www.genethique.org

Bioethic information and analysis newsletter

Following Letter

N°69 - September 2005

The discovery of 351 foetuses and bodies of still-born babies in the mortuary of Saint Vincent de Paul Hospital this summer upset public opinion and even left the Minister of Health “very shocked.” Why? At a time when 220 000 foetuses are extracted from their mother’s womb each year, this event cannot fail to make us wonder about the status of dead foetuses and embryos.

Surgical waste?
Are they considered as belonging to the order of inanimate things and thus treated like surgical waste such as human body parts left behind after an operation (e.g. veins, a leg after an amputation, the placenta after a birth)? Until the law on bioethics of August the 6^th 2004, the law did not provide for the case of embryos, even though extracting tissue from dead human embryos or foetuses for therapeutic, industrial or commercial ends was a common practice. They were the focus of the first advisory report released by the National Consultative Committee on Ethics, on May the 22^nd of 1984: “the embryo or foetus must be recognized as a potential human being who is or has been alive, and whom all should respect.”

A legal framework for the use of embryos or aborted foetuses
From now on, the law only provides a legal framework (along with a penal section) as far as the use made of them is concerned. “Tissues or cells of embryos or foetuses originating from terminated pregnancies can only be taken, kept and used for diagnosis, therapeutic or scientific purposes. Written consent must be given by the mother after she has been appropriately informed of the aims to which the tissue will be extracted. This information must be given to her after she has decided to terminate her pregnancy” (art. L.1241-5, Public Health Code.)The law also stipulates that any extraction of tissues for scientific research not aiming at finding the causes of the pregnancy termination must be carried out according to procedures cleared in advance by the Biomedicine Agency. Failure to obey these rules will result in up to two years in jail and a 30 000 euros fine.

Which method of disposal?
The rules concerning the disposal of aborted embryos and foetuses are particularly obscure, and in the absence of a clear law, one must resort to analogies.

A November the 6^th 1997 decree regulates the disposal of healthcare-related waste (both waste representing an infection hazard, and anatomic parts.) The decree specifies that, amongst those anatomic parts, any limbs, organs or organ-parts easily recognizable by a “non-specialist” must be cremated. Even though the law does not explicitly specify this point, remains of embryos and foetus less than 22 weeks old and weighing under 500 gr tend to be treated as hospital waste. Is the respect owed these “potential human beings” compatible with cremating or disinfecting them as if they were common domestic garbage?

What status for pre-natal beings?
Are the fates of those embryos much more enviable than that of those kept in jars at Saint Vincent de Paul Hospital? Is there really matter for such a scandal? As Claude Sureau, a gynecologist-obstetrician and a member of the NCCE, reminds us, “nobody seems shocked by what is, to my mind, a much more serious matter—that is, the fact that when a healthy child of more than 22 weeks dies because of a car accident or of a medical error, that destruction does not lead to penalties of any sort for the guilty party. We should make the most of this affair to reflect on what the status of pre-natal beings, dead or alive, should be.”

The NCCE’s advisory report
As a consequence of the “Saint Vincent de Paul Hospital affair,” the question of the status of foetuses and of the storage of foetus and embryo elements has been referred to the National Consultative Committee on Ethics. It will not, however, answer it, as it has declared itself incompetent to rule on the matter.

For more information, see: Dictionnaire permanent Bioéthique et Biotechnologies (Permanent Dictionary of Bioethics and Biotechnologies), « Statut du corps humain, de ses éléments et produits, » (Status of the human body, bodily parts and bodily fluids.)

Foetuses and still-born babies: what becomes of them?

The so-called scandal of the embryos and foetuses found in jars in Saint Vincent de Paul Hospital leads us to recall the legal framework concerning what is to be done with foetuses, still-born babies, and non-viable children.

The 30^th of November 2001 circular
The 30^th of November 2001 circular specifies the rules concerning the civil status, burial or cremation of the bodies.

Civil registration
Still-born and non-viable children may be registered as “lifeless children.” Registering their birth, often a very important step in the parents’ mourning process, is possible beyond 22 weeks of amenorrhoea or if it weighs more than 500 gr.

