Volume 9: Wales, Scotland and Northern Ireland
Part 1: Wales
5. Chronological account of specific Welsh issues
Welsh Office concerns
Risk from slaughterhouse practices
'Beef is safe'
Follow-up action on issues
Concerns over bovine heads
Challenging the DH line
The epidemiology concerns
Restricted access to SEAC deliberations
The meeting with Dr Tyrrell
PHLS involvement in SEAC and the CJD Surveillance Unit

Risk from slaughterhouse practices

5.8 In March 1988 Dr Ruth Jacobs joined the Welsh Office as SMO with an environmental health role, including responsibility for communicable diseases. In her statement Dr Jacobs said that in September 1989, when she returned from a year's maternity leave, WOAD was leading on the issue of BSE. Her role at the time involved receiving updates on the situation from DH and assimilating the information. ¹ In early May 1990 Dr Jacobs heard about the case of feline spongiform encephalopathy diagnosed by Bristol University and considered the implication that the disease might be capable of crossing another species barrier and thus be transmissible to humans. This caused her to regard proper enforcement in slaughterhouses of the ban on SBO as a particularly important issue. ² She asked Mr Ronald Alexander, Environmental Health Adviser at the Welsh Office, to look into and report on slaughterhouse practices for the removal of bovine brains. ³

5.9 Mr Alexander responded on 9 May 1990, commenting that local authority Environmental Health Departments had not received guidance on the interpretation of the Bovine Offal (Prohibition) Regulations 1989 introduced the previous November. This had resulted in differing standards of enforcement throughout Wales. He considered that two of the four methods in use to remove the bovine brain involved significant health and safety risks to slaughterhouse workers as well as the risk of contaminating the head meat. In addition, it was understood that bovine carcasses imported into Wales from the Republic of Ireland, where no parallel Regulations existed, were found upon inspection to contain spinal cord. ⁴

5.10 For Dr Jacobs, these pieces of information highlighted the link between meat hygiene and public health and safety issues. ⁵

5.11 Dr Deirdre Hine, the new CMO for Wales, ⁶ was told of Mr Alexander's concerns about slaughterhouses within the next few days. Having visited slaughterhouses herself, both as an undergraduate during her public health experience and as a postgraduate training in public health, ⁷ she was not surprised that there were variations in conditions at slaughterhouses. She told the Inquiry that, in her experience, they were not places where there was likely to be a uniform method of working. ⁸

'Beef is safe'

5.12 On 15 May 1990 Dr Hilary Pickles, Principal Medical Officer at DH, put a submission to the Parliamentary Under-Secretary, Mr Stephen Dorrell, copied to DH officials, with an update on the BSE situation. ⁹ The submission was also faxed to the Welsh Office. It advised that Sir Donald Acheson, the CMO in England, would make a statement the next day reassuring the public that beef was safe to eat. The proposed 'line to take' was:

According to the advice of outside experts given to the Government there is no scientific justification to avoid eating British beef. Beef can be eaten safely by everyone both adults and children. ¹⁰

5.13 In response to news of this imminent announcement, Dr Hine convened a meeting of the Health Professionals Group (HPG) on 16 May. The meeting was attended by Dr Jacobs, Mr Alexander, the two Deputy CMOs at the Welsh Office (Dr Michael George and Dr David Ferguson-Lewis), and Dr (now Professor) Stephen Palmer and Dr Roland Salmon of the PHLS. Dr Palmer had been Head of the Welsh Unit of the CDSC since 1983. ¹¹ Dr Salmon was a consultant epidemiologist with the CDSC Welsh Unit.

