HC Deb 05 May 1978 vol 949 cc730-44

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

4.3 p.m.

Mr. Phillip Whitehead (Derby North)

In raising this subject, I do not want to be thought to be plugging a particular brand name or suggesting that Naudicelle is a catch-all cure for the scourge of multiple sclerosis. However, I believe that it is of fundamental importance that we and the Department of Health and Social Security give the closest attention to the dietary supplement containing a committee on borderline substances and derived from the evening primrose, which is sold in this country under the name of Naudicelle, as I shall refer to it. We should look at reasons why an increasing number of multiple sclerosis sufferers are, in a sense, conducting their own trial and marking their own personal results by the money they have to spend on the preparation as well as the testimony they almost all give to it.

I was first interested in the properties of Naudicelle by my constituent and friend, Mrs. Josephine de la Mare, secretary of the Derby Multiple Sclerosis Society. I regret to say that after a long illness, which was fought every inch of the way, she died last week. It is right that I should pay my own tribute today to this brave lady. She led me, in early discussions about dietary supplements, both to Mr. Joe Osborne of Newhall in Staffordshire, who has been working in the Burton-on-Trent area, linking Naudicelle dietary supplements with a proper regime of exercise, and to ARMS, the action group for research into multiple sclerosis.

Mr. Osborne, through his own Member of Parliament, the hon. Member for Burton (Mr. Lawrence)—who has taken up his case energetically and who, I know, would have wished to be present today had he not been prevented by a prior engagement—and the ARMS group, in direct correspondence with the Department of Health and Social Security and the Medical Research Council, have been pressing for early publication of the results of recent trials at Newcastle, for further and wider trials of this substance and for support for the screening of close relatives of multiple sclerosis sufferers who may, it seems possible, be at greater risk, so that there shall be an early diagnosis of the disease.

I shall argue that such wider study of a substance with no known harmful side effects and for which much is claimed, would be helped by the availability of Naudicelle on prescription at the discretion of the local general practitioner. Professor Field at Newcastle, who has been a pioneer of research into demyelinating diseases and in the screening of young people who may be at risk, is strongly of the opinion that Naudicelle can be of help to acute sufferers from multiple sclerosis in reducing the number, severity and duration of the attacks which they incur.

There have been earlier experiments by Professor Millar and others into the effects of linoleic acids which principally derive from sunflower seed oils as a dietary supplement. The test which is most eagerly awaited now is the double-blind trial carried out by Professor Shaw, also at Newcastle upon Tyne. This, I understand, covers two groups of patients, the old chronic and acute relapsing patients respectively. Professor Shaw wrote to the hon. Member for Burton on 13th February to say: Our clinical trial has been completed but the results have not yet been fully analysed. Much of the statistical work has been done but there are still a few more calculations to be made before final conclusions can be drawn …. As you may recall, the results of the first part of the trial which were published in the British Medical Journal in October showed that Naudicelle had conferred no benefit on the treated patients. The part of the trial now under analysis deals with a different group of patients but I hope that no assumptions will be made about the outcome of the trial until the calculations have been completed. I am distressed to learn that in Italy Naudicelle has received wide publicity as an effective treatment for multiple sclerosis. This has raised hopes to a degree that is not in my view justified by the scientific information at present available. I include that last rider because it is important to stress very strongly that no one seriously asking for a wider study of the substance ought to claim, or ought to lead multiple sclerosis suffers to believe, that it is a cure for the disease. That is not what is claimed by those who have taken the greatest interest in it and, indeed, by the patients who claim, as I shall show, that it has many beneficial effects for them. It can, it is claimed, control the onset and severity of the attacks incurred by multiple sclerosis sufferers.

The earlier the disease is diagnosed and caught, the greater the beneficial effects have been, it is claimed, in nonscientific trials. That is why we are all anxious to see the early publication of the second series of tests on acute relapsing patients being conducted by Professor Shaw. I spoke earlier this week to Professor Shaw. He told me that he will be calling together in London a group of his learned colleagues in the next few days to evaluate the results that he has achieved in the second test, prior to publication.

In the nature of balloting for debates on the Adjournment, Mr. Deputy Speaker, it is not always possible to predict precisely when the debate will come. In a sense, it might have been better had we been able to have this debate a week or two after the publication of Professor Shaw's finding. However, what I shall be saying today will be argued ex hypothesi on the basis that if we learn something from the second series of tests conducted by Professor Shaw, that will be an additional reason and, I submit, an urgent reason for the Department's taking a fresh look at the claims which have been made so widely for this substance Naudicelle.

