Hansard: Vaccine Damage Compensation Debate: Westminster Hall, 8 July 2009
Dr Ian Gibson, who has recently stood down as MP for Norwich North, is a champion of the mass vaccination of young girls with Cervarix, the cervical cancer vaccine. Below, I am posting the full text of two important Parliamentary Debates both relating to vaccine damage.
In November 2006, the Group on Scientific Research into ME (the “Gibson Inquiry”) published a 32 page report resulting out of an unofficial inquiry that had been chaired by Dr Ian Gibson. Dr Gibson launched his inquiry, in the summer of 2005, “to assess the progress of scientific research on ME since the publication of the Chief Medical Officer’s Working Group Report into CFS/ME in 2002” with the objective that its findings would “stimulate public debate on the subject of ME and act as a catalyst for increased funding of research”.
The “Gibson Report” can be read here: http://www.erythos.com/gibsonenquiry/Report.html
Whilst this unofficial document generated much debate amongst its constituency of interest, the ME community, it received little political or media attention.
Despite Dr Gibson’s assurances at the May 2006 Invest in ME conference that his panel intended to consult before launching its final report, copies were emailed out to all MPs and sent to selected ministers and government departments with no consultation process having first taken place. The published document was littered with errors, misconceptions, ambiguities and contradictory statements. All five national ME patient organisations – Action for M.E., The ME Association, AYME, The Young ME Sufferers Trust, the 25% ME Group, advocates and individuals had called on the inquiry panel to amend and review specific sections within the report – for as it stood, the document could not be considered fit for purpose.
On 6 February 2007, Dr Gibson chaired a public meeting, in London, to discuss the content of the report and how it might be used as a campaigning document. At this meeting, Dr Charles Shepherd raised a number of concerns in relation to the report’s content, on behalf of the ME Association and the wider ME community, including a request for factual errors in the section on benefits to be addressed (errors since reiterated by journalists) and around the panel’s views and opinions on the issue of the potential link between vaccinations and the onset of ME.
The GSRME panel disbanded shortly after the public meeting in early 2007. No amendments to the document were made because the panel “owned” the report and Dr Gibson considered that he had no mandate to amend a document authored by a now disbanded panel. With no consideration of a process for draft consultation and amendments written into the panel’s Terms of Reference and as an unofficial committee, with no accountability to any agency, government department, commissioning body or organisation, the errors, misconceptions and ambiguities within the document remain.
Page 22 of the “Gibson Report”, states:
“Vaccination is often blamed for unexplained outbreaks of illness and regularly appears in the media being accused of such. The Group found that there is no strong evidence to link CFS/ME to vaccination and it is unlikely to be a cause…”
Extract from unofficial transcript prepared from audio recording of the public meeting held by the “Gibson Inquiry” panel in London, 6 February 2007:
[Extract picks up towards the end of the first half of the meeting]
Dr Charles Shepherd (Medical Advisor, ME Association) (CS): The second quibble is in 3.34 and what you said about vaccinations. I think your wording there is really going to cause people problems by saying that the Group found there is no strong evidence to link CFS/ME to vaccination and it is unlikely to be the cause. It is, I believe a cause or trigger factor in a significant minority of people with this – I’ve probably got more patients in the UK that anyone else with vaccine induced ME – these are anecdotal cases, OK – I think I’ve probably got about 200.
Dr Ian Gibson, (former MP for Norwich North) (IG): Well, we didn’t want to get into anecdotal things…
CS: I know…
[Ian Gibson talks over Charles Shepherd: ??????????]
CS: …but if you looked at your experts who gave evidence – besides myself, Weir, Pinching, Byron Hyde – all who reported anecdotal cases of vaccinations…
IG: Of association with vaccination…
CS: Of association, and the CMO’s Report acknowledged…we actually managed to get in into the CMO’s Report…
IG: We have to be very careful we don’t say it’s the cause of something.
CS: Yes, but I think you are over cautious, there, and you know, we’ve struggled to get these people industrial injury benefits and it really is a struggle and that statement is not going to be helpful…
Vaccine Damage Compensation Debate: Westminster Hall, 8 July 2009
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Vaccine Damage Compensation
Ian Stewart (Eccles) (Lab): I am pleased to have the opportunity to raise this issue today as chair of the all-party group on vaccine damaged children. I preface my remarks, as I always do, by saying that the all-party group supports a public vaccination programme and the protection of workers in the work place. We recognise the role that vaccination plays, and has played, in the reduction and eradication of disease, and like everyone, I want protection against disease for my nearest and dearest, and for everybody else’s too.
