CONCERN about unreliability was a primary consideration in evaluating the merits of a new screening test in 1990, the tribunal was told yesterday.
Dr Rosemary Boothman, a Department of Health Medical Officer at that time, said little was known about the natural history of hepatitis C when the test was developed and was being considered by the Department for approval for routine use by the Blood Transfusion Service Board.
Dealing with donors who tested positive was a major issue, she said. "The view of the Department would have taken into consideration that while blood is classified as a medicine, it is in fact a donation from one person to another, and the introduction of screening would have implications for the lives of both the donors and the recipients," she said.
Dr Alphie Walsh, chief medical officer at the Department between 1983 and 1990, told the tribunal that in considering approval of the test, the problems were its number of false positives, its expense and the need for a confirmatory test to augment it.
Dr Walsh had concluded that the test should not be introduced ahead of the UK or US, and had adopted a "wait and see" attitude.
The Department maintained a close relationship with its UK counterpart.
After an informal conversation with the deputy chief medical officer of the UK in July, 1990, he was told that the special UK advisory committee would shortly be recommending the test.
He wrote to Mr Donal Devitt, Assistant Secretary in the Department of Health, saying, "we would probably be wise to introduce testing at the same time".
Screening began in Ireland in October, 1991, a month after the UK. Following a request by Dr Terry Walsh of the BTSB seeking approval for the test in May, 1990, he had replied that the Department was waiting on a confirmatory test. "This was the one thing we were waiting for more than anything else," he said.
Dr Boothman told Mr James Nugent SC, for the tribunal, that the costing of the new hepatitis C test would have been worked out once the medical knowledge was there to justify using it. Costing was not a factor, but the medical issue and financial implications would have to be worked out as a parallel path. The test's sensitivity and specificity were not known. It was thought to be about 70 per cent to 80 per cent accurate, she said.
A fall-off in donors was likely if a high number of false positive results (cases mistakenly identified) became known. She said that for recipients, they may not have wanted to know about a diseases they had, they may have mistakenly thought they had contracted something, or they might have had a condition of which the implications were not known.
She would personally take the decision not to take a test if it had a high degree of non-specificity, unless there was a confirmatory test.
Dr Boothman, who was nominated to the BTSB board in August, 1993, was asked if she considered her responsibility was to the board alone. She said the Department did not have a representative on the BTSB board. Everyone was a ministerial nominee on an equal basis.
But she would have considered it a resigning matter if the BTSB chairman had not alerted the Department to the link established between a hepatitis C outbreak in Munster in February, 1994, and the administering of anti-D to women in 1977.
After missing a February 3rd meeting, she learnt of this link six days later. Eight days later, on February 17th, 1994, she notified the chairman, when he returned to Dublin from a trip. He then alerted the Department.
The month before there was a discussion on an outbreak of hepatitis C in the Munster region which appeared to equally affect males and females. The anti-D link had been considered but dismissed because males had been affected. At a later meeting ink January no mention had been made of either the numbers of rhesus negative people testing positive or any anti-D link. But the link was "very much on the cards" at the meeting on February 9th.