Volume 4: The Southwood Working Party, 1988-89
10. Discussion
The risk in relation to medicinal products

10.83 The Working Party were, from the outset, concerned about the risks posed by medicinal products, and in particular products that were administered by injection, that had been sourced from, or produced by, a process which involved the use of bovine tissues and fluids. They lost no time in urging those responsible for the safety of medicines to take steps to address those risks, and they continued to do so throughout the period that they were working on their Report. They emphasised that action was necessary both in respect of future application for licences, andin relation to 'existing products', which phrase they intended to cover products manufactured under existing licences, including vaccines held in stock. Sir Richard told us:

We really thought the medical problem was severe. I would not have written all the letters I did to Professor Asscher if I had not felt the problem was severe and if my colleagues had not agreed with me totally. ¹

10.84 We were concerned as to why the risks from medicinal products were described as 'remote' in paragraphs 5.3.5. and 8.2 of the Report. As to this, the following response was given to us on behalf of the Working Party:

We do not consider that there was anything misleading in these statements. This is not because the potential risk was remote. On the contrary the potential risk was relatively high. The evidence before the Working Party at the time of its Report was that the Licensing Authorities had been fully alerted to the risks and had indicated that they were taking appropriate action to prevent transmission. Professor Asscher said in his letter of 26 January 1989 to Sir Richard that 'I want to reassure you that CSM intends to take appropriate action in regard of products within its remit'. ²

10.85 Sir Richard confirmed that this was the position in his oral evidence. ³ It was not clear that Lord Walton agreed with this. His oral evidence suggested at one point that he thought that the risks from medicinal products were remote, even before any action was taken to deal with them, 'though not as remote as the risk from oral products.' ⁴ This followed a passage in which he had explained:

But we had to walk a very difficult tightrope between . . . not producing a report which was alarmist and might have had a serious effect on the vaccination programme, and nevertheless on the other hand giving advice to the Committee on Safety of Medicines and other organisations. I think the most important phrase is that we gave advice so that those bodies could 'take appropriate action'. That was our intention. ⁵

10.86 Sir Anthony Epstein said that he had been 'really happy with this phrase that you are dissecting' because, on 26 January 1989, Professor Asscher had written saying: 'I want to reassure you that the CSM intends to take appropriate action.' ⁶

10.87 Sir Richard commented that this assurance moved what had originally 'stood out as a very serious problem' into the remote category. ⁷

10.88 During this hearing, the Working Party were referred to an extract from a paper discussed by the CSM's BSE Working Group on 6 September 1989 which purported to quote the Southwood Report as finding that 'the risk to man of infection via medicinal products was remote'. Sir Richard said that this incorrectly stated the Working Party's view and failed to take account of all the warnings they had given. Sir Anthony agreed. ⁸

10.89 It appears from this evidence that the Working Party considered that the risk from medicinal products - in particular those administered by injection - would not have been remote in the absence of appropriate precautionary measures. This was not apparent to Mr Lawrence. He stated:

My clear recollection is that the Southwood Working Party concluded, on the basis of the evidence available to them at the time, that the risk of BSE to man was remote, even before any measures were taken. This is certainly confirmed by the passages of the Southwood Report at (eg) paras 5.3.5, 8.2, 9.2 and 10.4. The measures I am referring to are the measures recommended by Southwood, which were more extensive than simply the slaughter and compensation policy and any action by the Licensing Authority.

I am also asked whether any members of the Working Party said anything to me to suggest, or otherwise, to give me the impression that the assessments only referred to the position after the slaughter with compensation policy was introduced and after action was taken by the Licensing Authority under the Medicines Act. The answer, to the best of my recollection, is 'no'. ⁹

10.90 Dr Pickles also understood that from December 1988 onwards it was the Working Party's view that:

. . . the risk through medicinal products in the UK pharmacopoeia appeared remote, even in advance of the further steps which the Working Party believed were to be taken by the relevant bodies. ¹⁰

This was because the initial review by DH's Medicines Division showed that there were no products with bovine neural or lymphoid tissue as a major ingredient, although there was incomplete information on products where bovine material had been used in the production process. ¹¹

10.91 We are in no doubt that the Report conveyed the message that the Working Party considered the risk from medicinal products to be remote even before any remedial measures were taken. This is not a conclusion based on construing the Report like a legal document. It is to give the wording of the Report its natural meaning, in the way that Mr Lawrence has done. We can understand the anxiety of the Working Party not to include in their Report anything likely to provoke a boycott of vaccines with the inevitable adverse consequences which would follow. This, we think, could have been achieved by a simple statement that the Working Party had been concerned at the implications that BSE might have for certain medicinal products and had referred those concerns to the CSM, which had undertaken to address them. It was not, however, satisfactory, whether by oversight or by design, to include in the Report passages which gave the reader a false appreciation of the Working Party's assessment of the risk, and they should not have done so. This shortcoming was the more serious given their failure to explain what they meant by the word 'remote'.

10.92 We have set out in detail the considerable lengths to which the Working Party went, assisted by Dr Pickles, to ensure that the CSM secured appropriate action to meet the risks posed by medicinal products. These actions went beyond the duties that the Working Party had undertaken and were praiseworthy. We sympathise with the reassurance that the Working Party felt on receipt of Professor Asscher's letter of 26 January 1989.

10.93 In these circumstances we sympathise, too, with the following comment made to us by Sir Richard:

I cannot believe that the CSM and those other bodies, who were after all more expert in this field than ourselves, would have been so lulled into a sense of security by a particular two words in our Report. ¹²

Unfortunately this is what appears to have occurred.

