HC Deb 23 November 1962 vol 667 cc1676-88

Motion made, and Question proposed, That this House do now adjourn.—[Mr. G. Campbell.]

4.0 p.m.

Mr. Maurice Edelman (Coventry, North)

The thalidomide tragedy has focussed world-wide attention on the need for stricter and more extensive con-troll in the testing and marketing of drugs. I want to suggest that our own methods of testing and controlling the market in drugs are wholly inadequate and that what is required is a central drug licensing agency, free from commercial pressure, which will have the power to provide essential safeguards which do not exist today. It will not be my purpose to suggest that such an agency will be infiallible. All that I want to put forward is that such an agency, modelled, perhaps, on the pattern of the United States Food and Drugs administration, should have the power to prevent some of the abuses which undoubtedly exist in the sale and distribution of pharmaceutical products, and, more than that, which will be able objectively and honestly to give to the medical profession such information as may be available about the advantages or disadvantages of any particular drug.

It is traditional in debates of this kind to draw attention to the importance of the drug industry, and no one can deny that an industry which last year applied £113 million of its profits to the National Health Service alone is a great and powerful industry, an important exporter and, in purely commercial terms, it certainly is an element in the nation which is of the most vital concern to us all.

Having said that, I have the greatest respect for those scientists who make contributions to the pharmaceutical industry, to those who help to relieve pain and preserve life, and having added that we are all potentially the beneficiaries or the victims of the pharmaceutical industry, I want to say that the touchstone of its merits should be the service it offers to the patient rather than any commercial criteria which may be offered.

The achievements of the industry are well known. It is only when, as in the case of the thalidomide tragedy, we can see some of the damaging results that it occurs to us that, possibly, there is another side to the coin. Recently the eyes of the whole world have been turned on the unhappy mother at Liege, who killed her deformed child. But we should not lose sight of the fact that here in Britain, according to a very rough computation of the Chief Medical Officer of the Ministry of Health, over 390 children were born deformed as a result of taking the drug thalidomide. We should not forget the truer mercy and courage of the mothers of those children who have undertaken the responsibility of salvaging the human remains of what was essentially a man-made disaster; nor should we forget the heavy burden assumed by those dedicated people whether as volunteers or whether they act in a paid capacity who are now caring in institutions and in hospitals for the results of this unhappy situation.

This brings me to the first point, namely, that the Minister of Health should take powers and exercise them on the advice of the central drug licensing agency which I propose to prevent drug companies from making claims for their products which may not only be excessive but even dangerous to the consumer.

I would illustrate this with an example of an advertisement for Distaval, which is the trade name for the drug thalidomide. We know that drug companies use high-pressure methods of salesmanship. Perhaps I might be allowed to quote from one of the most eminent doctors, if not the most eminent doctor in the country, who has something important to say about the methods which have been used, and are being used, by the pharmaceutical industry to impress their products on the public.

Perhaps I may say in passing that as a result of the revelations of the Kefauver Committee in the United States on the American drug, we know that four times as much money is spent on the promotion of drugs, not on research or investigations, as is spent on running all the medical schools put together in the United States. No one knows exactly how much money is spent in Britain on the promotion of drugs but, judging by the incursions of the American pharmaceutical companies into the British industry and the adoption of publicity in which they specialise, I would say at a guess that, relatively speaking, probably a similar proportion is spent in the promotion of drugs here in Britain as in the United States.

I want to revert to what I was saying a moment ago. I should like to quote the testimony of Lord Cohen, the distinguished doctor, whose advice is so often sought by the Minister of Health. This is what he said at a symposium organised under the auspices of the Pharmaceutical Society of Great Britain in April of this year. He said: The majority of physicians receive their first and possibly their only information from the manufacturers. I should add that there is ample evidence that in many cases this information is biased, and at worst it is unreliable and misleading … We, the Cohen Committee, have been presented with reports which are deliberately misleading, not because of what is said positively, but because evidence of accepted facts is absent—matters which would have placed quite a different complexion on the preparations' categorisation. It is not use saying that reputable firms do not do this … I would ask you to read some of the advertisements, and I am perfectly certain that any unbiased observer would say that these were deliberately misleading. These are Lord Cohen's words and they involve strong language. But the illustrations which I am now going to offer to support Lord Cohen's thesis are entirely my own.

