§ 5.58 p.m.
§ Lord Clement-Jones rose to ask Her Majesty's Government whether the Department of Health plan to issue new guidance on MMR (measles, mumps and rubella) vaccine in the light of new medical evidence and litigation recently instituted against pharmaceutical companies manufacturing the vaccine.
§ The noble Lord said: I initiate this debate not so much as a Front Bench spokesman but more as the concerned parent of a small child of 10 months with the need to take a decision on whether or not to vaccinate in the next few months.
§ I wish to stress that I am not anti-vaccination as such; but the more I have looked at the facts surrounding the MMR vaccine, the more perturbed I have become. Many parents share my concerns. There are now well over 1,800 families who have contacted solicitors because they believe that their children have been permanently damaged after being given MMR or MR vaccination. Of those cases, more than 350 have now been investigated by the solicitors. The common factors are: first, that the parents are convinced that their children were developing normally before taking MMR vaccine; that the children were given the vaccine and that the children have acquired physical injuries and/or disabilities after receiving the vaccine.
§ The injuries recorded include conditions such as: autism, bowel problems, epilepsy, encephalitis, behavioural problems, diabetes and multiple sclerosis. Autism is numerically the greatest. The cost to society of caring for these injured children could be huge.
§ The original three MMR vaccines were: Pluserix, Immravax and MMRII. They were introduced into the UK in 1988. The Public Health Laboratory Service, when it first tested the vaccines, only looked at three weeks' experience after receipt of the vaccination. Pluserix and Immravax vaccines were hastily withdrawn in September 1992, following evidence from research commissioned by the Department of Health and carried out at Nottingham which, contrary to the Department of Health's expectations, demonstrated a strong link between the Urabe strain of mumps contained in the former two vaccines and meningitis. MMRII, which contains the Jeryl-Lynne strain of mumps, continued in use, but some 1,000 cases of injury appear to be related to this vaccine.
§ In February 1998, an article in the Lancet by Dr. Andrew Wakefield of the Royal Free Medical School and others postulated, but did not—as they acknowledged—prove a link between developmental and bowel disorders and MMR vaccination based on the study of 12 children.
§ The Department of Health shortly thereafter held, under the auspices of the then Chief Medical Officer, Sir Kenneth Calman, and Dr. John Pattison, a meeting of experts to review and discuss available evidence. This included neurologists, paediatricians and immunologists, including Dr. Wakefield.56
§ In its subsequent summary of the meeting, the Department of Health gave the impression that the meeting conclusively decided that no linking evidence between measles vaccine or MMR immunisation and either Crohn's disease or autism had been found.
§ In fact, however, the evidence was not treated as conclusive. The Medicines Control Agency set up a working party to examine links between autism and MMR vaccine which is due to be published shortly. The MCA clearly had genuine doubts, but did not share those doubts with the general public at the time.
§ What is the medical evidence we have so far? The most definitive study was carried out in 1994 for the US Centers for Disease Control—the Vaccine Safety Datalink Project—which monitored the progress of half-a-million children. Their key finding was that the incidence of seizure increased dramatically, by three times the norm, after MMR vaccinations. This was confirmed by a similar study carried out in the UK by the Public Health Laboratory Service, but it was withheld until the 1994 vaccination campaign, Operation Safeguard, was over.
§ Research suggesting a link between measles vaccine and acute encephalopathy was published by Robert Weibel and others in paediatrics in the US in March 1998. The most recent published evidence comes from the University of Michigan College of Pharmacy and has been published in the peer reviewed journal Clinical Immunology and Pathology. It was carried out by Drs. Singh and Yang and looked at a study of 48 autistic and 34 normal children and measured the levels of antibodies to measles virus. This study suggests that measles or MMR vaccines may in some way prompt some people's immune systems to act in a negative way to brain tissue.
§ In research, which is currently being prepared for publication, Mr. Paul Shattock, director of the autism unit at the University of Sunderland, has discovered a peptide derived from food in autistic children's urine. He postulates that the cause of the brain damage of all types to the children appears to be the lodging of measles virus in the gut which causes inflammatory bowel disease. This allows the peptide to cross the so-called blood-brain barrier and to effect neurotransmission, which leads to the behavioural disorders mentioned.
§ All those studies, while not proving a link beyond doubt, certainly provide powerful circumstantial evidence. It appears to be only a matter of time before further virological research proves the link. The fact is that our understanding of the immune system, whether in connection with research such as this, or that carried out into Gulf War syndrome, is still in its infancy.
§ The medical evidence is backed up by home video evidence in many cases, which demonstrates the children developing normally, talking, laughing and then suddenly, after the time of the MMR vaccine being administered, demonstrating behavioural problems, lack of speech and interaction. The most common age to develop autism is between one year and two years old. The videos show autism developing at much older ages.57
§ The guidance given to GPs on vaccinations is contained in what is known as the Green Book: Immunisation against Infectious Diseases. Guidance to the general public is given by the Health Education Authority. The plain fact is that the dangers of mumps, measles and rubella have in recent years been consistently overplayed in recent guidance and that the dangers of vaccination are underplayed.
Many of us had mumps, measles and rubella as children, as a matter of course. In the literature of the time, these were not described as serious or life-threatening diseases, but as being likely to go away within 10 days, without serious ill effects. Contrast that with this extract from a Health Education Authority publication of 1994:
Unfortunately, measles can be much more serious than people think. School age children who get it are likely to be very ill. Measles can cause pneumonia, blindness, deafness and even brain damage. Measles can also he fatal. In fact it's the disease most likely to cause inflammation of the brain".
