Tag: transplantation

Bioethics News

The Future of Bioethics: Organ Transplantation, Genetic Testing, and Euthanasia

By Ana Lita

When you think of bioethics, some of the first hot-button topics you may consider are organ transplantation, fertility and genetic engineering, and end-of-life-care. The Global Bioethics Initiative serves as a platform to address many bioethical questions and engages in public debates to develop resolutions to present and emerging issues.

Dr. Ana Lita, founder of the Global Bioethics Initiative, discusses the various areas GBI addresses and highlights the organization’s contributors in their prospective fields. She acknowledges the valuable contribution of the current president of GBI, Dr. Bruce Gelb, in the field of organ transplantation. She also addresses the original co-founder of GBI, Dr. Charles Debrovner, and his lifelong passion in the field of fertility and genetic engineering. Lastly, Dr. Lita offers a brief insight into the future of Bioethics in these uncertain times.

ORGAN MARKETS AND THE ETHICS OF TRANSPLANTATION 

Recent developments in immunosuppressive drugs and improved surgical techniques have now made it much easier to successfully transplant organs from one human body to another. Unfortunately, these developments have led to the rise of black-markets in human organs. This underground market is where people who need kidneys to survive or to improve the quality of their lives, for example, purchasing such organs from impoverished persons in the developing world. In January 2017, scientists announced that they successfully created the first human-pig hybrid and a pig embryo with some human characteristics. Given the increasing need for transplant organs, should such markets be regulated and legalized?  Could the success of therapeutic cloning eliminate the need to consider this option?

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 Semantics of Therapy, Part II

A previous blog post of “The Semantics of Therapy” posed three questions about the human genome being a “patient” to be treated. One reader found the post “provocative and disturbing” and called for further explanation and discussion of the questions posed. That will take some time and several postings.

The first of the questions to be considered is this: If the “patient” is a genome, to whom does the researcher answer?   An answer from recent history may shed some light on this important issue.

33 infertile couples underwent a novel procedure at New Jersey’s Saint Barnabas Medical Center during the years 1996-2001. Embryologist Jacques Cohen used cytoplasmic transfer–ooplasm from the oocytes of fertile women was transferred into the eggs of infertile women–in the hope of establishing pregnancies in the latter. The outcome was 13 pregnancies and 17 babies from the Saint Barnabas experience (see accounts here and here).

According to a 2014 BBC article, one resulting pregnancy, which ended in miscarriage, revealed a missing X chromosome in the fetus. The same anomaly was noted in another child: one of a set of twins from a different pregnancy. Later, one child showed evidence of developmental delay. In 2014, Cohen estimated that the worldwide experience of cytoplasmic transfer between oocytes had resulted in the births of 30-50 babies, although the FDA had effectively stopped the procedure in the U.S. in 2002.

What had the follow-up on the babies born through cytoplasmic transfer been in 2014?

Due to a lack of funding, Cohen says, it hasn’t been possible to find out about how any of the children like Alana who were born from cytoplasmic transfer are doing.

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

Equipoise and Caution Regarding “Ethical” Stem-Cell Therapy

You may have seen one of the many news reports this week about an “adult” stem cell treatment gone bad.  In it, doctors, not working in regulated industry or in the bounds of a clinical trial, injected stem cells derived from a person’s fatty tissue into the eyeballs of three people in an attempt to treat a vision-destroying condition called macular degeneration—and all three lost what remaining vision they had.  T

In a separate experience, two people received “reprogrammed” stem cells, also called “induced pleuripotent stem cells” or “iPSCs,” for the same condition, and they did not appear harmed, and may have been showing early signs of improvement, one year later.  In this second case, the cells are described as having undergone rigorous quality testing before being injected into the patients’ eyeballs.

The two cases are described in this week’s New England Journal of Medicine.  The links above are to those reports; subscription may be required to read them.  NEJM makes some of its editorials and perspective pieces generally available, other articles not.  Two such articles, one from FDA and one from a physician at Boston Childrens’ Hospital, address these cases.  In both opinion articles, the authors argue that careful regulation and quality control of stem cell studies is critical to their ethical testing.

To say this position is hard to argue with is a gross understatement.  I will confess that on this blog, in the past, I have wondered whether some use of “adult” or “somatic” stem cells is over-regulated, as, for example, when such cells are obtained from a woman’s fatty tissue, and reinjected into her in an attempt at breast reconstruction after surgery.  I’ve seen proposals in the past for work like that, and it seemed pretty straightforward—recovering a cell layer from a centrifuge, and reinjecting, all under sterile conditions.  The doctors in question in the case I saw were not in any way trying to cut any corners.  But existing regulation would have prevented their proposed breast-surgery work without a couple million dollars’ worth of the kind of work needed, and usually funded by industry, before commencing human trials of a new 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

ORGAN DONATION AFTER MEDICAL AID IN DYING

Jennifer A. Chandler describes some of the ethical and legal challenges surrounding organ donation following medical assistance in dying.

