Tag: guidelines

Bioethics Blogs

The Very Early Embryo & Its Moral Signifiance

by Andrew J. Prunty

As technology and biological research continue to develop in the twenty-first century, it is necessary to address and further define the ethical considerations of embryonic research and the appropriate rights that may limit the extent of human research on zygotes, blastocysts, and fetal scientific advancement. Because the area of harvesting embryonic stem cells remains significantly undefined, both legally and morally, there are vastly different opinions between researchers and bioethicists, mainly because of ethical limitations, on the rights that should be granted to cells with the potential to develop into human beings and the consequences of neglecting significant scientific research or advancement.

Current laws in the United States differ at the federal and state level, but there is no consistency in recognizing human embryos as humans, or affording them the same legal rights granted to a child; in fact, legal precedent actually detracts certain rights from developing embryos, favoring a human’s ability to destroy a potential human being (i.e. Roe v. Wade[i]) or the categorization of embryos as property (i.e. Davis v. Davis[ii], A.Z. v. B.Z.[iii], Marriage of Dahl[iv], or Reber v. Reiss[v]). These case law samples suggest the courts’ inability to reach a conclusion as to what is the status of an embryo.

The debate is not only circumscribed to matters of research, but to fundamental controversial and intertwined issues of bioethics such as: when life begins, embryonic stem cells, fetal rights, abortion, et cetera. All these topics are contentious and when one topic arises, they begin to comingle.

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

Unbefriended and Unrepresented: Better Medical Decision Making for Incapacitated Patients Without Healthcare Surrogates

How should we make medical decisions for incapacitated patients who have no available legally-authorized surrogate decision maker? Because these patients lack decision making capacity, they cannot authorize treatment themselves. Because they lack a surrogate, nobody else can authorize treatment either. Clinicians and researchers have referred to these individuals as “adult orphans” or as “unbefriended,” “isolated,” or “unrepresented” patients. Clinicians and researchers have also described them as “unimaginably helpless,” “highly vulnerable,” and as the “most vulnerable,” because “no one cares deeply if they live or die.”

The persistent challenges involved in obtaining consent for medical treatment on behalf of these individuals is an immense problem in ethics and patients’ rights. Some commentators describe caring for the unbefriended as “one of the most difficult problems in medical decision making.” Others call it the “single greatest category of problems” encountered in bioethics consultations.

Appropriately, this problem is getting more attention. Major policy reports from both legal and medical associations have focused on decision making for the unbefriended. Perhaps most notably, the elite mainstream media has repeatedly covered the problem of the unbefriended in the United States. Decision-making for the unbefriended has also been the primary topic of recent day-long or multi-day conferences, both themed, subject-specific conferences, and individual sessions at several national and regional professional association meetings.

Finally, the problem of the unbefriended has received increasing attention not only in the meeting halls of conferences, but also in the pages of academic literature. New articles have been printed in law journals, medical journals, nursing journals, long-term care journals, and bioethics journals.

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

Unbefriended and Unrepresented: Better Medical Decision Making for Incapacitated Patients Without Healthcare Surrogates

How should we make medical decisions for incapacitated patients who have no available legally-authorized surrogate decision maker? Because these patients lack decision making capacity, they cannot authorize treatment themselves. Because they lack a surrogate, nobody else can authorize treatment either. Clinicians and researchers have referred to these individuals as “adult orphans” or as “unbefriended,” “isolated,” or “unrepresented” patients. Clinicians and researchers have also described them as “unimaginably helpless,” “highly vulnerable,” and as the “most vulnerable,” because “no one cares deeply if they live or die.”

The persistent challenges involved in obtaining consent for medical treatment on behalf of these individuals is an immense problem in ethics and patients’ rights. Some commentators describe caring for the unbefriended as “one of the most difficult problems in medical decision making.” Others call it the “single greatest category of problems” encountered in bioethics consultations.

Appropriately, this problem is getting more attention. Major policy reports from both legal and medical associations have focused on decision making for the unbefriended. Perhaps most notably, the elite mainstream media has repeatedly covered the problem of the unbefriended in the United States. Decision-making for the unbefriended has also been the primary topic of recent day-long or multi-day conferences, both themed, subject-specific conferences, and individual sessions at several national and regional professional association meetings.

Finally, the problem of the unbefriended has received increasing attention not only in the meeting halls of conferences, but also in the pages of academic literature. New articles have been printed in law journals, medical journals, nursing journals, long-term care journals, and bioethics journals.

