HC Deb 31 January 1974 vol 868 cc718-30

8.34 p.m.

Mr. Jack Ashley (Stoke-on-Trent, South)

The purpose of this debate is to tear aside the veil of obscurity which has shrouded the fate of thousands of children, to suggest urgent action aimed at reducing the number of future tragedies, and to offer proposals to compensate those who are severely damaged.

An eminent virologist of international repute has spoken of "a conspiracy of silence" about reactions to a vaccine and warned that authorities "try to ' muzzle' critics".

While I recognise the fear that any discussion of risks may impair the public's confidence in immunisation procedures, I believe that it is time the conspiracy of silence was ended, because too many young lives are being devastated. I emphasise that I fully support the general immunisation programme. But we owe it to the children already damaged, and have a duty to those who may be damaged, to reveal the true situation.

The suffering of vaccine-damaged children, and their families, is appalling. I quote a few examples from some of the parents' letters I have received.

A mother writing from Pembroke, whose daughter was born in 1960, and took ill after her triple vaccine injection—diphtheria, tetanus and whooping cough—at the age of 11 weeks, wrote: At 13 Carolyn cannot walk, talk or help herself in any way. She is incontinent and has major epileptic fits which often result in pneumonia, although I have a supply of antibiotics and three suction units at home. Carolyn cannot even hold her head up and is of no mental age at all. She is tall and quite strong. We love her dearly and cherish and care for her 24 hours a day, but I feel dreadful that all this happened through an injection that should have prevented disease. Tragedy for a child; heartbreak for her parents; yet the Government and the medical profession have the insolence to discourage discussion of these effects.

Take another example: a 10-year-old Blackpool boy who was four and a half months old when he had the triple injection. He was a normal baby, but, I quote his mother: The same night he had the injection, he awoke screaming. He was rolling his eyes and jerking…ever since that day…he cannot help himself in any way, he cannot walk, talk, is still incontinent and has to be washed, dressed and fed. He has had the fits daily ever since the night of his injection; he can have as many as 12 a day. He has had to have three drugs three times a day for the last 9½ years, and has to continually wear a crash helmet to avoid injury to himself. How many cases of adverse reactions to vaccines are there? The shattering complacency of the Government was revealed two days ago, when the Under-Secretary of State for Health and Social Security admitted in reply to a Written Question from me that the majority of adverse reactions are not reported". That is a serious admission of gross neglect, which is not minimsed by the added limp comment that it appears that under reporting is less marked with the more severe reactions. If that is true, the Government should be able to provide the House with reasonably accurate figures of the more severe reactions. But they cannot. The Minister can speak only in generalities, and misleading generalities at that. For example, he said in answer to another Question last Tuesday that: The number of cases of permanent damage resulting from the use of licensed vaccines is very small."—[OFFICIAL REPORT, 29th January 1974; Vol. 868, c. 67–68.] How small is very small? A couple? Half a dozen? Perhaps even a score? I do not know. Perhaps the Minister does. If the Minister has reliable figures he should give them to the House tonight. If not, he is guessing. He has already admitted to me in a parliamentary answer that the machinery for notification is not working properly. He is, therefore, not only guessing but actually conducting a national immunisation service without full knowledge of the terrible risks involved for some of the children.

But data have been obtained from two cities—one in the Midlands and one in the South of England—which indicate that permanent brain damage followed whooping cough immunisation in one child in 5,000 or so. This can be compared with a Swedish survey which showed that between one in 3,000 and one in 6,000 children had some form of cerebral illness after the whooping cough vaccine.

Since nearly 10 million children have now been vaccinated by the whooping cough vaccine, it follows that if the estimated figure of the surveys of one in 5,000 children is correct, then we probable have some 2,000 seriously vaccine-damaged children in Britain.

I challenge the Minister. Does he deny that we have between 1,000 and 2,000 children brain-damaged for life as a result of the whooping cough vaccine? It is a direct challenge. If he denies it, what is his evidence? The House will expect to be told.

