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Drugs (Safety)

Volume 983: debated on Wednesday 23 April 1980

The text on this page has been created from Hansard archive content, it may contain typographical errors.

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

1.43 am.

The safety of medical drugs is an issue of world-wide concern because, although the benefits from them have been inestimable, the adverse effects can sometimes be devastatingly dangerous. If the fine balance of risk against benefit is tilted the wrong way, it can have a shattering effect on the lives of people. Experience has shown that drugs can blind, deafen, maim and kill.

The important problem of drug safety requires careful scrutiny and should be approached with a sense of responsibility. But I deplore the behaviour of the Secretary of State. Addressing a dinner of the pharmaceutical industry last Wednesday, he referred to
" the ever-popular sport of bashing the pharmaceutical industry ",
and he said that in recent weeks the " industry bashers " had gone to town with the allegations that certain products were unsafe. I presume that he was refrerring to those who have been concerned with Debendox.

Had the right hon. Gentleman attended a meeting I had last week with more than 80 parents of malformed children who believe that Debendox was the cause of their children's deformities, and had he seen their restraint yet their anxiety to ensure that other children do not suffer as their children have suffered, he would not call them " industry bashers ". Their aim is the prevention of handicap, and we should all share that. His abusive, prejudiced and emotive language is regrettable, especially after worried parents, concerned Members of Parliament and a responsible press have handled recent issues with great restraint.

There are various reasons for concern about drug safety, and, as our experience with thalidomide, eraldin, phenacetin and hormone pregnancy test drugs has shown, the process of establishing the danger of some drugs and then preventing their use is slow and cumbersome. Yet the Secretary of State elegantly condemns critics as " industry bashers ". He should substitute careful analysis for mindless abuse.

The scheme for reporting damage caused by drugs is ramshackle and ineffective. Only 10 per cent. or less of adverse reactions are reported by doctors, and, according to Dr. Inman, who was the chief medical officer on the Committee on Safety of Medicines,
" Very few spontaneous reports are received of congenital abnormalities which might be associated with maternal drug exposure."
Yet these grossly inadequate reports provide the Committee on the Safety of Medicines with no less than 70 per cent. of its information about drugs. This failure of doctors to report means that the Committee on Safety of Medicines is relying heavily on inadequate data while making crucial decisions. It is thereby allowing drugs to remain available, with no information concerning 90 per cent. of adverse reactions.

The whole purpose of the yellow card system of adverse reactions is to alert the medical profession to drugs that may damage those who take them. Ministers have admitted that these reports of adverse reactions have never yet given the first danger signals for any drug. They merely provide confirmation of warnings obtained elsewhere. Confirmation is useful, but it is not as important as the first danger signals. These first danger signals have in the past come too late and after there has been unnecessary damage. That is regrettable.

The system fails abjectly to protect the public. The Government have failed too, because after a year in office they have made virtually no progress in strengthening or complementing the yellow card system. For years, various schemes to monitor the effects of drugs on patients have been discussed. They have become less substantial as the negotiations have proceeded, and as the years have passed. Currently, we are left with the retrospective assessment of drugs scheme, commonly called RADS. Under this scheme all patients taking a new drug would be identified by special prescriptions, and this clinical progress would be monitored. It is a useful scheme, but the current proposal is to monitor in this way only one new drug a year, and even that limited proposal has apparently made no further progress since it was first given approval nearly a year ago by the General Medical Services Committee. I do not know the reason for the hold-up, but there is an interminable delay.

Instead of improving the system, the Secretary of State, in his " fairground " speech to the pharmaceutical industry, has announced proposals to introduce major changes in the system for giving approval to pharmaceutical firms wishing to launch clinical trials of new compounds. Apparently—and I have to quote the press release in the absence of a ministerial statement—although some aspects, not specified, are to be tightened up, the proposed changes will make it markedly easier for firms to carry out clinical trials than it has been in recent years.

