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"I don't think any of us would disagree that, if an alternative exists to a GE solution, it's to be preferred" Mr Hodson QC acting on behalf of the Life Sciences Network  at the New Zealand Royal Commission on Genetic Modification, 8th  Feb 2001
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1. Government experts sound death knell for pig organ transplants
2. Chances of Animal-To-Human Transplants Fade
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1. Government experts sound death knell for pig organ transplants
News Release Courtesy of Uncaged UK
8th February 2001

The Government's expert advisory committee on cross-species transplants has expressed serious doubts about the prospects of successful pig-to-human  organ transplants. The committee, called the United Kingdom Xenotransplantation Regulatory Authority (UKXIRA), held its third annual public meeting yesterday at Westminster. The Authority's Third Annual Report was also launched at the meeting.

In September 2000, the Authority had been sent an enormous cache of documents describing Imutran/Novartis's programme of pig-to-primate organ transplants. Imutran, a subsidiary of Novartis Pharma and based in Cambridge, had been seen as a world leader in the development of pig organs for transplant purposes. The documents had been leaked to anti-vivisection group Uncaged Campaigns, and were reported on in the Daily Express on 21st and 22nd September. They showed horrific animal suffering in the research, revealed the misleading nature of Imutran/Novartis publicity, and laid bare the research's startling lack of progress. The information clearly has influenced the Authority's thinking, though because of an injunction granted to Imutran/Novartis preventing publication of the documents on grounds of breach of confidentiality and copyright, the Authority would not discuss the documents and the accompanying Diaries of Despair report.

Members of the Authority stunned the audience as they acknowledged the lack of progress in overcoming the powerful rejection of pig organs by the human body and the growing fears over the virus dangers of pig organs. Authority member John Dark, a Newcastle heart transplant surgeon, told the audience that research involving the implantation of transgenic pig organs into primates, such as that conducted by Imutran/Novartis, had yielded "disappointing" results and had lead up a "blind alley". He concluded with deliberate irony: "Xenotransplantation is the future of transplants -and it always will be!"

Another UKXIRA member, Professor Herb Sewell, an immunologist based in Nottingham, said he could not see progress "within a ten year time scale, if at all." He also warned that the public predictions made by Imutran in 1995 of human trials of pig organs during 1996, emphasised the need for professionals to engage with the public in an accurate and balanced way.

In his presentation, virologist Professor Robin Weiss (Windeyer Institute of Medical Sciences) was scathing about Imutran/Novartis's approach to investigating the danger of viruses crossing from pigs to humans as a result of the cross-species transplants. He said he found it "extraordinary" that, despite his advice, the company had only searched for one class of pig viruses in a study of patients who had been exposed to living pig tissue. He was also critical in general about the failure of the company to conduct

sufficient research into the problem in the past six years. The danger to public health posed by pig viruses has been one of the most persistent obstacles to the technology of cross-species transplants.

The Authority was also critical of the decision by Imutran/Novartis to switch its pig-to-primate transplant research from the UK to the US and Canada, which lack animal welfare regulations. The Chairman of the Authority, Lord Habgood (former Archbishop of York), told the audience that the UKXIRA that "scientific research involving the use of animals is best conducted in countries where appropriate regulatory controls are in place to ensure that due regard is given to animal welfare."

Dr Maggy Jennings, an Authority member and a senior RSPCA official, focussed on the "serious and substantial" costs to pigs, primates and other animals in terms of suffering and death. She stated that the animal suffering had not been sufficiently considered when determining whether xenotransplantation research should be permitted by the Government. With the prospect of successful pig organ transplants receding, she recommended that the ethical question of whether the "benefits" to humans outweighed the substantial suffering endured by animals needs to be re-examined.

Dan Lyons, Director of Uncaged Campaigns, was present at the meeting. He said: "The death knell for pig organ transplants has been sounded. The Authority has finally arrived at the position we have been arguing for for five years: pig organ transplants are cruel, dangerous, and unlikely to even work. Furthermore, the positive developments in alternative approaches to dealing with organ failure that were identified by the Authority show that pig organ transplants are unnecessary. We urge Novartis to do the decent thing and stop this cruel and hazardous research."

For further information and interviews, please contact Dan Lyons on 07733 326068, or see our website at http://www.uncaged.co.uk www.uncaged.co.uk

The UKXIRA can also be contacted at 020 7972 4822
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2. Chances of Animal-To-Human Transplants Fade
Friday February 9 5:46 PM ET
By Richard Woodman

LONDON (Reuters Health) - Serious doubts about the prospects of successful animal-to-human organ transplants have been expressed by a Government expert advisory committee.

Several companies, including the UK's PPL, Switzerland's Novartis andAmerica's Biotransplant, are backing animal-to-human transplantation research in the hope that animal organs can alleviate the severe shortage of human donor organs available for transplantation.

But the chances of success may be receding, according to the annual reportof the UK Xenotransplantation Regulatory Authority which was set up threeyears ago regulate this new field. Any transplant between different species is called xenotransplantation.

The report, published by the Department of Health on February 5th, notesthat genetic modification of source animals to ``knock out'' the gene responsible for rejection and the inclusion of new genes needed to control later rejection--though promising--is still in the ``very early stages.''It adds that research in animals ``do not yet provide substantive data that xenotransplanted organs are capable of sustaining life in humans.

Researchers have indicated that this is related more to the inability tooptimise immunosuppressive regimes rather than the problems of physiology. Nevertheless the absence of data is a concern, not least because such data will only be obtained through further animal research.''

The report also voices concern that eliminating all possible risks of transferring diseases as a result of xenotransplantation is impossible atpresent.

``It seems therefore that the likelihood of whole-organxenotransplantation--particularly for heart transplantation--beingavailablewithin a clinically worthwhile time frame may be starting to recede,'' the authors of the report conclude.

The report says greater progress has been made in the development of cell transplant therapies for conditions such as Parkinson's disease, Huntington's disease, stroke, epilepsy, spinal injury anddiabetes.The authority has met several companies involved in this area, including Genzyme to discuss the firm's progress in xenotransplant cell therapies for Parkinson's disease, and the small UK firm Reneuron which is developing mouse and human neural stem cells for implantation into brains damaged by degenerative diseases.

The problem of rejection is less of a hurdle with this type of treatment,they say.

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