RESPONSE TO ASPI
Uncaged Campaigns response to Chief Inspector's Report concerning
Imutran's compliance with Project Licence Authorities
This briefing is an analysis of the Chief Inspector's report (see
www.homeoffice.gov.uk/docs/imutranreport.pdf)
into Imutran's 'compliance with project licence authorities', published
by the Home Office in July 2001 as a response to the Diaries of
Despair report. The analysis in the main body of this briefing establishes
the following conclusions:
General conclusions
-
The Home Secretary's decision to request a report from the
Chief Inspector (henceforth abbreviated to 'CI') with a narrow
remit was unjustifiable. The CI's report intrinsically lacks
independence and thoroughness. Our central criticism in the
Diaries of Despair report (henceforth abbreviated to 'DoD')
came about because of the strong evidence of inadequacies in
the Home Office's regulation of Imutran's research at Huntingdon
Life Sciences. This has not been investigated.
-
An investigation must be both independent and powerful enough
to order witnesses to appear and obtain all necessary evidence.
This is why we concluded that an independent judicial inquiry
would be the most appropriate form of inquiry.
-
The CI's report itself is unfair and stretches credulity in
several respects. Through its language and its selective and
distorted presentation of information, it seeks to exonerate
Imutran, hide HLS from criticism (by surreptitiously including
errors and regulatory breaches that were the responsibility
of HLS in this report) and unfairly discredit myself and Uncaged
Campaigns. The report also downplays the suffering experienced
by the primates. On occasions, the CI blatantly misrepresents
positions and statements in DoD.
-
Ironically, the main conclusion that can be confidently drawn
from the CI's report is that the Home Office continues to act
in bad faith and show disregard both for animal welfare and
the regulatory framework it is charged with executing.
^
1. Form of Inquiry
1.1 The then Home Secretary, Jack Straw, decided
to request the CI report, despite an earlier unequivocal statement
from his then Junior Minister, Mike O'Brien indicating that future
investigations into allegations of regulatory breaches would include
Animal Procedures Committee (APC - the advisory committee to the
Home Secretary) oversight because of deep concerns about the independence
and objectivity of Inspectorate reports. (Written
Answer, No.2, Mike O'Brien, Wednesday 1 November 2000.) Even
an Imutran witness statement written before the CI's review was
requested referred positively to possible APC supervision to investigate
our allegations of Home Office failure. The witness statement goes
on to say "Until the composition of the proposed inquiry is
known, it clearly cannot be said that it will be lacking in independence.
It can hardly be supposed that Ministers will appoint persons whose
conduct is criticised by the Defendants to investigate their own
conduct." If only that were true. Mr O'Brien has since refused
(three times) to explain to the APC why the original policy statement
was reneged upon. It has also now emerged that the Imutran projects
were personally authorised by a Minister or Ministers, revealing
a sharp conflict of interest.
1.2 Concerns regarding:
- the operation of the cost-benefit assessment,
- the potentially illegal severe suffering experienced by primates,
- inaccurate Parliamentary Written Answers,
- the collusive relationship between researchers and regulators
- lack of action in response to regulatory breaches
led us to conclude that an independent judicial inquiry was the
most suitable course of action to investigate in a thorough and
impartial manner the deeply troubling evidence contained in the
Imutran documentation.
1.3 The subsequent conduct of the Home Office,
including the CI report, has confirmed the implications of the Imutran
documentation:
The Home Office has not only failed to apply the
Animals (Scientific Procedures) Act 1986 in an objective and rigorous
manner, but it has done so deliberately and has since sought to
be as obstructive as possible.