Hon. Members who have communicated with the Department of Health and Social Security—as I know many of them have—have had to rely upon the testimony of those already using the substance, and the many doctors and others who have been working in this field, such as Mr. Osborne, to whom I referred earlier, who have used it often in conjunction with concentrated programmes of exercise and physiotherapy.

I think that in this short debate it would be right to quote from at least some of the testimony which is typical of that which so many hon. Members have received from individual sufferers from multiple sclerosis. I shall mention one or two of the letters as an example of the pressure which has rightly been brought to bear upon Members of Parliament to make the DHSS look again very carefully at this matter.

I have a number of letters here from which I shall quote very briefly. First, I have a letter from Mrs. Williams of Burton-on-Trent, who has had the disease for a long time and whose husband has worked closely with Mr. Osborne in that area. She says: In the space of 12 months—from 10th May 1977 to the present day, 4th May 1978—there has been no need for me to visit my GP from either attacks due to MS or, indeed, any other ailment. In fact, I have not lost one working day from my employment … Of course, there have been those days when I felt a little below par, but I think one would agree all normal people experience those. Looking back over these 12 months on Naudicelle, I will now stress more strongly where the greatest stability has been created. Firstly, there has been a tremendous improvement in my vision … and a marked improvement in my circulation. Mrs. Williams then goes on to describe other beneficial effects of the treatment. She has had the disease for a longer period of time, and her letter is typical of many that we get expressing the general view that this substance is very beneficial indeed as a dietary supplement.

The next letter is from a constituent of mine, Mrs. Mason, in Allestree, in Derby, who is talking of her husband. With this case, as with the previous one, I am following up a case which has been mentioned in the book published on the subject by Mr. Osborne. Clearly one wanted to look at such cases some months or a year later, to see whether this had been a false dawn in the case of the sufferers concerned. In each case that I have followed up it would appear that the improvement—or what they believe to be an improvement—has been sustained.

Mrs. Mason, in talking of her husband, writes: His wheelchair is now a thing of the past, now walking with either one elbow crutch or one walking stick, in the home on a very smooth surface he needs no aid at all, his arms are much stronger, his eyesight is better than it has been for years. She goes on to say that the doctor is very pleased by this improvement. To the amazement of the local Press, her husband entered the sports for the disabled recently and was able to win the discus competition, the shot put and the 60 metres freestyle walk. He will go on to compete at Stoke Mandeville in September.

Mrs. Mason says in the course of her letter that she thinks that the capsules should be available to multiple sclerosis patients on the National Health Service. She adds: It is cruel to deprive them of it. They are like insulin is to a diabetic, and where would they be without their insulin, and yet that is free for diabetics. I appreciate that there are very great differences between the need to provide insulin for diabetic sufferers and what is claimed and what is so far known of the gamma-linolenic concentrates. However, I feel that when people speak in those terms, although they may be using a figure of speech, they are expressing, in what is to them the clearest possible way, the amazing effect that the treatment has had on them and on their own lives. They are lives which, I remind my hon. Friend, have been largely without hope because one of the cruellest features of the disease multiple sclerosis is that when it is initially diagnosed all too often in the past people have been told "I am sorry. There is no effective treatment. We can ease the downward progression of the disease, perhaps. We can make you comfortable for long periods of time. You will enjoy periods of remission. But the overall prognosis is pretty hopeless." That is what has caused so much despair and dismay amongst those who have had the disease diagnosed and why it is so important that we should look at every possible way of helping them.

I have a number of other letters which it is perhaps unnecessary to quote at length because they all make the same basic point that their condition has stabilised and that some at least of the symptoms of this dreadful disease have been very much ameliorated over the course of months and years during which they have been taking this preparation as a dietary supplement.

This is no scientific trial. I accept that. It could not possibly be. But it is of importance that we have the widest possible knowledge of these case histories, and I want to ask my hon. Friend to say how many submissions there have been from general practitioners about Naudicelle and about the beneficial effects of linoleic and gamma-linolenic concentrates of this kind, whether based on the evening primrose, sunflower or safflower oils.

