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Randomised placebo-controlled trials of surgery: ethical analysis and guidelines

25 Oct, 16 | by miriamwood

Guest Post: Karolina Wartolowska

Paper [OPEN ACCESS]: Randomised placebo-controlled trials of surgery: ethical analysis and guidelines

Surgical placebo-controlled randomised controlled trials are, in many ways, like placebo-controlled drug trials. Like in case of drug trials, sometimes, a placebo-controlled design is necessary so that the results are valid and unbiased. Placebo control is usually necessary when a surgical trial has only subjective outcomes. This is often the case, because many surgeries are done to relieve pain and improve function. Validating the efficacy of a surgery in a well-designed trial helps to improve clinical practice. If the procedure is ineffective it should be discontinued and less risky treatment should be used instead. It also demonstrates the need for new effective interventions. But if the surgery is effective the resources should be allocated to the better intervention. If efficacy of intervention is never tested, many patients may be exposed to risks associated with a surgery but do not get any real benefits.  They also do not get other treatment, which may provide similar benefits without the risks and costs associated with surgery.

Surgical placebo-controlled randomised controlled trials may be undertaken in an ethical way. Firstly, there needs to be “equipoise”. In other words, there should be uncertainty, lack of strong evidence and lack of agreement among the clinicians whether the investigated surgery is effective or whether it is better than conservative treatment.  If there is equipoise, there is no true “best treatment” which can be recommended to the patient. Secondly, there should be some preliminary evidence that the surgery works (form animal studies, open-label trials). There is no point undertaking a surgical trial if it fails to show any improvement in the surgical arm. Thirdly, the risks associated with a surgical trial should not be disregarded. To be justified, such trials should have high scientific and clinical value and a potential to change clinical practice. Moreover, the risks of harm in both trial arms should be as small as possible. This is particularly important in the placebo/sham arm. The placebo mimics the active surgery but it also omits the surgical element which is the key part of the active surgery. So some procedures necessary in the surgical arm, for example anticoagulants or antibiotics, may be avoided in the placebo arm or can be replaced with a saline injection.  Ideally, the placebo/sham procedure should benefit the patients, for example as a diagnostic procedure. And last but not least, it is important that there is an uncertainty about the treatment allocation but there is no actual deception. Patients should understand which procedures are or are not performed and what are the associated risks in each trial arm.

Surgery is inherently risky but it is important to know whether it is also effective and worth taking these risks.

The End is Not What it Seems – Feasibility of Conducting Prospective Research in Critically Ill, Dying Patients.

14 Oct, 16 | by miriamwood

Guest Post by Amanda Van Beinum

Re: Feasibility of Conducting Prospective Observational Research on Critically Ill, Dying Patients in the Intensive Care Unit

Collecting information about how people die in the intensive care unit is important. Observations about what happens during the processes of withdrawal of life sustaining therapies (removal of breathing machines and drugs used to maintain blood pressure) can be used to improve the care of dying patients. This information can also be used to improve processes of organ donation. But when the Determination of Death Practices in Intensive Care Units (DDePICT) research group first proposed to start collecting prospective data on dying and recently dead patients, a common response from other clinical researchers was, “You’re going to do what?” The research community did not believe that prospective research using an informed consent model would be possible in patients dying after withdrawal of life sustaining therapies in the intensive care unit.

While the clinical research community supported the “big picture” idea behind conducting this research, they were skeptical about our prospective research design and our intent to obtain full informed consent from all families prior to the patient’s death. Some also felt that we would have a hard time obtaining institutional ethics board approval or would encounter barriers from research coordinators uncomfortable with approaching families for consent at a difficult and emotional time in the patient’s care. However, the DDePICt group was persistent, and succeeded in their efforts to design the first prospective, observational pilot study in Canada of patients dying in the intensive care unit after withdrawal of life sustaining therapies. As part of the study design, the DDePICt pilot study collected data for an ethics sub-study to investigate how these anticipated challenges were overcome. The ethics sub-study sought an answer to the question; can we conduct ethical, prospective, observational research on a critically ill and imminently dying population in the intensive care unit?


A Eulogy for the UK Donation Ethics Committee

13 Oct, 16 | by miriamwood

Guest Post by David Shaw

Re: The Untimely Death of the UK Donation Ethics Committee

Most people I know want to donate their organs after they die. Why wouldn’t they? If you have to die, you might as well do your best to save several other lives once you’re gone. But organ donation is a more ethically complex topic than many people realise. From Spring 2014 until April this year I was a member of the UK Donation Ethics Committee (UKDEC), which advised NHS Blood and Transplant and the various UK health departments on the ethics of organ donation and transplantation. The committee included doctors, lawyers, nurses, ethicists like me, and ‘lay’ members – ordinary members of the public. In my JME article, I discuss the committee’s work and why it came to an end.

