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How to Keep HIV Cure-Related Trials Ethical: The Benefit/Risk Ratio Challenge

20 Feb, 17 | by bearp

Guest Post by Nir Eyal

Re: Special Issue of the Journal of Medical Ethics on the ethics and challenges of an HIV cure

For most patients with HIV who have access to antiretroviral treatment and use it properly, that treatment works well. But the holy grail of HIV research remains finding a cure. Sometimes that means a literal, sterilizing cure that would remove HIV from the body. But increasingly the aim is to find a mere functional cure that would send HIV into sustained remission during which antiretrovirals would be unnecessary.

Early successes in cure-related research, most notably the apparent cure of ‘Berlin patient’ Timothy Brown, prompted the International AIDS Society and the US National Institutes of Health to declare cure-related research a high priority. Recent successes in animal models have re-kindled hopes, and cure-related research is ongoing.

But there is a catch. Many of the early-phase cure-related studies that are currently planned or under way carry risks that are either very high or hard to quantify. These risks come from toxicity (e.g., of stem cell transplantation in an immunocompromised population), necessary interruptions to antiretroviral treatment (either short ‘pauses’ or intentionally longer breaks), or invasive physical exams. They affect study subjects and, sometimes, third parties like sexual partners or foetuses.

While high or unknown risks are a mainstay of early-phase trials in areas like cancer research, cure study participants typically have a safe and efficacious alternative to those risks: remaining on antiretrovirals. Can we justify asking patients who are doing well on antiretrovirals to accept the risk and uncertainty of many HIV cure-related trials? If we cannot, we might need to give up on the hope of curing HIV, or of achieving controlled remission.

These ethical questions about HIV cure-related trials were first raised by an activist, then asked again and again. They also arise in human subject research beyond HIV cure-related studies: what should we do when it is hard to keep a socially-important study beneficial in prospect to study participants? Are we ever permitted to compromise the individual’s objective interests in the pursuit of collective goals? What are legitimate ways of pre-empting this dilemma? The entire February 2017 issue of Journal of Medical Ethics is dedicated to clarifying and trying to answer these questions.

After an introduction, the journal issue provides a background by leading HIV-cure related researchers Dan Kuritzkes and Kenneth Freedberg and Paul Sax, as well as myself, a philosopher. Articles by legally-trained bioethicists Rebecca Dresser and Seema Shah and philosopher Caspar Hare suggest ways to quantify and mitigate risks to participants of cure-related studies. Contributions by philosopher Lara Buchak, bioethicist and lawyer Emily Largent, and AIDS activist David Evans assess how much the potential benefits to study participants, ranging from the remote hope of being cured through financial incentives to the satisfaction of having helped others, can legitimately offset any remaining risks. Legally-trained bioethicist George Annas and philosopher Danielle Bromwich explore how much participants’ fully informed consent can count as ample protection in cure-related studies, and when that consent counts as full. Philosophers Dan Wikler, Nick Evans (with first author public health expert Regina Brown), Rahul Kumar, and Frances Kamm assess when, if ever, the potential public health benefits of research—e.g., finding a cure for HIV—can warrant placing individual study participants at high net risk. An afterword asks how these investigations should affect future directions in research ethics.

Many contributions agree that myriad ways exist to justify studies that, at least on the face of it, run counter to the best medical interests of candidate participants. Furthermore, one need not be a utilitarian to argue as much. Even so-called contractualist ethicists such as Rahul Kumar can justify such studies, provocative though they may be for current culture in clinical study oversight. That culture, these articles suggest, is hard to defend from a wide spectrum of ethical theories.


NOTE: This post will be cross-published at BMJ Opinion.

Professional Codes and Diagnosis at a Distance

6 Feb, 17 | by Iain Brassington

This is the second part of my response to Trish Greenhalgh’s post on the propriety of medics, psychiatrists in particular, offering diagnoses of Donald Trump’s mental health.  In the last post, I concentrated on some of the problems associated with making such a diagnosis (or, on reflection, what might be better called a “quasi-diagnosis”).  In this, I’m going to concentrate on the professional regulation aspect.

Greenhalgh notes that, as a UK medic, she is bound by the GMC’s Duties of a Doctor guidance,

which – to my surprise – does not explicitly cover the question of a doctor’s duty towards a public figure who is not his or her patient.


