Tag: ethics

Bioethics Blogs

How to make Nazi doctors

Most people who go into medicine have as at least part of their motivation the desire to help other people. I’m sure this was as true in 1930’s Germany as anywhere else. So how did a cadre of Nazi doctors come not only to commit crimes against humanity, but also to defend the moral correctness of their conduct when placed on trial for those crimes? The answer is complex, but one way was through the teaching of medical ethics.

An article in the April 18th Annals of Internal Medicine tells a cautionary tale for teachers and learners of bioethics. Entitled “Lectures on Inhumanity: Teaching Medical Ethics in German Medical Schools Under Nazism,” the article details how the Nazi party developed a curriculum for teaching ethics in medical schools that “was intended to explicitly create a ‘new type of physician’ . . . trained to internalize and then implement the Nazi biomedical vision . . . shifting the focus of ethical concern and medical care away from the individual patient and toward the general welfare of society or the people.” The curriculum included lectures in racial hygiene, the science of heredity, population policy, military medicine, and the history of medicine. Only long-standing members of the Nazi party were appointed lecturers. The lecturer at Berlin University, Rudolf Ramm, wrote the ethics textbook used in the curriculum, which emphasized physician paternalism in practicing their moral obligation to rid society of certain groups, and asserted that every (Aryan) person in Germany had a moral duty to stay healthy.

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

Final Rule, three months later

It’s been three months since the announcement of the new Common Rule. Some reactions so far:

Shweder and Nisbett hope for vast deregulation

On March 12, Richard A. Shweder and Richard E. Nisbett published an essay in the Chronicle of Higher Education celebrating the new final rule:

in January the federal government opened the door for universities to deregulate vast portions of research in the social sciences, law, and the humanities. This long-sought and welcome reform of the regulations requiring administrative oversight of federally funded human-subject research on college campuses limits the scope of institutional review board, or IRB, management by exempting low-risk research with human subjects from the board’s review.

In particular, they wrote that “the overhauled policy … holds that exempted research activities should be excused from board review with no requirement of IRB approval of the exemption.”

[Richard A. Shweder and Richard E. Nisbett, “Long-Sought Research Deregulation Is Upon Us. Don’t Squander the MomentChronicle of Higher Education, March 12, 2017.

Meyer asks, what’s new?

On March 16, Michelle N. Meyer tweeted a GIF showing that several of the provisions cheered by Shweder and Nisbett have been part of the regulations for decades. Indeed, since 2009, OHRP has grudgingly acknowledged that the Common Rule allows researchers to make exemption determinations. The problem has been persuading universities to take advantage of these longstanding provisions.

On the other hand, Meyer notes that the liberation of oral history is new, and that the exemption for “benign behavioral interventions” is, in her terms, “new & awesome.”

(GIF re-posted here with Meyer’s permission.)

Comments posted to the Chronicle website made similar points.

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

Research Ethics Roundup: New England Journal of Medicine Editor Wants Changes in Research Culture, Why Lab Animals Aren’t Simply “Human Stand-Ins,” Proposal for National Research Integrity Board, and FDA Approves Drugs Faster than European Medicines Agency

This week’s Research Ethics Roundup examines the New England Journal of Medicine’s (NEJM) editor-in-chief’s call for a new approach to sharing clinical trial data, how experts are trying to improve drug testing success rates by reviewing pre-clinical research assumptions, a National Academies committee’s call for a nongovernmental body to promote research integrity, and a new study that rebuts critics’ claims that the Food and Drug Administration (FDA) is slow to approve new drugs for the American market.

The post Research Ethics Roundup: New England Journal of Medicine Editor Wants Changes in Research Culture, Why Lab Animals Aren’t Simply “Human Stand-Ins,” Proposal for National Research Integrity Board, and FDA Approves Drugs Faster than European Medicines Agency appeared first on Ampersand.

Source: Ampersand, the blog of PRIM&R.

