Volume 6: Human Health, 1989-96
7. Human health developments from January 1996 to 20 March 1996
The response to the reports of the February meeting
Discussion
The gathering clouds
Judicial Review of the SBO (Amendment) Order 1995

Discussion

Reaction to Mr Eddy's minute of 6 February

7.165 In his original witness statement Mr Carden said this:

The first record I have found of my being made aware of the emerging indications of a new variant of CJD (nvCJD) is a minute from Mr T Eddy dated 6 February 1996 to the Minister's private secretary. This reported that SEAC, at a meeting on 1 February 1996, had received a report from Dr Will, Deputy Chairman of the Committee and Head of the CJD Surveillance Unit, about two papers on CJD that he was preparing for publication. One of these papers was a study of five cases of CJD confirmed in patients aged under 30 (abnormally young compared with other CJD cases). The paper was to describe an unexpected, extensive and unusual pattern of prion protein deposition. Mr Eddy's minute noted that some might suggest that the new form of CJD could have been 'caught from cattle', and commented that this could not 'be ruled out on the basis of the available evidence'. But it concluded that it would be premature to reach any firm view; SEAC was to do further work, and give agriculture and health Ministers a formal opinion.

Those of us who received Mr Eddy's 6 February report 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. ¹

7.166 In a subsequent statement Mr Carden added:

With the report that I and others in MAFF received from Mr Eddy of SEAC's 1 February meeting the position started to change. Although Mr Eddy reported that it was 'far too premature to draw any conclusions', Dr Will's findings were the first firm indications that the balance of probability might be shifting in favour of BSE actually being transmissible to man (contrary to what had generally been believed in MAFF up till then), and that one suspected means of transmissibility - ingestion of beef - had suddenly gained ground over the others that had been attracting more attention in autumn 1995. ²

7.167 Later in the same statement he elaborated:

It is a normal feature of the work of senior policy advisers to be on the watch for new developments and to be ready to react to them fast. Our actual approach in this instance of BSE and nvCJD, as described in the statements which I and others have put to the Inquiry at earlier stages, illustrates that I and my colleagues in MAFF devoted much time and energy in the first months of 1996 to watching every new indication of what was going on; that we moved into a state of high alert as events unfolded, and discussed and evaluated each new development intensively; with MAFF and DH in very close touch both at official and ministerial level at all key stages. ³

7.168 In her original witness statement Mrs Browning made no mention of the nature of the reaction of herself, or anyone else, to the receipt of Mr Eddy's minute of 6 February. ⁴ When she gave oral evidence in Phase 1 she said that she remembered receiving this minute and it was a matter of concern, but clearly there was more scientific work needed to give advice to Ministers. ⁵

7.169 Mr Hogg said that he had no recollection of seeing the minute, but the overwhelming probabilities were that he would have done. He added:

I do not actually recall my state of mind, but I know the sort of person I am. I would have been concerned. ⁶

7.170 When Mrs Browning returned to give evidence in Phase 2 she said:

I think Mr Carden is quite right to say that that information we received in Mr Eddy's minute gave us great concern, and that we were anxious, within the Ministry, to know as much as possible through the SEAC Committee as to their conclusions.

. . .

I think the imagination raced really to see what the advice was likely to be that eventually came forward from the scientists, and what one might do to mitigate that problem in terms of policy announcements and practical action that would then be needed. ⁷

7.171 Later in her evidence she said this about Mr Eddy's minute of 6 February:

I did not interpret Mr Eddy's minute as being one in which the compelling message was presentation. That was merely a component. I would say my own recollection of my own thinking about it was really far more concerned with what the scientists would find in terms of their additional research and the impact of that, rather than the presentation.

If I may just say that in the Ministry, although presentation was very often a difficult issue to handle, we did not in any way take presentation as our first priority. It was a matter of putting the policy into the public domain in a way that was safe and which was credible. The presentation really was the last thing to be considered. It certainly was not my interpretation of Mr Eddy's minute that it was about presentation.

Q. LORD PHILLIPS: That is helpful. As far as you were concerned it was quite enough to set the alarm bells ringing, that minute?

