Tag: clinical utility

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

Antibody Makes Alzheimer’s Protein Detectable in Blood

Caption: The protein tau (green) aggregates abnormally in a brain cell (blue). Tau spills out of the cell and enters the bloodstream (red). Research shows that antibodies (blue) can capture tau in the blood that reflect its levels in the  brain.
Credit: Sara Moser

Age can bring moments of forgetfulness. It can also bring concern that the forgetfulness might be a sign of early Alzheimer’s disease. For those who decide to have it checked out, doctors are likely to administer brief memory exams to assess the situation, and medical tests to search for causes of memory loss. Brain imaging and spinal taps can also help to look for signs of the disease. But an absolutely definitive diagnosis of Alzheimer’s disease is only possible today by examining a person’s brain postmortem. A need exists for a simple, less-invasive test to diagnose Alzheimer’s disease and similar neurodegenerative conditions in living people, perhaps even before memory loss becomes obvious.

One answer may lie in a protein called tau, which accumulates in abnormal tangles in the brains of people with Alzheimer’s disease and other “tauopathy” disorders. In recent years, researchers have been busy designing an antibody to target tau in hopes that this immunotherapy approach might slow or even reverse Alzheimer’s devastating symptoms, with promising early results in mice [1, 2]. Now, an NIH-funded research team that developed one such antibody have found it might also open the door to a simple blood test [3].

Scientists know that tau loosened from abnormal tangles exits the brain and enters the bloodstream.

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 – October 2016 by Livia Garofalo

Here is our “In the Journals” roundup for October. In addition to a rich selection of abstracts, also of interest this month are a Special Issue of Osiris on the “History of Science and Emotions” and two recent articles by Fernando Vidal on brains in literature and cinema (linked below). Enjoy!

 

Theory & Psychology 

Desire, indefinite lifespan, and transgenerational brains in literature and film

Fernando Vidal 

Even before the brain’s deterioration became a health problem of pandemic proportions, literature and film rehearsed the fiction of brain transplantations that would allow an aging person to inhabit a younger body, so that successive surgeries may result in that person’s immortality. Such fiction makes the brain operate like an immaterial soul that does not undergo physical decline. This article examines that fiction as elaborated in Hanif Kureishi’s The Body and several films in connection with older fantasies that articulate desire, eternal youth, and personal immortality, with philosophical discussions about brain and personhood, and with people’s assimilation of neuroscientific idioms into their views and practices of personal identity. In conclusion it discusses how, in contrast to philosophical approaches that tend to focus on self-consciousness, first-person perspectives, and individual autonomy, fiction may contribute to direct attention to relationality as constitutive of personhood.

SubStance 

Frankenstein’s Brain: “The Final Touch”

Fernando Vidal 

 

Critical Public Health

A critical examination of representations of context within research on population health interventions

Jean Shoveller, Sarah Viehbeck, Erica Di Ruggiero, Devon Greyson, Kim Thomson and Rodney Knight

Research that fulsomely characterizes context improves our understanding of the processes of implementation and the effectiveness of interventions to improve the health of populations and reduce health inequalities.

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 Child in Pain, BRAIN, and Neuroethical Issues in Pediatric Pain Research and Care

BY JAMES GIORDANO, PhD

A February 4, 2016 editorial in the Boston Globe addressed the recent Food and Drug Administration (FDA) approval of the opiate analgesic oxycodone (brand named OxyContin) for use in children. This has raised concerns about the relative safety and possible effects of such compounds, as well as the roles of industry and federal government in establishing guidelines and policies for the use of drugs – or any medical intervention. Pediatric pain can incur a host of lifelong neuro-biopsychosocial effects. Moreover, pediatric pain care is complicated by practical and legal issues of long-term and often escalated dosing of opioids, and there is a paucity of safety data and information about potential long-terms risks to the developing brain associated with commonly used analgesics in this fragile population.

Both the dictates of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative, and invocations of the Presidential Commission for the Study of Bioethical Issues speak to the imperative to translate brain research into viable clinical uses. In light of this, it becomes important to ask if and how novel neurotechnologies can meet the challenges and opportunities of assessing and treating pediatric pain. Research to date has shown promise: For example, neuroimaging studies have sought to identify and establish brain phenotypes for pain. As well, neurogenomics and proteomics may afford an understanding of pediatric pain syndromes and sensitivities to various pharmacotherapeutics. Such studies support the capability and potential clinical utility of neurotechnologically-based assessments. Interventional neuroscientific and neurotechnological techniques, including transcranial and in-dwelling approaches to neuromodulation (such as transcranial magnetic and electrical stimulation, (Moreno-Duarte, et al.;

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

Resistance to Colistin: A Doomsday Scenario?

