§ 6.33 p.m.
§ Lord Hodgson of Astley Abbotts asked Her Majesty's Government what they propose to do to increase the level of public trust in their vaccination and immunisation programme.
§ The noble Lord said: My Lords, the trigger for my decision to ask this Question was the Government's sudden decision in August this year to introduce a new five-in-one child vaccine called Pediacel. Pediacel replaces the four-in-one vaccine previously used and adds polio to the diptheria, tetanus, pertussis and haemophilus influenzae type B—HIB—vaccine. The other critical by-product of the introduction of Pediacel has been the withdrawal of the preservative thimerosal which consists of 50 per cent ethyl mercury.
§ The withdrawal of a toxin as potentially harmful as that contained in thimerosal from infants' vaccine, however small the amount contained therein, is a 957 positive development on which the Government are to be warmly congratulated. However, I am not clear as to why this step was taken, if one is of a cynical turn of mind, in early August during the holiday season when minimum press comment could be expected.
§ The withdrawal of thimerosal from vaccines in this country has been widely advocated over the past decade, but until now it has been resisted by the Government. It has already been withdrawn from almost all child vaccines in the USA and has even been withdrawn from animal vaccines in that country. A sizeable proportion of European countries have also discontinued its use. Those who have advocated the withdrawal of thimerosal have done so on the grounds of a possible relationship between the ethyl-mercury in thimerosal and ADD, which is attention deficit disorder, ADHD, which is attention deficit hyperactivity disorder, and autism in susceptible predisposed children. As long ago as 2000 the Committee for Proprietary and Medicinal Products of the EU recommended that manufacturers move to thimerosal-free vaccines. It is good that, albeit four years later, the Government have implemented that recommendation.
§ Most recently, a study by Doctors Hornig, Chian and Lipkin of Columbia University, published online on 8 June 2004 in the Nature publication, Molecular Psychiatry, indicated that postnatal exposure to thimerosal can lead to the development of autism-like damage in autoimmune disease susceptible mice. This reinforces previous studies, such as the works of Dr Mark and Dr David Geier, showing that a genetic predisposition in combination with certain environmental triggers can cause an increased risk of an adverse reaction.
To a Written Question I put down on 22 January 2003, the noble Lord, Lord Hunt of Kings Heath, the Minister's predecessor, answered that,
there is no evidence of harm from thiomersal contained in vaccines. Therefore, the CSM advised that the benefits of immunisation with thiomersal-containing vaccines outweigh any potential risks of vaccination".—[official Report, 22/1/03; col. WA 101.]
Such responses exemplify the Government's reaction to the thimerosal debate over the past two years. Until August this year the Government gave the impression that it was much ado about nothing and there was no reason for thimerosal to be withdrawn. In August, at the height of the holiday season, thimerosal was suddenly withdrawn.
§ Whether thimerosal does have an effect on certain autoimmune disease sensitive infants may be proved or disproved in times to come or there may never be a conclusive result. But what does matter is that the Government should maintain the highest degree of transparency and openness in their communications with the public in this important and sensitive area.
§ That leads me to the crux of what I wish to raise with the Minister this evening. Transparency and openness are themes on which this Government have placed great emphasis. In such circumstances it is rather strange, therefore, that the Government's vaccine programmes have so often seemed to be carefully shrouded. Communication concerning the MMR vaccination 958 and its possible side effects has been ineffective. I respect the decision of the Prime Minister to avoid disclosing whether his own newly-horn child had been given the MMR jab. I accept that this is a sensitive issue. All of us, including the Prime Minister's children, are entitled to privacy regarding our medical history. But, given the controversy surrounding MMR, that refusal to answer was bound to impact upon public confidence in the vaccination policy as a whole. There is hard evidence to prove that, for a number of reasons, including the one that I have given, the level of public trust has dropped dramatically.
§ In some areas of London less than half the children have been immunised with the MMR vaccine. Kensington and Chelsea recorded an uptake of only 49 per cent. Figures from the Department of Health show that the number of children given the MMR vaccine by their second birthday has fallen to 80 per cent. Epidemiologists suggest that the required level for the population to be safe from an outbreak of measles, mumps and rubella is set at 95 per cent.
§ Equally ham-fisted was the Government's decision to release information to doctors about the introduction of Pediacel well before any public announcement. Unsurprisingly, the news leaked out and, again, the public and the media felt bypassed and, rightly or wrongly, were suspicious that the Government had something to hide. In reaction to the headlines which followed, the Government countered one scare by starting another scare, stating that children would be in great danger if they were not given the vaccine. This neither convinces parents to give their children the appropriate vaccine nor helps establish public trust in the programme. If the Government, through the Minister, express surprise at the growing public distrust in their vaccination programme I hope that these brief examples will help to show how this has come about.
