MPs Call 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.
Uncaged Campaigns 29.04.98
The Independent on Sunday carried a report on 19th April that a new "draft analysis" on the application of the Animals (Scientific Procedures) Act 1986 to be presented to ministers later this year will remove commercial considerations from the cost/benefit analysis that is supposed to be undertaken before the issuing of licences for animal experiments. Depending on the exact wording and interpretation of this change, anywhere between tens and hundreds of thousands of animal experiments could be effectively prohibited.
Under the Act, which governs all animal experiments likely to cause "pain, suffering and lasting distress," the potential benefit likely to arise from a procedure must be balanced against the likely "adverse effects" on the animals involved before a licence is issued. The likely benefits have, however, always included economic benefits, including profitability and employment. That fact certainly gives the lie to the claim that animal experiments are all about health and the saving of human lives and is a sad reflection of the failure of the Act to offer meaningful protection to the animals used in laboratories - even if one accepts (which Uncaged does not) the cost/benefit principle. The usefulness of this legislation is further undermined by the secrecy surrounding the issue of project licences which makes it impossible to assess how that principle is actually applied. The 1986 Act needs to be replaced, not refined.
The proposal to drop the "profitability" element of the cost/benefit analysis is welcome, however, from a welfare point of view, but the devil is in the detail. About 10% of animal procedures involve the toxicology testing of non-pharmaceuticals - in theory all of these tests can be seen as taking place in order to promote the profitability of the companies who produce them. Even in the pharmaceutical sphere, which accounts directly for about a third of all animal tests (and indirectly for many more), many procedures are undertaken on so-called "me-too" drugs or products, ie products which mimic other products. These have no distinct therapeutic value or advantage and are designed simply to enhance the profitability of the company producing them. If all these kinds of procedures are seen as being justified economically then they could be threatened by this proposal. Obviously, a very elastic definition of profitability could affect many more procedures in the pharmaceutical sphere but clearly this is not the intention of the proposal.
However, the question is: will the Home Office, and the Department of Trade and Industry, accept the proposal? The draft analysis comes from within the Home Office, possibly from the Animal Procedures Committee or the Inspectorate itself although this is unclear, but the decision rests with the minister. And even if he does accept the proposal, how strictly will the Home Office apply it, and how will the public know how strictly they apply it?
Cross your fingers, but don't hold your breath.
Uncaged Campaigns 23.04.98
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.
Uncaged Campaigns 23.04.98
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.
(Pictured outside No. 10 - Dan Lyons, Norman Baker - M.P. for Lewes and Angela Roberts.)
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:
Uncaged Campaigns 01.04.98