I thank the Ceann Comhairle for giving me the opportunity to raise this matter.
I thank the Minister for Health and Children and his officials for the reply to a parliamentary question of last Wednesday and the reports enclosed therein. However, a number of question marks still hang over the debate. The major one is that on 24 September 1973 Dr. Dunleavy of the Eastern Health Board wrote to Wellcome enclosing a list of lot numbers of Trivax which had caused severe adverse reactions. Included in this report were two lot numbers which corresponded to Tribovax T. It must be noted that this report was compiled at the request of Wellcome so they could investigate the reasons for these severe reactions. Surely the first step performed on receipt of these lot numbers was to check the analytical log books to find the corresponding batch number. At that stage it should have been clearly evident that these two lot numbers corresponded to a Tribovax T and not a Trivax vaccine batch. If this was a transcription error why was the Eastern Health Board not contacted and asked to clarify the error? Why has GlaxoSmithKline not furnished any information in relation to this investigation of these lot numbers in its eight page report? Not a word is mentioned in that report and one must ask why.
Regarding the manufacturing procedures employed in the production of both vaccines it is the case that both vaccines were stored in the same cold store after their arrival in Dartford. Both vaccines were transferred to the filling room at approximately the same time due to the sequential lot numbers allocated to the batch of Trivax and Tribovax T. It is claimed in the GlaxoSmithKline report that the quality control procedures used to check the final product would have made it impossible to mistake the two vaccines. However, in 1991 Wellcome in the Best High Court case openly admitted its quality control procedures at that time were virtually non-existent. How can the company stand over its procedures in 2001 when it was not prepared to do so in a court of law ten years earlier?
It is a fact that three separate medical practitioners in three separate clinics at Rathfarnam, Crumlin and Temple Street Children's Hospital recorded that Tribovax T was administered to children. It is a fact that these children reacted severely to the vaccine and it is a fact that Wellcome received reports of these reactions on 24 September 1973 for the purpose of carrying out an investigation into those reactions. The statistical probability of three separate and eminent medical practitioners in three separate clinics recording in error a Tribovax T batch number instead of a Trivax number, while the Wellcome investigative team failed to pick up on that transcription error, is the same as that of winning the lotto twice in one week.
GlaxoSmithKline had a vested interest in ensuring that this was a transcription error yet the Minister has not provided a shred of evidence to support this claim. I ask him to reply to the following questions in his response. Does he agree that the formal record clearly states that these children were administered with an animal vaccine? Has he any evidence or record that states definitively that this vaccine was not an animal vaccine? Has he in his possession the results and conclusions of the Wellcome investigation into these severe reactions, which would have highlighted the transcription error, if that was the case? Have GlaxoSmithKline, the Eastern Regional Health Authority and the Department of Health and Children a copy of the correspondence that would have been sent by Wellcome to the Eastern Health Board pointing out that these batches were Tribovax T, not Trivax, and that this must have been a mistake?
Does the Minister honestly believe that there was a transcription error and that, if it had been a transcription error, Wellcome would not have raised the matter with the Eastern Health Board in 1973? I suggest to him that, on the basis of all the currently available information, the conclusions drawn by GlaxoSmithKline, the Eastern Regional Health Authority and the Irish Medicines Board are supposition and conjecture. The Minister has not yet provided one scintilla of evidence to support the claim of the company.