A drug company asked the Blood Transfusion Service Board to indemnify it from the consequences of any infection which might arise from the use of its blood products after one of its clotting factors caused HIV infection among haemophiliacs in Canada, it emerged at the tribunal yesterday.
The BTSB was asked to sign the indemnity form in January 1988. It sought to indemnify Armour in respect of HIV, hepatitis or other viral infections arising from the sale of its Factorate concentrate, used to replenish factor 8 concentrate in patients with the most common type of haemophilia.
A letter accompanying the indemnity form which was addressed to the BTSB's chief executive officer, Mr Ted Keyes, also asked that the Armour trademark and all references to the company be deleted from its packaging by the BTSB, which would pass the product on to hospitals around the State.
It also stated that Armour, which had been making the factor 8 blood-clotting agent for the BTSB from Irish plasma at a plant in west Germany, wished to change its method of viral inactivation from dry heat-treatment to monoclonal antibody technology, and would no longer be able to continue its contact with the BTSB whereby it made blood products from Irish plasma. It would not manufacture Factorate after December 31st, 1988, it said.
However Dr Emer Lawlor, the board's deputy medical director, told the tribunal yesterday that Armour did continue to supply the BTSB up to the end of 1989. Counsel for the tribunal, Mr John Finlay, said the letter from Armour to the BTSB followed its voluntary withdrawal of heat-treated factor 8 which was suspected of causing HIV infection among Canadian haemophiliacs.
He suggested to Dr Lawlor that the problem in Canada may have had something to do with the letter.
Dr Lawlor said she didn't think so. She said the dry heat-treatment used by Armour in Canada, which involved heating the product to 60 degrees celsius for 30 hours, had been shown to be totally inadequate and was different from the heat-treatment used at its plant in west Germany, from where the BTSB products came. These products were heat-treated at 68 degrees celsius for 72 hours.
Counsel said the infection of haemophiliacs in Canada was raised at a BTSB meeting in January 1988 and by this time Prof Ian Temperley, former National Haemophilia Director, was on the BTSB board. The minutes of the meeting showed he expressed concern about what occurred in Canada but said he was quite happy for the board to continue using Armour product manufactured in west Germany.
The Armour letter seeking indemnity from the BTSB came before a meeting of the BTSB on February 17th, 1988, and members decided it should be dealt with "strictly in accordance with the advice" of their solicitors.