Tag: guidelines

Bioethics News

Pregnant Women Absent from Zika Vaccine Trials

August 15, 2017

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This uncertainty is a major reason behind researchers’ hesitancy to expose pregnant women to newer vaccines. Women do indeed get vaccinated while pregnant—against the flu or tetanus, diphtheria, and pertussis (Tdap), for example. But “the overall safety for flu and Tdap vaccines was established in very large populations prior to being administered to pregnant women,” says August.

Some vaccines—such as the flu vaccine—included pregnant women in clinical trials. And, notably, pregnant women were included in Phase 3 trials for the new respiratory syncytial virus (RSV) vaccine that prevents a devastating, potentially fatal infection that targets infants.

But recommendations for vaccination during pregnancy are not always backed by clinical trials. “Historically, many of the recommendations have relied on observational data,” writes Johns Hopkins bioethicist Carleigh Krubiner in an email to The Scientist. She, along with August, is part of the working group who wrote the Wellcome Trust-funded guidelines for Zika vaccine administration in expectant moms. In these cases, pregnant women were either intentionally or unintentionally given vaccines, then mother and child were observed.

… Read More

See also: PREGNANT WOMEN & THE ZIKA VIRUS VACCINE RESEARCH AGENDA: ETHICS GUIDANCE ON PRIORITIES, INCLUSION, AND EVIDENCE GENERATION

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The Scientist

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Source: Bioethics Bulletin by the Berman Institute of Bioethics.

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

Does Female Genital Mutilation Have Health Benefits? The Problem with Medicalizing Morality

By Brian D. Earp (@briandavidearp)

Please note: this piece was originally published in Quillette Magazine.

 

Four members of the Dawoodi Bohra sect of Islam living in Detroit, Michigan have recently been indicted on charges of female genital mutilation (FGM). This is the first time the US government has prosecuted an “FGM” case since a federal law was passed in 1996. The world is watching to see how the case turns out.

A lot is at stake here. Multiculturalism, religious freedom, the limits of tolerance; the scope of children’s—and minority group—rights; the credibility of scientific research; even the very concept of “harm.”

To see how these pieces fit together, I need to describe the alleged crime.

* * *

The term “FGM” is likely to bring to mind the most severe forms of female genital cutting, such as clitoridectomy or infibulation (partial sewing up of the vaginal opening). But the World Health Organization (WHO) actually recognizes four main categories of FGM, covering dozens of different procedures.

One of the more “minor” forms is called a “ritual nick.” This practice, which I have argued elsewhere should not be performed on children, involves pricking the foreskin or “hood” of the clitoris to release a drop of blood.

Healthy tissue is not typically removed by this procedure, which is often done by trained clinicians in the communities where it is common. Long-term adverse health consequences are believed to be rare.

Here is why this matters. Initial, albeit conflicting reports suggest that the Dawoodi Bohra engage in this, or a similar, more limited form of female genital cutting – not the more extreme forms that are often highlighted in the Western media.

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

Does Female Genital Mutilation Have Health Benefits? The Problem with Medicalizing Morality

Does Female Genital Mutilation Have Health Benefits? The Problem with Medicalizing Morality

By Brian D. Earp (@briandavidearp)

Please note: this piece was originally published in Quillette Magazine.

 

Four members of the Dawoodi Bohra sect of Islam living in Detroit, Michigan have recently been indicted on charges of female genital mutilation (FGM). This is the first time the US government has prosecuted an “FGM” case since a federal law was passed in 1996. The world is watching to see how the case turns out.

A lot is at stake here. Multiculturalism, religious freedom, the limits of tolerance; the scope of children’s—and minority group—rights; the credibility of scientific research; even the very concept of “harm.”

To see how these pieces fit together, I need to describe the alleged crime.

* * *

The term “FGM” is likely to bring to mind the most severe forms of female genital cutting, such as clitoridectomy or infibulation (partial sewing up of the vaginal opening). But the World Health Organization (WHO) actually recognizes four main categories of FGM, covering dozens of different procedures.

One of the more “minor” forms is called a “ritual nick.” This practice, which I have argued elsewhere should not be performed on children, involves pricking the foreskin or “hood” of the clitoris to release a drop of blood.

Healthy tissue is not typically removed by this procedure, which is often done by trained clinicians in the communities where it is common. Long-term adverse health consequences are believed to be rare.

Here is why this matters. Initial, albeit conflicting reports suggest that the Dawoodi Bohra engage in this, or a similar, more limited form of female genital cutting – not the more extreme forms that are often highlighted in the Western media.

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

Right to Try: Why Logic and Facts Won’t Win This One

by Craig Klugman, Ph.D.

Last week the U.S. Senate passed bill S. 204, the Trickett Wendler Right to Try Act of 2017. Trickett Wendler was a woman with ALS. The ALS association and her family lobbied Congress to support this bill to give all patients living with a terminal illness the “right” to purchase experimental drugs from pharmaceutical companies. Essentially, this bypasses the FDA’s compassionate use program. Instead of filing an application for FDA compassionate use (which the FDA approves 99% of the time), the patient asks the drug manufacturer directly. As I have written in this space before, such laws threaten public health efforts through the FDA to ensure safe and efficacious pharmaceuticals.

