Background and Introduction:

The New Zealand Anti-Vivisection Society (Inc.) (referred to as "the Society" or "NZAVS" within this document) was formed in 1978 by Bette Overell.

The Society opposes vivisection on the grounds that it is medical and scientific fraud. We have adopted the CIVIS Principles, written by our Patron, Hans Ruesch, as our policy on vivisection. These Principles are included in this Submission as Appendix I.

Our campaigns have included a 1984 Petition to the New Zealand Parliament for the Abolition of the LD50 Test (recommended for "favourable consideration") and our 1989 Petition to the New Zealand Parliament calling for the abolition of vivisection (attaining over 100,000 signatures).

The Society has made submissions to the New Zealand Government on the moratorium on xenotransplantation that currently exists in New Zealand.

NZAVS has also made submissions to such agencies as the Xenotransplantation Working Party of the National Health and Medical Research Council of Australia (NHMRC).

In 2004 the Society made a written submission to the Ministry of Health's Review of Regulation of Human Tissue and Tissue-based Therapies, specifically addressing the issue of xenotransplantation. Phil Clayton, as Director, represented the Society at the Review's meeting in Christchurch.

The Review passed the Society's details to the Bioethics Council for the purpose of this dialogue.

The Society registered its interest in attending the proposed Christchurch public meeting dialogue event organised by the Bioethics Council. However, despite (or because of?) much general opposition to xenotransplantation in Christchurch, the public meeting was replaced by a hui concentrating on Maori spiritual and cultural values. The Society registered a complaint* on this matter with the Bioethics Council and instead of NZAVS being present at the Christchurch dialogue event, the Society's Auckland Co-ordinator, Margaret Jones, attended the Auckland public event on the Society's behalf.

* Note NZAVS has no objection to a hui being held, it was the cancellation of the general event that we are concerned about.

This Submission has been prepared on behalf of the NZ Anti-Vivisection Society Incorporated by Phil Clayton, Director, NZAVS. The writer is aware that other members of the Society have participated in the dialogue in a personal capacity -- on-line, by written submission or by attending dialogue events -- and the writer has received feedback from those who have participated.

The attached appendices form part of this Submission. The paper "Of Pigs, Primates, and Plagues" (Appendix II) prepared by the Medical Research Modernization Committee contains references for many of the points made in our Submission regarding the dangers of xenotransplantation.

Cross-species infection:

Transplanting living animal organs into humans circumvents the natural barriers (such as skin and gastrointestinal tract) that prevent infection, thereby facilitating the transmission of infectious diseases from animals to humans.

Viruses that are harmless (or asymptomatic) to their animal hosts can be deadly when transmitted to humans. For example, Macaque herpes is harmless to macaque monkeys but lethal to humans.
Campaign for Responsible Transplantation (NY), cited in The Civil Abolitionist, Vol. 9, Issue 2, Summer 1998, CIVITAS USA).

There is no way to screen for viruses that are not yet known, or have not yet mutated. New viruses in primates and pigs are continuing to be discovered that were unknown before.

An animal virus may mutate inside its human host or recombine with human viral elements creating new viruses that could be highly lethal.

Proceeding with xenotransplantation could expose patients and non-patients to a host of new animal viruses, which could remain dormant for months or years before being detected. And if at the end of this period a dangerous virus was detected in humans there may be no way of tracing it back to its origin of the xenotransplantation.

The danger is not only from viruses, but also from (potentially antibiotic-resistant) bacteria. Yersinia enterocolutica is a bacterium that uses pigs as a reservoir and can infect humans. It is currently spread via pork. Symptoms in humans range from abdominal pain, mimicking appendicitis, to severe septicaemia. Yet pigs harbouring the disease appear healthy.

Prions, fungi and parasites are other potential dangers that may be transferred from animals to humans via xenotransplants. One theory is that prions are responsible for BSE (Mad Cow Disease) and CJD (Creutzfeldt Jacob disease in humans).

It is impossible to guarantee a completely pathogen-free animal.
(C. Ray Greek MD & Jean Swingle Greek, DVM, 'Sacred Cows and Golden Geese: the human cost of experiments on animals', Continuum, 2000, p. 218-9).

The myth of guaranteeing safe and effective xenotransplants:

The Bioethics Council's stance as shown by the Discussion Document and their advertisements that appeared on websites such as scoop.co.nz is that xenotransplants can somehow be proven safe and effective.

Aside from the inability to screen for unknown micro-organisms, such as mutations of viruses, or new forms such as prions, and the inability to guarantee a completely pathogen animal; the methodology proposed by proponents of xenotransplantation, and bodies such as the NHMRC (Australia) and the Bioethics Council Discussion Document page 16, is to trial xenotransplant experiments involving animals other than humans in attempts to assure safety or effectiveness for xenotransplants involving humans.