Many people agree that the 1994 campaign—Operation Safeguard—undertaken by the Department of Health to promote the specific MR vaccine grossly over-dramatised the dangers of mumps, measles and rubella. The fact is that deaths and serious complications from measles are not now common in developed countries. Current Health Education Authority literature, MMR—The Facts, makes inadequate mention of the risks of vaccination and is even misleading.
§ In some other cases, the Department of Health has adopted the precautionary principle: animal growth promoters, human albumen and general anaesthesia for dentists. However, rather than adopting the precautionary principle here, they appear intent on promoting the vaccines in question. GPs are actually being given incentives to vaccinate their patients. To receive an annual bonus, they need to exceed a minimum 70 per cent. immunisation rate in their practice. They therefore have a direct incentive to reassure parents to allow their children to be vaccinated with MMR against a parent's better judgment.
§ The UK vaccine compensation scheme is wholly inadequate. Currently, the 1979 Vaccine Damage Compensation Payment Act only allows up to £40,000, the figure that was changed last year. It is wholly inadequate to compensate for the costs of bringing up a disabled child. Initially, when the Act was first passed, claimants were limited to £10,000—an even more inadequate sum.
§ There are many parents who may believe that their child has been damaged by a vaccine, but compensation under the Act is only available when that child is regarded as having its capacities impaired by more than 80 per cent. Many of the children are now in their 20s and 30s and are still being looked after by their parents. It is high time that justice is done for them. We need a scheme which pays compensation on a level with that in the US and Japan. In the US, over I billion dollars have been paid out over the past 10 years under their no-fault scheme.
§ The Medicines Control Agency receives reports under the yellow card scheme by which doctors, pharmacists and coroners are meant to report adverse reactions to 58 vaccinations. But there is evidence that only 5 per cent. of adverse reactions are reported. Has the Department of Health considered what improvements to the yellow card scheme could be made, to make it work effectively? Even the Medicines Control Agency has admitted that only a small percentage of even serious reactions gets reported. Some doctors appear to be unaware of the system.
§ One of the key concerns of campaigners is the fact that very little tracking is done of the incidence of autism. Although about 350 cases are reported each year, there appear to be as many as half-a-million children in this country with the condition. Yet this cannot be confirmed by the Department of Health because it has no central tracking system, so it is difficult to assess that there has been a growth in autism across the UK. The fact remains, however, that from a problem that was perceived to affect only a small proportion of the population a decade ago, there is now a huge number of cases in total which cannot be explained by better diagnosis alone.
§ One of the key problems also encountered by parents and others wishing to understand more about MMR and its consequences is secrecy. The advice and recommendations of the Committee on Safety of Medicines and the Joint Committee on Vaccination and Immunisation are secret. Information held by them on cancellation of product licences is commercially confidential. That is not so in the States. It is high time that this was remedied by a freedom of information Act.
§ What can parents do now? As a result of doubts about MMR and MR vaccines many parents seek to have their children vaccinated with single vaccines. The experience of helplines in this area is that many parents distrust MMR and believe that doctors are pressuring them to accept vaccination to fulfil their targets. The experience of parents, however, is that it is virtually impossible to obtain them in the UK except via enlightened pharmacists and a friendly doctor. Parents have to sign a disclaimer and even now they make trips to France to get their children vaccinated.
In the face of the desire of parents to obtain the single vaccine the statement in April by the then CMO was:
There is no evidence that it has any benefit and indeed may be harmful".
This seems to be based on the fact that children may have one injection a year rather than all in one go and are therefore "at risk" of contracting mumps, measles and rubella for rather longer. But how can the Department of Health explain the incredibly low incidence of any problems with the single measles vaccine in the 21 years before 1988? The UK appears to be the only EU country where single vaccines are not available.
§ In summary, what do I seek in initiating this debate? It is clear that a number of key steps must be taken by the department. First, there must be much more balanced guidance from the Department of Health to doctors and the public about the merits of the MMR vaccine and the risks of mumps, measles and rubella. Secondly, there must be a comprehensive programme of research to establish the links between MMR vaccination and 59 damage. Thirdly, a decision should be taken by the Department of Health to allow GPs to prescribe single vaccines for mumps, measles and rubella. Patients should not have to travel abroad or get these vaccinations for their children privately. Fourthly, there must be a much better system for tracking adverse reactions to vaccines such as MMR and for publicising them so that parents are clearly aware of what they can do to report problems. We need a comprehensive database of those children already believed to have been damaged so that it can be analysed fully. Fifthly, there must be an end to the secrecy of the Committee on Safety of Medicines and the Joint Committee on Vaccination and Immunisation so that it is clear to the public when there are problems with vaccines or the formulation of them is changed. They should be championing children's health not commercial interests
§ Sixthly, there should be a major improvement to the terms of the Vaccine Damage Payments Act so that the compensation payable is higher and parents of vaccine-damaged children can obtain compensation without having the current burden of proof which requires over 80 per cent. impairment. In addition, the levels of compensation paid out to vaccine-damaged children to date should be reviewed. Seventhly, the Department of Health should start immediate discussions to see if the current litigation between the drug companies and parents of children damaged by MMR vaccines since 1988 can be settled with proper compensation to the children. Eighthly, the department should cease giving incentives to GPs to immunise using the MMR vaccine. I look forward to the Minister's response.
§ 6.13 p.m.
§ Lord Winston
My Lords, I have great sympathy with the noble Lord, Lord Clement-Jones. Some years ago I took my febrile child to the casualty department of the Royal Free Hospital—the same hospital from which Dr. Wakefield emanates. The child had just had a convulsion having been vaccinated 24 hours earlier. I was convinced that I had damaged the child. It was only afterwards that it became quite clear that the viral infection that my child had had nothing to do with the vaccination but had been picked up three days earlier from contact with another infant. That is exactly the problem here. We are looking at something that has been reported in an extremely anecdotal fashion. While parents are quite justifiably worried about vaccination, a close look reveals a great lack of evidence that there is a serious cause for any concern.