1.4 We have recommended that an independent judicial
inquiry is necessary because the strong (and growing) evidence of
deliberate Government malpractice demands an inquiry that is both
independent and also powerful enough to conduct a thorough inquiry
and overcome inevitable Home Office resistance. An independent judicial
inquiry can hardly be expected to be pre-disposed towards an anti-vivisection
viewpoint: our recommendation demonstrates our open and democratic
approach to this issue. Our plea is simply for an honest, objective
and fair appraisal of the affair, and the most likely way to achieve
this is through a judicial inquiry. We cannot understand why anyone
could object to such a reasonable course of action
1.5 We would understand if the APC had considered
investigating the matter more deeply itself, although we believe
that the need for an independent judicial inquiry is already clear.
Our main concern, however, regarding this approach is the Committee's
vulnerability to interference and obstruction from the Home Office.
For example, we are not convinced that the failure to distribute
the primary evidence to Committee members, contrary to public statements,
was an innocent oversight: after all, how could the Committee reach
an informed view without the primary evidence (the Committee has
previously noted its difficulties when it was not in possession
of relevant information). The CI's report is so transparently inadequate
that we can only believe that it was written with a view to the
Committee being unable to check it against the Imutran documents.
^
2. The Cost-Benefit Assessment
2.1 The central argument of DoD concerned the
cost/benefit assessment undertaken by the Home Office for the Imutran
experiments. We believe that the evidence contained in the Imutran
documentation (together with other published material) casts grave
doubts over the legitimacy of the original decision to licence the
research and failure to respond to the lack of progress in the research.
Generally speaking, concerns focussed on the severity of suffering,
the suitability of HLS as a venue for such research, and the low
probability of benefit.
2.2 Since the publication of DoD, the United Kingdom
Xenotransplantation Interim Regulatory Authority (UKXIRA - an advisory
committee set up to advice the Government on xenotransplantation
matters) has confirmed the confidential remarks of Imutran and Novartis
about the lack of progress of the research and the considerable
biological obstacles to organ xenotransplantation. At the third
annual meeting in February 2001, UKXIRA member John Dark, a transplant
surgeon, confirmed that the Imutran research had lead up a "blind
alley". Mr Dark had previously been explicitly optimistic regarding
the Imutran experiments, and he has not been obviously sympathetic
to the animal welfare viewpoint. His scepticism about the probability
of Imutran's xenotransplantation programme reaping clinical benefits
was shared by the immunologist on the UKXIRA, Professor Herb Sewell.
We have been predicting this lack of benefit for several years,
and believe that had the Home Office taken an objective view of
the science of xenotransplantation, the lack of progress could have
been foreseen.
2.3 In paragraph
3.2, the CI claims: "The Home Office judgement of 'potential
benefit' was based upon new scientific insights that might be gained.
Imutran did not advance, and the Home Office did not consider, claims
of imminent clinical trials as a realistic short-term benefit."
Whether this is true or not, serious concerns are raised in each
circumstance.
2.4 The CI's claim here contradicts
the evidence of the Imutran documentation, and the public announcements
that were made by Imutran during 1995, the time when Imutran were
making an application to carry out "orthotopic" work:
- Document I3,
an Imutran memo, refers to plans for Imutran personnel to stress
the issue of 'imminence', and then refers to Q4 of 1995 as a goal
for first human trials.
- Document CY14
- meeting minutes from April 1995 - once again refer to plans
for clinical trials.
- Document CY21
is "Responses to Comments Raised by the Primate Sub-Committee"
[of the Animal Procedures Committee] which took place in spring
1999. Paragraph 4c)I states:
"... It should be noted that 120 animals
is a maximum figure and, as clinical trials are initiated, the
actual number of transplanted animals is likely to reduce."
2.5 What "potential benefits" were advanced
to the APC when the Committee considered xenotransplantation project
licence applications?
2.6 If, just for the sake of argument, we pretend
that the CI is accurate about the considered 'potential benefits',
then this raises different, but equally significant questions, particularly,
how the "new scientific insights" to be gained could justify
what seems to be the most extreme programme of animal experimentation
in the UK in the last seven years (taking into account the use of
wild-caught higher primates and the severity of the procedures).
^
3. Animals (Scientific Procedures) Act 1986 compliance issues
in the Chief Inspector's report
Here, these are dealt with in the same order that they are discussed
in the CI's report.
