HC Deb 16 July 1997 vol 298 cc360-8

1 pm

Mr. Llew Smith (Blaenau Gwent)

Jonathan Swift once said: Falsehood flies, and Truth comes limping after it; so that when Men come to be undeceived, it is too late, the Jest is over, and the Tale has had its Effect". How true that was and will be, as evidence is increasingly uncovered highlighting the potential implications of the rising incidence of autism and Crohn's disease in children, and the uptake of the mumps, measles and rubella and the measles and rubella vaccines. Indeed, the evidence shows that it is the cocktail of vaccinations that is likely to be the cause of the unexpected problem.

In the past two years, I have tabled dozens of questions and was granted an Adjournment debate on problems relating to measles and rubella vaccinations—problems ranging from lack of adequate information to parents and the possible side effects of the vaccinations to the damage itself. Over that period, I have become increasingly critical of the procedures and the side effects on some children from those vaccinations, but even my cynicism was stretched to breaking point when I read that in the latter part of the 1950s in the United States, and in the United Kingdom in the early 1960s, Down's syndrome children were used as guinea pigs in tests involving live measles vaccines. At that time, those living in the institutions concerned were described as "sub-normal".

Those tests were recently brought to the public's attention as a result of an article in The Sunday Telegraph by Victoria Macdonald, highlighting much of the research by solicitor Richard Barr and consultant Dr. Andrew Wakefield. In the past couple of weeks, articles in the Irish Independent also raised the issue. Their author, Brian McDonald, reported:

Children, some of whom were either mentally or physically handicapped, were used in drug trials carried out in Irish orphanages over twenty years ago. Some people, while deploring what happened in the 1950s and 1960s, may attempt to justify it on the basis that at that time we knew no better, but that is not a satisfactory explanation. For instance, Dr. Richard Nicholson, editor of the Bulletin of Medical Ethics, stated: People try to say that you cannot apply the same ethical standards today as you could in 1960. You have to do the research with the proper safeguards in place and the safeguards were there in 1960, but it was largely ignored by the doctors. Dr. Wakefield of the Royal Free hospital stated:

this is both a practical and ethical issue. You cannot extrapolate from brain damaged children to normal infants. The response by Jackie Fletcher, who set up the national organisation JABS—Justice Awareness and Basic Support—when her child was severely brain-damaged after one of these vaccinations, said: The more I go into this, the more horrific it becomes". We should be horrified, because, as Victoria Macdonald stated in her article: babies and young children with Down's Syndrome were used as guinea pigs by British doctors in 1960 to test an experimental vaccine for measles … children who were living in institutions for the "severely subnormal" (as they were then described) were subjected to the experiments because the doctor said it was "useful" having them in hospital where they could watch over them for adverse reactions. She went on to state: one of the children died seven days after being vaccinated from a common side effect of measles, but the doctors described it as coincidental in their reports. From an ethical point of view, tests such as those carried out in the UK in 1960 on Down's syndrome children—some of the most vulnerable people in our community—should never have taken place, because those children did not have the ability to say no. Because of their mental condition, they were passive recipients of the tests or anything else one wished to inflict on them. If we are to be worthy of the description "civilized", we can never condone those acts; otherwise, we debase our humanity. We hear of other instances, where people with severe learning difficulties have been taken advantage of; we have rightly condemned those acts and must continue to condemn them, but we must also ensure that we learn from our mistakes.

On the practical side, Dr. Wakefield argues that there are several factors which make that population entirely inappropriate for studies designed to detect adverse neurological events to measles vaccine. He states: The susceptibility of the damaged brain to acute and delayed adverse events to measles or measles vaccine is unknown, although this may be altered when compared with the normal brain. It was inappropriate and potentially hazardous, therefore, to extrapolate from that series of studies that the vaccines would be safe for the general population. The period of observation was limited to three weeks maximum in any one study, which is far too short a time either to detect or to exclude all adverse effects on the central nervous system.

