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Volume 1
Findings and Conclusions Executive Summary of the Report of
the Inquiry Introduction
By our terms of reference, we
have been required:
To establish and review the
history of the emergence and 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.
In this Executive Summary, we
give an overview of our key findings and conclusions. We refer to things
that went right as well as to some of the errors, inadequacies and
shortcomings that we have identified in the response to BSE. We do not
attempt here to explain or even list all of these. In particular we do not
explain the criticisms of individuals that appear in our Report. These
need as a matter of fairness to be read in their proper context, as we
explain at paragraph
30 of this volume.
Executive Summary of the Report of
the Inquiry 1. Key conclusions
- BSE has caused a harrowing
fatal disease for humans. As we sign this Report the number of people
dead and thought to be dying stands at over 80, most of them young. They
and their families have suffered terribly. Families all over the UK have
been left wondering whether the same fate awaits them.
- A vital industry has been
dealt a body blow, inflicting misery on tens of thousands for whom
livestock farming is their way of life. They have seen over 170,000 of
their animals dying or having to be destroyed, and the precautionary
slaughter and destruction within the United Kingdom of very many more.
- BSE developed into an
epidemic as a consequence of an intensive farming practice - the
recycling of animal protein in ruminant feed. This practice,
unchallenged over decades, proved a recipe for disaster.
- In the years up to March
1996 most of those responsible for responding to the challenge posed by
BSE emerge with credit. However, there were a number of shortcomings in
the way things were done.
- At the heart of the BSE
story lie questions of how to handle hazard - a known hazard to cattle
and an unknown hazard to humans. The Government took measures to address
both hazards. They were sensible measures, but they were not always
timely nor adequately implemented and enforced.
- The rigour with which policy
measures were implemented for the protection of human health was
affected by the belief of many prior to early 1996 that BSE was not a
potential threat to human life.
- 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.
- In dealing with BSE, it was
not MAFF's policy to lean in favour of the agricultural producers to the
detriment of the consumer.
- At times officials showed a
lack of rigour in considering how policy should be turned into practice,
to the detriment of the efficacy of the measures taken.
- At times bureaucratic
processes resulted in unacceptable delay in giving effect to policy.
- 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, but the 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 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.
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 pronouncements about risk was a further
casualty of BSE.
- Cases of a new variant of
CJD (vCJD) were identified by the CJD Surveillance Unit and 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.
2. The identification of
the emergence of BSE
- Individual cattle were
probably first infected by BSE in the 1970s. If some lived long enough
to develop signs of disease, these were not reported to or subject to
investigation by the Central Veterinary Laboratory (CVL) of the State
Veterinary Service (SVS).
- The Pathology Department of
the CVL first investigated the death of a cow that had succumbed to BSE
in September 1985, but the nature of the disease that had caused its
death was masked by other factors and was not recognised at the time.
This is not a matter for criticism.
- The Pathology Department
considered two further cases of BSE at the end of 1986 and identified
these as being likely to be a Transmissible Spongiform Encephalopathy
(TSE) in cattle. This identification was commendable.
- This part of the story
demonstrates both the benefits and the limitations of the passive
surveillance system operated by the SVS.
3. The cause of BSE
- Gathering of data about the
extent of the spread of BSE was impeded in the first half of 1987 by an
embargo within the SVS on making information about the new disease
public. This should not have occurred.
- By the end of 1987 Mr John
Wilesmith, the Head of the CVL Epidemiology Department, had concluded
that the cause of the reported cases of BSE was the consumption of meat
and bone meal (MBM), which was made from animal carcasses and
incorporated in cattle feed. This conclusion was correct. It had been
reached with commendable speed.
- The following provisional
conclusions of Mr Wilesmith, which were generally accepted at the time
as a basis for action, were reasonable but fallacious:
- - the cases identified between 1986 and 1988 were index (ie,
first generation) cases of BSE;
- - the source of infection in the MBM was tissues derived from
sheep infected with conventional scrapie;
- - the MBM had become infectious because rendering methods which
had previously inactivated the conventional scrapie agent had been
changed.
