DFA 16 ������ ����
�MID 1995 TO THE FINAL DAYS
Draft Factual Accounts ������������������������������������������������������� 7 July 1999
This is one of a series of documents intended to provide an account as at the date of publication of the factual evidence received by the Inquiry. The documents do not make any judgements about the implications of the facts or point to any conclusions. They are simply working drafts seeking in a neutral way to set out relevant evidence. They do not contain any expressions of opinions by the Secretariat or the Committee of the Inquiry. The series will only cover certain areas of the evidence.
The DFAs may contain inaccuracies and omissions. The purpose of publishing them is to invite corrections, additions and comments. The Inquiry has received suggestions for such corrections and additions in relation to DFAs already published. This is helpful in furthering the work of the Inquiry; all suggestions are considered and used to update the Secretariat�s working papers which will form the basis of the Committee�s Report in due course. The DFAs should not be treated as setting out a complete and accurate appreciation of the relevant facts.
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Responses should reach the Secretariat by 7 August 1999 for them to be of most assistance to the Inquiry.
DFA 16: MID 1995 TO THE FINAL DAYS
MID 1995 TO THE FINAL DAYS.................................................. 3
Before July 1995.................................................................................................................... 3
1992.......................................................................................................................................... 3
Farmer 1.................................................................................................................................... 3
1993.......................................................................................................................................... 4
Farmer 2.................................................................................................................................... 4
1994.......................................................................................................................................... 5
Farmer 3.................................................................................................................................... 6
1995.......................................................................................................................................... 6
Teenager 1................................................................................................................................. 6
July 1995................................................................................................................................. 7
August 1995.......................................................................................................................... 10
Teenager 2.............................................................................................................................. 12
September 1995................................................................................................................... 15
SEAC Meeting 20.................................................................................................................. 15
Farmer 4.................................................................................................................................. 16
October 1995........................................................................................................................ 18
SEAC Meeting 21.................................................................................................................. 19
SBO entering the food chain................................................................................................. 27
Teenager 3.............................................................................................................................. 30
November 1995.................................................................................................................... 33
SEAC Meeting 22.................................................................................................................. 45
Ban on the use of vertebrae................................................................................................... 49
December 1995.................................................................................................................... 50
Contingency Planning............................................................................................................ 67
January 1996........................................................................................................................ 68
SEAC Meeting 23.................................................................................................................. 69
February 1996...................................................................................................................... 83
SEAC Meeting 24.................................................................................................................. 83
Early March 1996................................................................................................................ 93
Friday 8 March 1996.......................................................................................................... 94
SEAC Meeting 25.................................................................................................................. 94
Monday 11 March 1996...................................................................................................... 98
DH........................................................................................................................................... 98
SEAC Meeting 26.................................................................................................................. 99
Tuesday 12 March 1996................................................................................................... 100
MAFF.................................................................................................................................... 100
DH/ Contingency Planning................................................................................................. 101
Wednesday 13 March 1996................................................................................................ 107
Thursday 14 March 1996................................................................................................. 112
Friday 15 March 1996...................................................................................................... 113
Saturday 16 March 1996.................................................................................................. 114
SEAC Meeting 27................................................................................................................ 114
DH and MAFF...................................................................................................................... 117
Sunday 17 March 1996..................................................................................................... 118
Monday 18 March 1996................................................................................................... 120
Minute 1 (from Mr Hogg and Mr Dorrell)........................................................................ 120
Minute 2 (from Mr Hogg).................................................................................................. 120
Minute 1 is sent................................................................................................................... 125
DH......................................................................................................................................... 127
Minute 2 is sent................................................................................................................... 128
Cabinet.................................................................................................................................. 129
Tuesday 19 March 1996................................................................................................... 129
SEAC Meeting 28................................................................................................................ 131
Wednesday 20 March 1996.............................................................................................. 135
Mid 1995 to the final days
This draft factual account is a narrative of the period from mid 1995, when the first cases of what was later identified as new variant CJD came to light, to the Government�s announcement of 20 March 1996 about possible links between this disease and BSE.
Before July 1995
1 Some events before July 1995 are mentioned below.
2 In the months before the announcement on 20 March 1996, there emerged several cases of CJD in farmers and in young people, which caused concern. Although the clustering of farmers� cases was the subject of some speculation, these did not turn out to be cases of what is now known as new variant CJD.
1992
Farmer 1
3 On 4 August 1992, Dr Ailsa Wight (DH, Health Aspects of the Environment and Food (HEF) Division) minuted her colleagues Dr Roger Skinner and Ms L Lockyer. She said that the CJD Surveillance Unit had informed her that a dairy farmer was suffering from probable CJD. The farmer had experienced a case of BSE in his herd. Dr Wight said she had discussed the case with Mr Thomas Murray (DH, SEAC Secretariat). Dr Wight noted that Dr (later Professor) Robert Will (Director, CJD Surveillance Unit, and member, later Deputy Chair of SEAC) felt that the existence of BSE on the farm and the farmer�s suffering from CJD was �probably a coincidence�.[1]
4 On 13 August 1992, Dr Wight minuted the private secretary to Dr (later Professor Sir) Kenneth Calman (CMO) to inform him about the farmer.[2]
5 On 22 October 1992 Mr Murray minuted Mrs Virginia Bottomley, Secretary of State for Health, advising that on 15 October SEAC had discussed the case of CJD in a dairy farmer to the effect that the farmer had since died and that a diagnosis of typical CJD had been confirmed by pathology. SEAC had come to the conclusion that it seemed to be a typical sporadic case of CJD.[3] The minute was copied to DH officials and Mr Lowson, Head of Animal Health Division, MAFF.
1993
6 The case of the farmer was published in the Lancet in March 1993.[4]
7 On 11 March 1993, in response to media interest in the case, Dr Calman issued a statement reassuring the public about the safety of beef.[5]
Farmer 2
8 In July 1993, Dr Will informed DH of a second case of CJD in a dairy farmer.[6] On 12 July, Dr Wight minuted Dr Calman and Baroness Cumberlege (DH Parliamentary Under-Secretary (House of Lords) with responsibility for BSE/ CJD) to inform them about this case.[7]
9 In a minute on 19 July 1993, Mr Kevin Taylor (Assistant CVO, MAFF) briefed the private secretaries to the MAFF Ministers with the details of the second case of CJD in a farmer. The minute was copied to numerous MAFF officials, Mr Charles Lister (DH, HEF Division, had replaced Mr Murray as SEAC Secretariat) and Dr Wight.[8]
10 On 19 July 1993, Professor Peter Smith (epidemiologist, London School of Hygiene and Tropical Medicine, and later a SEAC member) sent a fax to Dr Will.[9] He had done some �rough calculations� on the statistical significance of the two farmers� cases. He said:
�I would agree with your conclusion that the observation of 2 cases in workers on dairy farms with BSE-affected herds is disquieting, but the evidence is insufficient at this stage to draw any definite conclusion or to recommend any specific public health action. The appropriate action, in my view, would be to continue the surveillance. Certainly, if 2 more cases arise in the first five years of the surveillance scheme the possibility of an association which is not due to chance must be given very serious consideration�.[10]
11 This fax was among the papers considered at the SEAC meeting which was called at short notice, for 20 July 1993, to consider the two cases.[11]
12 At this 20 July meeting, SEAC decided that �no conclusions could be drawn from the available statistical information�.[12]
13 On the same day, Dr Jeremy Metters (Deputy CMO) minuted Dr Wight and Mr Lister about newspaper reports on the second farmer. He expressed concern about �how MAFF and DH would respond to public concern generated if there are further CJD cases among farmers�. He said:
�4.�� Unwelcome, though it may be to [SEAC], I think they must be asked at their next meeting to give further thought to what they might advise the Department and MAFF if another farmer (or two) develops CJD. Or, if a butcher or abattoir worker develops the disease.
�5.�� Although the Committee were given plenty of advance warning about the second farmer, they may not be so fortunate next time round. Some contingency planning on the Committee�s response to a further case of CJD in a farmer seems essential. At the same time the Committee should consider if there are special risks to farmers, for example their historical habit of chewing cattle nuts, that might be implicated.�[13]
14 At the SEAC meeting on 7 October 1993, members �agreed that if a third case of CJD in a farmer with BSE in their herd occurred, an immediate full Committee meeting would be required�.[14]
1994
15 In January 1994 there were media reports of a possible case of CJD in a teenager.[15] This was 16-year-old Victoria Rimmer. Ms Rimmer died on 21 November 1997.[16] Diagnosis had not been confirmed at the time that Mrs Beryl Rimmer, her grandmother, gave evidence to the BSE Inquiry in October 1998.[17]
16 On 8 September 1994 Dr Calman met Mr William Waldegrave, the MAFF Minister, to discuss BSE/ CJD. Among other items, Dr Calman �referred to the need to strengthen the clinical membership of SEAC�.[18] Mr Waldegrave endorsed �the need for a strong, effective committee�.[19] Dr Calman also noted that Dr David Tyrrell, the SEAC chair, �was in poor health and� his lack of vigour had affected his performance at times�. Dr Calman therefore wanted to find a replacement �fairly quickly�. Professor Pattison was a possibility. Mr Waldegrave suggested that DH also seek the views of the Royal Society.[20]
17 Professor (later Sir) John Pattison, Professor of Medical Microbiology and Dean of the University College of London Medical School, was prepared to join SEAC. After this meeting Mr Lister drafted a submission for Ministers, recommending Professor Pattison�s appointment.[21]
Farmer 3
18 In December 1994 the CJD Surveillance Unit informed DH of a possible third case of CJD in a farm worker. In a minute on 19 December 1994, Mr Lister informed the private secretary to Baroness Cumberlege about this third case. He copied the minute to Dr Calman�s private secretary, Mr Heppell, Dr Metters, Mr Bridges, Dr Jones, Dr Skinner, Dr Wight, Mr Cunningham, Mrs Sian Gordon-Brown (HEF, DH), Ms Kinghorn and Mr Tom Eddy (MAFF, Head of Animal Health (Disease Control) Division, and MAFF�s SEAC secretariat).[22] Mr Lister�s minute noted that there �has been local media interest in the case (before the man died) but nothing nationally, and there have been no enquiries to DH or MAFF press offices.�[23] Mr Lister suggested the following line to take in case of enquiries:
�We are aware of the case of a farm worker who died recently from suspected CJD. The case is being investigated by the CJD Surveillance Unit in Edinburgh, and the Department is being kept informed of developments. The Surveillance Unit�s third annual report (October 1994) concluded that there is no evidence of a link between occupational exposure to animals and animal products and risk of CJD.�[24]
19 Dr Calman said this minute was when he first learned of the third farmer case.[25]
20 Also on 19 December 1994, Mr Eddy minuted the MAFF Ministers� private secretaries to inform them about the possible third case of CJD in a farm worker. He attached an �interim press statement� which DH had produced �for use if the story breaks�.[26]
1995
Teenager 1
21 In May 1995 the CJD Surveillance Unit received material from a patient who was later diagnosed with nvCJD. The material was from a brain biopsy performed on a teenager.[27]
22 On 21 May 1995 19-year-old Stephen Churchill died of what was later diagnosed as nvCJD.[28]
23 On 24 May 1995, the Today newspaper reported Stephen Churchill�s death under the headline �Human mad cow disease tests on dead teenager�. His identity was not revealed.[29]
24 In a minute dated 24 May 1995, Mr John Howard (MAFF Animal Health Division, Head of Branch dealing with BSE policy) sent a minute to Mr Keith Meldrum (CVO), Mr Martin Haddon (Under Secretary responsible for the Animal Health Group), Mr Geoffrey Hollis (Head, MAFF Livestock Group), Mr K Taylor, Dr Cawthorne, Mr Raymond Bradley (Pathology Department, CVL) and Mr Webb (Press Branch). He copied it to Mrs Gurnhill and Mr Lister (DH). He said:
�1.�� Further to my earlier minute I have now had confirmation from DH of their line to take regarding the alleged case of CJD reported in today�s edition of Today is as follows [sic]:
��The report in the 24th May edition of Today is purely speculative and we are not prepared to comment further on individual cases.�
�2.�� Apparently the CMO has expressed views about not being pressed into commenting on individual cases reported in the press in order to protect patient confidentiality. As on previous occasions I suggest that any queries are referred to DH Press Branch.�[30]
25 The next mention of this teen-aged case in MAFF or DH files is at 1 August 1995; see below.
July 1995
26 On 5 July 1995, Mr Stephen Dorrell succeeded Mrs Bottomley as DH Secretary of State.[31] On 6 July 1995 Mr Douglas Hogg succeeded Mr Waldegrave as MAFF Minister.[32]
27 On 14 July 1995, Mrs Dorothy and Mr David Churchill (Stephen Churchill�s parents) wrote a letter to Mr Michael Ancram, their Member of Parliament. The letter was copied to MAFF, DH, and their Member of the European Parliament. The letter indicated that they believed their son had become infected with CJD via the food chain. It said, �As this cause of death is avoidable we feel it imperative to prevent others being stricken by this dreadful disease.� They �demanded� that Mr Ancram pursue the matter on their behalf, and obtain answers to a set of questions on the incidences of CJD, BSE and scrapie, action taken to prevent infected meat getting in to the food chain, and research being carried out.[33] Mr Ancram forwarded this letter to Mrs Angela Browning (MAFF Parliamentary Under-Secretary) on 19 July (see below).[34]
28 On 18 July 1995 the European Commission introduced new measures on beef exports. The provision permitting export of meat from animals slaughtered in the UK that were born after 1 January 1992[35] was replaced with a requirement for the animals to be aged less than 2� years at slaughter. This was in response to the news that some cattle born in 1992 had developed BSE.[36] Requirements for routine monitoring in feed mills were also introduced.[37]
29 On 18 July 1995 Mr Hogg held a meeting with Mrs Browning, Mr Richard Packer (MAFF Permanent Secretary), Mr Eddy, Mr Richard Carden (Head of MAFF�s Food Safety Directorate), Mr Meldrum, Mr Haddon, Mr Taylor, Mr Jonathan Haslam (MAFF Director of Information), Mr Fleetwood, Miss Wordley and Miss A Evans.[38] Among other things, they discussed the results of a survey on compliance with SBO controls. Of the 392 slaughterhouses and 43 head‑boning plants that were visited, failures to comply fully with the rules on SBO staining were found in 65% of plants, and failures to comply fully with the rules regarding the separation of SBOs from other materials to be sent for rendering were found in 14% of the plants.[39] Mr Meldrum reiterated that there was no public health problem, there was not [sic] question of SBOs entering the human food-chain, the risk was of cross-contamination of animal feed�.[40] Mr Carden told the BSE Inquiry that the results �clearly reinforced the case for tighter rules and tighter enforcement.�[41]
30 A MAFF news release the next day (19 July 1995) announced the following:
�A strengthening of the rules for preventing tissue potentially infected with the BSE agent from entering the cattle feed chain� The Ministry has also indicated that there is room for improvement in the application of the current rules in some slaughterhouses and further action is under way to deal with this.
�Mr Hogg emphasised that there were no implications for the human feed chain in these findings and that measures to protect human health were found to be working effectively in all cases��[42]
In answer to a written Parliamentary Question (PQ) from Edward Garnier MP (Harborough), Mr Hogg described the new SBO order that would be made. This was written in the Press Release. The Order is described at 15 August 1995 below.[43]
31 The announcement was �welcomed� by the Meat and Livestock Commission (MLC) in a �position statement.� The position statement stated that a �dramatic fall� in the incidence of BSE (BSE had reportedly fallen by 70% from a 1992 peak to less than 3000 cases per week) indicated the �success of measures so far to control the disease�. However, the presence of BABs meant that �the integrity of the [feed] ban is not 100 per cent and we must now tighten up controls to ensure they are totally effective�.[44]
32 The position statement finished with the statement that:
�There are no implications for human health because:
�1.�� visibly infected cattle are totally destroyed,
�2.�� all specified offals from all cattle are removed and destroyed before the meat enters the human food chain and
�3.�� despite research there is no evidence whatever that BSE, or its human equivalent CJD, can be caught by man through eating beef�.[45]
33 Also on 19 July, Mr Ancram forwarded the 14 July letter from Mr and Mrs Churchill to Mrs Browning. He said:
�As you will see, they raise a number of different points relating to this infection and feel that Stephen�s death could have been avoided had certain actions been taken by the relevant authorities in recent years. In view of the very sad circumstances of this case I would be most grateful if all the questions which they ask could be answered in full�.[46]
34 Also on 19 July 1995 there was a meeting of the MRC�s Allen Committee on the Epidemiology of CJD. The meeting was chaired by Professor Ingrid Allen, and attended by Dr Jeanne Bell, Mr Bradley, Professor Jeremy Brockes (Ludwig Institute for Cancer Research), Dr Jack Cuzick, Dr Sheila Gore (MRC Biostatistics Unit, Institute of Public Health, Cambridge), Dr Skinner, Mr John Wilesmith (epidemiologist, CVL), and Mrs Meg Wilson (BBSRC). Apologies were received from two new members of the Committee and from Dr MacOwan (Veterinary Science Liaison Officer (VSLO), MAFF), Dr Wight and Dr Will.[47]
35 Mr Wilesmith updated the Allen Committee on BSE epidemiology, and Mr Bradley reported that �the law regarding feed production would be changed shortly as there was also some evidence that the feed ban since September 1990 was not totally effective.�[48]
36 Dr Bell reported on CJD surveillance in Dr Will�s absence. She informed the Allen Committee of the fourth report of the CJD Surveillance Unit, which was still being drafted and was intended to be published in August (see below). The data was discussed in detail, including patients� genotypes and the epidemiological questionnaire.[49] It was noted that �if a further questionnaire were to be developed to investigate potential occupational exposure to BSE, this would require staff with a knowledge of farming practices�.[50]
August 1995
37 On 1 August 1995 Dr Wight sent a minute to the private secretaries to Dr Calman and Baroness Cumberlege about the first case of CJD in a teenager (a 19-year-old male) in the UK. The minute was copied to Dr Metters, Dr Eileen Rubery (Head of the HEF Division), Dr Skinner, Mrs Gordon-Brown, Mr Lister, Mr Gerald Robb (HEF1C), Dr Callaghan, Ms French, Miss Thompson and Mr Eddy (MAFF)[51]. The minute said �This case received some very limited press attention in May 1995� At that time the diagnosis had not been confirmed, but this has now been confirmed by histopathological examination�.[52]
38 The same minute discussed a �World in Action� programme to be screened on 14 August 1995 on CJD in teenagers and dairy farm workers.[53]
39 Dr Calman told the BSE Inquiry about his concern in relation to the death of the aforementioned 19-year-old:
�I recall being concerned primarily because of the age of the victim. Whilst sporadic CJD is very unusual it is not unheard of in teenagers. To date the cause of sporadic CJD was unknown. The CJD Surveillance Unit was set up in 1990 following the BSE epidemic in cattle so that any change in the pattern of human spongiform encephalopathy, CJD, that might be attributable to BSE, could be detected. At that point no link had been established between the consumption of beef products, or milk, and the development of CJD�.[54]
40 Also on 1 August 1995, Mr Eddy informed MAFF Ministers of the case of CJD in the 19-year-old, and of the proposed �World in Action� programme.[55] His minute went to the private secretaries of Mr Hogg, Mrs Browning, and Mr Packer, and to Mr Carden, Mr Haddon, Mr Meldrum, Mr Crawford, Mr Taylor, Mr Haslam (Information), Mr Bradley, Mr Gerald Wells (neuropathologist, CVL), Mr Wilesmith, Mr Rossington, Mr Paul Hayward (MAFF press officer with responsibility for BSE), Mr Fleetwood, Miss Mary Coales (MAFF Animal Health (Disease Control)), Mr Matheson (SOAFD), Mr Podmore (WOAD), Mr Pat Toal (DANI) and Mr Lister (DH).
41 On 3 August 1995 Mr Eddy wrote to Mr Lister about the results of a second round of unannounced visits to slaughterhouses and head-boning plants.[56]According to Mr Eddy, the second round of visits �revealed three instances where SBO was not being separated adequately from material for human consumption�.[57] Mr Eddy wrote
��We can no longer be as robust as we were in the press notice about no infective material entering the human food chain, but the problems are not such as to warrant a special announcement or any special new measures other than the immediate action that was taken at the plants concerned� I am inclined to await the results from the third round of unannounced visits, which should be out in the Autumn, before advising on any further announcements. I do not see it as necessary to issue press statements at every stage in what is a three stage process. I would welcome DH�s views.�[58]
42 On 4 August 1995 Mr Lister copied Mr Eddy�s letter to Dr Wight, stating that Dr Calman and the DH Ministers needed to be briefed on the findings. He said
��SEAC will clearly need to discuss the implications at the next meeting, but it comes down, as always, to the need for adequate policing of slaughterhouse practices. Once all the visits are completed � there is a third series to come in the Autumn � we will need to consider how the results affect our assurance to the public that, following the SBO ban, no potentially infective material can enter the human food chain...�[59]
43 Dr Calman became aware of these findings of non-compliance with the SBO ban either at the time of Mr Lister�s minute to Dr Wight or shortly after.[60]
Teenager 2
44 In August 1995 a second teenager was referred to the Surveillance Unit after a brain biopsy confirmed the diagnosis of CJD.[61] This was 17-year-old Gulcan Hassan.[62]
45 On 9 August 1995 Dr Wight informed Dr Calman�s private secretary of the possible second case of CJD in a young person (the 17-year-old).[63] The minute was copied to Drs Metters, Rubery, and Skinner, and Mr Lister.
46 In a 9 August 1995 minute to Dr Calman and Baroness Cumberlege, Mr Lister noted that �World in Action� were aware of the third case of CJD in a dairy farm worker. The minute said:.
��Apart from an article in �The Cornishman� in December 1994, this case has so far received no publicity within the UK. The WHO, the EC Scientific Veterinary Committee and the German Government were informed of the case earlier in the year��[64]
47 On 11 August 1995 Mrs Browning sent Mr Ancram a detailed reply, on behalf of MAFF and DH, to the letter of 14 July from Mr and Mrs Churchill.[65]Among other things, she said:
�SEAC is satisfied that no causal link between BSE in cattle and CJD in humans has been shown. The UK�s CJD Surveillance Unit has reported that there is no evidence of any change in the epidemiological characteristics of CJD following the advent of BSE and CJD is no more prevalent in the UK than in other parts of the EU. Nevertheless, the ultra precautionary measures described above have been put in place on the assumption that BSE could theoretically infect humans.�[66]
48 Mrs Browning enclosed a copy of the �most recent� (September 1994) CJD Surveillance Unit annual report, which, she said, �concluded that there was no conclusive evidence of any change in CJD that can be attributable to BSE�.[67]
49 Mr Ancram followed up with a letter to Mr Gerald Malone (DH Minister of State (Commons)) on 8 September 1995 (see below).
50 On 11 August Dr Wight minuted her colleagues in the DH Information Division (ID) about an embargoed press release from the Alzheimer�s Disease Society, announcing the launch of their CJD Support Network and information booklet. She wrote that she thought that the Society was a �responsible group� and that �without seeing the booklet, I think a �cautious welcome� to the initiative is in order�.[68]
51 Also on 11 August 1995 Miss Coales minuted Mr Haslam with a briefing to use in response to the �World in Action� programme on 14 August. She copied it to MAFF Ministers, Mr Packer and others in MAFF, CVL, Scottish, Welsh and Northern Irish Offices and Mr Lister at DH.[69]
52 On 14 August 1995, the front page of Today newspaper reported that Mr and Mrs Churchill were calling for a public inquiry into their son Stephen�s death on 21 May. They wanted to know if his death from CJD was linked to BSE.[70]
53 In relation to the Today article, Mr Eddy minuted Mr Smith (INF) and Ms Saunders (Press Office). He copied the minute to Mr K Taylor, Mr Lister, Miss Coales and Mr Wilesmith. He said that the article had mentioned that Stephen Churchill� had had several holidays in the past on a dairy farm�. The farm had been disbanded in 1986 and because ear tags had not been retained, MAFF were �unable to confirm whether or not any of the cattle sold in the dispersal sale subsequently went on to develop BSE�.[71]
54 Stephen Churchill�s case was a focus of the �World in Action� programme on television that night.[72]
55 Also on 14 August 1995, the Alzheimer�s Disease Society launched its CJD Support Network.[73]
56 On 15 August the SBO Order 1995[74] took effect. It tightened controls on record-keeping, introduced dedicated lines for rendering plants processing SBO, prohibited the removal of brains and eyes so that the whole skull must be disposed of as SBO, and prohibited the removal of spinal cord from the vertebral column apart from in slaughterhouses.[75]
57 On 16 August 1995 Mr Mark Clark (DH Press Office) informed Dr Wight that the front page of that day�s Sunderland Echo detailed a �doomed mothers anguish� [sic]. This was about a 38-year-old whom an �expert� from Edinburgh had confirmed was �98% sure� to have CJD. Mr Clark asked if Dr Wight was content that Press Office use the �lines we have taken to date?�[76]
58 On 18 August 1995 Miss Coales minuted Messrs Carden, Meldrum, Haddon and Mrs Gurnhill, and copied the minute to Mr Eddy and Mrs Townsend. She said that the �World in Action� programme had been �based, as expected, around the 19 year old CJD case. It was fairly balanced in approach, although much was made of the transmissibility of BSE to cats, and there was no mention of the various ways that CJD can be transmitted�. She noted that there had been no immediate upsurge in public interest � �indeed, the [MAFF] Press Office has had no enquiries at all, much to their surprise�.[77]
59 In a minute dated 18 August 1995 Dr Wight informed Dr Metters that a brain biopsy had confirmed the diagnosis in the second teenager, and that the two teen-aged cases would be discussed at the next SEAC meeting on 8 September.[78] She said she had informed Mr Kevin Taylor (MAFF) by telephone, who was to inform Mr Meldrum �next week�.[79] The minute was copied to Dr Calman�s private secretary, Dr Rubery, Mrs Gordon-Brown and Mr Lister.
60 On 22 August 1995, Mrs Gordon-Brown minuted Dr Calman�s private secretary to say that the second teenage case was confirmed.[80] She copied the minute to Drs Metters, Rubery, Skinner, Wight, and Callaghan, Messrs Lister, Robb and Wilson (ID), and Baroness Cumberlege�s private secretary. She sent a separate minute to Dr Wight, copied to Messrs Lister and Robb, detailing the clinical history of the teenager.[81]
61 Dr Calman told the BSE Inquiry that �given the unremarkable histories of both victims these cases were treated as sporadic incidences of CJD. Both were referred to the CJD Surveillance Unit for consideration�.[82] He said
�What we had was one case, then two cases. At that stage it is quite important to remember that the CJD Unit and particularly Dr [James] Ironside had not come to any conclusions about a differing pathology, it was the same pathology. That I think said well, maybe it is just young people with classic CJD. It was later on, about December, January, February, that there was a shift in the thinking about the pathology, not in the August, September time.�[83]
62 On 25 August 1995 Mr Meldrum wrote to Dr Metters (DH) regarding Mr Eddy�s letter to Mr Lister about the breaches that had been found of SBO regulations (see 3 August above). Mr Meldrum wrote:
�In my view this letter paints a more alarmist picture than is justified by the circumstances: although many faults were found, particularly related to the staining of SBO, there was no risk to public health in any of the three cases identified because each was spotted and corrected. It is of course, true that there may be other undetected cases where SBO is not properly removed and destroyed, but this has always been the case and is still the case now. The argument for strict enforcement is clear: the Meat Hygiene Service is aware of it, and the new SBO legislation has just been introduced, although primarily directed to protecting the health of cattle, should simplify their task in some respect. The Meat Hygiene Service has issued specific and detailed instructions to its staff on the checks that must be carried out to ensure compliance with our legislation.�[84]
63 In August 1995 the Fourth Annual Report of the CJD Surveillance Unit expressed concern over an apparently high incidence of CJD in farmers, particularly in three dairy farmers who had had BSE in their herds.[85] The report was released to the public on 5 October 1995.[86]
September 1995
64 On 8 September 1995 Mr Ancram wrote to Mr Malone to ask further questions in follow-up to the letter that Mrs Browning had sent on 11 August for Mr and Mrs Churchill.[87] He raised three issues. First he asked Mr Malone to check the CJD reporting system �to see if there should be clearer criteria for reporting deaths from CJD to ensure that there is a greater awareness of the symptoms of the disease and also more confidence in the figures of the incidence of the disease�. Secondly, he asked why there was not going to be a public inquiry into the death of Stephen Churchill. Thirdly, he asked whether SEAC co-ordinated SE research. His letter was replied to on 20 October 1995 (see below).
SEAC Meeting 20
65 At its meeting on 8 September 1995, SEAC discussed the information on enforcement of the SBO ban.[88]
66 SEAC also discussed the teenage cases, and decided that they could not draw any conclusions on these. They said:
�...the presentation of CJD in adolescents is exceptional but not without precedent. CJD has occurred in adolescents in other countries which are free from BSE and it would therefore be premature to conclude that its occurrence in a teenager in the UK was indicative of transmission of BSE. The Committee agreed that these cases should be studied in great detail and it should consider whether they had any implications for the cure or management of the disease�.[89]
SEAC released a statement to this effect at the end of October (see below).[90]
67 On 22 September 1995 Mr Eddy (who had attended the SEAC meeting) informed Mr Hogg about CJD in the second teenager, the 17-year-old girl.[91]
68 Mr (later Sir) Graham Hart (DH Permanent Secretary) told the BSE Inquiry that in September 1995 he
�became aware that, as well as more cases of CJD in farmers, there was one and possibly two cases of CJD in young people. I accepted the expert advice that such cases were not unprecedented, but I recall discussing the matter with the CMO. We agreed that it was vital that the CJD Surveillance Unit was monitoring the situation very carefully�.[92]
69 He further commented:
�we did not know and I suppose we still do not know for sure how accurate ascertainment had been in the past. There is always a danger, the possibility, when you are starting up a new particular kind of hunt as it were for a particular syndrome, condition or whatever, you will find cases that in the past would have been undetected�.[93]
70 He also said:
�I made a judgment that the world had not, you know, as it were changed catastrophically at that point. One obviously had at the back of one's mind at this time that there was a possibility here; still relatively remote, but real, but we had not reached the point at which, you know, one's balance of judgment tips over into it looks as though it is really bad news�.[94]
Farmer 4
71 On 28 September 1995 Dr Wight minuted Dr Calman�s private secretary about a probable fourth case of CJD in a beef farmer who had had a case of BSE in his herd four years earlier.[95] She copied the minute to Dr Metters, Dr Rubery, Dr Skinner, Mr Lister, Ms French (ID) and Mr Eddy (MAFF). Dr Wight noted:
�2.�� If he is confirmed as suffering from CJD, this brings the total number of cases in farmers in the UK to four. CMO will recall that earlier advice the SEAC had from Professor Peter Smith� was that the occurrence of a fourth case (in a dairy farmer) would be of serious concern�
�3.�� �The CJD Unit hope to visit tomorrow� more details will be available then.
