Transcript Slide 1

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
CVL’s 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 Wilesmith’s 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 the
“Human 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 1989 10,091 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
Party’s 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
1996. 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 1989. A series of urgent meetings of Ministers and then
of the Cabinet ensued and SEAC’s 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 SEAC’s 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 MAFF’s 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.
(c)
The BSE Inquiry
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 CMO’s:“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 Inquiry’s 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 Inquiry’s 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 Inquiry’s 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 Inquiry’s 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 Government’s response
to the BSE Inquiry Report
(e) The Government’s response
to the BSE Inquiry Report (cont)
(e) The Government’s response
to the BSE Inquiry Report (cont)
(e) The Government’s response
to the BSE Inquiry Report (cont)
(f) The Horn Committee’s
Conclusions
(f) The Horn Committee’s
Conclusions (cont)
(f) The Horn Committee’s
Conclusions (cont)
(f) The Horn Committee’s
Conclusions (cont)
(f) The Horn Committee’s
Conclusions (cont)
(g) Lasting Effects
1.
Reinforcement of public scepticism about Government’s 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.