HC Deb 02 November 1995 vol 265 cc490-8

Motion made, and Question proposed, That this House do now adjourn.—[Mr. Wells.]

9.59 pm
Mr. Llew Smith (Blaenau Gwent)

Towards the end of last year, more than 7 million children were vaccinated against measles and rubella. The official reason given by the Government—

It being Ten o'clock, the motion for the Adjournment of the House lapsed, without Question put.

Motion made, and Question proposed, That this House do now adjourn.—[Mr. Wells.]

Mr. Smith

As I was saying, the reason given by the Government was that we were facing a measles epidemic. The Department of Health predicted that between 100,000 and 200,000 cases would occur. Thousands of children would have to be admitted to hospital with measles complications, such as pneumonia … around 50 children would die. That prediction would obviously frighten the toughest of families, but what is important is whether it reflected reality.

Having spoken to many people—including many authorities on the subject—and read many research papers, I believe that there was no evidence to support the claim of an epidemic and its tragic consequences. If the Minister considers that I am wrong, will he please inform me where the documents for parents and doctors explain how those conclusions were reached? I have read the document for parents, and it gives no such information.

Where in the research papers produced by doctors from the Communicable Diseases Surveillance Centre, and in the paper by H. R. Hobad and others—listed by the Chief Medical Officer as being central to the Department of Health's policy—is it explained how those conclusions were reached? Will the Minister provide me with the calculations predicting such an epidemic in H. R. Hobad's paper? I want to be given the calculations, not the reading list that one doctor received when he requested the same information.

I have repeated that demand because, if the Minister's recent reply is correct, the method of calculation suggests that there has been an epidemic just about every year for the past decade, which is clearly arrant nonsense. I am not the only person to conclude that the Department of Health was not telling the truth in predicting such an epidemic. Eminent people such as Dr. Nicholson, editor of the Bulletin of Medical Ethics, stated: If government doctors are allowed to get away with basing the mass campaign on a lie, it will be all the easier for them to be untruthful the next time that suits their purpose. Like any other doctor, they must recognise that it is no longer acceptable to lie to patients. That is even more worrying when we consider that, in one of her many press releases, the former Secretary of State for Health stated that the public should be able to expect high standards of disclosure with a health service that had "public confidence" and where the public were "well informed." We now know that that was a publicity stunt, because those aspirations were certainly not met in last year's measles vaccination campaign.

What about possible side effects after the injection? The Department of Health and Health Promotion Wales stated in the literature that they sent to parents: Side effects are uncommon. They are usually very mild and disappear quickly. While the Department of Health carried out a scare campaign about the extent of the likely epidemic and the dangers of vaccination, it lulled parents into a false sense of security by giving them inadequate information. Professor Richard Moxon of Oxford university said: The concerns expressed by these parents are very plausible. There is a horrendous gap in the country's research. I should like to mention a family in my constituency, Mr. and Mrs. Gregory, whose child was vaccinated against measles and rubella. After a diagnosis of the child, their doctor recorded in her medical record that her ill health was the result of the vaccination. What is more, research that was conducted by the US Centres of Disease Control and Prevention identified 34 major side effects to MMR and DPT jabs.

In March 1995, the Communicable Diseases Surveillance Centre published a paper in The Lancet; the Government were aware of the results in that paper in mid-1994, six months before the vaccination campaign. The paper reported the results of research in which the side effects of immunisation were actively looked for rather than relying on the previous passive system of reporting by doctors. By linking hospital admission records, the authors showed that the incidence of various side effects was higher and more serious than had been previously thought. Why did not the Government tell parents the truth and not put out the kind of nonsense that they obviously did put out?

