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Safety Issues
Mad Cow Disease inquiry reveals how British government protected
pharmaceutical companies at expense of public health
By Paul Mitchell
9 December 1999
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this version to print
Most attention during the crisis surrounding Bovine Spongiform
Encephalopathy (BSE), commonly known as Mad Cow Disease, has focused
on the risk of eating beef. However evidence to the ongoing British
government BSE Inquiry shows how the potentially greater risk
from the use of cow by-products in vaccines and other medicines
was covered up.
The Blair government set up the BSE Inquiry in March 1998 and
it is due to report in March 2000. Its aim is to establish
and review the emergence and identification of BSE and its human
equivalent, and of the action taken in response to it up to 20
March 1996. This was the date that the then Conservative
Health Minister, Stephen Dorrell, admitted that there was a link
between BSE and a new form of the disease in humans called new
variant Creutzfeld-Jakob Disease (CJD). Forty-eight people have
died of the disease so far and the final number could be much
greater due to a suspected long incubation period. CJD may have
affected its latest, and youngest, sufferera 13-year-old
girl.
BSE and nvCJD are related diseases that attack the nervous
system and make the brain spongy, resulting in dementia and death.
It is almost impossible to eradicate. Most knowledge of the disease
comes from research into a variant of it found in sheep, Scrapie.
This disease has been known for more than 200 years but does not
appear to harm shepherds or those who eat lamb or mutton. From
the beginning of the epidemic it was assumed that BSE would behave
like Scrapie and not infect humans, despite the fact that feed
contaminated with Scrapie was thought to have caused BSE in cattle.
Because of the potential danger from Scrapie, pharmaceutical companies
did not use sheep as ingredients in medicines or in their production.
The Inquiry was told that the first hint that BSE was a health
problem arose in July 1987. John Sloggem, a government Pharmaceutical
Officer, was investigating a new medicine. He found that the Committee
for the Safety of Medicine (CSM) had refused it in 1984, because
it wanted proof that slow virus contamination was not a
problem in the cow brain used to make the medicine. He investigated
further and was told about a scrapie-like disease that is
occurring in cattle and had the impression that the
cattle slow virus issue was a matter that was not widely known
and should not be publicised.
It was not until December 1987 that the agricultural and farming
ministry, MAFF, produced an internal report entitled "BSEimplications
for biological products". It recommended a ban on the use
of suspected or confirmed cases of BSE and the most infective
materialsnerves and lymphin all cattle.
In February 1988 MAFF officials warned Sir Donald Acheson,
the Chief Medical Officer at the Ministry of Health, about BSE.
They said it was necessary to assess the risk in humans
in order to justify the cost of any control measures taken by
MAFF. They agreed to set up an expert working party to be
chaired by Sir Richard Southwood, Professor of Zoology at Oxford
University. Meanwhile the agreed approach was to await the
findings and report from the Southwood Working Party before finalising
our advice on BSE and medicines.
Guidelines to pharmaceutical companies
The Inquiry was told how the veterinary industry trade association,
the National Office of Animal Health (NOAH), met with MAFF and
felt that the publication of Guidelines was required to
protect the UK image and demonstrate to the (European) Commission
that we had a clear action policy.
By November 1988, the CSM had proposed draft guidelines. They
said no immediate action should be taken against medicines taken
orally in view of the widespread consumption of beef. The pharmaceutical
companies should use low risk by-products from certified healthy
herds and show that they could eliminate the Scrapie-like agent.
MAFF replied that many of the guidelines were unworkable. They
concluded, Extravagant action now to deal with a contingent
risk could (in the future) seem to be wholly disproportionate.
By now, according to the Inquiry, the CSM also realised
that virtually none of the current essential human or animal vaccines
could comply with (their own) Guidelines and there may be several
years of some vaccines in stock to make matters more difficult.
Public confidence in the vaccination programme must not be put
in jeopardy and yet supplies of some vaccines are very limited.
This was a genuine worry. A vaccination scare during the period
1980-88 had led to 123 deaths from measles and 50 from whooping
cough in England. There had been a number of other health and
food "scares" leading up to the BSE crisis, in which
the public had started to lose confidence in science and government.
This was the end result of a process involving commercial competition,
pressure from business interests, intensive farming techniques,
deregulation and cutbacks.
When the pharmaceutical companies received the guidelines,
they were told they were just best practice for the
future and a purely precautionary measure against
a remote risk.
The Southwood Report
The final version of the Southwood Report was published on
February 27, 1989. It said that cattle would prove to be dead-end
hosts for the BSE agent and it was unlikely that there would be
any implications for human health.
At the next meeting of NOAH and MAFF, the minutes record Sir
Richard Southwood's Report had thus far turned out to be a damp
squib. However, it was stressed that care must be taken to ensure
that certain elements of the press do not get hold of the wrong
impression about the safety of vaccinesboth human and veterinaryand
cause major problems.
On July 5, 1989, Southwood wrote to Dr. David Tyrrell who was
investigating what research was needed into BSE. He stated: I
just hope that the Ministry and others will, notwithstanding the
ridiculous attitude towards public expenditure, find the necessary
funds to undertake the high priority research.... You are absolutely
right to point out gently how we were forced to argue from analogy
with scrapie and one waits with some anxiety for the experimental
confirmation of that assumption. Personally I would have thought
the possibility of human infection was moderately high if some
medicinal products were made from tissues of infected animals
and injected into humans.
Kenneth Clarke, Secretary of State for Health at the time,
was shown the Tyrell letter at the Inquiry. He said he had not
seen it before and would have ordered the withdrawal of all suspect
vaccines. He admitted that a significant number of patients could
have become infected.
The case of company Z
Whilst the Inquiry revealed some of the secret workings of
government, pharmaceutical companies have been protected by confidentiality
clauses in the 1968 Medicines Act. The Inquiry was warned not
to mention their namesinstead the word "redacted"
appears in the transcripts.
The Inquiry heard how investigations found there were 111 medicines
administered by injection using the most risky by-productsbrain
and lymph. Most were made from imported material, but a range
of homeopathic medicines and surgical sutures were not. The sutures
used for sewing up tissues after operations were manufactured
by the main British supplier referred to as "Z". They
were made from cleaned cow intestines that the company processed
at the rate of 2,500 a day. Against the advice of their own guidelines,
officials renewed the licence on condition the company used intestines
from clean beef cattle 18 months to two years old.
A minority recommended the use of intestines from BSE-free
countries. The Inquiry was shown minutes where officials pointed
out that the agreement with the Company is confidential'
so that there will be no direct comparisons between the
conditions they had set and the recent ban on offals, including
intestines, for human consumption. Four years later, government
officials announced that a study had detected BSE infectivity
at the end of the small intestine from calves as young as six
months old.
By July 1992 the BSE Inquiry was told all vaccines available
in Britain fully complied with the guidelines and did not use
British cattle by-products. By the end of the same year 40,000
cattle had shown symptoms of BSE. The number incubating BSE was
much larger.
But what of the stocks of vaccines? According to the Daily
Telegraph, the BSE Inquiry has failed to establish what happened
to them and pharmaceutical companies have so far declined
to volunteer the information. One Inquiry spokesperson said,
It is possible that we will never know whether all these
vaccines were destroyed or whether they were used. All the
Labour Health Minister, Tessa Jowell would say is they were not
disposed of or discontinued.
See Also:
Human BSE/CJDAnatomy
of a Health Disaster
New book on BSE widely praised
[27 March 1998]
BSE/CJD
& Food Safety Issues
[WSWS Full Coverage]
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