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Law Changes and Slippery Slopes

13 Apr, 17 | by Iain Brassington

Apparently, there was a TV programme in Australia the other day in which a there was a discussion of assisted dying.  It got reported in The Guardian, largely on the basis that an 81-year-old audience member kept calling Margaret Somerville “darling” and then got mildly sweary.  I’ve only seen those clips from the programme that are linked in the Graun‘s report, so I’m not going to comment on the tone of the debate in particular.  Rather, I’m interested in one of the responses to the programme, from Xavier Symons, writing in The Conversation.

Symons takes the opportunity to unpick the idea of a slippery slope argument – in this case, the claim that allowing some forms of assisted dying will commit us to allowing… well, that’s open-ended, but it’s sufficient to say that it’d be terrible.  We’d want to avoid terrible things; therefore, the argument goes, we shouldn’t allow any of it.  This is well-worn stuff in the seminar room, but it’s a mode of argument that refuses to die.  Quite correctly, Symons points out that

there is a need for empirical evidence or sound inferential reasoning to support the claim that event B will necessarily (or probably) follow on from event A.  Without this evidence, the argument is invalid. I can’t just claim, for example, that the legalisation of medicinal marijuana leads to the legalisation of ice – I need to show some empirical or logical connection between the two.

So far, so standard.  (I’d say “unsound” rather than “invalid”, because the validity of an argument doesn’t depend on its evidence – or, at least, not in the same way; but that’s a small matter.)  He then makes another move, which is a bit more interesting:

But (and it’s a big but) there is such a thing as a good and valid slippery slope argument.  A good slippery slope argument demonstrates a causal or probable relationship between event A and B, such that event B can legitimately be expected to occur if event A is allowed to occur. […] There are, nevertheless, compelling empirical and logical slippery slope arguments available to defend more modest claims about the “normalisation” of assisted dying.

Is this correct? more…

Individually-Randomized Controlled Trials of Vaccines Against the Next Outbreak

11 Apr, 17 | by miriamwood

Guest Post: Nir Eyal, Marc Lipsitch

Paper: Vaccine testing for emerging infections: the case for individual randomisation 

The humbling experience of international response to Ebola taught the world a thing or two on preparing for Zika and for other emerging infections.

Some of those lessons pertain to vaccine development against emerging infections. One lesson was that vigorous vaccine development should start long in advance of outbreaks. CEPI, the Coalition for Epidemic Preparedness Innovations, was recently launched with an initial investment of half a billion US dollars from the Gates Foundation, Britain’s Wellcome Trust and the governments of Japan, Norway and Germany. There is also growing recognition that best practices on vaccine testing should be developed prior to outbreaks, from a study methodology viewpoint.

By contrast, in Zika, ethical guidelines on response in general and on an aspect of vaccine testing were created only once the pandemic erupted. Shouldn’t ethical disputes, e.g. on trial design for vaccine candidates, be ironed out in advance of emerging infections?

One persistent ethical question in vaccine testing pertains to individually-randomized control in efficacy trials. At the height of the 2014-5 Ebola outbreak, individually-randomized controlled trials were much maligned. Our paper at the Journal of Medical Ethics sets out to defend that approach for vaccine efficacy testing in emerging infections, including highly fatal and untreatable ones in developing countries.

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The Deadly Business of an Unregulated Global Stem Cell Market

30 Mar, 17 | by miriamwood

Guest Post: The deadly business of an unregulated global stem cell industry

Tereza Hendl and Tamra Lysaght

In our paper, we report on the case of a 75-year old Australian woman who died in December 2013 from complications of an autologous stem cell procedure. This case was tragic and worth reporting to the medical ethics community because her death was entirely avoidable and the result of a pernicious global problem – doctors exploiting regulatory systems in order to sell unproven and unjustified stem cell interventions.

The patient at the centre of this case, Sheila Drysdale, underwent a liposuction procedure administered by cosmetic surgeon, Dr Ralph Bright, at his private Sydney clinic. Dr Bright did not perform this procedure for cosmetic reasons, but rather to ‘treat’ her advanced dementia with adipose (fat) derived stem cells. Mrs Drysdale died within ten hours of the surgery. Following an inquest into her death, the New South Wales Deputy Coroner stated that the utilisation of stem cells to ‘treat’ dementia was “highly questionable” and displayed “some of the hallmarks of ‘quack’ medicine,” particularly owing to the lack of scientific evidence supporting such ’therapy.’ The Coroner, thus, called for a more rigorous regulation of ‘innovative’ medical procedures in Australia that would protect vulnerable patients. Sadly, the relevant regulatory authorities have done very little to bring about any justice for Mrs Drysdale, or to address the systemic problems in Australia’s legislative framework that allows medical professionals to offer unproven stem cell-based interventions to patients without any accountability.