- The cases of BSE identified
between 1986 and 1988 were not index cases, nor were they the result of
the transmission of scrapie. They were the consequences of recycling of
cattle infected with BSE itself. The BSE agent was spread in MBM.
- BSE probably originated from
a novel source early in the 1970s, possibly a cow or other animal that
developed disease as a consequence of a gene mutation. The origin of the
disease will probably never be known with certainty.
- The theory that BSE resulted
from changes in rendering methods has no validity. Rendering methods
have never been capable of completely inactivating TSEs.
- The theory that BSE is
caused by the application to cattle of organophosphorus pesticides is
not viable, although there is a possibility that these can increase the
susceptibility of cattle to BSE.
- The theory that BSE is
caused by an autoimmune reaction is not viable.
4. Assessment of risk posed
by BSE to humans
- One of the most significant
features of BSE and other TSEs is the fact that they are diseases with
very long incubation periods. Thus the question whether BSE was
transmissible to humans was unlikely to be answered with any certainty
for many years, and scientific experiments were bound to take a long
time. The Government had to deal with BSE against this background of
uncertainty as to the transmissibility of the disease.
- MAFF officials appreciated
from the outset the possibility that BSE might have implications for
human health.
- By the end of 1987 MAFF
officials had become concerned as to whether it was acceptable for
cattle showing signs of BSE to be slaughtered for human consumption.
However, the Department of Health (DH) was not asked to collaborate with
MAFF in considering the implications that BSE had for human health. It
should have been.
- Only in March 1988, by which
time MAFF officials had advised their Minister that animals showing
signs of BSE should be destroyed and compensation paid, did MAFF advise
the Chief Medical Officer (CMO) Sir Donald Acheson of the emergence
of BSE and ask him for his view of the possible human health
implications.
- On Sir Donald's advice, an
expert working party, chaired by Sir Richard Southwood, was set up to
advise on the implications of BSE. After their first meeting in June
1988, the Southwood Working Party advised that cattle showing signs of
BSE should be slaughtered and destroyed. This advice was of crucial
importance in safeguarding human health. The Working Party had concerns
about some occupational health risks in relation to BSE and some risks
posed by medicinal products. They notified the responsible authorities
of these concerns. On 9 February 1989 they submitted a Report to the
Government in the knowledge that it would be published. The report
concluded that the risk of transmission of BSE to humans appeared remote
and that 'it was most unlikely that BSE would have any implications for
human health'.
- This assessment of risk was
made on the following basis:
- - BSE was probably derived from scrapie and could be expected to
behave like scrapie. Scrapie had not been transmitted to humans in over
200 years and so BSE was not likely to transmit either.
- - So far as occupational and medicinal risks were concerned, the
authorities which had been notified about these could be relied upon to
take appropriate measures to address them.
- The Report did not, as it
should have done, make clear the basis for its assessment of risk. It
did comment that if the assessment was incorrect the implications would
be extremely serious. This warning was lost from sight. The
Southwood Report was, in years to come, repeatedly cited as
constituting a scientific appraisal that the risks posed by BSE to
humans were remote and that no precautionary measures were needed other
than those recommended by the Working Party.
- Precautionary measures were
nonetheless put in place that went beyond those recommended by the
Working Party. The wisdom of those measures was demonstrated as the
years went by and facts were learned about BSE which threw doubt on the
theory both that it was derived from scrapie and that it would behave
like scrapie.
- In May 1990 a domestic cat
was diagnosed as suffering from a 'scrapie-like' spongiform
encephalopathy. This generated widespread public and media concern that
BSE had been transmitted to the cat and might also be transmissible to
humans. Subsequently, more domestic cats were similarly diagnosed. These
events shifted the perception of some scientists of the likelihood that
BSE might be transmissible to humans. By 1994 the Spongiform
Encephalopathy Advisory Committee (SEAC) evaluated the risk of
transmissibility to humans as remote only because precautionary measures
had been put in place.
5. Communication of the
risk posed by BSE to humans
The increasing knowledge
about BSE over the years, which threw doubt on the theory that it would
behave like scrapie, was not concealed from the public. However, the
public was not informed of any change in the perceived likelihood that
BSE might be transmissible to humans.