There is another reason for concern, because people such as Dr. Nicholson highlighted the fact that the measles-rubella vaccination campaign was an experiment. He stated: In 1991, the Department of Health issued guidelines requiring all experiments in NHS patients to be reviewed in advance by local research ethics committees. No such committee approved this experiment. The fact that it was an experiment was made clear in a recent edition of the British Medical Journal, in an article written by the director of the immunisation division of the CDSC. She wrote: The campaign approach for delivering vaccines has not been tried before in an industrialised country…the comprehensive surveillance system in place…will show the consequences of the campaign to be associated accurately. Will the Minister explain why that experiment did not go before any of the ethics committees?

The mathematical model which it is claimed predicted the measles epidemic depends entirely on the rate of spread of measles among 10 to 14-year-olds being at least twice as high as the spread among five to nine-year-old children. Will the Minister please detail what empirical scientific evidence exists to support that assumption?

I shall now deal with compensation for the victims of vaccine damage. As Rosemary Fox of the Association of Parents of Vaccine-Damaged Children reminds us: In 1979 a Royal Commission recommended that the Government should be strictly liable for vaccine damage—not only because this was morally right, when damage resulted from a scheme promoted by the Government, but also because it would show that the Government had confidence in vaccination. Sadly, despite our long campaign to get the Government to compensate the injured, it has so far refused to do so. That is confirmed in an answer by the then Under-Secretary of State for Social Security, now the Secretary of State for Wales, to a question by my hon. Friend the Member for Birmingham, Northfield (Mr. Burden). The Minister stated: The payment is not compensation, but is designed to ease the present and future burdens of those suffering from vaccine damage and their families."—[Official Report, 27 April 1995; Vol. 258, c. 643.] In order to qualify, the individual must have suffered severe mental or physical disablement of 80 per cent. or more in cases where it could be sown that on the balance of probability, the damage resulted from any vaccination.

We must remember that while it may not be too difficult to prove who is at fault in a road crash and to obtain compensation, it is extremely difficult to the payment for experiencing horrific physical or mental injuries is a mere £30,000. Will the Minister consider amending the Vaccine Damage Payments Act 1979 to ensure far more generous compensation, not payment, for those whose lives have been destroyed, and will he ensure that the period for which claims can be made is extended? Will he also consider introducing a Freedom of Information Act, as they have in United States of America, to make information about licensing and side effects of pharmaceutical products publicly available?

I want to comment on the awarding of the contract to supply the vaccines. Will the Minister explain why the contract to supply approximately 8 million doses of vaccine, the cost of which must have been in excess of £100,000, was not advertised and put out to tender, as required by law, through the Official Journal of the European Communities?

Does the Minister accept that an excuse of "extreme urgency" does not stand up to serious analysis? If he denies that, will he inform me when the Department of Health decided to run a massive campaign of measles and rubella vaccination? Was there a period of five months before the vaccination campaign? If so, that is not a case of extreme urgency. Does he accept that it still does not qualify as "extreme urgency" by the laws of the European Union, to which we are subject, as those are concerned with emergencies caused by natural disasters such as earthquakes?

Will the Minister explain how the NHS Supplies Authority managed to equate "events unforeseeable" with the fact that the vaccine was needed precisely because the Department of Health claimed to have foreseen an epidemic? The Department cannot have it both ways—saying that the events were unforeseen and also that it had foreseen the events.

Will the Minister inform me whether the companies offered the contract already had supplies of measles and rubella vaccine that were left over from 1992, and for which there was no demand? Even allowing for that, does he accept that more supplies were still necessary and that it was surprising that tenders were not sought from other companies in other parts of the world supplying the vaccine?

Will the Minister inform me of the number of instances when financial penalties were applied to manufacturers of the measles and rubella vaccine used in the vaccination campaign in November 1994, because of an identified fault in the supply of the vaccines or instructions as to their preparation? Will he confirm that one of his former colleagues, Baroness Hooper, an ex-Minister in the Department of Health, became a non-executive director of one of the two companies—Smith-Kline Beecham—that were given the vaccination contract just one month after the national campaign was launched? Will he also confirm that, since 1989, one of those companies—again Smith-Kline Beecham—made donations to the Conservative party totalling £110,000 and of £35,000 to that right-wing think tank, the Centre for Policy Studies?

