Dáil Éireann debate -
Thursday, 28 May 1998

Vol. 491 No. 5

Written Answers. - Amerscan Pulmonate II.

Bernard J. Durkan

Question:

86 Mr. Durkan asked the Minister for Health and Children the number of persons who received Amerscan Pulmonate II treatment; the risk, if any, identified; if patients in the United Kingdom have been contacted by the authorities there; if this treatment is still in use in other European countries; if support groups exist in these countries; and if he will make a statement on the matter. [12587/98]

Minister for Health and Children (Mr. Cowen)

The number of persons who received the withdrawn Amerscan Pulmonate II product in Irish hospitals was 460. This figure was established following a request by my Department to each of the hospitals involved to identify all patients who were administered the product and to make arrangements to inform each person and to provide appropriate counselling.

As I informed the House on 16 December 1997, the advice I received from the CJD advisory group was that the risk of transmission of new variant CJD through this product was unquantifiable but likely to be very low. This view was reflected in decisions taken by the authorities in the United Kingdom and elsewhere not to contact patients who had received the product. The decision to inform patients in this country was taken, on balance, following very careful consideration of the ethical issues involved having regard to the extremely low risk of transmission of the disease, the lack of a diagnostic test for new variant CJD, the lack of any treatment and the unknown incubation period of the disease.

The extremely low level of risk involved was confirmed by the Committee for Proprietary Medicinal Products, CPMP, of the European Medicines Evaluation Agency, EMEA, in a position statement on new variant CJD and plasma-derived medicinal products, produced on 25 February last. This statement followed a workshop of international experts on transmissible spongiform encephalopoties, TSEs, convened by the CPMP to consider the available information on new variant CJD and relevant TSEs. It concluded that knowledge of other TSE agents suggests that the transmission of new variant CJD by medicinal products derived from human blood or plasma is very unlikely.

I understand from the manufacturer that the relevant Amerscan Pulomonate II product batches were recalled from all European countries where they had been supplied. I am not aware of any support groups that exist in these countries for recipients of the product.