We need to know what the medical profession, directly in touch as GPs are with the average MS sufferer, is now saying about this, and I think that we also sould know whether there are any known harmful side effects to this preparation. I know of none, and I have been told of none. It is important that this should be established. If we argue, as I am in this debate, that it would be greatly in the interest of arriving at some kind of conclusion about the possible beneficial effects of Naudicelle if we were to have it more widely available so that there could be a test within the general population, we need to know whether it has harmful side effects. I believe and I submit that it has none.

The Department has said in letters to me, to the hon. Member for Burton and to a number of other hon. Members that Naudicelle is a food and not a medicine, that it will keep a benign eye on tests into the efficiency of dietary supplements, and that it has allowed Naudicelle a Medicines Act licence under the 1968 Act with all the usual limitations, but no more than that.

The problem is that for the many thousands of multiple sclerosis sufferers time is very precious and hope is rationed. Many of the letters that I have mentioned speak of the utter despair of those who have had multiple sclerosis diagnosed. This is why, in terms of those who have it at the moment and even more so in terms of those many thousands who will have it diagnosed in the next few years, it is important that we should now have from the Department a promise of early action.

With that in mind, the questions which I wish to ask are these. Will the Department undertake to act on the results of the Newcastle tests if these happen to show beneficial results for acute relapsing patients? Will it, in those circumstances, be prepared to go back to the advisory committee on bordering substances and to the MRC and to consider once more the possibility of putting Naudicelle on the National Health Service at the discretion of the general practitioner concerned? Will it further extend the field trials under its own auspices prior to such reconsideration? At the moment we know of the double-blind trial which is going on at Newcastle and we know of the immense random sampling, if it can be so described, which has come to the surface as a result of the work of laymen such as Mr. Osborne and many individual branches and arms of the Multiple Sclerosis Society. We should like to see the Department itself intervening and taking a hand.

Finally, I wish to go slightly wide of the subject of this debate and ask my hon. Friend whether the Department will undertake to extend and further investigate the system of diagnostic blood testing which has been developed by Professor Field. It is in this area that there is the most hope for combating those forces which appear to act early on the acute multiple sclerosis sufferer. If any of the claims for these dietary supplements have been justified, it is obviously in cases where the disease has not progressed through all its acute stages. In that stage most can be done by the dietary supplements.

The badge of the Multiple Sclerosis Society is a key. We are all looking for the key which will unlock the mysteries of this disease. The most curious thing about the disease itself is that perhaps that key might be found in the seeds of that equally mysterious flower, the evening primrose.

4.22 p.m.

The Under-Secretary of State for Health and Social Security (Mr. Eric Deakins)

I am glad to have this opportunity of replying to the points raised this afternoon by my hon. Friend the Member for Derby, North (Mr. Whitehead). I know that his interest in this subject—which goes back a number of years—is shared by other hon. Members. Let me say frankly at the outset that there is very little I can add to what my right hon. Friend the Minister has already said on this matter in reply to hon. Members who have written to him and put down Questions in the House.

The reason for this is that in all fields of treatment and prescribing of medicines one must tread most carefully and cautiously and, as I hope I can show to the satisfaction of my hon. Friend that, in this area particularly, there is very good reason indeed for slow progress. Let me first explain something of the general context in which treatment under the National Health Service occurs.

Family doctors, under the National Health Service, are free to prescribe any drug or medicine they consider necessary for the proper treatment of their patients, though they may be asked to justify their prescribing decisions, if the cost appears excessive, or if the substance may not be a drug. Only the doctor concerned can decide whether something is necessary for the treatment of his patient and whether that substance is something that should properly be prescribed as a charge on the National Health Service.

If there is any doubt on the latter point, the doctor will consider carefully whether he would feel able to justify the decision to prescribe a substance if called upon to do so. If he is satisfied on this point, there is nothing to prevent him from issuing the prescription and it being dispensed in the normal way.

I emphasise that it is the doctor, and only the doctor, who can determine which medicines or drugs should or should not be prescribed for a patient. It is certainly not the Department's job and it would be quite wrong for it or anyone else—including the patient—to attempt to influence the doctor's decision.

My hon. Friend asked about representations from doctors. Over the course of some three years there have been 69 cases of family doctors who have defended their decision to prescribe Naudicelle for multiple sclerosis before their professional colleagues on the local medical committee. In 25 of these cases the doctor concerned was about to satisfy his colleagues that the substance had been properly prescribed in the circumstances.

