Tag: review

Bioethics News

Offshore Herpes Vaccine Trial Under Investigation

September 1, 2017

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The government of St. Kitts and Nevis has launched an investigation into the clinical trial for a herpes vaccine by an American company because it said its officials were not notified about the experiments.

The vaccine research has sparked controversy because the lead investigator, a professor with Southern Illinois University, and the U.S. company he co-founded did not rely on traditional U.S. safety oversight while testing the vaccine last year on mostly American participants on the Caribbean island of St. Kitts.

The trial received financial backing from a former Hollywood filmmaker who has asserted the vaccine was highly successful in stopping herpes outbreaks. Since then, a group of investors, including Donald Trump supporter Peter Thiel, have backed the ongoing vaccine research with a $7 million investment that could include additional clinical trials in Mexico and Australia.

Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing on the 20 human subjects. Now, the government of St. Kitts and Nevis says that the researchers also did not officially seek permission to test the vaccine, which took place from April to August 2016.

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Scientific American

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

Housing Equity Week in Review

Here’s the latest news from housing law and equity, from the week of August 21-28, 2017: Economists from the Federal Reserve of San Francisco show the enduring negative effects of redlining on communities of color, via the New York Times. … Continue reading

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

Book Review: Cells Are The New Cure (BenBella Books, Inc., 2017). ISBN 9781944648800.

$26.95. Reviewed by Michael S. Dauber, MA

 

Cells Are The New Cure, written by Robin Smith, MD, and Max Gomez, PhD, is a book about the history of medical research on cells, both human and non-human, and recent developments in these techniques that have made cellular medicine one of the most promising fields for therapeutic exploration. While the book’s title suggests an exclusive focus on the healing aspects of genetic modification and human stem cell therapy, the text is much more than that: it is a roadmap for understanding the origins of such techniques, the current state of affairs in cellular and genetic therapies, the administrative landscape investigators must traverse in conducting research, and the areas in which we still need to make progress.

Smith and Gomez make an argument that is structurally simple yet gripping: they suggest that targeted therapies involving stem cells and genetic modifications are the future of medicine by pointing to the immense amount of studies in those fields that have yielded beneficial results. While many readers might acknowledge this fact even before reading the book, many may not be aware of the full extent of the knowledge we have gained from research on cells and genetics, or the myriad ways this knowledge has been applied. Of course, Smith and Gomez cover the big diseases that most people think of when imagining medical research: cancer, heart disease, neurodegenerative conditions, etc. However, the book also contains detailed information about how we age, what may cause certain allergies, how the body repairs itself, and the ways stem cell therapies, genetic editing techniques, and other complex medicines that build on these methods can be used to treat these conditions.

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

Germany Takes an Ethics Stance on Driverless Cars

August 24, 2017

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The idea of autonomous cars has always raised a big question: in the event of a serious crash that involves life-and-death decisions, what should the vehicle do? Clearly, it’s possible to program cars to do as humans desire, but there isn’t necessarily a clear course of action to take in every situation.

That, however, hasn’t stopped German regulators from taking a stance on the issue. Reuters reports that autonomous-car software must be “programmed to avoid injury or death of people at all cost.”

… Read More

Image: By Grendelkhan – Own work, CC BY-SA 4.0, https://commons.wikimedia.org/w/index.php?curid=47467048

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MIT Technology Review

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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

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 News

Sickle-Cell Patients See Hope in CRISPR

August 23, 2017

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Hertz Nazaire is a soft-spoken artist who likes to paint in bright colors, with subjects like rainbow palm leaves and dancing women in twirling skirts. But one series of paintings he’s created is darker. Here, deep-red discs contrast with misshapen, bluish-purple ones against a black background. One canvas shows an African face drowning in the red and blue shapes, eyes streaming with tears, mouth agape in pain. The work reflects his lifelong struggle with sickle-cell disease.

Nazaire, a 43-year-old Haitian-American, figures he’s been hospitalized more than 300 times since he was a child. He and other sickle-cell patients will tell you that the worst part of the disease is the debilitating pain. “It’s a horrifying thing to have, because it’s extremely painful. It’s a major fight all the time,” he says.

Roughly 100,000 people in the U.S. have sickle-cell disease, most of them African-Americans and Latinos but also people of Middle Eastern, Asian, Indian, and Mediterranean descent. Compared with the average American, they live much shorter lives—about 40 to 60 years.

… Read More

Image via Flickr Attribution Some rights reserved by euthman

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MIT Technology Review

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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

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

Webinar Follow-up: Common Rule Exemptions and Types of Review

In June 2017, PRIM&R hosted the webinar series Focus on the Revised Common Rule. Comprising four sessions on the topics of informed consent, exemptions and types of review, biospecimens and identifiable private information, and implications for social, behavioral, and educational research (SBER), these webinars provided a close look at the most significant areas of change […]

The post Webinar Follow-up: Common Rule Exemptions and Types of Review appeared first on Ampersand.

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

A Feminist Neuroethics of Mental Health

By Ann E. Fink
Ann Fink is currently the Wittig Fellow in Feminist Biology at the University of Wisconsin–Madison, with an appointment in Gender and Women’s Studies and concurrent affiliations with Psychology and the Center for Healthy Minds. Her research in cellular and behavioral neuroscience has appeared in the Journal of Neuroscience, Journal of Neurophysiology, PNAS and other journals. Ann’s interdisciplinary work addresses the ethics of neuroscience in relation to gender, mental health and social justice. 

Emotionality and gender are tied together in the popular imagination in ways that permeate mental health research. At first glance, gender, emotion, and mental health seem like a simple equation: when populations are divided in two, women show roughly double the incidence of depression, anxiety, and stress-related disorders1-3. Innate biological explanations are easy to produce in the form of genes or hormones. It could be tempting to conclude that being born with XX chromosomes is simply the first step into a life of troubled mood. Yet, buried in the most simplistic formulations of mental illness as chemical imbalance or mis-wiring is the knowledge that human well-being is a shifting, psychosocial phenomenon. Learning and memory research offers a treasure trove of knowledge about how the physical and social environment changes the brain. Feminist scholarship adds to this understanding through critical inquiry into gender as a mode of interaction with the world. This essay explores how a feminist neuroethics framework enriches biological research into mental health. 
Problems with “Biology-from-birth” stories 
What if understanding gender and health isn’t a tale of two gonads (or genitalia, or chromosomes)?

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

Housing Equity Week in Review

Here’s the latest news in housing law and equity, for the week of August 15-21, 2017: The Urban Institute has released a new tool about using fair housing data. The report contains details on data sources related to demographics and … Continue reading

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.