§ 2.57 p.m.
§ Mr. Sydney Tierney (Birmingham, Yardley)
I am glad of the opportunity to raise as a subject the use of the drug Eraldin and its effects. Perhaps I ought to give a brief explanation at the very beginning in order to avoid any confusion. Practolol is a drug sold under the trade name Eraldin. It is a drug used for the treatment of angina and other serious heart disorders. If I may, I shall refer to Practolol by its trade name, Eraldin. It is generally best known as Eraldin, and the trade name will avoid confusion—apart from the fact that it will also eliminate some of my pronunciation difficulties.
Eraldin was first made available for use in June 1970. It has been estimated that the product has been used by more than 250,000 people for a period of at least a year each. In June 1974, four years after it was first brought on to the market, a letter appeared in theBritish Medical Journal relating to the appearance of an inflammatory condition of the eyes together with skin rashes and a suggestion that the only common factor was the use of Eraldin by the patients concerned.
This report was discussed by the Committee on Safety of Medicines and with Imperial Chemical Industries, which was the manufacturer of the drug. A warning 2374 was sent to doctors and to pharmacists by ICI on 12th July 1974, with a recommendation that any patients receiving Eraldin and suffering from the eye and skin conditions should have the treatment withdrawn immediately. A request was also made that reports on patients in whom this condition was seen should be sent to ICI and the Committee on Safety of Medicines.
On 9th October 1974, ICI sent a second warning letter. Then, on 21st December 1974, a letter from Professor Reed and others appeared in theLancet about a new side effect, sclerosing peritonitis, which consists, I understand, of a condition in which two layers of stomach lining fuse together. An operation is necessary to separate the tissues, and from a number of reports it is known that 10 people have died from the effects of such an operation.
In January 1975 the Committee on Safety of Medicines sent out a letter to all doctors drawing attention to the connection between certain side effects and the drug Eraldin, and a current, up-to-date position was given then. On 18th April 1975, ICI sent a third warning letter dealing particularly with the sclerosing peritonitis effect. On 30th July 1975, ICI restricted the use of the drug and it was withdrawn front general use. I understand that by 1st October 1975 its use was confined to hospitals and over short periods only.
On checking through this chronicle of events, many questions arise, questions which demand an answer and must be answered.
Why was there the long delay in the side effects being officially reported? Why was it necessary to rely on a letter in theBritish Medical Journal to disclose the side effects of Eraldin? How many reports were sent by general practitioners to the Committee on Safety of Medicines or to ICI in response to the various warning letters and requests for reports? To what extent did the established system operated by the interested bodies substantiate or fail to substantiate the existence of the side effects? To what extent was there a breakdown in communications? When ICI sent a warning letter to doctors and pharmacists on 11th July 1974, why did the Committee on Safety of Medicines not act until January 1975 in the same way?
2375 We have noted that Eraldin was withdrawn from general use in July 1975. Over a year later, on 23rd July this year to be precise, I received a letter from a Birmingham constituent who claims that he was on the drug up to June this year. He states that his prescriptions were mostly repeated by telephone without him seeing his doctor. He discovered the facts about Eraldin from his chemist. He had gone with his prescription to his chemist's shop. For some months, his chemist had queried whether he ought to be on the drug. In June, when he went along to his chemist with his prescription, he was told that the stocks of Eraldin had run out and that he would need some other kind of prescription on future occasions.
My constituent goes on to claim that in June he notified the doctors at the medical centre that he attended about the ban on the drug. I have since spoken to this constituent and he confirms what he stated in his letter.
If these allegations are true, and in the light of these events, efforts surely must be made to improve communications, to find out to what extent the drug is still being used, to ban its use, to determine what stocks chemists still hold, and certainly to take action to get the stocks withdrawn.
In a reply to a Question of mine on 19th July, the Minister of State said,I have asked the Committee on Safety of Medicines to look into a number of specific issues related to the restricted us of Eraldin."—[Official Report, 19th July 1976; Vol. 915, c.386.]I hope that my hon. Friend the Under-Secretary will say what those specific issues are. I appreciate that he is stepping into the breach and that I have not dealt with him on these matters, but I know that he will do his best.
In raising these questions today I feel the responsibility of not being destructive about the close working partnership that exists between the drug manufacturers, the medical profession who prescribe and the pharmacists who dispense. All are people of good will and integrity who save many lives and make life more tolerable for many more. I am not insensitive to the need to maintain public confidence. I have a great deal of respect and understanding for firms such as ICI for the way in which they research and 2376 experiment to help their fellow human beings, and it must be said that many have benefited from the drug Eraldin.
