Skip to main content
Normal View

Dáil Éireann debate -
Wednesday, 28 Nov 1962

Vol. 198 No. 2

Adjournment Debate. - Investigation of Drugs.

The Questions which I tabled today and which, with your permission, Sir, I now raise on the Adjournment, relate to the sale of a drug known as preludin and to the absence of any bureau of standards for drugs and medicines. The House generally will recollect that some time ago here and elsewhere there was considerable public anxiety in regard to the effects on expectant mothers of a drug known as thalidomide. In different parts of the world, those effects are still felt in human misery and in fearful social problems. Fortunately we in this country were spared the effects of that drug and, indeed, the Minister for Health very properly took action in regard to it. He banned and prohibited the sale of all drugs which were in any way associated with thalidomide.

Last Friday, I received a telephone call from a representative of a well-known paper, the Evening Herald. The person who phoned me asked me whether I had taken any action as a Deputy about the drug known as preludin. I had to confess to him that I was not aware of that drug or of any queries about it. He informed me that a day or two before, there was a news item in the English Daily Mail about that drug and reference to a comment in the current issue of the British Medical Journal, and that it was reported that the drug had been banned by the Ministers of Health in Italy, Denmark, Spain and Sweden.

Having learned of that situation I tabled Questions Nos. 2 and 4 on today's Order Paper. Following the tabling of those questions, and before they were answered, I read in today's paper a statement issued by the Minister for Health in which he, in effect, exercised the powers available to him to ban the sale, except on medical prescription, of preludin and also a drug known as meclozine. I should say that on Saturday this drug meclozine was also banned on the Continent.

I want to assure you, Sir, that the Questions which I tabled on this matter were intended to direct the attention of the Minister to the possible dangers arising from the possible use or consumption of these drugs. I am glad that he took action but I now raise the question of why this action was taken. I cannot help feeling that were it not for the telephone communication which I received, were it not for the Parliamentary Questions which I tabled the prohibition which the Minister announced this morning might not have been announced.

That raises a very serious problem in relation to the possible hazards to the people of this country from a drug which may be purchased in any chemist's shop without any doctor's prescription. I do not know whether the Minister was in his office in the Custom House last Saturday. If he were, he would probably have been informed of these two Questions, but if he was not there on Saturday and went in last Monday, he would have heard of them then. That raises with me the necessity for insisting on having what was the subject of Question No. 4 today, a bureau of standards to deal with drugs and medicines.

I have raised the question of a bureau of standards on a number of occasions in this House. I want to remind the Minister that in 1960 when certain tariffs were being imposed on imported drugs and medicines, it was suggested that some standard should be applied to the medicinal preparations which were available to our people. It was first raised in a Parliamentary Question to the Minister on 2nd March, 1960, by Deputy Dr. Browne who asked the Minister if he was aware that the President of the Pharmaceutical Society of Ireland had recommended the establishment of a pharmaceutical control laboratory. The Minister replied:

... although I have seen a Press report of a statement attributed to him——

——that is, the President of the Pharmaceutical Society——

——in October last, when a customs duty was imposed on certain imported medical preparations, which mentioned that we have no bureau of standards for drugs here.

I am at present giving urgent consideration to the question of the provision of a service of the type which a pharmaceutical control laboratory could provide.

Shortly afterwards in the same month, I raised the matter on the Imposition of Duties Bill, 1960, with the Minister's colleague, the Minister for Industry and Commerce. Indeed, he is reported in the Official Report, Volume 180, column 1233, as saying:

I agree with Deputy O'Higgins that it would be a good thing to establish a bureau of standards here and he goes on to refer to the fact that the matter is engaging the attention of the Minister for Health. Then at Column 1257 in the same volume the Minister for Industry and Commerce said:

The Minister for Health has stated that he envisages an even more technical type of organisation. In reply to a Question by Deputy Dr. Browne some few weeks ago, he stated that he was giving urgent consideration to the establishment of what he described himself as a pharmaceutical control laboratory. The Minister made that statement on 2nd March, and when he says he is giving urgent attention to the matter, I am sure he means what he says.

And so did everybody else feel that, when the Minister gave that undertaking on 2nd of March, he meant what he said. I am troubled and concerned that now, over two and a half years later, there is no pharmaceutical control laboratory. There is no bureau of standards. The prohibition of a drug which was extensively used in this country only took place following the tabling by an individual Deputy of a Parliamentary Question in relation to the matter.

