Tag: personalized 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 Blogs

Personalized Medicine: Our Future or Big Data Voodoo?

Kumar Ethirajan, MD

NOTE: Kumar Ethirajan, MD, an oncologist specializing in cancer genetics in the Kansas City area since 1993 and member of the Center for Practical Bioethics’ board of directors, will present this topic as part of the Center’s BIOETHICS MATTERS lecture series on Wednesday, July 19, 7:00 pm, at the Kansas City Public Library Plaza Branch, 4801 Main Street, Kansas City, MO. Bring your perspectives, questions and personal stories. Admission is free. All are welcome. 

Personalized medicine has the potential to revolutionize medicine. Actually, that’s not true. Personalized medicine IS REVOLUTIONIZING medicine. 

Personalized medicine IS our future! Yet, based on a 2013 survey by GfK, a global consumer research firm, just 27% of people have heard of the term personalized medicine and, of those, only 4% understand what the term means.

You may have heard personalized medicine referred to as genomic medicine, precision medicine or individualized medicine. Whatever you call it, it’s medicine that uses information about your genes to prevent, diagnose and treat disease. In cancer, it’s about using information about a tumor to discover certain biomarkers or genes and, hopefully, having a drug to treat it. So far, researchers have discovered more than 1800 disease genes, created more than 2,000 genetic tests for human conditions, and have 350 drugs currently in clinical trials.

So, this is great, right? Yes. But consider that some 30% of the world’s stored data is generated by the healthcare industry – and that a single patient on average generates 80 megabytes per year! With healthcare data exploding like this, shouldn’t we be thinking about the questions it raises?

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 2016

The biggest surprise of the year was probably the birth, in Mexico, of a baby who was conceived following controversial mitochondrial manipulation (“3-parent IVF”). The location was chosen by a New York-based fertility doctor who noted that in Mexico “there are no rules.” Since 3-person IVF is technically a form of inheritable genetic modification, one big question is whether its increasing use and normalization will open the door to wider acceptance of gene editing for human reproduction.

The gene editing shockwaves of 2015 – when Crispr was first applied in human embryos, and controversy about the prospect of using it for human reproduction became explicit – developed into a somewhat more predictable flood of activity and comment in 2016. The big, and unfortunate, news here is perhaps the non-news: the absence of any significant efforts to encourage public participation in deliberations about whether powerful new genetic manipulation tools should be used in efforts to control the traits of future children and generations.

The most consequential news of the year for biopolitics as for so much else may well turn out to be the US presidential election result, but the consequences themselves remain somewhat unclear. Trump’s comments about having “the right genes” are ominous warning signs, which are perhaps getting worse, as partly described below.

Cross-border commercial surrogacy was in the news this year because of scandals, disputes, and changes in the laws of several nations where it had taken hold. Commercial pressures were particularly apparent in the slick marketing being used to promote egg freezing among young women with no fertility problems.

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

Do It Yourself? When the Researcher Becomes the Subject

December 6, 2016

(Science) – Medical martyrdom is rarer these days, in part due to increased regulation of human subject research after World War II, and fewer researchers dying for their work can only be a good thing. Nonetheless, autoexperimentation continues. The access to the subject is matchless, and the allure of big data and personalized medicine seems to be some nudging self-experimenters toward new types of studies. However, the regulatory environment remains somewhat vague, leaving it up to researchers to weigh practicality against ethical considerations. But if care and diligence accompany the appetite for adventure, scientists can responsibly conduct self-experimentation studies that help advance science—and potentially offer some fun and personal benefit to boot.

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

World Bioethics Day: Human Dignity and Human Rights

World Bioethics Day: Human Dignity and Human Rights

The first World Bioethics Day, sponsored by the UNESCO Chair in Bioethics, is taking place on October 19. This year’s theme of Human Dignity and Human Rights will be celebrated in 55 countries worldwide (see here for a list of participating countries and here for a list of planned events).

While most countries are hosting one or two World Bioethics Day events, India has planned a whopping 29. The only event scheduled in the United States is at Indiana University Northwest, which will include presentations on bioethics and human rights and a screening of “No Más Bebés,” a documentary about Mexican-American women who were coercively sterilized at Los Angeles County-USC Medical Center in the 1960s and 1970s. (Filmmakers Virginia Espino and Renee Tajima-Peña joined CGS on the UC Berkeley campus in 2016 to screen the film as a part of the Being Human in a Biotech Age series. They were also interviewed for the CGS online series Talking Biopolitics by eugenics scholar and CGS advisory board member Alexandra Minna Stern, see here and on YouTube.)

