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Orphan vaccine scandal exposed

MORE than 120 Irish orphans in children's homes were used in commercial trials by drug companies to test new vaccines, a new report to be published by the Government later this week reveals.

The drug trials in the 1960s and 1970s were conducted in five children's homes by a research team from University College Dublin, allegedly without the consent of relatives in many cases. The report says that the tests on the vaccines may have left some of the children susceptible to serious illness.



It is understood that the Department of Health became aware of the controversy over seven years ago, but it was not made public.



The homes involved were: Madonna House, St Patrick's Home, the Bird's Nest and the Cottage Home in Dun Laoghaire. A mother and baby home at Bessborough in Cork was also the location for a trial in the early Sixties.



The report raises the consent issue, questions the legality of the vaccine and criticises the absence of documentation.



According to the report, the tests were legal at the time and the results published in some medical journals. However, today, under legislation introduced in 1987, such trials could not proceed without the consent of parents or guardians.



The report also says it is not possible to determine whether the legal requirements regarding vaccination, under the Therapeutics Substances Act, were complied with.



Some of the children on which the tests were conducted were handicapped. A number of babies were also involved. The trials were conducted to test new vaccines for diphtheria, tetanus and whooping cough. Trials were also conducted on polio and rubella vaccines.



The trials were led by top medical microbiologist Professor Irene Hillary, the former head of the UCD National Virus Reference Laboratory. She told the inquiry that she had the permission of the medical officers of the children's homes to conduct the trials, that the trials were for the public good and that the vaccine used was less strong than the standard vaccine.



According to the 40-page report, which has been seen by the Sunday Independent, there is no documentation regarding consent to the trials, consent could only have been given by parents or guardians and none of the children were followed up after vaccination.



An inquiry was ordered in 1997 into the affair by Mr Brian Cowen, when he was Health Minister. The report will be laid before the Dáil on Thursday by Health Minister Mr Micheál Martin. The final report was cleared in the last two weeks by the Attorney-General.



Many of the 123 children involved in the trials, now adults, have battled to have the full truth told about the events. The report also notes that many of those who were involved in the trials are since deceased.

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Prof Hillary also told the inquiry that the decision to use children's homes was due to the fact that they were a defined group, who were well-monitored by nursing and medical staff.



She also pointed out that most of the results of trials were published and permitted by the National Drugs Advisory Board and, as a result, there was nothing secret about them. Some of the trials were conducted in the community, with the consent of parents, as well as in the homes.



She emphasised that no child suffered any injury from the vaccination and that she did get permission from some mothers in the mother and baby homes for the trials.



In some cases, the vaccine was around 25 per cent less strong to see if it caused less reaction. According to correspondence contained in the report from the children's homes to the Eastern Health Board, it is claimed that some of the homes believed their children were being given the standard vaccine, rather than the experimental one. As a result, some of the children may have been left susceptible to illness, the report suggests.



The main trials were conducted on behalf of the drug company Wellcome, now called Glaxo Wellcome. The report says that some children used in one trial may have been more susceptible to polio infection as a result of being given the trial vaccine.



The trials were conducted in 1961, 1968 and 1973-1974. At the Bird's Nest and Cottage Home in south Dublin, around 60 children at a time were used for tests. These tests mainly involved the "three in one" vaccine for diphtheria, tetanus and pertussis (DTP). The aim of the tests was to improve the performance of the vaccine and to reduce the possible adverse side effects which can include fever, fits and more serious reactions.



In correspondence in 1993 with one of those used in the trials, the Department of Health said it was satisfied that there was no added risk to the children who received the vaccines.



It said that the studies were conducted in line with the ethical rules of the Irish Medical Council. At the time, it added, there were no statutory controls into how drug trials were conducted.



According to Glaxo Wellcome, in 1973, the Eastern Health Board noted an increase in reports of the level of adverse reactions among vaccinated children in Dublin. Wellcome undertook to investigate what was considered to be an improved form of Trivax (a triple vaccine) in Dublin to try and reduce the possible side effects.



Approval for the trial was sought from the National Drugs Advisory Board and a "no objection" letter was received from it. In total, 116 children participated in the 1973 study - 57 children in the care of two children's homes and 59 children living in the wider community.



The vaccine under investigation in the children's homes was considered to cause fewer reactions than the treatment already generally available, the company said. The company has insisted that there is no question of the trial being undertaken with children, simply because of their status as children in care. The report was prepared by the Department of Health's Chief Medical Officer, Dr Jim Kiely.




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