You don't need to be signed in to read BMJ Blogs, but you can register here to receive updates about other BMJ products and services via our Group site.

Adrenaline, Information Provision and the Benefits of a Non-Randomised Methodology

17 Aug, 14 | by Iain Brassington

Guest Post by Ruth Stirton and Lindsay Stirton, University of Sheffield

One of us – Ruth – was on Newsnight on Wednesday the 13th August talking about the PARAMEDIC2 trial.  The trial is a double blind, individually randomised, placebo controlled trial of adrenaline v. normal saline injections in cardiac arrest patients treated outside hospital.  In simpler terms, if a person were to have a cardiac arrest and was treated by paramedics, they would usually get an injection of adrenaline prior to shocks to start the heart.  If that same person was enrolled in this study they would still receive an injection but neither the person nor the paramedic giving the injection would know whether it was adrenaline or normal saline.  The research team is proposing to consent only the survivors for the collection of additional information after recovery from the cardiac arrest.  This study is responding to evidence coming from other jurisdictions that indicates that there might be some significant long term damage caused by adrenaline – specifically that adrenaline saves the heart at the expense of the brain.  It is seeking to challenge the accepted practice of giving adrenaline to cardiac arrest patients.

Our starting position is that we do not disagree with the research team.  These sorts of questions need to be asked and investigated.  The development of healthcare depends on building an evidence base for accepted interventions, and where that evidence base is not forthcoming from the research, the treatment protocols need changing.  This going to be tricky in the context of emergency healthcare, but that must not be a barrier to research.

There are two major ethical concerns that could bring this project to a grinding halt.  One is the opt-out consent arrangements, and the other is the choice of methodology.

Consent, then. more…

Advance Directives, Critical Interests, and Dementia Research

14 Aug, 14 | by BMJ

Guest post by Tom Buller, Illinois State University

In my paper, “Advance Directives, Critical Interests, and Dementia Research”, I investigate whether advance directives can be applied in the context of dementia research. Consider, for the sake of argument, the following fictional case. William, a 77-year-old man who has moderate to severe dementia. When he was first diagnosed and while still competent he declared on many occasions that he wished to do all he could to help future sufferers of the disease and find a cure for Alzheimer’s, and he repeatedly said that he very much wanted to participate in any clinical trials, even those that might involve hardship and risk. With the full agreement of his family William was enrolled in a five-year clinical trial testing a new treatment for Alzheimer’s that involves.

I think it can be legitimately argued that William has the right to make a future-binding decision to participate in the above trial, for the reasons that justify the use of a decision in the treatment context also apply in the present research context. First, William’s beneficent desire to help future sufferers of Alzheimer’s is part and parcel of his character and what gives his life value. Second, the principle of precedent autonomy is not invalidated by the fact the person is encouraging, rather than, refusing intervention, and that the chosen course of action requires the assistance of others. Third, William’s decision is not invalidated by the fact that it is motivated by beneficence rather than self-interest.

If this analysis is correct, then it would seem that there are good reasons to think that a competent person has the right to decide to participate in future research once competence has been lost, even research that is (significantly) greater than minimal risk.

 

Read the full paper online first here.

Paternalism up a Mountain

12 Aug, 14 | by Iain Brassington

“Paternalism” is one of those words that has a hell of a lot of power.  On several occasions, I’ve seen it used as a trump to shut down an argument: saying “But that’s paternalism” is, at least sometimes, treated as a way of showing that anyone arguing in favour of the allegedly paternalistic action is an imbecile, and has therefore lost the argument by default.  I suspect that this is due to a bastardisation of the (already iffy) “Georgetown Mantra”; but it does seem to be a position horribly common in medical schools.  It’s also very unsophisticated.  Whether or not something is paternalistic seems to me to be less important than whether it’s justified.  Something might be unjustified, and the reason for that might be because it’s paternalistic; but it doesn’t follow from that that no paternalism could be justified.  In just the same way, too much bleach or bleach in the wrong place is something you’d want to avoid; but it doesn’t follow that you should avoid bleach at all times and at all costs.

