THE LEGAL BATTLE
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1. Justified exposure of a horrific scandal
Five days after the original disclosure of the Diaries of Despair
on 21 September 2000, Imutran Ltd obtained a temporary injunction
from the High Court in London banning the publication of the report
and the entire haul of leaked documents. The injunction did allow
the documents to be disclosed to specified Government bodies. Imutran
had claimed that the Defendants, Uncaged Campaigns Ltd and Dan Lyons
(director of Uncaged Campaigns and author of the Diaries of Despair
report) had:
- used and disclosed confidential information; and
- infringed the copyright in those documents which they claimed
were copyright documents
Imutran's action was not based on denials of the truth of our allegations
and conclusions, but was founded exclusively on breach of confidentiality
and copyright. Imutran and Novartis Pharma (who joined the action
in April 2001) were seeking a permanent injunction preventing publication
of the documents, together with costs and damages from the Defendants.
We estimate their total costs to have been in the region of £500,000.
From the very beginning, we had defended our right to freedom of
expression on the grounds that there was an overwhelming
public interest (see report section
1.3) in the publication of the Imutran documents because they
revealed a number of extremely serious ethical and political concerns,
particularly:
- invasive and painful experiments on higher primates
- the risk of dangerous viruses being spread to humans by Imutran/Novartis'
experiments
- the Home Office's collusive relationship with Imutran and its
failure to monitor and apply regulations properly
- inaccurate claims made by Imutran/Novartis concerning the success
of their research and the welfare of the primates they have destroyed
- the infliction of "severe" suffering on animals which
is supposedly banned by British and EU legislation
Our legal argument relied on the common law Defence to a breach
of confidence action (exposure of wrongdoing in the public interest)
and on the similar statutory defence to actions for breach of copyright.
We further contended that our right to freedom of expression, and
the general public's right to receive information, under the European
Convention on Human Rights had been violated, and that as the documents
reveal public misconduct, a permanent injunction was not proportionate
and that limited disclosure to Government bodies was not sufficient
to remedy the violation.
The issue of the independence and integrity of the UK Government's
Home Office (the department responsible for enforcing laws regulating
animal experimentation) was a significant aspect of the Defence.
Imutran and Novartis argued that disclosure of the leaked documents
to the Home Office (and certain other Government departments) was
sufficient to meet any public interest concerns arising from their
documents. However, given that the documents provided strong evidence
of deliberate malpractice and bias on the part of the Home Office,
we believed that such disclosure was fundamentally inadequate in
a democratic society.
We have won the right to publish the majority of the
documents that we had listed as directly supporting the five
key elements of the public interest defence. In addition, the Diaries
of Despair report is now published in virtually complete form,
and it contains additional significant information extracted from
documents that remain injuncted. The names of individuals and collaborating
institutions have been removed from the documents, as well as the
names of drugs and dosing regimes.
The outcome of the legal battle is an overwhelming endorsement
for our campaign for an independent judicial inquiry into this horrific
scandal.
2. The public interest
(i) Invasive and painful experiments on
higher primates
The fundamental principle to bear in mind is that each document,
and the very fact of our legal victory, helps form a powerful case
that an independent judicial inquiry is necessary in order to investigate
and rectify the grave ethical, political and legal failures committed
by the Government in its handling of the concerns raised by the
Diaries of Despair exposé.
Animal experimentation is a matter of profound public interest.
Imutran's xenotransplantation research at HLS was particularly severe
and controversial. The Government has claimed that informed public
opinion is an influence on how animal research is regulated. (1)
Unfortunately, in practice, this is deceptive. Contrary to the rhetoric
which applauds democratic participation in Government decision-making,
the Government is behaving regressively and continues to block access
to the information necessary for an enlightened public debate (2)
and there is no evidence that the Government takes public opinion
into consideration when regulating animal experimentation.
Enabling an informed public debate has been a major public interest
consideration in favour of publishing the leaked Imutran documentation.
Not surprisingly, public opinion regarding experiments on animals
is strongly influenced by the severity of the suffering involved.
(3) This mirrors the cost/benefit
assessment which is at the heart of UK legislation on animal experiments
- an assessment which, in practice, is applied in a perverse manner
by the Government.
