Tag: uterus

Bioethics News

Viable human embryos CRISPR genetically edited in the USA. Technique and ethical controversies

Numerous complications could go unnoticed in this study

On 26th July, the journal MIT Technology Review  announced that the CRISPR technique (see HERE) had been applied in human embryos for the first time in the United States, in a study led by embryologist Shoukhrat Mitalipov of Oregon Health and Science University.

Gene editing has previously been performed on human embryos on at least three occasions in China. Accordingly, two articles from 2015 (see HERE) and 2016, respectively, reported the application of CRISPR on non-viable human embryos (see HERE) . Subsequently, in 2017, another paper reported the application of CRISPR on human embryos, this time viable (See HERE ). In all cases, the results revealed that there are still serious safety and efficacy obstacles before the method can even be considered for use in medical applications. Consequently, the editing was completely successful in only a very small number of embryos, and moreover, there were undesirable effects like mosaicism (when only some of the embryonic cells incorporate the desired change) and off-target mutations.

The findings of the new study were published on 2nd August in Nature. Most relevant, though, is not the fact that viable human embryos have been edited for the first time in the US, but that the problems of mosaicism and off-target mutations found in previous studies appear to have been largely overcome.

The technique

The experiment consisted of correcting a mutation in the MYBPC3 gene, which causes a heart disease. The mutation was found in the DNA of the sperm used to fertilize the eggs.

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

Charlie Gard Post-Mortem: Could He Have Been Saved?

Charlie Gard would have turned one year old tomorrow.

Two days before the British infant died of a mitochondrial disease on July 28, a short article in MIT Technology Review teased that Shoukhrat Mtalipov and his team at Oregon Health & Science University and colleagues had used CRISPR-Cas9 to replace a mutation in human embryos, a titillating heads-up that didn’t actually name the gene or disease.

Yesterday Nature published the details of what the researchers call gene correction, not editing, because it uses natural DNA repair. I covered the news conference, with a bit of perspective, for Genetic Literacy Project.

Might gene editing enable Charlie’s parents, who might themselves develop mild symptoms as they age, to have another child free of the family’s disease? Could anything have saved the baby?

A TRAGIC CASE

The court hearing testimony on the case between Great Ormond Street Hospital (GOSH) and the family, published April 11, chronicles the sad story. The hospital had requested discontinuing life support based on the lack of tested treatment.

Charlie was born August 4, 2016, at full term and of a good weight, but by a few weeks of age, his parents noticed that he could no longer lift his head nor support any part of his body. By the October 2 pediatrician visit, Charlie hadn’t gained any weight, despite frequent breastfeeding. After an MRI and EEG, Charlie had a nasogastric tube inserted to introduce high-caloric nutrition.

By October 11, the baby was lethargic, his breathing shallow. So his parents, Connie Yates and Chris Gard, took him to GOSH.

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

Charlie Gard Post-Mortem: Could He Have Been Saved?

Charlie Gard would have turned one year old tomorrow.

Two days before the British infant died of a mitochondrial disease on July 28, a short article in MIT Technology Review teased that Shoukhrat Mtalipov and his team at Oregon Health & Science University and colleagues had used CRISPR-Cas9 to replace a mutation in human embryos, a titillating heads-up that didn’t actually name the gene or disease.

Yesterday Nature published the details of what the researchers call gene correction, not editing, because it uses natural DNA repair. I covered the news conference, with a bit of perspective, for Genetic Literacy Project.

Might gene editing enable Charlie’s parents, who might themselves develop mild symptoms as they age, to have another child free of the family’s disease? Could anything have saved the baby?

A TRAGIC CASE

The court hearing testimony on the case between Great Ormond Street Hospital (GOSH) and the family, published April 11, chronicles the sad story. The hospital had requested discontinuing life support based on the lack of tested treatment.

Charlie was born August 4, 2016, at full term and of a good weight, but by a few weeks of age, his parents noticed that he could no longer lift his head nor support any part of his body. By the October 2 pediatrician visit, Charlie hadn’t gained any weight, despite frequent breastfeeding. After an MRI and EEG, Charlie had a nasogastric tube inserted to introduce high-caloric nutrition.

By October 11, the baby was lethargic, his breathing shallow. So his parents, Connie Yates and Chris Gard, took him to GOSH.

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

About That “First Gene-Edited Human Embryos” Story…..

July 28, 2017

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By Henry T. Greely

BREAKING NEWS: The sky is not falling. Brave New World and GATTACA are not right around the corner. And the newest “designer baby” breakthrough is, at most, an interesting incremental step.

The last few days have seen enormous attention paid to an unpublished human embryo paper—one, quite possibly, as yet unread by anyone commenting on it. According to the MIT Technology Review, Shoukhrat Mitalipov of the Oregon Health Sciences University will soon publish a paper about his successful use of the hot DNA technology CRISPR—clustered regularly interspaced short palindromic repeats—to modify viable human embryos.

