Cell Research: Medical Progress with Responsibility
An analysis of the government recommendations
This document has been produced for the benefit of Members of Parliament and others involved in the proposed legislation to permit cloning research on human embryos. It has been produced by the Joint Ethic-Medical Committee of the Catholic Union of Great Britain and the Guild of Catholic Doctors.
The Donaldson committee1 examined the issue of research into 'therapeutic' cloning and reported in June 2000. The governments response2 was published on 16th August 2000 and accepted the nine recommendations of the Donaldson committee.
The Joint Ethico-Medical Committee is composed of members drawn from the two parent bodies, the Catholic Union of Great Britain and the Guild of Catholic Doctors. The Catholic Union is an organisation of the Catholic Laity which is not affiliated to the hierarchy and which represents the Catholic viewpoint, where relevant, in Parliamentary and legislative matters. The Guild of Catholic Doctors represents Catholic Medical Practitioners of the United Kingdom. We have serious concerns about some aspects to the proposed avenues of research and address these in this document. We support research into advancement of the understanding of disease, but hold firm to our belief that all research must be conducted in an ethical framework which upholds the sanctity of life.
Recommendation 1: Research using human embryos (whether created by in vitro fertilisation or by cell nuclear replacement) to increase understanding about human disease and disorders and their cell based treatments should be permitted, subject to the controls in Human Fertilisation and Embryology Act 1990.
It is noted that the Donaldson report consistently uses the term "cell nuclear replacement" rather than the word which everybody knows - cloning. The only reason to avoid using the word cloning is that use of this term might be thought to be less provocative.
Of great significance is the clause "to increase understanding about human disease and disorders". This goes against the principle of the World Medical Association declaration of Helsinki, which deals with the research on human subjects. And the term 'human subjects' "includes research on identifiable human material." The Helsinki declaration was first formulated in 1964 and subsequently amended several times, the last being October 2000. The 1996 version states "In research on man, the interest of science and society should never take precedence over considerations related to the well being of the subject." And the 2000 version states "In medical research on human subjects, considerations related to the well_being of the human subject should take precedence over the interests of science and society."
The Donaldson report justifies the research by stating that the potential benefits of this research is enormous - ie the benefits to society are so great. Here embryos - which from the Catholic perspective we regard as life worthy of full respect - are being destroyed in the quest for pure basic science research. Extending this fundamental breach of an ethical principle is very dangerous.
Recommendation 2: In licensing any research using embryos created by cell nuclear replacement, the Human Fertilisation and Embryology Authority should satisfy itself that there are no other means of meeting the objectives of the research.
The Helsinki declaration states: - "Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature." At first reading this recommendation would appear to be in keeping with the Helsinki declaration. However, the types of research proposed in the Donaldson report have yet to be done in animals, and so the use of human embryos for the proposed research cannot, even by secular reasoning, be justified.
Advances in all aspects of science are continually being made. The Donaldson report recognises that stem cells can be obtained "from the blood cells of the umbilical cord at the time of birth; from adult tissues (such as bone marrow); and from mature adult tissue cells reprogrammed to behave like stem cells." These three sources of stem cells do not create the same serious ethical concerns as those derived from embryonic and foetal tissue. The scientific community should be concentrating its efforts in working on ethically non-controversial stem cells. In this way the benefits of the research will be able to be utilised by the vast majority of the population. There is a significant number of the population who will feel morally unable to use treatments derived from such research, and it is incumbent on government to ensure that all members of society can benefit from advances in medical treatment.
Recommendation 3: Individuals whose eggs or sperm are used to create the embryos to be used in research should give specific consent indicating whether the resulting embryos could be used in a specific research project to derive stem cells.
The objection to the use of the embryo is not altered by consent in effect given by a third party (the 'donor') and not the subject (embryo).
Recommendation 4: Research to increase understanding of and develop treatments for mitochondrial diseases using the cell nuclear replacement of human eggs which are subsequently fertilised by human sperm, should be permitted, subject to the controls in the Human Fertilisation and Embryology Act
(Mitochondria form the power house of the cell and provide its energy. They contain a small amount of extra-nuclear DNA coding for a few of genes not in the nucleus. There are a few gene defects of this non- nuclear genetic material associated with certain rare inherited diseases in the egg protoplasm). In the debates around the passage of the 1990 act parliament was unequivocally against cloning. At that time it was not realised that the cloning of "Dolly" the sheep would be performed by nuclear transfer into an unfertilised egg, therefore the wording of the Act did not cover this eventuality. The proposed technique of cell nuclear transfer to overcome mitochondrial diseases is the identical cloning technique currently used, and it is linguistic gymnastics to argue that it is not a clone.
