Humane Charities List 

"Primum  non  nocere"  (Latin)  -  Hippocrates.  "First, do no harm."

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2^nd round consultation – Animal-to-human transplantation research:

How should Australia proceed?

We are grateful that the XWP has provided an opportunity to participate in a second round of consultation. We had grave concerns that many views may have been expressed in the first round of consultation without respondents having a clear understanding of the consequences of xenotransplantation research for animals and for the community. The lay guide and the response paper has gone far to rectify this problem. How widely it has been read however, we cannot know.

Humane Charities Australia maintains its strong opposition to xenotransplantation research on the same grounds as those described in our first submission, and, having served on the XWP ‘Animals Issues Sub-committee’ meetings, being privy to the full set of submissions received and having gained a greater understanding of the issues at stake through the public consultation meetings, HCA has only strengthened it’s convictions in its opposition to such inhumane and risky research.

‘The greater good.’

Throughout the document there is reference to the ‘greater good’, and indeed there have been some concerns cited in the response paper that there has been no definition provided for this phrase. Our interpretation of ‘the greater good’ would be the Utilitarian ethic – which in its basic form, requires that our moral obligation is to obtain the maximum of happiness for everyone concerned.

According to Singer, the characteristic that entitles a being to equal consideration of interests is its capacity for suffering and/or enjoyment or happiness. Other characteristics such as intelligence, rationality or skin colour are arbitrary. Similarly, Jeremy Bentham has stated “The question is not, can they reason? Nor, can they talk? But can they suffer?”

Under these criteria, animals are considered to have interests in not suffering and should therefore be included in our moral frameworks.

The use of animals in xenotransplantation research means that an enormous number of animals will inevitably suffer greatly in order to satisfy human requirements, (despite the uncertainty of any successful outcome).  When we consider the interests of these animals and include them in the total summation of individuals that have the capacity to experience both happiness and suffering, the scales are greatly unbalanced. To rectify this imbalance, if we are to continue with our current use of animals in such vast numbers we need to improve their welfare and reduce their suffering so that the end result will obtain the greatest happiness and least suffering for the greatest number of individuals.  This appears impossible to achieve with xenotransplantation.

This leads to the suggestion that the NHMRC has no commitment to promoting the ‘3R’s’. Whilst we should certainly be working toward the reduction and replacement of animals in research, xenotransplantation only serves to increase the number of animals used by dramatic proportions, through increased genetic modification, development and testing of immunosuppressant drugs and invasive surgical procedures in pre-clinical studies as well as the deaths of the animals used in the actual clinical studies.

Animal Suffering

There is no doubt that animals will suffer (often greatly)  through xenotransplantation. Whilst animal welfare legislation exists, as do various codes of Practice there are loopholes that will allow suffering to occur.

For example, the Draft Policy on the Australian code of practice for the care and use of animals for scientific purposes states “The scientific validity of animal models of human disease rests in part on how closely a given model resembles a particular disease, which may include the animals experiencing the attendant pain or distress of the human disease state” (3.3.40). 

The nature of xenotransplantation means that animals will suffer pain and distress from the invasive procedures as well as the effects of the immunosuppressant drugs. This will include wound breakdown of the transplant site as the animals’ immune system will be unable to heal the wound.

There has also been reference to the ‘Diaries of Despair’ – a report written by UK group ‘Uncaged’, about documents that were ‘leaked’ from the Imutran xeno research in 2000.  An example follows of the observations of a baboon who was the recipient of a heterotopic pig’s heart (One typical example from many):

“X225m was euthanased after 15 days because of an infected haematoma, or swelling caused by clotted blood. On day 3 a ‘large volume of bloody mucoid faeces’ had been observed. By day 9 his right arm had become swollen around an injection site, and on day 11 the arm was badly swollen and bruised. Eventually:

Day 12            am       Quite but alert. Right arm still swollen, skin broken and oozing blood.

            pm       Quiet but alert on perch. No faeces seen. Transplanted heart beating.