Julie Perry calls for action to prevent antibiotics resistance.

__________________________________________

A report published in The Lancet Infectious Diseases on November 18, 2015 documented the emergence of a new form of antibiotic resistance in China. This report has garnered a lot of international attention because scientists found resistance to colistin, an antibiotic of ‘last resort’ without which many bacterial infections would be completely untreatable. Bacteria carrying this new resistance gene were found in raw meat, food animals, and some hospital patients.

As these bacteria spread, so too does resistance to colistin. What is most worrying to scientists is the fact that the resistance gene found in the bacteria was found on a mobile genetic element called a plasmid. This means that the resistance gene can easily spread amongst bacterial species and could eventually end up in bacteria that cause severe disease.

Antibiotics are drugs that kill bacteria. They do so by targeting structures or genetic pathways that are only found in bacteria (not in humans or animals), and are therefore generally very safe and effective drugs. Antibiotics are vital to the treatment of infectious diseases. They are also crucial to the prevention of infection following Cesarean sections, organ transplantation, cancer chemotherapy, kidney dialysis, and a myriad of other areas of modern medicine we now consider routine. The downside of the ubiquitous use of antibiotics, however, is the development of antibiotic resistance.

Hospital-Associated Methicillin-resistant Staphylococcus aureus (MRSA) Bacteria. Interaction of MRSA (green bacteria) with a human white cell. Credit: NIAID

Antibiotic resistance is generally a misunderstood concept.

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 Child in Pain, BRAIN, and Neuroethical Issues in Pediatric Pain Research and Care

BY JAMES GIORDANO, PhD

A February 4, 2016 editorial in the Boston Globe addressed the recent Food and Drug Administration (FDA) approval of the opiate analgesic oxycodone (brand named OxyContin) for use in children. This has raised concerns about the relative safety and possible effects of such compounds, as well as the roles of industry and federal government in establishing guidelines and policies for the use of drugs – or any medical intervention. Pediatric pain can incur a host of lifelong neuro-biopsychosocial effects. Moreover, pediatric pain care is complicated by practical and legal issues of long-term and often escalated dosing of opioids, and there is a paucity of safety data and information about potential long-terms risks to the developing brain associated with commonly used analgesics in this fragile population.

Both the dictates of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative, and invocations of the Presidential Commission for the Study of Bioethical Issues speak to the imperative to translate brain research into viable clinical uses. In light of this, it becomes important to ask if and how novel neurotechnologies can meet the challenges and opportunities of assessing and treating pediatric pain. Research to date has shown promise: For example, neuroimaging studies have sought to identify and establish brain phenotypes for pain. As well, neurogenomics and proteomics may afford an understanding of pediatric pain syndromes and sensitivities to various pharmacotherapeutics. Such studies support the capability and potential clinical utility of neurotechnologically-based assessments. Interventional neuroscientific and neurotechnological techniques, including transcranial and in-dwelling approaches to neuromodulation (such as transcranial magnetic and electrical stimulation, (Moreno-Duarte, et al.;

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

Biopolitical News of 2015

For controversy and consequence, no story in 2015 came close to the rapidly developing CRISPR-Cas9 “gene editing” tools, and the prospect of their use to modify the human germline. The 2015 wave of news about gene editing swelled to pervade many of our concerns, from inheritable genetic modification to assisted reproduction, from disability and racial justice to synthetic biology, from the legacy of eugenics to the general culture of biotech.

Of course, CRISPR wasn’t the only news of the year. The UK approved a form of inheritable genetic modification based on nuclear genome transfer techniques, based in part on a public consultation process that was represented as demonstrating broad support, but that actually did not. Biobanks and DNA databases grew ever larger, raising both hopes and concerns. Research on all kinds of stem cells continued, with a combination of advances, scandals, and major financial concerns. Products made using synthetic biology techniques began reaching the market. Cross-border surrogacy dominated the news about assisted reproduction.

The Center for Genetics and Society continues to work to raise public awareness, inform policy debates, and include a wide range of public interest perspectives in the regulatory and governance decisions that shape the way human assisted reproduction and biotechnologies develop. Here is a breakdown of highlights roughly grouped by topic:

INHERITABLE GENETIC MODIFICATION

In 2015, CGS’s core organizational concern about human heritable genetic modification moved from the realm of scientific fiction to a thinkable clinical prospect.

