The BSE Inquiry Findings, Lessons and Effects David Body 02 December 2006

The BSE Inquiry Terms of reference: November 1997 To establish and review the history of the emergence and the identification of BSE and variant CJD in the United Kingdom, and of the action taken in response to it up to 20 March 1996; to reach conclusions on the adequacy of that response taking into account the state of knowledge at the time; and to report on these matters to the Minister of Agriculture, Fisheries and Food, the Secretary of State for Health and the Secretaries of State for Scotland, Wales and Northern Ireland.

The BSE Inquiry (a) Findings of Fact 1.A TSE known as scrapie has been endemic in the sheep population of the United Kingdom for nearly two hundred years. At the end of 1986, pathologists in the Central Veterinary Laboratory (CVL) identified similar degenerative changes in the brain samples of diseased cattle in two different herds. These were early cases of BSE. 2.By May 1987 this novel disease had been confirmed in four herds. No publicity even within the State Veterinary Service (SVS) had been given to these early cases and others may have been unrecognised. From May 1987, the existence of this novel disease was disseminated and the Head of CVLs Epidemiology Department, John Wilesmith was asked to investigate. 3.Over the next six months reported incidence of the disease proliferated. By 15 December 1987, ninety-five cases on eighty farms. Mr Wilesmith thought provisionally that the cause of the outbreak was contaminated meat and bone meal (mbm) that had been incorporated in cattle feed. He concluded that the likely contaminant was the offal of scrapie infected sheep rendered down to make mbm.

The BSE Inquiry – Findings of Fact (cont) 4.On 18 May 1988 Mr John McGregor, Minister of Agriculture on the advice of Mr William Reece the Chief Veterinary Officer prohibited the feeding of ruminant protein to ruminants (the Ruminant Feed Ban). 5.Diseased cattle were going into the food chain. Scrapie was known not to be transmissible to humans but the same was not known to be true of BSE. By 19 February 1988, two hundred and sixty four cases of BSE from two hundred and twenty three farms had been confirmed. On 24 February, Mr Derek Andrews the permanent secretary at MAFF recommended in a submission to Mr McGregor that BSE should be made a notifiable disease and that a policy of compulsory slaughter with compensation be introduced. Reservations were expressed about such a policy and advice was sought from Sir Donald Acheson the Chief Medical Officer (CMO) about the outcome and complications for human health. 6.Sir Donald Acheson recommended that an expert working party should be set up to advise on the implications of BSE. This was done, the Chairman was Sir Richard Southwood.

The BSE Inquiry – Findings of Fact (cont) 7.On 21 June 1988, the Southwood Working Party made interim recommendations that included the compulsory slaughter of animals showing symptoms of BSE and the setting up of a Committee to advise on research. Slaughter was made compulsory on 8 August 1988 and compensation of 50% of sound value of the animal was paid if, at post mortem, it was shown to have the TSE and 100% if it did not. 8.By 13 January 1989, 2296 cases of BSE had been confirmed on 1742 farms. 9.The Southwood report was submitted to Ministers on 9 February 1989 and endorsed Mr Wilesmiths conclusion that source of infection was scrapie infected meat and bone meal. It concluded that it was:- Most unlikely that BSE would have any implications for human health. It recommended that the HSE and the Authorities responsible for human and veterinary medicines which had already been alerted by the Working Party should take appropriate measures to address possible risks posed by BSE.

The BSE Inquiry – Findings of Fact (cont) 10.The Working Party concluded that the risk posed by BSE infected animals which had not yet developed clinical signs did not justify any further measures to protect human food. The Government accepted this and on publication of the Southwood report, announced secondary legislation which would make it illegal to sell baby food containing the types of offal identified. MAFF Ministers however had concerns which, after discussion with officials and with Department of Health and after consultation led on 13 November 1989 to the introduction of a ban on the use for human consumption of specified bovine offals (SBO). This became known as theHuman SBO Ban. 11.On 27 February 1989, the Tyrell Committee was established to advise on research in relation to BSE and the interim report was delivered by this Committee on 13 June 1989 identifying key research questions and the priority in which they should be addressed. 12.By the end of ,091 cases of BSE had been confirmed in the United Kingdom. Anxiety having been expressed in some quarters that 50% compensation might be inadequate to procure compliance with the requirement to notify BSE suspects, on 14 February 1990 Mr John Gummer, Minister of Agriculture introduced entitlement to 100% compensation.

