LETTER TO MPS IN RESPONSE TO HOME OFFICE CLAIMS

7th January 2004

Dear Member of Parliament

Home Office letter regarding Imutran xenotransplantation research

It has been brought to our attention that the Home Office has recently written to MPs (copy enclosed) in an attempt to defend itself in the face of overwhelming documentary evidence of its failure to enforce the Animals (Scientific Procedures) Act 1986. The Home Office letter comes following support from 153 MPs for an independent inquiry into the affair (see EDM 1340 in last session) and consideration by the Home Affairs Committee of an inquiry into the Home Office's conduct.

Unfortunately, the latest letter is the most aggressive and inaccurate in a long series of defensive statements from the Home Office. I must say that it is deeply saddening that the Home Office should prefer to intensify the level of misinformation regarding the level of suffering experienced by animals rather than deal constructively with widespread and well-documented concerns about its operation of the 1986 Act. It is therefore absolutely vital that the record be put straight regarding this matter of public interest.

I should add that, although the letter is signed by Caroline Flint MP, the responsible minister, I know from meeting her (and this is often the case generally), that she is reliant on advice from Home Office civil servants and the Inspectorate, who were themselves involved in the regulation of the Imutran research. Having said that, it is clearly imperative that she and the Home Secretary 'get a grip' on the conduct of their officials as soon as possible: they must take some responsibility for the actions of those officials.


The basis of our allegations

The Home Office letter begins by asserting that they have "explained" that the allegations of wrongdoing on their part "are simply not borne out by the facts." In reality, far from "explaining" anything, the Home Office has simply made a series of inaccurate, unsubstantiated and often contradictory assertions regarding its regulation of Imutran's experiments. In contrast, our case regarding the Home Office's wrongdoing is carefully based on unique primary documentation regarding the experiments.

The derogatory implication of the Home Office assertion - that our case is somehow unfounded - is grossly unfair. Uncaged Campaigns and myself endured a two-and-a-half-year legal battle, with the threat of personal bankruptcy hanging over me, simply in order to be able to publish the confidential documents contained in two leaks, firstly from Imutran and then the Home Office itself. I spent a large part of those proceedings as a litigant-in-person, opposed by a multi-billion pound company represented by a major corporate law firm, Eversheds.

The key factor in favour of publication of the confidential documentation was the necessity to expose Home Office wrongdoing. Despite our enormous resource disadvantage throughout this traumatic process, we eventually won our case because I had worked incredibly hard to compare the voluminous evidence with the requirements of the 1986 Act. We did not have the power that comes from virtually unlimited financial resources, all we had to rely on was the strength of our argument. I had also checked my analysis with a scientific consultant who is a member of the Government advisory committee on animal experiments, the Animal Procedures Committee (APC). If my analysis had been significantly faulty, there is no doubt that we would have been crushed in the legal battle.

We received a second leak of documents relating to the Imutran research which came from the Home Office itself. The leak contained crucial confidential Home Office documents including the project licences that set out the legal terms upon which Imutran's research was licensed. These categories of documents are explicitly confidential and have never emerged into the public domain before. The Home Office had the opportunity to intervene in the proceedings by making an application to the High Court. (The Home Office has falsely denied this in an attempt to distance itself from the legal proceedings. We are currently considering our options regarding a response to this particular inaccuracy.) The surprising decision by the Home Office not to intervene to preserve confidentiality is a further indication of the strength of the public interest argument in favour of publication. This is borne out by the information contained with those documents.

I have written tens of thousands of words in the form of legal pleadings, reports, briefings and memorandums, all of which are extensively referenced. We have published over a thousand pages of primary documentation describing the Imutran research. In brief, we have gone to enormous lengths to be open and to explain fully our position. In contrast, the Home Office claims are extremely brief and contain very few references to the documentary evidence. In the circumstances, the increasingly bullying approach adopted by the Home Office and its attempts to smear my character represent politics at its nastiest.


Indulgent attitude towards licence applicants

The Home Office letter goes on to assert that Imutran's applications were rigorously challenged, that severity assessments were carried our correctly, and that these severity limits and other licensing requirements were fully enforced. These assertions range from highly implausible to plain false.

