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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.”


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.


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.


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?


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?


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.

Harm: Could It Sometimes Be a Good Thing?

9 Feb, 17 | by miriamwood

Guest Post: Patrick Sullivan

Response: Hanna Pickard and Steve Pearce, Balancing costs and benefits: a clinical perspective does not support a harm minimization approach for self-injury outside of community settings

BBC news recently reported on the approval of plans for facilities to support self-injection rooms to allow drug users to inject safely under supervision in Glasgow. Needless to say the initiative is  controversial and as yet is  only approved in principle. The plan would involve addicts consuming their own drugs and in some cases being provided with medical-grade heroin. The move aims to address the problems caused by an estimated 500 or so users who inject on Glasgow’s streets. This initiative again brings into the public eye the issue of harm minimisation.

The concept of harm minimisation has been widely applied in a number of areas such as drug misuse where needle exchange programmes are the obvious example. The basic idea is that where we are unable to stop people engaging in dangerous activities we may sometimes have to settle for the fact that the best outcome possible is that the harm associated with the activity can be reduced. Many day-to-day activities are associated with harm reduction; seat belts on cars, motorcycle helmets, safety measures to reduce risks in extreme sports, advice on safe drinking levels. People will drive, ride motorbikes, engage in dangerous sporting activity and drink alcohol. If they do these things then it is important that they are done safely. Basically this is what harm minimisation is about.

A controversial application of these ideas has been in the area of self-injury. The fundamental idea is that people are allowed to harm themselves safely in the short term, whilst longer-term change is facilitated through access to psychological support. In my recent paper  ‘Should health care professionals be allowed to do harm? The case of self-injury’, I revisit the ethical issues associated with using harm minimisation to support people who self injure. This idea is controversial and counter intuitive given the health care professionals obligation to do no harm.  I challenge this perspective, suggesting that many clinical interventions do in fact involve harm. For example anyone who has experienced surgery or even dental treatment will acknowledge this fact quite readily.

Now it is important to be clear that I am not supporting the routine use of this approach in clinical practice. There is a place, in my view, for paternalism and the ethical case can be made in a number of scenarios. For example the prevention of suicide in people with a psychotic depression. Furthermore, I do not underestimate the risks associated with implementation in a mental health care inpatient setting. I do, however, believe it provides an alternative perspective that could be adopted with some people who self injure.


Balancing Costs and Benefits: A Clinical Perspective Does not Support a Harm Minimization Approach for Self-injury Outside of Community Settings

9 Feb, 17 | by miriamwood

Guest Post: Hanna Pickard and Steve Pearce

Responding to: Harm may sometimes be a good thing? Patrick Sullivan

Sullivan’s emphasis on the importance of supporting autonomy and independence among vulnerable people who self-injure is fundamental to good clinical practice. This is why some forms of harm minimization, such as encouraging reflection, responsibility, safe cutting and where appropriate self-aftercare, are uncontroversial and already widely practiced within community settings. The situation is different, however, with respect to both secure and non-secure inpatient settings. It is also different when we consider the other forms of harm minimization that Sullivan advocates, namely, the provision of self-harming instruments on wards alongside education about anatomy.

In secure (forensic) inpatient settings, it is neither practical nor ethical to provide implements that can be used as weapons to any patient, for any reason. This would be to severely compromise staff and patient safety.

In non-secure inpatient settings, patients are likely to be detained under the Mental Health Act. This raises the question of the grounds of detention. Typically, patients who self-injure are detained because they are judged to be currently at risk of life-endangering or life-changing injury. As Sullivan notes, it is not clinically or ethically appropriate to provide patients with the means to self-injure when they are in this state of mind. This means that the relevant inpatient population for which a harm minimization approach could even be considered is relatively small: those who have a standing pattern of self-injury and who are detained on non-secure units for reasons other than acute self-injury.

Sullivan suggests that the long-term benefits of facilitating self-injury for such patients may outweigh the costs. He notes that self-injury functions as a way of coping with psychological distress – which restrictions of liberty can heighten – and suggests that harm minimization may improve therapeutic relationships with staff and outcomes for patients over time. However, the potential benefits of a harm minimization approach to a particular patient must be weighed – in clinical and ethical decision-making in a non-secure inpatient setting – not only against the potential costs to that patient but also against the potential costs to staff and other patients. Consider these in reverse order.

With respect to costs to other patients, it is well-established that self-injury can be contagious. Patients who are admitted onto a ward without a history of self-injury may learn to self-injure if they see other patients doing it – this risk may be especially pronounced if self-injury is part of a therapeutic engagement with staff – and patients with a history of self-injury may learn new means. Specialist inpatient units, including one at which SP worked in the 1990s, which have employed a harm minimization approach in the past have had difficulties with patients adopting techniques from one another and self-injury escalating. Put bluntly, witnessing or even just hearing about self-injury increases the chance that people try it themselves. The impact on other patients of facilitated self-injury on wards needs to be factored into any assessment of costs and benefits.