For what purpose has this appalling damage been inflicted? For a vaccine which a medical survey has shown to be of very limited effectiveness today; for a vaccine which the city of Hamburg dropped over 10 years ago—and there is no more whooping cough in Hamburg than anywhere else. These are significant facts.

Over 1,000 or possibly 2,000 young lives are shattered, not to mention the pain of loving families, because of a disease whose virulence is falling away anyhow—just like scarlet fever which has fallen in similar proportions over the years, and without the aid of a vaccine. This is an unacceptable price for a vaccine of controversial, even dubious, value.

This daunting human cost can be reduced by resolute Government action and the co-operation of the medical profession. The Government should take firmer measures to ensure that no child obviously at risk should be vaccinated and, if necessary, they should prescribe penalties for doctors who do not accept this injunction.

No child with a neural development defect, a current or recent infection, fits or convulsions, or close family relatives who have had fits or epilepsy should be vaccinated. Yet, in 1974—last night, in fact—a leading consultant at a famous children's hospital can tell me that one third of all children brain damaged by vaccination should never have been vaccinated at all. In these circumstances, mothers should refuse the whooping cough vaccine until they are assured by the doctor who is giving the vaccine that there are no factors present which place the child at risk. Doctors should also be urged to report reactions urgently, because time can be vital Yet so often time is wasted, to the detriment of the child.

The Government, in co-operation with the medical profession, must do much more to reduce the toll of children's health and happiness. They must insist on a comprehensive, statistical survey giving full information about adverse reactions. They must call for more careful checks as a precaution against vaccinating those at risk. They must alert doctors to the need for urgent action where there is adverse vaccine reaction.

When all this has been carried out, however, there will still be the tiny minority who slip through the net, because there is no universal test to discover the children at risk. It is for these children that the Government must act, and act decisively. They should provide compensation for all those already damaged and stop pretending that the Royal Commission can deal with this. It cannot and the Minister knows that it cannot deal with it.

The Government should also set up a State compensation scheme to underwrite the immunisation programme. Immunisation benefits society as well as the individual. It also entails known risks, and it is irresponsible for the Government to fail to insure against those risks. It is ludicrous that the victims of industrial, driving and criminal accidents should be compensated while the victims of vaccination are not. Six European countries and Japan have compensation schemes for vaccine-damaged children. They have no insuperable difficulty in linking cause and effect and in providing for those in need.

We in Britain should have led the world in our provision for these children. We did not; but we should have done. At least in following those European countries and the Japanese we can show that we can improve upon all previous schemes and do as much to relieve these families' burdens as any nation can possibly do.

8.47 p.m.

The Under-Secretary of State for Health and Social Security (Mr. Michael Alison)

I am glad that the hon. Member for Stoke-on-Trent, South (Mr. Ashley) has been successful in raising tonight the tragic question of children who have suffered damage from vaccination and immunisation against infectious diseases. I should like to assure him that this matter greatly concerns my right hon. Friend the Secretary of State and that I myself feel no less deeply about it than do the hon. Gentleman and his colleagues. For reasons which I shall explain, however, our approach to the matter may be a little different.

When the National Health Service Act came into force in 1948, policy on immunisation was confined to a very few diseases. Apart from any requirements for the purpose of international travel, vaccination against smallpox and immunisation against diphtheria were the only procedures officially recommended in England and Wales. The picture changed, however, with the availability of inactivated poliomyelitis vaccine, which gave us the possibility of controlling polio by a large-scale vaccination programme.

To consider the implications the Central Health Services Council and the Scottish Health Services Council jointly set up a Committee on Poliomyelitis Vaccine in 1955. The setting up of this joint committee marked the first stage in the evolution of arrangements which now exist for ensuring formal expert consideration of the use of vaccines in general.