�4.�� There is some urgency in dealing with this as the case is already in the public domain � BBC Wales are making a programme which refers to this case. In addition, the Lancet articles on the third UK farmer and on the European situation are to be published tomorrow. Together, these factors are very likely to provoke wider interest.�[96]
72 In a minute the same day, Mr Eddy informed the MAFF Ministers about the fourth farmer.[97] He said that DH would �take the lead in handling any media enquiries�.[98] He noted that the local media were aware of the case and �we understand will be running an item on it today. This could stimulate further media interest�.[99]
73 Mr Eddy�s minute recalled the (July) 1993 advice from Professor Peter Smith that �if four cases of CJD occurred in farmers over a five year period then �the possibility that the association was not due to chance had to be given very serious consideration��.[100]
74 Dr Calman met DH staff the next day (29 September) to discuss �the latest findings in research and any further safety measures which should be taken to minimise the risk to humans�.[101] An emergency meeting of SEAC was scheduled for the next week, on 4 October.[102]
75 On 29 September 1995 Mr Lister minuted Baroness Cumberlege�s private secretary, and copied the minute to the private secretaries of Mr Packer and Dr Calman, and to Drs Metters, Rubery, Skinner, Wight, and Callaghan, Mr Jobson, Mrs French (ID), Mr C K McIntosh (SHHD), Ms Liz Jones (WO), Mr T Robinson (DHSS NI) and Dr Render (MAFF). He invited Baroness Cumberlege to agree on a publication date for the CJD Surveillance Unit�s Annual Report, and he advised her of a fourth case of BSE in a farmer whose herd had suffered from BSE. He said that a special SEAC meeting had been called to discuss the case, and that the line to take in the meantime was �We are aware of the case. The necessary investigations are underway, and we cannot comment further at present�.[103]
76 On 29 September 1995 the press reported the third case of CJD in a dairy farmer.[104] This information was from a letter which had been published in the Lancet, dated 30 September 1995. The letter said:
�The occurrence of CJD in another dairy farmer with a potential occupational exposure to BSE is clearly a matter of concern. Statistical analysis indicates that the probability of discovering three or more dairy farmers with CJD by chance since 1990 in England and Wales ranges from 0.09 to 0.0002��[105]
77 In the same issue of the Lancet, there was a publication of the European statistics for CJD in farmers. It concluded that �there is no differential increase in the risk of CJD to farmers in the UK through potential occupational contact with cases of BSE�.[106] Dr Wight explained to the BSE Inquiry that on the continent there was also a �slight excess� of CJD cases arising in farmers.[107] Dr Will said it indicated that in the UK, CJD in farmers had �probably not� been transmitted from BSE.[108]
78 Dr Skinner (DH) told the BSE Inquiry that when he was advised at the end of September of the possible fourth case of CJD in a farmer, this information together with the slowly emerging information concerning breaches of the SBO ban, caused considerable unease.[109]
October 1995
79 On 3 October 1995 there was a meeting between MAFF and DH Permanent Secretaries. Present from MAFF were Mr Packer, Mr Carden, Mr Meldrum and Mr Dickinson, and from DH, Mr Hart, Dr Calman, Dr Skinner and Mr Lister.[110]
80 The DH files show some notes about this meeting. The notes identified two teen-aged cases of CJD, in a 19- and a 17-year-old, the second of which was not public �and should be treated as confidential�. It was noted that CJD had been �described previously in two adolescents in the USA �which is free of BSE and one adolescent in France at a time when it too was free of BSE�.[111]
81 DH�s minutes of the meeting record that DH and MAFF
�noted a suspected new case of CJD in a cattle farmer who had had BSE in his herd. There was no conclusive evidence that recent cases of CJD were linked to BSE, but it was agreed that it was important to keep the issue under close review, particularly in view of the long incubation period of CJD.�[112]
82 Mr Packer�s private secretary wrote to DH on 24 October 1995 suggesting some changes to these minutes, including deletion of the word �conclusive� (see 24 October below).[113]
SEAC Meeting 21
83 SEAC�s emergency meeting to discuss the fourth farmer was held on 4 October 1995.
84 SEAC reached the following main conclusions at the meeting:
�there had been a worrying number of cases in farmers exposed to cattle with BSE. However, if there were an occupational link, there would be other occupations that might be expected to be at greater risk, and there was no evidence for this;
�the stage was being reached where it was difficult to explain the cases as a chance phenomenon. However, although significant, the absolute risk remained extremely low;
�the evidence in the current case was exposure to BSE for a short period. There was also the likely presence of meat and bonemeal fed to poultry before 1990;
�it was unclear whether the potential risk factor might be association with animals with BSE or the food given to them (it was known that some farmers ate small amounts of calf and cattle feed but not whether they also ate pig and poultry feed). It was suggested that there might be a problem with dust from feed but that this should be more of a problem with dust compounders;
�given that there was a problem relating the case to a causal link, the transmission studies were particularly important;
�it was still necessary to make a final diagnosis of CJD in the possible 4th case.�[114]
85 At the meeting,
�Dr Will summarised recent cases of sporadic CJD in young people. There were currently two cases in teenagers � a 19 year old and a 17 year old. The case in the 17 year old had unusual pathology, although this could be related to age. There were also other cases in their 30s and 40s, which was unusual. However, although this was a change from previous experience, it was difficult to relate to BSE.�[115]
86 Also at the meeting, Dr Wight �invited members to make a fairly clear statement on how they viewed the significance of a fourth case. She also invited the Committee to consider whether they were satisfied that nothing else needed to be done in terms of practical measures.�[116] Dr Wight told the BSE Inquiry �I do not think that SEAC any more than anybody else had any idea of how to make sense of this at that stage�.[117]
87 In response to Dr Wight�s invitation, SEAC �agreed to draw up a statement which the Department of Health could issue in response to media enquiries�.[118]
88 The statement, attached to the minutes, said that SEAC had �not altered their advice to Government on the precautions necessary to protect either the public health [sic], including farmers, or animal health.�[119]
89 The statement said that SEAC had
�...also noted that surveillance of CJD elsewhere in Europe has shown a similar incidence of CJD in farmers, including dairy farmers, in countries with no or very few cases of BSE. They [SEAC] therefore felt that it was �important to undertake further epidemiological studies to detect any particular risk factors which might be involved, and reiterated their advice that the UK cases of CJD in cattle farmers and the strain of the agent recovered from them should be studied in detail.�[120]
90 This was Dr Tyrrell�s last SEAC meeting because he was retiring. Professor Pattison was taking over the SEAC Chair.
91 That day (4 October), after the meeting, Mr Eddy minuted the MAFF Ministers to alert them of the outcome of SEAC�s meeting. He copied his minute to a number of officials, including Mr Bradley (CVL), Mr Lister (DH) and Mr Huws (Welsh Office). He said that the CJD Surveillance Unit had
�downgraded the case from a �probable� to a �possible� which reflects some uncertainty about the diagnosis now that the symptoms have been examined in more detail by the experts but final confirmation will depend on further tests and ultimately the post mortem.
�SEAC concluded that, if the fourth case were confirmed, it would be worrying, especially as all four farmers with CJD would have had BSE cases on their farms. It was difficult to calculate accurately the likelihood of this being due to a series of random events; but looking at all male farmers and farm workers in England and Wales the chance of four CJD cases occurring randomly since 1990 was around 5/100; the chances of four cases of CJD occurring randomly in farmers with BSE in their herds was very much lower, around 3/10,000. The Committee therefore concluded that it was difficult to explain the incidence as a chance phenomenon. This is a change to the Committee�s position; it had said that the most likely explanation of the three previous cases of CJD in dairy farm workers was that they were chance phenomena...�[121]
92 Mr Eddy advised that SEAC had not recommended �any changes to the measures currently in place to protect human and animal health, including that of farmers and others handling cattle and BSE suspects�.[122]
93 The same day (4 October), Mr Eddy minuted Dr Danny Matthews (MAFF, technical adviser to SEAC) about discussions during the SEAC meeting. He copied the minute to Mr Keith Meldrum (CVO) and others. At the SEAC meeting, Dr William Watson, Director of the Central Veterinary Laboratory (CVL), had briefly listed four possible routes of infection �although neither he nor anyone else� felt any of them were particularly plausible�.[123]Mr Eddy listed them:
(i.) �that cattle were excreting the agent in some form � there is no evidence for this least of all from the epidemiology of BSE in cattle;
(ii.) �that farmers may be exposed through meat and bonemeal in cattle feed � again it was felt that if feed, rather than the cattle themselves, were a problem then there should be a similar excess of cases in pig and poultry farmers where more ruminant material would be in feed;
(iii.) �from normal food as for the rest of the population but it was unclear why this should discriminate in favour of cattle farmers;
(iv.) �through contact with animals � possibly animals killed on the farm and possibly with BSE suspects.�[124]
1. The last point entailed discussion of the slaughter procedures for BSE-suspect cattle and Mr Eddy suggested putting together a short note for SEAC to cover this point.[125]
2. Dr Matthews wrote a paper for presentation at SEAC�s next meeting on 23 November.[126]
94 In a press release dated 5 October 1995, DH announced the Fourth Annual CJD Surveillance Unit report.[127] The report showed an increase in the number of deaths from CJD in 1994. The press release quoted Dr Calman saying:
�I continue to be satisfied that there is currently no evidence of a link between meat eating and development of CJD and that beef and other meats are safe to eat. However, in view of the long incubation period of CJD, it is important that the Unit continues its careful surveillance of CJD for some years to come.�[128]
95 The press coverage the following day was extensive. Newspapers ran headlines on the increase in deaths from CJD throughout Britain for the year 1994. The Independent mentioned the deaths of the 19-year-old and three dairy farmers. The Daily Telegraph quoted the CMO�s statement from the press release.[129]
96 On 5 October 1995 Mr Meldrum minuted Dr Matthews about Mr Eddy�s minute of 4 October on possible routes of infection for farmers. He asked, �Is there any possibility that infectious agent could appear on the anterior surface of the eyeball and be picked up by the farmer when he was treating an animal�s eye or giving an injection for New Forest disease?�[130]
97 Dr Matthews responded on 10 October 1995:
�...I should like to make the following limited observations. I say limited because the amount of information available to us relating to the farms where farmers have been affected by CJD is restricted to that contained in the original epidemiological reports on their cattle, and information made available by Dr Will.�[131]
98 He commented that to date he did not have the names and addresses of the farms where the four farmers were from. However, a list had been requested.
99 He said that he was �conscious that:
(v.) �we have had no input into the medical epidemiological investigations in order to be confident that all opportunities of exposure have been considered (assuming that we know all potential routes of exposure). In effect the questioning by the Surveillance Unit staff may not have been informed by the knowledge of agricultural and veterinary practice.
(vi.) �we have not re-assessed the epidemiology on farm relating to the risk to owners. Nor have we re-assessed the epidemiology in relation to the cases identified and their sources. In other words, given the sensitivity of the circumstances, we have not specifically re-visited the farms to review risk after we became aware of the diagnoses in the farmers...�[132]
100 Dr Matthews also said �We are aware of the need to amend our epidemiological questionnaire to force VOs to ask questions about areas of risk that have of necessity been of lower priority in recent years�� He said, �While [the questionnaire] might also prove an ideal mechanism for gathering data on practices that might put handlers at risk, this might be considered too sensitive an issue to approach in such a way�.[133]
101 In answer to the question about eyeballs, posed by Mr Meldrum�s minute, Dr Matthews did not believe this risk to be zero but felt that there were other practices that were of greater risk. He noted that
(i.) infectivity from the bovine retina was known about but not the optic nerve or other tissue including the cornea;
(ii.) the Advisory Committee on Dangerous Pathogens� (ACDP) Precautions for work with human or animal TSEs includes eye in Category A (highest risk) along with brain, spinal cord, thymus etc, placenta and membranes;
(iii.) treatment for an eye condition in cattle would involve holding the animal by the snout, horn or ear. Excretion via nasal mucosae could lead to contamination of the hands;
(iv.) direct contact with or aerosol transmission from placenta at calving time would also be a more likely route of transmission to man.
(v.) other routes of transmission to consider were faeces, blood, milk, contact with organs post-mortem or during on-farm surgery, and consumption of SBO from home-killed animals. �It would be nice to know whether the Surveillance team interview the farmer�s veterinary practitioners for historical evidence of diseases and procedures on farms�.[134]
102 Dr Matthews commented that the presence of only a small number of affected cattle in the herds of the affected farmers was a puzzle. �Might one not expect risk due to association with cattle to be greater in herds with many cases of BSE?�[135] He also considered that consumption of meat and bone meal (MBM) in animal feed and accidental ingestion or inhalation of SBO-derived fertiliser were also real possibilities.[136]
103 Dr Matthews noted that Mr Ray Bradley (Head of Pathology, CVL) had suggested that there might be sub-strains of BSE which presented lesser or greater risk to man. Dr Matthews said that MAFF was still not in a position to evaluate the options as there was insufficient information about the herds and risks concerned. He said that the planned transmission studies of the brains from the farmers� cases might help.[137]
104 On 10 October 1995 Mr Lister forwarded Mr Eddy�s minute of 4 October to Dr Wight, with the suggestion that �we brief DH Minister and CMO once SEAC have agreed the statement�.[138]
105 On 13 October 1995, Mr Ancram wrote a second letter to Mr Malone about his 8 September letter about the Churchills� concerns. He said:
�I really would be most grateful for an answer as soon as possible as Mr and Mrs Churchill are continuing to pursue this and have contacted Tony Blair about their case. It would also be most helpful to have details of the latest research currently being conducted into this disease which was recently announced in the Press.�[139]
106 On 20 October 1995 Mr Meldrum informed Mrs Browning and Mr Hogg (copied widely to other MAFF Ministers, officials and territorial departments) about the first case of BSE in an animal born in 1993.[140] He said
�The fact that BSE occurs in an animal born in 1993 is not surprising, indeed we have said all along that we expected born after the ban cases (BABs) in animals from later years than 1992. It can readily be explained by our current thinking on the causes of BABs[141] and no further action is needed in response to this case. The leakage out of our BSE control system and through our feed mills is thought to have continued beyond 1992, and so cases born in 1993 and later years can be expected...�[142]
107 Mr Meldrum noted that the animal was only 25 month old at clinical onset, and that the EC, �possibly prompted by the Germans,� might want to shorten the current restriction on exporting beef from cattle over 30 months old. He said that this �would make exports more difficult and we would try very hard to resist this��[143] On making the case public, Mr Meldrum said:
�...we will shortly have to make details of it public in reply to a PQ put down by Mr David Hinchliffe MP (whose questions may be inspired by Professor Lacey) to ask the Minister:
��how many BSE cases born in each month since July 1988 were subsequently confirmed.�
�We could simply let the information become public in response to that question. However, that might leave us open to claims that we were reluctant to make such �difficult� news public, and that it had been �dragged out of us�. This could lead to attempts to discredit our policy of openness on BSE, and conceivably thereby create difficulties with the Germans...�[144]
He recommended making the 1993 BAB public in response to a �low key� arranged PQ the next week, and at the same time, informing the EC and the German Government about the case.[145]
108 On 20 October 1995, Mr Thomas Sackville (DH Parliamentary Under-Secretary (Commons)) replied to Mr Ancram�s letter to Mr Malone of 8 September and 13 October, about some concerns of Mr and Mrs Churchill.[146] Mr Sackville enclosed a copy of the CJD Surveillance report which had been released earlier that month. He responded to the three issues that Mr Ancram�s letter had raised. First, he noted:
�We share your concern that the monitoring of CJD in the UK should be as effective as possible. That is why we set up the National CJD Surveillance Unit in 1990. The monitoring system used by the Unit is kept under constant review by the Department and we are satisfied that the level of ascertainment of CJD is very high�[147]
109 Second, he stated that DH did not consider a public inquiry into Stephen�s death was necessary:
�The question of a public inquiry into the death of Mr and Mrs Churchill�s son was first raised by the Today newspaper in articles published on 14 and 15 August. Copies are enclosed for your information. The Department�s refusal of a public inquiry was in response to questions from the newspaper. We felt such an inquiry to be unnecessary because we have already established the independent Spongiform Encephalopathy (SE) Advisory Committee (SEAC) with a remit to advise Government on all matters concerning SEs, including CJD.�[148]
110 He added that �CJD in young people, although extremely rare, is by no means unique�.[149]
111 The third question had been whether SEAC co-ordinated SE research:
�The role of the SEAC in research is to advise the Ministry of Agriculture, Fisheries and Food (MAFF) and the Department of Health on all aspects of research into SEs, including research priorities, new work required, and advice on work in progress. MAFF and the Department of Health have responsibility for the co-ordination of that research.�[150]
112 On 23 October 1995 the Daily Mail reported the fourth case of CJD in a cattle farmer.[151] The newspaper had �received a late draft of the [SEAC] statement when it was faxed incorrectly by a DH official and went to a private Fax number�.[152]
113 On 23 October 1995 Mr Lister sent a minute to Mr Dorrell�s private secretary. He copied it to the private secretaries of Baroness Cumberlege and Dr Calman, and to Dr Rubery, Dr Skinner, Dr Wight, Mr Sutherwood, Dr Render, Ms George, Mr Robinson and Mr McIntosh. He attached the statement approved by SEAC on possible CJD in a cattle farmer and a list of �bull points� including:
�SEAC have not altered their advice to Government on the precautions necessary to protect the public health;
�There remains no current scientific evidence to link meat eating with the development of CJD. The Chief Medical Officer has advised that beef and other meats � and milk � are safe to eat.�[153]
114 Later that day, SEAC released, via DH, their statement announcing the fourth (suspected) case of CJD in a cattle farmer. The statement said:
�...it was difficult to explain this as simply a chance phenomenon. There is a statistical excess of cases in cattle farmers compared with the general population but the absolute risk, even for cattle farmers, is extremely low at about 2 cases per million per year. There may be other explanations for such an association besides infection with BSE, and the Committee noted that there are no reported cases in other occupational groups such as veterinarians who might be expected to be similarly exposed. They also noted that surveillance of CJD elsewhere in Europe has shown a similar incidence of CJD in farmers, including dairy farmers��[154]
SBO entering the food chain
115 On 23 October 1995 Mr Meldrum wrote to Dr Calman informing him of incidences of non-compliance with the SBO ban. At the third round of bi-monthly unannounced inspections, State Veterinary Service (SVS) staff had found four cases where spinal cord was still attached to bovine carcasses. Dr Calman had become aware of the problems arising from previous rounds of inspection at the time of, or shortly after, Mr Lister�s minute to Dr Wight on 4 August.[155] Dr Calman told the BSE Inquiry that although
�primary responsibility for compliance with the relevant legislation lay with those owning and operating slaughterhouses, cutting rooms and cold stores, the Department of Health and others including SEAC had always proceeded, (after the introduction of the legislation), on the basis that such bans were both in place and effective. Enforcement of all legislation relating to animal health fell within MAFF's jurisdiction.
�My concerns related to the fact that until the end of October 1995 I, the Department of Health, and others including SEAC had repeatedly made statements in relation to the consumption of beef and its risks to human health and BSE based upon the fact that:
�(1)� Legislative bans on potentially infected tissue were in place and effective
�(2)� There was currently no scientific evidence of a link between meat eating and the development of CJD.�[156]
116 Mr Packer�s private secretary wrote to DH on 24 October 1995 suggesting some changes to the minutes of the MAFF/ DH Permanent Secretaries� meeting on 3 October (see above). Suggestions included deletion of the word �conclusive� because �there is no evidence�.[157]
117 On 24 October, after discussion with Dr Wight, Mr Lister minuted Dr Calman on the subject of SBO removal. He said that BSE in animals born after the introduction of the feed ban meant that SBOs �may well have got into animal feed because of inadequate controls at slaughterhouses�.[158] He included a draft CMO statement that he and Dr Wight had drafted.[159]
118 For Dr Calman, this �confirmed as a possibility� the question of SBOs getting into human or animal food. He was �extremely concerned at this report and discussed... [his] concerns with Baroness Cumberlege and Mr Packer�.[160]
119 On 25 October, Dr Calman met Mr Packer for a more detailed discussion.[161] Dr Calman summarised the meeting to the BSE Inquiry as follows:
�I expressed a number of concerns I had as a result of the lapses in the SBO ban which had been identified. These were the continuing high number of BSE cases being reported, although this was declining, the high number of cases born after the feed ban which implied that controls in feed mills were inadequate and discovery that SBO had not always been properly removed in slaughterhouses and the fact that four farmers had contracted CJD. Despite the fact that I received assurances that enforcement of the SBO ban would be carried out vigorously in feed mills and slaughterhouses and that the Meat Hygiene Services would be left in no doubt of the high priority of this measure I requested an immediate meeting with the Minister.�[162]
120 Mr Packer arranged for Dr Calman to meet Mr Hogg on 7 November 1995.
121 On 25 October 1995 Dr Calman wrote down his thoughts on BSE.[163] He noted that �the evidence so far, suggests that there is no scientific evidence that BSE causes human disease�.[164] He went on to say that new information had become available over the last four months, necessitating review of the existing evidence. He cited four areas that the new information related to:
A. �The CJD Surveillance Unit providing information on the incidence, age, geography, food and occupation (including farmers)�,
B. lack of rapid decline in BSE, and BABs;
C. evidence of SBOs getting into the food chain; and
D. greater understanding of the science.[165]
122 He continued:
�4.�� These findings taken together do not give grounds for complacency and are not entirely reassuring. The uncertainty remains, and may even have increased. In view, in particular of the problems uncovered in the slaughterhouse procedures, it is impossible to give complete assurance that SBOs have not entered the food chain. However, it is exceedingly unlikely that this has happened to any great extent, and importantly there remains no scientific evidence of a link at present between the eating of meat and the development of CJD in humans. These conclusions have been confirmed by SEAC. The long incubation period needs to be remembered.
�5.�� The issue remains however, that the uncertainty has increased, rather than decreased. Urgent action is required to reassure the public that all steps are, and have been taken, to minimise any possible risk. It will be difficult to continue to provide complete reassurance unless food manufacturing plants; [sic]
�A.�� Action at farms, food manufacturing plants and slaughterhouses is effective;
�B.�� No new findings emerge from the surveillance and transmission studies.� [166]
123 Also on 25 October 1995 Mr Lister sent a briefing on BSE to Baroness Cumberlege. She had requested it after the previous day�s discussion with Dr Calman. The briefing gave statistics on the epidemic and described the SBO ban. It said that MAFF had explained the BABs as being a result of
�continued infection in feed. At first this was said to be due to supplies of infected feed stored on farms from before the ban. But it now seems likely that SBO� may have been getting into animal feed because of poor controls at slaughterhouses. MAFF have addressed this, at least in part, by transferring responsibility for slaughterhouse inspections from the local authorities to the Meat Hygiene Service.�[167]
124 In a minute dated 25 October 1995, Mr Eddy informed MAFF Ministers of �the formal announcement later in the week of two cases of CJD in adolescents.� The announcement was to be made in advance of the publication of two letters in the Lancet on Friday 27 October.[168] The minute also stated:
�4.�� This article is likely to raise further media interest in BSE and its possible relation to CJD, following the announcement of the possible fourth case of CJD in a farmer at the beginning of the week. Two other announcements to be made this week, of the first 1993 born after the ban case and of the findings of small amounts of specified bovine offal material being left attached to carcases after dressing in slaughterhouses, may well lead to sustained media pressure.�
125 A briefing on the recent media coverage of CJD in farmers was provided for the Prime Minister on 25 October 1995.[169] This was to help Mr Major prepare for his regular �Prime Minister�s Questions� slot in Parliament.[170] The background note attached to the briefing said that �SEAC�s statement makes it clear that they are not advising Government that extra precautions are needed to protect human health. Neither this case, nor the Committee�s statement, changes our fundamental advice that beef is safe to eat.�[171] The background note also brought the Prime Minister�s attention to the two confirmed cases of CJD in teenagers which were to be published in the Lancet that week (see 27 October below).
Teenager 3
126 In October 1995 a third young patient was referred to the CJD Surveillance Unit after a brain biopsy. Similar to the previous cases, plaque deposition was one of the pathological features in this case.[172]
127 In a minute dated 26 October 1995, Dr Render informed MAFF Ministers about a third case of CJD in a young person:
�DH also learnt today of a case of CJD in a 28 year old man. This has been confirmed by brain biopsy, although the man is still alive. It is unusual to see sporadic CJD in someone so young; apart from the two adolescents the Minister is aware of, the previous youngest sporadic CJD sufferer in the UK was 34 years old. Details of this case are not publicly known.�[173]
128 In a minute titled �CJD in young people� dated 26 October 1995, Mr Lister informed Baroness Cumberlege�s private secretary of the two letters to be published in the Lancet.[174] He attached a SEAC statement �which we will issue in response to media enquiries�.[175]
129 In addition, the minute informed Baroness Cumberlege that
�4.� The CJD Unit are also investigating a confirmed case of CJD in a 29 year old from London. The patient is still alive, and the diagnosis has again been confirmed by brain biopsy. This case is not yet public. There is also a probable case of CJD in a 38 year old woman � which is still young for CJD � which has attracted media attention.�[176]
130 This minute was copied to Dr Calman�s private secretary, Dr Metters, Mr Roy Sutherwood (ID), Mr Clark, Dr Rubery, Dr Skinner, Dr Wight, Mr Robb, Mr W Jobson (HEF1C), Dr Timothy Render (Animal Health (Disease Control) Division, MAFF), Mr McIntosh (Scottish Home and Health Department), Mr Robinson (Northern Ireland DHSS), and Ms George (Welsh Office).
131 On 26 or 27 October 1995[177] SEAC released, via DH, a statement on the two adolescent cases. It said:
�We note that two cases of CJD have been diagnosed in adolescents in the UK. It is not possible to draw any conclusions from this as confirmed cases of CJD have been found in the same age group in other countries. In addition, the two cases had no exposure to risk factors for CJD and no contact with BSE. It is essential, however, to study the patients in greater detail and consider whether there are any implications for the cause or management of the disease.�[178]
132 On 27 October 1995, Jan Mackenzie of the CJD Surveillance Unit sent two faxes to DH. One was to Mr Robb and it contained a table listing the numbers of referrals of suspected CJD by year, and the number of deaths per year.[179] This table was to assist in answering a PQ.[180]
133 The other fax was to Dr Wight: �I enclose a table of ranges from 1980-1984 England and Wales and 1989-Present for the UK. I have given the two youngest sporadic cases and the two oldest cases for each year�.[181]
134 Appended to these tables was a list of �those still alive�. This gave the ages of 6 patients (ranging from teen-aged to 42) and their status (two definite, one probable, one possible and two �?Other�). A seventh patient was added to this table (presumably by DH) in handwriting. Also appended to the tables was a list of age ranges for France, Italy and Netherlands.[182]
135 A submission dated 27 October 1995 from Mr James Brown (Assistant Secretary, Scottish Office Public Health Policy Unit) to the private secretary of Lord Selkirk (Scottish Office Minister of State) informed him of the two letters that were to be published in the Lancet, and gave information about the two cases of sporadic CJD in teenagers in the UK.[183] The submission was copied to Mr (later Sir) Michael Forsyth (Scottish Secretary of State), Lord Lindsay (Scottish Parliamentary Under-Secretary), the Scottish Health and Agriculture Departments, Dr Robert Kendell (Scottish CMO) and others. The submission reproduced SEAC�s recent statement on CJD in adolescents. It also noted that before 1995, the youngest case of sporadic CJD in the UK had been in a 34 year old. Those cases of sporadic CJD in teenagers known about in other countries were: a 16 year old in the USA in 1978, a 19 year old in France in 1982, a 14 year old in Canada (of UK origin) in 1988, and three cases aged 19, 23 and 27 in Poland, who were identified retrospectively in a study published in 1991. The submission also noted that Creutzfeldt�s first patient in 1920 was aged 23.[184]
136 On 27 October, the 28 October 1995 edition of the Lancet was published. It contained 2 letters (by numerous authors) about teen-aged CJD victims. One was about a 16-year-old (this was Gulcan Hassan) and the other was about an 18-year-old (Stephen Churchill).[185]
137 That day, Dr Render minuted Mr Hayward on CJD in the 17-year-old (ie. Gulcan Hassan). He noted that it was reported in the Lancet that she could have eaten cow�s brain in Cyprus. He said that Britain had not exported offals to Cyprus.[186]
138 On 30 October 1995 MAFF Ministers and officials met to discuss BSE. Mrs Browning and Mr Hogg expressed concern at the farmers� cases. In discussion of SBO breaches, Mr Packer:
�referred in particular to the potentially very serious matter of cases where SBO matter � in particular spinal cords � had not been properly removed from carcases. We had to take and be seen to take all necessary action to put this right. He recommended that the Minister should call in the Chief Executive of the Meat Hygiene Service to stress that he attached the highest importance to strict enforcement of our provisions�.[187]
This meeting was later arranged for 6 November. Also at the meeting on 30 October Mr Hogg agreed that representatives of the slaughterhouses should be invited to a meeting, and this was arranged for 9 November.
139 On 30 October 1995 a briefing was provided to the Prime Minister on CJD in the four farmers and two teenagers. The briefing repeated the advice in the 25 October briefing that there was no reason to be alarmed, because there was �currently no scientific evidence to link BSE in cattle with the development of CJD in humans�. It noted that SEAC�s advice had not changed, and that SEAC had not been able to draw conclusions on the teenagers, because CJD had been found in teenagers in other countries and the teenagers had no exposure to risk factors.[188] Mr Major told the BSE Inquiry
�I understood the phrase �it was not possible to draw conclusions� to mean that the two cases did not add any additional information to what was already known about BSE and did not provide any evidence of a link between BSE and CJD�.[189]
140 On 31 October 1995 Professor John Collinge, head of the Neurogenetics Unit at St Mary's Hospital, Imperial College, London, visited Dr Calman to relay his fears about the new cases of CJD in young people.[190] Professor Pattison was present. Following these discussions, Dr Calman asked Professor Collinge if he would be willing to serve as a member of SEAC.[191]
141 On 31 October 1995, DH received a table entitled �Cases of suspected sporadic CJD in young people notified to CJD Surveillance Unit in 1995�. The table listed information on 7 patients, including their age and location, date notified to the Surveillance Unit, and other notes.[192]
November 1995
142 On 1 November 1995 Mr Ancram wrote again to Mr Malone[193] (see 20 October above). He informed Mr Malone that a further two cases of CJD had been found in the locality where the Churchills lived. He said:
�I am conscious that it is important not to draw rash conclusions from this, but the fact of a geographical cluster is bound to cause concern, and reassurance is needed. The causes of CJD are unknown or unproven, as I understand it, which if anything causes greater concern.�[194]
143 On 3 November 1995 Mr Hogg wrote to the Cabinet Committee EDC(P) to inform them about SBO breaches that had been found.[195]
144 On 3 November 1995 Dr Wight sent a minute to the DH Press Office, noting that the fourth case of CJD in a farmer �has now been confirmed by the CJD Surveillance Unit�. She said that the family had been informed of the diagnosis, and the case was likely to be reported in the medical literature. There was �no merit in DH withholding information on the diagnosis until then if the Press appear to know anyway�.[196]
145 On 4 November 1995 Maurice Callaghan died of what was later diagnosed as nvCJD. He had been referred to the CJD Surveillance Unit in September.[197]
146 On 5 November 1995 Mr and Mrs Churchill wrote to Mr Ancram with comments on Mr Sackville�s letter of 20 October.[198] They raised similar issues to those Mr Ancram had raised on 1 November. They advocated the establishment of an �independent� inquiry into the death of their son, and said
�There are now compelling reasons for such an inquiry as there are now three �clusters� of CJD concurrently:-
������ �1. Three teenagers, the most ever in one country.
������ �2. Four � Six members of the farming community.
������ �3. One confirmed and two suspected cases in a small geographical area � Devizes.