May I deal first of all with the case of Distaval to which I have referred, the drug thalidomide. This drug was withdrawn by the manufacturers, the Distillers Company, after it appeared that it was a source of foetal deformaties. As late as 4th November, 1961, Distaval was being advertised—and here I am quoting directly from the advertisement—as a sedative and hypnotic which is both highly effective and outstandingly safe"— the word "safe" being underlined. The advertisement appears in the British Medical Journal and was widely circulated. It added: There is no case on record in which even gross overdossage of Distaval has had harmful results. Put your mind at rest. Depend on the safety of Distaval. The whole advertisement shows a child playing with a bottle of tablets, with the ambiguous headline: This child's life may depend on the safety of Distaval. In the correspondence columns of the British Medical Journal on the same date there were letters from doctors drawing attention to various harmful effects following the intake of this drug —I am not talking about the teratogenic effects—including peripheral neuritis, psychotic disturbances and disorders of various kinds. In fact, these letters were a follow-up to an article published on 30th September, 1961, by Drs. Pamela Fullerton and Michael Kremer in which attention was drawn to the neuro-toxic effects in 13 patients following treatment with thalidomide. The evidence was sufficient to show that the drug occurred in a number of cases attested by doctors to be damaging and unsafe.

It was not until 3rd December that the firm withdrew the drug from the market because of the reports of its potentially teratogenic effects. However, I am not talking about that now. I am merely saying that for a firm to continue to advertise that a drug was safe when neuropathic symptoms of a severe kind and on a substantial scale had been reported is something which should have the attention of the Minister and perhaps even of the courts, and may well engage the interest of those who have suffered from the drug.

I come now to other evidence in my possession. I want to speak rapidly because, although I do not wish to take too much time, I wish to put what I have before the House. The first example is the drug Doriden, otherwise known as glutethemide. This Doriden is marketed by Ciba Laboratories Ltd. It is a drug taken for insomnia, and it has features in its chemical structure in common with thalidomide. Recently, certain doctors drew 'attention to the possible dangers of this drug, but it was announced quite simply in a monthly index of medical specialities put out by the trade as appropriate for insomnia. After the criticism, the company put out a statement to the medical profession which said that Nothing known to us at present suggests that Doriden shares the teratogenic activity ascribed to thalidomide". An article in the British Medical Journal of 8th September, 1962, says: In view of the degree of chemical relationship between thalidomide and glutethemide (Doriden), there seems no doubt that until further information is available it would be sensible to avoid the use of glutethemide as a sedative in pregnancy". I am not in a position to judge the merits of this drug, nor, indeed, are the vast majority of doctors. All that they can go on, as Lord Cohen said, is the representations made to them by the drug companies. What I urge is that there should be a central licensing authority to interpose its wisdom between the commercial interests of the drug companies and the patients.

In conclusion, I have two other examples to offer to illustrate how drugs are promoted with misleading claims. I owe both of them to an eminent doctor who drew them to my attention. There is a drug called Neo-mercazole marketed by British Schering Ltd., with the description: The most potent and the safest anti-thyroid agent". It is also claimed that As far as is known it can safely be used for the treatment of the pregnant thyrotoxic patient". Its advertising claimed no danger for the mother or the baby and was supported by various medical references.

