Vol. 198 No. 2
asked the Minister for Health whether his attention has been directed to the report in the current issue of the British Medical Journal relating to possible dangers associated with the drug preludin; and, if so, whether he will ensure that this drug is not offered for sale in this country pending a full investigation.
3.
asked the Minister for Health whether his Department have taken steps to halt sales of preludin pending the completion of further test; and if, having regard to the growing public anxiety concerning the ease with which dangerous drugs can be made available without a doctor's prescription, he will take immediate steps to protect the public.
4.
asked the Minister for Health whether in view of the widespread public anxiety at the lack of any recognised Irish standard relating to the manufacture and sale of drugs he will take immediate steps to establish a bureau of standards for this purpose.
With your permission, a Cheann Comhairle, I propose to take Questions Nos. 2 to 4 together.
I presume that "the report in the current issue of the British Medical Journal relating to possible dangers associated with the drug preludin”, referred to in Question No. 2 is to a letter from two doctors in Britain which appeared in the issue of the Journal mentioned dated 17th November. That letter dealt with the birth of two deformed infants to one mother and concluded with the words “While it may be only a remarkable coincidence that the two pregnancies in which preludin was taken each ended in a similarly deformed infant, the possibility that preludin was responsible for the deformities cannot be ignored”. On the strength of the suspicion voiced in that letter, unsupported by any other evidence, I could not feel justified in taking the drastic action recommended in the question. In the last few days, however, it came to my notice that the same drug had come under consideration elsewhere and I have made an Order under Section 65 of the Health Act, 1947, providing as a precautionary, temporary measure, that the drug, or preparations containing it, may be sold in future only on the prescription of a medical practitioner. I understand that the suppliers of the drug, which is a slimming preparation, are in process of circularising all doctors in this country advising them, for the present, not to prescribe it for women who might be pregnant. The medical profession has not suggested that the drug may not safely be used in the treatment of men and, except during pregnancy, of women, and in these circumstances I do not feel that I would be justified in proscribing its use absolutely as the Deputy recommends. In fact, the Deputy's proposal raises an important question of general principle: the right of the Minister for Health to determine what drug should or should not be used by a properly qualified medical practitioner in his treatment of a particular patient and so interfere with the practitioner's liberty to afford to such patient the treatment he thinks most appropriate. I am sure the Dáil will agree with me that this is a matter which should be left to the individual doctor concerned.
My reply to Question No. 2 applies, mutatis mutandis, to Question No. 3.
As regards Question No. 4, the public anxiety to which the Deputy has referred does not arise from any lack of a recognised Irish standard relating to the manufacture and sale of drugs, but from the fact that drugs have been brought into use before all possibility of untoward results from their use by humans has been eliminated. I suggest, therefore, that the latter part of the question does not arise in the present context. In my reply last week to a question by Deputy Mullen and in reply to an earlier question by Deputy Kyne on 26th June last, I dealt in some detail with the whole complex question of the safety of drugs, particularly new drugs, in their clinical use. In relation to this particular aspect of the problem, it is pertinent to recall that preludin was in general use in very many countries for upwards of six years before its safety was questioned by any authoritative body of medical opinion.
Omitting his mutatis mutandis, the Minister has in fact adopted the suggestion contained in Question No. 3 and prohibited the sale of this drug except on a doctor's prescription. In regard to his reply to No. 4, however, would the Minister not consider establishing some section of his Department, for the time being at least, which would seek to collate all the literature being published in continental countries and the United States of America where warnings as to the untoward side-results of drugs are mentioned so that this literature would be constantly before the Department of Health, either for the purpose of taking such action as the Minister has decided to take in regard to this drug preludin, or alternatively, to enable him, where necessary, to invite the opinion of the Irish Medical Council on a particular drug which is appearing in the literature of more than one country as having dangerous side-effects?
I would welcome these supplementary questions, if the Deputy would put them in instalments.
It would greatly facilitate me, if the Minister would not answer three questions in a lump.
May I say that the question of dealing with these synthetic drugs, many of which do not occur in the ordinary way in nature has been under consideration in my Department for a long time and was one of the matters we had in mind when we asked the Oireachtas to pass the Poisons Bill of 1961 which set up a body, that is a fairly authoritative one, to consider the extent to which these drugs may be made freely available to the general public. There has been in my Department a collation of all the available published matter in relation to these particular drugs. I do not see how, with our resources, we can go further than that. As I mentioned in my reply, it remains a very grave question as to whether any person or authority in this country would be competent enough to impose restrictions on the ordinary medical practitioner in dealing with his patients. Some of these drugs have been in use for a great number of years and it is only recently, arising from the experience with thalidomide, that attention has been directed to the fact that they may be a possible cause of genetical disturbance—I say "they may be a possible cause". In the particular case of preludin the only minatory statement we have before us is that which appeared in the British Medical Journal of 17th November, in which the two doctors who drew attention to the matter said that the possibility that preludin, which had been taken in the case of two pregnancies, had occasioned the abnormalities could not be ignored. That amounts to a mere suspicion and it is difficult, on a suspicion to proceed to the lengths which Deputy O'Higgins asked the Minister to proceed when he put down his Question, asking that we ensure that the drug be not offered for sale pending full investigation. I have taken action which was long contemplated, and which has been under consideration by Comhairle na Nimheanna, to ensure that it will be available only upon certain prescribed conditions, that is, only on medical prescription. I do not think it is possible for me to go any further than that.
Would the Minister not agree that it is somewhat disturbing to the public generally that the action he has taken as regards Question No. 2 was only taken by him following the tabling of the question?
The Deputy's conceit of himself is tremendous.
That is a very uncivil interjection by the Taoiseach.
That is always the Taoiseach's way.
Would the Taoiseach wait until I have finished my question? The question was tabled by me after certain information was given by me to the Evening Herald. Are we now to have the situation that the Evening Herald or other papers will assemble information that it should be within the province of the Minister and his Department to have?
If the Deputy had been present at the Árd-Fheis last week, he would have seen that I replied to this question at length but, of course, the Deputy has not enough common sense to belong to the right Party.
I read it.
The Deputy did not read it all. He may have read a summary.
Is this a third speech?
And the Minister censored the report.
I do not know to what extent Fine Gael or the Coalition Government interfered with the liberties of the Press but Fianna Fáil do not interfere with them.
The Minister is an adept at changing his speeches. We all know that. If he does not do it himself, he gets somebody else to do it.
The first intimation that preludin might be associated with congenital abnormalities appeared in the British Medical Journal on 17th November.
The Minister had not read it.
Yes, I had.
It was only when my question went in that the Minister looked at the Medical Journal.
Well, well, well; I wonder where did the Deputy get his information and if he has an alter ego looking over my shoulder to see what I read. How does the Deputy know what I read and what I do not read? I am in the position to produce to the house documentary proof showing that the attention of the Department of Health was directed to this matter some time ago.
Why was it not mentioned last week?
The Minister should be allowed to make his reply.
It is only 20 minutes past three. He has plenty of time.
When Billy Boy stops, I will proceed.
The Minister must be allowed to proceed.
This matter has been under consideration for a considerable time and when the Poisons Bill was before the Dáil, I pointed out that one of the things we were going to do under it was to deal with this matter and that we were setting up Comhairle na Nimheanna for that purpose. I am sorry that the passage of that Bill through the Dáil and Seanad was delayed because the Deputy and his Party adopted an obstructive attitude and persisted in dragging red herring after red herring into the debates in an effort to delay the passage of the Bill.
I should like to give notice that I propose to raise the subject matter of these question on the Adjournment.
I shall communicate with the Deputy.