The BSE Inquiry – Findings of Fact (cont) 13.On 3 April 1990, a new Committee of the Spongiform Encephalopathy Advisory Committee was set up and was Chaired by Dr David Tyrell, it being Government policy in relation to BSE to act on the best scientific advice the Government thereafter looked to SEAC to provide that advice. One of the Southwood Working Partys recommendations was the establishment of surveillance for CJD cases in order to detect whether there were any changes in their incidence which might be attributable to BSE and in May 1990, the CJD Surveillance Unit was set up at Edinburgh under Dr Robert Will. 14.On 10 May 1990 it was announced that a Siamese cat had died of spongiform encephalopathy (the first known case of Feline Spongiform Encephalopathy (FSE). Public statements by the CMO and by Mr Gummer that beef was safe to eat failed wholly to reassure the public. An Inquiry by the House of Commons Agricultural Committee into BSE took evidence from the key players in the story and reported on 12 July 1990 that while there were too many unknowns to say anything with absolute certainty We heard no evidence of any sort to constrain those taking a more balanced view of the risks from eating beef. It found that the measures taken by the Government should reassure people that eating beef is safe

The BSE Inquiry – Findings of Fact (cont) 15.In the light of controversy as to whether SBOs that had been banned from human food should be permitted to be fed to animals, pet food manufacturers had voluntarily ceased to incorporate it into their products. The Feed Producers Association had pressed strongly for a ban on including SBO in the material rendered to make mbm for inclusion in pig and poultry feed and advised their members to exclude it. MAFF Officials and Ministers opposed a ban on the ground that it was without any scientific justification. SEAC was about to advise on this question when early in September a pig which had been inoculated with BSE infected brain tissue succumbed to the disease. In an emergency meeting SEAC advised that as a precautionary measure SBO should not be fed to any animals. 16.Among the many matters on which SEAC was asked to advise for slaughterhouse practices. There was concern that the removal of brain and spinal cord (both SBO) in slaughterhouses might contaminate meat going for human consumption. There was also concern about the practice of the mechanical recovery of ruminants meat and other tissues adhering to the vertical column and these might include scraps of spinal cord not cleanly removed by slaughterhouse operators. 17.By the end of 1990, 24,396 cases of BSE had been confirmed in the UK.

The BSE Inquiry – Findings of Fact (cont) 18.With compulsory slaughter of sick animals and the Human SBO Ban to deal with potentially infected tissues in apparently healthy animals incubating BSE, the Government considered that there were in place appropriate measures to deal with the risks that BSE might be transmissible to humans in food. Action was taken to see that medicinal products both for humans and for animals were not sourced from potentially infected bovine tissues. Ruminants were protected by the Ruminant Feed Ban and other animals by the Animal SBO Ban. No further major measures were considered necessary to protect human or animal health from the period up to March In March 1992, SEAC concluded That the measures at present in place provide adequate safeguards for human and animal health 19.More rigorous monitoring of slaughterhouses in 1995 disclosed a number of occasions on which meat inspectors had applied the health stamp to a carcass in which fragments of spinal cord remained attached. This led SEAC to recommend a ban on the practice of extracting Mechanically Recovered Meat (mrm) from the spinal column of cattle. MAFF accepted that advice and introduced the ban in December 1995.

The BSE Inquiry – Findings of Fact (cont) 20.In the course of 1995, a number of cases of CJD were reported amongst farmers whose herds had had BSE and in several young people, the latter being particularly significant because up until then the disease had almost invariably struck down victims late in life. In the face of the questions over the safety of beef offal from Sir Bernard Tomlinson, the CMO and the Secretary of State for Health each responded with public assurances that it was safe to eat beef. 21.The first two months of 1996 saw the CJD Surveillance Unit and SEAC concerned at the increasing number of young victims of CJD. On 16 March 1996, SEAC advised the Government that a new variant of CJD had been identified in young people and that the most likely explanation was that these were linked to exposure to BSE before the introduction of the SBO Ban in A series of urgent meetings of Ministers and then of the Cabinet ensued and SEACs advice was sought as to further precautionary measures.

