Select Committee on Science and Technology Written Evidence


Memorandum 21

Submission from Christian Action Research and Education (CARE)

EXECUTIVE SUMMARY

    —  There should be prohibition on the placing of a live human embryo into an animal, on the creation of an embryo containing cells made up of both human and animal chromosomes, on the mixing of animal and human gametes for any purpose and on the placing of a human cell nucleus into a nonhuman egg stripped of its nucleus because:

    —  It involves unknown risks (leading to tumour formation, cancerous cells and disease transmission, along with the unknown but significant role of maternal mitochondrial genes on both fertility and health, raising questions about the purpose of the research).

    —  It is unnecessary research (the same objectives for creating hybrid embryos have as much chance of being realised without involving either cloning or hybrid embryos).

    —  It is unethical research (The unnatural entities created will be less human than fully human embryos and natural boundaries will be violated. In thus crossing the species barrier, the definition of "being human" would no longer be clear-cut).

1.  INTRODUCTION

  1.1  Christian Action Research and Education (CARE) is a Christian charity, representing around 50,000 supporters, which seeks to combine practical caring initiatives with public policy on social and ethical issues.

  1.2  The UNESCO Declaration on Bioethics states that society must "... recognise the importance of freedom of scientific research and the benefits derived from scientific and technological developments, while stressing the need that such research and developments occur within the framework of ethical principles set out in this declaration and that they respect human dignity, human rights, and fundamental freedoms."

  1.3  The increasingly global character of science and technology, as well as corporate and scientific interests that wish to resist and limit regulation, are making it increasingly challenging—and important—for current regulatory processes to achieve a balance between democratic freedom and regulation. However we are encouraged that, despite the vocal demands of some scientists, the hesitation on the part of the Department of Health and the HFEA to automatically permit the creation of hybrid embryos indicates that there is a healthy caution in our regulatory processes.

  1.4  Nevertheless, we are concerned that a small group of scientists, who summarily dismiss the importance of the 535 public responses that the original Science and Technology Committee (STC) consultation received, expect their views to automatically be given over-riding weight. The views of the public are central to the democratic process because the methods, limits to and outcomes of, research will impact all of society. The scientific community cannot expect to regulate itself on matters that involve issues beyond scientific research, issues touching on the very nature of humanity by crossing a natural barrier between animals and humans for the first time. Indeed, preventing the crossing of this barrier is a principle reason for the enduring existence of laws forbidding bestiality in this country.

2.  UNKNOWN RISKS

  2.1  Despite claims in the media and by scientists that the proposed entities will be 99.5% human and thus will raise no new safety or ethical issues about mixing animal and human gametes, it is NOT fully understood what effect maternal mitochondrial genes do have on an individuals' development and identity. Indeed, indicators are that maternal mitochondrial genes actually play a significant role in both fertility and health. The role of the maternal mitochondrial genes should be neither underplayed nor ignored by scientists and media. The use of animal eggs should not be equated to the use of human eggs.

  2.2  A research report published in Nature confirms the significant impact of maternal mitochondrial genes on development. [7]

  2.3  Reprogramming human cells back to an embryonic state is difficult enough using human eggs; using animal eggs would introduce more uncertainties. The expression of genes (through their coding of proteins) can be very different across species and with the mixing of animal mitochondrial and human genes current concerns over creating new embryonic abnormalities will be exacerbated. Even in transgenesis, the interruption of essential gene functions has severely limited the amount of genes that can be successfully inserted into animal (or human) genomes. Indeed, progress with xenotransplantation has stalled as a result of concerns about inserting a few genes into animals and consequent unknown development and rejection risks.

  2.4  An acknowledged technical difficulty with using human embryonic stem (hES) cells for both research and treatment purposes is that the tumorogenic capability of these cells is difficult, if not impossible, to control. It is quite possible that the tumor formation in cell lines and gene expression defects in clones could be a potentially worse development that the disease itself! And another hindrance to effective or beneficial research.