It appears to me that at a stage and in an era when the entire world is being snowed under by expensive advertisements of one kind or another for magic drugs and wonder pills of a variety of kinds, when all these pills and drugs can be imported and purchased at any chemist's shop without the intervention of any medical prescription, there is obviously a danger— and a very grave danger—that serious harm may be done, as was done to countless hundreds of unfortunate families on the Continent of Europe, unless there is some form of investigation.

May I remind the Minister that thalidomide, which ravaged England and the continent, did not affect us. That was our good fortune. Thalidomide was never sold in the United States of America. It was not sold there because one doctor—a lady doctor who held an important post in America and who had the giving of a licence for its sale—had certain reservations in regard to its properties. She withheld the giving of the licence and it was never issued. By the time considerable pressure was being brought to bear on her Department, the whole story had emerged. That pinpoints the fact that in the United States a very strict supervision is exercised with regard to medicinal preparations and drugs of different kinds. No drug or medicine may be sold in the United States except by licence issued by the appropriate health authority.

In this country, unless there is actual ad hoc interference by the Minister for Health, the only legal sanction that could be exercised in relation to the sale of medicinal preparations is that contained in the Food and Drugs Act. It is merely a right of action in relation to the sale of a particular preparation on the basis that it does not correspond with the nature and substance of that which, in fact, was ordered. That is very much a case in which water has gone under the bridge and flowed away. It certainly does not protect the people in relation to a whole variety of new medicinal preparations with fancy names, wonderfully advertised, the properties of which may not be known.

The Minister said at Question Time today that I was, perhaps, unaware of his recent statement at the Fianna Fáil Árd Fhéis. I want to assure the Minister that I follow him everywhere he goes, although I stop short of the doors of the Fianna Fáil Árd Fheis. I watch everything he says and I read with interest what he said at the Árd Fheis about the difficulties of establishing a bureau of standards here. I can see those difficulties and I concede they exist but if there is not to be a bureau of standards, if that is impossible from an administrative point of view, then at least some other form of scientific screening should be available in this country. At least, can we not act automatically in relation to the steps taken by health authorities on the continent or elsewhere at the moment?

If, before the Minister's ban, thalidomide had been refused a licence in America, nothing would have been here to prevent its sale in our chemist shops. I heard the Minister say to himself: "That is untrue". It is not, in fact, untrue. The fact that at the moment a licence is withheld in another country does not prevent the sale of the particular drug or medicine here.

I am glad of the fact that most manufacturers of drugs and medicines act in a responsible and public-spirited manner. In fact, if any question arises to their knowledge in relation to a particular preparation, they withdraw it from sale. That is fortunate but it does not guarantee that in all cases that will be the position. There is a grave and definite margin for error here. The matter is too serious to be allowed to stay in the situation it is in. The Minister said in March, 1960 that this whole problem was engaging his urgent attention. That is two and a half years ago. Certain things have happened since that should not have happened. All I am anxious to ensure is that as a matter of urgency some such bureau be established here.

Deputy O'Higgins, in a manner which I think is unworthy of a person who held the office of Minister for Health and who knows that the Minister for Health must act in a responsible manner, has endeavoured to prejudice consideration of this question by harping and reharping on the tragedy of thalidomide. Thalidomide has nothing to do with the question he is raising on the Order Paper. The question on the Order Paper related to a drug of another kind, preludin. The Deputy says that were it not for the fact that he put a question down— inspired, apparently, by the Evening Herald on information supplied to him by the Evening Herald—I would not have acted in relation to preludin as I did.

First of all, let me say this. When the Deputy informed this House that the Evening Herald had told him on Friday that this drug had been banned in a number of countries, including Italy and Spain, this statement was not accurate. It was banned in Italy but it was not banned in Spain and, I believe, is not yet banned in Spain. When the Deputy comes in here and accuses me of being lethargic and of being absent from the Department on Saturday, he should at least base his allegations upon a fact and not upon a misstatement.

What is the position in relation to preludin? What has happened which moved certain health authorities, including this health authority, within the past few days—not over the past month or two months but within the past few days dating from the week-end—to take action in relation to preludin? It was a letter which appeared in the British Medical Journal on 17th November, 1962, over the names of two doctors, one I think a general practitioner and the other a specialist brought in on a case. I had better read part of this letter:

In 1958 a 35-year-old woman was delivered spontaneously of a full term, male infant which showed evidence of blue asphyxia at birth and died an hour afterwards. The following year she had a normal child. In 1960 an apparently normal pregnancy ended in the spontaneous delivery of a full term female infant which was cyanosed and died within a few minutes of birth. By a previous marriage she had had three normal children and two miscarriages.