The BSE Inquiry – Findings of Fact (cont) 22.On 20 March 1996, the Government announced the likelihood that the recent cases of CJD in young people had resulted from exposure to BSE before 1989 and stated its intention to adopt further precautionary measures in accordance with SEACs advice. These were the carcasses from animals aged over thirty months must be de-boned and that the use of mbm in feed for farm animals would be banned. These measures proved inadequate to reassure the public and within two weeks was replaced with a total ban on the use of cattle over the use of thirty months being used for human or other animal feed. 23.By 20 March 1996 approximately 160,000 cattle affected by BSE had been slaughtered. In addition about 30,000 cattle suspected of BSE but not confirmed to have the disease were slaughtered. These figures can be compared with over 3.3m cattle slaughtered and destroyed under the Over Thirty Month Scheme (OTMS) in the period between March 1996 to the end of 1999.

The BSE Inquiry (b) Key conclusions 1.The Government did not lie to the public about BSE. It believed that the risks posed by BSE to humans were remote. The Government was preoccupied with preventing an alarmist over reaction to BSE because it believed that the risk was remote. It is now clear that this campaign of reassurance was a mistake. 2.When on 20 March 1996 the Government announced that BSE had probably been transmitted to humans, the public felt that they had been betrayed. Confidence in Government announcements about the risk was a further casualty of BSE. 3.Cases of a new Variant CJD were identified by the CJD Surveillance Unit but the conclusion that they were probably linked to BSE was reached as early as was reasonably possible. The link between BSE and vCJD is now clearly established though the manner of infection is not clear.

The BSE Inquiry – Key conclusions (cont) 4.The Government was anxious to act in the best interests of human and animal health. To this end, it sought and followed the advice of independent scientific experts – sometimes when decisions could have been reached more swiftly and satisfactorily within Government. 5.In dealing with BSE it was not MAFFs policy to lean in favour of the agricultural producers to the detriment of the consumer. 6.At times officials showed a lack of rigour in considering how policies should be turned into practice to the detriment of the advocacy of the measures taken. 7.At times bureaucratic processes resulted in unacceptable delay in giving an effective policy lead. 8.The Government introduced measures to guard against the risk that BSE might be a matter of life and death not merely for cattle but also for humans, that a possibility of a risk to humans was not communicated to the public or to those whose job it was to implement and enforce the precautionary measures.

The BSE Inquiry (c) The attitudes displayed by Government 1.From the moment in December 1986 when Mr Bradley classified his first minute about BSE as confidential to the Chief Medical Officers reassuring recorded message on 20 March 1996, ending with the statement I myself will continue to eat beef as part of a varied diet Officials and Ministers followed an approach whose object was sedation. 2.The repeated statement that there is no evidence that BSE is transmissible to humans which should not explain that such evidence would take many years to emerge. 3.The repeated indication of the assessment in the Southwood Report that the risk to humans is remote, which continued long after the assumptions made by the Southwood Working Party had been shown not to be valid. 4.The agreed presentation of the Human SBO Ban as being a convenient means of giving effect to the baby food recommendation. 5.Statements that the transmission of BSE to a cat did not increase the likelihood of BSE transmission to humans.

The BSE Inquiry - The attitudes displayed by Government (cont) 6.The attempt to get SEAC to produce positive publicity sound bites 7.The public presentation of the medicines guidelines as if they had secured the situation without indicating that products were not being required to be withdrawn 8.Reassurance by the CMOs:- The campaign of reassurance focused particularly on the safety of beef. Successive DH CMOs and a CMO for Scotland made unqualified statements that it was safe to eat beef. They did so, not on the basis that they were satisfied that BSE was not transmissible in food, but on the basis that they were satisfied that the portions of the cow which might infect were not permitted to enter the food chain. This was not made clear to the public who acquainted statements that it was safe to eat beef with statements that BSE posed no risk to humans. The official line for the risk of transmissibility was remote and that beef was safe did not recognise the possible validity of any other view. Dissident scientists tended to be treated with derision and driven into the arms of the media and to exaggerate its statements of risk. Thus, the views expressed on risk became polarised. Dispute displaced debate.

The BSE Inquiry (d) Applying the findings: Dealing with uncertainty in the communication of risk Some argue that it is not the task of Government to protect the public against risk in circumstances where the individual can accept or avoid the risk by making his or her own informed choice. Where the hazard is transparent and one that the individual can regularly avoid, this argument has force. Most people believe however the Government has an important role to play in reducing the extent to which the consumer is exposed to hazard. They believe for instance that the Government should do all that is reasonably practicable to see that the food that they eat and the medicines they take are reasonably safe and Throughout the BSE story, the approach to communication of risk was shaped by a consuming fear of provoking an irrational public scare. This applied not merely to the Government, but to advisory committees to those responsible for the safety of medicines, to Chief Medical Officers and to Meat and Livestock Commissions. All witnesses agreed that information should not be withheld from the public, but some spoke of the need to control the manner of its release.