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Today, it is medically possible to donate organs following death brought about by medical assistance in dying. This currently happens in countries like Belgium and the Netherlands. People with neurodegenerative conditions like amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, or multiple sclerosis (MS) are eligible to donate organs. Those with cancer, however, are not eligible because of risks to recipients.

In Canada, people with neurodegenerative conditions who satisfy the legal eligibility criteria for assisted dying may also meet the medical eligibility criteria for organ donation. However, this possibility raises novel ethical, legal, and policy issues that must be carefully considered. The following four hypothetical cases illustrate some of these issues.

CASE 1 – A patient seeks assisted dying and wants to donate to a family member.

Some provinces allow people to direct their organ donations to relatives after they die. Some patients who choose assisted dying may derive some comfort from being able to help a family member in this way. There is the risk, however, that patients may feel pressured to seek assisted dying, in part, to benefit a sick relative.

CASE 2 – A family member is asked to consent to cornea donation for a loved one who passed away through assisted dying. The patient was not asked about this before his death because he was not registered as an organ donor, and nobody wanted to burden him with the decision. 

It seems inappropriate not to ask patients about organ donation prior to death, when they are capable of speaking for themselves.

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

Stem cell therapy remains a form of treatment

There is a picture of stem cell therapy: It is in harmony with the body’s own way of functioning. Damaged tissue is regenerated as the body always regenerates tissue: through stem cells maturing into new body cells.

Patients can then hope for a body without a trace of disease: a healed body that takes care of itself as a healthy body does. It is almost as if we were not dealing a treatment at all, for the body restores itself, as it always does.

Stem cell therapy is certainly an important step towards effective treatment of several currently incurable diseases. The methods can also be said to be based on the body’s own way to regenerate tissue.

Nevertheless, I think we should emphasize that stem cell therapies are treatments next to others, with risks and benefits. Cells are transplanted into patients whose immune system can react. The implants may need to be checked regularly, or even be replaced. The transplantation can go wrong. And so on.

Stem cell therapy does not “transcend” all disease treatment hitherto by supporting the body’s own way of healing itself. We are still dealing with treatments of patients, rather than with “salvation from disease.”

Rhetoric of salvation is dangerous. It invites magicians and our faith in them. It justifies sacrifices to the benefit of Mankind. It disturbs our judgement.

Pär Segerdahl

This post in Swedish

The temptation of rhetoric - the ethics blog

Source: The Ethics Blog.

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

How to Keep HIV Cure-Related Trials Ethical: The Benefit/Risk Ratio Challenge

Guest Post by Nir Eyal

Re: Special Issue of the Journal of Medical Ethics on the ethics and challenges of an HIV cure

For most patients with HIV who have access to antiretroviral treatment and use it properly, that treatment works well. But the holy grail of HIV research remains finding a cure. Sometimes that means a literal, sterilizing cure that would remove HIV from the body. But increasingly the aim is to find a mere functional cure that would send HIV into sustained remission during which antiretrovirals would be unnecessary.

Early successes in cure-related research, most notably the apparent cure of ‘Berlin patient’ Timothy Brown, prompted the International AIDS Society and the US National Institutes of Health to declare cure-related research a high priority. Recent successes in animal models have re-kindled hopes, and cure-related research is ongoing.

But there is a catch. Many of the early-phase cure-related studies that are currently planned or under way carry risks that are either very high or hard to quantify. These risks come from toxicity (e.g., of stem cell transplantation in an immunocompromised population), necessary interruptions to antiretroviral treatment (either short ‘pauses’ or intentionally longer breaks), or invasive physical exams. They affect study subjects and, sometimes, third parties like sexual partners or foetuses.

While high or unknown risks are a mainstay of early-phase trials in areas like cancer research, cure study participants typically have a safe and efficacious alternative to those risks: remaining on antiretrovirals. Can we justify asking patients who are doing well on antiretrovirals to accept the risk and uncertainty of many HIV cure-related trials?

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 Formation of the Global Bioethics Initiative Featured in IMPAKTER

In this series of global leaders, we will highlight an international non-profit healthcare organization that provides a bridge between patient care and the complexities of medicine. This area of healthcare is often referred to as Bioethics and in 2011, Dr. Ana Lita and Dr. Charles Debrovner co-founded Global Bioethics Initiative (GBI). This organization offers an all-inclusive resource that allow young and established healthcare professionals a place to learn about essential information about the ethical dilemmas in medicine. GBI is unique in their approach in that they make Bioethics approachable and tangible to everyone. This first installment of this series will layout the reasons behind making bioethics global, the reasons for forming GBI, and their educational programs.

WHY GLOBAL BIOETHICS?