10.94 The Report gave some who were responsible for dealing with medicinal products the impression that the Working Party had concluded that these constituted no more than a remote potential risk even if no precautionary measures were taken. The CMO received a draft minute to the Secretary of State prepared by Dr Pickles, which contained the following passage:

In Sir Richard's view the risk to human health is minimal. Nevertheless, he has alerted the Licensing Authority and the Health and Safety Executive to potential problems in their areas of responsibility. At the present time, we cannot give any complete guarantee of safety for human medicines that use bovine materials in manufacture, such as most vaccines. However, appropriate action is being taken by Medicines Division following advice from the Committee on Safety of Medicines, the Committee on Review of Medicines, the Committee on Dental and Surgical Materials and defensive briefing is being prepared for when the report becomes public. ¹³

10.95 On 9 February the CMO wrote to his deputy, Dr Ed Harris, as follows:

My attention has been drawn to a sentence in Dr Pickles's draft of a submission to the Secretary of State on this matter. It reads: 'At the present time we can't give any complete guarantee of safety for human medicines that use bovine materials in manufacture such as most vaccines.' Having looked at the Report I am not able to find any statement which supports this statement of concern. I have, however, therefore spoken to Dr Pickles on the telephone and she reports to me that for some considerable time she has had serious concern about the safety of bovine-based vaccines in the light of the fact it has been discovered that contamination with placental material (which is known to be heavily infected with the BSE particle) is a distinct possibility in the preparation of material for human vaccines derived from foetal serum. This matter as described to me by Dr Pickles gives me sufficient cause for concern to ask you to look into it urgently together with Medicines Division. ¹⁴

10.96 The steps taken consequent upon this initiative on the part of the CMO, which he described as 'quite contrary to my normal practice', ¹⁵ are described in vol. 7: Medicines and Cosmetics. We note that the initiative was stimulated by Dr Pickles rather than by the wording of the Report. Subsequently it appears that the Report, which had at the request of the meeting of 1 February been toned down so as not to risk alarming the public, provided unwarranted reassurance to those whose actions the Working Party were relying upon when describing the risk as remote. Thus the minutes of a meeting of the Human and Veterinary Medicines Briefing Group (HVMBG) on BSE on 22 February 1989 record that:

The slight theoretical risk of BSE being transferred to humans was considered to be more likely from products used parenterally or by implantation than by the oral route. ¹⁶

10.97 The CSM met on the next day. A note of the meeting records that the CSM:

. . . agreed with the Southwood Working Party that the risk to man of infection via medicinal products is remote . . . It was agreed that no special action was required on any existing products. ¹⁷

10.98 A Position Statement by the CSM and Licensing Authority on the implications of BSE for human medicinal products was produced which stated:

The Committee on Safety of Medicines (CSM) has considered the safety of human medicines in the light of the report of the Working Party on Bovine Spongiform Encephalopathy (BSE) - the Southwood Report. The CSM agrees with the Southwood Working Party that the risk to man of infection via medicinal products is remote. As a precautionary measure, and for the sole aim of seeking to guard against what is no more than a theoretical risk to man, the CSM and the Veterinary Products Committee (VPC) have agreed joint guidelines on good manufacturing practice for the manufacturers of human and veterinary medicines who use bovine, or other animal, materials either as an ingredient or in the production process. ¹⁸

10.99 A Q&A briefing prepared at the same time included:

3. Are the risks greater with some medicines than with others?

Theoretically, injectable ((parenteral) products might seem to pose a greater risk than oral medicinal products, but the CSM agreed that the risk from either is remote.

6. Are existing stocks safe?

The CSM agreed with the Southwood Working Party that the risk of transmission of BSE via medicinal products to man is remote and there is therefore no reason to question the safety of existing products. ¹⁹

10.100 In his statement to the Inquiry Dr Martin commented:

... I attended, on behalf of the Working Party, a meeting of the 'Human and Veterinary Medicines Briefing Group Re. BSE' chaired by Professor Gerry Collee on 23.2.89. I was left with the impression that those on the human medicine side regarded BSE as an animal problem and that we, on your Working Party, were being excessively apprehensive. ²⁰

10.101 We noted, with interest and surprise, the following statement in the minutes of the HVMBG meeting on 22 February 1989:

Normally, in matters where there is as little knowledge as there is in the case of BSE, CSM would have been advised to take no action but to monitor the situation. Due to the publication of the Southwood Report, this option is not open. ²¹

10.102 It seems to us that the Working Party, Dr Pickles and the CMO together stimulated a reaction from the DH Medicines Division and the relevant Committees to the emergence of BSE that might otherwise have been long delayed.

10.103 The terms of the Report also appear to have deceived those responsible for veterinary medicines as to the Working Party's assessment of risk in relation to these. Mr Alastair Kidd who, when the Veterinary Medicines Directorate was established at the CVL in March 1989, became Director of Licensing, told us that, in respect of veterinary medicines:

. . . manufacturers were advised to change the sources of supply of bovine and ovine materials as quickly as possible, where necessary, to minimise the risk of contamination of products. However, manufacturers were allowed to exhaust existing stocks as the Southwood Report and the VPC and CVL specialists in BSE had considered that the risk of BSE transmission by medicinal products appeared remote. ²²

10.104 The steps taken to address the risks posed by BSE in relation to human and veterinary medicinal products are set out in vol. 7: Medicines and Cosmetics.