Volume 11: Scientists after Southwood
5. Challenges to the Government's approach
Professor Lacey and Dr Dealler
Discussion

5.5 Professor Richard Lacey was Professor of Clinical Microbiology at the University of Leeds from 1983 until his retirement in 1998. Prior to becoming involved in the BSE story, Professor Lacey was a vocal critic of the Government's stance on food safety issues such as salmonella, listeria, cook-chill foods and the use of microwave ovens. ¹ Professor Lacey had been a consultant to the World Health Organisation since 1984 and advised MAFF as a member of the Veterinary Products Committee between 1986 and 1989 on preventing diseases in people that are derived from animals and food. ²

5.6 Dr Stephen Dealler is a consultant microbiologist and had previously been a medical senior registrar in Professor Lacey's department. ³ He worked with Professor Lacey on the study of listeriosis and listeria in cooked and chilled food.

5.7 Dr Dealler and Professor Lacey challenged certain aspects of the Government's stance on BSE, in particular the view that 'BSE was scrapie in cattle', and raised concerns over the possibility that the BSE agent could be present in beef and pose a risk to human health. ⁴ They also noted the risk of maternal and lateral transmission of BSE within cattle, questioned the Government monitoring of cases of CJD and BSE and challenged conclusions based on experiments on the infectivity of cattle tissue. ⁵ Coverage of their views in the media is described in the context of unfolding events in vol.6: Human Health, 1989-96.

Views from Professor Lacey following the discovery of FSE, May 1990

5.8 Professor Lacey told the Inquiry that he first took a particular interest in the emerging reports of BSE when he was researching for his book Safe Shopping, Safe Cooking, Safe Eating ⁶ in early 1989. He looked at various documents including the Southwood Report and the Tyrrell Committee Report in January 1990. ⁷ On 11 May 1990, the day after the Government's announcement that a spongiform encephalopathy had been diagnosed in a domestic cat, Professor Lacey was interviewed by a journalist from the Sunday Times and said that all herds infected with BSE should be destroyed. The paper ran the story on 13 May 1990. ⁸

5.9 Professor Lacey also told us that he was aware of the difficulties involved in raising the profile of BSE in the media:

The rising incidence of salmonella and other food poisoning, listeriosis, prompted me and my Department in Leeds in the mid 1980s to research the reasons why this was occurring, with a view to trying to reverse the trends. It was evident from the outset that there would be a conflict between the interests of the food producers and that of the consumers, particularly as both these were the responsibility of the same Ministry. I have adopted the attitude that fear of such a conflict should not be a deterrent to researching, analysing and raising the issues. The outcome of this research has in some areas been gratifying with hazards from listeriosis, cook-chill and microwave use, now considerably reduced compared with 10 years ago. Unfortunately food poisoning from salmonella has remained high. The concerns, which I expressed from 1988 about salmonella in egg, inevitably led to criticism from the egg farmers and their Parliamentary supporters. Similarly when I made known my concerns in 1989 about processed foods, including cooked chicken, soft cheeses and cooked chill food, this led to similar people disparaging me. I also pointed out at this time that E.-coli 0157 was a potential problem with cooked meat. Therefore I was aware that with this background, raising the profile of BSE would generate anger from those with a vested interest. Despite that, my training and professional responsibility required me to give priority to the welfare of the public. ⁹

5.10 Dr Dealler told us that Professor Lacey considered that 'there was no chance of getting any effect on the management of BSE unless it was done through the media'. ¹⁰ During oral evidence Dr Dealler said that he had discussed this approach with Professor Lacey:

I said to Lacey at the time, 'You are being more aggressive than will be effective'. I think that was one of the times that he said to me, 'You will get nothing done going through official channels.' I think it was right back then. He said it a number of times that to try to get things done through official channels would be ineffective. The only way to get things done would be through the media. I found he was right in the end. ¹¹

Agriculture Select Committee Inquiry into BSE, May to July 1990

5.11 On 16 May, the Agriculture Select Committee decided to hold an inquiry into BSE following an increase in public anxiety about the disease. ¹² Further details about the Select Committee's inquiry are given in vol.6: Human Health, 1989-96. Professor Lacey was invited, in collaboration with Dr Dealler, to produce a memorandum on BSE and related issues for the Select Committee. ¹³ Professor Lacey and Dr Dealler together produced a paper entitled, 'The risk to man'. ¹⁴ The paper outlined three reasons why there was concern over the infective agent in beef:

1. Peripheral nervous tissue may contain infectious agent. For example, it is well known that the sciatic nerve from scrapie-infected sheep can transmit the infection to goats (Pattison et al, 1962).
2. Lymphatics in channels and nodes around beef tissues may be infectious.
3. During the processing of the carcass after slaughter, the procedure to remove spinal cords, brains and other 'high-risk' tissues could easily contaminate the rest of the carcass. In particular, the use of mechanical saws to remove bone could be hazardous in this way. ¹⁵

5.12 Professor Lacey appeared before the Agriculture Committee on 13 June 1990 along with Professor Ivor Mills, Emeritus Professor of Medicine at the University of Cambridge, Dr Helen Grant, a retired neuropathologist, and Dr Gareth Roberts from the Department of Anatomy and Cell Biology at St Mary's Hospital Medical School. ¹⁶ In oral evidence to the Select Committee, Professor Lacey said that the process of removing the heads of cattle with saws may cause soft brain material to 'be spread around the slaughterhouse and contaminate other food items, in particular beef'. ¹⁷ He also said that there was a dose/time relationship to the disease in contrast to the generally accepted dose-only relationship. He stated that very small doses of infectious material could produce clinical symptoms many years later. ¹⁸ Professor Lacey suggested that, given that scrapie-type agent had been shown to be transmitted through peripheral nerves, there might be a danger from eating beef, since muscle is intrinsically linked with nerve tissue. ¹⁹

5.13 A Committee member criticised much of Professor Lacey's submission as being 'speculation and supposition and conjecture'. ²⁰ Professor Lacey was also asked by the Committee to comment on statements attributed to him in the press, including the statement that beef 'may be from BSE infected herds, which are most herds in Britain'. ²¹ Professor Lacey said in relation to the statement that he believed 'that for every animal that has clinical BSE there are a substantial number that have sub-clinical, are infected but do not appear ill'. Professor Lacey continued that this was an opinion and remained so because the Government had failed to undertake 'proper tests on the brains and other tissues of the non-clinically infected animals'. ²²

5.14 Professor Lacey was also asked to comment on a further statement of his that 'we cannot rule out the possibility of the disease spreading to humans, particularly pregnant women and young children'. He denied being 'sensationalist' and said that his opinions were formed on the basis of scientific knowledge. ²³

5.15 When asked about the 'difference between the incidence of human CJD vis a vis scrapie and the possibility of human CJD from bovine spongiform encephalopathy', Professor Lacey told the Select Committee:

I think the question of sheep scrapie going to man is unproven. The evidence is either uncertain or weak. There is no really good evidence that sheep scrapie goes to man and we have eaten a lot of sheep's brains, nerves, meat for many years. That is not in doubt. Some people say it is but I believe the evidence of sheep scrapie to man is small. The problem with BSE, we do not know if it has come from sheep in the first place. We do not know where it has come from. We do not know what it is. We do not know its host range. We have to look at BSE entirely as a new disease and I am not going to say it will go to man, I am not going to say it will not, I am saying we do not know. ²⁴

