Tag: regulation

Bioethics News

The amazing finding of senescent cells in embryos. Until now, these cells had been found only in aging tissue

The discovery raises the possibility that the start and end of life are intimately connected

The process by which cells cease multiplying is known as senescence. In 1961, biologists Hayflick and Moorehead cryoconserved human fetal cells and found that these divide around 50 times and then simply stop doing so, as occurs in the human body (see recent article, AGING CELLS ARE KEY TO FINDING FOUNTAIN OF YOUTH)

In fact, senescent cells are involved in many of the signs of aging: wrinkled skin, cataracts, and arthritic joints, which are produced by the effect of an increase in these cells. On the contrary, it has been found that by decreasing senescent cells in mice, signs of rejuvenation can be detected in these animals.

Considering that in all research, senescent cells have been found only in old or damaged tissues, the last place one would expect to find them would be at the very beginning of life, in the embryo. Now, however, three scientific teams have reported that they have observed the same phenomenon at this point.

Senescent cells in embryos

For the first time, senescent cells have been found in embryos, and scientists have presented proof that senescence is crucial for their proper development.

This discovery raises the possibility that the start and end of life are intimately connected. In order for life to have a good start, senescent cells are needed, i.e. youth needs a little bit of old age.

Scott Lowe, an expert in senescence at Memorial Sloan-Kettering Cancer Center, who did not participate in the research, has lauded the studies, which point to the unexpected role of old age, and predicted that it would provoke a spirited debate between developmental biologists, who study how embryos are formed.

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 v. Opana ER: Opioids, Public Health, and the Regulation of Second-Order Effects

Earlier this month, the FDA announced that it is asking Endo Pharmaceuticals to remove the opioid Opana ER from the market.  Opana ER is an extended-release pain reliever often abused by those who take it.  While opioid abuse is nothing new, … Continue reading

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

Fake News – A Role for Neuroethics?

By Neil Levy
Neil Levy is professor of philosophy at Macquarie University, Sydney, and a senior research fellow at the Uehiro Centre for Practical Ethics, University of Oxford.
 
Fake news proliferates on the internet, and it sometimes has consequential effects. It may have played a role in the recent election of Donald Trump to the White House, and the Brexit referendum. Democratic governance requires a well-informed populace: fake news seems to threaten the very foundations of democracy.
How should we respond to its challenge? The most common response has been a call for greater media literacy. Fake news often strikes more sophisticated consumers as implausible. But there are reasons to think that the call for greater media literacy is unlikely to succeed as a practical solution to the problem of fake news. For one thing, the response seems to require what it seeks to bring about: a better informed population. For another, while greater sophistication might allow us to identify many instances of fake news, some of it is well crafted enough to fool the most sophisticated (think of the recent report that the FBI was fooled by a possibly fabricated Russian intelligence report).
Moreover, there is evidence that false claims have an effect on our attitudes even when we initially identify the claims as false. Familiarity – processing fluency, in the jargon of psychologists – influences the degree to which we come to regard a claim as plausible. Due to this effect, repeating urban legends in order to debunk them may leave people with a higher degree of belief in the legends than before.

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

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 Crisis of Our Era: Can we find a way to talk about it?

So much of the fate of our planet, the human race, and all of God’s creatures depends on humans having an objective, causal understanding of the pressing problems we face and then, on that basis, developing some reasonably effective practical means by which those threats can be ameliorated—it’s called, using human intelligence and being connected to reality, at least reality with a small “r”, as in empirical reality. Just think of the causes of threats such as climate change, transmittable diseases and drug resistant viruses, gun violence, drug abuse, hunger, unemployment, poverty, lack of healthcare coverage, and on and on. Without reasonably sound knowledge of the causes of these threat humans are rendered helpless and vulnerable. And even with sound knowledge, without a practical, yes political, means, in the form of sound public policy, of collective action, to ameliorate them, we are cannot take meaningful action, and are still rendered helpless and vulnerable. Currently, in the United States there is vast disagreement not only over how best to formulate policy solutions to some our most pressing problems, there is often no agreement over how to understand the problem or even whether or not a problem exists. Climate change and gun control are two prominent examples. 

