Léim ar aghaidh chuig an bpríomhábhar
Gnáthamharc

Dáil Éireann díospóireacht -
Wednesday, 19 May 1999

Vol. 505 No. 1

Adjournment Debate. - Vaccination Programme.

I thank the Chair for giving me the opportunity to raise this important issue. I wish to give the Minister for Health and Children an opportunity to correct his reply to Questions Nos. 175 to 179, inclusive, on 11 May. The Minister said in column 788 of the Official Report: "The company [Glaxo Wellcome Limited] added that the results of all tests, mandatory and otherwise, together with expert advice which the company had sought, indicate that no other batch gave rise to the same level of potential concern as batch 3741." This is incorrect for a number of reasons. At approximately the same time as batch 3741 was released and administered, another batch of greater potency, batch 3732, was also released. Batch 3732 was 16 times greater than the British standard at the time. Batch 3741 was 14.5 times greater.

During the Kenneth Best case, when questioned under cross-examination by Mr. Dermot Gleeson as to whether other batches of similar or greater potency were released, Mr. Peter Knight, manager of the Immunological Product Support Group of the Wellcome Foundation stated: "There may have been a half dozen, a dozen or 100 more.Goodness knows what I would have found if I had looked wider." Does this not give rise to the same level of potential concern as batch 3741?

From May 1968, 14 batches of vaccine which were not subjected to the mouse weight gain test were released. This was a standard test at the time in the United States and recommended by the World Health Organisation. They were administered from approximately January 1969 to January 1970. During this period there was an enormous increase in reactions to the vaccine, so much so that it induced a Dr. Griffith of the Department of Clinical Immunology at the Wellcome Research Laboratories to suggest that the vaccine should be withdrawn at the start of 1970. Does this not give rise to the same level of potential concern as batch 3741?

Eastern Health Board records for 1973 show that the official in charge of the administration of the vaccine in the region was inundated with reports of severe reactions among the children who had received it. The person concerned wrote to the Wellcome Foundation to express concern and questioned the advisability of continuing the Trivax vaccine. This official obviously believed that the reactions gave rise to the same level of potential concern as batch 3741.

An expert medical group, established in November 1977 with three eminent doctors, which reported in 1982 recommended the establishment of such a group on a permanent basis to assess damage caused by immunisation. They obviously believed that other batches gave rise to the same level of potential concern as batch 3741.

Department records and correspondence clearly show the extent of the adverse reactions to the three-in-one vaccine and that these were not attributed solely to one batch. If no other batch gave rise to the same level of potential concern, why have the records and correspondence in the Minister's possession not been made available to the parents of brain-damaged children? Why was the report of the expert group never published? Why has the Department failed to follow up the concerns of staff of the Wellcome Foundation regarding its quality control pro cedures and release of vaccine, the safety of which was questioned in the Best case?

The House has been misled through no fault of the Minister who has been misled by his officials and Glaxo Wellcome Limited which wants to cover up the extent to which children have been brain-damaged by the three-in-one vaccine. The Minister has an opportunity to clarify the record and not to encourage misleading statements which have been fed to him by the Wellcome Foundation. I will not drop this issue until the full truth is known.

I am pleased to have the opportunity to outline the background to this issue and the up-to-date position. In 1993, following the Supreme Court judgment in the case of Kenneth Best, which attributed Kenneth's disability to the three-in-one vaccine, the Department of Health and Children wrote to Wellcome (Ireland) Limited in an effort to establish the extent to which vaccine from the batch in question, batch 3741, had been distributed in Ireland. The company's response indicated that the batch was produced around March 1968 but that due to the passage of time it was not possible to establish during what period the batch was distributed to specific parts of the country.

The Department wrote to the health boards in the matter but with the information then available the boards did not succeed in establishing the extent of the distribution of batch 3741. In 1997, following further consideration of the issue, the Department again approached the company seeking details of the specific vaccine lots produced from batch 3741. Glaxo Wellcome Limited, the successor to the company which produced Trivax three-in-one vaccine, furnished information regarding the lot numbers and quantities of vaccine produced from batch 3741. This vaccine batch was produced in the summer of 1968 and had a two year shelf life.

Following receipt of this information the Department again wrote to the health boards asking them to examine their records to see if the extent of usage of these lots in Ireland in the period 1968 to 1970 could be established. The period in question predates the establishment of the health boards. The health boards' responses indicate that in many cases immunisation records for the period in question are no longer in existence. Those which do exist do not always contain the lot number of the vaccine used as it was not routine practice to record this information at the time. Hence, the responses provide an incomplete picture of the situation in the period concerned.

The health boards' responses show that the use of vaccine from the lots in question was recorded in 295 cases. The boards in whose areas such usage was recorded were the Mid-Western Health Board, the Southern Health Board and the Western Health Board. The Mid-Western Health Board indicated that it had identified 183 immunisation records relating to children who had received vaccine from lot numbers 69684 and 69685. The Southern Health Board indicated that it had identified 109 immunisation records relat ing to children who had received vaccine from lot numbers 69684, 69685 and 69942. The Western Health Board indicated that lot number 69684 had been used in Galway in 1969 and that records indicated three cases where children had received vaccine from this lot.

Following statements made by the Deputy, the Department recently made further inquiries of Glaxo Wellcome Limited regarding tests carried out on batch 3741 and also regarding a number of other batches which, it had been alleged, did not pass certain tests. The company has indicated to the Department that a variety of tests were used to analyse Trivax in the late 1960s and that all batches of Trivax released for sale complied with the mandatory requirements at the time. The company added that the results of all tests, mandatory and otherwise, together with expert advice which the company had sought, indicate that no other batch gave rise to the same level of potential concern as batch 3741. The company further added that it was endeavouring to trace relevant documentation relating to the tests applied to batch 3741 which it would provide to the Department when available.

The Department is considering the health boards' responses and such other information as is available with a view to determining whether further action is appropriate in the matter and what, if any, conclusions can be drawn. This includes consideration of the issue of whether recipients of vaccine from the lots in questions should be contacted.

In relation to concerns regarding alleged vaccine-related brain damage, the Department has no evidence which would suggest that there is any link between vaccination and the subsequent development of neurological damage. Extensive international research has been conducted over many years regarding the possible link between the pertussis component of the DTP vaccine and chronic brain damage.

This is a standard reply and does not respond to the points I raised.

It is as up-to-date as we have at the moment. If any other information is forthcoming it will be given to the Deputy.

Barr
Roinn