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Xeno News

The Express expose of the Diaries of DespairDon't forget to visit our website that is totally dedicated to the ongoing Diaries of Despair case (with latest news, an online petition and sample protest letters) at www.xenodiaries.org

The drugs don't work - vivisectors lose their TRAIL

A ‘breakthrough’ cancer drug awaiting human trials that passed all animal tests, including in vitro animal cell tests, was found to have devastating effects on human in vitro cell cultures. The drug, TRAIL (an acronym for Tumour Necrosis Factor-Related Apoptosis-Inducing Ligand), was seen in animal experiments to destroy tumour cells by causing them to commit suicide. It appeared that it only affected cancerous cells, leaving normal ones unaffected. The team who conducted the cell culture tests noted in their report that:

"In a study with non-human primates, injection of soluble human TRAIL did not cause toxicity to tissue or organs, apparently ‘clearing the way’ for Phase I studies in humans."

However, the research team, led by Dr. Stephen Strom at the University of Pittsburgh in Pennsylvania, say they have found that TRAIL could also have a devastating effect on healthy cells. Writing in Nature Medicine, the scientists said that more than 60% of the human liver cells exposed to TRAIL in the laboratory were wiped out within ten hours.

"Apoptosis (programmed cell suicide) and cell death in human hepatocytes was massive and rapid," they reported. The cells shriveled and their DNA fragmented. Tests on liver cells in rats, mice and rhesus monkeys did not show the same response."

These results indicate that if TRAIL was used in human trials, "considerable hepatoxicity or fulminant hepatic failure could result." Yet this new drug had passed all animal tests, had all the usual hype that is routinely lavished on ‘breakthrough’ anti-cancer agents, and was ready to begin trials in human patients. This sorry story re-emphasises the pointlessness of animal experiments given the many important and complicated species differences. This is re-iterated throughout the report by Strom et al:

"These results indicate that there are species differences in sensitivity to TRAIL, and that substantial liver toxicity might result if TRAIL were used in human cancer therapy.

"TRAIL did not induce apoptosis in parenchymal hepatocytes from any other species other than human."

Furthermore, one has to ask why in vitro human cell culture tests were not conducted first, thereby saving innocent animals from being subjected to pain and death. Invasive procedures were conducted on rats, mice, and rhesus monkeys (culminating in death) some considerable time before Strom et al conducted five (5) in vitro cell culture experiments. The Animal Procedures Committee is supposed to ensure and enforce the principle that no license for animal tests will be granted if there are ‘alternative’ methods available. Strom et al conclude with what is surely a statement of the obvious:

"Moreover, the extrapolation of data from preclinical investigations in other species should be made with caution, and investigations with human cells should be included in the preclinical evaluation of therapeutic agents."

It speaks volumes about the mentality of the pharmaceutical industry that, by May 2000, human cell tests are not included in pre-clinical investigations already, and it takes a near disaster with a supposedly ‘magical’ drug for anyone to suggest this.

The final, frightening, word in the of this grisly farce goes to Shigekazu Nagata, from Osaka University Medical School who, again in Nature Medicine, said:

"It may still be possible to delay clinical trials until we have a better understanding of why some cells but not others are resistant to Trail." !

[Source: Nature Medicine, Vol. 6, No. 5, May 2000, p. 502-503, and p. 564-567]

Max Newton

Study holds serious implications for safety of xenotransplants

Many commentators on the danger of virus transfer posed by xenotransplantation have pointed to the example of HIV as a virus that appears to have crossed from animals to humans with catastrophic effect.

The precise route of transmission of HIV from chimpanzees to humans has been shrouded in mystery. Now, a painstakingly researched book, The River (Penguin, £25), presents a powerful case that the first polio vaccine trials to take place in Africa - in 1957 - were responsible for the global AIDS pandemic which has killed an estimated 15 million people. As the evidence grows that AIDS crossed from animals to humans via a medical product, the warning bells over xenotransplantation ring louder than ever.

In The River, author Edward Hooper produces evidence that a U.S.-based body, the Wistar Institute of Philadelphia, used chimpanzee kidneys to culture the polio virus that formed the basis of the vaccine. Wistar has always denied this, claiming that Asian monkeys were used which do not become infected with the relevant AIDS-like virus.

However, Hooper has traced eyewitnesses who recall that chimpanzees were indeed used in research and vaccine production at an animal research facility at Lindi, in what was then Belgian Congo. Hooper then shows the correlation between the use of the Wistar chimpanzee-derived vaccine in central Africa in the late 1950s and the first confirmed cases of HIV infection in the same region at the same time.

Chimpanzee kidneys are an effective medium for growing polio virus and would have been an obvious first choice for scientists. Significantly, the name of the primate species used to develop the vaccine was not published at the time by the leader of the project, Dr Hilary Koprowski.

The Wistar has always been very sensitive to suggestions that it was responsible for the creation of AIDS. However, it’s main argument against the polio vaccine theory was recently demolished. A British sailor, David Carr, who had returned from Africa shortly before the trials began, was thought to have been the first documented victim of HIV infection, thereby exonerating the vaccine from responsibility. But in 1995 it was revealed that Carr had not travelled to Africa, and he had not been infected with HIV.

One of the best ways to test Hooper’s theory would be to analyse samples of the polio vaccine used in the trials to see if they contain the progentor of HIV, the simian immunodeficiency virus (SIV). However, there are serious practical difficulties with conducting a relevant study. Wistar claims that the old vials of vaccine may not be exactly the same as the ones used in the trials. Furthermore, the forty-two year time period that has elapsed since the production of the vaccine means that there may not be enough of the virus present to yield meaningful results.