�These clusters and cases are only the ones we are aware of and we are sure that SEAC and CJD Unit will be aware of others.�[199]
147 Mr Ancram forwarded this letter to Mr Sackville on 15 November[200], and Mr John Horam (who was to replace Mr Sackville as Parliamentary Under-Secretary (Commons) for Health[201]) answered it on 7 December 1995; see below.[202]
148 On 6 November 1995, Mr Hogg met Mr Johnston McNeill, Chief Executive of the Meat Hygiene Service (MHS).[203] Mr Hogg
�stressed the importance of our controls on SBOs in our strategy for the control and eradication of BSE. He was very concerned about the results of the most recent SVS audit of SBO handling in slaughterhouses. Clearly there had been a number of failings. We had to consider together how to make the slaughterhouses do better.�[204]
149 To help prepare Dr Calman for the meeting with Mr Hogg on 7 November, Mr Lister prepared a minute about a paper on BSE/ CJD that had gone to a Cabinet sub-committee, EDC(P). MAFF and DH had differed in on how to word the paper, and Mr Lister said that MAFF�s position was:
�indicative of the unwillingness of some MAFF officials to accept the lapses in SBO controls as an issue of genuine public health concern, as opposed to one about the undermining of public confidence in the safety of British beef�.[205]
150 On 7 November 1995, Dr Calman and Dr Metters met Mr Hogg, Mrs Browning, Mr Packer and Mr Osborne.[206] Dr Calman had requested this meeting on 25 October. Mr Hogg informed Dr Calman of �the likely findings of the October SVS audit of the handling of SBOs in slaughterhouses: this merely confirmed the need to take decisive action�.[207]
151 The minutes record that: [208]
�Mr Calman said that he was concerned. We simply did not understand well enough the origins of the disease. He was less confident now than he had been a year ago that things were moving in the right direction. Much of the science itself was reassuring. Work done by Dr Collinge with mouse assays had so far suggested that BSE might not be transmissible to humans. However this was as yet confirmed [sic]. Comfortingly, analyses of the brains of CJD victims tended to point in the same direction. However other developments were less encouraging. The results of the CJD surveillance � based on much more sophisticated data than in other countries � were worrying, since the four cases in farmers had all occurred in producers with dairy herds which had had BSE. The increased incidence in young people was also worrying. Finally, he was disappointed that the BSE epidemic in cattle had failed to drop off as we had predicted, with cases occurring of animals born in 1993. His earlier confidence about the human health implications had been based partly on reassurances that BSE was itself a short-term problem.�
�Mr Calman continued that, in respect of our controls, there were clearly two critical points at the slaughterhouse and in the feedmill. If controls at these points were perfect potential problems and worries would be significantly less.�
�Although he could continue to say with complete confidence that there was no evidence that British beef, that is meat as commonly understood, was not safe, it could not be said with confidence that no offal which might have been contaminated had entered the food chain. This reduced confidence that the public was being properly protected. If he was pressed on this point � and therefore by implication on the safety of food containing mechanically recovered meat � he would be in a difficult position; he would need to think very carefully about a suitable form of words. He reiterated that we should bear in mind that there remained no evidence of a link between CJD and BSE; the difficulty was that we might not know for sure for another year or two. We were therefore still talking about no more than a hypothetical risk. But it was easy to imagine how quickly the connection would be made in people�s minds�.[209]
152 Dr Calman told the BSE Inquiry:
�I recall informing the Minister that my concerns would have been greatly reduced but for the recent findings which led to my concluding that there was a potential for contaminated offal to have entered the food chain. By implication this led to concerns about the safety of food containing mechanically recovered meat�.[210]
153 The hypothesis that the farmers may have been exposed by eating or tasting cattle feed was discussed at length, and Mr Hogg wondered about issuing a warning on the handling of animal feed. Dr Metters said that in theory, this should not be necessary because ruminant feed was not being fed to ruminants. And �any warning would imply that we accepted that there really was significance in the surveillance conclusions�. Also, Sir Richard Southwood had not thought there was cause for concern (although the issue of human consumption of cattle feed was not mentioned in his (1989) report). Dr Calman added that there might well be a problem with compliance with any such warning. It was decided to consult SEAC on this and possibly other questions.[211]
154 Dr Calman �implied� that if he were pressed on the point he would say that the processes to control SBOs which were now in place were satisfactory, but that those in the past had not been. Dr Calman �found the attitude of the farming industry and slaughterhouses astonishing, particularly given the threat to the whole future of the sector�. Dr Metters said that he had noticed MAFF�s significant attitude change over the last six weeks: �there was now no inclination to tolerate any failure to remove SBOs�. Mr Hogg told of his meeting with Mr McNeill the previous day, that he had told Mr McNeill not to hesitate in prosecuting if the evidence justified doing so and that Mr McNeill had said that there were no technical reasons why the industry should not be able to comply with the regulations. Mr Hogg added that he would shortly be seeing representatives from the slaughterhouse industry, and that his message would be �uncompromising�.[212]
155 In discussion about research, Dr Calman thought that the Government was �probably not� doing enough, though it was difficult to decide where more resources were needed, and that this should be pursued with SEAC.[213]
156 The BSE Inquiry asked Mr Hogg about this meeting:
SIR NICHOLAS PHILLIPS: �It seems to me what Dr Calman is saying here is, "I am happy to say it is safe to eat beef. I am certainly not happy to say it is safe to eat offals, and what is worrying me is it looks as though some of these offals have been getting into the food chain".�
MR HOGG: �It worried me too and that is why I took the action I did.�
MR WALKER: �Did you understand him to be saying that there was any change in his perception of the risk from SBOs, as opposed to the risk of SBOs getting into what humans eat?�
MR HOGG: �What you are putting to me I think is: was he changing his position on transmissibility? That is what you are putting to me, are you not?�
SIR NICHOLAS PHILLIPS: �Did he think the belt was being nibbled?�
MR HOGG: �Exactly. That is, I think, the question that is being put to me. I think the answer to that is no, not at that stage, but he was concerned about leakage of SBOs and I agreed with him. It was a serious matter�.[214]
157 Also at this meeting, Dr Calman suggested that Mr Hogg have a meeting with Professor Pattison. He also advised that additional members be appointed to SEAC in order to provide further clinical expertise.[215] Dr Calman told the BSE Inquiry, �I believed that there was a need for greater human health input to the Committee and this view was shared by others including Professor Pattison, the Chairman of SEAC�.[216] He had first raised this issue, along with �the need to appoint a new Chairman of SEAC� in September 1994, with Mr Waldegrave, the MAFF Minister.[217] However:
�First of all there needed to be some discussion first of all in terms of membership and secondly who the Chairman might be. Secondly, Dr Tyrrell, who had done a tremendous amount of work in terms of where SEAC had got to, wished to complete the report, and that happened in October 1995 and that was the time that change took place. There are no other reasons I can think of�.[218]
158 DH and MAFF discussed recommendations for appointments of experts in the areas of human and related animal diseases, public health, human epidemiology and statistics and virology and immunology.[219] The new appointees were announced on 14 and 20 December 1995 (see below).
159 Mr Hogg�s private secretary circulated his note of the 7 November meeting to Mr Eddy, the private secretaries of Mr Tony Baldry (MAFF Minister of State), Mrs Browning and Mr Boswell (MAFF�s two Parliamentary Under-Secretaries), and Mr Packer, and to Mr Osborne, Mr Carden, Mr Meldrum, Mr Haddon, Mr K Taylor, Dr Cawthorne, Mr Haslam, Dr Render and Mr Davidson. It was also copied to Mr Hart�s private secretary, Dr Metters and Dr Wight.[220]
160 On 8 November 1995 Mr Hogg wrote to Mr McNeill:
�I welcome the steps you are taking. However, given the importance of the SBO controls in our strategy on BSE, and especially for the protection of public and animal health, we agreed that I should formalise my instructions to you on this matter. I am, therefore, by this letter, formally instructing you, in accordance with the provisions of paragraph 4.3 of the Meat Hygiene Service�s framework document, to ensure that appropriate steps are taken to see that your staff in slaughterhouses enforce the Specified Bovine Offal Order 1995 fully. Failure to comply with these Regulations is an extremely serious matter. I must therefore ask you to make every effort to secure 100% compliance. In particular, your staff must ensure that all SBO is removed from a carcase before they give it a health stamp. Failure to do so should be viewed extremely seriously. I have discussed this with the Secretaries of State for Scotland and Wales and know that they fully share my concerns.�[221]
161 On the morning of 9 November 1995 Professor Pattison was interviewed on the radio programme Today. He had discussed this with Dr Wight the day before, and on 9 November she faxed him an outline of the likely main issues and responses. She copied the outline to the DH Information Division (ID).[222] She said that the interest had been prompted by families of CJD sufferers. She noted that �3 further cases� in Devizes (the Churchills� town) were �unsubstantiated�.[223]
162 On 9 November 1995 Mr Hogg met representatives of slaughterhouse operators �to discuss some failings found in the handling of SBOs�.[224] In the press release afterwards he said: �I said that I would only be satisfied with 100% compliance with the rules and informed them that the Meat Hygiene Service would enforce the controls most rigorously�.[225]
163 Also on 9 November The Times newspaper reported that the incidence of CJD �looks set to fall when the figures for 1995 are revealed�. The article said that there had been �fewer referrals� to the CJD Surveillance Unit. It said that �Dr Will confirmed yesterday that the figure for 1995 looks set to be substantially lower than 1994, although the final figure is not due to be published until mid-1996. �It looks very much as if there will be fewer cases, which is reassuring.��[226]
164 In a further article in The Times on 9 November 1995, it was reported that �despite all the work on CJD surveillance, �no evidence of a link between CJD and �mad cow� disease has been found so far�, and because of the long incubation time another 10 to 15 years of surveillance were needed. Dr Will was quoted as saying:
��My expectation is that we will not find any definite link� I still believe that very firmly, but I do think it will be years before we can be sure. Proving a definite association is a very difficult thing to do with a rare disease unless there is a major change. We have not had a major change.�
������������������ He believed that the two recent cases in teenagers was a reflection of better case ascertainment,[227] and pointed out that CJD had been found in teenagers in other countries.[228]
165 On the statistical links between CJD and consumption of venison and veal, the article said Dr Will thought they were �unlikely to be meaningful. �I still enjoy beef,� he says, pointing out that there have been several cases of lifelong vegetarians contracting CJD�.[229]
166 On 10 November 1995, Mr Robb sent an urgent fax to Dr Zeidler (in Dr Will�s absence) at the CJD Surveillance Unit.[230] He said that after yesterday�s article in The Times, Dr Calman had asked for the following information:
�1.�� The number of sporadic cases from January 1994 to October 1994 inclusive; and
�2.�� The number of sporadic cases from January 1995 to October 1995 inclusive.�[231]
167 Dr Zeidler telephoned Mr Robb that day with the information: there were 42 cases from 1 January to 31 October 1994, and 21 cases from January to October 1995.[232] Mr Robb sent this information in a minute to Dr Calman�s private secretary, copied to Dr Metters, Dr Wight and Mr Clark (Press Office).[233] He added that �Although the 1995 figures and the 1994 figures (at the time) are both provisional, there is evidence of a marked decrease�.[234]
168 On 31 October 1995, DH had been sent a table of information on 7 cases of suspected sporadic CJD in young people. An eighth patient was added to this table in handwriting from information received from Dr Zeidler on 10 November.[235]
169 Also on 10 November, Today newspaper reported that a Belfast father-to-be had died of CJD.[236] Mr Robb copied this report to Dr Wight and Mr Jobson.[237]
170 Again on 10 November, Mr Robb minuted Dr Calman�s private secretary, copied to Dr Metters, Dr Wight and Mr Clark (ID). He said:
�1.�� The TODAY newspaper today reported two suspected CJD cases: a 30 year old male who has recently died in Belfast, and a 42 year old male in Liverpool who we understand is currently in a nursing home.
�2.�� The CJD Unit is looking into these cases but has not yet completed its investigations. Our usual line in such cases is appropriate:
�We are aware of these cases. The necessary investigations are underway and we cannot comment further at this stage.��[238]
171 Mr Robb sent two further minutes that day to Dr Calman�s private secretary, copied to Dr Metters, Dr Wight and Mr Clark, about the possible CMO statement that Dr Wight and Mr Lister had drafted on 24 October.[239] �Minor� amendments had been received from MAFF and incorporated.[240] Dr Wight had suggested a revision be used as Press Office line over the weekend, if pressed.[241] The revised draft said that it was impossible to be certain that SBO had
�not entered the food chain. However, it is exceedingly unlikely that this has happened to any great extent and I am reassured by the steps taken to ensure that it does not happen in the future. I remain satisfied that there is no scientific evidence of a link between meat-eating and the development of CJD in humans�.
172 On 13 November there was extensive newspaper coverage of BSE, in advance of a television programme that night (see below). It was estimated that 600 infected animals each week were entering the human food chain. The Times said it had asked Mr Meldrum about a calculation that there were two subclinical cases for each one reported. He was quoted: �Yes, that is a calculation that's been made, that there are a significant number of cattle that could be going in for slaughter that could be incubating the disease�.[242] Also reported was a survey, which had found that 23 per cent of Britons had stopped eating beef because of BSE fears.[243]
173 On 13 November 1995 Dr Will sent a fax to Dr Wight at DH. The fax enclosed a table that had been researched by the CJD Surveillance Unit, entitled �Young Cases 13/11/95�.[244] The table listed 8 �suspect cases of CJD aged <50 a="" href="https://web.archive.org/web/20001121091600/http://www.bse.org.uk:80/dfa/dfa16.htm#_ftn245" name="_ftnref245" title="" years="">[245]
174 Dr Wight copied the table to Mr Robb, who copied it to Mr Jobson.[247]
175 That evening, there were two television programmes on BSE and CJD: �Watchdog� and �World in Action�. Mr Colin Maclean (MLC Director General) told the BSE Inquiry that the programmes suggested a �link between BSE and CJD and that the certification controls for export were being abused�.[248] Mr Meldrum, who had been interviewed for the �World in Action� programme, had earlier that day minuted Mr Hayward about the �hostility� of the programmers.[249]
176 There was newspaper coverage in the next few days.[250] The Daily Express reported that the �World in Action� programme had claimed that up to 600 BSE-infected cows �are being eaten every week� [MAFF] admits the situation could be that two infected cows are eaten for every one that is diagnosed and destroyed�.[251] Mr Taylor later told Mr Meldrum that this was based on a paper that MAFF had published, which included the calculations that for each sick animal that is diagnosed and destroyed, there may be two sub-clinical animals entering the food chain, and that this paper had been discussed with the World in Action team.[252]
177 In a minute for MAFF�s Press Office dated 14 November 1995 Mr Meldrum summarised the �five main issues� from the �World in Action� programme �which you may care to use if questions are asked by the press�.[253] They related to sub-clinically and clinically affected cattle entering the human food chain, infectivity in liver, �why can�t cattle be tested at slaughter for BSE�, and SBO removal.[254] On sub-clinical animals entering the food chain, he said �To some extent the number of cattle incubating the disease is immaterial because our precautionary measures are intended to meet just that situation�.[255] On SBO enforcement he noted that
�prosecution will follow when public health is jeopardised as a result of failure to meet the requirement to remove spinal cord from the split spinal column. The removal of spinal cord from the spinal column is relatively easy (as could be seen in the World in Action film) and there should be no splashing of material onto the carcase�.[256]
178 In an urgent minute on 14 November 1995, Mr Toal informed Baroness Denton (Northern Ireland Parliamentary Under-Secretary), who had just returned from abroad, that BSE had �taken on a much higher profile in the media�. He informed her of the previous evening�s television programmes. He also said the recent death from CJD of a Belfast man would be the focus of another programme later in the week (this was Mr Callaghan).[257]Baroness Denton was informed of the �line to take�:
�1.�� no evidence of any link between BSE and CJD;
�2.�� no evidence of risk to humans from eating beef (This is not just the Government line but is based on the findings of a completely independent scientific advisory committee.);
�3.�� Controls on BSE in Northern Ireland remove any risk to humans. The Veterinary Services operates a centralised meat inspection system. There is no evidence of any breakdown in slaughterhouses in Northern Ireland in the removal and proper disposal of Specified Bovine Offal
�4. If asked about sub-clinical disease the Minister should say:
�This is not relevant to the risk factor. BSE is only found in certain offals and all Specified Bovine Offal is removed from all animals both for human and animal consumption.�[258]
179 On 15 November 1995 Dr Wight minuted Mr Eddy at MAFF to arrange a meeting with the CMO to discuss research. She added that Dr Calman had:
�identified a need to establish what products are made from MRM for human consumption, as the DH view is that MRM poses a potentially greater risk than other bovine meats. I would be grateful if MAFF could indicate what types of products contain MRM�.[259]
180 On 15 November 1995 Mr Ancram forwarded to Mr Sackville the Churchills� letter of 5 November.[260] Mr John Horam (who was to replace Mr Sackville as Parliamentary Under-Secretary (Commons) for Health[261]) answered it on 7 December 1995; see below.[262]
181 On 16 November 1995 Mrs Browning met Mr Ashworth, from the Licensed Animal Slaughterers and Salvage Association, to discuss the handling of SBOs. The note of the meeting records that Mrs Browning said �Nothing less than 100% compliance was acceptable�.[263]
182 On 20 November 1995 there was a meeting between Mr Meldrum, Mr K Taylor, Dr Matthews, and Mr Wells and Drs Calman, Metters and Wight. They discussed the progress of transmission studies. They also discussed MRM. The minutes record that Mr Meldrum said the concern arose because of the possible inclusion of small residues of spinal cord.
183 Mr Meldrum
�made it clear that if all the rules were complied with then cattle cake should not be infectious to farmers or to cattle but born after the ban cases clearly indicated that there had been a problem. Because of the ruminant feed ban, if feed was a risk to humans then pig and poultry feed should, if anything, be a greater risk than cattle feed. There were no reported CJD cases in pig and poultry farmers�.[264]
184 Dr Calman
�took the view that if there was a genuine increased risk of CJD in cattle farmers it could be thought to be reassuring if feed was the possible cause because this might indicate an alternative source of infection which did not directly involve cattle, and could suggest that meat was not a risk�.[265]
185 Mr Taylor raised the point that CJD rates were higher in other European farmers. Dr Metters responded that �they were now querying these figures �much depended on which population of farmers you looked at and if you looked at cases in farmers with BSE in their herds then there was clearly a very marked excess in the UK and in the UK only�.[266]
186 Mr Eddy, who wrote the minutes for MAFF, added: �This is news to us � the figures came from DH�s surveillance unit.�[267]
187 The minutes continue:
�10. Mr Taylor said that animal feed was not labelled to say that it should not be eaten by people and pig and poultry food containing ruminant protein was not labelled to say that it must not be fed to cattle. The CMO said that Southwood said that the HSE [Health and Safety Executive] should be asked to advise on human health risks from BSE and the CVO said that they had done so. Dr Matthews made the point that the precautions already in place in abattoirs to protect meat from possible contamination by abattoir workers would also protect abattoir workers from possible risks from meat and that farmers already had an advisory leaflet. I [Mr Eddy] said that we had revised the leaflet for farmers and that the SEAC on 23 November would discuss the draft leaflet and be asked whether farmers should be given further advice. I also made the point that if we thought that animal feeds were a risk then� we should be warning pig and poultry farmers as well as cattle farmers�.[268]
188 In discussion of SBO breaches, it was �agreed that we could not guarantee 100% removal of spinal cord although that was the target that had been set to the industry and the Meat Hygiene Service�.[269]
189 It was noted that MRM was mainly produced from young animals. It was agreed that �MRM was an issue which needed to be revisited and this would be put to the SEAC at its meeting on 23 November�.[270]
190 In response to a PQ on 22 November 1995, Mr Hogg announced the results of the SVS�s unannounced visits to slaughterhouses. He said that
�In the most serious cases we found small pieces of spinal cord, ranging in size from 1 cm to one third of the spinal cord, left attached to the carcases after dressing. So far, we have found 17 such instances, including one found during preliminary visits in the summer and five found up to 10 November and one on 20 November in the latest round of visits�.[271]
191 He went on to outline the steps he had taken to ensure full compliance: he had asked the MHS to ensure �most rigorous� enforcement of the SBO order and to prosecute failing slaughterhouses where it has sufficient evidence, he had asked the SVS to double the frequency of its unannounced surveillance visits, and he had met slaughterhouse operators on 9 November �to impress on them the need for full compliance with these controls�.[272]
192 On 22 November 1995 Mr Hogg visited a slaughterhouse.[273]
193 On 22 November Dr Metters minuted Dr Wight about the next day�s SEAC meeting. He copied the minute to Baroness Cumberlege�s private secretaries, Dr Calman�s private secretary, Dr Skinner, Mr Sutherwood, Mr B Clark and Mr Robb. He said that Ministers wanted advice from SEAC on three issues:
�a.�� in the light of the number of failures to remove [SBOs] in slaughterhouses, what is SEAC�s view about the potential risk to human health from MRM? Ministers wish CMO to have SEAC�s advice on this specific point in case he (CMO) is asked that particular question.
�b.�� do SEAC have any further advice or explanation of the number of farmers with CJD. You will be aware that CMO is asked abut the labelling of animal feeds. A further question relates to SEAC�s advice and comments on recent cases of CJD among teenagers.
�c.�� arising from SEAC�s review of research, what further studies do they now recommend to Ministers.�[274]
194 The minute passed on Mr Dorrell�s emphasis that SEAC advice was for Ministers: �It was essential that any conclusions reached were notcommunicated direct to the public, despite the fact that SEAC is known to be meeting tomorrow�.[275]
195 On 23 November 1995 Dr Calman�s private secretary minuted Mr Robb, attaching embargoed copies of scientific articles that were to appear on that week�s edition of the BMJ. She asked Mr Robb to inform the Press Office and herself, and provide a line to take, if the articles were �likely to stimulate any press interest�. There were 6 articles about CJD and links with BSE.[276]
SEAC Meeting 22
196 On 23 November 1995, SEAC�s 22nd meeting was held.[277] This was the first meeting chaired by Professor Pattison. SEAC were concerned at the information about SBO breaches.[278] After discussion they agreed on a statement:
�Earlier in 1995 SEAC had concluded that �provided in the slaughtering process the removal of the spinal cord was done properly, the mechanically recovered meat (MRM) process was safe and there was no reason for the Committee to change its advice. In light of the current audit reports showing failure to remove parts of the spinal cord in a number of carcases the Committee expressed its grave concern. It noted the further tightening up of controls but felt that unless and until it was clear that the removal of SBO, particularly spinal cord, was now being undertaken properly in all cases it would be prudent, as a precaution, to suspend the use of vertebrae from cattle aged over six months, in the production of MRM.� [279]
197 Also at the meeting Professor Collinge gave a presentation on his work with transgenic mice.[280] Also discussed were CJD and blood transfusions, and a MAFF advisory note to farmers. SEAC �noted� a paper that Dr Matthews had written entitled �CJD in cattle farmers � possible health risks associated with MAFF procedures for slaughter and disposal of BSE suspects.� Dr Wight had discussed with Dr Gore a questionnaire to study changes in practices which might put farmers at risk. Professor Pattison asked Dr Wight to pursue this. He said that SEAC �needed more data on farmers as soon as possible and did not want the matter delayed because of difficulties of implementation�.[281]
198 On 24 November, Dr Wight minuted Dr Calman�s private secretary with the main points from the SEAC meeting. She copied the minute to Baroness Cumberlege�s private secretary, Dr Metters, Mr Robb and Mr Sutherwood. She quoted and discussed the statement on MRM that SEAC had agreed at the meeting[282] and summarised the other issues that had been discussed. As SEAC had not had time to discuss all the issues on their agenda, Dr Wight added that research priorities, MAFF�s transmission studies, and �an update on the CJD situation following the two recent cases in teenagers, will be discussed at a further meeting to be held in January�.[283]
199 Towards the end of 1995, Sir Donald Acheson, who had been CMO from 1983 to 1991, began to get �concerned about a cluster of cases of CJD in young people�. Dr Calman agreed that Sir Donald could visit DH for a briefing with officials,[284] and he met Dr Wight in November.[285] (See also 22 January below.)
200 On 25 November 1995 Michelle Bowen died of what was later diagnosed as nvCJD. She had been referred to the CJD Surveillance Unit earlier that month.[286] Mrs Bowen�s death was reported in the newspapers on 27 and 28 November 1995.[287]
201 On 27 November 1995 Dr Calman and Mr Packer met, to prepare for a meeting between Mr Dorrell and Mr Hogg the next day. The meeting was �useful in clarifying a number of issues.�[288]They proposed that the next afternoon, Mr Hogg should announce a ban on the use in food of MRM made from the �vertical column� of cattle.[289] They noted that for practical and enforcement purposes the ban would be for all cattle � not just those over 6 months old as recommended by SEAC. This was because it was hard to age spinal columns accurately.[290]
202 They also recommended that Dr Calman issue a detailed statement at the same time as Mr Hogg�s announcement: �this will make it clear that all beef products, including pies, sausages etc, are safe�.[291] In addition, Mr Hogg should �minute the Prime Minister tomorrow about what is intended immediately after [Mr Hogg�s] meeting with Mr Dorrell�.[292]
203 Mr Hogg agreed with these proposals at a meeting later that day.[293] On consultation, Mr Packer suggested a meeting later that week with interested parties. This was later arranged for 30 November 1995. Mr Hogg agreed and said he would take the meeting, and that he would indicate then that he intended to make the Order a week after that.[294]
204 Later that day, Mr Haddon minuted Mr Hogg�s private secretary, copied to the private secretaries of Ministers and to numerous officials. He attached a draft letter for Mr Hogg to send to the Prime Minister, explaining SEAC�s recommendation to ban the use of vertebral columns in MRM,
�immediately following his meeting with the CMO tomorrow morning. The proposed plan, as I understand it, is that the Minister should hold a Press Conference later tomorrow at which he will announce a short period of consultation on the proposed legislation banning the use of bovine vertebral columns for mechanically recovered meat as a precautionary measure�.[295]
205 He also attached a draft PQ answer for Mr Hogg.
206 Copies of the draft letter to the Prime Minister and the PQ answer were sent to Mr Dorrell�s private secretary.[296]
207 In the morning of 28 November, Mr Dorrell and Mr Hogg met.[297] Mr Packer, Mr Meldrum, Dr Calman, Dr Metters and others were present.[298] Mr Dorrell said that �we had to make very clear in our public statements that the potential source of infectivity was very narrowly defined�.[299] It was said that SEAC had referred to the proposed ban as a �prudent precaution,� therefore �the issue was not unduly urgent: there would be no problem with making the Order around 7 December�.[300] Dr Calman �repeated that he would be welcoming this particular step as closing a minor loophole. We had done all that was needed to safeguard public health. Beef continued to be safe�.[301]
208 On 28 November 1995 Mr Hogg minuted the Prime Minister, copied to other Cabinet members and Sir Robin Butler (Cabinet Secretary), to tell him about the action he was taking on MRM. He quoted from the SEAC advice that had been received. He said that after discussion with Mr Dorrell and Dr Calman, they had agreed to act quickly on the advice, and to introduce legislation banning the use of bovine vertebral column in the manufacture of MRM. He explained why the ban would be for all cattle, including those under 6 months.[302]
209 Mr Hogg identified that the economic impact of the ban would be �quite small� at around �2 million a year. He said �in such a potentially serious area the economic aspect must be outweighed by the need to protect the public as advised by SEAC�.[303]
210 On the handling of the announcement, he noted that it
�could spark renewed fears about the safety of beef and meat products on the shelves despite the reassuring statement that the CMO will issue with mine. However, SEAC specifically said at its meeting that they were content that beef, including cuts containing parts of the backbone� was safe. I will obviously stress this point, and the precautionary nature of the new measures�.[304]
211 Also on 28 November, a briefing on BSE /CJD was provided to the Prime Minister to help him prepare for Prime Minister�s Questions in Parliament.[305] The briefing noted the recent death of a young mother from CJD, and the four farmers and two teenagers. It stated that �there is currently no scientific evidence that BSE can be transmitted to humans or that eating beef causes CJD in humans�.[306]
Ban on the use of vertebrae
212 Following a PQ in which Mr Hogg announced a ban on the use of any cattle vertebrae in the production of MRM, there was a press release on 28 November. [307] Mr Hogg said:
�I am grateful for SEAC�s advice and have acted upon it as quickly as possible. This removes the risk of spinal cord tissue entering the human food chain. The new measures, like the others in place, are precautionary. They are designed to protect public health from any remote theoretical risk of BSE. I would reiterate that we have no evidence of any link between BSE and the similar human disease, CJD.
�These new measures are a consequence of the failings in the handling of SBOs we have found in slaughterhouses. They do not reflect any concerns about the MRM process itself. I have previously expressed my grave concern about the failings found in slaughterhouses, and taken steps to address them. I look to slaughterhouse operators now to deliver 100 per cent compliance with the SBO controls.�[308]
213 The same press release contained a statement from Dr Calman:
�There is currently no scientific evidence that BSE can be transmitted to humans or that eating beef causes CJD.
�Specifically, all the studies to date on transmission have shown that beef is safe. There is no epidemiological evidence of transmission from beef to humans or of transmission when muscle (meat) from cattle clinically affected with BSE is injected into mice.
�The SBO ban introduced in 1989 was intended to remove from the food chain all tissues that might have contained the BSE agent. Since that ban there has been a very remote risk based solely on rare accidental failure to remove small amounts of one of the SBOs, the spinal cord, from the vertebral column which may have been used to produce mechanically recovered meat (MRM).
�I welcome the new restrictions banning the use of bovine vertebral column in the production of MRM. These are a prudent precaution to eliminate any risk from this source, however small. I also welcome the Minister for Agriculture�s emphasis on the need for vigorous enforcement. This further extends the precautionary measures already in place to protect human health against any remote risk from BSE.
�I repeat my previous assurances that if any new evidence comes to light that BSE could transmit to humans, I will bring this to the attention of the public.�[309]
214 Mr Hogg was quoted in The Daily Telegraph on 28 November as saying that he could not give �a 100 per cent categorical guarantee� that mad cow disease could not spread to people, following several reported breaches of the SBO legislation.[310]
215 On 29 November 1995 Mr John Horam replaced Mr Sackville as Parliamentary Under-Secretary (Commons) for Health.[311] Responsibility for BSE/ CJD at this level remained with Baroness Cumberlege in the House of Lords until 31 January 1996.[312]
216 On 30 November 1995 Mr Hogg convened a meeting with representatives of the meat industry, retailers and food manufacturers, to hear their views on SBO enforcement. Mr Carden recalls this as a �very difficult discussion, at which some of the industry representatives became very heated at the impact that the proposed ban would have on their businesses�.[313] Mr Hogg defended the public health need for his decision and stated that �The risk [to humans from consumption] was small but we were not prepared to take any chances�.[314]
217 Some industry representatives initiated litigation, and leave was obtained to pursue a judicial review of the decision to ban the use of vertebrae.[315]
218 The ban on the use of vertebrae came into effect on 15 December 1995 (see below).
December 1995
219 On 1 December 1995 Professor Sir Bernard Tomlinson (Emeritus Professor of Pathology, University of Newcastle upon Tyne) appeared on BBC Radio Four�s �You and Yours� Programme. He said
�Until we can say quite positively there really is no evidence now that BSE transfers to humans, until we can say that, I believe we�ve got to pay that price and all offal should be kept from public consumption. But I certainly don�t eat any longer beef pies, for instance, or puree, I wouldn�t eat a burger�.[316]
220 He presumed that �everybody in the country over about the age of fifteen would have already been exposed to BSE�.[317]
221 The same day, the Daily Star reported that Sir Bernard �last night vowed NOT to eat beefburgers for fear of mad cow disease� [He] said: �I wouldn't eat a burger at the moment in any circumstances.��[318] The Daily Express ran a similar story.[319]
222 Mr Haslam told the BSE Inquiry that the BBC established a �help-line�
�for listeners to call for advice about how they should react. The Meat and Livestock Commission discovered that the advice given by the �help-line� included the suggestion that meat stock-cubes were unsafe. This was a matter of great concern to companies such as Oxo, whose product was derived from South American sources. I made a telephone call complaining to the BBC. However, damage to public confidence had resulted. This lead to the reaction from schools with many declaring that they would take beef off their menus�.[320]
223 On 3 December the Sunday Times reported that Mr Hogg was asked whether he thought beef was �perfectly safe� to eat. He replied
��Yes, I do�. Questioned about the mounting concern of scientists, however, he admitted, �I cannot on the evidence before me give a categoric [sic] guarantee that it cannot be transmitted. We believe it cannot be and the scientific evidence suggests it cannot be��.[321]
224 On 3 and 10 December 1995, the MLC issued two newspaper advertisements to reassure British consumers on the safety of eating British beef. They listed a series of �fictions� and �facts� about British beef, and quoted supporting comments from Drs Calman and Will respectively.[322]
225 The advertisements stated the following �facts� in response to �fictions� that it listed:
(i.) �BSE is a disease which affects only cattle. CJD affects only humans. There is no evidence whatsoever of any link between them�.
(ii.) BSE cases were on the decline.
(iii.) CJD cases had �remained stable for as long as records go back�.
(iv.) �CJD has been recorded in vegetarians as well as meat eaters, and occurs at pretty much the same rate in countries where BSE is not even present�.
226 The 3 December advertisement (only) said:
(v.) �Fiction: There must be some truth in the scare otherwise they wouldn�t be taking so many control measures.
(vi.) �Fact: No, the truth is that the control measures are implemented to reassure the public�
227 Both advertisements continued:
(vii.) �Fiction: Control measures are just an empty gesture.
(viii.) �Fact: Far from it. British veterinary and abattoir regulations, along with their enforcement, are as strict as the strictest in the world. Altogether, eight separate controls are in place embracing the farm, auction market and meat plant. With such stringency, even the remotest perceived risk is avoided.
(ix.) �Fiction: They talk about beef being safe but some forms of beef are probably safer than others.
(x.) �Fact: Beef is beef is beef. Be it prime cuts, mince, burgers, pies or sausages. All play a key role in providing the nation with a healthy, balanced diet. Enjoy it, just as you have always done.
(xi.) �Fiction: The weight of opinion suggests beef is not safe.
