(ABC News) – U.S. health officials on Tuesday approved the nation’s first gene therapy for an inherited disease, a treatment that improves the sight of patients with a rare form of blindness. It marks another major advance for the emerging field of genetic medicine. The approval for Spark Therapeutics offers a life-changing intervention for a small group of patients with a vision-destroying genetic mutation and hope for many more people with other inherited diseases. The drugmaker said it will not disclose the price until next month, delaying debate about the affordability of a treatment that analysts predict will be priced around $1 million.
(Quartz) – The US government has fired a warning shot across the bow of junk science, promising to chase down the makers of sham medicine. The announcement was made on Monday (Dec. 18) by Food and Drug Administration commissioner Scott Gotlieb. In a statement, Gotlieb described the homeopathic medicine market as being filled with a slew of ineffective placebos, and also as potentially dangerous.
(Reuters) – The early hope that stem cell therapy would make the paralyzed walk, the blind see and cure diabetes have given way to a long list of failures, highlighted by early stem cell champion Geron Corp abandoning the field in 2011. But two small companies, Athersys Inc and Mesoblast Ltd, are beginning final stage trials in hundreds of patients that they – along with loyal investors – say could change the course of devastating stroke and heart failure. Both have overcome major hurdles to manufacturing stem cell treatments on a large scale that are off-the-shelf products derived from healthy donor bone marrow and do not face immune system rejection issues.
(Sydney Morning Herald) – Medical tourism should come with a health warning, according to the coroner examining the painful death of a young man who had extreme plastic surgery overseas. When Melbourne man Leigh Thomas Aiple booked in his plastic surgery holiday to Malaysia, he was told that he could expect to be treated at hospitals with “internationally recognised standards”.
Genetics in Medicine (vol. 19, no. 10, 2017) is available online by subscription only.
- “Laboratory Diagnosis of Biotinidase Deficiency, 2017 Update: A Technical Standard and Guideline of the American College of Medical Genetics and Genomics” by Erin T Strovel, Tina M Cowan, Anna I Scott, and Barry Wolf
- “Making Genomic Medicine Evidence-Based and Patient-Centered: A Structured Review and Landscape Analysis of Comparative Effectiveness Research” by Kathryn A. Phillips et al.
Clinical Trials (vol. 14, no. 5, 2017) is available online by subscription only.
- “Motivations, Enrollment Decisions, and Socio-Demographic Characteristics of Healthy Volunteers in Phase 1 Research” by Christine Grady et al.
- “Phase 1 Healthy Volunteer Willingness to Participate and Enrollment Preferences” by Stephanie C Chen et al.
Journal of Medical Ethics (vol. 43, no. 10, 2017) is available online by subscription only.
- “Ethics of Patient Activation: Exploring Its Relation to Personal Responsibility, Autonomy and Health Disparities” by Sophia H Gibert, David DeGrazia, and Marion Danis
- “Family Presence During Resuscitation: Extending Ethical Norms from Paediatrics to Adults” by Christine Vincent and Zohar Lederman
- “Is There a Place for CPR and Sustained Physiological Support in Brain-Dead Non-Donors?” by Stephen D Brown
- “Antimicrobial Stewardship Programmes: Bedside Rationing by Another Name?” by Simon Oczkowski
- “Using Stem Cell-Derived Gametes for Same-Sex Reproduction: An Alternative Scenario” by Seppe Segers et al.
- “Bridging the Education–Action Gap: A Near-Peer Case-Based Undergraduate Ethics Teaching Programme” by Wing May Kong and Selena Knight
- “The Moral Bioenhancement of Psychopaths” by Elvio Baccarini and Luca Malatesti
- “Nudge Me, Help My Baby: On Other-Regarding Nudges” by Hafez Ismaili M’hamdi, Medard Hilhorst, Eric A P Steegers, and Inez de Beaufort
- “Empirical Evidence Against Placebo Controls” by Sadhvi Batra and Jeremy Howick
- “Pathogenic Variants in the Healthy Elderly: Unique Ethical and Practical Challenges” by Paul Lacaze et al.
Hastings Center Report (vol. 47, no. 5, 2017) is available online by subscription only.