These fears are extremely reminiscent of those relating to pertussis vaccine in the early 1970s. When pertussis vaccination in this country fell from about 81 per cent. to 30 per cent., there was a great rise in whooping cough and in consequence children who could have been saved died. This happened not only in this country but in several others. In other countries the reduced coverage of this vaccine resulted in a very serious crisis, with many children being lost who need 60 not have died. There is a very close parallel between what happened in the mid-1970s and what could happen if we look at MMR vaccination in the wrong way.
The evidence relating to inflammatory bowel disease and MMR was based initially on a study of women in pregnancy. It showed that in pregnancy women who contracted measles were more likely to give birth to children with inflammatory bowel disease. A larger study showed that this was purely anecdotal and that there was no real evidence. The studies by Wakefield published in The Lancet, which are the most crucial ones in this area, probably should not have been published, certainly not in the form of an early report. An early report is to an extent hypothetical.
In 1978 I published an early hypothesis in The Lancet which turned out to be totally wrong. Very often The Lancet is happy to publish preliminary data which may spark debate that influences how people think about a particular medical situation. I believe that the publication of Wakefield with regard to bowel disease contains so many flaws in both the histological methodology—the way that bowel biopsies were viewed through the microscope to see whether or not the virus was present—and the selection of the 12 children who were studied in this anecdotal report that it might have been better to look at more comparative data. The truth is that when that study has been repeated with a much more precise look at the RNA—the molecular fingerprint of the virus—we have not been able to find any evidence of it in the bowels of children with Crohn's disease or inflammatory bowel disorders.
Nor is there any clear evidence of a link between autism and MMR. After all, MMR has been in use in the United States for 25 years, with some 200 million doses of MMR having been given. There is simply no evidence that autism has increased during that time. A detailed study on this very issue which has taken place in Sweden has also proved negative. Studies have been made to try to link both inflammatory bowel disease and autism. These have also not shown any significant rise, which would be expected in populations where this vaccine was in use.
I should like to quote from a paper by Duclos and Ward published within the last three weeks in Drug Experience. These people have no vested interest in this matter. This does not have a financial aspect. I regret that a suggestion has been made that there may be some financial motive behind the suggested need for vaccination. I am sure that the noble Lord, Lord Clement-Jones, did not intend to say that. However, here we are talking about the protection of children worldwide. Duclos and Ward say:
During 30 years of worldwide use measles vaccination has proven to be one of the safest and most successful health interventions in the history of medicines. It is not a 'perfect' vaccine but the benefits far outweigh the risks even in countries with a low incidence of measles and a higher rate of measles vaccine coverage".Let us consider the risks. If a child has measles its chances of contracting otitis media, which can be very serious, are between 7 and 9 per cent. With this vaccination, the chances are nil. One's chances of getting pneumonia are between 1 and 6 per cent. With vaccination, the chances are nil. The chances of getting 61 diarrhoea are 6 per cent. but with vaccination the chances are nil. With measles the chances of getting encephalomyelitis are between 0.5 and one per 1,000 children, which is a very high incidence. If one has the vaccine, the chances are one in 1 million. The chances of getting thrombocytopenia—admittedly, a condition that results in the loss of blood platelets temporarily—are nil with the infection and about one in 30,000 with vaccination. The chances of getting an anaphylactic reaction with the injection of any protein is a possibility, but it is not a very great one and it has never been fatal.
The chances of death with measles are something between 0.1 and 1 in a 1000 children. That is a very high incidence. In the developing world the chance of dying from measles may be as high as between 5 and 15 per cent. The chance with the vaccination is nil: no deaths have been reported with vaccination.
I do not think that we should base very serious medical decisions on anecdotal data. The noble Lord referred to the meeting of the Medical Research Council, which included a string of experts of great repute. He said that their findings were equivocal. The main conclusions of the meeting were as follows:
- "(a) That the balance of available biological and epidemiological evidence was against the persistence of measles in Crohn's disease.
- "(b) There was no correlation between measles or mumps infection alone and Crohn's disease or ulcerocolitis.
- "(c) There was no current evidence linking bowel disease or autism with MMR vaccine and that there was thus no reason arising from the work considered for a change in the current MMR vaccination policy."
§ Lord Clement-Jones
My Lords, the finding of the experts, all of whom had a number of preconceptions, it appears, was fairly unequivocal, but how can the noble Lord explain the reason for the MCA commissioning further research into the links between autism and the MMR vaccine? Dr. Wakefield, who was asked to give a view to that gathering, was the only one who held the view that he did; all the others, known in advance, were not of that view, yet the MCA still decided to commission further research.
§ Lord Winston
My Lords, I am very grateful for the intervention, but that is exactly the point of the report: they are simply being responsible, as scientists should be. They are looking at something which is shown to be anecdotal and they want to continue to see the evidence. However, Mr. Wakefield himself said that the notion that there should be a change in vaccination policy was not his view, in spite of his publication in The Lancet.
It would not be a good idea to split the vaccination into separate aliquots. That would mean submitting children to six vaccinations a year and would inevitably reduce coverage of the vaccination. More children would slip through the net. Why should we impose a different regime in this country, when there is no justification for doing so for any solid medical reason, and yet say that it is perfectly all right for the rest of the world? We should not undermine the credibility of a vaccine which has saved something like two million lives per annum.
§ 6.23 p.m.
§ Lord Colwyn
My Lords, as we can see, there are few more emotional areas in medicine than those involving vaccination or immunisation.