National Health Service legislation does not define a "drug". The question of which items or substances should or should not be regarded as drugs, which form part of the pharmaceutical services under the National Health Service Act, has been considered on several occasions by independent professional committees. Precise terminology has varied, but the basic conclusion of each committee has been that substances of a primarily nutritional nature cannot be regarded as drugs and, because they are therefore "foods", cannot be provided on National Health Service prescription.

Often the question whether a particular substance is a drug depends upon the circumstances, and no definition could hold good for every case. However, for practical medical purposes, it is reasonable to expect that, where a substance is prescribed for a patient, the substance will have both pharmacological and therapeutic effect on the condition being treated.

In certain conditions, a "food" may have the characteristics of a "drug". To advise on the circumstances in which items may be regarded as "drugs"—and therefore prescribable at National Health Service expense—the Department and the profession are very fortunate to have the services of an independent professional body chaired by Professor Barbara Clayton of the Hospital for Sick Children. This body is known as the advisory committee on borderline substances.

The advisory committee plays a continuing role in examining claims of therapeutic efficacy for individual substances and preparations in relation to particular conditions—that is, whether in particular conditions they may be regarded as having the effect of a drug. Such is the prestige of this independent committee of experts among their professional colleagues that any recommendation which is made is usually acceptable to all concerned. However, I must point out again that whatever the committee's recommendations, the final decision whether a substance should be prescribed for a patient's condition rests with the doctor.

The practical effect of this is that if the committee recommends that a substance acts like a drug for a particular condition then, if the doctor prescribes it for that condition, the National Health Service pays for it. If the committee does not so recommend, decisions to prescribe that substance may be challenged, but—and to re-emphasise the point that I made at the beginning about the prescribing freedom of the family doctor—doctors can and often do successfully defend their prescribing decisions, through the machinery laid down in regulations for this purpose, notwithstanding an advisory committee recommendation.

I have described this framework in some detail, because it is germane to the fundamental question raised by my hon. Friend why the substance known as Naudicelle cannot at present be provided at National Health Service expense in the treatment of multiple sclerosis at home. I say "at home" deliberately, because a patient in hospital is provided with all his daily needs. These include whatever food and toilet preparations may be considered advisable for him and which he would be expected to provide for himself as necessities of normal life if he were living at home.

As those who have had anything to do with the disease will know—my hon. Friend stressed this matter—multiple sclerosis is a very distressing disease and one which is most difficult to treat. I understand its effects are so variable between individual patients and that the course the disease follows is so erratic that often it is difficult for a layman to appreciate that a multiple sclerosis patient in remission is ill. I am told that many of the features of multiple sclerosis can present—variability, erratic and unpredictable developments—make every patient's case uniquely individual.

That being so, formidable barriers are presented to those evaluating the efficacy of particular types of treatment. At any time patients may experience spontaneous remissions of the condition, sometimes of long duration, so that it can be most difficult to know whether encouraging changes are in fact due to treatment.

Multiple sclerosis is the general term given to cover many symptoms of weakness and loss of use occurring in different parts of the body. Experts differ in their views on the disease, and for this reason no single method to treat the condition or alleviate the symptoms has been arrived at. One view is that if the proportion of saturated fat in the diet were reduced relative to unsaturated fat, it might help a patient's nervous system function more effectively. To explore the validity of this theory, multiple sclerosis patients have been given oils such as sunflower seed oil which contain the unsaturated fat, linoleic acid. An even less saturated fat, gamma linoleic acid is, I understand, found in the oil of the evening primrose, as my hon. Friend pointed out, and it is this oil which is contained in Naudicelle capsules.

The capsules are a proprietary preparation manufactured by Bio-Oils Research Limited of Nantwich, Cheshire. From the outset it has claimed that the Naudicelle capsules contain a pre-digested form of linoleic acid which acts more directly and more quickly than other linoleic acid derivatives.

This claim was included in the evidence submitted to the advisory committee on borderline substances in July 1974. At that time the committee convened a special meeting to consider in detail the whole question of the use of dietary supplements and linoleic acid and its derivatives in the management of multiple sclerosis. The committee examined in great detail all the available evidence published during the preceding years. In addition, it considered the written evidence from several consultants—some of whom participated at the meeting—who were either known to the chairman or who had been recommended by the Medical Research Council as being or having recently been engaged in research into the problem. I am advised that the research for the meeting, the trouble taken to canvass informed opinion and members' keen interest and sympathy combined to make this probably the most carefully prepared exercise the advisory committee on borderline substances had ever undertaken.

