by NexDev | February 16, 2018 | Bioethics, Medically Assisted Procreation, Prenatal diagnosis
On February 13th, the French Biomedicine Agency (“ABM”) published its report on the application of the bioethics law, just three weeks after the official launch of the National Bioethics Conferences on January 18, 2018.
The ABM reviewed 4 major topics for which it has been declared competent: organ donation, assisted-reproductive techniques (ART), prenatal diagnosis and embryo research. According to the report, the 2011 bioethics law has generally lived up to expectations. However, the ABM questions the issues related to the very fast progress of science and technology. Several risks that the Bioethics law could deteriorate, and lead to major ethical dilemmas, are noted in the conclusion as well as some recommendations for future action plans.
For embryos and embryonic stem cell research, the ABM questions again the authorization of research, in cases where no other alternative exists.
But whereas the ABM report questions the use of induced pluripotent stem (iPS) cells as a reliable alternative to the classic embryonic stem (ES) cells, the authors, at the same time, paradoxically wish to debate on the artificial gametes produced from these same iPS cells, to possibly manufacture embryos for research, although this is currently banned.
Since both INSERM and the French Medical Academy have recommended conducting genome modification research on embryos and gametes, the ABM also tables the question of authorizing this research.
The agency does not mention ART for cases other than medical indications (for single women or same-sex couples), nor auto-preservation of oocytes for non-medical reasons, nor the anonymity of the donation of gametes. These 3 issues are part of the debate in the current National Bioethics Conferences.
On the other hand, the ABM addresses the ban on post-mortem insemination. The agency recommends setting an age limit for insemination with ART and authorizing the dual donation of gametes, which is now forbidden, and specifies that at least one member of the couple should be genetically related to the unborn child.
As proof of the growing pressure to obtain gametes, the ABM advocates relinquishing the requirement for the donor’s spouse to consent to a donation. They go as far as advocating the management of oocyte donations to the lucrative private sector.
Wouldn’t this circumvent the principle of gratuity?
The ABM report also proposes facilitating the procedures involving donation of embryos, which currently require authorization from the High Court’s president for both the donor couple, and the recipient couple, considering the responsibility of transferring one’s own embryo to another couple.
The ABM deemed it inadvisable to review the presumed consent to organ donation, but finds it appropriate to link this to the advance directives.
The agency suggests extending the reciprocity system for organ donation to an international level (for living donors and recipients). In addition, the ABM proposes harmonizing the collection and donation of hematopoietic stem cells (cord blood, bone marrow donation, etc.).
Scientific progress, such as genome sequencing, continues to raise more ethical issues. Without offering any conclusions, the ABM instead tables a series of questions. For example: what would happen if prenatal screening included sequencing the whole genome; what would the consequences entail?
by NexDev | February 16, 2018 | Medically Assisted Procreation
On 15 February 2018, the Appeals Court in Versailles, France validated two adoption applications for children born by assisted-reproductive technology (ART) for 2 homosexual female couples.
Last year, on June 29, 2017, the High Court in Versailles had refused the applications for full adoption on the grounds that “perhaps one day, a hypothetical father would come forth to claim” his child.
For the Appeals Court, “the possibility that the biological father would one day desire to file claim for his child (was) purely hypothetical without any consistent evidence”.
In September 2014, the Court of Cassation gave a verdict aimed at legitimizing full adoption by the female spouse of a woman who had obtained the child abroad by artificial reproduction with an anonymous donor. Since then, several French Appeals’ Courts have given similar rulings. In the “Cassation Opinion” dated September 22, 2014, n°s. 14-70.006 and 14-70.007: “The use of assisted-reproductive techniques (ART) with artificial insemination by an anonymous donor abroad, does not preclude the child from being adopted by the mother’s female partner, provided the legal conditions for adoption are met and that it is in the best interest of the child. “
During the debates on same-sex marriage Alliance VITA already warned against this domino effect. The important issue remains that of the interest of the child. As Alliance VITA has pointed out invariably, the adoption process is being turned upside-down. Adoption is not intended to “obtain” a child for people who have conceived it illegally. Adoption is intended to provide a family to a child who is already living, a child who has suffered a significant trauma from being accidentally deprived of his father and / or mother. Instead of healing an injury, the adoption process is now being used in these cases to endorse the initial abuse of the child.
by NexDev | February 16, 2018 | News
Established on September 9, 2013, the French National Suicide Observatory (“ONS”) recently published their 3rd report entitled “Ethical issues in suicide prevention, the specific case of teenage suicide “. Published on February 5, 2018 the report declares that the suicide rate in France decreased by 26% between 2003 and 2014, although it still remains one of the highest in Europe, ranking 10th out of 32, behind Finland, Belgium and a number Eastern countries.
