Passion For Life.

 

Six Labour MPs have written to Gordon Brown, taking issue with his March open letter on the Human Fertilisation and Embryology Bill.

In the letter, which will be sent to all Labour MPs, they challenge the Prime Minister's claims about the Bill, and call for a free vote to be extended to all areas involving new ethical issues.

Jim Dobbin MP, chairman of the All Party Parliamentary Pro Life Group said: "We have sent out the letter to inform Members of Parliament of the details of the Bill and to highlight the dangers of ignoring the factual evidence relating to adult stem cells. The available evidence indicates to us that major parts of this bill, such as the creation of interspecies and hybrid embryos are completely unnecessary."

The letter points out that the Bill allows for the mixing of animal and human gametes to create true hybrid embryos and notes that in his evidence to the Joint Committee on 6th June 2007, the chief medical officer, Sir Liam Donaldson said "it was felt...there was no clear scientific benefit; there was no clear scientific argument as to why you would want to do it, and, secondly, a feeling that this would be a step too far as far as the public are concerned."

The MPs also note that the Bill would not limit the creation of "saviour" siblings to the treatment of 'rare genetic conditions,' but would enable their creation for any unspecified "serious" condition.

They also criticize the the granting of HFEA licenses to scientists at Newcastle and London universities to create cloned interspecies embryos before parliament has considered the HFE Bill and notes that the licenses may not even have been legal under the 1990 Act.

"An unelected body must not be allowed to usurp the place of Parliament, and attempts by Newcastle to create 'facts on the ground' ahead of the debate, through releasing a highly premature report of embryos that only survive 'up to three days,' no embryonic stem cells, and where the work has not been fully validated and is not even ready to start writing up for peer review, must be ignored," the letter says.

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The letter is pasted below...

 

The Prime Minister
Rt Hon Gordon Brown MP
House of Commons
London, SW1A 0AA

18th April 2008

Dear Gordon

Human Fertilisation and Embryology Bill

Thank you for your letter of 25th March regarding the Human Fertilisation and Embryology Bill. You raise many points, but we are deeply concerned that they misrepresent what is actually in the Bill. For example, the implication that saviour siblings would only be used to obtain blood and only for rare genetic diseases, whereas the Bill would actually permit their deliberate creation for part-organs, and for ‘serious’ diseases. No reference is made to full hybrids, indeed it is implied that there is only one type of hybrid in the Bill (interspecies cloned embryos). There is much hype around this issue. We wish to reply to your points in greater detail than is possible in this letter, and would be very happy to provide further information, references or clarification.

1. Regarding ‘saviour siblings,’ the Bill would permit the deliberate creation of children to provide part-organs such as a liver lobe etc, to treat any unspecified ‘serious’ condition. The expectation of ‘donations’ of various parts of the body, not just umbilical cord blood, from the deliberately-created child could be a lifetime business, depending on the type of disease, its progression and how effective the first ‘donations’ were. This could result in the deliberate creation of a child with a lifetime sentence hanging over it. Is this really what we want to legislate for?

Furthermore, the situation is even worse as a result of the Human Tissue Act 2004 since once born, they could be used to obtain immune-matched whole organs such as a kidney. Additionally, there would be no such thing as the child (and eventually adult) being able to give true, free informed consent, in the context of their having been created for the specific purpose of providing tissue including part-organs for their existing older sibling. We are in no way convinced that provisions in the 7th HFEA Code of Practice or the Human Tissue Act Codes of Practice are sufficient protection.

2. We agree on the importance of finding treatments to alleviate the suffering of those with profoundly disabling diseases. However, this must be done using means considered ethically acceptable by as many people as possible. Fortunately, recent developments with various adult and umbilical cord stem cells make it clear that they are capable of treating a far wider range of medical conditions than cancer, immune and heart disorders which are mentioned in your letter of 25th March.

For example, from recent research, stem cells from sources such as human bone marrow and umbilical cord appear to be capable of creating in culture many key cell types of medical interest, such as the type of nerve destroyed in Parkinson’s disease (1- 5), while another adult stem cell has even been used to generate what appear to be functional (6) motor neurons (6, 7) and yet another has formed rod photoreceptors with the potential to treat age-related macular degeneration (8). Stem cells from bone marrow have been found to make insulin-secreting pancreatic islet cells (9) and Type I diabetes in animal models of the human disease has now been reversed through adult stem cells (10, 11). It has also been reversed through removing the autoimmune reaction, thus allowing existing stem cells and/or progenitor cells in the patient to recover (12, 13). Rats paralysed by severing of the spinal cord have been very effectively treated by adult stem cells (14), and a variety of adult stem cells have also been found to ameliorate other spinal cord injuries in animals (15–20). A number of other diseases such as stroke (21, 22), traumatic brain injury (23) and Duchennes Muscular Dystrophy (24) have also been significantly improved by adult or umbilical cord blood stem cells in animal models. They may work through a variety of mechanisms. Regarding Alzheimer’s disease, owing to its complexity, Lord Winston has indicated that he considers Alzheimer’s disease probably insoluble by stem cells (25), despite the frequent references to this disease in the media.