I have great respect for the medical profession and the pharmacists, who in turn have the confidence of their patients to a great degree, but eminent people in the medical profession have continually made public statements about the use of drugs. They have said many times that one cannot be certain whether a drug has side effects, and that is accepted. Many drugs are known to have unpleasant side effects but they continue to be used. It is a question of balance and experience in the use of drugs.
Generally, the public accept the reality of the situation, and nothing that I say in this House about Eraldin will change that. They will always allow for and accept a degree of imperfection in this life, but they will not wish to use—knowingly or unknowingly—a drug such as Eraldin with such tragic side effects if used for long periods.
I submit that once the link has been established between the drug and the chronic side effects, any semblance of hoodwinking about the cause and the effect of their medical condition will not be tolerated, and nor should it. Here lies the real threat to the close working partnership that I have mentioned and to public confidence, and that is why I want to say as emphatically as I can that everyone concerned must co-operate fully to bring into the open the true facts about Eraldin, determine what went wrong and establish how many people are affected and to what degree. Some already know that they are affected. Some have come to know in the past few weeks as a result of newspaper reporting. Some still do not know. I say that they have a right to know, and I say, too, that it is the duty of all of us who are concerned to see that they are informed.
I have read newspaper reports that about 500 people are affected. In reply to a Question, again on 19th July, my right hon. Friend the Minister of State said:The Committee on Safety of Medicines comparative index of adverse reactions currently shows 60–70 cases of sclerosing peritonitis and nearly 500 cases of eye reactions and about the same number of skin reaction."—[Official Report, 19th July 1976; Vol. 95, c.386.]2377 Those are cases known by the committee. I claim that those figures are unrealistic and do not in any way represent the real extent of this tragedy.
I set off with one case in my constituency. Three weeks ago, after an article in the BirminghamSunday Mercury, I soon found six more cases in my constituency. An action group has been formed in Birmingham to cover the West Midlands, and up to a week ago it had found 60 more. Most of them had been alerted by further reports that had appeared in the BirminghamPost and Mail and up to the time of reading the report they had no knowledge of the link between Eraldin and their medical condition.
These newspapers have done a public service for people in the West Midlands. I am convinced that if this were repeated in the towns and cities of this country, hundreds more would be found. The Department or the Committee on Safety of Medicines ought to contact these newspapers or, better still, the secretary of the action group, a Mrs. Trainor, of 261 Barclay Road, Warley, whose mother, a constituent of mine, suffers from side effects. I am sure that it would enable them to bring their numbers up to date, and they would get a better insight into the depth and gravity of this problem. This group has my full support. It is determined to find those who are affected, to find out to what extent they are affected, and to inform them how to proceed.
Many Members of this House, who have constituents who are in particular difficulty, have contacted me. Only this morning my hon. Friend the Member for Edmonton (Mr. Graham) mentioned a Mr. Edwards in his constituency, and people are being added to the list day by day. It is also thought that some general practitioners must know of some patients whom they have treated with Eraldin and who still remain on their list and are now being treated for the side effects. It is thought that some doctors can help in this situation.
ICI, the manufacturers of the drug, claim that it has no legal liability to compensate patients who have suffered ill effects. No doubt it holds this view sincerely and, in these circumstances, the 2378 company can be said to be acting reasonably well when it has offered to make compensatory payment. It has also advised people who think that they have a claim first to consult their doctor and then to consult a solicitor. ICI has said that it will meet the medical and legal costs of any genuine claim made to head office. That is also a most helpful gesture.
Even so, I am sure that ICI will readily admit that its attitude on liability is based on sound legal advice that it has obtained. While the company feels that this is sound advice, which it can safely accept, it cannot be deemed to be conclusive or final in any way. Advice is never final. There is always plenty about and more to come. I feel sure that ICI will agree that further negotiations between interested parties and their representatives will need to take place about reasonable compensation payments.
I wrote to the Secretary of State on 12th July and enclosed letters from my constituents who have suffered from the chronic side effects of this drug. Their letters tell the story of the misery and suffering caused by the use of the drug, such as loss of eyesight caused by the drying of the tear ducts, severe skin rashes, deafness in some cases, and damage to the stomach, which I mentioned previously. In that letter I asked my right hon. Friend to make an immediate statement which would help and to show some concern for those who are victims of this drug and, in the longer term, to hold an official inquiry into the whole affair in order to maintain public confidence and to ensure justice and fair treatment.