Reluctantly, after much deliberation, the committee decided that there was no evidence which could justify recommending that linoleic acid or its derivatives should be regarded as a drug in the management of multiple sclerosis. The committee was particularly concerned that any advice offered should be founded firmly on scientific evidence. It felt that it would be wrong to offer advice that might raise false hopes among multiple sclerosis patients, their families or friends, that an effective palliative or cure was close at hand—a point emphasised by my hon. Friend. Members noted that research into the value of unsaturated fats in the management of multiple sclerosis was continuing and expressed their readiness to reconsider their decision if and when fresh scientific evidence became available.

Moreover, in October 1974 a conference on multiple sclerosis, arranged jointly by the Medical Research Council and the Multiple Sclerosis Society of Great Britain and Northern Ireland, reached broadly the same conclusion on the question of dietary supplements as the advisory committee on borderline substances. Furthermore, it is worth pointing out that the Medical Research Council's annual report for 1975–76 stated: The evidence for a beneficial effect of linoleic acid supplements in the diet is unconvincing but the existing studies should be continued; meanwhile no further trials should be supported. I must take serious note of this view. It is an expert one and is endorsed by my medical advisers in the Department.

To give the House further evidence of the Government's constant concern to leave no stone unturned in this matter, I should like to point to my right hon. Friend's meeting with a deputation from the Multiple Sclerosis Action Group early last year. Particular attention was paid at that meeting to the claims that were being made for Naudicelle capsules and the superior virtues of their active ingredient, gamma-linolenate as compared with those of linoleic acid and to the need for further research. The deputation included a distinguished research scientist who, I understand, is engaged in the field of multiple sclerosis research and who explained the claims for gamma-linolenate very lucidly. However, my right hon. Friend had to tell the deputation that, having consulted the Department's medical advisers afresh about these claims and the value of further research, he felt that he would not be justified in initiating or supporting more research. He promised to ensure that any new scientific evidence that may appear is placed before the advisory committee without delay.

I understand that, in addition to the research mentioned in the MRC report that I quoted earlier, a trial financed by the Multiple Sclerosis Society of Great Britain and Northern Ireland of dietary supplements, including Naudicelle capsules, has been undertaken at a hospital in the North-East. The results are expected shortly. The chairman of the advisory committee is in touch with the research teams concerned and hopes to convene at an early date a meeting of the committee, augmented by other experts invited for the occasion to consider these results. Of course, we can make no assumptions yet about the outcome of the trials.

Since the submission to the advisory committee in 1974, Bio-Oils Research Limited has applied for and been granted a product licence for Naudicelle capsules under the Medicines Act 1968 as dietary supplements where unsaturated fatty acids are needed". Aside from the researches sponsored by MRC and the Multiple Sclerosis Society, I understand that Bio-Oils Research Ltd. has been granted a clinical trial certificate to enable it to have its product tested in relation to multiple sclerosis. The certificate is valid until November this year. Naturally, if the firm were then to produce evidence of the efficacy of its product in relation to multiple sclerosis, it would be open to it to apply for its existing product licence to be varied so as to specify the disease.

If such a variation were granted there would be no question that Naudicelle might be regarded as a drug in the management of multiple sclerosis.

The Government regard the promotion of health and the prevention and eradication of disease as a prime responsibility of my Department. However, we cannot will the results or the developments that we desire. I know of nobody who does not wish that a drug that would cure or alleviate multiple sclerosis were available.

Certainly the moment any substance or preparation is shown scientifically to have a beneficial effect, then, whatever it is, it will be made available as soon as possible as a drug for the treatment of the disease. However, I am bound to remind the House, as I implied at the outset, that the history of research into multiple sclerosis is one of repeated disappointments.

My hon. Friend has raised a number of issues including early diagnosis and the possibility of the Department having field trials about which I shall write to him. In the meantime, let me repeat that the reason why Naudicelle would be challenged if prescribed by a family doctor at National Health Service expense is that we are advised that the only scientifically reliable evidence that we have does not justify the belief that dietary supplements such as Naudicelle capsules are helpful in the management of multiple sclerosis.

Question put and agreed to.

Adjourned accordingly at twenty-seven minutes to Five o'clock.