With respect to the costs to staff, it is of course accepted that clinical work requires managing the psychological burden of treating challenging patients like those who self-injure. But facilitating self-injury through the provision of implements in non-secure inpatient settings would significantly increase this burden. Risk assessment is not an exact science and mistakes will occur – especially, perhaps, in the current NHS context where wards are both overpopulated and understaffed. If staff provide implements to people to self-injure in inpatient settings, they not only bear the psychological cost of knowing they have facilitated – and in that sense sanctioned – the process of self-injury. There will also be occasions where patients accidentally or deliberately kill themselves. Staff will then be in a position of having provided the means to this devastating outcome. Obviously by far the most important cost in such a situation is to patients. But the psychological burden of working with this risk – let alone dealing with its actual occurrence – and its potential impact on staff stress levels and burn-out will not be negligible, and again needs to be taken into account.

Finally, consider the potential costs to patients themselves. We do not deny that it is extremely difficult for patients who have a standing pattern of using self-injury as a way of coping with psychological distress to have it curtailed. No doubt, care would be improved by better awareness and attention to the impact this has on detained patients. But people self-injure not only to manage psychological distress. Self-injury is also a communication to others as well as linked to low self-esteem, negative core beliefs, and emotions like shame and self-hatred. It can both express and reinforce a person’s deeply held belief that they are bad, worthless, and deserving of punishment. This is part of its meaning. The impact of staff facilitating self-injury within a therapeutic relationship risks fuelling this mindset by implicitly sanctioning it. This risk might be mitigated in contexts where staff are highly trained and skilled in offering complex psychological interventions with vulnerable patients – as well as expertly supported and supervised – but, again, this is not a realistic expectation on today’s NHS wards.  Long-term self-injury is correlated with suicide. This is one reason why so much effort is made to address it across all mental health settings. Correlation is not causation, and we must acknowledge that mechanisms are as yet unknown, but it is natural to speculate that one reason is that self-injury maintains a negative self-concept –a known risk factor for suicide.

Indeed, even something as seemingly innocuous as education about anatomy carries risks that Sullivan does not acknowledge. In this respect, it is noteworthy that the medically trained population has higher suicide completion rates than the general population. Sullivan seems to presume that teaching someone about, for example, the important structures in the wrist, will enable them to cut with less risk. But we cannot assume knowledge is benign: rather than being used to self-injure more safely, it can, instead, be used to enable people to cut more dangerously and effectively.

The abstract principles of harm minimization are laudable, but from a clinical and practical ethical perspective, the devil is in the details. Apart from uncontroversial measures already practiced in community settings, we do not believe that – for self-injuring patients themselves, let alone when we factor in the potential impact on other patients and staff – the balance between costs and benefits tips in its favour.

Combating Doping in Sports: More of the Same or What?

7 Feb, 17 | by miriamwood

Guest Post: Bengt Kayser and Jan Tolleneer

Paper: Ethics of a relaxed antidoping rule accompanied by harm-reduction measures

Doping in sports continues to be prominently present in the media. Regularly ’scandals’ surface that then trigger flurries of articles, documentaries and reactions in the media. The general tone is one of moral opprobrium, dopers are considered deviant and bad. Frequently these episodes are accompanied by arguments for more means for repression of doping. These efforts, in principle coordinated by the World Anti Doping Agency (WADA), aim at eradicating doping from sports.

Doping is  considered cheating and dopers are bad. But despite increasing means doping remains rife, leading to what some call an arms race in a war on doping. Anti-doping still continues to cling to its essentialist objective, getting rid of this behaviour, even though it appears increasingly clear that this objective cannot be reached. Already today athletes have to comply with exceptional rules, such as the obligation to inform about their whereabouts 365 days a year in order to allow in and out of competition unannounced urine and blood sampling for anti-doping controls. But calls for more means and more repression resound. Increasingly countries, pressurized by the International Olympic Committee and WADA, introduce criminal law to repress doping, in several countries also applicable to non-athletes.

But repression of human behaviour comes with a cost. Prohibition of alcohol in the USA in the first part of the last century is good example, as is the so-called war on drugs. Like the latter, anti-doping also has unintended side-effects and it is possible that the overall societal cost of anti-doping may surpass the positive effects of anti-doping. The question then arises if there exist alternative approaches to dealing with doping. But so far the only two discourses on alternatives for dealing with doping focus on either repression or liberalisation.

In our recently published paper in the Journal of Medical Ethics we argue that there is an ethically acceptable alternative somewhere mid-stance. Our point of departure is a partial relaxation of the anti-doping rule, accompanied by harm reduction measures, in a dynamic setting, i.e. adaptable over time in reaction to what the effects would be. We develop our arguments on five levels: (1) What would it mean for the athlete (the self)? (2) How would it impact other athletes (the other)? (3) How would it affect the phenomenon of sport as a game and its fair play basis (the play)? (4) What would be the consequences for the spectator and the role of sports in society (the display)? and (5) What would it mean for what often is considered as essential to being human (humanity)? Our analysis suggests that a partial relaxation of the anti-doping rule accompanied by harm-reduction measures appears ethically defensible on all five levels. Our proposed alternative framework thus potentially provides an escape from the present spiralling towards criminalisation of doping and doping-like behaviour in society. It is time to start discussing the practical details of such a policy change and to start experimenting.

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