In addition to the actual evidence of the underestimation of animal suffering and a failure to punish breaches of severity limits, other leaked documents provide a damning insight into the Home Office's relationship with Imutran:

1. During the assessment of Imutran's main project licence which covered the majority of the primate experiments, an Imutran executive recaps on action points following a meeting with a senior researcher:

"[The researcher] agreed to talk to [an Inspector] at the Home Office re technical failures (1), life supporting heart in baboon and to generally chew the cud and ensure smooth and rapid passage of forthcoming 19b application (2). Important that [the Inspector] understands the issues (technical difficulty, imminence (3), etc.) and will give us upward support of the application for orthotopic work. We have to work to make him look like a jolly good bureaucrat and yet achieve our goals as well!" (emphasis added)

2. The notes of an Imutran meeting (4) the following week describe tactics for progressing the research:

"Sandoz (5) have suggested kidney transplants, the Home Office will attempt to get these classified as moderate procedures."

The Home Office letter makes an unsubstantiated attempted to deny the validity of Imutran's description of the Home Office's conduct, and claims that they did not "deliberately, or otherwise, underestimate the severity of the procedures". This denial is highly implausible. Firstly, given that the severity of the procedures was in fact unequivocally greater than 'moderate' (see below), and that the Home Office continues to falsely deny this, this strongly indicates that the Home Office underestimation was deliberate. A deliberate underestimation of animal suffering is entirely consistent within the overall pattern of the Home Office's regulatory failure.

Secondly, there is no strong reason why one should doubt the veracity of the internal Imutran note. I cannot see what motivation they would have for misrepresenting the Home Office's conduct. It is simply a matter-of-fact reference to Imutran's dealings with the Home Office. Only a full independent inquiry can get to the bottom of this question and it seems significant that the Home Office appears desperate to frustrate our attempts to ensure due process and accountability.

3. Two documents (6) in the run up to the assessment of a later licence - for kidney transplant experiments - provide further evidence of a collusive relationship between Home Office Inspectors and Imutran in order to facilitate licence approval. A letter from Imutran to Huntingdon Life Sciences describes a telephone call between Imutran and their Inspector. It relates:

"For your information he also told me that our application for a kidney transplant licence has been reviewed by the inspectorate and that we should expect to have some "I's to dot and some T's to cross" before it goes to the APC."

A few months later, on the eve of the APC meeting to discuss this application, the same Inspector is referred to again in the minutes of an Imutran meeting:

"The existing project license expires on the 21st April 1999. [The Home Office Inspector] has on several occasions expressed his view that the new License will be approved before the existing license is revoked and that Thursday [the date of the APC meeting] will be merely a 'rubber stamping' exercise."

Therefore, apart from the actual concrete evidence of the underestimation of severity, the evidence we have strongly suggests (to put it at its mildest) that this was associated with a collusive relationship between Imutran and the Home Office intended to evade the requirements of the regulatory system.


Assessment and enforcement of severity limits

The Home Office letter goes on to claim that the levels of suffering experienced by the primates, while appearing to be severe, did not exceed the 'moderate' severity limit assigned to them. This denial is, without a shadow of doubt, false.

The observations made of the primates following the xenotransplantation procedures demonstrate that, in spite of any attempts that may have been made to ameliorate the animals' suffering, they endured severe pain and distress which is commensurate with either the 'substantial' category of pain and distress, or represents 'severe' suffering, which is formally prohibited.

In a crucial passage the Home Office has recently stated in relation to the assessment of Imutran's research:

"a moderate severity limit would be appropriate in the case of heterotopic organ transplants, where the recipient animal's own organ would remain in situ and continue to function... Failure or rejection of the rejected organ should not seriously impair the welfare of the animals, rather it would cause local problems and not interfere with the normal working of the animals' own organ.

"a substantial severity limit would be appropriate in the case [where]... some animals might die before appropriate clinical investigation and management, or euthanasia, could be applied."
(Emphases added)

Here are some examples of the fate of primates in supposedly 'moderate' experiments:

In study IAN004, monkey Y239m was observed before his "sacrifice": "Appears to be in discomfort/ clinging to front of cage, head back, no response to external stimuli, shallow breathing/slow respiration rate, weak, salivating, enlarged abdomen, discoloured gums." On Y210f's final day she was described: "Collapsed on cage floor, appears weak and unable to get up, breathing shallow and rapid, salivating, heavy lidded eyes, body and limb tremors." Y49m was seen "Lying on cage floor, little reaction to external stimuli, later collapsed on cage floor" before he was killed. A9m, who was experimented upon as part of study IAN010, was killed after being observed "grinding teeth... eyes rolling... sitting on cage floor leaning against side, eyes rolling, heavy lidded, reluctant to move even when stimulated." Y242f, during study IAN013 was sacrificed having been observed: "Lying on cage floor, little response to stimuli, dilated pupils, cold to touch, rapid respiration in lower abdomen, occasional vocalisation, vacant expression, motionless."

