RTL BRIEFING PAPER

CLONING
The New Human Vivisection


November 2000


BRIEFING SUMMARY:

Overwhelming public opposition to cloning
Government and Donaldson Committee obscure proper debate with 'smokescreen' language
No ethical or practical difference between 'reproductive' and 'therapeutic' cloning
Human embryos not the only source of stem cells
Scientists favouring human cloning camouflage true intentions
Commercial considerations politely overlooked
Britain out of step as international opinion condemns cloning
Government 'spin' may dupe Parliament over Donaldson



PUBLIC OPPOSITION TO CLONING
All available sources indicate that the public is very much opposed to human cloning. Every opinion poll has shown public opposition to the point that a pro-cloning article in The Independent (August 20, 2000) referred to the public being 'vehemently opposed' to cloning. A Report produced by the Wellcome Foundation highlighted the fact that public opinion on therapeutic cloning is generally supportive until people realise exactly what is involved. They said that many people did not understand the terminology used by doctors and scientists. The Report states:

'The research suggests that the language chosen when describing scientific research has a major impact on participants' responses to the ideas... (but as their) awareness increased, so did their concern and apprehension. It was unclear whether many participants realised that an embryo created for research would be a genetic extension of a living individual. However, for those who did grasp this fact, their concerns were further heightened.'

On a warning note the Report adds: '...it was felt that there could be the potential to mislead participants, it being accepted that several aspects of the scientific research would not in fact be 'therapeutic'.'

It is, therefore, not surprising that obscure language should be used in the Report of the Chief Medical Officer's Expert Advisory Group on Therapeutic Cloning (commonly called 'The Donaldson Report' after Professor Liam Donaldson, the Chief Medical Officer). For example, throughout the Report cloning is referred to as 'cell nuclear replacement', a morally neutral term.

As part of the 'spin' the Report states that the 'Government will introduce specific legislation to ban reproductive cloning...'

However, reproductive cloning is already illegal - but putting this forward as an assertion gives the impression that the present administration is tabling legislation to protect respect for human life. Members of the Government (including Mr Tony Blair) have sent out scores of letters to voters declaring that the Government will be introducing legislation to re-enforce our laws against reproductive cloning. As there has been no suggestion of introducing reproductive cloning - it is obviously a defence tactic, a smokescreen to obscure government policy which supports the manufacture of clones for the production of cells and other purposes.

CLONING TECHNIQUES
A human clone would be an exact genetic copy of another human being. A clone of any animal species can be produced by two techniques:
1. The nucleus from an oocyte (an unfertilised female egg) is removed and is replaced by the nucleus of a cell taken from a donor animal (which, in fact, will be the genetic twin of the new clone). This was the technique used to produce 'Dolly the Sheep'. It is, however, extremely hazardous and of over four hundred of trials - some of which produced malformed sheep - only one, Dolly, succeeded. In the event Dolly was found by chromosomal analysis to be six-years-old at birth, the age of the donor sheep.
2. Cloning can also be achieved by 'splitting' an embryo's cells at a very early stage of development, thus creating one or a number of clones.

REPRODUCTIVE AND THERAPEUTIC CLONING
There is no difference between the techniques for 'reproductive cloning' and 'therapeutic cloning'. The difference lies solely in the purpose of creating the clones - whether it be to implant into a woman so that the embryo can develop in the normal way as a baby, or if it is intended to use the clone in the production of stem cells or bio-chemical products.

In both cases, the clones would be genetically complete humans. Even the Warnock Committee stressed that 'the embryo of the human species ought to have special status'.

EMBRYONIC STEM CELLS
Stem cells can be obtained from adult tissue, the umbilical cord of a newborn baby, and from embryos. There are no ethical problems involved in using adult stem cells or those from the umbilical cord.

Unlike ordinary cells, stem cells have the capacity constantly to renew themselves and to form or to differentiate into the different cell types needed by the body. That is why stem cells may be used to replace tissue in cases of severe burns or in cases where the tissue has been destroyed by cancer, or through diseases such as Parkinson's and Alzheimer's.

A human embryo has been described as 'a stem cell par excellence'. 'It is a most wonderful being who has the capacity to initiate, sustain, control and direct its own development'. Its cells will provide all and every different kind of cell and tissue which make up the human body - skin...nerve...muscle...bone...organ.

The Chief Medical Officer's Advisory Group describes stem cells as 'unspecialised cells which have not yet differentiated into any specific type of cell and tissue' - which is somewhat short of the mark.

Stem cells are pluripotent - that is they can '...proliferate with almost unlimited potential, maintaining a pool of growing and dividing cells, with the added ability that some of the daughter cells can differentiate into specific cell types'. (David A Prentice, Professor of Medical & Molecular Genetics at Indiana State University, in his testimony to the American Congress, February 2000.)