My reading of the GMC guidance is that in extreme circumstances, even acknowledging the expectation of how doctors should normally behave, it may occasionally be justified to raise concerns about a public figure (for example, when the individual is relentlessly pursuing a course of action that places many lives at risk). Expressing clinical concern in such circumstances seems to involve a comparable ethical trade-off to the public interest disclosure advice (Duties of a Doctor paragraphs 53-56) that breach of patient confidentiality may be justified in order “to prevent a serious risk of harm to others.”

Well, to be honest, it’s not that much of a surprise to me that the GMC guidelines doesn’t stretch to public figures – but that’s a minor point.

The more interesting thing for me is what the relationship is between the practitioner and the GMC.  Greenhalgh ends her post by saying that she “wrote this blog to promote further debate on the topic and invite the GMC to clarify its position on it”.  But why should the GMC’s position be all that important?

OK: I’m going to go off on a bit of a tangent here.  Stick with me. more…

Should Doctors Perform “Minor” Forms of Female Genital Mutilation (FGM) as a Compromise to Respect Culture?

25 Feb, 16 | by bearp

by Brian D. Earp / (@briandavidearp), with a separate guest post by Robert Darby

A small surgical “nick” to a girl’s clitoris or other purportedly minimalist procedures on the vulvae of young women and girls should be legally permitted, argue two gynecologists this week in the Journal of Medical Ethics. Their proposal is offered as a “compromise” solution to the vexed issue of so-called female genital cutting or mutilation (FGM).

According to the authors, Kavita Shah Arora and Allan J. Jacobs, legally restricting even “minor” forms of non-therapeutic, non-consensual female genital cutting is “culturally insensitive and supremacist and discriminatory towards women.” Discriminatory, apparently, because non-therapeutic, non-consensual male genital cutting (a.k.a. male circumcision) is widely tolerated in Western societies; why shouldn’t women and girls be allowed to participate in — or be subjected to — analogous cultural rites that are important to members of their own groups?

I take issue with the authors’ proposal. In a commentary published in response to their piece (currently available “online first” along with two other commentaries: see here and here), I argue that to allow supposedly minimalist female genital cutting procedures before an age of consent in Western societies would result in numerous ethical, legal, political, regulatory, medical, and sexual problems, creating a fiasco. So problematic, in my view, is the proposal by Arora and Jacobs, that I have prepared a separate online supplementary appendix to expand upon my published commentary, in which I address each of their specific claims and arguments one by one: see here.

Rather than continuing to tolerate childhood male circumcision, and using this as a benchmark for allowing supposedly “minor” forms of FGM, I argue that we should instead be moving in the opposite direction. In other words, I suggest that the time has come to consider a less tolerant stance toward both procedures. As I write in my piece:

“Ultimately, I suggest that children of whatever sex or gender should be free from having healthy parts of their most intimate sexual organs either damaged or removed, before they can understand what is at stake in such an intervention and agree to it themselves.”

In the initial flurry of media coverage of the controversial new proposal by Arora and Jacobs, some commentators have attempted to drive a wedge between male and female forms of non-therapeutic genital alteration by referring to supposedly distinct symbolic meanings (FGM is “all about” controlling the sexuality of women, according to this view, whereas male circumcision is claimed not to be rooted in norms of sexual control), as well as health implications (FGM “has no health benefits,” it is claimed, whereas male circumcision does or at least may).

However, both of these claims are misleading at best, and at worst, downright false, as I (among other scholars who specialize in this area) have argued at length in other contexts: see also here, here, and here. For a short, reader-friendly introduction to the empirical and conceptual problems with these oft-repeated tropes, please see my essay in Aeon magazine, “Boys and Girls Alike.”

This is not the place to re-state my arguments. Instead, interested readers can explore the links above and reach their own conclusions. What I would like to do now is turn to an interesting new commentary on the proposal by Arora and Jacobs by Dr. Robert Darby, a medical historian and expert in male and female genital cutting rituals as they take place across a range of social contexts. His commentary is published below as a guest post on this blog. Please note that its contents should be taken to reflect the views of Dr. Darby, and not necessarily those of the Journal of Medical Ethics, its editors, or anyone else. 

Male and Female Genital Cutting: A Sex-Neutral Approach?

By Robert Darby, Ph.D.

Two contrasting views on female genital cutting (FGC) have been aired in recent weeks. Writing in the Journal of Medical Ethics, two American obstetricians, Kavita Arora and Allan Jacobs, argue that Western societies should tolerate – and doctors should perform – purportedly mild forms of non-therapeutic genital cutting on female infants and girls if the parents so request. In contrast, Ms. Meiwita Budiharsana, a lecturer in public health in Indonesia – where such forms of FGC are very common and increasingly medicalized – argues that the authorities should discourage such practices and that medical personnel should not perform them.