It was interesting to note that in a conversation with other scientists attending the press launch of the Donaldson report one research charity agreed that this was a "grey area". Another argued against strict prohibition of reproductive cloning, as it was likely that successful treatment of mitochondrial diseases would depend on full reproductive cloning by transfer of the nucleus into an unfertilised egg which do not carry the genetic defect in its mitochondria. The science is more complex than the recommendation acknowledges. If the nucleus of a human egg cell is removed and a donor nucleus substituted the offspring would have two different mothers and one father. The possible psychological effects of this cannot be envisaged.
Recommendation 5: The progress of research involving stem cells which have been derived from embryonic sources should be monitored by an appropriate body to establish whether the research is delivering the anticipated benefits and to identify any concerns which may arise.
Recommendation 6: The mixing of human adult (somatic)cells with live eggs of any animal species should not be permitted.
This does not exclude the mixing of human gametes like eggs or sperm with animal species. This omission we believe is because this is already taking place and is used to test sperm potency.
Recommendation 7: The transfer of an embryo created by cell nuclear replacement into the uterus of a woman (so called reproductive cloning) should remain a criminal offence.
As cloning is the line of research recommended by the government for this disease, it would seem improbable that this apparent ban on "reproductive cloning" would not eventually be lifted. The report is full of the potential benefits of embryo stem cell research, and its current proposals are already a significant way down the slippery slope. If cloning research is allowed to the investigate the cure of mitochondrial diseases, then it is logical that if successful the research will be implemented as a treatment - and so we will have full reproductive cloning allowed.
It is noticeable that the documents are coy about calling cell nuclear replacement to create an embryo for research purposes a clone as in recommendations 1, 3, & 4 above.
Recommendation 8: The need for legislation to permit the use of embryo_derived cells in treatment developed from this new research should be kept under review.
Obviously the intent is that should cloning research prove successful, then that research needs to be implemented as clinical treatment and the recognition that the law would require to be changed. Already the emphasis is on the great potential benefits, and therefore there will be great pressure to implement successful research. Will this be a good thing? Already doctors with conscientious objection to abortion have been excluded from taking up careers in obstetrics and gynaecology. Embryo research will always remain morally impermissible for a large section of the population. Similarly, doctors with a conscientious objection will not be able to take part in treatments with material derived from these sources. For the same reason patients, who hold the absolute sanctity of life from conception until natural death, will be unable to accept treatments derived from such research.
How will the medical profession behave towards such patients? Will best medical practice demand that only cloned techniques are available, so denying treatment to those with conscientious objection? This will not be an area affecting a few high-powered research individuals, but will have an impact on the whole of society. It is imperative that advances in treatment are made in an ethically non-controversial way so that all of society may benefit from its findings.
Recommendation 9: The Research Councils should be encouraged to establish a programme for stem cell research and to consider the feasibility of establishing collections of stem cells for research use.
The Donaldson report lists six potential sources of stem cells. Two sources of stem cells are from embryos, one from foetal tissue - these three sources cause ethical problems. The last three are ethically acceptable to all - from the blood cells of the umbilical cord at the time of birth; from some adult tissues; from mature adult tissue cells reprogrammed to behave like stem cells. Professor Donaldson stated at the press launch of the report that use of adult stem cells was the "Holy Grail" of research. Therefore the research councils - which are substantially funded by government money - should be directed to fund research in the non-controversial adult and umbilical cord sources. Since the publication of the Donaldson committee report, medical literature has been published which shows that adult stem cell research is proving fruitful and therefore should be further supported.
A great disappointment in the Donaldson committee report is the grouping of all stem cell research together. It is crucial to distinguish the source of the stem cells because some are ethically unacceptable to many, whilst others should be ethically acceptable to all.
There is an editorial in The Lancet of 24th August which is entitled "Over Excitement on Embryo Stem Cells." It states:- "However the use of "therapeutic" when only research is meant has raised the stakes too high, and there is confusion between cloned material from an individual patient for that patients benefit and factories of cells for commercial purposes".
We urge parliament and society to reject the above government recommendations. The European Parliament has passed four resolutions and two directives against cloning in all its forms, including for research. Great Britain is out of step with its European partners.
Dr Michael Jarmulowicz. FRCPath., MB.BS., BSc
Master of the Guild of Catholic Doctors
Dr I. M. Jessiman. MA., MB.BChir., FRCP.
Vice President, Catholic Union of Great Britain
23 October 2000
- Stem Cell Research: Medical Progress with Responsibility - A report from the Chief Medical Officers expert group reviewing the potential of developments in stem cell research and cell nuclear replacement to benefit human health. Published by Dept of Health, PO Box 777, London SE1 6XH. Also on department of Health Website at http://www.doh.gov.uk/cegc/
- Government response to the recommendations made in the Chief Medical Officers expert group report "Stem Cell Research: Medical Progress with Responsibility" Published by Stationary Office Ltd. PO Box 29, Norwich, NR3 1GN. Tel No: 0870 600 5533.