I am grateful to the noble Lord, Lord Clement-Jones, for giving us the opportunity to debate the issues involved with the administration of the MMR vaccine. I have followed his written Questions on this subject over the past three months and have myself raised this issue on various occasions over the past 15 years. I listened with great interest to the noble Lord, Lord Winston. I have the greatest respect for his views and I am delighted that his daughter suffered no ill effects. My interest in MMR started after my youngest daughter was vaccinated in 1983. She collapsed and did not utter a sound for three days after the injection. Luckily she made a full recovery, but other children have not been so lucky.
The noble Lord's opening speech has dealt with most of the issues and much of what I wished to say has already been covered, but I should like to emphasise some of the points. Since the conception of the NHS, the Government, the medical profession and the public have come to accept that immunisation is a good thing and that any criticism is unforgivable since it could lead to the death of weak and defenceless infants. The debate has been going on for over a hundred years and it was only in the mid 1990s that the anti-vaccination lobby gave up their campaign, succumbing to public indifference and media overkill. Immunisation is a divisive issue which cannot easily be resolved. There are important questions which should be answered.
Are measles, mumps, and German measles really that dangerous? If the available statistics are examined, they clearly show that measles is not the random killer that medicine would have us believe. In the American epidemic of 1990, when 27,000 cases were reported, 89 people died but most of the deaths were among children of low income families, where poor nutrition and failure to treat complications were probably the significant factors. Of course, I am aware of the complications of rubella and pregnancy, but research has shown that the vaccination produces immunity until the age of 11 to 13, whereas actual contraction of the disease gives the life-long immunity which is so important.
Death from measles is not common in developed countries. The year before the MMR vaccine was launched, there were six deaths out of 42,165 reported cases in Britain. Between 1979 and 1983, 83 children died out of 467,732 reported cases, this lower percentage probably reflecting the fact that doctors had a better understanding of how to treat the disease.
Until recently, about 93 per cent. of pre-school children received the live triple vaccine. This followed a £20 million extensive media campaign by the government in 1994, aimed at 5 to 16 year-olds, which suggested that measles was a deadly, debilitating disease.
63 I have received today a brief from SmithKline Beecham. Under the heading "the safety of MMR vaccine", they state:if the vaccine were to be suspended, a large number of healthy children would be put at unnecessary risk from the potential complications of measles, mumps and rubella. Put simply, children would die.The information given to the public has always been that the MMR vaccine has been safely used in other countries, particularly the United States, and that it provides lifelong protection against all three infections with a single administration. What the public are not told is that in a study that was completed before the launch of the 1994 MMR campaign, children given the injection were three times more likely to suffer convulsions than those who did not receive it, and that the vaccine caused five times more cases of the rare blood disorder thrombocytopenia purpura than expected. Besides sometimes causing dangerous mutations like atypical measles, the vaccine has been associated with numerous side effects, including deafness, encephalitis, febrile convulsions, Guillan-Barre Syndrome and sub acute sclerosing panencephalitis—a fatal wasting disease that is only very rarely associated with measles. The noble Lord, Lord Clement-Jones, mentioned the possible connection with autism.
I have the figures for the adverse reactions to the MMR vaccine reported in the United States between July 1960 and April 1994. There were 5,799 unexpected reactions; 3,063 required emergency treatment; 616 were taken to hospital; 363 were left disabled in some way and 30 died. The US National Vaccine Information Centre believes that, because of massive under-reporting, these figures represent only 10 to 15 per cent. of the total number of side effects, which means that the true figure could be as high as 60,000 adverse effects over the four years since record-keeping began.
As a dental surgeon, I have just been told by the General Dental Council—I presume with government compliance, although I have not received an answer as yet—that dentists cannot now give a general anaesthetic in their surgeries because it is too dangerous. In the same period that we are discussing in relation to this vaccine there has been one incidence of a death caused by a general dental practitioner in about 2 million administrations. When looking at the problems of MMR, I am not sure that I understand the logic of that ruling. I hope the Government will soon be able to explain it to my profession.
I wanted to discuss whether immunisation methods protect to anything like the degree claimed. Time prevents me from giving your Lordships more figures, but it is a fact that epidemics of measles still occur at three-year or four-year intervals despite the fact that immunisation rates in some areas are as high as 98 per cent. Do the Government have a view as to whether the short-and long-term side effects of immunisation are a reasonable price to pay for the possible protective benefits?
64 Finally, what advice would I give to parents who are trying to decide whether to have the vaccination? I have said it many times from my place on this side of the House; I have said it countless times from the place I used to occupy on the other side of the House. Resistance to disease is about having an intact, healthy, efficient immune system. It is about healthy nutrition, which can be helped—and here I declare my interest as President of the All Party Group for Alternative and Complementary Medicine, and the Natural Medicines Society—by herbal, homoeopathic and vitamin supplementation. I could speak on that subject for another half an hour or so, but I shall stop. Perhaps the noble Earl, Lord Baldwin, will take it up.
I hope that the Government will examine seriously the points that arise during our interesting debate.
§ 6.30 p.m.
Earl Baldwin of Bewdley
My Lords, I am grateful to the noble Lord for putting down this Question, as I believe that it raises an important issue wider than the MMR vaccine itself which we all need to take seriously if we value our health. I agree with virtually everything he said.
I, too, have wondered for some time about the risk/benefit ratio of vaccination, having read uncomfortable reports which suggest that not all the evidence is presented to the public, and that dangers are sometimes understated and successes exaggerated. For example, just as much of the improvement in mortality rates over the past century has come about through social rather than medical measures, such as better housing and sewerage, so much of the reduction in infectious diseases has occurred for reasons unconnected with vaccination, which often came along only when the disease in question was already a spent force. Graphs plotted against time make this clear.