§ I appreciate that the Government face a complex set of issues in this matter. Scare stories in the media are not unknown and the last thing that any of us wants is to trigger a reaction among the public that discourages essential vaccines from being taken. However, transparency on such issues is essential, as public confidence in vaccination policy will inevitably dictate how widespread the use of the vaccines will be. For it is only natural for the parents of a newly born child to be concerned about the impact of the injection of single vaccines, let alone multiple ones.
§ Government health Ministers, medical experts and many doctors have warned about the dangers of parents conducting their own research and drawing their own conclusions. However, parents are bound to search for alternative information when they feel that the Government's policy lacks credibility. Information about vaccines and drugs is now available from thousands of sources on the Internet—some of them undoubtedly reputable and informative, but some of them no doubt unfounded and damaging. The NHS has a useful immunisation information website with fact sheets which cover both the practical and medical implications of each vaccine and answer some frequently asked questions. While that is all highly 959 commendable, the fact sheets, for example, give no trial or clinical data. Such data as are referred to in the fact sheets are never disclosed.
§ There is also the problem of the perceived independence, or lack of it, of the NHS—a large bureaucracy with its own agenda. One wonders whether it can ever win the full confidence of the public. Therefore, I believe that there is a case for considering the establishment of an independent institution to evaluate research, issue appraisals and secure full disclosure of clinical drug trials.
§ Several experts, including Dr Richard Horton, the editor of the Lancet, have suggested the creation of such a new body—the national agency for science and health, called "NASH" for short—which would evaluate scientific studies and provide impartial guidance. It would mean that research findings would be free from the influence of industry, and scientific outcomes would be free from political considerations.
§ In proposing the creation of such an independent national body which focuses on the accuracy of medical research, it is possible to draw on lessons learnt in the development, structure and experience of organisations that already exist in this country as well as overseas—most notably in the United States.
§ The Food Standards Agency is a good example of an independent watchdog body within this country. Although it is only four years old, it has begun to build an impressive reputation for independence. The FSA, government-funded though it may be, operates at arm's length from the Government. It is free to publish what it wishes and has no requirement to report to a particular Minister.
The FSA's key principles are: first, to put the consumer first; secondly, to be open and accessible; and, thirdly, to be an independent voice. A wealth of information about the FSA is readily available to the public. The introduction to the FSA's Strategic Plan 2001–2006 states that its central aim is,
to be trusted as the UK's most reliable source of advice and information about food".
The Strategic Plan goes on to say on page 5:
The Agency aims to be candid where there is doubt; when decisions need to be made on the basis of incomplete information we will explain both what we know and what we do not know, and what we are doing to decrease the uncertainty".
That approach appears to be light years ahead of the Government's communication policy on science and health. If it is agreed that public confidence is a matter of significant concern for the Government when it comes to the nation's food, surely the nation's health and science policy deserves at least equal scrutiny.
A more precise example exists in the United States, where the Institute of Medicine (IOM) provides science-based advice on matters of biomedical science, medicine and health. Its website explains:
The Institute provides a vital service by working outside the framework of government to ensure scientifically informed analysis and independent guidance. The IOM's mission is to serve as adviser to the nation to improve health. The Institute provides unbiased, evidence-based, and authoritative information and
advice concerning health and science policy to policy-makers, professionals, leaders in every sector of society, and the public at large".
The aims, priorities and remit of the IOM appear eminently sensible and they could form the basis of a model for such an institution within this country.
§ In conclusion, when he comes to reply, no doubt the Minister will point to the Government's plans to merge the Medicines Commission and the Committee on Safety of Medicines next year. I understand that that will see new arrangements for those employed in the licensing and safety of medicines, enforcing full declaration of financial interests and debarring from the commission anyone who has personal interests in the pharmaceutical industry. While that is unarguably a positive step, it appears to be one with a narrow objective; namely, to allay fears over potentially unethical relationships between industry and medicines regulators. However, I am advocating the creation of a much broader advisory body. independent of both industry and government.
§ NASH would end the culture of secrecy. The establishment of a body of scientists and specialists, independent from the Government, to evaluate research, promote openness and influence health policy would encourage renewed trust among the public. It would also help to remove the concerns that have led many to lose confidence in the Government's vaccination policy. The nation's health demands no less.
§ 6.45 p.m.
§ The Countess of Mar
My Lords, I must apologise to noble Lords and to the noble Lord, Lord Hodgson, in particular for not having put my name down for this debate, and I am very grateful to have this opportunity to speak in the gap.