The BSE Inquiry Applying the findings: Dealing with uncertainty in the communication of risk (cont) You can see the temptation on occasion to wish to hold the facts close so that you can have internal discussion in the formation of a consensus so that a simple message can be taken out into the marketplace. My view is strongly that the temptation must be resisted and the full messy process whereby scientific understandings arrived at with all its problems has to be spilled out into the open. Sir Robert May, Chief Scientific Advisor to Government There is nothing more nannyish than withholding information from people on the ground that they may react irrationally to that information. Sheila McKechnie, Director of the Consumers Association

The Governments response to the BSE Inquirys Report February 2001 Set out 167 detailed findings made by the Inquiry. Annex 1 sets out the Governments Response to each finding Some responses suggested that old habits might die hard Finding 91 Consideration should be given to combining in the same laboratory research in the scientific issues that have common application to human and animal health by scientists practicing in the field Volume 1 Para 1269

(e) The Governments response to the BSE Inquirys Report (cont) Informal links already exist between those working in government medicine and veterinary research establishments. Consideration will be given to whether more formal links will be required.

(e) The Governments response to the BSE Inquirys Report (cont) Finding 143 Although likelihood of a risk to human life may appear more remote where there is uncertainty all reasonably practicable precautions should be taken… [Vol 1 Para 1283] Finding 144 Precautionary measures should be strictly enforced even if the risk that they address appears to be remote

(e) The Governments response to the BSE Inquirys Report (cont) The Government is committed to applying the precautionary principle where appropriate. Measures to improve communications with enforcers and to monitor effectiveness of enforcement are already in place in the Food Safety area via The Food Standards Agency

(e) The Governments response to the BSE Inquiry Report

(e) The Governments response to the BSE Inquiry Report (cont)

(f) The Horn Committees Conclusions

(f) The Horn Committees Conclusions (cont)

(g) Lasting Effects 1.Reinforcement of public scepticism about Governments role as Regulator 2.The emergence into public debate of the precautionary principle 3.The establishment of the Food Standards Agency 4.The pervasive culture of risk assessment in Government and beyond 5.The justification for a Freedom of Information Act 6.The recognition of the need for a Human Rights Act 7.The recognition that a few people can achieve a lot

Achieve Citizenship : What the families of vCJD victims have done 1.Identification of the need for and campaigning for a BSE Inquiry; creating a victims families support group 2.The BSE Inquiry: contribution of evidence and setting of the agenda at that Inquiry highlighting the public health consequences of BSE and its effect on individual families. 3.Highlighting the need for consistency in care of vCJD patients; campaigning for a National CJD Care Scheme. 4.Lobbying for the no fault compensation scheme for families. This Parliamentary Campaign involved numbers of families in meeting MPs for the first time and highlighting the contrast between the treatment given to the livestock industry and the inequity represented by requiring families to litigate claims to be compensated. 5.Negotiation of the No Fault Compensation Scheme.

Achieve Citizenship : What the families of vCJD victims have done (cont) 6.Implementation of the No Fault Compensation Scheme –Interim payments through the Interim Payments Trusts –Work on care cost policy with the Department of Health –Guidance on care with the Trustees and their Solicitors –Preparation of individual claims in the light of this guidance; examination of points of principle arising from individual cases –Guidance on particular hardship –Completing claims on behalf of the families who have suffered a bereavement –Completing claims on behalf of families in which a patient is still alive

Achieve Citizenship : What the families of vCJD victims have done (cont) 7.Achievement of a consistent policy on experimental treatment for CJD –Bringing about first treatment with Quinacrine in USA or UK –Contributing to the development of the PRION 1 trial of Quinacrine –Court action to validate experimental use of Pentosan Polysulphate (PPS) –Lobbying MRC to fund an observational study of PPS as a human treatment –Co-operation with Professor Ian Bone in the preparation of that report –Co-operation with CJD Surveillance Unit and NPC in the cohort study designed to follow the Bone Report. 8.Lobbying the Department of Health on the institution of a consistent policy of psychiatric care and support for families of vCJD victims.