Despite these difficulties, the publication of The River will increase the pressure on Wistar to find an independent research team to test the old vaccine samples. Although negative results would not rule out Hooper’s theory, positive results would confirm it.

The parallels with xenotransplantation are clear. Hooper’s convincing theory demonstrates how a virus that has existed for millenia in its natural host can suddenly become modernity’s most lethal infectious disease. Misguided and cruel exploitation of animals may well have created the AIDS pandemic. Incredibly, we are now on the threshold of embarking on another hazardous medical experiment: the implantation of animal organs and tissue into humans.The most important lesson to be learned is the utter folly of the whole concept of xenotransplantation.

Dan Lyons

(19/08/99)

Imutran / Novartis study brings false sense of security - risk of epidemic from animal organ transplants remains

The following statement is issued by Uncaged Campaigns in response to the publication in this week’s edition of the journal Science (20.8.99) of a study of 160 patients who had received live pig tissue. Some reports claim that the study provides evidence to support the case that animal organs will not pose a risk to public health as a result of virus transmission from pigs to humans.

Dan Lyons, spokesperson for Uncaged Campaigns, says:

"The findings of this study are not a reliable guide to the risk of virus transfer in the event of xenotransplantation taking place. There are numerous problems with the design of the study:

  • It is too small - in statistical, public health terms, 160 people is a very small sample.
  • The tests employed are, it is generally accepted, not powerful enough to guarantee that any PERVs present will be definitely detected. The collection and analysis methods used could also impact the results.
  • It is universally acknowledged that there will be unknown pig viruses present which cannot be tested for reliably.
  • The numbers of cells (and therefore viruses) transplanted was much less than would be the case in the event of whole organ xenotransplantation.
  • None of the patients had received transgenic pig tissue. Imutran/Novartis’s xenografts would be transgenic. Virologists such as Robin Weiss have warned that the transgenic xenografts could increase the chances of a pig virus infecting a recipient and then the wider population.
  • The explanation given for the presence of PERV DNA in some patients, that pig cells have survived for up to eight and a half years in the bloodstream, is not reassuring. Retroviral infections can remain latent for many years before causing ill-effects. These kind of infections can then transmit undetected through the human population for many years, as the tragic example of HIV demonstrates.

Laboratory studies have already demonstrated that PERVs can infect human cells. Furthermore, there are several examples of diseases crossing from animals to humans with catastrophic effect . For example, the Spanish influenza epidemic of 1918 that killed between 20 million and 40 million people is thought to have been transmitted by pigs. Most new human diseases originate in animals, and xenotransplantation provides a uniquely efficient way of transmitting a new disease.

We fear that the results of this inconclusive study will be used by Imutran/Novartis in a desperate attempt to protect their multi-million pound investment in xenotransplantation, despite the abundant evidence already available which demonstrates the intrinsic dangers of the technology.

We hope that the UK Government and regulators around the world will resist ill-founded and irresponsible calls for clinical trials to commence. Their first duty must be to protect public health, not promote the commercial interests of the biotechnology industry. That means banning xenotransplantation."

For more information and interviews, please contact Dan Lyons on 0114 2530020 or 07990 584158.

-ends-

Notes for editors

  • Uncaged Campaigns are the leading opponents of xenotransplantation in the UK. Through our public education work we have submitted 125,000 signatures to the Government calling for a ban on xenotransplantation, and the Health Secretary has received 20,000 postcards from members of the general public expressing opposition to xenotransplantation on public health and animal welfare/rights grounds.
  • Dan Lyons is a PhD researcher into the ethics of xenotransplantation, as well as directing Uncaged Campaigns project, Xenotransplantation Concern.
  • Uncaged Campaigns latest action against xenotransplantation took place in Cambridge, the home of Imutran, on 24 July this year. 400 concerned people from around the country joined together in a massive ring-a-roses (see 'A'Tissue!' story below). Ring-a-roses is a medieval children’s rhyme commemorating the devastating effects of the Great Plague. The aim of the event was to highlight the danger of creating a modern epidemic posed by xenotransplantation.   

16/02/99

Uncaged Campaigns hold protests outside xenotransplantation companies

Outrage at "Frankenstein" animal experiments

A demonstration took place outside the troubled animal-testing firm Huntingdon Life Sciences (HLS), at 12 noon Monday 15th February, in response to the revelation that the company has provided facilities for controversial experiments where transgenic pig hearts and kidneys have been transplanted into primates, including baboons captured from the wild. This new information has been uncovered by a BBC Radio 5 Live documentary, 'Ed Hall Investigates...', broadcast 12 noon on Sunday 14th February.

HLS has also been exposed as a hiding place for the herd of unique pigs containing human genes. The pigs are owned by IMUTRAN LTD, a Cambridge-based subsidiary of NOVARTIS. The location of these pigs has been a closely-guarded secret until now.

Dan Lyons, spokesperson for pressure group UNCAGED CAMPAIGNS, organisers of the demonstration, explains:

"This research programme involves perhaps some of the cruellest experiments currently taking place in Britain. Humanised pigs are kept in unnatural, sterile conditions - condemned by the RSPCA - that frustrate the natural desires and instincts of these highly intelligent animals. Some primate recipients of pig organs have suffered and died because of the poisonous effects of high doses of immunosuppressant drugs that have been tested on them. Other primates have died because of infections that have arisen because their immune systems have been so damaged. The misery inflicted on these animals at HLS should not be allowed in a civilised society."

HLS has been in financial difficulties since employees of the company were filmed cruelly treating beagle dogs in the Channel Four documentary "It's a dog's life" in March 1997. With HLS's involvement in more controversial research now exposed, it's future looks even more uncertain. "This could be the final nail in HLS's coffin", remarks Dan Lyons.