The situation seems rich in paradox. Two doctors from a society that has traditionally abhorred (and in fact criminalised) any form of FGC, believe that certain mild forms should be permitted. At the same time, a health expert from a society where certain mild forms of FGC are the norm believes that this is wrong and that such practices should be opposed.

What is going on here?

In this commentary I would like to focus primarily on the short opinion piece from Ms. Budiharsana. This is partly because Arora and Jacobs’s paper has already received both thoughtful peer commentary as well as heated discussion in the media (and is likely to receive much more); and partly because I think that the paper by Ms. Budiharsana in itself provides an interesting commentary on Arora and Jacobs’s controversial proposal.


Stay Classy, BMJ.

14 Feb, 16 | by Iain Brassington

Lord only knows, it pains me to jump to George Osborne’s defence – more so by resurrecting a meme that was already past it when I was first invited to run this blog in 2008 – but on this one occasion, I’m going to have to do it.

Last week, the BMJ reported about a case in which a psychiatrist was struck off the medical register for having entered into a sexual relationship with a vulnerable client.  That’s dodgy enough in its own right; but he also asked her at the beginning of the affair to promise not to report him to the GMC.  That shifts the whole case from being only (!) deeply dodgy to downright despicable – in effect, he’s admitted in that that there is cause to report him for his behaviour, but then gone ahead with that behaviour anyway.  The vulnerability of the woman with whom he was having the affair adds extra piquancy to the whole sorry tale.

I don’t think that there can be any objection to this sort of thing being reported, though it doesn’t get reported often.  I don’t know how often the GMC hears this kind of case, or whether every hearing attracts coverage.  Maybe cases like this get reported whenever they happen, but that they don’t happen all that often.  Or maybe they’re not infrequent, but the GMC has the consistent bad luck only to hand down its verdicts on days when there are bigger news stories to eclipse them.

Or maybe – and I have a suspicion that this is so – it’s the kind of case that is much more likely to get reported when the perpetrator happens to be the brother of the Chancellor of the Exchequer.  Call me a cynic, but that seems… tolerably likely.

Exhibit A on the evidence table: the opening sentence of the story in the BMJ.

Adam Osborne, the psychiatrist brother of the United Kingdom’s chancellor of the exchequer, George Osborne, has been struck off the UK medical register for “blatant disregard of the fundamental tenets of the medical profession.”

Quite what George has to do with the story, and why the link to him is worth drawing is beyond me.

Ha!  Just kidding.  It’s not beyond me at all.  It’s almost entirely to do with making the story enticing.  Adam’s behaviour is no better or worse by dint of his family connections; they do nothing except to add a detail to something that would otherwise be merely sordid.  And if you can offer a whiff of guilt-by-association by drawing a link between a creepy doctor and a prominent member of a government currently deeply unpopular among medics… well, so much the better, eh?

Now, the BMJ is not the only organisation to make this move: Adam Osborne has been in trouble before, and the BBC, for example, has never been reluctant to point out the family link.  Here’s the thing, though: I don’t think that the Beeb should be doing it either.  For sure, the BBC is at the very least a general-interest news provider, whereas the BMJ could, I think, be expected to concentrate on medicine and medics; yet even that partial mitigation of the BBC is so dismally weak that the only reason to articulate it is to provide a space to air doubts about whether it should have been articulated.

The BBC shouldn’t be doing it; no news organisation should be doing it; the BMJ shouldn’t be doing it.

The same principle applies to other people with embarrassing siblings, of course.  Yes, we know that climate-change “sceptic” Piers Corbyn is Jeremy’s brother.  Unless Jeremy’s policies on CO2 emissions are influenced by Piers, though, that’s neither here nor there; and in the event that Piers does something even dafter than predicting that another ice-age will begin in the middle of next week, there’d almost certainly be no justification for roping in his Jeremy.  The same rules apply.  But since that’s not a medical matter, I’m not going to moan about it here.

I just want to make it clear that I’m not holding a torch for George on this.  I may disagree with him about any number of things, but the conduct of his brother is one thing for which we shouldn’t throw brickbats at him.  Leave George alone.


24 Dec, 15 | by Iain Brassington

Here’s an intriguing letter from one John Doherty, published in the BMJ yesterday:

Medical titles may well reinforce a clinical hierarchy and inculcate deference in Florida, as Kennedy writes, but such constructs are culture bound.