5.16 The submission to the Select Committee by Professor Lacey and Dr Dealler contained several recommendations for further research. During oral evidence to the Select Committee, Professor Lacey highlighted two particular research projects which he considered were 'serious omissions' from the Report of the Tyrrell Consultative Committee on research:

One, the testing of brains and spinal cord from slaughtered cattle and cows that are clinically well, looking for the various proteins associated with this disease. I want to know why this has not been done before, it is the first thing that should have been done to identify the scale of the problem. This is a very serious and major omission. The second point is if we are going to address the most dreadful question, which is to what extent is the human population at risk, then there are various things that could be done. For example, people dying could have their spleens examined. If this infection gets into the human population we can assume its progress will resemble that of other spongiform encephalopathies with the spleen being one of the first organs. ²⁵

5.17 Professor Lacey also commented during his oral evidence to the Select Committee that 'if our worst fears are realised, we could virtually lose a generation of people'. ²⁶

5.18 In his statement to the Inquiry, Dr Dealler said in relation to Professor Lacey's appearance at the Select Committee Inquiry;

I was shocked by the way in which Professor Lacey was questioned. It was as if the Members of the Committee had not been informed adequately about this kind of disease. I left and went over to MAFF and asked to be able to give information to the people involved. They refused to see me personally and after about 20 minutes sent a secretary to collect the information. I sat and wrote notes on each of the scientific articles I had brought over, which were then taken by the secretary. The Ministry returned the articles to me 3 weeks later. The articles showed that in other species muscle and other meats that we were continuing to eat had been shown to be infective. ²⁷

5.19 On 10 July 1990, the Agriculture Committee produced its report. This included a passage about Professor Lacey's evidence:

That not all scientists carry equal authority was amply borne out in our evidence. Professor Lacey, in particular, showed a tendency to extrapolate sensational conclusions from incomplete evidence in order to publicise his long-standing concerns about food safety. The result was a mixture of science and science fiction - a quite unsuitable basis for public policy. When he told us that 'if our worst fears are realised, we could virtually lose a generation of people' he seemed to lose touch completely with the real world. We do not doubt the sincerity of Professor Lacey's concerns, but we must question the judgement of television producers and newspaper editors who beat a path to his door as an authority on all aspects of food safety. ²⁸

Dr Dealler consults other scientists with an interest in TSEs - summer 1990

5.20 In summer 1990, Dr Dealler visited several groups both in Britain and the USA to discuss BSE. At the Neuropathogenesis Unit (NPU) in Edinburgh he met Dr Hugh Fraser and Dr Moira Bruce. ²⁹ In evidence to the Inquiry, Dr Dealler said that Dr Fraser was concerned about the research that was being done and about the length of time taken for the offal ban to be introduced. Dr Dealler also said that Dr Fraser was concerned that tissues other than the specified offals may present health risks. ³⁰

5.21 The research being carried out by Dr Fraser at the NPU involved inoculating mice with BSE infected tissue. Dr Dealler stated that this research would not necessarily give any indication of the infectivity present in those bovine tissues. ³¹

5.22 Dr Dealler visited Dr Stanley Prusiner's laboratory in San Francisco during the same period, where he met and spoke to Dr David Westaway who worked there. ³² Dr Dealler reported Dr Westaway as saying that it was difficult to get bovine tissues from MAFF in the UK. ³³

5.23 Dr Dealler also visited Dr Bruce Cheesebro at the National Institute of Health (NIH) in Montana. Dr Cheesebro similarly disputed that the mice experiments would show the infectivity of different bovine tissues. ³⁴

5.24 Dr Dealler sought a meeting with Dr Joe Gibbs of the NIH in Maryland. Prior to the visit, Dr Gibbs wrote to Mr Ray Bradley of the CVL enquiring both about the identity of Dr Dealler and the prospect of undertaking collaborative research with Mr Bradley. Mr Bradley replied saying that Dr Dealler worked with Professor Lacey and that:

As a result of the interviews of Professor Lacey by the [Agriculture Select] Committee, he has been very much discredited as an alarmist. ³⁵

5.25 However, Mr Bradley did not know where Dr Dealler stood on the issue of Professor Lacey's 'high profile and sensationalist approach'. He advised:

. . . caution in forming a close liaison with the Department [of Microbiology, Leeds], particularly on the subject of meat and bone meal analysis, if that is the intention.

5.26 Mr Bradley also added that:

We are always willing to consider collaboration and supply of materials to institutes of excellence like your own, provided the objectives are sound and there is approval of importation of materials by the Federal Authority. ³⁶

5.27 Dr Dealler said that at their meeting, Dr Gibbs was determined that BSE presented no risk to humans at all, although his researchers did not agree. ³⁷

MAFF/DH response to Professor Lacey's and Dr Dealler's article in Food Microbiology, August 1990

5.28 Professor Lacey and Dr Dealler published an article in the journal Food Microbiology on 30 August 1990 entitled 'Transmissible Spongiform Encephalopathies: The threat of BSE to man'. ³⁸ The paper was a general review of TSE knowledge to date and provided views on histopathology, epidemiology, possible sources of infectivity and the risk to humans. They concluded that while there was little reason to suspect the presence of the TSE agent actually within or around muscle fibres, peripheral material - such as nervous tissue, lymphatics in channels and nodes around the beef tissue - was certain to contain infectious material if it was present. They considered that the means of processing beef, specifically the use of mechanical saws, would not remove these tissues and would increase the likelihood of contaminating the meat with brain and spinal cord. Thus there was a distinct possibility that man could acquire spongiform encephalopathy from consumption of contaminated beef. In addition, calculations were made regarding the infectivity of beefburgers, on the basis of an estimation of the amount of BSE infected brain tissue present in a beefburger. Professor Lacey and Dr Dealler concluded that the crucial question was:

Is a high infective dose required to provide the certainty of the infectious agent entering a cell at a specific receptor? If this were the case, then the consumption of small amounts of agent on numerous occasions could provide the same risk as consumption of the total number of particles on more than one occasion.

They thought that:

More research is required to assess the risk to man, and to develop methods for early detection of TSEs before the onset of clinical symptoms.

5.29 This article was circulated within MAFF and DH ³⁹ on 19 December 1990 by Mr Maslin, who commented that the article contained 'numerous errors and misrepresentations. I recommend that it not be read by those with high blood pressure.' ⁴⁰ Dr Pickles replied that the paper should be circulated to SEAC. ⁴¹

5.30 Mr Kevin Taylor prepared a critique of the article at the request of Mr Gummer, which included a note from Dr Pickles. Dr Pickles noted, amongst other points, that:

This paper is a mixture of scientific review, comment and speculation . . . This is not an authoritative work . . . There are several errors of fact . . . Apart from the flavour of scaremongering, it is not easy to extract the main points the authors are trying to make in this paper. ⁴²

5.31 On 15 January 1991, Mr Meldrum sent Mr Gummer a critique based on Mr Taylor's and Dr Pickles's critiques. ⁴³ On 1 March 1991, Mr Lowson wrote to colleagues in MAFF and DH asking for views on a possible public response from SEAC to the Food Microbiology article. ⁴⁴ He enclosed a draft version of the response to the Dealler/Lacey article which had already been shown to Ministers.

