DRUG TESTING (Hansard, 2 August 1962)

§ BARONESS SUMMERSKILL
My Lords, I beg leave to ask the Question which stands in my name on the Order Paper.

§ THE LORD PRESIDENT OF THE COUNCIL AND MINISTER FOR SCIENCE (VISCOUNT HAILSHAM)
My Lords, I should like, if I may, to use the noble Lady's Question to put together certain facts about drug testing which I think will be of interest to the House. On the direct Question which the noble Lady asks, she will be glad to hear that my right honourable friend is seeking advice on testing new drugs generally through his Standing Medical Advisory Committee, which is the appropriate body. The noble Lady will not therefore expect me to pursue this matter further now. The noble Lady will also be aware of other studies of this which are in progress.
Since the recent events relating to thalidomide, I have myself made inquiries of the Medical Research Council on the rôle they can expect to play in advancing methods of testing. The noble Lady will have seen that the Medical Research Council have this week announced their intention to appoint a Committee, under the chairmanship of Sir Charles Harington, to study the methodology of toxicity testing. I attach great importance to the work of this Committee and I am sure the House will agree with me in wishing it all success.
It is not the Medical Research Council's responsibility to carry out routine testing programmes on drugs or other chemicals, from the point of view of either efficacy or toxicity. In promoting research likely to lead to the advancement of knowledge, they do, however, sponsor many clinical trials of new preparations of particular promise for specific purposes and have for many years undertaken fundamental research in the field of toxicology, especially with regard to the difficult methodological problems which arise in devising tests to demonstrate possible long-term 407 effects which may be produced, for example, by such substances as food additives.
The Council have a special responsibility, however, for advising the Ministry of Health on the scheduling of drugs under the Therapeutic Substances Act. Its rôle in this respect is limited to biological preparations and does not cover ordinary chemicals. The noble Lady will also have seen a well-informed article in The Times newspaper yesterday on the history of the introduction of thalidomide itself.

§ BARONESS SUMMERSKILL
My Lords, may I say how gratified I am that the noble Viscount the Leader of the House, in his rôle as Minister for Science, has thought it appropriate to answer this Question? Is he aware that, although what he has said, that the Medical Research Council is prepared to identify itself with the research, is highly desirable, the Council has already stated that it can only advise and not control? Is he also aware that he has not made one statement which could be interpreted in terms of practical action which will safeguard, not only the pregnant mothers in the community but also every individual who is consuming drugs? Is he aware that it was last year—I repeat, last year—when it was decided to withdraw thalidomide? All these months have passed. Drugs are going on the market every day, about which the Minister of Health has been warned of what has been happening. Now we are adjourning for the long Recess and all we are being told is that the Medical Research Council are setting up a Committee and that they will advise, whereas the time has come surely when the Minister of Health should direct these firms to examine the drugs which are still being distributed, in order that the population should be protected.

§ VISCOUNT HAILSHAM
My Lords, I hope that I made it clear from my Answer that I welcome the noble Lady's general interest in this important topic. Whether her particular suggestions have the slightest scientific validity is a matter upon which opinions might differ. It is not correct, of course, that the only thing contained in my Answer was the announcement of the Medical Research Council's Committee. The first part of 408 my Answer describes the action taken by my right honourable friend.
So far as thalidomide is concerned, I myself took careful steps to find out the history of this matter from my own advisers. They consulted a number of their expert advisers and found that there was general agreement that, in the existing state of knowledge, it is extremely unlikely that the most rigorous programme of screening tests would have suggested that an effect was to be expected on the developing human embryo. I must say this to the noble Lady, who, I think, rather over-simplifies this problem. One of the great difficulties in handling a question of this kind is that obviously a good deal of work needs to be done upon improving the methods of testing. If we have, as some countries have, a system like a sieve imposed by the Government on the issue of drugs, which tin effect gives a clean bill of health to drugs which get through the sieve, and if it is scientifically proved, as I am advised appears to be the case, that there is no sieve devised which could give an absolutely clean bill of health effectively to a particular drug, you might very well get a situation in which both manufacturers and clinicians tended to overlook their own responsibilities in the matter and to put forward drugs without taking adequate steps themselves; and this might very well be a worse state than that Which exists at the moment. It is very important, if I may say so, in dealing with matters of great human importance to follow the dictates of science as well as of the emotions.

§ BARONESS SUMMERSKILL
My Lords, may I ask the noble Viscount-he stood up in a most self-righteous manner and queried the scientific validity of my question—whether he has not been informed this week that my Question embodies the wishes of some of the most eminent doctors of the University College Hospital and has been echoed by the British Medical Journal this week? Has he not been informed of this important matter which I think in itself is significant, and can he query the scientific validity of one of the most famous teaching hospitals in London?

§ VISCOUNT HAILSHAM
My Lords, I will not, of course, endeavour to enter into a competition with the noble Lady 409 in the matter of self-righiteousness, but where scientific information is concerned all I said was that the scientific efficacy of this particular situation is precisely one of the matters which Sir Charles Harington will be inquiring into; and I am informed, at any rate, that there are two views about this matter, notwithstanding the noble Lady and the distinction of her Mends. All I would say about it is that my advice is that there is general agreement in the scientific world that, had her suggestion been accepted, it is not necessarily true that thalidomide would have come off the market.

§ LORD DOUGLAS OF BARLOCH
My Lords, may I ask the noble Viscount, having regard to his statement that pretesting of drugs does not necessarily ensure their safety, whether some steps can be taken, when clinical trials of drugs are made, to inform the patients that they are being subjected to an experiment the result of which is not certain?

§ VISCOUNT HAILSHAM
My Lords, I was seeking to make the first point myself: that these pre-clinical trials do not necessarily give assurance of safety. Of course clinicians themselves must exercise great responsibility, and I have no doubt they do. But the mere fact that complete security is not given by pre-clinical trials does not render pre-clinical trials any the less necessary.

§ LORD DOUGLAS OF BARLOCH
My Lords, with all respect, that was not my point. My point was that the patient who becomes the ultimate subject of the experiment should be informed that the treatment is experimental.

§ VISCOUNT HAILSHAM
My Lords, I think that is very desirable but it is, after all, the responsibility of the physician or the clinician to tell the patient what, in his sense of responsibility, he thinks that patient ought to know about his own treatment.

§ VISCOUNT ALEXANDER OF HILLSBOROUGH
My Lords, may I ask whether the noble Viscount, the Leader of the House might be willing, as he is also the Minister for Science, to ask the drug manufacturers if they would make a substantial grant, perhaps of their profits from thalidomide, to Lady Hoare's fund for the victims of it?

§ VISCOUNT HAILSHAM
My Lords, that is another matter, and I should like to consider what the noble Viscount has said. I do not think myself that it is the appropriate duty of a Minister to suggest the particular directions of free donations given by any individual citizens, otherwise we might make a great number of suggestions to a great number of people.