UKDEC dealt with a wide variety of topics. We advised the Welsh Government on the ethical implications of a switch to ‘deemed consent’ to organ donation in Wales, undertook an analysis of the role of the family in donation, and engaged with ethnic minorities and religious groups to facilitate discourse about donation. Most of all, our work was important because we provided practical ethical guidance to healthcare professionals who were often unsure about the ethics and sometimes the legality of new developments in organ donation. Every year new technologies emerge that can enable donation where it was previously impossible, or which can improve the viability of donated organs. Sometimes doctors would approach UKDEC for our advice on their protocols that wished to make use of these new innovations. One of UKDEC’s final publications was a discussion paper concerning so-called “elective ventilation”, where a patient is placed onto on life support not because it will physically benefit him or her, but in order to facilitate organ donation.

But perhaps the most important contribution UKDEC made concerned organ donation after circulatory death (DCD). Nowadays, over 40% of UK donations involve DCD. But until around a decade ago, almost all organ donation in the UK took place after neurological determination of death – in other words, you had to be “brain-dead” before your organs could be donated and transplanted into recipients. In contrast, DCD involves organ donation after a patient’s heart has stopped beating. This might sound relatively straightforward, but in fact many doctors and nurses objected to DCD because of concerns about the potential reversibility of death, the burden on families and perceived conflicts of interest. Indeed, with the use of new technologies, heart donation after circulatory death is even possible, which might seem paradoxical.


Natal Nativism

12 Oct, 16 | by Iain Brassington

Scene: the boardroom of a large NHS Trust, somewhere in England.

“And so that brings us neatly to the last item on the agenda: passport checks for pregnant women who want a checkup.  The thing is, you see, that it turns out that we’ve been providing obstetric care to some women who aren’t actually UK citizens.  And, clearly, that has to stop.”
“To stop?”
“Well, maybe not stop.  But you know what I mean.  We can’t go providing treatment to anyone who comes knocking at the door!  Why, we’d have a queue from here to Timbuktu, not to mention the cost!”
“Oh, quite.  No, I quite agree that we can’t be the world’s supplier of healthcare.”
“No.  So that’s settled, then.  No more obstetric services to women who can’t demonstrate their eligibility.”
“You don’t look convinced.  What’s the problem?  These women aren’t eligible.”
“Well, no.  But… well, look.  Remember when Dr Smith retired, and when Dr Jones got that transfer to work in the Inner Hebrides?”
“All too well.  Two great losses to the Trust.  What’s your point?”
“Well, I seem to remember that we pooled together to buy them nice leaving presents.”
“We did.  It was the least we could do.”
“I agree.  But, you see, the thing is, they weren’t actually entitled to them.  If you see what I mean.”
“I’m not sure I follow.”
“No.  Well, you see, the thing is, we bought them those presents, and gave them to them, because it’s the decent thing to do.  There’s no rule that says that we have to buy them.  They wouldn’t have been wronged if we hadn’t.”
“Yeeeeeeessssss…  I mean, no.  But yes.”
“But we gave them the presents anyway.  Because the rules set out what’s minimially decent.  Not an upper limit.”
“Well, you see, I was just wondering: might the same apply in other contexts?  Allowing for the obvious differences, of course.”
“You’re losing me again.”
“I thought I might be.  Well, you see, it’s like this.  We’ve been providing treatment to pregnant women without paying attention to whether they’re entitled by the strict letter of the law.  And that law specifies who is entitled to treatment.  But that doesn’t necessarily impose any exclusions.  You see, I wonder if by getting bogged down in the rules, we might… um…”
“Might what?”
“Well, you see, the thing is…”
“Go on…”
“Look: we might end up looking like utter shits.”

Wholly fictional, this, of course.  No such conversation took place.  On the other hand, as reported by the Beeb, here’s a document from St George’s University NHS Trust.  Skip to p80: more…

Victims, Vectors and Villains? Are Those Who Opt Out of Vaccination Morally Responsible for the Deaths of Others?

11 Oct, 16 | by miriamwood

Guest Post by Euzebiusz Jamrozik, Toby Handfield, Michael J Selgelid

Re: Victims, vectors and villains: are those who opt out of vaccination morally responsible for the deaths of others?

Who is responsible for the harms caused by an outbreak for vaccine preventable disease?

Are those who opt out of vaccination and transmit disease responsible for the resultant harms to others?

