Charities Commission Registration CC22512

The submission on the Bioethics Council dialogue on Xenotransplantation
from Diabetes Youth New Zealand - May 2005

This submission is endorsed by NZORD. The numbered questions are from the Bioethics Council discussion document.

Introduction
This submission is made on behalf of Diabetes Youth New Zealand, and is the result of a long-term interest our organisation has maintained in scientific advances in the treatment and potential treatment of Type 1 diabetes.  We were an Interested Party appearing before the Royal Commission on Genetic Modification in 2000, we appeared before the Select Committee that deliberated the legislation introducing an effective moratorium on xenotransplantation in New Zealand in 2002, and we have taken part in the Bioethics Council discussion groups on xenotransplantation in Auckland, Palmerston North, and on the internet.
Diabetes Youth New Zealand (DYNZ) is an organisation that represents children and youth with diabetes, and their families, providing support, education and advocacy services on behalf of its members through support groups based in 12 different centres, and on the internet.  As an organisation we are affiliated to Diabetes New Zealand, and are acknowledged as the “voice of youth” by that organisation.
There are about 1,500 children and youth of pre-school and school-age in New Zealand with Type 1 diabetes (the auto-immune form of the disease) and less than 100 children diagnosed New Zealand-wide with Type 2 diabetes (the “degenerative” form of the disease).
Xenotransplantation is of greatest relevance to people with Type 1 diabetes – which is most commonly diagnosed in adolescence – but can develop in children in their first year of life and in young adults in their 20s and early 30s.  In 2000, Diabetes Youth New Zealand ascertained, on the basis of information on insulin useage in New Zealand shared by the supplying pharmaceutical companies and gathered by Eli Lilly, that there were 15,000 people with Type 1 diabetes in New Zealand.  Rates of diagnosis would indicate this number is rising significantly.  (This information was first made available to the Royal Commission on Genetic Modification as part of DYNZ’s submission as an interested party to the Commission.)
Type 1 diabetes is an auto-immune disease caused when the immune system attacks and destroys the body’s insulin-producing cells in the pancreas.  Insulin is required for converting food into energy that can be used by the body’s cells.  Without insulin the body dies quite quickly, both as a result of wasting from lack of energy (a form of starvation), and as a result of unused sugars rising to toxic levels in the blood system (ketoacidosis leading to coma and death).
Since the discovery of insulin in the 1920s, people with Type 1 diabetes have avoided immediate death from the disease, but – as injected insulin is a crude method for controlling blood sugar levels – have still been subject to complications as a result of long-term cell damage caused by abnormal blood sugar levels eg. blindness, kidney disease, heart disease, poor circulation and healing leading to infection and limb amputation.
Injected insulin is a therapy, but not a cure.  Ironically, injected insulin itself can cause death if managed incorrectly as a result of unnaturally low blood sugar levels (hypoglycaemia) inducing coma and death.
People with Type 1 diabetes dance a tightrope between hypo (low) and hyper (high) glycaemia (blood sugar) on a daily basis all their lives, and under a shadow of possible long-term health complications no matter how much care they take.

1. What spiritual or cultural perspectives influence your view of xenotransplantation?   
Children and youth with Type 1 diabetes and their families are largely pakeha, but the disease is diagnosed in children in families from a range of cultures, including Maori, and a range of religious and spiritual persuasions – Christians, agnostics, atheists, vegetarians, animal lovers, and so on.