(xii.) �Fact: Not at all. British beef has been endorsed by independent scientists, world health organisations, and government authorities, both in the UK and European Union�.[323]
228 The 3 December advertisement finished with a quote from Dr Calman: �British beef is perfectly safe to eat�.[324]
229 In an interview on London Weekend Television on 3 December 1995, Mr Dorrell agreed with the interviewer that there was no �conceivable risk� of anyone eating beef being infected with BSE:
�I had been invited onto the programme to discuss the National Health Service, but in view of the topicality of BSE Mr Dimbleby commenced the interview by asking about the government�s assessment of the risk that BSE could be transmitted to humans in the form of CJD. I said that science suggested that there was no link, but even if science was wrong on that subject, government had removed from the human food chain the organs that could conceivably be linked to a transmission. Mr Dimbleby said �So, there is you are saying no conceivable risk from what is now in the food chain; that�s the position?� and I responded �that is the position.� I regretted that response because Mr Dimbleby�s summary of my words went further than the words of the Chief Medical Officer. As a consequence of this interview, I was reported in some newspapers the next day as having said that there was no conceivable risk from eating beef.�[325]
230 The Times on 4 December 1995 reported that Mr Dorrell and Dr Calman had �issued the assurance in the face of growing doubts by eminent scientists about the safety of beef�.[326]
231 Mr Dorrell told the BSE Inquiry:
�Well, the only basis on which we felt, I felt, my colleagues felt free to say �beef is safe� is on the basis that these safeguards were in place and being enforced. So beef is safe given these safeguards. Clearly if the safeguards were not being enforced, then we had -- we could not, on the evidence of -- on the advice available to us, have felt that beef was in the normal meaning of the word safe.�[327]
232 On 4 December 1995 Dr Metters faxed Mr Carden at MAFF to complain about an advertisement by the MLC that had appeared in the Sunday (3 December) newspapers. The advertisement had misquoted Dr Calman as saying that British beef was �perfectly safe�. Dr Calman had not used the phrase �perfectly safe�. Dr Metters said that it was in neither the MLC�s nor DH�s interests �for the CMO�s words to be manipulated so that he has no alternative but to issue a public clarification of his position�. Mr Metters copied his fax to nine colleagues.[328]
233 Mr Carden responded on 5 December that the MLC had assured him it had not intended to distort the CMO�s words, and that it would aim to avoid doing so in future.[329]
234 Dr Diana Walford, Director of the Public Health Laboratory Service (PHLS), told the BSE Inquiry that since her appointment in January 1993, she had been in periodic communication with DH, offering the services of the PHLS in relation to the epidemiology and surveillance of CJD, insofar as it might be helpful to, and supportive of, the work of the CJD Surveillance Unit. However, she was advised that there was no requirement for PHLS involvement in SEs:
�I was deeply concerned that my repeated offers of assistance by the PHLS were rebuffed on each occasion. This exclusion of the PHLS from a role that appeared to fall squarely within its corporate purpose of protecting the population from infection caused dismay and frustration amongst our staff. It also elicited adverse criticism from those outside the Service of the perceived inaction by the PHLS in an area in which is might reasonably have been expected to play a significant, if not a leading, role.�[330]
235 When the report of a small number of cases of CJD in young people became known in November 1995, Dr Walford again became concerned that the PHLS was not involved in prion work. She contacted Dr Will to ask him if there was any epidemiological assistance that the CJD Surveillance Unit would welcome from the PHLS.[331] On 5 December 1995 Dr Walford noted the outcome of her conversation with Dr Will in a memorandum to Dr Chris Bartlett, Director of the Communicable Disease Surveillance Centre (CDSC). Her note stated:
�At first, Dr Will seemed slightly wary of my approach, appearing to believe that we were questioning the basis of CJD surveillance within the neurological community. I hastened to assure him that this was not so and that my sole purpose in making this informal contact was to offer any additional expertise in either surveillance or in analytical epidemiology that his Unit might find helpful. He seemed reassured by this and was grateful for the approach. His Unit is receiving epidemiological advice from Professor Peter Smith of the London School of Hygiene and Tropical Medicine together with Dr Simon Cousins also, I believe, at the LSHTM. I mentioned to Dr Will the recent cases of CJD in teenagers and said that I was aware that the BPASU was interested in including paediatric CJD in its surveillance programme. Dr Will became quite animated at this point and said that he believes that paediatric CJD may well have been misdiagnosed in the past and classified as subacute sclerosing pan-encephalitis [SSPE]. He also mentioned another condition which I think he called Alper�s syndrome. He is therefore keen to see the paediatric surveillance initiated. I left it that I would contact Peter Smith to see whether he would value any additional input from CDSC at the moment. In any case, our offer to assist in ways appropriate to our statutory function, is now firmly on the table.�[332]
236 Dr Walford contacted Professor Smith. The agreement was that a meeting should be arranged, early in the new year, for two or three key PHLS experts to meet Dr Will with Professor Smith or his colleague, Dr Simon Cousens, another epidemiologist at the London School of Hygiene and Tropical Medicine.[333] Dr Walford informed Dr Calman of her discussions with Dr Will on 14 December 1995 (see below).
237 On 5 December a briefing on BSE and CJD was provided for the Prime Minister to help him prepare for Prime Minister�s Questions.[334] It said that Sir Bernard Tomlinson had caused �unnecessary and unjustified alarm about the safety of beef products such as burgers and pies. We have invited him to submit any new evidence� for SEAC to consider.[335] It said that Sir Bernard had been unaware of the MRM controls announced on 28 November.[336] An additional briefing from MAFF stated that the number of BSE cases had �fallen dramatically in the past couple of years�.[337]It also stated that changes in rendering practices in the 1980s were not due to changes in regulation, but to changes in commercial practice.[338]
238 On 5 December 1995 Dr Metters wrote to the Editor of The Times about �increased recent speculation� of a causal link between BSE and CJD. He said that the CJD Surveillance Unit and SEAC were established to advise on this, and that the CMO �has consistently stated that if he became aware of evidence [of such a link] he would immediately advise the public. There is, however, no current scientific evidence that BSE can be transmitted to humans�.[339]
239 On 7 December 1995 Mr Horam replied to Mr Ancram�s letter of 15 November 1995 about the Churchills� concerns. He said that the CJD Surveillance Unit had reported that there was no cluster of �definite or likely� CJD cases in the Devizes area. Nor had it found any �conclusive evidence of space time clustering�. He said it would not be appropriate to set up �another independent inquiry� because �the Government already receives independent expert advice from SEAC�.[340]
240 He said that SEAC had advised it was not possible to draw conclusions on the teen-aged cases because CJD had been found in teenagers in other countries, also �the cases had no exposure to risk factors for CJD and no contact with BSE�. He said that SEAC had asked for more information. He added that �there are only two cases of CJD in teenagers in the UK�. The Churchills, in their letter of 5 November, had said there were three teenagers.[341]
241 He said that SEAC had also asked for more information on farmers. He said they had not found increased incidence �in other occupational groups such as veterinarians, who might be similarly exposed, whilst other groups, for example, vicars, who have no reason to be exposed to BSE, show a greater excess than farmers.� SEAC had also noted a higher incidence in farmers elsewhere in Europe.[342]
242 On 7 December 1995 Mr Hogg, Mrs Browning, Mr Packer, Mr Osborne, Mr Carden, Mr Meldrum, Mr Haslam, Mr Kent and Dr Render met �to discuss the latest state of play on BSE�.[343] It was agreed that Messrs Meldrum and Carden discuss with Professor Pattison �the sort of points which he might cover in a letter to the papers�, and Mr Hogg said that �he had not ruled out the possibility of paying for space, possibly to publicise the SEAC paper�. It was also agreed that Mr Hogg put a set of questions to SEAC with a view to publishing the answers. Mr Packer told the meeting that Dr Calman �had come forward with names of three doctors who might be appointed� to SEAC. It was agreed that Mr Hogg hold a press briefing on 14 December 1995, accompanied by Professor Pattison, Dr Calman and Mr Meldrum; and that MAFF Ministers write to leading parliamentarians setting out the latest position in full.[344]
243 Also on 7 December 1995 the Prime Minister was sent a briefing for Prime Minister�s Questions on BSE and CJD.[345] The briefing explained that existing MRM products would not be withdrawn from the shelves unless the CMO or SEAC advised otherwise. It also noted that the CMO had �confirmed his previous assurances that if any new evidence comes to light that BSE could transmit to humans he would bring this to the attention of the public�.[346] It also said there was no need for a Royal Commission because SEAC was an independent group.[347]
244 That day (7 December), there was a Cabinet meeting at which Mr Hogg raised the renewed media interest over the past week in CJD, �fuelled by doubts expressed by a number of eminent scientists�.[348] He said that he had issued draft orders that day banning the use of bovine vertebral column in MRM manufacture. He put forward the proposals discussed at the earlier meeting that day.[349] The points were made that it might be wiser to issue a statement sooner than 14 December, and that discussion on BSE should remain open and non-partisan. The credibility of the NFU and MAFF were not high, so it was important to get independent scientific opinion. The possibility was mentioned that Sir Bernard Tomlinson might be invited to offer a further view �but he might still feel obliged to register some qualification which would leave doubt in the public mind�.[350] It was noted that the CMO and the CVO
�ought to be by far the most convincing spokesmen for the Government on the key question of whether BSE could be transmitted to humans from infected meat. Their assurances on that point might, however, be undermined if they could not give unqualified advice that meat products currently on sale, which had been produced prior to the orders banning the use of vertebral column in MRM, were safe to eat. Such meat currently held in deep storage could be prevented from entering the food chain but it would be going a considerable step further to withdraw all meat products containing such meat from retail outlets. To do that would carry the danger of precipitating a degree of panic among the public with devastating effects for the livestock industry and a strong possibility of claims for compensation which the Government might find it extremely difficult to resist�.[351]
245 Mr Major summed up the discussion at the end of the meeting:
�there was a disturbing degree of public anxiety over BSE once more and that the Government must be ready with an immediate and coherent response. The key element in that response should continue to be the assurance from the Government�s chief professional advisers that there was no evidence that the disease could be transmitted to humans. It would be essential, however, to clarify what should be said about the safety of meat products already on sale, bearing in mind the potential impact on the livestock industry and the possibility of claims for compensation. He therefore invited the Lord President of the Council to meet urgently with the four Agriculture Ministers, the Secretary of State for Health and the Chief Secretary, Treasury with the Chief Medical Officer and Chief Veterinary Officer in attendance to concert a public statement and to convey it immediately to Cabinet colleagues in order to maintain the credibility of the Government�s stance on this sensitive issue.[352]
This action was agreed by Cabinet.[353]
246 Also on 7 December 1995, Ms Heather Robinson (DANI) sent a minute explaining the process of MRM to the private secretaries of Baroness Denton and Mr Ancram. She copied the minute to Mr John Murray (DANI Permanent Secretary), Mr Elliott (Northern Ireland DHSS), Mr David Carnson, Mr Ron Martin (Northern Ireland CVO), Mr Toal and Mr Sinclair. Baroness Denton had requested the minute. It explained that MRM was made by crushing bone and allowing the meat and bone marrow to escape through a fine mesh. Spinal column was a principle ingredient of MRM.[354] The minute noted that MRM was not produced in Northern Ireland although it was imported and used in production processes.[355] It identified the �line to take: Beef is safe to eat� The new measures proposed are precautionary and designed to eliminate any remote theoretical risk from BSE�.[356]
247 On 7 December 1995 Dr Kendell (Scottish CMO) issued a statement in response to media interest and reports that schools and caterers were starting to remove beef from menus.[357] The statement said:
�The Government�s independent scientific advisers are saying consistently that there is no evidence at all that eating beef or other foods derived from beef is dangerous. My general advice to people is therefore to carry on eating what you want to eat as you were before.
�We have no evidence of any connection between BSE and CJD. However, both conditions are being closely monitored and studied by scientists, in this country and abroad, as there is much about both that is still unknown.�[358]
248 Dr Kendell told the BSE Inquiry, �I was not trying to say beef is safe but to say that we have no good evidence to believe that it is unsafe� I do not know whether I expected it to be reassuring or not. I wanted it to be accurate.�[359]
249 The same day (7 December), Dr Kendell minuted Scottish Ministers to inform them of his action. After quoting his public statement, he said:
�The core of the dilemma is there is no evidence of any connection between BSE and CJD, but on the other hand neither I nor anyone else can give a cast iron guarantee that eating beef or beef products from UK farms does not carry any risk of transmitting the causal agent of CJD, a disease which is invariably fatal. Worse still, this uncertainty may last for 10 years or more.�[360]
250 Mr Forsyth (Scottish Secretary of State) thought that Dr Kendell had probably discussed the statement with him beforehand.[361] He added that �[Dr Kendell] in that statement actually, I thought, produced a very balanced statement of the facts as they were known at the time.�[362]
251 On 7 December 1995 Sir David Naish (President, National Farmers� Union, England and Wales) sent a letter to Mrs Gillian Shephard (Secretary of State for Employment and Education), copied to Mr Dorrell and Mr Hogg. The letter proposed that the Department
�ensure that all the facts are placed before local education authorities and schools, citing the evidence an [sic] statements of the Chief Medical Officer, so that all those involved in deciding menus for children�s lunches can come to a reasoned decision.�[363]
252 Also on 7 December 1995, McDonald�s Restaurants circulated a statement to MPs outlining the �strict quality control standards� that McDonald�s took with its food.[364]
253 In an article for The Independent on 8 December 1995 Dr Will said
�there is a risk of over-interpreting small numbers of cases, and statistical analysis may be unreliable�
�There are limitations in the epidemiological study of a rare disease as it may be impossible to assess the significance of minor changes, although continued surveillance of CJD will allow any major change to be identified, particularly if comparisons with other countries without BSE continue�
�No link between BSE and CJD has been established, but the possibility of such a link cannot be excluded for many years because of the long incubation period in these diseases. In my view, the possibility of such a link remains theoretical, but even if the BSE agent were a risk to man, oral transmission would require exposure to high levels of infectivity, as in kuru.
�That is why the SBO ban is so important and why I believe the risk from eating beef is negligible� I do not believe it is reasonable to conclude that there is significant risk from eating beef. I have therefore not altered my consumption of beef or beef products, and neither have any of my colleagues at the CJD Surveillance Unit�.[365]
254 On 8 December Professor Pattison and Dr Will sent a letter to The Times that was almost identical to their open letter of 13 December (see below). Professor Pattison faxed a copy of the letter to Dr Wight.[366]
255 On the invitation of Mrs Browning, Sir Bernard Tomlinson wrote a letter to Professor Pattison dated 8 December 1995.[367] He said he believed it was �unjustifiable, in the light of knowledge� to state that BSE could not transmit to humans �under any circumstances�.[368] He said
�If scrapie has transmitted to cattle it demonstrates with alarming clarity the dangers of assuming that the species barrier will totally protect humans who ingest beef tissues infected with BSE. That would be so even without the plentiful evidence that the TSE�s [sic] in most species can be transmitted to other species.�[369]
256 He was concerned about recent cases of CJD in farmers and young people, and asked what evidence SEAC would need before proposing further precautionary measures.[370] He was also concerned about SBO from cattle under 6 months old,[371] liver,[372] and SBO regulation enforcement.[373]
257 Professor Pattison replied on 15 Dec, and sent a copy to DH (see below).
258 On 9 December 1995 in The Independent, Professor Pattison �refused to support� Mr Dorrell�s 3 December statement that there was �no conceivable risk� of BSE spreading to humans. He was quoted as saying �I freely admit that we cannot yet give anyone absolute guarantees�.[374]
259 In an article for The Sunday Telegraph on 10 December 1995, Dr Calman said there was �no need for more safeguards� I remain satisfied that human health is properly protected�.[375]
260 Also on 10 December 1995, the MLC issued a newspaper advertisement on the safety of beef. It is described at 3 December above. It finished with a quote from Dr Will: �I do not believe there is a significant risk from eating beef and I have therefore not altered my consumption of beef or beef products, neither has any of my colleagues at the CJD Surveillance Unit�.[376]
261 In a column for the newspaper News of The World on 10 December 1995 Mr Hogg answered �the 64,000 dollar question � is beef safe to eat?�:
�Yes. Professor Pattison says so. The members of his committee say so. The Chief Medical Officer, Dr Kenneth Calman says so� I spoke to him this week and he told me: �I am satisfied that any beef or beef product allowed by the regulations is safe to eat.��[377]
262 The Daily Telegraph on 11 December published an article headed �Public urged not to panic over beef�. It quoted from a statement by Professor Pattison and Dr Will that was almost identical to their letter of 13 December (see below).[378]
263 In a �Dear Colleague� letter dated 11 December 1995, Mr Hogg informed Conservative Members of Parliament of �the new steps I will be taking to protect public health from the very remote risk from BSE and to reassure the public that British beef is safe�. Mr Hogg outlined the slaughter and compensation scheme, the SBO regime, the use of vertebral column in MRM, the decline in number of cases of BSE and research funding. Under a final subheading, he stated:
�A Policy of Openness
�The Government is pursuing a policy of complete openness on BSE and CJD. All new findings are put into the public domain as quickly as possible. I invite those scientists who have raised public fears about the safety of beef to submit any new evidence they have for consideration by our independent expert advisory committee, SEAC.
�I will continue to give Parliament regular updates on the action we are taking to protect the public and eradicate BSE. On Thursday, I will be placing in the library of the House of Commons our regular comprehensive progress report on BSE.
�At the risk of repeating myself, let me give you this final assurance. British beef is safe. It is safe for school children and it is safe for adults. That is not simply my view. It is the view of the Chief Medical Officer, the World Health Organisation, the international veterinary organisation, the OIE, and the European Commission.
�My first duty is to protect the public. You can be sure that I will not allow anything to put public health at risk.�[379]
264 On 11 December 1995 Dr Calman�s private secretary minuted Dr Wight, copied to Dr Metters, asking her to provide the other UK CMOs, Dr Kendell, Dr Hine and Dr Campbell with key documents on BSE. She said �All the CMOs are coming under increasing pressure to respond to the media, and feel that they require a steer from us as to the most up to date line�.[380]
265 On 12 December 1995, Dr Render minuted Mr Eddy, copied to Mr K Taylor, Dr Matthews, Dr Wight and Mrs Gurnhill.[381] He suggested a standard information paper for use in replying to the large amount of correspondence that was being received. He attached a note that he had drafted, and asked for comment by 13 December. He circulated a final copy on 17 December; see below.
266 In a letter dated 13 December 1995, Professor Pattison and Dr Will wrote to Mr Dorrell and Mr Hogg, answering the �many questions [that had been asked during the last two weeks] about BSE, CJD, the public health and British beef�. The letter said
�On the basis of the measures taken SEAC had a high degree of confidence that the beef reaching the shops is safe to eat. We are equally confident that offal which is not included in the ban, for example liver, is safe to eat because no BSE infectivity has been found in liver, either from infected cows or from experimentally infected calves.
�The restrictions on the use of bovine offal have been strengthened since they were first introduced in 1989 and, through inspections, the application of these bans is being much more rigorously applied. If there was any risk to human health from BSE, and there may be none, then we have no doubt that risk is very much less in December 1995 than it has ever been. There is therefore no need to take extreme measures with respect to the British beef that is allowed to enter the human food chain.�[382]
267 This letter was given to reporters at a press conference on 14 December 1995, given by Mr Hogg, Mrs Browning, Dr Calman and Professor Pattison.[383]
268 At the press conference Mr Hogg announced the appointments of four new members to SEAC, and the fifth was announced on 20 December. They were Professors Collinge, Peter Smith and Jeffrey Almond (School of Animal and Microbial Sciences, University of Reading), Dr Michael Painter (consultant in Communicable Disease Control) and Mr Bradley (formerly of the CVL).[384]
269 On 14 December 1995 Dr Walford telephoned Dr Calman to let him know of her discussion with Dr Will (see 5 December above), and that she had invited Dr Will to the PHLS at Colindale in order to give him access to the PHLS database on cases of sub-acute sclerosing pan-encephalitis (SSPE, a chronic measles condition).[385] She followed this up with a letter on 22 December (see below).
270 On 15 December, The Daily Telegraph reported Mr Hogg as saying �the Government was acting with an abundance of caution even though he [Mr Hogg] and his team of expert advisors, viewed beef as �wholly safe��.[386]
271 The newspaper also reported that Professor Pattison had said �that it could take �decades� to provide �the final proof� scientifically that BSE could not spread to people.� Nevertheless, Professor Pattison was �sure that beef was safe in the light of the increasing amount of scientific evidence that was building up.�[387]
272 The newspaper also quoted Dr Calman as saying that there were no financial constraints on BSE research. Dr Calman added:
�It is understandable why the public are concerned. That is not unreasonable. What we need to do is to reassure them, as much as we can, that beef is safe�.[388]
273 On 15 December 1995, the SBO (Amendment) Order 1995[389] took effect. The Order prohibited the use of the bovine vertebral column in the manufacture of MRM and also in the production of some other products for human consumption, and required all plants producing bovine MRM to register with MAFF.
274 On 15 December 1995, Professor Pattison responded to Sir Bernard Tomlinson�s letter of 8 December.
�You ask what epidemiological data concerning CJD would lead the committee to re-examine the regulations with respect to cattle offal. In principle we are seeking to identify a significant and sustained deviation from the expected in relation to CJD in the UK compared to Europe which can be correlated with BSE. You rightly draw our attention to the difficulties with statistical analyses of small numbers and to the recent paper by Sheila Gore, who has of course attended SEAC to advise it on two recent occasions. We monitored the apparent rise in overall incidence of CJD in the UK between 1990 and 1994. This is a general trend in other countries as well, and we ascribe it to better identification of cases. The UK rise will not be sustained in 1995. However the unusual events this year are the occurrence of the fourth case in a cattle farmer and the two teenage cases. As Sheila Gore point out there is a higher incidence of CJD in dairy farmers in other European countries and this does not correlate with BSE in their herds. Clearly we need to pursue this association further in respect of cattle farming practices and the personal diet and habits of the farmers but we recognise the great difficulty of this.
�The other unusual and tragic events of 1995 are the two cases in teenagers. Cases of CJD in teenagers in other countries have been described previously and again there is no link to BSE in these other countries. Mis-diagnosis in young people of illness that turned out to be CJD has been described and there have also been the occasional unexplained small clusters of cases in the past. We have not defined a specific number of teenage cases that will lead us to re-examine our conclusions because we reconsider the situation after every single new case in young people (or farmers).�[390]
275 Professor Pattison also explained the science relating to the SBO ban in under-6-month-old cattle. Experiments had not found transmissibility in the organs permitted from these cattle.[391] He said that with the current enforcement regime SEAC were satisfied that the current list of SBOs did not need to be extended. He said,
�As scientists we do still have to be properly cautious in our statements. We lack the knowledge on many important aspects of SEs in general and BSE and CJD in particular. The duration of experiments is usually measured in years, there is no simple test of infectivity and the strain-typing methods so crucial in the control of any transmissible disease are not as rapid as we would like ideally. Thus it is proper at this stage to continue to say �there is no evidence.� However I am struck by the fact that every time we receive new experimental data or pass a new milestone in the pathogenesis experiment the data reinforces the adequacy of the current controls rather than the opposite. I do think that human health considerations are paramount and that the Government is taking all the necessary steps to protect it.�[392]
276 The previous day, Professor Pattison had sent Sir Bernard�s letter and his own draft reply to Mr Carden for comment. Mr Carden had circulated the letters to Mr Meldrum, Mr Eddy, and the private secretaries to Mrs Browning and Mr Packer.[393]
277 On 15 December 1995 Mr Eddy minuted Dr Wight, copied to Mr Meldrum, Mr Haddon and Dr Render. He said
�1.�� I have been thinking about ways in which we can try to get across to people just how small the risk from CJD currently is. Clearly the one in a million mortality rate does not seem to get through. I wonder whether we could look at it in another way.
�2.�� My back of the envelope calculations suggest that about 800,000 people a year die of which 50, ie. 1 in 16,000, die of CJD. I would quite like to draw up a table with the real figures if you could get hold of them from somebody in DH on mortality rates for different diseases showing, say, for 1994, total number of deaths, total number from CJD, total number from cancer, heart disease, road accidents and total number believed to be related to smoking and to drinking and possibly to other avoidable risks if you can think of any. We could then perhaps use this as another way of trying to get people to look at this particular issue in a more balanced context. Do you think this is a good idea and could you try and get hold of the necessary figures?�[394]
278 On 15 December 1995 Mr Peter Grimley (MAFF Animal Health (Disease Control) Division) invited various consumer and catering groups to a meeting on Monday 18 December, to discuss BSE. Attached to the invitation was a �short paper which sets out the Government�s perspective on this question which you may find helpful�.[395]
279 On 16 December 1995 The Guardian published an interview with Dr Calman. In discussion of beef, Dr Calman said
�We say that beef is safe. That is not to say, please go and eat beef. All we say is that, on all the evidence, we believe it is safe. Safe, that is, up to a point. We take the science and stretch it as far as we can and then give the best possible advice we can.�[396]
280 On 17 December 1995 Dr Render circulated a Q&A note for use in replying to the large number of letters on BSE. He sent it to Mrs Browning�s private secretary, and copied it to the private secretaries of Messrs Hogg and Packer, and to Messrs Osborne, Carden, Haddon, Meldrum, K Taylor, Eddy and Haslam, and Dr Wight.[397] The note included questions on BSE control and statistics, CJD, the safety of beef, SBO enforcement and SEAC.[398]On the question of whether beef was safe, the note read:
�Yes. This is the clear advice of the Government�s Chief Medical Officer and the independent Spongiform Encephalopathy Advisory Committee (SEAC), which advises the Government on all matters to do with BSE and CJD. They and other international bodies, such as the World Health Organisation, consider that the control measures that the Government has put in place are sufficient to protect the public�.[399]
281 The note went on to describe the measures that the Government had put in place to �protect the public from any remote theoretical risk from BSE�: the slaughter policy and the SBO regulations.[400]
282 On 18 December MAFF held a meeting with various consumer and catering groups to discuss BSE.[401]
283 On 20 December 1995 Dr Wight forwarded Mr Eddy�s minute of 15 December to Mr W R Hageman, and copied it to Mr Robb. She asked him to provide the mortality statistics that Mr Eddy had outlined for comparison to CJD deaths.[402]
284 On 21 December 1995 Mr Forsyth wrote a letter about BSE to Mr Hogg. He copied it to Mr William Hague (Secretary of State for Wales), Mr (later Lord) Patrick Mayhew (Secretary of State for Northern Ireland), Mr Dorrell and Mr (later Baron) Ian Lang (President of the Board of Trade[403]). He suggested that SEAC be encouraged to �set out publicly their scientific opinions� so putting the Government in a �strong position to argue that our policy on BSE is similarly based on the best available scientific and medical advice�.[404]
285 Secondly, he pointed out that there were �persistent rumours that the total scientific effort on BSE is being weakened. It is coupled with the unfounded assertion that we have something to hide.�[405] He noted that this was not helped by organisational and funding difficulties in the BBSRC/ MRC Neuropathogenesis Unit (NPU). Mr Forsyth told the BSE Inquiry:
�it was becoming more and more difficult to fend off allegations that information was being suppressed and things of that kind. That underlines how difficult it is to deal with a public health issue in the context of normal politicals and the media. One of the suggestions I made� which I think is quite important, and I am in no way criticising either the Prime Minister or the then leader of the Opposition, but it would have been so much better if in dealing with this we could have had an all party approach�
�So one of the lessons I take from this is that it is extremely difficult to deal with these very sensitive public health issues in the context where people are wanting for other reasons to present Ministers as being driven by a considerations which will lose them support. I think that is the most difficult thing. And if we -- if your Inquiry were to encourage people in the future to develop that kind of approach, I think it would be a very much more sensible way to go about our business.�[406]
286 Mr Hogg replied to Mr Forsyth on 17 January 1996 (see below).[407]
287 On 21 December 1995 Dr Wight minuted Dr Calman�s private secretary about a suspect case of CJD in an abattoir worker. She copied the minute to Dr Metters, Dr Rubery, Mr Robb and Mr Clarke. �If confirmed�, she said, �this would be the first such case� There will be an opportunity for SEAC to consider possible implications, if necessary in the light of the [CJD Surveillance] Unit�s investigations, on 5 January.�[408]
288 On 22 December 1995 Dr Wight provided more information about the abattoir worker. In a minute (to the same people), she noted that the case had been reported in the Guardian newspaper.[409] She said she had spoken to Dr Will who said that it must be regarded as a �possible� case. She said that SEAC would �pick up� the case at their next meeting. There was a second case mentioned in the newspaper but the CJD Surveillance Unit did not know about this.[410]
289 On 22 December 1995 there were various newspaper reports of an abattoir worker being admitted to hospital with symptoms of CJD.[411]
290 On 22 December 1995, Dr Walford wrote to Dr Calman to tell him what had transpired after an afternoon that Dr Will had spent at the PHLS examining the SSPE database. She informed Dr Calman of a proposed informal meeting between herself, Dr Will, Professor Smith, and �one or two� PHLS consultant epidemiologists, �to exchange ideas about possible study designs�.[412] Dr Calman responded on 12 January 1996 (see below).
Contingency Planning
291 Dr Rubery told the BSE Inquiry that the cases of CJD reported towards the end of 1995 alerted her to the fact that �the evidence base for the policy was changing�. [413] By the end of 1995, she felt that if more cases of CJD in teenagers were identified �this would further undermine the evidence base for SEAC�s advice about the absence of a relationship between BSE and CJD�.[414]
292 Around November 1995, Dr Rubery had therefore discussed the situation with Mr Hart (DH Permanent Secretary). They agreed that Dr Calman had a leading role to play and that Dr Rubery and her staff needed to continue to support him as fully as possible. They also agreed that Dr Rubery needed to be able to support Mr Dorrell if a greater need developed for advice beyond the medical aspects.[415]
293 At the end of 1995 or the beginning of 1996,[416] Dr Rubery spoke over the telephone to Mr Carden to discuss forward planning:
�I did say to him, �It looks to me as if it is conceivable that if another case turns up of CJD in a teenager, then it is going to be difficult for SEAC to continue to say there is no link; should we meet to develop a plan and see how we should take things forward in the longer term?�, but he was adamant we could not do that. He felt that if anybody discovered that we were meeting, if the press got wind of this, that this would cause problems and also it would be difficult to get information from the relevant people they needed on the MAFF side to plan the consequences.
�So I did not do anything more on that side. I did continue to think about what we should do from the point of view of the Department of Health side, but most of the actions that we needed to take on that side were really relatively short-term, they were to take action once we had got the cases and therefore there was nothing more that I felt we needed to do in terms of long-term planning�[417]
��Because I have managed Chernobyl, I know how bad it can be to have to deal with these crises, so it did seem to me a bit of forward planning would be useful, but MAFF were clearly not keen on doing that. As most of the planning one needed to do was for them rather than us, it did not seem to me it was worth pushing it, if he was clear he did not want to do that.� [418]
January 1996
294 On 3 January 1996 Mr Taylor circulated the World Health Organisation�s �just published� report on public health issues related to human and animal TSEs[419], to 14 MAFF colleagues plus Dr Wight at DH. He said that its conclusions and recommendations
�are not unhelpful. The decline in the UK BSE epidemic is recorded, and there is a useful statement that �Current control policies are considered adequate to minimise the risk of exposure to BSE of all species, including humans.� The statement� that �tallow does not appear to be a risk for human and animal health� is also helpful.�[420]
295 On 3 January 1996 Mr Eddy sent a minute to Mr Hogg�s private secretary.[421] The minute was written in response to Mr Hogg�s request for advice on some of the German L�nder (Regional Governments) voting to ban the import of British beef.[422] Mr Eddy noted the possible courses of action that Germany might take, and what responses Britain could take: �The question is whether there is anything that we or the Embassy in Bonn can do at this stage to encourage the German Government to reach [the] conclusion [that would avoid any problems in Europe]. I do not think that there is.� However, if Germany introduced a law banning the import of UK beef, then MAFF should lobby the EC Agriculture Commissioner, Mr Franz Fischler at once to take legal action. Mr Eddy concluded that the British Embassy in Bonn should continue to monitor the situation closely.
296 Also on 3 January 1996, Mr Don Curry, Chair of the MLC, wrote to Dr Rubery with an MLC �briefing paper�, which Mr Curry hoped she might �find useful when addressing this and related issues�.[423] The briefing paper began �British beef is safe to eat.� It went on to quote from various scientists, and quoted Sir Kenneth Calman as being satisfied that �there is no scientific evidence of a link between meat eating and CJD and that beef and other meats are safe to eat�.
297 Mr Mike Skinner (DH, HEF1C Division, had replaced Mr Lister as SEAC Secretariat) drafted a reply for Dr Rubery on 15 January 1996 (see below).
SEAC Meeting 23
298 On 5 January 1996 SEAC held its 23rd meeting.[424] This was the first SEAC meeting for several new members.[425] Present were Professor Pattison, Dr Will, Professors Almond, Brown, Collinge and Smith, Messrs Bradley and Pepper, and Drs Hueston, Kimberlin, Painter, and Watson. Observing were Dr Matthews (MAFF) and Dr Wight (DH), and from the Secretariat were Messrs Eddy (MAFF) and Skinner (DH). �In attendance� were Mrs M Wilson (BBSRC), Dr Dukes (MRC), Mrs Gurnhill (MAFF) and Mrs Townsend (MAFF).
