I welcome the Minister to the House. While I am not under the illusion that the Members of the Seanad rely on me for medical opinions, because of my medical qualifications I try to be especially careful when speaking on health matters.
When the Minister spoke in the Seanad on 23 February on the Anti D immunoglobulin and hepatitis C problem, I supported all he had done. I praised him for alerting women rather than having them in a state of alarm and I praised the transparency of his Department in this situation. This was a contrast to the problems we have had in obtaining information in the past. I still support the line he has taken. I was delighted to see that in the programme, Shaping a healthier future — A strategy for effective healthcare in the 1990s, the Minister has set up an expert group to advise him on this problem.
While I support all he has done, I was under the impression when I spoke on 23 February that the Anti D immunoglobulin which was being introduced into the country to replace our own product, even though the latter appeared to be all right, had the approval of the US Food and Drugs Administration. This body was established about 50 years ago and has the highest standards for verifying the qualities of any drugs or products.
The Minister rightly stressed that from the date he learned of the problem with our own Anti D immunoglobulin, albeit in the past, one of his immediate concerns was the protection of all future recipients of the product. Quite rightly he said that despite everyone's best endeavours all over the world, the use of blood and blood products carry some risks and the benefits of treatment must be weighed against any risk.
For women who may have received Anti D, the benefit of treatment with Anti D immunoglobulin is enormous for Rhesus negative women who give birth to Rhesus positive children. I am old enough to remember in the 1960s the sad situation of it being virtually impossible for women who had one Rhesus positive child to have subsequent children; there could be subsequent miscarriages, stillbirths or the birth of children with brain damage.
While I am not suggesting that the product involved here — WinRho — is in any way suspect, I would have asked far more questions on 23 February if I had not been under the impression that it had FDA approval. I realised it could not have been evaluated in this country because it was brought in over a weekend and there was no possibility of the National Drugs Advisory Board being able to evaluate it in such a short period. We cannot expect everything to be evaluated by the board. One must consider not only the number of products but also that we could lose out on very good drugs because it costs money to have a drug evaluated by the NDAB. If the company involved does not think it is worth while having a drug investigated, we might lose out. I find it perfectly acceptable that the product might not have been evaluated by the board.
Last week I visited the FDA in Washington about a different matter. While there, I discussed with FDA officials the Anti D products which are available. To my astonishment I found out that WinRho did not have FDA approval but that approval was pending and it might be a month or more before a definite decision was made. While I cannot definitely say that this is why it is pending, I got the impression from my detailed discussion with the officials — they discussed with me methods of production and I believe the method of production of WinRho is very similar to our own — that the delay was probably because the manufacturers of WinRho had asked for a second use for it, that is, in the treatment of idiopathic thrombocytopaenic purpura. This is an unusual condition. The delay has probably occurred because the FDA insists that not only should a drug be safe but it should also be efficacious.
On my return, I immediately wrote to the Minister to ask him to check the FDA status of WinRho and asked when he spoke in both Houses on the topic, did he think it had FDA approval. On Saturday morning one of his officials kindly phoned me. This showed that the Minister took immediate action, for which I was grateful. I know it was impossible to contact the FDA for some time because it was closed due to the funeral of Richard Nixon, former President of the USA. The official told me that I was right in saying approval was pending. Because I had been so positive in my support for the Minister's actions, I felt I should inform the House as soon as possible — which is today — that, while I stress I have no reason to be suspicious of the drug, I would be grateful if the Minister would clarify its international status. There are three FDA approved Anti D immunoglobulins widely in use in the United States. I do not know why one of them or one of the well monitored European brands was not chosen. Is WinRho considered to be the drug of choice in the USA and Europe?
Contamination of blood products by hepatitis C appears to be of international concern. I am sure this is being carefully monitored by the Minister and his Department. I do not suggest that these are fly-by-night products. An extremely good gamma globulin called Gammagrad had to be withdrawn the other day because of contamination by hepatitis C. This is a difficult problem. If we are not producing a drug what criteria do we lay down before we accept products from abroad? Do we require FDA approval or do we seek approval from another well established authority in Europe? I am not suggesting that Canadian approval is inadequate, but I would be very grateful for clarification. Should we not aim for the highest standard? The FDA is reckoned to be the gold standard for approvals. Thanks to the vigilance of the FDA, there are no thalidomide children in the USA. Unless we have an emergency, we should go for the highest possible approval status of any drug we might import.