2. What concerns do you have about the effect of various types of xenotransplantation on the recipient’s identity?
If xenotransplantation could safely reverse the effects of diabetes without recourse to anti-rejection drugs, then Diabetes Youth NZ would rejoice in children and youth with diabetes (and their families) regaining a life free of anxiety, stress and depression – conditions which are closely associated with Type 1 diabetes – as well as regaining spontaneity of thought and action (which is not possible when someone is tied to a regime of multiple daily blood testing, multiple daily injections, regular and controlled food intake and well-modulated exercise).  In these ways diabetes does have a very profound affect on identity, and this is not well-understood by others.  We believe successful xenotransplantation would have a very positive affect on the recipient’s sense of self, and his/her place in the world.
We have noted no comments about whakapapa made by anyone within our organisation.  As President of Diabetes Youth NZ, I attended a Bioethics Council discussion group in Auckland and noted that Maori comment about disrupted whakapapa was not necessarily negative to xenotransplantation.  The comment was that all Maori currently experienced disrupted whakapapa through cross-cultural marriage and had developed strategies to cope with that.  Strategies to deal with disrupted whakapapa due to xenotransplantation (if it became a reality for Maori in the future) did not currently exist – this is the issue Maori would have to deal with.
Further to this, however, we note that – while some fears have been expressed about whether or not there was potential for transfer of genetic material - xenotransplantation would not be expected to change the genetic make-up of the recipient, or contribute to genetic changes in children conceived by a recipient.
As an organisation, we note that recipients of whole organ human transplants sometimes have psychological aspects of the transplantation to come to terms with – but these are not necessarily psychological issues associated with identity, but with life and death itself if the donor is known to have died.  We have not heard of any such issues associated with tissue transplants, and would not expect such issues to arise with cell transplants.
We would hold that identity is a complex amalgam of brain chemistry, memory, experience, and the self-awareness that is built up from a combination of the aforementioned mental attributes (including the self-assessment of one’s personality and one’s place in society), and morphological (major physical) attributes of one’s own body, such as gender, race, size, and facial characteristics.  We do not hold that identity is tied to a specific organ or set of cells in the body, other than ascribing central importance to the chemistry of the brain.