3.1 "5.2 Project licence authority secured before
studies undertaken: compliance confirmed."
This issue was not raised in DoD. Rather, one of the central concerns
was whether the project licence should have passed the cost-benefit
assessment, the severity limits and banding aspects of the project
licence, and the question of whether the project inevitably involved
severe suffering. These complex and fundamental questions have been
ignored bar a couple of sentences in the CI's report.
3.2 "5.3 Allegation that regulated procedures were
performed whilst project licence authority was suspended: compliance
confirmed."
In the context of DoD, this is a relatively minor incident (e.g.
it doesn't appear in the summary of the chapter in which it is discussed.)
3.3 The Chief Inspector claims that the project
licence was not "suspended" in the normal sense of the
term. I find this perplexing because in a letter from Imutran to
HLS dated 12 November 1997, Imutran comment on the incident: "Unfortunately
this has resulted in yet another delay in our surgery schedule..."
(see document HLSAPP5A.6).
3.4 "5.4 Source of animals - provenance: compliance
confirmed."
Again, DoD did not raise concerns about whether Imutran obtained
animals without the knowledge or consent of the Home Office. However,
we did raise concerns (see report section
3.1) about the fact that the Home Office had approved Mann &
Miller Ltd's establishment as a supplier of wild-caught baboons
on the basis of evidence supplied by Imutran rather than independent
assessments. The facts that four captured baboons were subsequently
killed by a lightning strike and that the eventual number of baboons
imported fell from 37 to 28 also raises concern, not so much about
the compliance of Imutran with Home Office requirements, but of
the adequacy of the Home Office requirements themselves.
3.5 "5.5 Authority to use animals from overseas non-designated
sources - journey times: compliance confirmed."
The CI's comments on this matter seem to imply that "compliance"
is regarded by the Home Office as automatic, regardless of discrepancies
between predicted and actual journey times. This is particularly
concerning given the admission of the Chief Inspector that the journey
times "are used to judge the likely contingent welfare costs."
Clearly, the longer the journey, the more suffering is caused. The
cavalier attitude of the Chief Inspector to substantially longer
journey times is typical of the systematic lack of consideration
given to animal welfare.
3.6 The Chief Inspector claims that the expected
journey times are "reasonable estimates of likely transit times"
and "are regarded as indicative". The two actual journey
times that we have evidence for are 34 hours for the May 1999 consignment
of wild-caught baboons (compared to Imutran's claim of 20-24 hours
on their permission form) and approximately 50 hours for the August
1998 consignment of cynomolgus monkeys (compared with 30 hours on
the application form). These discrepancies cannot reasonably be
described as "reasonable estimates" or indicative.
3.7 The gravity of this issue is demonstrated
by the fact that three monkeys died in the 50 hour August 1998 shipment
(see report section
5.2), which MAFF advice claims was due to a combination of several
factors, one of which discussed was the matter of journey times.
It is disturbing that the Chief Inspector can claim that Imutran
complied with their authorities even though three primates died
who may not have done had Imutran adhered to the journey time upon
which the licence was issued.
3.8 "5.6 Re-use of
Animals: Compliant with one exception..."
Although the illegal re-use of animals occurred within the Imutran
project, the 'human error' referred to by the CI appears to have
been committed by a member of staff at HLS:
"11 November 1997. [an Imutran manager] discusses
the situation with member of HLS staff who confirms that the error
lay within HLS and that no Imutran staff are at fault.
"11 November 1997 [an Imutran manager] discusses
the situation again with another HLS employee who reports a similar
finding to that of the first."
(Document hlsapp5a.2:
"A report on the Accidental reuse of animals under Project
Licence PPL 80/848" by [Imutran manager], 13 January 1998)
"It is clear from what you have said that any
remedial actions that may be required lay within HLS, and were not
the result of an error here at Imutran... In hindsight you may recall
that we requested a complete listing of stock animals, with clear
indication of previous use, at our review meeting on the 16 October
1997. Unfortunately this listing has still not appeared, which is
a pity as it would have prevented this situation arising."