5.32 At their meeting on 7 March 1991, SEAC concluded that it did not want to respond to the article and that there was nothing in the article causing them to question their previous advice. ⁴⁵

5.33 A critical response to the article was, however, submitted to Food Microbiology by Mr Taylor, and was published as a letter to the editor in September 1991. ⁴⁶ Mr Taylor wrote to the CVO and Mr Bradley informing them of his response, stating that:

I see little point in further argument about factual errors, most of which Dealler and Lacey claim not to be errors anyway, and propose to do no more than suggest that black will still be black however often you say that it is white. ⁴⁷

5.34 In his letter published in Food Microbiology, Mr Taylor stated that:

The major shortcoming of the paper is not, however, the cavalier attitude to well-established facts that these errors reflect, but rather the assertions that are made about the implications of BSE for human health. ⁴⁸

5.35 He added,

. . . the 'estimates' of BSE infectivity in human food are entirely misplaced. On the basis of experiments in natural scrapie, in the few subclinically infected British cattle now being slaughtered and in those parts which are permitted for human consumption, we would not expect any 'infective units' even by assay by intracerebral infection into susceptible mice. The added safety margin of oral exposure, which usually requires a dose 10⁵ - 10⁹ higher to lead to infection, and a species barrier, was found entirely reassuring by the Tyrrell Committee.

5.36 Professor Lacey and Dr Dealler replied to Mr Taylor in the same edition of the journal. ⁴⁹ Their response contained point by point rebuttals of Mr Taylor's arguments. In particular they asserted their own accuracy in calculating the infectivity in food and argued that their assumptions for the relationship between oral and injected doses were accurate. The two letters disputed each other's facts. Professor Lacey and Dr Dealler demanded that the Government initiate experiments with transgenic mice bearing the human PrP gene. They said that if, when injected with BSE infected material, these mice succumbed to disease and produced human PrP, it would show that BSE was infectious to humans.

5.37 On 24 August 1991, Mr Bradley minuted Mr Meldrum and Mr Taylor recommending a brief response correcting major errors and a general comment on disagreement with the Dealler and Lacey reply. He said that the response should avoid personal criticism and base all criticism on scientific facts, supported where possible with published papers. He continued:

. . . I advise caution here because this is essentially Dealler's article (and he has even more extreme and bizarre views than Lacey judged on a meeting JW [John Wilesmith] and I had with him). . . ⁵⁰

5.38 On 30 August, Mr Meldrum wrote to Mr Taylor about this correspondence. He said:

The response from Dealler and Lacey makes inflammatory reading and you will need to respond in your inimitable style knocking down the main issues raised. ⁵¹

5.39 Mr Meldrum suggested that Mr Taylor should seek input from Mr Bradley and from Dr Richard Kimberlin in putting together a further response.

5.40 On 4 September, Dr Pickles sent a note to Mr Taylor on Dr Dealler's and Professor Lacey's reply saying:

The latest note from Dealler and Lacey is so full of errors yet again I agree there is no purpose in a point by point rebuttal. But in not doing so, we need to point out that this should not be taken to imply that either their facts or arguments are any more valid this time than last. ⁵²

5.41 Professor Lacey repeated his concerns about contaminated beef in a book published in 1991 entitled Unfit for Human Consumption. ⁵³

5.42 In oral evidence, Dr Tyrrell was referred to the August 1990 article of Professor Lacey and Dr Dealler in Food Microbiology.

MR WALKER: . . . If I could just take you to the last sentence of the summary at the beginning? It is:

'There is a distinct possibility that man could acquire spongiform encephalopathy from consumption of contaminated beef.'

Is that a conclusion that members of the Committee disagreed with?

DR TYRRELL: I do not think so, sir. What we have said already round this table, we always thought it was a possibility. I think our disagreement with a lot of the Lacey and Dealler statements, and some of their papers, was that in elaborating their ideas, which after all, in many cases, were just restatements of the data which had been collected by MAFF, they then added hypotheses about, for instance, the amount of infectivity to be found in various tissues, using for this, in almost every case, the worst case, which could be extracted from research publications. I mentioned this in my statement. Our philosophy was not to deny unpleasant possibilities occurring, but to try to use a biologist's feel, if you like, for the overall situation, and say that 'the most likely thing to happen is the following'.

It was when we got to that point that we parted company with Dealler and Lacey, both of whom are very able people in many ways. But that particular statement, as I have said, would have fallen into the category: 'Well, what is there more to say? They have looked at the data, we have looked at the data. We come out with different views. They know what our views are, we know what theirs are.' ⁵⁴

Professor Lacey proposes that BSE is endemic in Great Britain, February 1992

5.43 On 7 February 1992, Mr Kevin Taylor sent a minute to the MAFF Parliamentary Secretary, Mr David Maclean, informing him that Professor Lacey had written to the Veterinary Record using answers to Parliamentary Questions (PQs) to suggest that BSE was established as an endemic disease in Great Britain. The editor had invited Mr Taylor to reply and was intending to publish both letters in the 15 February issue. Mr Taylor attached copies of Professor Lacey's letter and his intended reply. In his minute to Mr Maclean he said that:

It is clear that Lacey is attempting to start a story. We know that he has contacted a number of journalists, including [James] Erlichman of the Guardian, saying that the information revealed by the recent PQ answer is cause for concern. ⁵⁵

5.44 On 15 February 1992, both letters were published in the Veterinary Record. ⁵⁶ Professor Lacey said:

Three disturbing trends are seen: the total number of BSE cattle in 1991 is over threefold that in 1989, the mean age in 1991 is somewhat lower, and some BSE cows in 1991 could well have not been fed with contaminated offal. This suggests that BSE is now an established endemic, even though it was initiated or aggravated by feeding offal. ⁵⁷

5.45 Mr Taylor replied that:

I do not believe that any evidence exists to justify Professor Lacey's suggestion that BSE is now an established endemic. Nothing has yet happened to alter the view that sources of infection other than food are unlikely to be important for the future of the epidemic, and continued monitoring of the epidemic, though not yet conclusive, gives cause for optimism. ⁵⁸

5.46 Professor Lacey presented figures published in Hansard to compare the ages of death of BSE cattle in 1991 and 1989 and concluded that BSE was an established endemic disease even though it was initiated or aggravated by feeding offal to cattle. Mr Taylor's response supported the feed hypothesis and the view that cattle had received MBM when they should not have done. He expressed concern that Professor Lacey was being selective in his choice of data and said that inferences drawn from incomplete data were 'fanciful'.

5.47 On 14 and 15 April 1992, Professor Lacey was reported in the media as claiming that an epidemic of BSE was 'likely to hit the human race by the end of the century'. He was reported in the Evening Standard on 14 April as suggesting at a conference organised by the Townswomen's Guild that there was a 70 per cent chance of the disease being transmitted to humans and that children were particularly at risk. ⁵⁹

5.48 Mr Lowson briefed Mr Gummer on Professor Lacey in a minute on 22 April 1992:

Professor Lacey's latest speech is based on no new information; his assertions remain as questionable as they have always been.

