Tag: disclosure

Bioethics Blogs

Jewish Guide to Practical Medical Decision Making

Check out
this new 368-page
book
 from Rabbi Jason Weiner: Jewish Guide to Practical
Medical Decision Making.


Due to rapid advances in the medical field, existing books on Jewish medical
ethics are quickly becoming outdated. 
Jewish
Guide to Practical Medical Decision Making
 seeks to remedy that by
presenting the most contemporary medical information and rabbinic rulings in an
accessible, user-friendly manner. 


Rabbi Weiner addresses a broad range of medical circumstances such as surrogacy
and egg donation, assisted suicide, and end-of-life decision making. Based on
his extensive training and practical familiarity inside a major hospital, Rabbi
Weiner provides clear and concise guidance to facilitate complex
decision-making for the most common medical dilemmas that arise in contemporary
society.


1. Facilitating Shared Decision-Making 

A. Understanding Terminology: Key Concepts to Facilitate
Collaborative Decision-Making

B. Truth-Telling: When Painful Medical Information Should
and Should Not Be Revealed 

C. Mental Illness: Determining Capacity and Proper Treatment
in Accordance with Jewish Law  


2. How Much Treatment? 

A. Risk and Self-Endangerment: Determining the
Appropriateness of Attempting Various Levels of Dangerous Medical Procedures

B. Making Decisions on Behalf of an Incapacitated Patient

C. Pediatrics: Jewish Law and Determining a Child’s Consent
and Treatment 

D. Palliative Care and Hospice in Jewish Law and Thought


3. Prayer  

A. Is Prayer Ever Futile? On the Efficacy of Prayer for
the Terminally Ill 

B. Viduy: Confessional Prayers Prior to Death


4.  At the End of Life

A. Advance Directives and POLST Forms  

B. End-of-Life Decision-Making: DNR, Comfort Measures,
Nutrition/Hydration, and Defining “Terminal” in accordance with Jewish Law

C. Withholding vs. Withdrawing: Deactivating a
Ventilator and Cessation of Dialysis and Cardiac Defibrillators at the End of
Life

D. Case

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

Françoise Baylis and Carolyn McLeod (eds), Family-Making: Contemporary Ethical Challenges, Oxford University Press, 2014

This fascinating anthology focuses on the question of how we make families, and how bionormative assumptions shape or distort our collective thinking about parenting, children’s welfare, and state obligations to parents and children. The editors are primarily interested in the question of whether parents’ moral responsibilities toward children differ for children produced through assistive reproductive technologies (ART) compared to children brought into the family via adoption. As the editors point out, in the realm of ART, most of the philosophical literature has been focused on parental autonomy and rights to assistance in reproducing, while the adoption literature is almost entirely focused on the protection of children. The anthology does an excellent job of exploring this disconnect, and probing assumptions about moral responsibilities within family-making. Taken as a whole, the chapters explore “whether people should rely on others’ reproductive labour in having children, whether they should ensure that they will have a genetic tie to their children or that their children will have some connection to genetic relatives, whether they should bring a new child into the world at all, whether they should agree to what the government would require of them for an adoption, where they should live if the family they make is multi-racial, at what age they should forgo having children, and the list goes on” (6).

The first section of the book sets the stage with two excellent chapters on the goods of parenting (Harry Brighouse and Adam Swift) and the goods of childhood (Samantha Brennan). The goods of parenting are distinguished from other related goodsintimacy with another adult or friend, friendship with a child, being an uncle, having a pet, etc.

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

Rethinking the Belmont Report? Yes!

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research.  This effort reached fruition under The Federal Policy for the Protection of Human Subjects or the “Common Rule” that was issued in 1991.  Since then, there have been no major changes to the regulations – until now.  After a five-year process and thousands of comments, the new “final rule” was released on January 19th, 2017.  The July 2017 issue of the American Journal of Bioethics addresses these changes.  In addition to our usual open peer commentaries, we are posting a number of blog posts written in response to the AJOB target article.


by Emily Caldes, MA, CIP and Jennifer B McCormick, Ph.D., MPP

As noted by Friesen, Kearns, Redman and Caplan in their review of the Belmont Report, the Belmont Commission tackled the difficult task of distinguishing research from practice. The report defines research activities as those intended to develop or contribute to generalizable knowledge, and it defines practice as activities intended to enhance the well-being of particular individuals or groups of individuals.

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

FDA Advisory Committees and Industry-Funded Patient Advocacy

Cross-posted on Objective Intent and Notice & Comment.

Industry funding of patient advocacy organizations recently has received attention from media and researchers.  For example, one 2017 study in the New England Journal of Medicine found that over 80% of patient advocacy organizations with annual revenues of at least $7.5 million reported receiving industry funding; another study in JAMA Internal Medicine found that approximately 65% of patient advocacy organizations with a median annual revenue of about $300,000 reported receiving industry funding; and a post on the Hastings Center’s website (and an earlier JAMA Internal Medicine editorial) reported that one pharmaceutical company funded an advocacy organization that, in turn, recruited other patient advocacy groups to speak in favor of the company’s drug when the FDA was considering approving it.  This last story highlights one area where the rubber meets the road with respect to FDA and patient advocates’ conflicts of interest: advisory committee meetings.