If we are to have more drugs on clinical trials under what the Minister has called a " negative clearance scheme", and if there is no improvement in the reporting of adverse reactions, the problem will become more difficult. If the case for a new and improved system of checking adverse reactions was strong before—and I believe that it was—it will be stronger still when the Minister implements the plans that he has anounced to the pharmaceutical industry.

We need a strong, vigorous, independent surveillance agency assessing drugs and reporting to the Committee on Safety of Medicines. This could start with the RADS scheme, but, if it is to be effective, rapid expansion and the development of a more ambitious scheme are essential.

It is against that background that I want to take a brief look at Debendox. This is a drug—almost certainly the only one—which is approved by the Committee on Safety of Medicines. Yet it has been found by the unanimous verdict of a jury in a court of law to cause deformities. That verdict cannot be lightly dismissed.

The Committee on Safety of Medicines has paid lip service to the court verdict and said that it took " due note ", but it has been forced to admit, in response to parliamentary questions, that it had sent for a transcript of the trial only after it pronounced that there was no evidence against the drug. Had the committee bothered to read the transcript before, it would have seen the evidence of Dr. McBride, the distinguished Australian who first discovered the link between thalidomide and deformity. He did not claim that Debendox was a thalidomide—nor do I—but he stated quite categorically that Debendox was a low trade teratogen which can cause deformities, especially limb reductions.

The committee would also have seen the evidence of the American pharmacologist, Dr. Palmer, who analysed the original notebooks used in the drug company's animal studies and found that
" the animal data absolutely contra-indicates its (Debendox's) use in humans until further experimentation is performed."
It would be understandable if the Committee on Safety of Medicines decided to disagree with both these witnesses and others at that trial. It is incredible that it did not even consider such expert testimony.

But it is not only the medical evidence that is crucial. The epidemiological validity of the surveys of women who have taken Debendox is also important. An American epidemiologist, Dr. Manard, has prepared a report for Congressman Don Edwards, in which she criticises the existing surveys, partly because they suffer from poor selection of controls which biases the results. But the most important point that she made is that all of the studies are too small to show whether there is an unacceptable risk of Debendox being a low grade teratogen.

No one would suggest that the surveys should seek to detect risks as high as one in a million, or even one in 100,000. But the remarkable fact elicited from parliamentary questions is that the surveys on which the Committee on Safety of Medicines has relied could not even detect risks as high as one in 100. That admission by the Minister for Health torpedoes the credibility of the committee's assurance. We can now understand its carefully negative phrasing that it found no evidence that Debendox caused malformation. It appears that it also has no evidence of its relative safety. It is as if it has been trawling for piranha fish with a whale net.

Let me remind the House that Debendox is a drug taken by millions of women—3½ million in Britain, and 30 million world wide. If there is a risk of damage as low as one in 1,000 that means that 30,000 damaged babies are in existence. If the risk is one in 100, there could be 30,000 damaged babies.

Debendox is causing concern because the American court found that it caused malformations and because the committee has not studied all the disturbing evidence at that trial. In view of the considerable public and scientific interest, the committee should be asked to produce a detailed report explaining why it continues to approve Debendox. It should respond to expert witnesses who have criticised the drug. It should also specify what degree of safety it believes to be attached to the use of the drug.

Some people ask me " Why raise this issue of Debendox when it causes worry to pregnant women who have taken the drug? " That is a very dangerous line of argument to use. If we accept it, we would never take off the market any drug taken by pregnant women, because there are always pregnant women. We would never have got rid of thalidomide if we had accepted that argument. Of course peace of mind is important, but it is far more important to ensure that every precaution is taken to ensure perfectly formed babies.

The Secretary of State has made his announcement to the pharmaceutical industry, assuring it of his anxiety to help. What we now need is a similar statement to the women, assuring them that immediate steps will be taken to improve the post-marketing surveillance of drugs to avoid unnecessary malformation. To economise on that is false economy. The approximate cost for each severely disable child is £125,000, but we are far more concerned to prevent the recurring human tragedy of lifelong disability. I urge the Minister to take account of that.