According to the French Center for Epidemiology on the medical causes of death of Inserm (“CépiDcInserm”), 8,885 suicides were officially reported in metropolitan France in 2014. This figure is equivalent to 24 deaths per day, or one death every hour. Since the report only tallies deaths which are recorded as voluntary, the figure of 8,885 suicides may be underestimated by 10%; the actual figure could reach 10,000.
One section of the report deals with the suicidal behavior of young people, a major public health concern, which was not evaluated in the previous two Observatory reports. After car accidents, suicide is the second leading cause of death among 15-24 year-olds, accounting for 16% mortality in 2014. Although this suicide rate is relatively low compared to other age groups, it seemed pertinent to evaluate this phenomenon. The suicide of a young person has an undeniable effect on his loved ones, his acquaintances, the media and society in general.
In metropolitan France, the average suicide rate was 17 per 100,000 inhabitants for the years 2012-2014. More men committed suicide than women (23.1 vs. 6.8 per 100,000). Suicide rates increase sharply with age according to this report. The highest rate was between ages 45-54, and after age 75, with respective numbers of 33.4 and 59.4 per 100 000 men. In addition, suicide rates are higher in the northern half of France. Significant differences were also observed in socio-professional categories, especially among farmers (296 deaths recorded in the years 2010-2011).
In 2015, following an attempted suicide, 78,128 patients were hospitalized in a medical or surgical ward; a figure that has remained stable since 2013. Among these patients, who are mainly female, there is a 1st peak for young girls aged 15-19 (averaging 39 per 10,000) and a 2nd peak in the 45-49 year-old group (averaging 27 per 10,000). On January 26, 2018, the Health Minister, Agnès Buzyn, in a speech on psychiatry announced that over the next 2 years, she intends to implement psychiatric help for patients discharged from hospitals after an attempted suicide.
This recent report contains a section focused on the ethical issues of suicide prevention, in particular a possible «right-to-die” issue, stating that according to “French law, the right to die constitutes a right of freedom (one is free to kill oneself) but not a right to be helped to die (one cannot claim assistance in dying as a due). In countries that allow the “right-to-die”, it is important to look at the implications on suicide prevention. There are concerns about the difficulty of organizing suicide prevention in countries where assisted or medically-assisted suicide or even euthanasia are legally authorized or under discussion. Suicide may thus be more considered more readily as a possible option, without genuinely exploring other alternatives “(…)”. The report encourages further research on listening lines, developing off-site, or remote support methods, emergency prevention, and the relationship between end-of-life legislation and suicide prevention. It also recommends targeting research on prevention in young people, where there is still much to discover.
by NexDev | February 8, 2018 | End of life, Palliative care
After evaluating advance directives for a year, the French National Center for Palliative and End-of-Life Care (“CNSPFV”) released a twofold survey* on February 6, 2018, commissioned by the French Market Research Institute “BVA” entitled “Advance Directives, in the opinion of the French and General Practitioners. “
This survey reports, that 85% of the general practitioners and 60% of the French age 50 and over, are aware that an end-of-life law exists. The majority became aware of the 2016 law thanks to the media, demonstrating that it is gradually becoming known.
In this age group, 42% are aware that this end-of-life legislation provides for advance directives, but only 19% exactly know the details. Similarly, 85% of general practitioners are aware of legally established guidelines, but only 36% really know what it is about.
Most of the French who were surveyed (77%) are favorable to the possibility of drafting advance directives. Yet only 11% of those aged 50 and over (and 4% of general practitioners) have already written them. The majority who have drafted their advance directives are women (13%), people aged 65 and over (14%), people in poor health (22%) and people with a household income less than 1,500 €/month (16%).