With protection, however, comes responsibility. Society must accept its duty to give financial support to the small number of workers who have a serious, adverse reaction to a vaccination. The vaccine damage payment scheme, which we are discussing today, is administered by the Department for Work and Pensions, but the Department of Health has an input too. The DWP was first in the drawer for this debate, so I went for it first, but I hope to tackle the DOH at the earliest opportunity. The all-party group has established a good working relationship with the DWP, but sadly the same cannot be said of the DOH. Some of my remarks are intended for the latter, but basically I want to consider what financial support is, or could be, offered to workers damaged by vaccines, whether through the payment scheme, industrial injury benefits or, if appropriate, a new 21st century system of assistance.
Today’s debate focuses on adults such as those in the medical professions. 1993 DOH guidance required, as a condition of service, that all new employers in “exposure prone procedures” should receive hepatitis vaccines. However, people in other jobs are affected too, and I have listed them in my recent early-day motion 1646, which has attracted 138 signatories from all parties represented in the House. I repeat that the numbers affected are small, but, as with all vaccine victims, the casualties are completely innocent; their lives, and those of their families, have been sadly diminished through no fault of their own. This is a family issue.
Mr. Denis Murphy (Wansbeck) (Lab): I congratulate my hon. Friend on securing this debate and on his many years of excellent work, in this House, in trying to secure justice for individuals such as Mr. Robinson, a constituent of mine, who, six years ago-when he was a fit, young man of 43 years-had to be vaccinated for hepatitis B as part of his work as a forensic scientist. Two days later he was taken ill, and unfortunately several weeks later had to finish work. He is now 60 per cent. disabled. Does he agree that this vaccination has had a very detrimental effect on some people’s lives and health, and that they should be compensated?
Ian Stewart: I have met with Mr. Robinson and my hon. Friend, and I wholly accept his remarks. Unfortunately, however, this is not just about one worker. Having said that, we must keep the figures in realistic terms; the number of people affected is relatively small, so, in my view and that of the all-party group, the issues should be easier for the DWP and the DOH to tackle.
One victim wrote:
“The injuries we suffered as a result of the Hepatitis B vaccination are devastating. We have permanent serious health problems, lost our jobs, our careers, independence, ambitions, family life and the joy of life.”
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That statement was made by a medical doctor suffering from vaccine damage. On 19 May, the all-party group held a meeting with workers who reasonably claimed to have been damaged by hepatitis vaccines. Some were receiving industrial injuries benefits, one was receiving a reduced NHS pension, and another was receiving a medical pension. All have had to fight, over a number of years, for those benefits. A number of MPs, from all parties, who could not attend the meeting, wrote to me about adult constituents who might have been damaged by hepatitis vaccines, and to offer their support to the all-party group.
The vaccine damage payment scheme has been described by Ministers as a scheme to provide assistance-not compensation-for people damaged by routine childhood vaccinations. DWP Ministers have stated that the scheme is designed-I emphasis “designed”-to cover routinely recommended vaccines in the childhood immunisation programme. Nothing in the Vaccine Damage Payments Act 1979 appears to state that the scheme relates only to children. It is my contention, therefore, that it could apply to adults also damaged by vaccines and who meet the criteria laid down in the scheme.
Mr. Tom Clarke (Coatbridge, Chryston and Bellshill) (Lab): I apologise for arriving two minutes into my hon. Friend’s speech. We all welcome the fantastic job that he has done in this field, but will he comment on the problem of vaccine-damaged children who become adults, but whose families continue to fight on their behalf?
Ian Stewart: My right hon. Friend has a long and esteemed history working in this area and has done far more than me on it and the area of care and health in general. He is of course correct: some of these “children” are now in their 50s and so of similar ages to some in this Chamber. Problems might begin in childhood, but will continue into adulthood, if the individual lives long enough-unfortunately some do not live long lives.
Today, however, we are concentrating wholly on adult workers damaged by hepatitis vaccines. In the majority of cases, people may apply for a payment only before, and up to, the age of 21. Adults can receive a vaccine damage payment for an adverse reaction to polio, rubella, meningitis C or human papilloma virus vaccines, though not for diphtheria, tetanus, pertussis and others, and some vaccines, such as those for hepatitis and influenza, are excluded completely. Applications under the payment scheme often go to appeal, which is adversarial, and for which no legal funding is available to help applicants.
