DOUBTS ON PIG ORGAN TRANSPLANTS IGNORED

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DOUBTS 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 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 document, 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.

 

The Observer