(Document hlsapp5a.6:
Letter from Imutran manager to HLS staff member, 12 November 1997)
3.9 The significance, therefore, of this incident
relates to the light it sheds on the question of whether HLS satisfied
the 16 conditions laid down by the Home Secretary in the wake of
It's a Dog's Life. This question is the focus of the discussion
of this incident in DoD. In particular, the fifth condition stipulated:
"That adequate provision has been made for regular
and effective means of communication between those entrusted with
responsibilities under the Act.."
3.10 The issue raised in DoD was concerned with
the fact of the procedural breakdown and its timing/context rather
than its actual consequences: if no additional insult to the animals'
welfare occurred, this would have been due more to luck than judgment
(see report section
7.5). Yet the CI's report does not comment on our central conclusion
that this incident demonstrates that HLS did not satisfy the 16
conditions.
3.11 However, we note that the CI states: "It
is not believed that any significant unnecessary animal suffering
resulted." (emphasis added) This, of course, is not the same
as saying that the illegal act caused no suffering. What was the
actual biological/clinical impact of the illegal dosing?
3.12 We are also concerned with the lack of seriousness
with which the Home Office views "formal infringements"
such as this. We suggest that the "formal" qualification
is spurious and undermines the validity of the regulatory system.
As an analogy, if a restaurant is found to be breaking environmental
health standards, or a company is breaking health and safety standards,
then those incidents are still treated seriously even if no adverse
consequences actually occur, because such breaches are indicative
of malpractice which has the potential to cause undesirable consequences.
The whole idea of having rules is that they should be observed.
It is hard to imagine the Government having such an indulgent attitude
to law-breakers in any other sector, and it demonstrates the general
unwillingness of the Government to live up to the rhetoric of "strict
regulation." It would be helpful if the Home Office could explain
what sanctions they imposed following this "formal infringement"
and respond to these general concerns.
3.13 "5.7 Allegation That Baboons Were Held As Stock
Beyond The Time Scale Prescribed By The Home Office: no
compliance issue."
The CI claims that no compliance issue arises here. And he omits
to mention the very grounds for our concerns: the acknowledged (by
HLS) ethical/welfare implications of the incarceration of wild-caught
baboons for up to and in excess of seven months. In fact, the CI
also fails to mention the fact that the baboons were wild-caught,
which is an important contributory factor to the welfare impact
of incarceration. Thus the CI's description of this matter serves
to conceal the true extent of its ethical implications.
3.14 The relevant document, a letter from HLS
to Imutran (see document WCB26.1),
refers to the perceived desirability of not halting the use of wild-caught
baboons in research in ethical terms:
"the ethical considerations surrounding the
capture of wild baboons means we all have a responsibility to ensure
that these animals do not spend unnecessary time in what must seem
to them to be small enclosures."
and also in order that Imutran's 'commitment to the Home Office
will be honoured'.
3.15 Therefore we have what surely must be acknowledged
as a 'commitment' with significant ethical and welfare consequences.
In the light of this, we find it genuinely disturbing that the CI
claims that there is 'no compliance issue' in this instance. It
renders the important commitment made by Imutran to minimise animal
suffering completely worthless. If it is true that no compliance
issue arises, why was this the case? Could one not have been attached
to this aspect of the research programme, given its welfare implications?
3.16 For the CI to claim that the Home Office
merely "expected" that Imutran would "honour"
a "commitment" once again belittles the gravity of the
incident: even if the 'commitment' was not backed by law, the breaking
of it should still be acknowledged properly, rather than concealed.
3.17 Earlier shipments of wild-caught baboons
were held in captivity for between six months and nearly two years.
The animal welfare implications of this situation are very worrying
indeed, yet the CI makes no reference to them (this may be partly
due to the narrowness of the report's remit, which is a central
problem).
