The French HAS publishes its Recommendations for Sedation at the End-of-Life

On March 15, 2018, the French High Authority for Health (“HAS”) published its recommendations for good practice in implementing “deep and continuous sedation until death”.
These recommendations have been awaited since “Claeys-Leonetti” end-of-life law was enacted in February 2016, giving new rights for those at the end-of-life.
Before the law was voted, “deep and continuous sedation until death” had been previously practiced by professionals in rare cases, for circumstances of unbearable, resistant suffering which could not be relieved by any other means, and when faced with a short-term vital prognosis. Basically, sedation alters the patient’s consciousness and thus severs any further relationship. The sedative doses may be proportional to the intensity of the symptoms and reversible. Professionals prioritize using painkillers which allow patients to remain conscious.  Conversely, sedating a patient whom we know will not wake up is difficult for both loved ones and caregivers. The official High Health Authority “HAS” text correctly emphasizes this and provides specific support for the various participants concerned to ensure that these situations are not trivialized, and must remain a rare practice.
The law provided that sedation request could be initiated by the patient himself. When stopping or restricting care, including nutrition and hydration, this practice risks to veer towards euthanasia.
Alliance VITA, participates in the movement Relieve Suffering without Killing” which also brings together health professionals, and together they denounced this gray zone during debates for revising the law. Relieve Suffering without Killing” recalled these warnings during the “Let’s Speak about the End-of-Life” campaign organized by the public authorities in March 2017 to promote the law. “The simplistic promotion of a” right to deep and continuous sedation until death, “without justifying its’ objective, may open the door to a drift toward euthanasia (…) On this complex and often sensitive subject, it would be grave injustice to threaten the confidence between caregivers and patients to imply that the law partially allows abolishing the prohibition to kill.
 
In an attempt to remove this ambiguity, the authors of the recommendation endeavored to differentiate this type of sedation from euthanasia, whose intention is to provoke death. They explained the six characteristics below:
 

  Deep and continuous sedation until death Euthanasia
Objective Relieve a persistent unbearable suffering with doses adapted to obtain deep sedation Respond to the patient’s request for death
Means Deeply alter conscienceness Provoke death
Method Use of sedatives Use lethal doses of medication
Result Deep sedation until death due to natural causes of illness progression Immediate death of the patient
Time-frame You can’t say when death will occur Death is rapidly provoked by the lethal product
Legislation Autorised by law Illegal, (homicide, poisoning …)

 
The recommendation more clearly defines safeguards for avoiding expansive interpretations, while accepting the complexity of situations at the end-of-life:

  • Collegiality of the decision and the evaluation of the request;
  • Resistant aspect of pain, with no other alternatives for relief;
  • Short-term vital prognosis: beyond a few days time, a reversible sedation must be practiced.

 
The most critical situations concern the limitations or treatment stoppage in situations whereby people cannot express themselves.
The “HAS” specifies that the constrictions for limitations are mainly for artificial ventilation, in very specific cases, which qualify as unreasonable obstinacy and that patient’s vital prognosis is short-term. “The doctor may be confronted with this situation when there is a request to stop life-sustaining treatments: mechanical ventilation (for example: patients undergoing cardiopulmonary assistance, patients with amyotrophic lateral sclerosis or other neurodegenerative diseases and dependent on artificial ventilation, etc.). Patients who suffer from a disease for which the absence of treatment will cause death only in the long term or, will not lead to unbearable sufferings, are not immediately affected by this law of deep and continuous sedation. Each case is unique: the treatment, adapted to the symptoms and to the patient’s request, will be given, including the possibility of appropriately measured sedation.
Alliance VITA declares that ambiguity still persists for those in a pauci-relational state, unable to express themselves.  “The deep and continuous sedation until death aims to prevent a possible pain. If the only life-sustaining treatment is artificial nutrition combined with artificial hydration, its arrest may lead to a longer duration of deep and continuous sedation until death (of the order of 7 to 14 days): this duration requires special support from relatives and caregivers “. Such an analysis would require further clarification. Recall that the people mentioned are not at the end-of-life, and a priori do not suffer from unbearable suffering which cannot be relieved, but are unable to clearly express themselves.

French ‘INED’ Points out 4 Demographic Changes in the Past 50 Years

For the 50th anniversary of the scientific newsletter “Population and Societies” the March issue has detailed 4 “demographic surprises”, which have actually already been established as known evolutions, according to “INED” (French National Institute for Demographic Studies). For the period from 1968 to 2018 the article mentions: the increase in life expectancy; postponement of births; the increase births outside marriage and the increased numbers of civil solidarity pacts or “Pacs”.