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 – April 2017 by Danya Glabau

Critical Public Health

On difference and doubt as tools for critical engagement with public health

Catherine M. Will

This paper argues that critical public health should reengage with public health as practice by drawing on versions of Science and Technology Studies (STS) that ‘de-centre the human’ and by seeking alternative forms of critique to work inspired by Foucault. Based on close reading of work by Annemarie Mol, John Law, Vicky Singleton and others, I demonstrate that these authors pursue a conversation with Foucault but suggest new approaches to studying contemporary public health work in different settings. Proposing that we ‘doubt’ both the unity of public health and its effects, I argue that this version of STS opens up a space to recognise multiplicity; to avoid idealising what is being criticised; and to celebrate or care for public health practices as part of critique. Finally I oppose the view that considering technologies, materials and microbes leads to micro-level analysis or political neutrality, and suggest that it allows us to reframe studies of public health to account for inequalities and to draw attention to weak or retreating states, active markets and the entangled relations of humans and non-humans across the world.

 

Biopolitical precarity in the permeable body: the social lives of people, viruses and their medicines

Elizabeth Mills

This article is based on multi-sited ethnography that traced a dynamic network of actors (activists, policy-makers, health care systems, pharmaceutical companies) and actants (viruses and medicines) that shaped South African women’s access to, and embodiment of, antiretroviral therapies (ARVs).

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

Shouldn’t Dead Be Dead?: The Search for a Uniform Definition of Death

Check out “Shouldn’t Dead Be Dead?: The Search for a Uniform Definition of Death” in the latest Journal of Law Medicine & Ethics 45(1). 


NYU authors Ariane Lewis, Katherine Cahn-Fuller, and Arthur Caplan conclude:


“It is clear that variation in the definitions of death throughout the United States persists. The Hailu case introduced a medical, ethical, and legal quandary by questioning the medical determination of death and setting a legal precedent that the Harvard criteria for brain death should be treated as the only accepted medical standard for brain death determination, despite the fact that these criteria have been replaced by the AAN guidelines.  Variations in the definition of death yields uncertainty and confusion and can undermine public trust in both medicine and the law.”


“The President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recognized that it was imperative that the definition of death be identical throughout the United States. While they felt that individual states should have laws about the definition of death, they noted the role of the federal government in defining death was to ‘usefully bring together experts and representatives of different streams of thought on the matter [to] clarify support,’ such as was the case in both the Hailu and McMath cases, so that practices in such situations are uniform and thus understood by families, the media and the public.”


“The Commission hoped that the UDDA would prompt homogeneous medical and legal  management of all decedents, but it is clear that this goal has not been achieved.”

Source: bioethics.net, a blog maintained by the editorial staff of The American Journal 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

Debate Reponse: Charlie Gard, Interests and Justice – an alternative view

Dominic Wilkinson

Responding to Julian Savulescu

The sad and difficult case of Charlie Gard, which featured in the media last week, is the latest in a series of High Court and Family court cases when parents and doctors have disagreed about medical treatment for a child. Doctors regard the treatment as “futile” or “potentially inappropriate”. Parents, in contrast, want treatment to continue, perhaps in the hope that the child’s condition will improve. In the Charlie Gard case, the judge, Justice Francis, rejected Charlie’s parents’ request for him to travel to the US for an experimental medical treatment. He ruled that life-sustaining treatment could be withdrawn, and Charlie allowed to die.

Two reasons

As Julian Savulescu argues,there are two different ethical reasons for health professionals to refuse to provide requested medical treatment for a child. The first of these is based on concern for the best interests of the patient. Treatment should not be provided if it would harm the child. The second reason is on the basis of distributive justice. In a public health system with limited resources, providing expensive or scarce treatment would potentially harm other patients since it would mean that those other patients would be denied access to treatment.

The importance of resources

When doctors and the courts consider cases of ostensibly “futile” treatment, they often focus exclusively on best interests. That is understandable, since the prevailing ethical and legal frameworks largely ignore the question of limited resources. The courts have no mechanism, statute or precedent, to allow them to assess whether or not a treatment would be too expensive or of too little benefit to provide it.