Imutran - "Global dealers in death"

A further demonstration took place at 3.00pm, Monday 15th February 1999, outside the offices of Imutran Ltd, Douglas House, Trumpington Road, Cambridge (by junction with Bentley Road).

Imutran are the Cambridge-based biotechnology company researching animal-to-human organ transplants. Campaigners are angry that Imutran have exported 95 transgenic pigs to countries all over the world. This information has come to light in a BBC Radio 5 Live documentary to be broadcast on Sunday 14 February, 12.00 noon.

Until now, press reports and Government Dept of Health answers, have indicated that only two pigs had been exported, in May 1998, to the Netherlands.

Imutran, who are owned by the multinational drug company Novartis, have exported pigs for research and breeding purposes to the Netherlands, Canada, the USA, Japan, Spain and Italy. The transgenic pigs contain human DNA so that the pigs' organs may be suitable for transplant into humans, Imutran claim.

By exporting the transgenic pigs from the UK, Imutran are avoiding relatively strict British regulations on animal experiments and human trials.

In animal experiments in the UK, welfare regulations have forced Imutran to euthanase suffering primates who have received transgenic pig organs.

Thus, Imutran have lost the opportunity to gain more knowledge about how the pig organs are rejected by the primates. Back in 1995, Imutran claimed that they were ready to start trials of pig hearts in humans by the end of 1996.

However, the UK Government has consistently refused permission for human trials because of the fear of transferring a new viral disease into the human population as a result of such experiments, among other reasons. Similar sentiments caused the parliamentary assembly of the Council of Europe to vote on the 29 Jan for an on-going ban of human trials.

Dan Lyons, spokesperson for UNCAGED CAMPAIGNS, organisers of the demonstration, comments:

"Given that Novartis, owners of Imutran, are a global company, it is not surprising that they have taken the pigs to wherever they can conduct their experiments as quickly as possible. Imutran claim that they are concerned about safety and animal welfare, but their behaviour clearly demonstrates that they are prepared to sidestep safeguards in their haste to try to develop this technology. At the same time, Imutran/Novartis are inflicting immense suffering on intelligent, sensitive animals, while threatening to expose the public to the potentially lethal risk of new viruses."

References
1 John Wallwork, "Current status of xenotransplantation", International Journal of Cardiology 62 Suppl. 1 (1997) S38.
2 David Dickson, "Pig heart transplant 'breakthrough' stirs debate over timing of trials", Nature, 377, 21 September 1995: 185.

International Week of Action Against Xenotransplantation

22nd February to 28th February 1999

An international week of action against xenotransplantation (animal-to-human transplants), running from 22 February 1999 to 28 February 1999, has been initiated by Sheffield-based pressure group Uncaged Campaigns, one of the UKs leading opponents of the technology.

A BBC Radio 5 Live documentary broadcast on Sunday 14th February 1999 uncovered an international trade in genetically engineered pigs. The transgenic pigs were bred by Imutran, a Cambridge-based biotechnology company owned by the multinational drug company Novartis. Ninety-five pigs have been exported to the USA, Canada, Japan, Italy, Spain and the Netherlands for both breeding and research purposes. Imutran claim that they have now bred two thousand transgenic pigs, most of whom are probably in the UK.

By exporting the transgenic pigs from the UK, Imutran are avoiding relatively strict British regulations on animal experiments and human trials. In animal experiments in the UK, welfare regulations have forced Imutran to euthanase suffering primates who have received transgenic pig organs.1 Thus Imutran have lost the opportunity to gain more knowledge about how the pig organs are rejected by the primates. Back in 1995, Imutran claimed that they were ready to start trials of pig hearts in humans by the end of 1996.2 However, the UK Government has consistently refused permission for human trials because of the fear of transferring a new viral disease into the human population as a result of such experiments, among other reasons. Similar sentiments caused the parliamentary assembly of the Council of Europe to vote on the 29 Jan for an on-going ban of human trials.

Given that Novartis, owners of Imutran, are a global company, it is not surprising that they have taken the pigs to wherever they can conduct their experiments as quickly as possible. Imutran claim that they are concerned about safety and animal welfare, but their behaviour clearly demonstrates that they are prepared to sidestep safeguards in their haste to try to develop this technology. At the same time, Imutran/Novartis are inflicting immense suffering on intelligent, sensitive animals, while threatening to expose the public to the potentially lethal risk of new viruses. Uncaged Campaigns contacted scores of animal protection organisations in several countries to ask them to participate in the week of action. Particular attention has been paid to groups in countries where xenotransplantation research is taking place, such as those countries that have imported Novartis transgenic pigs.

One of Canada's largest animal protection groups, Animal Alliance of Canada, are particularly worried about their domestic situation because trials involving the hooking up of patients to pig livers outside the body appear to be imminent. However the Canadian Government has failed to draw up any guidelines to regulate xenotransplantation, and public debate has been virtually non-existent. Canadian bioethicists fear that these experiments may go-ahead before the Canadian public has even had an opportunity to contribute to the debate. Uncaged Campaigns are organising a letter to be submitted to the Canadian High Commission in London, respectfully requesting that the Canadian Federal Government consider our case for a complete ban on research into xenotransplantation.

Much of the UK activity has been focussed on Cambridge, home of Imutran. Events have taken place in Cambridge on every day of the week of action, instigated by a local organisation, Animal Rights Cambridge. Wednesday 24th February was the date for the largest action in the UK. A crack team of bio-troubleshooters successfully sealed off Imutrans offices on Trumpington Road, Cambridge, to symbolise our efforts to protect the public from the risk of viruses passing into the human population as a result of Imutrans activities. There were between 30 and 40 of such intredpid bio-troubleshooters - all dressed in blue boiler-suit style uniforms replete with biohazard symbols and face-masks. The day, and indeed the whole week, was a great success in bringing to the public's attention the immense dangers that could be unleashed upon the human population for the next millenium, as well as the abominable experiments being carried out on pigs and primates in the pursuit of this 'science' in Britain and around the world today.

