Failed method used by BTSB in product research, says scientist

The BTSB spent three years unsuccessfully trying to manufacture blood products for Irish haemophiliacs using a technology which had already been dismissed as "not viable" in the UK, the tribunal was told.

Dr James Smith, a scientist with the British Plasma Fractionation Laboratory (PFL), said it had tried from the mid-1970s to make intermediate-purity factor concentrates using the "Gail Rock method", pioneered by a Canadian doctor of that name.

The Oxford laboratory failed to produce the desired yields, he said, and concluded at the latest in 1981 that the method was not viable. He added that the BTSB would have been told of this by 1981.

The tribunal has heard that in 1981 the BTSB initiated a research project, led by the former chief technical officer, the late Mr Sean Hanratty, into the same method of production.

It was abandoned in 1984 when the blood bank chose to make products under a contract fractionation arrangement with an overseas drugs company.

Had the project proved successful it would have reduced the BTSB's reliance on imported concentrates and thus lowered the chance of haemophiliacs becoming infected with HIV.

Some 97 of the estimated 105 Irish haemophiliacs who became HIV-positive are believed to have been infected by imported concentrates.

Asked whether he thought the "Gail Rock" method was a viable way of producing intermediate-purity Factor 8, Dr Smith replied: "As we found it . . . I would have said not."

He was aware, however, that other laboratories "continued bravely" to try to make it work, particularly the regional blood centre in Groningen, northern Holland.

Not long afterwards, he said, in the mid-1980s, Dr Rock's laboratory in Canada was closed.

Dr Smith said PFL manufactured intermediate-purity Factor 8 throughout the period using a different technology. Scotland's protein ractionation centre, where he worked as chief scientist up to 1975, succeeded in manufacturing the product.

Regarding the feasibility of the BTSB following suit, Dr Smith said a small facility could have moved from cryoprecipitate production to making a low volume of intermediate-purity Factor 8.

Doing so would have required somewhat larger laboratories than those which he saw at Pelican House in the 1970s and 1980s, he said.

Because the Scottish unit was underutilised at the time, it would have found the option of making factor concentrates for the Irish market "quite attractive".