. . . nothing has happened to suggest that BSE is likely to transfer to humans; the 70 per cent chance that he mentions is pure fantasy. ⁶⁰

5.49 On 9 June 1992, Professor Lacey wrote to Mr Wilesmith with comments on an article by Mr Wilesmith which had appeared in the Veterinary Record of 30 May. ⁶¹ Professor Lacey voiced concerns about the data, namely that:

The suggestion that the offal banning of July 18^th 1988 can only be expected to have an observed effect during 1992 would seem to me incompatible with the large number of 3-year-old animals that develop the disease. ⁶²

5.50 He suggested that urgent research was necessary to identify the number of animals at slaughter which were infected but not clinically ill. Mr Wilesmith drafted a response which he copied to Mr Taylor and others for comments on 11 June 1992. ⁶³ This contained rebuttals of Professor Lacey's concerns but no comment on the suggestion of research into identification of non-clinically ill cattle at slaughter. ⁶⁴ On 19 June 1992, Mr Meldrum commented on the draft response and said:

. . . we should be aware that this letter is likely to get into the public domain and therefore in my opinion should be shown to Ministers and Press Branch before despatch.' ⁶⁵

5.51 Mr Gummer approved the draft response on 26 June 1992. ⁶⁶

Further developments in 1992

5.52 On 12 June 1992, David Hinchliffe MP asked a Parliamentary Question which Professor Lacey told the Inquiry had been on his behalf. He requested details of the animal experiments which had been or were being carried out for the Government. The information was placed in the Library of the House and Mr Hinchliffe provided Professor Lacey with a table of results. ⁶⁷

5.53 On 29 July 1992, Mr Lowson informed the Minister that Professor Lacey had asked Dr Tyrrell for a meeting to discuss BSE. Dr Tyrrell had replied that he would be happy to arrange a discussion and suggested that someone from MAFF, possibly Mr Bradley, should also attend. ⁶⁸

Dr Dealler seeks MAFF's views on the use of cattle brains for human consumption, early 1993

5.54 On 26 January 1993, Dr Dealler wrote to Mr Maslin asking about the amount of potentially infected tissue that would have been in the diet of the human population prior to 1989. ⁶⁹ Mr Maslin replied on 29 January 1993 and again on 11 March 1993 after consulting colleagues in MAFF about the use of cattle brain for human consumption. All agreed that cattle brains would have been little used before the specified bovine offals (SBO) ban. Mr Maslin also said that there was information that suggested that none of the offals specified in Schedule 2 of the Meat Products and Spreadable Fish Products Regulations 1984 were used before the SBO ban was enforced. Use of the thymus was also reported as rare. ⁷⁰

5.55 Dr Dealler replied on 12 March 1993. ⁷¹ He was not convinced that bovine brains were not being used for human consumption before 1989, since he felt that wherever there was an economic benefit to selling even small scraps of material it would happen. He suggested that MAFF should fund work looking at treatments for Creutzfeldt-Jakob Disease (CJD) 'if only to cover themselves' in case of being found at fault for the whole outbreak of BSE. He said that the Southwood Report was 'exceedingly misleading' and that BSE should have been assumed to be infective to humans 'because the risks were simply too high'. He recommended to Mr Maslin that results of experiments examining infectivity in different cattle tissue should not be published as they would be 'shot down in flames'. He said that the amounts of tissue used were 'very small and crossing a species barrier', so that one would not be expected to see infectivity. ⁷²

5.56 Further Dr Dealler said he did not, at that time, intend to publish any further work on BSE that included information about human intake of tissue banned under the SBO regulations. He pointed out that Professor Lacey was still his 'boss', which meant he could not send Mr Maslin articles in advance of publication unless he was assured Mr Maslin would not 'let anyone know about it'. ⁷³

5.57 Together with his own letter, Dr Dealler also forwarded to Mr Maslin a copy of an article yet to be published, entitled 'BSE - The Offal Ban Fails', which was written by Professor Lacey. The article discussed the spread of BSE, and possible maternal and horizontal transmission in cattle. It noted that BSE in zoo animals was disturbing and that experiments on other host animals led to the conclusion that 'as with the spontaneously-infected animals, the potential host range for the BSE agent is very wide indeed'. After discussing the implications of the number of cattle with BSE to date, Professor Lacey concluded:

Thus the BSE epidemic is continuing despite the offal ban and must pose a very serious threat to many animals, including man. ⁷⁴

5.58 Mr Maslin circulated Dr Dealler's letter and Professor Lacey's article along with a proposed reply to Dr Dealler to Mr K Taylor, Mr Lowson and Mr Bradley, amongst others, noting Dr Dealler was not 'prepared to alter his view that we are all doomed'. ⁷⁵

5.59 Mr Bradley said about the proposed reply to Dr Dealler that he had:

No comment, but frankly the gentleman has calmed down quite a lot since we first met him. This might be due in part to various contacts we have had over the years but I still rest uneasy. Is it all a timebomb waiting to go off or not? Caution is the word. If in doubt leave it out. ⁷⁶

5.60 On 7 April 1993, Mr Maslin replied briefly to the letter (but not the article) based on comments from colleagues. ⁷⁷ He advised that he had 'not gone through' Professor Lacey's article, as it raised 'issues that go beyond my expertise and policy concerns', but that he imagined it would be refereed by 'experts in the field of CJD' before publication. ⁷⁸

5.61 Mr Maslin suggested that there had been no economic benefit to removing and using brains in food, so suspected that the practice had not occured. He also reminded Dr Dealler that considerable research into both BSE and CJD was being carried out by MAFF, the Medical Research Council and the Agriculture and Food Research Council as well as others. Mr Maslin denied the suggestion that the Southwood Report was misleading, since it recommended certain precautions to be taken in light of the fact there was a remote but potential risk to human health. With regard to the mouse experiments, Mr Maslin explained that the mice were a special laboratory strain particularly susceptible to spongiform encephalopathies, which had been used in scrapie research for many years. Given that bovine tissue was being injected into the mice intracerebrally, a route 100,000 times more effective than the oral route, Mr Maslin said that he believed that the experiments would give a good indication of the risk via the oral route to species not known to be susceptible. ⁷⁹

Developments prior to the meeting between Professor Lacey, Dr Dealler and Dr Tyrrell - March to June 1993

5.62 On 25 March 1993 Professor Lacey forwarded a copy of his article, 'BSE - The Offal Ban Fails', to Dr Tyrrell, saying that he would be interested to have SEAC's view. The draft began with a summary which stated:

Hopes that the offal ban in July 1988 would result in the resolution of the epidemic have not been fulfilled. It is proposed that the infective agent of BSE is primarily a cattle pathogen, perhaps initially spread by contaminated offal, but in recent years propagated chiefly by maternal (vertical) transmission with variable manifestation of the clinical disease. ⁸⁰

5.63 In the draft article, Professor Lacey said that it may not be possible formally to prove his hypothesis but that 'it seems to be the only explanation'. ⁸¹

5.64 We noted earlier that Mr Maslin circulated the draft article within MAFF. On 16 April 1993, Mr K Taylor replied to Mr Maslin saying that Professor Lacey's paper was:

. . . a strange document, more polemic than scientific paper . . . ⁸²

5.65 MAFF sent the draft article to Dr Tyrrell and members of SEAC to discuss at their meeting on 22 April. The Committee considered Professor Lacey's article and it was agreed that Dr Tyrrell should write to Professor Lacey 'pointing out the errors on which his conclusions had been based'. ⁸³ As agreed, Dr Tyrrell duly wrote to Professor Lacey with the views of SEAC on his article. ⁸⁴ He said:

There are a number of errors in your article but the Committee did not feel that they should give a detailed critique of it. There are however two major factual points that need to be corrected as they are central to the arguments contained in the article.