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Family Presence During Resuscitation: Extending Ethical Norms from Pediatrics to Adults

28 Mar, 17 | by miriamwood

Guest Post: Christine Vincent and Zohar Lederman

Paper: Family presence during resuscitation: extending ethical norms from paediatrics to adults

Family Presence During Resuscitation is an important ethical issue for discussion within the medical community. Currently, family presence is more commonly accepted in paediatric cardiopulmonary resuscitation (CPR) than adult CPR. However, we argue that this fact is not morally justified and that the case for family presence during adult CPR is indeed morally stronger. In our paper we provide an ethical argument for accepting both family presence during adult CPR and pediatric CPR.

Arguments commonly used by ethicists and medical professionals to justify family presence during resuscitation (FPDR) in the emergency room revolve around scarce evidence of harm to patient outcome, strong evidence demonstrating benefits to relatives, and respect for patient’s wishes. However, we argue that these three main reasons all seem to be stronger in the case of adult patients than pediatric ones.

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Treatment of Premature Ejaculation: Alleviating Sexual Dysfunction, Disease Mongering, or Both?

25 Mar, 17 | by bearp

by Brian D. Earp / (@briandavidearp)

An interesting new paper, “Distress, Disease, Desire: Perspectives on the Medicalization of Premature Ejaculation,” has just been published online at the Journal of Medical Ethics. According to the authors, Ylva Söderfeldt, Adam Droppe, and Tim Ohnhäuser, their aim is to “question the very concept of premature ejaculation and ask whether it in itself reproduces the same sexual norms that cause some to experience distress over ‘too quick’ ejaculations.” To prime the reader for their project, they begin with a familiar story:

a condition previously thought of as a variant within the normal range, as a personal shortcoming, or as a psychological issue is at a certain point cast as a medical problem. Diagnostic criteria and guidelines are (re-)formulated in ways that invent or widen the patient group and thus create or boost the market for the new drug. Those involved in developing the criteria and the treatment are sometimes the same persons and, furthermore, cultivate close connections to the pharmaceutical companies profiting from the development. Sufferers experience relief from personal guilt when they learn that their problem is a medical and treatable one, whereas critics call out the process as disease-mongering.

Something like this pattern has indeed played out time and time again – methylphenidate (Ritalin) for ADHD, sildenafil for erectile dysfunction, and more recently the development of flibanserin for “hypoactive sexual desire disorder” (see the excellent analysis by Antonie Meixel et al., “Hypoactive Sexual Desire Disorder: Inventing a Disease to Sell Low Libido” in a previous issue of JME). Having set up this narrative, Söderfeldt, Droppe, and Ohnhäuser turn their attention to the case at hand—the “medicalization” of premature ejaculation (PE).

The begin by noting that certain selective serotonin reuptake inhibitors (SSRIs), normally used to treat depression (itself the “medicalization of sadness” on some accounts), have been known since at least the 1990s to sometimes delay ejaculation as a “side-effect.” They then call attention to a 2004 application by Johnson & Johnson for FDA approval of dapoxetine for on-demand—as opposed to off-label—“treatment” of PE.

Rather than digging into debates over medical evidence concerning the efficacy of the drug, they jump right to a set normative questions touching on the medicalization of sexual experience and behavior. As they note, ethical discussions concerning the prescription of Ritalin and sildenafil (among other pharmaceutical innovations) centered on questions about what we see as “normal” behavior—and on how adding drugs to the mix might change those perceptions in ways that are potentially concerning.

But with few exceptions, according to Söderfeldt et al., the introduction of dapoxetine as a “treatment” for PE “has not yet elicited reactions of that sort.” They see this as surprising, because PE is to a large extent “a diagnosis that reflects cultural standards and is contingent on normative social behavior.”

