Tag: standards

Bioethics Blogs

Harvey and Irma: Bioethics in Natural Disasters

by Craig Klugman, Ph.D.

This is a time of disaster. Last week Hurricane Harvey devastated Southeast Texas, a place where I did my doctoral studies. This week we are awaiting Hurricane Irma, the strongest hurricane to head toward South Florida in 25 years. My family lays in the path of that coming storm. I first became interested in natural disaster in 1989 when my college campus was jolted by a 7.1 earthquake in Northern California.

Bioethics has a role in responding to and preparing for these natural disasters. Most every state, large city and county, and most hospitals have been working on crisis standards of care plans. In 2009 and again in 2012, the Institute of Medicine recommended governments to undertake such planning. Many of us working in bioethics have been involved in these efforts. More specifically, we have been involved with developing ethical frameworks for decision-making, policy-making, and operations during emergency planning.

I worked with Texas during its planning for pandemic flu and for the last 3 years have been part of the ethics subcommittee of Illinois’ workgroup, most recently as chair. Similar groups have produced excellent reports in many places such as Delaware, North Carolina, Michigan, Minnesota, Tennessee, Texas and Toronto. They offer guidance and justification for a varied set of guiding principles and ethical frameworks. All of them hold certain core ideals in common.

First, all of the reports agree that transparency and open communication is essential. Planning needs to involve not only government officials, but also community members.

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

Jahi McMath Case Now Headed to a Jury Trial on Whether She Is Now Alive

Alan Shewmon  allowed to testify

Earlier this year, the medical defendants in Jahi McMath’s medical malpractice lawsuit filed a motion
to dismiss her claims. They argued that McMath lacks standing to sue for
personal injuries because she was pronounced dead in December 2013.

Yesterday, the Alameda County Superior Court denied those motions for
summary adjudication. “[T]hough Defendants have shown that the
determination of brain death in December 2013 was made in accordance with
accepted medical standards . . . a triable issue of fact exists as to whether
McMath currently satisfies the statutory definition of ‘dead’ under the Uniform
Determination of Death Act.”

“[D]espite the fact that Dr. Shewmon has not performed a formal determination of brain death as addressed in the Guidelines, Defendants have not cited authority that his opinions are of no weight or admissibility in addressing the changed circumstances alleged in the First Cause of Action.”

“[W]hile the Guidelines are generally accepted medically, there is some discrepancy between what the Guidelines diagnose and what the statutory definition of death specifies . . .  In re Guardianship of Hailu (Nev. 2015) . . .”

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

We Can and Must Rebuild the Bridges of Interdisciplinary Bioethics

by Darryl R. J. Macer

This editorial is made available on bioethics.net. The editorial along with the target article and open peer commentary is available via tandfonline.com

Although we can argue that bioethics is holistic and found in every culture, and still alive among people of many indigenous communities as well as the postmodern ones, the academic discipline of bioethics as interpreted by many scholars has attempted to burn bridges to both different views and to persons with different life trajectories and training. The bridges between different cultural and epistemological foundations of bioethics have also been strained by the dominance of Western paradigms of principlism and the emergence of an academic profession of medical bioethics.

This editorial reacts to the points made in the article by Lee, “A Bridge Back to the Future: Public Health Ethics, Bioethics, and Environmental Ethics.” This issue of the American Journal of Bioethics (AJOB) includes a number of commentaries on this theme, and challenges readers to reconsider the manner in which they conceive of bioethics, as well as the range of literature and scholars that they consider to as legitimate sources of wisdom. Such a new approach will not only breathe fresh light into the important work of all scholars, students, and teachers, but also offer some fresh references for contemporary policy changes that face us. Let us approach these issues like an ostrich who is taking her head out of the sand after some years of monodisciplinary focus. To be clear, Lee and some others writing here have apparently not had their head in the sand, as the interrelatedness of health and the environment is clear through the examples shared.

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

Guest Post: Track Authorities Are Wrong To Ban Women With Naturally High Testosterone levels

Michael S. Dauber, MA

 According to a story by Catherine Caruso published in STAT News this week, authorities at the International Association of Athletics Federations (IAAF) are getting set to debate whether or not women with hyperandrogenism, or higher-than-expected testosterone levels, should be restricted from competing against women with “normal” or “expected” levels. The debate over the IAAF rules began in 2011, when a rule was first created to prevent women with high testosterone levels competing because of the belief that their hormone levels gave them an unfair advantage. The rule was challenged in 2015, and the IAAF was given two years to provide further justification for its position.

