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 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)


Baboon hands
Credit: Organ Farm

"The outcome of the Home Office internal inquiry is a report that is even more incoherent and unreliable than we expected.

"The Chief Inspector's review is a blatant attempt to cover-up wrongdoing and unfairly discredit the Diaries of Despair report.

"On several occasions the review explicitly distorts the facts: it is breathtaking in its brazen dishonesty and inaccuracy."
























































Cynomolgus monkey (macaca fascicularis)
Credit: Molluscan Pictures


See the New Documents for further damning evidence of Imutran's claims of likely imminent clinical trials, which condemns the Home Office response as a dishonest cover-up.

















































































































































































































































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