Joint Ethico-Medical Committee
The Catholic Union of Great Britain
Guild of Catholic Doctors
Submission to House of Lords Select Committee
on Stem Cell
Question 1: Do the additional purposes in the 2001 Regulations raise issues of principle different from the purposes specified in the 1990 Act?
Yes. The creation of an embryo by nuclear transfer is a human being whose right to continued life should be respected. It should not be used as a commodity or means to an end. The intention of Parliament in drawing up the 1990 Act was to totally ban cloning which was then foreseen as transferring a nucleus into an enucleated embryo. However the legislation was drafted in terms of the scientific data of the time and had not anticipated that cloning would be undertaken using an unfertilised ovum. The Government has now used a legal loophole to allow cloning, relying on the 'defective' legal definition in that the technique (as in "Dolly") used an unfertilised ovum. The Select Committee should insist that the original will of Parliament is upheld and all forms of cloning should be forbidden.
Secondly, widening the scope of research further establishes the human embryo as a mere commodity for use as a research animal and moves away from Dame Warnock's assertion that the embryo deserves special respect.
Question 2. There is a range of different views world-wide on the acceptability of research on embryonic stem cells. What considerations underlie these differences? Do changes in the law here have implications for practice overseas and vice versa?
Yes. The European Parliament has voted against all forms of human cloning, and President Bush, President Chirac and Hubert Heupe have joined in condemning the British decision. Most of the differences between Britain and other countries are due to the lowly status that is afforded the human embryos in this country. Britain is almost isolated in Europe in its failure to afford the human embryo any meaningful status, as attested by the huge number of embryos produced and destroyed.
Some forms of stem cell research such as the use of cells from adults or cord blood, are not controversial. The Donaldson Report is, however, wrong in bracketing all stem cells together as if there were no moral issues concerning their origins. Stem cells from cord blood or adult tissues do not give rise to the same moral considerations as those derived from embryos or cloned embryos or aborted foetuses.
Although there is globalization, we should not take the lowest common denominator and allow a practice because other countries may or do allow it. It is however a fact that many countries look to the UK as a model for law making and do follow the lead set by the UK. On the topic of cloning we should set an example by outlawing it in all its forms, cloned babies and so called "therapeutic cloning" (which is a misnomer as at this stage no therapeutic benefit will result from the cloned embryo).
Question 3. Have increased globalization and other international commercial developments, in relation, for example, to e-commerce and patenting, changed the context of the debate in the UK? Would issues relating to research on embryos benefit from more attention at international level?
Yes. Indeed, it is to be hoped that an international treaty can be agreed maybe through UNESCO. Patenting discoveries in this field should not be permitted, following a similar course to that adopted with the genome project. We do not think Britain should "go it alone" in such an area of importance to mankind, scientifically and morally.
The arguments for cloning have been driven by powerful vested interests. In the year 2000 biotechnology stocks performed better that their dot-com counterparts. In the last twelve months alone the Intersuisse biotechnology index rose by 30%. Mr Blair says the European biotech industry will be worth $100 billion by 2005 and the day after the British Parliament gave the green light for therapeutic cloning the leading commercial player was rewarded with a substantial jump in share value.
Question 4. What are the potential medical benefits of stem cell research 9 what is the most likely time scale for realising them? what are the potential risks?
The possible benefits of stem cell research are unknown or at best speculative, though the prospects appear superficially attractive. The time scale is uncertain but undoubtedly long. The Parliamentary Secretary of State for Health acknowledged in the debate that it could be 30 years before any benefit from these experiments might be seen "we do not know long it will take" she admitted.
The principles of stem cell development and differentiation should be researched in animals. Science, supported by the human genome project has already shown that many of the basic "cell control" processes are common across a wide range within both animal and plant kingdoms. Animal work is the basis of much fundamental scientific work, with human subjects being used only at a late stage, in accordance with the World Medical Association Declaration of Helsinki "Ethical Principles for Medical Research involving Human Subjects". Allowing human cloning research before animal work has validated any of the hypotheses is unethical.
