Tag: health care

Bioethics Blogs

Dueling BRCA Databases: What About the Patient?

The news release Monday morning grabbed my attention:

“Study finds wide gap in quality of BRCA1/2 variant
classification between Myriad Genetics and a common public database.”

Myriad Genetics had been exclusively providing tests, for
$3000+ a pop for full BRCA gene sequencing, for 17 years before the Supreme
Court invalidated key gene patents back in 2013. Since the ruling a dozen or so
competitors have been offering tests for much lower prices. Meanwhile, Myriad
has amassed a far deeper database than anyone else, having been in the business
so much longer. And it’s proprietary.

CLASSIFYING GENE VARIANTS

(NHGRI)

Public databases of variants of health-related genes have
been around for years too. The best known, ClinVar, collects and curates data
from the biomedical literature, expert panels, reports at meetings, testing
laboratories, and individual researchers, without access to Myriad’s database.
ClinVar uses several standard technical criteria to classify variants as
“pathogenic,” “benign,” or “of uncertain significance.” (“Likely pathogenic”
and “likely benign” were used more in the past.)

ClinVar lists 5400 variants just for BRCA1. The criteria
come from population statistics, how a particular mutation alters the encoded
protein, effects on the phenotype (symptoms), and other information.
Bioinformatics meets biochemistry to predict susceptibility. The BRCA1 protein
acts as a hub of sorts where many other proteins that control DNA repair
gather. DNA Science discussed the genes behind breast and ovarian cancers here.

As gene sequences accumulate in the databases and troops of
geneticists and genetic counselors annotate them, the proportion of pathogenic
and benign entries will increase as that of the unsettling “variants of
uncertain significance” — VUS — will decrease.

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

Dueling BRCA Databases: What About the Patient?

The news release Monday morning grabbed my attention:

“Study finds wide gap in quality of BRCA1/2 variant
classification between Myriad Genetics and a common public database.”

Myriad Genetics had been exclusively providing tests, for
$3000+ a pop for full BRCA gene sequencing, for 17 years before the Supreme
Court invalidated key gene patents back in 2013. Since the ruling a dozen or so
competitors have been offering tests for much lower prices. Meanwhile, Myriad
has amassed a far deeper database than anyone else, having been in the business
so much longer. And it’s proprietary.

CLASSIFYING GENE VARIANTS

(NHGRI)

Public databases of variants of health-related genes have
been around for years too. The best known, ClinVar, collects and curates data
from the biomedical literature, expert panels, reports at meetings, testing
laboratories, and individual researchers, without access to Myriad’s database.
ClinVar uses several standard technical criteria to classify variants as
“pathogenic,” “benign,” or “of uncertain significance.” (“Likely pathogenic”
and “likely benign” were used more in the past.)

ClinVar lists 5400 variants just for BRCA1. The criteria
come from population statistics, how a particular mutation alters the encoded
protein, effects on the phenotype (symptoms), and other information.
Bioinformatics meets biochemistry to predict susceptibility. The BRCA1 protein
acts as a hub of sorts where many other proteins that control DNA repair
gather. DNA Science discussed the genes behind breast and ovarian cancers here.

As gene sequences accumulate in the databases and troops of
geneticists and genetic counselors annotate them, the proportion of pathogenic
and benign entries will increase as that of the unsettling “variants of
uncertain significance” — VUS — will decrease.

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

Global Health Policy: Trump and the Reinstatement of the Global Gag Rule

By: Jorge Luis Rivera-Agosto

On January 23, 2017, President Trump signed a Presidential Memorandum reinstating the so-called Mexico City Policy. The Memorandum conditions U.S. global health and family planning assistance to a strict rule that precludes foreign non-governmental organizations (also known as “NGOs”) from promoting or performing abortion as a method of family planning. Also known as the “global gag rule,” this policy represents a blow specifically to women’s health worldwide. Thanks to this new action, it will become harder, like in past years when it was in effect, to have resources to support family planning and reproductive health services, such as “family counseling, contraceptive commodities, condoms, and reproductive cancer screenings.” Even though the U.S. government won’t retract from the Memoranda until this Administration ceases, global efforts should be made to ameliorate the negative effects the new policy will cause.