5.14 Professor Palmer told the Inquiry that at that time:

Our assessment of the evidence, limited as it was, suggested that there was a case that could be made that there certainly was a significant potential for BSE to be transmitted to humans either by inoculation or by the consumption of infected meat. ¹²

5.15 This conclusion was based on published evidence (see paragraph 5.29) which could be interpreted as suggesting an association between the consumption of sheep offal and classic CJD, and also between classic CJD and exposure to small biting animals such as mink, which were known to be subject to transmissible spongiform encephalopathies. He made the point that the absence of evidence of risk was not the same as the presence of evidence of no risk, and that he and his colleagues felt at the time that this distinction was not being made clearly. They therefore advised caution in making categorical statements that beef was safe or 'completely safe'. ¹³

5.16 At the meeting it was concluded that the Welsh Office should not separately endorse the views of Sir Donald Acheson. It was decided further that, if the Welsh Office could not avoid commenting publicly, it should state that:

We have been informed by the Department of Health that they have concluded, based on the advice of their outside experts, that there is no scientific justification to avoid eating British beef. ¹⁴

Follow-up action on issues

5.17 Those at the meeting on 16 May agreed a number of points which Dr Jacobs should pass on to Dr Pickles seeking clarification of the 'very helpful information she had already given'. ¹⁵ Dr Jacobs wrote to Dr Pickles on the same day. The letter, which was approved by Dr Hine, contained the following points:

1. The Welsh Office asked whether it would be possible to see a protocol of proposed studies to be carried out by Dr Robert Will, Director of the CJD Surveillance Unit (see vol. 8: Variant CJD).
2. The practice of continuing to feed pigs and poultry with feedstuffs containing bovine offal was felt to be 'severely in question'.
3. The continued use of sheep offal as an animal feedstuff in species other than bovine was felt to be 'similarly questionable'.
4. Dr Jacobs asked whether there was any evidence from the age distribution of cattle with signs of BSE coming for slaughter which suggested a point source of exposure.
5. An update on views on vertical transmission of BSE (ie, from dam to offspring) was requested.
6. The continuing export of animal feedstuffs which were not considered to be acceptable within the UK was questioned 'if for no other reason than self-interest, since beef or live animals fed on such feedstuffs may re-enter the UK'.
7. The three issues raised by Mr Alexander were included, ie: the danger posed by imports from the Republic of Ireland; the lack of guidance to local authorities on interpretation of the SBO Regulations; and the variation in slaughterhouse practices leading to a consequent risk of cross-contamination. ¹⁶

5.18 At the same time, Dr Jacobs wrote to Mr Peter Lister of the Health and Safety Executive (HSE) drawing his attention to the lack of guidance on the interpretation of the Bovine Offal (Prohibition) Regulations 1989 and the importation of possibly infected carcasses from the Republic of Ireland. She noted Mr Alexander's advice that none of the four methods of removing bovine brains in slaughterhouses could guarantee the effective removal of the brain without the head becoming contaminated. Two of the methods involved significant health and safety risks to workers in the slaughterhouses. Her intention was to ensure that he was aware of practices in slaughterhouses and to assist him in formulating occupational health advice for slaughterhouse workers. ¹⁷

Concerns over bovine heads

5.19 Dr Jacobs copied this letter to Mr Alan Huws, Head of Farm Animal Health and Welfare at WOAD. Mr Huws immediately sent Dr Jacobs a copy of a request for comments on proposed guidelines for slaughterhouses which he had received from his MAFF colleagues. Mr Huws noted that Dr Jacobs's points about contamination during brain removal went contrary to the guidelines, and asked for advice on which methods of brain removal were acceptable. ¹⁸ Dr Jacobs and Mr Alexander replied jointly to Mr Huws, re-emphasising that, as none of the methods of brain removal was safe, head-splitting should be expressly prohibited. Head meat should be obtained without splitting the head, which should then be disposed of intact and in such a way as to prevent any brain material from entering the human food chain. This letter was copied to DH and HSE. ¹⁹

