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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:
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
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
"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.
"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.
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