3. To what extent should cultural and spiritual views about xenotransplantation be taken into account when the government is making decisions about the use of this technology?
Any health treatment should be designed to ensure that the recipient is not the object of revulsion or disgust, or made an outcast in his/her society.  This would be counterproductive to the purpose of the treatment.  Whether a health treatment is undertaken for the sake of better health and/or better quality of life, any health treatment should be designed to enhance the recipient’s ability to be a well-adjusted, contributing member of society.
Religious views
We note that most of the world’s major religions find xenotransplantation acceptable, and none would stand against the choice of the individual to accept xenotransplantation.
We note that participants at the Bioethics Council discussion group who espoused different religious backgrounds (including Buddhist) did not object to xenotransplantation on religious grounds.
The Council of Europe recently documented the following religious viewpoints on xenotransplantation:
Baha’I - Xenotransplantation is acceptable, although unnecessary suffering to the animals should be avoided. Reasons: human beings are different and of higher order than animals.
Buddhism - Xenotransplantation is unacceptable, although some individual Buddhists may avail themselves of xenotransplantation dependent upon their “stage of perfection.”  Reasons: Proper ethical conduct reduces hurt and suffering in both animals and humans since both feel pain in their consciousness.
Christianity - A variety of responses toward xenotransplantation, however, generally accepting. Would want to minimise suffering of animals.  Reasons: human beings have been given authority to rule over creation and over animals. Arguments against include: interfering with creation - playing God.
Hinduism: Hindus do not believe in transplantation - either allotransplantation or xenotransplantation, although exceptions might be made to accept an organ. It is an individual choice.  Reason: the body must remain whole to pass into the next life. The cow is sacred to Hindus; however, pig and sheep would be acceptable.
Judaism: Xenotransplantation is acceptable because the over-riding value in Judaism is to save life. This over-rides other considerations such as the prohibition on the consumption of pig flesh. Concerns were raised over safety, the suffering of the animals, and over interfering with the order of Nature.
Islam: A diversity of opinion, but generally xenotransplantation is acceptable. Like the Jewish tradition there is an emphasis on the preservation of life. Also, concerns were raised over the suffering of animals and that should be minimized.
Sikhism: The consensus is that xenotransplantation would be acceptable. Again, like other religious traditions the minimization of animal suffering is a priority.
Native American - Traditional leaders regard any form of transplantation as an unacceptable violation of the integrity of the human body, however the decision whether to accept xenotransplantation is regarded as an individual one.
[Source : Council of Europe 2000: Working Party on Xenotransplantation, Strasbourg, July 2000.]
Christian heritage is a central part of New Zealand culture
While our current Government may describe New Zealand as a secular state, our culture is based on Christianity and the Christian tradition, and both Maori and Pacific Islanders have absorbed Christianity to the extent that there is a strong argument to say that Christianity is a central and inescapable part of their culture too. Where once every local and central Government meeting started with a prayer in English, now in public life, it is Maori who are called on to say a Karakia.
The xenotransplantation debate should therefore be examining Christian attitudes towards xenotransplantation in particular. While "non-theologian" Christians tend to debate the merits of "mankind's dominion over the earth", "God-given choice", and concern with "playing God", theologians debating the merits of cutting-edge science tend to concern themselves with the "ongoing creative work of God" and mankind's inextricable part in it (frequently describing humans as "co-creators" with God), and the importance of valuing human dignity.
In respecting the traditions of other cultures, New Zealanders too often overlook the importance of examining their own Christian cultural roots.
We note the following comment by the American theologian, Ted Peters, on theological attitudes to genetic modification - which is a useful starting point for examining attitudes to xenotransplantation:
"It is worth noting that virtually all Roman Catholics and Protestants who take up the challenge of the new genetic knowledge seem to agree on a handful of theological axioms. First, they affirm that God is the creator of the world and, further, that God’s creative work is ongoing. Second, the human race is created in God’s image. In this context, the divine image in humanity is tied to creativity. God creates. So do we. With surprising frequency, we humans are described by theologians as "co-creators" with God, making our contribution to the evolutionary process. Third, these religious documents place a high value on human dignity."
[Ted Peters is a professor of systematic theology at Pacific Lutheran Theological Seminary and the Graduate Theological Union in Berkeley, California. He served as principal investigator of the CTNS research project funded by the NIH to study the "Theological and Ethical Questions Raised by the Human Genome Initiative." He is author of Playing God? Genetic Determinism and Human Freedom (Routledge 1997).]
We note that a contributor to the Bioethics Council’s website discussion provided this quote from the Vatican on xenotransplantation:
"For a theological reflection that will help to formulate an ethical assessment on the practice of xenotransplantation, we do well to consider what the intention of the Creator was in bringing animals into existence. Since they are creatures, animals have their own specific value which man must recognize and respect. However, God placed them, together with the other nonhuman creatures, at the service of man, so that man could achieve his overall development also through them.
It should be noted that this role of "service" rendered to man by other creatures occurs in different ways according to the cultural advances of humanity. Limiting ourselves to scientific and technological progress in the biomedical field, the service of animals to man represents a totally new application in xenotransplantation, which, therefore, in principle is not in conflict with the order of the creation. On the contrary, xenotransplantation represents for man a further opportunity for creative responsibility in making reasonable use of the power that God has given to him.
Furthermore, even if one limits oneself to a purely rational analysis, without desiring to make use of theological reasoning, one can reach the same conclusions on a practical level.
A simple look at humanity's long presence on the earth is sufficient to show an irrefutable fact clearly: it is man who has always directed the realities of the world, controlling the other living and non-living beings according to determined purposes. It is moreover in its relationship with man that the axiological measure (moral value) of every existing reality is revealed in a universal harmonic and orderly design that indicates all the fullness of the sense of reality.
In particular, man has always made use of animals for his primary needs (food, work, clothing, etc.) in a sort of natural "cooperation" that has constantly marked the different stages of progress and the development of civilization.
Such a position of "excellence" is a witness to and also demonstrates the ontological superiority of mankind over the other beings of the earth; this superiority is founded on the very nature of the human person, whose rational and spiritual dimensions place man at the centre of the universe, so that he may use its existing resources (including animals) in a wise and responsible manner, seeking the authentic promotion of every being."
Maori cultural heritage
We note that there are Maori who say there are as many Maori views on xenotransplantation as there are Pakeha views.
We note the comments made [in Q. 2] above with regards whakapapa.
We note that at the turn of the 19th century, Maori tended to be against blood transfusions, but that this does not seem to be an issue anymore - perhaps because the benefits are now well understood. Perhaps there will be a similar pragmatic attitude towards xenotransplantation as this issue is played out.