In the ordinary way, doctors tend to accept medical references in a learned journal as having the force of Holy Writ, and they do not bother to pursue inquiries. However, this doctor followed up the reference to pregnancy and found that the reference was, in fact, to the Medical Journal of Malaya in 1959 in which a Dr. Ong described the cases of 12 pregnant patients who had been treated with the drug. Of the 12, only 9 had been delivered when the paper was written. No mention was made of whether the outcome of pregnancy was successful, whether the babies had congenital goitre, which had been known to follow the use of the drug in pregnancy, or whether the babies were abnormal in any way. The author of the paper, to which the drug company had referred, went on to speak of the rate of relapse of thyrotoxicosis during pregnancy and said: The high incidence of relapse is a drawback in this method of treatment, but if the treatment is continued throughout pregnancy, there is a marked risk of harming the foetus". He discussed the matter no further but gave a reference to another paper which, in fact, advised against the use of the drug during pregnancy on the ground that it carried a higher risk for both mother and child than any other form of treatment.

This is the medical reference which the drug manufacturer was using to promote his product, a reference which, in fact, pointed to the exact opposite of what he was claiming. This was the reference given in the course of a large and expensive advertisement so designed as to impress gullible or incurious doctors.

I know that the Parliamentary Secretary has very little time, but I wish to give this further example. I refer to the drug Diabinese made by Harvey Pharmaceuticals, a department of Pfizer Ltd. This drug, an oral hypoglycaemic drug, is widely used in this country, but it was discovered by the Kefauver Committee in its inquiries that the firm promoting it had substantial and undisclosed information about the side-effects of the drug, which included jaundice, exfoliate dermatitis and death from hypoglycaemia, which, as the hon. Gentleman will agree, is a side-effect of some importance. The Committee found that the company had made no attempt to supply this essential information to physicians in the course of its advertising. Now, three years later, although advertisements for this drug, following the Kefauver investigations in the United States, mentioned the potentially dangerous side-effects, in the British Press—I have here an advertisement in the Lancet for 11th August, 1962—there is no indication whatever that toxic and noxious effects may emerge.

The illustrations which I have given are, unhappily, not exceptional in the promotional material of the pharmaceutical industry. They involve the suppression of vitally important evidence. If a commercial prospectus were published in this form, I believe that the directors concerned would be subject to criminal prosecution.

We now have enough evidence from doctors and pharmacologists and only recently from the chairman of the Glaxo Group, Sir Harry Jephcott, supporting the need for some form of central drug testing agency or some central drug licensing committee. I know that the sub-committee has given the Minister advice on the safety of drugs and in its third recommendation recommended that there should be an expert body to review evidence and offer advice on the toxicity of new drugs. But I do not believe that this goes far enough. What is required is something much wider, such as a body on the model of the F.D.A. of the United States which will have power to end this extraordinary abuse on the part of pharmaceutical companies.

In this matter, prudence advises not the snail's pace to a decision, which seems to be the gait of the Ministry of Health, but a rapid decision and urgent action.

4.16 p.m.

Mr. Peter Emery (Reading)

I am sure that hon. Members would wish to thank the hon. Member for Coventry, North (Mr. Edelman) for bringing this matter to our attention. However, I am sure the House will remember that only on Wednesday this week I introduced a Bill to set up a drug advisory board, which received its First Reading.

It would be quite wrong at this stage for us to make an attack on the pharmaceutical industry, which, I am afraid, was the main object of the hon. Gentleman's speech. I believe that, on the whole, it does a superb job for British medicine. I think that it is incorrect to lay too much emphasis on advertising claims. Most companies go a lot further than the hon. Gentleman indicated in his speech. My view is that the question of advertising should Dome very low in the consideration of this matter by an advisory board.

It is essential that a board should be appointed, but I believe that it should deal not only with the toxic properties of drugs but also with the clinical tests. If my hon. Friend could say something about that, it would be of great benefit to the country.

4.18 p.m

The Joint Parliamentary Secretary to the Ministry of Health (Mr. Bernard Braine)

I agree with my hon. Friend the Member for Reading (Mr. Peter Emery) that we should be grateful to the hon. Member for Coventry, North (Mr. Edelman) for providing us with an opportunity to discuss this important matter. I express my appreciation to the hon. Gentleman for the way in which he dealt with it.