Almost identical abnormalities were found in the two infants which died. While no external malformation or defect was present, there was in each a huge defect of the left diaphragmatic leaf with herniation of the stomach, ileum, proximal colon, pancreas, and spleen into the thorax, and displacement of the normal intrathoracic viscera to the right. The left lung was rudimentary in each instance.

In the fourth to twelfth weeks of the two pregnancies which ended in a malformed infant, and not in any of the other pregnancies, the mother took "preludin" (phenmetrazine hydrochloride) one tablet (25 mg.) thrice daily. The drug had been obtained without prescription and was taken, on the advice of a friend, on account of weight gain, the mother not realising initially that she was pregnant. It is noted that although phenmetrazine was added to Part I of the Poisons List and placed in Part B of the Fourth Schedule in 1960 obesity in pregnancy is still listed as one of the possible indications for its use.

That is the occurrence. I do not want to dilate on the fact that there were some other abnormalities in the case of infants born to this woman which were not traceable to preludin, though it is not insignificant that there were. With regard to the drug, however, the two doctors went on to say this:

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.

Was there ever a milder statement of a suspicion than that? The doctors were quite careful to say no more than that in their view the possibility of a casual association between the drug and the deformities could not be ignored. The drug in question is being made by a reputable firm and they, having regard to the history of thalidomide, immediately took steps to try to make the facts known wherever the drug was sold. So far as I am aware, the drug preludin was banned in Italy either on the 23rd or the 24th of this month, that is, either last Friday or Saturday. Since then another drug, not preludin, was banned in Denmark and Sweden, and also in Holland.

The Minister's information is incorrect.

All right; then I have been misinformed.

Has the Minister read the Sunday Times of last Sunday?

Some of these announcements were not made until the 26th and 27th November. Our announcement, to which the Deputy takes exception was made on the 27th, that is yesterday. How quickly can one be after a thing like this? Does he think that we have the resources here which these other countries have? Does he think we have a huge pharmaceutical manufacturing industry, that we are in close touch with the manufacturers and that we have the immediate, direct knowledge available to these people? We cannot get it except through the normal official channels, and we were pursuing this matter very energetically. Upon what were we acting? A suspicion, a suspicion which has not been acted upon in the way Deputy O'Higgins has called for in Spain, in Canada——

——or in France. It has not been acted upon in Spain, Canada or France, unless I am misinformed.

I think the Minister is misinformed.

I do not know what contact Deputy O'Higgins has had with the authorities in these countries, but I have had contact with them.

I merely read the Sunday Times and The Observer.

I take my information from official sources. It would be well if the Deputy would verify the accuracy of his statements—I do not want in any way to suggest that he tells untruths—before he makes them. We should not have had this manifestation on his part of, if I may say so, vanity. The Deputy comes in and puts down a question on Saturday and subsequently I take action, which was responsible and well considered action, action which had been under consideration for days before. From this Deputy O'Higgins wishes the public to infer that I took action because he put down a question! He suggests that if he had not put down a question, the action would not have been taken! Could there be a more absurd example of the fallacy post hoc, propter hoc? This has been under consideration in my Department for a long time.

It is such a difficult problem that even the British, with all their resources, have not yet been able to deal with it. If the Deputy is so well informed, why did he not read the report by Lord Cohen of Birkenhead about the bureau of standards. What did that report of a sub-committee of the Advisory Council—a sub-committee which consisted of the most eminent representatives of the medical, surgical and pharmaceutical professions in Great Britain—say? It said the sub-committee had carefully considered the matter but for the present firmly rejected as neither desirable nor practicable the suggestion that at this stage of their evaluation the responsibility for testing drugs should be transferred to a central authority. The very thing Deputy O'Higgins proposes has been rejected by this body of professional experts.

Deputy O'Higgins is a very good and sound lawyer. He is excelled by no one at making a bad case appear to be a good one and making an unsound case appear to be a plausible one, but I cannot rate him very highly either as a medical practitioner or as a therapeutic chemist.

And I do not rate the Minister either.

The Dáil adjourned at 11 p.m. until 10.30 a.m. on Thursday, 29th November, 1962.

Top
Share