§ For many years, governments and scientists were trusted implicitly when it came to the matter of deciding what was best for public health. We are all used to having vaccinations against numerous diseases endemic in the UK and when we wish to travel abroad. That trust continued until the first cases of disability caused by whooping cough vaccines came to light. Parents fought a long and painful battle to win recognition, and then compensation, for their damaged children.
§ I propose to confine myself to the measles, mumps and rubella vaccine that is currently causing angst among parents. It is a fact that rates of diagnosed autism in pre-school and school children have increased exponentially. In Scotland, the past 10 years have seen a fourfold increase to 3,400 diagnosed cases.
§ Even before Dr Andrew Wakefield published his now notorious paper in 1998—which, incidentally, did not establish a link between autism and MMR vaccine but one between autism and inflammatory bowel disease— parents were making an association between vaccination and a change in their children's development. Their fears were dismissed. That is not an uncommon phenomenon in the medical or scientific professions. Perhaps I may say, cynically, that I speak from huge experience.961
§ When the pressure becomes too great, the Government and their advisers retreat behind the curtain of epidemiological studies. Without concurrent clinical studies, I have concluded that they are the medico-scientific equivalent of the parliamentary filibuster.
In the Lancet of 20 July 2002, Chi-Tai Fang and Wen-Yi Shau wrote that,
the validity of observational research depends on the validity of existing knowledge about the cause of the studied disease. In other words, causal association cannot he established by data from observational research alone. Supportive evidence from experimental research, including basic science and randomised trials, is essential rather than optional for causal inference in medicine".
They have expressed concisely what I have been trying to convey for years.
§ The parents of autistic children are crying out for proper clinical studies to be conducted in order to underpin or disprove the epidemiological findings. Why have Ministers consistently refused to ask for such research to be commissioned? That is the very first action that Ministers should take to restore public confidence in infant vaccination unless, of course, they have a very good reason for not doing so. If there is a reason, the public should be told.
§ Will the Minister confirm that manufacturers of single measles, mumps and rubella vaccines have been instructed not to market within the UK and that, if any of their single vaccines are found here, they will lose their licences? If it is the Government's intention to eliminate these diseases, are they going to gain or lose public trust by taking such draconian measures?
§ Will the Minister also say how many of the combination of measles, mumps and rubella components in the live vaccine actually seroconvert at the first inoculation? I am aware that unpublished evidence shows that in more than 50 per cent of cases at least one component does not seroconvert. This is a serious failure and I cannot help feeling that somehow, so far as concerns MMR, we have all been betrayed. There are some parents with extremely sick children out in the world, and they need to be listened to and not swatted away like flies.
§ 6.49 p.m.
§ Lord Jopling
My Lords, I am grateful to have an opportunity to speak in the gap and I want briefly to raise one matter which is of great concern to me. I refer to the danger in the United Kingdom of a terrorist attack using smallpox as a biological weapon. During the Committee stage of the Civil Contingencies Bill, I moved an amendment in your Lordships' House in which I tried to strengthen the nation's preparation in the event of a situation as horrific as smallpox being used as a biological weapon. I am appalled at the very low level of preparation.
§ I asked a Written Question last July about how many people in the emergency services had been vaccinated to deal with a smallpox attack. I was told then that throughout the whole of the country only 141 doctors, 126 nurses, 19 scientists and six ambulance staff have been vaccinated to deal with 962 that. I was told, and I have since told your Lordships, that in the United States 40,000 emergency service workers have been vaccinated.
§ In talking to the Department of Health, I was told that there is a reluctance among people in the emergency services to be vaccinated. They have a low level of trust. That is largely because of the side effects of smallpox vaccination. I am hound to say that .1 do not remember much concern about that when I was young.
§ I was told that the side effects of the smallpox vaccination can be significantly alleviated using what is called vaccinia immunoglobulin (VIG). That significantly reduces the side effects of smallpox vaccination. The Government have a large stock of smallpox vaccination shots, which are held in preparation for a terrorist attack using smallpox. The Minister will recall that I have asked questions over the past few weeks. On a rough calculation of how many people might need to be treated for the ill-effects of smallpox vaccination, it would be necessary for the Government, with the stock they already hold, to have 10,000 VIG shots available to deal with those side effects.
§ However, I find the Government have none or virtually none of these at the moment. In an Answer to my Question, it appeared that they were just starting a programme to acquire VIG stocks. I do not suggest for a minute that my Question caused that. However. I think that it is gross negligence that the Government in a complementary way with their basic vaccination shots have not acquired adequate numbers of VIG shots to deal with those side effects.