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

Research Ethics Roundup: New England Journal of Medicine Editor Wants Changes in Research Culture, Why Lab Animals Aren’t Simply “Human Stand-Ins,” Proposal for National Research Integrity Board, and FDA Approves Drugs Faster than European Medicines Agency

This week’s Research Ethics Roundup examines the New England Journal of Medicine’s (NEJM) editor-in-chief’s call for a new approach to sharing clinical trial data, how experts are trying to improve drug testing success rates by reviewing pre-clinical research assumptions, a National Academies committee’s call for a nongovernmental body to promote research integrity, and a new study that rebuts critics’ claims that the Food and Drug Administration (FDA) is slow to approve new drugs for the American market.

The post Research Ethics Roundup: New England Journal of Medicine Editor Wants Changes in Research Culture, Why Lab Animals Aren’t Simply “Human Stand-Ins,” Proposal for National Research Integrity Board, and FDA Approves Drugs Faster than European Medicines Agency appeared first on Ampersand.

Source: Ampersand, the blog of PRIM&R.

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

Dueling BRCA Databases: What About the Patient?

The news release Monday morning grabbed my attention:

“Study finds wide gap in quality of BRCA1/2 variant
classification between Myriad Genetics and a common public database.”

Myriad Genetics had been exclusively providing tests, for
$3000+ a pop for full BRCA gene sequencing, for 17 years before the Supreme
Court invalidated key gene patents back in 2013. Since the ruling a dozen or so
competitors have been offering tests for much lower prices. Meanwhile, Myriad
has amassed a far deeper database than anyone else, having been in the business
so much longer. And it’s proprietary.

CLASSIFYING GENE VARIANTS

(NHGRI)

Public databases of variants of health-related genes have
been around for years too. The best known, ClinVar, collects and curates data
from the biomedical literature, expert panels, reports at meetings, testing
laboratories, and individual researchers, without access to Myriad’s database.
ClinVar uses several standard technical criteria to classify variants as
“pathogenic,” “benign,” or “of uncertain significance.” (“Likely pathogenic”
and “likely benign” were used more in the past.)

ClinVar lists 5400 variants just for BRCA1. The criteria
come from population statistics, how a particular mutation alters the encoded
protein, effects on the phenotype (symptoms), and other information.
Bioinformatics meets biochemistry to predict susceptibility. The BRCA1 protein
acts as a hub of sorts where many other proteins that control DNA repair
gather. DNA Science discussed the genes behind breast and ovarian cancers here.

As gene sequences accumulate in the databases and troops of
geneticists and genetic counselors annotate them, the proportion of pathogenic
and benign entries will increase as that of the unsettling “variants of
uncertain significance” — VUS — will decrease.

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

Dueling BRCA Databases: What About the Patient?

The news release Monday morning grabbed my attention:

“Study finds wide gap in quality of BRCA1/2 variant
classification between Myriad Genetics and a common public database.”

Myriad Genetics had been exclusively providing tests, for
$3000+ a pop for full BRCA gene sequencing, for 17 years before the Supreme
Court invalidated key gene patents back in 2013. Since the ruling a dozen or so
competitors have been offering tests for much lower prices. Meanwhile, Myriad
has amassed a far deeper database than anyone else, having been in the business
so much longer. And it’s proprietary.

CLASSIFYING GENE VARIANTS

(NHGRI)

Public databases of variants of health-related genes have
been around for years too. The best known, ClinVar, collects and curates data
from the biomedical literature, expert panels, reports at meetings, testing
laboratories, and individual researchers, without access to Myriad’s database.
ClinVar uses several standard technical criteria to classify variants as
“pathogenic,” “benign,” or “of uncertain significance.” (“Likely pathogenic”
and “likely benign” were used more in the past.)

ClinVar lists 5400 variants just for BRCA1. The criteria
come from population statistics, how a particular mutation alters the encoded
protein, effects on the phenotype (symptoms), and other information.
Bioinformatics meets biochemistry to predict susceptibility. The BRCA1 protein
acts as a hub of sorts where many other proteins that control DNA repair
gather. DNA Science discussed the genes behind breast and ovarian cancers here.

As gene sequences accumulate in the databases and troops of
geneticists and genetic counselors annotate them, the proportion of pathogenic
and benign entries will increase as that of the unsettling “variants of
uncertain significance” — VUS — will decrease.