Vaccines tend to give only partial protection in any case. Added to this, one must beware of the phenomenon known as "re-diagnosis", whereby a belief in the efficacy of a vaccine can lead doctors to change their diagnosis of a child with measles or whooping cough to something different once they learn that he or she has been vaccinated, thus subtly improving the figures for that vaccine's effectiveness.
But we are concerned this evening with safety. My interest in the MMR vaccine was aroused by a letter in the medical press on 21st March 1988 which stated that,published pre-licensure studies of MMR vaccine safety have been restricted to 3 weeks".The noble Lord, Lord Clement-Jones, has already referred to that. Accustomed as I was to medical oddities, I found this claim so extraordinary that I followed it up by writing and later talking to its author—he is also one of the authors of the work cited by the noble Lord—in order to be assured of its accuracy. For a procedure which involves the forceful disturbance of infant immune systems, by a route which does not mimic nature, and when viruses are well known to linger in the body ready to resurface later in life, three weeks seems wholly inadequate.
65 A commentary in The Lancet on 28th February, while critical of the research suggesting a possible link between the MMR vaccine and bowel and behavioural abnormalities, spoke of the "extremely high standards for vaccine safety" that were demanded. This does not quite add up. Although I have not been able to give him notice of the question, I should like to ask the noble Lord who will wind up to let me have a note in due course of the justification for the absence of longer-term safety studies in this case. Until much more is known I, too, join the noble Lord, Lord Clement-Jones, in urging that at the very least the component vaccines should be given separately and that more open-minded and active surveillance should become the order of the day. I say "open-minded" because it clearly takes inordinate pressure from parents to get cases of damage reported, so strong is the official belief in the relative safety of this measure.
My chief reason for speaking this evening, however, is not that suggested by the noble Lord, Lord Colwyn, but to draw attention to what I believe to be an inherent danger in public health initiatives. I referred to it in the debate in my name on 16th December on the fluoridation of the water supply. While it is crucial that in measures affecting whole populations the science should be impeccable, it is a paradoxical fact that science often takes a back seat behind other considerations. These initiatives all too quickly become campaigns, whether over smoking, recreational drug use, AIDS, fluoridation, or vaccination. Public positions are taken up, often before the science is properly done and this, when coupled with the tendency towards premature consensus among scientists who are uncomfortable with uncertainty, can result in the defending of positions rather than the weighing of evidence. And of course the longer this goes on the more difficult it becomes to climb down, and the more face is lost.
This situation is not helped by the pressure from big interest groups, such as the makers of the vaccines or AIDS drugs. On my way here today, I found the long and well-presented briefing by SmithKline Beecham, referred by the noble Lord, Lord Colwyn—impressive on the surface but one-sided and tendentious. There was no mention of much of the research referred to by the noble Lord, Lord Clement-Jones. Nor is the situation helped by the laudable wish among politicians as well as scientists to be seen to make a difference—to protect children against mumps or dental decay and to protect the public against passive smoking. Causes such as these carry great emotional power. It is not just the financial aspect mentioned by the noble Lord, Lord Winston. In no time there is a bandwagon rolling and a politically or scientifically "correct" view established which it is more than anyone's career is worth to challenge publicly. Solidarity becomes the watchword, and anyone who casts doubt on the underpinnings of the edifice is seen as a threat and treated accordingly. And if doctors are paid more money the more children they vaccinate, they of all people are unlikely to question its basis.
In such a climate it is very difficult for dissenting voices to be heard, even in the medical press. The Lancet, as we have heard, had to defend itself for 66 publishing the recent research on the MMR vaccine and autism, even with all the disclaimers and qualifications that went with it, in the face of the argument that is familiar in such campaigns, "How dare you raise doubts about this measure and put children's health at risk". But of course it is precisely to protect children's health that these questions are raised by responsible researchers, who are simply trying to say, "Please come out from behind your fortifications and look with unbiased eyes at the evidence we are presenting".
The dangers of fashion and dogma are as real in science as they are elsewhere, and the greater the exposure in the public domain, with all its pressures connected with interest groups, money, careers and reputations, the greater these dangers are, and of course the wider the potential for harm.
I should like to end by restating the tentative law which I aired in winding up my debate in December, which is drawn from experience over a number of these cases, to the effect that the quality of the science is usually in inverse proportion to the public profile of the issue. In the true spirit of science I welcome from your Lordships examples which appear to refute as well as confirm this hypothesis. But in the meanwhile I would appeal for an openness over this particular vaccine, a willingness to listen to patients and to reappraise cherished notions when new evidence emerges, and (dare I say it?)a certain scepticism towards official scientific advice which can have its own inbuilt biases and does not always get things right.
§ 6.38 p.m.
My Lords, the noble Lord, Lord Clement-Jones, has raised a topical and interesting subject for debate today, and the House will be grateful to him for doing so. I believe that he has also earned our thanks for speaking to his Motion in such a succinct and helpful way.
Without wishing to go over too much ground already covered by the noble Lord, I think that it is important that at the outset we root our thinking in some of the underlying facts. Childhood immunisation against measles, mumps and rubella has been available under the NHS in the form of the combined MMR vaccine since 1988. It has been widely used in other parts of the world, notably in the United States, for considerably longer. Indeed, over a period of over 27 years literally hundreds of millions of doses have been administered world- wide in accordance with guidelines issued by the World Health Organisation. In the UK the Department of Health has given an unqualified recommendation to the use of the vaccine in line with advice received from the independent committee on vaccination and immunisation.
The results of this immunisation policy are clear. Since 1988 some 1.2 million children a year have been vaccinated with MMR in the UK. The consequence of this has been a fall in the reported number of measles cases from over 50,000 a year to less than 5,000. The number of deaths from acute measles has fallen from around 20 a year to nil from 1989 onwards.