3.18 "5.8 Animal Accommodation: compliance
confirmed."
In paragraph 5.8.1, the CI claims that HLS complied
with relevant Home Office Code of Practice. No attempt is made to
explain or justify this position. Chapter 7 of DoD (and the accompanying
documentation), focus on HLS' performance with respect to a number
of parameters, including Good Laboratory Practice (GLP), Home Office
Codes and commercial requirements. GLP compliance also affects satisfaction
of Home Office Codes and conditions, such as the third of the sixteen
condition set HLS in the wake of 'It's a dog's life'.
3.19 Chapter 7 of DoD sets out our concerns in
this area in meticulous detail. However, in brief, we would like
to highlight the explicit remarks made by Imutran regarding "fundamental
deficiencies" in HLS performance of Imutran studies (see report
section
7.3, document hlsapp1)
and the inability to "provoke, within HLS, the degree of flexibility
required by Imutran" which meant that Imutran would have to
"accept that the service from HLS will fall short of their
expectations."
3.20 I have already referred to the illegal re-use
of animals which appeared to be the fault of HLS. Section 7.8 discusses
a "Further Drug Administration Error" at HLS (this incident
is dealt with briefly by the CI at 5.17.3 and 5.17.4, though it
should also come under the present heading). Following very strong
criticism from Imutran, HLS apologise: "There can be no excuses
that can be made for the failure of individuals to follow the operating
procedures that have been set down to ensure the smooth conduct
of studies."
3.21 One of the relevant codes in this context
is to be found at Paragraph 2.6 (ii) of the 'Guidance...' in force
at the time, which states that Designated Establishment Certificate
Holders must ensure that the "named day-to-day care persons
discharge their duties effectively."
3.22 Paragraph 4.32 (v) claims that consideration
of "whether the facilities at the establishment are adequate
for the scientific procedures;" are taken into account when
assessing project licence applications. Given the repeated explicit
criticism levelled at HLS by Imutran, there are serious question
marks over how seriously the Home Office takes this consideration.
Yet the CI's report (typically) completely by-passes this issue.
3.23 Paragraph 5.8.2 of the CI's report refers
to "unfounded" "[C]oncerns in the Uncaged report"
regarding understaffing..." However, no such concerns are raised
in DoD. In fact, DoD refers - unambiguously - to difficulties that
HLS appeared to face with regard to fulfilling contractual obligations
to Imutran (see section 7.7), which is consistent with the description
of the documents given by the CI in the second sentence of paragraph
5.8.2. We did not claim that HLS was understaffed with respect to
the 1986 Act and related regulation.
3.24 Dan Lyons has spoken to the CI about his
claim of "unfounded concerns" in DoD because he was mystified
as to what the CI was actually referring. The CI stated that he
had referred to this issue because, he claimed, a few people had
interpreted the report as saying that HLS was understaffed (though
we cannot see how someone could draw this conclusion). The CI acknowledged
that we did not actually raise these concerns. The reason we did
not raise such concerns was because the documents did not include
evidence to support such concerns, and we were extremely careful
not to raise concerns for which there was no evidence.
3.25 Why has the CI given a false impression that
we have raised unfounded concerns with regard to this matter? (The
use of the term 'concerns' rather than 'allegations' does not make
the CI's assertion accurate.) Why could he not publicly explain
the situation truthfully, in the same terms that he did to Mr Lyons?
3.26 The CI's unfair and inaccurate claims in
paragraph 5.8.2 demonstrate the political nature of the CI's report.
The overarching strategy is to try to undermine the credibility
of Uncaged Campaigns while simultaneously striving to protect HLS,
exonerate Imutran (apart from minimal token and highly qualified
criticism) and completely deny the very existence of our concerns
about the conduct of the Home Office itself. This incident is a
particularly unsubtle example of a wider policy which is dishonest
and disreputable.