This was all despite the rather bizarre presence of some sort of private investigator who attended all the events and even followed people home!

In addition to the Cambridge actions, Uncaged Campaigns will be touring towns and cities across the UK during the next week to distribute thousands of organ donor cards and registration forms (see Alternatives to Xenotransplantation), and to alert the public to the dangers of xenotransplantation.

References:

John Wallwork, Current status of xenotransplantation, International Journal of Cardiology 62 Suppl. 1 (1997) S38.

David Dickson, 'Pig heart transplant ' breakthrough stirs debate over timing of trials, Nature, 377, 21 September 1995: 185.

Dan Lyons

(22/01/99)

Uncaged Campaigns discover first application to conduct trials of pig-human transplants has been received by UK Department of Health

Yesterday (Thursday 21st January 1999), the UK Department of Health revealed that the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA) has received its first-ever application to conduct a trial of pig-to-human transplants. The application was received just before Christmas. No such trials have yet been permitted in the UK. The historic information emerged in answer to an inquiry made to the Authority today by Dan Lyons from the pressure group Uncaged Campaigns, who have been lobbying against xenotransplantation for the past two and a half years.

The Government has so far prevented human trials of xenotransplantation, mainly because of the risk of viruses transferring from pigs to humans and creating new disease in the general population. Test tube research has discovered that pig retroviruses can infect human cells. The genetic engineering of the pigs to try to prevent rejection, ironically, could make it easier for viruses to infect a recipient of pig tissue and then infect contacts of the patient.

An all party Commons Motion will be tabled calling for a brake on xenotransplantation trials until legislation is put before Parliament to discuss whether, and how, xenotransplantation should be regulated. Patients who receive pig tissue would have to be monitored for the rest of their lives for signs of viral infection, according to UKXIRA guidelines. However, such surveillance regimes are currently impossible to enforce - the necessary legislation simply doesn't exist at the moment.

Dan Lyons comments: "To permit trials of this hazardous procedure without even being able to minimise the risk of viruses spreading is to multiply the danger to public health. I cannot believe that the Government would give permission for any trial before the issue is debated in Parliament."

-ends-

For more information and interviews, please contact Dan Lyons on 0114 2530020 or 0421 056014.

Notes for Editors

  • The final decision on whether to permit human trials of xenotransplantation procedures rests with the Secretary of State for Health, Frank Dobson, after UKXIRA have made their recommendation as to whether the trial should be permitted or not.
  • When guidelines for applications for clinical trials were published by the Government on 30 July 1998, Imutran Ltd, the leading UK researchers into xenotransplantation, announced their intention to conduct a trial involving filtering the blood of human patients through a pig liver housed externally to the patient in a matter of "months to years". Imutran then intend to move towards transplanting pig kidneys directly into humans. The Department of Health have refused to reveal any information about the nature of the application for reasons of protecting "commercial confidentiality". Imutran have denied that they have submitted the application. Imutran are owned by the multibillion pound pharmaceutical firm Novartis.
  • The main signatories on the House of Commons Early Day Motion are Norman Baker MP, Tom Brake MP (both Lib Dem), Maria Eagle MP, Paul Flynn MP (both Lab), David Amess (Con).
  • Uncaged Campaigns have formed and lead a network of organisations perturbed by xenotransplantation, called Xenotransplantation Concern (XtC). Other participants in XtC include Animal Aid, the British Union for the Abolition of Vivisection (BUAV), the National Anti-Vivisection Society, Compassion in World Farming (CIWF), Genetic Engineering Network and the Green Party.
  • Uncaged Campaigns have submitted 125,000 signatures to the Government calling for a ban on research and trials of xenotransplantation on animal rights/welfare, medical and safety grounds. As a result of another Uncaged Campaigns initiative, the Department of Health has so far received approx. 17,000 postcards from members of the public expressing opposition to xenotransplantation on ethical and medical grounds. A Teletext opinion poll on 1st August 1998 discovered 79% opposition to animal-to-human organ transplants. A poll conducted for the BUAV and CIWF by NOP found 54% of respondents disagree with transgenic research into xenotransplantation.
  • Text of EDM:
  • That this House notes the recent submission of an application to the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA) to conduct a clinical trial of xenotransplantation procedures on humans; notes that, despite the theoretical benefits to transplant patients, there are major scientific obstacles and hazards to public health (in particular, the potential of introducing a new viral pathogen into the wider population) which remain to be addressed; observes that the required legal sanctions to enforce the UKXIRA-recommended surveillance regimes for any recipients of animal tissue are currently absent; recognises serious ethical and animal welfare concerns generated by the practice; acknowledges the existence of widespread public unease regarding xenotransplantation, as evidenced by opinion polls and petitions; and, in the light of these gaps in scientific knowledge, regulatory powers and the absence of informed public consent, calls upon the Government to withhold permission for human xenotransplantation trials pending unequivocal evidence of the microbiological safety and clinical effectiveness of xenotransplantation, and categorical public consent for the commencement of human trials and, subsequent to these conditions being satisfied, the introduction of the necessary legislation to ensure public health.

