Tag: adoption

Bioethics Blogs

Responsibility in the age of precision genomics

by Alexa Woodward

Alexa is a fellow in the Precision Medicine: Ethics, Policy, and Culture project through Columbia University’s Center for the Study of Social Difference. The following is her reflection on the ongoing discussion around the Precision Medicine Initiative that has been the subject of recent political, social, and popular media attention. A recent presentation by Sandra Soo-Jin Lee, PhD, from the Center for Biomedical Ethics at Stanford University spurred our multi-disciplinary discussion of some of the following themes.

What is normal, anyway?

Genetically speaking, that’s precisely the question that the Obama administration’s Precision Medicine Initiative (PMI) seeks to answer. In recruiting and collecting comprehensive genetic, medical, behavioral, and lifestyle data from one million Americans, the scientific and medical communities will be better able to understand what constitutes normal genetic variation within the population, and in turn, what amount of variation causes or contributes to disease or disease risk.[1] Using this data, researchers could potentially create tailored approaches for intervention and treatment of an incredible range of diseases.

The PMI has a secondary aim: to increase the representation of previously underrepresented populations in research – primarily African Americans and Hispanics/Latinos. Inclusion of these groups in research has been a challenge for decades, with lack of access, distrust in the medical and research systems, and institutionalized racism all playing exclusionary roles. More broadly, outside of the government initiative, the promise of precision medicine ultimately seeks to alleviate disparities by finding and addressing supposed genetic differences, and empowering people with information to take responsibility for their health.

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

Jeremy Howick, The Philosophy of Evidence-Based Medicine, Wiley-Blackwell, 2011

The idea that prescribing physicians should be guided by the most reliable scientific evidence seems obvious, but the actual methodology of evidence-based medicine was only introduced in the early 1990s by an international group of clinicians and researchers led by Gordon Guyatt. Since then it has provided a new paradigm for the scientific foundation of medicine and has influenced other disciplines outside of medicine, for example, evidence-based psychotherapy, science and government. The novel concept of evidence-based medicine is based on hierarchies of evidence from opinions of respected authorities, mechanistic reasoning (pathophysiologic rationale), and reports of expert committees at the bottom to various levels of observational studies and finally to randomized clinical trials (RCTs) at the apex of the pyramid. Since RCTs provide the most rigorous testing of therapies, they are the gold standard. When treatments long believed to be safe and effective are subjected to RCTs, many turn out to be as useless as the quackery of snake oil or as harmful as mercury. So, attention to RCTs as the evidence informing clinical judgment and practice is perhaps analogous to results of rigorous experiments in physics which turn out to be very different from our intuitions. Everyone, it seems, is on the bandwagon, from medical societies and pharmaceutical companies to general practitioners and surgeons, in the quest for an evidence-based practice.

Since evidence-based medicine was conceived with the practical aim of improving the efficacy of medicine, it does not appear that there is much of philosophical interest in the concept until one raises the epistemological question, as Jeremy Howick does in this book: What is the evidence for evidence-based medicine philosophy of evidence (9)?

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

Controlling Direct Access to Personal Health Information

By Sarah Duranske

In 1978, for the first time, an American woman could take a pregnancy test in the comfort of her own home. Critics claimed that home pregnancy tests only would be used by promiscuous or immoral women who were too ashamed to visit their doctors, but the appeal to women was undeniable. [1] Today, eight out of ten women learn they are pregnant from a home pregnancy test.[2]

In the 1980s, as the AIDS crisis swept the nation, the FDA banned the use of at-home AIDS tests over fears of poor test reliability and insufficient counseling.[3] Advocacy groups bolstered these fears by highlighting the suicide of a man who jumped off the Golden Gate Bridge after testing positive for HIV.[4]  But with improvements in testing technology and treatment options – and stymied by a stubbornly high infection rate – the FDA reversed its stance.  It encouraged home test kit applications in 1990 and approved two home collection kits in 1996.[5]  Within a year, more than 175,000 people purchased kits, and the expanded screening was not associated with any increase in the suicide rate.[6]

In 2013, the FDA shut down 23andMe’s health-related genetic tests due to concerns that users would act, or fail to act, to their detriment based on incorrect test results or unsupported clinical interpretations. In spite of experts’ concerns, 23andMe had genotyped around 400,000 individuals between its 2007 market entrance and the FDA’s 2013 action.[7] Studies consistently demonstrate (for better or worse) that people don’t change their behavior based on genetic tests that report on disease risk.

