A PREVENTABLE DISASTER
Dr. André Menache, BSc(Hons), BVSc, MRCVS
Article in Chemistry & Industry, No.17, 17 Sept 1998. "Comment", p. 712The transplantation of organs from animals to humans is perhaps one of this century’s most controversial medical technologies. It combines genetic engineering and modern transplantation surgery, with a view to solving the human organ donor shortage.
Since 1963, approximately 55 animal organs, such as hearts, liver and kidneys, have been transplanted into people worldwide. - a technique known as xenotransplantation. However, most of the recipients died very soon after the operation. On this basis alone it is difficult to imagine why the UK government could possibly want to go ahead with xenotransplants. But it has recently invited application to undertake clinical trials involving human beings.
Even more alarming is the admission by the government-appointed Advisory Group on the Ethics of Xenotransplantation that "there is insufficient knowledge about the known viruses to make it safe to proceed to clinical trials at the current time". That report was published in 1996. Since then, leading virologists have continued to warn the public about the dangers of animal virus (known and unknown) which could infect the human population. A worse-case scenario could mean another Aids-like epidemic with little promise of containment.
The organisation Doctors and Lawyers for Responsible Medicine (DLRM) believes that there is overwhelming scientific evidence to justify a total ban on xeno- transplantation in the interests of safeguarding public health, and would like to see legislation enacted which would prohibit xenotransplants altogether.
However, in the absence of such a move at present, the government should ensure that clinical volunteers be provided with life insurance cover at the expense of the pharmaceutical company concerned. In addition, the company should satisfy the government that it has the necessary financial reserves to handle class action civil litigation, should the occasion arise.
However, since xenotransplantation is so novel, from a medico-legal perspective the obvious question arises: who do you sue if things go wrong? The answer is much less obvious, since there are many links in the chain, including the transplant surgeon, the hospital, the hospital ethical committee and the pharmaceutical company.
In considering a compensation scheme for recipients of xenotransplants it may be worth looking at the case of vaccine damage. Like animal-organ transplants, vaccination involves bypassing some of the body’s natural defence systems in order to introduce a virus or bacterium - usually inactivated - into the body. In the case of animal-organ transplants, the introduction of known and unknown viruses and bacteria is unintentional and highly undesirable, but unavoidable nevertheless.
A further similarity between the two is the risk of disease transmission from the person receiving the disease-causing agent to the general population. Just as a young child who receives a live polio vaccine can infect a susceptible adult, so can an animal-organ recipient infect susceptible individuals with the animal viruses and bacteria contained within the organ.
In terms of legislation, the introduction of no-fault liability, based on the similarities between the two situations, has been suggested. However, experience in some countries shows that such legislation is grossly inadequate in terms of compensation. For example, in Israel no fault compensation of vaccine-damaged individuals pays out approximately £41,000 compensation for an individual who is 100% disabled. Anyone who has been in the unfortunate position of having to make a house ‘wheelchair friendly’ soon realises that these sums are far from realistic, especially when close relatives are no longer around and hired nursing services are required for years to come. Needless to say, those individuals who do opt for no fault compensation are automatically barred from applying for civil litigation.
With civil litigation, huge sums of money can sometimes be awarded by the courts. But the burden of proof lies with the damaged individuals, who must also pay lawyers’ fees. It is likely that some damaged individuals will consider their financial, physical and psychological situation to be too weak to even consider civil litigation.
However, precedents do exist where a group of individuals has banded together after the damage has been done to pursue a class action. A good example is the silicone breast implant class action against Dow Corning. Following a landmark court decision, the company set aside $4bn to settle claims worldwide.
But xenotransplants have an added dimension which is largely unquantifiable: whereas silicone breast implants can only affect the individual concerned, it is conceivable that diseases transmitted through xenotransplants could infect other people as well. As the number of people affected could be much higher, this could lead to correspondingly much higher claims for compensation.
Xenotransplantation is still a dangerous and highly experimental technique about to be unleashed upon an uniformed (and possibly also misinformed) public, against its will. The present situation whereby xenotransplantation is being allowed to proceed is both untenable and intolerable and should be challenged on several fronts - in the media, in the courtroom, and through scientific debate. In the words of veterinary virologist Jonathan Allan: "Seldom, if ever, have we had as much knowledge to prevent a future epidemic. What is lacking is the wisdom to act upon that knowledge."