Lindsay slams board over delay in recalling blood product

The Irish Blood Transfusion Service Board (formerly BTSB) has been criticised for delays in recalling the blood product Factor IX used for treating haemophiliacs in the report of the Lindsay tribunal.

The 577-page report by the Chairwoman of the Lindsay Tribunal Judge Alision Lindsay has investigated the circumstances in which an estimated 252 people infected with HIV and/or hepatitis C through blood products used for the treatment of haemophilia.

Seventy eight have died, six of them since the tribunal was established.

Judge Alision Lindsay has investigated the actions of the BTSB, the Department of Health, the National Drugs Advisory Board, hospitals, doctors, and the Irish Haemophilia Society.

The report says 95 people with haemophilia A were infected as a result of being treated with commercial blood concentrates Factor VIII before January 1st 1985. After this date these products were heat-treated to kill the HIV antibody.

However, the risk of HIV being transmitted by transfusion was mentioned at a BTSB board meeting in July 1983. The decision to continue to import commercial concentrates for transfusion to haemophiliacs is regarded as "inexplicable" by the report.

Heat-treating commercial products only became a priority following a letter from Professor Ian Temperley, the then medical director National Haemophilia Treatment Centre (NHTC) in December 1984 to the BTSB.

Factor IX was required for persons infected with haemophilia B. They represented a smaller group of the haemophilia population and the BTSB produced this product from Irish donors.

Concerns that the HIV virus could enter supplies of untreated Factor IX led to the BTSB purchasing a quantity of the heat-treated product in February 1985.

The report says that from that point on "the BTSB was supplying both heat-treated commercial Factor IX concentrate and its own unheated Factor IX".

In August of that year Dr Helena Daly, a locum director of the NHTC requested that the BTSB heat-treat all BTSB Factor IX immediately. In her evidence to the Tribunal, she said the BTSB appeared to be reluctant to accept the necessity to heat-treat their Factor IX. From January 1986 all BTSB Factor IX was heat-treated.

The Tribunal found that two batches of non heat-treated Factor IX, issued in 1985 were the probable source of infection of seven people with haemophilia B. Five of these have now died and one has passed the infection on to their partner.

Continuing to issue unheated Factor IX until the end of December 1985 despite new evidence on the dangers of transmitting HIV was "clearly inappropriate, the report finds.

Even once the decision to heat-treat all BTSB Factor IX was taken, the report notes that the BTSB did not instruct hospitals to immediately return any untreated stock held by hospitals - nor did it say explicitly that only heat-treated Factor VIII and Factor IX should be used. The Tribunal found no justification for the failure to do so.

The report was also critical of the consultant haematologist at the Cork Regional BTSB centre, Dr Paule Cotter. The report said it is clear from the evidence that Dr Cotter had formed the view in the beginning of 1985 that the use of heat-treated products was safer than non heat-treated. The Tribunal said she should have taken greater steps to ensure her patients got the safer products.

An "unwarranted delay by the BTSB in the introduction of HIV antibody testing of blood donations" was also identified by the report.

The financial position of the BTSB led to questions during the Tribunal hearings about whether the board had put profit ahead of safety.

In the report it is noted that the board was "inclined to promote and `push' its own products rather than commercial products. While the Tribunal accepts that as time went on the contribution made to the income of the BTSB by the sale of concentrates may have been a welcome addition to its cash flow, it does not accept that the decision to distribute such concentrates was motivated by financial considerations".

The failure to introduce retrospective checks on donors who test positive for HIV had their previous donations checked to see if they had passed on the virus until 1989 was also condemned by the report. It said the BTSB should have introduced such a procedure by late 1986 or at least 1987. The focus of this mechanism on current and future donors was also criticised.

One consequence of this failure is that "Mary Murphy" was not informed until 1996 that she had been HIV positive since the mid-1980s. "This was unacceptable since she was left at risk of unknowingly being the cause of onward infection", the report stated.

Another source of considerable anger at the Tribunal hearings was the non or delayed disclosure of test results. The Tribunal found that in the early 1990s this was due to concern over the accuracy of a test for hepatitis C.

Supervision from the Minister of Health was also criticised in the report. The Tribunal noted that there were administrative weaknesses evident in the BTSB that should have been dealt with.

The failure to resolve staffing and structural problems in the BTSB contributed to the boards difficulties in dealing with the significant problems following the spread of Aids.

Judge Lindsay said a recurring theme in the 196 days of evidence was the distress caused by a delay in obtaining results and the absence of appropriate counselling.

The Tribunal decided that the report would not be sent to the Director of Public Prosecutions stating: "It is not the function of the Tribunal of Inquiry to decide issues of criminal or civil liability.

Among the recommendations is an improvement in the method of keeping medical records, which the tribunal found to be "unsatisfactory and incomplete".

A sufficient number of consultant haematologists should be appointed, the report recommends. The report notes that at in the mid 1980s Prof Temperley was doing the work now being carried out by eight haematologists. The number of consultant haematologists remains grossly inadequate, the Tribunal notes.

The publication of the report was welcomed by the Minster for Health Mr Martin who said the Government will act to implement the report's recommendations.

Judge Lindsay concluded hearings in November last year.