I want here to tell you a story based on something that happened just over a week ago. more…

On Conflicts of Interest

28 Jul, 14 | by Iain Brassington

It’s only a few days since Richie’s paper on providing IVF in the context of global warming was published, but already there’s been a couple of lines of objection to it that have been fairly widespread; I thought it might be worth nodding to one, and perhaps offering an attempt of a defence against the other.

The first objection is that there’s no justification for the claim about same-sex couples in Richie’s paper – that she shouldn’t have treated homosexuality as a lifestyle choice and as “non-biological” infertility.  I think that there’s significant merit to this objection to the paper; and though neither Dominic nor I mentioned the objection explicitly, I think that it’s there between the lines of each of our commentaries.  (It’s certainly an aspect of the paper that’s picked up by the Telegraph‘s coverage of the paper, and it’s been mentioned a couple of times on Twitter and Facebook by people I know and follow.  (I note that the Telegraph also gave a highly bastardised version of my post here.  Ho hum.))  I think that Richie’s argument would have been at least as strong if she’d talked about providing IVF to anyone whatsoever – the qualifications about different “sorts” of infertility and lifestyle, I suspect, weakened the paper, inasmuch as that a paper with unnecessary and argumentatively weak aspects is more vulnerable to objections generally than one in which those aspects have been left out.  So, yeah: I think that that might count as having been – at best – a strategic error on Richie’s part.

Here’s the other claim that I’ve seen a few times about the paper: that it’s weakened by a conflict of interest because of the author’s affiliation.  This isn’t directly a claim about the quality of the argument in the same way that the previous objection is.  Rather, it’s a claim that there’s something unreliable about the very fact of the argument’s having been put.  (I’m not articulating the distinction very well, but I think you can see what I mean.)  In essence, the worry is this: Richie works for a Jesuit Institution; this isn’t clear from her affiliation in the paper; there’s something iffy about this; this iffiness is some form of conflict of interest and her argument is likely to be biased.

I’m not sure what to make of this. more…

Gaia Doesn’t Care where your Baby Comes From

25 Jul, 14 | by Iain Brassington

Guest Post by Dominic Wilkinson, Associate Editor, Journal of Medical Ethics

In a provocative paper published today in the Journal of Medical Ethics, US theologian Cristina Richie argues that the carbon cost and environmental impact of population growth in the West should lead to restrictions on artificial reproduction.  She points to the substantial carbon emissions that result from birth in developed countries like North America.  Seven percent of the world’s population contribute fifty percent of the world’s CO2 emissions, and children born by in vitro fertilization are likely to be in this seven percent.  Richie argues in favour of a carbon cap on artificial reproduction and argues that IVF should not be funded for women who are “biologically fertile”.

Richie is correct to point to the enormous carbon cost of additional human population. One of the most significant ways that individuals in Western countries can reduce global carbon emissions is by having fewer children. However, her focus on artificial reproduction and on the “biologically fertile” is not justified.

Richie ignores questions about the moral implications of climate change and climate cost for natural reproduction.  She sets to one side “the larger realm of sexual ethics and procreation”.  Yet there are two reasons for thinking that this is a mistake.  First, as Richie notes, “Reproduction-related CO2 is primarily due to choices of those who have children naturally: a huge majority of all births.”  Only 2% of all children born in the UK are conceived by IVF.[1]  Therefore interventions to reduce the number of children naturally conceived will potentially have a fifty fold higher impact on carbon emissions.  Secondly, it is profoundly unjust to apply restrictions to reproduction only on those who are unable to conceive by natural means.  It could be justified to limit the reproductive choices of women because of concern for the environment.  However, if this were justified, it would be equally justified to try to limit the reproduction of the naturally fertile and the naturally infertile.  It is ad hoc and unfair to confine our attention to those who must reproduce artificially.