Over the years it became clear that a number of issues relating to immunisation, other than against poliomyelitis, were being referred to the Joint Committee on Poliomyelitis Vaccine because there was no other authoritative body. In 1962 the natural step forward was taken and the committee was superseded by a new Joint Committee on Vaccination and Immunisation, appointed by the Central and Scottish Health Service Councils, with the following terms of reference: To advise the Health Ministers on all medical aspects of vaccination and immunisation. The joint committee continually reviews the use of existing vaccines and considers the possible application of new vaccines. For example in 1968, after careful consideration of all the available facts, it recommended the introduction on a national scale of measles vaccination for all susceptible children between one and 15 years, and in 1970 the use of rubella vaccine for all girls between their eleventh and fourteenth birthdays. Subsequently rubella vaccination was extended to other groups considered to be at special risk.

In 1971 the joint committee took the historic decision that, because routine vaccination against smallpox had proved so effective in dealing with the disease it need no longer be recommended. It reached this decision after careful consideration of the World Health Organisation's smallpox education programme and concluded that the occasional serious complications in childhood had by that time become out of proportion to the likely risks from smallpox in Britain, and routine vaccination could therefore be stopped.

At present the joint committee recommends routine vaccination against the following diseases: diphtheria, tetanus, pertussis or whooping cough, poliomyelitis, measles, tuberculosis and rubella. The success of the immunisation campaign can be measured by the virtual eradication of such killing and maiming diseases as diphtheria and poliomyelitis.

Between 1933 and 1942, for example, there was an average annual total of 55,125 notifications of diphtheria in England and Wales and 2,783 deaths, whereas in 1973 provisional figures indicate four notifications and no deaths. In 1955, before immunisation against poliomyelities was introduced on a national scale, there were 6,331 notifications and 270 deaths, whereas in 1973 provisional figures indicated a total of seven cases and no deaths. In addition various vaccinations are recommended for people travelling abroad. I know the hon. Gentleman will agree that such figures illustrate the value of our immunisation programmes and the work that the joint committee is doing.

Mr. Ashley

We have plenty of time and I hope that the Minister will not mind if I interrupt occasionally. As he has been quoting the effects of the various vaccines, can he inform the House of the extent to which scarlet fever has decreased in this country? It is not a disease which is subject to a vaccine. Is it true or false to say that scarlet fever has fallen in exactly, or almost exactly, the same proportions as whooping cough, without a vaccine? Does this indicate that whooping cough vaccine is not necessarily the saviour that the Minister would like us to believe?

Mr. Alison

I cannot without notice give the categorical answer that the hon. Member seeks about scarlet fever. But the figures which I have given have not touched upon the effect that vaccines have on whooping cough.

I come back to the point I was making. In spite of misgivings that the hon. Gentleman has about whooping cough, he will agree that the figures I have given for poliomyelitis and diphtheria illustrate the striking value of our immunisation programmes and the work that the joint committee is doing. No immunising procedure is entirely free from risks or ill effects or, as they are technically known, adverse reactions.

Mr. Ashley

I am sorry to interrupt the hon. Gentleman again, but would he care to challenge my figure that in Hamburg, in Germany, the rate of decline of whooping cough has been the same as in Britain, where we were using a vaccine? Therefore, in Hamburg there have been no adverse reactions to whooping cough vaccine and the people there have enjoyed a fall in the incidence of whooping cough in the same way as we have done.

Mr. Alison

That may well be the result of the momentum generated by an earlier period of vaccination, similar to the momentum that we have discovered associated with the eradication of smallpox. It is conceivable—it certainly happened in the case of smallpox—that ultimately a particular vaccination or immunisation programme can be superseded, but I am not prepared to say that at present we have reached that stage in the case of whooping cough.

As I have said, no immunising procedure is entirely free from risk or from adverse reactions. Some of these risks can be avoided by recognising contraindications before treatment—for example, eczema in the case of smallpox or a history of convulsions in the case of whooping cough; and by the observance of careful techniques in administering vaccines. Some risks are unpredictable and are to that extent unavoidable in the individual—for example, the exceedingly rare development of paralysis after live poliomyelitis vaccine has been used.