5.66 The first suggested error was that Professor Lacey had confused the SBO ban for human and animal consumption with the ban on feeding ruminant derived protein to ruminants. The second was that a misunderstanding had led Professor Lacey to fail to appreciate that prior to the ruminant feed ban for ruminants, young animals were the major recipients of this feed.

5.67 Dr Tyrrell invited Professor Lacey to attend a meeting to discuss the issues he had raised on BSE.

5.68 Professor Lacey replied to Dr Tyrrell on 11 May 1993. ⁸⁵ He thanked Dr Tyrrell for his letter and said that he had made appropriate revisions to his paper. He agreed to a meeting with Dr Tyrrell and Mr Bradley and restated his concerns regarding the epidemiology of BSE.

. . . I am particularly concerned about the epidemiology of BSE and there seem to be two totally incompatible phenomena. MAFF's proposal that the high number of cases in the last few years is due to re-cycling of bovine infectious agents which would suggest an extraordinarily high potency of infectivity for the oral route would seem to be incompatible with the claim made by Kimberlin, Ridley and members of your committee that these agents have very low infectivity by the oral route. Something is seriously wrong. ⁸⁶

5.69 During May 1993, Mr Bradley spoke with Professor Lacey over the telephone on two occasions (10 and 13 May) and gave him some information on BSE statistics and experiments. ⁸⁷ On the second occasion, Professor Lacey said he would welcome a visit and discussion with Dr Tyrrell and Mr Bradley and gave his available dates. Mr Bradley sent these to the SEAC secretariat so that they could arrange the meeting.

5.70 On 17 May 1993, Mr Meldrum wrote to Mr Taylor asking for a 'list of the faulty arguments being deployed by Professor Lacey together with a brief rebuttal of each one in the form of a speaking note'. ⁸⁸

5.71 On 18 May 1993, Mr Wilesmith sent a minute to Mr Bradley with comments on a revised draft of Professor Lacey's article, now re-titled 'BSE - The Gathering Crisis'. He noted that he had prepared the critique prior to the CVO's request, but hoped that it would be useful nevertheless.

5.72 In the note, Mr Wilesmith referred to Professor Lacey's article as '. . . Professor Lacey's latest exposure of his ignorance on this topic'. He also said

. . . I feel that we have two basic options for dealing with this tendentious individual who has failed to apply any scientific scholarship to his so-called critique of BSE. The first is to ignore him and hope that he will keep digging his own grave. The second is to launch an all out attack at every opportunity particularly with respect to his published musings. ⁸⁹

5.73 Mr Wilesmith said that he would 'tend towards the second option'. He also mentioned the proposed meeting with Professor Lacey and suggested he might attend 'otherwise, my fear is that the arguments may persist as he clearly feels that I am, personally, cooking the books'. ⁹⁰

5.74 On 17 June 1993, Mr John Howard of MAFF's Animal Health Division informed the Private Secretary to the Parliamentary Secretary, Mr Soames, that Dr Tyrrell would be meeting Professor Lacey on 22 June. The note said that Mr Bradley, Mr Wilesmith and Dr Dealler would also attend. ⁹¹ The note referred to the detailed critique of 'BSE - The Gathering Crisis' prepared by Mr Wilesmith, which Dr Tyrrell would use at the meeting. ⁹²

5.75 The critique gave a detailed discussion of each paragraph, emphasising suggested inaccuracies and misunderstandings of information and epidemiological studies.

5.76 Professor Lacey's article was published in the British Food Journal in July 1993. ⁹³

The meeting at Stoneleigh, 22 June 1993

5.77 On 22 June 1993, Dr Dealler and Professor Lacey met Dr Tyrrell, Mr Wilesmith and Mr Bradley in the MAFF pavilion at Stoneleigh National Agricultural Showground. ⁹⁴

5.78 Mr Bradley prepared a note of the meeting, ⁹⁵ in which he said in summary that:

Professor Lacey's views and the main points of controversy concerned:

1. His claimed ineffectiveness of the mouse model.
2. The potential importance of cumulative exposure to BSE agent.
3. The need to include offals of calves <6 months and bones of all cattle in the SBO ban with immediate effect.
4. Maternal and horizontal transmission were important.
5. The recent data on age-specific incidence was not believed.
6. [Bovine] Eyes were constituents of MRM though data was not quantifiable.
7. Human exposure was still high from calf offals, bones and bone products.
8. CJD should be made notifiable now or not at all. ⁹⁶

5.79 The note of the meeting was not distributed at the time either to Dr Dealler or to Professor Lacey, who told us '. . . despite initiating this meeting I had not been informed of the existence of the minutes nor had I seen a copy until 26 February 1998'. ⁹⁷

5.80 Mr Wilesmith explained that animals affected with BSE and born after the feed ban (BABs) were due to leftover feed. Professor Lacey said that there were too many BABs for that to be valid. He also made it clear that the material rots and that fungal spores would not allow the feed to be saved for any length of time. Dr Dealler asked for statistics 'showing the age distribution of cattle with BSE and the age distribution of cattle in the bovine community'. These were provided. ⁹⁸

5.81 Mr Bradley's note of the meeting records that '. . . neither Professor Lacey nor Dr Dealler accepted the validity of the mouse model for establishing the safety of tissues for human consumption . . .' ⁹⁹ Professor Lacey and Dr Dealler said that a mouse inoculation test could not give exact figures for infectivity unless the sensitivity of the mouse test was known. This was not accepted by Mr Bradley, who (according to Dr Dealler) said: 'We should accept the mouse inoculation test as being the test that was available and that it was the right answer.' ¹⁰⁰

5.82 Dr Dealler told us that 'Professor Lacey decided that this was such bad science that it was totally unacceptable'. He added that Professor Lacey was determined that:

. . . inadequate research was being carried out to find out the level of infectivity in the tissues and until this was available we must not make statements indicating that beef was safe. ¹⁰¹

5.83 Professor Lacey also criticised Professor R.M Barlow's recent paper in the Veterinary Record. ¹⁰² He claimed that 'the deductions of safety of certain tissues for consumption by man were misleading', and that 'in negative experiments mice could not live long enough to accommodate the incubation period'. ¹⁰³

5.84 Professor Lacey said that since infectivity had been found in meat of hamsters, goats and mink, it should be assumed that infectivity was present in beef at a low level and it should be calculated whether the quantity eaten by humans represented a risk. Mr Bradley did not accept this and stated that if there was infectivity when inoculated into mice then 'we should worry about it'. ¹⁰⁴

5.85 Maternal transmission and evidence to support MAFF's position were discussed. Mr Bradley's note recorded that:

Professor Lacey stated his belief (without evidence) that maternal and horizontal transmission was important especially later in the epidemic. He dismissed the evidence that placenta was not detectably infected and thought this was the origin of both the types of transmission he favoured.