Second, Richie proposes that public funding for IVF be confined to those who are “biologically infertile”, excluding same sex couples and single women.  However, she provides no reason at all for restricting the availability of IVF for these women.  Put simply, the carbon cost of artificial reproduction is exactly the same for a woman who is infertile because of endometriosis or polycystic ovary syndrome or because she does not have a male partner.  The only possible reason for making a distinction between biologically infertile and biologically fertile women is because Richie believes that lesbian and single women are less deserving of public funding because of their lifestyle choices.  However, that argument, as problematic and contentious as it is, is completely independent of the question of environmental impact.  The carbon cost of children born to gay couples is likely to be exactly the same as the carbon cost of children born to women with endometriosis.

The carbon cost of additional births might well be sufficiently important for the state to justify limiting reproductive freedom.  However, if the state is going to interfere in couples’ decisions about whether to have children or the number of children that they have, it should do so fairly and equally.  Carbon caps should be applied equally to those who conceive naturally and those who require artificial reproductive treatment.  They should not be used as a way to discriminate against those who are single or gay, or have some other ‘undesirable’ characteristic.

 

[1] http://www.hfea.gov.uk/ivf-figures-2006.html#1284

ARTs in a Warming World

25 Jul, 14 | by Iain Brassington

There are some people who disagree, but we can take some things as read: there is such a thing as global climate change, it is at least substantially anthropogenic, and there are moral reasons to try to minimise it.

With that in mind, how should we think about reproductive technologies?  These are techniques whose intent is to create humans, and – presumably – those humans will have an environmental impact.  This is a question that Christina Richie confronts in her paper in the JME:

The use of ART to produce more human-consumers in a time of climate change needs to be addressed.  Policymakers should ask carbon-emitting countries to change their habits to align with conservation.  And though all areas of life – from transportation, to food, to planned technological obsolescence – must be analysed for ecological impact, the offerings of the medical industry, especially reproductive technologies, must be considered as well.

One of her suggestions is of carbon-capping for the fertility industry; she’s more reluctant to suggest a moratorium on the use of ARTs.  But she does suggest thinking quite seriously about who should get access to fertility treatment.  After all, she points out, fertility treatment is unlike other medical treatments in a number of ways.  Not the least of these is that someone whose life is saved by medicine will go on to have a carbon footprint bigger than it might have been – but that’s not the intention.  The whole point of fertility treatment is to create new humans, though – and therefore the treatment has not just a footprint, but a long-lasting carbon legacy.

I wonder, actually, whether the argument could be radicalised. more…

Post Birth Streisand effect?

18 Jul, 14 | by David Hunter

While I am wary on this blog talking about what we commonly refer to as “The paper that shall not be named” for fear of inciting yet more criticism, complaint and work for myself and Iain there is a certain amount of schadenfreude to be had at the impact three years on of the controversy that ignited on the blog regarding that paper about post-birth abortion.

Google Scholar has recently published its 2014 ranking of top journals and in the subcategory of bioethics the Journal of Medical Ethics is tops and at least one person (you know who you are…) has suggested this is because of the post-birth abortion paper.

The impact factor of the Journal of Medical Ethics is 1.4 which implies the average number of citations a paper in the JME is 1.4. The post birth abortion paper has received an astonishing 74 citations thus far. And while I am sure it would have received some citations organically I am also sure that the vast majority of those citations would not have happened without the controversy. This is the academic equivalent of the Streisand effect (the effect whereby trying to hide something makes it much much more well known and readily available).

At the very least there is a lesson here for those who want to shut down particular areas of academic debate, giving these issues oxygen and attention makes them more rather than less likely to succeed. I’m hoping that anyone bothered by this post takes that lesson on board…

Are FIGO’s Regulations Risking the Lives of Pregnant Women?

10 Jul, 14 | by Iain Brassington

Guest post by Douwe Verkuyl

The International Federation of Gynecology and Obstetrics (FIGO) Committee for the Ethical Aspects of Human Reproduction and Women’s Health believes that there is never an indication for a tubal occlusion (TO) to be performed at the time of caesarean section or following a vaginal delivery in cases where this sterilisation has not been discussed with the woman in an earlier phase of her pregnancy.  This applies even if there is a uterus rupture.