The Animals (Scientific Procedures) Act 1986 makes it clear that
the interests of animals should be taken into account when the Secretary
of State assesses licenses. Without access to documents such as
those leaked from Imutran, which undisputedly identify significant
levels of suffering on the part of the animals involved, the general
public cannot be in a position to hold the Secretary of State to
account when deciding whether (s)he has given adequate weight to
the consideration of animal welfare. By publishing Imutran's documents,
Uncaged Campaigns are attempting to ensure that the interests of
animals are recognised and weighed in the balance, as required by
law, and that the general public is in a position to hold the Secretary
of State to account in this respect.
Our legal victory means that the public can now view the evidence
and judge for themselves, rather than relying on the selective presentation
of information by those responsible for animal experimentation.
Much of this evidence is set out and explained in the Diaries
of Despair report, particularly in chapters
4 & 6.
The following documents also reveal the suffering and harm endured
by the animals:
- the 'experimental design' and
the 'clinical signs' from the study reports
- WCB29
(Document/Table: "Use of Baboons in Comparative IS Study."
Estimated date: mid-May 1997. Includes information about "Outcome"
of experiments such as 'Technical Failure', 'Rejection', 'Rejection
Type', and 'Comments' such as 'Collapsed', 'Died on table'.)
- WCB30
(Letter from Imutran to a Home Office Inspector, 13 January 1998,
including surgery reports for November and December 1997. Includes
reports of outcome of experiments, such as "Renal Failure",
"Euthanased, poor condition".)
- WCB31
(Letter from Imutran to a Home Office Inspector, 20 April 1998,
including surgery report for March 1998. [Similar to WCB30])
- CY16
("Kidney Summary since Sept. 1". Describes fates of
animals, e.g. "Grossly enlarged kidney...")
- CY17
(MD Application, Pig to primate renal xenotransplantation. Describes
intended experiments.)
- CY18
(Letter from Imutran to Home Office, 4 February 1998. Describes
"unusually high level of technical failures", "pancreatitis",
"renal vein thrombosis".)
- CY19
(Letter from Imutran to Home Office, 11 February 1998. Attached:
surgery reports for February 1998 and summary of results of study
IAN009.
[Similar to WCB30
& WCB31.])
- CY22
("Clin/Path Meeting Minutes". Date of meeting: 26th
March 1999. Date of minutes: 12th April 1999. Describes outcome
of experiments e.g. "Severe CMV infection", "AVR
with renal failure and primarily problems with the wound site
which lead to euthanasia.")
- CY23
("Clin/Path Meeting Minutes". Date of meeting: 23rd
April 1999. Date of minutes: 26th April 1999. [Similar to CY22.])
- HLSAPP5B
(Internal Imutran Memorandum, 9 August 1995. Refers to suffering
of monkeys in study ITN3
- 'general debility and non-specific diarrhoea', 'nausea secondary
to the immunosuppressive agents'.)
- HLSAPP7B
("Database entries," letter from Imutran, 14 May 1999.
Includes pathology results e.g. "AVR/CXR with pneumonitis
+ pleural effusion".)
^
(ii) The risk of dangerous viruses being spread to humans by
Imutran/Novartis' experiments
Imutran's internal documents and correspondence with infectious
disease experts at the Ministry for Agriculture, Fisheries and Food
(MAFF) reveal transplant procedures mistakenly carried out on primates
carrying Herpes B virus, which is regarded as a potential danger
by the UK Government. There is a clear public interest in establishing
the facts about the possible threat to public health posed by this
error, particularly in light of the fact that the experimental transplant
procedures were conducted by transplant surgeons who would then
perform transplants on immunosuppressed human patients - a worrying
scenario highlighted in MAFF's advice.
- WCB21
(Letter from Ministry of Agriculture, Fisheries and Food to Huntingdon
Life Sciences, "IMPORT OF BABOONS... ", 8 February 1999.)
- WCB22
(Imutran Document, "Pre-surgery Anti-pig Antibody titres
in baboons", 06/03/98.)
- HLSAPP4A
("LATE ARRIVAL OF BLOOD SAMPLES," fax to HLS from Imutran,
23 October 1996.)
^
(iii) The Home Office's collusive relationship with Imutran and
its failure to monitor and apply regulations properly
In addition to the specific concerns raised within the originally
leaked documents and dealt with here, there are other instances
that demonstrate the Home Office's bias and unwillingness to enforce
the regulations supposed to govern animal experiments, leading to
horrific animal cruelty and a failure to punish breaches of the
law. These are discussed in the "Home Office" section.
a. Deliberate underestimation of animal
suffering
Document CY14
(minutes of an Imutran/HLS meeting) describes how, back in 1995,
Imutran report that "the Home Office will attempt to get [kidney
transplants] classified as moderate procedures." An examination
of the effects of these procedures on animals (see report section
6.5 and the clinical signs
for all the kidney studies will demonstrate that a 'moderate' categorisation
for their severity (as opposed to a 'substantial' rating or a prediction
of severe suffering which would automatically prohibit them) is
impossible to justify (see box right). By underestimating suffering,
the Home Office helps make it easier for the experiments to be permitted.