How does the Minister respond to the people who argue that vaccinations are not effective? For example, Wrexham general practitioner Dr. Joanna Cleeson was reported in The Guardian as stating: These diseases declined before vaccination with improved sanitation, hygiene and nutrition; vaccination has not affected the rate. Scarlet fever disappeared without a vaccine. Sweden does not have whooping cough or diphtheria jabs and their decline has been the same as in other countries. My position is one of concern that far too many components are given in one go, and I support the view of the national body, JABS—Justice Awareness and Basic Support—that vaccinations are not suitable for all children, that there should be health examinations before children are vaccinated, together with checks for signs or a family history of atopic reaction, and that vaccines should be offered separately if a child is felt to be at extra risk of side effects. Will the Minister comment on those demands?

I want to comment on the response of organisations such as Gwent Community Health to concerns expressed by families in my constituency such as Mr. and Mrs. Gregory of Tredegar, when they feared that their child was dying as a result of the vaccination. They were treated with disdain by the representative from Gwent Community Health when they were in desperate need of support and guidance. I would have thought that their concerns should have been listened to, respected and acted upon, but the opposite was the case. So much for the principles of the NHS customer charter launched this year.

The very same family also sent a report on vaccinations to Gwent Community Health, asking for its observations. They were told in March this year that the report had been sent to the relevant Government Department for comment. About six months later, I telephoned Gwent Community Health asking why Mr. and Mrs. Gregory had still not received a reply. A few days later, I received a copy of the reply, which was stamped 14 February 1995. Why did Gwent Community Health write to my constituents saying that it had sent the report to the Government and were awaiting a reply when it had received that reply a month earlier?

Will the Minister investigate all the complaints that I have made against Gwent Community Health? If such an investigation is carried out, it will go some way towards proving that the current Minister for Health was sincere when he said in one of his press releases: Health authorities need to show that they are listening to the views of local people. I am not alone in the belief that there should be a full public inquiry to examine these and many other issues raised by a number of eminent people. If the Minister agreed to such an inquiry, he would be responding positively to promises made in many statements from the Department of Health about "honesty" and "accountability". That would ensure that the words of the previous Secretary of State for Health were a reflection of reality and not just a public relations exercise. The previous Secretary of State said: the public are not just users of the NHS, but shareholders. If the Minister is unable to answer some of my questions for a variety of reasons, I am sure that they will be answered in writing in the next few days.

10.17 pm
The Parliamentary Under-Secretary of State for Health (Mr. Tom Sackville)

I congratulate the hon. Member for Blaenau Gwent (Mr. Smith) on raising this important issue but I agree with very few of his conclusions. In fact, I advise him to be more careful about the sources for the information that he has put before the House.

As the hon. Gentleman knows, to many parents measles is an inconvenient and infectious disease from which many children suffer. To the World Health Organisation, measles is one of the main killing diseases of childhood and is responsible for at least 1 million childhood deaths each year. It is not a trivial illness and should not be underestimated. It can lead to complications such as pneumonia and encephalitis with the possibility of epilepsy and brain damage.

Nor is it just a serious disease in developing countries. In the United States epidemic of 1989–91, 130 children died of measles and its complications despite the availability of modern intensive care facilities.

Our record on measles in recent years has been good. Through our progressive efforts, such as the introduction of target-based payments for GP immunisation services, we have been able to raise immunisation coverage to levels well in excess of 90 per cent. Accordingly, target diseases have fallen to very low levels.

That apparently satisfactory situation has led some people to think that measles is no longer a problem and that, because there have been so few deaths, we need not worry. We have not been complacent, because the pattern of measles is like a volcano—after years of smouldering it suddenly explodes, producing an epidemic. That is exactly what occurred recently in Holland, Czechoslovakia and Hungary. When such epidemics occur now, they affect people who are older than those who used to catch measles, and for them the complications and chances of death are much higher.

