justice revealed in August 2014 in a letter to the Dutch Parliament that there were no signs of a further increase in 2014. Meanwhile, in Canada, Ms Wente claims as a fact dramatic increases in the numbers of psychiatric patients being euthanized. You need to do that, when all you have are 110 cases over a fair number of years, that don’t quite sustain claims of slippery slopes and out of control actions by laissez faire doctors. A number of those patients whose requests were denied eventually committed suicide by other means, a not uncommon occurrence among people with intractable depression. Among this small number (ie 110 people over a 4 year period in a country of about 17 million people) of psychiatric patients, the authors of the study that Wente goes on and on about in her column, looked more closely at only 66 of those cases, slightly more than half. It turns out that the majority of those cases consisted of patients suffering from depression. That is highly significant, because there are good reasons to make intractably depressed people (who can be assessed for competence and, because they are not imminently dying, for the endurance of their wish to die) eligible for access to assisted dying. I have published last year a journal article, co-authored by Professor Suzanne van de Vathorst, MD PhD, of Erasmus University Medical School in which we make the ethical case for why such people should be eligible for access to assisted dying, provided certain sensible safeguards are met.

Trudo Lemmens, a law professor at the University of Toronto has published two pieces in the Globe and Mail – apparently the ideological headquarter for this sort of activism. Not content with that, he published yet another piece (with more or less similar content) at the Impact Ethics website. I shall focus on the piece he has published there. Lemmens essentially has the same concerns that drive Wente and relies on the same evidence. He claims, ‘The [Canadian parliamentary, U. Sch.] Committee ignores the Court’s emphasis on the narrow basis of its ruling and the exclusion of “euthanasia for minors or persons with psychiatric disorders”. I encourage you to do a search for this quote in the SCC judgment and you’ll see that the Court actually did nothing of the kind. Nowhere does it exclude competent patients with psychiatric disorders from access to assisted dying. It’s plainly obvious already from the access criteria I began with, so Lemmens is using bits and pieces from rejected expert testimony to make his case. To be absolutely clear on this subject: there is no exclusion of competent psychiatric patients writ large in the Supreme Court of Canada judgment. Lemmens and Wente might not like it, but it is what it is.

Lemmens uses the same study that excites Wente to make the case that the Netherlands and Belgium have gone down a slippery slope that we would end up on if we made assisted dying available to patients who are not terminally ill. It is worth noting that the Supreme Court in its judgment explicitly rejects that line of reasoning. It writes, ‘The regime [in Belgium, U. Sch.] simply regulates a common pre-existing practice.  In the absence of a comparable history in Canada, the trial judge concluded that it was problematic to draw inferences about the level of physician compliance with legislated safeguards based on the Belgian evidence (para. 680).’ In any case, the study that is used by Wente and Lemmens to show how far down the slippery slope the Netherlands has gone, relies on the interpretation of 66 cases, of which the majority were patients with depressive disorder. Its authors conclude, ‘The granting of their EAS requests appears to involve considerable physician judgment, usually involving multiple physicians who do not always agree (sometimes without independent psychiatric input), but the euthanasia review committees generally defer to the judgments of the physicians performing the EAS.’ The important bit here is that requests for assistance in dying made by psychiatric patients involves considerable physician judgment, usually involving multiple doctors. That doesn’t look like powerful evidence of a country gone down the slippery slope to terrible abusive practices.

Lemmens eventually resorts to anecdotes from TV documentaries. We apparently have to take his word for it that the cases he describes are uncontroversial examples of abuse. It is my understanding that those who provided assistance in dying to the patients featured in the documentaries do not agree with Lemmens, so perhaps the story told by those who oppose the practice might be a tad bit on the biased side of things.