The public was repeatedly
reassured that it was safe to eat beef. Some statements failed to
explain that the views expressed were subject to proper observance of
the precautionary measures which had been introduced to protect human
health against the possibility that BSE might be transmissible. These
statements conveyed the message not merely that beef was safe but that
BSE was not transmissible.
The impression thus given to
the public that BSE was not transmissible to humans was a significant
factor leading to the public feeling of betrayal when it was announced
on 20 March 1996 that BSE was likely to have been transmitted to
people.
6. Measures to eradicate
the disease in cattle
Once Mr Wilesmith had
identified MBM as the probable vector of BSE, the Government introduced
the appropriate measure to prevent further infection and to stop the
spread of the BSE agent - a ban on incorporating ruminant protein in
ruminant feed. This had a dramatic effect in reducing to a fraction what
had been an escalating rate of infection. It did not, however, bring
infection to an end.
The manner in which the
Government introduced the ruminant feed ban was influenced by
misconceptions as to:
- - the scale of the infection;
- - the amount of infective material needed to transmit the
disease.
- Ignorant of the fact that
the rate of infection had escalated to thousands of cases a week, the
Government gave the animal feed trade a 'period of grace' of some five
weeks to clear existing stocks of feed before the ban took effect. Some
members of the feed trade, being given an inch, felt free to take a yard
and continued to clear stocks after the ban came into force. Farmers in
their turn used up the stocks that they had purchased. This led to
thousands of animals being infected after the ruminant feed ban came
into force on 18 July 1988.
- More serious was a failure
to give rigorous consideration to the amount of infective material that
was proving capable of transmitting the disease. The false assumption
was made that any cross-contamination of cattle feed in feedmills from
pig or poultry feed containing ruminant protein would be on too small a
scale to matter.
- In fact, as subsequent
experiments were to demonstrate, a cow can become infected with BSE as a
result of eating an amount of infectious tissue as small as a
peppercorn. Cross-contamination in feedmills resulted in the continued
infection of thousands of cattle. Because it takes, on average, five
years after initial infection for the clinical signs of BSE to become
apparent, this was not appreciated until 1994.
- From September 1990
contamination of cattle feed with pig and poultry feed should not have
resulted in infection. This was because, following the experimental
transmission of BSE to a pig, MAFF on the advice of SEAC introduced a
measure in September 1990 aimed at protecting pigs and poultry from BSE.
This was a ban on the inclusion in pig and poultry feed of MBM derived
from the parts of the cow that might be expected to carry high
infectivity if an animal were incubating or suffering from the disease -
'Specified Bovine Offal' or SBO.
- However, there was a failure
to give proper thought to the terms of this measure when it was
introduced. The animal SBO ban was unenforceable and widely disregarded.
Infectious bovine offal continued to find its way into pig and poultry
feed and then, by cross-contamination, into cattle feed.
- Only in 1994 did the fact of
the continuing infection and the reasons for it become appreciated.
Regulations were revised and a rigorous enforcement campaign launched to
coincide with the takeover in 1995 by a new national Meat Hygiene
Service (MHS) of the enforcement duties in slaughterhouses, previously
carried out by local authorities. The success of these measures is now
becoming apparent. They were replaced after 20 March 1996 by the radical
step of banning the incorporation of all animal protein in animal feed.
7. Measures to address the
risks posed by BSE to humans Slaughter and
compensation Food risks
Slaughter and compensation
- Compulsory slaughter and
destruction of all animals showing signs of BSE was a crucial measure to
protect human health and, incidentally, animal health. It prevented the
use, for any purposes, of sick animals, which could otherwise have been
sent to the slaughterhouse for human consumption.
- A compulsory slaughter and
compensation scheme was introduced in August 1988, following the
commendable interim advice of the Southwood Working Party. Had there
been prompt and adequate collaboration between MAFF and DH, this measure
could and should have been introduced months earlier.
