-Caveat Lector-
http://www.smh.com.au/articles/2004/10/22/1098316861644.html
Millions given infected polio vaccine
By Gary Hughes
October 23, 2004
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Children line up for their shots in September 1961.
Children line up for their shots in September 1961.
Photo: Sydney Morning Herald
A federal government agency knowingly released polio vaccine
contaminated with a monkey virus in the 1960s that has since been
linked to a range of cancers, including mesothelioma.
The virus contaminated at least four batches of vaccine totalling
almost three million doses between 1956 and 1962.
Two of the batches were released after testing positive to
contamination. The other two were released before tests could be
done. An unknown number of earlier batches were also almost certainly
contaminated.
An investigation by The Age has found documents from the Commonwealth
Serum Laboratories which reveal bosses there released one batch of
about 700,000 doses of contaminated vaccine in 1962 on the grounds
that "much vaccine issued in the past was probably similarly
contaminated".
Australia's leading experts on the virus, which is known as simian
virus 40 or SV40, have found traces of it in human tumour cells and
are calling for urgent funding to clarify the links.
Commonwealth Serum Laboratories knew from its own internal research
that the monkey virus was a potential cause of cancer in humans. The
research, which was never made public, was carried out in August
1962, while contaminated batches of vaccine were still being
released. Tests carried out at the time also showed monkey virus
contamination of some of the "seed" polio virus used to produce all
Salk polio vaccines between 1956 and 1962.
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Commonwealth Serum Laboratories produced more than 18 million doses
of Salk polio vaccine, enough to vaccinate six million Australians,
during that period. Nine out of every 10 Australian children aged
between 5 and 14 are estimated to have been injected with Salk
vaccine by 1965, when it was replaced with Sabin oral vaccine. Polio
vaccinations were given to children as young as three months.
SV40 was known to have contaminated polio vaccines in the United
States and other countries before 1963. A spokeswoman for the federal
Health Department said the charge that Australian polio vaccines may
have been contaminated had been previously acknowledged but no proof
had been found.
Scientists have already linked SV40, which is known to cause cancers
in small animals, to a range of rare human lung, brain and blood
cancers, but opinion is split on whether the virus actually causes
human cancer.
Professor Bruce Robinson, of the University of Western Australia's
school of medicine, and Dr Roger Reddel, head of the Cancer Research
Unit at the Children's Medical Research Institute at Westmead
Hospital, say more research needs to be done in light of the vaccine
revelations.
Professor Robinson, who has found SV40 traces in meso-thelioma lung
tumours in Australian patients, said relatively little research had
been done locally on SV40. "We do need to know what's going on in
this country because we have the world's highest incidence [of
mesothelioma]," he said.
Dr Reddel
said that while the "jury is still well out" on whether the virus
causes cancer, "I really still think there is a case to be answered
and it needs a lot more research".
A spokeswoman for the federal Health Department said Australia's
medicines watchdog, the Therapeutic Goods Administration, was
monitoring research by the US Centres for Disease Control into SV40
and cancer.
She said vaccine manufacturers now followed strict safety guidelines,
with all vaccines on the Australian market being thoroughly tested
before release.
Commonwealth Serum Laboratories, which was privatised in 1994,
supports the call for further research. Its director of public
affairs, Rachel David, said establishing whether SV40 caused cancer
would be difficult, but "I don't discount the debate that's going on".
She said the company's practices had changed dramatically and the
public could be "very confident about the quality and safety of
vaccines being produced at the moment".
She said the decision to release contaminated vaccine would have been
reached after "balancing off" the very real risk of polio epidemics
against what was at the time a "small theoretical risk" from the
monkey virus. "We stand by the safety of what we produce now, but to
go back 40 years and start talking about the decisions that people
were making in that environment, I can't pass judgement on that," she
said.
Polio vaccinations are no longer routinely given in Australia
following the declaration in 2001 that the western Pacific region was
polio-free.
Documents held in the National Archives relating to Commonwealth
Serum Laboratories' production of Salk polio vaccine show that the
first tests for SV40 were carried out in February 1962, after the
alarm was raised internationally in 1961 of possible contamination.
They were found earlier this year by a Melbourne researcher, Brenda
Coughlan, who was searching for material for a book.
SV40 came from pulped infected monkey kidneys used to produce cell
cultures to grow the polio virus. The polio virus was then killed
using formaldehyde to produce the vaccine, but SV40 survived the
process.
The Age confirmed the contents of the documents, including research
work notes, with the biochemist who carried out the SV40 testing in
1962 for Commonwealth Serum Laboratories. His name is John Withell
and he was later head of the Therapeutic Goods Administration's
laboratory in Canberra.
Minutes of a meeting held at Commonwealth Serum Laboratories on May
1, 1962 record how the organisation's then director, Ron Greville,
confirmed that SV40 had been found in vaccine batch number 64, which
was being readied for release.
"Dr Greville opened the discussion by stating that although SV40 was
present in batch 64, the batch would be issued; a decision which was
founded on the belief that probably much vaccine issued in the past
was probably similarly contaminated," the minutes say.
The agency's records show that batch 64 was officially released in
December 1962.
Mr Withell's research results show that three other batches of
vaccine also tested positive for SV40: batch 49, released in October
1959, batch 63, released in February 1962 and batch 65, released in
January 1963. Batch 66 was also positive, and was destroyed after an
attempt to rid it of SV40, ordered by health authorities in Canberra,
killed the vaccine's effectiveness. The authorities said no further
vaccine containing living monkey virus could be released.
Later batches of vaccine were made from the kidneys of monkeys shown
to be free of SV40 infection. Only one batch of those tested, number
58 released in September 1961, was negative.
Mr Withell also tested three "seed" polio viruses that had been
originally obtained from the Salk laboratories in the US in 1955 and
used to manufacture Australian polio vaccines.
His test results contained in the National Archives show that one of
the seed viruses was heavily contaminated with SV40.
"Type two [polio seed virus] was stuffed full of SV40," Mr Withell said.
He stressed that the negative results for the other two types of
polio seed virus did not necessarily show they were free from SV40,
because the test was not sensitive enough.
Research notes also show that in August 1962 Mr Withell tested the
effect of SV40 on human embryo cells. The SV40 caused
"transformation" in the cells, which indicated it was potentially
carcinogenic.
Mr Withell said the results were reported to an internal research
panel for Commonwealth Serum Laboratories, but were never made public.
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