(22/03/99)

UKXIRA Open Meeting Report

Monday 7th December 1998

UKXIRA (United Kingdom Xenotransplantation Interim Regulatory Authority) was created in March 1997 following the publication of the report, Animal Tissue into Humans, two months earlier. Its terms of reference are as follows:

To advise the Secretaries of State of the UK Health Departments on the action necessary to regulate xenotransplantation, taking into account the principles outlined in Animal Tissue into Humans, and worldwide developments in xenotransplantation. In particular to advise:

a. on safety, efficacy and considerations of animal welfare and any other pre-conditions for xenotransplantation for human use, and whether these have been met.
b. on research required to assess safety and efficacy factors in xenotransplantation procedures;
c. on the acceptability of specific applications to proceed with xenotransplantation in humans; and
d. to provide a focal point on xenotransplantation issues within government.

UKXIRA held its first open meeting on Monday 7th December 1998 at the Queen Elizabeth II Conference Centre, Westminster, to launch its first Annual Report and provide an opportunity for interested parties to discuss issues with the panel of UKXIRA members. Alistair Currie and Dan Lyons from Uncaged Campaigns were amongst an invited audience that included scientists, representatives from xenotransplantation company Imutran/Novartis , and other animal welfare and animal rights campaigners such as Joyce D' Silva (Compassion in World Farming) and Dr Gill Langley.

Presentations were given by various UKXIRA members through the afternoon, and the main issues to surface from the meeting are summarised here:

Impossible to measure risk
Professor Sheila McLean, Professor of Law and Ethics in Medicine, Glasgow University gave an articulate and well-organised presentation explaining the criteria by which applications for clinical trials will be assessed. Although those criteria included an assessment of the safety/risk of the procedure to both the patient and the wider population, Professor McLean admitted that there is currently "insufficient information to undertake microbiological risk assessment." In other words, there is no way of accurately assessing the risk of a new viral disease emerging via xenotransplantation procedures: this is the major issue worrying scientists and regulatory bodies across the world.

Professor McLean revealed that each application to undertake a clinical trial will be scrutinised by several "independent" assessors, selected by UKXIRA for their expertise in relevant areas. However, upon further questioning, Professor McLean confirmed that none of the "independent" assessors had expertise or a particular interest in safeguarding animal welfare, despite the requirement to consider issues of animal welfare when regulating xenotransplantation contained in the terms of reference of UKXIRA. Already, we sensed that the minimal commitment to consider animal welfare was more rhetorical that real.

Viral transfer issues remain unanswered
Next on the podium was Professor Herb Sewell, Professor of Immunology at Nottingham University. Professor Sewell reported to the meeting the findings of the Workshop on Retroviruses convened by UKXIRA in August. Professor Sewell outlined the evidence obtained from in vitro tests which established that two known pig retroviruses (PERVs) do indeed infect human cells in culture, albeit relatively slowly. Another PERV, closely related to viruses that cause certain cancers in human beings, may infect human cells. As yet, there is no evidence to confirm that these viruses can either cause disease in humans, or be transmitted from human-to-human. Pig-to-monkey experiments cannot provide any answers to these burning questions because, unlike humans, the monkeys subjected to these experiments do not have the kind of receptors on their cells that allow these viruses to infect and replicate.

Studies of previous recipients of pig tissue are currently being undertaken. However, once more these procedures do not offer any kind of reliable guidance as to the safety of whole organ xenotransplantation because they have involved:

  • relatively small numbers of cells
  • very short term ex vivo perfusion of patients blood with pig organs
  • non-genetically-modified pig tissue
  • most patients have not been immunosuppressed
  • the overall number of patients being studied is small in statistical terms - approximately 160.

These factors make the transfer of pig viruses into these patients far less likely to occur than in the case of full-scale xenotransplantation, especially should the procedure become an established procedure with many xenografts taking place.

The first three events in a sequence of seven, which would result in a new virus transferring from pigs to humans, have been fulfilled. Professor Sewell announced that there are "no clear answers on the safety of pigs as tissue donor sources," and said that decisions on whether the risk of viral xenozoonosis were low enough to permit the commencement of human trials should be taken by "industry, clinicians, scientists and the public." One of those decisions could be to "abandon xenotransplantation."

Surveillance cannot be guaranteed
After a short break, Professor George Griffin, Professor of Infectious Disease at St George's Hospital discussed the work of the newly-formed Surveillance Working Group. Professor Griffin outlined various measures designed to monitor patients for the emergence of a new viral disease. Professor Griffin admitted that the kind of intensive, life-long surveillance regimes required to monitor recipients of pig tissue that offer the best hope of containing any pig virus are, it appears, not strictly enforceable: the legislation to ensure compliance with these strict regimes simply does not exist at present, apparently. This seems to reveal a gaping hole in UKXIRA and the Government's plans to regulate xenotransplantation and protect public health.

Open discussion
The meeting ended with an open discussion of the Authority's work and xenotransplantation. The discussion was dominated by questions regarding the animal welfare remit of UKXIRA. It was this discussion which reinforced the impression that animal welfare was not taken seriously by UKXIRA. Joyce D'Silva asked the panel a direct question regarding the relevant difference between pigs and primates which justified the exploitation of pigs, but not primates, for source tissue, as outlined in Animal Tissue into Humans. The members of the Authority had great difficulty addressing this issue. Professor Griffin even went so far as to deny that Animal Tissue into Humans had ruled out the use of primates on ethical grounds. This is quite disturbing as UKXIRA is supposed to base its considerations on that report, which concluded:

" ... it would be ethically unacceptable to use primates as source animals for xenotransplantation, not least because they would be exposed to too much suffering." [para. 7 and 4.28].

Professor Griffin also revealed a rather cavalier attitude to the whole question of animal welfare and primate use. Another member of the Authority, Mr John Dark, Consultant Cardiothoracic Surgeon at the Freeman Hospital, Newcastle appeared openly hostile to the animal welfare viewpoint.

