Tag: labeling

Bioethics Blogs

Will CRISPR fears fade with familiarity?

With all these ‘test tube’ babies grown up, how have our reactions to the technology evolved? AP Photo/Alastair Grant

The first “test-tube baby” made headlines around the world in 1978, setting off intense debate on the ethics of researching human embryos and reproductive technologies. Every breakthrough since then has raised the same questions about “designer babies” and “playing God” – but public response has grown more subdued rather than more engaged as assisted reproductive technologies have become increasingly sophisticated and powerful.

As the science has advanced, doctors are able to perform more complex procedures with better-than-ever success rates. This progress has made in vitro fertilization and associated assisted reproductive technologies relatively commonplace. Over one million babies have been born in the U.S. using IVF since 1985.

And Americans’ acceptance of these technologies has evolved alongside their increased usage, as we’ve gotten used to the idea of physicians manipulating embryos.

But the ethical challenges posed by these procedures remain – and in fact are increasing along with our capabilities. While still a long way from clinical use, the recent news that scientists in Oregon had successfully edited genes in a human embryo brings us one step closer to changing the DNA that we pass along to our descendants. As the state of the science continues to advance, ethical issues need to be addressed before the next big breakthrough.

Birth of the test-tube baby era

Louise Brown was born in the U.K. on July 25, 1978. Known as the first “test-tube baby,” she was a product of IVF, a process where an egg is fertilized by sperm outside of the body before being implanted into the womb.

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

Call for Papers: Health and Food Ethics

August 14, 2017

October 2018

Health and Food Ethics

Hippocrates once said, “Let food be thy medicine and medicine be thy food.” Physicians in some U.S. cities have followed this advice by writing prescriptions for patients to obtain fresh produce through healthy food outreach programs. Clinical encounters, however, cannot fully reverse the negative health effects of low quality diets. Further, millions remain hungry as the quantity of the global food supply is at risk. Providing safe, nutritious, and environmentally- sustainable food to all is a great challenge, and if the global community cannot find solutions to feed the world, economic and social costs will be high. “Ending hunger, achieving food security, improving nutrition, and promoting sustainable agriculture” is one of the Sustainable Development Goals set forth by the United Nations. As such, a central question worth exploring in the October 2018 issue of the AMA Journal of Ethics is: What should be the roles of health professionals in promoting accountability by governments, non-governmental and civil society organizations, and the food and beverage industry in promoting strategies that can meet the nutrition and health needs of our global population? Other issues include: reducing and redistributing food loss and waste; incentivizing responsible food production and labeling practices; communicating about food practices and food access during clinical encounters; and strategies to promote food security as a goal of health professions.

Manuscripts submitted for peer review consideration and inclusion in this issue must follow all Instructions for Authors and be submitted by 12 February 2018.

Link for more information


Image: By Original: lyzadangerDerivative work: Diliff – http://www.flickr.com/photos/lyza/49545547,

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

Nonpublication of Neurology Trials for Stalled Drugs & the Ironic Nonpublication of Data on those Stalled Drugs

In my experience, peer review greatly improves a manuscript in the vast majority of cases. There are times, however, when peer review improves a manuscript on one less important axis, while impoverishing it in another more important one. This is the case with our recent article in Annals of Neurology.

Briefly, our manuscript created a sample of FDA-approved neurological drugs, as well as a matched sample of neurological drugs that did not receive FDA approval- but instead stalled in development (i.e. a 3 year pause in testing). We then used clinicaltrials.gov to identify trials of drugs in both groups, and determined the proportion of trials that were published for all approved drugs, as well as FDA non-approved drugs. We found- not surprisingly- that trials involving stalled neurological drugs were significantly less likely to publish. What- for us- was the bigger surprise was that the proportion of trials published at 5 years or more after closure was a mere 32% for stalled neurological drugs (56% for licensed). Think about what that means in terms of the volume of information we lose, and the disrespect we show to neurological patients who volunteer their bodies to test drugs that show themselves to be ineffective and/or unsafe.

We shopped the manuscript around numerous places- eventually landing at Annals of Neurology. The paper received glowing reviews. Referee 1: “The research is careful and unbiased and the conclusions sound and impactful.” Referee 2: “This is an excellent and very important paper. It rigorously documents a very important issue in clinical trial conduct and reporting.