Remarkably, the Globe and Mail refused to allow for critical responses to these commentary style pieces. Because false claims were made in these pieces about supposedly terrible things happening to vulnerable mentally ill people in Belgium I asked an actual expert, Professor Jan Bernheim, MD PhD of the University of Brussels End-of-Life Care Research Group in its Faculty of Medicine for a reply to these diatribes. He kindly agreed to do so. It is noteworthy that the Globe and Mail chose not to publish his reply. At least a brief letter from the chairpersons of the provincial-territorial expert advisory group correcting the most flagrant error in one of the Globe and Mail pieces was published.

Contributions such as Wente’s and Lemmens’ do a disservice to the debate on what kind of regulatory regime we should introduce in Canada. Their campaign is difficult to understand, especially given the very small number of cases (anecdotes, to be frank) that opponents of a permissive regime rely on. I wonder whether it’s due to their inability to appreciate the suffering that many competent patients with intractable psychiatric disorders encounter throughout their lives. Or do they simply believe that such patients should just ‘stick it out’? The existential suffering patients with depression encounter, and that patients with intractable depression experience throughout their lives is equal to the most severe physical ailments. Empirical evidence from a large-scale study suggests that intensity of mental suffering, on average, is equal only to the most severe physical conditions. (Bernheim JL, Theuns P, Mazaheri M, Hofmans J, Fliege H, M.Rose. The Potential of Anamnestic Comparative Self-Assessment (ACSA) to Reduce Bias in the Measurement of Subjective Well-Being Journal of Happiness Studies. 2006;7(2):227-250.)

Several comprehensive surveys of assisted dying regimes across Europe as well as the Netherlands in particular concluded that there is no evidence that these permissive regimes put the vulnerable at increased risk. It is remarkable that that evidence is studiously ignored by campaigners like Wente and Lemmens. They are playing to public concerns about vulnerable psychiatric patients. We should be concerned about the suffering of many psychiatric patients, but the reality is that today, with the best available treatments, a large percentage of these patients do not consider their lives worth living. A few of those patients would avail themselves of assistance in dying. They are entitled to receive assistance once it has been established that they are competent to make that decision and once it is clear that their wish remains stable over time. The Supreme Court of Canada, in its wise decision on this subject matter heard evidence and concerns along the lines presented by Wente and Lemmens and concluded that we will be able to design a permissive regulatory regime that does not put psychiatric patients at risk, the same conclusion was reached by the parliamentary committee as well as the provincial-territorial expert panel in their respective reports. That is reassuring. I hope the upcoming governmental regulations both federally and provincially will be in line with the Supreme Court’s criteria and do not arbitrarily exclude competent patients with intractable illnesses that render their lives not worth living to them.   

Hiatus - Apologies

I have been unusually slow in terms of up-dating this blog. It's not for lack of content to write about. The CMA is embarrassing itself currently on the issue of conscientious objection and assisted dying, behaving like a true trade union would, without much concern for patient access to such services that its members will likely be monopoly providers of. The reason why I have not been able to actually blog about this is that I am swamped with publication deadlines. Editorials for both Bioethics and Developing World Bioethics had to be written, I was also briefly a Visiting Professor at St George's this January where I managed to catch up with colleagues like Cheryl Cox and Matthew Wynia, and I had to travel to Belgium as part of consultancy work I did for MSF/Doctors without Borders in 2015. - I have been travelling way too much. I also gave talks during events organised in November by the FDA/CDC and NIH in Bethesda as well as one organised a week or two later by the German National Ethics Council and the country's national science academy in Berlin. Then there were various paper deadlines, one of which I met, the other is one that I am working frantically toward meeting.  One of these papers is on conscientious objection, and I have finally managed to submit it for consideration to guest editors of a bioethics journal, then there is a response I need to write to someone who responded to an Editorial I had in Bioethics (ya, a reply to a reply, very academic), as well as another article I need to produce on the issue of catastrophically ill patients' moral entitlement to access unregistered medical interventions. I have written about this before, but this paper will add new arguments to what I have said in the past on this topic. Yes well, then there are departmental obligations. I must produce our departmental newsletter, and I'm looking forward to doing just that. I'm also busy preparing for a bunch of lectures that I'm giving in various countries during the next few months.