The Mexico City Policy was first enacted by President Reagan in 1984 – and at the time, it represented an expansion of existing legislative restrictions of the use of U.S. funds for abortions internationally. It was then rescinded by President Clinton in 1991; reinstated by President Bush in 2001; rescinded by President Obama in 2009; and reinstated and expanded by President Trump in 2017. The policy requires foreign NGOs “to certify that they will not perform or actively promote abortion as a method of family planning, using funds from any source (including non-U.S. funds), as a condition for receiving U.S. government global family planning assistance and any other U.S. global health assistance.” The reason given to enact such policy was that the U.S.

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

An Assessment of Mitochondrial Replacement Therapy

By: Alexa Woodward

Last year, a baby boy was born from an embryo that underwent mitochondrial replacement therapy (MRT). MRT was used to prevent this child from inheriting a mitochondrial disease from his mother, specifically infantile subacute necrotizing encephalomyelopathy – a disease that affects the central nervous system and usually results in death within the first few years of life. While controversial, assisted reproductive technologies (ARTs) such as MRT provide prospective parents with additional options and have the potential to improve the quality of human life by preventing disease.

This story is of bioethical interest because this technique results in germline modification, which is the alteration of DNA in the reproductive cells of humans that will be passed on to their offspring. Implementing MRT in humans has consequentially garnered much criticism, from simple health-related implications (such as unknown harms to potential offspring and eugenics concerns) to the futuristic next logical step of scientific intervention; directly editing the nuclear genome.

With MRT, modifications affect the mitochondrial genome (mtDNA), not the nuclear genome. Researchers emphasize the lack of bearing that mtDNA has on personal characteristics and the overall maintenance of “genetic integrity,” especially when compared to using the whole donor egg with an “unrelated” nuclear genome.1 Even so, additional concerns arise regarding the long-term anthropological effects, blurring the distinction between therapy and enhancement, and issues of resource allocation.

Mutations and deletions  in the mitochondrial genome can result in mitochondrial diseases affecting the neurological, musculoskeletal, cardiac, gastrointestinal, renal, and other systems, all of which are incurable.  MRT uses the intended parents’ nuclear DNA in conjunction with a donor’s mitochondria.

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

Breakthrough Immunotherapies Seem Like a Dream Come True for Children with Leukemia

Guest Post: Nancy Jecker, Aaron Wightman, Abby Rosenberg, Doug Diekema

Paper: From protection to entitlement: selecting research subjects for early phase clinical trials involving breakthrough therapies

A breakthrough therapy to cure cancer in children suffering from acute lymphoblastic leukemia (ALL) is a dream for many families.  New immunotherapies appear to make this dream a reality. Such therapies use a person’s own immune cells to recognize and combat their disease. In the largest study to date of ALL patients treated with a form of immunotherapy known as Chimeric Antigen Receptor (CAR) T-Cell therapy, a 93% remission rate was reported. Such results are a glimmer of hope for those whose prognoses were previously considered very poor.

However, the good news is tempered by the fact this potentially lifesaving experimental therapy may not be available to everyone who might benefit. And demand is growing as word spreads. Since CAR T-cell therapy for ALL is available only through clinical trials, do patients have a right to participate? How should we choose among medically suitable candidates?

We have faced these questions before. Most recently, with ZMapp to treat Ebola Virus Disease, azidothymidine (AZT) to treat HIV and AIDS, and Immunitab (Gleevac) to treat Chronic Myleogenous Leukemia. Are patients suffering from devastating, life-threatening diseases entitled to breakthrough therapies?

In a recent paper, we argue that benefit is a continuum, from the complete uncertainty associated with standard research, to an intermediate stage where evidence of benefit mounts and reaches a peak, to a final stage of clearly demonstrated benefit that is sufficient to gain approval for clinical applications.

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 Bioethics View of Executions in Arkansas

by Craig Klugman, Ph.D.

This week the state of Arkansas had planned to execute 8 death-row inmates in 4, back-to-back killings using lethal injection over 10 days. The last execution in Arkansas was 12 years ago, so why the sudden rush? As part of the three-drug cocktail used by this state, their supply of midazolam—an anesthetic—is about to expire. If they do not use the drug by the expiration date, then they can’t use it and the company that makes the drug will not sell it to the state for this purpose.

