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Drugs agency 'failed' on BSE
in vaccine risk
By David Derbyshire, Medical Correspondent
(Filed: 06/07/2002)
The drugs safety watchdog was criticised yesterday for
allowing polio vaccines made from banned cattle products to be given to
hundreds of thousands of people.
Prof Sir Liam Donaldson, the Chief Medical Officer,
said the Medicines Control Agency should have taken extra care and acted
more proactively to stop the potential contamination with BSE infected
material in the late 1990s.
Although he stressed that there was no health risk, he
accused drugs companies of giving inaccurate information about vaccines
and called on the MCA to monitor the industry more carefully.
His report investigated a brand of oral polio vaccine
recalled in October 2000 after fears that it could be contaminated
with BSE.
The vaccine, one of two used in Britain, was made using
British foetal calf serum dating from the mid 1980s.
Sir Liam said the health risk from the vaccine was
"incalculably small" and that all vaccines since 2000 had been made with
serum from BSE-free countries. That conclusion was backed up by a report
from the Committee on Safety of Medicines, also published yesterday.
However, Sir Liam said: "Of more significance and
concern is the fact that this problem was not identified by the MCA. The
agency is very reliant on information supplied to it by pharmaceutical
companies. A more proactive approach might have identified the problem
with the oral polio vaccine."
When the MCA became aware of the problem, "there was
not a sufficient awareness of the potential seriousness of the situation
and of the importance of reviewing rapidly the need for precautionary
action", he said.
In 1989, the MCA asked all pharmaceutical companies
about their stocks of bovine material. Wellcome, the original
manufacturer of the polio vaccine, told the MCA that its supply of
British calf serum used for vaccines would have been used up by 1994.
Production of the vaccine changed hands during the late
1990s, passing to Evans Medical, which changed its name to Medeva before
being sold to Celltech. In 2000 an audit revealed that British calf
serum was still being used in the vaccine. By then, the product had been
banned.
"It was apparent to many that the transfer of oral
polio vaccine manufacture from Wellcome to Evans could be problematic,"
said Sir Liam. "The MCA might have been expected to know this and to
have taken extra care."
The MCA should review its procedures for checking on
the validity of information from drugs companies, he said.
If a company makes an important health product and is
being taken over, information on the manufacturing process should be
disclosed to the new buyers - even if there is no legal duty, he said.
Following the report, the Government admitted that it
had given "incorrect or misleading" information to the House of Commons
over whether vaccines complied with guidance.
Hazel Blears, the public health minister, said
"inaccurate advice" from the MCA was to blame. Contrary to earlier
advice, the guidelines had never ruled out the use of UK derived bovine
material, she said. Statements that the MCA would not licence any
product that did not comply with the guidelines were also wrong. In
fact, the MCA could licence products that did not fully comply.
And despite earlier reassurances to the contrary, some
highly processed fats from cattle were found in finished vaccines,
although there was no health risk, she said.
Calf foetal serum is used as a culture medium in
vaccine production. It is is "washed out" in the final stages and should
not be present in the vaccine given to patients. Vaccines now use bovine
material from Australia, New Zealand, the US or Canada.
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