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Lord McNally: My Lords, to clarify my concern, last year I spent a lot of time on the Competition Act with the noble Lord, Lord Simon, as DTI Minister. We spent many happy hours talking about competition in the telecommunications industry and how the Competition Act would help ensure that. It remains a worry to me, particularly in view of technology convergence, that part of the forest seems to be policed by the DTI and part by the Minister's department and yet the beasts are increasingly entering both parts.

Lord McIntosh of Haringey: Yes, my Lords, I had noticed that the noble Lord took some part in the deliberations on the Competition Act. The Whips noticed as well. This is not an order about competition policy. I merely repeat my previous remarks. We recognise the convergence. That is why we published the Green Paper. That is why both the Broadband Britain document and the convergence document are joint publications of the Department for Culture, Media and Sport and the Department of Trade and Industry. That is why our plans for regulation recognise the fact of convergence and we shall be prepared for that fact. At the same time, I hope it offers some assurance to the noble Lord that the restrictions on BT in regard to Channel 3 and Channel 5 continue. There is no relaxation of the regulatory provisions.

It is true that the whole process that we are undergoing will be subject to continuing change. I have no doubt that this will not be the last piece of secondary legislation placed before Parliament before we reach the stage in due course of primary legislation.

I hope that the noble Lord's party took the opportunity to respond to the convergence document. I hope that when we come to report to Parliament he will find some matter in it with which to disagree. Meanwhile, I rely on the universal support that the order has received again to commend it to the House.

On Question, Motion agreed to.

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MMR Vaccine

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.

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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.

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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 be 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 1 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

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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

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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

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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

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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."

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