When I worked in outback Australia the patients called me “Mate,” which is what I called them.

They still wanted me to be in charge.

Intriguing enough for me to go and have a look at what this Kennedy person had written.  It’s available here, and the headline goes like this:

The Title “Doctor” in an Anachronism that Disrespects Patients

Oooooo-kay.  A strong claim, and my hackles are immediately raised by the use of “disrespect” as a verb – or as a word at all.  (Don’t ask me why I detest that so; I don’t know.  It’s just one of those things that I will never be able to tolerate, a bit like quiche.)  But let’s see…  It’s not a long piece, but even so, I’ll settle for the edited highlights: more…

On the other hand…

20 Jul, 15 | by Iain Brassington

… the phenomenon of apologising for the wrong thing comes alongside people taking umbrage at the wrong thing.  Last week, the BMJ ran a head-to-head feature on the “question” of whether doctors should recommend homeopathy.  This was the latest in a series of articles in which a question is posed, apparently strictly on the understanding that it’ll accommodate a polarised debate, and one person is invited to give a “yea” response, and another to give “nay”.  I won’t bother here with a screed about homeopathy: Edzard Ernst does a good job in the BMJ piece, as have many others across the blogosphere.  (You could do worse, for example, than to have a wander through the Anomalous Distraction blog, which is written by an ex-schoolmate of mine, and which also has lots of pretty pictures of proteins and things.)  Since it’s a nice day, and I’m in a reasonably good mood, I’ll even admit that when Hahnemann was working, something like homeopathy was probably as good a punt as anything else that medicine had to offer.  But… y’know.

Aaaaaanyway…  A rather angry letter appeared.  I think it’s worth examining, because it makes a number of normative and value claims; and if norms and values aren’t the meat and veg of an ethicist’s life, then we might as well go home. more…

The Legal and Moral Significance of Implantation

23 Jun, 15 | by BMJ

Guest post by Sally Sheldon

We tend to talk about contraception and abortion as if they were two separate and readily distinguishable practices, the former preventing pregnancy and the latter ending it. This understanding has a very important effect in current British law, where a relatively permissive approach to the availability of contraception stands in stark contrast to the morally grounded, onerous criminal sanctions against abortion. Yet is the distinction between abortion and contraception really so clear cut?  How and why do we make it? And is the line that we have drawn between the two morally defensible?

As a matter of biological fact, the development of human life is not characterised by bright lines. As the eminent lawyer Glanville Williams once put it, “abstract human life does not ‘begin’; it just keeps going.” A seamless biological continuum exists through the production of sperm and egg, their joining together in a process of fertilisation, the gradual development of the new entity thus created throughout pregnancy, birth, subsequent growth, eventual death and ensuing decay of the body. Defining what happens along the way as an ‘embryo’, ‘fetus’, ‘person’, ‘adult’, or ‘corpse’ requires an attempt to draw lines on the basis of criteria selected as holding significance for legal or other purposes. How and where we draw such lines is a tricky business, involving careful moral reflection informed by medical fact.

The “regulatory cliff edge” between the relatively permissive regulation of contraception and the criminal prohibition of abortion relies on a line drawn on the basis of the biological event of implantation, where the fertilised egg physically attaches itself to the wall of the womb some six to twelve days after ovulation. Yet while enormous legal weight has been placed upon it, little consideration seems to have been given as to why implantation matters morally. The voluminous philosophical literature on the ethical status of the human embryo and foetus offers little support for the view that implantation is an important marker.

Further, while it might once have been suggested that implantation offers a conveniently timed moment for a necessary gear change between the appropriate regulation of contraception and abortion, this argument is difficult to sustain in the light of modern medical science. more…

Flogging and the Medic

3 Mar, 15 | by Iain Brassington

You must, by now, have heard of the Saudi Arabian blogger Raif Badawi.  Just in case you haven’t (really?), here’s a potted biography: having set up the secularist forum Free Saudi Liberals, he was arrested for insulting Islam and showing disobedience.  Among the formal charges he faced was one for apostasy, which carries the death penalty in Saudi.  The apostasy charge was dropped, but he was convicted on other charges and sentenced to seven years in prison and 600 lashes.  He appealed, and this sentence was changed: it became 1000 lashes and 10 years in prison.  Why?  Does it matter?  Because Saudi Arabia.  The latest update is that the apostasy charge may be renewed, so for a second time, he faces beheading.  Part of the evidence against him is that he “Liked” a post on a Facebook page for Arab Christians.  (Remember: Saudi is one of our allies against religious extremism.)