299 A number of items were discussed, including publicity and dealing with the media, gelatin, MRM, tallow, a paper that had been written by Dr Stephen Dealler (a consultant microbiologist at Burnley General Hospital), blood transfusions, update on the CJD situation, human growth hormone and scrapie, an MRC workshop, research update and priorities, and the questions that had been put to SEAC by MAFF.[426]
300 Dr Will �reaffirmed that the incidence of CJD in dairy farmers in Europe showed an excess over the incidence for the population as a whole except in the Netherlands�.[427] He also �confirmed that there is now a CJD suspect in a 52 year old� who had a history of having been an abattoir worker�.[428] Professor Smith commented that
�taking into consideration the affected farmers as well, and even though the abattoir worker was in an apparently relatively low risk category, the �box� of �at risk� occupations was getting full compared to expectation on pure chance, and could not be dismissed�.[429]
301 In addition, Dr Will reported that he was worried about the number of cases in those aged under 30, over a very short period:[430]
�Between 1970 and 1989 there had been no cases under 30 except for those due to growth hormone treatment. Since 1990 there have been four definites and one possible. These comprised the 17 and 19 year olds which were already published, a 29 year old diagnosed on the basis of cerebral biopsy, a 29 year old diagnosed post mortem and a 29 year old who was still alive and classified as no more than �possible�. There were also a 30 and 38 year old confirmed and a 35 year old suspect, who now looks unlike CJD. In one of the 29 year olds and the 30 year old the pathology is unique with very extensive plaques in both the cerebellum and cerebral cortex and Dr Will considered there is a very high chance that these two are genetic.�[431]
302 Dr Kimberlin asked whether the lack of previous cases had been due to misdiagnosis. Dr Will thought this unlikely because the �the disease was unusual in the young�. He had ruled out the possibility of misdiagnosis as sub-acute sclerosing pan-encephalitis (SSPE): he had �checked through 35 cases of suspect but negative SSPE and had found none which looked like CJD��[432]
303 Dr Will reminded the Committee that if two of the cases in young adults were genetic then the figures were perhaps not so worrying at this stage, given the fact that there had been two in France although over a 15 year period and two in Japan and other cases reported in the Netherlands and Australia under 30.[433]
304 Professor Collinge was �extremely worried at the occurrence of this number of young cases in such a short period, which could suggest a link to BSE. He requested that a formal statistical analysis be carried out to assess this further.�[434]
305 SEAC concluded that �the situation demanded the continuation of the intensive monitoring of CJD�.[435]
306 As a result of the December 1995 media interest in BSE and CJD, Mr Hogg had put nine questions to SEAC, mostly relating to the safety of beef.[436]Members agreed that �individual members might be asked to give some thought to individual questions with a view to circulating draft replies� before a further meeting at the end of January�.[437] These were in fact discussed at the next meeting on 1 February 1996.
307 That day (5 January 1996), Ann Richardson died of what was later diagnosed as nvCJD.[438]
308 On 9 January 1996 Dr Wight minuted the private secretary to Sir Kenneth Calman (he had now been knighted) about the SEAC meeting of 5 January.[439] She copied the minute to Dr Metters, Dr Rubery, Mr Skinner and Dr Skinner. She summarised �the main agenda items discussed.� First was
�CJD Update � There have been 5 definite and one possible case of CJD in individuals aged 30 years or under in the last 4 years (though two of these may be genetic cases). Although this is a significant increase over the incidence in the UK in this age group during the preceding surveillance period, it is not without precedent worldwide. The Committee will be provided with a more definite statistical analysis, from Professor Smith, at its next meeting.�[440]
309 She also summarised the two other main agenda discussions: a theory about human Growth Hormone (hGH) and scrapie, and research priorities.
310 Also on 9 January 1996 Mr Skinner minuted Baroness Cumberlege�s private secretary about a Parliamentary debate on BSE and CJD which was to be held on 10 January. He copied the minute to Mr Horam�s private secretary, Dr Wight, Dr Render and Mr Robb. He attached a Q & A briefing for use during the debate. It was addressed to Mrs Browning, and covered CJD (general), Government action on CJD (including research), CJD incidence and surveillance, BSE and CJD risks to human health, and CJD deaths in four farmers and two teenagers and an abattoir worker.[441]
311 On the possibility of a CJD epidemic, the answer was that the
�CJD Surveillance Unit will need to continue for a number of years before producing conclusive results. There is no evidence to date of an emerging CJD epidemic. The CJD Surveillance Unit has so far found no evidence of any change in CJD that can be attributable to BSE, nor is there any other current scientific evidence that BSE can be transmitted to humans�.[442]
312 The briefing went on to state the measures that were in place to protect public health: the slaughter of suspected cattle, destruction of their milk, and the SBO ban. The briefing said that these �were in line with, or more restrictive than, the WHO and OIE recommendations and have been approved by the European Commission�.[443]
313 It also said, that there was �no current scientific evidence� BSE could be transmitted to humans or that eating beef causes CJD.
�Specifically, all the studies to date on transmission have shown that beef is safe. There is no epidemiological evidence of transmission from beef to humans or of transmission when muscle (meat) from cattle clinically affected with BSE is injected into mice.
�The Chief Medical Officer has recently reiterated previous assurances that if any new evidence comes to light that BSE could transmit to humans, he will bring it to the public�s attention�.[444]
314 On the four farmers, two teenagers and the abattoir working, the briefing stated that it was not yet possible to reach conclusions.[445]
315 At a meeting on 9 January 1996, the UK CMOs discussed BSE and CJD �lines to take�. Under the heading �CJD and teenagers� the note of the meeting stated:
�It is not possible to draw conclusions about the cases of two teenagers recently reported in the Lancet because cases of sporadic CJD in teenagers, although rare, have been found in other countries before the appearance of BSE and the two cases had no exposure to risk factors for CJD and no contact with BSE�.[446]
316 On 10 January 1996, Mrs Richardson�s death was reported in the press as �suspected CJD�.[447]
317 On 10 January 1996, Dr Metters wrote a minute to Dr Calman in relation to Dr Walford�s letter dated 22 December 1995. Dr Metters said that Dr Walford�s letter �contained the broad hint that PHLS should be brought in to advise the CJD Surveillance Unit and SEAC on the epidemiological studies of CJD�. He continued:
�This is not the first time Dr Walford has sought to involve PHLS in Spongiform Encephalopathy research. Yet the experience of recent weeks has shown how important it is for the Government to have a single source of independent scientific advice. With this in mind I have drafted the attached reply which is slightly stronger than Dr Wight�s initial draft.�[448]
318 On 12 January 1996 Sir Kenneth Calman responded to Dr Walford�s letter of 22 December 1995.[449] On the proposed epidemiological meeting, he said:
�When we previously corresponded about the Government�s sources of scientific advice on prion disease, I emphasised the importance to DH and MAFF of having, in SEAC, a single source of independent advice. Given that SEAC�s membership has been specifically strengthened epidemiologically by Peter Smith�s appointment, I think it would be preferable for SEAC to decide whether it requires further help over study design before an informal meeting is arranged between any of your consultant epidemiologists, Bob Will and Peter Smith.
�You may also know that SEAC have been asked to take stock of their research recommendations. This will provide an opportunity for the Committee to review the human epidemiological data provided for them by Bob Will�s unit.�[450]
319 Dr Walford therefore cancelled the meeting (see 19 January below).
320 On 12 January 1996 Mr Packer, Mr Carden, Mr Hollis and Mr Hayward met Mr Maclean (MLC) and Mr Glyn Howells (MLC Marketing Manager). They discussed recent statistics showing a drop in beef sales, and market analyses that had been done.[451]
321 The MLC �felt that urgent PR action was required�.[452] In addition to �conventional� promotion (advertising), they said that the �strategy on putting positive messages into the public domain was more complex�. The MLC proposed �a seminar to educate a range of scientists on BSE and the risks�, �a more proactive approach to schools through the Local Education Authorities [LEAs], especially those which had banned beef�[453], and �mechanisms to educate GPs�.[454] Mr Packer �told Mr Maclean that he would write to the Minister explaining the MLC�s position and that he was prepared to consider the seminar and a fresh approach to the schools. It was, of course, important to monitor the situation in the next few weeks�.[455]
322 Later that day Mr Packer minuted Mr Hogg on three issues, and copied the minute to Mrs Browning, Mr Hadley, Mr Carden, Mr Hollis, Mr Meldrum, Mr Haddon, Mr McNeill, Mr Eddy and Dr Render. First, he informed Mr Hogg that the Government of Ireland �wanted to run an advertising campaign for beef in the UK (without any differentiation of origin of the product)�.[456] Second, he informed the Minister about the meeting earlier that day with the Director General of the MLC.[457] Third, he alerted him to �new evidence of seemingly widespread fraud over BSE status by slaughterhouses producing beef for export from cull cows.� (A cull cow is an old or poor quality dairy cow which is removed from the herd and sold for slaughter.[458]) Mr Packer said
�This is likely to hit the newspapers soon, causing both a renewed spate of press interest in BSE, as well as firing concern in Europe. I cannot say I am surprised. The existing EC rules on UK beef virtually constitute an incentive for fraud. So do Irish national rules. Fraud in both the UK and Ireland is therefore not unexpected. However, the discovery of fraud now is very awkward especially as the profile of BSE was fading somewhat.�[459]
323 On 15 January 1996 Mr Skinner drafted for Dr Rubery a letter to Mr Curry, in response to the MLC letter of 3 January 1996. In his covering note to Dr Rubery, Mr Skinner noted that the MLC paper �takes a very strong pro-safety of beef line and overstates the weight of interim conclusions from current scientific evidence.�[460] He said that the paper mentioned Professor Pattison, Dr Will and Professor Collinge
�in a way which appears to associate them with the conclusions in the paper. We do not feel these are altogether legitimate and they may well agree. The best way forward would be to let them have copies of the briefing paper and invite them to comment.�[461]
324 Mr Skinner recalled that the MLC had
�misquoted CMO�s advice to their advantage in a newspaper advert before Christmas for which they subsequently sent CMO written apologies. They have misquoted him again and also relied on an announcement which has since been superseded�.[462]
325 Dr Rubery sent the response to Mr Curry on 18 January.[463] Mr Skinner sent the MLC paper for comment to Dr Will and Professors Pattison and Collinge on 12 February 1996.
326 On 16 January 1996, Mr Hogg met Mrs Browning, Mr Packer, Mr Meldrum, Mr Eddy, Mr Osborne, Mr Carden, Mr Hollis, Mr Haddon, Mr Taylor, Mr Kent, Mr McNeill, Mr Soul, Mr Corbett and Dr Render.[464] In discussion of the possible fraud in slaughterhouses, Mr Hogg:
�3.�� �agreed that our initial line should be to say that if the police had any evidence of fraud, they should ensure that that [sic] evidence was passed on to the appropriate authorities. We should not interfere in the process in any way. We could add that it would be helpful if we were informed of any decisions on this matter taken by the police or other relevant authorities.
�4.�� On our current controls, Mr McNeill said that OVSs [Official Veterinary Surgeons] took great care to check the validity of declarations. However, this was a very difficult task. Mr Haddon said that it had been agreed to have a thorough look at our checks to see whether they could be tightened up. You said that we would almost certainly have to be able to show the Commission and the Germans that we had introduced some substantive changes. Mr Meldrum said that we might be able to do more to ensure that ear-tags and declarations matched up or to trace back the declarations themselves. We were discussing this with the MHS. In the meantime, we would step up our checks on ear-tags. The Minister agreed that we had to address these issues. He asked for a package of proposals to be put forward to Mrs Browning, including advice on how to handle the Germans and the Commission and on the line to take in public in the meantime (Action: Mr Eddy). Mr Haddon commented that we would also need to address the question of who would bear the costs of any additional checks.
�5.�� It was agreed that we would not call in the industry for a meeting, at least until the police and others had followed through their current inquiries. Mr Meldrum commented that our increased checks on ear-tags would themselves convey a message to the industry.
�6.�� Mrs Browning said that there were signs that the prime beef industry was becoming increasingly irritated by problems which were largely the fault of the cull cow trade. Mr Taylor said that some would argue that cull cows should not go for human consumption. [Mr Eddy] stressed the importance of this trade for the economics of the dairy industry and the heavy cost of taking all cull cows off the market at taxpayers� expense. [Mr Packer] said that there would also be considerable difficulties with the disposal of large volumes of carcases.�[465]
327 In discussion of the MLC�s proposals, the Ministers did not want to back a seminar for scientists.[466] They agreed that contacts with LEAs should be followed through with further written material and oral briefings if necessary.[467] �Mr Hogg concluded as follows:�
�(i)�� [MAFF�s] principal role was to put factual information into the public domain. We should take opportunities to repeat the press conference we had held in December. This could be done, for example, at the launch of the next six-monthly report, or when we published the answers to our questions to SEAC;
�(ii)� we should not be involved with the MLC campaign. However, we should be prepared to support a bid to Brussels for EU money;
�(iii) we should prepare an up-to-date pack of written briefing material. [Mr Eddy] should discuss this with the Information Division;
�(iv) we should identify nationally particular groups where briefing would bear fruit. This would include both written material and oral briefing. The team for the latter might be Mr Kimberlin, Mr Bradley, Mr Taylor and possibly, a CJD expert. [Mr Eddy] should submit to Mrs Browning a list of the groups we should target;
�(v)� at the local level, we should, at least initially, concentrate on the LEAs. We did not for the time being have the resources necessary to provide anything other than written material for other groupings.�[468]
328 On 16 January 1996 there was a regional television programme from Harlech TV, alleging a cluster of CJD cases in Devizes. MAFF and DH were aware of the programme.[469] Mr Robb had spoken to the CJD Surveillance Unit who said they were aware of one possible case in the area.[470] He attached to a minute to Miss Thompson (ID) the line to take in response to media enquiries:
�The National CJD Surveillance Unit is aware of a possible case of CJD in the Devizes locality and is obtaining information about it. If the case should subsequently be confirmed, the occurrence of two cases in a locality would not be unusual or necessarily significant�.[471]
329 On 17 January 1996 Mr Hogg replied to Mr Forsyth�s letter of 21 December. He noted:
�It seems that the media furore over BSE has now died down, in part at least as a result of our efforts to ensure that a clear and detailed explanation of the scientific information was available. The willingness to give interviews and the comments of the Chairman of SEAC, Professor Pattison, was I think particularly helpful. This seems to have bought a more balanced and considered approach from at least some in the media.
�I agree with you that we need to maintain a strong scientific base to all our BSE policies. This applies both to the advice we receive, where the newly appointed members of the SEAC will increase that Committee�s breadth of skills and knowledge, and in our research programme. Let me reassure that research on BSE remains one of MAFF�s highest priorities. This is shown by the fact that we are increasing our funding in this area by �1 million to �6.4 million next financial year.
�I also agree that the Neuropathogenesis Unit in Edinburgh is one of the leading laboratories in the UK working in the BSE field. It will, no doubt, be a strong contender to bid for more funds for research next financial year from the extra we will have available, although, of course, I cannot make any commitments at this stage as all project proposals will have to be evaluated in the normal way. I appreciate that the changes to the BBSRC�s funding arrangements for this Unit have caused some concern, although I am told that there will be no job losses among the scientific staff there. I also recognise that the shift in MRC funding practices might create difficulties in due course. I know that SEAC value highly the CJD strain typing which the NPU is doing, funded by the MRC, and hope to see this important work expanded. No doubt Ian Lang will be able to provide more information on the actions and plans of the two research councils over the NPU.�[472]
330 On 18 January 1996 Mr Eddy minuted MAFF�s Deputy Chief Press Officer Mr Smith and his colleague Mr Wagstaff. He copied the minute to Mr Carden, Mr Meldrum, Mr Haddon, Mr K Taylor and Dr Render.[473] He said
�It is clear from the meeting which we had with the Minister earlier this week that we need to produce a document aimed at the intelligent layman on BSE. One potential audience would be local authority education committee members who we need to persuade to drop bans on beef in schools. Very roughly I think we are talking about aiming at Telegraph rather than Times readers and at people who have an interest but not a scientific background or the inclination to wade through a large amount of technical detail.�[474]
331 He said the information pack might include: �a new version of the document �BSE and the Protection of Public Health�[475] which Mr Taylor had drafted, which again is probably a little long and upmarket for the more general reader.�[476]
332 Mr Eddy asked for the Press Office�s views on
�(a) what might go in an information pack, (b) whether we should produce such a note. There seems to be a general view amongst senior management that we should (c) if so, how do we go about doing it and (d) in conjunction with the CVO and Mr Haddon�s Groups, what it should cover.�[477]
333 On 18 January Dr Rubery sent her response to the MLC�s briefing paper of 3 January, saying that it was �in line with current Government advice� on the safety of beef. �However,� she said,
�you have misquoted the Chief Medical Officer. The statement you quote is taken from our press notice of 5 October 1995 (copy attached) and should have read �I continue to be satisfied that there is currently no scientific evidence of a link between meat eating and the development of CJD and that beef and other meats are safe to eat.� In our view, the reference should continue to be to current scientific evidence until the results of further research and surveillance become available and this may not be for some years. However, I need to also point out to you that CMO has revised his advice since 5 October 1995 and this is now set out in the MAFF press notice of 28 November 1995. Again I enclose a copy and you will see the relevant section reads: �There is currently no scientific evidence that BSE can be transmitted to humans or that eating beef causes CJD.��[478]
334 On 19 January 1996, Dr Render minuted Mr Boswell�s private secretary with a �line to take on the allegation that BSE had arisen as a result of changes to regulations as a result of the Government�s deregulatory policies� He copied the minute to the private secretaries of Mr Hogg, Mr Baldry, Mrs Browning, Lord Lucas, Mr Packer, Mr Osborne, Mr Carden, Mr Haddon, Mr Meldrum, Mr K Taylor, Mr Eddy, Mr Haslam and Mr Haywood.[479]
335 Dr Render said that it was one of the many myths that BSE was due to regulatory changes. He suggested the following line for Ministers to take:
�The contamination of ruminant feed in the early 1980s which led to the BSE epidemic was not the result of any regulatory changes introduced by the Government. A number of changes to the rendering process were introduced for commercial reasons. It is thought that these allowed the infections agent to remain active in meat and bovine meal.�
�It was not possible at that time to foresee the impact of what appeared to be relatively minor technical changes to the rendering process.�[480]
336 Dr Render noted that the changes in rendering included �a reduction in the time and temperature of rendering and also the elimination of an organic extraction step�, which had been removed for health and safety reasons.[481]
337 On 19 January 1996, in response to a request by Mrs Browning for a background note on BSE and CJD to circulate to MPs, Dr Render sent her a set of Questions and Answers plus a draft cover letter from Mrs Browning.[482] He copied it to the private secretaries of Mr Hogg and Mr Packer and to Mr Osborne, Mr Carden, Mr Haddon, Mr Meldrum, Mr K Taylor, Mr Eddy, Mr Haslam, Miss Evans, Mr Skinner and Mr Comport (Department for Education and Employment). The Qs & As were based on the note that Dr Render had circulated for use in replying to letters from members of the public (see 17 December above).
338 The note now quoted from Professor Pattison�s and Dr Will�s letter of 13 December: �If there was any risk to human health from BSE, and there may be none, then we have no doubt that that risk is very much less in December 1995 than it ever has been�.[483]
339 As a result of Dr Calman�s 12 January letter, Dr Walford wrote to Professor Smith on 19 January 1995 to cancel the plans for an epidemiology meeting,[484] and on 22 January she wrote to Sir Kenneth Calman accepting that, in light of his request, the proposed meeting should be deferred until SEAC requested additional help over the design of epidemiological studies.[485]
340 Also on 22 January 1996, Sir Donald Acheson, who had visited DH in November, wrote to Professor Pattison (who was Dean of the University College Medical School at which Sir Donald now worked part time[486]).[487] The letter was copied to Sir Kenneth Calman. Sir Donald said he had now had a chance to study the recent reports of the CJD Surveillance Unit (August 1995), the ACDP (1994) and SEAC (1994). He had also re-read the Southwood Report. He said:
�The principal point I want to make is that subsequent events have shown that the assumption made in the summary of the Southwood report in 1989� that the BSE epidemic is due to the presence of the scrapie agent in meat and bone meal fed to cattle is now less secure than it was then.
341 Sir Donald then quoted from the Southwood Report[488]:
�The epidemiological evidence suggests this new disease has appeared as a result of contamination of meat and bone meal derived from sheep offal and fed to British cattle from the early 1980s. Contamination has arisen because modern rendering practices failed to destroy the agent of scrapie, the endemic Spongiform Encephalopathy of sheep.�
342 He continued his letter:
�At that time the basis for the reassurance that we gave the public (�beef is safe�) rested on the analogy with scrapie. Thus, this condition, although it had been endemic in sheep since 1732 and sheeps� brain and offal had been freely available for human consumption; had not led to spongiform encephalopathies in man. Nor did the global distribution of scrapie bear any relation to the distribution of CJD.
�In the interim, however, it has become clear that the agent of BSE either did not originate from scrapie material in sheep or, if it did, changed in passage through cattle. Two lines of evidence point in this direction. In the first place, while there is no evidence of scrapie having transmitted to the domestic cat it became clear late in 1991 that BSE had transmitted by the alimentary route [ie. orally] to the domestic cat. Later, evidence emerged of transmission to various exotic cats in captivity. In other words the inter-species transmissibility pattern of BSE differs from scrapie�.[489]
�The second line of evidence comes from experiments using the mouse model. These confirm that there are differences between the scrapie and BSE agents. Various experiments have shown that unlike scrapie BSE appears to act as a single strain, appears to be more heat resistant and produces a different and consistent pattern of disease and incubation period in mice.�[490]
�While this does not necessarily mean that BSE is any less innocuous to man than scrapie it means that much of the reassurance which the scrapie analogy afforded and on which the original policy was based has unfortunately fallen away. Happily the potentially serious implication of the successful transmission by cerebral inoculation of BSE to primates (marmoset) in 1993 is offset by the fact that scrapie has also been transmitted to marmosets.
�In the circumstances, and bearing in mind that the small number of pathogenesis experiments using tissue from cattle provide at best a weak negative, it seems appropriate for DH and MAFF to review once more its policies in relation to BSE to see whether any further steps should be taken to protect the health of the public. The elimination of calf brain and other offal and of beef liver from food permitted for human consumption including baby food would seem to be matters for reconsideration, and there may be others�.[491]
343 On 24 January 1996, at the 25th meeting of MAFF�s Consumer Panel, MAFF tabled a paper called �BSE: the Government�s Perspective�.[492] It presented a brief history and description of TSEs, and discussed BSE in relation to human and animal health. It stated that:
�There is clearly no question of determining by experiment whether or not BSE can transmit to humans. It has been transmitted experimentally by brain inoculation to marmosets, a type of primate, but the incubation period is longer than for sheep scrapie which suggests that it is less easily transmitted to marmosets than scrapie, which we already know does not affect man. BSE does transmit to certain strains of experimental mice and experiments are now underway with recently developed strains of mice which have human genes as well as, and in some cases, instead of their normal mouse genes for the proteins believe to be involved in this disease. The first results of these experiments will be published shortly.�[493]
344 The paper continued:
�More than two centuries� experience with scrapie in sheep indicated that there is no link whatsoever between CJD and eating sheep meat. Indeed CJD has been known to occur in lifelong vegetarians and occurs at the same rate in the UK as in countries like Australia which are free of scrapie and BSE. Equally there is no evidence of any link between beef eating and CJD. All cases of CJD in the UK are intensively studied by the CJD surveillance Unit which publishes an annual report each summer. The number of cases fluctuates from one year to another, but early data for 1995 shows that the number of cases will be lower than in 1994. It has been suggested that one reason for the lack of correlation between scrapie and CJD in humans has been that sheep brains are not regularly consumed, but this is not the case as can be readily established by anyone with any experience of culinary practices in France and the Middle East. There is no excess of cases of CJD in countries such as France where sheep�s brains and eyeballs are often consumed as part of the diet. At one time there was a suggestion that there was an excess of CJD cases in one Middle Eastern country, attributed to the consumption of sheep�s eyes, but further work by Israeli scientists has established that this was due to a pocket of genetic disease in an extended family of Sephardic Jews who had emigrated to Israel from Libya�.[494]
345 The paper described the two control measures that had been taken in response to BSE: the slaughter policy and the SBO ban.[495] It referred to the recent cases of CJD in four farmers and two teenagers, and noted that SEAC had not changed its advice in the light of these cases.
346 The paper also discussed breaches of the SBO ban, and said
�we published the results of unannounced audit visits to slaughterhouses, which are undoubtedly disappointing in that they show that a very small number of slaughterhouses have not fully removed the spinal cord in each and every case. Ministers have made it clear that this level of performance is not good enough and that they must be able to guarantee 100% removal of spinal cord in all cases. The policing of the controls has been tightened up considerably and the industry and the enforcement authorities are in no doubt about the standard expected of them�.[496]
347 It went on to explain the ban on the use of vertebral column that SEAC had recommended.[497] It continued:
�18. The Chief Medical Officer said in November last year that there is no scientific evidence that BSE can be transmitted to humans or that eating beef causes CJD. But he welcomes the new restrictions as a prudent precaution to eliminate any risk from this source, however small. He also welcomed the Minister of Agriculture�s emphasis on the need for vigorous enforcement and noted that this further extended the precautionary measures already in place to protect human health against any remote risk from BSE. The Chief Medical Officer went on to repeat his previous assurance that if any new evidence comes to light that BSE could transmit to humans he will bring this to the attention of the public.
�19. The Chairman and Deputy Chairman of SEAC, who are both leading medical doctors, have written an open letter to Ministers to make their views clear. A copy is attached�.[498]
348 After discussing animal health measures, the paper concluded:
�This paper has been written to explain the control measures taken to protect animal and public health in the light of independent advice and a substantial ongoing research programme. Government has made it very clear that its overriding priority must be the protection of human health. Economic considerations are secondary. The control measures which have been taken are consistent with this stance.�[499]
349 Dr John Godfrey of the Consumer Panel wrote a response to the MAFF paper.[500] His final paragraph stated:
�5.�� However, these cases demand most careful consideration. CJD is a disease of the old. If BSE proves to have been able to jump the barrier species to man it can be expected to present as CJD, or a CJD-like encephalopathy, May I suggest a few initial thoughts?
������ -These cases will probably prove to have been a cluster of no discernible significance. The history of epidemiology is largely, a history of clusters that demanded attention, but deserved eventual dismissal.
������ -The putative importance of these cases has to be judged on the strength of the evidence that they are the first ones here, and among very few worldwide. If numerous cases have died without being diagnosed there is not much to worry about. This is a matter of clinical judgement, that I lack. The authors of the papers quoted write: ��it seems unlikely that CJD, and particularly cases with typical clinical presentation and histology, would have been previously missed in teenagers.� It seems likely that this statement is intended to apply only to countries with an advanced health service. That all the cases have been reported from Europe and North America may well be due to failure to diagnose other cases that died unrecognised elsewhere.
������ -If the tiny cluster is due to people having been infected, further cases are likely, perhaps many of them. It seems best for government to plan now for this highly improbable possibility. This should include: (a) taking statistical advice on what will be taken as significant evidence, leading to action (did R. A. Fisher work on an efficient test for very small samples?); (b) what advice should be given to consumers. It should the aim to get advice across to us before the predictable reactions to what would be major tragedy, but also a major news story; (c) what action should be taken, in this hypothetical situation, to make the beef that could be eaten by consumers in the future safe again. This would obviously cost a lot, and be technically difficult, but possible.�[501]
350 On 29 January 1996 Miss Jill Wordley (MAFF Consumers & Nutrition Policy Division) minuted Mr Eddy with her thoughts on �groups to be briefed about BSE�. She mentioned consumer organisations and the MAFF Consumer Panel, the disadvantages of relying �too heavily on the MLC�: �It seems to me that as far as the general consumer is concerned, the MLC are perceived as being in the �save the meat industry� camp. A better impression of impartiality might be given if MAFF organised as much as possible itself.� She also mentioned scientists, food and health writers, the internet and schools.[502]
351 Mr Eddy told the BSE Inquiry, �I don�t recall this exercise [ie. publicity] progressing further and believe that it was simply overtaken by the aftermath of the nvCJD announcement.�[503]
352 Baroness Cumberlege was �concerned about the possibility that she might be perceived to have a conflict of interest in dealing with BSE issues because of her husband�s involvement in dairy farming�.[504] On 31 January 1996, therefore, she handed over the BSE/ CJD part of her portfolio as Parliamentary Under-Secretary for Health to Mr Horam, her counterpart in the House of Commons.[505]
February 1996
SEAC Meeting 24
353 On 1 February 1996 SEAC held its 24th meeting. Present were Professor Pattison, Dr Will, Professors Allen, Almond, Collinge, and Smith, Messrs Bradley and Pepper, and Dr Kimberlin. Messrs Eddy and Skinner provided the Secretariat, observing the meeting were Drs Matthews and Wight, and �in attendance� were Mrs M Wilson (BBSRC) and Mrs Townsend (MAFF). Apologies were received from Dr Heuston, Dr Painter, Dr Watson and Dr Havercroft.
354 Dr Will updated SEAC on the suspect CJD case in a 52-year-old who had worked in an abattoir for 18 months from 1989, and who was reported to have sustained an injury while working there. He had in fact been kicked by a steer and had received no hospital treatment�.[506] Dr Will �had been advised of one possible case of CJD in a German who had worked in a abattoir for 10 years, 30 years prior to death, and of one confirmed case in France in 1995 in a man aged 59 who had worked for 36 years in an abattoir�.[507]
355 Dr Will reported that
�the 1995 incidence of CJD appears to be about 20% down on the 1994 level and updated SEAC on the now 5 pathologically confirmed individuals under 30 years of age. Three of these patients have died and 2 remain alive. Genotyping is incomplete� Two cases of CJD have been confirmed by pathology in 30-39 year olds and a further patient in this age group has pathology suggestive of GSS [Gerstmann-Str�ussler-Scheinker syndrome, a rare familial form of CJD]. Dr Will also reported a further confirmed case of CJD in a 41 year old.[508]
�2.1. In all of the cases mentioned above (except the GSS case and one where results are incomplete) there was extensive plaque formation in the cerebral cortex, cerebellum and spinal cord. An extensive and unusual pattern of PrP deposition was an unexpected finding. Dr Will reported Dr Ironside�s view that it is premature to decide that these cases are linked with BSE. Cerebellar and spinal cord plaques are evident in hGH cases. Recent findings suggested that there are 2 subsets of sporadic CJD: those with an extended duration of illness with plaques in the spinal cord and cerebellum and those with a short duration of illness which do not show these plaques. Dr Will said there were no apparent environmental factors identified, except that 5 of the 9 spinal cord positive cases had had abdominal surgery, in three cases in the 1950s/60s. None of the spinal cord negative cases had had abdominal surgery.�[509]
356 Dr Will said that
�the crucial issue is not simply the young age or pathology of recent cases but the short time scale in which 5 cases in individuals under 30 years of age had occurred� dates of onset of symptoms were February 94, May 94, June 94, January 95 and April 95��[510]
357 Professor Pattison �concluded that the unusual data on young cases is of greater concern than the cases in farmers which appeared to be classical sporadic cases with typical pathology.�[511] Professor Collinge was of the opinion that �5 cases in people under 30 years old in little over a year must be very significant in statistical terms�. Professor Smith agreed.[512]
358 Professor Collinge told the BSE Inquiry that it seemed to him that �these young cases showed a unique and remarkably uniform disease pattern. This would be consistent with their being exposed to the same prion strain. I again reiterated my concerns that this was likely to represent BSE transmission to humans�.[513]
359 Dr Will informed SEAC that he intended to publish the genetic and clinico/pathological data of the young cases soon. He agreed to show SEAC a proof copy of the paper, but it was to remain confidential and would not be for amendment by SEAC.[514]
360 SEAC decided to invite Dr Ironside to make a presentation at their next meeting.[515]
361 Mr Hogg�s questions to SEAC[516] were discussed. Professor Pattison confirmed with Mr Eddy that Mr Hogg wanted �the Committee�s views, in a publishable form to issue as a press release�.[517] SEAC went through five of the questions, but time ran out and the last four questions were postponed to the next meeting.[518]
362 The same day (1 February), Anna Pearson died of what was later diagnosed as nvCJD.[519]
363 On 2 February 1996 Dr Wight minuted Sir Kenneth Calman�s private secretary about points raised at the 1 February SEAC meeting.[520] She copied the minute to Mr Horam�s assistant private secretary, Dr Metters, Dr Rubery, Mr Skinner, Mr Sutherwood and Mr Jobson. Under the heading �CJD Update� she advised:
�(i)�� There are now 5 confirmed cases in the UK in patients under 30 years of age, all presenting in the last two years. It is likely that these will be sporadic rather than familial cases. This is clearly unusual compared with earlier data on age distribution of disease.�[521]
364 After describing the features of the disease in these cases, she continued:
�The detailed findings will be submitted for publication later in the year, and although it is premature for any conclusions to be drawn, clearly the media could make much of this in terms of BSE being responsible for a �new� type of disease pattern.
�(ii)� A paper is currently in preparation by the CJD Surveillance Unit which describes variations in the degree and site of plaque formation in a subset of cases of sporadic CJD. Again, this could be interpreted by some as signalling an aetiological link with BSE.