Day 13            am       Quiet and slightly huddled. Right arm swollen.

pm       Quite and huddled. Right arm swollen with large open wound, heavily bruised, not bleeding. Vomit during dosing. Transplanted heart bleeding.

Day 14            am       Quiet but alert, sitting at front of cage. Slow movement. Large open

wound on right arm, discharging pus. Normal faeces.

pm       Quiet but alert, moves when stimulated. Wound on right arm larger than observed earlier.

Day 15            am       Quiet and huddled, sitting on perch. Reluctant to use right arm. Further

wound breakdown. Sacrificed for humane reasons.”[1]

Also in an interview on FRONTLINE’S “Organ Farm”, Dan Lyons, director of Uncaged Campaigns UK stated:

“One of the most unfortunate animals had a piglet heart transplanted into his neck. It was a particularly disturbing example, I think, because for several days he was holding the heart. It was swollen. It was seeping blood, it was seeping pus as a result of the infections that often occur in the wound site. He suffered from body tremors, vomiting, diarrhea. And the animal just sat there. I think living hell is really the only sort of real way you can get close to describing what it must be like to have been that animal in that situation.”

Whilst the NHMRC may argue that it is necessary to ensure that sufficient regulations and guidelines are put into place to protect animals from suffering, how can we ensure that similar acts will not occur here when the UK also has stringent animal welfare legislation and regulatory bodies.

The XWP have stated that best code of practice will be required to minimise animal suffering and distress. Despite the UK having many laws to protect the welfare of animals, these laws are invariably broken when conducting xenotransplantation research. Animal xenotransplantation models cannot be done without significant suffering incurred on recipient animals. This is perhaps one reason why Imutran/Novartis have shifted their operation to some parts of Europe and North America i.e. areas where there is no legislation that places limits to pain and suffering on experimental animals. Whilst Australian society might consider it ethical to inflict pain and suffering on baboons or cynomolgus monkeys for the perceived greater good, there should be no misrepresentation that this will be insignificant.

The recent experience in the United Kingdom is only briefly alluded to in the response paper. There is no mention of the prolonged legal battle that occurred over documents exposing the extent of animal suffering endured by experimental animals, an issue that developed into a major scandal. Imutran/Novartis misled public presentation of their research, underestimating the level of suffering inflicted on non-human primate animals, and in so doing breached animal welfare laws in the United Kingdom. These documents have been referred to as the "Diaries of Despair" (as quoted above) and are described in detail at www.xenodiaries.org and should be viewed by the XWP. In the spirit of fairness and transparency, I would urge the XWP bring the realities of xenotransplantation animal models into the public domain. It is inevitable that companies will attempt to downplay the level of suffering inflicted on experimental animals, and the true depth of suffering should at least be acknowledged.

The Imutran reports which were open to public scrutiny only after lengthy legal proceedings, led the UK RSPCA to comment on the particularly informative nature of the clinical signs in determining the degree of suffering experienced by the primates. The UK RSPCA regarded subsequent attempts by both Imutran and the Home Office to downplay the clinical signs as dishonest. There is clearly a problem if the RSPCA and researchers have a different view of what defines pain and suffering in experimental animals.

Public Opinion

Despite assurances at the public meetings that a decision on whether or not to proceed with clinical studies of xenotransplantation was dependent on the response to this second round of consultation, it is the view of many animal welfarists that the decision has already been made. In light of recent media reports that the XWP will recommend that clinical studies go ahead (despite the closing date for submissions not having being reached) and from personal discussions with members of the XWP it would appear that this certainly is the case.

Clearly there is a great deal of opposition to xenotransplantation for a number of serious issues. This has been expressed through the submissions received in the first round of consultation, as well as the overwhelming opposition at the public consultation meetings around Australia.  We consider that the analysis of submissions tabled in the response paper has misrepresented the overall view, as those ‘inferred from text’ have only agreed to clinical studies of xenotransplantation proceeding IF major hurdles can be overcome – which they likely cannot.