The Home Office also classified the following experiments as "moderately"
severe:
The suffering caused by these experiments was also far in excess
of 'moderate'. The new documents leaked
from the Home Office reveal that Imutran hugely underestimated
the level of suffering in their applications for permission
to conduct the research.
b. 'Rubber stamping': the Inspectorate's
private view of the regulatory framework
The minutes of an Imutran meeting in March 1999 (see document CY24.2)
record that their Home Office Inspector "has on several occasions
expressed his view that the new License will be approved before
the existing license [sic] is revoked and that Thursday [i.e. a
meeting of the Animal Procedures Committee to discuss the licence
application] will be merely a 'rubber stamping' exercise."
The APC relies on information given to them by applicants and the
Inspectorate in their deliberations on whether to recommend to the
Home Secretary that a project of animal research should be licensed
and under what circumstances.
c. Direct concealment of regulatory violations
from Parliament and public
The closeness of the Home Office's relationship with Imutran and
their associates even went so far as covering up for mistakes that
lead to animal suffering and death during the xenotransplantation
programme:
Three primates imported specifically for the Claimant's research
died en route from the Philippines to Huntingdon Life Sciences (HLS),
the company contracted by Imutran to carry out the work (see document
CY5).
The inadequate space and ventilation in the transport crates were
considered to be contributory factors. Apart from the important
ethical issue of the suffering of the animals in the course of this
journey, which lasted 48 hours, the crates also breached fundamental
requirements of international air transport regulations on size
and ventilation - with tragic consequences. However, both the minutes
for the APC's February 1999 meeting and Mr O'Brien's Parliamentary
Answer of 28 June 2000 (Written Answers, Hansard 28 June 2000, Column
522W & 521W) fail to register this fact. Indeed, Mr O'Brien's
statement in his answer of 28 June 2000 - "IATA minimum dimensions
were not breached" - was untrue.
Other documents that expose weak regulation of primate importation
are discussed in chapters 5 and 6 of the Diaries of Despair report.
Published documents relating to this issue are:
- WCB1
(lack of independent advice regarding approval of supplier of
wild-caught baboons)
- WCB3
(underestimation of journey time in applications to import wild-caught
baboons)
- CY7
(report on discussion with Home Office Inspector)
- CY8
(letter and application to import monkeys)
- CY10
(same as CY8)
d. Covering-up for Huntingdon Life Sciences
The Home Office decided to re-issue Huntingdon Life Sciences (HLS)
with a new Certificate of Designation (essentially a permit to conduct
animal experiments) in 1997. In re-issuing the Certificate, the
Home Office announced to Parliament and to the public that HLS had
satisfied 16 conditions which were designed to prevent incidents
of malpractice and regulatory breaches at the company, some of which
were exposed by an undercover investigation broadcast on Channel
Four in March 1997 ('It's a dog's life'). However, Imutran's documents
show this not to have been the case (see report section
7.5).
For example, just one month after the Home Office had given a new
Certificate to HLS, a group of monkeys were illegally re-used in
experiments at the establishment (see document HLSAPP5A).
This breach of the law should have been prevented by the implementation
of the improvements that formed the 16 conditions laid down by the
Home Office - but the department did not revoke HLS' Certificate
in the light of these illegal procedures. Furthermore, Home Office
ministers, officials and others have continued to claim, falsely,
that HLS fully satisfied the 16 conditions. Errors and omissions
in the conduct of the studies also took place during the period
when HLS were said to be in the process of meeting the 16 conditions,
and directly afterwards.
Perhaps the most startling errors at HLS are revealed by correspondence
dated January 1999 (see report section
7.8 and documents HLSAPP7C
& HLSAPP7D).
The letters themselves tell a powerful story as an Imutran scientist
berates HLS for an accidental quadruple overdose of one monkey who
died the following day, and the failure to take a vital blood sample
at the necessary time.