Precise estimates of the degree of risk are difficult to make. Illnesses or disabilities reported as adverse reactions may often have another explanation. In the individual patient it is often difficult—frequently impossible—to determine whether the illness or disability is causally related to the immunising procedure or has arisen as a coincidence. Estimates of rates depend on collecting information on a series of patients and are influenced by the criteria used for deciding that the alleged reactions are causally related.

The balance of benefits and risks from immunisation is kept continually under review. There is no doubt that all vaccines currently recommended for routine immunisation carry risks substantially less than that of remaining unvaccinated. For instance, the risk of developing serious disorder of the central nervous system as a result of natural measles is probably at least 100 times greater than that associated with the present measles vaccine.

The fact that there are risks associated with immunisation—as with most forms of medical treatment—is generally known, but it is a moot point how far it is desirable to do more to warn individuals or parents about possible risks when these are exceedingly remote. For example, the risk of developing paralysis after the use of live poliomyelitis vaccine is about one million, or less; and warnings may do less to assist in a rational decision on merits than they do to deter some people from accepting protection which at a later date may save a life. I must ask the House to bear this point in mind.

Mr. Ashley

I am astonished at that admission by the Minister. Is he suggesting that it is a deliberate act of Government policy to hide or to obfuscate the truth, which he has admitted, that there is the possibility of adverse reaction and that by cool calculation he is deceiving people about the possibility of that adverse reaction?

Mr. Alison

Those risks are properly handled by the proper medical adviser of the patient who is interested in securing vaccination. It is up to the adviser to advise the patient on the risks, but he would be doing a disservice to the patient by stressing too deliberately the very small risks which may derive in comparison to the real benefit which may accrue, either then or at some time in the future when the disease may be rampant.

I should like to say a little about the care taken to ensure the safety of vaccines. The Committee on the Safety of Medicines has statutory responsibilities in relation to the safety, quality and efficacy of vaccines, as of other medicinal products, and for measures taken to promote collection and investigation of information about adverse reactions. Control is exercised through a system of licensing, but the collection of information about such reactions relies on a system whereby all doctors, dentists and manufacturers have been asked to submit summarised reports of any cases where it seems possible that use of a medicinal product may have harmed a patient. Reports are assessed by doctors experienced in monitoring. If it appears likely that risks associated with a particular product outweigh probable benefits, or that possible side effects are too serious in relation to the purpose of a product, the committee may take action to ensure that it is withdrawn from the market or to restrict its availability in some way.

In less serious cases the committee may decide to send a warning to all doctors about adverse reactions which have followed the use of a product. In 1967 doctors were specially reminded about the importance of reporting adverse reactions to vaccines. While 100 per cent. reporting cannot be guaranteed under any system which partly relies on voluntary co-operation of so many people, I am satisfied that valuable information is being obtained, much of which can be used to identify new problems as they arise or to highlight the need to initiate new studies of existing problems. I understand that a total of about 170 reports of adverse reactions to vaccines of all types are received each year.

The hon. Gentleman has raised the question of compensation in cases where, unfortunately, adverse reactions occur. While a vaccination programme of any kind is in a sense for the common benefit of society, its primary purpose is to protect individuals. Those who consent to vaccination do so for their own benefit or that of their children. The fact that there is risk involved in vaccination does not make it different from many medical and surgical procedures, when there are often very serious risks.

Clearly the implications of compensation for the ill effects of vaccination, where there is no question of negligence, are wide, not only with vaccination but in general medical care. Great difficulties could arise, first in deciding whether a particular disability was properly attributable to a particular procedure and, secondly, in deciding what degree of disability was admissible and the right levels of compensation. It has therefore been the Government's view—and, I should emphasise, the view of previous Governments as well—that the grant of compensation payments in these particular cases is not appropriate or feasible.

