This stuff has been going on for years – an old report about an even older wicked event – still worth sharing. Truth Prevails after all!
Photo: The Age
Millions of Australians were given a polio vaccine infected with remnants of a cancer-causing virus. Scientists knew the dangers but released the vaccine anyway, writes Gary Hughes.
The eight scientists gathered in the meeting room at the Commonwealth Serum Laboratories in Melbourne included the key researchers who had helped turn the tide in the fight against polio in Australia.
But the mood was far from celebratory as the meeting started on May 1, 1962. The team responsible for developing and producing the local version of the Salk polio vaccine in 1956, which had been given to millions of Australians during the following years, was faced with a crisis.
Four days earlier CSL biochemist John Withell had completed laboratory tests that confirmed what had been feared: the latest batch of polio vaccine was contaminated with a newly discovered virus that came from monkey kidneys used to produce it.
The virus had been designated SV40 – the 40th simian virus that had been identified – but this virus, first discovered by British researchers the previous year, was different. Tests in the United States had shown it could cause aggressive cancers in small animals and was not killed in the normal process used to manufacture polio vaccine.
In the words of Withell, who went on to become head of the government’s Therapeutic Goods Administration laboratories in Canberra, SV40 “was recognised straight away as a fairly nasty virus”.
Those at the meeting were confronted with the dilemma of what to do. The discovery of SV40 contamination could not have come at a worse time for the government-run CSL. The laboratories, which carried out virtually all vaccine research and production in Australia, had just undergone one of the most turbulent periods in its history, with mounting political pressure over delays in producing the polio vaccine, the removal of its director, management upheavals and rising costs.
While the introduction of Salk vaccine in Australia in 1956 had blunted the threat of polio, outbreaks had continued: in Victoria, Tasmania and South Australia in 1960-61 and in Queensland and NSW in 1961-62.
The spectre of poliomyelitis, which could lead to death or permanent paralysis, was still enough to cause widespread public panic, in turn pressuring politicians and health authorities.
In 1961 state health authorities and health ministers were pressing Canberra to provide increased amounts of the vaccine amid a growing shortage caused by production problems at the laboratories. Two entire batches of vaccine, representing about 1.4 million individual doses, had been destroyed in November 1961 because they had failed safety tests. The release of other batches had been delayed because independent tests showed the vaccine still contained live polio virus, forcing it to be reprocessed.
The pressure was showing among senior staff, with some worried about standards being compromised.
In September 1961, batch 58 was issued despite a written warning from the laboratories’ senior medical consultant that “it does not meet CSL’s accepted standards in potency and is a long way short of the increased potency approved by the National Health and Medical Research Council”.
In August 1961, senior researcher John Graydon wrote a memo saying important decisions on the release of vaccine that failed safety tests were being influenced by the supply situation. Effectiveness and safety, he said “should be the determining criteria”.
The shortages, production problems and the continuing demand – by 1961 fewer than half the population had been vaccinated – had led authorities to secretly buy polio vaccine from overseas manufacturers.
CSL was no stranger to the lurking simian viruses, which contaminated vaccines through the kidneys of monkeys imported from Asia by the hundreds. The monkey’s kidneys were removed and pulped to make cell cultures in which the polio virus was grown before being killed and turned into vaccine.
The laboratories’ production records in the National Archives show the presence of a simian virus disrupted safety tests of finished vaccine in 1957. In 1958 a batch of finished vaccine was destroyed after a live “non-polio virus” was detected. That same year a virus “consistent with its being a simian virus” was found in another batch. Simian viruses along with other factors such as stress were also causing the laboratories’ imported monkeys to “die like flies” at Melbourne Zoo where they were kept, according to Withell.
Scientists at the serum laboratories were first warned about SV40 contamination of Salk polio vaccine and its potential threat in April 1961 by the US Department of Health, after the monkey virus had been found to have survived the process used to kill live polio viruses used during American vaccine production.
The US authorities said they had found SV40 in half of the samples it had tested from its own vaccines and urged other manufacturers around the world that “every effort should be made to institute a program of testing each lot of vaccine to ensure that vaccine reaching the market is free of simian agents”. The Americans also adopted the policy of not releasing any new batches of vaccine until its had been shown to be free of SV40.
CSL received a first-hand account of the problem in November 1961 when one of its most senior researchers, Allan Duxbury, visited America’s Biological Standards Laboratory. In a three-page report sent back to Melbourne, Duxbury said the “most interesting” part of his visit was the study of SV40 and the fact it had been shown to cause malignant tumours in hamsters “unlike any previously produced by other viruses”.
But according to CSL records, the first testing of local vaccines had not started until February 1962, which eventually led to confirmation in April that batch 64 was contaminated.
Now a decision had to be made by the laboratories’ new director, Ron Greville, on how to cope with this new threat and further potential embarrassment. According to the notes of the meeting held at CSL on May 1, 1962: “Dr Greville opened the discussion by stating that although SV40 virus was present in batch 64, the batch would be issued; a decision which was founded on the belief that probably much vaccine in the past was probably similarly contaminated.”
Greville went on the say “every effort” should be made to produce vaccine free of SV40 “as soon as practicable”.
One of those working on polio vaccine production at the laboratories at the time was Dr Alan Hampson, now the deputy director of the World Health Organisation centre for influenza research, based at CSL. “I would not be at liberty to discuss what might have been found in vaccines issued by CSL,” he said this week.
The man who found SV40 in CSL’s vaccines, John Withell, reviewed his original research workbooks for this story after they were found in the National Archives. Withell, 72, was surprised at how few samples there were of previously released batches of polio vaccine available for testing for SV40. Records show that the samples retained for safety testing were frequently combined to produce new batches of vaccine to overcome shortages.
“I know I certainly went back to look at old batches of polio vaccine which had been kept in storage, but I think there were only a very small number,” he recalls.