  2.5  Several studies have shown that the longer embryonic stem cells are maintained in the laboratory (or, presumably, in the tissues of human patients), the more likely they are to convert to malignant cancer cells. Again, such significant technical difficulties will severely hamper any usefulness of the proposed research.

  2.6  The many profound genetic and epigenetic flaws in cloned embryos, in hES cell lines and the risks of mitochondrial dysfunction are likely to create so many technical obstacles as to counter any useful scientific benefits. Thus the research could simply become an opportunity for an academic "study in artefacts"[8] with no long-term therapeutic benefit to patients. Again, the public underplaying of the problems associated with the use of hES cells and the use of animal eggs is disingenuous of scientists.

  2.7  There is also a real risk of disease transmission from viruses crossing the species barrier and developing in the host. An experiment in which human hematopoietic stem cells were injected into fetal pigs was reported in Nature Biotechnology 2006. The authors warned that the resulting fused cells were capable of transmitting a pig virus to uninfected human cells, jumping the species. [9]

3.  UNNECESSARY RESEARCH

  3.1  It is perfectly conceivable that the same objectives for creating hybrid embryos have as much chance of being realised without involving either cloning or hybrid embryos.

  3.2  Dr William Peacock, Australian Chief Scientist and acknowledged cloning supporter has stated: "Stem cell research could proceed without using animal eggs as incubators. `The use of animal eggs is not necessary.'" Even the Royal Society states that: "There is at present insufficient scientific justification for creating human-animal hybrid embryos."

  3.3  It is disturbing that, despite promises, claims and hype, science has so far provided almost no convincing evidence that embryonic stem cells can be reliably differentiated into normal adult cell types, to be used in therapies. Before progressing over this next boundary, it is important to revisit the promises in light of current research findings. Over the past five or so years, research has been heavily focused on cloning as the ideal resolution to the problem of immune rejection and to provide patient-specific stem cell repair kits. However human cloning has been far more challenging than anticipated, partly because human eggs are more fragile than eggs of other mammalian species and they do not survive the procedures that were successfully used to clone animals.

  3.4  It is extremely difficult to clone any animal, not just humans. Cloned embryos are generally very abnormal, with those that are sufficiently normal to survive to live birth representing between 0.1 and 2%. ".. the claims that `therapeutic cloning' and embryonic stem cell-based therapies can fix the immune problem facing humans seems thus far entirely unsupported by the scientific evidence." [10]Indeed, when cells derived from embryonic stem cells are transplanted into adult animals, their most common fate is to die.

  3.5  In other words, despite the fact that researchers have had increased funding to conduct research on animal embryonic stem cells, the serious scientific problems remain as problematic as ever. Immune rejection, tumor formation, and embryonic development have proved to be profoundly serious scientific challenges, and are likely to remain so for decades into the future.

  3.6  Everyone would be delighted to see treatments developed for debilitating diseases, including ourselves. But this should be within ethical limits. To this end, we note the rapid progress in therapeutic research and treatment using alternative sources of stem cells (such as easily available cord blood, or amniotic fluid) and recommend that available funding be directed to this ethical and promising research. A paper published last week states: "The risk of tumor development from transplanted embryonic stem cells is an ongoing concern for their use in therapy. The potential of long-term culture followed by tumor-free cell transfer thus gives multipotent adult progenitor cells a therapeutic advantage ..." [11]Many similar examples can be found at www.cloning.org.uk.

  3.7  The promising work being done on "adult" stem cells not only limits the need for general embryo research; it makes the need for cloning human hybrid embryos unjustifiable. And if funding for research is limited it surely makes most sense to direct it towards research that procures results and cures, rather than towards unethical, risky research with serious scientific problems.

  3.8  The purpose of UK policy is to support research that helps identify the most promising avenues for curing devastating diseases, but within clear boundaries. The goal of developing new treatments for debilitating diseases is already being served as we see that non-embryonic cell therapies have, in the past five years, quickly moved forward to perform many of the tasks once thought to be possible only with hES cells. There must be greater openness over the real need or purpose for creating hybrid embryos for research and whether benefits will accrue to patients or just to commercial companies and scientists.