5.20 Mr Huws sent these comments on to MAFF on 23 May. ²⁰ He was advised by a letter dated 25 May that the guidelines had already been amended and submitted to the newly established Spongiform Encephalopathy Advisory Committee (SEAC), which had met for the first time on 1 May. A copy of the amended guidelines was enclosed. ²¹ Concerned that the Welsh Office views had not been incorporated, Mr Huws wrote back on 5 June to ask that the points about head-splitting be put to the Advisory Committee. Ms Bronwen Jones of MAFF responded that the guidelines had already been sent to the members of SEAC, who had not been presented with arguments for or against head-splitting, but had been left to form their own views about 'technical' issues. She noted that the question whether head meat should be removed before the head was split had already been discussed at MAFF, ²² and the general view was that the approach taken by the guidelines was sufficient, particularly since DH had agreed them. Ms Jones indicated that it remained to be seen what SEAC would decide but that the views of the Welsh Office would be drawn to the attention of MAFF Ministers. ²³ In the event, at their meeting on 13 June, SEAC decided that as a commonsense measure the removal of bovine brains before the head meat was harvested should not be permitted. ²⁴ The MAFF guidelines issued on 14 June 1990 duly indicated that bovine head meat intended for human consumption should be recovered from the intact skull before the brain was removed. ²⁵ This was later made a statutory requirement by the Bovine Offal (Prohibition) (Amendment) Regulations 1992. ²⁶

Challenging the DH line

5.21 As noted above, Sir Donald Acheson made his public statement on the safety of beef on 16 May 1990. ²⁷ Shortly after this Dr Salmon prepared a memorandum of advice for Dr Hine articulating several concerns about assumptions underlying the statement. ²⁸

5.22 Dr Salmon's memorandum reviewed in general terms the evidence for transmission of animal spongiform encephalopathies to man, and stated that a small risk of transmission to humans could not be excluded. The memorandum concluded: 'All this adds up to a numerically extremely small risk but that risk is of a particularly catastrophic outcome.' Dr Salmon viewed this conclusion as inconsistent with the terms of the statement on the safety of beef issued by Sir Donald. In addition, in his view it was more difficult to impose stricter Regulations, or educate the public, when policy statements were being issued that presented the risk as minimal to the point of not existing.

5.23 At this stage, Dr Hine received a copy of the memorandum submitted by Dr Gerald Forbes, Director of the Environmental Health (Scotland) Unit, to the House of Commons Select Committee on 8 June 1990, ²⁹ expressing concerns about the apparently limited involvement of medical officials in a public health problem. ³⁰ Dr Forbes's paper concluded that it was clear that no absolute guarantee could be given that the eating of beef was safe.

5.24 On 12 June 1990 Dr Pickles wrote to Dr Jacobs to assure her that all the issues raised in her letter of 16 May 1990 were being considered. ³¹

5.25 On 27 June Dr Hine forwarded a copy of Dr Forbes's Select Committee memorandum to Mr John Davies (Grade 3 Head of WOAD) and Mr John Lloyd (Deputy Secretary, Social Affairs/WOHD). Her covering minute said:

I thought you should see the attached papers which I received recently since they are a very clear and accurate statement of my own opinion on this subject. ³²

5.26 The next day Mr Davies replied to Dr Hine, agreeing that the comments made by Dr Forbes were 'by and large, objective'. He did, however, take issue with Dr Forbes's point in relation to claims that beef was 'absolutely safe'. Mr Davies said that it was not being asserted by anyone that beef was 'absolutely' safe, and added that this was 'not a petty comment' as 'it is the degree of risk which lies at the heart of the argument'. ³³

5.27 In early July 1990 Dr Hine was informed that Mr Davies was not happy that HPG had raised points with DH which were more properly within the remit of WOAD. Dr Hine considered that Mr Davies had not immediately recognised that HPG, rather than making statements, had been posing questions to professional colleagues at DH. Mr Davies and Dr Hine then agreed to hold a meeting between WOAD and HPG to share opinions and discuss areas of overlapping responsibility. ³⁴ The meeting was held on 17 July. Dr Jacobs recalled:

The Chief Medical Officer explained to Mr Davies that it was entirely appropriate that we should approach the Tyrrell Committee [ie, SEAC] through Dr Pickles to express our concerns in the form of a series of questions and statements. And I think he was quite happy with that explanation before the meeting took place . . . we amicably resolved any misunderstandings which might have arisen as a result of the letter I wrote. He then went on to press our concerns, and very strongly, with MAFF, which of course he was entitled to do because his Department liaised directly with MAFF. ³⁵