In February, the UK Parliament carved out an exception to its law prohibiting human germline modification, allowing the HFEA to begin licensing clinics to create children via “3-person IVF,” also known as mitochondrial manipulation or nuclear genome transfer.

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

Too much of a good thing

https://commons.wikimedia.org/wiki/File%3ANude_mouse.jpg

A novel anti-cancer drug is found to shrink every tumour type tested in experimental animal models. Let’s rejoice and start clinical trials without delay!

Well, not so fast.

Preclinical experiments in animal models are aimed at showing that a new drug will be useful in human beings. However, individual animal experiments are often too small to support inferences about clinical utility. Techniques such as meta-analysis offer an attractive method for pooling individual studies and supporting more confident assertions regarding the potential clinical utility of a new drug.

With this in mind, our team undertook a meta-analysis using the anti-cancer drug sunitinib (Sutent). Since its publication in eLife, the meta-analysis has been covered in the BMJ, Nature, The Guardian, and Retraction Watch. We were primarily interested in whether the properties of sunitinib observed in preclinical studies would correlate with those observed in patients

What we found were many avoidable roadblocks to proper meta-analysis. Firstly, poor reporting quality in many experiments made it impossible to include them in the analysis. Examples include lack of error bars or no sample size given. Secondly, poor methodological practices such as lack of blinding and randomization, or reliance on single models were common, calling the quality of the data we were extracting into question. Furthermore, there was no discernible dose-response relationship connected across experiments in the same malignancy. Finally, trim and fill analysis (a tool to detect the possibility of publication bias) suggested that the overall efficacy of sunitinib across all malignancies could be inflated as much as 45%.

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

What should Investigators be Doing with Unexpected Findings in Brain Imaging Research?

Guest Post by Caitlin Cole

Incidental findings in brain imaging research are common. Investigators can discover these unexpected findings of potential medical significance in up to 70% of their research scans. However, there are no standards to guide investigators as to whether they should actively search for these findings or which, if any, they should return to research participants.

This complex ethical issue impacts many groups in brain imaging: participants and parents of child participants who may desire relevant health information, but alternatively may suffer from anxiety and financial burden; investigators who must ethically grant their participants autonomy, but who also may suffer from budget and personnel restrictions to manage the review and report of these findings; Institutional Review Board (IRB) members who must provide ethical oversight to imaging research and help mandate institutional standards; and health providers who must interface with their patients and assist with follow up care when necessary.

Our research study shows these groups share some ideas on the ethics of returning incidental findings – the researcher has an ethical responsibility or obligation to tell a subject that there’s something there, however they do it, but just inform the subject, even though it’s not part of the research” – yet also acknowledge the inherent risk in reporting medical research information. As one of our IRB members commented, I mean [in regards to withholding findings] one reason would be to protect the patient from doing something stupid about them.”

When participants are asked about incidental findings, they consistently state that they want to receive all information pertinent to their health.

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 Should the U.S. Regulate Genetic Testing?

Stanford Law School’s Center for Law and the Biosciences held a conference Monday to tackle the increasingly important question, ‘How Should the U.S. Regulate Genetic Testing?

I attended the conference along with some hundred others to hear twenty experts address the question from various perspectives: government, professional, payor, industry, and academic. Notably, social and ethical perspectives were not explicitly included, and only inched in at the peripheries.

Nonetheless, the conference was fascinating and incredibly informative. The biggest take-away of the day was that better regulation of genetic testing is certainly needed, but that it is a hugely complicated problem, from every perspective.

Center Director Hank Greely asserted that population-wide, next-generation sequencing will be the future and asked how we can maximize the benefits of this coming sea change while minimizing the harms. This may be obvious, but it’s actually critical, since in some cases people are receiving life–and-death information of relevance to the whole family from these tests.

The timing of the conference couldn’t have been any better, since the FDA just released its draft guidance on laboratory developed tests (LDTs) for comment, and will be holding a webinar October 23 to address questions. While not all genetic tests are LDTs, an awful lot are, and the FDA has good reason to cast light on this opaque world:

The FDA has identified problems with several high-risk LDTs including: claims that are not adequately supported with evidence; lack of appropriate controls yielding erroneous results; and falsification of data. The FDA is concerned that people could initiate unnecessary treatment or delay or forego treatment altogether for a health condition, which could result in illness or death.

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.