In the age 65 and over group, the statistic of 14% having drafted advance directives appears relatively consistent, given the margin of error for polling, compared with the 14% of French who declared having done so, in an Ifop survey commissioned by VITA in October 2017 (which reported 15% in the 50-64 year-old group; and 17% for those 65 and over).
Among the others surveyed who have not written their advance directives, 32% say they are ready to do so, although 51% do not want to, and 6% remain undecided.
Among the reasons cited for not writing their directives, 47% say they trust their loved one to decide what will be best for them at the end of their life, and 33% don’t want to make those kinds of plans for the future. For the general practitioners, 44% say they don’t know what they will want when the time comes.
Among the general practitioners, 77% discuss the issue with their patients, 60% report being questioned directly by their patients, and 30% attest to being questioned more than in the previous years. For physicians who discuss advance directives with their patients, 61% think this is an easy topic to discuss and 85% felt that the conversation was not difficult.
In 2017, the French National Center for Palliative and End-of-Life Care “CNSPFV” led the first national public awareness campaign entitled “The end-of-life; shall we talk about it?” Regional meetings were also organized to collect questions and feedback on advance directives. This year, they intend to do another campaign. A working group to evaluate the promotional efforts for advance directives has determined that citizens are beginning to focus on the issue. In addition, it is noteworthy that advance directives may initiate discussions on patients’ values, which may influence choices for their end-of-life care.
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* All representative of the French population: 201 General Practitioners were surveyed between January 8-12, 2018, and 964 French people aged 50 and over between January 19-23, 2018.
by NexDev | February 8, 2018 | Medically Assisted Procreation
Doctors in Newcastle, UK, have just been granted permission to create Britain’s first “3-parent babies” for two women with mitochondrial diseases.
On Thursday, February 1st, Britain’s ethical authority on human reproduction, the Human Fertilization and Embryology Authority (HFEA), granted approval for the in vitro fertilization procedure (IVF) for 3 parents. In February 2015, the British Parliament gave the green light for this artificial reproductive technique to eliminate the risk of transmission of a genetic disease by the biological mother. In March 2017, the Newcastle fertility center received its license to use this procedure.
After reviewing the medical and family history of the two women – who wish to remain anonymous – the HFEA judged that “any child conceived could have a serious, progressive illness that would greatly affect his quality of life.” In this scenario, all the embryos would be infected with the disease and thus pre-implantation genetic diagnosis (PGD) would be of no use.
The 3-parent IVF technique creates a human embryo in vitro, by using gametes from 3 three different people: one man and two women (the mother and an oocyte donor). The objective is to give birth to a child without the disease transmitted by organelles present in the ovum of the mother: the mitochondria (refer to Notexpert).
Mitochondria are essential to allow all the cells of the human organism to operate properly. Moreover, they contain DNA, 1% of an individual’s total genome. Any embryo thus conceived would contain all 3 parents’ DNA: both parents’ chromosomes and the DNA transmitted by the oocyte donor’s mitochondria.
Vertiginous ethical issues are raised by this very controversial technique. It is deliberately imposed on the child, and represents significant risks for his health. The interactions between nuclear DNA and mitochondrial DNA are still poorly understood; thus it is even more perilous to add the mitochondrial DNA of a third person. Moreover, according to the technique, abnormal mitochondria may nonetheless still be present in the newly created embryo. Therefore the risk of pathologies related to defective mitochondria cannot be entirely eliminated. Thus, nothing guarantees that the child will be in perfect health nor exempt from unpredictable negative side-effects. It is impossible to have preliminary clinical verifications, since the child will be his own full-scale test specimen.
In April 2016 the media reported a first child born in Mexico using this 3-parent technique. Since then, the technique was also used in Ukraine in 2017 to give birth to many other babies for reasons totally unrelated to mitochondrial diseases but only as a remedy for some forms of infertility. Injecting mitochondria from younger women’s oocytes would be presented as a remedy attempting to “rejuvenate” older women’s oocytes.
Alliance VITA reminds that it has never been proved as yet that this technique is safe. Since it is certain that those embryos will carry a serious disease, it is inconceivable to use an artificial reproductive technique to create them at all costs. It is completely irresponsible to put at risk both the child and its family by genetically modifying human embryos. Such a violation of Human Rights should unquestionably and whole-heartedly be condemned by the international community.