DWP Ministers have always told me that the budget for VDPs is not capped, and I accept that assurance unreservedly. However, I have come to believe that DWP officials do not believe that there is such a thing as vaccine damage. In my view, they think that children and adults might have soreness and some local swelling after vaccination, but no significant or long-term damage as a result. I have no medical background, but I accept the word of the Government’s immunisation policy adviser, who said:
“There are side-effects with all vaccines.”
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The recognised side-effects are published in the Department’s patient information leaflet. Workers tell me that they not only had no pre-vaccination discussion about the contents of the patient information leaflet, but did not even see it. I hope that the Department of Health will address that matter. Consent can be meaningful only if people have all the necessary information.
In the UK, the Department of Health acknowledges that chronic fatigue syndrome, rheumatoid arthritis and multiple sclerosis have been reported under the yellow card system as adverse reactions to hepatitis B vaccines, but points out that the reporting of the adverse reaction does not necessarily mean that it was caused by the drug or vaccine. I should like to put it on the record that I had correspondence and a meeting with NHS Direct, now re-established as NHS Choices, about the deletion of vaccination as a possible contributor to myalgic encephalomyelitis in its online directory after 2006. Up to that time, vaccination was listed as a possible contributory cause. I have been told that although there is no paper trail to say how the deletion came about, it is nevertheless correct as, in its view, there is no link between the hepatitis B vaccination and ME. It is small wonder that workers who are damaged by vaccine are suspicious, and I have to say here that I am suspicious, too. Furthermore, the information leaflet on HBvaxPRO, which was published in 2005, stated that
“serious side effects occur less frequently, and include allergic reactions certain severe types of rash, joint pain, muscle disorders such as Guillain-Barré syndrome and central nervous systems disorders such as multiple sclerosis.”
So what happens elsewhere? The US has had a vaccine court since 1989. The system is simple, transparent and relatively quick. The judges are vaccine specialists. It is not a lawyers’ paradise, with just one legal representative and one expert allowed on each side. In 2007 and 2008, more than half of the cases that were compensated in the US were those of adults. Some 146 hepatitis vaccine cases out of a total of 578 have been fully compensated since the court was established. Therefore, the US accepts that hepatitis vaccines can cause significant and sustained damage to a small number of people.
The difficult truth is that what we have in place in the UK is not fit for purpose. It is not usual for me to use such new Labour jargon, but, in this case, it is appropriate. The system was designed in 1979 for a specific purpose. It now needs to be redesigned, upgraded or perhaps replaced with something better. The Labour Government improved the vaccine damage payment scheme in 2000 for which I give them full credit. To be frank, I am very proud that our Labour Government did that. Now, we urgently need further improvements. Since 1997, we have introduced significant and wide-ranging social security reforms. We need a fundamental review of how best to help vaccine victims.
As I said earlier, the vaccine damage payment scheme does not include hepatitis vaccines. Yet the all-party group was informed that at least one person whose hepatitis B claim failed was then told that they could appeal. As the vaccine is not part of the scheme, that has to be a waste of everybody’s time. So, what other help can the Department for Work and Pensions offer? There is industrial injuries assistance. I asked a number of parliamentary questions regarding industrial injuries
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claims for people who have had an occupational vaccine and can no longer work. Unfortunately, I was told that the information was not available. I also asked about the position of student doctors and nurses who are not covered by employee benefit schemes as they are classed as being in training. Again, the information was not available.
I have been informed by a voluntary group, which has had contact with about 200 people who believe that they have been damaged by a hepatitis vaccine at work, that only one of its number received industrial injuries benefit without going to a tribunal. Five of its members have received industrial injuries benefit following an appeal. Some appeals are still pending. One trainee doctor and one trainee nurse went through the whole tribunal hearing only to be informed that they were not eligible as they were trainees and not employees. So, the cases are there, but the DWP statistics are not.
The DWP knows that workers have been damaged by vaccines because it is, in some cases, paying them industrial injuries benefits. However, if we do not record what is happening, we do not identify the problems. It would appear that we have a postcode lottery of support, with some areas more likely to grant industrial injury payments than others.
I would have thought that the Health and Safety Executive would be interested in such information, particularly when people are assessed as having a 50 or 60 per cent. disability. It is hardly surprising, therefore, that a constituent of my hon. Friend the Member for Wansbeck told the all-party group that
“the benefit system is a complete mess when it comes to those with a vaccine related illness. There is no consistency in its decisions or its knowledge of people’s problems, leaving many to lose confidence in the system that should help them in their need. Where is the duty of care?”
In highlighting the shortcomings of the present system, I hope that we can all work together to meet our duty of care to workers who are vaccine victims. As I said in my early-day motion 1646, I am flexible about what the best solution is. I hope that the Minister will work with his ministerial colleagues, MPs, peers and stakeholders to ensure that reforms are made and that a wrong is put right.