All of these experiments involved the kidney transplant experiments that the Home Office sought to categorise as 'moderate'. The terrible state of these animals clearly corresponds to a "serious impairment" of the animals' welfare and went far beyond "local problems" with the transplanted organ, in direct contradiction to the Home Office's description of 'moderate' experiments.

A similar situation exists for the 'cervical heart transplants' - where piglet hearts were transplanted into the necks of wild-caught baboons. One baboon W201m suffered a stroke and was not euthanased until a day after it had collapsed and suffered "uncoordinated limb spasms" - hardly a "local problem" with the transplant. In the same study, W205m was quiet and huddled with the transplanted heart "swollen and red", and "seeping yellow fluid" for several days. Before he was finally put out of his misery on the afternoon of day 21, he was noted "reluctant to move... animal showing obvious discomfort".

If this evidence were not clear enough, then the fact that animals were found dead in these procedures "before appropriate clinical investigation and management, or euthanasia, could be applied" (taken verbatim from Home Office description of substantial severity quoted above) proves our case beyond reasonable doubt. During kidney study ITN13, monkey W14f was "Found dead" on the morning of day 8. X535f was "Found dead on cage floor" on day 6 during study ITN21.

In another set of 'moderate' procedures, involving the transplantation of pig hearts into the abdomens of monkeys, three - W741m, W264f and W747m - were "found dead" during this study. There are many further examples of severe suffering.

The RSPCA was so concerned by the suffering caused by the Imutran experiments that the Society intervened in the proceedings in order to win permission to produce their own report. (7) The main author of the report was Dr Maggy Jennings, who is a member of both the Animal Procedures Committee and the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA). Commenting on the kidney xenotransplantation project, the report concludes:

"We believe that a substantial classification was without doubt necessary for this project."

On the question of enforcement, to take the most blatant regulatory breaches, if primates are "found dead" on a moderate severity limit then this is an infringement of the severity condition, one of the key tools supposed to limit animal suffering. However, the Chief Inspector's review of Imutran's compliance with the law fails to acknowledge, never mind respond to, these failures to adhere to the moderate severity limit. It is therefore transparently false for the Home Office to claim that "licence conditions were in all cases fully enforced."


Conclusions

The indisputable evidence of regulatory bias and maladministration on the part of the Home Office, and the increasingly implausible and aggressive attempts by the Home Office to deny this wrongdoing, demonstrate the urgent need for independent scrutiny of the Home Office's conduct in relation to the Imutran research.

I am currently completing a detailed response to a submission by the Home Office to the Home Affairs Committee. (I have included an extract from my response that highlights a truly extraordinary example of the Home Office's duplicity - surrounding their description of who initiated the cessation of Imutran research programme.) The Home Affairs Committee will then decide whether to initiate an inquiry. In order to facilitate due process and accountability, I would urge you to write to the Committee to encourage the establishment of an inquiry. We are also hoping to retable the EDM calling for a broader independent inquiry.

I have included some of the documents referred to herein, and the recorded observations of the animals are available at www.xenodiaries.org/studies.pdf. If you have any queries at all, then please do not hesitate to contact me.


Yours sincerely,

Dan Lyons
Director


FOOTNOTES

  1. "Technical failures" refers to failures in the xenotransplantation surgery causing the death of the primate and the failure of the procedure. This means that the primate died without any information being gained - a waste of a life. The overall technical failure rate was very high at approximately 25%.
  2. This refers to a new application for permission to conduct xenotransplantation experiments.
  3. This refers to Imutran's claims that they would be in a position to commence clinical trials of pig organs in the near future. This claim, relevant to the assessment of Imutran's applications, turned out to be a gross exaggeration. For the following five years Imutran tried and failed to overcome the next stage in the development of pig organ transplants.
  4. Document CY14
  5. Sandoz was the pharmaceutical company funding Imutran's research.
  6. CY7 and CY24
  7. RSPCA report available at www.rspca.org.uk

 

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"Our case regarding the Home Office's wrongdoing is carefully based on unique primary documentation regarding the experiments."

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pig operation
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Monkey
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