3.27 Ironically, the CI himself (rather than Uncaged
Campaigns) has directly raised concerns about understaffing in paragraph
5.12.6, revealing that a procedure was conducted "in the absence
of a trained theatre nurse."
3.28 "5.9 Production of Genetically Modified Animals:
compliance confirmed."
DoD and the Imutran documents did not cover this issue, which seems
to have been included in the CI's report in order to make an additional
claim of compliance on behalf of Imutran.
3.29 "5.10 Anaesthesia And Analgesia (Regimens): compliance
confirmed."
The bare assertions made by the CI in paragraphs 5.10.1 and 5.10.3
are so vague as to be hard to comment on (How are "timely"
and "appropriate" defined?). Without any supporting evidence
and justification for them, and in the light of the explicitly dubious
aspects of the CI's report, it is hard to take them seriously.
3.30 In paragraph 5.10.2, the CI makes unsubstantiated
assertions that directly contradict the unambiguous evidence of
the Imutran documentation (which was a letter/report to the Home
Office Inspector - document CY18). If we assume for the sake of
argument that the CI is telling the truth, why, then, did an Imutran
member of staff tell the Home Office that the doses of Diazepam
were "very high" if they were, according to the CI, "within
the normal clinical range"? And why did Imutran tell the Home
Office that the animals had to be destroyed because of their "failure
to recover" from the "very high doses" when, according
to the CI, they were dying from some "other processes and pathologies"
(the CI is once again very unspecific)? We find it hard to believe
that Imutran could be so grossly and pointlessly inaccurate in their
reports to the Home Office: the CI's assertions lack credibility.
3.31 Indeed, the CI's attempt to deny the lethal
effect of the Diazepam doses directly contradicts Imutran's own
statement in the company's response to DoD submitted to the RSPCA.
3.32 We can only conclude that the CI has chosen
to mislead in his report in order to hide the unfortunate consequences
of these procedures.
3.33 "5.11 Anaesthesia (Administration)..."
As the CI points out, this was not mentioned in DoD.
3.34 "5.12 Operative Surgery..."
Paragraph 5.12.2 refers to the technical failure rate, which the
CI claims was approximately 20%. Imutran's own report to the Home
Office says 25%. The CI states this is directly comparable with
paediatric transplant surgery failure rates. In terms of the relevance
of the technical failure rate to the cost-benefit assessment, comparisons
with clinical practice are beside the point.
3.35 The direct comparability of the xenotransplantation
programme with paediatric transplant procedures has not been established.
Although the size of the primates may be comparable, it seems to
us that the comparison is more complex. Different protocols would
bring with them differing challenges and potential complications.
Furthermore, many of the procedures performed on the primates would
have differed to paediatric transplants, particularly the various
forms of heterotopic transplants that comprised the bulk of the
experiments.
3.36 In fact, four out of six cervical cardiac
xenografts were deemed to be 'technical failures'. The overall technical
failure rate for the baboon experiments was at least 31%. The CI's
reference to overall technical failure rates masks particularly
disastrous phases.
3.37 Paragraph 5.12.3: the CI contradicts his
previous attempts to deny the occurrence of substandard surgery
by admitting that a high technical failure rate in one study (50%
in IAN022, nicknamed the 'Full Monty' by Imutran) forced Imutran
to halt their programme to reassess protocols and practice.
3.38 The CI ignores at least two other periods/studies
where high rates of technical failures occurred. Another study that
took place at this time also exhibited a 50% technical failure rate
- IAN012 (see document CY23,
report p.93).
The CI's review has ignored this.
3.39 The CI's review also omitted the "unusually
high level of technical failures" experienced by Imutran in
winter 1997-98 during study IAN009. In addition to the aforementioned
"very high doses" of diazepam, Imutran explain that the
problems arise from "recent changes in our surgical team and
the lull in surgery". The company goes on to explain: "...
as you know in the past we have experienced increases in technical
failures when the surgical team are made to perform stop-start surgery,
and this has certainly contributed to this unacceptable situation."
