Non-use of UK plasma treatment 'inexplicable'

It was "inexplicable" that the Blood Transfusion Service Board failed to pursue an agreement with a centre in Scotland to deliver…

It was "inexplicable" that the Blood Transfusion Service Board failed to pursue an agreement with a centre in Scotland to deliver safer blood products for Irish haemophiliacs, the tribunal report states. It was a missed opportunity that could have reduced the risk of hepatitis C infections.

The report details the BTSB's efforts after 1986 to secure safer blood products with a lower risk of either HIV or hepatitis C viral contamination.

It highlights the range of options considered by the BTSB and questions the suitability of some of the decisions taken.

Early heat treatments had eliminated the risk of infection with the AIDS virus, HIV, and there was no evidence of HIV infection in any Irish haemophiliac receiving BTSB products after January 1987.

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Hepatitis C infection remained an ongoing threat, however, and new treatments were examined to reduce this risk, the tribunal report states.

The tribunal came to the view "that the BTSB were not, at this time, actively pursuing inquires into alternative methods of viral inactivation which might be more effective against the risk of non-A non-B hepatitis" [later named hepatitis C].

It refers to BTSB contacts with the Protein Fractionation Centre at Edinburgh, which processed plasma supplies sent from Northern Ireland to produce Factor VIII and Factor IX. The centre had developed a new heat treatment, which involved heating the product at 80 degrees for 72 hours.

There was no follow-up contact with the Edinburgh centre.

"The tribunal finds the failure of the BTSB to pursue the possibility of an arrangement with the Protein Fractionation Centre, Edinburgh, to fractionate plasma for the BTSB inexplicable," the report states. Scotland's willingness to enter an arrangement was recorded in November 1986 and the BTSB had data which showed there were no non-A/non-B infections after the product's use.

"The tribunal believes the BTSB ought to have pursued the possibility of an arrangement with Edinburgh and their failure to do so represented a significant missed opportunity."

The tribunal acknowledged the emphasis at that time was the prevention of HIV transmission. "However, by 1987 the tribunal believes the BTSB should also have been seeking protection against the risk of transmission of non-A/non-B hepatitis."

The report also questions the wisdom of continuing an arrangement with the Armour company for the supply of heat-treated Factor VIII.

In December 1987, six haemophilia A patients in Canada had become infected with hepatitis C after receiving Armour's Factor VIII. It had been treated by the company at 60 degrees for 30 hours.

The BTSB had in 1987 contracted Armour to provide products treated at 68 degrees for 72 hours, but the company informed the BTSB it was unwilling to continue with the agreement.

Armour also demanded an indemnity against infections.

This, the report states, "was a clear and worrying indication of concern on their part about the safety of the product".

Yet in June 1988, the BTSB renewed its contract with Armour for 1989.

The tribunal considered it "quite inexplicable" that the BTSB would ignore the option of an agreement with Edinburgh. "It would seem to the tribunal that such an arrangement was an obvious option to be considered in response to the Armour letter," it states.

"In the tribunal's view, by June 1988, the Board of the BTSB ought to have been distinctly unhappy and uncomfortable at the prospect of continuing to supply a product treated with a system of viral inactivation believed to be inadequate to destroy the non-A/non-B hepatitis virus."

"It ought to have looked for alternatives," the tribunal added.