Another area of concern surrounds the issue of how the public were integrated into the consultation process. When addressing this question, the Chair of UKXIRA, Lord Habgood of Calverton, expressed scepticism as to whether the House of Commons was a fit body to be discussing such complicated matters. Though, to be fair to Lord Habgood, his comment was made rather tongue-in-cheek, the issue of democratic scrutiny is a very important one, and once again UKXIRA seem to be paying lip service to the notion of public involvement, without seriously incorporating it into their deliberations.

The overall impression of UKXIRA that I and others received is of a body which although it is working within a framework that could allow for a relatively fair and balanced consideration of xenotransplantation issues, is composed of members of rather mixed ability and attitudes, and is failing to meet some of the complex demands required of it, particular in the area of animal welfare. Too little attention is being paid to the precautionary principle, and far too much faith is being placed in the ability of science and technology to assess and control risks which are not understood and are literally beyond the limits of scientific knowledge. The inevitable presence of unknown viruses was not mentioned once during the meeting. Given the immense repercussions of xenotransplantation, any shortcomings in UKXIRA are a cause for great concern.

Dan Lyons

(29/09/98)

Xenotransplantation research "in breach" of RSPCA policy

Correspondence with Dr Maggy Jennings, Head of Research Animals at the RSPCA, has revealed that substantial elements of Imutran's research programme are incompatible with RSPCA policy. The RSPCA is opposed to all experiments which cause pain, suffering or distress; is opposed in principle to manipulating animals' genetic constitution; is opposed to the use of wild-caught animals; is opposed to the import and export of laboratory animals; and is opposed to all forms of farming that deprive animals of the opportunity to indulge in their natural behaviour. Of the last of these, Dr Jennings writes:

The RSPCA has always expressed serious concern at the welfare implications of keeping pigs in SPF/QPF conditions [Specific Pathogen-Free/Qualified Pathogen-Free]. Part of Imutran's herd is kept in QPF conditions. We believe that this seriously limits their ability to express their normal behavioral repertoire and therefore seriously curtails one of the Five Freedoms widely recognized as important for farm animals.

Imutran's research, genetic manipulation and breeding programme on pigs, its export of a transgenic pig to Holland and its transplantation experiments on primates including wild-caught baboons contravene these policies. 

Max Newton

(20/08/98)

Govt prepare the way for xenotransplantation trials

At the end of July Frank Dobson announced the Department of Health's guidelines on applications for clinical trials in xenotransplantation. Immediately before the Government announcement Imutran announced their intention to make an application under the guidelines to use pig liver tissue in a supportive role outside the body, although they did not specify when they would be ready to do this.

The Guidelines contained nothing very surprising to close observers of the issue. The Government's basic position is that the organ donor shortage is unlikely to be solved by other means (which is true if they continue to be unwilling to consider changes in current donation policy and laws) and that they are, therefore, unwilling to stand in the way of a potential solution to that problem if they can be convinced of its safety. Mr Dobson re-iterated the line the government has already taken in Parliamentary Questions and other statements that:

"Trials in xenotransplantation involving humans will only be allowed to take place if and when we are fully satisfied that the risks associated with such procedures are acceptable taking account of all the available evidence at the time."

Applications for trials will be considered by the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA) and the final decisions rest with ministers. Steps have been taken to ensure that all NHS hospitals and ethics committees comply with these regulations, which are non-statutory. The Government states it is willing to introduce legislation but has no timetable at all for doing so at present. Other details include the inclusion of a specific animal welfare role for UKXIRA, preparation of guidelines on source animal welfare by the Home Office and preparation of surveillance procedures (ie testing for evidence of infection or virus transfer) for organ recipients.

(20/08/98)

Virus transfer symposium takes place beind closed doors

A Government-sponsored meeting of experts to discuss virus transfer took place at the beginning of August. Unfortunately details of what was discussed have not been made public, despite the obvious implications for public health. Speculative reports in the scientific press suggest that the message on risk was mixed. Apparently studies of previous xenograft (i.e. tissue such as skin or pancreatic cells) recipients show no evidence of virus transfer so far, although these patients were not generally immunosuppressed and, of course, did not receive tissue containing human genetic material. There is also evidence that a third kind of endogenous virus (i.e., a virus "inbuilt" into pig DNA) carried by pigs can infect human tissue in the laboratory. Two other endogenous viruses have already been shown to do this.

Public announcement of the results of Imutran's study of 160 previous xenograft recipients is still pending, as are the results of Prof Robin Weiss' research into the implications of the introduction of genetic material which may make it possible for viruses to "disguise" themselves as human tissue.

(29.4.98)

MPs calls for urgent Commons Debate on pig-to-human transplants

Following a press briefing held by Imutran, the Cambridge biotechnology comapny researching pig-to-human transplants (xenotransplantation), outlining their intended path to clinical trials of the procedure, an Early Day Motion (No.1255) has been tabled by Paul Flynn MP for Newport West (Lab.) and Norman Baker MP for Lewes (LibDem) calling for a Parliamentary debate to discuss the far-reaching public health and animal welfare implications of xenotransplantation.

Virologists have warned of the potentially devastating consequences of a pig virus contaminating the human population, following research demonstrating that pig viruses can infect human cells.

"Should xenotransplantation trials go-ahead, the entire population of Britain will be the subject of a dangerous and unnecessary experiment", commented Dan Lyons of pressure group Xenotransplantation Concern (XtC).

Over 100,000 signatures opposing xenotransplantation research and clinical trials were handed in to the Government last month. The Department of Health has received in excess of 15,000 postcards from members of the general public registering opposition to xenotransplantation.