The increase in life expectancy

In the past 50 years, life expectancy has increased by 11 years, from age 71.5 in 1967 to age 82.5 in 2017 for both men and women. In recent years, however, the trend has started to taper off, suggesting life expectancy could soon plateau at a certain limit (+ 2 months per year since 2010 vs. + 3 months per year on average for the past 50 years).
Part of these statistics could be attributed to the decline in infant mortality which fell by 50% decrease from 1950 – 1960. It continued to drop during the following decade to 18% in 1970.  Nevertheless it currently represents only a small percentage of mortality; and even if the decline would continue, it has almost no effect on life expectancy.
Life expectancy has increased due to the success in the combat against mortality in adults, in particular for individuals at an advanced age where most deaths occur. At one time, it was believed that mortality could not decrease beyond a certain point and that human lifespan would encounter a biological ceiling. It is significant to note how medical progress has contributed in recent years: preventative actions, early treatment and diagnosis. Currently the main causes of mortality are cardiovascular disease and cancer.
Nonetheless, life expectancy after age 60 has not increased in the past 3 years. In 2014 – 2017, it remained at 23.2 years for men, while decreasing slightly for women (27.7 years in 2014, 27.6 years in 2017).

Postponement of births

Since the end of the baby boom, the average is approximately 2 births per woman. The mothers’ age has risen steadily since 1977. While previously the average was age 24 for the birth of the first child, it has reached an average of 30.7 years in 2017. There may be several reasons associated with these increasingly late maternities: extended years of study, an increase in women’s employment and the growing desire to a child only when certain living conditions are ensured. As highlighted by “INED” there is an impact due to the widespread diffusion of different contraceptive methods and the legalization of abortion.
It is possible that the average age for maternity will continue to rise up to an average of age 32. In Spain, in 2015, it had already reached 31.9 years old. If women delay their pregnancy to later in life, they may not be able to become pregnant when they so desire. The average risk of not becoming pregnant increases with age: 4% at age 20 years; 14% at age 35, 35% at age 40, practically 85% risk of not being able to bear a child at age 45. Although some women who experience difficulties conceiving are tempted to resort to ART (Assisted Medical Techniques), many are not aware that medicine remains powerless after age 40, according to the news bulletin. Only 4% of babies born in 2016 had mothers aged 40 and over.

The increase in births outside marriage

In 1966, only 6% of the babies born in metropolitan France had parents who were not married. In 2016, the statistic has jumped to 58.5% or 435,000 out of 745,000 births. Clearly, the social norm has changed: births to unmarried couples now outnumber births to parents who are married. Frequently they occur in couples with a stable relationship. Nevertheless these births necessitate recognition by the father. In 2005, 5 out of 6 babies were recognized compared to 1 in 5 during the early seventies. In total, less than 4% of all babies are not recognized during their year of birth.

The increase in civil solidarity pacts (“PACs”)

From 2001 until 2016, the number of PACs has risen sharply from 20,000 to 192,000. Originally PACs were intended in part to allow same-sex couples to be registered in a civil union. However the sharp increase in PACs has largely been due to male-female couples, which has been multiplied by twelve in a 15 year time-frame (184,000).
Simultaneously the number of marriages decreased from 2001 to 2016, from 296,000 to 233,000 respectively. Conversely, if some PACs are contracted for simple legal or tax reasons, this is usually not the case for weddings.

Alliance VITA Interviewed by the French Ethics Committee

On Thursday, March 8, 2018 Alliance VITA had a long interview with the French National Ethics Consultative Committee: the “CCNE” as part of the National Bioethics Conferences.
These hearings are part of a larger program established by the “CCNE” including public debates, internet contributions via their website www.etatsgenerauxdelabioethique.fr, a citizens’ committee composed of individuals selected by a polling institute; contributions from ethical committees from national establishments such as the medical research unit:  “INSERM”, the National Center for Scientific Research: “CNRS”, and both the Academies of Medicine and Sciences. These interviews by the National Ethics Committee will not be held uniquely for associations, but also for focus groups, learned societies, religious organizations and health professionals.
The CCNE will summarize these interviews and send them by June 4th to the OPCEST and to the government. The CCNE will give their own conclusions in July 2018 on a number of issues considered during the National Bioethical Conferences.
After their meeting with the CCNE President, Professor Delfraissy, the three Alliance VITA representatives, Tugdual Derville, General Delegate, Caroline Roux, Deputy General Manager and Head of Listening Services, and Blanche Streb, Director of Training and Research, spoke in this order before a CCNE delegation of 8 members, on the main issues for the National Bioethical Conferences.
Based on their experience in listening services (SOS Baby and SOS End-of- Life), the Alliance VITA representatives requested that priority be given to infertility issues (causes, prevention and genuine therapy) and handicap issues to help accommodating those with disabilities. They called for an ethical reaction to fight against eugenics, researches which destroy human embryos, interventions on embryos’ genomes (especially the “3-parent IVF”, and using CRISPR-Cas9 on embryos) resulting in genetically-modified human beings. They also requested protection for the child who is the most vulnerable in the so-called “ART for everybody” slogan; emphasizing the slippery slope leading to procreation and even surrogacy just for convenience purposes.
More generally, in view of some inviolable principles, Alliance VITA criticized the unceasing reconsideration of ethical boundaries which had previously been voted by law. Accompaniment for those at the end-of-life, and issues related to artificial intelligence were also discussed.
After responding to CCNE’s questions, Alliance VITA ultimately cautioned of the inherent risk in passing new bioethical laws. France could become a global or state-controlled reproductive marketplace. If ART is no longer performed only for therapeutic reasons, the current healthcare model, based on the non-merchandisation of the body and impartiality for users, would be threatened. If ART becomes a business, whereby the rich “benefit”, it would be the beginning of inequality for the French population of today, and for children of tomorrow, because the law would no longer be able to defend the weak against the desires of the strong.