The fact that climate change is real and greatly accelerated by human activity is a fact about which there is clear scientific evidence. Practically all scientific societies, science academies, and governmental and intergovernmental agencies, are in complete agreement, which means the evidence for this empirical claim being true is about as compelling as anything we know about the natural phenomena.

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 Crisis of Our Era: Can we find a way to talk about it?

So much of the fate of our planet, the human race, and all of God’s creatures depends on humans having an objective, causal understanding of the pressing problems we face and then, on that basis, developing some reasonably effective practical means by which those threats can be ameliorated—it’s called, using human intelligence and being connected to reality, at least reality with a small “r”, as in empirical reality. Just think of the causes of threats such as climate change, transmittable diseases and drug resistant viruses, gun violence, drug abuse, hunger, unemployment, poverty, lack of healthcare coverage, and on and on. Without reasonably sound knowledge of the causes of these threat humans are rendered helpless and vulnerable. And even with sound knowledge, without a practical, yes political, means, in the form of sound public policy, of collective action, to ameliorate them, we are cannot take meaningful action, and are still rendered helpless and vulnerable. Currently, in the United States there is vast disagreement not only over how best to formulate policy solutions to some our most pressing problems, there is often no agreement over how to understand the problem or even whether or not a problem exists. Climate change and gun control are two prominent examples. 

The fact that climate change is real and greatly accelerated by human activity is a fact about which there is clear scientific evidence. Practically all scientific societies, science academies, and governmental and intergovernmental agencies, are in complete agreement, which means the evidence for this empirical claim being true is about as compelling as anything we know about the natural phenomena.

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

I <3 Intended Use (and why some new technologies may fall within FDA jurisdiction)

Cross-posted on Objective Intent

A few news stories over the past week or so—one in the Wall Street Journal about “neurotech,” one in Geek Gadget about “neuroscience wearables,” one in the Washington Post about baby monitors for measuring an infant’s vital signs, and one in Gizmodo about “vaginal wellness products” marketed on Etsy—reminded me how much I enjoy questions of intended use.  As I wrote more about here, intended use is a critical concept in FDA law, in part because a product’s intended use is crucial to determining whether it meets the law’s definition of drug or device within the FDA’s jurisdiction.  And, for whatever reason, I have an unabashed and—as far as I can tell—limitless love for thinking through questions about whether, and how, products fall with the definition of a drug or device.

As for the reported neurotech, neuro-wearable, baby monitor, and vaginal wellness products, it seems to me that many of these products may fall within the Federal Food, Drug, and Cosmetic Act’s (FDCA) definitions of drugs or devices.  Why is that?

The FDCA defines drugs and devices as products “intended for use” in the diagnosis, cure, mitigation, treatment, or prevention of diseases, or “intended to affect the structure or any function of the body.”  And this definition is very broad.

The “disease” piece of the definition captures things like cancer therapies and artificial heart valves—products that fit comfortably within what many commonly understand to be drugs and devices subject to FDA regulation.  But, because implicit claims about addressing disease can also cause a product to fall with the definition of a drug or device, this part of the definition also might capture things like baby monitors marketed as measuring breathing and oxygen levels.

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

2nd International Conference on End-of-Life Law, Ethics, Policy, and Practice

Check out this remarkable collection of concurrent sessions coming up at the 2nd International Conference on End-of-Life Law, Ethics,
Policy, and Practice (ICEL) in Halifax.



The Ethics of POLST
Lloyd Steffen


The Perils of POLST
Jean Abbott


Advanced Directives and Advanced Care Planning
Peter Saul


“Rock, Paper, Scissors” – Ideologies of End of Life Care for Older People in Hospital
Laura Green


The Cultural Construction of End of Life Issues in Biomedicing: Anthropological Perspectives
Betty Wolder Levin


Caregiver Perspectives of Palliative and End of Life Care for Individuals at End-Stage Dementia in Newfoundland and Labrador: A Qualitative 
Phenomenological Perspective
Barbara Mason


