HC Deb 24 February 1984 vol 54 cc1142-8

Motion made, and Question proposed, That this House do now adjourn.—[Mr. Garel-Jones.]

2.32 pm
Mr. Eddie Loyden (Liverpool, Garston)

I am grateful for the opportunity to raise the subject of the drug Osmosin this afternoon, not simply in the interests of those who have used it but because of its wider implications and the Government's attitude towards this drug in particular and drugs in general.

As someone who suffers from arthritis, although not of the severe kind, thank God, I fully understand the problems facing those who have to rely on drugs to make bearable what can be a painful and sometimes crippling disease. I also understand the pressures that are placed upon doctors and the medical profession in general when presribing drugs to relieve that pain to make life more bearable and to allow people to use their bodies to the maximum.

There is sufficient evidence to confirm that such drugs have side effects which, in many cases, are highly dangerous. I am concerned that there appears to have been a lack of responsibility on the part of the Government and the Secretary of State in responding to a serious matter.

I first raised the matter of Osmosin—an inlomethacin drug—as early as August 1983. At that time, I wrote to the Secretary of State about a small item in one of the national papers—less than a column—which sent out signals about the drug. I do not understand why that small item of information was not taken up by any section of the media — press, radio or television. I reached the conclusion that I had come across that piece of information virtually by accident, and I immediately stopped taking the drug.

I began to ferret through the various places in the House to obtain information about Osmosin. It appeared that the Secretary of State was being somewhat coy in responding to my letters. I eventually went to that fount of wisdom, the House of Commons research section — scientific division—which provided me with information about the drug. The information disclosed that there had been about 600 adverse reports on the drug, with possibly 20 related deaths. I again wrote to the Secretary of State in August pointing out that information. Unfortunately, the matter was not taken up by the press, which usually alerts people to the risks associated with such drugs.

What shook me was that when the drug was eventually withdrawn it was because of an approach to the manufacturer by the Federal Republic of Germany, on the basis of United Kingdom figures. That is astonishing. The Secretary of State was sitting on the adverse reports about the drug causing irritation or perforation of the bowel and, in some cases, death. The father of one of my constituents was, in the opinion of my constituent, a healthy man for his age. He entered hospital because of a duodenal ulcer, suffered kidney failure, and died. He had been taking Osmosin.

It is a shame and a scandal that it should have been the German authorities, on the basis of United Kingdom figures of which the Secretary of State was aware, that made the approach to the manufacturer to withdraw the drug from the German market. Perhaps because of EC regulations — I know not—the manufacturer withdrew the drug from the whole of Europe. It was withdrawn through pressure not by the United Kingdom — the Comittee on Safety of Medicines or the Secretary of State — but by the Federal Republic of Germany. The company withdrew the drug from Europe as a whole rather than only from Germany.

Something that further shocked me was a letter I received from the Secretary of State in which he said that he was reluctant to make a further statement—I had asked for a statement in the House about the dangers faced by those who were prescribed the drug—for commercial reasons. It is a shame and a scandal that the Secretary of State should have guarded the commercial interests of a drug manufacturer rather than the health and safety of about 80,000 people who were taking the drug. I have made strenuous efforts to bring the Secretary of State to the House to make a statement so that he could inform the medical profession and people who take the drug. There has been a lack of publicity. It is not the responsibility of one Member of Parliament to pursue information on behalf of the Secretary of State to safeguard the interests of people taking a drug.

The only newspaper that seriously dealt with the matter was the Liverpool Echo. Although it is unusual for me, I am grateful to it for raising the problem. Even though it has a fairly small circulation, I have many letters from people who have taken Osmosin and suffered side effects. Many letters were written to the Secretary of State so that he could be made aware of the response that I received from Liverpool and its surroundings. One of those letters mentioned the death of a man in his sixties.

I believe that I have a perfect right to accuse the Secretary of State of negligence, because he did not respond to my pressures to make a statement to the House. It was only after the Daily Mail mentioned the dangers of the drug on its front page last week that the Minister for Health made a statement to the House and mentioned an inquiry. I have been pressing him on this matter since September last year. I am therefore entitled to feel angry about his inactivity.

I hope that the Minister will wander from his brief to answer some of my points. I understand that about 1 million people in Britain suffer from arthritis. If we include people who suffer from rheumatism, the numbers of people affected run into millions. They are painful and sometimes crippling complaints. What is the Government's policy towards this form of ill-health and what do they intend to do about it?