As the hon. Gentleman said, it has been only too tragically illustrated in the last year how a drug may be found to have unexpected toxic effects after a considerable period of general use. There has certainly been a growing feeling among medical men, in Parliament and in the Press that more searching tests and trials should be undertaken before a new drug is introduced. My right hon. Friend recognised this very quickly—he shared it—and in reply to a Question from the hon. Gentleman on 23rd July he said that he was seeking advice through his Standing Medical Advisory Committee on the question of testing new drugs generally. He has already received interim advice to which I shall refer later.

The question posed in this debate is by what machinery these tests and trials should be conducted. Perhaps some new safeguarding machinery will have to be established, but at this stage we are dealing with a situation which is not susceptible to quick, easy and simple solutions, and I propose to explain why.

The problem of drug safety is a complex one. Clearly, three needs must be met. First, there is the need for adequate toxicity testing before a new drug is tried out on human beings. Secondly, there is the need for clinical trials to be undertaken on as wide a scale as is practicable before the drug is introduced generally. And thirdly, there is the need to make known to doctors and pharmacists the fullest possible information about the effects of drugs, both those that are desirable and possible side effects.

The emergence of distressing—even irreparable—side effects in a drug, as was the case with thalidomide, is a matter of the deepest concern to my right hon. Friend and to the Secretary of State for Scotland, who is the other health Minister, as, indeed, it is to us all. But it is not for either Minister to judge when adequate trials of the safety of a new drug have taken place. At present, the responsibility rests with those who make the drug available and those who prescribe its use.

It is the manufacturer's responsibility to decide on the extent of safety testing that his product needs before he is justified in making it generally available; it is the doctor's responsibility to exercise his clinical judgment in deciding whether to prescribe a drug for a particular patient; and it is my right hon. Friend's responsibility to see whether any further safeguards are required to provide the greatest possible protection to the general public. This is a responsibility which my right hon. Friend is exercising now.

Perhaps I should make it plain at this stage that the interim advice already tendered to my right hon. Friend makes quite plain that the pharmaceutical industry generally discharges its responsibilities effectively within the limits of contemporary knowledge of methods of testing. I endorse entirely what my hon. Friend the Member for Reading said on this point. Doctors obtain information about therapeutic uses of new and existing drugs through their professional journals, through the Prescribers' Journal, which is distributed by my Department and the Department of Health for Scotland to all doctors in the Health Service, and which contains articles contributed by persons of eminence, and also from manufacturers' literature and representatives.

When considering the all-important subject of safeguards it is essential to recognise the difficulties inherent in the subject. I am advised that it is improbable that any really effective therapeutic substances are entirely without any undesirable effects in certain cases. Drugs which carry a recognised hazard in therapeutic doses may yet be justifiably used by doctors in the treatment of certain diseases, provided that the risk is related to the benefit that the drug may confer. Thus the laboratory testing of drugs, important though it is, is not the only consideration which should guide us in regard to the safety of drugs in the treatment of disease.

Moreover, any drug that is potent is by its nature liable to exert side-effects. These may arise in circumstances which, in the light of the medical and scientific knowledge of the day, could not be detected by means of initial testing on animals or human volunteers.

We must recognise that toxicity testing and clinical trials can never be as complete as ideally may be desirable, nor can they give an absolute guarantee of safety. Even the most carefully conducted clinical trials may sometimes fail to reveal a toxic side-effect which may emerge only in medical practice, possibly after long use in a considerable number of patients. I mention these considerations because they show the great complexity of the matter and 'the need to ensure that whatever action my right hon. Friend takes is based upon the best possible expert advice which he can secure.