The question we have to ask is what lessons have we have learnt from the mistakes of the early trials. The inadequacy of the three-week safety trials, particularly in relation to children with Crohn's disease, is highlighted by Dr. Wakefield, who states that there may be a diagnostic delay of up to two years. Indeed, he goes on to say that there have been no prospective studies of measles vaccine safety beyond the initial 3–4 weeks follow up period … Beyond this time, safety was assumed. It is notable that trial cohorts from 1964 continue to be monitored for vaccine efficacy 31 years later. It is also notable that in 1995 it was possible to use the same trial cohort to examine a possible link between measles vaccines and inflammatory bowel disease. Those points were also made by Thompson writing in The Lancet in 1995.

Mr. Don Touhig (Islwyn)

As my hon. Friend knows, I have some knowledge of the problem of Crohn's disease, as my eldest daughter has been a sufferer for the past 10 or 11 years. Will my hon. Friend comment on the case of David Lawrence, a young constituent of mine who had a measles vaccination in 1994 and became very ill with a serious virus about 10 days later? Over the past two years, he has gone from being a healthy, fit young lad to a weak and sickly young lad. Three weeks ago, he was diagnosed as having Crohn's disease. His family are convinced that all his medical problems stem from that vaccination.

Mr. Smith

Solicitors and consultants involved with this work have received hundreds of similar complaints about children who have ended up with either Crohn's disease or autism. What saddens me is the response of the medical profession, which more often than not implies that there is no relationship between the vaccination and autism or Crohn's disease. People in the profession often say, "These are merely scare stories," but the example that my hon. Friend has given is repeated in my constituency. Within an hour of the measles vaccination, a young girl became seriously ill, and a couple of years later she is having treatment for autism and Crohn's disease. There are not just one or two cases: there are hundreds of cases.

Vaccine experts state: standard dose "further attenuated" measles vaccines are among the safest vaccines in use today". Although the implication of that statement is that live measles vaccines are safe, it is of course relative and meaningless if safety trials of other vaccines were as inadequate as those conducted on measles vaccines.

No one denies the benefits of vaccinations, but what about the risks? Vaccines should be safe. The children are not ill; they do not have any disease when they are vaccinated. Vaccines are given as a preventive measure. The only acceptable side effects of a vaccine are those which produce no long-term damage. More than 800 families have now contacted solicitors or support groups in the belief that their children have been seriously damaged by vaccines in the same way as the child referred to by my hon. Friend.

It is worth noting that Crohn's disease among children was unheard of 15 to 20 years ago. What safeguards were in place to monitor the risks of two-dose vaccine schedules, which had been highlighted as of particular concern to international measles virus experts in the early 1990s? There was none—safety was assumed on the basis that certain Scandinavian countries, such as Sweden, had been administering two doses of measles vaccine for some years. But had Sweden or any other Scandinavian country ever conducted any safety trials of two-dose measles or measles, mumps and rubella vaccines? No, they had not.

We cannot make assumptions about the safety of the administration of, or exposure to, live biological agents. How many times in recent years have we been reminded of that fact, whether it be in relation to the Gulf war, BSE or E. coil? The chief medical officer, Sir Kenneth Calman, claimed in the Daily Telegraph on 5 December 1996 that Britons were dangerously blasé about disease. Unfortunately, the assumptions made by his Department about the safety of a second dose of measles vaccine show that the Department was equally blasé.

The Department of Health claimed that the procedure was safe because it had been given to millions of children world wide. That is not a qualification of safety. Thalidomide was given to thousands of women, but that did not make it safe. Dr. David Salisbury, principal medical officer for vaccines, had ample warning of potential problems as early as 1992. Indeed, these points have been made on many occasions to officials at the Department of Health. Unfortunately, I suspect that those who were advising the previous Government are now advising the Labour Government.