But what if a mother of 5 children, living in rural Africa near a Catholic clinic, unexpectedly needs referral to a government hospital because of arrested labour, and faces a journey of at least 4 hours over a dirt road?  Does the Committee’s recommendation against belated TO counselling still apply if referring establishments have deliberately ignored its advice to counsel pregnant women early in pregnancy about the option of a concurrent sterilisation in the event that a caesarean section is needed?  Catholic institutions – which are often the only health facility for miles around – not only ignore this advice, but also fail to assist a woman with “sinful” modern contraception after she has returned with a scarred uterus.  In many Western, developed countries, Catholic contraception doctrines are mostly inconvenient, guilt-provoking and expensive.  In rural Africa, Latin America and the Philippines, they often kill.

Imagine a 37-year-old woman in labour in a well-equipped and staffed Doctors Without Borders (DWB) emergency hospital which happened to be located near her home.  She has previously given birth, with some difficulty, six times at home, and now there is a full civil war.  The doctors detect foetal distress.  They think there might be a 10%-30% chance her child will be damaged or die before it is born.  On the other hand, with the uncertain political situation – consider that on 17 June a DWB hospital was bombed in Sudan – and poor infrastructure, it might be the case that her chance of dying from a uterine scar during a subsequent labour is around 30%, and the probability that she has continuous access to reliable reversible contraception for the next 13 years is zero.  If she would choose to have a TO with a caesarean section that would solve the quandary.  Is it really unethical to ask her, or unethical not to give her that choice?

Read the full paper in the latest edition of the JME here.

Legal Comment on Nicklinson, Lamb and AM Appeals

27 Jun, 14 | by Iain Brassington

Guest post by Alexandra Mullock, University of Manchester

The Supreme Court, in the long awaited verdict in the Nicklinson appeals, essentially delivered both good news and bad news for all concerned. The appeals by Jane Nicklinson (continuing her late husband’s battle), Paul Lamb and AM (known as Martin) were all rejected. The DPP won her appeal against the court of Appeal’s decision that a more specific prosecution policy was needed. However, the upshot of this highly unusual judgment is that the losers have good reason to feel quite cheerful and the DPP has won a rather hollow victory.

To recap on the facts, the late Tony Nicklinson, who suffered from locked-in syndrome following a catastrophic stroke several years ago, began his legal challenge in the High Court with an application for a declaration that it would be lawful for a doctor to give him a lethal injection or to assist him in terminating his own life by virtue of the common law defence of necessity. If that was not possible, Mr Nicklinson asked the court to declare that the current law (regarding murder and assisting in suicide under the Suicide Act 1961) was incompatible with Article 8 of the Convention. The High Court rejected all these arguments. Immediately following his defeat, Mr Nicklinson refused all food and medical treatment, dying a few days later. However, Mrs Nicklinson continued her late husband’s legal battle and she was joined in the Court of Appeal by another man, Paul Lamb, who applied for the same relief as Tony Nicklinson. A third man, Martin, wants a carer or health care professional to assist him to travel to Dignitas in Switzerland in order to have an assisted suicide, but, in view of the current prosecution policy – which places professional assistors at greater risk of prosecution – such a person would run the risk of a criminal prosecution. Consequently, Martin asked for an order to compel the DPP to clarify and modify her policy so that a compassionate carer, doctor or nurse could assist him. Martin’s claim also failed in the High Court but unlike the others, he won a partial victory in the Court of Appeal.

Following media reports that the Supreme Court Justices were at loggerheads over their verdict, the judgement reflects this conflict and is remarkable in a number of ways. more…

Nicklinson Loses Right-to-Die Case

25 Jun, 14 | by Iain Brassington

No surprises at the result, but the ruling itself looks like it might make for interesting reading.  Analysis to follow…

Latest from JME

Latest from JME

Blogs linking here

Blogs linking here