Within this period of the year, you are a
number to ask questions about the ethical scope of certain scientific choice
of the AFM. This is a short reminder of lasts facts.
September 2007: inauguration of the Institute of human embryonic
stem cells, I-STEM
- The Téléthon allowed financing the creation of the first high scale
French centre of test for research on human embryo: the institute I-STEM
(Institute for Stem cell Therapy and Exploration of Monogenic diseases). We
remind that research on embryo means that we take cells from the embryo (we
destroy them) to use them as research material.
Welcome by the Genopole of Evry, it is
managed by Marc Peschanski who explains the origin of the I-STEM research
project1: "this project came to my mind in 2002. Then I proved
that we could improve the status of Huntington patients by grafting them
foetal neurones". To face the lack of available foetal cells, he thought
about the embryonic stem cells which can be cultured and differentiated
in vitro. His purpose: to study embryonic stem cells. Then he
particularly relies on the French
Association against Myopathy (AFM), the Inserm and the university of
Evry-Val d'Essonne. "I-STEM was created in
2005 with 7 million euros for two years"1 which make it "the
biggest centre working on human embryonic stem cells"1.
Marc Peschanski underlines the participation of the AFM in this project: "We
had an AFM support of 3.4 million euros over 2 years, which covered half of
our expenses"2. According to
Les Echos, "the board of directors of the AFM commits
itself for the next years, subject to the annual success of the Téléthon, to
double the amount of public financing obtained by the project"2
"within the framework of its development 2007-2010, I-STEM develops
taking possession of 1,600m2 of laboratories refurbished and
equipped by the AFM"3.
- I-STEM was inaugurated in September 2007, in the presence of
Valérie Pécresse, Minister in charge of
Higher Education and Research.
- The bioethics law of 2004 authorises the researches on “supernumerary
embryos, without parental project”. But waiting for the application decree,
some researchers financed by the Téléthon were impatient. Thus they obtained
from February 2005, from ministers in
charge of Health and Research, special authorisations to import
embryonic cells in order to be able to start
the research without delay within the I-STEM4. Another
authorisation was signed in September 20055.
- In June 2006, the first effective
authorisations for research on human embryo were signed in France. Thus
the first team which will attempt in
France to create cell lines from human embryos
will be co-directed by Mr Peschanski and S. Viville6.
- among the teams which work within the I-STEM, some are interested in stem
cell lines developed from ill embryos rejected after a
preimplantation diagnosis (PGD). Another team
works on the production of a cell line mutated from a healthy
embryonic stem cell line.
- On 8 October 2007, Inserm announced it has created a first line of
human embryonic stem cells in France. It was
obtained after destruction of an embryo coming from in vitro
fertilization and carrier of chromosomal anomalies detected during
preimplantation diagnosis (trisomy 1 and antimongolism). The works have been
carried out by the team of the University of Paris-Sud XI, specialist of
embryonic stem cell culture and by the team of Antoine Béclère de Clamart
hospital which works on the embryo7. 38 couples have been
solicited to give their embryos pour. Three couples refused, two for
religion reasons; they are Muslim.
Researches would succeeded in differentiate some of these cells into nervous
cells. Theses will be put at Pr Marc Peschanski’s disposal from the
Genopole of Evry.7
Announcing the first international conference on human embryonic
stem cells from 1st January to 2nd February at the Genopole of Evry
The objectives of this event are to create, for the first time in France, an
international display of research on human embryonic stem cells, to gather
and federate the researchers around this research. In one word: to dynamize
the research on the embryo. This event has a vocation to become "The"
international conference of research on embryo. Industrials, public
organisations, investors, the press, etc are invited to participate under
collaboration. Marc Peschanski will intervene. This colloquium is announced
on the I-STEM website8.
1- Libération, 16/10/007
2- Les Echos, 25 /09/07
3- www.afm-france.org, 24 /10/07
4- Le Monde, 18/02/05 ; Le Figaro, 19/02/05 ; Actualités de
l'Institut de Myologie, 04/03/05 (in Orphanews)
5- Le Quotidien du Médecin, 02 /09/05
6- Gènéthique, octobre 2006 ; Le Monde, 22/06/06 ; Le
Quotidien du Médecin, 23/06/06
7- Le Figaro, 24/10/07
8- Collaboration file on www.istem.fr
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After the adoption of the law relative to immigration which authorises the
recourse to DNA tests for the candidates wanting to join their family, the
mass media dedicated a number of files to the temptation of the genetic
“all” and to the financial stakes of these tests. If the amendment Mariani
opens a way which worries a large number of observers, we have to admit that
concerning health, a red line has already been crossed.