As Caruso writes, the main focus of the current controversy is the legal case of Dutee Chand, an Indian athlete whose testosterone levels exceed “the 10 nanomoles per liter limit, the level deemed to be the lower end of the ‘male range,’” i.e., the amount of testosterone in the blood typically exhibited by male athletes. Testosterone is widely considered a hormone that assists in athletic performance, given that it increases the rate of muscle development and bone mass, among other traits. The idea behind the IAAF’s position is that “unnaturally” high levels of testosterone that exceed levels typical of one’s gender would give such athletes an unfair advantage over other competitiors. Insofar as the IAAF is concerned with creating the fairest competition possible, the presence of elevated testosterone levels in a select group of athletes, like Chand, presents a serious problem.

The problem with the IAAF’s position, however, is that it overlooks one of the central nuances of sporting ethics.

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

Lessons from the West African Ebola epidemic

Conventional wisdom—and an article in the Journal of Medical Ethics reviewed on this blog two years ago—advise that health research should not be conducted during times of crisis. Yes, such conditions compromise the controlled environments that studies typically require to produce reliable results, but they can also threaten the ethical integrity of research. Without institutional mechanisms to hold them accountable, investigators may cut corners, violate standards of privacy and informed consent, and even endanger participants. Disruption in the normal function of medical services can also apply pressure on individuals unable to access care by traditional means to seek it out by participating in risky research. And even if one assumes that researchers display honesty beyond reproach, it is still unreasonable to expect that they would be able to keep their cool in the midst of widespread panic and social collapse. But there is a fly in the ointment, at least when it comes to crises caused by epidemics. Public health organizations are first-responders at these moments, but they would be dead in the water without relevant data collected under real-world conditions to guide their actions. In this situation, the precautionary principle alone is not enough to stop a study altogether. In fact, it could be argued that an absolute prohibition against biomedical research in such situations may itself be unethical. The question then becomes, not whether, but how to guarantee ethical research during outbreaks?

The Ethics Review Board (ERB) of Médecins Sans Frontières (MSF) had to contend with this question during the 2014 Ebola epidemic. They recently chronicled their experience in the April issue of Public Health Ethics.

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

Drugs that Go Through FDA’s Expedited Review Might Be Better Drugs

August 14, 2017

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A new paper in the latest issue of Health Affairs is worth a look. “Drugs Cleared Through The FDA’s Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process“:

We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. We identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) associated with drugs approved in the period 1999–2012 through expedited (seventy-six drugs) versus conventional (fifty-nine) review processes.

The FDA has a strict process for drug approval, requiring a number of phases of testing to establish safety and efficacy. It can, however, expedite this process when it thinks a drug may address an unmet clinical need. Of course, you want such a process to be fair and work. You want it to be focused on “better” and “more important” drugs. The 21st Century Cures Act moved even further. Some worry that loosening standards will lead to increased exposure to harm, especially if there isn’t proof that these drugs provide more benefits.

… Read More

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The Incidental Economist

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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

Ethics Committees Should Have Standards in Preparing New Members

Guest Post: Danish Zaidi and Jennifer Kesselheim
Paper: Assessment of orientation practices for ethics consultation at Harvard Medical School-affiliated hospitals

Ethics advisory committees (EACs), or clinical ethics committees, fulfill an important role in hospitals, providing ethics consultation, contributing to hospital-wide policies, and educating staff on ethical dimensions of medical practice. Our study built upon a central question: what qualifies one to serve on these sorts of committees? It’s a question with added relevance to us as authors: Danish Zaidi was part of the inaugural class of the Harvard Medical School Master of Bioethics program and Jennifer Kesselheim is an EAC co-chair and the founding director of the Harvard Medical School Master of Medical Sciences (MMSc) in Medical Education program. We studied how EACs recruit and educate members of their committees. In particular, what orientation practices were use in educating new members of EACs and how did members perceive confidence were member in fulfilling their duties on the other end of their “orientation”?