Burial or cremation
The family can then have the child’s body buried or cremated, for which they will bear all costs. If the family will not take care of the body, the healthcare institution will, in the ten days following the foetus’s death, no matter how long the gestation period, carry out its burial or cremation, for which it will bear all costs. It would seem that these rules were not respected at Saint Vincent de Paul Hospital. The Prime Minister has therefore asked the General Inspection Agency on Sanitary Matters to conduct an administrative inquiry, in order to determine who is responsible for this lapse.

Loosening of legal requirements for post-mortem extraction of organs and tissue

The law concerning the conditions for the extraction of organs and tissues was made more flexible over the summer, in the hope of raising the number of post-mortem extraction, and thus of usable organs for transplants.

State of persistent cardiac and respiratory inactivity
Until now, organs could only be extracted from persons in a state of brain death, on mechanical respiratory assistance, and retaining hemodynamic function. This principle is still the general rule, but the texts published in the Official Gazette this summer, provide for some exceptions. A decree and two administrative orders dated from August the 2^nd 2005 (Official Gazette, August the 6^th) have loosened the legal requirements for the extraction of certain organs and tissues from deceased persons in a state of persistent cardiac and respiratory inactivity. From now on, extraction of the following tissues and organs is allowed: the liver and kidneys, the skin, the bones, soft musculoskeletal tissues, the cornea, the cardiac valvae, the arteries and veins.

All healthcare institutions
This decree now serves as framework for the participation to the organ donation networks of healthcare institutions that are not allowed to extract organs or tissues themselves.  It defines the conditions on which they can participate in the process by signing conventions with institutions that are allowed to extract organs. The Ministry of Health hopes this will help solve the problem of organ shortage.

What definition for death?
We should remember the concerns of Dr. Marc Andronikof, head of the emergency department at Antoine Béclère Hospital in Clamart, as exposed in his book “Médecin aux urgences” (“Being a doctor in the emergency room”) (see Gènéthique issue n°62.)  Should our definition of death adapt itself to our growing needs for organs?  And can we make this necessity compatible with the respect we owe to the departed?  

Umbilical cord stem cells: reality and promises

A promising future
Researchers at Kingston University in England have managed to mass-produce stem-cells extracted from umbilical cord blood thanks to new technological means.  This technique, originally created by NASA, uses microgravity-based bioreactors. Some of the cells extracted that way have successfully been transformed into cells with properties close to that of the liver. This research was published in the review Cell Proliferation1.

For Valérie Planat, a CNRS researcher who works with Louis Casteilla on adult stem cells extracted from adipose tissues, “this study sounds very interesting and extremely original.  It is, to my knowledge, the first time that microgravity has ever been used to conduct research on stem cells. If the umbilical stem cells live up to their promises, it will be necessary to find donors whose tissues are compatible with the patients’ and increase the number of umbilical blood banks.”

Umbilical cell banks: an international network

In the United States, Congress passed in 2004 a law granting funding of $150 million to the development of those bio banks. In Italy, 15 umbilical blood banks are currently operating, and the Cordon Blood Bank, one of the largest in the world after those of New York and Düsseldorf, was founded in Milan in 1993. The GRACE (Group for the conservation and development of haematopoietic cells,) an international network enabling patients to find donors thanks to a computer-based archive system connected to marrow and placenta blood donor records all over the world was founded in 1995.

A reality and some successful treatments For Pr. Giuseppe Leone, the head of Haematology Institute of the Catholic University of Rome and in charge of the umbilical stem cell bank of the Gemelli Polyclinic, “no patient has ever been cured using embryonic stem cells; on the other hand, adult stem cells like those of the umbilical cord have proved their efficiency in the field of bone marrow transplant; for example, to treat thalassemic syndrome, for children suffering from leukaemia and patients suffering from congenital immunodeficiency, and in many cases, it possible to speak of a successful treatment: for immunodeficiency, we reach a 70-80% rate of recovery, and for leukaemia, one of about 35-40%.Today, there is also hope for the discovery of a cardiopathy treatment, whereas embryonic cells have never been used and have therefore never proved that they have any sort of therapeutic utility. »