The epidemiology concerns

5.28 In response to a request by Mr Davies at the 17 July meeting, Dr Palmer and Dr Salmon sent a joint memorandum to Dr Michael George, one of the two Deputy Chief Medical Officers at the Welsh Office, querying the conclusion of SEAC that the epidemiological evidence of a lack of association between scrapie and human disease appeared to be secure. ³⁶ Drs Palmer and Salmon expressed surprise to find no detailed discussion in SEAC's papers of work by Harries-Jones, Knight, Will, Cousens, Smith and Mathews. ³⁷

5.29 According to the two doctors, the paper by Harries-Jones et al. reported the results of the only controlled epidemiological study of CJD from the UK at that time. ³⁸ The study had been designed to examine potential risk factors, including dietary factors and animal contact. In the view of Drs Palmer and Salmon, the paper contained 'some data, and other statements suggesting data exists, which shows associations between animal and offal exposure and CJD'. ³⁹ They concluded by expressing their reservations about the proposed CJD study by Dr Will and in particular about the methods of case definition and case ascertainment. They also suggested that such a long-term and complex study might be better handled by the Medical Research Council or PHLS or both, and that a study of abattoir workers over the previous five years would be reassuring. ⁴⁰

5.30 The day after his meeting with Dr Hine and her team, in the margins of a MAFF Regional Panel Meeting, Mr John Davies discussed some concerns that Dr Hine had been expressing about the work and composition of SEAC with Mrs Elizabeth Attridge (MAFF Under Secretary, Grade 3, responsible for animal health). ⁴¹ Mrs Attridge minuted Mr Keith Meldrum, Chief Veterinary Officer at MAFF, about this discussion, suggesting that Mr Meldrum have a word with Mr Davies as, in her view:

It would be better if we could put their minds at rest before they took up a position different from that of DoH as otherwise it seems to me we are going to be in some difficulty of the kind exemplified by the differing views put out by Mr Gerry Forbes from Scotland. ⁴²

5.31 Shortly afterwards Mr Raymond Bradley, Head of the Pathology Department at the Central Veterinary Laboratory (CVL), wrote to Mrs Attridge about the Welsh Office concerns saying that they were 'likely to result from ignorance'. He was of the view that 'the epidemiological judgements should be made after consideration of all the evidence from numerous case control studies'. ⁴³

5.32 During July 1990 Dr Jacobs continued to investigate matters relating to BSE. She wrote again to Dr Pickles, to ask whether, in the light of SEAC's identification of a potential risk posed by dissection of bovine eyeballs, any guidance had been issued or was planned to be given to schools. ⁴⁴ She also asked Dr John Hodgson, an HSE epidemiologist, whether any epidemiological study of CJD was planned. Dr Hodgson was unaware of any such work and this answer was conveyed to others in HPG. ⁴⁵

5.33 On 27 July Mr Davies sent a letter (prepared in draft by Dr Jacobs) to Mrs Attridge, summarising the Welsh Office queries. This document raised a number of points including the following:

1. The Tyrrell Committee (ie, SEAC) papers contained no indication that the Harries-Jones paper had been discussed in detail.
2. The Welsh Office wished to know whether the raw data on which the Harries-Jones paper was based had been examined.
3. The Welsh Office queried the wisdom of dismissing the associations indicated by the data in the Harries-Jones paper between CJD and contact with mink, cats and other animals.
4. The fact that SEAC had no recognised human epidemiologist was surprising. ⁴⁶

5.34 Dr Jacobs sent Dr Pickles a copy of the letter, along with Mrs Attridge's note of her discussion with Mr Davies and a note of HPG's concerns regarding the protocol for Dr Will's studies at the CJD Surveillance Unit. ⁴⁷

5.35 Four days later Mrs Attridge responded to the letter. ⁴⁸ She observed that if the Southwood Working Party (see vol. 4: The Southwood Working Party, 1988-89) had checked the raw data in relation to the Harries-Jones et al. paper, there would be little point in SEAC going over it again. She suggested that Mr Alan Lawrence, who had been joint secretary to the Working Party, could look up the data presented to it. She added: 'Certainly the possibility of any association with scrapie was very fully considered.'