People are beginning to appreciate more deeply the bonds between human well-being and the unrelenting pace of medical and technological advances. The progress made in life sciences, medicine and biotechnology in recent years has provided us with exciting and novel ways of treating, preventing, and curing human diseases. Some (relatively) recent notable and controversial developments in medical science and biotechnology include: markets in organs and transplantation therapy, the accessibility of biotechnological developments in reproductive healthcare, genetic testing and gene therapy, the End-of-Life, the “right to die” and palliative care, as well as life extension, healthy aging and regenerative medicine. While the positive impact of these advances on individuals and societies must be applauded, the ethical consequences of such developments necessitate our attention. The increasing power that new biotechnologies offer us requires that we consider not only whether something can be done, but whether it should it be done.

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

Human-Pig Chimeras: The Potential and Concerns Of Hybrid Human-Animal Organs

One of the great advances in modern medicine has been the success of organ transplantation. Whilst complications still arise from its use, the refinement of drugs designed to reduce organ rejection alongside other improvements, mean that the procedure is often lifesaving.

As is frequently the case however, there is a caveat to this “wonder-cure”, namely, that far more people require organs than there are organs available. This global shortage has given rise to a host of complex ethical challenges. Several of these issues have already been explored here, including the implementation of ‘opt-in’ organ donation systems and the appropriateness of receiving organs on the basis of ability to pay1, 2, 3.

The development of chimeric human-pig embryos announced in the journal Cell last week may therefore be hailed as the much-needed answer to this problem of organ shortages. With over 120,000 people on the national transplant list in the US alone and 22 people on that list dying each day, any opportunity to increase the numbers of transplantable organs has an obvious appeal4. However, this development is far from a perfect solution.

Chimeric embryos are early life forms that are composed from 2 or more different sets of genetic material. In this case therefore, one set of genetic material is from a pig and the second from a human. These chimeras were initially made in the laboratory, before being transplanted into surrogate sows. In the study, only a fraction of the total embryos transplanted (just over 10%) showed successful development, surviving for 3-4 weeks5.

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

First child born after mother-daughter uterus transplant

The outcome of the first case in which a child was born after a uterus transplant between mother and daughter arises the debate

Uterus transplantation is accompanied by an intense clinical and ethical debate (see HERE). The outcome of the first case in which a child was born after a uterus transplant between mother and daughter (50 years old and 28 years old, respectively) has recently been revealed. The pregnancy was achieved after transfer of the first embryo and was uneventful up until week 34, when the patient developed cholestasis (obstruction of bile flow output) and pruritus. She subsequently underwent a caesarean section at week 35, giving birth to a healthy baby boy weighing 2335 grams. Three and a half months after the birth, she underwent a hysterectomy (removing the transplanted uterus). The child developed normally and mother and daughter do not present any special health problems 3 years after the transplant. This is the first case of uterus transplantation between mother and daughter, and the second using a donor uterus.

La entrada First child born after mother-daughter uterus transplant aparece primero en Observatorio de Bioética, UCV.

Source: Observing Bioethics.

This article was originally published by the Bioethics Observatory of the Catholic University of Valencia. Up-to-date news and reports from the Bioethics Observatory at the Catholic University of Valencia (Spain), covering a wide range of bioethical issues including stem cell research, abortion, assisted suicide and much more. General interest and specialised topical articles with ethical implications, based on the latest research findings from some of the world's top medical and scientific 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

Ethics and law of stem cell treatment of diabetes

Many people support in various ways medical research, which they perceive as urgent in view of the needs of various patient groups. But patients typically won’t benefit from research unless the results are translated into development of medical products.

Type 1 diabetes is an incurable disease that requires daily life-sustaining treatment and strict dietary rules. Disease onset usually occurs at an early age.

In Sweden, about 50 000 people have this form of diabetes and of these around 8 000 are children. In type 1 diabetes, the immune system attacks the insulin-producing cells. Without insulin the body cells cannot use glucose for energy, and the sugar level in the blood rises. Energy is recovered instead from fat and protein, which causes waste products that can cause diabetic coma and attacks on vital organs.

Today, diabetes is treated with daily insulin injections, or by using an insulin pump. This requires continuous measurement of blood sugar levels, as incorrect doses of insulin entails risks and can be life-threatening. It is not easy to live with diabetes.

An alternative treatment, which is still at the research stage, is to generate new insulin-producing cells using human embryonic stem cells. The insulin-producing cells detect blood sugar levels and regulate the secretion of insulin. In order not to be attacked by the immune system, the transplanted cells are encapsulated in a protective material. It may become easier to live with diabetes.

But research alone doesn’t treat diabetes. Encapsulated insulin-producing cells need to be produced and made available also to patients; not only to research participants. But this is a big step and a host of ethical and legal issues, including embryo donation, patentability and consent, need to be examined and discussed.

The Swedish Research Council recently granted funding for a project to examine these issues. The project is led by Mats G. Hansson at CRB and is a collaboration with Olle Korsgren, professor of transplantation immunology, as well as with lawyers Anna-Sara Lind and Bengt Domeij, and philosophers and ethicists Jessica Nihlén Fahlquist and Pär Segerdahl.

The step from stem cell research to available treatments requires reflection. I look forward to start thinking about the ethical and philosophical questions.

Pär Segerdahl

This post in Swedish

Approaching future issues - the Ethics Blog