We should contrast the Government's policy on reviewing the possible negative health effects of the MMR vaccination campaign on some children with the rapid way in which Ministers have rightly intervened to support the alleged victims of Gulf war syndrome.

The previous Government tried to deny and then to avoid all responsibility for Gulf war syndrome. Yet when it comes to initiating a widespread review or reassessment of the MMR-MR vaccination campaign, Labour Ministers are sticking to the same policy reassurances as their Conservative predecessors. For example, in 1995 Tom Sackville, the then Conservative Minister, said in a written answer to me: There is already a well-established satisfactory system in place for monitoring adverse reactions to all medicines, including vaccines.—[Official Report, 6 November 1996; Vol. 265, c. 610.] More recently—on 22 May—in a written question I asked the Secretary of State for Health whether he would establish a review of (a) the effectiveness of and (b) side effects arising from the most recent national MMR vaccination campaign. The Minister for Public Health replied: The effectiveness of, and side effects arising from, the 1994 measles/rubella (MR) school-based immunisation campaign have been carefully reviewed … The campaign was very successful."—[Official Report, 22 May 1997; Vol. 294, c. 174.] Essentially, her reply was the same as that given by the Conservative Minister.

I want to restate the need for an independent commission to study the possible links between MMR and MR and Crohn's disease and autism in children. I have been advised that work done in America by Dr. Hugh Fudenberg and Dr. Gupta, and in the United Kingdom by Paul Shattock of the University of Sunderland, demonstrates the link between vaccine damage and autism. I urge my hon. Friend the Minister to investigate that further.

What concerns me and others is Government inactivity over more than 300 cases in which parents claim that their children have been injured by one or other of the vaccines. In particular, there seems to be an extraordinarily high incidence of autism among the children concerned and a surprising number of cases of what appears to be Crohn's disease.

Autism has been dismissed as a side effect by Elizabeth Miller of the Public Health Laboratory in a memorandum to health professionals. She argues that it is simply a coincidence because most autism is diagnosed at about 18 to 30 months, which happens to coincide with the time of vaccination. What Dr. Miller does not explain in that rather simple answer is why the vaccinated children develop other symptoms at the same time as becoming autistic. Many of them develop a raging thirst; many acquire bizarre eating habits; sleep patterns are disrupted and children lose their temperature control. A characteristic common to many of the late-onset autism cases is that speech which had been previously acquired is lost. In other words, the children do not simply fail to develop—they lose what they already had.

That all tends to point to an encephalitic event, and even the Government's chief medical officer concedes that there is a possibility that the vaccine causes autism. In a memorandum to directors of public health on 7 February, he states: It is therefore unlikely that MMR vaccine plays a part in the development of autism in children who do not have significant neurological manifestations after immunisation. The inference is that he concedes that the MMR vaccine does play a part if there is a significant neurological manifestation.

Crohn's disease and autism are not the only side effects reported in respect of the MMR vaccine. My attention has been brought to 122 cases in which epilepsy developed after vaccination, and numerous other cases of problems with the immune system.

Finally, nothing can be done about the decision to use Down's syndrome children as guinea pigs for live measles vaccinations in 1960. We now know that the vaccines were not innocuous. We need to be rigorous in the design of safety standards. We need an independent investigation into the links between MMR and MR and Crohn's disease and autism in children. Until then, we should consider suspending the multi-dose MMR vaccines in favour of single-dose vaccines. We should also suspend the revaccination programmes because no safety trials have been conducted on them.

1.17 pm
The Minister for Public Health (Ms Tessa Jowell)

I thank my hon. Friend the Member for Blaenau Gwent (Mr. Smith) for raising this important issue. I pay tribute to his relentless pursuit of information and inquiry.

I was very concerned when I heard about the use of the measles vaccine on children in residential care in the United Kingdom in 1961—the issue that has prompted this debate. I have uncovered as much of the story as possible and will set out the facts available to me. It is important that hon. Members should recall the context and the extent and seriousness of measles at the time.