5.86 Because of this view, Professor Lacey considered that the specified offals from calves under 6 months old should be included in the ban. Professor Lacey and Dr Dealler also considered that there was a risk from bovine bones and gelatine and it was their belief that 'bones of cattle should form part of the SBO ban and be instituted immediately'. ¹⁰⁵

5.87 Dr Dealler spoke to Mr Wilesmith about the analysis of statistics. Dr Dealler said that he was surprised that the CVL had not done retrospective or adequate prospective analyses to calculate the number of infected cattle that were being eaten. They had produced predictive figures for the number of cases of BSE for the Treasury, but had not carried out the analysis which Dr Dealler had undertaken. ¹⁰⁶

5.88 Dr Dealler gave Dr Tyrrell a copy of his paper, 'Current and future dimensions of the epidemic of bovine spongiform encephalopathy, and assessment of its potential effect on the human population'. ¹⁰⁷ The paper said that scrapie could not be used as a guide to the infectivity of bovine tissues to humans. It concluded that the dose of infectivity for BSE in humans should not be assumed to be high. Dr Tyrrell passed the paper to Mr Bradley, who said that a response would come from SEAC soon.

5.89 Mr Bradley's minute noted in conclusion:

Professor Lacey and Dr Dealler were satisfied with the data given to them and certain aspects of their understanding were undoubtedly improved. However unsound firmly held views were unshakeable. ¹⁰⁸

He felt that to remedy this position they would need the results of:

1. the case control study;
2. the comparative assays in mice and cattle;
3. the placenta transmission in cattle;
4. the pathogenesis study;
5. the attack rate study;
6. more firm evidence of a continuing downturn in the epidemic.

5.90 Professor Lacey and Dr Dealler, for their part, left the meeting with the feeling that they had not been given a fair hearing. Dr Dealler told the Inquiry that: ¹⁰⁹

It seemed initially that Professor Lacey and I were being treated as people who simply did not understand the subject and we had to be taught the truth so that we did understand. It was as if anything that we put forward was treated as invalid if it did not agree with their point of view whereas much of what they were saying the other way was accepted. ¹¹⁰

Dr Dealler added:

The impression that I got from the meeting was that Dr Tyrrell was accepting MAFF's position on BSE as fact and as such it would be very difficult to get information to be assessed independently in the UK. ¹¹¹

5.91 In oral evidence, Dr Tyrrell agreed that at the meeting that 'he considered the points being put forward by Lacey and Dealler and that no other body pre-determined [the] role'. He also confirmed that:

It was sad that no more fruitful relationship grew out of this contact, since some of Professor Lacey's ideas, such as the possible infectivity of bones have proved to be correct. ¹¹²

5.92 He added in his oral evidence that it 'was something which he, like many of us, made a guess about and turned out to be right'. ¹¹³

5.93 Mr Bradley sent a minute to Mr K Taylor, Mr Eddy and Mr Wilesmith about the internal record of the meeting. He noted that:

Dr Tyrrell wished to send a copy to Professor Lacey as he considered the report may be a step towards resolving some of the irrational views Professor Lacey holds. ¹¹⁴

Mr Bradley said he had discussed this with Mr K Taylor and both had agreed that this was not the purpose of the minute, and it should remain an internal record of what took place.

5.94 Mr Bradley commented in hindsight about the meeting that:

There were several points at issue between us, but what we considered unsound views were vigorously upheld by Professor Lacey and Dr Dealler. I disagree that there was no scientific dialogue. I concede that the dialogue could have been better . . . particularly on some points like maternal transmission, but the entrenched views held permitted little helpful discussion. Perhaps a subsequent meeting after digestion of the first would have enabled a better dialogue to develop. ¹¹⁵

5.95 Mr Wilesmith discussed the meeting in a statement to the Inquiry and denied he played a 'pre-determined role' at the meeting.

As is evident from the record of the meeting, Professor Lacey and Dr Dealler did not suggest any additional epidemiological research within my domain and responsibility. In my view the record of the meeting, together with what is evident from my scientific publications would suggest that I (and my colleagues involved in research) kept an open mind in terms of the scientific hypotheses which I have investigated related to understanding the epidemiology of BSE . . . It is certainly not correct to say that I had, or have, a predetermined role; nor a closed mind. To the best of my recollection Professor Lacey did not make any practical suggestions as to further epidemiological research that should be undertaken at CVL. ¹¹⁶

Newspaper coverage of the Stoneleigh meeting

5.96 On 3 July 1993, an interview with Professor Lacey appeared in the Guardian, where he discussed the Stoneleigh meeting. ¹¹⁷ He said that experiments indicated that BSE could be contracted from the liver and bone marrow of affected animals, and that since these products were used so much more frequently than brain and spinal cord, there was a significant risk to public health. Mr K Taylor was reported as dismissing Professor Lacey's arguments, saying that the high-risk tissues had been identified and removed from the human food chain. He was reported as saying, 'We believe there is no cause for public concern as the dose of the infective agent is what is important'.

5.97 On 8 July 1993, Dr Tyrrell wrote to Mr Bradley about the Guardian article. ¹¹⁸ In relation to the meeting with Professor Lacey and Dr Dealler, Dr Tyrrell said about Professor Lacey:

On the whole I regard this as an experiment to give an opportunity to a senior academic to return to a normal type of scientific interchange. It has failed, but we did express genuine goodwill and reasonableness and were unambiguously rebuffed. I don't think we should waste any more time or energy on the matter. I certainly don't wish to bother with any more letters. We may well have to expect more substandard behaviour in the future, and I suggest we just ignore it all.

5.98 In July 1993 Professor Lacey published 'BSE: The Gathering Crisis' in the British Food Journal. ¹¹⁹

Further correspondence with Dr Dealler after the Stoneleigh meeting

5.99 On 30 June 1993, shortly after the Stoneleigh meeting with Professor Lacey and Dr Dealler, Mr Bradley minuted Mr Eddy of the Animal Health (Disease Control) Division. He advised that Dr Tyrrell had read Dr Dealler's draft paper and had asked for it to be reviewed by SEAC at the next meeting in October. ¹²⁰ He reported that Dr Tyrrell considered the paper interesting even if parts were 'quite wrong'. He also commented that although Dr Dealler had agreed at the Stoneleigh meeting that the paper could be circulated to other members of SEAC, Dr Tyrrell wanted his agreement in writing and had asked Mr Bradley to deal with it. Dr Dealler told us that Mr Bradley sent him numerous requests for permission to distribute the document to SEAC and he sent repeated agreements that this should go ahead. ¹²¹

5.100 On 9 July 1993, Dr Dealler wrote to Dr Tyrrell following up the Stoneleigh meeting. He was concerned that 'a lot of pressure may be put on Dr Wilesmith and Mr Bradley to try to rubbish the data that I have given you'. ¹²² He also said that a number of scientists in the field were being told how to carry out experiments by 'poorly qualified MAFF personnel'.

5.101 Dr Tyrrell responded on 19 July 1993. ¹²³ He asked that Dr Dealler send written permission for the circulation of his paper to SEAC as soon as possible. He also asked for specific examples of Dr Dealler's criticisms which could be discussed at the next SEAC meeting.

