Tuesday, 9 July 2013
PRESS RELEASE & DECIPHERING
The Presidents' conference of the National Assembly has just announced it: examination of the draft law aimed at liberalising research into the human embryo, planned for Thursday, has been advanced to the afternoon of Wednesday 10 July. This last minute change to the agenda will not make things easier in a context which is already incompatible with a real societal debate while the MPs intend to cause an upheaval in a fundamental aspect of the bioethics law. Not only has the public forum not been invited to attend, contrary to the terms of article 46 of the 2011 bioethics law, but the draft is part of the agenda of an extraordinary session held just before the Parliament closes for holidays. However, deliberation is more than legitimate and France could even repeal the system prohibiting research into the embryo which it has always supported, in particular in 2011, following widescale public forum discussions. This is particularly the case in that the research is neither ethical nor scientifically necessary considering the alternatives that exist and which have generated general enthusiasm among the international scientific community, for instance the iPS cells discovered by the Nobel Medicine Prize-winner. In addition, far from being a technical subject confined to scientists alone, research into the embryo is more than anything an ethical and eminently political issue. Plus, in March, an initial attempt was made to mobilise the public which, in the words of the Minister, Mme Fioraso, "flooded" the National Assembly with protest cards. On the European scale, more than 710,000 union citizens had already signed the "One of us" initiative which in the autumn will be submitting to the European commission a document urging the authorities to stop the community financing of research into the human embryo.
- In an interview granted to Journal du Dimanche last week, Geneviève Fioraso, Ministry of Research and Higher Education, put forward more than arguable claims in favour of the draft law. In particular, she mentions the Jérôme Lejeune Foundation. Here is our right of response:
Minister's argument: "By voting this draft through, France will finally be among the advanced countries. In this area of research, we have dropped from 7th world ranking 10 years ago to the 17th position today. Research into embryo stem cells is crucial for an entire medical segment known as 'regenerative' ".
Our answer: None of the countries which has authorised research into the embryo is ahead of France, which, accordingly, cannot be late. In 20 years of research all over the world (for instance in Great Britain), work on the human embryo has not produced any significant results pertaining to cellular therapy or "regenerative" medicine. Now that Pr. Yamanaka has discovered iPS cells, by preferring to conduct research without destroying human embryos, it is this French obstinacy to research into the human embryo and embryo stem cells which is causing France to drop behind in terms of stem cell innovation. France is not actually investing the necessary amounts into efficient research, such as that rewarded by the Nobel Medicine Prize which is not only efficient, but respects ethics.
Minister's argument: "patients awaiting new therapies" could count on research into the human embryo.
Our answer: Adult stem cells and umbilical cells and amniotic liquid are now already being used in cellular therapy. For some types of pathologies, such as skin lesions or diseases (injuries, burns, epidermolysis bullosa) or for blood diseases (leukaemia, hemopathy, thalassaemia, anaemia) non-embryo stem cell grafts are already being used to care for patients.
In this segment of cellular therapy, human embryo stem cells and IDS stem cells run up against the same obstacle: the development of tumours. This research into human embryo stem cells which has not produced results in 20 years, is barely at the stage of early clinical research. Only 3 clinical tests have been launched. The first, started in 2010, has already been stopped. The other two, concerning very similar retinal pathologies (Stargardt macular dystrophy and AMD, age-related macular degeneration), involves a level 1 clinical tests, that is, tests aimed at checking for the absence of negative reactions. Before proving that treatment is efficient, there is a major step which has not yet been taken. As far as iPS cells (discovered in 2006 by Professor Yamanaka, Nobel Medicine Prize-winner} are concerned, already considered efficient for screening molecules and modelling pathologies (is used for in the pharmaceutical industry", they offer openings in terms of cellular therapy. They are to be considered with the greatest seriousness since the issue of immunity rejection (graph) does not arise with cells coming from the patient himself or herself (not the case for human embryo stem cells). In 2013, Japan has just initiated clinical testing into the treatment of AMD.
Minister's argument: "Even if authorisations are granted, it is not very appealing to work in a stigmatised discipline"
Our answer: The Biomedicine Agency (ABM) is currently in charge of issuing waivers regarding the principle of the prohibition on research into the human embryo. Since 2004, the Biomedicine Agencyhas issued 173 authorisations concerning research into the embryo with only 9 refusals. This makes it impossible to support reasonably the idea that the current system of interdiction with waivers "stigmatises" researchers wishing to use human embryos in their research. Furthermore, during parliamentary discussions about the bioethics law in 2011, none of the researchers stated that they were hampered by the interdiction system. Accordingly, there is nothing to justify adopting an authorisation system.
Furthermore, recourse action taken against some of the Biomedicine Agency authorisation decisions do not justify any change of the law as it stands. It is not because ABM does not comply with the current waiver conditions that the principle of interdiction should be abolished to the benefit of across the board authorisation being adopted. In registering its recourse actions, the Jérôme Lejeune Foundation simply wants the law to be obeyed. This must not be changed just to suit the desires of researchers or pharmaceutical laboratories or to avoid legal action. The law must continue to act in the service of justice and must not be instrumentalised according to particular interests or an ideology.
Minister's argument: "In support of its criticisms, this foundation [Jérôme Lejeune Foundation] brandishes photographs of foetuses aged six months whereas the embryos used for research are less than one week old. These masses of cells, invisible to the naked eye, are created by in vitro fertilisation techniques".
Our answer: If there is any need to justify the fact that human life is sacred whatever the stage of development, the image referred to does represent an "embryo" (and not a foetus) is as any doctor will confirm. The matter of its protection applies from the very first moment of the life of any human being (article 16 of the civil code). It is worrying to see a Minister of the Republic measure her respect for the human being according to its size, age and the number of cells.