Advisory committees play an important role at FDA, including for new drug approvals.  Often when FDA is considering whether to approve a new drug, it will ask an advisory committee—a group of outside experts—to provide the agency with advice on various scientific questions about the drug.  At a typical drug-related advisory committee meeting, the drug company and FDA will each take a turn presenting the scientific evidence about the unapproved drug, then there will be an open public hearing at which any interested member of the public may speak, followed by the advisory committee’s discussion of, and vote on, the questions that FDA has posed 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

Access to Physicians’ Prescription Habits

Jean-Christophe Bélisle-Pipon calls attention to issues of accessibility and transparency related to the collection and sale of physician prescribing data by data solution companies.

__________________________________________

QuintilesIMS is a data solution company that provides services to the pharmaceutical industry. In 2002, the company was authorized by the Commission d’accès à l’information du Québec to receive and make use of personal information held by Québec pharmacies about physician prescribing practices, provided that: 1) specific professional acts were not linked to specific professionals; 2) physicians could refuse to have their information used; and 3) use of the information was restricted to reaching out, informing and training physicians. Data related to physician prescribing practices is sold by Québec pharmacies to QuintilesIMS. In turn, QuintilesIMS collects, collates this data and sells it to pharmaceutical companies for marketing purposes.

Recently, information related to QuintilesIMS business practices were leaked to the media.

Allegations have been made suggesting that data detailing the prescribing practices of 7,000 Québec physicians (including identifying information) have been disclosed to pharmaceutical companies. If proven true, this would represent an unauthorized practice, that contravenes the Act respecting the protection of personal information in the private sector. The issue at stake in the allegations is not the disclosure to companies, but rather, the disclosure of identifying information.

Physician prescribing data must be clustered in groups of 30 that have similar prescribing profiles. Thus, it is impossible in Canada (contrary to the US) to have access to individual physician prescribing profiles. In Québec, physicians can opt out of this data collection, and those who allow their information to be used, freely have access to their own prescribing profile.

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

Silence = Death

May 18, 2017

by Sean Philpott-Jones, Chair, Bioethics Program of Clarkson University & Icahn School of Medicine at Mount Sinai

Silence = Death

As Donald Trump fights for his political life following new revelations about wholly inappropriate disclosure of classified materials and potential obstruction of justice, he has quietly issued new orders that will condemn thousands of women and children around the world to death.

Largely overlooked given the media frenzy about the appointment of a special prosecutor to investigate Russian interference in the US Presidential election was an announcement that the TrumpAdministration will vastly expand the scope of the “Global Gag Rule”, the international anti-abortion policy first enacted by Ronald Reagan in 1984.

Also known as the Mexico City Policy, the rule prohibits organizations that receive family planning money from the United States Agency for International Development (USAID) from providing or promoting abortion. This is true even if they do so with private money. In fact, if they take so much as a single dollar from the US, they can’t even mention the word ‘abortion’ regardless of whether or not these organizations actually provide such services.

Every time a Democrat is in the White House, the global gag rule is rescinded. Every time a Republican enters the Oval Office, it is reinstated. President Trump himself did so just three days after assuming office. Until now, family planning organizations around the world have largely learned to deal with this ebb-and-flow. That is all about to change.

On Monday, Trump announced a new policy called Protecting Life in Global Health Assistance. That policy expands the scope of the Global Gag Rule.

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

40th Annual Health Law Professors Conference

If you teach health law, come to the 40th Annual Health Law Professors Conference, June 8-10, 2017, at Georgia State University College of Law in Atlanta.  Here is the schedule:


Thursday, June 8, 2017
8:00-12:00 AM Tour of the Centers for Disease Control and Prevention (Separate registration is required. Participants meet in the lobby of Georgia State Law to take a shuttle to the CDC.)


9:45 – 11:15 AM Tour of Grady Health System (Separate registration is required. Participants meet in the lobby of Georgia State Law and will walk over to Grady as a group.)


2:00 – 5:00 PM Conference Registration – Henson Atrium, Georgia State Law


3:00 – 5:00 PM Jay Healey Teaching Session – Knowles Conference Center, Georgia State Law
Experiential Teaching and Learning in Health Law
The format for this session is World Café roundtables, with plenty of opportunity for the collegial exchange of teaching ideas and insights among your colleagues. Come prepared for a lively, interactive workshop.
World Café Hosts:
Dayna Matthew, University of Colorado Law School
Charity Scott, Georgia State University College of Law
Sidney Watson, Saint Louis University School of Law
Invited Discussants and Participants:
Rodney Adams, Virginia Commonwealth University School of Health Administration
Christina Juris Bennett, University of Oklahoma College of Law
Amy Campbell, University of Memphis Cecil C. Humphreys School of Law
Michael Campbell, Villanova University Charles Widger School of Law
Erin Fuse Brown, Georgia State University College of Law
Cynthia Ho, Loyola University of Chicago School of Law
Danielle Pelfrey Duryea, University of Buffalo School of Law, State University of New York
Jennifer Mantel, University of Houston Law Center
Elizabeth McCuskey, University of Toledo College of Law
Laura McNally-Levine, Case Western Reserve University School of Law
Jennifer Oliva, West Virginia University College of Law and School of Public Health
Thaddeus Pope, Mitchell Hamline School of Law
Lauren Roth, St.

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.