In addition to the potentially devastating impact these failures
may have had on animal welfare, they also represent evidence of
manifold Good Laboratory Practice (GLP) shortfalls as well as undermining
further the notion that HLS really did satisfy the 16 conditions
set by the Home Secretary. Yet in a letter to Gerry Steinberg MP,
Minister Mike O'Brien continued to maintain that "There have
been no significant problems at Huntingdon Life Sciences since the
events of 1997..."
e. Breaches of absolute legal limits on suffering
See section 2(v) below.
f. The cost/benefit assessment
The cost/benefit assessment, which lies at the heart of the regulatory
framework created by the 1986 Act (Section 5(4)), states that the
Secretary of State must weigh the likely adverse effects on the
animals to be used in a research programme against the benefits
supposed to accrue as a result of the research before deciding whether
to issue a licence for the animal experimentation.
These are the features of the crucial cost-benefit assessment described
by the head of the Home Office Inspectorate charged with scrutinising
applications to conduct vivisection:
- "Judgement on the likely severity of the adverse effects
on animals"
- "Standards of care and accommodation"
- "Technical competence of the people and establishments
to be involved in the project"
- "Relevance of the animal 'model' to human condition"
- "Likelihood of 'success' "
- "How the data generated will be used"
- "Utility of the product or substance being tested"
Many factors relating to these considerations have already been
discussed above. The Imutran documents reveal damning evidence that,
far from conducting a rigorous assessment, the Home Office fails
to take the suffering of animals into account while lacking the
will to question either the 'benefits' predicted by researchers
or their competence to conduct the experiments (see report section
8.1).
Index of documents that demonstrate Home Office misconduct:
- All documents referred to in connection with (i) above (invasive
and painful experiments on primates), because they demonstrate
the "costs" inflicted on animals (due to be taken account
of in the cost-benefit assessment).
- All the "New Documents" leaked from the Home Office
in October 2002. See discussion of these documents for their relevance.
- I3
- Note of meeting between Imutran executives, 20 April 1995. (Reveals
intention to manipulate the Home Office Inspector to ensure "upward
support for the application"... while making him feel like
"a jolly good bureaucrat")
- WCB1
- Letter from Home Office to Imutran, 21 February 1997: "Animals
(Scientific Procedures) Act 1986 - Overseas source of baboons."
(Approval of baboon cages on basis of information supplied by
Imutran.)
- WCB3
- "Application from a Project Licence Holder or Deputy for
Permission to Acquire Non-Human Primates from a Non-Designated
Breeding Centre for use in Regulated Procedures." Submitted
23.6.98. Approved 29.7.98. (Wild-caught baboon acquisition form
- journey time underestimated.)
- WCB14
- Fax from wildlife broker to Imutran, 15.4.99. (Refers to South
African baboon breeding project which was part of strategy to
evade animal welfare regulations, known by the Home Office.)
- WCB18
- Letter from Imutran to Home Office Inspector, 10 February 1999.
(Presumption of re-approval of monkey supplier following deaths
in transit - reference to enclosed fax from South African institution
regarding baboon breeding programme there which was part of Imutran
strategy to evade animal welfare regulations.)
- WCB19
- Discussion document. "Cape Town possibilities for expanding
Imutran XenoTx." (Reveals intention of Novartis to evade
animal welfare regulations by relocating to South Africa.)
- WCB20
- Fax from South African Institution re: "BABOON BREEDING
PROJECT", 31 May 1999.
- WCB26
- Fax from HLS to Imutran, shortly after Wednesday 23 June 1999,
"Xenotransplantation Programme at Huntingdon Life Sciences."
(Baboons held in captivity for several months in breach of a commitment
to Home Office.)
- WCB24.1
"Home Office Six Monthly Report. July-December 1999. Imutran."
(Confirms that baboons held in captivity at least six months,
and lack of progress in the research.)
- CY5
- Letter (with attachments) from Imutran to Home Office Inspector,
11 August 1998, "RE Delivery of 33 Cynomolgus Macaques on
6 August 1998." (Deaths in transit, very long journey time
compared to estimate, breaches of regulation denied by Home Office.)
- CY8
- Letter from Imutran to Home Office Inspector, 22.1.99. (Example
of 30 hour journey time estimate.)
- CY10
- Letter from Imutran to Home Office Inspector, 10.5.99. (Example
of 30 hour journey time estimate.)
- CY7
- Fax, Imutran to HLS, 19.11.98. ('Cosy' notice from H.O. inspector
of likely re-approval of monkey supplier.)
- CY14
- "Notes of the Meeting at HRC, 28 April 1995." (Kidney
xenografts - "the Home Office will attempt to get these classified
as moderate procedures.")