In the short time that I have available in this debate I have raised many questions, but there are many more to be asked. All need to be answered, and the only way that the many vexed questions will be answered is by an inquiry. Any help and advice which is quickly forthcoming from my hon. Friend's Department will not only please the many people who have suffered side effect illnesses from Eraldin—those that are known and the many that are unknown—but will also please many Members in this House who are greatly concerned that their constituents should be treated fairly and justly in the tragic circumstances they endure.
2379 The people of this country are usually reasonable and understanding about these matters when they are properly informed and consulted. They will not be ignored. I ask my hon. Friend to act now and to give all Eraldin sufferers a fair deal.
§ 3.15 p.m.
§ The Under-Secretary of State for Health and Social Security (Mr. Alfred Morris)
With the leave of the House, may I say that my hon. Friend the Member for Birmingham, Yardley (Mr. Tierney) has raised an important matter with all his customary concern for the interests of his constituents. He is a constant friend of people in special need, whether they be in his constituency or elsewhere, and it is typical of him that he should be here on the day that the House rises for the Summer Recess to press the interests of people who have sought his help.
May I say at the outset how much share my hon. Friend's concern about the side effects which have now been shown to be caused by the use of Eraldin? I am anxious to ensure that if there are any lessons that can be learned from the history of this drug Ministers and their expert advisers will do so to the fullest extent.
I should like to express my sympathy with my hon. Friend's constituents and all the other patients who have suffered adverse reactions to Eraldin. I know of the anxiety of my hon. Friend the Member for Edmonton (Mr. Graham) about the case of his constituent, Mr. Edwards. My hon. Friend the Member for Edmonton can be relied upon to do everything possible to help his constituents. He and other hon. Members on both sides of the House will read the report of this debate with a personal interest.
Over recent years ICI has led the development of a new class of compounds which were found to have beneficial effects on the heart in people with faulty rhythms of the heart, or who had angina produced by a disorder of the heart or high blood pressure. These drugs are called beta-adrenergic blockers—beta blockers for short—and have proved to be a major advance in the treatment of patients with these life-threatening heart diseases.
2380 Eraldin was the second drug of the type to be marketed. It represented an advance because, unlike the earlier drug, it could be given to patients with heart disease complicated by asthma or bronchitis. As with all other drugs, Eraldin was subjected to extensive animal tests before it was marketed. It was then investigated in patients in a number of clinical trials.
These studies did not predict the type of adverse reactions that have emerged over the past two years. It was on the basis of these initial investigations that the Committee on Safety of Drugs cleared Eraldin for marketing in 1970. As it was on the market by 1st September 1971, it automatically received a product licence under the Medicines Act 1968 under the provision that all products on the market at that time were eligible for licences of right.
I should explain at this point that when the nature of the adverse effects became apparent it so happened that an additional long-term study in animals was being conducted. The animals in this study were very carefully examined to see whether there were any adverse effects on their eyes or skin, or of any other kind, and no such effects were found.
It is usually possible for doctors to identify a particular pattern of symptoms as being caused by adverse reactions to a drug only when they become aware of an increase in the occurrence of those symptoms in patients for whom the drug has been prescribed. In some cases it is easy to recognise an association. For example, certain drugs which can cause anaemia were fairly quickly recognised as being the cause. But where the reaction is infrequent and is unexpected it may take considerable time for an association to become apparent.
In this particular case, it was not until 1974 that certain specialists, to whom patients suffering from the severer forms of the side effects of Eraldin had been referred, realised that new types of skin and eye reaction were occurring almost exclusively in patients who were taking or had taken Eraldin. When they had seen a number of such cases they communicated with the manufacturers to warn them of their suspicions.
It is customary for doctors to publish series of this kind in the medical Press 2381 as well as informing the Committee on Safety of Medicines. A meeting was held in July under the chairmanship of Professor Sir Eric Scowen, Chairman of the Committee on Safety of Medicines, to discuss these reports.
It was then agreed that ICI should write to all doctors and pharmacists drawing their attention to the possibility of such adverse reactions, though the number that had been reported at that time was low. The letter stated that ICI had consulted representatives of the Committee on Safety of Medicines and was working closely with the committee. This co-operation and communication with ICI and the committee has continued up to the present. The ICI letter stimulated doctors to report additional cases and a second warning was issued by ICI in October 1974 which led to still more reports. A total of 460 reports were received in 1974.