- “The Case for Resource Sensitivity: Why It Is Ethical to Provide Cheaper, Less Effective Treatments in Global Health” by Govind C. Persad and Ezekiel J. Emanuel
- “Are Transplant Recipients Human Subjects When Research Is Conducted on Organ Donors?” by Kate Gallin Heffernan and Alexandra K. Glazier
- “Charlie Gard and the Limits of Parental Authority” by Arthur Caplan and Kelly McBride Folkers
Artificial Intelligence and Law (vol. 25, no. 3, 2017) is available online by subscription only.
- “Theoretical Foundations for the Responsibility of Autonomous Agents” by Jaap Hage
- “Of, for, and by the People: The Legal Lacuna of Synthetic Persons” by Joanna J. Bryson, Mihailis E. Diamantis, and Thomas D. Grant
- “On the Legal Responsibility of Autonomous Machines” by Bartosz Bro?ek and Marek Jakubiec
- “Robot Sex and Consent: Is Consent to Sex Between a Robot and a Human Conceivable, Possible, and Desirable?” by Lily Frank and Sven Nyholm
- “Do Androids Dream of Normative Endorsement? On the Fallibility of Artificial Moral Agents” by Frodo Podschwadek
- “On the Problem of Making Autonomous Vehicles Conform to Traffic Law” by Henry Prakken
- “The Ethical Knob: Ethically-Customisable Automated Vehicles and the Law” by Giuseppe Contissa, Francesca Lagioia, and Giovanni Sartor
(Quartz) – From the 1980s, however, clinical research began to indicate that episiotomy should not be considered routine medical practice. It can be a life-saving intervention under certain circumstances but for most births, “snipping” does more harm than good. The procedure is associated with higher levels of pain, edema, bleeding and incontinence – and actually increases the risk of severe tearing. Today, the American College of Obstetricians and Gynecologists and the UK’s National Institute for Health and Care Excellence (NICE) recommend against routine use of episiotomy. NICE’s guidelines on intrapartum care state it should only be done if there is a “clinical need,” such as to relieve fetal or maternal distress.
(CNN) – A gene-therapy trial by London researchers has seen remarkable success in finding a long-term cure for hemophilia A. The trial, by researchers at Barts Health NHS (National Health Service) Trust and Queen Mary University of London, used gene therapy to inject one dose of a missing gene in patients with the condition, and the gene continued functioning in the body for more than a year. This is the first successful gene therapy to treat the condition.
(Reuters) – A 30-year prison sentence for a woman in El Salvador who said her child was stillborn is appalling, U.N. human rights spokeswoman Liz Throssell said on Friday. The Second Court of Appeal of San Salvador on Wednesday upheld the sentence for Teodora Vasquez, who was convicted in 2008 of aggravated homicide in the death of her child the previous year.
The Journal of Medicine & Philosophy (vol. 42, no. 5, 2017) is available online by subscription only.
- “Organ Vouchers and Barter Markets: Saving Lives, Reducing Suffering, and Trading in Human Organs” by Mark J Cherry
- “Ethical and Logistical Issues Raised by the Advanced Donation Program ‘Pay It Forward’ Scheme” by Lainie Friedman Ross, James R Rodrigue, and Robert M Veatch
- “Banking on Living Kidney Donors—A New Way to Facilitate Donation without Compromising on Ethical Values” by Dominique E Martin and Gabriel M Danovitch
- “Kidney Vouchers and Inequity in Transplantation” by Samuel J Kerstein
- “The Body as Gift, Commodity, or Something in Between: Ethical Implications of Advanced Kidney Donation” by Julian J Koplin
- “From Directed Donation to Kidney Sale: Does the Argument Hold Up?” by James Stacey Taylor
Global Health: Science and Practice (vol. 5, no. 3, 2017) is available online by subscription only.
- “Maternal Death Surveillance and Response: A Tall Order for Effectiveness in Resource-Poor Settings” by Marge Koblinsky
- “Implementing Maternal Death Surveillance and Response in Kenya: Incremental Progress and Lessons Learned” by Helen Smith et al.
- “Family Planning in the Context of Latin America’s Universal Health Coverage Agenda” by Thomas Fagan et al.
- “Upgrading Supply Chain Management Systems to Improve Availability of Medicines in Tanzania: Evaluation of Performance and Cost Effects” by Marasi Mwencha et al.
- “Increasing Contraceptive Access for Hard-to-Reach Populations With Vouchers and Social Franchising in Uganda” by Benjamin Bellows et al.
- “Overcoming Operational Challenges to Ebola Case Investigation in Sierra Leone” by Samuel T Boland et al.