4. What is important to think about when deciding whether or not xenotransplantation is an acceptable use of animals?
New Zealand is a farming nation that breeds animals like cows, sheep, pigs and poultry for human consumption.  If, as a society, we accept that it is ethical to breed and slaughter animals for human consumption, then there should be no ethical barriers to breeding and slaughtering these same types of animals for medical purposes that contribute to human health, such as xenotransplantation.
Comments made at a Bioethics Council discussion forum in Auckland by a vet responsible for inspecting animal research laboratories in New Zealand would indicate that research animals are treated with the highest degree of humaneness and respect, whereas our farming practices fall woefully short of the standards expected of research laboratories.
We note that the Animal Welfare Act provides guidance on balancing the harm to animals against the human benefits of research.
We note that the demands of xenotransplantation would require that animal donors be from the most disease-free sources possible, and the highest standards of animal husbandry be employed.
We note, by way of example, that we have been told by Living Cell Technologies NZ Ltd that the pigs bred by that company are regarded as the “cleanest [most disease-free] pig herd in the world”, and that, while isolated from other herds, are allowed to breed normally.  Furthermore the company declares it subscribes to the highest standards of animal husbandry.
Within Diabetes Youth NZ we have a few members who are vegetarians and many who are animal lovers.  We have noted comments by one such vegetarian member that she may not contemplate xenotransplantation even if it were to become a registered clinical treatment.  However, she is also clear that she would not object to others receiving xenotransplantation because of the nature of the burden of the diseases being contemplated as possible subjects for xenotransplantation research.

5. How should we weigh the welfare of animals against that of humans?
We note, from taking part in the Bioethics Council’s discussion forums, that there are individuals who believe that animal welfare is as important as, if not more important than, human welfare.
However, we believe that, in general, New Zealand society subscribes to the view that the value of human life and welfare outweighs the value of animal life and welfare.  If put to the acid test, in a situation in which one had to choose between the life of a child and the life of an animal, most New Zealanders would choose to save the life of the child.
Animal welfare should not be treated capriciously, however, and there may be a point at which we decide animal welfare is more important than the desire of humans for merely cosmetic enhancement.  On the other hand, there is a grey area at the boundary between the merely “cosmetic” and cosmetic surgery which genuinely enhances health and/or quality of life.
Xenotransplantation to cure or provide long-term treatment for Type 1 diabetes could potentially provide such a major leap in the health and quality of life of children/youth with Type 1 diabetes that there should be no confusion that this would represent a fundamental improvement to human welfare and would not be merely considered a “cosmetic” procedure.
Xenotransplantation research is currently aimed at serious genetic diseases that are not self-induced, and that are judged incurable by the standards of modern, conventional medicine. Aside from patients suffering from organ failure, xenotransplantation could potentially treat those with hemophilia, AIDS, diabetes, Alzheimer's disease, Parkinson's disease, and Huntington's disease. Apart from AIDS (depends on how contracted), these are not diseases caused by modern lifestyles.
Xenotransplantation research aimed at these serious genetic diseases has judged the relative merits of the value of human and animal welfare in an acceptable way.

6. Does it matter which animals (for example, primates, domesticated farm animals, mice, fish) are being used for xenotransplantation. If so, why?
Safety and efficacy for the recipient, and for society at large, would be the major factor that should be taken into account when judging the answer to this question.
For these reasons, pigs are currently the favoured donor animal by xenotransplantation researchers and reviewers, and primates are not favoured.
Nevertheless we note that successful research on primates is a requirement of the FDA before permission can be sought in the US to proceed to human trials.
FDA requirements also stipulate that strict standards of animal husbandry must be maintained on donor animals to ensure that they are healthy and free from disease.