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.

Bioethics Blogs

Luhrmann and Marrow’s Our Most Troubling Madness by Murphy Halliburton

Our Most Troubling Madness: Case Studies in Schizophrenia Across Cultures

T.M. Luhrmann and Jocelyn Marrow, editors

University of California Press, 2016, 304 pages

 

A key premise of this volume of ethnographic case studies is that schizophrenia, or the various conditions we label as schizophrenia and related psychoses, varies in crucial ways in terms of experience, prognosis and outcome in different sociocultural contexts. Tanya Luhrmann’s introduction to the volume, which features twelve articles presenting twelve individuals diagnosed with schizophrenia (including three cases presented by Luhrmann), casts doubt on the biomedical model of schizophrenia, or at least the strong biomedical model where an individual’s biology is the determining factor in the pathogenesis of schizophrenia. Support for this critique comes from within the fields of psychiatry, psychology and related disciplines, and not just from anthropology, the disciplinary home base of many of the authors in this compilation. This supports the volume’s efforts to speak to an audience beyond the contributors’ own disciplines and “serve as a positive catalyst for change” in how we treat psychosis, especially in European and North American settings (5).

The introduction also briefly traces the history of theories of schizophrenia in psychiatry and anthropology, including moments when the two fields overlapped as with Gregory Bateson’s theory that schizophrenia results from a “double bind” that develops in a person’s psyche from conflicting social cues. This theory, put forth by an anthropologist, had a significant place in psychiatrists’ understanding of pathogenesis until the rise of the medical model deflected the blame from families toward “random bad genetic luck” (16).

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

Mandatory Reporting of Pharmacy Prescription Errors?

Following the widely-reported 2014 case of a Cincinnati pharmacist incorrectly filling a prescription which led to a serious patient injury, the Ohio State Board of Pharmacy is now poised to promulgate a new regulation requiring pharmacists to report errors and to the board. This may be the first attempt by a US state board of pharmacy to require dispensing error reporting. (However, about six years ago, the Canadian province of Nova Scotia instituted a required reporting system that has resulted in over 20,000 reports of errors and “near-misses” each year.)

The facts of the 2014 case are direct: A pharmacist was responsible for mistakenly filling a prescription written to supply labetalol but instead dispensed lamotrigine. As a result, the patient suffered permanent kidney damage requiring long-term dialysis. However, because of more in-depth news reporting, an investigator for a local television station made the claim that pharmacists deal with mistakes in “secrecy” and recommended that prescription errors reporting be mandated.

Regrettably, dispensing errors are an unfortunately fact of a pharmacist’s life. In a 2003 observational study attempting to assess prescription dispensing accuracy in 50 pharmacies in six US cities, pharmacy researchers Elizabeth Flynn, Kenneth Barker, and Brian Carnahan showed that the error rate was 1.7% for the 4481 prescriptions reviewed. Of the 77 identified mistakes, the team considered five to “clinically important.” (J Am Pharm Assoc. 2003;43:191-200). Interestingly, the accuracy rate did not vary significantly by pharmacy type or city.

In a 1998 report, a national pharmacist liability carrier provided information to authors Walter Fitzgerald and Dennis Wilson that 85% of its claims resulted from “mechanical errors,” including dispensing the wrong drug or dose, or labeling the prescription incorrectly.

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

Mandatory Reporting of Pharmacy Prescription Errors?

Following the widely-reported 2014 case of a Cincinnati pharmacist incorrectly filling a prescription which led to a serious patient injury, the Ohio State Board of Pharmacy is now poised to promulgate a new regulation requiring pharmacists to report errors and to the board. This may be the first attempt by a US state board of pharmacy to require dispensing error reporting. (However, about six years ago, the Canadian province of Nova Scotia instituted a required reporting system that has resulted in over 20,000 reports of errors and “near-misses” each year.)

The facts of the 2014 case are direct: A pharmacist was responsible for mistakenly filling a prescription written to supply labetalol but instead dispensed lamotrigine. As a result, the patient suffered permanent kidney damage requiring long-term dialysis. However, because of more in-depth news reporting, an investigator for a local television station made the claim that pharmacists deal with mistakes in “secrecy” and recommended that prescription errors reporting be mandated.

