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SUBMISSION OF THE NEW ZEALAND ANTI-VIVISECTION SOCIETY INCORPORATED TO THE XENOTRANSPLANTATION WORKING PARTY, NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL (AUSTRALIA) ON DRAFT GUIDELINES FOR CLINICAL XENOTRANSPLANTATION RESEARCH

Background: The New Zealand Anti-Vivisection Society (Inc.) (referred to as "the Society" 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). We have made submissions to the New Zealand Government on the moratorium on xenotransplantation that currently exists in New Zealand (our Submission on xenotransplantation to the New Zealand Finance and Expenditure Committee on Supplementary Order Paper No 231 is included as part of this Submission in Appendix II). With control of New Zealand's health and safety matters often being put in the hands of joint Australia/New Zealand agencies, it is pertinent that we have input into Australian regulations towards the possibility of xenotransplants one day being regulated or, rather, prohibited by such a joint agency.

Recommendations:

  • That results from experiments of transplants from non-human animal to non-human animal have no bearing on determination of safety or otherwise of clinical xenotransplantation involving humans, due to the cross-species differences between humans and other animals that render such results unreliable at best.
  • That xenotransplantation experiments involving transplants from non-human animal to non-human animal be prohibited, due to the risk of cross-species infection, unreliability of results, animal welfare and other concerns.
  • That due to the potential danger of cross-species infection, clinical xenotransplantation be prohibited.
  • That the Australian Government actively lobby for a worldwide ban on clinical xenotransplantation.
  • That non-Australian citizens who may undergo xenotransplantation be prohibited from entering Australian territory.
  • That Australian citizens who may undergo xenotransplantation outside of Australia be quarantined.
"All transplant surgery is a confession of failure, of unsuccessful early diagnosis and treatment."
(Dr M H Pappworth, Human Guinea-Pigs, 1969.)

The Response Paper states that "a total ban may prevent progress in a research field that has the potential to yield future benefits" (Section 2.29). However it could equally be asserted that a total ban would encourage research into fields other than xenotransplants. Areas that may yield future benefits without the risks of xenotransplants.

The need for Australia to lobby through organisations, such as perhaps the World Health Organisation, for a worldwide ban on xenotransplants is highlighted by Section 2.30 "a total ban in countries such as Australia may also force research offshore".

Section 2.31 states that there is a need for those who may receive xenotransplants overseas to be identified upon entry to Australia. With this identification procedure in place such people could be turned away at the border easily. Australian citizens however could be whisked away to quarantine. Australia is renowned for its detention centres for immigrants or refugees. One such centre could possibly be easily modified into a quarantine unit where Australian citizens who may have received xenotransplants can be housed until their transplant fails, is rejected or they otherwise die. If a worldwide ban on xenotransplants is imposed through an international organisation and there is significant publicity about quarantine or deportation for xenotransplant recipients then it is unlikely there will be many (if any) needing to be quarantined.

Section 3.21 states "before a procedure is considered for animal-to-human transplantation trial, extensive research is needed in animal models". Why? At best the results from studies in animal models will be unpredictable when applied to humans, but are potentially misleading and dangerous. Experiments in animal models should be prohibited. Refer Appendices I and II.

Section 3.29 is internally contradictory. "…such trials would need to be based on strong scientific evidence (from animal-to-animal studies) of therapeutic benefit." Yet, animal studies are inherently unscientific and can provide no evidence that would predict therapeutic benefit in humans. Refer Appendices I and II.

Sections 3.46 and 3.47 deal with the current moratorium in place in New Zealand. Campaigns are underway to have this become a permanent ban. Refer Appendix II.

Section 5.2 suggests that "the majority view is that some use of animals in biomedical research is justified to safeguard and improve health, and to alleviate suffering of human beings". Even if it's true that the majority have been conned into believing that vivisection can improve human health it doesn't mean that it actually does.

Animal Ethics Committees (Section 5):
It should be noted that such committees do not exist for the protection of animals but for the protection of the vivisectors. For instance refer Appendix III. The Society has always been opposed to such committees, prior to their establishment in both Australia and New Zealand, as such Committees give a false sense of legitimacy to vivisection and serve to placate the public thus protecting the vivisectors rather than the animals.

The 3Rs (Section 5.13) is another position advocated by phoneys or vivisectors protecting themselves. A critique of the 3Rs written by Prof. Pietro Croce, MD is attached as Appendix IV. The 3Rs should be disregarded.

Section 5.34 states that "the development of human organ transplantation in the 1960s and 1970s involved a similar range of animal studies as those described here for the development of animal organ transplantation". It fails to note that these animal studies were not able to be predictive of the human condition and in many cases were disastrous.

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 immunosupression 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.)

Section 5.84 states that non-human primate "studies give the best indication of the predicted efficacy of a proposed procedure in humans". No evidence is cited to back this up or explain why it would be better than, say, tossing a coin. Refer Appendix I.

"Section 6: Alternatives to animal to human transplantation"
The "alternative" is to not perform such transplantation.

Section 6.3 says that the supply of human organs has not kept pace with demand. What needs to be addressed here is not how to increase the supply of organs but how to reduce the demand. 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 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. Thus people for whom the Response Paper suggests have treatable conditions by transplant that are not lifestyle related would likely be no better off.

Section 6.54 states that prevention programmes have long lead times and that in the meantime many people are in need of medical help. However nobody is suggesting that xenotransplantation can bring about immediate help. It is still very much in the experimental stage with many risks, hazards and barriers already noted, while prevention programmes can be implemented almost immediately.

Prevention programmes would not just impact on organ transplantation but on areas such as cancer and heart failure that don't involve transplantation.

Summary:
The extrapolation of results from animal experiments to humans retards medical progress and is a hazard to human health, thus results from 'animal-to-animal' transplants cannot be used to indicate safety or efficacy of 'animal-to-human' transplants. Clinical xenotransplantation should be prohibited due to the risks of cross-species infection (outlined in Appendix II).

Phil Clayton
Director
New Zealand Anti-Vivisection Society Incorporated
February 2004

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
NZAVS Submission to the (New Zealand) Finance and Expenditure Committee on Supplementary Order Paper No. 231
This document discusses the risks of cross-species infection from xenotransplantation.

Appendix III
Ethics Committees
This article, published in the Society's newsletter, Mobilise!, No. 46, March 1998, pages 6-7, discuss animal ethics committees in Australia and New Zealand.

Appendix IV
The 3Rs
Excerpt from Prof. Pietro Croce's book "Vivisection or Science?" (Zed Books, 1999, page 83) discussing this pro-vivisection principle.


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