However, there are already pilot Phase I clinical trials with adult stem cells (some including mobilization of stem cells within the patient) treating human patients for a range of conditions such as spinal cord injury (26), stroke (27), Type 1 diabetes (28), traumatic brain injury (29) and liver diseases (30-32). Liver cells generated from umbilical cord blood stem cells are also currently being tested for clinical application including drug discovery (33). Professor Neil Scolding in Bristol (34) and others (e.g. 35) are currently carrying out clinical trials on Multiple Sclerosis using the patients’ own bone marrow, and it has been reported that a Harvard clinical trial for Type I diabetes, using the approach that permits recovery of the patient’s own stem cells/progenitor cells after removing the autoimmune reaction, is also commencing (36).

It has been claimed that interspecies cloned embryos would be essential to generate
patient-specific stem cell lines for neurodegenerative and genetic diseases, to investigate the mechanisms of these diseases and to develop novel treatments and drugs for them. However, this has already also been proposed with various adult stem cells; for example, stem cells from the dermal layer of the skin (SKPs) which can generate various cell types including different cells of the nervous system (37-39). Professor James Thomson and others have also recommended that induced pluripotent stem (iPS) cells (adult cells obtained from the skin or other tissue, which have been modified to become pluripotent) could also be used in this way. Professor Lensch of Harvard University has just announced the generation of 8 such disease-specific iPS cell lines, including muscular dystrophy and Huntington’s disease (40), while Professor Yamanaka also announced plans to start this month to make cell models of ten intractable and incurable diseases including muscular dystrophy, diabetes and neurodegenerative diseases using iPS cells, and to develop new medicines to treat these diseases (41).

3. On a point of clarification, regarding ‘human admixed embryos’ we request that there is no inadvertent conflation of the different types of hybrid and chimeric embryos permitted in the Bill. The letter of 25th March describes ‘human admixed embryos’ as those in Clause 4A(5)(a), i.e. interspecies cloned embryos. This is not merely a semantic point, since the impression is given that interspecies cloned embryos are the only type of ‘human admixed embryo’ in the Bill, or that all ‘admixed embryos’ are considered vital for stem cell research and would all have ‘miniscule’ amounts of animal DNA.

However, full hybrids (created by the fertilization of human eggs with animal sperm or vice versa) comprised of 50% human and 50% animal DNA are also in the Bill (Clause 4A(5)(b)). It is important to be open with the public about this. Regarding these hybrids, the Chief Medical Officer in his evidence to the Joint Committee on 6th June 2007, commented regarding earlier discussions: “it was felt…there was no clear scientific benefit; there was no clear scientific argument as to why you would want to do it, and, secondly, a feeling that this would be a step too far as far as the public are concerned.” No scientist speaking to the Joint Committee on the draft Bill could think of a good reason for making them.

There are two other types of hybrid and chimera which are specified in the Bill. Human-animal chimeric embryos, which would be human embryos with an unspecified proportion of animal cells added (Clause 4A(5)(d)), and human-animal transgenic embryos being human embryos that could have an unspecified proportion of animal DNA added (Clause 4A(5)(c)). Again, there does not appear to be any scientific interest in making such embryos.

4. Although to reassure the public, it is frequently claimed that interspecies nuclear transfer between human cells and enucleated animal eggs (the type of ‘admixed embryo’ specified in your letter of 25th March) would result in embryos with only ‘miniscule’ amounts of animal DNA, this is not strictly true. Although the number of mitochondrial genes is relatively small (the basis on which the claim is made), mammalian eggs happen to contain hundreds of thousands of copies of the mitochondrial genome, comprising around half of total DNA, for example, in human eggs. Early cloned interspecies embryos may therefore contain a far higher proportion of animal DNA than indicated.

