Tag: control groups

Bioethics News

Sex and gender. New findings, new controversy

‘Patients who had undergone sex reassignment surgery at his hospital, stated that the problems presented by patients before the surgery had not been resolved, at either human relationship, work or emotional level.’

Introduction

Sex and gender. Dr. Lawrence S. Mayer, an epidemiologist specialising in Psychiatry, and Dr. Paul R. McHugh, said to be the most important American psychiatrist of the last half century, have recently published a study entitled “Sexuality and Gender” in the journal The New Atlantis (see HERE), which offers an exhaustive review of more than five hundred scientific articles related with this matter. “I was alarmed to learn that the LGBT community bears a disproportionate rate of mental health problems compared to the population as a whole”, says Dr. Mayer, one of the authors of the article. 1

Background

In November 2014, Dr. McHugh had already published a report on the website First Things2, in which he explained his decision as head of the Psychiatry Department at John Hopkins hospital in Baltimore, US, to no longer propose any sex reassignment surgery, in view of the negative findings that he obtained after a retrospective examination of patients who had undergone the procedure.

In the current article, the authors looked at studies published in recent years, in an attempt to establish statistically significant, well-proven evidence. Compared to other related studies, which often offer contradictory results on the topic, this one is distinguished by the large amount of data from many different sources, which gives it special credibility, as well as the backing of its indisputably eminent authors.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Sex and gender. New findings, new controversy

pdf‘Patients who had undergone sex reassignment surgery at his hospital, stated that the problems presented by patients before the surgery had not been resolved, at either human relationship, work or emotional level.

Introduction

Sex and gender. Dr. Lawrence S. Mayer, an epidemiologist specialising in Psychiatry, and Dr. Paul R. McHugh, said to be the most important American psychiatrist of the last half century, have recently published a study entitled “Sexuality and Gender” in the journal The New Atlantis (see HERE), which offers an exhaustive review of more than five hundred scientific articles related with this matter. “I was alarmed to learn that the LGBT community bears a disproportionate rate of mental health problems compared to the population as a whole”, says Dr. Mayer, one of the authors of the article. 1

Background

In November 2014, Dr. McHugh had already published a report on the website First Things2, in which he explained his decision as head of the Psychiatry Department at John Hopkins hospital in Baltimore, US, to no longer propose any sex reassignment surgery, in view of the negative findings that he obtained after a retrospective examination of patients who had undergone the procedure.

In the current article, the authors looked at studies published in recent years, in an attempt to establish statistically significant, well-proven evidence. Compared to other related studies, which often offer contradictory results on the topic, this one is distinguished by the large amount of data from many different sources, which gives it special credibility, as well as the backing of its indisputably eminent authors.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Novel system to get dying patients an experimental cancer drug raises hopes — and thorny questions

The drug was still experimental, but clinical trials suggested it could be a lifesaver for patients with a lethal form of blood cancer called multiple myeloma.

And those patients were clamoring to get it. They overwhelmed drug maker Janssen Pharmaceuticals with requests for the medication.

Most companies don’t know how to handle such requests. Often, it’s the richest patients, or the best connected, or those who run the most compelling social media campaigns who end up getting the drug. Everyone else is out of luck.

Janssen’s parent company, Johnson & Johnson, decided on a unique approach: Rather than try to deal with the barrage of requests itself, it asked a leading bioethicist to create an independent committee to determine which desperate patients could get access to the limited supplies of its experimental drug, known as daratumumab.

A year and a half later, the company and patient advocates deem the process a success — and the bioethicist, Arthur Caplan, is looking to replicate it with other drugs, starting perhaps with a psychiatric therapy.

But the novel system has also raised some thorny questions.

One ethicist who strongly supports the concept in general nonetheless asks whether it is truly wise to eliminate all personal lobbying and decide who gets access to drugs based only on anonymous medical records. What if someone like scientist Stephen Hawking is in the mix, he asked: Shouldn’t he get priority access to a lifesaving drug, for the good of humanity?

“Imagine if he wasn’t saved, what a difference in the world there might have been,” said Dr.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

APHA Ethics Section Interview with Dr. Celia B. Fisher on Conversion Therapy Report

The following is an interview with the American Public Health Association’s Ethics Section with Fordham University Center for Ethics Education Director Dr. Celia B. Fisher who served as an advisor for a White House panel on conversion therapy.