The long and short of it is that I didn't have time to blog as frequently as I would have liked to. I'll try to do better.

Future Infectious Catastrophic Disease Outbreaks: Ethics of Emergency Access to Unregistered Medical Interventions and Clinical Trial Designs

The mass media excitement about Ebola has receded. The 2014-2015 West African outbreak has been brought under control not thanks to the deployment of successful treatment regimes, because there are none that are known to work. I participated recently in an international meeting of experts debating the ethical and methodological issues pertaining to trial designs for emerging infectious diseases like Ebola. It was both astounding and also immensely frustrating that to a large extent the controversies that exercised the minds of the delegates of this meeting exercised the minds of many an AIDS activist and clinical trials’ expert prior to the advent of highly active antiretroviral therapy, a good quarter of a century ago.[1] [2]Are placebo controls an ethically defensible methodological tool when patients face a terminal illness? Different alternative trial designs involving placebo controls, adaptive trial designs, and multi-stage approaches involving active controls were discussed during the meeting. The heated nature of some of these debates reminded me strongly of the passion that was on display during the early HIV trials. It turns out, despite decades of informed debate about these issues, a number of significant normative questions have not been settled.

A cluster of difficult ethical questions that engendered justifiably a lot of debate has to do with the use of placebo controls in trials involving patients facing a very high mortality risk (some in excess of 90%) and a fast-acting infection resulting in the death of these patient within 2-8 days after admission to a treatment centre. This scenario mirrors the sobering reality faced by a subset of Ebola Virus Disease patients. This issue was already highly contentious during the early HIV trials, and then patients and clinical investigators were faced with a virus that was nowhere near as fast-acting as the Ebola virus. The ethical conflict that arises here is this: We know that those randomized into the placebo arm face the same greater-than-90%-risk of death within a few days as those who receive the standard of care treatment. In some trial design the placebo control arm could be identical to the gold standard of (unsuccessful) clinical care provided in a particular clinical setting. Given that those who are randomized into the arm featuring the unregistered medical intervention might do better, or might do worse, or might do roughly as badly as those in the placebo control arm, the ethical question remains whether a trial design featuring a placebo control is ethically justifiable, given the almost certainty of imminent death faced by those randomized into the placebo arm. During the meeting I alluded to earlier a fairly contentious debate arose also over the question of whether trials producing less reliable results than placebo controlled trials might be acceptable under such circumstances.

What exacerbates the ethical challenges for those who undertake such trials is that their trial participants are arguably not true volunteers. Their – dying - trial participants are not given the opportunity to choose between participating in the placebo controlled randomized trial versus accessing the unregistered medical intervention on their own volition outside the trial process. It is perfectly conceivable that some patients might choose to participate in such trials in order to facilitate the development of a successful intervention capable of helping future patients like them. Or they might accept that there exists true clinical equipoise between the trial arms and they might be volunteering to be randomized under such circumstances. In the absence of alternative access routes to the unregistered medical intervention, we can never be certain that the patients agreeing to be randomized are not simply responding to what constitutes a coercive offer.

Clinical investigators colluding in this process, and arguably benefiting from it, are not absolved of their ethical responsibilities because they did not create the regulatory frameworks that gave rise to the problem. It is true that they did not create the regulatory framework under which they operate, but they undoubtedly benefit from its existence. We could respond to this kind of argument by pointing to the societal need for sound trial designs and the detrimental impact of permitting patients to access unregistered medical interventions outside the clinical trials’ system. The likely impact of permitting patients access, as a senior biostatistician attending the workshop rightly pointed out to me, would be a significant slowing-down in the trial recruitment process. Some trials might never be able to recruit sufficient patients, because most patients might be voting with their feet and opt to take their chances with the unregistered medical intervention. Surely that is not quite what is in the best interest of any society battling an emerging infectious disease such as Ebola. Does this justify coercing dying people into particular trial designs? I do not think so, but this is a contentious issue where reasonable, well-informed people can justifiably differ. A WHO panel looking at this question argued that while it would be ethically defensible to offer emergency access to unregistered medical interventions to Ebola patients, this should be subject to that emergency access not slowing down trial recruitment.[3] The panelists (not featuring a single expert or disease survivor from the affected countries) took a policy line here that mirrors US regulations. Other countries, including Canada and South Africa do not make this a threshold condition for emergency access. As it is with these sorts of panels, the advice it rendered on this controversial topic is not actually reasoned for, so policy makers and regulators as well as patient rights advocates aiming to balance the competing interests of access versus trial recruitment in a fair manner will be left wondering about the ethical reasons for this policy stance taken by the WHO panel, assuming there are any.

