A PROCESS for inactivating the hepatitis C virus in anti D could have been introduced four years before the treated blood product became available at Pelican House in February 1994, the tribunal of inquiry was told yesterday.
Dr Terry Walsh, BTSB chief medical consultant and national director between 1985 and 1995, said he examined the issue of virally inactivating the anti D manufactured at Pelican House in 1989.
In October of that year, the BTSB contacted the New York Blood Centre which had licensed its solvent detergent method as applied to anti D. "The concept of applying SD (solvent detergent) to the anti D product in 1989 was certainly very novel and as far as I know had not been introduced anywhere else. I would say we were ahead of the posse in that regard," Dr Walsh said.
In the reply on November 14th, the centre said it was willing to license qualified anti D manufacturers, it had "extensive experience in transferring the technology", and representatives could attend a workshop in New York.
"Am I right in saying that as of November 14th, 1989, the New York Blood Centre were telling you that they could show you how to introduce a solvent detergent method into your anti D manufacturing process?" asked Mr James Nugent SC, counsel for the tribunal.
Dr Walsh: "That is correct." He said the BTSB became aware in 1992 that a Canadian company could provide the product treated with the solvent detergent method.
He admitted he "probably should have been more active" in following up the communication with the New York centre. A second and final letter was sent by Ms Cecily Cunningham, the head of the anti D manufacturing unit, in January 1990, requesting further details of the licensing arrangement.
"The difficulty at the time was we did not know actually what sort of structural or additional capital and machinery would be required in terms of the technology," Dr Walsh said.
He agreed there had been no letter to the Department of Health outlining the development or seeking funding. His recollection was that the BTSB chief executive officer, Mr Ted Keyes, visited the centre in 1990 or 1991.
Mr Nugent asked if it was not the case that nothing was done between January 1990 and May 1992, when there were discussions with the Canadian company.
Dr Walsh said validation studies of the process were not available from the Canadian company, which adopted the New York method, until early 1993. He added that in 1991 and 1992, the National Drugs Advisory Board (NDAB), which issued recommendations on product licensing, was unconvinced of the efficacy of the new process.
Prof Ian Temperley, a medical director of the National Haemophilia Treatment Centre (NHTC) from 1971 to 1995 and a BTSB board member since 1987, said infected factor concentrates were "a well known risk" in the early 1980s. "Up until the development of viral inactivation it was seen as an unavoidable consequence of improving the standard of life of haemophiliacs.
Since the introduction of the solvent detergent method of treating factor concentrates in June 1990, no NHTC patients had tested positive for hepatitis C.
"It would have been my impression personally that donors, a few donors, maybe a small percentage, would have had hepatitis non A, non B. That was a running on problem."
He agreed with Mr John Rogers SC, for Transfusion Positive and the McCole family, that there was a clear appreciation throughout the 1980s that viral inactivation. . was a most desirable step".
Prof Geoffrey Savage, director of the Haemophilia Reference Centre, Guy's hospital and St Thomas's Hospital Trust, said that a viral inactivation process for anti D should have been "seriously thought about" in the late 1980s.
He said clinical trials in the late 1980s centred on tests for inactivating the HIV virus. "The whole gay rights movement in the US was behind a number of actions to deal with HIV in blood and blood products. So hepatitis C, or non A, non B, was put on the back burner as not of interest for the simple reason as it did not have the same level of morbidity as HIV".