5.36 On 9 August Dr Pickles wrote to Dr Jacobs responding to the matters raised by the Welsh Office in their letter of 27 July. ⁴⁹ In Dr Hine's view, 'The letter . . . was a fairly general reassurance to us that these concerns were being looked at and acted upon.' ⁵⁰ However, Dr Pickles complained:

I do think the way you have handled this is surprising. Many of the comments suggest you have a keen interest in BSE and CJD but are in possession of only some of the available information. In these circumstances, surely it would be preferable to check out your ideas on the 'phone before they get formalised into an official viewpoint put to another Government department.

I have done my best, as you acknowledge in your letter, to keep you informed of the main developments but it is quite inappropriate for me to share with you all the detail. If there is an aspect you think the experts may have overlooked, please feel free to raise it with me on the 'phone or in writing. For my own part, I do not see there is a particular Welsh 'angle' to BSE/CJD, and am surprised you feel it necessary to put so much effort into challenging the views of colleagues at DH who are more senior, more experienced in the area, devote a higher proportion of their time to the topic, and have frequent access to the real experts in the field.

We go to great lengths to keep working side by side with MAFF on this topic and it would be a shame, as Mrs Attridge notes in her minute of 18 July, if the Welsh Health Department decide to take a separate line. ⁵¹

5.37 Dr Hine told the Inquiry:

We were well aware that we were not in possession of the full facts, though we had tried very hard to obtain access to the Committee [SEAC] and to all the evidence, and we were getting very much generalised responses back, rather than specific responses. However, I was, to a certain extent, understanding of the position of my colleagues in the Department of Health who were dealing with very difficult, very sensitive matters, on which we did not have the whole information and therefore we were asking awkward questions and we, of course, had the luxury of not having the responsibility for the policy lead. So to some extent I can understand the slight degree of irritation which is creeping into the correspondence. ⁵²

5.38 Dr Jacobs, commenting on this letter from Dr Pickles, told the Inquiry that there was a legitimate Welsh interest in that she and her colleagues had a duty to advise the population in Wales on public health matters and this was not something that could be done on the basis of summarised evidence alone.

What I did find very disturbing was that she actually said that it was not appropriate for us to have all the detail. ⁵³

5.39 Dr Jacobs, with Dr Hine's approval, replied to Dr Pickles's letter on 26 September 1990. She explained that WOHD had not raised matters with MAFF but had supplied information to WOAD, which had then raised certain points with MAFF. She noted that Sir Donald Acheson had recently agreed that Scottish and Welsh Office representatives should attend SEAC meetings as observers (but see paragraphs 5.41ff below). She protested that HPG had no intention of 'taking a separate line' from DH but, as medical and environmental advisers to the Welsh Office, HPG had:

. . . a duty which the Department of Health cannot entirely relieve us of to continue to put whatever time and effort we judge to be appropriate into attempting to understand the problem more clearly. ⁵⁴

5.40 During August Drs Palmer and Salmon had written to Dr George with observations on correspondence to date. ⁵⁵ With regard to the letter from Mrs Attridge to Mr Davies discussed in paragraph 5.35 above, they noted that the text of the Southwood Report did not suggest that the Southwood Working Party had examined the raw data in the Harries-Jones study, as opposed to just the published literature. In response to Dr Pickles's comments on Mr Davies's letter of 27 July, the doctors said that they thought that epidemiological expertise on SEAC would be helpful 'because there is a need for direct empirical evidence [of] the risk (or otherwise) to human populations from animal spongiform encephalopathies'. They considered that if a 'Welsh Angle' was required (before commenting on proposals from DH), it was that the incidence of CJD in Wales was 0.859 cases per million population per year, higher than any region of England and almost double the England and Wales average of 0.49 cases per million per year.

