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
- "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%.
- This refers to a new application for permission
to conduct xenotransplantation experiments.
- 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.
- Document CY14
- Sandoz was the pharmaceutical company funding
Imutran's research.
- CY7
and CY24
- RSPCA report available at www.rspca.org.uk
|