Currently, 37 states have such right-to-try laws and more have considered them. The push for these laws begins with the Barry Goldwater Institute, a libertarian think-tank, funded in part by the Koch brothers. Last month I had the surreal experience of debating two right-to-try supporters (one from a business school and one from the Goldwater Institute) about these laws which they base in a “right to self-medicate.” There were two of us against self-medication and two in favor of it.  You can read the commentaries and responses of the debaters here.

In this essay, I do not plan to restate my arguments against right-to-try. You can read my thoughts on this policy here and here. Instead, this post will examine the tools of argumentation that my opponents employed in the debate. It is important to show their debate techniques so that we all have a better understanding of how to analyze claims to support right-to-try and to realize why better facts and better arguments are falling on deaf ears.

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

How Much Should Your Boss and the U.S. Department of Labor Know About Your Opioid Prescription History?

As the
price of health care and uncertainty about health insurance coverage increases,
employers are taking more of an interest in their employees’ health. Indeed,
this is not a new trend as the United States health insurance system has been
employment-based since its creation. However, this trend may seem more
justifiable when the federal government also takes an interest in employees’
health.  From a public health
perspective, monitoring a society’s health is very important but it must be
balanced against the individual’s privacy interest as well as the harms and
benefits of that monitoring. There is also the issue of who/what is the most
appropriate entity to be doing the monitoring.

On June
27, 2017,
the
United States Department of Labor announced
it
will officially be
monitoring
use of opioid prescriptions by workers
under the
Federal Employees’ Compensation Act, which is the law surrounding the worker’s
compensation system.  The announcement
expressed a safety concern based on overdoses and addiction of opioids in the
midst of our current opioid crisis.

When an
employee files a worker’s compensation claim,
the
employer must be notified
and the employer
has access to the health records included in that claim
.
The employer’s access to health records is limited to whatever is included in
the claim and is justified based on the premise that the employer has an
interest in the worker’s compensation claim. However, this new monitoring
system means that an employer will now have access to its employees’ opioid
prescription history, as this is information the U.S. Department of Labor will
be monitoring as part of the worker’s compensation process.

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

How Much Should Your Boss and the U.S. Department of Labor Know About Your Opioid Prescription History?

As the
price of health care and uncertainty about health insurance coverage increases,
employers are taking more of an interest in their employees’ health. Indeed,
this is not a new trend as the United States health insurance system has been
employment-based since its creation. However, this trend may seem more
justifiable when the federal government also takes an interest in employees’
health.  From a public health
perspective, monitoring a society’s health is very important but it must be
balanced against the individual’s privacy interest as well as the harms and
benefits of that monitoring. There is also the issue of who/what is the most
appropriate entity to be doing the monitoring.

On June
27, 2017,
the
United States Department of Labor announced
it
will officially be
monitoring
use of opioid prescriptions by workers
under the
Federal Employees’ Compensation Act, which is the law surrounding the worker’s
compensation system.  The announcement
expressed a safety concern based on overdoses and addiction of opioids in the
midst of our current opioid crisis.

When an
employee files a worker’s compensation claim,
the
employer must be notified
and the employer
has access to the health records included in that claim
.
The employer’s access to health records is limited to whatever is included in
the claim and is justified based on the premise that the employer has an
interest in the worker’s compensation claim. However, this new monitoring
system means that an employer will now have access to its employees’ opioid
prescription history, as this is information the U.S. Department of Labor will
be monitoring as part of the worker’s compensation process.

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

Human genome editing: We should all have a say

Françoise Baylis stresses that decisions about the modification of the human germline should not be made without broad societal consultation.

__________________________________________

Shoukhrat Mitalipov, a reproductive biologist at Oregon Health and Science University, is nothing if not a pioneer. In 2007, his team published proof-of-principle research in primates showing it was possible to derive stem cells from cloned primate embryos. In 2013, his team was the first to create human embryonic stem cells by cloning. Now, in 2017, his team has reported safely and effectively modifying human embryos with the MYBPC3 mutation (which causes myocardial disease) using the gene editing technique CRISPR.

Mitalipov’s team is not the first to genetically modify human embryos. This was first accomplished in 2015 by a group of Chinese scientists led by Junjiu Huang. Mitalipov’s team, however, may be the first to demonstrate basic safety and efficacy using the CRISPR technique.

This has serious implications for the ethics debate on human germline modification which involves inserting, deleting or replacing the DNA of human sperm, eggs or embryos to change the genes of future children.

Those who support human embryo research will argue that Mitalipov’s research to alter human embryos is ethically acceptable because the embryos were not allowed to develop beyond 14 days (the widely accepted international limit on human embryo research) and because the modified embryos were not used to initiate a pregnancy. They will also point to the future potential benefit of correcting defective genes that cause inherited disease.

This research is ethically controversial, however, because it is a clear step on the path to making heritable modifications – genetic changes that can be passed down through subsequent generations.

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

Guidelines Needed to Help Terminally Ill Patients Gain Access to Trial Drugs

Stacey Lee, an assistant professor at JHU’s Carey Business School, suggests a more transparent process for patients

Source: Bioethics Bulletin by the Berman Institute of Bioethics.

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.