The National Drugs Advisory Board failed in its duty to contact the BTSB to see what steps the blood bank was taking to heat-treat its product to guard against HIV, it was suggested at the Lindsay tribunal yesterday.
Dr Marie Burns, former deputy medical director of the NDAB, said there was no evidence to indicate the regulatory agency wrote to the BTSB in 1985, when concern about AIDS was reaching a peak, asking for information on whether and how it was heat-treating its products.
This was despite the fact that the NDAB had written to pharmaceutical companies, including Armour, Travenol and Immuno, seeking such information from them.
The decision to write to the drugs companies followed an announcement by Prof Ian Temperley, director of the National Haemophilia Treatment Centre, that he was purchasing only heat-treated commercial concentrates from 1985.
In a letter early that year to the late Dr Allene Scott, then medical director of the NDAB, Prof Temperley said he had been assured by Pelican House that BTSB cryo would be heat-treated "in about one month's time" and that BTSB factor 9 "will be shortly heat-treated".
However, cryo was never heat-treated, as it proved impossible, and BTSB factor 9 was only first heat-treated in late1985 resulting in non-heat-treated material being used up to February 1996. This Pelican House factor 9 infected seven haemophilia B patients with HIV, five of whom have died.
Counsel for Prof Ian Temperley suggested to Dr Burns that the issue of BTSB factor 9 ought to have been followed up by the NDAB in line with the agency's functions under its 1966 founding statutory instrument.
Dr Burns said, however, that she was not sure what the legal position was regarding the NDAB's duties in the area. She noted "we probably would have followed it up had we been requested to do so by anybody."
The tribunal has already heard that for a number of years BTSB factor 9 was used in the State without authorisation from the NDAB. Another witness from the agency is to explain how this occurred, the tribunal was told yesterday.
Dr Burns said it appeared the NDAB first became concerned about the risk of hepatitis infection in the late 1970s/early 1980s; and about HIV in mid1983.
The NDAB's 1993 annual report stated that no blood product would be accepted for marketing unless it could be "so processed as to minimise the possibility of transmission" of HIV and hepatitis.
She said Dr Scott assessed virtually all of the products, and in doing so she relied on treating specialists as "the authorities" in the area.
Dr Burns described Dr Scott as a "very committed and devoted person" for whom the NDAB was probably her whole life. Between 1978 and 1988, Dr Burns said, there were only three medical doctors in the agency, which was in "stark contrast" to other European regulatory bodies.