There are other ethical issues that arise in this context: Some experimental agents existed at the time only in insufficient quantities, for instance ZMapp, an unregistered medical intervention composed of monoclonal antibodies, was only available in very limited quantities. In light of this situation, is it acceptable to prioritize patients in comparable clinical circumstances who are willing to be randomized in a placebo controlled trial over patients clamoring for direct emergency access, given that the available quantities of this unregistered medical intervention would have been used up in the placebo controlled trial?

And here is another difficult question: While the AIDS activists of days gone by were highly educated about their disease and about the available unregistered medical interventions considered for expanded access programs, this is not quite the case with regard to the average West African Ebola patient. These patients were unlikely able to provide valid first person informed consent, because they were unable to demonstrate a reasonable person understanding of what was known about the unregistered medical intervention, about their options and so on and so forth. This is the case both because of educational limitations as well as disease progression. Are short-cuts to informed consent ethically justifiable under such circumstances? Given that time is of the essence and proxy consent might not be feasible due to family members being deceased or in a far-away village, are our informed consent requirements reasonable under such emergency circumstances?

The WHO panel suggests that evidence from nun-human primate experiments might be sufficient to justify offering a particular unregistered medical intervention for emergency access. Is that an ethically justifiable stance, given the high mortality rate and fast-acting nature of the infection?

Let me leave you with a final difficult question to ponder: Imagine you were running a medical NGO providing access to unregistered medical interventions to patients you care for in your emergency medical centre. By some fluke your unregistered medical intervention permits some of your patients to survive, but that survival comes at a high price, debilitating after-effects of the Ebola virus as well as of the unregistered medical intervention. Given concerns about your patients’ capacity to provide valid informed consent, should you accept responsibility for the patients’ future care and upkeep, given the lack of state infrastructure to assist these patients? If you accept responsibility for their care, say, by taking out an insurance package from some provider for them, you will expend a fair amount of donor monies on these patients (potentially for decades) that you cannot use to assist patients also facing life-threatening illnesses in other parts of the world. In other words, you face another ethical challenge, a resource allocation challenge. How should that medical NGO go about addressing this challenge?

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[1] U Schuklenk, C Lowry. 2009. Terminal illness and access to Phase 1 experimental agents, surgeries and devices: reviewing the ethical arguments. British Medical Bulletin 89: 7-22.

[2] U Schuklenk, C Hogan. 1996. Patient access to experimental drugs and AIDS clinical trial designs: ethical issues. Cambridge Quarterly of Health Care Ethics 5: 400-409.

[3] WHO. 2014. Ethical considerations for the use of unregistered interventions for Ebola virus disease.  WHO: Geneva 2014: p. 5.

Trudeau Curtails Harper's Anti-Choice Activist End-of-Life Panel Activities

This is brilliant. Former PM Stephen Harper appointed in the dying weeks of his government a smallish panel of anti-choice activists to advise his government on how to implement the Supreme Court of Canada's ruling on assisted dying. The CBC reports today that PM Trudeau's government has moved to curtail this panel's scope of activities. It doesn't want advice from the panel on possible legislation any longer, the federal government simply asks the panel members to summarise the results of its consultation. I'm pretty sure the results of this panel's activities will be filed away right after that. Game over for these anti-choice activists. Here is some more background information on two of them. Note that both of them were expert witnesses on behalf of the Harper government fighting the case against assisted dying in our courts. Their expertise sank without a trace when the Supreme Court decided unanimously that depriving us of access to assisted dying violates our Charter rights. Mind boggling the amount of tax monies that were wasted on their activities.