1.59 am

This is an issue which commands wide public interest and it is right that it should be debated at intervals in the House. I am not one of those who argue that such matters are best left entirely to the scientific community and to academic debate. Hon. Members and the media can serve a valuable role when they ventilate problems in this complex area. They can also act as a constant reminder to Ministers and their scientific advisers that, while proper regard to the legal procedures and to scientific principles is essential, in the final analysis it is the protection of the patient which is the real objective.

It would be regrettable, however, if the subject were to be clouded by emotion or personal feelings. The safety of drugs is not really a political issue. Ministers of both parties have looked to the Committee on Safety of Medicines for impartial expert advice. The interest of the press in the question is of course somewhat different and is not exclusively concerned with the safety of patients.

I think it only right to say that up till now the right hon. Member for Stoke-on-Trent, South (Mr. Ashley) has commanded the respect of both sides of the House for the indomitable campaigns that he has waged on behalf of minority groups who believe that they have a genuine grievance which has not been dealt with adequately. It is also a tribute to him that on most occasions he has not tempered his activities to suit the changes in political fortune; he has pressed his point with equal vigour whatever the political allegiances of the Ministers of the day.

However, I regret the right hon. Gentleman's attack on my right hon. Friend and I hope that on reflection he will reconsider that section of his speech and agree that it did not live up to the high standards that we expect of the right hon. Gentleman. I also found some sections of his speech unnecessarily alarmist.

I should like to utter a note of caution which I hope the right hon. Member will accept is spoken in sorrow rather than in anger. He must never come to feel that he has a monopoly of compassion for the unfortunates and handicapped of our society. Ministers, their officials and many independent scientific advisers are equally concerned about the welfare of the community and individuals within it.

I should like to assure the right hon. Gentleman that he need not for a moment doubt the good intentions of those who have the difficult job of deciding on matters relating to drug safety, or that they would shrink from taking an unpopular decision if they felt it to be right.

There are some on the fringes of drug safety whose good intentions I do doubt. Foreign lawyers tour this country like, as one magazine recently put it,
" a band of septic poltergeists who hover around beds of adversity to make a good living ".
No more attractive are those who engage in what an article called recently " trial by media". Such people bear a heavy responsibility for the fears, false hopes and revived memories of old sufferings which they conjure up.

I turn to the question of Debendox. If I use strong words, it is because I feel strongly about this subject. The fact is that the system of evaluating the safety of drugs licensed in this country is among the best in the world and, some would agree, is the best. The Committee on Safety of Medicines comprises some of the most eminent men in their particular specialities. They are an invaluable source of informed, impartial and independent advice. To suggest that the Health Minister of this country should act in response to scaremongering or the verdict of a lay jury in the United States, rather than on the advice of expert committees, is to align oneself with a movement which is at heart anti-science, anti-progress, anti-medicine and anti the welfare of the people of this country.

The important thing to remember is that the committee is there to advise on the scientific data. It would be inappropriate for the committee to depend on other people's opinion on the data, such as those expressed in the court case on Debendox in the United States as the right hon. Gentleman has suggested on many occasions recently that it should. If there had been any new scientific evidence produced at that trial, the committee would naturally have wanted to consider it before reaching a view on the drug. There were, however, good reasons for believing that that was not the case, and this has been borne out by a review by the secretariat of the CSM of the complete transcript.

Moreover, apart from the fact that it was itself highly ambiguous and interpreted differently by the parties to the case, I can see no force whatever in suggesting that a verdict by six laymen in the United States should influence decisions on drug safety in this country. The CSM is perfectly competent to reach its own judgment on the data.

I cannot myself see what else is required over and above what the chairman of the CSM, Sir Eric Scowen, stated in his letter to my right hon. Friend who has related Sir Eric's letter to the press. Sir Eric points out that the CSM has studied the evidence and, in its professional judgment, it proves no reason for taking the drug off the market.