§ The Government are now in the process of getting bids to acquire those VIG shots. I ask the Minister: why have they not been acquired? Why, when they have been acquiring basic vaccination shots, have they not acquired the VIG shots? I think this is gross complacency by the Government and I should like an explanation from the Minister.
§ 6.53 p.m.
§ Baroness Barker
My Lords, I begin by thanking the noble Lord. Lord Hodgson of Astley Abbots, for intoducing the debate. I also want to thank him for very succinctly putting an end to a puzzle. Since I read the title of the debate I have tried to work out why he wanted to discuss the subject. He gave a very clear explanation.
§ I have chosen to address the topic in a slightly different way, but I shall come back to some of his arguments because I think they are very important.
§ I have to begin by declaring an interest. I am an employee of Age Concern England. That may not seem immediately relevant, but I assure noble Lords that it will be. I took this issue of public trust rather than the efficacy of the vaccination as being at the heart of the debate. That led to my finding some really fascinating and interesting publications on the Internet, as the noble Lord, Lord Hodgson, said.963
§ What are the factors that determine public trust in government policy? As the noble Lord pointed out, one of the key factors is access to information by the general public. The Guardian very helpfully this week listed 10 health websites one can go to to obtain health information, such as the National electronic Library for Health, the Hi Quality website, which was launched on March 2002 by the Centre for Health Information Quality, which is a division of the Help for Health Trust. That is designed to help raise standards of Internet health information and to give guidance and tips which enable people to make judgments about the credibility and quality of health information.
§ The Research Councils UK website was launched on 1 May to provide information on the work of the Research Councils, including the Medical Research Council, the SERC and the Biotechnology and Biological Sciences Research Council. There is an unparalleled wealth of information available. However, there are no means of enabling people to evaluate the quality of the information which is put before them. Therein lies one answer to restoring trust.
§ It seems—not least from listening to the "Today" programme and its seemingly weekly stories on yet another piece of health research—that the Government, and perhaps scientists too, have not yet fully woken up to the extent to which individual patients believe themselves to be far better informed than in the past and the extent to which that knowledge has undermined the assumed authority of government and, indeed, of healthcare workers to pass on information. We are a long way away from the time when doctors and scientists were seen to be the deliverers of authoritative information.
§ It therefore seems to me that we have gone past the point when it is acceptable for government to communicate merely the conclusions of research studies. We are now at a point where it is essential that the methodology of research is communicated. The noble Lord, Lord Hodgson of Astley Abbots, was absolutely right when he cited the announcement on 9 August of the move to the combination five-in-one vaccination. Against an unparalleled scepticism on the part of individuals about MMR, this simple announcement was made, smack in the middle of the school holidays when the people who should be its targets were away, that this would change.
§ From my reading of the literature, the work of the different agencies, for example the Medicine and Healthcare Products Regulatory Agency, which regulates vaccines and the Health Protection Agency, which monitors the incidence of infectious disease against vaccine take-up, is more widely available. Why do we have two separate bodies; how do they work together; and do they use the same epidemiological information? I accept that the Government have, to some extent, moved—not least in the yellow card system whereby a range of health professionals can report apparent adverse reactions to immunisation; and that is to be extended to individual patients and parents. How will patients—and I think for that read "parents"—be 964 informed of their rights to be involved in making contributions to that important epidemiological information?
§ In the South East Thames Region of the NHS, a new system is in place to investigate vaccine safety. It is a system whereby hospital admission records are linked electronically to data about vaccination from child health and GP records. How will that system be evaluated and are there any plans to roll it out across the rest of the country?
§ In this country, vaccination take-up in general is high. That is a product of three factors. The first is years and years of public health information campaigns. The second is easy availability and low cost. There is perhaps something that the Government need to analyse in terms of generational difference. People of a certain age have a common experience of seeing people who had contracted polio. They had an immediate understanding of what vaccines were about. Small children grew up knowing about the work of Dr Salk. I suspect that there is now a generation of parents for whom that is not necessarily an immediate part of their experience. Their scepticism is therefore likely to be higher.
§ I do not want to repeat the statistics about the take-up of MMR given by the noble Lord, Lord Hodgson of Astley Abbotts, but launching the one-in-five vaccine against the backdrop of such deep scepticism seems almost inevitably to lead to the Government knowing that a large percentage of parents in some areas will opt out of vaccination altogether. That will result in children having less disposition to immunity.