�Further, there are some loose similarities between the appearances in this subset and in the young onset cases, and that found in hGH recipients, where there is a peripheral route of exposure as would be the case if there was any link with sporadic disease to BSE. This could add to the possibility of misleading deductions being made when these various findings are published.�[522]
365 Dr Wight went on to summarise SEAC�s discussions on research priorities.[523]
366 On 6 February Mr Sutherwood responded to Dr Wight�s minute of 1 February. He said:
�Sounds as if we had better get together to discuss the handling of the publication of the latest data on the five UK cases under 30 years of age and relevant international comparative findings sooner rather than later!
�Pat Wilson is visiting the Surveillance Unit on 14/15 February to discuss media relations and, in particular, the merits of having someone with a full or part-time liaison role on the media front in Edinburgh�.[524]
367 On 6 February 1996, Mr Eddy circulated the information from SEAC�s 1 February meeting to the private secretaries to Mr Hogg, Mrs Browning, and Mr Packer, and to Mr Osborne, Mr Carden, Mr Meldrum, Mr Haddon, Mr Hollis, Mr K Taylor, Mr Smith, Mr Cowan, Dr Cawthorne, and Dr Render. He said that the meeting focussed mainly on research priorities and on answers to Mr Hogg�s list of questions. However, SEAC had not reached a final conclusion on the questions, and they would continue to answer them at their next meeting on 8 March.[525]
368 Mr Eddy said that Dr Will was preparing two papers for publication, the first of which
�3.�� �describes the fact that using modern biological techniques, they have identified two distinct subsets of Creutzfeldt-Jakob Disease. In one form the disease appears restricted to specific parts of the brain. In the other form disease is more widespread and is found in the spinal column, and shows similarities to CJD in recipients of growth hormones. The conclusion which some of our critics will draw, although there is no evidence, is that the form of CJD with the widespread spongiform appearance represents the kind of disease which can be �caught� and that those who have this form of disease and have not had any form of medical intervention may have caught it from cattle. Dr Will�s paper will not say that but others will try to interpret it in that way.
�4.�� The second paper which has not yet been drafted, looks at the five cases of CJD which have now been confirmed in patients aged under 30. All five cases look the same under the microscope, with extensive plaques in both the cortex and cerebellar parts of the brain and in the spinal cord, which is an unexpected finding, and may relate to age of onset. Again, the analogy will be drawn by our critics between these cases and those described in the first paper with more extensive spongy appearance in the spinal cord and the suggestion is likely to be made that the five young cases again represent a new form of the disease which, by extension, can be �caught� and was no doubt caught from cattle. These are major leaps of logic but cannot be ruled out on the basis of the available evidence. It is far too premature to draw any conclusions and much work needs to be done on previous cases in the UK and on cases from abroad��[526]
369 Mr Eddy said that SEAC would give Agriculture and Health Ministers a formal opinion on the implications of the second paper, probably in the Spring.[527]
370 Mr Hogg told the BSE Inquiry that he believed that at this time he was already aware of two cases of CJD in young people.[528] He does not recall discussing SEAC�s concern with DH.[529]
371 Mrs Browning told the BSE Inquiry that she and Mr Hogg �were concerned [at Mr Eddy�s minute] but clearly there was more scientific work needed to give specific advice to Ministers�.[530]
372 Mr Carden said that for more than a month after Mr Eddy�s minute of 6 February 1996, the tentative indications from SEAC's meeting on 1 February were all that officials had to go on.[531] Mr Eddy did not update the 6 February information until his minute on 12 March 1996 (see below).
373 Mr Carden said that those who received Mr Eddy's 6 February minute
�were aware that we could be on the edge of a very far-reaching change in the picture we had of BSE. My recollection is that from then on until SEAC reached a concluded view on 20 March 1996, we felt in a state of high alert. We - I am referring to myself and the circle of people within Government to whom the news at that stage was deliberately confined - paid extremely close attention to each new indication from the leading experts. But for more than a month the tentative indications from SEAC's 1 February meeting were all we had to go on. The hints of bad news remained tentative, and we lived in suspense�.[532]
374 Mr Carden said that from about 6 February 1996 MAFF officials were �thinking closely about the worst case� with Ministers.[533] This thinking did not take a concrete form because �there was not much basis for thinking, usefully, about things that would have to be done if the worst case conclusion was reached.�[534]
375 On 8 February 1996, Peter Hall died of what was later diagnosed as nvCJD.[535]
376 On 12 February 1996 Mr Skinner forwarded to Dr Will, Professor Pattison and Professor Collinge the briefing paper that the MLC had sent to Dr Rubery on 3 January. In his cover letter, Mr Skinner summarised Dr Rubery�s response of 18 January to the MLC, in which she said that their paper was in line with current Government advice on the safety of beef and that the quote from Sir Kenneth Calman should have read �there is currently no scientific evidence that BSE can be transmitted to humans or that eating beef causes CJD�.[536] Dr Will replied on 23 February 1996; see below.
377 On 14 February 1996 Mr Baldry met the Mauritian Minister of Agriculture. He received a briefing at the meeting dated 12 February from Mr D V Orchard of MAFF�s International Relations & Export Promotion (IREP) Division, copied to Mr Packer�s private secretary, to Mr Hadley, Mr Hepburn, Ms F Proctor (ODA), Miss A Blackburn (STOP), Dr Render, Mr Roberts (IREP) and Mr Griffin (IREP).[537] The �line to take� included the statement that �British beef is safe to eat. There is no scientific evidence which suggests that British beef is a risk to human or animal health�.[538]
378 In a 14 February submission from Mrs Jane Brown (head of Meat Hygiene Division, MAFF), Mrs Browning was invited to sign the proposed Fresh Meat (Inspections for the Treatment of Specified Bovine Offals)(Charges) Regulations 1996, requiring the meat industry to pay for enforcement of the SBO controls. Mrs Brown noted that these proposals were opposed by the industry.[539]
379 Peter Hall�s death was reported in the newspapers on 15 and 16 February.[540]
380 On 15 February 1996 Dr Wight minuted Mr Clark (ID) about another young case of CJD. She copied the minute to Dr Metters, Mr Skinner, Mr Robb and Mr Jobson. She said that
�1.�� A 30 year old man has been confirmed as having died from CJD in Belfast. Apparently the parents are very upset and, according to MAFF sources, are driving a publicity campaign. There is to be an inquest imminently, at which the coroner may be sympathetic to the parents� concerns and take the opportunity of raising various issues (re: BSE?) publicly.
�2.�� There are no factors of note in the man�s history (though he spent two days observing abattoir practices 9 years ago as part of his training as a food engineer).
�3.�� SEAC will be considering fully the recent cluster of young onset cases at their next meeting (this man is not one of the five under 29-year-olds referred to in my minute of 6 February). I hope that we will then be in a position to draw on SEAC�s advice with respect to the significance of cases in this age group and any public health implications.
�4. � In the meantime there is not much we can say, other than that the case is being fully investigated, and offering sympathy to the family�.[541]
381 In a minute dated 16 February 1996, Mr Skinner informed Mr Horam�s private secretary of the death of Peter Hall, and of the involvement in his case of the CJD Surveillance Unit and Dr Harash Narang (a scientist formerly of the Public Health Laboratory Service (PHLS)). The minute said that diagnosis �may take up to 10 weeks� because of the time needed to fix the brain tissue. The minute was copied to the private secretaries of Mr Dorrell and Sir Kenneth Calman, Dr Metters, Dr Rubery, Dr Skinner, Dr Wight, Mr Wilson (ID) and Mr Eddy (MAFF).[542]
382 The same day, Mr Eddy minuted Mrs Browning�s private secretary with some background about the case. He copied the minute to the private secretaries of Mr Hogg and Mr Packer, and to Mr Osborne, Mr Carden, Mr Haddon, Mr Meldrum, Mr Taylor, Mr Smith (Press Office), Dr Cawthorne, Dr Matthews, Dr Render and Dr Wight.[543]
383 On 17 February 1996, Alison Williams died of what was later diagnosed as nvCJD.[544]
384 On 20 February 1996 the Parliamentary Food and Health Forum held a meeting at the House of Commons.[545] The topic of discussion was �BSE and CJD � The Current Situation�. Speakers were Dr Will and Dr Dealler. Mr K Taylor from MAFF was present. Dr Will
�opened by saying that the theoretical risk of BSE to the human population was judged to be remote by the Southwood committee in 1989� current evidence did not suggest any definite change in the pattern of CJD that could be attributable to BSE, but it would be many years before such a change could be finally excluded�.[546]
385 In discussion of CJD Surveillance, Dr Will said that
�5.�� �there was no overall change in the age-specific incidence of CJD in the UK, and that the incidence of CJD amongst farmers showed no mechanism for the transference of BSE�
�6.�� �while current information was reassuring, any risk to man from BSE might not be evident for some years, although there was currently no proof of a link between CJD and BSE�.[547]
386 Dr Dealler spoke next, about BSE and the risk to humans. He said that there was a 70% chance of BSE being transmitted to humans.[548] When asked about this, Dr Will said that �the 70% was important, and that there was confusion between methods of transmission � transmission between species required a large dose of infectivity�.[549]
387 Also on 20 February 1996, Mrs Browning met Mr Hogg to discuss Mrs Brown�s submission of 14 February. They expressed their concern that the Regulations (to charge the industry for enforcement of SBO controls) might cause difficulty when laid before Parliament, because of �widespread opposition� to them.[550] They decided to examine the consequences of not proceeding with the Order.[551]
388 On 22 February 1996 Mr Colin Smith, MLC Press and Industry Relations Manager sent a �BSE News Update� to �All Industry Organisations�, to �bring� you up-to-date with recent MLC activity to defend the industry against damaging BSE publicity�.[552] In his covering letter, he said that he had attended the meeting on 20 February, where Dr Will
�gave a reassurance that beef is safe to eat. He confirmed that CJD cases were lower in 1995 than 1994, that there is no evidence that CJD is linked to occupation or diet and that the two confirmed cases of CJD in young people in the UK are not unique. There are, in fact, eight other known cases in teenagers around the world, including three in Poland��[553]
389 On 23 February 1996 Dr Will replied to Mr Skinner�s letter of 12 February about the MLC�s briefing paper. He said:
�My view is that there is a remote theoretical risk that BSE in cattle might cause disease in humans. The risk from beef and beef products is likely to be negligible provided statutory measures are fully enforced. I would also agree with the statement that there is currently no scientific evidence that BSE can be transmitted to humans or that eating beef causes CJD.[554]
390 On 23 February 1996, Mr Hogg�s private secretary informed the Cabinet sub-committee ECD(P) about the regulations discussed on 20 February, and MAFF�s public line that �it is quite proper for the industry to pay for the enforcement of these controls, which are essential for the maintenance of public confidence in British beef�.[555]
391 Mr Packer told the BSE Inquiry that �the possibility of charging was overtaken by the events following 20 March 1996�.[556]
392 On 23 February Dr Render circulated a revised version of his Q&A note for use in answering correspondence. He sent it to MAFF Regional Directors and to the State Veterinary Service (SVS) throughout the country �to allow them to use as they saw fit in response to public enquiries on BSE they might face�.[557] The note was similar to the one described at 19 January above.
393 On 27 February 1996 Mr Robb faxed Dr Will about the CMO�s report for 1995.[558] He asked him for any further comments on the contribution to the report on the National CJD Surveillance Unit. This was followed up by Mr Skinner on 29 February, when he visited the Unit. Mr Skinner told Mr Robb that Dr Will was content with the contribution �provided report covers up to 31/12/95 only�.[559] The contribution said:
�In 1995, there were 34 deaths from CJD (29 sporadic cases and 4 iatrogenic cases � see Table [ ]). The number of sporadic cases represents a significant decrease on the 1994 figure of 59 cases although this remains provisional until the 1995 data is finalised. The make up of cases recorded included the fourth farmer and the first teenager to have died from CJD in the UK. A second case of CJD in a teenager was confirmed in 1995, but the patient remains alive. These cases are unusual but not outside the bounds of probability�.[560]
394 Dr Will followed this up with a fax to Mr Robb on 4 March 1996 (see below).
395 In February 1996 MAFF reissued two booklets that had been revised, called �BSE and the Protection of Human Health�[561] and �BSE and the Protection of Animal Health�.[562] Mr Kevin Taylor had originally drafted these booklets in August and October 1994, respectively.[563] According to Mr Taylor, �the original impetus for writing these was my perception that some practising veterinary surgeons had little understanding of the measures which were being taken or the rationale for those measures�.[564] The Animal Health booklet had been revised in April 1995[565] and both had been appendices to the May 1995 Progress Report to Office International de Epizooties (OIE).[566] They had now both been revised again, at the request of Dr Render.[567]
396 Mr Taylor told the BSE Inquiry that the booklets were �withdrawn from general use after the events which followed the announcement about nvCJD in March 1996�. See 13 March below.[568]
397 On 29 February 1996, Dr Wight minuted Dr Metters, copied to Mr Horam�s assistant private secretary, Sir Kenneth Calman�s private secretary, Dr Rubery, Dr Skinner and Mr Skinner. She said:
�1.�� Dr Rubery, Mr Skinner, and I met MAFF officials yesterday and one item we discussed was how to address public concerns about BSE.
�2.�� MAFF have produced a detailed �information note� for consumers, industry, food writers etc., which the Department has had an opportunity to comment on and which takes account of comments made by the MAFF Consumer Panel.
�3.�� The attached leaflet is a distillation of the main points for easy consumption, and intended for wide distribution. We considered there was some merit in the leaflet being issued jointly by both Departments��[569]
398 The attached draft leaflet was entitled �British Beef and BSE: The Facts�. On its front page it stated:
�Two facts should be made absolutely clear at the outset:
�Fact 1�������� There is currently no scientific evidence to indicate a link between BSE and CJD.
�Fact 2�������� The independent expert committee set up to advise the Government on all aspects of BSE is satisfied that British beef is safe to eat.�[570]
399 The draft leaflet went on to list a series of questions and answers about BSE.[571]
400 Mr Carden told the BSE Inquiry that the work on publicity material was concluded in the early part of 1996 and went to Ministers �on the precise day when the first report suggesting there was new variant CJD came through and it was overtaken�.[572]
Early March 1996
401 On 1 March 1996, Dr Metters minuted Dr Wight expressing his concerns about MAFF�s proposed publicity information on BSE.[573] He copied the minute to Mr Horam�s assistant private secretary, Sir Kenneth Calman�s private secretary, Dr Rubery, Dr Skinner and Mr Skinner. He was �not in favour of DH being co-authors of the documents�. He said
��some statements are too definite and in time may be seen to be wrong. We should not follow MAFF�s hyperbole of reassurance. We must leave DH Ministers and CMO in particular, an escape route if any of these categorical statements turns out to be WRONG.�[574]
402 At the end of November 1995, MAFF had announced its decision to ban the use of vertebrae in the manufacture of MRM (see above). Around 1 March 1996 a food company obtained leave to seek a judicial review of this decision.[575] The MAFF Press Office was getting enquiries. Mr Eddy informed them of the line to take (that he had agreed with MAFF�s Legal Department) and copied it to MAFF Ministers and officials and territorial officials:
��The decision to introduce this legislation was based on independent advice from [SEAC]. It is intended to protect consumers against any possible risk which might arise a as result of the use of bovine vertebrae in the production of MRM if small pieces of spinal cord were not fully removed from those vertebrae. The Ministry is confident that the action it has taken is fully proportionate reasonable and legal both in terms of UK and EC law.�[576]
403 On 4 March 1996 Dr Will faxed Mr Robb with a table for inclusion in the CMO�s 1995 report. The table showed the incidence of sporadic, iatrogenic and familial CJD, and GSS, for each year from 1985 to 1995. In his covering letter Dr Will said �I take it that the CMOs report [sic] addresses data in 1995 because there have been developments in 1996 which may alter the conclusions particularly in relation to young cases�.[577]
Friday 8 March 1996
SEAC Meeting 25
404 On 8 March 1996 SEAC met. Present were Professor Pattison, Dr Will, Professor Almond, Mr Bradley, Professor Collinge, Dr Hueston, Dr Kimberlin, Dr Painter, Mr Pepper and Professor Smith. Dr Matthews (MAFF) and Dr Wight (DH) were observers. Messrs Eddy and Skinner were there (MAFF and DH Secretariat). Also attending were Dr P Dukes (MRC), Dr P Grimley (MAFF), Dr Ironside (CJDSU), Mr Jobson (DH), Mr Robb (DH), Dr Rubery (DH), and Mrs Wilson (BBSRC). Apologies were received from three members: Professor Allen, Dr Fred Brown and Dr Watson.[578]
405 The meeting was largely taken up with a presentation by Drs Will and Ironside about the �new variant� CJD cases.[579] Dr Will
�drew the Committee�s attention to the 12 confirmed or possible cases of CJD in people under the age of 40. 9 of these cases had been confirmed� All these cases had onset dates since 1994 except one which had an onset date of 1991. Apart from one case in the 1960s, there had been no confirmed cases of sporadic CJD in people under 30 before 1995. Over the last six months, there had been five such cases. The duration of illness in these cases in young patients had been more prolonged than in previous sporadic cases. The EEGs in all except one case were unusual. There was genetic evidence in 7 cases of which all except one [were] negative for genetic mutation��[580]
406 Dr Ironside distributed his paper on the neuropathology of eight[581] of the cases. The paper said
�A subset of adults with CJD has been identified with the following features:
� �Young age at onset
� �Tendency to a long duration of illness
� �No PrP gene mutations (Most are MM at codon 129)
� �Characteristic neuropathology with �florid� plaques throughout the brain � not previously identified by the CJD Surveillance neuropathology project
� �Extensive PrP deposition with multiple plaque morphologies combined with pericellular and diffuse deposition � not previously identified in the CJD Surveillance neuropathology project�.[582]
407 The paper raised the question whether these cases constituted �a new or hitherto unrecognised variant of CJD�.[583]
408 Dr Ironside told the BSE Inquiry that the evidence he presented to SEAC emphasised that although florid plaques are characteristic of �nvCJD�, they are not the only unique pathological features. Other features, particularly pericellular PrP deposition, were also said to be characteristic and unique to �new variant� CJD.[584]
409 Dr Will told the meeting that the Surveillance Unit had found that
�there appeared to be two distinct subsets of sporadic CJD cases. The first with extended duration of illness with plaques in the brain and spinal cord, and the second with a short duration of illness which did not show these features. The presence of plaques in the spinal cord might be related to the extended duration of illness which allowed time for centrifugal spread of PrP down the spinal cord.�[585]
410 Dr Will reported that the Surveillance Unit had compared the young cases with the 17 cases that had been found worldwide since 1965 in patients under 30 years old. �The clinical features and the duration of illness were variable� There were no plaques recorded except in the case of a 27 year old� which could have been GSS�.[586]
411 Drs Will and Ironside concluded that the young cases in the UK �could be� a new form of CJD. They preferred the results to remain confidential until they were published (in a peer-reviewed journal), but they �would be prepared for them to be made public now should the Committee and Government consider that necessary�.[587]
412 Dr Ironside left the meeting after lunch and was not party to SEAC�s further discussions.[588]
413 After discussion, SEAC expressed the following views:
(i.) Professor Collinge said that �the findings suggested that there was a new risk factor for CJD which may be BSE, and that the existing public health precautions should be reviewed�.[589]
(ii.) �Several members queried whether these cases could have been identified because of increased ascertainment [ie. increased referrals because of increased awareness] and whether this new form of CJD could have been present, but unidentified, in the population for some time�. Dr Will did not believe so �because there had been growing awareness of CJD among neurologists over a number of years and in some of these cases identification had not been straightforward and mainly by neuropathology�. Dr Ironside noted that the pathology here was different to the young cases abroad.[590]
(iii.) Dr Kimberlin suggested the need for a �quantitative risk assessment based on information from the meat industry about the extent to which [SBO] had entered the human food chain since the advent of BSE and possible risk exposures of these young CJD cases�. It was said that �one new control measure might be to prohibit tissues from older cattle, which were known to have higher titres of BSE in the central nervous system, from entering the food chain�.[591]
(iv.) Several members said that �young cases of CJD should be investigated further to identify any other potential risk factors such as pharmaceuticals, for example, and indicated concern about sheep which had been fed the same infective feed as cattle� The Secretariat should commission a paper on the use of meat, offal and other tissues from sheep and lambs in the human food chain��[592]
(v.) High priority should be given to strain typing.[593]
414 At the end of the discussion, Professor Pattison confirmed that SEAC would keep the information confidential pending publication. He would inform the CMO and the CVO of the findings. �It would be for Ministers to decide whether or not they should be put into the public domain now.�[594] He told the BSE Inquiry that he did not inform Dr Metters and Mr Meldrum personally, but that the secretariats from DH and MAFF informed their respective chief officers of the findings, and that SEAC would have asked for a review by other neuropathologists. �I think the CVO and CMO were willing to wait until Dr Will and Dr Ironside had finished those consultations and reported back to us before taking it any further.�[595]
415 SEAC were due to meet again on Monday 11 March for a visit to an abattoir.
416 On 8 March 1996 Mr Skinner minuted the private secretaries of Mr Horam and Sir Kenneth Calman. He copied the minute to the private secretaries of Mr Dorrell and Sir Graham Hart, and to Dr Rubery, Dr Wight, Mr Eddy and Mr Wilson. The minute advised recipients about the presentation to SEAC by Drs Will and Ironside. It said
�In the opinion of the Unit all this indicates that these cases have been subject to some new factor which has precipitated the disease. If incubation periods similar to other spongiform encephalopathies have occurred the exposure would have taken place some 8 � 10 years ago. It is of course not possible to link this positively to exposure to BSE in the 1980s but, after SEAC had considered the data, it considered that this is a likely explanation, although other possibilities have to be considered.� [596]
417 Mr Meldrum told the BSE Inquiry that he was made aware of the new findings �a few days� before the 8 March SEAC meeting.[597]
418 Mr Hogg found out about the results of the SEAC meeting from Mr Packer:
�there was one meeting between me and Mr Packer, Richard Packer, which is not referred to in this statement, which is about this time. I suspect it was after 8th March, but I am not sure about that. One night -- I mean to say between 6.00 and 7.00, but that is broadly speaking right -- Richard came into my office, I said that he often came in. This was late in the evening; Frank Strang may have been there, he was my Private Secretary, but he came in and said something like -- the language is not right, but this is the substance of it: "There is a very dark cloud on the horizon, which is that SEAC think, or are coming to the view, that BSE is transmissible". I said, "This is a very serious state of affairs". He said something like, "They have not come to that view yet, but they may come to that view". I said something like this, "You had better keep very close to Pattison so we can see how this thing is developing". I remember saying to him, "But what you must not do is in any way try and shape their deliberations or conclusions, but what you must do is to keep as close as possible, so we understand what is happening and you must keep me fully posted".
�That is not a meeting which is recorded. It was an entirely informal meeting, he just came into the office, and I suspected -- I have tried to date it in my own mind, it was probably about ten days before the announcement, and my bet is it was after the meeting of SEAC on 8th March, but I cannot be more precise.[598]
�
�My suspicion is that I did not at that moment talk to Angela [Browning] or my Ministerial colleagues.�[599]
Monday 11 March 1996
DH
419 Sir Kenneth Calman became aware on 11 March 1996 of the outcome of SEAC�s 8 March meeting.[600] He called a meeting that morning with Dr Rubery, Dr Metters, Dr Wight and Mr Skinner.[601]
420 These officials noted that in light of the confirmatory work to be done, publication of the new findings was �unlikely for a month�.[602] It was noted that Sir Kenneth would call a meeting with MAFF and Professor Pattison that day (later postponed until Wednesday 13 March), with the possibility of further meetings of officials on 21 March, about 28 March, and during the week of 8 April.[603]
421 Also discussed at this meeting was MAFF�s proposed publicity material about BSE.[604] A note of the meeting recorded �It was agreed that in the light of the new information available to the DH and MAFF on Friday it would be sensible to delay further progress on the leaflet�� [605]
422 After the meeting Sir Kenneth Calman wrote to Mr Packer to say that, in view of the new findings, �it would seem very unwise to disseminate information which could later be seen as falsely reassuring�.[606]
423 Sir Kenneth later met Mr Dorrell to discuss the new findings[607].
424 Later that day, at Sir Kenneth�s request, Dr Rubery spoke to the Chief Executive of the Medicines Control Agency (MCA) �to request a paper on pharmaceutical aspects of the new information for CMO and Ministers urgently�.[608] She also spoke to a DH official with responsibility for vaccines, �to alert him to the issue in relation to vaccines�.[609]
425 The same day (11 March), Sir Dai Rees of the MRC (whose representative Dr Dukes had attended the SEAC meeting on 8 March) wrote to Sir John Cadogan, Director General of the Research Councils, Office of Science and Technology (OST), with a summary of the new information. He said,
�You should know that new findings, while not proving such a connection are consistent with one, and will undoubtedly have major implications. One can reliably predict a major health scare and a potentially devastating effect on the meat and livestock industry.� [610]
426 Sir John Cadogan forwarded this letter to Mr Lang (President of the Board of Trade) on the same day.[611]
SEAC Meeting 26
427 Also on 11 March 1996, members of SEAC visited a slaughterhouse. Present were Professor Pattison, Mr Bradley, Dr Kimberlin, Dr Painter, Mr Pepper and Professor Smith. Mr Eddy (MAFF Secretariat) and Mr Skinner (DH Secretariat) were there, as was Dr Matthews (MAFF observer). Dr Rubery, Dr Render and Mrs Townsend were there, and Mr Meldrum attended during the latter part of the visit.[612] Apologies were received from Dr Will, Professor Allen, Dr Brown, Professor Collinge, Dr Watson, Professor Almond, Dr Hueston, and Dr Wight.
428 After the visit, members discussed the presentation given by Drs Will and Ironside at the last meeting. They called for
�[i] Peer review to ensure that this was indeed was a distinct variant of CJD;
�[ii] a review of the literature by experts to ensure that this presentation was new and had not been seen, possibly in an unidentified form, in earlier years;
�[iii] review of overseas cases to see whether this variant was unique to the UK or had been observed overseas.�[613]
Tuesday 12 March 1996
MAFF
429 On 12 March 1996 Mr Eddy minuted the private secretary of Mr Packer, and copied the minute to Mr Carden, Miss Kate Timms, Mr Meldrum, Mr Haddon, Mr Hollis, Mr K Taylor, Mr Blakeway, Mr Cowan and Dr Render.[614] Mr Eddy�s minute summarised the information presented by Drs Will and Ironside on 8 March 1996 and said that the Surveillance Unit �have now firmed up their views� on the emergence of a subtype of CJD in younger people.[615] It said
�The cases are confined to younger patients ranging from 18 to 42. Depending on medical tests still underway there could be as many as 8 or 9 such cases all dating from the past 2 years. Cases in young patients are unusual but not unknown. But we have had more in the past 2 years than in the previous 10 and more than in other countries. Furthermore the disease looks different both clinically and under the microscope where there are �plaques� which are not found in normal CJD.�[616]
430 The minute said that the Surveillance Unit were �confident� when �probed� by SEAC that �the disease really was new�.[617] SEAC had been �extremely concerned and noted that a possible explanation of this new form of the disease occurring apparently only in the UK was that it was related to BSE�.[618] Another concern was that �some sheep would have been fed with the same contaminated feed as cattle in the 1980s and could have contracted BSE unrecognised because it might look like normal scrapie�.[619]
431 The minute also mentioned the likely period of inoculation of the victims of the new disease:
�there is� no reason to believe that they were not potentially exposed before the SBO controls were introduced in November 1989. It is unlikely in logic that these cases reflect exposure post 1989 given the long incubation period of the disease and the expectation that exposure would be lower after the SBO ban than before; but this is not easy to prove. One of the SEAC members, Dr Kimberlin, will be doing a formal risk analysis calculation to assess the likely risk prior to the SBO ban and since. This will take time but will be important in considering the implications in SEAC and in presenting them to outside scientists. In essence he will be able to calculate odds to help answer the question �do these cases tell us that BSE was a risk to humans or that BSE still is a risk despite the precautions taken�.�[620]
432 Mr Eddy explained the genotypes of the young victims:
�all of the cases of the new subtype of CJD have the same amino acid, methionine, at a particular place in their PrP protein� In humans there are two forms of the protein, one with methionine and one with valine. People can have either all methionine (MM) (because they have inherited methionine from both parents) all valine (VV), or half methionine and half valine � one from each parent (MV). In the Caucasian population as a whole these occur in a ratio of 37%MM: 51%MV: 12%VV. There is an excess of MM and VV genotypes over the MV genotype in human cases of CJD, most sporadic cases (around 80%) are MM and most iatrogenic forms are VV. All, so far, of these special cases tested are methionine only (MM).�[621]
433 Mr Eddy detailed the areas identified by SEAC on 11 March as requiring extra work before publication of the findings.[622] He also commented that �the mood of the meeting on 11 March was less bleak than that of 8 March and rather more sceptical of the CJD Unit�s findings, but some of the leading medical members of SEAC, including the head of the CJD Unit, were not present�.[623]
DH/ Contingency Planning
434 On 12 March 1996 Dr Rubery minuted Sir Kenneth Calman�s private secretary, copied to Drs Metters, Skinner and Wight and Mr Skinner, with her own notes from SEAC�s meeting the previous day.[624] She noted that SEAC had concluded that �in light of the information provided by Bob Will and John Ironside [sic] on Friday and their visit to the abattoir today there was no need to change their advice on the SBO bans��[625] She also noted that
�The data are consistent with BSE causing a subset of CJD which is clinically atypical, with an unusual EEG and amyloid plagues [sic] on PrP staining but:-
�(1)� This could also be identification of a disease previously unidentified but present
�(2)� The description of the new disease is not necessarily evidence for a causal relationship to BSE exposure of the population, although this is a possible explanation.�[626]
435 She noted several points that would be followed up by DH, if the new variant was related to BSE: �It will be important to investigate the likely levels of exposure at different times in the past.�[627] She noted that information would be needed on feline spongiform encephalopathy (FSE), the consumption of brain, MRM, intestines, catgut, vaccines, cheek meat, and abattoir workers.[628]
436 Also on 12 March 1996, Dr Rubery minuted Sir Kenneth Calman with a �status� paper.[629] She summarised SEAC�s discussion on 8 March 1996, then set out 11 �next steps� required �to address the hypothesis of a causal link with BSE and to determine the actions necessary�.[630] These steps were
(i.) Obtaining advice from MAFF on the likely timing of exposure, assuming that the route was via beef and beef products.
(ii.) Obtaining all available data on incubation periods of TSEs that might be relevant.
(iii.) MAFF needed to consider ways to further protect the human and cattle food chains.
(iv.) MAFF and DH needed to consider the same question in relation to BSE in sheep.
(v.) Consideration by the CMO of what advice he needed to give and when on public health, political and creditability grounds.
(vi.) The setting up of a predictions group to plot out the likely future of the epidemic (with Professors Peter Smith and Roy Anderson involved).
(vii.) Consideration of other routes of exposure, such as catgut, vaccinations and gelatine capsules.
(viii.)Consideration of other possible causes of the new disease, for example recreational drugs.
(ix.) Consideration of how the disease might be present in older people.
(x.) Urgent assessment of future resource needs for surveillance and research.
(xi.) Urgent development of a communication strategy and a helpline once the announcement was made. Dr Rubery noted a number of ways in which information could be passed to GPs and other doctors, members of the NHS and Environmental Health Officers, and recommended that SEAC�s policy on communication with members of the public be �sorted out.� She suggested considering the issuing of a press statement after each SEAC meeting, like the Advisory Committee on the Microbiological Safety of Food.
437 Dr Rubery told the BSE Inquiry that she could not recall how she devised this list of �next steps�, but she thought that it would have been based upon the discussions in SEAC, conversations with the secretariat of SEAC and her staff responsible for the area, and her previous experience of handling public health related episodes (such as Chernobyl and other food-related issues such as salmonella).[631] She said that she would have sent the paper in draft form for comment to others in the HEF Division before she finalised it.[632]
438 In addition to Sir Kenneth Calman, the status paper went to Sir Graham Hart, Dr Metters, Dr Skinner, Dr Wight and Mr Skinner. Dr Rubery said that it subsequently served as a helpful aide memoire for her and others to refer to at meetings held over the following few days.[633]
439 She also discussed the paper with Dr Metters before he went on sick leave on 12 March. She forwarded the various points that arose from this discussion in a minute to Dr Wight, copied to Sir Kenneth�s private secretary, Dr Metters, Dr Skinner and Mr Skinner. The points were about advising clinicians, the use of gelatin, foetal calf serum used in vaccines, dates of likely human exposure, and information on hGH and kuru cases.[634]
440 Dr Rubery told the BSE Inquiry that she thought that the timing of her 12 March 1996 action plan was �about right�, and that while it was rushed, the CMO took forward the issues that she identified �largely within the timeframe�.[635] In her view there was nothing obvious that needed to be done before this time. Referring to her action plan, she said:
�Most of those issues are things that really you can only put into place once you know you have a problem. They are not issues � you cannot start to set up a predictions group until you have some cases you need to follow. You cannot really do the communications strategy until you have something to communicate, and all the links in the communication strategy were there, one knew that the CMO has a good communication network out and so on.
