http://observer.guardian.co.uk/polit...987110,00.htmlDoubts on pig organ transplants ignored
'Buried' report says controversial technique could put NHS at risk of legal action if potentially lethal viruses emerge. Mark Townsend reports
Sunday June 29, 2003
A damning report revealing profound misgivings over the harvesting of animal organs for human transplants has been secretly buried by government officials.
Commissioned by the Department of Health to explore the legal and ethical implications of xenotransplantation, the document was designed to help formulate a strategy for proceeding with the contentious technology.
Yet the conclusions of the independent advisers from the University of Glasgow they selected are so damning they warn that the animal organ technique might even have to be abandoned in favour of other alternatives. Their findings could prove a fatal blow to hopes that the technique could create new organs for thousands of critically ill people on the transplant waiting list.
The report argues that not only has the Government ignored ethical and public concerns over the technology, its use on patients could prove so dangerous that the Government could face a multi-million pound compensation bill.
Professor Sheila McLean and Dr Laura Williamson from the University of Glasgow spent 16 months putting together the 700-page docu ment, considered by many to be the most comprehensive analysis into the legality of xenotransplantation.
Its conclusions, leaked to The Observer, warn that the NHS and companies involved would be liable for a huge lawsuit if new, potentially lethal viruses emerge from the practice of putting pig cells and organs into the human body. And if the disease - which some experts have warned could create a new HIV-type virus - spreads across the world, the Government could then be sued for breaching international law.
Patients would, in effect, have to choose between death and agreeing to lifelong monitoring and consenting not to have unprotected sex and even children, in case any disease was passed on to another generation.
For years, the technique has been hailed as the solution to ending the critical shortage of donor organs which sees two-thirds of patients on UK waiting lists die before they can have a transplant.
At stake for companies hoping to produce genetically altered pigs that will not be rejected by the human immune system is a global market worth billions of pounds.
To help facilitate the acceptance of xenotransplantation, the Government two years ago commissioned three reports into technology. Two of them - on the risk of disease transmission and the practicalities of transplanting animal organs - have already been published.
The authors of the final, most controversial document were stunned when they got a letter from a senior government official dated 19 June - explaining it had decided not to publish their work. Instead, it claims its findings did not meet the needs of the UK Xenotransplantation Interim Regulatory Authority (UKXIRA), which offers expert guidance to the Government on the issue, and 'lacked balance in some areas'.
The decision to suppress the report has caused outrage among animal welfare groups, which have expressed deep unease about the ethics of creating 'organ farms'.
Dan Lyons, of Sheffield-based animal rights group Uncaged Campaigns, said: 'It is nothing short of sinister that the Government should suppress such an important report, written by its own expert advisers. Its professed commitment to open, democratic debate is a sham, plain and simple.'
Co-author Williamson said: 'Failure to publish this report suggests that UKXIRA will continue to give insufficient attention to the substantial ethical questions raised by xenotransplantation.'
Yet it is the legal implications identified by the authors arising from the creation of new disease that appears likely to prove most damaging to the future of xenotransplantation.
Many experts fear that putting pig cells and organs into the human body could create new viruses. The pig genome contains many porcine endogenous retroviruses - chunks of viral DNA that pose no risk to the animal, but which might act in unpredictable ways in the human body.
But research into pig-to-human transplants is proceeding because of the acute shortage of human organs and scientific confidence that problems can be overcome.
In fact, although xenotransplantation is banned in Britain and America, the Government's body is still accepting testing applications from companies.
Hope has been bolstered by the announcement by PPL Therapeutics - the company behind Dolly the cloned sheep - that trials of animal-to human transplants could begin within two years. It followed the birth of cloned piglets genetically engineered so their organs are unlikely to be rejected by patients.
Yet McLean argues that problems concerning the legalities of the technology mean that other techniques, such as the use of stem cells to repair organs that have become diseased or damaged, should be considered.
'If such therapies exist or could be developed in the relevant timescale, it becomes much more difficult ethically to make the case for xenotransplantation,' she concludes.
Researchers have identified the pig as the best potential candidate for an alternative organ source because of the similarity between human and pig organs.
A Department of Health spokesman explained that UKXIRA was considering whether a further review may be necessary which will also take into account recent developments in the field.
'There are no plans currently to publish McLean's report as a government document, but she is free to publish as she wishes,' he added.