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

Kathy Greenlee’s Reflections on Paths to Person-Centered Planning

Challenging Us to See the Whole Person at All Stages of Life

Kathy Greenlee, VP for Aging and Health Policy

The Center for Practical Bioethics hosted the Joan Berkeley symposium on Thursday, April 6. The title for the day was “Paths to Person-Centered Planning.” In planning the event, my objective was to focus on tools and techniques grounded in a disability policy perspective that could benefit healthcare professionals and bioethicists. The day brought articulate and engaged speakers, raised new questions, introduced different language, and ultimately affirmed the strength of a multi-disciplinary approach to supporting people and their families as they face serious illness and end of life. 

Four distinct concepts emerged:
1) the perspective of the person as patient,
2) similarities and differences between shared decision-making and supported decision-making, 
3) the balance between what is “important to” a person and “important for” a person, and
4) the need to see a patient within the context of their family, however defined.

Person-Centered Communication

The panelists who opened the day demonstrated the importance of listening to people and the first speaker stole the show. 
Cathy Enfield, member of Self-Advocates Becoming Empowered (SABE), is an articulate adult woman with a developmental disability. She uses an iPad for communication assistance. She gave a first-person account of having healthcare providers look past her and talk directly to her caregiver. 
To communicate, Cathy needs support. Yet, public policies ranging from transportation to healthcare create barriers and financial disincentives that require her to be accompanied by someone to assist. Cathy’s comments were so compelling one of the medical educators in the audience intends to make them required reading for his first-year medical students.

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

Mari Mikkola, The Wrongs of Injustice: Dehumanization and its Role in Feminist Philosophy, Oxford University Press, 2016

Mari Mikkola identifies three primary forms of social injustice—oppression, domination, and discrimination—and asks what makes them wrong. She argues that feminist philosophy has thus far focused heavily on gender as a lens or anchor through which to understand and respond to injustice. In Mikkola’s view, this orientation around gender (and what she terms “the gender controversy”) is limiting feminist philosophers’ theoretical engagement with the roots of injustice. To remedy this problem, she builds a case for moving toward a more broadly humanist conception of injustice. The humanist feminism that she puts forth centers dehumanization as a way to theorize injustice; dehumanization, for Mikkola, is the very foundation of injustice.

Following an introductory chapter that frames Mikkola’s approach and argument, the book is divided into two parts. The first part of the book is dedicated to articulating Mikkola’s argument for moving beyond the “gender controversy” in feminist philosophy. She explains that the perspectives debated in the gender controversy produce two kinds of puzzles: one semantic, the other ontological. The semantic puzzle asks: “Given that ordinary language users tend not to distinguish sex and gender (treating ‘woman’ largely as a sex term, or a mixture of social and biological features), what precisely are feminists talking about when they talk about ‘women’? What are the necessary and sufficient conditions that the concept woman encodes, if any such conditions exist to begin with?” (28). The ontological puzzle, by contrast, is concerned with: “How should we understand the category of women that is meant to undergird feminist political solidarity, if there are no necessary and sufficient conceptual conditions underlying our gender talk?

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

Would You Want to be a Savant?

By John Banja
John Banja, PhD is a medical ethicist at Emory University’s Center for Ethics, a professor in the Department of Rehabilitation Medicine, and the editor of AJOB Neuroscience.
Darold Treffert (2010), a psychiatrist who has devoted the better part of his career to studying savants, notes that there are at least 3 kinds.
First, those who manifest the “savant syndrome” and display the most astonishing of savant abilities, such as Kim Peek who was the inspiration for Dustin Hoffman’s character, Raymond Babbitt, in the movie Rain Man. Peek, who died from a heart attack in 2009, was remarkable even by savant standards: He memorized more than 12,000 books and was able to read two pages simultaneously, one page with the right eye, the other page with the left. He also had a remarkably hospitable form of dyslexia where he could read words on a page turned sideways or upside down or backwards—such as reflected in a mirror. He could add a column of numbers from a telephone book page and instantly tell you the mean of those numbers, and he could do lightning calendar calculations like telling you which day of the week you were born upon knowing your birth date (Treffert, 2010, pp. 120-129). These were only a few of his talents. 

I might also mention Daniel Tammet who, on March 14th, 2004 on “International Pi Day”—get it?: 3.14—recited from memory Pi to 22,514 decimal places (p. 161). Or George Widener who can tell you what day of the week June 25th will be in the year 47,253 (p.

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.