In recent years, the American Society for Bioethics & Humanities (ASBH) has made efforts to improve and standardize practices in ethics consultation across medical institutions. The ASBH has published two foundational books regarding ethics consultation and recently their Board of Directors approved the development of a healthcare ethics consultation (HCEC) certification program. Such efforts allude to a desire for standards in ethics consultation. As such, we turned to the ASBH Core Competencies in Healthcare Ethics Consultation to identify areas that we felt committee members should have familiarity with, using these competencies as metrics to develop our survey instrument.

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 – July 2017 by Danya Glabau

American Quarterly

Regina Kunzel

Among the central themes of the eclectic field of mad studies is a critique of psychiatric authority. Activists and academics, from a range of positions and perspectives, have questioned psychiatry’s normalizing impulses and have privileged mad-identified knowledges over expert ones. One of the most successful assaults on psychiatric authority was launched by gay activists in the 1960s and early 1970s, resulting in the removal of homosexuality from the American Psychiatric Association’s (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM) in 1973. But if that event marked an inspirational victory against psychiatric power, it was also, as Robert McRuer notes, “a distancing from disability.”1Revisiting this history through analytic lenses offered by disability and mad studies defamiliarizes familiar historical narratives and unsettles the critique of psychiatric authority, especially when countered by claims to health.

 

Conflicts over the value, meaning, and efficacy of vaccination as a preventive practice suggest that vaccination resistance stages disagreement within modern biological citizenship. This paper explores how immunity circulates in both vaccination controversy and biopolitical philosophies. Two positions—one characterized by somatic individualism, flexible bodies, reflexive approaches to knowledge, and the idea of the immune system as “the essential relation the body has with its vulnerability,” and another characterized by the immunitary paradigm, biosecurity, trust in expert systems, and vaccination—emerge. Understanding that oppositional relation can reframe public understanding of vaccine skepticism and public health responses to it.

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

Charlie Gard: Three Issues That Did Not Make Social Media

by Ann Mongoven, Ph.D., MPH

All hearts go out to the Gard family in this time of grief for their son, Charlie.

The legal wrangling over Charlie’s care became a political football–unfortunately, about many things having little to do with Charlie.

Despite the involvement of Pope Francis, this was not a case about abortion rights or the sanctity of human life. Catholic tradition warns both that quality-of-life arguments can dehumanize the disabled, and that unduly burdensome medical care can become assaultive. There is no “Catholic” view of the case, and Catholic moral theologians disagree about it.

Despite the involvement of Donald Trump, this was not a case about the relative merits of the U.K. National Health Service (NHS) versus other health systems. It was not a case of utilitarian ethics pitted against duty-based ethics or love. The NHS provided extremely expensive intensive care for Charlie for most of his life, and British courts governed cases related to his care solely by a “best interest of the child” standard– amidst heated disagreement between Charlie’s parents and doctors about his interests. The European Court of Human Rights backed the British court decision.

The case did address questions about who should decide when parents and doctors disagree about a child’s medical interest. But contrary to some portrayals in the American press, it neither changed conventional parameters for addressing those questions, nor exposed major differences in legal reasoning used to address them in the U.K. and the U.S.  Both countries appeal to “best interest” standards for resolution, and both reject an absolutist interpretation of parental rights.

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

Brain Death: Legal Fiction Used to Justify Ending Lives Prematurely – Another California Lawsuit

Brain death is a legal fiction used to justify ending lives prematurely. That is how the family of Israel Stinson frames its argument in a new brief filed in a California federal court, last week.


Israel Stinson’s family is challenging the constitutionality of the California Uniform Determination of Death Act (CUDDA). Contrast the claims made by the family of Jahi McMath. They contend only that Jahi does not (as a matter of fact) satisfy the CUDDA standards. They do not attack the (legal) validity of the standards themselves.


The Stinson family argues that “the biological basis for brain death is hotly disputed and central to this case.”  They allege that Israel remained alive AFTER an official death certificate was issued. They describe brain death as a “haphazard, uneven, and utilitarian-driven rush to declare patients dead, ignoring that possibility they might be alive.”


The State of California filed a motion to dismiss the family’s Third Amended Complaint on jurisdictional grounds. The hearing is scheduled for August 11.

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.