7. How should the interests of the individual be weighed against those of the public, community, iwi, hapu or whanau?
The interests of the individual, no less than the objections of a minority, should be considered very seriously in this debate to moderate an outcome that can be as acceptable as possible to all. We live in a democracy where decisions tend to reflect majority opinion - but this opinion is moderated by all sorts of individual and "minority views", people from different cultures, people with special scientific knowledge, geopolitical considerations (such as the benefits or non-benefits of harmonising regulations with other countries), people with special needs, and so on. One could even say that a majority is formed from a coalition of minority interests. No single minority group should "hold sway" unless the majority deems that the needs or arguments of that minority are of sufficient breadth or depth of effect to persuade the rest, either in terms of benefits or "disbenefits" from the issue being decided.
There is a view that has been expressed within Diabetes Youth NZ that the longer that society debates the merits of xenotransplantation without making a decision to allow research, the longer that people with Type 1 diabetes, and other diseases like Huntington’s, are forced to wait for a potential cure, and as a result the more will die or become permanently disabled in other ways.
Individual need versus public risk is, of course, the nub of the debate.
One of the greatest difficulties is that few people in New Zealand have kept up with the science to be able to debate this satisfactorily. What has held us up in this area is the fear of something like AIDS. AIDS apparently came from the great apes whose blood systems are most similar to humankind. While there is a fear of pig transplantation and PERV - we understand pig blood systems are completely different from humans and our immune systems could be expected to react satisfactorily. While pig retrovirus can be transferred to human cells in a laboratory culture dish, this occurs under conditions in which there is no immune system able to be activated!
On the other hand, PERV is not necessarily a disease-causing virus. It may be completely inert.  Whether it would actually cause a disease should it transfer to human cells in vivo has not been established.
In the case of diabetes - both pig insulin and cattle insulin has been used extensively over very many years (and animal insulins are still available). DYNZ is not familiar with the  conditions under which this insulin is extracted – other than it involves a crude grinding process using animal pancreases from meat works - so it is difficult to imagine you could completely purify this insulin to protect against PERV otherwise you would destroy the insulin. Outside the lab and the single experiment mentioned, there have been no recorded cases of PERV transmission - or even of PERV antibodies being activated in recipients of pig islet cells, pig heart valves, pig Factor 8, or pig insulin. In fact - the irony is that at one stage when AIDS was most feared in the US, there was a great resurgence in interest in the use of pig Factor 8 for haemophilia.  Subsequent tests have shown that pig Factor 8 is filled with PERV virus, but there is no evidence of any PERV virus transferring to, or infecting, or sparking the production of antibodies in the human hosts.

8. What is your view about exposing non-consenting third parties to the risks that xenotransplantation might create?  Does it make a difference which type of xenotransplantation is involved?
One has to weigh the potential level of risk to third parties against the potential health benefit to the individual, and the potential long-term cost-saving benefit to society.
If the potential level of risk to third parties is judged to be low, and the potential health benefit to the individual, and the potential long-term cost-saving benefit to society, are both judged to be high, then further research should be allowed to refine this risk calculation via a path from clinical trials to potential clinical treatment.
The level of risk involved in researching pig islet cell xenotransplantation is now judged by those working in the field to be much lower now than a few years ago when a research team claimed to be able to transfer viral material from pig cells to human cells in vitro.  This same team has now, we understand, clearly stated that it has not been possible to transmit PERV  to live animals despite many attempts.
The potential health benefit of xenotransplantation to the individual patient suffering Type 1 diabetes is extremely high, and the potential future costs to the economy are growing with the growth in incidence of Type 1 diabetes in the population.
Diabetes Youth New Zealand believes the relative risk factors are balanced in such a way that research on cellular xenotransplantation involving non-genetically modified pigs should be allowed to continue in this country.
The type of xenotransplantation is important.  Currently, whole organ xeno-transplantatin cannot take place without either genetic modification of the animal, or the use of anti-rejection drugs.  Both these techniques prevent the recipient’s immune system from working properly, and so any incipient disease in the xenotransplant could not be detected and destroyed.
Cellular xeno-transplantation, however, can occur without genetic modification of the animal or the use of anti-rejection drugs in the recipient – thus leaving the recipient’s immune system intact in case it is required.  This is because the cells can either be protected by the simultaneous xeno-transplantation of sertoli cells (naturally-occurring cells in the testes that protect sperm from immune attack) as currently happens in xenotransplantation procedures for Type 1 diabetes in Mexico, for example, or they can be protected from attack by the immune system with the use of a special alginate coating (eg. the LCT procedure).

9. What would be your response if a family member living with you wanted to undergo xenotransplantation?
DYNZ believes its family members would only be generally supportive of children/youth receiving xenotransplantation when the technique has undergone further research to confirm safety and efficacy of the procedures under scrutiny.
If a family member wished to be part of a clinical trial, then we believe most other family members would be supportive if the family member was an adult, had researched it properly, and had determined that the potential benefits for him/her outweighed the risks.

10. What public health restrictions would it be right to impose on the recipients of xenografts performed in New Zealand?  Does it make a difference which type of xenotransplantation is involved?
In the early stages of research DYNZ believes it would be in order to ask individuals to volunteer for regular testing as a part of this research.  Beyond that it is difficult to assume what, if any, public health restrictions would be necessary given the evidence so far that no infection is expected as a result of pig xenotransplantation, and the lack of any evidence to suggest that in the unlikely event that a xeno-recipient was “infected” with PERV that such an infection would be transmittable to a third party. 
The irony is that despite the considerable concern expressed by New Zealand health authorities that has led to a de facto embargo of xenotransplantation in this country, the health authorities have never sought to conduct and maintain regular tests of the health of New Zealanders who have already undergone xenotransplantation.
We note that there has been little if any recourse to the law allowing or imposing restrictions on individuals even with infectious disease – save for tuberculosis (where a patient may be required to accept treatment) and HIV/Aids (where a sufferer must inform sexual partners).  We note that a number of infectious diseases are “notifiable” but without further recourse, in practise, to exercising legal restriction on the patient.