Finally out - my new bioethics textbook

After a year's worth of intensive sourcing of new content and a year's worth of intensive deliberations with Helga Kuhse and Peter Singer, the new edition of Bioethics - An Anthology is finally out. In case you care about bioethics, check it out. Amazon currently has the Kindle version on sale, but I understand that the print copy is arriving in warehouses as I write this.

Do we need a delay on the implementation of assisted dying in Canada?

There's movement on the assisted dying frontiers. Yesterday representatives of religious organisations held a press conference declaring that they are opposed to assisted dying and that we ought to strive to improve palliative care. As far as I can see they are not insisting any longer - democracy be damned - that assisted dying must not come to Canada, no matter what. The reason for this, presumably, has also to do with the fact that their own followers are in favor of the decriminalization of assisted dying. Other than that, they stated the obvious, it's a good idea to improve the state of palliative care in the country. It's not an either-or type situation, of course. We can have assisted dying and improved palliative care!

We also had a federal election that turfed out Stephen Harper and his merry band of evangelical government ministers. After the Supreme Court judgement declaring the bits of our criminal code that criminalize assisted dying unconstitutional - government was given 12 months to change relevant legislation - Mr Harper did nothing to implement the ruling. Eventually, in the dying days of his government, and seeing the writing on the wall for a return to power, he quickly installed fellow anti-choice activists as a federal panel to advise his government on the implementation of the Supreme Court ruling. His political calculus with regard to this panel might well be paying off. Its chairperson was yesterday on the CBC's Power and Politics and announced that he thinks his panel is still appointed to report to government, alas, the government that appointed him doesn't actually exist any longer by the time it plans to release its recommendations. Because it's also so very partisan in terms of its membership, it's unclear why anyone would want to take its views as anything other than the utterances of people who supported the Harper government's efforts during the Supreme Court hearings. They worked tirelessly to prevent Canadians from exercising their constitutional rights. Well, that's true for two of the three panelists.

Comes Justin Trudeau, our Prime Minister elect. He will ask the Supreme Court to give him another 6 months to implement the ruling. Initially I thought that that was not unreasonable, but then I wondered. The delay is supposedly needed for his government to decide on how to regulate the matter. The question is whether that is actually needed. The Supreme Court declared parts of the criminal code invalid. Health care is a provincial matter. The provinces and territories have established a task force aimed at advising them on how to implement the Supreme Court judgment. Quebec's legislation is already in place. Once the other provinces have put their legislation and regulations in place, there does not seem any need for federal regulations.

So, why wait?

Quixotian attack on Bioethics journals leads to retraction

I have blogged a few weeks ago on this website about a Quixotian attempt by a team of authors aimed at blaming leading mainstream subscription based bioethics journals for their alleged imperialist nature and what not else. A version of this blog entry has since been published here. I pointed out that the analysis of said article rested essentially on a questionable letter by the same team of authors that manipulated categories of the Human Development Index in order to generate a particular result plus false empirical claims about the availability of these journals through access schemes administered by the World Health Organisation.

I am pleased to report that the journal that published said article as a peer reviewed output has since retracted said content. There is no shame in retracting content found significantly wanting.

Discussion of 'Treatment resistant depression and assisted dying'

Readers of this blog might recall that Suzanne van de Vathorst and I published a paper in the Journal of medical ethics arguing for the desirability to make assisted dying available to competent treatment resistant depressed people. There has been a bunch of responses, namely this and this and this and this and this to which we responded here. Since then Frank Miller also offered a thoughtful commentary here to which we responded here.

Today a website dedicated to mental health issues has published a lengthy summary of the debate in the hope of triggering a discussion about our analysis and those of our critics.