The implantation of embryonic cells is theoretically very hazardous. Some of the most aggressive tumours in childhood are embryomas, due to the persistence of active embryonic cells. Whether cloned stem cells would be more or less dangerous is uncertain. Clearly many difficulties will have to be overcome.
The Donaldson report stated that "In the long term the scientific view is that it will be possible to reprogram adult cells to make them behave like stem cells with the full potentiality of embryonic stem cells but without the morally contestable need to create an embryo". As adult stem cell research is advancing, why legalise cloning research in humans?
Question 5. There are different views on the extent to which potential treatments could be developed from non embryonic stem cells, such as adult and umbilical cord stem cells. What are the advantages and disadvantages of working with these alternative sources of stem cell?
Since the Donaldson Report the literature has shown a marked shift away from embryonic and towards adult stem cell usage. Adult stem cells are already being used in the treatment of leukaemia. There is an increasing host of scientific papers which indicate that the best way forward is with the patient's own adult stem cells. A very recent paper (Krause DS et al. "Multi-organ, multi lineage engraftment by a single bone marrow derived stem cell7". Cell. 2001;105;369-377) has shown that, contrary to previous held views, bone marrow derived stem cells are continually repopulating other organs including lung, stomach, intestine and skin. Work should be geared to advancing knowledge into adult stem cells rather than promoting ethically objectionable human cloning and embryonic stem cell research. A recent article in Nature by Peter Aldhous (April 5th) states that, aside from the problem with the supply of human egg cells and ethical objections to any therapy which requires the destruction of human embryos, many researchers doubt whether it will be efficient enough to be commercially viable. It has been described as "astronomically expensive". A major disadvantage is that if the embryonic stem cells do not come from the patient's own cells the problem of rejection remains. A possible solution would be the use of immuno-suppressive drugs but in the long term these may contribute to an increased risk of infection and cancer.
It is also important to consider patient acceptability of new treatments. Some patient's would feel obliged to refuse these treatments on ethical grounds, and although some patient groups have supported the new proposals we doubt if they have properly grasped what was entailed in an approach based on clones.
Question 6. What are the commercial interests research in this area? Does increased commercial involvement create additional ethical difficulties?
Yes. Globalization of the pharmaceutical industries allow key workers to be moved to the most permissive environment and the power of legislative bodies can be side-stepped. That is why it is imperative that Governments work together towards international agreements ,and companies should be invited to agree codes of conduct even before this. This area of research is too important to humanity for it to be left to an economic and ethical 'free for all'. In the first instance Britain should seek to harmonise its policies with its European neighbours.
Companies interested in regenerative medicine are now rumoured to be stripping nuclei from embryonic stem cells and embryonic germ cells, fusing them with various cells to wind back the developmental clocks of the latter. One company, PPL Therapeutics, claimed in January to have reprogrammed skin cells using this method from ES-like cells, some of which developed into heart muscle. According to Nature (April 2000) commercial secrecy cloaking much of the work on cellular development reprogramming is causing much frustration. Enthusiasm for therapeutic cloning may have dimmed but regenerative medicine is still a hotbed of activity.
Question 7. Human reproductive cloning (the transfer of an embryo created by cell nuclear replacement into a woman's uterus) is unlawful in the UK, and the Government has announced its intention of reinforcing this ban by specific primary legislation.
If creating cloned babies ('reproductive cloning') is already unlawful - as stated unequivocally above - what is the justification for a new law to 'reinforce' the ban, other than as a smokescreen to direct attention away from permissive legislation on cloning?