For example…

The Salvation Army (X035) recognizes the potential benefits to patients, but also suggest that the risk of the inadvertent transmission of infectious agents to recipients and the wider community is of concern.  Despite the XWP being unable to allay that concern they have counted this submission as a ‘yes’ vote.

RSPCA (UK) (X091) have also been designated as a ‘yes’ vote ‘provided that animal welfare issues are adequately addressed’. It is clear from the nature of xenotransplantation that sufficient animal welfare standards could never be attained.

Also worth considering is that of those who are in favour of clinical studies proceeding, how many would have a vested interest? It is highly questionable that these views should be seen as being objective. (X016? X056? X080?). On the other hand, there are many submissions from medical experts that raise serious concerns and are strongly opposed to xeno research. These include:

Dr Anthony Raizis (X034), Dept. of Molecular Biology, Christchurch School of Medicine & Health Services NZ.

Dr Peter Collignon (X063), Infectious Diseases Physician & Microbiologist, Canberra Hospital.

Claude Reiss (X072), Molecular biologist, Sciences Enjeux Sante

Dr Judy Carman (X078), Epidemiologist, Flinders University

Surely such serious concerns by recognized experts should carry great weight in the decision process!

Unfounded arguments

A case used by the NHMRC to argue in favour of implementing xeno guidelines is that we will otherwise have no way of monitoring those people who travel overseas to ‘rogue researchers’. This however cannot be regarded as a legitimate reason as firstly there will always be the possibility of ‘rogue researchers’ operating overseas regardless of whether we conduct the research here. Secondly, the monitoring of these people who arrive in Australia becomes a quarantine issue and should be addressed regardless of whether or not xenotransplantation occurs in Australia.  Australia should aim to lead the way in ethical scientific progress rather than adopt the lowest common denominator approach claiming ‘if we don’t do it, someone else will’.

The various alternatives to xenotransplantation have each been dispelled as being incapable of resolving the shortfall issue. However, as an aggregate they have the potential to increase the availability of tissue and organs by a vast proportion.

Legal changes to increase availability of human tissue/organs such as adopting the ‘opt-in’ system have been portrayed as being difficult to accomplish, yet only recently the media has reported that the Minister for Health is considering changing legislation that will prevent relatives from refusing organ removal – a current hurdle for transplant hopefuls. The unfortunate death of cricketer David Hookes recently and subsequent lives saved from his organs resulted in a dramatic increase in people registering to donate their organs. These examples illustrate that greater availability of human organs and tissue can certainly be achieved through legislative change and further promotion of the human donor scheme.

Draft Guidelines

Humane Charities Australia feels that it is inappropriate to comment on draft guidelines as we do not consider that xenotransplantation should proceed under any circumstances.  We feel strongly that we should not be attempting to regulate a practice that will cause immense suffering to animals and poses the risk of exposing the community to a new epidemic. We should be taking measures to STOP it!

Conclusion

Despite HCA’s strong opposition to clinical studies of xenotransplantation proceeding, we acknowledge that it is a decision to be made by the community – providing they have the full information to enable them to make such an informed decision. For this reason we call for

In summary, we can only reiterate our original concerns which have in no way been alleviated by the XWP response paper. Australia simply cannot allow research into xenotransplantation to proceed. It would cause extreme cruelty to countless animals, expose entire communities to the risk of a potential zoonotic epidemic and appears to hold little promise of resolving the problem of a shortage of human organs and tissues. These concerns go over and above those regarding ‘general’ animal-based research.  We strongly urge the NHMRC to abandon such inhumane and high risk research and instead redirect funding into the more ethical and promising alternatives.

Helen Rosser

National Coordinator

Copyright © 2004 AAHR
Last modified: June 23, 2005