Martin raises concern for children in vaccine trials

The Minister for Health has raised serious questions about the standard of care afforded to children used in vaccine trials in institutions more than 30 years ago, saying the Laffoy Commission on Child Abuse will be asked to investigate the affair.

Publishing a report yesterday on three vaccine trials in the 1960s and 1970s, Mr Martin said the Laffoy commission was now the appropriate place for the issues to be examined. Mr Martin rejected Fine Gael demands that the Oireachtas Committee on Health be allowed to hold hearings and call witnesses on the matter, although the report will be debated there.

The report covers three trials of vaccines on close to 200 children - 118 of them in children's homes - in the 1960s and 1970s. The current health status of most of the children, who were in at least six different homes, is unknown.

Mr Martin will now refer the report to the Laffoy commission within days, while next Tuesday he will propose a motion in the Dail referring the report to the Oireachtas committee for debate. The report is substantially the same as a draft whose details were published six months ago in this newspaper.

There are a number of changes, however. In response to the initial report's serious questioning of whether effective consent was given for the performance of clinical trials on children in institutional care, the final version reports that the main consultant in the trials, a leading medical microbiologist, Prof Irene Hillary has asserted repeatedly that she "invariably sought the consent of the appropriate authorities whether it was parent, management or medical officers" before conducting the trials.

A number of other points, such as some questioning the value of the trials and suggesting some children could have been put at risk of infection as a result of receiving experimental vaccine, were also omitted during the lengthy period of correspondence. The Laffoy commission is now to examine these matters, but the report draws no conclusion on them.

Mr Martin told the Dail he had to ask a number of questions concerning the care of children that were not answered in the report.

"If one group of children was given the more experimental vaccine, why was it the children in care who got that one?" he asked. This is a reference to one trial where children in institutional care received the vaccine that was being tried out, while children living with their families received the standard approved vaccine.

"What rationale led to the decision that children not in the State's care got the regular vaccine and children in the State's care got the variant?" he asked.

"Was the end result from each trial for the public good or for the commercial advantage of a manufacturer? Why were some medications given to children who were outside the age group at which those medications were known to be effective? Above all, we must ask why the records of some of the trials are so woefully inadequate at almost every point?"

Mr Martin said the issue of consent could not be fudged, and he was not satisfied that there was evidence of "solid, informed consent" given by those entitled to give it. Mr Martin described the lack of documentation relating to the trials as puzzling and unsatisfactory.

While the trials appeared to have had no medically negative consequences for any of the children, this was not the end of the matter, he said.

"When a child comes into the care of the State," he said, "the State must fight fiercely for all of that child's rights, including bodily integrity. The State does not have the right to view children in care as lesser citizens."