In April of this year, President Barack Obama announced his support for state efforts to pass Leelah’s laws. Such laws seek to ban conversion therapy, a practice which claims to change individuals with LGBTQ identities to a heterosexual identity and is named for an American transgender girl who committed suicide after undergoing conversion therapy. Celia B. Fisher is the Marie Ward Doty University Chair in Ethics and Director of the Center for Ethics Education at Fordham University and an Ethics Section member. She served as an advisor for a White House report released last fall, Ending Conversion Therapy: Supporting and Affirming LGBTQ Youth.

She joins us this month for a Q & A, sharing her insights into one area of contemporary public health ethics in practice:

Q: What are the highlights Ethics Section members should know about the report Ending Conversion Therapy?

A: The report was commissioned by the Substance Abuse and Mental Health Services Administration (SAMHSA) with the assistance of the American Psychological Association (APA) under the auspices of White House interest. The goal of the SAMHSA-APA committee was to investigate the empirical case supporting, and not supporting, the use of conversion therapy. And so, a committee was brought together, the majority of members were researchers in the field of child development, pediatric physicians and mental health practitioners, or those who study gender identity formation.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Autonomous Killing Robots Should Be ‘Prohibited’, Experts Say

April 13, 2016

(Wired UK) – Humans should remain in control of robotic killing machines, the Red Cross and arms control groups have said. Experts discussing autonomous weapons argued that people should still be able to control weapons systems as they advance to levels where they can act independently. “Mandating meaningful human control of weapons would help protect human dignity in war, ensure compliance with international humanitarian and human rights law, and avoid creating an accountability gap for the unlawful acts of a weapon,” a report from Human Rights Watch and the Harvard Law School International Human Rights Clinic said.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Mitochondrial replacement techniques – US-style

This post first appeared in BioNews on 15 February 2016.

On 3 February the US National Academies of Sciences, Engineering, and Medicine published a report on the ethical, social and policy considerations relating to mitochondrial replacement techniques (MRTs – a somewhat misleading description but one the authors defend in the report). The report was written by a committee convened to advise the US Food and Drug Administration (FDA). This line of accountability may be significant.

The committee’s report reflects many of the conclusions of the Nuffield Council on Bioethics’ 2012 report Novel techniques for the prevention of mitochondrial DNA disorders: an ethical review and subsequently embodied in UK legislation and HFEA licensing guidance.¹ At its centre is the concern to minimise any risk to a child who may be born as a result of the procedure. It recommends, accordingly, that the safety and efficacy of the procedure should be established through preclinical research, and that it should be resorted to only in cases in which there is an undisputed risk of transmitting a severe mitochondrial disease. As in the UK, the report recommends that the treatments should only take place in specialist centres, that patients should be given appropriate information and support, and that there should be long term follow up of any children born. It is also welcome that the report takes the position that MRTs do not constitute a treatment for disease but an expansion of the reproductive options available to those who know themselves to be at risk of passing on a severe, inherited mitochondrial disorder.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Varieties of Tulpa Experiences: Sentient Imaginary Friends, Embodied Joint Attention, and Hypnotic Sociality in a Wired World by Samuel Veissière

“The intention to know”, from Annie Besant & C. W. Leadbeater (1901) Thought-Forms. London: The Theosophical Publishing House.

Introduction

This article presents a summary and discussion of key findings from ten months of experimental cyberethnography among tulpamancers.[i] Tulpas, a term reportedly borrowed from Tibetan Buddhism, are imaginary companions who are said to have achieved full sentience after being conjured through ‘thought-form’ meditative practice. Human ‘hosts’, or tulpamancers, mediate their practice through open-ended how-to guides and discussion forums on the Internet and experience their Tulpas as semi-permanent auditory and somatic hallucinations.

Studying Tulpas and their hosts is fascinating on many counts, not least because it provides an opportunity to observe an emerging culture and the mediation of new kinds of persons – in this case, that of multiple humanoid and non-human persons ‘hosted’ in single bodies and a large-scale sociocultural matrix of ‘healing’ generated without physical interaction between members. As an anthropologist who underwent retraining in cognitive science, however, I am less concerned with the seemingly ‘strange’ and ‘exotic’ aspects of Tulpamancy and am most interested in what the practice can reveal about fundamentally human mechanisms and processes. Thus, I seek to investigate (but in no pre-determined order) how neurocognitive, attentional, and narrative processes invariably shape all forms of sociality and experiences of personhood on the one hand, but also how social, political, and technological processes invariably shape mechanisms of attention, cognition, and perception. I gravitate toward sociocognitive, enactive models of hypnosis as ways of mediating sociality and personhood.