Doctors are understandably under a great deal of pressure from the hard selling of drugs and because they have only a limited time to deal with their patients to prescribe drugs to respond to patients' requirements. We are rapidly becoming a drug-orientated society. There is now much dependence on drugs. We must examine the weaknesses of the relevant legislation with regard to dangerous drugs. I understand that the Secretary of State has power under the Medicines Act 1968 to withdraw a drug for at least three months. That gives sufficient time to investigate adverse reports.

Ultimately, people who have suffered from taking the drug are entitled to be considered for compensation if it is proved that the adverse effects on them were drug-related; and, where death has occurred, dependants should be entitled to be considered for compensation.

The Secretary of State should investigate this area of ill-health in order to see what medical innovations can be introduced to relieve the suffering and pain of millions of people. He should also consider the extent to which fringe medicine could relieve arthritis and rheumatism. Although I agree that at present we have to be cautious about fringe medicine, there is evidence that certain aspects of it could be used as an alternative to the taking of drugs.

I hope that the Minister will consider the questions that I have raised and, in particular, explain why he or his right hon. Friend have resisted requests for them to come to this House since August or September 1983 when I first raised the matter. Until this week, no statement had been made in the House, and thousands of people who were taking the drug were thereby at risk.

With regard to the mechanism for the withdrawal, of a drug, I accept that if on a Monday the Secretary of State says that a drug should be withdrawn, it is not reasonable to expect that on the following day the drug will he completely off the market. For that reason, it is possible for a drug to continue to be prescribed beyond the date of withdrawal.

I received a letter from one of my constituents, a lady in her fifties, for whom the drug had been prescribed. After the date of withdrawal, she returned to her doctor and the drug was prescribed again; indeed, she was given two months' supply. Therefore, her consumption of the drug went far beyond the point at which it was meant to be withdrawn. That shows a weakness in the mechanism for withdrawal.

I hope that the Minister will discuss with his right hon. Friend measures that could be taken to ensure that, when a drug is withdrawn, it is not left on the shelves of pharmacists or chemists, or even in the hands of doctors who may be unaware of the withdrawal of the drug, and who may continue to prescribe it to patients. The Minister may tell me that notice was given to doctors, but we know that procedures take a considerable time to percolate into every corner of the medical profession.

As a Socialist, I believe that the drug industry should be nationalised and under the care of the state. Drug manufacturers put tremendous pressures on doctors to prescribe drugs. That results in the National Health Service having an enormous bill to pay for drugs.

My disclosures this afternoon show that there is a need for a far closer watch and control over the use of drugs. That can be done only by making the drug industry part of the National Health Service. I do not expect a sympathetic response from the Under-Secretary to that argument, but I hope that he will note what I have said about the effects of the drug, the Government's policy towards the drugs industry, the investigation of alternative medicine and innovations in the NHS to meet the needs of the many people who are suffering greatly and doubt whether drugs are the answer to their problems.

2.50 pm
The Under-Secretary of State for Health and Social Security (Mr. John Patten)

I thank the hon. Member for Liverpool, Garston (Mr. Loyden) for raising this important subject which has been in the public eye this week and needs to be ventilated. I am sure that I would be called to order if I went down the avenues that the hon. Gentleman opened up on the nationalisation of the drugs industry. I hope that he will forgive me if I do not deal with those matters today.

I express my sympathy for those who were prescribed Osmosin and have suffered reactions. The hon. Member for Garston told us that he suffers from arthritis and was prescribed the drug. Therefore, I can understand his interest in the problem, although I am sure that he would have been just as interested had he not suffered personally. The Government share his concern about the number of people who died, including, apparently, one of his constituents.

The hon. Gentleman raised a number of general matters about the treatment of arthritis, the relief of pain and possible ways of alleviating suffering. I wish to deal with a number of important questions and, as I have only a short time available, I hope that the hon. Gentleman will forgive me if I do not follow him down that road either. I would just say that, through the Medical Research Council, the Government are supporting considerable research into arthritis, the alleviation of pain and the relief of suffering. The medical community intends to battle hard towards those ends.

I welcome the hon. Member for Garston's proper and responsible efforts to satisfy himself that the question of the safety of the drug was considered promptly and thoroughly and that the necessary action was taken without undue delay. I hope that what I have to say will go some way towards satisfying him on those aspects, although I cannot accept his swingeing criticisms of my right hon. Friend the Secretary of State.

I shall set out for the House what happened from 1 September last year, because it is important to get the chronology of withdrawal right. On 1 September, following discussions with the United Kingdom licensing authority and at its request, the manufacturers ceased marketing Osmosin — later, they announced the same action worldwide. On the same day, they issued a statement to doctors about the decision to discontinue the sale of the product in the United Kingdom. It was not felt necessary at that stage to request the withdrawal of stocks of Osmosin from pharmacists; that allowed patients using the product to complete their courses of treatment and to discuss further treatment with their doctor.

