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, "substantial", involves:

"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 limit. (1)

'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." (2)

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" categorisation.

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


FOOTNOTES

  1. These definitions are taken from the Home Office's Guidance on the Operation of the 1986 Act for the relevant period.
  2. RSPCA Report: Non-human Primates in Xenotransplantation Research in the UK, June 2002, p.32.
  3. 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.
  4. See document hlsapp5b.2.
  5. See studies pp.41 & 45.
  6. See paragraph 3.11-3.12 of minutes for February 2003 meeting of the APC: www.apc.gov.uk/reference/feb03.htm.

 

Pig

"The documents reveal that the vast majority of the pig organ transplant experiments performed by Imutran were given a 'moderate' severity categorisation."

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Baboon operation
Credit: Organ Farm

"The procedures reported involve major abdominal surgery. This, by its very nature, will cause pain, suffering and distress..."

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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