(See document CY18.)
3.40 Additionally, another document (discussed
at report p.95),
consists of an email from a Novartis executive to senior staff at
Imutran dated 3 February 2000: "In view of the recent experimental
failures and as discussed by phone with [a senior Imutran executive],
I would like you to interrupt any further experiments until better
understanding of the reason for these failures has been determined."
Originally, we presumed that Novartis were referring to technical
failures, but we can see now that they may have been referring to
other kinds of failures. Were these technical failures, and if so
why are they not referred to (even to be corrected, if necessary)
in the CI report?
3.41 Paragraph 5.12.6 (swab left inside abdomen
of primate): the CI states that a "decision to operate in the
absence of a trained theatre nurse was, in his opinion, both a significant
error of judgment and a causal factor..."
3.42 Interestingly, the CI fails:
- to acknowledge that this incident came to light as a result
of DoD (although the background reasons were discovered by the
review) - whenever incidents are discovered by the CI but were
not mentioned in DoD, the CI is quick to point this out!
- to state the painful and lethal effects on the primate (A464m
in study IAN020) caused by the error - his spleen went septic
and he had to be killed (see document CY22.2
and report p.92)
- to inform us about another failure in the surgical procedure
revealed in Imutran's analysis of DoD submitted to the RSPCA.
3.43 Furthermore, the Home Office appears to be
taking no action in relation to either the understaffing and error
of judgment which caused this incident, nor in response to the failure
of Imutran to disclose the incident to the Home Office in a progress
report.
3.44 Paragraph 5.12.7: the CI claims that DoD
refers to a kidney being "frozen solid", when in fact
it was merely frosted on the surface. We have reviewed DoD and cannot
find any such reference to 'frozen solid'. This seems to be another
attempt by the CI to undermine the credibility of the report. The
relevant Imutran documentation refers simply to the kidney being
"frozen", and DoD reflects that evidence.
3.45 Significantly, the CI goes out of his way
to make the point that the kidney was transplanted and that this
is "Contrary to the Uncaged report..." Whether our presumption
that the kidney was not transplanted is correct or not does not
seem to us to be an issue that has any real significance, especially
since it seems to us a reasonable presumption. This is another gratuitous
dig at Uncaged.
3.46 The CI goes on to reveal that Imutran were
economical with the truth in their reports to the Home Office, and
acknowledges that the decision not to terminate the procedure at
the point when the kidney did not perfuse properly was an "error
of judgment". Yet no reference is made to whether these failures
constitute regulatory breaches. If they do not, then there must
be serious concerns over the adequacy of regulations and/or the
licence conditions that cannot or do not deal with such failures.
3.47 The fact that the kidney malfunctioned during
transplantation creates confusion about the CI's unwillingness to
offer an opinion on the decision to go ahead with the transplant
of the damaged organ in the first place. The subsequent malfunction
would seem to confirm the common sense view that the decision to
commence the transplant would have been an error of judgment. It
seems the CI is palpably reluctant to criticise Imutran whenever
he can possibly avoid doing so.
3.48 "5.13 Post-operative Care: compliance
confirmed"
It is inaccurate for the CI to claim that the twice daily clinical
observations of the animals reproduced in the DoD do not take account
of treatments given to primates (paragraph 5.13.1). Clearly, the
recorded observations give a prima facie impression of the condition
of the animals in the context of any treatments given, and DoD did
not assert that no such treatments were administered. Naturally,
we knew that further information would exist that would provide
greater detail about the entire programme of experimentation: that
is why all our conclusions in DoD were provisional and/or tentative
and why our central recommendation was for an independent judicial
inquiry to be able to hold a thorough investigation.
