Tag: review

Bioethics Blogs

Responsibility in the age of precision genomics

by Alexa Woodward

Alexa is a fellow in the Precision Medicine: Ethics, Policy, and Culture project through Columbia University’s Center for the Study of Social Difference. The following is her reflection on the ongoing discussion around the Precision Medicine Initiative that has been the subject of recent political, social, and popular media attention. A recent presentation by Sandra Soo-Jin Lee, PhD, from the Center for Biomedical Ethics at Stanford University spurred our multi-disciplinary discussion of some of the following themes.

What is normal, anyway?

Genetically speaking, that’s precisely the question that the Obama administration’s Precision Medicine Initiative (PMI) seeks to answer. In recruiting and collecting comprehensive genetic, medical, behavioral, and lifestyle data from one million Americans, the scientific and medical communities will be better able to understand what constitutes normal genetic variation within the population, and in turn, what amount of variation causes or contributes to disease or disease risk.[1] Using this data, researchers could potentially create tailored approaches for intervention and treatment of an incredible range of diseases.

The PMI has a secondary aim: to increase the representation of previously underrepresented populations in research – primarily African Americans and Hispanics/Latinos. Inclusion of these groups in research has been a challenge for decades, with lack of access, distrust in the medical and research systems, and institutionalized racism all playing exclusionary roles. More broadly, outside of the government initiative, the promise of precision medicine ultimately seeks to alleviate disparities by finding and addressing supposed genetic differences, and empowering people with information to take responsibility for 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

FDA Advisory Committees and Industry-Funded Patient Advocacy

Cross-posted on Objective Intent and Notice & Comment.

Industry funding of patient advocacy organizations recently has received attention from media and researchers.  For example, one 2017 study in the New England Journal of Medicine found that over 80% of patient advocacy organizations with annual revenues of at least $7.5 million reported receiving industry funding; another study in JAMA Internal Medicine found that approximately 65% of patient advocacy organizations with a median annual revenue of about $300,000 reported receiving industry funding; and a post on the Hastings Center’s website (and an earlier JAMA Internal Medicine editorial) reported that one pharmaceutical company funded an advocacy organization that, in turn, recruited other patient advocacy groups to speak in favor of the company’s drug when the FDA was considering approving it.  This last story highlights one area where the rubber meets the road with respect to FDA and patient advocates’ conflicts of interest: advisory committee meetings.

Advisory committees play an important role at FDA, including for new drug approvals.  Often when FDA is considering whether to approve a new drug, it will ask an advisory committee—a group of outside experts—to provide the agency with advice on various scientific questions about the drug.  At a typical drug-related advisory committee meeting, the drug company and FDA will each take a turn presenting the scientific evidence about the unapproved drug, then there will be an open public hearing at which any interested member of the public may speak, followed by the advisory committee’s discussion of, and vote on, the questions that FDA has posed to it.  Partly because advisory committee meetings may be the first public airing of the agency’s questions about an unapproved drug and partly because the agency follows advisory committee recommendations roughly 75% of the time, these meetings and recommendations frequently are closely watched.

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

Book review: Traces of the Future: An Archaeology of Medical Science in Africa by Damien Droney

Traces of the Future: An Archaeology of Medical Science in Africa

Paul Wenzel Geissler, Guillaume Lachenal, John Manton, and Noémi Tousignant, editors

Intellect Ltd./University of Chicago Press, 2016, 256 pages, 500 color plates

 

The first reaction to an encounter with Traces of the Future: An Archaeology of Medical Science in Africa is likely to be a set of questions. Firstly, “what is it?” This 7×9” hardcover book, brimming with pleasingly displayed full-color photographic contributions by 18 authors, resembles a museum exhibit as much as it does a conventional academic volume. The contributing authors themselves describe it as a “sutured assemblage” (12) and a “fragmentary and idiosyncratic” (27) result of collaborative research presented in “a book-like package” (12).

Traces of the Future is the remarkable product of a long-term collaborative research project by a group of anthropologists, historians, and photographers. It examines the legacies of twentieth century biosciences in Africa in five historical sites of transnational medical science. Each of these sites manifested dreams of medical modernity and social progress characteristic of the twentieth century, dreams which are unevenly remembered in these sites today. The book is driven by the diverse research objects that it assembles. Beyond some rewarding orienting essays, the bulk of the book appears as a profusion of material. Each chapter includes an array of images, including fieldwork snapshots, archival documents, blueprints, manuscripts of musical scores, and unearthed beakers. These images are interspersed with timelines, interview transcripts, fieldnote excerpts, quotes from academic literature, and essays.

It also features haunting professional art photographs of Amani Hill Research Station by Evgenia Arbugaeva and Mariele Neudecker.

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

How to Fight Superbugs

Drug-resistant bacteria is rapidly outpacing the development of new drugs. A 2016 report, The Review on Antimicrobial Resistance, estimates that globally 700,000 people die each year from drug-resistant bacterial infections. Part of the problem is that developing new drugs has become increasingly difficult

Source: Bioethics Bulletin by the Berman Institute of Bioethics.