11. What public health restrictions would it be right to impose on xenotourists? Does it make a difference which type of xenotransplantation is involved?
See above. In our view it would be better to allow xenotransplantation in this country, where the animals are disease-free and the regulations can be established to the satisfaction of the NZ population, than to sit back and allow xenotourism to occur (as it undoubtedly will) with New Zealanders travelling to countries that may not have “clean” animal donors, and that may not share our values or our demands for high standards of clinical and research procedure.

12. What decisions do you think the New Zealand government should make about xenotransplantation?
The New Zealand government should consider aligning its regulatory control of xenotransplantation research with that of the FDA in the United States.  The FDA is the Western government regulatory body with the most experience of dealing with xenotransplantation research.

13. Are there any other issues you would like to raise concerning xenotransplantation?
(a) The devastating cost of the diseases which are potential candidates for xeno
Aside from patients suffering from organ failure, xenotransplantation could potentially treat those with haemophilia, AIDS, diabetes, Alzheimer's disease, Parkinson's disease, and Huntington's disease. Apart from AIDS (depending on how it was contracted), these are not diseases caused by modern lifestyles
Type 1 diabetes - which is one of the diseases prominent in the xenotransplantation debate - is one of the oldest genetic diseases known to man and was described by the ancient Greeks. It is not a result of poor nutrition or people not looking after themselves.
Prior to the discovery of insulin, people who developed Type 1 diabetes wasted away before sinking into a coma and dying. Insulin now prolongs their life, but unless insulin can be used in a very sophisticated way, the abnormal blood sugar levels associated with the disease will actually cause other serious conditions in the body - loss of eyesight, kidney disease, circulatory problems leading to the loss of limbs. In adolescents with poorly-controlled Type 1 diabetes, eyesight and other problems can begin to occur within five years.
This is devastating for the person concerned and their families - it also makes this a very expensive disease. Not only is the insulin very expensive, but the secondary and tertiary (hospital) treatment required for people suffering these secondary conditions (such as kidney dialysis) is also extremely expensive.
Potentially, xenotransplantation could not only give these people a chance at a normal life, but also relieve the State of the cost of the secondary and tertiary treatments that these people may require as they go through life.
The best nutrition, exercise and health care known in the world today is not going to prevent Type 1 diabetes. It is a genetic auto-immune disease in which the body's immune system attacks and kills the body's islet (insulin-producing) cells, and which is most commonly diagnosed in school-age children.
Currently, Type 1 diabetes can neither be prevented nor cured. Xenotransplantation offers these people the first hope of a "cure" in the history of mankind, and could also substantially reduce the long-term cost and burden on the health sector.
(Please note that while DYNZ understands that xenotransplantation offers the hope of a long-term treatment, which is not technically a cure for Type 1 diabetes, we regard a long-term treatment that would remove or substantially reduce dependence on insulin, and allow the body’s bio-mechanisms to work “normally”, as the next best thing to a cure.)
(b) The potential for increased human donor rates to reduce the need for xeno
It takes two to three human donors to provide enough islet cells for a transplant for one person with Type 1 diabetes - obviously this is impractical given the large number of people in the world with Type 1 diabetes (15,000 in New Zealand alone) - and that is why scientists are seriously considering xenotransplantation using pig islet cells.
Furthermore, human islet cells are still prone to immune attack and would either need to be coated/protected against attack by the recipient’s immune system, or the recipient would need to take anti-rejection drugs (as per the Edmonton procedure for islet cell transplants.)  There is no way an otherwise healthy young person with Type 1 diabetes should “swap” their diabetes for a life on anti-rejection drugs with all the implications this has for their long-term health as well.
(c) Stem cell research
There are some contributors to this debate who are saying we would be better to wait for the advancement of stem cell research and to reject xenotransplantation.
This attitude is misconceived.
Currently, stem cell research is inextricably intertwined with xenotransplantation as nearly all stem cell lines in research labs around the world are nurtured on a bed of mouse cells.  If these stem cells are used in human trials, these trials would be regarded as xenotransplantation.
