http://bmj.com/cgi/content/full/323/7305/128/a
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Doug Payne Dublin
The Irish authorities are again investigating reports related to the bungled
administration of child vaccines more than 30 years ago.
The drug company involved has promised its full cooperation. It is
becoming clear, however, that not only were Irish, and some British, children
injected with highly toxic batches of whooping cough vaccine (Trivax), but also
some Irish children were injected with an animal drug with a similar name
(Tribovax T).
It seems that some health experts in the Republic Ireland and the United
Kingdom were highly critical of the use of Trivax, but their concerns, and
those of parents, were brushed aside. Among the experts was Gordon Stewart,
emeritus professor of public health at Glasgow University, who advised the UK
Department of Health in an unpublished 1989 report that he believed the vaccine
to have been "too toxic."
In a major legal case in Ireland in the 1990s, Kenneth Best was awarded
£Ir2.7m (£2.1m; $2.9m) in damages for severe brain damage after being given
toxic pertussis vaccine in 1969. However, Irish health authorities only
recently received additional details from the drug company about the toxic
batches, enabling the Department of Health in March to try to trace 296
children.
It emerged last week, however, that only one health board has so far
reported making contact with any of the people who received doses of the toxic
batches of the vaccine.
More worrying is the news that in the early 1970s the drug company,
Wellcome, may have sent batches of a cattle vaccine—Tribovax T—to Ireland by
mistake.
GlaxoSmithKline, as the drug company is now known, said it first learned of
this aspect of the story from newspaper reports and expressed "deep
concern" at the reports. The health minister, Micheál Martin, expressed
shock at the revelations.
But information given by the company to Irish authorities makes it clear
that not only were the names of the two drugs quite similar but the batch
numbers were similar. As a result, the company initially said that reports that
children may have received an animal vaccine could have been the result of
transposed figures in the vaccination records that existed from that time.
On the basis of information supplied by the company, the minister of state
for health, Mary Hanafin, told the legislature that "copies of vaccination
records for children with adverse events include, amongst others, records where
the batches involved are Trivax batches, numbered 84769, 84496, and 84795. Each
of these three batch numbers differ from the Tribovax batch number (84796) by
only a single digit or by reversing two similar digits."
But it has now been reported that 84795 is actually Tribovax T and not
Trivax, so there may have been more adverse events than thought.
Opposition politician Denis Naughten said that the information "clearly
exposes the inability of the company to divulge all the facts behind this
scandal." The Irish Medicines Board said that it had not previously been
informed of any inadvertent use of an animal vaccine on a child.
"The Irish Medicines Board intends to fully investigate this issue with
the manufacturer of the product and liaise with the Department of Health and
Children and the health boards on this matter," the board said.
The health minister has also confirmed that more than 11 000 out of date
oral polio vaccines were given by GPs to children, with over 3600 of these
administered more than one month after their expiry date. The names of children
identified as having received out of date vaccines have now been sent to the
relevant GPs so that the parents can be contacted regarding revaccination, he
said. The vaccines were given between January 1998 and December 2000.
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