Check it out when you have a minute, well worth reading.

Mustn't we talk in universities about whether trans women are women?

I have been watching for some time with ever-growing horror a movement of - let's be honest, mostly progressive - folks, aka my friends, that strives to limit what we can and cannot debate in university settings. It happens on various levels and is quite insidious. There's the thing about trigger warnings where we are supposed to warn our students each time they might encounter something in class that might deeply upset, disturb or even distress them. Well, I teach bioethics, there's a fair chance that that could happen in every class that I teach. My students are also all of mature age, so should I really aim my classes at not upsetting their emotional well-being or should I aim to challenge and potentially even upset them? It's a rhetorical question. I begin my classes by issuing a general trigger warning for the rest of the course, including every class without exception. Box ticked. Sorted. Would I change my content based on whether a student might be deeply disturbed by the topic, or a case scenario, or a video clip? Not a chance. What's the point of taking a bioethics class and not being challenged frequently to reconsider how you look at the issues we are considering in class. There is no way to run a class on, say, the ethics of animal experimentation, abortion, euthanasia, even cochlear implants, without upsetting someone.

I'm not a junior faculty member in a tenure track position, 'student led' teaching evaluations will neither make nor break me. I doubt junior colleagues would be able to afford doing the same.

Part of this ongoing campaign to keep universities conflict free, and to avoid 'offending' students are no-platform events. No-platform events are events where particular speakers are no platformed, meaning they are prevented from speaking on campuses. This is either achieved by student organisations declaring particular speakers persona non grata, or by university administrations preventing invited speakers from speaking due to 'security' concerns. This has been going on for some time, mostly in the UK, not so much in North America. Initially the objective was to keep neo-Nazi organisations off college campuses. No platform to the BNP or the KKK, that sort of thing. More recently though the victims were secularist speakers aiming to address Muslim fundamentalism on college campuses (including enforced seating arrangements for men and women attendees, enforced head covers, and other such medieval niceties) and there were invariably 'concerns' expressed and offense taken about their 'racism'. 'Racism' here is the preferred misnomer for critiques of a man made ideology.

The latest round of no-platform campaigning has hit feminist author Germaine Greer. She doesn't think that trans women are women. I do think one can have a legitimate debate about human-made categories such as 'man' and 'woman'. However, I also think it's pathetic that student activists think they ought to prevent such debates from occurring by declaring that people who were born 'male' could now define 'woman' in such a way that it includes some of them and that this should be binding on the rest of society. I understand the desire of trans women that society should see them in the same way as other women, as much as I understand that some feminists as well as other people will find that idea offensive. It's a great debate to have - we should teach classes on this subject.

Alas, trigger warnings will be considered necessary in many universities, student activists queer and otherwise will need to be placated and what not else. None of this is acceptable. If we cannot interrogate (there's that dreaded term) these sorts of concepts and categories in universities, where else should or could we do so? How would we even be able to determine whether our culturally evolved categories about ourselves are fit for purpose? And for what purpose?

What's troubling about this defense of free speech on college campuses is that there is a price to be paid for such open debate, and it is mostly to be paid by trans people, that is people who are subjected already to unacceptable forms of societal discrimination and disapprobation. They will find their claims analysed and critiqued, courtesy of the internets, in ways that will be vicious at the best of times. That is deeply troubling seeing that suicide rates among trans people are as sky-high as they are. And yet, while pleading for civility, I am convinced that a public airing of these issues is what is in the best interest of trans people themselves. It helped liberate gays and lesbians, we had to subject ourselves to debates about normality, and naturalness, whether we suffer from a mental illness, perversion, and what not else. Being able to debunk these falsehoods one by one worked for gays and lesbians. I'm afraid trans people and their allies will have to face these issues head-on, make their case with the best arguments and evidence available and win the argument in the public domain as well as in the academy.

No platforming speakers we disagree with is counter productive. The idea that these issues will go away by suppressing debate about them is naive at best.