Restricted access to SEAC deliberations

5.41 Dr Hine felt that Health officials from Scotland, Wales and Northern Ireland should attend SEAC meetings. In August 1990, at a meeting of UK CMOs, she asked that consideration be given to allowing her or a member of her staff to attend SEAC meetings, at least as an observer. Dr Hine commented in her evidence that this 'would have allowed me and HPG to put the advice we were receiving into the context of the discussions between the experts and if appropriate to put our concerns to them at first hand'. ⁵⁶

5.42 Dr Jeremy Metters (Deputy CMO at DH) responded in November by letter, reporting that Dr David Tyrrell, the SEAC chairman, was anxious about the present size of his Committee and was firmly opposed to any further enlargement. Dr Metters also said that, given the strength of Dr Tyrrell's opposition, Sir Donald Acheson felt that this issue should not be forced, but they would ensure that communication with interested Departments was improved. ⁵⁷

5.43 Dr Jack McKenna, Northern Ireland CMO, who received a similar letter from Dr Metters, told the Inquiry that in his view:

Dr Tyrrell was saying he did not want his committee encumbered by people who were there because they had particular geographical hats as opposed to people there for their expertise. I did not have any real basis for demanding that somebody should be there. ⁵⁸

5.44 Wales, Scotland and Northern Ireland were not granted representative status on SEAC during this period, but Dr Metters did assure all three CMOs that they would see the papers and minutes. ⁵⁹ However, in oral evidence Dr Jacobs, Professor Palmer and Dr Salmon concurred that the flow of information from SEAC was infrequent and that it was often not in the form of SEAC's minutes but rather summarised versions of evidence presented to the Committee. ⁶⁰

5.45 The refusal to allow other Health Departments to have observers attend meetings of SEAC was raised again with Sir Donald Acheson by Dr Hine on 22 November 1990 at another meeting of the UK CMOs. ⁶¹ Sir Donald said that he supported Dr Tyrrell's view that the other Health Departments could be kept in touch with SEAC by circulating papers. Therefore, the following January Dr Hine wrote to Dr Metters, saying that 'in the face . . . of the strong opposition you report by the Chairman, it is obviously inappropriate for us to press for inclusion in the Committee'. ⁶² However, she added that she intended to invite Dr Tyrrell to visit the Welsh Office to discuss some of the points of interest raised previously and to give a general briefing on the work of the Committee. ⁶³ Dr Metters later replied, saying that DH would be very happy for the proposed meeting with Dr Tyrrell to take place. ⁶⁴

5.46 At this point, Dr Jacobs's involvement in BSE effectively ended, although she did attend the subsequent meeting with Dr Tyrrell. ⁶⁵ She gradually handed over her responsibilities in this sphere to Dr Jane Ludlow, who took up full-time duties as an SMO with responsibility for communicable disease control in January 1991. ⁶⁶

The meeting with Dr Tyrrell

5.47 The meeting with Dr Tyrrell, accompanied by Dr Pickles, to discuss the Welsh Office's involvement in BSE, was arranged for 23 July 1991. Shortly beforehand Dr Salmon prepared a Discussion Paper for use at the meeting which reiterated his and Dr Palmer's concerns and ended with several questions relating to research and policy. ⁶⁷ Among these were the issues of case ascertainment and controls in Dr Will's study, and statements on the safety of beef.

5.48 The meeting was attended by WOAD officials, Mr Alexander, Dr Hine and other HPG staff including Dr Jacobs. Items on the agenda for this meeting were:

1. the responsibilities of the Welsh Office in agriculture and public health;
2. the terms of reference and work to date of SEAC;
3. epidemiological aspects of spongiform encephalopathies;
4. current policies, maternal transmission of BSE and future eradication;
5. slaughterhouse practices, disposal of BSE-infected carcasses and the infection risk from those buried earlier; and
6. the monitoring of cattle and other animals, and animal feedstuff production and importation. ⁶⁸

5.49 Mr Alexander raised a number of points which he believed had not been addressed by Dr Pickles: in particular, the practices he had observed in relation to the removal of spinal cord, the varying degrees of success achieved and the resulting contamination; and the possible human and animal health risk from buried carcasses of BSE-infected animals. He did not receive answers to these questions at the meeting, but was instead told that SEAC was pursuing these points. Mr Alexander said later that he was unaware of any substantive response ever being received on these issues. ⁶⁹

5.50 Dr Salmon told the Inquiry that he considered that Dr Tyrrell's approach 'placed greater emphasis on the 'biological hunch' rather than statistically based population studies'. ⁷⁰ Both he and Dr Hine were left with the impression that 'the [Committee] was not completely on top of the epidemiological aspects of the CJD Survey'. ⁷¹