§ In the face of that, do not the Government see that there may be a case for adopting single vaccine immunisations, while ensuring that they are tightly monitored and controlled? They could set up a control group to test the efficacy of that control group. As far as I understand it, at present, there are no data on the efficacy of single vaccines. Do the Government plan to carry out research about the prevalence of mumps among students? We now have a cohort of people who have not been immunised against that condition.
§ In the short time available to me, I want to respond to the points made by the noble Lord, Lord Hodgson of Astley Abbotts, about the independence of research. I find myself in some disagreement with him if he believes that taking research wholly out of the NHS will increase its credibility. I listened to what he said about the independence of research in the United States of America. I am not convinced that independence is necessarily any higher in the USA, because so much of the research is privately funded. We know from the work of the Health Select Committee in your Lordships' House in 2002 that that does not necessarily raise its credibility. Also, I would fear the lack of accountability that comes with taking research out of the NHS.
§ The noble Lord is right to stress to the Government the need for strict transparency. We need to push the Government on how they will engender trust by enabling individuals to evaluate the efficacy and quality of health information. Will that be an integral 965 part of the legislation that will follow the publication of the public health White Paper? If we are to restore trust and confidence, that is key.
§ 7.4 p.m.
§ The key word in his Question, as he emphasised, is the word "trust''; and it is right that we should acknowledge as a general backdrop to this debate two recent trends. The first is the growing propensity of patients and the public to abandon the kind of unquestioning trust in politicians and doctors that was typical 40 or 50 years ago, although trust in doctors remains a whole lot more buoyant than trust in politicians. The second is the growing tendency for the lay patient to regard himself as an authority in his own right on matters medical, however ill-informed he actually is. So for a politician—I am not making a party point—to step forward and assure the public of the safety of this or that is almost bound to be greeted by instant suspicion, if not instant rebuttal, no matter who that politician may happen to be.
§ The debate about the safety of MMR has suffered from that kind of blanket mistrust and pressure group assertiveness, which have served to make it that much more difficult to achieve balance and clarity. Before pursuing that thought, I should perhaps make my own position clear. I do not dissent—I do not believe that any of us sensibly can —from the view of the World Health Organisation that, after the provision of clean water, vaccination is the most effective health intervention known to man. No vaccine can ever be totally safe but, in general, the risks associated with being vaccinated are infinitesimal compared with the risks of not being vaccinated.
§ I believe that we can say unequivocally that MMR has a proven track record of safety and efficacy over many years and I am a firm advocate of it. I am also a firm advocate of all other vaccines administered under the NHS including, let me say now, the new five-in-one vaccine introduced a few weeks ago for diphtheria, pertussis, tetanus, hib and polio.
§ However, none of that can obscure the separate but parallel issue of whether the public's mistrust of what they are told about vaccines is in some way understandable. Earlier this year, the Lancet published a case-control study drawn from a large number of records from across UK general practice that showed that the hypothesis of a link between the MMR vaccine and increased risk of autism or other pervasive developmental disorders has no convincing evidence to support it. Of all the studies published on the issue, that one, funded by the Medical Research Council, was by common agreement one of the most authoritative to date. The results showed that 78 per cent of cases diagnosed with a pervasive development disorder had 966 been given the MMR vaccine, but a slightly higher proportion of controls, 82 per cent, who had received the vaccine did not have a disorder.
§ Authoritative the study may be, but are the parents of autistic children convinced? They are not. The reason that they are not is very simple, and was alluded to by the noble Countess, Lady Mar. It is that conclusions drawn from statistics and percentages are no substitute for conclusions based on direct observation of real children. Rule one in the art of medical diagnosis is always supposed to be, "Listen to the patient". In this case, it is, "Listen to the parent". The questions that parents want the researchers to ask are: what is wrong with this child and why did this child change from being healthy to being autistic?
§ Epidemiology has its place, but it is a blunt tool when it comes to reassuring particular individuals about why they or their children are suffering. Parents of autistic children do not feel that their worries are being treated with due respect and seriousness. They point to the tenfold rise in autism since 1988 and say that the only way that we shall be able to determine the causes of autism is by examining children who are autistic. Until now, none of the published studies has done that.
§ Meanwhile parents' anxieties are fuelled in other ways. Earlier this year Professor Jeff Bradstreet delivered to the vaccine safety committee of the Institute of Medicine in the United States a paper which purports to show two things: first, the presence of the measles virus in the cerebrospinal fluid and brains of children with autism; and, secondly, the toxic role of thiomersal in the autoimmunity and neurodevelopment of individuals with certain genetic characteristics. I am in no position to judge the merits of that paper, except to say that, for parents of autistic children, it is couched in terms that appear almost bound to perpetuate fears rather than to allay them.