However, this method cannot work because:
Every species of animal is a different biomechanical and biochemical entity. Non-human animals are different, not only from humans, but also from each other, anatomically, physiologically, immunologically, genetically, and histologically (down to the basic cellular structure). The dog is different from the cat and the cat is different from the rat. The rat is also different from the mouse. And they are all different from human beings.

Animals react differently to different drugs, vaccines, and chemical substances, not only from humans, but also from each other. Aspirin kills cats and penicillin kills guinea-pigs. Yet guinea-pigs can safely eat strychnine - one of the deadliest poisons for humans, but not for monkeys. The list is endless. Consequently every year thousands of pharmaceutical drugs - drugs that had been found "safe" based on animal tests and approved for human consumption - are pulled off the shelves because of the serious health problems they cause in human beings.

Different animals suffer from different illnesses. Humans suffer from around 30,000 illnesses, but only a "paltry number" (Page, Dr T., 'Vivisection Unveiled', 1997, p. 6) are shared with other species. Even when a species of animals suffer from a disease that may also coincidentally occur in humans the cause or symptoms may differ.

"The rabbit is more susceptible to bovine Mycobacterium tuberculosis than to human Mycobacterium TB. The guinea-pig reacts in the opposite fashion. But in neither guinea-pig nor rabbit does tuberculosis have any characteristics in common with the disease in humans."
(Croce, Prof. Pietro, MD, 'Vivisection or Science? - a choice to make', Zed Books, 1999, p. 24).

Animals used in xenotransplant experiments may have been healthy, which is a huge difference from humans who may be considering xenotransplants due to some illness, disease or defect. If the animals undergoing xenotransplant experiments have had the disease or some of the symptoms recreated (or more accurately attempted to be recreated), then this is still different from diseases that have arisen in humans spontaneously in an uncontrolled environment. This also applies to genetically modified animals.

Small differences between species can result in large differences in outcomes. This is illustrated by Neal D. Barnard, MD ("Growing Skepticism over Animal Tests", 'Good Medicine', Vol. VIII, No. 4, Autumn 1999, p.15) using the example (which has relevance in terms of anti-rejection or other drugs that may be used in xenotransplant experiments) of drugs or chemicals entering the body:

"…it [a drug or chemical] is subjected to a range of actions that can dramatically differ from one species to the next. First, it must be absorbed. Then it disperses into various tissues. Third, enzymes in the liver or other organs may break it apart or change it into any number of other compounds. Finally, the chemical - or whatever other chemical compounds it has become - is excreted from the body… toxicology experts have found that enzyme systems animals use for eliminating chemical toxins differ dramatically between species".

Similarly the effects of the immune system of differing species to the presence of micro-organisms are subject to chaotic effects, where even 'small' differences between species can result in large outcomes due to the complexity of living systems.

"Since one never knows all the variables between animals and humans in advance when testing a new chemical or procedure, one never knows how or when the animal is going to 'trip one up' in one's foolhardy attempts at extrapolation"
(Page, Dr. T., 'Vivisection Unveiled', 1997, p.18-19).

With particular relevance to xenotransplants, different animals have different immune systems and immune reactions. Due to these differences, results from experiments on animals cannot be used to predict results for humans.

Also note that in the field of transplantation, animal experiments have not and do not have predictive value for humans for instance:

"Results from animal experiments in the 1960s suggested that there might be important advances in transplantation and there-by prompted a large amount of further research into heart and kidney transplants in rats. But tissue differences between humans and rats proved that animal experiments were once again misleading. The encouraging results had raised hopes that a major advance in clinical immunosuppression for transplantation was in the offing, but these hopes have now faded and nothing of the great mass of work has been translated into clinical practice."
(John Fabre of Oxford's Nuffield Department of Surgery, 'Transplantation', Vol. 34, 1982, pages 223-234.)

The costs and consequences should the risks eventuate:

"All transplant surgery is a confession of failure, of unsuccessful early diagnosis and treatment."
(Dr M H Pappworth, 'Human Guinea-Pigs', 1969.)

If organs were to be genetically-engineered and marketed, it has been estimated that (prior to any surgery or hospital charges) they may cost between $US 100,000 to $US 500,000 each.
(C. Ray Greek MD & Jean Swingle Greek, DVM, 'Sacred Cows and Golden Geese: the human cost of experiments on animals', Continuum, 2000, p. 213).

Xenotransplants would divert funds and resources away from more effective, safer forms of treatment for many diseases. Allowing xenotransplantation could potentially stifle valid research into more effective and safer treatments for any diseases or conditions that were the prompt for the xenotransplant.