- CY20
- "Progress Review Meeting Minutes". Meeting held 29
January 1999. Minutes generated 1st March 1999. ( Reveals intention
to kill 'unsuitable' monkeys - ethical and cost/benefit issues
(wasted lives).)
- CY21.3
- "Responses to Comments Raised by the Primate Sub-Committee"
(estimated date - circa March 1999) ("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." Demonstrates exaggeration of likelihood of successful
research, raising concerns about cost/benefit assessment and showing
Chief Inspector's review to be inaccurate.)
- CY24
- "Progress Review Meeting Minutes". 30th March 1999.
(Reveals dismissive attitude of Home Office Inspector to Animal
Procedures Committee - "rubber-stamping")
- HLSAPP1
- "Subcontractor Inspection Report" by Imutran, 8 February
1996. (Reveals GLP/competence failures at HLS).
- HLSAPP2
- "A report on the Good Laboratory Practice (GLP) status
of historical studies conducted at Huntingdon Life Science on
behalf of Imutran and recommendations for improvement" by
Imutran, 28 February 1996. (Imutran criticism of HLS's ability
to perform studies effectively.)
- HLSAPP4A
- "LATE ARRIVAL OF BLOOD SAMPLES," fax to HLS from Imutran,
23 October 1996. (Demonstrates inadequate service from HLS - these
samples required to calculate immunosuppressant doses, etc.)
- HLSAPP4B
- Fax to HLS from Imutran, 13/12/96. (Reveals sub-optimum performance
of studies - reference to "recent graft failures" &
the need to "reduce the drug related side-effects".)
- HLSAPP5A
- "A report on the Accidental re-use of animals under Project
Licence PPL 80/848," (including accompanying correspondence),
13 January 1998. (Illegal reuse due to communication breakdown
- 6 weeks after re-issue of HLS' Certificate of Designation after
supposedly meeting 16 conditions designed to prevent such failures.)
- HLSAPP7C
- "Further Drug Administration Error," letter from Imutran
to HLS, 6 January 1999.
- HLSAPP7D
- Fax from HLS to Imutran, 15 January 1999. (Acknowledging mistakes
and failures at HLS during Imutran's studies.)
- HLSAPP8B
- "Primate review report", internal Imutran email, 17/09/99.
(Reveals "severe problems with data" - how the data
is used is an element of the cost-benefit assessment, plus there
are GLP considerations - this document also refers to "Regulatory
impact " of the study data.)
(iv) Inaccurate public statements by Imutran/Novartis
It is vitally important in a democratic society that truthful information
is available to satisfy the justified high level of public interest
and concern relating to animal experimentation and xenotransplantation
research. Uncaged Campaigns and Mr Lyons argued in Diaries of Despair
and in the legal proceedings that the Imutran documents revealed
that public statements made by the company were on occasions significantly
inaccurate, incomplete and misleading. Such economy with the truth
would be likely to affect both the ethical and political debate
regarding Imutran and Novartis' xenotransplantation research and
could adversely affect animal welfare and the interests of patients.
Furthermore, Imutran submitted false information to the Government
in its applications for licenses to perform its experiments, a potentially
criminal breach of the Animals (Scientific Procedures) Act 1986.
a. Hyping xenotransplantation
Imutran and Novartis have been highly selective when disclosing
the results of their xenotransplantation research programme. This
would tend to encourage public and commercial support for the experiments
- a level of support that may not have been forthcoming had the
full facts been in the public domain. Only a small proportion of
the primates sacrificed in the research are acknowledged in public
- and these tend to represent the very longest surviving monkeys
and baboons. The leaked documentation revealed significant differences
between the version of events presented by Imutran in published
scientific papers, and the real results of the research.
For example, one published paper - "Three-Month Survival of
HDAFF Transgenic Pig Hearts Transplanted Into Primates", Transplantation
Proceedings, 31, 958 (1999) - corresponds to two studies, ITN19
and ITN25 (see discussion in report section
4.2). The confidential documents raised concerns about the accuracy
of the reported drug regimes administered to the animals. The paper
focussed on nine of the ten longest survivors from a group of 22
baboons - a major concern arising from this is that the public image
of the results of the research does not reflect the full reality.
On balance, the research caused far more suffering and death with
lower average survival times than would be apparent from Imutran's
statements - these considerations would have a direct impact on
public opinion and the results of the cost-benefit assessment required
in the licensing of the research.