The reasons for the cyclical epidemics are well understood. With 90 per cent. vaccine coverage of the target population each year and 90 per cent. vaccine efficacy, only 80 per cent. of the population has full protection. Each year one accumulates 20 per cent. of the year's cohort as susceptible and, after about five years, the scene is set for a resurgence of measles.

To use the volcano analogy again, over the past few years our measles experts in the Department of Health and in the Public Health Laboratory Service have been acting as seismologists. They have been collecting information and carefully monitoring the situation. Unlike a volcano, which cannot be prevented from erupting, we have the capacity to prevent a measles epidemic.

In 1993, using the most extensive surveillance data, two groups of scientists based at the Public Health Laboratory Service and at the university of Oxford gave evidence to the Department of Health's independent expert advisers—the Joint Committee on Vaccination and Immunisation—that a measles epidemic was likely. The estimated date for the epidemic was 1996 or 1997. The predictions of both groups pointed to between 150,000 and 200,000 cases and up to 50 deaths. The JCVI reviewed all the available data, which included the experience of other countries with measles epidemics, and took account of the experience of adverse reactions associated with the relevant vaccines.

The committee agreed that it was right to prevent an epidemic when that could be done. It recommended that the most effective way to do so was to re-immunise all children aged five to 16 years simultaneously. That approach is fully supported by the World Health Organisation. Only last week, at a meeting of world experts on immunisation, Sir Gustav Nossal, chairman of the WHO scientific advisory group of experts and of the children's vaccine initiative, described measles immunisation campaigns as examples of a brilliant strategy appropriate to the purpose of preventing a disease causing 1 million deaths a year.

Following the recommendation of the JCVI in late 1993 and its acceptance by Ministers, the Department of Health started to lay down plans to implement an immunisation campaign. By mid-1994, however, it became clear that there were important changes that meant that the planned timetable needed to be accelerated if an epidemic was to be averted. Measles cases in England and Wales were occurring at a higher frequency, and among older children, than in previous years. It also became clear that an epidemic was already occurring in parts of Scotland. During the winter of 1993–94, 138 young people were admitted with measles to one hospital alone in Glasgow. Since 1970, there has been only one occasion—1973—when epidemics occurred simultaneously in England, Wales and Scotland.

In the light of those events, the group charged with implementing the measles campaign decided that there was no alternative other than to implement a campaign in the autumn of 1994 if an epidemic was to be averted. That plan had the full support of the chief medical officer and Ministers. I should point out at this stage that the only way to prove a prediction of an epidemic correct would be to let it happen. To do that would have been a gross dereliction of our responsibility for public health and would have been indefensible. Imagine the feelings of any parent of a child who died of measles if it transpired that the Department of Health knew that an epidemic had been predicted and efforts had not been made to prevent it.

The hon. Gentleman has made much of an article written by a Dr. Richard Nicholson, whom he described as an eminent source. All the expert advice at my disposal leads me to believe that Dr Nicholson at least does not fully understand the technicalities of immunisation, of mathematical modelling or of vaccine manufacture. Furthermore, Dr Nicholson has made some allegations of impropriety by the Department of Health in the vaccine purchase arrangements and he has even gone so far as to suggest that the Department's staff deliberately misled the medical profession and lied to the public. These are very serious charges.

Mr. Llew Smith

Will the hon. Gentleman give way?

Mr. Sackville

I will not, as I have very little time left.

I unconditionally refute these allegations, and I regret that the hon. Member has made use of his position in the House, under parliamentary privilege, to repeat them. I hope that he will reconsider.

Following the decision to implement the campaign in November 1994, the NHS Supplies Authority approached every vaccine manufacturer to alert them to the country's requirements and to establish their ability to supply the required amounts of vaccine.

Mr. Smith

Will the hon. Gentleman give way now?