5.51 In due course Dr George received two bundles of SEAC papers dated 28 November 1991 ⁷² and 16 September 1991 respectively, which he passed to Drs Salmon and Palmer for comment and advice. Dr Salmon replied in two memoranda which he discussed in his statement to the Inquiry:

I took issue with some of the epidemiological conclusions in the Medical Research Council Coordinating Committee on Research Report which was among the papers that I had received. I also queried whether any response had been received from the Tyrrell Committee to the Discussion Paper. ⁷³

5.52 The first memorandum commented on the draft Report of the Medical Research Council Coordinating Committee on Research on the Spongiform Encephalopathies, chaired by Professor Kenneth Murray. The Report discussed the opportunities and priorities for research on the spongiform encephalopathies of relevance to man. ⁷⁴ Dr Salmon concluded that 'some published epidemiological data flatly contradicts confident assertions in the report', notably the assertion that:

. . . studies in the UK (Matthews), France and elsewhere have failed to implicate contact with animals in the epidemiology of CJD. ⁷⁵

5.53 The second memorandum commented on the minutes of the SEAC meeting of 16 September 1991 and asked Dr George whether the Committee had responded to the points raised in the Discussion Paper. Dr Salmon noted that his understanding of the meeting of 23 July 1991 was that Dr Tyrrell 'specifically undertook' to take the Discussion Paper to the main Committee. ⁷⁶

5.54 Accordingly, on 3 March 1992, Dr Salmon wrote to Dr Tyrrell to enquire when he might receive a response to the several points raised in the meeting the previous July. ⁷⁷

5.55 Almost two months later, in May 1992, Dr Will wrote to Dr Tyrrell with his comments on Dr Salmon's Discussion Paper. Dr Salmon received Dr Will's comments a further three months later, in August. ⁷⁸ He forwarded a copy to Dr Hine, who told the Inquiry: 'I was not reassured by the lengthy delay, almost 13 months, before I had sight of Dr Will's response.' ⁷⁹

5.56 Dr Will's reply dealt in detail with the points raised in Dr Salmon's Discussion Paper but concluded:

. . . the Welsh Office Paper raises a large number of important issues which have been previously addressed and the decision has been made that the current epidemiological survey is sound methodologically although inevitably has disadvantages in relation to the practicalities of the project and the necessarily prolonged nature of the surveillance programme. ⁸⁰

5.57 In Dr Salmon's view, Dr Will's commentary:

. . . contained judgements about the published epidemiological literature with which I disagreed. Detailed comments about the survey methods used by the National Creutzfeldt-Jakob Disease Surveillance Unit in the same paper were also inadequately addressed in the commentary. That commentary also betrayed what appeared to be a basic misunderstanding of the concept of statistical power which I commented upon at the time. This raised concerns in my mind about how adequately analysis of the National Creutzfeldt-Jakob Disease Surveillance Unit survey would be carried out and led me to express the concern to the Welsh Office that 'surveillance may be being carried out less than optimally'. ⁸¹

5.58 Although Dr Salmon was pleased that his Discussion Paper had received serious consideration, he still had concerns. ⁸² In October 1992, after agreement with Dr Palmer, he sent a minute to Dr George which concluded: 'I know you and CMO will share any concern that surveillance might be being carried out less than optimally and I am sure you will choose to represent such concerns appropriately.' ⁸³

5.59 The main issue that arose in this correspondence was whether Dr Will and SEAC ignored earlier research indicating the probability of transfer of transmissible spongiform encephalopathies from animals to humans. We do not think Dr Will did so - indeed he was a co-author of the original paper.