A: Yes. Absolutely. ⁸

7.172 When Mr Hogg returned to give evidence in Phase 2 he gave a different picture of his reaction to Mr Eddy's minute. As he had no actual recollection, he viewed it afresh. Of the reference to Dr Will's papers being 'potentially tricky' and needing 'careful handling' he commented 'that sounds, although we go on, that this is essentially a presentational problem rather than one of substance'. After going through the minute he concluded:

. . . reading this again, and I am coming basically afresh to it because I do not remember this, this is not a red alert at all. This is saying that something is happening, you need to know about it, it may have handling problems of a substantial kind, but it is not a warning of transmissibility. It really is not. And had I thought it was, I would have acted and so would all my people around me. ⁹

7.173 In characteristic style, Mr Hogg commented, when referred to Mr Meldrum's evidence that alarm bells were ringing for him:

I am sure he did not ring the alarm bells in my office. Had he done so Lord Phillips, again you may have got this impression of me already, I am an interventionist Minister. I do not hesitate to call for persons and papers, and to make up my own policy. After all, at the end of the day the policy of the 16th March, 20th March, was mine and not by the Permanent Secretary or the officials. So I do not hesitate to intervene. Had I been told that, 'Look this is becoming very serious, we think the thing is transmissible', I would have swooped like an eagle.

. . .

I do not blame officials. I am in the business of recognising that Ministers are responsible. That is why I took the responsibility of the policy without worrying about that, it is my business. I suspect that Meldrum and friends did not think that they had hard enough information to come to me with recommendations or a form of concern, but they did not. Had they done so, there would have been some evidence of that in the paper trail, if only because I would have said, 'I want to see Meldrum'. I would not have sat on my backside with this kind of commotion around. ¹⁰

7.174 Mr Hogg was referred to Mr Carden's reference to MAFF being in a state of high alert after the SEAC meeting. He commented:

That does not accord with my recollection. It may be that it was at official level. I am not saying he is wrong. All I can tell you is that he did not bring that to my attention, nor do I think that paper justifies it. ¹¹

7.175 When told that Mrs Browning had said that Mr Eddy's paper set alarm bells ringing, he added:

All I can say is it did not set my alarm bells ringing and I am pretty sensitive. I am bound to say, reading the thing again, I am reinforced in that view.

. . . there was nothing to set the alarm bells ringing. It was quite plain that we were dealing with something where there was time, time and where there was not evidence of transmission, we were dealing essentially at that point with a handling difficulty, not a substantive difficulty, at that stage. ¹²

7.176 The evidence of Mr Meldrum and Mr Packer also differed as to the effect on them of Mr Eddy's minute. Mr Packer said in a witness statement:

After 6 February 1996 it became much more likely that we would be faced with the possibility SEAC would conclude that transmissibility of BSE to humans had been proved or was probable. ¹³

7.177 In oral evidence he said that the information contained in Mr Eddy's minute raised, obviously, a number of serious issues and referred, in particular, to the identification of two distinct subsets of CJD. ¹⁴

7.178 In contrast to this, in a supplementary statement Mr Meldrum said:

The comments in the minute dated 6 February 1996 to Ministers are very important. Firstly Mr Eddy, who was simply reporting the views of SEAC, commented that it was too early to draw any conclusions and also indicated that further advice would be submitted by SEAC when the paper was published, which officials knew would be some time away. This does not indicate that SEAC were unduly worried and nor does it indicate that they considered that any urgent action was required, quite the opposite. Whilst the five cases of CJD confirmed in patients aged under 30 were extremely worrying it was clear that neither the CJD Surveillance Unit, particularly Dr Will, nor SEAC had come to any conclusions, not even tentative conclusions, as to the implications of these cases on the issue of the transmissibility of BSE to humans. ¹⁵

7.179 In oral evidence he added:

But if you look at the note of the meeting put to Ministers, from the February meeting of SEAC, it does not give me the feel that alarm bells were being pressed at that particular time. There was no urgency about the next meeting, for instance. There was no comment about 'We need to have a meeting in two weeks time', there was nothing about 'We need to review the literature or look at other sections from elsewhere in Europe as a matter of urgency'. It says: 'We are going to publish in four to six weeks', or something like that. It did not indicate to me, that minute alone, that there was the degree of concern that some witnesses have indicated. ¹⁶

7.180 The evidence that we have summarised suggests that different witnesses in MAFF had different perceptions of the implications of the matters discussed at the SEAC meeting of 1 February as described in Mr Eddy's minute. We are conscious of the difficulties of recollecting attitudes of mind several years after the relevant events and we propose to examine the reliability of this evidence. We shall do so later in this chapter, in the context of considering the extent to which officials and Ministers carried out any contingency planning in relation to the action that would need to be taken, should the new cases of CJD be shown to be linked to BSE. Next, however, we wish to consider the reaction of DH witnesses to the account of the SEAC meeting set out in Dr Wight's minute.