DNA Tests and safety
According to the weekly newspaper La Vie, the national computerised
file of genetic footprint (Fnaeg), created in 1998 for only sexual offenders,
counts today with 500,000 nominative sheets (vs 4 million in Great Britain).
It could contain 3 million in 2010. Since 2003, 137 infractions may give
rise to a genetic test. These genetic have widely proved their efficacy in
criminal investigations, to identify the offender and to find innocent false
suspects. The Fnaeg could have resolved this way more than de 600 cases.
DNA Tests and health: the red line
In France, the bioethics law of 2004 authorises the recourse to genetic
tests within a medical or scientific framework. Theses tests can only be
prescribed by a physician and require a previous ‘informed consent’ from the
patient. The results of these tests have to be given and explained by the
physician who prescribed them. The legislation also foresees that the Agency
of Biomedicine authorises physicians and pharmacists to perform these tests,
but the decree is not yet signed. For Carine Camby, director of the Agency
of Biomedicine, these tests give rise to two major issues: their
understanding by users because they are difficult to interpret; and their
growing availability via Internet. Finally, another issue exists, the
results of the tests can interest the members of the family concerned...
How to not be worried about a possible extension of using these tests for
insurance or job? Even if, fort he moment, the Civil Code and the Public
Health Code prohibit it. According to Carlos de Sola, head of health and
bioethical department in the European Council, the threat of using genetics
is important for the insurances: "if a consensus exists around the job, a
fundamental right, it is not necessarily the same for private insurances".
In Switzerland, for example, genetic tests can be required to subscribe a
life insurance over 400,000 Swiss francs (250,000 €).
If genetics allowed real therapeutic progresses, the genetic tests also
allowed the selection of a child according to his/her genetic criteria.
Today, in France, 98 % of child with Down’s Syndrome detected in utero
do not simply have the right to live. From now, is the red line crossed? For
the philosopher Olivier Abel, professor at the University of Protestant
Theology of Paris and member of the national consultative ethics committee,
"to believe that we are going to resolve all with genetics is naive".
Thus, "to know the irreversible handicap which will make part of a
children life, or to know which disease he/she swill develop and when, does
not always give the means to correct the anomaly observed... apart from the
threatening power of selection, before the birth, the existences which can
live and the one which cannot, according to their handicap, the "losers" of
this selection".
"To avoid any form of exclusion, we could invoke the confidentiality
(...). The moral foundation here could be to respond "I do not want to know
it"."
Tests and business
In 2006, the global market of in vitro diagnosis represented more
than 30 billion euros. The daily newspaper Le Monde dedicated an
interesting file to this business.
Moreover the actors of the healthcare system, the major targets of this
market are individuals, shops, schools or companies. More and more patients
particularly buy over the counter tests. The in vitro diagnosis at
the same time relies on traditional techniques of analyses (haematology,
immunology, biochemistry, microbiology...) and on two more recent
techniques: glucose tests and molecular diagnosis. The molecular tests (or
genetic) study and measure the variations and mutations of human genetic
material. They represent 20% of global market and increase every year from
12 to 15%. These tests are used in the advanced medicine, in the fight
against bioterrorism, in the food or in the public health, and more and more
on the development of targeted new drugs which open the way to customised
medicine. These genetic tests should allow elaborating custom-made drugs.
The newspaper cites the example of a genetic diagnosis company,
Labgenetics, which proposes, via Internet, two kinds of genetic
diagnosis, for individuals or professionals. The first tests have a medical
purpose: they allow detecting a predisposition to such or such disease
(Alzheimer, Parkinson...). The second one, which represents the 3/4 of
individual demands, concerns the paternity. Regarding the professionals
which are interested in such tests, they are in general private detectives.
Labgenetics states it does not deal with insurance companies. In
2007, the activity of Labgenetics increased by 40% compared to 2006 and its
turnover is estimated at 400,000 €.
In 2005, the first ten in vitro diagnosis producers made 80% of
global turnover. Some giants of the pharmaceutical industry - including
Roche, Siemens, General Electric Healthcare - have the market in their
hands. Pharmaceutical laboratories and specialist of medical imaging fight
with billions around a new concept: the customised medicine.
J.-J. Cassiman, professor of human genetics at the Catholic University of
Louvain, estimates the potential turnover of genetic test market in Europe
between 900,000 € and 28 million € per million of inhabitants, "according
to the extent of the prescriptions of healthcare professionals"...
Source :
La Vie, 01/11/07
Le Monde, 23/10/07
Le Quotidien du Médecin, 24/10/07 |
