Fully heat-treated product would have saved lives

Further damaging disclosures about the Blood Transfusion Service Board's reaction to the HIV crisis emerged at the tribunal yesterday…

Further damaging disclosures about the Blood Transfusion Service Board's reaction to the HIV crisis emerged at the tribunal yesterday as the agency's former principal biochemist, Ms Cecily Cunningham, began her evidence.

Ms Cunningham, who was criticised in the 1997 Finlay report on the infection of women with hepatitis C through anti-D supplied by the board, was questioned about her role in the production of BTSB factor 9. Seven haemophiliacs were infected with HIV from two batches of factor 9 - five of whom have since died.

Perhaps the most startling revelation from Ms Cunningham's evidence was that the board began heat-treating samples of factor 9 to guard against HIV as early as December 1984.

Samples from one or two batches were taken each month between then and mid-1985 to examine possible negative side-effects from heat-treatment, said Ms Cunningham. Ironically, one of the batches selected was that numbered 90753 which, the tribunal has heard, was infectious.

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Had the board decided to heat-treat the batch in total, rather than just a sample, a number of lives would have been saved; among them a patient at St James's Hospital, Dublin. He continued to inject factor 9 from batch 90753 into himself at home up to February 20th 1986.

Why didn't the BTSB begin heat-treating all its factor 9 then?

By December 1979, the State's leading haemophilia treater, Prof Ian Temperley, had been calling for such treatment to be "urgently" considered. Explaining the board's thinking, Ms Cunningham said it was concerned heat-treatment might have given rise to negative health effects in haemophiliacs. First, there was a fear patients might be exposed to a greater risk of thrombosis. Second, there was a danger that a protein, or part of the factor 9 product, would be destroyed in the heat-treatment process and this might cause reactions. A further belief existed within the board that the "washing, freezing and thawing" process involved in the production of factor 9 removed the HIV virus.

The tribunal has not seen any scientific evidence to support this view, however, and it subsequently proved unfounded.

A key question arising from Ms Cunningham's evidence was whether Prof Temperley was informed of the board's concerns and the fact they were obstructing a move towards heat-treatment.

In his evidence, Prof Temperley said he could not recall any discussion about thrombosis with senior BTSB officials Dr Jack O'Riordan or Mr Sean Hanratty. To treaters, he stressed, the possible danger of thrombosis was less than the danger of HIV. His view was supported by Dr Helena Daly, a fellow treating doctor, who told the tribunal the thrombosis risk "was not a major issue".

Following the intervention of Dr Daly in August 1985, the BTSB agreed to heat-treat its products starting from the following November. Prof Temperley has said he understood the board needed some months to get the process up and running.

However, Ms Cunningham's evidence suggested the board had the capacity to begin heat-treating in August, if not earlier. She said she was "surprised" at what "an easy matter" it was. All that was required was to place the factor 9 in an incubator for the appropriate time and at the right temperature, which she said she did with selected batches from 27th August 1985.

She confirmed the board made a deliberate policy decision to continue issuing untreated factor 9 alongside the new heat-treated product, which she understood was to undergo an initial "clinical trial". She said St James's Hospital, where Prof Temperley was based, was to receive the heat-treated material, while other hospitals were to get untreated batches pending the outcome of the trial.