3.49 The treatments given to the animals cannot
contradict the clinical observations, even if those observations
do not give the complete picture. The fact of the matter is that
despite any "clinical management", those harrowing observations
were made. Hundreds, if not thousands, of observations record that
primates endured "vomiting", "diarrhoea", "swellings",
"seeping wounds", "body tremors", that they
were "subdued" and "reluctant to move", "collapsed",
were "unsteady", suffered "breathing difficulties",
were "distressed" etc. That cannot be argued with. Clearly,
whatever treatments were administered only had a limited effect,
otherwise those observations simply would not have been made.
3.50 The deeper point which the CI has side-stepped
is the intrinsic and unavoidable severe suffering caused by the
entire procedures: the surgery, the immunosuppresssants, the failing
organs, the infections, etc.
3.51 The fact that the CI's report:
- fails to even acknowledge the concerns about the severity of
suffering, and simultaneously
- attempts to undermine the validity of the clinical observations
is stark evidence of the agenda behind the CI's report and the
callous attitude of the Home Office Inspectorate. Many of those
animals must have suffered greatly, and the CI's refusal to deal
with the issue is very disturbing.
3.52 The cervical heterotopic heart xenotransplants
were cause for extreme concern (studies ITN6
& ITN11), yet the CI has chosen to ignore these procedures.
3.53 Paragraph 5.13.2 of the CI's report goes
on to claim that six observations were made every day, whereas the
clinical observations in the study reports only cover the first
and last observations. We are not sure what point the CI is trying
to make here, as we did not claim that only two observations were
made, we were simply presenting the available evidence.
3.54 "5.14 Implementation of Endpoints: perceived
non-compliance..."
The token criticism in this section is so heavily qualified that
the CI has practically absolved the culprits. Given that the significant
consequences of these failures - higher primates enduring prolonged
suffering caused by kidney failure - the desperate attempt to mitigate
the failure to implement the endpoints ("in several instances")
is once again symptomatic of the CI's lack of regard for animal
welfare. Furthermore, we note that the Home Office has chosen to
send a 'letter of admonishment' to the culprits - a desperately
inadequate response.
3.55 "5.15 & 5.16 Blood Sampling..."
The CI's report does not examine evidence that seven baboons were
transplanted in March 1998 without an important blood sample being
taken (for anti-pig antibodies).
3.56 These baboons were also said to be positive
for herpes B and should not have been worked on according to Imutran.
Imutran have since claimed that the strain of virus infecting these
animals is not considered pathogenic to humans by some regulatory
authorities - but it is considered a potential pathogen in this
country (and by virologists such as Jon Allan) and MAFF & Porton
Down (the Government's chemical and biological weapons research
establishment) clearly believe this is an area of concern, at the
very least.
3.57 "5.17 Drug Administration..."
The two errors related by the CI in paragraph 5.17.3 and 5.17.4
were unequivocally the fault of HLS (who explicitly apologised to
Imutran - see paragraphs 3.21-3.23 of this report), and thus it
is misleading for them to be included in the CI's narrow Imutran-focussed
paper, at least without any full explanation as to who was actually
responsible for the error. Maybe this is why the CI concluded that
Imutran complied with the regulatory requirements in this area,
despite the occurrence of these errors.
3.58 Some of the additional specific issues not dealt with
by the CI report:
- Manipulation of Home Office inspector by Imutran ("jolly
good bureaucrat" - document I3.1,
DoD
p.11)
- Home Office's attempt to get kidney transplants classified as
'moderate' procedures (document CY14.1,
DoD p.81)
- Imutran's Home Office Inspector's opinion of an APC consideration
of Imutran project licence as a "rubber-stamping exercise"
(document CY24.2,
DoD p.11)
- Home Office role in development of baboon-breeding facility
in South Africa, a facility designed to help circumvent UK (and
other developed countries') regulation of primate research (documents
WCB18,
19
& 20,
DoD section
3.2)
- Discrepancies (additional to those listed above) between Imutran
reports to Home Office and actual events as related by the documents
(e.g. euthanasia/death of X206f (document WCB31,
DoD p.58)).
Dan Lyons
Uncaged Campaigns
September 2001 (revised February 2003) |