Regrettably, dispensing errors are an unfortunately fact of a pharmacist’s life. In a 2003 observational study attempting to assess prescription dispensing accuracy in 50 pharmacies in six US cities, pharmacy researchers Elizabeth Flynn, Kenneth Barker, and Brian Carnahan showed that the error rate was 1.7% for the 4481 prescriptions reviewed. Of the 77 identified mistakes, the team considered five to “clinically important.” (J Am Pharm Assoc. 2003;43:191-200). Interestingly, the accuracy rate did not vary significantly by pharmacy type or city.

In a 1998 report, a national pharmacist liability carrier provided information to authors Walter Fitzgerald and Dennis Wilson that 85% of its claims resulted from “mechanical errors,” including dispensing the wrong drug or dose, or labeling the prescription incorrectly.

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

Predicting Psychosis: Exploring Pre-Clinical Signs for Mental Illness

By Sunidhi Ramesh

This post is based on the January edition of the “Neuroethics and Neuroscience in the News” series in which Dr. Elaine Walker from Emory University discussed the ethics of assessing risk and treating brain diseases before they can be diagnosed.
This self-portrait is often used to depict the distorted
reality that many schizophrenia patients face.
(Image courtesy of Wikimedia Commons.)

“This calculator,” a 2016 headline states, “can predict your risk of developing psychotic disorders.”

Psychotic disorders, including schizophrenia and bipolar disorder with psychotic features, are characterized by noticeable deficits in “normal” behavior accompanied by hallucinations, delusions, paranoia, an early onset (the average age of onset is in the late teens or early twenties), and a derailed life course.
Because of its early age at onset, the DALY (disability adjusted life years) value for psychosis is significantly greater than that of other illnesses (1). It’s no surprise, then, that researchers are asking questions. Are there measures that can be taken to keep at-risk populations from enduring a life-hindering disability?
Fifteen years ago, the answer would be no. Today, it (just might be) yes. 

How? Researchers have recently identified patterns in pre-clinical psychotic symptoms— patterns that many psychotic patients exhibit long before they are formally diagnosed with a disorder.
In schizophrenia and other psychotic disorders that “interfere with a person’s ability to think clearly, manage emotions, make decisions and relate to others,” this pre-clinical period is called the prodromal period. During this time, patients often experience gradual disruptions in behavioral functioning (like being suspended from school or losing friends) that are accompanied by subclinical or reduced psychotic symptoms (like hallucinations and delusions).

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

Top Posts for 2016

As we enter 2017, a brief pause to look back at some of our top posts from the past year:

 


The Climate Crisis Call For Fewer Children

September 12, 2016

Our Travis Rieder continues the debate about climate change and the ethics of having children.

 

 


A Path towards Moral Resilience in Nursing

August 26, 2016

After nearly 30 years of research into moral distress there are no clear-cut answers for how to reduce its detrimental impact. In August, 46 nurse leaders convened at Johns Hopkins to address these challenges.

 


Play Review: Under the Skin

January 29, 2016

Our own Peter Young reviews Everyman Theater’s Under the Skin, which features an inside look at the ethical complexities of kidney donation within a broken family. Is blood truly thicker than water?

 


Chemotherapy Shortages & Difficult Choices

January 29, 2016

In a new paper and New York Times Special Report, oncologist and bioethicist Yoram Unguru tackles one of medicine’s most wrenching dilemmas.

 

 


Is the ‘Lesser of Two Evils’ an Ethical Choice for Voters?

August 12, 2016

Moral philosophy meets politics as our Travis Rieder explores whether we can be morally obligated to vote for someone we dislike in order to avoid greater harms.

 

 


Bioethics and the Precision Medicine Initiative

March 2, 2016

Berman Institute faculty members are at the table to plan the largest government research undertaking in US history.

 

 


New Food Labeling Law

September 13, 2016

‘Victory wrapped inside a defeat’?

 


Zika Highlights Need for Research on Pregnant Women

June 8, 2016

Bioethics scholars discuss the necessity and complexity of medical research with pregnant women, in the context of Zika and beyond. 

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.