I draw the attention of the hon. Member for Garston to what my right hon. and learned Friend the Minister for Health said in his statement to the House on Monday about the rare occasions when doctors would prescribe a drug that was generally banned. They would have particular clinical reasons for doing so, would weigh up the pros and cons of prescribing the drug and would do so only if the benefits outweighed the disbenefits. That happens rarely and should not happen often.

Reports in the Liverpool Echo—I note what the hon. Gentleman said about that paper—and the Daily Mail drew attention to the fact that too many repeat prescriptions were being written for drugs such as Osmosin. That is a cause for deep concern. Compliments are not often given in this Chamber to the national press —indeed, it is often the other way round. However, the Daily Mail has acted very responsibly indeed by releasing all its information immediately to Government in the interests of introducing change rather than mounting a campaign merely to score a number of publicity points.

That having been said, the developments last September followed similar action in Germany, announced on 1 September, and made at the request of the German regulatory authority pending an inquiry there into the drug's safety, which was established.

Information is swapped and traded among European countries in this way. Sometimes we learn from the experience of other European countries, and on other occasions other European countries learn from us. In the case of the drugs Opren and Flosint, the United Kingdom took the lead in withdrawing them from the market, and the Germans, acting on the information given by the British Government, followed suit. Therefore, there is nothing odd in our seeking information from our European colleagues.

Mr. Loyden

The point that puzzled me was that the German authorities responded to the United Kingdom figures, of which the DHSS must have been aware, and first made an approach to the drug company to withdraw the product. That cannot be explained away.

Mr. Patten

The Germans acted not only on our figures but on their own.

The Commitee on Safety of Medicines duly considered Osmosin at its meeting on 22 September, and advised that the licensing authority should revoke the product licence on grounds of safety. This decision was notified to the manufacturers, who in turn decided to exercise their legal right of appeal to the committee. That right is at present enshrined in law. But they requested a delay in order to gather evidence for their case. This was agreed provided that the company agreed immediately to withdraw all stocks of the product from pharmacies. Eventually in January this year, the company decided not to proceed with the appeal and surrendered its product licence at that stage.

There are some important general issues to which I wish to refer in the remaining four minutes of the debate. The first relates to the decision to license Osmosin. Decisions on product licences of new products are taken by the licensing authority after a rigorous evaluation of the scientific evidence by the Committee on Safety of Medicines.

That certainly occurred in the case of Osmosin. New information about the safety of the drug did, however, become available after marketing. In some cases that is inevitable. No matter how meticulous the pre-marketing clinical trials of drugs are, they can involve only a limited number of patients, and it is always possible that a rare and unpredicted reaction will not be exposed during such trials. That is exactly why special post-marketing surveillance procedures, including the "black triangle" mark in the British National Formulary, are applied.

A second important issue is the adequacy of our present methods of monitoring adverse reactions to drugs such as Osmosin. Clearly — I say this on behalf of the Government—we still need to improve our methods of identifying adverse reactions to drugs. But these methods are not wholly in the hands of Government—oh that they were! They cannot simply be introduced by legislative means. It depends so much on medical advance and technology, as I am sure the hon. Gentleman will appreciate.

The third issue, which is of great importance, is whether there was any delay in acting on the adverse reactions report on Osmosin. The product was closely monitored by the Committee on Safety of Medicines from the date on which it was marketed. As soon as adverse reactions were reported the committee considered them, and it continued to monitor reactions and consider them throughout the period.

It is always difficult to know exactly when the right moment has come to withdraw a drug from the market on safety grounds, but we are satisfied, having taken a first look at this issue, that there was no unreasonable delay in acting on the evidence available at the time. When my right hon. and learned Friend the Minister for Health announced, with characteristic rapidity, the investigation into these important issues—he is as fast on his feet in making policy announcements as he is in debate in the House—he meant that the Government had referred to the Medicines Commission an important range of investigations which it must undertake. We look forward to receiving a report from the commission in the near future.

It has been suggested, although not by the hon. Member for Garston, that doctors should give patients more information about adverse reactions. Perhaps I may give a word of caution there: as an interested layman with a professional interest, I have examined product sheets, and I did not understand many of them. It is clinically correct for doctors to be cautious before they make evidence freely available to patients, who might not be able to judge its weight.

I welcome the hon. Gentleman's debate, although I think that he was more than unfair to my right hon. Friend the Secretary of State's about the Government's actions. He and I will await the evidence in the report of the Medicines Commission on this important topic of public concern.

Question put and agreed to.

Adjourned accordingly at one minute past Three o' clock.