4.  UNETHICAL RESEARCH

  4.1  There is an apparent fear by scientists that some current chimeric and transgenic research might also be outlawed in the process of limiting human/animal hybrid research. Clearly there needs to be differentiation between the different types and purposes of research and the STC must distinguish between that which is ethical and necessary and that which is unethical and unnecessary.

  4.2  The insertion of a single human gene into another species appears not to cause observable changes in the resulting transgenic animal and does not change the animal's phenotype, nor does it produce observable human characteristics. Thus we have fewer ethical concerns with the insertion of single human gene or cells into a animal to address a serious disease.

  4.3  However the more we cross the species barrier, the less clear cut will become the definition of being human. When more human DNA is mixed with animal DNA we need to ask what percentage of human genes make an animal more than just animal and what percentage of animal genes make a human less than human?

  4.4  Even transgenics harbours significant, albeit potential, problems in the future. Weissman has already proposed experiments with human neural stem cell transplants, to make mice with brains that are partly or wholly human. Thus begging the ethical question: could mice with human brain cells have human consciousness?

  4.5  The proposed research to create hybrid embryos would take us well beyond current practices. To many people, mixing human and animal reproductive cells to create new animal-human entities will give rise to real concerns. The mixing of human and animal would challenge the very concept of being entirely human. The unnatural entities created will be less human than fully human embryos and natural boundaries will be violated. In crossing the species barrier, the definition of "being human" would no longer be clear-cut.

  4.6  What weight or significance should we give intuitive public revulsion (the "yuk" factor) to crossing species boundaries? How can we judge the humanity or moral worth of ambiguous hybrids? Some researchers claim that these hybrids would simply be cells in a dish, with no moral status, to which we may therefore do what we like. Yet this is out of step with UK law, which takes the view that human embryos, whilst not having the status of people, should be accorded moral status above that of other cells. If that is so, would hybrid embryos derived from human nuclear DNA and animal cytoplasm also have moral status, depending how "human" they are? Scientists currently claim they are "human", thus presumably they will be offered some protection and limits to research?

  4.7  It is wrong to summarily dismiss those who feel, or sense, that this is a threshold that should not be crossed, or ignore those who hold a natural revulsion to the introduction of animal reproductive cells into homo sapiens, whatever stage of life "it" is at. Humans are unique and distinct from animals, with a higher moral status, yet this proposed research will blur the boundaries between the two and demean what is fully human by degrading the life in question with animal content.

  4.8  Once a line is crossed, it will become harder to say "no" to further research and more mixing.

  4.9  In fact, to permit this research will only lead to even further difficult questions, that need to be considered now:

    How much further mixing between humans and animals should be permitted?

    On what basis will limits be set?

    Will human embryos be regarded as having little more value than animal embryos?

    What should our moral obligations be to transgenic or hybrid animals?

    Which parts of the body are more "functional", and which are more linked to the "identity" of a person?

    What should we think of combining human embryonic stem cells with animal embryos, or blending animal genes with human embryos?

    Will this lead to germline engineering?

    What about using mammalian eggs, such as from closely related primates, to create hybrids?

    Will human embryos become ever more dispensable?

    What are the implications for animal welfare?

  4.10  The question as to whether an embryo formed from an animal egg with human DNA is a human or animal embryo is not just a theoretical question because in most other European countries human embryos are offered far greater protection than the UK. The UK stands out on a limb in not signing the Council of Europe Convention on Human Rights and Biomedicine[12] which states in Article 18(2) (Research on embryos in vitro) that: "The creation of human embryos for research purposes is prohibited."

  4.11  This question is of central importance to the HFEA also. Whether or not research comes under current UK legislation mainly depends on whether or not the entities created can be properly described as "human". The HFE Act does not currently provide adequate clarification on the specific nature and status of human-animal entities. If they are defined as "human" embryos, then their creation for research purposes needs a license from the HFEA. Our concern is that the HFEA has no power to regulate many experiments fusing human and animal material because loopholes and a lack of legal clarity allows scientists to create hybrid cells without need for a licence.