The lashes were to be administered in batches of 50, weekly, after Friday prayers.  As I write this, he has only been flogged once; doctors have attested that he is not well enough to be flogged again.  And – with thanks to Ophelia for the link – it’s  not hard to see why:

Dr Juliet Cohen, head of doctors at Freedom from Torture, explained: “When the cane strikes, the blood is forced from the tissues beneath… Damage to the small blood vessels and individual cells causes leakage of blood and tissue fluid into the skin and underlying tissue, increasing the tension in these areas.

“The more blows are inflicted on top of one another, the more chance of open wounds being caused. This is important because they are likely to be more painful and at risk of infection, which will cause further pain over a prolonged period as infection delays the wounds’ healing.”

There is also the long-term damage done to the victim’s mental health caused by flogging.

“Psychologically, flogging may cause feelings of fear, anxiety, humiliation and shame. Anticipation of the next scheduled flogging is likely to cause heightened emotions especially of fear, anxiety and difficulty sleeping… pain and fear together over a prolonged period have a deeply debilitating effect and recovery from such experiences may take considerable time,” said Cohen.

At the beginning of February, Vincent Iacopino had a post on the main BMJ blog in which he claimed that health professionals should play no part in Badawi’s flogging: more…

Athletic Sex

11 May, 14 | by Iain Brassington

There was an interesting article published in the BMJ a few days ago on the subject of athletes and their sex.  Here’s the opening gambit:

The International Olympic Committee (IOC) and international sports federations have recently introduced policies requiring medical investigation of women athletes known or suspected to have hyperandrogenism. Women who are found to have naturally high testosterone levels and tissue sensitivity are banned from competition unless they have surgical or pharmaceutical interventions to lower their testosterone levels.

The primary justification offered seems to be one of reducing unfair advantage, with a secondary justification that investigations of this sort might be to the medical advantage of the athletes themselves. Rebecca Jordan-Young and her colleagues aren’t impressed, and think that the policy is ethically suspect: not the least of their worries is that the policy effectively medicalises an unusual but benign characteristic of some people.  This could lead to medically useless surgery.  However, the potential problems are wider than that:

When pharmacological intervention or gonadectomy is a precondition for eligibility to compete, an athlete has to make a profound life and health altering decision for non-medical reasons. These are not merely individual decisions: athletes are embedded in families, teams, organisations, and even nations that depend on them to compete. Athletes can be “regarded as vulnerable to undue, even extreme situational pressures arising from the decision-making environment,” especially when a competitive career is also a path to economic mobility and stability.

I have to admit that I’m fairly relaxed about surgical interventions being undergone for non-medical reasons; more…

Rescuing the Duty to Rescue

1 May, 14 | by BMJ

Guest post by Tina Rulli and Joseph Millum

It is commonly thought that individuals have a moral duty to rescue others in peril. Bioethicists have leveraged this duty to rescue for a variety of purposes—including to criticize the use of placebo controls in trials in developing countries; to defend duties of researchers to return urgent incidental findings and provide ancillary care; to argue for a duty to become an organ donor; to defend allocating resources to develop drugs for rare diseases and to fund costly end of life care.

Despite their widespread use, there are serious problems with the two most cited duties to rescue: the individual duty of easy rescue and the institutional rule of rescue. The latter—the psychological tendency to support allocation of large amounts of money to rescuing identifiable victims at the opportunity cost of helping anonymous others—is indefensible.  (See Peter Singer’s opinion piece in the Washington Post criticizing donations to Make-a-Wish). The former can be defended, but has its own problems. One concerns its force: does it really apply only to very low-cost rescues? Consideration of physicians’ duties to warn suggests otherwise. Another problem concerns its scope: whom do I have to rescue? If it applies to everyone who needs rescue, even low-cost rescues may place enormous demands on individuals (cf Peter Singer’s famous essay: “Famine, Affluence, and Morality”).

We identify two further conceptions of the duty to rescue that have received less attention. An institutional duty of easy rescue would justify spending institutional dollars on rescue cases that are not too costly, while leaving room for institutions to fulfill lesser, but still important needs of others. A professional duty to rescue recognizes the more demanding duties certain medical professionals have. Both provide traction in answering some outstanding rescue dilemmas. We conclude our paper by proposing research priorities for bioethicists to help researchers and doctors sort through the obligations they have to people in need of medical rescue.

Read the full paper in the JME here.

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