Dr Robert Roach. Australia
Almost 3 million doses of polio vaccine produced between 1956 and 1962 were contaminated by a monkey virus linked to a range of cancers, according to a newspaper report. The Sydney Morning Herald reports an investigation by The Age newspaper, which found that a federal government agency knowingly released the infected vaccine. At least four batches of vaccine released by the Commonwealth Serum Laboratories, totaling almost 3 million doses, were contaminated by the virus known as Simian Virus 40 or SV40.
The paper said two of the batches were released after testing positive to contamination, while the other two were released before tests could be performed. An unknown number of earlier batches were almost certainly contaminated by the virus, it said. Internal research conducted by the laboratories in 1962, but never made public, showed that the monkey virus was a potential cause of cancer in humans, it was reported. The virus came from pulped infected monkey kidneys used to produce cell cultures to grow the polio virus. Scientists have linked it to a range of rare human lung, brain and blood cancers, including mesothelioma.
The paper said the laboratories produced more than 18 million doses of the Salk polio vaccine, enough to vaccinate 6 million Australians, between 1956 and 1962. Ninety per cent of Australian children aged between 5 and 14 were injected with the Salk vaccine by 1965, it said. Commonwealth Serum Laboratories was privatised in 1994. Company spokeswoman Rachel David told the newspaper the company’s practices had changed dramatically and the public could be very confident about the quality and safety of vaccines currently being produced. She said the decision to release the contaminated vaccine would have been made after balancing the real risk of a polio epidemic against “a small theoretical risk” posed by the monkey virus.
War on disease … a pupil at Melbourne’s Scotch College receives a Salk vaccine injection in 1956, as did thousands of other children around Australia. A federal agency used babies in orphanages and children’s homes to test a new quadruple antigen vaccination that included polio vaccine possibly contaminated with a monkey virus since linked to cancer. Commonwealth Serum Laboratory records show the trials were carried out on babies as young as three months in five institutions between December 1959 and early 1961. Quadruple antigen, containing Salk polio vaccine, was not publicly released until November 1960. An investigation by the Melbourne Age, reported in the Herald at the weekend, revealed that millions of doses of Salk vaccine produced by the then government-owned CSL between 1956 and 1962 were contaminated with a monkey virus called SV40. Researchers have found traces of the virus in a range of human cancer cells, including mesothelioma lung disease.
It is not clear from the CSL records whether polio vaccine used to produce quadruple antigen used in the tests came from contaminated batches. The federal Health Minister, Tony Abbott, has ordered a departmental inquiry into CSL’s decision to release contaminated vaccines and any risks associated with it. Health authorities stressed there was no proven link between SV40 and cancer and have also reassured the public that polio vaccines still routinely given to all babies were safe and free from the virus and other known contaminants. However, a national support group for victims of contaminated medical products yesterday called for a royal commission into CSL.
“The track record of CSL demonstrates the need for a royal commission into all their operations,said Charles MacKenzie, president of the Independent Blood Council. CSL research records in the National Archives show that 56 babies under the age of 12 months were used in the Victorian vaccine trials. One baby is recorded as having died of meningitis in August 1960, less than three months after finishing a course of three quadruple antigen injections. The records list the names of the institutions, the names and ages of the babies, the doses of quadruple antigen given and the results of blood tests conducted before and after the vaccinations to measure polio antibodies. There is no indication of who gave formal consent for the babies to be used in the trials, which were carried out by CSL’s virus research department. Further development and use of the quadruple antigen, which also provided vaccination against whooping cough, diphtheria and tetanus, appeared to have been abandoned during 1962-63. Salk vaccine was replaced with Sabin oral polio vaccine by 1965. The Age revealed in 1997 that Victorian babies homes and orphanages had been used by several medical and research bodies, including CSL, for trials of a range of experimental vaccines.
The reports led to inquiries by the state and federal health departments, which concluded that there was no evidence of any other similar medical trials. Neither report referred to the quadruple antigen trials. The state government report, a copy of which has been obtained under freedom of information by Melbourne researcher Brenda Coughlan, found no record of the Department of Human Services providing formal consent for state wards to be used in trials. The Age’s revelations were examined by the Senate’s inquiry into mistreatment of state wards, which said in its report in August that it was unclear who was legally responsible for allowing the children to be used. It concluded that any long-term health effects on children used in the experiments were unknown.
Dr Rachel David, director of public affairs at CSL, which was privatised in 1994, said it would have been a logical decision to trial the new vaccinations in such institutions at that time, when community attitudes were different, because lots of kids died of communicable and vaccine preventable disease”. “It’s easy to pass judgment in retrospect, but I’d suggest we can’t do that. In that day and age people didn’t’t give consent for any medical procedures really, not in the way we understand informed consent now, where they have to sign a form and it is a very formal procedure.”