EDM 1718 'Health Service Ombudsman's Report PA-2823'
EDM 1718 highlights the fundamental flaws in the
Ombudsman's report into illegal cruelty to primates in organ transplant
experiments. Leaked records revealed debilitating and lethal experiments,
in clear breach of regulations. EDM 1718 calls upon the Government
to establish an independent inquiry into the affair. The text for
this Early Day Motion is as follows:
"That this House notes the Parliamentary
and Health Service Ombudsman's (PHSO) investigation report PA-2823
that rejects Uncaged's complaint against the Home Office's regulation
of Imutran's pig-to-primate organ transplant research, laid before
Parliament in December 2006; further notes that Uncaged won a
legal battle having asserted Home Office maladministration in
this case; further notes that at least 17 primates that were
used in Imutran procedures categorised as of only moderate severity
were found dead or in a collapsed state, rather than being euthanased
before they suffered a significant departure from their health
as required by the moderate severity limit according to published
policy; is deeply concerned about the PHSO's erroneous reasoning
at paragraph 13, which confuses the degree of harm caused by
death in itself with the level of harm involved in this case
where the experiments were allowed to continue until the animal
is found dead as a direct result of the experiment (i.e. death
as the endpoint); notes that the PHSO has repeatedly refused
to respond substantively to Uncaged's expert submissions regarding
this unsound reasoning; and asks the Government to establish
an independent inquiry into the numerous significant outstanding
concerns regarding the regulation of this research programme
in the light of PHSO's flawed investigation."
In 2003, Uncaged achieved a historic 'David-and-Goliath' legal victory over
pig organ transplant research company Imutran and their parent
company Novartis Pharma. Having initially sought complete suppression
of the documents when the case began in 2000, Imutran/Novartis
eventually caved in and settled out of court after the Defendants
had been awarded legal aid.
This allowed the publication
of thousands of
pages of leaked research documents, on the grounds
that there was a public interest in the disclosure of Home Office
misconduct. Uncaged subsequently lodged a complaint with the Parliamentary
and Health Service Ombudsman in respect of the Home Office's failure
to apply laws and regulations to Imutran's animal experiments.
The main concern focussed on the regulatory breaches in the way
that animal suffering was assessed and controlled. According to
stated regulations, animal experiments are assessed as 'moderate'
when not a single animal is in danger of suffering a 'major departure
from their usual state of health or well-being' or 'significant
post-operative suffering': such adverse effects are supposed to
be categorised as 'substantial' severity. One clear distinction
between 'moderate' and 'substantial' severity is that in 'substantial'
experiments, the experiments might continue until the animals die.
The main adverse effects caused by the Imutran experiments involved
acute drug toxicity, infections and organ failure. Many monkeys
and baboons were allowed to suffer for so long that they were literally
'found dead' or
'in a collapsed state'. Uncaged point out that
these were flagrant breaches of the moderate severity limit, and
they prove that the original assessment was mistaken. Moreover,
the Home Office has turned a blind eye to these breaches of the
moderate severity. A
leaked minute of a Imutran meeting reveals
just one example of the collusion between the Government and the
animal research industry: "Sandoz [Imutran's funders and collaborators
at the time] have suggested kidney transplants, the Home Office
will attempt to get these classified as moderate procedures".
The Home Office probably bent the rules because they wanted to
help Imutran to get permission for these experiments more quickly
and easily than if the correct 'substantial' or 'severe' severity
assessment had been made.
The RSPCA have also called for an independent inquiry. Their
report into this affair describes the adverse effects endured by
the primates - such as whole body shaking, grinding of teeth, haemorrhaging,
vomiting, weakness, wound-weeping, gangrene, tremors and diarrhoea
- as 'severe,... serious and very unpleasant'. They go on to criticise
the 'moderate' severity rating, arguing that a 'substantial' rating
was 'without doubt' necessary: 'to alert the scientists and technicians
involved to the need for greater vigilance, and in order to ensure
a meaningful, realistic and honest cost-benefit analysis'. The
'cost-benefit assessment' - as it is officially known - of animal
experimentation projects is supposed to be the cornerstone of the
UK regulatory system, determining whether experiments are permitted
and, if so, how much suffering is authorised. When the regulations
refer to 'costs', what they really mean is the degree of harm suffered
by animals.
The Ombudsman's report (ref: PA-2823), was finally laid before
Parliament on 15 December 2006. The key finding was the exoneration
of the Home Office's categorisation of lethal pig-to-primate organ
transplant experiments as of merely 'moderate' severity. However,
the Ombudsman has let the Home Office off the hook on the basis
of an elementary misunderstanding of the facts of the case and
the requirements of the regulatory system. The Ombudsman states
that death, in itself, does not count legally as a 'harm' to the
animals and thus does not necessarily indicate a breach of the
moderate severity limit. However, the Ombudsman's position is derived
from regulatory
discussions about experiments performed under terminal
anaesthesia, where the animal is not conscious during any part
of the experiments and is killed before it comes round. Clearly,
this is completely irrelevant to this case.
On the contrary, in
many of the Imutran experiments, death was the 'endpoint'. In other
words, some of the experiments with their severe adverse effects
continued while the animals were conscious for several days until
they died. The whole point of an effective 'moderate' severity
limit is that the experiment must be stopped - normally
by euthanasia - before an animal becomes significantly unwell or dies as a result
of the adverse effects caused by the procedure. So 'death in itself'
is completely irrelevant to Uncaged's complaint. Consequently,
the Ombudsman's decision is totally unsound.
Furthermore, and contrary to their letter to MPs, the Ombudsman
has refused to consider these submissions by Uncaged, despite the
fact that they raise unique, novel substantive issues.
Click here to lobby your MP on EDM
1718 now!
^ |