§ One positive development in recent months has been the enhancement of the yellow card scheme to allow for direct reporting by patients. Potentially, the piloting of different ways of reporting adverse reactions holds out not only the prospect of providing more data to researchers but, perhaps equally importantly in the context of this debate, also the promise of a much higher level of confidence and trust among patients. One of the main complaints of the mothers of autistic children who believe that vaccinations were implicated in their children's autism was the failure, as they saw it, of the yellow card system. It would be helpful to hear from the Minister how well the pilot is proceeding.
§ I know all this about the parents involved because I have met some of them. I can tell the Minister that they are not fanatics; they are perfectly reasonable, intelligent people. I welcome much that the Government have clone to try to allay their concerns about vaccine safety but I would only add, in the gentlest way, that perhaps it is in the Government's interests to look also at some of the things that I have been talking about, so that the deep anxieties of these individuals no longer boil to the surface, as they have had a habit of doing, thus causing alarm among a much wider public.967
§ As it is, rates of MMR take-up in London are only 70 per cent, with the figure as low as 62 per cent in south-east London. That is clearly a serious situation. A measles epidemic over the next few months has been predicted as highly probable. One can only hope that, as in previous years, the prediction is not borne out by events. The new programme of PCTs offering MMR jabs in schools is an excellent initiative. As an aside, the immunisation targets for GPs, although perfectly laudable on one level, do not help to build confidence in vaccines, in a prevailing climate of suspicion.
§ I hope that the Minister will tell us that the uptake of the new five-in-one vaccine has been universal. If it is, the Department of Health has escaped disaster by the skin of its teeth. By that I mean simply that the manner of the vaccine's announcement in August was so disorderly and ill managed as to have risked undermining its credentials from the word go. Only the reassuring intervention of Dr David Salisbury from the department restored a measure of equilibrium. But the episode brought home to many of us that the lessons of MMR have, sadly, not been fully learnt. I am sure that in hindsight the communication strategy would have been handled differently, but the fact remains that it is no use wishing away or ignoring the public's suspicions on such matters because the suspicions are there.
I am wholly persuaded that the new vaccine is safer and better than its predecessors. I am afraid that a lot of nonsense is talked about the risks of overloading babies' immune systems with an excessive number of viral and bacterial challenges. An understanding of the underlying biological science is one of the things that must be promoted if the battle for public trust is to be won. It is no wonder that Dr Salisbury was quoted as saying that the conflicting views about thiomersal had left parents feeling like,
ping pong balls being batted between experts".
His clear view is that the dangers of thiomersal have been seriously overstated. With due deference to my noble friend, I respect that opinion absolutely.
§ The principal benefit of the five-in-one jab is not so much the removal of thiomersal but the introduction of acellular pertussis and the replacement of a live polio vaccine with dead virus. There is a lower chance of an adverse reaction to the vaccine, not a higher one. Nevertheless, perhaps it would have been better to have introduced the vaccine in an even greater spirit of openness; for example, by allowing public access to meetings of the Joint Committee on Vaccination and Immunisation. Understandably, many questions were asked about the vaccine's safety record. Although the Government have provided largely reassuring answers, the Canadian experience may not have been quite as benign as has been made out because of possible widespread under-reporting of adverse reactions. I should be delighted if the Minister could knock that story on the head.
§ My only other point relates to the Medicines and Healthcare products Regulatory Agency (MHRA). Last month the Minister made a welcome announcement to 968 promote even greater transparency in the regulation of all medicines. There are much tighter rules on conflict of interest for the chairman and members of the new commission, and a greater role for patients and the public. Pharmaceutical companies are being encouraged to be more open with their clinical trials data. All of that is good. But my noble friend has posed some good questions about regulation and independent advice.
§ One idea that the Government might consider is whether in the specific context of new vaccines NICE could be given a role in the evaluation of safety. In my judgment, NICE has gained a very wide measure of public confidence in the way that it works. It already evaluates safety issues in the context of new interventional procedures. So the principle of NICE, as a non-partial body, examining the safety of new vaccines would not be a radical departure. If it served further to reassure the public, as I believe it would, that could only be positive.
§ I agree with the noble Baroness, Lady Barker, that communicating with the public on the benefits and risks of vaccines—NICE has learned to communicate particularly well—is a sine qua non of a less frenzied and more measured climate of public debate, a state of affairs most earnestly to be desired.
§ 7.17 p.m.