However, the pathway of differentiation from stem cell to a specific cell type varies according to the cell type required. Without a clear understanding of such differentiation pathways it would be extremely dangerous to implant undifferentiated stem cells into an adult human. In comparison, evidence now suggests that adult stem cells are easier to manage and if transplanted to their normal environment (eg brain cells into brain tissue) they will produce only the cell types necessary for that tissue (Science, Feb 25.2000, Vogel, G.).

USE OF STEM CELLS & ASSERTIONS OF DONALDSON
One of the most serious criticisms of the Donaldson Report is that it was already outdated when published.

For example it claimed that '...stem cells derived from early embryos have the greatest potential to develop into most types of tissue....stem cells can be extracted from some adult tissues but their potential to develop into other kinds of tissue is also likely to be limited.'

Yet, at the time that the Report was presented to members of the Government and subsequently to the public, there had already been a number of papers published showing this to be incorrect.

Why at the press conference to launch the Report on August 16 did the Department of Health spokespersons - and Professor Donaldson in particular - not admit that advances had been made in the use of adult stem cells?

In any event, research is now continually emerging from Scandinavia, Britain, America and elsewhere on the uses of adult stem cells showing the Donaldson Report to have been eclipsed.

ADULT STEMS CELLS 'VIABLE ALTERNATIVE'
In fact, contrary to the Donaldson assertion, a majority of research scientists now consider adult stem cells to be 'pluripotent' - of almost unlimited potential.

For at least a year they have been used '...either exclusively or in combination with other treatments to achieve significant 'healthcare benefits' for sufferers of the following conditions: Brain tumours, ovarian cancer, solid tumours, multiple myeloma, breast cancer, non-Hodgkin's Lymphoma, Multiple sclerosis, systematic lupus, rheumatoid arthritis, anaemia, stroke, blindness, immuno-deficiency.' (Scottish Council on Human Bio-Ethics, Briefing Paper).

A number of papers demonstrating the therapeutic use of adult stem cells have already been published - in 'Blood' (March 2,000), the Journal of Clinical Oncology (July 1999 edition, and October 1999 edition); the Journal of Neuroscience Research (August 2000) and elsewhere.

In comparison the only published material so far on the use of embryonic stem cells has been in the form of 'promises'.

SCIENTIFIC & MEDICAL BODIES BACKING DONALDSON
The Royal Society, the Medical Research Council, the Nuffield Council on Bio-Ethics, the British Medical Association (others to be listed) all support the Donaldson Report.

It is a matter of some consternation that the Report was published on August 16 after Parliament had risen for the summer and was followed by a very carefully co-ordinated publicity campaign promoting the concept of cloning. In other words before Parliament was given the opportunity to consider the recommendations of the Committee, MPs and the public were bombarded with propaganda from a number of bodies making claims, many of which are highly questionable.

For example, despite the evidence regarding adult stem cells the Royal Society has produced a Report that indicates that 'there is no scientific justification for rejection (of Donaldson) - and that to do so would send an ominous message about the future of research in Britain.' (The Times on the Royal Society Report on Therapeutic Cloning, 8.11.2000.)

In fact, not surprisingly, Germany has the strictest regulations regarding human vivisection, including embryo research and cloning, of any country in Europe. Yet, their bio-technological industry has outstripped the industry in the United Kingdom.

THE HUMAN FERTILISATION AND EMBRYOLOGY ACT
An almost identical public relations exercise was mounted in 1990 when Fellows of the Royal Society, spokespersons of the Medical Research Council and others bodies seduced parliamentarians with their promises of cures for genetic diseases, degenerative conditions and other tragedies...if experimentation on human embryos were made legal. Ten years later we are still awaiting the realisation of their promises - whereas therapeutic advances have been (and are being) made by the application of ethical methods of research. Yet, the empty words of these 'experts' have resulted in the destruction of rising one million human embryos.

At 1990 meetings in the Houses of Parliament, Fellows of the Royal Society and others actually told MPs that the conceptus was not a human life until the 14th day after fertilisation; before then, it was only a 'pre-embryo'. This propaganda ploy was used persistently in some newspapers and convinced many Parliamentarians. However, once the Human Fertilisation & Embryology Act became law no more was heard of a pre-embryo. The term was dropped completely and many of to-days MPs will be totally unaware of its usage.

ANY COMMERCIAL REASONS FOR THE CLONING CAMPAIGN?
Scientists and doctors are not above commercial considerations and the potential rewards in the field of biotechnology are overwhelming. As already stated the human embryo initiates, sustains, controls and directs its own developments by virtue of its ability to synthesise a whole range of biochemical products which could be utilised in other fields of biotechnology. These can be extracted, refined, purified - and sold to the worldwide biotechnology industry. Such products could be used in many areas of basic biological research and in the pharmaceutical industry. The Wellcome Report 'accepted that several aspects of the scientific research would not in fact be 'therapeutic'.'