- Levels of compensation to
farmers were adjusted on two occasions, but at no time did they lead to
any significant failure to comply with the duty to notify the SVS of
animals showing signs of BSE.
Food risks
- The Southwood Working Party
considered that all reasonably practicable precautions should be taken
to reduce the risks that would exist should BSE prove to be
transmissible to humans. However, they did not make this plain in their
Report and did not recommend that the possible risks from eating animals
incubating BSE but not yet showing signs of the disease ('subclinical
cases') called for any precautions, other than a recommendation that
manufacturers should not include ruminant offal and thymus in baby food.
This was a shortcoming in their Report.
- Because of a failure to
subject the Southwood Report to an adequate review, MAFF and DH
failed to identify this shortcoming. Concern about the food risks posed
by subclinical cases was, however, expressed by some scientists, by the
media and by the public. With the agreement of DH, MAFF reacted by
announcing in June 1989 that those categories of offal of cattle most
likely to be infectious (SBO) were to be banned from use in human food.
The introduction of this vital precautionary measure was commendable.
However, this ban was presented to the public in terms that underplayed
its importance as a public health measure.
- Careful consideration was
given by MAFF and DH in 1989 to the terms of the human SBO ban, with one
important exception. During the consultation process, concerns were
raised about the practicality of ensuring the removal of all of the
spinal cord during abattoir processes, and about the practice of
mechanical recovery of scraps left attached to the vertebral column for
use in human food ('mechanically recovered meat' or MRM). However, MAFF
officials discounted these concerns without subjecting them to rigorous
consideration - in particular no advice was sought as to the minimum
quantity of spinal cord that might transmit the disease in food.
- MAFF gave detailed
consideration to spinal cord and MRM in 1990. A lengthy paper was
submitted to SEAC, the Government's new expert advisory committee on
TSEs. Unhappily, as a result of a breakdown of communications, MAFF
officials understood that the members of SEAC were not concerned about
the inclusion in human food of an occasional scrap of spinal cord, so
that no action was called for. In fact the advice of some, at least, of
the members of SEAC was premised on the false assumption that spinal
cord could readily be removed from the carcass in its entirety, and
would be so removed.
- This was one of a number of
occasions that has given rise to lessons for the future about the proper
use of expert committees by the Government.
- Not until 1995 was action
taken in relation to MRM. Following the takeover by the Meat Hygiene
Service of the enforcement of Regulations in slaughterhouses, occasional
instances were discovered of failure to remove all spinal cord from the
carcass. Strenuous and successful steps were taken to improve standards
of compliance with the Regulations in slaughterhouses. Eventually, in
December 1995, on SEAC's advice the extraction of MRM from the spinal
column of cattle was banned.
- Up to 1995, MRM was a
potential pathway to the infection of humans with BSE, not merely
because of the risk of inclusion of the occasional portion of spinal
cord, but because the material recovered by the MRM process included
dorsal root ganglia. These were peripheral nervous tissues which were
not thought to be infectious at the time, but which have since been
demonstrated to be infectious in the late stages of incubation.
8. Medicines
- Despite the highly regulated
licensing regime for medicines, systematic records of the action taken
in response to BSE in respect of individual medical products are
lacking.
- Past experience of the
transmission of animal disease through vaccines, and of transmission of
CJD through medication and through the contamination of surgical
instruments, showed that minute particles of infected tissue from an
apparently healthy donor could transmit a TSE.
- MAFF officials recognised in
1987 that there was a risk that BSE might be transmitted through
veterinary products and began to take steps to address this risk which
were commendable. They failed, however, to share their concerns with
those in DH who were responsible for handling human medicinal products.
This was inadequate interdepartmental liaison.
- On learning of BSE in March
1988 the CMO, Sir Donald Acheson, sought to ensure that the potential
risks that the disease posed in relation to human medicinal products
were addressed. However, Medicines Division (MD) did not bring the
matter before their advisory committees until November 1988. Of this
period, two months' delay was attributable to a failure to accord the
matter appropriate priority.