Reaction to Dr Wight's minute of 6 February

7.181 In a supplementary witness statement Sir Kenneth Calman dealt with the question of whether DH should have carried out any contingency planning before March 1996 to address the possibility that BSE might be shown to be transmissible to humans. He commented:

Up until the date that I received a briefing of the matters discussed at SEAC's 1st February 1996 meeting, I and the Department of Health had consistently been receiving advice from the Government's Expert Advisory Committee that any risk to human health posed by BSE was remote and that there was no scientific evidence to suggest that there was a link between BSE and any human disease. ¹⁷

7.182 After setting out the terms of Dr Wight's minute, he commented:

There was nothing in this minute which suggested at this stage any change in SEAC's advice. It was premature for any conclusions to be drawn. In the circumstances it was not appropriate for me to have addressed at this stage the issue of what action might be required should scientific advice be received that it was probable that there was a link between BSE and a disease in humans. ¹⁸

7.183 He went on to say that he considered all aspects were being properly reviewed and that further deliberations would be required by SEAC.

7.184 When giving oral evidence Sir Kenneth was asked whether his reaction would have been any different had Dr Wight mentioned the concerns of Professor Pattison and Professor Collinge. He replied that he did not think it would, because it was always necessary to get the genetic data. ¹⁹ He went on to remark that it was not until the end of February that things began to change. ²⁰

7.185 Dr Metters remarked, in a supplementary witness statement, that there was nothing in Dr Wight's minute to suggest that there had been any change in SEAC's advice that there was no evidence of a link between BSE and CJD. SEAC had drawn no conclusions from the developments discussed at its meeting on 1 February. ²¹

7.186 When giving oral evidence, Dr Metters said this of Dr Wight's minute:

That is not, in terms, 'stop press, there is urgent material here'. That is, in a way, Dr Wight saying 'CMO, there are a number of things arising out of SEAC's meeting of which you might wish to be aware'. No alarm bells ringing as a result of paragraph 1.

. . . But until SEAC actually come up and say: 'Look, it is time you did something because we believe the situation has changed', I did not think that this was an alarm ringing note.

. . . At the time it was not a cause for the alarm to go off in my view, especially as she then, after 'CJD Update', goes on to research priorities which had been a cause of much more concern, and which she was urgently seeking a resolution of. ²²

7.187 Dr Rubery's evidence suggested that she had a different reaction. In a statement she spoke of her concern about the cases of CJD in young people. She went on to speak of a meeting with Dr Roger Skinner recorded in her diary, at which 'I am sure I would have discussed the SEAC meeting and its implications'. She continued:

After that date my diary shows I met with Dr Skinner in one to one meetings on 9, 16 and 26 February 1996, I also met on 26 February 1996 with Dr Wight and Mr Skinner and Mr Murray to be briefed for my meeting with the CVO at Tolworth. These more frequent meetings with Dr Skinner reflect my and the Department's growing concern about the CJD cases in young people. This would certainly also have been reflected in many informal contacts and discussions with Dr Wight, Mr Skinner, Dr Metters, the CMO and Mr Hart, the Permanent Secretary, during the course of our day-to-day business. I am not able to recall any further details of these informal meetings and because of their informal nature do not have any written record of them. ²³

7.188 If this plethora of meetings about CJD cases in young people is said to have taken place as early as February 1996, we do not believe that Dr Rubery's recollection can be correct. Had they taken place we feel that there would be some documentary record of at least some of them. There were a number of recorded meetings during this period involving Dr Rubery, to which she referred in her original statement. These included meetings about research ²⁴ and a meeting with the CVO on 28 February, at which she was brought 'up to date on MAFF aspects of BSE'. ²⁵ It was, we believe, at this meeting that a leaflet was agreed for distribution to reassure consumers as to the safety of beef. ²⁶ There is no trace of any meeting to discuss concerns about young cases of CJD.

7.189 Dr Rubery was called to give oral evidence with Dr Roger Skinner in Phase 1 of the Inquiry. In the course of her evidence Dr Rubery said:

. . . I must have talked about BSE and CJD to Dr Skinner from time to time, and we would have thought about the issues of, 'Are we doing all we need to in terms of forward planning?', because that is part of what those regular meetings would be about. ²⁷

7.190 We sought to explore with both witnesses when this was. Their evidence suggested the end of February or later. ²⁸

7.191 In the light of all this evidence, we have concluded that Dr Rubery's evidence of a series of informal meetings at which the cases of CJD in young persons was discussed cannot relate to the month of February 1996.

