Unauthorised products used on patients, hearing told

A number of "unauthorised" blood products were used to treat haemophiliacs in the State in the 1980s, it emerged at the Lindsay…

A number of "unauthorised" blood products were used to treat haemophiliacs in the State in the 1980s, it emerged at the Lindsay tribunal yesterday.

The products were described by counsel for the National Drugs Advisory Board (NDAB) as unauthorised because they had not been approved for use by NDAB, now known as the Irish Medicines Board.

Among the products which were used extensively but without a product authorisation were: Koate, a factor 8 product made by the Cutter pharmaceutical company, and which was given mainly to patients for home therapy; PPSB IX, a factor 9 product made by Travenol/Baxter; and a range of products made by the former Blood Transfusion Service Board, including cryoprecipitate which was a form of factor 8, and BTSB factor 9.

Cross-examined by Mr Tony Aston SC, for the NDAB, about the use of these products, Prof Ian Temperley, former director of the National Haemophilia Treatment Centre, said he believed at the time that BTSB products did not require a product authorisation from the NDAB.

READ MORE

Prof Temperley said he believed PPSB IX was authorised. He said the national treatment centre would have been supplied with the product by the BTSB and he believed if it supplied it, it was all right to use. Prof Temperley said he wrote to the NDAB in January 1985 outlining the products he planned to use that year.

He believed the NDAB should have written back and told him if the products were unauthorised.

"This was a time of great tension and great stress," he said. "To a certain extent some of the details of the type of product used were probably lost in the need to get things going," he added.

He also pointed out he had to switch to products for safety reasons before they were authorised.

He added his first thought was to get the right product, not to see if it was authorised or not.

He said permission had been given by the NDAB to use some of the products on a named patient basis, but they were used more extensively than that.

A further product used without authorisation was made by the Octapharma pharmaceutical company and had to be withdrawn in the early 1990s after it caused an outbreak of hepatitis A, the tribunal was told.

Earlier, Ms Deirdre Murphy SC, for St James's Hospital, Dublin, said the hospital conceded that facilities for haemophiliacs were "spartan" in the 1970s but they were no worse than for other patients.

She added that in the 1980s cutbacks meant expanding services in the hospital had to compete for shrinking finances.

Prof Temperley agreed.

Ms Murphy also suggested to Prof Temperley he was mistaken in earlier evidence when he suggested body bags were used for patients who died of AIDS because mortuary attendants at the hospital expressed concern about possible infection risks.

She said the policy was medically based and was advised by the Centre for Disease Control in Atlanta.

Prof Temperley said it certainly was not his policy but he stood corrected.