- MD did not appreciate the
extent of the concern felt by the Southwood Working Party about
medicines administered by injection and about the existing stocks of
these. This was compounded by the wording of the Southwood
Report, which described the risk posed by medicines as remote
without making it plain that this risk assessment was predicated on the
assumption that remedial measures were being taken to address the
risk.
- Having regard to the
legislative constraints, it was reasonable to issue guidelines in
relation to both human and veterinary medicinal products rather than
resort to direct regulatory action.
- Production of the relevant
human and veterinary medicines involved similar raw materials and
processes. The approach in respect of each needed to be consistent. Yet
DH and MAFF did not discuss joint guidelines until January 1989. Once
again this reflected inadequate interdepartmental liaison.
- The decision to continue to
use existing vaccine stocks until these could be replaced was
reasonable. Vaccines cannot be produced overnight. An embargo on
existing stocks would have led to interruptions, potentially lengthy, in
vaccination programmes. The overwhelming professional opinion at the
time was that there was bound to be death and disablement in the event
of breaks in the vaccination programmes, on a scale which far outweighed
the potential risks from BSE. Some comfort can be derived from the 1993
results of tests carried out on bovine serum by the Neuropathogenesis
Unit (NPU), which failed to lead to infection in mice.
- The task of identifying
medicinal products to which the guidelines applied was made more
difficult and protracted by:
- - the inadequate database of licensed products;
- - the need to make case-by-case enquiries in relation to
thousands of products;
- - inadequate staffing;
- - unclear management responsibilities; and
- - the administrative dislocation involved in reorganisation at
the time of the relevant DH and MAFF divisions as Executive
Agencies.
- Staff from the two new Agencies - the Medicines Control Agency
(MCA) and the Veterinary Medicines Directorate (VMD) - worked diligently
to overcome these difficulties.
- The establishment of the BSE
Working Group with a high-powered membership to advise all of the
section 4 committees on human medicinal products thought to pose a
potential risk was a sound decision.
- The small number of products
that included high-risk tissues as an ingredient was identified and
dealt with reasonably promptly.
- The role of the BSE Working
Group, like that of the Committee on Safety of Medicines (CSM) and
Veterinary Products Committee (VPC), was purely advisory. The task of
identifying individual products for consideration by the Group and
following up recommendations made by the Group was for officials.
- Decisions taken in relation
to individual medicinal products were reasonable, but the speed with
which decisions were taken and followed up suffered from lack of clear
and purposeful leadership in the MCA.
- More effective handling
arrangements were adopted within DH's Procurement Division (serving the
National Health Service) to review medical devices.
- Existing stocks of a small
number of human vaccines prepared using bovine tissues may have been
used up to 1992 and of animal vaccines for even longer.
- The decision to continue
using existing stocks of vaccines was not considered to be one that
needed to be taken or approved by Ministers. Had it been, we consider
that Ministers would have accepted the overwhelming professional advice,
but would have been concerned to see that the process of phasing out
these stocks was more vigorously pursued.
- Officials in the MCA and VMD
do not appear to have been systematically accountable to anyone for the
manner in which the phasing out exercise was handled. Nor, given the
low-profile handling, was there any parliamentary or public scrutiny of
their actions.
9. Cosmetics
- Cosmetics, like topically
applied medicines, might be applied to the skin, eye or mucous membranes
but were covered by a less stringent regulatory regime under the aegis
of the Department of Trade and Industry (DTI). The category presenting
the highest risk comprised 'exotica' or 'premium products', such as
anti-ageing creams, which might contain lightly processed brain
extracts, placental material, spleen and thymus.
- MAFF and DH failed to alert
DTI to the need to consider the risk through cosmetics from BSE despite
this having been identified by the Tyrrell Report in June 1989.
This contributed to several months' delay in the start of action to
secure their safety.
- Guidance was provided to the
industry in February 1990 on the initiative of DTI, but was made
available only to members of the cosmetics and toiletries trade
association. This was the most significant single action to address the
risk from cosmetics.
- Thereafter no further
initiative was taken by DTI. A muddled situation developed about lead
responsibility for action. Responsibility for taking action should have
been clearly understood to rest with DTI with professional advice from
DH.
