Tag: medicine

Bioethics Blogs

Response to the Common Rule Special Issue: Attention to Health Disparities

by Nicolle K. Strand, JD, MBioethics, and Nora Jones, PhD

The article and commentaries on recent revisions to the Common Rule published in the July 2017 issue of AJOB are missing, we believe, a key perspective. The target articles and open peer commentaries suggested strategies for revising or overhauling the Common Rule to best address subject protections in light of the new and unique features of our contemporary research landscape, including the move from prospective research to research using existing data and biospecimens, personalized medicine, the increase in international collaboration, and the uptick in data sharing across institutions.…

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

Paolo Macchiarini, Fraud, and Oversight: A Case of Falsified Stem Cell Research

by Michael S Dauber, GBI Visiting Scholar

According to a recent story by John Rasko and Carl Power in The Guardian, surgeon Paolo Macchiarini’s research in artificial windpipes, previously hailed as pioneering medicine with the promise to save many lives, has been exposed as a fraud. Miacchiarini had previously received public praise for creating artificial windpipes by grafting stem cells onto plastic frames, which allowed him to “grow” new trachea for his patients.

While much of the scientific community was eager to believe Miaccharini had made significant breakthroughs, not everyone was convinced. According to a Swedish TV series called Experimenten, most of Miaccharini’s patients died within a few years of their procedures, and it was unclear that the experimental surgeries actually helped: in fact, they may have made matters much worse. Deeper investigation revealed that Macchiarini had actually falsified much of his data, and that institutional checks that normally prevent fraudulent individuals from being hired had been ignored. For example, according to an “external inquiry,” he was hired by the Karolinska Institute in 2010 despite various fraudulent, concerning, and questionable information on his resume (including a claim from a reference that he had been “blocked from a professorship in Italy”). The report also found that there had been inappropriate contact between Macchiarini and the Karolinska Institute’s Vice-Chancellor during his recruitment.

Even more troubling, the Institute failed to comply with government regulations designed to ensure research and clinical interventions are practiced ethically. According to Rasko and Power, Macchiarini failed to test his artificial airways in animals before implanting them in three human patients, and he did not apply for approval from an institutional review board or other ethics committee, despite the fact that Stockholm’s board was housed at the Institute.

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

IBM Pitched Its Watson Supercomputer As A Revolution In Cancer Care

It’s nowhere close. It was an audacious undertaking, even for one of the most storied American companies: With a single machine, IBM would tackle humanity’s most vexing diseases and revolutionize medicine.

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

Robotic Exoskeleton Could Be Right Step Forward for Kids with Cerebral Palsy

More than 17 million people around the world are living with cerebral palsy, a movement disorder that occurs when motor areas of a child’s brain do not develop correctly or are damaged early in life. Many of those affected were born extremely prematurely and suffered brain hemorrhages shortly after birth. One of the condition’s most common symptoms is crouch gait, which is an excessive bending of the knees that can make it difficult or even impossible to walk. Now, a new robotic device developed by an NIH research team has the potential to help kids with cerebral palsy walk better.

What’s really cool about the robotic brace, or exoskeleton, which you see demonstrated above, is that it’s equipped with computerized sensors and motors that can detect exactly where a child is in the walking cycle—delivering bursts of support to the knees at just the right time. In fact, in a small study of seven young people with crouch gait, the device enabled six to stand and walk taller in their very first practice session!

For people with cerebral palsy, crouch gait is now treated with a variety of approaches, often including wearing orthotic ankle braces that help to stabilize their legs. Still, about half of kids with cerebral palsy can’t walk by early adulthood. Their muscles simply can’t keep up with their growing bodies.

That’s led to development of many robotic training devices, though most are still restricted to use in a supervised clinical setting. In the new study, led by Thomas Bulea at the NIH Clinical Center in Bethesda, MD, the team wanted to develop a wearable system for potential home use to help keep more kids walking as they grow into adulthood.

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

The Neuroethics Blog Series on Black Mirror: White Bear

By Kristie Garza
Image courtesy of  Wikimedia Commons.

Humans in the 21st century have an intimate relationship with technology. Much of our lives are spent being informed and entertained by screens. Technological advancements in science and medicine have helped and healed in ways we previously couldn’t dream of. But what unanticipated consequences of the rapid expansion into new technological territory? This question is continually being explored in the British sci-fi TV series Black Mirror, which provides a glimpse into the not-so-distant future and warns us to be mindful of how we treat our technology and how it can affect us in return. This piece is part of a series of posts that discuss ethical issues surrounding neuro-technologies featured in the show and will compare how similar technologies are impacting us in the real world. 



*SPOILER ALERT* – The following contains plot spoilers for the Netflix television series Black Mirror. 

Plot Summary


“White Bear” begins with Victoria, the episode’s main character, awakening in an unfamiliar room in front of a TV displaying an unfamiliar symbol. She has no memory of who she is or how she wound up in the room.
Afraid, Victoria begins to explore her outside surroundings, where she finds “onlookers,” individuals in a trance-like state, filming her with their phones. A masked man then appears and begins chasing Victoria. While fleeing, she meets Jem, a fellow individual not under the trance. Jem explains to Victoria that the onlookers were put in their trance due to the strange symbol on the screens and that the masked man is a “hunter,” part of an evil people not affected by the strange symbol.