Assisted Reproductive Technology (ART) Limited to Age 59 for Men

On March 5th, the Versailles Administrative Court of Appeal ruled on the age limit for men to have assisted reproductive technology (ART) at “approximately age 59”.
The Administrative Court was solicited to rule on the appeal filed by the French Biomedicine Agency. The Administrative Court had refuted Biomedicine Agency’s decision which previously denied a male couple authorization to export gametes and germ cells on the basis that the 2 men were aged 68 and 69 respectively. The agency based their decision on Article L. 2141-2 of the French Public Health Code which reserves access to ART for couples “of childbearing age”.
In June 2017, a 69-year-old French man requested to have his frozen gametes returned to have ART performed in Belgium. The Biomedicine Agency was then forced to accept transferring his gametes. The following month, in July 2017, the Advisory Council of the Biomedicine Agency recommended establishing an age limit for ART at age 60 for men and age 43 for women.
The issue being debated is the age for childbearing. Most professionals already practice an age limit, especially since 2005 when the National Health Insurance stopped reimbursing ART for women over 42, since thereafter successful results becomes diminished.
The Administrative Appeals Court in Versailles, in referring to the legislators’ intention, considered that “the unborn child must be shielded from being exposed to certain inherent risks with ART” and equally that of “women due to the harrowing experience of ovarian stimulation techniques which are not without risk”. The “childbearing age” should be defined as “the time whereby the procreative capacities of men and women have not been altered by natural effects of aging”. The Court relied on “the most recent available scientific data, noting that after age 59, the male reproductive capacities are generally modified due to the statistical increase risk of malformations and other medical complications “.
The age limit for becoming parents via ART should be included in the current revision of French bioethical laws.

Natural Birth Control Methods Besieged by Misinformation and Amalgams

Subsequent to a press release by the National Federation of Medical Gynecology Colleges (FNCGM) *, a hundred professionals immediately retaliated in defense of natural contraceptive methods based on observation of female fertility periods.
In their press release, the FNCGM discredited “natural birth control methods” as being unreliable; quoting “an approximate failure rate of 17-20%“. These gynecologists allege that there is a connection between the high abortion rate in 20-24 year olds and the use of natural birth control methods.
To refute this misinformation, over a hundred of caregivers, doctors, pharmacists, gynecologists and midwives have asked “to cease misinformation on natural methods”. In the aftermath of the press release and numerous articles that followed, it seemed “important to rectify and clarify the situation for women to receive genuine and truthful information” regarding “the various amalgams”. In addition, on March 1st, an on-line petition was created. Due to the amalgams with other contraceptive practices, they reiterate that “very reliable natural methods are available, have been scientifically evaluated and have been proven to be efficacious on a worldwide basis”. They have been developed by medical researchers and the techniques are taught by accredited instructors. They explain that “to guarantee a high rate of effectiveness, the methods require rigor and training, (no autodidact or self-taught improvising)”. They testify that “numerous women and couples are perfectly satisfied with these methods and with the ease of incorporating them into their life-style”.
The elevated number of abortions in France pertains to what the authorities refer to as the French contraceptive paradox. According to the Inspectorate General of Social Affairs “IGAS”, 72% of French women who aborted said they were using contraceptives when their pregnancy was announced. The ramification whereby complete trust in technology is proven infallible makes an unplanned pregnancy more arduous to accept. Abortion is frequently a systematic recourse, often due to outside pressure from the partner; or pressure from family members for teenage pregnancies. Nonetheless, “It is illusory to believe that fertility can be perfectly controlled. [1]”: pregnancies occur even when using IUD’s, and when taking birth control pills, (which can sometimes be forgotten).
For those aged 20-24, (the group with the highest overall number of abortions), the actual proportion decreased slightly between 2010 and 2016. As the French National Institute for Demographic Studies “INED” states: “Despite more tolerant and diversified family life styles, (Déchaux, 2009), restrictive criteria for reproduction prevail. Besides the requisite of being a couple (and having a stable relationship with a mutual consensus to become parents), there are now supplementary norms concerning age, financial resources for child-rearing, and the “ideal” spacing between 2 births.  These criteria regulate contraceptive and reproductive practices throughout a woman’s reproductive life cycle, including the period of “sexual adolescence”. Despite a high use of contraception and the progress made in fertility control, the assertion of abortion as a right, as well as the extension of the “adolescent” period, have led to an increase in abortion rates for the 18-25 year-old group.”
Following the crisis with the 3rd and 4th generation birth control pills, women have become more reluctant about using medical contraception. Currently, a new trend is developing where some women are reconsidering their contraceptive choices and are requesting a more “organic” or natural approach for their bodies’ overall health. Gynecologists, and society as a whole, need to discuss the challenge launched by these women’s aspirations for being treated more “naturally”, whith more respect for their body. There is room for discussion, provided it is an open, non-biased discussion.
[1] IGAS 2010, French report on abortions performed