Recorded incidences of hyperacute rejection (HAR) of transgenic
pig organs that occurred during study ITN19,
the abolition of which was said to have been the fundamental breakthrough
achieved by Imutran, were not disclosed in this paper. If the transgenic
organs did not reliably quell HAR then a fundamental question mark
would have hung over the viability of Imutran's hDAF organs and
undermined the potential benefits of the research claimed for by
Imutran.
In this paper, Imutran also claimed that the immunosuppressive
regime was "well tolerated by the recipients" - a perusal
of the clinical signs for study ITN19 (see
ITN19 clinical signs) casts serious doubt on the accuracy of
this statement.
Another paper - published in the Journal of Heart and Lung Transplantation
in February 2000 - focussed on one single baboon who was the longest
survivor with a life-supporting pig heart. The image of a totally
healthy animal portrayed in this paper is exposed as an exaggeration
by the confidential clinical signs (see study IAN007
clinical signs) and the unreported fact that the heart had swollen
to three times its original weight by the time the baboon had collapsed
and died (see report section
4.3).
Transplant patients and the public in general have consistently
been led to believe that xenotransplantation offers a realistic
prospect of providing a supply of organs for patients with organ
failure. In 1995, Imutran predicted that the first human trials
of their transgenic pig hearts would take place the following year.
(4) In 1998, imminent trials
of pig kidneys were forecast. (5)
But despite an intensive research effort that has sacrificed hundreds
of higher primates and thousands of pigs, the goal of achieving
viable xenotransplantation remains as remote as ever. The development
of the particular line of transgenic organs that Imutran had tested
in cruel experiments for five years - known as hDAF - appeared to
be in crisis, with Novartis setting an 18 month time limit (as of
April 2000) for achieving a quantum leap in survival times (see
report page
15).
For example, in a promotional booklet that was distributed at a
meeting attended by MPs at Parliament in December 1999, Imutran
and Novartis talk of
"refining the immunosuppressive protocols
that will be used to prevent subsequent rejection
following xenotransplantation" (emphasis added). (6)
However, a confidential report (see document WCB24.1)
submitted by Imutran to the Home Office at the end of 1999 admits
that
"at this time there is no therapy of which we are aware that
will reverse this process [of rejection of xenotransplanted organs]."
This does not square with the notion of "refinement
of immunosuppressive protocols", we submit.
Behind the scenes, Imutran scientists consistently hinted at imminent
clinical trials of their pig organs throughout their communications
with the Home Office regulators in order to smooth the process of
licence approval through the existence of such claims was explicitly
denied in the Home Office's response to Diaries of Despair. (See
section 2 of New Documents.)
Patients and their families have a genuine interest in knowing
the true state of progress in relation to such technology. Furthermore,
the potential to skew Government policy on transplantation is an
obvious unwelcome repercussion of such hype, and the possibility
of undermining the effectiveness of the human organ donor register
- resulting in less organ transplants and therefore human suffering
- has been noted by an expert advisory committee. (7)
b. Secret suffering
Some of the statements highlighted in the previous section served
a dual purpose of showing both the progress of the xenotransplantation
research and also the animal welfare implications through rose-tinted
spectacles. In fact, when responding to questions prior to publication
of the exclusive newspaper story, Imutran told the Daily Express:
"the animals do not suffer" and the newspaper reports
this extraordinary comment three times in the initial
exposé on 21 September 2000. It is also repeated in a
Cambridge Evening News article. (8)
This is a blatant falsehood, and a very significant one at that.
The 1986 Act specifically regulates procedures likely to cause
pain, suffering, distress and lasting harm. Clearly, the clinical
signs show that the animals suffered. The RSPCA's report into
the Diaries of Despair takes Imutran to task for its failure to
acknowledge the suffering its research caused to animals:
"The Uncaged report also criticises Imutran
for not acknowledging the extent of the suffering of animals in
the research. This is also true of our experience of the statements
made by the company outside of the scientific community and within
the public domain. The RAD [The Society's Research Animals Department]
has itself strongly criticised an Imutran leaflet for not acknowledging
the animal suffering associated with the development of xenotransplantation."