In the 1950s, measles in the UK had settled into a cycle of large epidemics every other year. The annual notifications ranged from a minimum of 150,000 to a maximum of 700,000 cases, with up to 300 deaths a year. Measles was a killer both in this country and around the world. Against that background of serious disease, work was progressing internationally to produce safe and effective vaccines. During the 1950s, candidate vaccines had been developed and by 1960 many had already undergone clinical trials in the United States. The results of those trials were reviewed and evaluated in the New England Journal of Medicine on 28 July 1960.

Mr. Llew Smith

Does my hon. Friend accept that the trials conducted in the United States involved about 170 to 180 children, the vast majority of whom would have been regarded at that time as mentally sub-normal? I know that that is an awful phrase, but it was the one used at that time.

Ms Jowell

I should be very happy to supply to my hon. Friend all the information available to me on those studies. I should be happy also to supply him, for his information, with the material that has been provided to me for this debate.

Based on encouraging results from the tests, the authors provided suggestions for future study and subsequent use of measles vaccine. Based on their safety and efficacy data, the authors concluded: At this time it seems appropriate to recommend the extension of clinical trials of attenuated measles vaccine in special groups. A "special group" means one in which measles causes high levels of serious illness and death.

I have made a point of starting my reply to this debate with information about the 1960 published review, because it predates the first United Kingdom trial of measles vaccine. The authors of the 1961 UK study referred to the 1960 review in their research. The UK study was built on the US work, and based on the recommendation that special high-risk groups be examined.

Some children have long been known to be at higher risk of suffering severe consequences of measles. Those groups include children with conditions such as Down's syndrome, cerebral palsy, cystic fibrosis and malnutrition. Children with Down's syndrome, such as those in the study, have congenital heart disease, which means that they are much more likely than other children to die or suffer serious injury from measles.

Children in residential care are also a high-risk group. Not only do those children often have underlying medical problems, but measles spreads very rapidly in closed communities. It has been estimated that the introduction of measles into residential units was associated with 70 per cent. to 90 per cent. of attack rates in susceptible children. It is worth nothing that, in May 1968, when measles vaccine was eventually offered to all children, the then Chief Medical Officer wrote to all doctors stating that those who should receive vaccine first, despite anticipated shortages of vaccine, should include

susceptible children living in residential establishments aged between 1 and 7. Prior to the 1961 study, therefore, the researchers were in the following position: first, they knew that an outbreak of measles was coming; secondly, they knew that children with disabilities such has Down's syndrome were at particularly high risk from measles; thirdly, they knew that the US studies had shown the vaccine to be sufficiently safe and effective to recommend that it be given to special high-risk groups; fourthly, they had an opportunity to give the vaccine to such a high-risk group.

More importantly—I believe that this point has not yet been raised in the debate—the researchers then approached the parents of those children. As reported in Hansard on 4 December 1961 at columns 925–26, the children's parents had been asked and gave their consent to the trial in writing. The study went ahead, with immunisation occurring in January and February 1961.

In 1961, the largest recorded measles epidemic in the United Kingdom occurred, in which 764,000 cases were notified. Of those, 152 deaths were reported. Of those deaths, 132 occurred in the first six months of 1961. Of those 132 deaths, 66 deaths—exactly half—were among people with chronic disease or disability. If we examine those 66 deaths more closely, we discover that more than half those people either had Down's syndrome—accounting for 20 deaths—or were classified as having mental retardation or deficiency, accounting for a further 17 deaths. Most of the 66 people had been resident in hospitals or institutions for at least six months before the onset of measles and all but eight of them were aged under 15.

I am sure that my hon. Friend will agree that those figures tragically demonstrate the heavy toll paid by children with Down's syndrome or mental retardation during measles outbreaks before immunisation.