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

Nevada Amends Uniform Determination of Death Act

In a sign of things to come, Nevada has

Justice Pickering

amended the Uniform Determination of Death Act (UDDA).  Expect other states to make similar amendments soon.  On Friday, June 2, Governor Sandoval signed A.B. 424.  

The bill was a direct response to the problems identified by the Nevada Supreme Court in the Aden Hailu case.  I discussed that case here and posted case materials here.

The UDDA requires that clinicians determine brain death in accordance with guidelines set forth by either the American Academy of Neurology or the Pediatric Section of the Society of Critical Care Medicine. The statute identifies the guidelines by name: “Evidence-based Guideline Update: Determining Brain Death in Adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology” and “Guidelines for the Determination of Brain Death in Infants and Children: An Update of the 1987 Task Force Recommendations.” 

Furthermore, recognizing that the guidelines might be updated, the statute preserves flexibility. It requires that clinicians determine brain death in accordance with the “subsequent revisions approved” by the guidelines authors.

Explicitly referencing specific guidelines eliminates the need to determine whether these guidelines qualify as “accepted medical standards.” This has been a significant problem. Since adoption of the UDDA in the early 1980s, there has been significant variability in the brain death determination guidelines followed by hospitals across the United States.

At least in Nevada, that variability should be eliminated by the new statute. By unambiguously identifying which guidelines are authoritative, the statute eliminates uncertainty over which medical standards are “accepted.”

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

‘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 Blogs

The Ethics of In Vitro Gametogenesis

Françoise Baylis comments on the ethics of using gametes derived from human induced pluripotent stem cells for future human reproduction.

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A recent New York Times article, provocatively titled “Babies from Skin Cells? Prospect is Unsettling to Some Experts,” has once again drawn attention to controversial research by scientists at Kyushu University in Japan who succeeded in making fertile mouse pups using eggs created through in vitro gametogenesis (IVG). This is a reproductive technology that involves creating functional gametes (sperm and eggs) from induced pluripotent stem cells. Induced pluripotent stem cells are cells derived from adult body cells (such as skin cells) that have the ability to become other body cells including reproductive cells (sperm and eggs).

Supporters of this reproductive technology eagerly anticipate similar research in humans. Indeed, enthusiasts are quick to trumpet the potential benefits of in vitro gametogenesis. These benefits fall into three general categories.

First, we are told that research to derive human gametes from induced pluripotent stem cells is important for basic science. It will advance our understanding of gamete formation, human development, and genetic disease. In turn, this increased understanding will create new options for regenerative medicine.

Second, we are told that this research will allow clinicians to improve fertility services. For example, with in vitro fertilization (IVF), women typically have to undergo hormonal stimulation and egg retrieval. This can be onerous in terms of the time required for interviews, counseling, and medical procedures. It can also be harmful. Potential psychological harms include significant stress and its sequelae.

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

An IVF Keepsake?

As a father of two teenagers (and one who will join that esteemed company in a month), I am fluent in “sarcasm,” the native tongue of this group. Mine only use English sparingly, to do business. So, I often read headlines of stories in newspapers (remember those?) and online as sarcastic, and the articles they lead as spoofs. This one, in the “Parenting” section of an Australian web journal called “Kidspot,” immediately led me there. It speaks of a company that will take embryos from in vitro fertilization (IVF) that have not been implanted, and for which the biological parents have no plans of implanting, and turn them into keepsake jewelry. But this is no spoof.

The couple interviewed in the piece, having completed a 6-year journey through infertility and IVF, has a 4-year old son and twin toddlers. With seven remaining embryos, they had a decision to make. For them, “Donation wasn’t an option, the annual storage fee was an added financial strain, and disposing of them unimaginable.” Enter a company called “Baby Bee Hummingbirds,” who placed the embryos in a heart-shaped pendant.

My first impulse, not without some merit, was to find this all a rather ghastly business. Each of these embryos is a unique genetic human created in the image of God. I find myself critical of parents who don’t seem to have fully thought out the ramifications of fertilizing ten or more eggs. If these are genuinely human beings, then the creation (if that’s the right word) of “leftovers” is itself deeply problematic.

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

Ethical questions about mitochondrial replacement in humans. Three parents babies

We thus consider it necessary to establish a moratorium on their use in humans, at least until more is known about these aspects. If this knowledge is obtained, ethical questions would still remain to be resolved, among which we consider the most relevant to be those related to the dignity and identity of the human embryo.