When I say this I do not for one moment forget the heavy burdens that are placed on families in those rare cases where serious ill effects result. These are recognised in the various benefits that are provided for such families. This includes the attendance allowance for severely disabled people who fulfil certain conditions, which have been extended to include the less severely disabled children since 1st October 1973. From the age of 16 those without an insurance record and unable to earn their own living are normally entitled to benefits under the Supplementary Benefit Scheme designed both to give them an income and to meet special needs. For the disabled adult who can work, the basic provision lies in the special employment services of the Department of Employment.

In those countries for which information is available, claims for compensation for disability resulting from vaccination appear usually to be made by way of action in the courts against manufacturers, practitioners, hospitals and so on. In the Federal German Republic there also exists a foundation from which financial assistance is given to such claimants. The foundation is financed jointly by the Federal Government and a drug manufacturing firm, and provides help over and above that granted under the social insurance system.

That fund, primarily established for thalidomide victims, is now used for relieving the victims of other adverse reactions or therapeutic misadventures. The parents of the child victim need to sue either the manufacturer or the doctor by civil action, and the degree of permanent disability is assessed by two medical assessors.

In Denmark the effects of disability are mitigated financially by means of invalidity allowances based on impaired or lost earning capacity. The evaluation of compensation is handled by the directorate of industrial insurance and the disablement benefit, paid from public funds, depends upon the degree of incapacity. No damages are paid for minor adverse effects of short duration.

In Switzerland an integrated cash and care system exists which, either directly or by agency arangements, seeks to meet most of the needs of the disabled, including disabled housewives and children. The disabled child who reaches 18 years with impaired earning capacity is entitled to an invalidity pension at the half or full rate according to the extent of the capacity and in addition to an allowance at one of the three grades in respect of attendance needs. Certain other special payments are available.

In France no legislation exists governing compensation in these circumstances. Claims have to be made through a legal tribunal. In Japan there is no special legislation but the Government are considering an Act dealing with accidents due to medicines.

The House will know that the Royal Commission on Compensation and Civil Liability is now sitting. The Royal Commission's terms of reference include ill-effects incurred by children as a result of immunisation. I understand that the commission intends to begin to seek evidence shortly and will be inviting anyone it knows to be interested in this problem to give evidence. This, it seems, offers the most constructive course for the hon. Gentleman to undertake in pursuing this matter. Clearly, any decision by the Government must await the Royal Commission's report. I am bound to remind the House, however, that my right hon. Friend the Prime Minister made the matter clear in his statement of 19th December 1972 about the setting up of the commission—and in the context of the tragic thalidomide cases—when he said that No recommendation the commission may make could have any retrospective effect."—[OFFICIAL REPORT, 19th December 1972: Vol. 848, c. 1120.]

Mr. Ashley

Is the Minister now telling me, contrary to what he has told me in parliamentary answers, that the Royal Commission cannot take account of any retrospective legislation? Does that mean that children already damaged by vaccines will receive no compensation? Further, is he aware that I offered him a challenge this evening to deny that there are living in Britain between 1,000 and 2,000 gravely impaired children who have been impaired as a result of vaccine? If he is able to do so, will the Minister please answer that challenge?

Mr. Alison

On the hon. Gentleman's first point, I must confirm what my right hon. Friend the Prime Minister said and what I said earlier—namely, that the Royal Commission has no power to make retrospective recommendations, and any children suffering damage from any medical or therapeutic cause at present must seek to recoup damages, if damages can be recouped, by civil action or by proving negligence in some way.

I am in some difficulty in accepting the hon. Gentleman's challenge because of the extreme difficulty of establishing a causal relationship between certain events which follow a vaccination or immunisation procedure. In many cases those events may follow a substantial time after such procedures. That is a real difficulty with which we are faced.

To conclude, I once again thank the hon. Gentleman for raising this important subject. I hope I have shown that the introduction of vaccines is handled responsibly and in the light of rigorous scrutiny, and that the risks are very very small indeed. I am glad also to have been able to draw attention to the Royal Commission, and I hope that the hon. Gentleman and anyone else who has something to contribute will assist its task by offering evidence.