Mr. Sackville

No, as I have very little time and a great deal to cover.

Only two manufacturers could provide the quantities of vaccine in the time available. Competitive tenders were sought and contracts awarded. The usual rigorous criteria for licensing and testing were applied. With only three months available to manufacture, pack, label, test and supply vaccine, the EC rules for awarding contracts in emergency circumstances were followed, and appropriately so. The price negotiated was close to the lowest paid worldwide, and far lower than that paid by any other industrialised country.

At that stage, detailed market research was undertaken by the Health Education Authority to establish the information requirements for the campaign. Draft material was fully tested with parents and young people and evaluated in one district where a pilot immunisation campaign was run. A commercial sector advertising agency developed four different approaches for television advertising, and they were market-tested. The version that was used for the advertising campaign had by far the strongest support from parents.

In advance of the campaign, studies were undertaken by the Public Health Laboratory Service to investigate adverse reactions in children receiving second doses of measles and rubella vaccine. Colleagues from the United States and the Netherlands provided evidence based on their experience with second doses of the relevant vaccines. All relevant evidence pointed to a very low likelihood of adverse reactions.

The campaign was implemented in November 1994. In England, more than 7 million children were immunised, with school staff playing an essential part in ensuring the smooth running of the campaign. The results of the campaign have been excellent, with 92 per cent. of children aged between five and 16 being immunised. Since the campaign, the only two cases of measles that have occurred in the age groups covered have been in children who were not immunised in the campaign. A predicted epidemic has been averted.

As with all immunisations, however, the possibility of adverse reactions is always taken very seriously. We recognise that under-reporting of adverse reactions occurs, but there is far less of a problem with the reporting of more serious reactions, and they are the ones that matter most. It must also be emphasised that over-reporting can and does occur. The fact that an event occurs after an immunisation does not necessarily mean that it has been caused by the immunisation. It is very understandable that parents might make that association when faced with a problem in a child who had been immunised recently.

Doctors were alerted by the chief medical officer to report adverse reactions on yellow cards—the usual method—on three separate occasions before the campaign. In view of the high profile and magnitude of the campaign, it is surely reasonable to suggest that there was good compliance on reporting. Furthermore, professional staff of the Medicines Control Agency followed up serious reported cases to obtain detailed information on a child's medical history.

Approximately 8 million children were immunised in the United Kingdom. A total of 2,735 reactions were reported among 1,202 children—a rate of one child affected with any reaction whatsoever for every 6,700 immunisations. Most of the reports were of minor conditions, many of which were unlikely to be linked to immunisation. There were no deaths. There were 530 reports of serious reactions—one for every 15,000 immunised children. One quarter of these reports were of immediate allergic-type reactions from which no serious or long-lasting effects are known to have resulted. In the remaining three quarters, there was a full recovery in those children with late onset reaction expected to have been caused by the vaccine.

All those cases reported on the yellow card scheme, with a clear link between the reaction and the vaccine, made a complete recovery. For children in whom recovery has been incomplete, the evidence did not support an association with the vaccine. All such reported conditions are known to occur in the absence of immunisation.

Last November saw an outstanding public health exercise. Not only has a measles epidemic been averted, but measles is now at an historic low level in this country. As anticipated, adverse reactions were either trivial, or those that were serious occurred very rarely and were unlikely to be caused by the vaccine. Our actions were in full accordance with WHO policies. Knowing that an epidemic was imminent, it would have been indefensible not to implement this campaign.

Since we ran the campaign, we have spent considerable time and resources ensuring that a full evaluation has been undertaken. The monitoring of adverse reactions has been a keystone of this work. I shall be placing a full report on the campaign in the Library.

I regret some of the hon. Gentleman's comments and I reject his conclusions. I believe that we took the right action, that we took it at the right time and that we have achieved the right results.

Question put and agreed to.

Adjourned accordingly at twenty-nine minutes past Ten o'clock.