Arkansas had planned to use a combination of 3 drugs in the execution, midazolam (an anesthetic), vecuronium bromide (a paralytic), potassium chloride (to stop the heart). This cocktail would be used to kill the 8 men.

I say “had planned” because last week, two of the prisoners had judges issue stays on their executions. This move is not unusual as there is often a flurry of court appeals and filings in the time before an execution. What is unusual is that over the weekend, another judge placed a stay on all executions on the request of drug companies and distributors—Pfizer, Fresenius, West-Ward Pharmaceuticals, and McKesson—who do not want their drugs to be used in an execution. McKesson’s concern is that when they learned the reason the state bought the vecuronium bromide, that they refunded the cost and asked for the drug to be returned. Drug manufacturers and distributors have come out against their products being used to kill prisoners. The association is unlikely to be good for sales or brand reputation.

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 Apple, Google, and Other Tech Titans Aim to Shake Up the Way We Treat Disease

…[E]ven if Silicon Valley does deliver a useful project, the rest of the health care system will need time to catch up and work through issues such as patient privacy and data security.

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 News

How Behavioral Economics Can Produce Better Health Care

[O]ur behavior is powerfully influenced by our emotions, identity and environment, as well as by how options are presented to us.

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

VR and PTSD: Healing from trauma by confronting fears in virtual reality environments

By Katie Givens Kime
Image courtesy of Flikr

What are the ethical implications of therapeutically re-exposing patients to trauma via virtual reality technologies? Of the 2.7 million American veterans of the Iraq and Afghanistan wars, at least 20% suffer from depression and/or post-traumatic stress disorder (PTSD), and other studies peg that percentage even higher. As a chronic, debilitating mental illness, one PTSD symptom is hyperarousal, in which a person repeatedly re-experiences a trauma in the form of nightmares, panic attacks, and flashbacks.  One of the most long-trusted therapeutic approaches to PTSD is exposure therapy; now, virtual reality technology is increasingly being used to simulate exposure to traumatic events and to environments related to the traumatic event.


Image courtesy of Flikr

Last month’s Neuroethics and Neuroscience in the News event featured the recent research and observations of Barbara O. Rothbaum, who is the Paul A. Janssen Chair in Neuropsychopharmacology at the Emory University School of Medicine and Director of the Emory Veterans Program & Trauma and Anxiety Recovery Program. Rothbaum outlined the way in which exposure therapy (with or without the aid of virtual reality technology) is based on principles of learning and also discussed reliable findings with animals and phobic disorders (Foa & Kozak, 1986). The underlying premise of such therapy is that repeated and prolonged exposure to feared but realistically safe stimuli leads to habituation, and eventually to extinction.

The virtual reality exposure therapy (VRE) combat environments for “Virtual Vietnam” (developed by Georgia Tech and Emory Universities) includes a virtual Huey helicopter, a “fly” over the jungles of Vietnam, a “walk” in clearings near jungles and swamps, and other imaginal immersions in Vietnam-related stimuli.

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

Sliding down along the slippery slope

Debates on euthanasia, abortion or embryonic stem cell research frequently invoke slippery slope arguments. Here is an example of such reasoning:

Legalizing physician-assisted suicide (PAS) at the end of life pushes healthcare morality in a dangerous direction. Soon, PAS may be practiced even on people who are not at the end of life and who do not request it. Even if this does not happen, the general population’s trust in healthcare will erode. Therefore, PAS must be forbidden.

Reasoning about the future is important. We need to assess consequences of allowing new practices. However, how do we assess the future in a credible way?

In an article in Medicine, Health Care and Philosophy, Gert Helgesson, Niels Lynøe and Niklas Juth argue that many slippery slope arguments are not empirically substantiated, but are based on value-impregnated factual assumptions. Anyone who considers PAS absolutely wrong considers it as a fatal step in a dangerous direction. Therefore, it is assumed that taking such a step will be followed by further steps in the same dangerous direction. If you chose the wrong path, you end up further and further away in the wrong direction. It seems inevitable that a first step is followed by a second step…

The problem is that this prophesying is based on the original moral interpretation. Anyone who is not convinced of the fatality of a “first” step does not have a tendency to see it as a “first step” with an inherent tendency to lead to a “second step” and finally to disaster.

Thinking in terms of the slippery slope can sometimes be experienced as if you yourself were on the slippery slope.

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.