5.60 Dr Hine's conclusion on the exchange of correspondence was that formal representations on the risks of transmission of BSE would be viewed by MAFF and DH as irrelevant, irritating or both. Consequently she decided to address further issues (such as the absence of a medical epidemiologist on SEAC and the need for involvement of the PHLS) informally through routine meetings with the other CMOs. ⁸⁴

PHLS involvement in SEAC and the CJD Surveillance Unit

5.61 Dr Hine thought that the Public Health Laboratory Service (PHLS), as the Government advisory agency responsible for monitoring communicable disease, should be more closely involved in the investigation of BSE and CJD, and that all the various medical bodies with expertise in the field should contribute:

All I was anxious about was that this whole area of work was so potentially serious that, if you like, all the medical tribes should actually contribute, and I was concerned that one of the medical tribes was seeming to be excluded. ⁸⁵

5.62 In her view, excluding one body had the effect of reducing the amount of information going out to public health doctors in the field. ⁸⁶ As she understood it, 'to involve PHLS would give substance to the idea that there was indeed a human health hazard associated with BSE'. ⁸⁷

5.63 The role that Dr Hine envisaged for the PHLS was surveillance, research, and development and monitoring of control methods. In particular, she anticipated that the PHLS's knowledge of field survey methodology and of dietary intake surveys (albeit usually on a much shorter timescale) would add an expertise to the study and discussions which others could not match. ⁸⁸

5.64 She also felt that the PHLS could have provided expertise in epidemiology at two levels. Firstly, to SEAC itself:

. . . in the discussion of general epidemiological questions, particularly from the point of view of a body which had a lot of experience of communicable disease epidemiology . . . I felt that that would have reassured the public health community that, in fact, this was being taken very seriously . . . I think they could have contributed to the assessment of risk then. ⁸⁹

5.65 Secondly, she felt that the CJD Surveillance Unit (CJDSU) could have benefited from the considerable experience of the PHLS in the design of the surveillance study and of occupational and dietary questionnaires, and in the administration of those questionnaires. ⁹⁰

5.66 Dr Palmer, too, was of the view that the skills and capabilities of the PHLS should have been utilised by DH in their investigations into BSE and CJD. The PHLS was a national organisation which was set up to identify and control new communicable diseases of public health importance. As such, he had never been satisfied that there were cogent reasons why the Service should not have been involved in investigating BSE. ⁹¹ He had raised this issue in early 1990 with his immediate superior, the Director of the CDSC in London, Dr Christopher Bartlett, who agreed with him. However, Dr Bartlett made it clear that the issue had been considered and the PHLS was not to involve itself formally, since DH believed that BSE was an animal health issue only. ⁹²

5.67 The roles that Dr Palmer envisaged for the PHLS in the BSE investigation were: firstly, to assist with resources and expertise in the area of design and implementation of epidemiological studies and surveillance; ⁹³ secondly, to make a significant contribution to risk assessment analysis; ⁹⁴ and, thirdly, to provide ongoing experience and expertise to SEAC as issues arose and developed. ⁹⁵

5.68 Dr Palmer told the Inquiry that he was aware that others who held the same view had also put pressure on the Director of the PHLS, Mr (later Sir) Joseph Smith. ⁹⁶ Sir Joseph's opinion, expressed several times to DH officials, ⁹⁷ was that:

Even though the expert view as reflected in the Southwood Report was that the risk that the disease was transmissible to humans was remote, I thought that the PHLS should be involved in its study, particularly on the epidemiological side. The Service was experienced in tracing the sources of infection and the links between cases, including those requiring reports from clinicians. CDSC in particular had expertise in case-control studies and in field epidemiology. This included case-finding and the design and use of questionnaires to examine, for example, the foods eaten by patients and by control groups which could help to identify the foods through which infection may have been transmitted. ⁹⁸

5.69 Despite this, the PHLS Board concluded in April 1990 that it could not disregard the express wishes of DH that the PHLS should not become involved in epidemiological work on BSE/CJD. ⁹⁹ However, when Dr Diana Walford succeeded Sir Joseph as Director of the PHLS in 1993, she too formed the view that the PHLS's expertise in communicable disease epidemiology and experience in dealing with major national incidents could be utilised by the CJDSU. ¹⁰⁰ Dr Walford's initiatives in this direction came to nothing in the face of continuing DH resistance. It was not until the announcement on 20 March 1996 of a possible link between BSE and the new variant CJD that the PHLS became involved in a number of aspects of work on CJD. ¹⁰¹

5.70 Between 1992 and 1996 Dr Hine had regular meetings with the other UK CMOs at which she continued to raise and discuss the above issues. However, she told us that she was in a minority, as the others did not entirely share her concern. ¹⁰²