- Following a request from
SEAC in July 1991 for the cosmetics guidance to be updated, DH omitted
to advise DTI about this and subsequently made its own unsuccessful
approach to the trade association in April 1992 seeking detailed
information. DTI was brought back into the picture only in September
1992 at a meeting between DH, MAFF and the trade association.
- The confusion about lead
responsibility both between Departments and within DH continued
thereafter, and responsibility for updated UK guidance was effectively
left with the trade association. The topic became embroiled in
protracted negotiations at European level on EU guidelines, and the
trade association UK guidance did not emerge until 1994.
- The hallmarks of the
handling of BSE in relation to cosmetics were lack of purposeful
leadership and an absence of a sense of urgency. Manufacturers were left
to use up stocks, and checks were not made to ensure they reformulated
their products. This has left unanswered questions both about what
material was being used, and about how long production continued and on
what scale.
10. Occupational risk
- The possibility of
contracting illness from contact with diseased animals or their tissues
was a well-recognised occupational hazard. Workers in a wide range of
occupations were potentially in contact with the tissues of BSE-infected
cattle or with those of human victims. All of these occupations needed
to be identified and to receive appropriate guidance about the
precautions to reduce risk in respect of BSE and other TSEs.
- The delays in issuing advice
to many of those concerned were unacceptable. Ultimately the main
occupations at risk were identified and advice given. But a detailed
chronology shows that it took over three years to complete the task of
issuing simple warnings and basic advice to the most obvious high-risk
trades.
- Work began in 1991 on
guidance to those handling risk tissues in laboratories, hospitals and
mortuaries. This took until September 1994 to be completed and issued.
During that process a so-called 'fast track' professional letter took 14
months to prepare.
- In a different field, it
took two-and-a-half years for advice to be issued to schools about risks
from dissecting bovine eyeballs, though SEAC had asked in June 1990 for
this to be done.
- The slow and erratic
responses have indicated weaknesses in the standard system for handling
a wide-ranging disease threat. The slow tempo of action, in part
attributable to time spent on polishing and refining advice, stemmed
from three factors:
- - a failure in communication: the perception that the
Southwood Report had indicated that the risk to humans from BSE
was remote even without any further action, and a belief in the Health
and Safety Executive (HSE) that action was being taken simply as a
response to political and media pressures;
- - the absence of a comprehensive review of pathways of
transmission, which might have helped pinpoint where the issue of urgent
advice could not wait;
- - the decision to use the slow-paced existing consultative and
drafting arrangements. This ought not to have been at the expense of
prompt and straightforward interim warnings.
- The mistakes made in
handling the occupational threats from BSE and the questions raised by
them need to be carefully considered by the HSE.
11. Other pathways of
infection
- There was a need to
establish all the pathways by which bovine products or by-products might
come into contact with humans or other animals. This need was recognised
by MAFF officials at an early stage and also by the Government's expert
advisers on BSE. However, the exercise was never carried out prior to
March 1996. As a result, no coordinated or comprehensive consideration
was given to the various routes by which BSE might infect human beings
or other animals.
12. Pollution and waste
control
- MAFF was directly
responsible for disposing of cattle carcasses from the compulsory
slaughter scheme. Major problems included the large volume of carcasses
and initial serious underestimation of the numbers that would arise.
MAFF handled this difficult and unpopular disposal task energetically
and competently.
- The disposal of SBO material
was not MAFF's direct responsibility and was less straightforward to
manage. Initially this material did not constitute waste as such because
it was a marketable product for rendering into tallow and MBM. It did
not become controlled waste, to be disposed of only at a licensed
destination, until after the animal SBO ban and SEAC advice that the
protein product of SBO should not be used as an agricultural
fertiliser.
- Other forms of waste
included effluent passing down drains to sewers and rivers. None of the
usual precautions or conditions attached by water authorities to
discharges would have inactivated the BSE agent.
- Blood, slaughterhouse and
rendering plant waste, including that from plants that rendered SBO, and
sewage sludge from works handling their effluents, might lawfully be
spread as agricultural fertiliser.