The Committee on Safety of Medicines issued a formal adverse reactions warning to all doctors in January 1975. This drew their attention to the incidence of side effects with Eraldin, and recommended that doctors should maintain careful observation of all patients for whom Eraldin was prescribed.
The committee, in the light of additional expert advice from cardiologists, was anxious to avoid the sudden withdrawal of therapy in patients with heart complaints because such sudden withdrawal could be hazardous. The seriousness of the problem became more evident because at around this time a number of reports were received of patients developing an unusual form of peritonitis which caused intestinal obstruction. A number of these patients needed operations, and the Committee on Safety of Medicines has recieved reports on 12 patients who died following surgery.
In view of the incidence of these reactions it was decided in July 1975, in consultation between ICI and the Committee on Safety of Medicines, that Eraldin should be withdrawn from sale through retail pharmacists. It was also decided that it should be supplied only to hospitals for use in the emergency treatment of certain organic heart diseases associated with abnormal heart rythms.
2382 Turning to the question of compensation, I must begin by saying that it is for the courts to determine whether compensation is payable, and this is not a matter in which I could intervene. However, ICI has announced that it has established a scheme under which patients who suffered permanent damage following adverse reactions to Eraldin may be eligible for compensation payments.
The Royal Commission on Civil Liability and Compensation, under the chairmanship of Lord Pearson, is considering the whole question of how those who suffer injury should be aided. I shall ensure that its attention is drawn to this debate so that it may consider the implications of the Eraldin story.
My hon. Friend referred to a constituent of his who continued to use Eraldin until June 1976. It is, of course, for a doctor to decide on the appropriate treatment for each individual patient. However, I am surprised that Eraldin should have continued to be available through retail pharmacy until that time. I shall ask my Department to undertake an urgent investigation and I shall not hesitate to take any necessary action.
Finally, let me try to summarise the important issues that arise. The use of any drug in clinical practice involves a consideration of the relative risks and benefits of using the drug. My hon. Friend readily accepted that point.
The current system of drug registration requires the assessment of a large amount of information on the drug's properties before approval for marketing is given. This enables us to prevent the release of clearly hazardous or ineffective new drugs.
Despite extensive studies with a drug in animal experiments or in clinical trials in patients, there will be occasions when adverse reactions to a drug become apparent only after its widespread clinical use. To detect such adverse reactions before marketing would require clinical trials involving many thousands of patients. Apart from the enormous expenditure of time, money and energy in such trials, there would be a considerable delay in the introduction of the drug into clinical practice. This delay could itself impose a cost in that patients would be denied access to a valuable drug—alternative drugs already available might be less effective or more hazardous.
2383 This then leads us to the examination of ways of detecting any unexpected adverse reactions at the earliest possible moment after marketing in order that doctors can reassess the risk-benefit ratio for the drug. For instance, a monitoring system might be established to record any symptom developing in patients treated with a new drug instead of relying as at present on the suspicions of doctors as to whether a particular symptom was drug-related. My Department, in consultation with the Committee on Safety of Medicines, is giving careful and detailed consideration to the possibility of establishing such a scheme on a limited scale. although, clearly, its introduction would involve considerable consultation and discussion.
My hon. Friend asked me to consider establishing a public inquiry, but, as my right hon. Friend the Minister of State explained in his letter to him, it is our view that there would be little to be gained by holding a public inquiry at this stage. My right hon. Friend the Minister of State has, however, asked the Medicines Commission, an independent advisory body, to consider the issues relating to the use of Eraldin.
My hon. Friend pressed me strongly on the question of a public inquiry. It will, of course, be open to the Medicines Commission to recommend that an inquiry should be held and as to whether it should be conducted by members of the commission or by a specially appointed panel. This would be analogous to the commission's report on the prevention of microbial contamination of medicinal products following the Devonport incident.
In my view, what the Eraldin story shows us is that one can never assume that potent drugs are safe in every instance, but if we can devise systems which would lead to earlier detection of unexpected adverse reactions, at least something positive may have come out of the many individual tragedies which have resulted from the use of Eraldin.
I thank my hon. Friend again for raising this important matter, and I assure him that I shall arrange for him to have any outstanding issues cleared in correspondence with my Department.