Journal of Community Health (vol. 42, no. 5, 2017) is available online by subscription only.
- “Differences in Perceived Severity of Zika Virus Infection and Dengue Fever and its Influence on Mosquito Control Practices in Malaysia” by Li Ping Wong et al.
- “Practices and Attitudes of Missouri School Nurses Regarding Immunization Records and Select Immunizations of Graduating High School Seniors” by Darson L. Rhodes, Michele Draper, Kendra Woolman, and Carol Cox
- “Adolescent Participation in HPV Vaccine Clinical Trials: Are Parents Willing?” by Jennifer Cunningham Erves et al.
- “Improving HPV Vaccination Through a Diverse Multi-state Coalition” by Echo L. Warner, Brynn Fowler, Laura Martel, and Deanna Kepka
- “Clarifying Values and Preferences for Care Near the End of Life: The Role of a New Lay Workforce” by Debra K. Litzelman et al.
- “Reassessing the Ecology of Medical Care in Japan” by Tsuguya Fukui et al.
JAMA (vol. 318, no. 11, 2017) is available online by subscription only.
- “Nonvoluntary Psychiatric Treatment Is Distinct From Involuntary Psychiatric Treatment” by Dominic A. Sisti
- “The United Kingdom Sets Limits on Experimental Treatments: The Case of Charlie Gard” by Robert D. Truog
- “Drug Development at the Portfolio Level Is Important for Policy, Care Decisions and Human Protections” by Vineet Chopra and Sanjay Saint
- “Humanizing the Treatment of Hyperactive Delirium in the Last Days of Life” by Pratik P. Pandharipande and E. Wesley Ely
Public Understand of Science (vol. 26, no. 7, 2017) is available online by subscription only.
- “Decline in Ethical Concerns about Reproductive Technologies Among a Representative Sample of US Women” by Arthur L. Greil et al.
Ethics & Medicine (vol. 33, no. 3, 2017) is available online by subscription only.
- “The Moral Significance of Pain for Synthetic Human Entities Derived from Embryo-Like Cell” by William P. Cheshire, Jr.
- Telling the Truth in Therapeutic Encounters” by Joshua D. Niforatos, Gregory W. Rutecki, and F.D. Yates, Jr.
- Patient Medical Consent from an Islamic Perspective” by Taghreed Ayyad, Ammar Al-Kashimiri, and Sina Muscati
- Slathered, Zapped, Nipped, and Tucked: An Ethical Analysis of Cosmetic Dermatology” by Barbara, J. Lowe
- The Trinitarian Nature of Biblical Bioethics: A Theological Corrective to Frame’s Philosophical Paradigm” by Daniel Heimbach
- The Higher-Brain Concept of Death: A Christian Theological Appraisal” by Allen H. Roberts, II
Ethics & Medicine (vol. 33, no. 2, 2017) is available online by subscription only.
- “Telemedicine and the Ethics of Medical Care at a Distance” by William P. Cheshire, Jr.
- “When Parents Disagree” by Helen O. Williams
- “CRISPR – Cas9: The Latest Fashion in Designer Babies” by Daryl F. Sas and Hannah Martin Lawrenz
- “Length and Format of Informed Consent Forms in Clinical Trails in Different Patent Populations (Pediatric, Adult, Elderly) Base on Samples from Poland” by Agata Bloswick and Dr. Hab. Agnieszka Skowron
- “Three End-of-Life Cases: Resolving Their Moral Dilemmas” by Renee Mirkes
Ethics & Medicine (vol. 33, no. 1, 2017) is available online by subscription only.
- “Loopthink: A Limitation of Medical Artificial Intelligence” by William P. Cheshire, Jr.
- “Double Effect Reasoning : Why We Need It” by Helen Watt
- “Autonomy in Applied Medical Ethics” by Joseph Freer
- “The Relationship of Gametes to Those who Procreate and Its Impact on Artificially Generated Gamete Technologies” by Michal Pruski
- “Embracing PVS 2.0 (The “Permanent? Vegetative? State”): Medical Research Beckons Ethicists Considering the Issue of ANH Withdrawal to Adopt a More Challenging Situational Narrative” by Erik M. Clary
- Are Parents Liable for Their Babies’ Prenatally Acquired Injuries?” by Carlo V. Bellieni and Alberto M. Gambino