Previous inquiry failed to elicit the full facts

THE new tribunal of inquiry into hepatitis C infection may have the opportunity to address several questions which the 1995 expert…

THE new tribunal of inquiry into hepatitis C infection may have the opportunity to address several questions which the 1995 expert inquiry report into contamination of anti-D immunoglobulin was unable to fully answer.

That inquiry, chaired by Dr Miriam Hederman O'Brien, confirmed suspicions that the Blood Transfusion Service Board had failed to respond to a series of indications of potential contamination of anti-D. Its main findings were

. In 1976, the BTSB knowingly used plasma to manufacture anti-D which had been taken from a woman who had been jaundiced.

. The BTSB failed to withdraw the anti-D product in 1991 when it was informed of evidence of its contamination.

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. A 1991 donor tested negative to hepatitis C even though she was found to have the virus in 1994.

. Eight doses of anti-D were administered after the February 1994 public alert about its contamination.

. There were major communication gaps between the board of the BTSB, the medical staff and senior management, and non-medical staff were not fully briefed on medical matters.

The inquiry team remained dissatisfied in several crucial respects regarding the BTSB's handling of the contamination. In 1976, the BTSB ceased manufacturing anti-D from the plasma of a donor after she became jaundiced. When she had apparently recovered fully, however, it began again to use her plasma to make anti-D.

Dr Hederman O'Brien said when the report was published that the BTSB had been "unable to give an adequate explanation" of why it knowingly used the plasma of this woman who had a history of jaundice. The inquiry team was told by the BTSB that the woman's jaundice was due to environmental factors.

Last April, the BTSB told a Dail committee that, in a search of its files after the expert inquiry, it came across a file, dated 1977, which showed that the original plasma donor had "infective hepatitis", not environmental.

The BTSB said that the doctor in charge of the file died eight years ago. It denied that it "covered up" this evidence at the time of the expert inquiry.

The BTSB also told the team that, in 1977, six women who received anti-D developed signs of jaundice, but it concluded at the time that this was not due to the blood product, but to environmental factors.

When it investigated this issue, the inquiry team was told that a named Dublin consultant had written a report linking environmental factors to these six cases.

However, the BTSB could not locate a copy of the report and, when contacted, the consultant told the team that he had not in fact investigated the incident.

The expert inquiry further found that the six cases of jaundice in 1977 were not the first signs of potential contamination and that an earlier case of jaundice if it had been responded to could have prevented the major contamination which occurred in 1977.

The inquiry also found that the BTSB gave no adequate explanation about its failure to withdraw anti-D from use in 1991 following the emergence of evidence linking it to hepatitis C.

The report found that, in December 1991, the BTSB's chief medical consultant received a letter from Middlesex Hospital Medical School which said that there was "considerable evidence" that antiD was implicated in the occurrence of hepatitis C in 1977.

The letter put a series of questions to the BTSB in order to further investigate the matter. The letter was acknowledged by the BTSB and referred to its principal biochemist for further investigation. However, the inquiry report found that "no further action appears to have been taken at that time".