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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.


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…

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.

Bridging the Education-action Gap: A Near-peer Case-based Undergraduate Ethics Teaching Programme

6 Feb, 17 | by miriamwood

Guest Post: Dr Selena Knight and Dr Wing May Kong

Paper: Bridging the education-action gap – a near-peer case-based undergraduate ethics teaching programme

Medical ethics and law is a compulsory part of the UK undergraduate medical school curriculum. By the time they qualify, new junior doctors will have been exposed to ethics teaching in lectures and seminars, through assessments, and during clinical placements. However, does this really prepare them for the ethical minefield they will encounter as doctors?

Following my own graduation from medical school I started as a foundation year doctor in a busy London teaching hospital. Despite having had more exposure to ethics and law teaching than most by having completed an intercalated BSc in the subject, I found as a new doctor that I was often encountering ethical dilemmas on the wards but felt surprisingly ill-equipped to deal with them. I was generally able to identify that I was facing an ethical dilemma, but frequently found myself stuck when coming up with a practical solution.

If I felt like this having had an additional year of studying ethics and law, how on earth were other new doctors coping? In fact, when questioning my peers about their experiences they described that they also encountered dilemmas, but either didn’t specifically identify them as ethical in nature (e.g. they described feeling uncomfortable or uneasy with a decision made or a particular situation but couldn’t pinpoint why) and frequently described being unable to do anything to improve the situation either because they didn’t know what to do or they didn’t feel confident to speak up/rock the boat e.g. if they experienced a consultant acting unprofessionally

It became clear that even if ethics teaching at medical school was providing sufficient knowledge to enable junior doctors to identify ethical dilemmas, it was failing to prepare them to actually deal with such issues in practice. My own experiences, together with those I heard from my peers, formed the inspiration for the teaching programme that was subsequently designed.


The Importance of Disambiguating Questions about Consent and Refusal

2 Feb, 17 | by miriamwood

Guest Post: Rob Lawlor

Re: Cake or death? Ending confusions about asymmetries between consent and refusal

Imagine you have an adolescent patient who is in need of life saving treatment. You offer him the treatment, assuming that he would consent, but he refuses. As he is not yet a competent adult, you decide to treat him despite the fact that he wishes to refuse treatment.

Now consider the question: does it make sense to say that there is an asymmetry between consent and refusal?

If you are familiar with the term “asymmetry between consent and refusal”, the chances are that you will believe that you know what the question means and you are likely to have an opinion regarding the answer. And if you are like John Harris, you may also think that the answer is obvious and that any other answer would be “palpable nonsense”. However, if you are not familiar with the term or with the relevant literature, you may be far less confident that you even understand the question.

Despite their lack of familiarity with the question, I believe the latter group may have a better understanding of the issue than the first group. Why? Because these people are wondering, “What does this question mean?” My claim is that we would make more progress if more people took the time to ask this question. The phrase “the asymmetry between consent and refusal” allows us to capture the topic of a particular debate in a fairly succinct way, but I suggest that it obscures the ethical issues, rather than illuminating them.


A Matter of Life and Death

10 Jan, 17 | by bearp

Guest Post by Professor Lynn Turner-Stokes

Re: A matter of life and death – controversy at the interface between clinical and legal decision-making in prolonged disorders of consciousness

In an article published in the JME, I highlight the confusion that exists amongst many clinicians, lawyers and members of the public about decisions with withdraw life-sustaining treatments from patients in permanent vegetative and minimally conscious states.

Recent improvements in acute care for patient who have suffered catastrophic brain injury undoubtedly save lives. However, some patients who would otherwise have died now survive but remain profoundly disabled. Many patients experience a brief period of unconsciousness (or ‘coma’) lasting a few days or weeks. However, an unfortunate few with very severe brain injury remain in a vegetative and minimally conscious state (VS/MCS) for many months – or in some cases permanently.

Unfortunately the lay press, and even much of the medical literature, tends to conflate VS/MCS with coma, but they are in fact very different. Coma is a state of ‘unrousable unresponsiveness’ from which the patient cannot be awakened. It rarely persists for more than a few days or weeks, as the large majority of patients will either die or start to regain consciousness. Patients in VS or MCS are awake, but have either very limited awareness of themselves and their environment (MCS), or none at all (VS). With supportive treatment, many will live in these states for a decade or more.


Dissenting from an analysis of opt out forms

14 Nov, 16 | by miriamwood

Guest Post: Paraskevas Vezyridis

Article: Dissenting from An Analysis of Opt-out Forms

In our article, which is part of a wider project examining the technical, social and ethical challenges of big data in primary care, we simply wanted to explore how varied opt out forms can be when there is no standardised form available. We took as our case study opt out forms from; the highly controversial (scrapped in July 2016) programme of work by NHS England and the Health and Social Care Information Centre (HSCIC) to extract and link (in one central database) healthcare information from GP practices and other NHS and social care services for all sorts of administrative and research purposes. This was an important research question for us since wordings, available options and even design layouts could influence the decision of patients whether to allow the sharing of their GP record for the programme.

While it relies on the individual’s inertia (and often lack of awareness) an opt out is usually considered a more practical and valid approach to consent when compared to an opt in, particularly for low risk, population level studies where highly representative samples are required. For, two types of opt outs were possible: data would either not be extracted from GP records and/or shared outside of the HSCIC in any identifiable form. However, there was no standardised opt out form released, like with the Summary Care Records (SCR). GPs had to come up with their own forms to register patients’ dissent. We searched websites of GP practices to retrieve around 100 unique forms. We did not examine the information provided on GP practices’ websites. While there are around 8,000 GP practices in England, we believe that our sample was big enough to study any evident variability and make a point about the need to standardise these forms so that everyone, from GPs to patients, is on the same page.

What was striking for us was that, while the majority of these forms provided patients with the 2 types of objection, there were some forms that provided only one option (opt out from altogether). There was also variability in other information provided: who was responsible for this programme (HSCIC and NHS England), what was it about and it was important for the NHS and researchers, where patients could have found more information, how data was to be protected, who could had access to this data and whether the programme had any support, for example, by a healthcare professional association.


Randomised Placebo-Controlled Trials of Surgery: Ethical Analysis and Guidelines

25 Oct, 16 | by miriamwood

Guest Post by Karolina Wartolowska

Re: Randomised placebo-controlled trials of surgery: ethical analysis and guidelines [open access]

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

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

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

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