Dr. John Murphy:

Deputy O'Reilly hit upon a very important issue on the discrepancy in figures. There is always a problem with data collection, in how it is collected and how we centralise the collection of that data, particularly when a drug has a number of side effects. If it clearly had one side effect, and one side effect only, one would imagine that the relationship would be very clear but this one was different. Sometimes it causes a physical disability, other times it causes a problem with a child's learning abilities and so on. Those are very different issues. The other problem about malformation is that they vary. For instance, a child might be born with a cleft lip or palate and will go into the service with plastic surgeons, or a child will be born with spina bifida and will be sent off with neurosurgeons. A child might have a hand or thumb deformity and will be dealt with by an orthopaedic surgeon. It means that early on, the children will go off in very different directions. How it will happen that the relationships will be made, and how it is reported centrally, or will it be reported back to the company which makes the drug is an important issue.

If the child only has neurodevelopmental problems, they will not manifest early on, they may only develop and become apparent in the second half of the first year when the child is a toddler. That is well after the pregnancy has ended and the relationship may not be remembered or enough emphasis might not be placed on it. That leads to discrepancies.

With an agent such as this, one needs an association, for starters, that someone has been on a medication during pregnancy and now it is associated with a problem with the child. One has to look to see if the relationship is clear and the child does not also have some other underlying problems. That must be tightened up in the future. Geneticists are the key people to bring closure on a place and to decide that, one needs a genetic input. As a specialist, I might identify the problem and know there was an association with Epilim, I will put it together but get a geneticist involved to ensure there is no other factor that could have affected the child in the womb, and that no other cause for the malformation occurred in the womb. That is an important area.

We described a series of 29 cases which were very carefully reported by the group in Crumlin. That is the kind of model that we would need.

Someone asked what is happening in other countries. I was speaking to a colleague who is a geneticist in the United Kingdom. They have processed and evaluated 100 cases. That would need to happen. We would need to collate cases where parents have had the issue of Epilim in pregnancy and they have a child with challenges or difficulties. They would have to go through the system to ensure that the diagnosis is correct for their sake and establish whether the children have some other problems as well. It would be a great help if that could happen. There is a model there but we will need clearer figures in future because that has been an issue.