“According to people familiar with the scientific results,” Mitalipov edited “a large number of one-cell embryos.” Mitalipov and colleagues “are said to have convincingly shown” that they could avoid two problems encountered in other CRISPR experiments in editing embryos: off target effects, where CRISPR changes the wrong bits of DNA, and mosaicism, where CRISPR changes some cells but not all. The embryos were destroyed after “a few days” and were never intended to be transferred into a woman’s uterus for possible implantation and birth. Sperm from men carrying disease mutations was used to make the embryos, though Technology Review “could not determine which disease genes had been chosen for editing.”  The story discusses legal bans on making babies using this method but ends with “Despite such barriers, the creation of a gene-edited person could be attempted at any moment, including by IVF clinics operating facilities in countries where there are no such legal restrictions.“

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 case of deceased donor uterine transplantation. It is a relevant medical and social issue

Being able to resolve the reproductive problems suffered by women who have no uterus – whether due to an organic cause or functional abnormality of the uterus – is unquestionably a major medical and social issue.

The two possible solutions to this problem are uterus transplantation or surrogacy, the latter solution presenting objective ethical difficulties.

Uterus transplants to date have been performed using living donors, with unpredictable outcomes. Now, the first case of deceased donor uterine transplantation performed in the United States has been published. The recipient of the uterus was a woman with Mayer-Rokitansky-Kuster-Hauser syndrome, that is, she had no uterus.

The journal Fertility and Sterility has disseminated a video describing the essential steps in this transplantation process, particularly as regards selection of a suitable donor with no history of infertility or uterine malformations. The death of the donor should be determined by presentation of brain death but not cardiac death. The authors concluded that: “Uterine transplantation, although currently experimental, has gained the potential to become the first true treatment for uterine factor infertility. This procedure can become a promising option for the approximately 1.5 million women worldwide for whom pregnancy is not possible because of the absence of the uterus or presence of a nonfunctional uterus. Deceased donor uterine transplantation will further serve to broaden accessibility for this treatment.”

Ethical approach

For our part, as the organ donor is a deceased person with brain death (see true definition of this death HERE), we see no ethical issue for this practice; on the contrary, it seems an encouraging medical prospect to resolve the reproductive problem of women who have no uterus or whose uterus is not functionally useful, although the risk-benefit balance must always be taken into account, especially as regards the surgical act.

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

Medical tourism for controversial treatment options

By Dominic Wilkinson

 

Baby C’s parents had done their research. They had read widely about different options for C and had clear views about what they felt would be best for their child. They had asked a number of doctors in this country, but none were willing to provide the treatment. After contacting some specialists overseas, they had found one expert who agreed. If the family were able to pay for treatment, he was willing to provide that treatment option.

However, when C’s local doctors discovered that the parents planned to leave the country for treatment the doctors embarked on court proceedings and contacted the police.

One of the questions highlighted in the Charlie Gard case has been whether his parents should be free to travel overseas for desired experimental treatment. It has been claimed that the NHS and Great Ormond St are “keeping him captive”. Why shouldn’t C’s parents be free to travel to access a medical treatment option? When, if ever, should a state intervene to prevent medical tourism?

On the face of it, stopping patients or parents from undertaking medical tourism appears to violate two important freedoms – the freedom to travel and the freedom to make decisions about medical treatment. There might be reason for a country not to provide a particular treatment option – for example because it is unaffordable within a public healthcare system, or because doctors in that country do not approve of it, or lack experience or expertise in providing it. But why should patients or parents be prevented from accessing treatment overseas.

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.

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 Blogs

Samaritan Ministries and Ectopic Pregnancies

As I was reading Laura Turner’s Buzzfeed essay about Christian health sharing ministries this past week, I was startled to discover that Samaritan Ministries, the insurance alternative my husband uses, does not cover expenses related to ectopic pregnancies.

In Section VIII of the Samaritan Ministries Guidelines, “Needs Shared by Members,” Ectopic Pregnancies is listed as the ninth item under “Miscellaneous Items Not Shared.” The guidelines state:

“Expenses related to the termination of the life of an unborn child are not publishable. The removal of a living unborn child from the mother which results in the death of the child is a ‘termination of the life of the child’ unless the removal was one for the primary purpose of saving the life of the child, or improving the health of the child. This means that the removal from the mother of an unborn child due to an ectopic pregnancy (outside the normal location in the uterus) is not publishable unless the member states they believed the child was not alive before the procedure. Considerations of the health or life of the mother does not change that the removal of a living unborn child from the mother may be a termination of life.”[1]

Ectopic pregnancy occurs when a fertilized egg implants outside of the uterus, most commonly in one of the fallopian tubes.[2]  The condition is highly dangerous to the mother, who is at risk of internal rupturing and blood loss.[3]  While there are different classifications of ectopic pregnancies and a few different methods of treatment, Turner approximates the cost of surgery to save the life of the mother to be around $15,000.

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 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.