Human dignity and human rights, in addition to being the theme of this first annual World Bioethics Day celebration, form the primary framework of most of the international and national legislation worldwide that prohibits inheritable genetic modification, also known as human germline modification. The most notable among these is the Council of Europe’s 1997 Convention on Biomedicine and Human Rights (see here for a global list of national legislation banning inheritable genetic modification).

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

The Cure for Cancer Is Data–Mountains of Data

October 19, 2016

(Wired) – For a decade we’ve been talking about the potential of gene sequencing and personalized medicine, how advances in computer processing power combined with an increasingly intimate understanding of our individual genomes has put us on the threshold of an age of miracles. With enough data, the theory goes, there’s not a disease that isn’t druggable. But as Schadt has learned, it’s not enough to plumb the depths of an individual’s DNA. It requires a universe of data—exabytes worth—to detect patterns in a population, apply machine learning, find the network of mutations responsible for disease, and do something about it. The bigger these data sets become, the more accurate and powerful the models and the predictors become.

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: Epigenetics: Barriers to the translation of scientific knowledge into public policies

Written by Charles Dupras and Vardit Ravitsky

Bioethics Programs, School of Public Health, University of Montreal

 

Environmental epigenetics is a rising field of scientific research that has been receiving much attention. It explores how exposure to various physical and social environments (e.g. pollution or social adversity) affects gene expression and, eventually, our health. Environmental epigenetics can sometimes explain why some of us carry increased risks of developing specific diseases. It provides activists a powerful vocabulary to promote environmental awareness and social justice. This new vocabulary, which allows us to discuss the consequences of disparities at the molecular level, has been enthusiastically mobilized as an effective way of stimulating political will for promoting public health preventive strategies.

However, this perspective – that we call the ‘policy translation’ of epigenetics – can be contrasted with a ‘clinical translation’ that targets the development of novel biomedical tools to assess epigenetic risks and reverse a detrimental epigenome. In a recent paper published in The Hastings Center Report, we argue that these two approaches are competing for public resources. We suggest that in Western contexts, the clinical translation of epigenetics may end up being prioritized over the policy translation of epigenetics, to the detriment of efforts to promote policy and public health. We highlight four potential barriers or biases that may impede the ‘policy translation’ of epigenetics, with the aim of cautioning against this scenario.

First, our societies operate under the ‘technological imperative’, a culturally engrained preference for technological solutions. In the context of epigenetics, this means that research findings are likely to be translated into biotechnological innovation that targets individual 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 News

New RNA Stem Cell Editing Reduces Unintended Genetic Complications

October 5, 2016

(Science Daily) – An international collaboration of government, university, and industry resources showed the promise of using RNA as a safe way to both make and modify induced Pluripotent Stem Cells (iPSCs) from patient cells for clinical applications in regenerative medicine, tissue engineering, and personalized 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 News

The Families That Launch Their Own Autism Studies

September 30, 2016

(The Atlantic) –  The growing interest in personalized medicine and the quantified self, in which people use technology to track their own physiological data or symptoms, is beginning to shift researchers’ views toward N-of-1 trials. The search for effective treatments for a variety of chronic conditions has led to a boomlet of N-of-1. The conditions run the gamut, ranging from speech disorders to stroke, bipolar disorder, cancer, and fibromyalgia.  Although N-of-1 trials are on the rise in every area of medicine, they have had a particularly large impact on autism research. Based on work by Rodakis and other parents, some autism researchers are beginning to explore potential causes and novel treatments they might otherwise have missed.

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

US Personalized-Medicine Industry Takes Hit from Supreme Court

August 24, 2016

(Nature) – Over the past decade, the Supreme Court has used a series of patent cases to clarify what the USPTO should consider patentable. Natural phenomena and abstract ideas, for example, are not patentable, according to section 101 of the US patent code, and the court has attempted to distinguish between these categories and true inventions. Two of those Supreme Court cases touched directly on the biomedical industry. In 2012, the Mayo Collaborative Services v. Prometheus Laboratories, Inc. decision struck down two patents on medical diagnostics, and in the 2013 Association for Molecular Pathology v. Myriad Genetics ruling, the court threw out patents on gene sequences used to assess cancer risk. In the wake of those decisions, many lawyers predicted that patents on inventions that are important to personalized medicine — particularly, diagnostic tests that could match individuals to a particular therapy — would be hard to come by, potentially driving away investors.

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.