Timely action by the board to remove potentially infected products might have prevented seven people being infected, writes Dick Ahlstrom, Science Editor
The Blood Transfusion Service Board failed to discharge its duty in the mid-1980s to warn doctors treating haemophiliacs about the risk of infection from blood products, the tribunal report states. Timely action by the board to remove potentially infected products might also have prevented seven people being infected with the AIDS virus.
The tribunal report outlines the developing use of Factors VIII, IX and other blood-derived products in the treatment of haemophilia here. It describes how the BTSB sought "self-sufficiency" in the supply of those products, and accepts the board was correct to source products from outside the Republic because of the volume of blood products required to meet demand.
New treatments and products were coming on stream at the time that the AIDS virus, HIV, began to emerge. The possible viral risk to blood derived products including HIV and hepatitis C, then referred to as non-hepatitisA/non-hepatitisB, would have been available to the BTSB, the report states.
The board had a clear duty to explain the risks of non-A non-B hepatitis associated with the blood products, the tribunal says, adding it was "extraordinary" that any question about this should even be posed.
This was despite the difference in standards for the disclosure of information prior to June 1982.
"The tribunal nonetheless takes the view that even by the then applicable standards and in the light of the then available information the BTSB had such a duty." While the board was not the only body with a responsibility to draw risks to the attention of treating doctors, "it did have a duty in all the circumstances as distributor of the commercial products to do so which it failed to discharge".
By mid-1985 there was sufficient evidence to suggest that all blood products should undergo heat treatment to reduce the risk of HIV transmission, the report indicates. The tribunal has taken the view that by August 1985 the BTSB should have both maintained "proper contact with events in the United Kingdom" in relation to heat treatment, "and they should also have ceased by that date issuing non-heat treated" Factor VIII blood products produced by the board.
"It is clear they had taken neither of these steps," it states. Use of non-heat treated products had begun in Britain by May 1985 and "had the BTSB responded appropriately" release here of untreated Factor VIII and Factor IX should have stopped by August. The BTSB began supplying treated Factor VIII by that October and non-heat treated Factor IX continued to be supplied until December 1985.
"This was clearly inappropriate and was accepted to be so by the counsel for the BTSB in his closing submissions to the tribunal," the report states.
The discovery of HIV positive donors [then referred to as HTLV III positive] in October 1985 "should also have prompted a recall of unheated BTSB Factor IX. This was not done."
The report describes evidence of a notice issued on January 30th, 1996, to the medical officer in charge of each hospital blood bank regarding the then status of blood products.
"The tribunal has already stated its view that a withdrawal of unheated Factor IX should have taken place by August of 1985. Since this did not occur, the tribunal is satisfied that the withdrawal notice on January 30th, 1986, should have contained an explicit and clear instruction to hospitals to only use heat treated Factor VIII and Factor IX products from then on and also a clear and explicit instruction to return any non-heat treated BTSB Factor IX which was held in stock," the report states. "The relevant officials in the BTSB who were involved in the drafting and the issue of the notice should have ensured this was done."
It considered the "probable consequences" had the BTSB taken such steps. Had untreated Factor IX been withdrawn by August 1985 "it is probable that most, though not all, of the seven persons [treated for haemophilia B] would have avoided infection".