Switch to pasteurised blood product was possibly `illegal'

Children with haemophilia were switched on to a pasteurised blood product in the late 1980s in a possibly "illegal" fashion, …

Children with haemophilia were switched on to a pasteurised blood product in the late 1980s in a possibly "illegal" fashion, the tribunal heard yesterday.

Prof Ian Temperley, former medical director of the National Haemophilia Treatment Centre, said the move followed concern over the continued use of a more widely available Factor 8 product manufactured under conventional heat-treatment conditions.

In November 1987 the National Drugs Advisory Board gave permission to the drugs company Cutter to have its Koate HS pasteurised product used on not more than six patients.

Prof Temperley said, however, that in a manoeuvre which might be termed illegal, he began diverting quantities of the product, which was seen to have been safer regarding the risk of hepatitis C infection, to children in 1988.

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This continued until 1989 when products made with solvent detergent technology, which was also shown to be effective in eliminating hepatitis C, became available on a trial basis.

The doctor agreed he had engaged in this "rather extraordinary" manoeuvre because of growing concern about the existing Armour product at the time. This product was heat-treated to protect against HIV, but had not been otherwise treated to guard against hepatitis C.

Asked why he had not taken similar steps to protect children and "virgin" patients (those not previously exposed to infectious concentrates) with Factor 9 deficiency, Prof Temperley replied that he had not been aware of a pasteurised Factor 9 product on the market at the time.

Mr John Finlay SC, for the tribunal, said it seemed no such product was available in this country in 1988. However, he said, there was available a UK product made under super-heat-treatment conditions, which eliminated the risk of hepatitis C infection and which UK haemophilia treaters were "unequivocally recommending" be used for Factor 9 deficiency.

Prof Temperley agreed there was a proven study to show the UK product was safer. He further agreed there would have been no difficulty getting sufficient quantities for virgin Irish patients. However, he said, "I did not think of it at the time, surprisingly."

Later Prof Temperley admitted he gave no written instruction to medical staff at the NHTC to cease using heat-treated products when safer, solvent detergent ones became available.

In June 1990 he instructed that no further heat-treated products be ordered. However, no protocol was laid down for doctors in the wards.

Prof Temperley was being questioned as to how a mild haemophiliac called "Luke" received heat-treated BTSB Factor 9 in October 1990, causing him to be infected with hepatitis C, one month after he received a solvent detergent product. Both treatments were for relatively minor dental care.

Prof Temperley, who did not administer the Pelican House product, agreed Luke should not have received it. The only explanation he could give was that there was some shortage of the solvent detergent product at the time, although there was no evidence of this.

Asked whether he agreed it was his responsibility to ensure something like this did not happen, Prof Temperley replied: "I accept the overall responsibility", but to ask him to supervise every detail of this was "a bit unfair".

He said he had presumed the product had been stopped at source following his June 1990 instruction.

Joe Humphreys

Joe Humphreys

Joe Humphreys is an Assistant News Editor at The Irish Times and writer of the Unthinkable philosophy column