Suppose that health care systems make vaccines widely available and easily affordable–but some choose not to be vaccinated, resulting in an outbreak. If the outbreak only affected those who could have been safely and effectively vaccinated, but nonetheless opted out, then we might say that those who become infected consented to the risks involved and are thus responsible for their own illness. What should we think, however, about scenarios where harm occurs to those who cannot be safely or effectively vaccinated – e.g. vulnerable groups such as infants and the immunosuppressed? These groups are often at the highest risk of severe harm, and depend upon herd immunity (resulting from high vaccination rates) to protect them from vaccine-preventable infections. Members of such groups bear the burden of others’ freedom to opt out of vaccination, and this can cost them their lives. In 2015, for example, an immunosuppressed woman died in the United States during a measles outbreak made possible by a lapse in local vaccination rates[1].

Our recent article in the Journal of Medical Ethics argues that imposing risks of infection on others without good justification is morally blameworthy–and that individuals who opt out of vaccination are thus morally responsible for resultant harms to others. In defence of this thesis we address numerous important questions, and our answers may have significant implications for public health policy.


Amoral Enhancement

10 Oct, 16 | by miriamwood

Guest Post by Saskia Verkiel

Re: Amoral Enhancement

A reply to Douglas’ reply to Harris’ reply to Douglas regarding the issue of freedom in cases of biomedical moral enhancement

Wouldn’t it be awesome if we could just swallow a pill and become better people?

With many aspects of life, growing numbers of people are embracing biomedical interventions to improve physical or cognitive performance and endurance, whether indicated for those purposes or not. Think doping in sports. Think Ritalin in college. Think beta blockers in stage performers. Think modafinil in pilots and surgeons who have to be alert for long stretches of time.

The funny thing is that when it comes to moral enhancement, we tend to think more in terms of its application to others, who are ‘obviously’ not such good people. Swindlers. Rapists. Basically all kinds of performers of crime.

Thomas Douglas was the first to write an analysis specifying when certain kinds of biomedical moral enhancement would be permissible, in 2008, and he realised that it’s important to make this distinction of whom we want the enhancement for. He focused on voluntarily enhancing the self. It’s a jolly nice read.

This paper triggered a cascade of replies.

To be fair, seeing the replies fly back and forth in this debate is not unlike watching a ballgame, albeit more enlightening (or so I think). Compare with Monty Python’s Philosophers’ Football. There’s team “Let’s put it in the drinking water!” (roughly: Oxford) and there’s team “Hold it, hold it…” (captained by John Harris and including yours truly).


Sex and Other Sins: Public Morality, Public Health, and Funding PrEP

8 Oct, 16 | by bearp

Guest Post by Nathan Emmerich

In the UK, a recent high-court decision[1] has reignited the debate about whether or not Pre-exposure Prophylaxis (PrEP) should be provided to those who are deemed to be at high-risk of contracting HIV.[2] Despite the fact that NHS England is now appealing,[3] it was a fairly innocuous decision: having suggested that they were barred from funding PrEP, the court ruled that it would be legal for the NHS to fund PrEP and that they should therefore consider doing so.3

What is less innocuous are debates about whether or not access to PrEP should be publicly funded at all. Whilst individuals report being able to buy a month’s supply online for around £45,[4] the annual cost of the drug to the NHS could be more than £4,000 per patient. Although this may seem a relatively exorbitant expense, it makes economic sense to provide PrEP; doing so could prove to be cheaper than providing treatment[5] to those who would otherwise become HIV positive.

Despite this sound economic rationale, the media, or certain sections of it, have predictably focused on one particular group who are candidates for the drug as they are at higher risk of contracting HIV: homosexuals. In particular, the debate has centred on promiscuous gay men or, to use the academic term, men who have sex with men. This includes individuals who regularly have sex with new partners, as well as those who engage in protected and unprotected group sex.

Perhaps as a result of this focus, the view that public funds should not be used for PrEP[6] seems fairly widespread. But while public acceptance has not yet been fully achieved, the Equality Act (2010)[7] means that it is illegal to discriminate against individuals on the basis of protected characteristics[8] such as sexual orientation.[9] We should, therefore, be concerned that arguments against funding PrEP might be motivated by some degree of homophobia.[10] If this charge is to be answered then we need to consider the arguments for and against the funding of PrEP in more detail.

There are, of course, plenty of other social groups that could benefit from PrEP, including some who are stigmatised, such as sex workers, and others who tend not to be, such as monogamous sero-discordant couples (i.e., a monogamous couple, one of whom is HIV positive and one of whom is not). However, reading the commentary on this issue would seem to indicate that the disinclination to fund PrEP is not applied equally. Thus, providing PrEP to hetero- or homo-sexual couples seems to attract support, but this is not extended to those whose sexual practices involve promiscuity.

As such, it would seem the opprobrium at work in this matter is primarily directed at non-monogamous ‘lifestyles’ and with sexuality playing a secondary role.