�So in terms of forward planning for the Department of Health � you cannot actually set up the research either on the cases until you actually have cases to inject into mice, so until we actually knew there were cases, there did not seem to me to be any issues that we needed to do more on than we had done. It seemed to me there might be issues that MAFF could usefully forward plan. That was why I raised it with Mr Carden. His view was we could not do all the planning on that side, therefore I let it lie�.[636]
441 Mr Carden talked generally about whether he was aware of any thinking about a contingency plan. He said
�We did not have a file marked �contingency plan�. We were certainly thinking more and more actively from autumn 1995 onwards about what might follow if ... and there were two strands to the thinking. Measures that might need to be taken to protect public safety and measures that might need to be taken to handle the drop in demand of beef that would inevitably follow if there was evidence of a link between BSE and CJD. That of course came about.
�We did not take our contingency thinking into very great detail down either of those tracks, for different reasons. It would have been very difficult to have developed a contingency plan on the human health side for any new measures that might need to be taken� With the development in February, March 1996 we were looking to SEAC for guidance, we, the Government Ministers and officials were all looking to SEAC for a view on what they felt needed to be done�
�It would not, I would suggest, have been sensible for us to try to draw up a blueprint in abstract of measures of that kind. We needed scientists' advice. As to the collapse in the beef market and what should have been done about that, plenty of suggestions after March 1996 that that should have been planned out in detail beforehand. The difficulty there, I think, was quite different. It did not take long to work out that if the news that had come through had come through, you would get a collapse in the consumption of beef.
�We did some assessments of the order of drop in demand that might take place and some very sketchy thinking about measures that could be needed to react to that. But to take that thinking into any great detail we would have needed to discuss with authorities outside the Intervention Board, the Meat and Livestock Board, the European Commission in Brussels, had we done that there would have been very high risk of that becoming public knowledge; and in the climate of the time I think had that become public knowledge it would have produced the event we were contingency planning for, without the backing of science that we had come March 1996��
MR WALKER: ��When you say, �We were thinking from autumn 1995 onwards�, who were the people turning their minds to this?�
MR CARDEN: �A very small number of people. Discussions that I had about this were with the Permanent Secretary primarily as to the collapse in the market and what might need to be done about that. I had one or two discussions with the, I think, with the Head of the Beef Division, Richard Cowan�.[637]
442 Dr Calman told the BSE Inquiry:
�I think Dr Rubery raising it with MAFF is perhaps inappropriate because MAFF would not have picked up the human consequences, which is why particularly around the time of the human growth hormone issue the real question for me, and indeed within the Department, and I discussed this with the NHS Executive side, was if the number of cases build up and if there is no treatment available, both of which remain could be true, how was the service going to cope with that? That was the contingency issue. It was the planning for looking after people, together with the research and funding more treatment. That would have been the implication. Therefore I had a number of discussions with the Executive about how we would deal with that in terms of contingency planning.�
MRS BRIDGEMAN: �You had already as it were begun the shadow planning for the worst?�
SIR KENNETH CALMAN: �But again assuming this would build up slowly rather than rapidly. I do not know the answer to that either, there would have been time to think about that. But the implications for neurology services, diagnostic services, pathology services, nursing care, all very considerable, and therefore we had taken that into account and had been thinking about that. That I do not think is a MAFF issue. That is very much a National Health Service issue which is where it would be appropriately discussed.�[638]
443 On the subject of making contingency plans, Mr Dorrell told the BSE Inquiry:
�I think it is very hard, is the answer, to make contingency plans for this because what we are talking about is how should we care for patients who are diagnosed as having this disease or having a form of spongiform encephalopathy related to BSE? Now, clearly the National Health Service had traditionally cared for CJD victims as we still believe unrelated to BSE cases previously. Any contingency planning would have required assessment of how many cases were likely to arise, whether the condition was different from CJD or whether the clinical treatment of it needed to be the same, and no doubt a range of other factors as well. And I am all in favour of people thinking about contingencies, but the range of options that would have been potentially open if somebody had asked that question in the autumn of 1995 seems to me so wide that I am not sure a useful policy conclusion could have flowed.�
MR FREEMAN: �Do you think a centralised care plan could have been formulated earlier than March 1996 and indeed ought to have been formulated?�
MR DORRELL: �I think the question of how doctors care for patients is something that is best handled through the leadership of the medical profession. I think that the Department of Health and the National Health Service has a role to play as a catalyst for discussion between senior doctors on which experience is best; but my experience of the medical profession is that particularly with this kind of relatively unusual condition, doctors caring for patients that suffer from these kind of diseases do share their experiences and do seek to learn from each other.�[639]
444 Mr Packer was asked about his attitude to contingency planning:
MR WALKER: �To what extent had you given thought before March 1996 of what should be done if they were to find what they were seeking?�
MR PACKER: �Did we have a contingency plan?�
MR WALKER: �Yes.�
MR PACKER: �No we did not, and rightly so. But it is appropriate to deal with the two separate aspects. One is what would we do as regards reassurance of the public in the public health domain, and what would we do vis a vis support for the beef industry.�
445 On the first aspect, he said:
�We had emerging two disquieting features. One was the CJD in dairy farmers which for a prolonged period was of more concern than was the second, which was CJD in adolescents. It is evident that any contingency plan for dealing with -- or any plan for dealing with CJD in dairy farmers would differ in kind enormously from dealing with CJD in adolescents, because CJD in dairy farmers, presumably the route of exposure is by some means other than food. And that would require different response and it is apparent that we would need to seek scientific advice from SEAC and indeed possibly more widely. That is one point.
�The nature of the end result is not known, the fact that there has been a dramatic development does not mean in the past you can predict what it is actually going to be. Therefore you cannot make a contingency plan for it. There are a whole host of other objections to contingency plans of that sort, like the sheer difficulty of drawing them up. They would necessarily involve the very people who are engaged in actually setting policy and dealing with the ongoing work on the crisis. You devise a framework. Events never fit into the framework, you waste a lot of time trying to force developments into the framework you have made which is of no use.
�I am going on, but there are so many objections. We have spent billions of pounds on BSE since 20th March 1996. Any committee which looked at the subject would have had to have a member of the Treasury. No member of a Treasury would ever agree to a contingency plan which involved pending billions of pounds. He just would not do it. Furthermore, my experience of Ministers is that they would be very wary of having such a committee, having justified fears that if existence of it would leak, it would precipitate the very event it is designed to set a contingency about. There are a whole host of objections to that sort of contingency plan which to my mind are wholly overwhelming.
�
�SEAC eventually came up with a recommendation that we should debone beef from animals over 30 months. No one predicted that would be their final recommendation up to and including the day before. Given it is SEAC's recommendation, that is what one would expect to have been forced to do. In the event we did something else. So that the scale of movement suggests to me that contingency plans would -- the effort devoted to devising a contingency plan would not have been valuable.�[640]
446 On the second aspect of contingency planning, dealing with shops and industry, Mr Packer said:
�By 20th March 1996 we were already well aware of what that would have to consist of�
�that is a much simpler aspect because you have to keep the essential lines flowing, which is the rendering industry, the slaughterhouses, farmers. All that is sort of less difficult, because obviously one can define there what needs to be done. It is in the protection of the public, where you do not know what the final finding is going to be, nor what the recommended way of dealing with it would be. I would defy anybody to, unless shortly before 20th March, to have concluded (a) that deboning beef over 30 months was going to be a significant part of the conclusion, and (b) that the exclusion of them between the feed chain would be...�[641]
Wednesday 13 March 1996
447 Mr Packer, Sir Kenneth Calman, Professor Pattison, Mr Meldrum, Dr Rubery, Dr Wight, Mr Eddy, Dr Skinner, Mr Carden, Mr Haddon, Mr Taylor, Mr Hollis, Dr Matthews, Mr Blakeway and other officials met at MAFF at 10:30am on 13 March.[642] Sir Kenneth and Mr Packer agreed on the need to be �absolutely sure� the data was right before it was published, because of the �possibly immense implications� of the new findings.[643]
�Taking all things into account, the CMO still envisaged that a sub-type of CJD in younger patients was likely to be identified. He needed to plan on the basis that there was a new risk, there was a new form of spongiform encephalopathy, and that the likely source was BSE in cows. He also had to assume that the whole population had been exposed over a 10 year period��[644]
448 Professor Pattison told the meeting that SEAC�s slaughterhouse visit on Monday had �reassured members that the SBO ban could be made to work effectively.� Mr Meldrum said he was �more confident today than before April last year that the rules were being applied�.[645]
449 In discussion of what new controls might be introduced, Professor Pattison said that SEAC could consider �tweaking the SBO ban to remove more potentially infective organs, but this would not be rational�, and �removing cows over 2 or 2� years from the human food chain. However, this was a very complicated question in view of the economic consequences�.[646]
450 Professor Pattison �confirmed that SEAC would meet in the next few weeks� (this was later set for 16 March).[647] He asked for guidance on the limits of SEAC's considerations. Mr Packer advised that
�SEAC should consider what it thought appropriate, although comments on how the situation might have arisen would be helpful. If SEAC made a recommendation, the Government was likely to follow it. Although economic consequences were secondary, clearly any recommendations should be balanced. As evidence came forward, it changed the balance of reasonableness of what we were doing; however, any changes to the rules had to be proportionate. It did not follow from the worst case scenario that the current rules needed to be changed.�[648]
451 Mr Meldrum asked Professor Pattison to �bear in mind the logistical effects of any recommendations, and to consider the wider uses of products such as bonemeal eg. for pig rations�.[649]
452 Sir Kenneth had drafted a press statement dealing with publication of the research, which he read out to the meeting.[650]
453 On MAFF�s publicity information, Mr Packer told the meeting
��It would be inappropriate for MAFF to issue any more copies of the reassuring publications. Where commitments had been made to send out such publications, these should not be honoured. The briefings planned with local authorities and so on should also be cancelled.�[651]
454 Mr Packer told the BSE Inquiry that
�following the developments at the end of 1995 we thought it appropriate to change the literature, because there were statements that were incorrect�
�And like, for instance -- well, there were statements that were incorrect. And this took some time and it was being revised constantly. Of course, inevitably the emerging conclusions of SEAC were, and I hasten to add legitimately kept confidential for a period, so that they may well have been worked on by someone who was not aware of what was happening. I think I am right in saying that the revised version never came forward for approval�
�But in any event, as my statement here records, it was clearly well beyond the point where anything that had been issued previously could be issued and we needed to start from scratch.�[652]
455 Sir Kenneth pointed out that the Lancet was published on a Friday, �the wrong day for taking proactive action.� He suggested that they make the findings public and set out what they proposed to do, before they were published in the journal. Professor Pattison thought the article would be published in the Lancet within two weeks. Later publications could give rise to leaks. [653]
456 Mr Packer �thought it would be difficult to go public other than on the basis of a recommendation from SEAC on further action�.[654]
457 After this meeting Mr Packer held a �wash-up meeting� with Mr Eddy, Mr Carden, Mr Meldrum and Mr Haddon.[655] Mr Packer �had some reservations. For example, why were only young people going down with this form of CJD?�[656] Mr Eddy answered that �Professor Will�s explanation was that younger people were more disposed to buy hamburgers�. Mr Packer �did not find this convincing�,[657] and he followed up his reservations afterwards in a letter to Sir Kenneth Calman and Professor Pattison (see below).
458 Also at this �wash-up meeting�,
�It was agreed that it would be helpful if the work by Kimberlin was completed before publication. The Secretary suggested we offer to pay him to work on this full time. We could also offer to provide a statistician if that would help, unless this might be thought to compromise the findings. In the meantime, we should take the line that SEAC should not make recommendations for the sake of it if they were confident that the controls were adequate. We should also make contingency plans in terms of market support and disposal of carcasses�.�[658]
459 After the (first) meeting, Dr Rubery spoke again to the MCA, to ask what line DH could take on the effectiveness of current measures on pharmaceuticals, and for details about the possible exposure from medical products manufactured before the current measures were put in place. Dr Rubery also arranged to meet Dr Painter (one of the new SEAC members, and a Consultant in Communicable Disease Control, Manchester) and Eileen Smith (from the CMO�s office) to devise a communications strategy.[659]
460 Mr Packer wrote to Professor Pattison shortly after the meeting with further thoughts. He noted the �very considerable political and economic damage� that might be caused by an announcement, and wondered whether it was prudent to suggest a link between nvCJD and BSE unless it followed the same pattern as BSE, rising steadily with decreasing intervals between cases. He also said they needed to discuss why the new variant had been found only in young people.[660]
461 Mr Packer recalls that �both Professor Pattison and the CMO telephoned to say that they regarded the points I had made to them as valid considerations�.[661]
462 Later that day (13 March), Mr Packer minuted Mr Hogg about �developments on BSE and possible links with CJD which are potentially extremely serious.� He summarised SEAC�s discussions and the meeting earlier that day,[662] and said that SEAC had �recognised that given the seriousness of the implications of any statement from an authoritative source to the effect that BSE might well cause CJD, it behoves them to clear that Dr Will�s claims on singularity are accurate�.[663] He said that MAFF needed to plan on a �worst case� basis.[664] He continued:
��if BSE/CJD transmissibility does exist then it is highly probable that cases seen so far result from exposure before any measures were taken against BSE in the middle 1980s. Moreover... measures and enforcement have been progressively tightened up. Accordingly, whatever the position on transmissibility, it does not follow that any further measures would need to be introduced now. I said as much to Professor Pattison since elements in SEAC are apparently thinking in terms of recommending a ban on the consumption of beef from animals over two years old and it is far from clear that the cost of such a measure would be proportionate to any reduction in risk.�[665]
463 Mr Packer went on to say that he was sure that the public and market reaction to an acknowledgement of the possibility of BSE transmission to humans �would be such that the political and economic effects would be a disaster of unparalleled magnitude so far as UK food scares are concerned. The consumption of beef would be likely to fall immediately to a small proportion of its former level��.[666]
464 On timing, Mr Packer noted that Sir Kenneth Calman was �very anxious that all this should be pushed forward as rapidly as possible, not least to avoid leaks�.[667] He commented that �it is even more important not to rush into public announcements before we are clear that there is a genuine cause for concern�.[668]
465 Mr Hogg agreed with this. He told the BSE Inquiry:
�In early December or very late November, there had been a series of television programmes about the unsafety of beef. That did have a very serious though short lived impact on the consumption of beef. In a sense therefore we were very alert to how febrile public confidence was and therefore I would not have wanted to have run the risks of leaks until such time as I had something positive to say, because I knew what the consequences would be. We had been through it, in a very played down form, in the latter part of 1995.�[669]
466 Mrs Browning told the BSE Inquiry:
�One of the ways which SEAC was verifying Dr Will's theory on the link between BSE and nvCJD was to speak to overseas scientists, to see if they had seen such new variant cases before. This was a necessary exercise, although it caused particular concern, because by discussing a possible link between nvCJD and BSE with other scientists, there was a increased risk that this link would be leaked to the press before the Government had had time to consider its response, and before SEAC had had time to make sensible recommendations. Since the emergence of Dr Will's theory, it had been a very tense time for Government. We were extremely anxious to have advice from SEAC as soon as possible. We did not feel that we could go to the public with an announcement that BSE and nvCJD might be linked, but without any recommendations as to how to deal with it. We therefore needed SEAC to give firm advice as soon as possible.�[670]
467 13 March 1996 was the day of the Dunblane tragedy, Scotland. A man shot and killed 16 children and their teacher while they were in school.[671]
Thursday 14 March 1996
468 On 14 March, Dr Rubery attended a meeting with Sir Kenneth Calman and Dr Wight. Dr Wight had spoken to Professor Pattison, who had heard from Drs Kimberlin, Ironside, Will and Professor Collinge that the pathology of the new variant CJD cases had been confirmed by three other neuropathologists. The new disease �seemed to be real�. Sir Kenneth concluded that SEAC should meet again on 16 March, to advise Mr Dorrell. It was agreed that some form of statement would probably need to be made the following week. After the meeting, Dr Rubery updated Mr Dorrell�s private office on BSE/ CJD.[672]
469 Mr Packer and Mr Hogg spoke several times on 13 and 14 March to discuss Mr Packer�s minute of 13 March. They agreed that a public statement could not be made until SEAC had advised on the accuracy of Dr Will�s claims and the steps which the Government should take.[673] They also agreed that they should �avoid seeking to influence in any way the conclusions to which SEAC itself would come�.[674] Mr Hogg noted the need to �get clear advice from the Committee as to the facts and the steps which the Government should take�.[675]
470 As a result of these discussions, Mr Hogg wrote to Professor Pattison asking him to submit SEAC�s views to the Government as soon as SEAC was �in a position confidently to do so�.[676]
471 Mr Packer and Mr Hogg also discussed the possibility that after SEAC�s meeting on (Saturday) 16 March, Mr Hogg might need to write to the Prime Minister on 18 March. Mr Dorrell had informed MAFF that he would be content with this procedure.[677]
472 In the afternoon of 14 March 1996 there was a pre-arranged meeting of the four UK CMOs: Sir Kenneth Calman (DH), Dr Henrietta Campbell (Northern Ireland), Dr (later Dame) Deirdre Hine (Wales), and Dr Kendell (Scotland).[678] Dr Campbell told the BSE Inquiry that Sir Kenneth:
�showed Dr Hine, Dr Kendall and myself a sheet of paper which set out the 9 cases of CJD which showed a different presentation and pathology to CJD as it normally occurred. We were profoundly struck by the significance of these figures and discussed the implications deep into the night. Sir Kenneth was heavily involved in meetings with the Cabinet and we were aware of the overwhelming sense of shock within Whitehall. The next day I returned to Belfast to brief my own Minister and to await the statement in the House�.[679]
473 Dr Hine recalled that Sir Kenneth told them that the most likely explanation of the �new variant� was
�exposure to BSE before the introduction of the Bovine Offal (Prohibition) Regulations in 1989. I was party during the next 24 hours with my fellow CMOs to detailed discussions which explored the implications of this information in preparation for a statement to be made to Parliament by the Minister for Agriculture and the Secretary of State for Health the following week. In view of the gravity and sensitivity of the new information I decided to return to the Welsh Office on Friday 15th March 1996 to brief the Permanent Secretary, Mr. Michael Scholar, and the Secretary of State for Wales, Mr. William Hague MP, orally, which I did in the late afternoon of that day�.[680]
Friday 15 March 1996
474 On 15 March 1996 Mr Skinner drafted a minute entitled �Spongiform encephalopathy in humans: latest developments� to the private secretaries of Sir Kenneth Calman and Mr Dorrell, copied to Mr Horam�s private secretary, Dr Metters, Dr Rubery, Dr Skinner, Dr Wight, Ms Christopherson and Mr Wilson.[681] Mr Skinner informed recipients that the CJD Surveillance Unit had discussed their findings with three neuropathologists in Glasgow, one CJD expert in Oxford and one in the USA: �All confirm that the pathological features identified are closely similar in all cases and quite unlike any others encountered previously either in practice or in literature. It now seems clear that we are dealing with a clinical entity which has not been identified before�.[682]
475 Mr Skinner said �In the event that we were forced to conclude that BSE could not be ruled out as a possible cause this would change the whole approach to the protection of public health which has proceeded so far on the basis that the risk to the human population is only theoretical�.[683] He said that SEAC needed to give advice on �any further action which needs to be taken to protect the public health�.[684]
476 He noted that an announcement could be either be made �in the next few days� and promise further information and advice when the significance of this has been clarified�, or it could be deferred �until we have built up as complete a picture as possible and are ready to announce any new public health measures; this might take four to six weeks�.[685] He discussed the benefits and disadvantages of these actions.
477 Mr Skinner concluded by noting that in the event of any �disclosure�, the line to take was that SEAC had received a report from the CJD Suveillance [sic] Unit on which it �has not reached any conclusions and has asked for further work to be done�.[686]
478 On 15 March 1996 Sir Kenneth �received information from SEAC indicating that they were convinced at the possibility that there was a new disease�.[687] He discussed this with the Welsh, Scottish and Northern Irish CMOs.[688]
479 Also that day, a minute was circulated to MAFF officials and Mrs Browning of the discussions between Mr Packer and Mr Hogg the previous day.[689]
Saturday 16 March 1996
SEAC Meeting 27
480 An emergency meeting of SEAC was held on 16 March 1996. Present were Professor Pattison, Dr Hueston, Dr Will, Professor Smith, Professor Almond, Mr Bradley, Dr Kimberlin, Dr Painter, Mr Pepper and Professor Collinge, and the Secretariat (Messrs Eddy and Skinner). Observing were Dr Matthews, Dr Wight, Mrs Wilson (BBSRC) and Mr Dukes (MRC). �Also in attendance� were Dr Render and Mrs Townsend (both MAFF).[690]
481 First, Dr Will described what he and Dr Ironside had discovered about the new variant of CJD:
�initial clinical presentation was in younger patients than normal for CJD and with psychiatric or behavioural problems which then developed to neurological problems and eventually dementia. The disease had a comparatively long incubation period, had abnormal EEG and showed distinct histopathology, with large distinct plaques�.[691]
482 Dr Will reported that since the 8 March meeting, another case had been described in a 31-year-old. Annex 1 to the minutes was two tables, showing details of nine �confirmed� and three �suspect� cases of CJD in young patients.[692] Members discussed other young cases of CJD in the UK[693] and in other countries.[694]
483 The data had been examined by three independent neuropathologists in Glasgow, who considered that this was a �distinct entity unlike any previously seen form of CJD�. These experts had felt that pathologists in the 1970s and 80s would have been able to describe the plaques even without the new technique of immuno-staining. They noted that it was usual [sic] for young patients not to be given a biopsy or post-mortem.[695]
484 Dr Will had discussed the findings with Professor Walter Matthews, Professor Emeritus of Oxford University. Professor Matthews, a leading authority on CJD, had supervised Dr Will�s early CJD surveillance work. He had commented that �The evidence cannot� be regarded as conclusive and I am not wholly convinced that such cases might not have been overlooked in the past�.[696] However, Dr Will told the meeting that the cases he mentioned had not been of this new variant of CJD.[697]
485 SEAC felt that the new cases could not be explained by ascertainment bias. No cases had been reported before 1994 (and a significant number of cases had been seen only in the last 8 months) despite widespread interest in BSE/CJD throughout the 1990s.[698]
486 SEAC also noted that of the six patients who had been genetically analysed, all were methionine only (MM).[699]
487 Dr Will explained that geographically, the cases were spread across the UK although it was hard to draw conclusions with the small number of cases.[700]He also confirmed the absence of hormone treatment or neurosurgery in the medical histories of all of the cases.[701]A review of the patients� medical records and genetic analysis to eliminate other possible causes �suggested that exposure to a previously unidentified risk factor was as likely an explanation as any other of the cause of these cases�.[702]
488 Professor Pattison reported MAFF�s advice that SEAC should not be constrained by economic or practical considerations when making recommendations for action, although if their recommendations were impractical MAFF might come back for SEAC�s opinions on other options. �However, it was clear that the responsibility for taking decisions on the way forward rested with politicians�.[703]
489 SEAC concluded that the new variant was a distinct entity, and that it could be linked to a new risk factor. SEAC agreed that they �must take very seriously the possibility that this new risk factor was BSE, although it was noted that the data did not allow this conclusion to be drawn firmly. Similarly, the fact that other specific risk factors could not be described in detail did not mean they did not exist�.[704]
490 SEAC recommended that all necessary steps be taken to ensure that the SBO ban was rigorously enforced.[705]
491 SEAC discussed risks of infectivity from eating beef. Different tissues had different levels of infectivity (eg brain was more infective than muscle meat). Oral transmission between species (eg. cow to mouse) was less effective than within species. Younger animals were less likely to be infected, and if they were, the infectivity of their tissues was lower than in affected older animals (over 2� years). It was agreed that �more detailed figures� were necessary for �this sort of risk analysis�.
492 They decided that the time had come to extend the ban on mammalian protein in ruminant rations to include all farm animals to avoid any possibility of perpetuating the BSE epidemic through cross contamination either in feed mills, in transit or on farms.[706]
493 They also considered but did not reach a conclusion on the need for further action in relation to SBOs. They discussed a complete ban on cattle over 2� years old in the food chain. Mr Bradley commented that this would be tantamount to saying the SBO ban was not effective. As an alternative, they discussed a requirement that animals over 2� years old should be completely de-boned and their obvious nervous and lymphatic tissue, which was likely to be the next most infectious tissue after central nervous system, removed. SEAC decided to give this issue further thought.[707]
494 SEAC also concluded that it was important for the HSE and ACDP to review the significance of the new findings and �if necessary issue new guidance as quickly as possible�.[708]
495 Late on 16 March, in response to Mr Hogg�s letter of 14 March requesting formal advice[709], SEAC �agreed a statement�[710] that the CJD Surveillance Unit had
�identified a previously unrecognised and consistent disease pattern� This is cause for great concern. On current data and in the absence of any credible alternative the most likely explanation at present is that these cases are linked to exposure to BSE before the introduction of the SBO ban in 1989� The Committee are actively seeking further data from both the UK and abroad to help assess the full significance of the Unit�s findings� The Committee emphasise that it is imperative that current measures to protect the public health are fully enforced and are considering the need for further measures.�[711]
DH and MAFF
496 This statement was discussed on the evening of Saturday 16 March, at a meeting between Mr Dorrell, Mr Hogg, Mrs Browning, Sir Kenneth Calman, Mr Packer, Mr Meldrum, Mr Carden, Dr Rubery, Dr Wight, Ms Christopherson and Mr Blakeway.[712] Mr Hogg said that he intended to make a statement to the House of Commons on Wednesday (20 March). He proposed
(i.) to announce a judicial inquiry into the Government�s reaction to BSE;[713] and
(ii.) to ban the sale of beef and beef products derived from UK animals over the age of 2� years, the manufacture of products from bovine material from the same category of animals, and the export of such beef and beef products. The 2� year age limit was already used in the context of EU exports and only about 84 out of a total of around 160,000 cases of BSE had been in animals below this age.[714]
497 Mr Hogg told the BSE Inquiry that he had begun to formulate these proposals after his informal discussion with Mr Packer on (approximately) 8 March.[715] Mr Hogg also said, �I suspect there were discussions between the 10th and 13th in my room on a very private basis as to what happens if SEAC does say this, but I may be wrong about this. I cannot explain it� I am clear as to the conclusions but not quite as to the process�.[716]
498 The proposals on animals over 2� years would be an interim measure until recommendations were received from SEAC, which was due to meet again the next Saturday (23 March). The record of the meeting stated that
�According to indications received so far from SEAC�s chairman, Professor Pattison, the proposed measures fell �within the spectrum� of what SEAC would think necessary, though probably at the pessimistic end of the scale. However, SEAC was unlikely to recommend anything less than these measures once the Government had already announced them. Mr Hogg felt strongly that his measures represented the minimum that the Government could defensibly do�.[717]
499 Sir Kenneth Calman outlined the consequences for DH of SEAC�s statement. He said they would have to investigate the safety of non-food products such as vaccines, medicine, gelatin and tallow. They would also have to investigate risks to abattoir workers. DH would need to brief doctors and NHS staff to help them deal with the �likely flood of enquiries�. DH would need to consider setting up a helpline and running advertisements. It could also respond �positively� to SEAC�s recommendations for urgent research.[718]
500 Instead of a helpline, Mr Dorrell preferred putting extra staff on existing DH/NHS lines. Mr Dorrell agreed that advertisements and information to GPs should go out by Thursday morning.[719]
501 Mr Hogg asked about compensation for the victims of nvCJD. Mr Dorrell �felt strongly that the Government could not accept responsibility for compensation. The Government had at all stages followed the advice of SEAC and its predecessors��[720]
502 It was suggested that Mr Hogg�s statement might be followed by a separate one from Mr Dorrell, then by a joint press conference with Dr Calman, Mr Meldrum and Professor Pattison. It was also noted that �the handling of the announcements would need further consideration in the course of the next day�, and that collective agreement would need to be sought on the contents of the announcement.[721]
503 Mr Carden told the BSE Inquiry that SEAC�s desire to give further thought to the need for new measures caused acute difficulty over the following three days, in the run-up to the announcement. At meetings over the next few days, Mr Hogg, Mr Packer and officials explored with Professor Pattison what SEAC's likely recommendations might be, but it became clear that SEAC could not reach a final view until it had fully assessed all the options.[722]
Sunday 17 March 1996
504 On 17 March, a meeting was held between Mr Packer, Sir Kenneth Calman, Mr Meldrum, Professor Pattison, Dr Rubery, Dr Wight, Dr Skinner, Mr Carden, Mr Haddon, Dr Matthews, Dr Render, and Mr Eddy.[723] Professor Pattison briefed those present on the lines along which SEAC was thinking. It was noted that at its meeting the next weekend, SEAC would consider recommendations that covered �the whole range of possibilities from doing nothing (except reinforcing the current controls) to the destruction of the national herd�.[724] It would also consider the implications for sheep (including the possibility of an ovine offal ban).[725] Mr Packer considered it necessary to make a public announcement within three to four days to forestall a leak, which was becoming increasingly likely as the information was by then widely known.[726]
505 Sir Kenneth asked Professor Pattison whether it was safe to eat beef. Professor Pattison said that SEAC did not feel they should ban eating beef:
�If the SBO ban was fully implemented, meat which reached the market for human consumption, especially from young animals, was very likely to be risk free. However, the Committee could not give a 100% guarantee; it estimated the risk to the individual as between [one in] 3 x 1010 and 3 x 1016. The question for today was whether it was safe to eat beef in 1996, whereas the likely exposure was in the mid-1980s. However, unfortunately, this distinction was likely to get blurred.�[727]
506 Sir Kenneth ran through the text of �a proposed statement� which concluded that there was no evidence that �eating beef today� caused CJD.[728]
507 Mr Packer had drafted a minute for Mr Hogg to send to the Prime Minister[729] which was �discussed and agreed� at this meeting.[730] (The minute went to Mr Major the next day, and is described in detail below.)
508 After the meeting, Mr Packer sent Mr Hogg the draft minute for the Prime Minister.[731] Attached to the minute was SEAC�s statement of 16 March.[732] In his covering note, Mr Packer said �I deduce alternative hypotheses [to explain the new variant] have been seriously tested and no plausible one identified�.[733] He noted that the CMO and Professor Pattison were �content with the terms� of the draft statement.[734]
509 He also said that there were �vast implications� for MAFF:
�not merely is it probable that we will need to propose schemes of support for the beef industry likely to run into hundreds of millions of pounds per annum, but the organisation of it all will also have a cost. We, therefore, face some weeks of turmoil in which difficult decisions will have to be taken.�[735]
510 Also on 17 March, Sir Kenneth telephoned Mr Dorrell to tell him of SEAC�s 16 March findings. A meeting was arranged for the following afternoon.[736]
Monday 18 March 1996
511 Mr Frank Strang (Mr Hogg�s principal private secretary) commented that �18 March was a busy day�.[737] In the course of the day, two minutes were submitted to the Prime Minister.[738]
Minute 1 (from Mr Hogg and Mr Dorrell)
512 The first minute was from Mr Hogg and Mr Dorrell, informing Mr Major of SEAC�s 16 March advice.[739] It was based on Mr Packer�s draft of the previous day.[740] Mr Dorrell approved it over the telephone because he was engaged in constituency matters that morning.[741] It was sent at lunchtime (and is described below).