An acceptance of xenotransplantation would further the 'spare-parts' mentality and that would result in increased demand for transplants. Merely increasing the number of organs available (as it has been suggested xenotransplantation may allow) will not address this, as the demand for surgeons, operating theatres and the associated resources will also increase, placing further strain on 'health' services that are struggling to cope at the moment.

Our economic survival is at stake. New Zealand spends over six billion dollars each year on what is euphemistically called 'health care'. The fact is that, after more than 100 years of massive animal-based research at a cost of countless billions of dollars, crippling and deadly diseases of all kinds are affecting an ever-increasing number of New Zealanders. Far from curing anything, we are losing ground in the fight against cancer, cardiovascular diseases, diabetes, AIDS, muscular dystrophy, multiple sclerosis, Alzheimer's disease, and birth defects, just to mention a few. Soaring 'sickness care' costs are having a major impact on our economy.

If our 'sickness system' had to cope with an outbreak of a xenogeneic virus or other xenotransplant related pandemic, the system would likely collapse. It would only take one xenotransplant that has 'unintended' consequences for this to happen. The costs of dealing with the pandemic and of compensation would bankrupt the New Zealand economy.

If a xenotourist came to New Zealand for a xenotransplant, or a recipient of a xenotransplant in New Zealand travelled overseas and commenced or added to a pandemic then the international consequences would see New Zealand as a pariah and could be required to pay international compensation further devastating the New Zealand economy. Our tourism industry would be demolished, and there could be potential harmful effects for animals other than humans in New Zealand, who may also be affected by a pandemic.

Xenotourism:

One of New Zealand's advantages is its relevant geographical isolation, the argument that potentially somewhere else in the world may be stupid enough or corrupt enough to allow xenotransplants is no excuse for New Zealand to be as stupid or corrupt.

Our geographical isolation and island status may give us the opportunity to close our borders should an outbreak of a pandemic occur overseas.

Performing xenotransplantation in New Zealand would have a major negative impact on that advantage. We must not jeopardise our economy, tourism industries etc on a financially costly, risky and potentially ineffective procedure when there are more effective and safer areas of treatment for a myriad of other ills that are short of funds and other resources.

Faced with a choice between closing our borders to keep a pandemic out or closing them to keep one contained within our country, it is probable most in New Zealand would opt for the former.

Legislation prohibiting xenotransplantation should be robust enough that it can be promoted as a model for other countries and for international organisations. New Zealand must become a world leader in advocating worldwide prohibition of xenotransplantation.

In the meantime, the Ministry of Health should launch and maintain a publicity campaign, highlighting the dangers of and lack of effectiveness of xenotransplantation, in order to discourage any misguided New Zealanders wanting a xenotransplant from travelling (for that purpose) to those countries stupid enough or corrupt enough to permit xenotransplantation.

This publicity campaign should be backed up by rigorous legislation for the detention, quarantine or deportation of xenotourists.

If the publicity campaign is effective and New Zealand's international advocacy is effective then such drastic measures may never need to be carried out.

Other reasons to oppose xenotransplantation:

Other reasons to oppose xenotransplantation include:

• animal welfare/rights
• environmental effects of farming and disposal of (possibly genetically-modified) animals
• rejection rate of organs
• failure rates of transplants
• Maori opposition
• Other spiritual or cultural opposition
• Financial costs of xenotransplantation depriving others of health resources

Discussion Document Questions:

The Bioethics Council released a "Discussion Document" containing 12 questions on various aspects of xenotransplantation, this section provides the Society's responses to the questions:

Questions 1-3

1. What spiritual or cultural perspectives influence your view of xenotransplantation?
2. What concerns do you have about the effect of various types of xenotransplantation on the recipient's identity?
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?

NZAVS response:
The spiritual, cultural and political perspectives of the Society's members and supporters are many and varied. It is for our members to address these issues from a personal perspective in any personal participation that they may have in this dialogue.

Questions 4-6

4. What is important to think about when deciding whether or not xenotransplantation is an acceptable use of animals?

NZAVS Response:
The important factors that render xenotransplantation unacceptable include:

• the risks of cross-species infection and the affects of those risks should they transpire;
• the inability of results from experiments on non-human animals to predict safety or efficacy for humans or other species;
• the diversion of scarce resources from less risky, more effective procedures or prevention strategies.

These factors alone render xenotransplantation unacceptable, however there are other issues that add to or complement the unacceptability of xenotransplantation including such things as animal welfare, economic costs, spiritual values, rejection/failure rates.