Children with two mothers and a father

In January 2017, the prestigious scientific journal Bioethics published a special edition dedicated to the ethical aspects of nuclear transfer techniques aimed at preventing the transmission of mitochondrial diseases, a topic that we have extensively addressed in our Observatory (see HERE).

Its editorial, Ethics of mitochondrial replacement, starts by referring to the recent birth of the first baby resulting from these techniques (see HERE). It then provides a brief description of the main characteristics of mitochondrial diseases, which are inherited exclusively from the mother. It explains that mothers who carry mutations in their mitochondrial DNA (mtDNA) face the uncertainty of not knowing if their genetic children will or will not inherit a serious mitochondrial disease. However the emergence of mitochondrial replacement techniques (MRT) offers these mothers hope, as healthy mitochondria from a donor are used to replace those of the mother. These techniques are maternal spindle transfer (MST) and pronuclear transfer (PNT), which consist, respectively, in removing the nucleus from a healthy egg or zygote, which will keep its mitochondria. The nucleus of the mother’s oocyte (patient or carrier of the mutation) or of another zygote obtained by fertilising the mothers egg is then transferred into the enucleated oocyte or zygote.

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

An Assessment of Mitochondrial Replacement Therapy

By: Alexa Woodward

Last year, a baby boy was born from an embryo that underwent mitochondrial replacement therapy (MRT). MRT was used to prevent this child from inheriting a mitochondrial disease from his mother, specifically infantile subacute necrotizing encephalomyelopathy – a disease that affects the central nervous system and usually results in death within the first few years of life. While controversial, assisted reproductive technologies (ARTs) such as MRT provide prospective parents with additional options and have the potential to improve the quality of human life by preventing disease.

This story is of bioethical interest because this technique results in germline modification, which is the alteration of DNA in the reproductive cells of humans that will be passed on to their offspring. Implementing MRT in humans has consequentially garnered much criticism, from simple health-related implications (such as unknown harms to potential offspring and eugenics concerns) to the futuristic next logical step of scientific intervention; directly editing the nuclear genome.

With MRT, modifications affect the mitochondrial genome (mtDNA), not the nuclear genome. Researchers emphasize the lack of bearing that mtDNA has on personal characteristics and the overall maintenance of “genetic integrity,” especially when compared to using the whole donor egg with an “unrelated” nuclear genome.1 Even so, additional concerns arise regarding the long-term anthropological effects, blurring the distinction between therapy and enhancement, and issues of resource allocation.

Mutations and deletions  in the mitochondrial genome can result in mitochondrial diseases affecting the neurological, musculoskeletal, cardiac, gastrointestinal, renal, and other systems, all of which are incurable.  MRT uses the intended parents’ nuclear DNA in conjunction with a donor’s mitochondria.

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 the Journals–March 2017, Part II by Julia Kowalski

This is Part II of March’s article round-up. You can find part I here.

In addition to the articles below, Theory, Culture and Society features an interview with Michel Foucault from 1983.

New Genetics and Society

Everything and nothing: regulating embryo research in Canada

Alana Cattapan & Dave Snow

This article examines how medical and scientific professionals experience and engage with the governance of embryo research in Canada. Drawing on the history of embryo regulation in Canada and the findings of a survey conducted with lab directors in Canadian fertility clinics, we identify a disjuncture between the rules established by legislation, regulations, and research ethics guidelines and the real-life experiences of professionals in the field. This disjuncture, we argue, is the result of both the absence of implementation mechanisms that would give substance to the governing framework, as well as an inability on the part of medical and scientific professionals to engage in robust self-regulation. Overall, we demonstrate that in an ethically charged and highly technical area of policy-making like embryonic research, clarity about the roles and responsibilities of government and professionals in policy-making and implementation is critical to effective governance.

Not just about “the science”: science education and attitudes to genetically modified foods among women in Australia

Heather J. Bray & Rachel A. Ankeny

Previous studies investigating attitudes to genetically modified (GM) foods suggest a correlation between negative attitudes and low levels of science education, both of which are associated with women. In a qualitative focus group study of Australian women with diverse levels of education, we found attitudes to GM foods were part of a complex process of making “good” food decisions, which included other factors such as locally produced, fresh/natural, healthy and nutritious, and convenient.

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.