BTSB did not tell drugs board product was causing infection

The Blood Transfusion Service Board failed to inform the National Drugs Advisory Board, and at least one doctor treating haemophiliacs…

The Blood Transfusion Service Board failed to inform the National Drugs Advisory Board, and at least one doctor treating haemophiliacs, that one of its products was causing HIV infection in haemophiliacs, it emerged at the tribunal yesterday.

A doctor treating haemophiliacs in Galway wrote to the BTSB in September 1986 saying he was "very disappointed" to have to learn of the situation from a third party.

Dr Ernest Egan of University College Hospital, Galway, added: "I feel that it is your responsibility to communicate this sort of information to the likes of myself so that appropriate action can be taken at our end."

Dr Egan was informed by letter of the problem by Prof Ian Temperley, former director of the National Haemophilia Treatment Centre, in August 1986. But the BTSB had been informed three months earlier by Prof Temperley of his concerns that some patients taking BTSB factor 9 were testing HIV-positive after it had been agreed to introduce heat-treatment to inactivate the HIV virus. The first patient tested positive in Cork in July 1985.

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Dr Terry Walsh of the BTSB, in his reply to Dr Egan, said he thought he had discussed the matter with him but, if not, he apologised.

The BTSB's deputy medical director, Dr Emer Lawlor, who was spending her fourth day in the witness box yesterday, said that as far as she knew the problem was not reported to the National Drugs Advisory Body either.

The tribunal again looked at the length of time it took the BTSB to introduce heat-treated blood products for haemophiliacs. It was only after "a critical intervention" by doctors in August 1985 that the practice was adopted, said counsel for the tribunal, Mr John Finlay SC.

Dr Helena Daly, a locum for Prof Temperley, had a meeting with Dr Jack O'Riordan, former director of the BTSB, and Mr Sean Hanratty, former senior technical officer with the BTSB, on August 13th, 1985, and told them it was now considered unethical to continue giving haemophiliacs untreated clotting agents.

Prof Temperley then wrote to the BTSB on August 21st from London, where he was on sabbatical, stating that he thought he had made it plain that all products for haemophiliacs would have to be heat-treated.

"Of course, we would be failing in our duty knowing what we now know about retroviruses if we allowed anybody in future to become infected," he wrote.

Counsel for the tribunal pointed out that it was seven days after this letter that heat treatment started at the BTSB.

However, the board continued to issue equal amounts of heat-treated and untreated product up to December 1985 and failed to recall all untreated products from hospitals in Cork, Galway, Dublin and Drogheda.

Dr Lawlor said the untreated products issued at this time turned out not to be infectious. It was product which was not recalled that caused infection, and one patient of St James's Hospital continued to use untreated factor 9 manufactured by the BTSB at home up to February 20th, 1986.

But the Department of Health had asked the BTSB at the end of 1985 or early in 1986 to recall all stock which had not been heat-treated. Dr Terry Walsh of the BTSB wrote to hospitals asking them to return untreated stock to manufacturers, but did not specifically mention the BTSB-made factor 9 which was not treated.

He had to write to the hospitals again in June 1986 asking them to return untreated Pelican House products after Prof Temperley informed him there were five or six patients using the product who were HIV-positive at this stage.

Evidence was also presented that in Scotland commercially heat-treated products were given to haemophiliacs from February 1985, several months before Ireland, while they waited to heat-treat their own product. Dr Lawlor agreed this would have been an option for the Republic also.