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 – August 2017 by Livia Garofalo

Here is the article round-up for August, put together in collaboration with Ann Marie Thornburg.  There is a special issue section of Social Science and Medicine out this month on Austerity, Health, and Wellbeing (abstracts below). Also of note is a recent ‘Takes a Stand’ statement on the End of AIDS published in Global Public Health by Nora Kenworthy, Richard Parker, and Matthew Thomann. You can take advantage of the article being temporarily free access and on early view here. Enjoy!

 

Cultural Anthropology (Open Access)

Tangles of Care: Killing Goats to Save Tortoises on the Galápagos Islands

Paolo Bocci

If calls to care for other species multiply in a time of global and local environmental crisis, this article demonstrates that caring practices are not always as benevolent or irenic as imagined. To save endemic tortoises from the menace of extinction, Proyecto Isabela killed more than two hundred thousand goats on the Galápagos Islands in the largest mammal eradication campaign in the world. While anthropologists have looked at human engagements with unwanted species as habitual and even pleasurable, I discuss an exceptional intervention that was ethically inflected toward saving an endemic species, yet also controversial and distressing. Exploring eradication’s biological, ecological, and political implications and discussing opposing practices of care for goats among residents, I move past the recognition that humans live in a multispecies world and point to the contentious nature of living with nonhuman others. I go on to argue that realizing competing forms of care may help conservation measures—and, indeed, life in the Anthropocene—to move beyond the logic of success and failure toward an open-ended commitment to the more-than-human.

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

Julia Powles on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale Subscribe to TWIHL here! We talk with legal scholar and journalist Dr. Julia Powles. At Cambridge, Julia was associated with the Centre for Law, Medicine and Life Sciences and Centre for Intellectual Property and Information Law, and a Research Associate … 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

Abortion pills at home: the new sinister face of the global abortion business

Dutch website “Women on web” is offering to deliver abortion drugs based on mifepristone (RU-486) and misoprostol for use at home, through a simple request on their website (there are lots of sites like this, after which they ask for “a donation of at least 90, 80 or 70 euro”. The website literally states that “a medical abortion can be done safely at home as long as you have good information and have access to emergency medical care in the rare case that there are complications”. Both drugs legally require a medical prescription, so their sale on the internet is illegal.

Abortion pills at home

A woman who feels tempted to make an “abortion” request on this site should know that the side effects of RU-486 are common and objective (see HERE), particularly vaginal bleeding, abdominal pain, nausea, vomiting and fatigue [2]. In some cases, the intensity of the vaginal bleeding requires a blood transfusion  [3], [4]. A total of 607 adverse events were reported between September 2000 and September 2004 : 237 hemorrhages, which included 1 fatal, 42 life-threatening, 168 serious, and 68 requiring blood transfusions; 66 infections, which included 7 cases of septic shock, 3 of which were fatal while 4 were life-threatening; 513 patients required a subsequent secondary surgical intervention, 235 urgent and 278 non-urgent. The need to have a surgical abortion after failure of the chemical abortion can be considered a side effect, and occurs in between 1% and 10% of cases. This second surgical intervention can increase the risk of permanent sterility http://journals.sagepub.com/doi/pdf/10.1345/aph.1G481a.

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

Navigating the Research-Clinical Interface in Genomic Medicine: Challenging the Traditional Dichotomy Between Research & Clinical Care

By Susan M. Wolf & Wylie Burke Translational genomics challenges the traditional view that research and clinical care are distinct activities that should be governed by separate norms, rules, and law. Beginning with the Belmont Report and emergence of regulations governing … 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 Blogs

FDA Approves First CAR-T Cell Therapy for Pediatric Acute Lymphoblastic Leukemia

Caption: Cancer survivor Emily Whitehead with her dog Lucy.
Credit: Emily Whitehead Foundation

Tremendous progress continues to be made against the Emperor of All Maladies, cancer. One of the most exciting areas of progress involves immunotherapy, a treatment strategy that harnesses the natural ability of the body’s own immune cells to attack and kill tumor cells. A lot of extremely hard work has gone into this research, so I was thrilled to learn that the Food and Drug Administration (FDA) just announced today its first approval of a promising type of immunotherapy called CAR-T cell therapy for kids and young adults with B-cell acute lymphoblastic leukemia (ALL)—the most common childhood cancer in the U.S.

ALL is a cancer of white blood cells called lymphocytes. Its treatment with chemotherapy drugs, developed with NIH support, has transformed ALL’s prognosis in kids from often fatal to largely treatable: about 90 percent of young patients now recover. But for those for whom the treatment fails, the prognosis is grim.

In the spring of 2012, Emily Whitehead of Philipsburg, PA was one such patient. The little girl was deathly ill, and her parents were worried they’d run out of options. That’s when doctors at Children’s Hospital of Pennsylvania, Philadelphia, gave Emily and her parents new hope. Carl June and his team had successfully treated three adults with their version of CAR-T cell therapy, which is grounded in initial basic research supported by NIH [1,2]. Moving forward with additional clinical tests, they treated Emily—their first pediatric patient—that April. For a while, it was touch and go, and Emily almost died.

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.