My investigation is grounded in the study of interactions between environment, cognition, and culture.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Nancy Cartwright on the Limits of RCTs

Guest Post by Bill Gardner @Bill_Gardner

Many researchers and physicians assert that randomized clinical trials (RCTs) are the “gold standard” for evidence about what works in medicine. But many others have pointed to both strengths and limitations in RCTs (see, for example, Austin Frakt’s comments on Angus Deaton here). Nancy Cartwright is a major philosopher of science. In this Lancet paper she provides insights into why RCTs are so highly valued and also why they are by themselves insufficient to answer the most important questions in medicine.

RCTs have been taken to be a gold standard because they are, according to Cartwright, “self-validating.” What this means is that an RCT can establish a causal connection between a treatment and an outcome more or less by virtue of the design.

all features causally relevant to the outcome other than the treatment (and its downstream effects) are distributed identically between treatment and control groups. If the outcome is more probable in the treatment than the control group,… the only explanation possible is that the treatment caused the outcome in some members of that group.

An RCT done right means that correlation between treatment and outcome does imply causation. In most sciences, you need strong theories to understand what the data mean and to justify your causal interpretation of an experiment’s results (see here). There are no control groups in astrophysics. In an RCT, the evidence for the causal effect of the treatment comes from the experimental design and doesn’t depend on your theory about what makes the treatment work.

Because RCTs stand on their own without a superstructure of theory, Cartwright says that RCTs provide “clinchers” to arguments.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

In Redesigned Room, Hospital Patients May Feel Better Already

[The New York Times]

 

PLAINSBORO, N.J. — Can good design help heal the sick?

The University Medical Center of Princeton realized several years ago that it had outgrown its old home and needed a new one. So the management decided to design a mock patient room.

Medical staff members and patients were surveyed. Nurses and doctors spent months moving Post-it notes around a model room set up in the old hospital. It was for just one patient, with a big foldout sofa for guests, a view outdoors, a novel drug dispensary and a bathroom positioned just so.

Equipment was installed, possible situations rehearsed. Then real patients were moved in from the surgical unit — hip and knee replacements, mostly — to compare old and new rooms. After months of testing, patients in the model room rated food and nursing care higher than patients in the old rooms did, although the meals and care were the same.

But the real eye-opener was this: Patients also asked for 30 percent less pain medication.

Reduced pain has a cascade effect, hastening recovery and rehabilitation, leading to shorter stays and diminishing not just costs but also the chances for accidents and infections. When the new $523 million, 636,000-square-foot hospital, on a leafy campus, opened here in 2012, the model room became real.

So far, ratings of patient satisfaction are in the 99th percentile, up from the 61st percentile before the move. Infection rates and the number of accidents have never been lower.

Often ignored by front-rank architects, left to corporate specialists who churn out too many heartless buildings, hospitals are a critical frontier for design.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Issues of Research Ethics in the Facebook ‘Mood Manipulation’ Study: The Importance of Multiple Perspectives (full text)

 

By: Michelle Broaddus, Ph.D.

A recent paper published in the Proceedings of the National Academy of Sciences describes a mood manipulation experiment conducted by Facebook scientists during one week in 2012 that suggests evidence of “emotional contagion,” or the spread of positive and negative affect between people. The backlash to this publication has been significant. As two examples, Slate.com published a piece entitled “Facebook’s Unethical Experiment: It intentionally manipulated users’ emotions without their knowledge” and The Atlantic’s piece, “Even the Editor of Facebook’s Mood Study Thought It Was Creepy.”

In the interest of full disclosure, I have a personal but not close acquaintance with the lead author of the study, through conferences, and of course, Facebook. I have not been in direct contact with the lead author since the publication of the study.

So, was it unethical? One of the pillars of ethically conducted research is balancing the risks to the individual participants against the potential benefits to society or scientific knowledge. So first, what were the benefits? What did we learn? Previous research (some of it using Facebook) has suggested an effect of emotional contagion, but these previous studies used observational data. In other words, there was no “manipulation.” Therefore, the researchers could not conclude a causal effect of emotional contagion, given the possibility of several other variables that could have contributed to the spreading of emotions. The only way to conclude the possibility of a causal effect of one person’s mood on another is to randomly assign participants to experience different stimuli, or “manipulate” their exposure to stimuli.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.