67 Since the introduction of routine vaccination against rubella—and this, of course, goes back further than 1988—reported cases of congenital rubella syndrome in babies have fallen by more than 90 per cent.
That is the millpond into which Dr. Andrew Wakefield and his associates cast their stone in March last year with the publication of The Lancet article to which the noble Lord, Lord Clement-Jones, referred. That article sought to do something relatively limited; that is to say, it aimed to posit a hypothesis linking the MMR vaccine with the appearance of a new syndrome involving inflammatory bowel disease in children combined with a regressive developmental disorder most readily characterised as a form of autism. The precise nature of this alleged link was not spelt out; indeed, the authors of the paper stated in terms that no causal relationship had been proved. Nevertheless, such was Dr. Wakefield's reported concern about the prima facie evidence of an association between the vaccine and the syndrome that he felt compelled to publish.
Limited in its aims or not, the result of that article has been entirely predictable. Press coverage of its central hypothesis has been widespread and prominent, as has coverage of the pending legal action by individuals who claim that their children have been damaged by the MMR vaccine. It is therefore unsurprising that reports are now arriving from many parts of the country of parents refusing to allow their children to be vaccinated against MMR and of some who, in line with advice contained in Dr. Wakefield's Lancet article, are seeking to have their children immunised with the single components of the MMR vaccine as separate injections a year apart. Single vaccinations of this kind are not recommended by the Department of Health, for clinical reasons that were outlined by the noble Lord, Lord Winston, and are not available under the NHS. As the noble Lord mentioned, some people are therefore going abroad with their children to countries where they can obtain these vaccinations.
This is the juncture at which I must declare my hand by expressing grave concern over the direction that events have taken since the publication of the article by Dr. Wakefield and his team last year. Unusually, I find myself in disagreement with the noble Lord, Lord Clement-Jones, in his call for amended guidance on the use of MMR vaccine. I know that I am in danger of appearing to the noble Earl, Lord Baldwin, as part of the established edifice, but I do not believe that there is anything approaching a sound basis on which to doubt the safety and efficacy of the vaccine. The fact is that all authoritative medical opinion, not only in the UK but overseas, has comprehensively repudiated the hypothesis that Dr. Wakefield and his colleagues have advanced. It has been unequivocally rejected by 37 experts convened under the auspices of the Medical Research Council; it has been rejected in equally emphatic terms by the Chief Medical Officer; and in April last year a paper was published by a research team in Finland which came to an identical conclusion based on a survey of 3 million past recipients of the MMR vaccine. Among those 3 million recipients not a single case of Crohn's disease or autism was found.
68 In July there were further interesting findings, first from Dr. Wakefield's team at the Royal Free, who reported that they had, after all, been unable to trace the presence of the measles virus in the lesions of inflammatory bowel disease, despite using the most sensitive screening techniques available; and then from a Swedish research team who examined the medical records of a group of children with autism. The Swedes found that there was a higher incidence of autism in those children who had not been vaccinated than in those who had—the very opposite of what one would expect if there were any direct correlation between MMR vaccination and autism.
The advice of the Department of Health therefore remains, as I am sure the Minister will tell us, that MMR vaccine continues to be the safest way for parents to protect their children against measles, mumps and rubella. That is not to say that the claims of parents who believe that their children have been damaged by the MMR vaccine should be dismissed without the fullest investigation; of course they should not be. I understand that to that end the Medicines Control Agency is currently considering case reports of suspected adverse reactions in children following MMR vaccination and it has also commissioned a study to look specifically at the possible association between the MMR vaccine and autism. That is the right and proper course to take. But it is quite another thing to regard this, as the noble Lord, Lord Clement-Jones, appears to do, as a cue for amending Department of Health guidance on the use of the vaccine.
Indeed, I have to ask the noble Lord what form he believes the new guidance should take. The purpose of any such guidance is to give the patient an informed choice. As it is, a GP has a duty to advise a parent of the recognised risks associated with vaccination. In many types of vaccination, including MMR, there is a fairly strong possibility of mild and temporary side effects and a very remote risk of an allergic reaction leading to serious and lasting harm. Those are recognised hazards. Each parent has to weigh up the relative risks and benefits associated with vaccination and non-vaccination respectively, based on the known statistical evidence. Most GPs strongly advise that the risk of not being immunised far outweighs any risk associated with the vaccination.
If one then tells a GP to add a rider to the effect that there is currently a hypothesis, as yet unproven—indeed comprehensively rejected by medical authorities—that MMR vaccine may be linked to Crohn's disease and autism, what is the patient supposed to make of that? It is a way of proceeding which encourages the very antithesis of informed choice. Once doubts have been raised in a patient's mind, no matter how unfounded they are, they thereby acquire a weight and emphasis out of all proportion to their significance.
It is very important that guidance issued to GPs and subsequently promulgated by them to patients is based on proven evidence. If that does not happen, the consequences can be profound. The noble Lord, Lord Winston, mentioned the case of pertussis vaccine. The scare surrounding the pertussis vaccine in the 1970s led to a sharp fall in whooping cough vaccinations and three 69 epidemics of whooping cough affecting 300,000 children, of whom more than 70 died—a far greater cost in life and suffering than would have occurred if the immunisation programme had continued uninterrupted. Any vaccination campaign depends for its success on a high level of uptake, under which those who are vaccinated effectively act as a screen against infection for those who have not been vaccinated. I do not know—perhaps the Minister can tell us—what the fall has been in the uptake of MMR vaccine since last spring.
In that context, we should not forget the serious consequences that can ensue from contracting measles—and not just in developing countries. In France, where vaccination coverage is not as good as it is in the UK, 15 children died of measles between 1992 and 1994. According to the Health Education Authority, encephalitis, which is an inflammation around the brain and has a 15 per cent. mortality rate, occurs in one in 5,000 children with measles. Twenty to 40 per cent. of survivors have residual problems. After MMR vaccination the incidence of encephalitis is one in a million.
