Vol. 505 No. 5
12 Mr. Naughten asked the Minister for Health and Children if he has satisfied himself with information he has received from a company (details supplied) in relation to the safety of the Trivax three in one vaccine produced in the late 1960s and early 1970s; and if he will make a statement on the matter. [12950/99]
52 Mr. Naughten asked the Minister for Health and Children if his Department will make contact with the 295 children vaccinated with the Trivax three in one vaccine from batch No. 3741; the further action, if any, he will take in relation to this matter; and if he will make a statement on the matter. [12951/99]
I propose to take Questions Nos. 12 and 52 together.
In 1992, the Supreme Court attributed the disability of an individual to Trivax vaccine which he had received which came from batch 3741, manufactured in 1968. My Department has been in correspondence with the company in question to seek details of this and certain other batches of Trivax vaccine produced in the late 1960s and this correspondence is continuing. As I have already indicated, the company has stated 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. My Department will consider any additional information which the company can provide and whether this enables any conclusions to be drawn about the particular vaccine batches concerned.
My Department is considering the information received from the health boards in relation to those individuals identified as having received vaccine produced from batch 3741.
How can the Minister stand over the statement that no other batch gave rise to the same level of potential concern when during the Best case it was known that batch 3732 was 16 times stronger than the British standard at that time, that 14 batches which were released between 1969 and 1970 never had the mouse weight gain test which was a standard test at that time? Will he explain why there was such an increase in the adverse reactions between 1969 and 1970 following the release of those 14 batches, and how can he stand over the statement that no other batch caused the same level of potential concern?
The Deputy raised this matter on the Adjournment on 19 May last. We do not know if any of batch No. 3732 was distributed in Ireland and we do not have information on the lot numbers made from it. The statement attributed to Mr. Knight in the Best case appears to be in the realms of speculation. His view that there might have been as many as 100 batches of high potency does not appear to be substantiated. The Department has written again to Glaxo Wellcome asking for any information available on batch No. 3732.
In relation to the report of severe reactions, the Deputy said that the Eastern Health Board official responsible for the administration of vaccine in the region obviously believed that the reactions gave rise to the same level of potential concern as batch 3741. The significance of batch No. 3741 only came to notice during the Best case, which was 15 years later. Therefore, the person referred to in the Eastern Health Board could not have had the belief the Deputy ascribes to him. The reactions experienced by the vaccine recipients in 1973 were never officially categorised as serious or non-serious as it appears that few, if any, were reported at the time to the National Drugs Advisory Board which has a system of classification of the adverse reactions notified to it.
Why did the Department not follow up the 14 batches and the toxic batch No. 3732? Why has it taken until now for the Department to contact the Wellcome Foundation? This information became available during the Kenneth Best case in 1992. It has taken seven years for the Department to contact Wellcome for the relevant information. Does the Minister accept that Mr. Justice Liam Hamilton at that time described the company as negligent and criticised its quality control procedures? This issue raises questions.
Regarding Question No. 52, how many children have had severe reactions from batch No. 3741? Has this been checked by the various health boards? What is the reason for the delay in contacting the parents of these children to let them know that they received batch No. 3741?
The Deputy asked why this matter has been ongoing for so long. However, he will be aware that I am the first Minister who has made any progress on it in terms of getting information about it. I can only deal with the information that becomes available. I cannot deal in the realms of speculation. I reiterate that we do not know if any of batch No. 3732 was distributed in Ireland. We do not have that information. Correspondence about that batch is continuing with the pharmaceutical company concerned. Our inquires and attempts to glean further information, if it is available, are not concluded. We are currently considering what needs to be done in relation to batch No. 3741. My information is that approximately 188,000 children were born between 1969 and 1971, half of whom received the vaccine. The issue is whether a general statement needs to be made and those considerations are being dealt with in the Department at present.
In relation to the 14 batches that were not subjected to the mouse weight gain test—
Fourteen batches?
Yes. There were 14 batches, not 14 lot numbers. Some of the 14 batches were definitely distributed and administered in Ireland because they were the only batches produced at that time. Does the Minister agree this raises concerns because they did not undergo a standard test which was in place at that time? This test was approved in the United States and recommended by the World Health Organisation.
That may be the case, but the issue is what documentary evidence is available to suggest that there is a direct relationship between a vaccine and subsequent brain damage. This is the issue in each case. In the Best case, no reason for the brain damage other than the vaccine could be found. The batch number was obtained and from that the Bests were able to prove to the satisfaction of the court that there was negligence on the part of the pharmaceutical company.
The dearth of documentary evidence is a major issue in any legal matter. I am trying to follow all avenues which I have been asked to follow in relation to these matters. However, ultimately, I cannot close the circle for everybody. The line of evidence must be available to people. I have met people who have children who are brain damaged and it is very sad. However, I can only do what is possible, which is to get as much information for them as I can, and I am endeavouring to do that.