(9)
Indeed, references to experiments on primates are conspicuous in
their absence from Imutran's PR material. (10)
Imutran's attempts to distort the evidence of the clinical signs
continued in its submissions to the RSPCA and the Court. The RSPCA
report is scathing about Imutran's attitude:
"In their response to the Uncaged report
and in comments reported elsewhere, Imutran, however, seem either
unwilling to acknowledge that the primates used suffered, or are
ambivalent with regard to animal suffering." (11)
The Society's report goes on to criticise Imutran's
attempt to dismiss the relevance of clinical signs, where they claim
that observations such as "quiet" and "huddled"
are of no concern. These brazen denials were also made in an Imutran
submission to the High Court. The RSPCA goes to some lengths to
critique this interpretation, citing reports from animal behaviour
experts who explain that "quiet" may instead "reflect
listlessness due to illness, or apathy and withdrawal due to an
under-stimulating environment." The Society goes on to make
clear that the "huddled" monkeys were "at least
as likely" to be in pain, and:
"In any case, it is not common place for healthy
primates to rest in the presence of human technicians conducting
thorough monitoring."
Contrary to their public statements however, Imutran's own
confidential project licence applications, which they refused to
disclose to the Court, make clear that such observations are indeed
indicators of serious illness and suffering:
"Clinical signs associated with progressive
and irreversible renal failure can typically be characterised by
a number of common features... Physically the animal becomes progressively
quieter (listless) and adopts a huddled/hunched posture, reflecting
the rising blood creatinine level." (12)
(See document ND24.23)
These documents casts doubt on the accuracy of Imutran's public
statements:
- 'Clinical Signs'.
- Study report IAN007,
clinical signs, pp.63-65 for X201m (Discrepancy between public
version and reality.)
- Study ITN19
- Clinical signs (These observations contradict Imutran's claim
that the immunosuppressive regime used in this study (or in the
animals focussed on in the paper) was "well tolerated".)
- WCB19
(South African baboon breeding programme representing a "unique
opportunity" to evade regulations, contrary to Imutran claims
of not wishing to avoid regulation.)
- WCB24.1
- ("At this time there is no therapy of which we are aware
that will reverse this process." - Contrary to claims of
"refinement" and "imminent clinical trials".)
- WCB26
(Together with WCB24.1,
reveals wild-caught baboons in captivity raising serious ethical
considerations and breaches of commitment to Home Office, contrary
to assertions by Imutran that animal welfare is a top priority.)
- WCB29
(Reveals unreported incidents of hyperacute rejection )
- See also discussion of "New Documents" leaked from
Home Office in October 2002.
(v) Illegal severe suffering?
In addition to the general public interest in the availability
of information regarding the suffering of animals in research, our
Defence also argued that Imutran's experiments contravened Schedule
2A to the Animals (Scientific Procedures) Act 1986 (which enacts
Article 8 of the European Directive 86/609), (13)
as stated in sub-paragraphs 3.1 to 3.3 below.
3.1 All experiments shall be carried out under general or local
anaesthesia;
3.2 If anaesthesia is not possible, analgesics or other appropriate
methods should be used in order to ensure as far as possible that
pain, suffering, distress or harm are limited and that the animal
should not be subject to severe pain, distress or suffering;
3.3 An anaesthetised animal, which suffers considerable pain once
anaesthesia has worn off, shall be treated in good time with pain-relieving
means or, if this is not possible, shall be immediately killed
by a humane method.
Even the Chief Inspector's review admits "However, I am of
the opinion that in several instances there is, in retrospect, sufficient
evidence (as recorded in the original study documents) for irreversible
renal failure to have been diagnosed up to 24 hours before the endpoint
was applied. I conclude that, in these cases, failure to implement
the endpoint earlier did result in some unnecessary animal suffering."
Our contention is that the study design (as described in the surgical
procedures and dosing regimens) would have inevitably caused 'severe'
(according to any reasonable definition of the term) suffering,
and thus they should not have been authorised by the Home Office
in the first place. The following documents reveal particularly
severe animal suffering caused by Imutran's research:
Clinical signs records for:
- W205m, W201m (ITN6)
- X214f, X229m, X200f, X225m, X207m, X211m, X240f (ITN19)
- X198f (ITN25)
- X215m, W213m, W211m, X221m, V687m (ITN9)
- X239m, X202f, X201m, X206f (IAN007)
- W264f (ITN3)
(The clinical signs here are particularly vague, but other readings
demonstrate 'severe' suffering. In document HLSAPP5B
(see below) the lethal effects of 'general debility and non-specific
diarrhoea' are referred to, with 'nausea secondary to the immunosuppressive
agents'.)
- W762f, W774f (ITN5)
- W17m (ITN8)
- 341m, 343f, 344m, 345f (ITN20)
Following studies are renal xenotransplantation experiments. See
Chief Inspector's comment above.
