THE NEED FOR AN INDEPENDENT INQUIRY
Home Office disregard for animal suffering
Since the leaked Imutran documents were first presented to the
Home Office over three years ago now, the strategy of Home Office
officials at the Animals (Scientific Procedures) Inspectorate ('ASPI')
has been to defend themselves at all costs rather than consider
legitimate concerns about the adequacy of their implementation of
the 1986 Act. However, Uncaged's legal victory - on public interest
grounds - in April 2003 has allowed the publication of important
confidential information and permits public scrutiny not only of
the original experiments and their regulation, but also the Home
Office's defence of their conduct.
One of the most serious areas of concern surrounds the ASPI's underestimation
of the severity of the experiments. These estimations become part
of the cost/benefit assessment, which is at the heart of the Act
and is the fundamental determinant of whether animal experiments
are legally permissible. The lower the expected level of suffering,
the easier for the experiments to pass the cost-benefit test. Normally,
the operation of the cost-benefit assessment is cloaked in secrecy.
The documents reveal that the vast majority of the pig organ transplant
experiments performed by Imutran were given a 'moderate' severity
categorisation. In the context of UK regulations, 'moderate'
severity involves experiments where:
"suffering can be controlled by reliable post-operative
analgesia and care."
On the other hand, the most severe level of permitted experiment,
"a major departure from the animal's usual state
of health or well-being... likely to include significant morbidity
or death [as] an endpoint, ...[and] models of disease and major
surgery where significant post-operative suffering may result."
If just one animal is likely to suffer "substantially"
then the procedures must be given a "substantial" severity
'Moderate', 'substantial' or 'severe'?
I would like to focus on just one example of the Imutran experiments
in order to demonstrate regulatory misconduct and the subsequent
inadequacy of the Home Office response. This type of experiment
involved the transplantation of transgenic pig hearts into the abdomens
of cynomolgus monkeys, a species of macaque monkey, imported specifically
for use in this research. The procedures were permitted on the basis
of a "moderate" severity classification.
Before we describe the actual effects of the experiments, the RSPCA's
comments on these procedures are worth noting:
"The procedures reported involve major abdominal
surgery. This, by its very nature, will cause pain, suffering
and distress - even if analgesia is administered. Tissue rejection
and immunosuppressive treatment cause further suffering."
The severity of the surgical procedures alone is further indicated
by the fact that 33 out of the 61 transplant experiments in this
study were deemed to be "technical failures" and resulted
in the deaths of the imported primates within 48 hours. On the surgery
aspect of the procedures alone, the experiments clearly conform
to a "substantial" rather than "moderate" classification.
The main objective of the experiments was to develop an immunosuppressive
drug regime to prevent the rejection of the pig hearts, an extremely
complex process that was not, and still is not, understood. It was
a hugely speculative goal. (3)
However, in the project licence, which is a product of collaboration
between Imutran researchers and Home Office Inspectors and sets
out the terms on which the licence is issued, the potential for
suffering caused by the toxic effects of the experimental drug regimes
is explicitly ruled out.
In a leaked internal report written by an Imutran transplant surgeon,
it is observed that a major cause of the primate deaths is "general
debility and non-specific diarrhoea." The surgeon
deduces that the monkeys lose weight and become weak "due
to nausea secondary to the immunosuppressive agents".
A published paper admits that "five animals... had
to be euthanased due to gastrointestinal toxicity, resulting in
severe diarrhoea" (4)
as a result of drug toxicity. Once again, the dramatic ill-effects
of these experiments clearly conform to a "substantial"
At least three animals - W741m, W264f and W747m - were literally
"found dead" in their cages. (5)
"Death" was the actual endpoint in these procedures. This
clearly corresponds with "substantial" severity rather
than "moderate". Furthermore, the responsible personnel
from Imutran and Huntingdon Life Sciences had clearly failed to
apply an 'endpoint' in these experiments which was consistent with
a moderate severity limit.
At this point, a significant anomaly in the UK regulations must
be highlighted. European and UK law states that "severe"
suffering is not permitted under any circumstances. However, it
is hard to detect a meaningful difference between "substantial"
severity and severe suffering. This is a fundamental aspect of the
regulations that demands immediate attention.
Home Office response
The Home Office response to the concerns initially raised by the
Diaries of Despair report and documents was to commission a "routine
review" by the very body, the ASPI, that stood accused of regulatory
bias and maladministration. The results of the review were published
during the information vacuum created by the injunction. The review
was limited to Imutran's compliance with regulations and does not
address the adequacy of regulatory enforcement by the ASPI. Both
the format and the remit of the ASPI review have drawn criticism
from the statutory advisory Animal Procedures Committee (APC). (6)
The APC's concerns have been ignored by the Home Office.
Thus, the ASPI review does not address the clear miscategorisation
of the aforementioned abdominal transplant experiments. Furthermore,
the clear failure of research personnel to end the experiments before
the suffering exceeded a "moderate" limit is entirely
ignored. Apart from giving a misleading impression of the facts
surrounding the research, such omissions ran the risk of prejudicing
the legal proceedings against Uncaged Campaigns and Dan Lyons. Without
the second leak of documents and the extraordinary legal victory
achieved by Uncaged, these and many other facts would remain unknown.
We relate this one feature of the Imutran research and its regulation,
and the subsequent response from the Home Office's ASPI, in order
to provide a stark illustration of the ASPI's general approach to
these matters and the consistent strategy of 'cover-up' that has
been adopted. Thus, there is an urgent requirement for an independent
inquiry to investigate the adequacy of Home Office's enforcement
of the 1986 Act.
Dan Lyons, Uncaged Campaigns, October 2003
- These definitions are taken from the Home Office's
Guidance on the Operation of the 1986 Act for the relevant period.
- RSPCA Report: Non-human Primates in Xenotransplantation
Research in the UK, June 2002, p.32.
- This is borne out by the fact that five years
and some 500 primates later, Imutran had failed to achieve their
objective to overcome the next stage of rejection.
- See document hlsapp5b.2.
- See studies pp.41
- See paragraph 3.11-3.12 of minutes for February
2003 meeting of the APC: www.apc.gov.uk/reference/feb03.htm.