There already is pressure to resist such a ban and from the Government itself! The Donaldson report addressed the problem of women with mitochodrial myopathies. In our submission to the HFEA and the Donaldson committee we argued on the grounds that this was germline gene therapy. It was therefore noteworthy to see that following the revelation that cytoplasmic transfer has already been undertaken in the USA and resulted in live births, both infertility experts and the HFEA condemned the practice arguing that it was 'germline gene therapy'.
The ethical or moral arguments relate to human dignity and the dignity of human procreation (we note your papers use of the word "production"). We say that human procreation is always more than biology. The very word "production" betrays an inappropriate attitude shorn of spiritual meaning. We do not believe that this reflects the view of British citizens in general, and certainly does not accord with the views of virtually all the Faith communities here. What is more, Faith communities by their nature are world-wide which is why so many are watching to see how Britain proceeds in this area. Our reputation as a morally responsible society is in the balance.
The scientific arguments relate to the large number of congenital abnormalities and possible premature ageing that has been seen in animal cloning. The technique is regarded as simple but the results are extremely chancy and dangerous as the background to Dolly the sheep has shown. It is known that some have embarked on efforts to create a cloned baby. Although Federal funding in America is banned from helping this process, it is possible in the private sphere. It may end up in the Supreme Court but as The Economist (April 14) points out the judges may be swayed by public opinion. If a cloned baby was to be born with terrible abnormalities, the public outcry against genetic research would be immense, and bans imposed on several fronts. On the other hand if there was a totally healthy cloned child, then quite possibly every fertility clinic in the country will begin to offer the technique.
The asexual bringing into being of another person by a process without parallel in nature and outside all known patterns of kinship raise huge questions for society, and unimaginable ones for the child, not least his/her relationship with the one copied. In terms of justice between generations, the cloned person would be an entity contrived by science and in a permanent subservient position to his/her progenitors. This is a fundamental injustice. The cloned person would lack that equality of worth which is fundamental to human rights.
Question 8. Does the existence of human embryonic stem cell research, and in particular the technique of cell nuclear replacement therapy (therapeutic cloning) - designed to grow tissue for therapeutic purposes - increase the likelihood of human reproductive cloning in the future?
Of course. The term 'slippery slope' is used because the reality is that once a small step has been made, society and individuals will find it easier to make the next. Once human cloning has been performed, someone will argue that there is a special case for full baby cloning. We already see that the cytoplasmic transfer (in essence a variation of nuclear transfer) which has resulted in live births (although only later released that two babies had Turner's syndrome - one spontaneously miscarried, one aborted) is evidence that full reproductive cloning will be justified by 'therapeutic' cloning.
Question 9. Has the regulatory framework established by the 1990 Act operated effectively? Is it likely to remain adequate for the foreseeable future? Have any gaps appeared in the regime as a result of development since 1990?
The HFEA is in favour of human cloning for medical research (Cloning Issues in reproduction, Science and Medicine HGAC/HFEA Report, December 1998). We do not think, however that the HFEA can cope with the implication of cloning decisions for reasons given above pending international treaties and codes to deal with the magnitude of the issues involved. We do not see how the HFEA can properly cope with cloning decisions when they have no legal basis or guidelines (either national or international) for doing so. It would obviously be wrong for Government to fail to address these issues and take shelter behind one of its bodies, which as at present constituted, is not even answerable to Parliament.
Question 10. Do additional guidelines need to be developed to assist the HFEA in issuing licences in accordance with the new regulations? If so what should the guidelines contain.?
Government should instruct the HFEA to deny any licence to clone humans forthwith for all the reasons given above. Because of the inadequacy of using an unamendable Statutory Instrument Parliament has not had the opportunity to consider the issue of using embryos as separate from clones, the only adequate remedy constitutes suitable primary legislation.
In conclusion we have the utmost respect for science, but where man is concerned science must be at the service of man and not the other way round. What man is lies at the heart of this whole matter.
Dr A P Cole
Chairman, Catholic Union of Great Britain
Dr Michael Jarmulowicz
Master, Guild of Catholic Doctors