End of Life Regulation and Recent Evolutions in France
Veronique Fournier


To Live and Let Die. Withholding and Withdrawing Life Sustaining Treatment in Argentina: From Therapeutic to Judicial Obstinacy
Maria Ciruzzi


When and How I Shan’t Live: Refusing Life-Prolonging Medical Treatment and Article 8 ECHR
Isra Black


Divorcing Mercy Killing from Euthanasia
Bryanna Moore


The Shift Away from Suicide Talk: Incorporating Voices of Experience
Phoebe Friesen


Elderly Who are Ready to Give Up on Life and the Right to Autonomy
Michelle Habets


Dutch GP’s Views on Good Dying and Euthanasia
Katja ten Cate


Medical Aid in Dying in New York State: Physician Attitudes and Impact of Framing Bias
Brendan Parent


Physicians’ Perceptions of Aid in Dying in Vermont
Ari Kirshenbaum


A New American Threat to Open Discussion of End-of-Life Issues
Robert Rivas


Demedicalised Assistance in Suicide
Martijn Hagens


The Human Rights Implications of the Blanket Ban on Assisted Suicide in England and Wales
Stevie Martin


A Year in Review: The Who, When, Why and How of Requests for Medical Aid in Dying in Quebec
Lori Seller and Veronique Fraser


Medical Aid in Dying: An Update from Québec
Michelle Giroux


Regulating MAiD: The Medical Regulatory Perspective
Andréa Foti


Patients with Parkinson’s Disease, Caregivers’, and Healthcare Providers’ Perspectives on Advance Care Planning on End-of-Life Care
Kim Jameson


‘You’re Going to Die.

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 biological status of the early human embryo. When does human life begins?

“Those who argue that that embryo can be destroyed with impunity will have to prove that this newly created life is not human. And no-one, to the best of our knowledge, has yet been able to do so.”

Introduction

In order to determine the nature of the human embryo, we need to know its biological, anthropological, philosophical, and even its legal reality. In our opinion, however, the anthropological, philosophical and legal reality of the embryo — the basis of its human rights — must be built upon its biological reality (see also HERE).

Consequently, one of the most widely debated topics in the field of bioethics is to determine when human life begins, and particularly to define the biological status of the human embryo, particularly the early embryo, i.e. from impregnation of the egg by the sperm until its implantation in the maternal endometrium.

Irrespective of this, though, this need to define when human life begins (see our article  is also due to the fact that during the early stages of human life — approximately during its first 14 days — this young embryo is subject to extensive and diverse threats that, in many cases, lead to its destruction (see HERE).

These threats affect embryos created naturally, mainly through the use of drugs or technical procedures used in the control of human fertility that act via an anti-implantation mechanism, especially intrauterine devices (as DIU); this is also the case of drugs used in emergency contraception, such as levonorgestrel or ulipristal-based drugs (see HERE), because both act via an anti-implantation mechanism in most of the time.

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 biological status of the early human embryo. When does human life begins?

“Those who argue that that embryo can be destroyed with impunity will have to prove that this newly created life is not human. And no-one, to the best of our knowledge, has yet been able to do so.”

Introduction

In order to determine the nature of the human embryo, we need to know its biological, anthropological, philosophical, and even its legal reality. In our opinion, however, the anthropological, philosophical and legal reality of the embryo — the basis of its human rights — must be built upon its biological reality (see also HERE).

Consequently, one of the most widely debated topics in the field of bioethics is to determine when human life begins, and particularly to define the biological status of the human embryo, particularly the early embryo, i.e. from impregnation of the egg by the sperm until its implantation in the maternal endometrium.

Irrespective of this, though, this need to define when human life begins is also due to the fact that during the early stages of human life — approximately during its first 14 days — this young embryo is subject to extensive and diverse threats that, in many cases, lead to its destruction (see HERE).

These threats affect embryos created naturally, mainly through the use of drugs or technical procedures used in the control of human fertility that act via an anti-implantation mechanism, especially intrauterine devices (as DIU); this is also the case of drugs used in emergency contraception, such as levonorgestrel or ulipristal-based drugs (see HERE), because both act via an anti-implantation mechanism in 50% of cases.

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.