Furthermore, stem cell research is many years away from providing solutions to the diseases being considered possible candidates for xenotransplantation, including Type 1 diabetes. (This serves to add fuel to the argument that while we wait there will be a lot more suffering among our members and others diagnosed with Type 1 diabetes.)
A stem cell solution seems to be fighting insuperable odds of success in terms of finding a cure for diabetes.  Islet cells that produce insulin (Islets of Langerhans) are among the most sophisticated groupings of cells in the body.  The Islets contain four types of cells, including Beta cells that produce insulin, and other cells that trigger the production of glucagon, and so on.  These cells work together in ways that are still not fully understood to regulate the body with far greater efficiency than single insulin-producing cells on their own.  Thus stem cells would have to be coaxed into producing not just one type of cell, but four, in groupings and proportions that are not yet understood.  If stem cells released into the pancreas or liver could be coaxed into turning into these sophisticated cell groupings in the body, they would still be subject to auto-immune attack.  A protective coating could not be applied to the stem cells before transplantation into the body as this would undoubtedly hamper or prevent the transformation and growth of the stem cell into the islet cell clusters required, and sertoli cells could not be used unless both they and the stem cells were confined within an artificial area, so again the only protection that could conceivably be used for stem cells would be anti-rejection drugs.
Xenotransplanted islet cells are complete clusters which can be successfully coated prior to transplantation, and which – according to research undertaken so far – could continue to work efficiently in the host for a potential effective period of up to two years, providing the host with natural fluctuations in the production of insulin to match the needs of the body much more closely than injected insulin. 
(d) The prospects for children/youth with diabetes – fierce competition for treatment
With the exponential growth in the number of people being diagnosed with both Type 1 and Type 2 diabetes – most particularly Type 2 – there will be an ever-increasing demand and ever-increasing competition for scarce resources such as opthalmology services and kidney dialysis services – which are already stretched to breaking point in this country.  The prospects for children/youth with diabetes is that in 10 –20 years’ time they may not be able to access the treatments they need in the future when they need it, unless the Government makes the unlikely decision to begin investing enormous sums of money into the treatment of diabetes complications now.
We note, also, that current insulin production in the world is only just keeping pace with current demand, and that a considerable ramping up of production will be required to keep pace with the growth in demand expected from the exponential growth in the incidence of diabetes.
We need to find new solutions to treating this disease as quickly as possible, and xenotransplantation is the only likely current candidate.
(e) The case for cellular xenotransplantation for treating diabetes
We still have a lot to learn about cellular transplantation from a scientific viewpoint. It appears to have promise - but this has to be proven. It is impossible to prove it unless research can be undertaken.
The reaction of some people is to advise following the "precautionary principle". The precautionary principle operates to prevent action where risk is uncertain and cannot be precluded. Had the precautionary principle been operating in the twentieth century, we may have averted some mistakes (certainly not all), but we would have also prevented huge advances in science and technology. The "precautionary principle" may therefore not be as helpful as it seems if it is relied upon too much.
The potential good, and reduction in human suffering, that could come from a breakthrough in this area is enormous - but we will never know unless the research is undertaken. Are the spiritual, ethical and cultural arguments against xenotransplantation great enough to prevent any further research in NZ, or are they great enough to prevent xeno treatment in the future if it becomes a medical reality? DYNZ would like to think not.
Cellular transplantation - which uses well-husbanded disease-free donor animals, avoids genetic modification of the donor animal, protects the xenotransplanted cell from attack by an alginate coating, and leaves the hosts immune system intact without the use of anti-rejection drugs – is the “clean green” of xenotransplantation.  This not only fits with New Zealand’s ethos and image, but also allows xenotransplantation to take place in a well-regulated and modern Western health system.  DYNZ believes this is better protection for New Zealanders than doing nothing and allowing xenotourism to grow in those countries where medical regulatory regimes may not be developed to our satisfaction.
We suggest the Government consider adopting the regulatory principles of the American FDA, which is allowing xenotransplantation research provided stringent controls and requirements are followed.

Submitted for and on behalf of Diabetes Youth New Zealand Inc