The hon. Member for Coventry, North referred to the interim advice from the Joint Sub-Committee of the English and Scottish Standard Medical Advisory Committees set up in August, which was not very long ago, under the distinguished chairmanship of Lord Cohen of Birkenhead, who is Chairman of the Central Health Services Council. I was pleased to hear the tribute paid by the hon. Member. He should take comfort from the fact, having quoted Lord Cohen authoritatively, that this is the gentleman who is presiding over the Committee from which my right hon. Friend has already received interim advice and is expecting to receive final recommendations. This Sub-Committee found that in present circumstances there was no need to change the present practice, under which the experimental testing of new drugs before they are used in clinical trials rests upon the pharmaceutical manufacturer, since the industry as a whole discharges this duty satisfactorily. It observed that knowledge of methods of testing is constantly being extended by research—and this is a warning against hindsight—and that it is the intention of the Medical Research Council to give advice and guidance from time to time.

The hon. Member has suggested that there should be set up a drug testing council under Government auspices.

Mr. Edelman

A licensing council.

Mr. Braine

A licensing council. I cannot, of course, say at this stage precisely what my right hon. Friend will decide to do when he receives the Sub-Committee's final recommendations. He must clearly wait to see what they are, hut I am bound to say that the interim report came down firmly against such a proposal.

On the other hand, one safeguard which it recommended, though only one of many which it thought might be needed, was that there should be an expert body to review the evidence and offer advice on the toxicity of new drugs whether manufacturered in this country or abroad before they are used in clinical trials. The Sub-Committee expressed the hope that it would be able to formulate detailed advice on the composition and terms of reference of this advisory body and declared its intention to continue consideration of the general problem. My right hon. Friend announced his acceptance on 6th November of the first two recommendations, and he said that he would await the further advice of the Joint Sub-Committee with regard to the expert body suggested.

Mr. Kenneth Robinson (St. Pancras, North)

Cannot the hon. Gentleman at least tell the House that the Minister accepts in principle the third recommendation, even though awaiting further details from the Sub-Committee?

Mr. Braine

I must not commit my right hon. Friend on a matter of this importance, but what I want to emphasise is that, apart from the final report of the Sub-Committee which he now awaits, and as the hon. Gentleman, who is very well informed on these matters, knows very well, a good deal is happening. For example, the Medical Research Council has appointed a committee under the chairmanship of Sir Charles Harington to study the methodology of testing for toxicity; the Association of the British Pharmaceutical Industry has set up an expert committee on drug toxicity under the chairmanship of Dr. Hennessey of the Wellcome Foundation; and the College of General Practitioners is taking steps to ask doctors in the National Health Service to report to their epidemic observation unit any evidence of toxic reactions to new or established drugs. All these things are happening.

The Cohen Sub-Committee made it plain in its interim report that it had exchanged views with the Medical Research Council Committee on the methods of testing for toxicity as well as having discussions with representatives of the industry. I think that this indicates that all concerned are aware of one another's activities and researches, and I have no doubt that effective liaison, and a high degree of urgency, is being maintained.

I know that my right hon. Friend will be most interested in hearing what has been said by the hon. Member and by my hon. Friend this afternoon, but the prudent course, I suggest, must be to await the further advice by the Joint Sub-Committee before attempting to judge whether a drug testing council or licensing board would be a useful body to have and the extent to which it should be fostered or regulated by a Minister of the Crown. My right hon. Friend has every confidence that the Joint Sub-Committee will press on with further consideration of this subject, and I can give this assurance to the House, that, for their part, the Health Ministers will give the closest and most urgent attention to its further recommendations.

Clearly this is the most sensible course. I hope I have made it plain that we are not dealing here with a simple straightforward problem of providing a piece of machinery. My right hon. Friend is fully alive to the need for ensuring the best possible safeguards, but to do this it must obviously be desirable to study all aspects of the problem to avoid coming to a premature decision.

I listened carefully to what the hon. Gentleman said on the question of the claims of advertisements and this needs much closer scrutiny. Doctors should be as fully informed as possible with regard to the effects which have been noted in the use of drugs and in the claims made in advertising. All this will be considered by the Joint Sub-Committee. Incidentally, advertising is not directed at the general public, but made in the journals of the profession.

The Question having been proposed at Four o'clock and the debate having continued for half an hour, Mr. SPEAKER adjourned the House without Question put, pursuant to the Standing Order.

Adjourned at half-past Four o'clock.