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Conscientious Objection Accommodation in Healthcare – Clashing Perspectives

24 Mar, 17 | by bearp

by Brian D. Earp / (@briandavidearp)

On behalf of the Journal of Medical Ethics, I would like to draw your attention to the current issue, now available online, which is almost entirely dedicated to the vexing question of conscientious objection in healthcare. When, if ever, should a healthcare provider’s personal conviction about the wrongness of some intervention (be it abortion, euthanasia, or whatever) be accommodated?

In a paper that has already attracted much attention, Ricardo Smalling and Udo Schuklenk argue that medical professionals have no moral claim to conscientious objection accommodation in liberal democracies.

In part, they base their argument on their judgment that “the typical conscientious objector does not object to unreasonable, controversial professional services—involving torture, for instance—but to the provision of professional services that are both uncontroversially legal and that patients are entitled to receive” (emphasis added).

It seems clear that a lot hinges on what is meant by “unreasonable” there–and on who should get to decide what falls under that label. One answer to this question might be, “society should get to decide, through the enactment of laws, which ideally express the view of the majority of people as to what is reasonable or unreasonable in medical and other contexts.”

“Therefore,” this answer continues, “if a doctor thinks that some legally allowed service X is immoral, then she should rally her fellow citizens to lobby their representatives to change the relevant law; but she should not be excused from providing the service, if by law the patient is entitled to receive it.”

“And if she really doesn’t want to do X,” the answer concludes, “she can always leave the profession and take up some other line of work.”

This is a rough summary of what Smalling and Schuklenk do in fact say. I’d be curious to hear what people think. My hunch is that a person’s attitude toward the answer (i.e., whether they see it as good and convincing or not) will depend in large part on what they substitute for “X” in their minds when thinking about conscientious objection.

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Aid-in-Dying Laws and the Physician’s Duty to Inform

22 Mar, 17 | by miriamwood

Guest Post: Mara Buchbinder

Paper: Aid-in-dying laws and the physician’s duty to inform

Why do so many people assume that any clinical communication about aid-in-dying (AID, also known as assisted suicide), where it is legal, ought to be patient-initiated? Physician participants in my ongoing study tend to assume that physicians should wait for patients to initiate discussions of AID. The clinical ethics literature on communication about AID has reinforced this expectation by focusing on how to respond to patient requests. Consequently, bioethics has largely remained silent on whether there is a professional duty to inform terminally ill patients about AID laws and their clinical and legal requirements.

As a medical anthropologist, I pay attention to such gaps in professional discourse, as they often indicate ideas that are so taken for granted that they escape formal expression. In this case, bioethics’ silence on professional obligations to inform patients about AID suggests to me that initiating such a discussion is widely viewed as dangerous. But why? My recent article in the Journal of Medical Ethics began with this puzzling question.

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So, What is Not to Like about 3D Bioprinting?

21 Mar, 17 | by miriamwood

Guest Post: Gill Haddow & Niki Vermeulen

Paper: 3D bioprint me: a socioethical view of bioprinting human organs and tissues

Bioprinter developed by Alan Faulkner-Jones and Wenmiao Shu (Strathclyde University), picture made by Beverley Hood (Edinburgh College of Art) during a recent laboratory visit.

Bioprinter developed by Alan Faulkner-Jones & Wenmiao Shu (Strathclyde University).  Picture made by Beverley Hood (Edinburgh College of Art) during a recent laboratory visit.

Picture this: It is twenty years’ from now and , one of your organs has stopped functioning properly or even at all. You will not need to wait in the long line of the human organ transplant list however. Instead, you can have an organ ready made for you. Bespoke design and ready to use. Who would not want this as a future scenario? While 3D printing is working with inorganic materials, the intention of bioprinting is to work with organic materials (including living cells) to create structures approximating body parts. These new forms of printing, should they be fully realised, will, it is argued, have the same revolutionary and democratising effect as book printing in their applicability to regenerative medicine and industry. Individually designed biological structures or body parts will become as available as text in modern literate societies. Not only would it make organs widely available to those who need them, but 3D printing organs would also resolve entrenched ethical problems ranging from eliminating the market in human organs and avoiding recipient rejection to averting human or non-human animal organs. Therefore, long-term 3D bioprinting has the potential to be a ‘game-changer’, no longer necessitating the need for living or deceased human donation as human organs would be printed on demand.

