Factor 9 could not have been `safely issued any earlier'

The BTSB's former principal biochemist told the tribunal yesterday that once the decision had been made to heat-treat concentrates…

The BTSB's former principal biochemist told the tribunal yesterday that once the decision had been made to heat-treat concentrates for haemophiliacs to guard against HIV, "it could not have been done any faster".

Ms Cecily Cunningham said while heat-treatment was quite a simple procedure, and could be done almost immediately, a number of laboratory tests had to be carried out before the product was available for issuing to hospitals.

She was being asked why the first batch of heat-treated BTSB factor 9 was not ready for issuing until October 1st, 1985, six weeks after the decision to start heat-treating was apparently made.

Ms Cunningham said the product could not have been safely issued any earlier. Samples had to be sent for laboratory testing at a number of institutions including St James's Hospital, Dublin; UCD and a haematology centre in Oxford.

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She said the board would have asked the various laboratories "to make haste" in doing the tests, and as a result their results came back quicker than normal.

Earlier, Ms Cunningham, one of whose duties at the board was the production of factor 9 under the instruction of the chief technical officer, said the board would have needed a lead-in time of probably more than six months in January 1986 to make the product from plasma which had been screened for HIV.

She said it normally took up to half a year between the collection of plasma and the dispatch of the factor 9, following production and testing.

In early 1986, however, there was an added delay as the fractionation unit had to wait for enough screened plasma to build up following the introduction of HIV screening in October 1985.

Asked by Mr Charles Meenan SC, for Dr Terry Walsh, a former consultant haematologist to the board, what would have happened if the BTSB had requested hospitals to return all factor 9 made from unscreened donations in January 1986, Ms Cunningham replied they would have been left to use only commercial product.

She said she did not know whether this would have been made from screened plasma.

Her evidence supports that of Dr Walsh, who told the tribunal it was not a practical proposition to withdraw all products made from unscreened donations, as demanded by the Department of Health, without a substantial lead-in time.

Joe Humphreys

Joe Humphreys

Joe Humphreys is an Assistant News Editor at The Irish Times and writer of the Unthinkable philosophy column