"Our experience clearly shows that the public are very concerned about xenotransplantation from both a public health and an animal welfare viewpoint. The very least they deserve is that a technology with such massive implications receives democratic scrutiny", says Dan Lyons. So far, Government policy on this issue has been determined behind closed doors.

Early Day Motion 1255 Xenotransplantation. Tabled 28th April 1998

That this House notes the public health risks associated with pig-to-human transplants, including the introduction of novel infectious and dangerous microorganisms into the human population and the immunological, anatomical, and biochemical discrepancies between pigs and humans; recognises the potential for substantial cost implications for the National Health Service should the risk of infection or other medical complications materialise; notes the considerable suffering endured by pigs and primates in the course of xenotransplantation experiments and the prospect of an increase in the level of suffering endured by pigs should xenotransplantation become a routine clinical practice; and, in the light of these profound implications for public health and animal welfare, calls upon the Government to preserve the moratorium on clinical trials, to initiate as a matter of urgency a full and wide-ranging Parliamentary debate on xenotransplantation to facilitate the democratic scrutiny that xenotransplantation demands, and to ensure that the precautionary principle applies to xenotransplantation whereby one of the conditions to be fulfilled before clinical trials are considered is that the safety of the procedure is guaranteed.

(23/04/98)

Xenotransplantation clinical trials imminent?

It was recently reported that an Israeli surgeon has expressed his desire to perform a pig-to-human heart transplant using genetically-modified pigs obtained from Imutran in the UK, and the reports implied that a clinical trial was imminent in the UK. The Department of Health were caught on the hop by these reports and when we contacted them they had only just managed to confirm that clinical trials were not imminent by phoning Papworth Hospital. This suggests that either regulation of possible clinical trials may not be nearly as tight as it should be, or that internal communication within the Dept of Health is imperfect.

There has been a "moratorium" on human clinical trials of xenotransplantation since January 1997 but as there is no legislation governing xenotransplantation the Government is not in a position to directly ban it, especially if it were to take place in a non-NHS hospital. A British hospital ethics committee would be unlikely to approve a clinical trial without Government approval but it remains theoretically possible for one to take place. In fact, the Dept of Health is willing to consider human trials if it can be satisfied that all risks, including the risk of virus transfer or other infection, could be adequately controlled - in effect the "moratorium" is moribund. The United Kingdom Xenotransplantation Interim Regulatory Authority receives applications for clinical trials and is responsible for advising ministers, but this process takes place entirely behind closed doors - all we know of UKXIRA's work is its remit and the names of its members. We do know that they are in close contact with Imutran, and while this is clearly appropriate given their role, it gives Imutran - who through their parent company, Novartis, have resources beyond your wildest dreams - lobbying opportunities denied to groups such as ourselves.

Xenotransplantation Concern remains committed to the complete prohibition of xenotransplantation and we believe that a better informed public and political community will promote that end. We also believe that the risks involved in this procedure render it unacceptable for decision-making to take place behind closed doors. We are currently working to promote greater open-ness in this process through our political contacts and will provide more details of this component of our campaign soon.

(01/04/98)

100 000 say NO to Xenotransplantation

Xenotransplantation Concern presented a 100 000 signature petition to 10 Downing St on 31st March 1998, calling for an immediate end to xenotransplantation research and a ban on clinical trials. Norman Baker MP formally presented the petition to the House of Commons on the same day.

The petition was originally launched by Uncaged Campaigns in 1996, but now forms part of the broad-based campaign against xenotransplantation being co-ordinated by XtC. It calls for an immediate cessation of xenotransplantation research on the grounds of microbiological risk, the danger to human recipients, the neglect of policies to increase human organ donation and ethical objections to the use of animals in this way.

Alistair Currie of Xenotransplantation Concern said:

"Opposition to xenotransplantation is not confined to a minority of activists and pressure groups, as some may like to believe. This petition is clear evidence of the strength of public concern over xenotransplantation, concern that is strongly justified by the risks associated with this procedure. The introduction of living animal tissues and the viruses they contain into living human bodies is a potential biological time bomb. Any progression to human clinical trials would not only be dangerous to the patients involved but to the community as a whole and would represent a contemptuous disregard for the concerns of the public. Once the first xenotransplant has taken place it will be too late to decide the risk is unacceptable. This might be our last chance."

(29/05/98)

Imutran still promising jam tomorrow

Leading xenotransplantation researchers Imutran held a press briefing in April to discuss their plans for the future. The briefing, which included a contribution from Prof Robin Weiss, an immunologist who has warned of the dangers of virus transfer, painted a picture of prudence. They are currently undertaking a retrospective study of patients who have received pig tissues, such as skin grafts, to look for evidence of infection in humans by porcine viruses. If this should produce no evidence of infection they hope to commence a trial involving pig liver cells outside the body, similar to those which have been undertaken in the USA. They also hope to undertake kidney transplantation, but were noncommittal about the timing, finally suggesting five years down the line when pressed by journalists.

In 1995 Imutran claimed they were ready to proceed to human trials in early 1996. In October of last year, Alistair Currie of Xenotransplantation Concern attended a meeting at which one of the surgeons involved in the research said they could proceed to trials "next week" if the government would permit them. From the point of view of human welfare their new found caution is welcome: unfortunately it is likely to lead to much more animal suffering in the course of pursuing the increasingly unlikely possibility that xenotransplantation will ever provide an effective therapy.

(26/06/98)

Transgenic pig imported to Holland

It has come to light that Imutran, the UK's leading xenotransplantation researcher, has been conducting research in a controversial animal laboratory in Holland, and that it recently exported a transgenic pig to the laboratory where its organs have been harvested and transplanted into monkeys.

