Scandal in lethal blood product is that no one shouted stop

ON November 5th, 1977, Brigid McCole was given an injection that was meant to save the life of her baby but that, 18 years later, caused her own death.

In common with about 5,000 other Irish women every year, she was faced with what is known as haemolytic disease, a condition that occurs when antibodies in the mother's blood attack the red blood cells running through the veins of her baby.

To prevent this she was given an injection of anti D immunoglobulin, made from human blood. She had every reason to believe that a progressive, caring society which prided itself on the high value it gave to motherhood had her interests at heart.

Since Brigid McCole's death earlier this year, words like "tragic" and "mistake" have been applied to her fate. Yet this week, in the first few days of the Hepatitis C Tribunal, those words seemed utterly inadequate.

As we began to learn what was known to the Blood Transfusion Service Board (BTSB) before Mrs McCole received her fatal injection, any lingering belief that she was merely the victim of a cruel trick of fate quickly evaporated.

The story emerging is not one of tragic ignorance eventually dispelled by shattering revelations. On the contrary, all the evidence this week suggests that, in essence, the facts were already known to the BTSB before Mrs Cole received her fatal injection.

Almost four months before Mrs McCole was injected a general practitioner, Dr Dermot Carroll, was working as a locum in the Dublin suburb of Raheny, filling in for a doctor on holidays. On July 18th 1977 he saw a patient, M. McG, for the first time and treated her for jaundice.

A month later she returned with a much more serious case of jaundice. He diagnosed her as suffering from hepatitis "non A, non B" (now called C). And he identified the source of her infection: an anti D injection she had been given at the Rotunda Hospital the previous May.

As required by law, he informed the Eastern Health Board. And he contacted the BTSB. He spoke on the phone to a member of its medical staff, probably, he said, Dr Terry Walsh.

The consultant to whom he referred M. McG, Mr John Lennon at the Mater Hospital, also wrote to him that one of his colleagues "has been in touch with Dr Walsh in the Blood Bank and we are following your suggestion up concerning the anti D injection". That letter was written on October 4th, a full month before Brigid McCole was given her fatal injection.

Moreover, Dr Carroll was not alone. Three other Dublin GPs gave broadly similar evidence to the tribunal. In fact, from July 12th onwards the BTSB had been receiving alarming reports of at least seven, and perhaps as many as 10, cases of severe hepatitis among women who had been given anti D injections.

Around July 25th, the BTSB began to react to those reports. Significantly, its then director, Dr Jack O'Riordan, seems to have known precisely where to look for the source of the problem, batches of anti D made from the plasma of a woman known as Patient X.

Before the tribunal, Patient X had generally been regarded as the source of the hepatitis C problem. Because she was infected with hepatitis C, and her plasma was used to make the anti D, she has hovered over the whole story as the imagined plague spreader.

One of the first, saddest and most startling facts to emerge at the tribunal is that Patient X was herself an innocent and unknowing victim. From the testimony of her gynaecologist, Dr Eamon McGuinness, and from the outline of agreed facts presented by counsel for the tribunal, James Nugent SC, two things are clear.

One is that Patient X herself contracted hepatitis C from infected blood with which she was being treated. And the other is that neither she nor her doctor ever knew of or consented to the use of her plasma for the manufacture of anti D. Contrary to the report of the Expert Group chaired by Dr Miriam Hederman O'Brien and published in January 1995, she was not in any sense a donor, not only was Dr McGuinness not told that his patient's plasma was being used to make anti D but, according to his sworn evidence, he was actually, told the opposite. He told the tribunal that before her treatment began, he discussed with Dr Terry Walsh of the BTSB the idea of busing her plasma in this way, hoping that this might offset some the cost of her treatment.

Dr Walsh, he said, told him that this could not and would not be done. Dr Walsh, however, has told the tribunal that he will dispute this evidence when he himself appears as a witness later this month.

There were two very basic reasons why the BTSB should never have used plasma taken from Patient X. One is that she was receiving multiple transfusions. In September 1976 Patient X was a patient at the Coombe maternity hospital in Dublin, but she was transferred to Crumlin Hospital three days a week for plasma exchange treatment which involved, essentially, a complete change of blood.

Dr Lewillis Barker, an American specialist, told the tribunal on Monday that plasma from such a patient should never have been used to manufacture anti D.

The second reason was that by November 17th, 1976, she had been diagnosed as having infectious hepatitis. The BTSB accepts that it is probable she had contracted the disease from blood which it had supplied for her treatment. And from a series of documents opened to the tribunal by Mr Nugent on Monday, it is absolutely clear that the BTSB had, from May 1968 onwards, a clear rule that blood was never to be taken from anyone who ever had jaundice of any kind, except as an infant.

Precisely how X's blood became infected in the first place may never be known, but the evidence of a former BTSB biochemist, Dr Stephen O'Sullivan, suggested at the very least that the BTSB's practices were not always rigorous.

He told the tribunal that in 1975 the entire stock of anti D in the BTSB headquarters Pelican House was placed in a fridge in a special hepatitis laboratory, exposing it to the risk of cross infection. He demanded that the entire stock be destroyed, and was told that this would be done.

He subsequently discovered, however, that only the outer wrappers of the bottles of anti D were in fact discarded, and that the entire stock remained in use. Whether or not this had any direct bearing on the subsequent events Dr O'Sullivan's contention that, it had was challenged by Mr Nugent and by John Rogers SC, for Positive Action and the McCole family - it was in itself deeply disturbing.

Whatever the source of Patient X's infection, however, it is clear that the BTSB knew about it almost from the start. Her gynaecologist, Dr McGuinness, said he was "sure" he told Dr Terry Walsh of the BTSB, with whom he was in "fairly regular communication" about her illness.

In any case, Crumlin Hospital was sending samples of Patient X's plasma to the BTSB for testing. Nine of these tests were marked "infective hepatitis". The BTSB also tested for hepatitis B a sample of Patient X's blood sent to it by the Coombe Hospital. Yet, for reasons yet to be explained, it went ahead and made anti D from her plasma.

However extraordinary that decision, it could and should have been reversed in July or August 1977, when the BTSB was told that cases of hepatitis were being found in women who had been given anti D injections.

Both Dr Barker and Prof Hans Hoppe from the University of Hamburg, who initially trained BTSB staff in methods of manufacturing anti D, told the tribunal that, as soon as the reports came in, the BTSB should have withdrawn all anti D made from Patient X's plasma.

Instead its director, Dr Jack O'Riordan, made what Mr Nugent described as a "truly remarkable" decision, to stop using that plasma for making antiD but to carry on using the anti D already made from it. One of the batches released for use in September was batch 250, the one from which, in November, Brigid McCole's dose was taken.

Why that happened, why it continued for 17 more years, why no one in authority tried to stop it, and why it was only this week, over 2 1/2 years after the whole scandal broke, that these basic facts became public, are the hard questions that Judge Finlay will have to answer in his report.