The gathering clouds

Further CJD victims reported

7.192 During February further cases of deaths caused by CJD were reported in the press. The reports inevitably focused on the possibility that the cases were caused by or linked to BSE. On 8 February 1996, Peter Hall died of what was later diagnosed as vCJD. ²⁹ His death was reported in the Guardian on 15 February 1996 in an article entitled 'Mad cow disease kills man'. ³⁰ It reported that a post-mortem was being carried out on a 20-year-old man who, it was claimed, had died of CJD. The article reported that Dr Harash Narang, a clinical microbiologist, who believed that mad cow disease could be transmitted to humans, had tested the victim's urine and found 'a unique CJD virus'. On the same day an article in the Independent entitled 'BSE "cause of death" ' reported Dr Narang's view that the death was caused by the 'human form of BSE' but concluded by stating that 'The official Government view is that Mad Cow Disease - or bovine spongiform encephalopathy (BSE) - cannot be transmitted to humans'. ³¹

7.193 On 16 February 1996 The Times reported the case in an article entitled 'Vegetarian's brain tested', as did the Daily Express in an article entitled 'Did mad cow bug kill a vegetarian?'. The Daily Express reported that the victim's parents believed their son had 'caught' CJD before he gave up meat two years previously. ³² The article went on to report that the victim, who would have been 21 years old the following day, had 'wasted away in hospital after a two-year battle with the illness'. Dr Harash Narang was quoted as saying:

One supply of infected meat could be enough to start the disease if a person is susceptible . . . The most worrying thing is that there could be hundreds of other cases across the country - even vegetarians like Peter Hall - but nobody will know unless they are diagnosed properly.

7.194 On the same day the Daily Star reported the case in an article entitled 'Veggie boy is killed by mad cow disease'. ³³ This reported that Peter Hall's family had blamed the 'beefburgers he loved as a child for infecting him with the fatal illness'. The family stated that 'the most frightening thing was the similarity between his condition and the disease we have seen cows suffering from - shaking, nervousness and what appeared to be hallucinations'. It was reported that Dr Narang had diagnosed the victim as suffering from CJD.

7.195 On 18 February 1996 the Mail on Sunday in an article entitled 'Exclusive: Fourth teenager is killed by CJD' reported that Peter Hall had been 'killed' by CJD, which was described as the 'human equivalent of Mad Cow Disease (BSE)'. ³⁴

7.196 On 15 February 1996, Dr Wight minuted Mr Clark (Information Division, DH) about an earlier case of a 30-year-old man who had died of CJD in Belfast. She stated:

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. ³⁵

7.197 On 16 February 1996, Mr Mike Skinner informed Mr John Horam ³⁶ of the death of Peter Hall, and about the CJD Surveillance Unit's involvement in the case. The minute stated that diagnosis 'may take up to 10 weeks' because of the time needed to fix the brain tissue. ³⁷

7.198 On the same day, Mr Eddy minuted Mrs Browning with some background about Peter Hall's case. ³⁸ Among others, the minute was also copied to Mr Hogg, Mr Packer, Mr Meldrum, Mr Carden and Dr Wight. Mr Eddy stated:

Department of Health tell me that this is a somewhat untypical case, a possible rather than probable CJD case . . .

7.199 On 17 February 1996, Alison Williams died of what was later diagnosed as vCJD. ³⁹ It appears that this case was not reported at the time.

7.200 On 20 February 1996 Dr Will made a presentation at a meeting called by the Parliamentary Food and Health Forum to discuss the relationship between BSE and CJD. Dr Dealler was the other invited speaker at the meeting. ⁴⁰ Dr Will's presentation is discussed in vol. 8: Variant CJD.

Judicial Review of the SBO (Amendment) Order 1995

7.201 We describe in Chapter 6 the ban introduced in December 1995 on the use of the spinal column in the production of meat and bone meal (MBM). Great Harwood Foods Ltd, a producer of MBM, was given leave to seek Judicial Review of this measure on 1 March 1996. The point of law which was raised was that, once definitive measures for a relevant outbreak of disease were adopted by the European Commission at the community level, it followed that Member States were no longer entitled to adopt unilateral measures.

7.202 The point raised by Great Harwood Foods on their application for Judicial Review involved a difficult question of European law. As the European Commission had adopted measures at European Community (EC) ⁴¹ level in the case of BSE, it was said that the UK Government could not take measures on its own, but would have to follow the procedure laid down in the relevant directives for animal products (89/662/EEC) and live animals (90/425/EEC) to bring about amendment of the decisions taken by the European Commission. This point sufficiently impressed the judge to lead to grant of leave to seek Judicial Review.

Discussion

7.203 We have since explored with MAFF lawyers whether they had an answer to this point. It seems that a similar point is currently before the European Court of Justice. The amendment of the SBO Order to deal with the possible risk from mechanically recovered meat (MRM) was an urgent measure. The possibility that urgent measures of this kind should be open to challenge on the grounds that they were impermissible under European law is a matter of concern. We expect that this issue will be reviewed by MAFF when the European Court of Justice decision is known. If there remains any danger that emergency measures may be readily susceptible to challenge by way of Judicial Review in this way, we think it desirable to consider steps which might minimize this danger.