Mr. Smith

The point that I am trying to make is that conclusions reached as a result of tests on Down's syndrome children cannot be applied to the general population. That is my argument and my criticism of the way in which the tests were conducted. I accept that parents signed agreements to the tests—most people would expect them to have signed agreements—but such agreements do not justify the tests.

Ms Jowell

Clearly, there is an issue of consent. The issue would have arisen then, and it arises now. The important factor, however, is that the parents of those children gave consent to testing—on a group of children who, on the information available to me, were at high risk of measles.

In the 1961 UK vaccine study, the authors reported that none of the 56 vaccinated children developed measles and that none of the children suffered serious side-effects. The authors went on to recommend that the number of instances of rash and fever after immunisation in the study might be reduced by work further to weaken the vaccine virus strain used.

I understand my hon. Friend's concern about such studies and I, too, am determined to ensure that clinical trials are conducted to the highest standards of ethical behaviour and ethical practice. On the evidence available, however—because written parental consent was obtained, supporting research had already been conducted, an epidemic was imminent and the group being vaccinated was at high risk from the disease—I do not believe that that research can be equated with the situations that my hon. Friend mentioned in the Republic of Ireland or Australia.

It may be helpful to the House if I explain the process by which vaccine safety is ensured in the United Kingdom and how we continue to monitor vaccines after they are in widespread use. All manufacturers wishing to market vaccines in the United Kingdom have to apply for marketing authorisations. The applications include full data on the manufacturing process and quality control of the vaccines. The applications are reviewed by staff of the Medicines Control Agency, and advice is taken from experts on the Committee on Safety of Medicines and its biologicals sub-committee.

Each vaccine is considered individually, and a marketing authorisation is licensed only if all aspects of its quality, safety and efficacy are satisfactory. Furthermore, vaccines used in the childhood immunisation programme are batch released by the National Institute for Biological Standards and Control, which means that no vaccine is issued in the United Kingdom unless it passes the highest standards for purity.

Once that rigorous process of licensing has been completed, the licensed vaccine is available for use. Measles vaccine was introduced into routine use in the UK in 1968, by which time the UK had observed the experience in the US, where measles vaccine was first licensed and recommended for use in 1963.

Once vaccines are used, all reported adverse reactions to them are carefully monitored by the Committee on Safety of Medicines and the joint committee on vaccination and immunisation, which advises my Department. I tell my hon. Friend the Member for Blaenau Gwent that I am keen to ensure that all fresh evidence about any possible adverse reactions are submitted to that committee for proper scientific assessment and appraisal.

Mr. Smith

I should like to make three quick points, all of which I am sure that you will answer. Will you tell me, first, what safety trials have been conducted on re-vaccination? Secondly, will you comment on the studies by Dr. Andrew Wakefield of the Royal Free Hospital? Thirdly, do you accept the link between vaccination, measles, MMR and MR and autism and Crohn's disease? If not, can you explain—

Mr. Deputy Speaker (Sir Alan Haselhurst)

Order. I remind the hon. Gentleman that he is addressing the Chair.

Ms Jowell

In the time left in this debate, I will endeavour to cover the points raised by hon. Friend. If time runs out, however, I will write to him to deal with them. I am aware of the concern about an alleged link between measles, autism and Crohn's disease. I understand that evidence submitted to the joint committee on vaccination and immunisation could not establish such a link, and that the absence of such a link has been confirmed by a further study of the evidence by the World Health Organisation. I make it clear to my hon. Friend, however, that, if fresh evidence becomes available, I will insist that further investigation of that evidence is undertaken.

Secondly, I know that Dr. Andrew Wakefield of the Royal Free hospital has conducted research in this area, and I will ensure that proper attention is given to it and its conclusions by my officials. However, I have to make it clear that it is the joint committee on vaccination and immunisation—an independent body—which currently advises the Department on vaccine safety.

Mr. Deputy Speaker

Order. We now come to the next debate.