  4.12  One of the chief ethical concerns raised by the creation hybrid embryos is that it would necessitate the use and destruction of human embryos. Even among many who do not assign fully human embryos the moral standing of "full persons", intentional destruction of developing human life is a cause for ethical disquiet. To regard developing human life as a mere means—even a means to a good end, such as the alleviation of suffering—presents a moral problem. Embryos produced solely for research purposes are treated purely instrumentally. They simply become a "resource" or tool for gaining scientific and medical knowledge. It is even harder to see what respect is being shown in creating an embryo, solely to extract cells from it, which is a hybrid of human and animal, and thereby so disrupted that it could never be viable.

  4.13  As research in this area progresses and draws more funding, it is important that limits are set to prevent the fusion of animal and human genomes and, more specifically, the placing of human cell nucleus into an animal egg. The danger is that by trying to solve one ethical dilemma (that of using ova from women) another ethical dilemma is created instead.

5.  CONCLUSION AND RECOMMENDATIONS

  5.1  All too often it seems that economics, practicalities and safety considerations have become society's determining values or "ethics". As a result, in the absence of a clear ethical or moral foundation for humanness, "ethical" decision-making is increasingly being driven by the combined interests of private entities—biotechnology firms, scientists, lawyers and sometimes physicians. These are entities over which the public has very little control because they are private or non-democratic. We sincerely hope that the STC committee, and Parliament, will follow the lead of the many countries that have already banned this research, such as France, Germany, Italy, Netherlands, Belgium, Canada and most recently Australia. And that close note will be taken of public views in the UK on this issue, because science and Parliament must be fully accountable to the public for whose benefit this research is proposed.

  5.2  There should be prohibition on the placing of a live human embryo into an animal (or vice versa), on the creation of an embryo containing cells made up of both human and animal chromosomes, on the mixing of animal and human gametes for any purpose and on the placing of a human cell nucleus into a nonhuman egg.

  5.3  The UK should sign and ratify the Council of Europe Convention on Human Rights and Biomedicine, to stay in line with the majority of European countries on embryo research and other bioethical issues.

  5.4  Clarity is recommended for the definition and nature of the proposed human/animal entities and their legal status, because the HFEA does not necessarily have responsibility to license their creation.

  5.5  There should be a fuller, longer and more open public debate on such a significant issue as this. Providing less than two weeks to respond excludes many members of the public who do not have time to grasp the issues and respond in such a short length of time.

January 2007











7   "... Mitochondria carry genes that are passed unchanged from mother to child. But when Wallace's group created mice with mitochondria from two mothers, the mitochondria swapped genetic material in the offspring. Wallace says these mice had fewer pups, implying an effect on fertility and possibly on health. Wallace is worried that assisted reproduction may subvert a natural system that protects mitochondria from changes that could perturb their function. "Mitochondrial DNA programs are highly adapted and integrated. It's extremely bad planning to put those different programs in the same cell ... " Gene study raises fears for three-parent babies, Nature 438, 12 (3/11/05). Back

8   SCHB report on Embryonic, Fetal and Post-Natal Animal-Human mixturesBack

9   "Platt also found that whereas porcine endogenous retrovirus isn't normally infectious to people, the fused cells were capable of transmitting the virus to uninfected human cells. `We think viral and host cell fusion and genetic recombination turns on the virus,' Platt says. `We noticed it only during one passage of cells-it didn't persist beyond that.' This phenomenon may help explain how a retrovirus can jump from one species to another and shed light on the origin of diseases, such as AIDS and severe acute respiratory syndrome." Chimeras in the crosshairs, Nature Biotechnology, Vol 24 No. 5 May 2006. Back

10   Condic, M. Back

11   Cell replacement therapy-are MAPCs the answer? Published online 16 Jan 2007, doi:10.1084/jem.2041iti1, The Journal of Experimental Medicine. Back

12   Signed by 31 of the 45 Council of Europe Members States, http://conventions.coe.int/Treaty/en/Treaties/Word/164.doc Back


 
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