§ Lord Warner
My Lords, this is an important issue, which the Government take very seriously. I am grateful to the noble Lord for giving us an opportunity to set the record straight on a number of areas, particularly where he was not altogether fair in his presentation of the Government's position—I hope that he will appreciate that later. I was grateful for the extremely balanced contribution of the noble Earl, Lord Howe, and that of the noble Baroness, Lady Barker. It is slightly surprising that two of the six speakers did not manage to put their names down to speak. I will certainly read the contribution of the noble Lord, Lord Jopling, with interest. I do not accept his criticism and I have nothing much to add to the full information given to him in our Written Answers. I will deal with the points made by the noble Countess, Lady Mar, in my remarks on MMR.
§ In the past 200 years the two most significant contributions to better health have been clean water supplies and vaccines; both have saved millions of lives throughout the world. That is why the immunisation programme in this country is key to the continued health of children. Parents' trust in immunisation is crucial for its success. Diseases such as smallpox and polio used to cause illness, disability and death. Because of vaccination, smallpox has been eradicated from the world. Polio has been eliminated from Europe and most other parts of the world. In my youth, polio was one of the scare concerns of many parents.
§ Even though smallpox and polio have been consigned to the history books, we accept that we cannot rest on our laurels. We continue to review our immunisation programme to see how it can be improved. Noble Lords will remember clearly the growing problem that we had 969 with meningococcal C infection in the late 1990s. That terrible illness causes permanent disability and, all too frequently, death. Meningitis was the commonest infectious cause of death overall in children aged one to five in the UK.
§ The UK was the first country to introduce the meningitis C vaccine—in 1999. That was the result of collaborative research and work in this country. That research ensured that the vaccine was effective and had an excellent safety profile. It is worth bearing that bit of very recent history in mind. Parents all over the country welcomed the initiative, as it offered protection for their children against meningitis, the disease that, parents continued to tell us. they feared the most. As a result, cases of meningitis C have plummeted by over 90 per cent and continue to decline.
§ I accept totally that, if parents lose confidence in the safety of vaccines or underestimate the seriousness of the diseases, those diseases can and will return. In recent years, Ireland, the Netherlands and Italy have suffered from outbreaks of measles. In each outbreak, children have died. The UK has been more fortunate. There have been no childhood deaths in the UK from acute measles for over 10 years, but recently we have had to deal with inaccurate media-driven stories that have done much to make parents question whether to have their young children vaccinated.
It is not just Ministers who say this; it is worth reflecting on some of the independent research published by a number of groups on the MMR story. The King's Fund stated in its study on MMR and the media that,
Arguably this is a case of media coverage affecting public behaviour in ways that may increase rather than reduce health risks".
A report from the University of Cardiff about the media coverage of the purported link between MMR and autism showed that the media coverage was,
unintentionally misleading in creating the impression that the evidence for the link was as substantial as the evidence against it".
A study from the University of Birmingham found that,
The media have been a particularly important, largely negative, source of information",
particularly on MMR. That is not the Government's special pleading; those are the views of people who are independent of government and who have examined what we have had to contend with.
§ Given those quotations, it is hardly surprising that there is uncertainty in the mind of some parents. The decision to vaccinate a child should be straightforward. The benefits that vaccines bring to children enormously outweigh any risks. I was grateful to the noble Earl, Lord Howe, for his brisk dispatch of the idea that babies cannot cope with combined vaccines. That view is plain mistaken. Despite the anxieties that some parents have expressed recently, the vast majority choose to have their babies vaccinated. More than nine out of 10 infants complete all their immunisations by their first birthday. More than eight out of 10 children receive a dose of the combined MMR vaccine by their second birthday. Although the MMR figures are lower than the ideal, 970 MMR uptake has risen in three of the past four quarters. That can be happening only because parental confidence in vaccine safety is returning—perhaps not as fast as we would like. We want to work hard to make sure that that trend continues.
§ I shall say something about what we are doing to improve patient confidence. In order better to understand parents' concerns about immunisation, the department commissions surveys every six months, involving about 1,000 parents of young children. The in-depth interviews with each parent help us to know the real concerns of parents and what they need to help them make decisions about vaccination. One clear message from parents is that they want clear, factual information. We are trying hard to meet that need by producing a wide range of resources, such as leaflets, factsheets, and websites. All of the material that we produce is tested first with parents to make sure that it meets their needs.
§ In all that work, parents have consistently told us that they have a high level of trust in primary care staff—the practice nurses, GPs and health visitors who are the frontline staff who play a crucial role in implementing any of our immunisation programmes. They are the professionals with whom parents can discuss their concerns and who provide advice on what is in the child's best interests.