Those of us whose memories go back 30 years will remember that in the 1960s about a thousand deaf-blind children were horn within a period of four years as a result of congenital rubella syndrome. In the five years 1990 to 1995 there were 25 cases in total, dramatic proof of the effectiveness of the vaccination campaign.
I am personally convinced that the right course is for the Department of Health to remain undeflected in this matter and to continue as hitherto with the national vaccination programme. That is not to say that minds should be closed in any way whatever. That is the course advocated by the World Health Organisation and by scientists worldwide. I believe that it is the only responsible course if we are not to see a resurgence of three devastating diseases.
§ 6.49 p.m.
§ Lord Hunt of Kings Heath
My Lords, I begin by thanking the noble Lord, Lord Clement-Jones, for raising such an important subject and also for giving me advance notice of some of the questions that he intended to raise. I also thank other noble Lords for their contributions to what has been a short but extremely important debate. It is important not just in terms of the Government's public health policy but important to all of us as parents who must make decisions about our children. In the past 20 years, parents have sometimes been bewildered and confused by conflicting reports in the media and elsewhere and I welcome the opportunity to put forward the Government's views on this important issue.
The noble Lord, Lord Colwyn, referred to the history of immunisation. Vaccines have been one of the greatest successes of public health medicine in this country. It was a little over 200 years ago when Edward Jenner first demonstrated the protection against smallpox that material from cowpox could offer. At the time Jenner was working, few people reached adulthood without having caught smallpox; and around 10 per cent. of 70 people who did catch smallpox died. Today the smallpox virus is extinct. That success story was built on a programme of widespread immunisation. The programme involved giving vaccines to hundreds of millions of babies, children and adults around the world.
That highlights the important difference between immunisation and other medical interventions: vaccines are generally given not to people who are already unwell as a remedy but to healthy people to prevent future illness. As such there is clearly a critical responsibility on those who develop, licence and recommend vaccines to ensure that they are as safe as is possible.
Safety of vaccines is uppermost in my mind when considering immunisation. I am sure that many noble Lords present here today will recall the scare in this country over the safety of whooping cough vaccine in the 1970s. We were forcefully reminded of that by my noble friend Lord Winston. Public and professional alarm over stories of alleged brain damage caused by the vaccine caused the number of children being immunised to collapse, from a rate of over 80 per cent. in 1972 to around 30 per cent. in 1975. The result was a resurgence of whooping cough in the late 1970s, which led to three major epidemics of over 300,000 notifications and at least 70 deaths. Although subsequent studies and inquiries failed to support the alleged link, by then the damage had been done.
I describe this background as it is important to today's debate. The noble Lord has raised the issue of the safety of the measles, mumps and rubella—or MMR—vaccine. This subject has received much press coverage in recent years, yet much of the coverage has failed to inform readers fully of the balance of evidence and the real risks and benefits of the vaccine. It is first worth setting out the background to why MMR vaccine is recommended.
In the UK, immunisation policy is based on the recommendations of a statutory independent expert committee—the Joint Committee on Vaccination and Immunisation. Before the introduction of MMR vaccine in 1988, the immunisation programme against measles, mumps and rubella consisted of immunisation against measles for everyone at 12 to 18 months; and immunisation against rubella for schoolgirls only at age 10 to 14. There was no immunisation against mumps.
Despite that policy, measles vaccine uptake was relatively low. In the last year before MMR was introduced in England 86,000 children caught measles and 16 died.
The lack of control of mumps meant that it was the leading cause of viral meningitis in children under 15 and caused about 1,200 hospital admissions each year in England and Wales.
The policy of only immunising schoolgirls against rubella failed to stop the disease circulating in the ready reservoir of all males and girls under immunisation age. That circulating disease was then caught by the 5 to 10 per cent. of pregnant women in whom the vaccine had not worked or by those who had not been immunised. Rubella damage to unborn babies is devastating. In the year before MMR was introduced there were 164 71 confirmed cases of rubella infections in pregnancy. Now there are fewer than 10 cases annually. The noble Earl, Lord Howe, very much underpinned those points.
But as the noble Lord, Lord Clement-Jones, explained, a theory that MMR might be linked with new adverse reactions has been raised. The publicity has centred on one group of workers at the Royal Free Hospital who have developed a theory that MMR vaccine might be linked with autism and inflammatory bowel disease. I hope that noble Lords will find it helpful if I set out the work that has been undertaken to examine that theory.
It is our duty to ensure that the advice the Department of Health gives to the medical profession and to parents is based on the view of independent experts. Therefore both the Committee on Safety of Medicines and the Joint Committee on Vaccination and Immunisation have both looked in detail at all aspects of the safety of MMR, as well as any possible links with autism and inflammatory bowel disease.
The Chairman of the Joint Committee on Vaccination and Immunisation along with committee members visited researchers at the Royal Free Hospital to hear about their work at first hand. The committee has reviewed all the evidence on numerous occasions and has advised UK Health Ministers that there was no link between MMR and autism or inflammatory bowel disease.
In March 1998 the Medical Research Council convened a meeting of 37 independent experts under the chairmanship of Sir John Pattison. The group examined published and unpublished research into the suggested association between MMR and autism and inflammatory bowel disease. Researchers from the Royal Free Hospital team presented their work extensively. The independent experts—this was referred to by my noble friend Lord Winston but it bears repetition—concluded:There is no evidence to indicate any link between MMR vaccination and bowel disease or autism".They went on to say:There is therefore no reason for a change in the current MMR vaccination policy".The noble Lord, Lord Clement-Jones, asked about the potential link between vaccination and autism. As he has already suggested, the Medicines Control Agency has responded to requests for individual cases to be studied where parents have associated the onset of autism with MMR vaccine. That review, which is being undertaken by independent specialists, is close to completion. I should point out also that a large study on children with autism in the North Thames region, covering the period before and after the introduction of the MMR vaccine, is also close to completion.