A World Without Bioethicists? On Sally Phillip’s “A World Without Down’s”

8 Oct, 16 | by bearp

Guest Post by Nathan Emmerich, Queen’s University Belfast

On Wednesday night, BBC2 broadcast a documentary entitled ‘A World Without Down’s Syndrome?’ Even if you did not see the programme itself, you may have heard about it on the radio, read some of the commentary published over the past week, or spotted it on Twitter under the hash tag #worldwithoutDown’s. In my case, it was the presenter Sally Phillips’s appearance on Frank Skinner’s On Demand, that first drew my attention to the programme. There, Phillips talks about Peter Singer’s appearance on HARDtalk (in which he discusses related issues) and – whilst she is hardly alone in doing so – I felt that she misunderstood what Singer has to say. As a result I intended to watch the documentary to see which bioethicists appeared and if their views were represented accurately.

Despite the programme consisting of Phillips speaking with various people involved with questions re: testing for Down’s Syndrome – including doctors, scientists, individuals with the syndrome and their parents, those who run support groups and one brave women who had terminated a pregnancy following a positive test for Down’s – she did not actually speak to a bioethicist or, indeed, explicitly discuss any bioethical ideas.* Thus, whilst one could think that this documentary was about a bioethical issue – prenatal testing and screening for Down’s Syndrome – there was not any real discussion of the matter from a bioethical perspective.


We’re all Gonna Die… Eventually

6 Oct, 16 | by Iain Brassington

It might just be a product of the turnover of people with whom I have much professional contact, but I’ve not heard as much about human enhancement in the past couple of years as I had in, say, 2010.  In particular, there seems to be less being said about radical life extension.  Remember Aubrey de Grey and his “seven deadly things“?  The idea there was that senescence was attributable to seven basic processes; those basic processes are all perfectly scrutable and comprehensible biological mechanisms.  Therefore, the argument went, if we just put the time and effort into finding a way to slow, halt, or reverse them, we could slow, halt, or reverse aging.  Bingo.  Preventing senescence would also ensure maximum robustness, so accidents and illnesses would be less likely to kill us.  To all intents and purposes, we’d be immortal.  Some enterprising people of an actuarial mindset even had a go at predicting how long an immortal life would be.  Eventually, you’ll be hit by a bus.  But you might have centuries of life to live before that.

Dead easy.

I was always a bit suspicious of that.  The idea that death provides meaning to life is utterly unconvincing; but the idea that more life is always a good thing is unconvincing, too.  What are you going to do with it?  In essence, it’s one thing to feel miffed that one isn’t going to have the time and ability to do all the things that one wants to do: life is a necessary criterion for any good.  But that doesn’t mean that more life is worth having in its own right.  Centuries spent staring at a blank wall isn’t made any better by dint of being alive.

But a letter published this week in Nature suggests that there is an upper end to human lifespan after all.  In essence, the demographic data seem to suggest that there’s an upper limit to survivability.  That being the case, we should stop worrying about making people live longer and longer, and concentrate on what’s going on during the 125 years or so that Dong, Milholland and Vijg think is allotted to us. more…

Further Clarity on Co-operation and Morality

4 Oct, 16 | by miriamwood

Guest Post by David S. Oderberg, University of Reading

Re: Further Clarity on Co-operation and Morality

The 2014 US Supreme Court decision in Burwell v. Hobby Lobby was a landmark case on freedom of religion and conscience in the USA. The so-called ‘contraceptive mandate’ of the Affordable Care Act (aka Obamacare) requires employers to provide health insurance cover for contraception used by their employees. The Green family (Evangelical Christian), owners of the Hobby Lobby chain of arts and crafts stores, challenged the mandate as they objected to providing cover for at least those methods of contraception that are abortifacient. They were joined by the Hahn family (Mennonite Christian), owners of a furniture company.

The case wound up at the Supreme Court, where the majority, led by Alito J, agreed with the plaintiffs. Under the Religious Freedom Restoration Act 1993, the plaintiffs were ‘substantially burdened’ in their exercise of religious freedom. They sincerely believed that by providing insurance cover that violated their religious and moral beliefs, they would be complicit in sinful behaviour. Violation of the RFRA, the court decided, meant the plaintiffs were entitled to an ‘accommodation’ or ‘opt-out’ of the contraceptive mandate.

The case is remarkable for a number of reasons. Conscientious objection is not new to the courts, particularly as regards service in war. Nor is Hobby Lobby unusual for recognising that a legal person such as a corporation can have its freedom of religion violated in virtue of what its owners/executives are required to do by law. After all, the contraceptive mandate already exempted churches and other purely religious bodies. In the present case, however, the plaintiff corporations were not religious in nature: it was their owners/executives who claimed a corporate exemption based on their personal religious and ethical beliefs. The judgment thus radically extends the potential scope for religious freedom litigation under RFRA, something that will occupy the courts for many years to come.


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