5.102 On 23 July 1993, Mr Bradley wrote to Dr Dealler asking for written permission to distribute the paper. ¹²⁴ On 18 August 1993, Dr Dealler gave written permission for his article to be circulated to SEAC. He also requested that he be present at the meeting when SEAC discussed his paper. ¹²⁵ Mr Bradley sent a minute to Mr Howard on 1 September 1993 recommending that Dr Dealler should not attend the SEAC meeting. ¹²⁶ Mr Howard agreed and wrote accordingly to Mr Eddy. ¹²⁷ Dr Dealler's paper was given to SEAC shortly before the meeting on 7 October 1993.

5.103 In August 1993, Dr Dealler published a method for calculating the number of cattle slaughtered for food while incubating the disease. ¹²⁸ The underlying figures with which he worked had been obtained from Mr Wilesmith in 1992. ¹²⁹ He claimed that approximately seven cattle with BSE infection were eaten for every one that died with symptoms. Dr Dealler told the Inquiry that the method was repeated more accurately by Professor John Kent, Professor of Statistics at Leeds University, and himself in 1995 (see paragraph 5.156). ¹³⁰

SEAC discusses Dr Dealler's draft paper, October 1993

5.104 On 7 October 1993, SEAC discussed the draft paper which Dr Dealler had given to Dr Tyrrell at the Stoneleigh meeting. ¹³¹ Dr Dealler was not asked to attend the SEAC meeting, although he had requested he attend to answer any criticisms of his paper. SEAC considered that the paper needed clarification regarding the assumptions on which estimates of infectivity were made. In addition, the paper was thought to contain too many assumptions acting together, that Dr Dealler had attempted absolute answers on non-absolute data, and had not related his assumptions to scrapie. ¹³²

5.105 Dr Tyrrell wrote to Dr Dealler on 26 October 1993 and advised him that SEAC did not accept the validity of the paper. Dr Tyrrell explained that SEAC members did not accept the level of infectivity in the tissues and were unhappy with the methods used. They also did not accept the idea that infectivity was cumulative. Dr Tyrrell commented that if different experimental data had been used there would have been a 'different conclusion about the hypothetical potential exposure of the human population to this agent'. ¹³³

5.106 On 22 November 1993, Dr Dealler replied to Dr Tyrrell. ¹³⁴ He did not accept SEAC's points. The letter was circulated to members of SEAC on 3 December 1993. ¹³⁵ The Committee added no further comments. ¹³⁶

5.107 Dr Dealler's paper was published in the British Food Journal in November 1993. ¹³⁷ Professor Lacey had edited the article. ¹³⁸ On 30 October 1993, an article by James Erlichman about Dr Dealler's paper appeared in the Guardian entitled, 'Research claims 1 in 10 could be at risk from beef-eating'. The article stated:

Dr Stephen Dealler says in the British Food Journal that very low doses of the infectious BSE agent in meat, liver, and kidney can become cumulatively fatal because we eat so much beef and live so long.

Many BSE-infected cattle will have been eaten because they were incubating the disease before slaughter but had not yet shown symptoms.

Kevin Taylor, the Government's assistant chief veterinarian said: 'Dr Dealler has been perfectly fair in setting out his assumptions but we do not agree with his conclusions.'

Dr Dealler rejects the government argument that sheep have had their form of the disease for centuries without passing it on. He says: 'We eat more than twice as much beef as lamb, and BSE is 100 times more common in cattle'.

Mr Taylor said that meat from BSE-infected cows had been injected into the brains of mice, but tests completed last month showed no signs that mice had caught the disease. 'We therefore remain confident that beef is perfectly safe to eat,' he said.

. . .

[Dr Dealler] argues that, if man is susceptible to BSE, then at least 8 million adults are likely to have eaten enough to get Creutzfeldt-Jakob Disease (the human form) unless they die first from other causes. Mr Taylor said the assumption about cumulative consumption was highly speculative and not accepted. ¹³⁹

5.108 On 3 November 1993, Mr Soames gave a Written Answer to a Parliamentary Question from Mr Martin Redmond MP about Dr Dealler's paper. The reply stated that Dr Dealler's paper had been considered at the SEAC meeting on 7 October and as a result, Dr Tyrrell had written to Dr Dealler:

That letter drew attention to the fact that Dr Dealler had drawn his conclusions on the basis of assumptions made about the BSE infectivity of various tissues by extrapolation from the disease scrapie in sheep. Using these assumptions he had gone on to calculate the potential numbers of people who had been exposed to various levels of BSE agent. The letter from Dr Tyrrell informed Dr Dealler that recent experiments conducted with tissues from BSE infected cattle have shown that only the brain and spinal cord have a detectable level of infectivity and that the range of other tissues considered by Dr Dealler including meat, liver, kidney and lung do not have any detectable infectivity. The implication of using these actual results, rather than extrapolating from sheep disease, is that there is no evidence of any significant risk from the consumption of tissues other than brain and spinal cord from adult cattle. Brain and spinal cord are among the specified bovine offals whose use is banned under the BSE Order 1991 and which do not therefore enter the human or animal food chain. The SEAC has not advised Government to amend their safeguards as a result of its consideration of Dr Dealler's article. ¹⁴⁰

5.109 On 9 November 1993, Mr Eddy wrote to Lord Howe, Parliamentary Secretary at MAFF, in response to his request for advice following Mr Erlichman's article on Dr Dealler's paper. ¹⁴¹ The note said Dr Dealler's paper had been considered by SEAC before publication and that SEAC had not advised the Government to amend its safeguards as a result of the paper.

Further input from Professor Lacey, Autumn 1993

5.110 In autumn 1993, Professor Lacey became concerned about Government figures on the epidemic. He told us:

In the autumn of 1993 I became concerned that the Government was massaging the figures for BSE cases by back-dating deaths to earlier years. The Lancet on 25 September 1993 said that 51,875 cattle died from BSE between 1988 and 1991 but on 26 November 1992 a House of Commons answer to a question from Mr Hinchliffe said 48,526 died in that period. I alerted James Erlichman to the discrepancy who published a story about it in the Guardian on 2 October 1993. He quoted me correctly as saying that presumably some recent cases of BSE had been added to the previous years to falsify the epidemic. I said that we needed an independent inquiry into the true state of the epidemic. According to Mr Erlichman, the Ministry accepted that there was a significant discrepancy, but the figures reported in the Lancet related to the date at which farmers first reported symptoms, while the deaths in the Commons answer were logged by the dates when veterinary surgeons ordered animals to be slaughtered. ¹⁴²

5.111 On 25 October, Mr Bradley minuted Mr Eddy, Mr Dixon and Mr Taylor about Professor Lacey and his interest in the safety of gelatine, liver and kidney from cattle. ¹⁴³ Mr Bradley concluded by saying:

. . . it would be helpful to be prepared for his next bombshell if it materialises. Knowing the enemy is the first step in developing a sound defence.

