Inspector not told of reaction to anti-D

A RETIRED inspector with the National Drugs Advisory Board (NDAB) told the tribunal of in yesterday that the board had never been told of any adverse reactions to blood products supplied by the Blood Transfusion Service Board (BTSB).

Mr Frank O'Dowd, who retired in May 1990, said he expected the NDAB would "have been told" about the outbreak in 1977 of hepatitis like symptoms in women who had received anti-D manufactured at Pelican House. He felt "disappointed it wasn't".

Had the NDAB been told, "very rapidly a conclusion would have been reached to withdraw the product, or suspend it", he said. An NDAB team would have gone through the whole (manufacturing) process at the BTSB, which might have taken up to three weeks.

His inspections concerned the manufacturing process only and not observations on or investigations of the blood products. Anything to do with the products he thought "very strongly" was "a medical field".

He had nothing to do with donor selection, except in ensuring that "the nothing to do with donor selection, he would have asked for a medical colleague (in the NDAB) to accompany me on such a visit".

He conducted what he agreed with counsel were "very meticulous inspections", of premises, equipment and staff, in the manufacturing process. His reports went to the NDAB secretary and he generally sat in at meetings when licence recommendations were being discussed.

On November 11th 1973 he first inspected the BTSB. It went as far as the law allowed at the time but was not a full inspection. There had been two further unrecorded visits to the BTSB before it was granted a licence in 1975, but he agreed that "no full inspection" had taken place before then.

There had been numerous unrecorded visits, mainly concerning the Pelican House transfer from Leeson Street to Mespil Road in Dublin, before the licence was renewed in 1978. He had not inspected the manufacturing process at Mespil Road before that renewal went through. However, he was then "thoroughly familiar" with BTSB manufacturing processes, due to close involvement with its move from Leeson Street.

On October 13th 1981 he inspected the Mespil Road premises, and again on November 15th 1984. He agreed with counsel that by then he was carrying "a severe workload" with large (pharmaceutical) companies moving in here in a big way" and which had to be monitored constantly". His last inspection of the BTSB was on July 14th 1987.

Responding to comments from counsel, he observed that in premises frequently visited by inspectors "standards tended to be high".

Places less frequently visited did not really present a problem, as Ireland was a small country.