§ We need to ensure that health professionals have the information resources that they need to carry out their work. Every year, the department carries out a survey of health professionals, just as we do with the parents. We give seminars to health professionals all over the country. I shall give the House some idea of the range of that work. The Department of Health has issued over 12 million leaflets and factsheets directly related to the immunisation programme. Our websites received over 20,000 hits and received 2,000 questions from concerned parents so far this year, all of which have all been answered. We have given presentations at nearly 50 seminars for health professionals and for parents. We have done a lot of work in that area.
§ We also want the public to be able to access the expert advice on which we base our work. Both the independent—I stress the word "independent"—Committee on Safety of Medicines and the independent Joint Committee on Vaccination and Immunisation do much to ensure that their work is available to all by publishing information about their activities on their websites. We are working all the time to see how we can bring more of that work into the public arena.
§ The noble Lord, Lord Hodgson of Astley Abbotts, suggested that decision making on vaccines should be transferred to an independent body similar to the Food Standards Agency. We do not accept that. I do not have time to go into all the arguments, but we have great confidence in the MHRA and the Committee on Safety of Medicines. It is independent and has served this country well. As noble Lords have acknowledged, we are doing much to improve the perception of transparency and the reality of that transparency. There are changes taking place in the regulatory environment that involve restructuring the Committee on Safety of Medicines and tightening up the approach, to ensure that its advice is 971 seen much more to be impartial and entirely transparent. I am unconvinced, as a result of the work that we have been doing—it is one of my ministerial responsibilities—that setting up a further independent body would change the minds of concerned parents in the way that has been suggested.
§ The noble Lord, Lord Hodgson of Astley Abbotts, raised the subject of thiomersal. It is important to state clearly again the fact that the MMR vaccine does not contain thiomersal and never has. You cannot use thiomersal in live vaccines, and MMR is a live vaccine. Thiomersal is a preservative that has been widely used in vaccines for over 60 years. It is added in very small amounts to vaccines to prevent bacterial and fungal contamination, particularly in multi-dose vials where repeated doses are withdrawn, once the vial is opened.
§ There have been numerous studies. I do not have time to go through all of them, but I will give the House the references. I am happy to write to all noble Lords with the data. A major study in Denmark examined the question, and the Committee on Safety of Medicines has considered the available evidence. Work has been done by the European Medicines Agency. The United States has had a major review of all the evidence. The World Health Organisation is clear on the issue. The overwhelming finding of all that work by independent bodies is clear: all the evidence on the safety of thiomersal in vaccines has been thoroughly investigated, and the consistent message is reassuring.
§ However, from September this year, we accepted that the vaccines offered in the current routine childhood immunisation programme should not contain thiomersal. We switched to new vaccines in September because they contained a slightly safer form of the polio vaccine—an inactivated polio vaccine—which replaced the oral polio vaccine that had been used for many years. There is a very slight risk—about one in a million—of the oral polio vaccine causing a condition known as vaccine-associated paralytic polio. That slight risk does not occur with the inactivated polio vaccine that we have used since September.972
§ Despite all the remarks made by the noble Lord, Lord Hodgson of Astley Abbotts, about what we were up to in the summer, that is the straightforward explanation of the change. We had hoped to present it to health professionals in a more orderly way, but the story broke in a particular paper—very inaccurately. As happens in life, we had to deal with that as best we could. It happens sometimes. I recognise the helpful comments of the noble Earl, Lord Howe, about the contribution of Dr David Salisbury. It was a major contribution and it helped to settle matters down. Thankfully, parents do not believe everything that they read in the newspapers. The story died within a few days and all the information that we received from around the country is that the new vaccine has simply replaced the old one.
§ I do not have time to respond to all the points that were made. I shall briefly turn to MMR and autism. Experts from around the world, including the World Health Organisation, agree that there is no link between MMR and autism. It is true that there has been a steady increase, as the noble Countess, Lady Mar, mentioned, in the number of children diagnosed with autism since the mid-1980s. An MRC report on autism found that the increase was likely to be due to raised awareness of the condition, particularly among health professionals and parents, combined with a wider definition of autistic spectrum disorders.
§ The MRC has already supported a number of significant projects. In February 2002 the Government committed a further £2.5 million to the MRC for autism research. We are working on this particular area. It is also true that single vaccines in the MMR area can be imported from abroad unlicensed. It is the duty of the MHRA to assess the safety and efficacy of any applications for importing unlicensed vaccines into this country.
§ That is the best that I can do in the time available in responding to those issues. This has been a helpful debate in many ways. It has given me the chance to put the record straight on a number of issues. I shall certainly consider very carefully the points that I have been unable to deal with in responding to the debate and I shall write to all noble Lords on those points.
§ House adjourned at twenty-nine minutes to eight o'clock.