Minute 2 (from Mr Hogg)
513 Mr Hogg, Mrs Browning, and Mr Baldry met Mr Packer and other MAFF officials at 9:30am on 18 March 1996.[742] Mr Hogg said that it was not enough to say �whether or not beef was safe�. He considered it necessary to set out the positive steps being taken. He proposed a ban on the sale of beef from cattle over 2 years old, the withdrawal of meat products and the establishment of an Inquiry, and asked for a (second) minute to the Prime Minister to be prepared putting forward these proposals.[743]
514 Mr Packer did not support either suggestion. He objected to the ban. He said that the legal basis for taking such steps would be difficult. He considered that �The key point here was proportionality. The proposals which the Minister had in mind would have very severe cost implications. We would need the recommendations of scientists before taking such steps�.[744] Mr Baldry agreed that they should wait for the advice of SEAC.[745]
515 Mr Hogg responded that he was concerned that the effectiveness of the SBO regulations could not be guaranteed: �We no longer had our belt and braces�.[746] Mr Hogg told the BSE Inquiry:
��once the belt had gone [ie. the absence of evidence of transmissibility], I did not think it was responsible or proper, as we were dealing with the serious issue of public health, to rely on the abattoir controls, because I did not believe they would be implemented fully and therefore I was determined to find another belt and the belt that I had found, which I had obviously found before this, was the 30 month rule, so I was determined to reinstate both and I was not going to be persuaded to take a different view because I thought it was my duty to put in place as comprehensive a set of public health controls as I could. And Mrs Browning I am glad to say agreed with me.�[747]
516 Mr Packer also questioned whether an Inquiry was necessary, as MAFF �had given a full account to Parliament in relation to the 1990 Select Committee Report�.[748]
517 It was agreed, however, that Mr Packer would draft a note to the Prime Minister with Mr Hogg�s two proposals.[749]
518 After this meeting, Mr Hogg, Mrs Browning, Mr Packer and Mr Carden discussed with Mr Meldrum, Mr Middleton and Mr Eddy the practical implications of Mr Hogg�s proposals.[750] Mr Meldrum noted that there was a danger that Mr Hogg�s proposals might be seen as disproportionate to SEAC�s advice. �More generally, this would be the first time we had ever pre-empted the conclusions of the scientific experts.�[751] Mr Hogg said he wanted MAFF to be ready to introduce his measures, that it was important to be able to deal �with the situation which arose until such time as SEAC had given its considered advice�.[752] In regard to the age limit, Mr Meldrum noted that very few BSE cases had been found in under-2�-year-olds, and that the levels of infectivity of organs in those cases was low. It was also easy to identify cattle at this age from their teeth.[753] Mr Hogg also said he was inclined to the option of withdrawing products from the market.[754]
519 After these meetings, Mr Packer submitted a draft minute for Mr Hogg to send to the Prime Minister (or Cabinet colleagues) on �extra measures� that would have to be taken to protect human health.[755] This draft included the suggestion that it was �essential� to adopt these extra measures �even though SEAC has not yet made definite recommendations�.[756] Mr Packer explained in his covering note that the draft followed the earlier discussions, save in one particular. Mr Packer thought that in relation to the plan �of removing all beef products from the food chain� the difficulties are almost insuperable and the potential cost enormous�.[757] Mr Packer said these difficulties seemed to render this element of the proposed interim response �disproportionate to an extent that it is not acceptable�[758].
520 Details of the plan that Mr Packer was referring to, and the difficulties involved, were explained in more detail in a minute dated 18 March 1996 by Mr Hollis.[759] Mr Packer had asked him for a �rapid assessment� of the implications of a ban on �the sale for human consumption of all beef from UK cattle of more than 2� years of age, including meat products�.[760] In his minute, Mr Hollis described the difficulties involved in recalling such meat.
�Small retailers, caterers and wholesalers will not know the age of their meat. The major supermarkets have sophisticated systems which permit them to know this information and most of their fresh meat comes from young animals. In theory they should not therefore be adversely affected in this area, but the strong likelihood is that they would withdraw all meat from their shelves, whatever the age of the animal from which it came. Customers may well return all the beef in their freezers. In practice it would be impossible to refuse the return of any meat or meat product because there would be no way of saying how old was the animal from which it came.�[761]
521 Mr Hollis� �conservative guess� of the costs involved in such a recall was �at least �1 billion�.[762]
522 He also estimated the cost of compensation to producers for cull cows compulsorily slaughtered to be of the order of �350m per year plus a further �200m for slaughter and disposal costs.[763] Mr Carden told the BSE Inquiry that the latter proved to be a reliable estimate of the costs involved in the �Over Thirty Month� (OTM) scheme that was implemented after 20 March 1996.[764]
523 Mr Hogg had further discussions with Mr Meldrum which Mr Meldrum followed up with a minute the next day.[765]
524 At 1:00pm on 18 March[766], Professor Pattison briefed Mr Hogg, Mr Boswell, Mrs Browning, Mr Packer and others on the background to SEAC�s 16 March advice.[767] Professor Pattison told the meeting that
�It was clear that a new form of CJD had developed in the 1990s and � assuming it had not arisen spontaneously � that the relevant event had taken place in the mid to late 1980s. Although it was possible that there was some other factor, the Committee had concluded that the most likely explanation was BSE (Professor Pattison put the likelihood at 60%)�.[768]
525 Asked about the likely spread of the new disease, Professor Pattison said that:
��it was possible that the 9 cases were in some way special and that there would be no more. Alternatively, the disease might spread as with BSE in cats, with a number of cases � say, 4 or 5 � each year � its spread is unlikely be like that of BSE itself. The fact that cattle had been fed back to cattle had inevitably amplified that disease. However, it may be conceivable that humans might be particularly susceptible.�[769]
526 He said that it would be clear �within about a year� how the disease would develop.[770]
527 Mr Hogg asked what SEAC was likely to advise by way of response measures. Professor Pattison outlined a range of ideas but said that SEAC would not be in a position to advise until their meeting at the weekend (23-24 March). He said that some members felt that existing SBO controls would suffice �provided they were enforced in 99.9% of cases�, but that others were not sufficiently confident in the controls. Professor Pattison stressed the relative degrees of risk in cows older and younger than thirty months.
��on the worst case scenario, we could expect around 5,000 older cows (i.e. over 2 years) which were incubating the disease to reach the foodchain (although, of course, the SBO material would have been removed). Unfortunately, we could also expect around 24,000 infected young animals to reach the foodchain. However, older animals were likely to be at least 10 times more infectious than younger ones� Action on older animals was therefore likely to take out at least half the potential problem. Such action might involve either removing the animals from the foodchain altogether or insisting that the meat be boned out, with all lymphatic nodes and nerves being removed.�[771]
528 Mr Hogg said he was minded to take interim measures, including the prohibition on the sale of meat from cattle over 2 years of age, withdrawal of all beef products from the shelves and a ban on the export of such goods.[772] Professor Pattison �was not at all surprised at the Minister�s intentions and understood his wish for a bigger margin of safety�. He described this option as �justifiable, logical and not irrational� and said �SEAC was likely to be debating conclusions of this very nature�.[773]
529 Mr Hogg was also minded to ban the use of MBM in all feed. Professor Pattison agreed, �particularly given the continuing risk of cross-contamination�.[774]
530 Mr Hogg told the BSE Inquiry
�I had come to a firm view and SEAC had not, but I wanted to be sure that it was in the spectrum of what Pattison thought that SEAC would be recommending and did not lie outside the spectrum. I did not think they would recommend anything more dramatic, but I did not want to be doing anything which was manifestly silly, so I was saying to Sir John [Pattison], "This is what I have in mind, I would like to test it with you". The phrase, as you can see at the top of the next page, "justifiable, logical and not irrational", was I was asking him whether I was subject to judicial review if I did it. I put the test to him as I understood it. That is how that conversation went�
�we had lost our belt. I knew therefore that there was a risk of transmissibility, or at least SEAC thought there was a risk of transmissibility and I was not going to depart from that view. I knew full well that the SBO controls were not adequate in my judgment. Therefore I had to put something else in place. I was testing out on him whether the 30 month rule was something that he thought was sensible, whether it fell within the spectrum of what he judged sound, and it did, he said so.�[775]
Minute 1 is sent
531 After this meeting, at �around lunchtime�[776], the first minute to Mr Major was sent, from Mr Hogg and Mr Dorrell.[777]
532 The submission alerted Mr Major to �a very serious development on BSE�. It explained that the CJD Surveillance Unit �appears to have identified a new variant� of CJD in young people in the UK, and that SEAC had �concluded that exposure to BSE is the most likely explanation�. Exposure �almost certainly� had been in the middle 1980s.[778]
533 The note included an outline of DH and MAFF responsibilities:
DoH Responsibilities
� Reassure public anxiety about the current safety of beef.[779]
� Ask the Health and Safety Executive (HSE) to look at worker safety as a matter of urgency.[780]
MAFF Responsibilities
� MAFF acknowledged that it faced a major crisis of confidence in British beef. The financial implications of that for individuals, companies and the Government would be severe. The beef industry�s output was valued in 1995 at �2 billion. It also accounted for investments probably running into the billions and the export market for calves (currently at 500,000 p.a.) would disappear.[781]
� It was noted that MAFF�s responses would depend partly
�on SEAC�s recommendations and policy conclusions that will flow from them. We may, for example, even have to prevent cattle over the age of 2 [sic] from entering the human food chain. Some consequences are predictable: the reduction in consumption is likely to lead to large sales of beef from younger animals into intervention. Older ones� most of which are currently exported in the form of various cuts of beef, and which could be thought to present a greater risk of transmitting BSE� will become virtually unsaleable and we could face major problems of carcass disposal. The export market for calves (currently running at some 500,000 p.a.) could disappear. There are implications for slaughterhouses and other types of business. The financial implications for individuals, for companies and for [the Government] could be severe�.[782]
� �The milk industry is considerably bigger than the beef industry and because there is no reason to doubt the safety of milk, it is essential and right that nothing is said which undermines the confidence in the product.�[783]
534 The note suggested that a leak was increasingly possible and that there should be an announcement to the House and the public in next day or two.[784]
535 At 4:00pm,[785] Mr Hogg met Mr Michael Heseltine (Deputy Prime Minister). Mr Heseltine had seen the first submission from Messrs Hogg and Dorrell to the Prime Minister.[786] He �asked about the implications� of slaughtering the entire national herd.[787] Mr Hogg told the BSE Inquiry that he did not take this as Mr Heseltine�s considered view or suggestion, merely as a question that he �threw� out as a possibility�.[788]
536 Mr Major had not yet seen the minute from Messrs Hogg and Dorrell. Mr Heseltine told the BSE Inquiry
�I took the unusual step of interrupting a meeting that the Prime Minister was holding and provided him with a summary of the information that had been provided to me by Mr Hogg. I drew Mr Major�s attention to the minute that had been prepared by Mr Hogg and Mr Dorrell�.[789]
537 Later on 18 March, Mr Packer submitted to Mr Hogg a revised draft of the second minute for the Prime Minister.[790] The draft said that Mr Hogg proposed taking interim measures in advance of SEAC advice.[791] It set out �the very minimum we can do�, which was to ban beef, beef products, the manufacture of products and exports from cattle over 2� years old.[792]
538 In contrast to the earlier version,[793] the revised draft now included the proposal for the possible withdrawal of all beef products. It said that Mr Hogg favoured this proposal though he acknowledged the �enormous financial and other implications� and that a collective decision would be needed.[794]
539 The revised draft minute also identified the possibility that Mr Hogg had discussed earlier with Mr Heseltine: that �the announcement we are about to make will finish the UK cattle industry for decades and we might as well accept the fact and order a complete slaughtering and restocking�.[795]
540 In his covering note to Mr Hogg, Mr Packer said that he regarded this measure, and �to a lesser extent� the beef withdrawal proposal, as �disproportionate and unjustified�.[796] Mr Packer told the BSE Inquiry that he viewed this as a �possible prelude to my seeking an Accounting Officer Direction if such a policy were decided upon�.[797] As the Accounting Officer for MAFF, Mr Packer was responsible for the Ministry�s spending. To seek such a Direction would mean that he was advising against the expenditure and would not implement it without a specific instruction to do so from the Minister.
541 The revised draft also now included the recommendation for a formal Inquiry into the BSE issue by a High Court judge.[798]
542 This draft note was similar to the version that Mr Hogg eventually sent to Mr Major in the evening of 18 March.[799]
543 The same day (18 March) Mr Packer minuted Mr Hogg about the implications of a �possible collapse of the beef market�.[800] He attached a note that had been prepared by Mr Cowan, discussing �arrangements for supporting the beef market under current EC rules and analysing what the implications might be for the situation with which we are likely to be faced�.[801] The note discussed various options for supporting the beef market, including intervention buying, a calf slaughter scheme, and an over 30 month slaughter scheme.
DH
544 On the same day in the Department of Health, Sir Kenneth Calman held a meeting of health officials. Dr Rubery telephoned David Salisbury about vaccines, Jenny Bacon, Chief Executive of the Health and Safety Executive (HSE) about occupational aspects, Drs Jones and Jefferys at MCA, Professor Swales� office about research needs and the Medical Research Council (MRC) about their input. The Medical Devices Agency (MDA) were also informed.[802]
545 Dr Rubery and Sir Kenneth between them identified the persons they regarded as important medical professionals who should be informed in advance about the latest findings. These included Dr Tyrrell, Sir Richard Southwood and Sir Donald Acheson[803].
546 In the afternoon, Mr Dorrell met Sir Kenneth, Sir Graham Hart, Dr Rubery and others. At 7:15pm[804] they were joined by Mr Hogg and MAFF officials.[805] Mr Hogg set out his proposals for a ban on beef older than 2� years, and an Inquiry into the Government�s response to BSE. Sir Kenneth set out the consequences for DH of the findings, which included investigations into the safety of non-food beef products (for example, vaccines) and communication with health professionals so that information could be passed on to the public. Mr Dorrell repeated his views that there was no need for a separate �helpline� to be set up but that existing lines be bolstered by extra staff, and that there should be no compensation for nvCJD victims because the Government had all times followed the advice of its committees.[806]
Minute 2 is sent
547 After this meeting, the second minute to the Prime Minister was submitted.[807] In it, Mr Hogg proposed taking interim measures in advance of SEAC advice:
�The balance of probability concerning the transmissibility of BSE to man has been fundamentally altered by the SEAC statement. It is right to act now to protect and be seen to protect the public further. The likely Parliamentary and public perceptions point the same way. I would propose to explain to the House that such measures were interim and awaited definitive SEAC advice before being confirmed or amended. Obviously though it would be sensible to work with the trend of the discussions in SEAC. This, following a conversation I have had with Professor Pattison, I have sought to do in the following proposal.�[808]
548 He proposed �the very minimum we can do�:
�(i) banning the sale of beef and beef products derived from animals from UK herds and from animals over 2� years of age;
�(ii) banning the manufacture of products from bovine material from animals from UK herds and from animals over 2� years of age;
�(iii) banning the export of such beef and beef products�.[809]
549 The minute proposed the possible withdrawal of all beef products. It said that Mr Hogg favoured this proposal though he acknowledged the �enormous financial and other implications� and that a collective decision would be needed.[810]
550 Mr Hogg estimated that compensation for owners of cattle over 2� years old �could amount to somewhat in excess of �500m.p.a.�[811]
551 The minute also identified �a much more cataclysmic view. On this basis the announcement we are about to make will finish the UK cattle industry for decades and we might as well accept the fact and order a complete slaughtering and restocking�.[812]
552 The minute also recommended a formal Inquiry into the Government�s reaction to BSE, chaired by a High Court judge.[813]
Cabinet
553 In the late evening of Monday 18 March, Mr Hogg and Mr Dorrell met the Prime Minister, other members of Cabinet, and officials to discuss the two minutes that had been circulated that day.[814] Among other things, Mr Hogg pointed out that �Once one admitted the possibility of transmissibility to humans, then one had equally to admit that controls were ineffective. Controls had been tightened in 1995 but those controls continued to be breached�.[815]
Tuesday 19 March 1996
554 On the morning of 19 March, Mr Dorrell met Sir Kenneth Calman and Dr Rubery before attending a meeting chaired by the Prime Minister.[816]
555 Also before the meeting, Mr Kenneth Clarke, Chancellor of the Exchequer, who was not present at the meeting, minuted Mr Major with his views. He said �the Government should make public as rapidly as possible the full facts it has at its disposal�.[817] He said that any action which the Government took must be proportionate to the risk to public health: �We want to be in a position in 4 weeks time whereby intelligent people can look back and say that the Government�s actions were measured and sensible, and not an absurd over-reaction which made things worse�. He noted that the �behaviour of the Government following the salmonella and listeria crises [when he was Secretary of State for Health] are widely seen to have been foolish and excessive, causing lasting damage to British agriculture�.[818] He compared the risk to other risks such as smoking, and said
�I would regard a complete ban on beef products, or the culling of the beef and dairy herds, as completely over the top. Moreover, I suspect the general public would soon take a similar view, faced with endless media coverage of burning cattle piled high on funeral pyres�.[819]
556 Mr Clarke emphasised that his perspective was �not based simply on the potential public expenditure implications,� but on his view that �the duty of the Government is to give a responsible and calm lead to public opinion in the face of disturbing events�.[820]
557 Mr Major chaired a �large and long�[821] meeting of Ministers, with Professor Pattison present. Mr Hogg presented his proposals:
��we had to date adopted a belt and braces approach. The belt being that there was no risk of transferability from cattle to humans, the braces being that SBO controls were in place should such an unlikely event occur. Now that there was thought to be the likelihood of a link between cattle and humans, the belt had been removed leaving only the braces� The panic which would ensue from any statement would destroy the beef industry� It might be possible to save it if a firebreak could be erected and he had offered the best advice he could. He commented that the difficulty was that we knew that SBO controls were not wholly adequate and in the changed circumstances of the new information this made the Government�s position untenable.�[822]
558 Mr Major said that taking drastic action in advance of further advice would �make the Government look silly and would open it to significant legislation [sic] if premature action was taken�.[823] Mr Hogg�s proposals were rejected by the meeting. Mr Hogg accepted the collective decision.[824]
559 Professor Pattison explained SEAC's conclusions but would not be drawn into giving advice in advance of SEAC's meeting scheduled for the weekend, on the wide range of measures which might be introduced in response to this development. Ministers agreed that any statement had to include substantive recommendations and an early meeting of SEAC was therefore �encouraged�.[825]
SEAC Meeting 28
560 After that meeting, Dr Rubery went to assemble as many SEAC members as could be found at such short notice. The meeting started at 4:00pm. A number of members who could not be present were kept in telephone contact with the discussions.[826] Present in London were Professors Pattison, Almond and Smith. Dr Will and Professor Collinge were there �for part of the meeting�. Mr Bradley and Dr Kimberlin participated via a telephone link to Paris. Observing were Drs Matthews and Wight. Messrs Eddy and Skinner (Secretariat) were there. �In attendance� were Dr Kendell, Mr Robb, Mr G Ross (MAFF), Dr Rubery, and Mr Wilesmith. Sir Kenneth Calman and Mr Meldrum attended for part of the meeting.[827]
561 Professor Pattison explained that the meeting would focus on the adequacy of existing control measures to protect animal and human health. SEAC agreed that matters requiring detailed consideration in the light of new information would need to be dealt with at the meeting on 23 March.[828]
562 Dr Will said that a 10th case had been confirmed, in a 20-year-old.[829]
563 SEAC felt there was no evidence that milk could act as a vehicle for BSE or other TSEs. Also, slaughtering the entire UK beef herd was not considered a justifiable course of action in the light of scientific evidence.[830]
564 Information from Mr Wilesmith indicated that �onset� of BSE in cattle under 2� years old was extremely rare. Professor Smith calculated that there could be a possible 500-fold reduction in risk if cattle over 2� years old were removed from the food chain.[831]
565 The option of de-boning beef was also discussed.[832]
566 Also on 19 March, Mr Baldry sent Mr Hogg two minutes, copied to Mr Boswell, Mrs Browning and Mr Packer. The first expressed his view that MAFF should not act without the advice of SEAC. He said there was no reason to announce more than that the Government were expecting further recommendations from SEAC on which they would seek to act:
�I� feel very strongly that for Ministers to indicate action now in advance of any SEAC recommendation has every possibility of being �over-reaction� and to lead to much more draconian consequences than in the event are necessary, for which the government and Ministers will attract opprobrium�.[833]
567 In his second minute Mr Baldry gave his opinion on the legal implications of three matters that Mr Hogg had raised with him. On the first, compensation, he advised that at �the very minimum, it should be full market value compensation for cattle which cannot otherwise be sold, but there is no way in this situation that we can just compensate farmers and no-one else�.[834]
568 On the question of a BSE Inquiry, Mr Baldry considered that this would be �likely to undermine confidence in SEAC�. It was best to invite members of certain Royal Colleges to examine �whether the right terms of reference have been given to SEAC i.e. are they sufficiently broad�.[835] He noted that setting up any other kind of Inquiry �would almost certainly imply political acceptance of fault on the part of MAFF. As we have fully complied with all scientific advice so far this seems unnecessary, setting us off on the back foot�.[836]
569 Thirdly, Mr Baldry �strongly� recommended that MAFF should not make an Order until they knew SEAC�s recommendations. This was because laying an Order under the Food Safety Act
�requires asserting imminent risk of injury to health. That immediately would signal that we have no confidence in the existing control measures, goes way beyond what SEAC has said and runs the risk of MAFF being involved in litigation for some very considerable time�.[837]
570 Just before a 6:30pm meeting (below), Mr Hogg had a brief meeting with his junior Ministers, Mr Packer, Mr Carden, Mr Haddon, Mr Taylor and Mr Blakeway.[838] They discussed Mr Baldry�s minute. Mr Baldry stressed that �it would be a mistake to pre-empt SEAC�,[839] and Mr Boswell �stressed the need not to lead SEAC in any way�.[840] Mr Carden noted the need not to place SEAC under �unreasonable time pressure�.[841]
571 At 6:30pm Mr (later Lord) Anthony Newton (Lord President of the Council) chaired a meeting with Ministers including Mr Dorrell, Mr Hogg, Mrs Browning, Mr Forsyth and Mr Hague. They agreed that there would be an announcement in the House the next day. They also agreed that SEAC should be asked to provide urgent advice by 10:30 the next morning.[842]
572 The notes of this meeting record that Mr Fischler had already been �warned� and that he would be telephoned again before the statement was made in the House.[843]
573 Mr Robert Lowson (formerly Head of the Animal Health (Disease Control) Division of MAFF) was now the �Agriculture Minister� at the UK Permanent Representation to the European Union in Brussels (UKRep). On 19 March, two officials (Mr Cameron (SOAFED) and Ms Kate Timms (a MAFF Deputy Secretary)) told him about the imminent announcement, but added that they had no authority yet to inform the European Commission. Mr Lowson said
�This was the first I had heard of this; UKRep had not been involved in any discussion of handling at European level. I spoke to MAFF (Mr Carden) to emphasise the importance of ensuring that the Commission had advance warning and reported accordingly to senior colleagues in UKRep.�[844]
574 Dr Rubery relayed requests for further advice from the meeting chaired by Mr Newton back to the SEAC meeting.[845] She also went to No. 10 Downing Street at about 10:00pm to brief Mr Major about the latest developments. He wanted to know what conclusions SEAC appeared likely to reach.[846]
575 Mr Heseltine telephoned Mr Dorrell that evening. He felt that given the concern about health, it was time to break with precedent and that tomorrow�s statement should be made by the Health Secretary, not by the Agriculture Minister.[847]
576 At 10:30pm SEAC had not reached final conclusions on all issues. Members agreed to reconvene at 8:00 the next morning.[848]
577 A number of other matters also occurred on 19 March 1996:
578 Mr Meldrum advised Mr Hogg that the proposed ban on beef from cattle more than 2� years of age should be described as interim because SEAC might take the view that the meat from such cattle could safely be put on the market for human consumption, provided it was first deboned. Mr Meldrum favoured �the banning of head meat from all cattle�.[849]
579 Mr Hollis (Livestock Group) estimated the cost of slaughtering the entire national herd. Mr Heseltine had asked Mr Hogg about this option the previous evening. The estimate was based principally on the value of milk that would be lost (value of milk production per year multiplied by 5, this being Mr Hollis� estimate of the number of years it would take milk production to return to normal). Mr Hollis remarked that the cost of such a slaughter programme would seem likely to �comfortably exceed �20 billion in the dairy section alone�.[850]
580 Also on 19 March, Dr Rubery and other officials met with representatives of the MLC to discuss the �consequences and how one might handle things on 20 March�.[851]
581 Dr S M Ludgate of the MCA minuted Dr Wight with the point that: �Animal tissues and substances of animal origin derived from cattle, used in medical devices in the Health Service, are all sought from animals located outside the UK, predominately Australia and America�.[852]
582 Dr Painter sent a fax on 19 March to Dr Wight with a detailed set of questions and answers, presumably to be used in dealing with the media.[853] Also, Mr Robb faxed a (different) set of questions and answers to Mr Skinner, with Dr Render�s comments in manuscript.[854]
583 Also that day, Mr Packer drafted a statement for Mr Hogg to make to Parliament. It left open the question of new protective measures pending the imminent advice from SEAC.[855]
Wednesday 20 March 1996
584 Fears that the news would leak were realised on the morning of 20 March 1996, with newspapers reporting that Mr Dorrell was expected to announce today that there might be a risk of humans contracting a form of BSE from infected meat. The Daily Mirror said
�Humans could catch Mad Cow Disease from eating infected beef, the government will admit today.
�Health Secretary Stephen Dorrell will accept for the first time that the brain wasting disease may have been passed to people from infected animals.
�The U-turn by Ministers � who for 10 years have insisted it was impossible � will spark calls for tough new curbs on suspect meat��[856]
585 That morning Sir Kenneth Calman prepared a first draft of his statement before attending the resumed meeting of SEAC.[857]
586 SEAC recommenced its meeting at 8:00am. Present in London were Professors Pattison, Almond, Smith and Collinge, Mr Pepper and Dr Painter. Dr Kimberlin and Mr Bradley were to return from Paris that morning, but the flight was cancelled.[858] The telephone link to Paris was re-established at 8:45am. Dr Will had gone back to Edinburgh and he too participated by telephone, from 8:50am.[859] Dr Matthews continued as an observer. Messrs Eddy and Skinner (Secretariat) were there. In attendance were Dr Rubery, Mr Wilesmith, Lord McColl (Mr Major�s private secretary) and Dr Render. Sir Kenneth Calman and Mr Meldrum attended for part of the meeting.[860]
587 SEAC resumed their discussion of the deboning option as �the best way forward�.[861] They also considered the option of removing from the food chain materials which would have been banned from human consumption, and decided against this �in view of the extreme precautionary nature of [SEAC�s] recommendations�.[862] On their 16 March recommendation to ban all MBM in farm animal feed,[863] they decided there was no need to ban MBM in pet foods or fertilisers.[864] They also discussed worker safety.[865]
588 At 9:30am Mr Hogg was �informed of initial (but still uncertain) indications � received by telephone � of SEAC�s likely advice�.[866]
589 SEAC finished their meeting and produced their final statement at 9:30am.[867] The statement emphasised that �it is imperative that current measures to protect the public health are properly enforced and [we] recommend constant supervision to ensure the complete removal of spinal cord.� It also recommended:
�a.�� that carcasses from cattle aged over 30 months must be deboned in licensed plants supervised by the Meat Hygiene Service and the trimmings must be classified as SBOs.
�b.�� a prohibition on the use of mammalian meat and bonemeal in feed for all farm animals.
�c.�� that HSE and ACDP, in consultation with SEAC should urgently review their advice in the light of these findings.
�d.�� that the Committee urgently consider what further research is necessary�.[868]
590 After this, Sir Kenneth redrafted his statement.[869]
591 Mr Hogg discussed the recommendations briefly with Mr Packer and Mr Carden. He said that �we should do no more and no less than SEAC was recommending�. It was noted that the orders would not be under the emergency provisions of the Food Safety Act and would therefore need to be consulted on.[870]
592 Mr Hogg also noted that since there was no product recall, there would be no need to decide immediately on issues around compensation. �We would, however, need to consider the mechanisms for providing for MAFF-approved plants for deboning�.[871]
593 Mr Major convened a meeting of Cabinet Ministers at No. 10 at around 10:45am which lasted until after noon. Sir Kenneth and Professor Pattison attended for the first part of the meeting and presented SEAC�s advice.[872] After they had left, Cabinet discussed and accepted SEAC�s advice. They decided that Mr Dorrell should make the opening statement and Mr Hogg should follow with a statement on the agricultural implications. They also decided that the Opposition should be offered a briefing from Sir Kenneth, and Sir Robin Butler was asked to arrange this.[873]
594 At lunchtime, Mr Packer, Sir Kenneth, and Sir Robin Butler briefed the Opposition spokespeople on health and agriculture on the background to the announcements to be made that afternoon. Mr Packer was concerned when Sir Kenneth �speculate[d]� during the briefing that, despite SEAC�s official advice, some members of SEAC might prefer their own children and grandchildren not to eat beef. Mr Packer inferred that this was Sir Kenneth�s own position. Mr Packer noted that Ms Harriet Harman�s (Opposition spokesperson on Health) interest was attracted by this comment.[874]
595 After the Cabinet meeting Mr Dorrell went to his office to prepare his statement. Dr Rubery and other DH officials helped him. Mr Dorrell told the BSE Inquiry that in the course of preparing his statement,
�I was reminded of speculation in the press that children were at particular risk of infection from BSE. I asked the Chief Medical Officer what his advice was. He told me that he did not feel qualified to respond. Since it was clear that I would be (and indeed was) asked the question, I asked the CMO to ensure that SEAC considered this specific question at the further meeting which they planned to hold over the weekend�.[875]
596 Sir Kenneth also prepared a further redraft of his statement.[876]
597 Mr Packer had the previous day prepared a statement for Mr Hogg to make to Parliament.[877] Following the decision that Mr Dorrell should make the main statement, Mr Packer drafted an alternative version for Mr Hogg which was delivered broadly as drafted (see below).[878]
598 A note was sent from the Prime Minister�s office to MAFF, copied to DH, outlining two points that Mr Major wanted to see brought out in any statements that were made that day. The first was that there was no proven link between BSE and CJD. All that had happened was that �the balance of probabilities has now shifted in the light of new evidence. The Prime Minister feels it is important to emphasise this so as to explain earlier statements about there being no scientific evidence of such a link�.[879]
599 The second point was that the scientists whose advice the Government had received should be named. �The Prime Minister feels that simply to say �we are advised� will sound very weak when there will be other scientists prominently saying �we told you so��.[880]
600 Mr Hogg told the BSE Inquiry that he did not remember this note. He did not use the particular phrasing in it. He made his statement to the House in his own words.[881]
601 Earlier in the morning of 20 March, Mr Carden had telephoned Mr Lowson (UKRep) and the UK Embassy at Bonn to brief them about the breaking story.[882] Later, he faxed the text of Mr Hogg�s statement to Mr Lowson, and followed this up with a telephone call.[883]
602 UK Embassies at Paris and Dublin were also informed individually.[884] Other UK Embassies were sent a telex via the Foreign and Commonwealth Office (FCO).[885]
603 It was Mr Hogg�s intention to inform Mr Fischler, who had earlier been warned of the developments,[886] by telephone.[887] He did so at 2:30pm.[888]
604 Mr Dorrell made his statement in Parliament at 3:30pm. Mr Hogg�s statement followed.[889]
605 Mr Dorrell�s statement reported the new findings of the CJD Surveillance Unit and the view that SEAC had reached on those: �the most likely explanation at present is that [the 10 cases of CJD� identified in people aged under 42] are linked to exposure to BSE before the introduction of the specified bovine offal ban in 1989�.[890]
606 He went on to explain the recommendations that SEAC had made on research and on food safety: �the Committee has concluded that the risk from eating beef is now likely to be extremely small and there is no need for it to revise its advice on the safety of milk�.[891]
607 Mr Dorrell said that the CMO would write today to all doctors. He quoted from the CMO�s statement, in which Sir Kenneth said that he would continue to eat beef �as part of a varied and balanced diet�.[892]
608 Mr Dorrell then referred to the particular question that had �arisen about the possibility that children are more at risk of contracting CJD.� He said he had asked for specific advice from SEAC on this issue.[893] He told the BSE Inquiry that he referred to this issue because he was aware of speculation in the press that children were at particular risk of infection from BSE.[894]
609 After Mr Dorrell�s statement, Mr Hogg in a shorter statement explained SEAC�s recommendations for action by the agriculture departments, namely that:
(i.) carcasses from cattle aged over 30 months must be deboned in specially licensed plants supervised by the MHS, and the trimmings kept out of any food chain; and
(ii.) mammalian MBM be banned in feed for all farm animals.[895]
610 Mr Hogg confirmed that the Government had accepted these recommendations and would put them into effect as soon as possible; and that with immediate effect he had instructed that existing controls in slaughterhouses and other meat plants and feed mills should be more vigorously enforced. He did not refer to a beef withdrawal scheme.[896]
611 Mr Hogg also pointed out that �the Government�s Chief Medical Officer advises us that there is no scientific evidence that BSE can be transmitted to man by beef�.[897]
613 There was a press conference at 5:30pm. At the same time, Mrs Browning held a meeting with industry representatives to discuss the announcement.[900]
614 Also on 20 March 1996, Mr Hogg wrote to the German Health Minister to advise him of that day�s announcements and to �let you know that I am keen we should continue to keep you fully informed�.[901]
615 SEAC met again on the weekend of 23-24 March to give advice on children in the light of the research findings and on several other issues.[902] Mr Dorrell made a further statement on the safety of beef for children on 25 March 1996.[903]