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

Our latest round-up of the biggest stories in housing law and equity, for the week of June 12-18,2017: The Joint Center for Housing Studies of Harvard University released the yearly State of the Nation Housing report. The report encourages a … Continue reading

Source: Bill of Health, examining the intersection of law and health care, biotech & bioethics.

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

Stakes of Life: Science, states, policies, publics and ‘the first thousand days’ by Fiona C. Ross

Welcome back to the “First Thousand Days of LifeSomatosphere series. Here we continue to explore the ways that a global health initiative driven by new findings in epigenetics and neuroscience and by a reframing of theories about health and disease in terms of developmental origins shape ideas about (global) health and population futures, invigorate campaigns, and take form and settle in localized contexts. Understanding the links between science, biomedicine, policy, population, well-being and relationship as simultaneously both meshed and contingent, our series posits questions about what affordances and limitations lie in new modalities of understanding human illness and well-being. It examines how policy is made and with what effects for its recipients, how states are implicated in health and its others, what forms of the everyday materialize under the lens of new findings in epigenetics and epidemiology, what modalities of knowing emerge and how they settle with older forms, and how ethnography might contribute.

Describing the research programme driven by the Thousand Days research group at the University of Cape Town, I noted that,

The emergent field both synergises a range of disciplines in the bio- and social sciences and develops new sites of humanitarian intervention, reframing current debates about population, well-being and ‘the best interests of the child’ in newly biological ways. As these findings are taken up in policy and practice, we are witnessing the making of a social object with material effects’ (www.thousanddays.uct.ac.za).

Our project has explored that making, its prior conditions and its effects.  As Michelle Pentecost noted in her opening to the Somatosphere series, the framing ‘offers fertile ground for careful thought about contemporary concepts of life, life-giving and care, offering spaces for critically assessing not only how states and people understand and enable health and well-being but also how life is conceptualized by different disciplines.’  We have traced both the ways that medical and scientific knowledge about life come to be interpolated in everyday worlds and the ways that people engage with, respond to – or indeed, ignore and subvert – it as they grapple with the possibilities that reproductive worlds afford.

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

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant … Continue reading

Source: Bill of Health, examining the intersection of law and health care, biotech & bioethics.

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

Using AI to Predict Criminal Offending: What Makes it ‘Accurate’, and What Makes it ‘Ethical’.

Jonathan Pugh

Tom Douglas

 

The Durham Police Force plans to use an artificial intelligence system to inform decisions about whether or not to keep a suspect in custody.

Developed using data collected by the Force, The Harm Assessment Risk Tool (HART) has already undergone a 2 year trial period to monitor the accuracy of the tool. Over the trial period, predictions of low risk were accurate 98% of the time, whilst predictions of high risk were accurate 88% of the time, according to media reports. Whilst HART was not so far been used to inform custody sergeants’ decisions during this trial period, the police force now plans to take the system live.

Given the high stakes involved in the criminal justice system, and the way in which artificial intelligence is beginning to surpass human decision-making capabilities in a wide array of contexts, it is unsurprising that criminal justice authorities have sought to harness AI. However, the use of algorithmic decision-making in this context also raises ethical issues. In particular, some have been concerned about the potentially discriminatory nature of the algorithms employed by criminal justice authorities.

These issues are not new. In the past, offender risk assessment often relied heavily on psychiatrists’ judgements. However, partly due to concerns about inconsistency and poor accuracy, criminal justice authorities now already use algorithmic risk assessment tools. Based on studies of the past offenders, these tools use forensic history, mental health diagnoses, demographic variables and other factors to produce a statistical assessment of re-offending risk.

Beyond concerns about discrimination, algorithmic risk assessment tools raise a wide range of ethical questions, as we have discussed with colleagues in the linked paper.

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

Ethical Challenges in the Development and Review of Genetics Research

From sequencing the human genome to discovering the underlying causes of many diseases, genetic research has the ability to profoundly influence the health of individuals and populations. However, despite genomics’ exceptional capacity to contribute to our understanding of disease, the nature of genetic research introduces many ethical considerations that may not arise in other types of biomedical research.

The post Ethical Challenges in the Development and Review of Genetics Research appeared first on Ampersand.

Source: Ampersand, the blog of PRIM&R.

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

Baby Genome Sequencing for Sale in China

June 15, 2017

Be the first to like.
Share

A Boston-based DNA sequencing company is offering to decode the complete genomes of newborns in China, leading some to ask how much parents should know about their children’s genes at birth.

Veritas Genetics says the test, ordered by a doctor, will report back on 950 serious early- and later-life disease risks, 200 genes connected to drug reactions, and more than 100 physical traits a child is likely to have.

Called myBabyGenome, the service costs $1,500 and could help identify serious hidden problems in newborns, the company says.

… Read More

Be the first to like.
Share

MIT Technology Review

Tags: , , , , ,

Source: Bioethics Bulletin by the Berman Institute of Bioethics.

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.