Inquiry could take insult from injury in blood saga

LAST year, when the official report on the infection of as many as 1,800 people, most of them women, with Hepatitis C was released…

LAST year, when the official report on the infection of as many as 1,800 people, most of them women, with Hepatitis C was released, there were very good reasons for taking the report at face value. The story it told was so scandalous, such a terrible betrayal of public test by the Blood Transfusion Service Board (BTSB), that it was simply unthinkable that the reality could actually be worse. The report was so utterly damning that, paradoxically, it inspired a kind of confidence. If there had been any kind of cover up, surely this amount of disturbing information could never have emerged.

The report revealed that a series of explicit warnings had been ignored with dreadful consequences for the lives of a large group of women. Firstly, a woman whose blood had been used to make five batches of the anti D vaccine in 1976 had developed jaundice shortly afterwards. Then, the following year, six other women who had received the anti D treatment were found to have developed clinical jaundice a few weeks later. In December 1991, the Middlesex Hospital which had tested blood samples from some of these women and retained them, reported to the BTSB that four of the samples had now been shown to have Hepatitis C antibodies, and that there was "considerable evidence" anti D was implicated.

The BTSB did nothing much about it for a full two years, until, in January 1994, the regional director of the Munster Blood Transfusion Service submitted a report to the BTSB showing an unusually high incidence of Hepatitis C in women who had received anti D treatment. In the meantime, the virus was being passed on to unsuspecting women. Even seven months after the BTSB had woken up and withdrawn the anti D product, it was still in use. At least eight doses were administered after February 1994 when the product was recalled.

These facts were so horrible in themselves that they made it hard to focus on a few stray suggestions in the report that the expert group was not getting full information at every stage. The expert group noted in the introduction that it had difficulty getting "adequate information" from the BTSB in "the initial stages" of the investigation. It also mentioned anomalies in what the BTSB told it about the six women who had developed jaundice in 1977. The BTSB's explanation for its failure to take action on foot of these cases was that it had attributed the jaundice to "environmental factors" rather than to a virus. But the expert group found "no written evidence from that time that the BTSB attributed the cases to environmental factors".

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EVEN more oddly, a "number of staff of the BTSB" told the expert group that a Dublin consultant, whom they named, investigated these six cases and submitted a written report stating they were caused by environmental factors rather than by a hepatitis virus. But the BTSB could not produce a copy of this report and the consultant named by the BTSB staff told the expert group he had not in fact investigated the incident at all.

These two anomalies are important because together they suggest the BTSB was offering to the expert group an explanation for its failure to act on the problems in 1976 and 1977 that it believed the cases of jaundice were due to environmental factors and not to a virus - for which it could not produce evidence.

Over the past month, in the early stages of a High Court case against the BTSB, it has emerged that the BTSB knew all along that the woman whose blood had been used to make anti D in 1976 had jaundice, not because of environmental factors, but because, in the words of an affidavit submitted to the court, she "had been clinically diagnosed as suffering from infective hepatitis". It has also emerged that her plasma was used for making anti D "without her knowledge and consent" and without consultation with the doctor treating her.

This is stunning information. It turns a case of terrifying incompetence into what has been described by Maire Geoghegan Quinn in the Dail as a case of "absolute recklessness". It raises the question of whether there has been, again in her words in the Dail, "a massive cover up of that recklessness".

If the BTSB knew from 1977 onwards that plasma used to make anti D came from a woman infected with hepatitis (Hepatitis C had not been specifically identified but the existence of "non A, non B" Hepatitis was fully understood), then the daims made to the expert group about the supposed existence of mysterious medical reports proving that environmental factors alone were involved in the later cases of jaundice take on a new significance.

It is clear the expert group knew neither that the BTSB was aware that the women involved had been diagnosed as having infectious hepatitis, nor that her plasma had been used without her knowledge. They described her throughout as a "donor" and reported that the BTSB had concluded in December 1976 that her jaundice was "due to environmental factors". So why and how was critical information withheld from the expert advisory group?

Answering that question is made all the more difficult by a speech in the Dail on March 28th last by Brian O'Shea, the Minister of State at the Department of Health. He said: "It is obvious from the information in the report that the expert group ... was informed by the BTSB that the donor in question was clinically diagnosed as having infective hepatitis in 1976. As a result of this clinical diagnosis, the BTSB ceased using her plasma for the anti D programme.

THIS statement is frankly bizarre. Each of these two claims is the direct opposite of what appears in the report. If the expert was told by the BTSB that it knew the woman had infective hepatitis why did it say the BTSB had concluded that her jaundice was due to environmental factors? And, according to the report, the BTSB did not stop using her plasma - it "decided to resume using her plasma for anti D production" precisely because it had allegedly concluded that her jaundice was not an indication that she had infective hepatitis. Either the Department of Health has not read the report, or the "cover up" alleged by Maire Geoghegan Quinn is continuing.

This is an immensely serious business. As things stand, it appears that the lives of hundreds of women were recklessly put at risk by a State agency, that the State's official report into this scandal is seriously misleading, that the tribunal hearing claims for compensation has been acting on the basis of seriously incomplete information, and that the Department of Health is at best grossly ignorant of the truth, or at worst a party to a denial of the facts. The case for an independent inquiry which might at least remove the insult of untruth from the injury these women have suffered is unanswerable. If this scandal doesn't stop now, there will, with time, be blood on the floor.