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

Debate Reponse: Charlie Gard, Interests and Justice – an alternative view

Dominic Wilkinson

Responding to Julian Savulescu

The sad and difficult case of Charlie Gard, which featured in the media last week, is the latest in a series of High Court and Family court cases when parents and doctors have disagreed about medical treatment for a child. Doctors regard the treatment as “futile” or “potentially inappropriate”. Parents, in contrast, want treatment to continue, perhaps in the hope that the child’s condition will improve. In the Charlie Gard case, the judge, Justice Francis, rejected Charlie’s parents’ request for him to travel to the US for an experimental medical treatment. He ruled that life-sustaining treatment could be withdrawn, and Charlie allowed to die.

Two reasons

As Julian Savulescu argues,there are two different ethical reasons for health professionals to refuse to provide requested medical treatment for a child. The first of these is based on concern for the best interests of the patient. Treatment should not be provided if it would harm the child. The second reason is on the basis of distributive justice. In a public health system with limited resources, providing expensive or scarce treatment would potentially harm other patients since it would mean that those other patients would be denied access to treatment.

The importance of resources

When doctors and the courts consider cases of ostensibly “futile” treatment, they often focus exclusively on best interests. That is understandable, since the prevailing ethical and legal frameworks largely ignore the question of limited resources. The courts have no mechanism, statute or precedent, to allow them to assess whether or not a treatment would be too expensive or of too little benefit to provide it.

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

Blinded by the Promise of Stem Cell Treatments

Alan F. Cruess cautions against the use of unproven stem cell ‘treatments.’

__________________________________________

Recently, many of you may have read about three patients who are blind after receiving stem cell ‘treatments.’  The patients were ‘treated’ at a Florida clinic for age-related macular degeneration. This common eye condition is the leading cause of vision loss among people over the age of 50. The clinic harvested stem cells from the patients using liposuction and then injected these stem cells into their eyes. Again, these three patients, are now all blind as a result of this unproven ‘treatment.’

There are two types of age-related macular degeneration: ‘wet’ and ‘dry.’ In recent years, treatment of wet macular degeneration has been transformed by new drugs which can be very effective if they are applied early. Meanwhile, treatment of the more common dry macular degeneration remains elusive. As such, patients with dry macular degeneration may be desperate to prevent and reverse blindness and willing to try emerging regenerative therapies.

Some experimental stem cells treatments to prevent blindness are promising, and they are being studied worldwide in laboratories and highly regulated clinical trial settings. In these settings, the safety and efficacy of experimental treatments can be closely monitored. Yet, the safety and efficacy should be called into question when these so-called ‘treatments’ are marketed outside of the research context. This was the case at the Florida clinic.

Before subjecting oneself or a loved one to any new ‘treatment’ with stem cells patients should be informed about the risks and potential benefits of the proposed treatment.

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

Jelly Beans, Booze and B-Vitamins

The FDA’s policy guidelines on nutritional fortification include the so-called “jelly-bean rule:” the FDA considers it inappropriate to fortify candy or soda with nutrients because to do so would allow “misleading health claims” to be made about a putatively unhealthy … 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

Individually-randomized controlled trials of vaccines against the next outbreak

Guest Post: Nir Eyal, Marc Lipsitch

Paper: Vaccine testing for emerging infections: the case for individual randomisation 

The humbling experience of international response to Ebola taught the world a thing or two on preparing for Zika and for other emerging infections.

Some of those lessons pertain to vaccine development against emerging infections. One lesson was that vigorous vaccine development should start long in advance of outbreaks. CEPI, the Coalition for Epidemic Preparedness Innovations, was recently launched with an initial investment of half a billion US dollars from the Gates Foundation, Britain’s Wellcome Trust and the governments of Japan, Norway and Germany. There is also growing recognition that best practices on vaccine testing should be developed prior to outbreaks, from a study methodology viewpoint.

By contrast, in Zika, ethical guidelines on response in general and on an aspect of vaccine testing were created only once the pandemic erupted. Shouldn’t ethical disputes, e.g. on trial design for vaccine candidates, be ironed out in advance of emerging infections?

One persistent ethical question in vaccine testing pertains to individually-randomized control in efficacy trials. At the height of the 2014-5 Ebola outbreak, individually-randomized controlled trials were much maligned. Our paper at the Journal of Medical Ethics sets out to defend that approach for vaccine efficacy testing in emerging infections, including highly fatal and untreatable ones in developing countries.

Nearly everyone agrees that scientifically, individually-randomized controlled trials are the gold standard of clinical research. But during the Ebola outbreak, ethicists, leaders, and humanitarian workers opposed them. For testing vaccine against a highly fatal infection without approved drugs or vaccines, they deemed these designs unethical.

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.