GLAXO Wellcome Ireland has strongly rejected reports that the three-in-one Trivax vaccine trials in Ireland in 1973 were undertaken with children simply because of their status as children in care. Trivax is a DTP - diphtheria, tetanus, pertussis - preventive vaccine.
The company said there was "no question" of this being the case and stressed that Wellcome had conducted its studies in accordance with the accepted medical and ethical standards of the time. "Neither the children, their families nor the child-care homes involved were paid for their participation in the trial programme.
It pointed out that the DTP vaccine was a beneficial vaccine which had saved lives and prevented disabilities in millions of people inoculated worldwide. "For necessary reasons of medical and legal confidentiality, it is not appropriate for Glaxo Wellcome to comment publicly on individual patients." It said it was willing to assist the Department of Health and the Eastern Health Board in any way it could.
A number of parents are calling on the Minister for Health, Mr Cowen, to set up a tribunal of inquiry into the effects of the vaccine and the medical trials carried out on orphans.
Glaxo, which acquired Wellcome in 1995 to form Glaxo Wellcome, said that during the 1960s, and up to mid-1995 the three-in-one Trivax vaccine was used extensively in Ireland. The vaccine was promoted by the Department of Health during this period as part of an ongoing national vaccination programme.
"Vaccines are known to save lives and prevent disabilities. The diseases controlled by vaccines - can cause considerable injury and even death. There would have been medical awareness and the company warned that the DTP vaccinations can cause side-effects, e.g. sore arms, fever and irritability."
The company said that in 1973 the Eastern Health Board noted an increase in reports of the level of adverse reactions among vaccinated children in Dublin and these were carefully investigated. A spokeswoman for the Eastern Health Board said last night the studies took place a long time ago and they were trying to establish the facts.
"Wellcome undertook to investigate what was considered to be an improved form of Trivax locally in Dublin in order to reduce the possibility of side- effects while maintaining the vaccine's effectiveness and benefits in preventing the diseases diphtheria, tetanus and pertussis.
"Physicians in Ireland, who were already known for their research thoroughness on previous occasions, were interested in carrying out trials on the newly-formulated DTP vaccine. Approval for the trial was sought from the then National Drugs Advisory Board and in April 1973 a 'no objection' letter was received from the board.
"The trial was conducted in dependently by the physicians who recruited the patients for the study. The trial was funded by a modest research grant from the Wellcome Research Laboratory."
In total, 116 children participated in the study.