A number of noble Lords asked whether a disease such as measles is perhaps less serious than is presented to the public. As my noble friend Lord Winston made clear, measles can be a very serious matter. In an epidemic of measles in the United States in 1989–91, about 160 children died. To me, that is a serious matter.
72 I am not able to answer the points raised by the noble Lord on payments under the vaccine damage payments scheme but I shall ensure that his concerns are conveyed to the Department of Social Security which is responsible for such matters.
The noble Lord, Lord Clement-Jones, also raised the issue of litigation. It is my understanding that a vaccine manufacturer has received writs from a solicitor acting on behalf of a number of parents. But that is a matter for the manufacturer and not the Department of Health. Furthermore, before there could be any consideration of compensation, evidence will need to be provided, which is not apparent in the scientific literature, that MMR vaccine has indeed caused some of those purported problems.
Noble Lords raised the question of single vaccine prescription and asked whether general practitioners could be allowed to prescribe single vaccines for measles, mumps and rubella. My noble friend Lord Winston supplied much useful information on that matter. However, the Government see no evidence whatever that convinces us that it should contribute to putting children's lives at risk. All available published and unpublished material purporting to show risks associated with the MMR vaccine has been studied by the Joint Committee on Vaccination and Immunisation and the Department of Health's independent expert advisory group on vaccines. That committee saw nothing to convince it that there are risks associated with the combined vaccine that would be avoided by separating the components. Indeed, the committee was mindful that separating the components would leave children at heightened risk and recommended against that practice.
Since there is no evidence of benefit and only reason to assume risk, it seems extraordinary for the Department of Health to be asked to promote less than the highest standards of preventive care. When the World Health Organisation reviewed the work suggesting that there may be some link between MMR vaccine, inflammatory bowel disease and autism, its assistant director-general wrote to my right honourable friend, Tessa Jowell, expressing alarm and pointing out that the present study does not meet the requirements for establishing such a causal relationship. Dr. Henderson went on to conclude,We believe none of these data provide a basis for providing the different components of this vaccine in separate schedules".The noble Lord, Lord Clement-Jones, asked about the Joint Committee on Vaccination and Immunisation. The recommendations of the committee are published regularly in the guidance sent to all doctors and other health professionals involved in immunisation in the book Immunisation Against Infectious Disease. At the committee meetings discussions take place that are commercially and clinically sensitive and for that reason the minutes are not published. But wherever there are problems with vaccines, they are conveyed as quickly and effectively as possible to health professionals and the public.
The noble Lord, Lord Clement-Jones, suggested that the department should no longer provide general practitioners with incentives to immunise using MMR 73 vaccine. The target payment scheme for general practitioners has been highly effective in achieving and maintaining high coverage that did not exist beforehand. Since there is no evidence that points to real risks associated with the vaccine, it would be extraordinary for the Government to give tacit acknowledgement that the work has failed.
I remind the House of the comments made by Duclos and Ward in its review article on adverse events with measles vaccines, published only a month ago in Drug Safety,We suggest that the real issue is one of good science versus bad science. We believe that several of the reports alleging an association between Crohns, autism and measles vaccine are in the public domain due to a failure of the peer review process".The noble Lord, Lord Clement-Jones, asked about balanced guidance from the Department of Health. The department produced extensive guidance on MMR vaccine in the form of fact sheets for health professionals to use in their discussions with parents and as information leaflets for parents to receive directly. The information within those leaflets represents the best available information on both the benefits of MMR immunisation and the risks. Where there is clear evidence that there truly is a risk associated with the vaccine then that has been accurately reflected.
The noble Earl, Lord Baldwin, asked about risk benefits. I can perhaps quote to him the World Bank's description of immunisation as being the single most cost-effective health intervention. On the other issue he raised in relation to long-term studies, he asked me to provide him with a note and I shall be happy to oblige in that regard.
The noble Earl, Lord Howe, asked whether, in the light of current publicity, there has been a fall in uptake. My understanding is that at the moment there has been a fall of between 4 and 6 per cent. Thankfully, that is 74 nothing like that compared with the situation in relation to whooping cough, but it is a warning of what can happen in the light of such publicity.
Perhaps I might conclude by posing three questions. What possible motive could the Department of Health have for continuing to provide a vaccine that may harm children? The answer is straightforward. There is no evidence that MMR harms children in the ways imagined and much evidence that it benefits them. Why does no other country take seriously the claims about MMR? It is because the evidence has been examined over and over again and found to be lacking in scientific merit to convince national authorities. Why has it proved so difficult to find corroborating evidence for the allegations in relation to the risks from MMR vaccine? The answer is clear. As so many commentators have said, when scrutinised the work fails to stand up to the requirements of scientific evidence for causal association. The burden should now fall on those thinking up the stories to actually prove them before causing more anxiety in the minds of parents trying to do their best for their children.
The noble Lord, Lord Clement-Jones, came to this subject as a concerned parent of a small child who needed to take a decision on whether or not to vaccinate. I hope sincerely that the noble Lord has been reassured. I can say to him that the Department of Health has taken every step possible to examine every piece of information made available to it suggesting that there were new problems with MMR vaccine. The weight of evidence is overwhelming that MMR vaccine does not cause those purported conditions. I hope the noble Lord will be reassured and that his decision will be that of so many parents who agree to have their children protected in the appropriate recommended fashion with MMR vaccine.
§ House adjourned at five minutes after seven o'clock.