5. Again on a point of clarification, the description of a shortage of embryonic stem cells is normally used with reference to countries where the creation or importation of embryonic stem cells is restricted. This does not apply to the UK, since embryonic stem cells can be made from spare IVF embryos, which is permitted in the UK. Permitting animal eggs to be used for cloning would not change the position with regard to the availability of embryonic stem cells (from non-cloned embryos). However, fresh eggs are required for making cloned embryos, and this is why some have proposed using animal instead of human eggs, to make cloned interspecies embryos. It would be helpful not to conflate this issue with normal embryonic stem cells, since it wrongly gives the impression that banning the creation of interspecies cloned embryos would result in a shortage of (ordinary) embryonic stem cells.

6. Regarding claims of the achievements of ‘admixed embryos,’ there appears to be considerable misunderstanding (“admixed embryos…research on genetic conditions such as Alzheimer’s has progressed on the basis of this approach in London and Newcastle” (i.e. using ‘admixed embryos’ of the cloned human-animal kind))

(i) There is in fact only one article on cloned human-animal embryos which has claimed to obtain embryonic stem-like cells (Chen et al, 2003). They did no work on Alzheimer’s or any other disease. They did not even, by their own admission, fulfill all the criteria to demonstrate that they had obtained genuine embryonic stem cells. Yet the considerable hype about the promise of ‘human admixed embryos’ is based on this one article alone.

(ii) London and Newcastle received licences from the HFEA in January, on the condition that they did not commence before receiving Local Research Ethics Committee approval (although part of Newcastle’s project was approved). London may therefore not have commenced the work, whilst Newcastle have only developed embryos “up to three days old,” and are nowhere near obtaining embryonic stem cells. It is therefore very unlikely that any research on genetic conditions such as Alzheimer’s has been carried out using this approach anywhere in the world.

(iii) There is also considerable doubt as to how biologically-normal and therefore medically-relevant these embryos would be. The animal eggs used would not be ‘empty’ shells as claimed by many: animal reprogramming factors would reprogramme the human genome and there would also be mis-match between the products of human nuclear DNA and animal mitochondrial DNA. Virtually all cloned embryos are abnormal, and the interspecies nature of this new type of cloning would add an additional layer of abnormality. The reliability of using such embryos as models of ‘normality’ is therefore in considerable doubt.

7. Furthermore, there is serious concern that the HFEA licences may not be legal under the 1990 Act. Indeed the Government acknowledged this on page 147, paragraph 24 of the draft Human Tissue and Embryos Bill, and commented on these specific licence applications that: “Projects of this type would not be allowed to proceed, unless regulations were made to allow the creation of such embryos for research under licence.” May we therefore request that the Government keeps to its word in the draft Bill not to allow these projects to proceed, until the issue is considered by Parliament? An unelected body must not be allowed to usurp the place of Parliament, and attempts by Newcastle to create ‘facts on the ground’ ahead of the debate must be ignored.

8. We have to express doubt regarding expectations of an imminent breakthrough regarding embryonic stem cell therapies. For example, embryonic stem cells form a specific type of tumour called a teratoma, which is comprised of a bizarre mixture of different cell types such as hair, cartilage and teeth. It can be fatal, particularly if it forms in the brain or heart – two of the main organs considered for embryonic stem cell therapy.

The standard test that embryonic stem cell scientists use to determine if they have genuine embryonic stem cells or not, is to test whether they will form this tumour. If they do not, then they are not embryonic stem cells. It is the intrinsic Achilles heel of embryonic stem cell therapies. A few days ago, the US FDA again refused to permit clinical trials with embryonic stem cells to go ahead because of this.

Various ways of attempting to overcome this problem are being tried, such as pre- differentiation. However, since only two undifferentiated embryonic stem cells (the form that makes tumours) are required to make teratomas (42), whereas hundreds of thousands to tens of millions of cells would be used in transplantation, the degree of purification required is currently impossibly high and the death of animals treated therapeutically with cell cultures pre-differentiated from embryonic stem cells is a not-infrequent occurrence.

9. In your letter, you explain the areas in which you will approve a free vote at Committee and Report Stages – i.e. where Parliament will be debating specific ethical issues for the first time. Whilst we wish a free vote in every area of the Bill, we ask you to consider a free vote in each area of the Bill where new ethical issues are to be debated.

10. Finally, we share your concern for those who are suffering from dreadful diseases, but believe that treatments should be obtained via ethical means, without for example, creating interspecies cloned embryos, full hybrids, or saviour siblings for part-organs.

Yours sincerely


Jim Dobbin MP Geraldine Smith MP Claire Curtis-Thomas MP


Joe Benton MP Rt Hon Tom Clarke MP David Drew MP