5. How should we weigh the welfare of animals against that of humans?

NZAVS response:
The welfare of animals should be given equal weighting with the welfare of humans. Veterinary medicine should be undertaken with similar policies as those that should apply to humans including: no artificial, violent interventions on healthy animals to inflict maladies and mutilations, but careful study and sympathetic treatment of spontaneous diseases and natural accidents.

6. Does it matter which animals (for example, primates, domesticated farm animals, mice, fish) are being used for xenotransplantation. If so, why?

NZAVS response:
We make no distinction between the species of animals proposed to be used for xenotransplantation, aside from the observation that results from xenotransplant experiments cannot be used to predict safety or efficacy for xenotransplants going the opposite way between the species used in such experiments, and likewise cannot be used to predict safety or efficacy for xenotransplants involving species not involved in the experiments.

Questions 7 - 11

7. How should the interests of the individual be weighed against those of the public?

NZAVS response:
The public is comprised of individuals.

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?

NZAVS response:
All xenotransplantation should be prohibited and no third parties (consenting or otherwise) should be exposed to the risks of xenotransplantation.

9. What would be your response if a family member living with you wanted to undergo xenotransplantation?

NZAVS response:
If a member or supporter approached the Society regarding this issue, they would be informed that there is a current moratorium on xenotransplantation in New Zealand and the reasons for this would be explained to them, including the risks to themselves and the rest of the world from xenotransplantation. They would be provided with a complimentary NZAVS information pack on the subject of xenotransplantation. If the family member were suffering from a disability or disease, then sympathy would be extended to them and their family regarding their suffering. If appropriate more effective and less risky options for treatment may be suggested for them to investigate. We would enquire as to what influenced the family member to wish to undergo xenotransplantation and, if appropriate, take action against that influence.

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?

NZAVS response:
All xenotransplantation should be prohibited in New Zealand. Any illegal xenotransplantation performed should result in prosecution of all those involved in the procedure (including any human recipients). Any qualified medical person involved should have their medical licences revoked. Human recipients of illegal xenografts should be kept in permanent quarantine and have their passport and citizenship revoked. Non-resident recipients should be deported provided the destination for deportation has and will enforce adequate quarantine procedures.

11. What public health restrictions would it be right to impose on xenotourists? Does it make a difference which type of xenotransplantation is involved?

NZAVS response:
New Zealand should rigorously pursue international prohibition of all xenotransplantation. In the meantime:

Case 1:
A New Zealander who travels overseas to a country that may allow xenotransplantation.

New Zealand should enact legislation similar to legislation that can be used to prosecute those citizens who engage in child sex overseas. New Zealanders who travel overseas with the intention or who actually receive a xenograft should be prosecuted. They should be placed in permanent quarantine if they return to New Zealand.

Case 2:
People from overseas who have had xenografts and then visit New Zealand.
They should be subject to immigration constraints similar to the most stringent for those who have infectious disease.

Question 12

12. What decisions do you think the New Zealand government should make about xenotransplantation?

NZAVS response:

• All xenotransplantation should be prohibited under legislation.
• This legislation should be a model for other countries and international agreements
• New Zealand should rigorously pursue international agreements to prohibit xenotransplantation.

Meanwhile:

• Legislation should be enacted to deter and if necessary prosecute xenotourists originating form New Zealand.
• Provision should be made in legislation for deportation or quarantine of xenotourists.
• The New Zealand Government should undertake local and international publicity campaigns to discourage and deter xenotourists
• The New Zealand Government should take heed of the example given by xenotransplantation of the futility and danger of vivisection and delete Part 6 of the Animal Welfare Act 1999, and amend all other relevant regulations or legislation so that zero or negative weighting is given to the results of animal experiments when attempting to predict or determine safety or efficacy for humans of products, substances or procedures.

Summary and Conclusion:

The New Zealand public must not be put at risk from cross-species infection by allowing xenotransplantation to take place in this country. The method proposed, to determine safety or efficacy of xenotransplants for humans, of xenotransplant experiments not involving humans cannot work as the differences between species makes predictive results impossible to obtain.

To minimise the risks from xenotourism, the New Zealand Government should become a leader in advocating international prohibition of xenotransplantation.

The consequences for the health of New Zealanders and the potential bankrupting of the New Zealand economy, should even just one xenotransplant performed in this country result in a pandemic from a cross-species infection, render xenotransplantation unviable - noting that safer and more effective treatments for many illnesses and conditions are under-resourced.

Phil Clayton
Director
New Zealand Anti-Vivisection Society Incorporated
May 2005

Appendix I
CIVIS Principles
These principles, written by NZAVS Patron, Hans Ruesch, have been adopted as the policy of the New Zealand Anti-Vivisection Society Incorporated.

Appendix II
Of Pigs Primates and Plagues
Full text and references from this report on xenotransplantation published by the Medical Research Modernization Committee.