The work being conducted at the Biomedical Research Centre (BPRC) appears to involve the testing of immunosuppressant regimes, and has been conducted since at least November 1997 using non-transgenic pigs and macaques. A transgenic pig (accompanied by a companion animal, slaughtered on arrival) was flown to Amsterdam in early May, both of its kidneys being removed after slaughter and transplanted into two macaques whose own kidneys had been removed.

It appears that Imutran are attempting to circumvent the relatively tough regulation that applies to their experimental procedures in the United Kingdom - why else would they undertake such an expensive exercise for procedures that appear to be the same as those conducted in this country? The Animal Procedures Committee has explicitly stated that it is willing to delay the progress of research on animal welfare grounds and a representative of Imutran admitted in 1997 that British regulations have sometimes prevented them from concluding experiments as they would wish - ie they have not been permitted to keep animals alive indefinitely who are suffering substantially.

BPRC has, incidentally, been criticised by groups such as the RSPCA for the condition in which its primates are kept. This latest development serves to emphasise how low a priority animal welfare actually takes in this research.

(04/06/98)

Wild-caught baboons used in xenotransplantation

The answer to a parliamentary question put by Norman Baker MP has revealed that wild-caught baboons have been used in xenotransplantation research. A previous answer by George Howarth of the Home Office, had admitted that wild-caught baboons were still being used in experiments despite the need for "exceptional and specific justifications" for their use. Baboons are the most advanced primate permitted to be used for research in the UK. Pursuing this answer, Norman Baker asked what these justifications were. The answer, to Written Question no 176, asserted that baboons had to be used as no other permitted primate was large enough, and sufficient quantities of captive-bred baboons were not available, despite "extensive efforts" by the research team to obtain them from captive sources.

The baboons appear to have been used in heart transplant surgery, as part of the xenotransplantation research programme, presumably by Imutran, who are the only researchers undertaking this kind of work in the UK at present. The suffering of these animals is profound, as they undergo major surgery and then the consequences of trasnsplant. Imutran's published research suggests that their experimental subjects tend to survive periods of weeks following surgery, before, presumably, dying of complications related to the transplant.

That such suffering should be permitted to be inflicted on any animals for so speculative a prospect as xenotransplantation is an indictment of the 1986 Act. That it should be inflicted on animals on top of the distress of being caught in the wild and transported to this country is profoundly shocking.

(01/04/98)

Another new virus

As recently as 26th of February a new pig virus was reported to have infected two workers in Sydney, Australia. Causing deformities and stillbirths among pigs and severe flu-like symptoms in the two workers, the virus was traced back to a colony of fruit bats near the piggery.

One of the most frightening potential consequences of xenotransplantation (animal-to-human tissue transplants) is the transfer of viruses carried by donor animals into the human population. Pigs are considered to be "safer" donors, microbiologically-speaking, than primates as the infections from which they suffer are less likely to cause human disease than those of primates, but it has already been shown in the test tube that their viruses can infect human tissue. Xenotransplantation's advocates have claimed that screening could eliminate viruses but we have no mechanism to detect unknown viruses. As Australian virologist Peter Kirkland told a meeting in Sydney "you can't screen for disease agents that you don't know about." The discovery of this new virus, and the fact that it transferred from bat to pig to human being through a far less direct route than the implantation of living tissue inside the body, is yet another reminder of the level of our ignorance in this area, and the potential risks of this procedure.

(28/01/98)

Scientists call for moratorium on xenotransplantation

Seven specialists with an interest in xenotransplantation, led by Fritz Bach of Harvard Medical School have called for a moratorium on human trials in the USA until an informed public debate on the issue has taken place. In a letter to Nature, published 22nd January, they note the risk of infectious agents crossing from pigs to human beings and write:

"given the potential risk to the public, the issue is first and foremost an ethical one..an informed public debate is needed so that the public can decide whether it wishes to consent to clinical xenotransplantation at all and, if so, under what conditions."

Nature's editorial counselled caution, and another editorial in The Economist on 24th Jan wrote "to allow any further xenotransplants without a far clearer idea of the potential risks - and a strong, international system in place for monitoring recipients - would be folly indeed."

The risk of transfer of pathogens and the potential for a transferring virus to cause an epidemic has been highlighted by the recent outbreak of flu originating in chickens in Hong Kong - HIV 2 is also known to have originated in monkeys. In October 1997 British scientists announced the discovery of viruses carried by pigs' own DNA which can infect human tissue and which, according to one researcher may be impossible to eradicate prior to transplant (New Scientist 18/10/97). Screening for unknown viruses is an even greater challenge.

As Bach writes, the risk of infection in the general population renders the issue one of concern to everyone; in effect any human trial constitutes an experiment on the entire population. For a critically-ill individual patient offered a xenotransplant in the absence of a human organ, the risk of infection may appear to be worth taking; the possible consequences of that decision have far wider ramifications however. It is essential therefore that an informed public debate precedes any progression to clinical trials. This is particularly important at present as the UK government's decision on human trials is expected to be announced within a month.

Of course, many scientists and others consider the unknowns surrounding xenotransplantation an indication for more animal research. The fact is, of course, that no animal experiment can prove the safety of animal organs which, theoretically, could last twenty years in a human being. Even the smallest immunological difference between humans and experimental animals could become the gateway for a pathogen. The moral and prudent solutions to the shortage of organs are prevention of conditions that may lead to the need for a transplant, improving the supply of usable human organs and improving the long term success of human transplants.

It is interesting to note that opinion polls have shown some divergence in attitudes to xenotransplantation between the USA and the European Union. In the US 75% of people would consider an animal organ for a loved one if no human organ was available. In the EU only 36% thought the practice morally acceptable. Most interestingly, the US study found opposition to xenotransplants strongest among those people with the highest level of knowledge about it.

No big surprise?

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