However, the technology is not yet at the level required to bioprint entire organs. A realistic and short-term goal for 3D bioprinting is therefore to create alternatives to animal testing. For example, bioprinting can replace animals for drug testing through organ-on-a-chip devices. Moreover, this increases the speed of drug testing via the high throughput the technology enables. A mid-term gain relates to the creation of tissue components such as human heart valves. This is especially beneficial for younger members of the population (e.g. paediatric patients) who suffer specific problems with current bio-prosthetic or mechanical heart valve options. The required tissue components are not only created from the patient’s own cells (thus reducing the risk of rejection) but also the geometry (size and shape) of the components can be customised to match perfectly with the patient’s requirements. The valves can grow with the young person growing. Unlike mechanical implants, such engineered tissue components that are 3D bioprinted have the ability to grow with the patient, eliminating the need for further operations to replace components, which are no longer suitable. Along with avoiding questions around the subversion of  the species boundaries and ending the market in human organs, practically, socially, and ethically 3D bioprinting has a lot going for it. more…

Rationing of Antibiotics in the Critically Ill: Not if, but How?

16 Mar, 17 | by miriamwood

Guest Post: Simon Oczkowski
Paper: Antimicrobial stewardship programmes: bedside rationing by another name? 

The threat posed by antimicrobial resistant organisms (AROs) has long been recognized by the medical community as an emerging problem in public health. Though slow and insidious changes in the ability of bacteria, fungi, parasites, and viruses have real and profound effects on patients around the world, it is often dramatic examples of patients dying from infections resistant to all antibiotics which receive the most attention.

What is the solution to this problem? Given its complexity it is unlikely to be a single, simple intervention. The development of new antimicrobials could promises to have a major impact on reducing the mortality, morbidity, and cost of ARO infections, developing new antimicrobials takes time and significant financial resources. The development of AROs resistant to almost all known antimicrobials only a century from their initial widespread use suggests that this is a biological arms race that we can not win.

A systematic reduction in antimicrobial use can actually prevent the development of AROs. In simplistic terms: when bacteria, fungi, parasites, and viruses are exposed to antimicrobials, the individuals which are susceptible to the antimicrobial die, leaving behind those who have some resistance to the organism to live and multiply and to spread their resistant genes on to the next generation, or to other nearby organisms. In short— the use of antimicrobials, over time, will result in the development of AROs. So how can we fairly reduce the use of antimicrobials?

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Response to ‘A Matter of Life and Death: Controversy at the Interface Between Clinical and Legal Decision-Making in Prolonged Disorders of Consciousness’

3 Mar, 17 | by miriamwood

Guest Post: Julian Sheather, British Medical Association

Response to: A matter of life and death: controversy at the interface between clinical and legal decision-making in prolonged disorders of consciousness (also available as a blog summary)

The law has to work in generalities. The prohibitions it imposes and the liberties it describes are set for all of us, or for large classes of us. But we live – like we sicken and die – as individuals. Lynne Turner-Stokes gives a vivid account of an area of clinical practice where these truisms come into conflict. Practice Direction 9E (PD9E) doesn’t sound like much, a piece of dry-as-dust procedure for the Court of Protection, but it governs an area of keen moral concern: for our purposes, decisions relating to the withdrawing or withholding of clinically-assisted nutrition and hydration (CANH) from patients in a persistent vegetative state (PVS) or a minimally conscious state (MCS). According to PD9E, all such decisions should be bought before the Court of Protection.

On the face of it, given the seriousness of the decisions involved, court involvement looks like an important safeguard – these are, inevitably, life or death decisions on behalf of people who cannot determine their own interests. That its origins lie with Anthony Bland and one of the most important judgments in recent medico-legal history seems to confirm it. But there are some crucial distinctions. Anthony Bland was young. His brain damage was sudden onset – the result of asphyxiation. Unless CANH were withdrawn, he could live for many years. The lawfulness of withdrawing CANH in these circumstances was legally untested. The question before the courts was whether withdrawal could be distinguished from unlawful killing.

But disorders of consciousness are not solely the result of trauma in the otherwise healthy. As Lynne Turner-Stokes points out, many people can move into and through them as part of the ordinary process of dying. And the withdrawing – or withholding – of artificial nutrition and hydration can be a part of appropriate clinical management. And this is where PD9E can come under stress. As Turner-Stokes points out, states of disordered consciousness arise in clinical practice in many contexts, often unlinked to sudden-onset brain injury. If PD9E arose from the specifics of Bland, how do we distinguish between those cases that should go to court, and those that form part of ordinary clinical care?

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