Dr Dealler establishes the Spongiform Encephalopathy Research Council

5.112 Dr Dealler told the Inquiry of his concerns that there was insufficient research on BSE. Further, he was concerned that 'many ideas were just accepted as being valid and not tested (eg, tallow not being infective) even when there was little evidence to believe them'. ¹⁴⁴ In 1993, as a result of these concerns and 'after the failure to publish information showing that humans may have been exposed to sufficient infectivity to transmit the disease from cattle', he decided to set up the Spongiform Encephalopathy Research Council (SERC), a registered charity. ¹⁴⁵ The Trust Board was to include Dr Ann Maddocks, a retired medical microbiologist, as Chair and Professor Roy Postlethwaite, a retired virology professor, and Dr Martin Schweiger, a consultant physician in public health. ¹⁴⁶

5.113 On 21 January 1994, Dr Dealler wrote to Mr Michael Jack, MAFF Minister of State, about his intentions to establish SERC and to seek help. He said:

Research into the effect of BSE on the human population has been depressingly lacking. Now that it has become clear that the human risk from BSE may well have been unacceptably high for the past 7 or 8 years (see enclosed information sheet) this must change . . .

Could we ask you for some help? This would mainly be in bringing to view the realisation that BSE is becoming a medical rather than an agricultural issue and that research carried out so far gives little indication of the risks that are being taken by the human population of the country. ¹⁴⁷

5.114 Dr Dealler told us that soon after the establishment of SERC, MAFF was coming under increasing pressure to expand its BSE research programme:

By the time that the SERC was registered as a charity, information was reaching the press in such a way as to put pressure on MAFF to increase BSE research. As a result SERC has not been a useful organisation except as an indicator to official figures that inadequate research is being carried out by official bodies. ¹⁴⁸

Dr Dealler investigates the death of a suspect BSE case

5.115 During mid to late November 1993, Dr Dealler became involved in the diagnosis of a suspected case of BSE in a cow that was the offspring of a confirmed BSE dam. On 22 November 1993, Mr K Taylor minuted Mr Soames about this case, warning him that Dr Dealler might be using the case to seek evidence with which to embarrass the Government:

[Dr Dealler] recently asked staff at the Central Veterinary Laboratory to carry out histopathological examination of brain tissue which he had obtained from a cow which had been reported by the owner as a suspect case, but which was not considered by the veterinary officers who carried out the diagnostic visits to be affected with BSE. They acted in close cooperation with the owner's veterinary surgeon, and the decision to remove restrictions from the suspect was based on clinical observation over 4 days, an alternative diagnosis supported by biochemical evidence, the cow's response to treatment, and the conclusion that the cause of the clinical signs was not BSE.

The owner, who farms in the York area, was not pleased by the decision . . . he refused an offer to have the cow destroyed voluntarily whilst under BSE restrictions (in which case some ex-gratia payment would have been made, the carcass would have been incinerated and the brain examined by MAFF) and instead arranged for the animal to be destroyed by his own veterinary surgeon, after restrictions had been removed, and the head made available to Dr Dealler. ¹⁴⁹

5.116 In the event, BSE was confirmed in the suspect cow following diagnosis by a local veterinary laboratory in the York area, and by Dr Tony Palmer, a retired neurologist/neuropathologist at the University of Cambridge Veterinary School, and later by Mr Wells of CVL. On 10 December 1993, Mr Eddy updated Mr Soames about these developments, attaching defensive briefing for MAFF Press Office. In his covering minute Mr Eddy said:

. . . This [diagnosis] is unfortunate but we are satisfied that all the veterinary staff acted correctly, and that their judgement was justified by the alternative diagnosis which was supported by laboratory evidence, and the response of the suspect animal to treatment.

. . .

Dr Dealler will no doubt claim that the downturn in BSE cases reflects systematic attempts by the Department to hide the scale of the BSE epidemic by refusing to slaughter every BSE suspect which is notified. This is of course not true. In any case the headline figures which show the 12% decline in BSE are the figures for suspects put under restriction and this cow would have been included in that figure . . . ¹⁵⁰

5.117 On 16 December 1993, Dr Matthews minuted Mr K Taylor to report, amongst other things, that Mr Wells had been given, in confidence, a draft letter from Professor Lacey and Dr Dealler to the Veterinary Record about this BSE case. The draft letter suggested that the case indicated the occurrence of vertical transmission of BSE. ¹⁵¹ Dr Matthews commented: '. . . the letter is so full of errors that I feel it would be best to do nothing until published, and then to respond fully in the Veterinary Record.'

5.118 On 17 December 1993, Mr Wilesmith sent Dr Matthews his comments on the draft letter and included a draft reply calling into question the validity of Professor Lacey's and Dr Dealler's conclusions. ¹⁵²

5.119 On 1 February 1994, Mr Robertson of the Animal Health and Veterinary Group minuted Mr Meldrum, enclosing a copy of the letter to the Veterinary Record on this BSE case from Dr Dealler and Professor Lacey. The letter had been sent to MAFF by the editor on a confidential basis. Mr Robertson noted that the letter was due to be published on 5 February and a response was being 'prepared with a view to publication in the issue of 12 February'. ¹⁵³

5.120 Dr Dealler's and Professor Lacey's letter, 'Suspected Vertical Transmission of BSE', was published in the Veterinary Record on 5 February 1994. ¹⁵⁴ The letter reported that BSE had been confirmed in a female Friesian-Holstein calf born on 4 July, 1989, nearly a year after the ruminant feed ban and that its dam had been one of the eight confirmed BSE cases on the farm in question. Professor Lacey and Dr Dealler described the initial confusion surrounding diagnosis, and went on to suggest that it was possible:

. . . that young and vertically transmitted BSE cases show less prominent signs of disease in the standard histology; perhaps this is accentuated because farmers are becoming more experienced at recognising the early disease. We believe that BSE is much commoner than formally reported among animals under five years of age, and that the endemic is being maintained, at least in part, by vertical transmission. ¹⁵⁵

5.121 Dr Dealler told us that he was telephoned at home by the local MAFF veterinary officer after the publication of the letter in the Veterinary Record and that MAFF demanded the brain of the animal. Dr Dealler considered that this may have been to make sure that he did not carry out further research. ¹⁵⁶

5.122 On 19 February, the Veterinary Record published a response from Mr Wilesmith, Mr Wells, Miss Linda Hoinville and Mr Simmons. This set out to present the scientific perspective of the work that was being carried out on maternal transmission and the laboratory diagnosis of BSE. ¹⁵⁷ On the possibility of maternal transmission, Mr Wilesmith and his co-authors commented that for various reasons:

. . . it has not been possible to assess the risks for individual cases of acquiring infection from sources other than feed. We therefore cannot support the suggestion made by the authors that the case described inevitably was the result of vertical transmission, although that explanation is certainly one possibility.

An analytical epidemiological approach is required to estimate the risks of infection in this subset of animals from the three potential sources: feedstuffs, their dams and as a result of horizontal infection. To this end a case-control study of animals born after October 30, 1988, has been initiated at the earliest opportunity. ¹⁵⁸

5.123 On the laboratory diagnosis of BSE, Mr Wilesmith and his co-authors described the research in progress and commented:

. . . there is no correlation between short clinical duration and mild or equivocal histological changes since there is wide variation in the severity of lesions irrespective of recorded durations of signs. There is therefore no evidence for the claim made by the authors that young, or any other subpopulations of BSE cases, have, preferentially, less prominent lesions. Indeed, the case reported was diagnosed using the routine method and the findings included severe spongiform