- Some of the failures to
identify and address these matters promptly can be attributed to the
defective state of environmental regulatory action at the time, and the
transitional turmoil of measures to rectify this.
- General waste disposal
systems as a potential transmission pathway for BSE received scant
attention from those handling BSE prior to 1996. The matter was not
referred to or addressed by the Southwood Working Party, the Tyrrell
Committee or SEAC. All of them advocated a systematic review of the
destination of all bovine materials. Had this been carried out, it might
have identified waste disposal issues.
13. The identification of
vCJD
- The Southwood Working Party
noted that if BSE were to be transmitted to humans it would be likely to
resemble CJD and suggested that surveillance be put in place to identify
atypical cases or changing patterns of the disease.
- The task of detecting any
variation in the characteristics of cases of CJD which might indicate
infection with BSE was entrusted to the CJD Surveillance Unit (CJDSU), a
research team of dedicated medical scientists headed by Dr Robert Will,
a neurologist with extensive experience of CJD.
- No role in this was given to
the Public Health Laboratory Service (PHLS), an established service for
the surveillance of new and existing disease, among other things.
- The decision to establish a
new team specifically for this purpose was vindicated by the prompt
detection of the emergence of vCJD by the CJDSU.
- The conclusion reached by
SEAC on 16 March 1996 that the most likely explanation for the cases of
a new variant of CJD in young people was exposure to BSE has since been
compellingly supported by scientific evidence.
- It should have been apparent
to both MAFF and DH by early February 1996 at the latest that there was
a serious possibility that the scientists would conclude that it was
likely that BSE had been transmitted to humans. The two Departments
should have worked together, in consultation with SEAC, to explore the
possible policy options that would be available should this
occur.
- There was no
interdepartmental discussion or consideration of policy options within
either Department until the middle of March 1996. The views of SEAC were
awaited, both as to whether the cases of vCJD were linked with BSE, and
as to what action should be taken if they were. This was an inadequate
response.
- Under intense pressure from
the Government, on 20 March 1996 SEAC advised among other things that
the appropriate course was that carcasses from cattle over 30 months old
should be deboned in licensed plants supervised by the Meat Hygiene
Service and the trimmings classified as SBO.
- The Government immediately
announced that it was accepting this advice. In doing so it was
wrong-footed, for this course proved neither practicable nor acceptable
to the public. A policy of banning consumption of cattle over 30 months
had to be introduced instead.
14. Victims and their
families
- The unusual problems of the
diagnosis, treatment and care of the early cases of vCJD meant that for
some of the victims and their families the tragic horror of the disease
was made the more difficult to bear by lack of the appropriate
treatment, assistance and support.
- Victims of vCJD and their
families have special needs which should be addressed.
15. Research
- The Southwood Working Party
made wise recommendations in relation to research, not least that an
expert committee be set up to advise on this.
- That committee, the Tyrrell
Committee, rapidly recommended research priorities which formed the
basis of much of the research that followed.
- After some initial delay,
BSE research was adequately funded by the Government.
- Attempts to agree that a
director, or 'supremo', should oversee and coordinate research were
initiated by Sir Donald Acheson but foundered in the face of concerns on
the part of the Research Councils and MAFF for their
independence.
- Coordination of research
effort is desirable in order to achieve:
- - identification of gaps in research;
- - determination of research priorities;
- - identification of the best sources of expert
assistance;
- - a well-constructed plan for funding from the outset;
- - competition for research projects;
- - peer review of projects; and
- - efficient arrangements for provision of clinical material to
researchers.
- A research supremo might
have identified the following areas where research could profitably have
been started earlier or pursued with more vigour:
- - experiments to transmit scrapie to cattle to test the scrapie
origin assumption;
- - tests for BSE in sheep;
- - identification of the minimum infective dose which could
transmit BSE orally to cattle;
- - assessment of the sensitivity of mice to BSE for use in
experiments;
- - ante- and post-mortem tests for BSE;
- - a test for ruminant protein in compound feed;
- - epidemiology.
16. Some general lessons
- The lessons to be learned
from the BSE story are set out in Chapter
14 of this volume.
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