The controversy surrounding Debendox has, however, had one beneficial result in bringing out into the open the difficulties of establishing the risks attaching to the use of drugs after they are on the market. These difficulties are particularly acute in the case of drugs used in pregnancy and were summarised in what I thought was an excellent article on the safety of drugs in pregnancy by Dr. Tony Smith in The Times of 9 April. He said:
" Surely, nearly 20 years after thalidomide, drugs prescribed to pregnant women should have been properly tested to guarantee their safety ".
But, he went on,
" in practice no such complete reassurance is possible ".
He then set out cogent arguments why this was the case. I therefore sympathise with the right hon. Gentleman's concern over Debendox, and understand the emotions that lie behind the call for the banning of the drug. He must, however, realise that, as Dr. Smith has explained, in the real world it is just not possible to give him or expectant mothers the absolute assurances he and they seek.

On the other hand, we probably know more about this drug than any other which might be used for vomiting in pregnancy, and what we know is reassuring—that is, that all the research that has been carried out suggests that a woman who takes Debendox is no more likely to put her unborn child at risk than a mother who does not. That is also the view of the Australian drug regulatory authority.

It would be a tragedy if the campaign against the drug forced doctors into prescribing less well tested drugs or persuaded expectant mothers who suffered from severe vomiting not to take medicines prescribed by their doctors as there is some evidence to suggest that the condition itself, if untreated, is a cause of malformations in babies.

As the right hon. Gentleman knows, however, there is one area of drug safety to which he has drawn attention tonight where we ought to look for improvement. The pharmaceutical companies devote very substantial resources to testing drugs in animals and in carefully controlled trials in man before they are marketed. This ensures that an enormous amount is known about the effects of a drug before it is licensed for marketing. This cannot mean that the new drugs are completely free from the risk of adverse effects. Given the potency of modern drugs, wherein lies their efficacy, that is an impossible dream. We cannot have the benefit without a degree of risk.

Despite all these precautions, however, there remains a possibility of adverse effects coming to light after a drug has been on the market for some time. It is clearly important that the time lapse should be reduced to the minimum. To try to meet this need, and to supplement the long-standing yellow card system, the CSM has put forward proposals for pilot studies to test two new systems known as retrospective assessment of drug safety—RADS for short—and record linkage. These proposals are at present under careful consideration.

I am entirely in agreement with the right hon. Gentleman that improvements are desirable in the procedures for monitoring the effects of drugs on patients. It is not, however, simply a question of pouring in money, providing more facilities, or setting up new independent organisations to produce instant results. These are highly complex matters having substantial resource implications.

If the right decisions are to be made, which may settle the system of monitoring drugs in this country for years to come, I and my right hon. Friend will need time to consider carefully all the issues involved and ensure that we obtain best value for money. I can assure the right hon. Member, however, that we will make a statement on our proposals just as soon as we possibly can.

May I say a word or two about the risk/benefit ratio? The first thing that must be understood in considering the safety of modern drugs is that there can be no absolute guarantee of safety. No one can give the patient a guarantee that if he takes any particular drug he will not suffer from some adverse side effect. The balancing of risks against the benefits lies at the core of decisions on the safety of drugs. It is what a doctor must consider before prescribing a drug for a patient and what the CSM must consider before advising that a new drug should be licensed.

The risk, therefore, is not in itself a reason for banning a drug. The question has in every case to be decided on the basis of professional judgment, and a layman should venture on to this ground only if he has some exceptionally good reason or new information that he feels is not available to others. In other cases he can do far more harm than good.

In conclusion, I stress again the need for a rational and unemotional approach to drugs. This applies to the value of new products, which might be hailed as " wonder drugs " or " miracle cures ", as much as to those drugs which it is currently fashionable to denigrate. This House, the media, the pharmaceutical industry and the professions carry a serious responsibility to ensure that the public accepts that modern drugs inevitably have risks as well as benefits, and that complete safety is attainable only at a cost which most of us would regard as unacceptable—that is, turning our backs on progress. I am sure that is not what the right hon. Gentleman is seeking to achieve by this debate or his other actions, and if he comes to accept the points that I have been making tonight this debate will have been well worth while.

Question put and agreed to.

Adjourned accordingly at eleven minutes past Two o'clock.