- W435m, W556f, W560f, W548f, V337m, T381m, T397m, V7, T407m (ITN4)
- W39m, W144f, W47m, V510f, W43m, V484f (ITN12)
- V812f, W35m, W14f, W27m, X523m, X527m, X529m (ITN13)
- X525m, X531f, X532f, X537f, X528f, X524f [observed: "huddled
on perch with head in its hands"], X536f [observed: "looking
very weak with head in hands... vomiting profusely"] (ITN16)
- X541f, W704f, X526f, X533f (ITN18)
- X538f, X539f, X540f, X665m, X657m, X535f, X666f, X660f, X661m,
X662f (ITN21)
- W337m, X664f, W50f, X520f, X530f, X652f, Y205m, Y203m, Y199m,
Y207m, Y202f, Y213m, Y215m (ITN26)
- Y225m, Y148f, Y256f, Y251m (IAN009)
- A170f, A167f, A457m, A174f, A178f, A461m, A459m, A462f, A451m,
A464m, A465m (IAN020)
- A171f, A472f, A467m, A338f, A475m, A474f (IAN022)
Other documents:
- WCB29
- (Mentions 'outcomes' such as 'Collapsed', 'Cerebral incident
observed'.)
- WCB30
- (Includes surgery report stating 'Outcomes' such as 'Euthanased,
poor condition, 'Renal failure/diarrhoea', 'Retroperitoneal bleeding',
Pneumothorax', 'Wound infection'.)
- WCB31
- (Another surgery report, referring to 'outcomes', e.g.: "Found
dead, stroke", "Euthanased, Myocardial infarction.")
- HLSAPP5B
- (lethal effects of 'general debility and non-specific diarrhoea'
are referred to, with 'nausea secondary to the immunosuppressive
agents'.)
- CY18
(Describes (for study IAN009)
"unusually high level of technical failures", "pancreatitis",
"renal vein thrombosis".)
- CY19
- (Surgery reports for February 1998 and summary of results of
IAN009,
such as "Diarrhoea, a febrile", "Pancreatitis",
"Ureteric obstruction".)
- CY22
- (Describes outcome of experiments e.g. "Severe CMV infection",
"AVR (Acute Vascular Rejection) with renal failure and primarily
problems with the wound site which lead to euthanasia.")
- CY23
- (Clin/Path meeting minutes describing animals with obstructions
of the ureter, "cautery injuries in the ureter and bladder
wall", "peritonitis in the colon with a leak from the
bladder and a collection of pus in the pelvis... many bleeding
sites", "clot in the ureter, which resulted in the animal
being euthanased for renal failure".)
- HLSAPP7A
- (Clin/Path Meeting Minutes describing animals: e.g. A459 - "Euthanased
due to worsening condition with bilateral effusion and respiratory
failure... with possible bilateral pneumonitis/infection."
- HLSAPP7B
- (Pathology report - "Balantidium infection + sepsis",
"Severe CMV infection")
FOOTNOTES
- The Chief Inspector has stated that this process
of weighing involves "... precedent, but also [must] accommodate
developments in welfare, science, ethics, political thinking and
informed public opinion" (emphasis added).
Report of the Animal Procedures Committee for 1997, paragraph
3.8, p.52
- Uncaged
Campaigns statement, 20.01.03.
- "Let the People Speak", New Scientist,
22 May 1999.
- "Pig heart transplant 'breakthrough' stirs
debate over timing of trials", Nature, Vol 377, 21 September
1995, pp.185-186. "Pig-to-human heart transplant slated to
begin in 1996", Nature Medicine, Vol 1, Number 10, October
1995, p.987.
- New Scientist, "Waiting
for a miracle - time is running out for organ transplants from
animals", 12.01.02, p.3.
- "Xenotransplantation" by Novartis/Imutran,
distributed e.g. at House of Commons December 1999.
- "Animal tissue into humans", A report
by the Advisory Group on the Ethics of Xenotransplantation, Department
of Health, 1996, para 4.110.
- "Demo-hit biotech company to quit city",
Cambridge Evening News, Wednesday 27 September 2000.
- See page 12 of the RSPCA report, available via
the RSPCA
website.
- See for example, leaflet ("Animal welfare
- Xenotransplantation", Imutran, 1999 (distributed at House
of Commons, December 1999)). Briefing ("Xenotransplantation"
by Novartis/Imutran, distributed e.g. at House of Commons December
1999).
- See section 5.2.3 of the RSPCA
report.
- Rising blood creatinine levels are an indicator
of kidney failure. Creatinine is a waste product caused by muscle
activity which is usually excreted in the urine.
- See report section
2.2.
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