Guidelines for conducting unethical and dangerous research should NOT be sanctioned in Australia

The National Health and Medical Research Council (NHMRC) has been conducting a public consultation on its proposed guidelines for performing clinical trials in xenotransplantation – a dangerous and unethical method of research. Submissions close today.

Xenotransplantation involves the transplantation of cells, tissue or organs from one species (usually genetically-modified pigs) to another and carries the risk of inactive viruses jumping across the species barrier resulting in a ‘xeno-zoonotic’ disease.

In 2004, I served on the NHMRC’s Animal Issues Sub Committee which provided recommendations to the Xenotransplantation Working Party (XWP) as part of the NHMRC’s review on this subject.  I was therefore privy to the full set of submissions received which addressed grave concerns and illustrated huge public opposition to the practice. After a lengthy consultation process the NHMRC recommended that no clinical trials involving animal to human transplantation should be conducted in Australia for five years as the risk of animal to human viral transmission was not well understood.  

The moratorium was sanctioned for good reason:

• Continuing risks to the community
• Public opinion
• Animal welfare and suffering

The NHMRC reviewed its decision in December 2009 and the ban was overturned pending release of ‘guidelines’ for conducting xenotransplantation.  Now that these so-called guidelines have been released, clinical trials of xenotransplantation can proceed once the expected commencement date has been agreed.

Importantly, it has recently been reiterated to Humane Research Australia by medical experts that the critical concerns, which resulted in the 2004 moratorium being announced, remain unchanged.

The uncertainty of risks of disease transmission, particularly across the species barrier, has been acknowledged by researchers.  Clearly, this is not just a theoretical possibility but a very possible outcome.  AIDS is already believed to have been contracted from chimpanzees. BSE and Ebola viruses originated from cross-species contamination.  Some of the major flu epidemics from the start of last century were believed to have originated from pigs.  Porcine Endogenous Retrovirus (PERV) has already been discovered in the animals intended to be used as source animals. With continued emergence of new zoonoses from unexpected sources, the inability to diagnose potential xenozoonotic viruses with current tests and their unknown pathogenic behaviour, the chances of cross-species infection seems to be exceedingly and unacceptably high.  Even more alarming is that, even if detected, the viruses are largely untreatable.

The global panic over Swine flu could perhaps serve as a (very modest) precursor of how the world might react should a new zoonotic disease emerge from xenotransplantation. While the outbreak of the H1N1 virus (Swine flu) was declared by the World Health Organisation to be a “public health emergency of international concern”, a more virulent strain might easily have a much higher level of transmissibility and far more serious health consequences.

Chapter 3.6 of the draft guidelines acknowledges this risk and states:

“Xenotransplantation differs from most other medical research where it is research participants who are predominantly exposed to risks. In xenotransplantation, not only the research participant but also their identifiable contacts and members of the wider community may be exposed to risk. Xenotransplantation research involves some known and, potentially, some currently unknown infection risks to those other than the research participant. The possible risk of xenotransplantation causing novel or latent infectious and potentially untreatable diseases raises an ethical issue that cannot be addressed by the consent of the research participant alone, since others may also be exposed to risk by the research. Further, because of the possible public health risk, research participants will need to participate in long-term monitoring programs.”

There remains serious concern about allowing this research to proceed. Aside from the individual patient’s risk of contracting a zoonotic disease, they are putting the health of the entire community at risk.  An individual has the right to expose themselves to any risks involved in scientific research but to further expose that risk to the wider community that has not given consent, is highly unethical.  The number of individuals that could suffer and die from a new epidemic  or without wishing to overstate the risk, even pandemic, could greatly exceed those potential lives which xenotransplantation was supposed to have saved in the first place.

Xenotransplantation research also inflicts great suffering on animals. HRA has uncovered disturbing cases including baboons rendered diabetic and set to receive pancreatic islet cells from genetically modified piglets; and a baboon known as Conan who received a renal transplant (a kidney from a transgenic pig) and was then killed  due to the development of disseminated intravascular coagulation. [Widespread activation of clotting in small blood vessels throughout the body leading to compromise of tissue blood flow and multiple organ damage.]

For such dangerous research to even be contemplated we would need:

• A full public debate, making it a community decision rather than leaving it to the research community as it will be the general public that will pay the ultimate penalty of any fallout;
• The Productivity Commission to report on the full economic impact of xenotransplantation should it be allowed to proceed – including the possibility of epidemics and emergency response plans in such events ;
• A moratorium on all current pre-clinical xenotransplantation studies until further notice. 

Australia simply cannot allow research into xenotransplantation to proceed. Not only does it expose the recipient to further complications and disease, but it exposes entire communities to the risk of potential zoonotic epidemics, causes extreme and unnecessary cruelty to countless animals and holds little promise of resolving the problem of a shortage of suitable human organs and tissues. The added shame is that people with conditions awaiting transplants may believe that xenotransplantation is an effective cure – it is not - and may only lead to more misery, disappointment and complications.

A full copy of HRA’s submission can be found here.

For further information about animal experiments: Please visit www.HumaneResearch.org.au
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