The commercial pressures to give the go-ahead despite ethical concerns are clear. On the 10th November this year The Times reported that ReNeuron, a recently formed company whose shares had just begun trading, had raised 18 million pounds and were likely to raise a further three million pounds by an over-allotment option. They are planning to be the first to begin trials using cloned human stem cells derived from aborted foetuses. This is commercial scientists seeking by force majeure to ensure parliamentary and public approval.

Moreover, although the Government asserts it is completely opposed to reproductive cloning, Lord Winston among other fertility experts has affirmed, 'therapeutic cloning will lead to reproductive cloning within twenty years' (The Independent, 20.8.2000).

In 1990 it was suspected that possible commercial interests might dominate some sections of the medical and scientific community. A series of amendments were tabled to the Human Fertilisation & Embryology Act so that research on human embryos would be confined to the development of cures and treatments for genetic diseases and other fields for which scientists claimed embryo research was vital. Every amendment was bitterly opposed by the scientific community and failed to reach the statute book. We have no doubt that the same tactics would be used today.

We feel it is also important to ask why Donaldson made no reference to the possible commercial stakes in cloning. They are well documented - and it was US commercial scientists who first established a technique to keep embryo stem cells alive in a culture. To what extent was the motive for their work dominated by commercial considerations? Nobody seems to have asked.

WHAT'S HAPPENING IN EUROPE?
Britain is totally out of step with the rest of Europe in the matter of cloning. Cloning is completely outlawed in Germany, Denmark, Norway, Sweden, Spain, Switzerland and Slovakia.

In the last three years (in March 1997 and on 7th September 2000) the European Parliament has voted for a ban on human cloning. The latest resolution called on the UK Government to review its position on human embryo cloning and called on MPs to 'exercise their votes of conscience (to) reject the proposal to permit research using' human embryos.

The Council of Europe has also condemned human cloning.

DONALDSON COMMITTEE & THE HFEA
The Donaldson Committee was preceded by a joint Working Party of the Human Fertilisation & Embryology Authority and the Human Genome Advisory Commission. Its four members had all expressed pro-cloning views before joining the committee and two had pecuniary interests (connected with the pharmaceutical industry).

The fourteen members of the Donaldson Committee also appear to be totally biased in favour of cloning and their constant reference to the expertise of the Human Fertilisation & Embryology Authority and the strict controls it maintains is ludicrous in view of its history demonstrating utter incompetence: five years after the HFE Act came into operation the Authority was forced to admit that they had lost all track of thousands of parents of frozen embryos and there have been many reports of inefficiency and neglect since then.

Only last weekend (November 12) the Sunday Times carried a story that 'At least 100 women have been mistakenly implanted with another couple's embryos because of incompetence by infertility clinics'.

Rather than any expression of concern, The Sunday Times report stated: 'The HFEA denied that there were widespread problems in infertility clinics and said any errors were a tiny fraction of the total number of IVF treatments'.

A number of members of the Authority are involved in the IVF industry - and for many years parliamentarians have complained of the fact that 'the poacher is playing game keeper'.

The whole history of the Authority shows them to be utterly incapable of taking on the role of policing cloning which could have very sinister connotations.

Finally, it is important to question the manner in which legislation and changes to regulations are being presented to Parliament.

GETTING THE DONALDSON RECOMMENDATIONS PAST PARLIAMENT
The change in regulations to the HFE Act to allow human cloning for 'therapeutic purposes' will be presented as an Affirmative Instrument. This means that, in principle, both Houses will debate the issue and will be given a 'straight yes or no' vote. There will no opportunity to amend the details of the regulation. The Government has promised debating time but it is possible that the actual vote could be taken in a Committee rather than on the floor of the House meaning that the vast majority of MPs could be denied the opportunity to vote.
The vigilance of MPs and Peers and the resounding defeat of the Harris Bill (which in our view was a stalking Horse for the Government and the pro-cloning campaign) have fortunately much diminished the possibility of a vote in Committee. Nonetheless, the country is still in the ridiculous position of a major change in the Human Fertilisation & Embryology Act by Affirmative Instrument on a matter which was never debated during the process of the Bill in 1990. This, surely, is an abuse of Parliament.

In comparison, the move 'to strengthen' our laws against reproductive cloning will be presented to Parliament as 'specific legislation'. This will be fully debated and voted upon with MPs given the opportunity to table amendments. However, the whole exercise is futile as reproductive cloning is already illegal. But, as we said at the beginning, it gives a 'positive spin' to the Government's activities.



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