The Parliamentary Under-Secretary of State for Work and Pensions (Jonathan Shaw): I congratulate my hon. Friend the Member for Eccles (Ian Stewart) on raising this important issue. He has presented his case in his usual way. He is focused, sceptical on behalf of the people for whom he is fighting, relentless and principled. He is exactly the type of union steward that one would want on one’s side. Importantly, he is also modest as well. He takes collective pride in the fact that the Government have increased their awards from £40,000 in 1988 to £100,000 now. However, we know that much of that increase was down to his hard work. We pay tribute to him for that. It has changed lives. That is what all who come into this place hope to achieve on behalf of our constituents and others in our country. He has done it, and we are very proud of him.
I acknowledge my hon. Friend’s constructive chairmanship of the all-party group on vaccine damaged people and I am pleased to hear that there is a good working relationship with the Department for Work
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and Pensions. I am committed to maintaining and improving that relationship, and I can assure him that the Department will work closely with health officials on the vaccine damage payments scheme and to deal with issues that have arisen in this debate, including those raised by my hon. Friend the Member for Wansbeck (Mr. Murphy) and my right hon. Friend the Member for Coatbridge, Chryston and Bellshill (Mr. Clarke), who also has a distinguished record of working with disabled people.
Mr. Russell Brown (Dumfries and Galloway) (Lab): I, too, congratulate my hon. Friend the Member for Eccles (Ian Stewart) on securing this debate. Far be it from me to steal his thunder, but the Minister said that he would endeavour to work closely with Ministers in the Department of Health. On a previous occasion, my hon. Friend met two Secretaries of State to push the case for advances on payments for vaccine damaged children. If there were a request for a meeting with the Minister and someone from the Department of Health, would he accede to it?
Jonathan Shaw: Of course, I would gladly accede to such a request. Our hon. Friend the Member for Lincoln (Gillian Merron) now has policy responsibility as Minister of State, Department of Health, and colleagues who know her will know that one of her qualities is that she engages with colleagues from across the House, which is her responsibility. She and I will gladly see a delegation to discuss this important matter.
I realise that my right hon. and hon. Friends are familiar with the vaccine damage payments scheme and its operations, but for the record and to inform the debate, it would be helpful briefly to outline its background and explain how it works in practice. I am pleased that my hon. Friend the Member for Eccles categorically stated that he and the all-party group support a public vaccine programme. Immunisation with vaccines is a vital way of protecting individuals and the community from serious diseases. It is an important part of our public health policy and it continues to have a tremendous positive impact on the health of our population.
Vaccinations are safer now than they have ever been, but I recognise that on rare occasions, vaccines can cause severe disability, which can put individuals and their families under considerable strain-my hon. Friends the Members for Eccles and for Wansbeck were right to describe those human tragedies in the House. That is one of the main reasons why the Government established the vaccine damage payments scheme at a time, which is thankfully in the past, when there were valid concerns about child vaccines. We believed that the measure of financial help provided by the scheme would help to ease the present and future burdens of those who are severely disabled as a result of vaccine damage.
The scheme, which as my hon. Friend the Member for Eccles rightly said was introduced by a Labour Government in 1979, provides a tax-free, lump-sum payment of £120,000 for those who are severely disabled as a result of a vaccination against the diseases listed in the Vaccine Damage Payments Act 1979. It also acknowledges that people who are severely disabled early in life have less opportunity to save and earn.
However, it is important to note that the vaccine damage payments scheme is not intended to address all the financial implications of disablement for those affected
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by vaccines; it is only one part of a wide range of support and help available to severely disabled people in the UK. For example, the disability living allowance provides an important non-contributory, non-means tested and tax-free cash contribution towards the extra disability-related costs incurred by severely disabled people.
On the side effects of vaccination and hepatitis B, my hon. Friend perceives that the Department of Health does not recognise that vaccines can cause damage. That is not the case. I hope that Ministers from the DWP and the Department of Health can assure my hon. Friend the Member for Dumfries and Galloway (Mr. Brown) of that at the meeting he requested.
Ian Stewart: Although we expected to get some answers today-hopefully we will get some-the Minister cannot possibly answer everything we have put to him. Therefore, this short debate is the stepping stone towards other debates and meetings in pursuit of our constituents’ interests.
Jonathan Shaw: I am aware, as my hon. Friend said, that the debate is part of a process. As I said in my opening remarks, he is focused, principled and relentless, so this will not be the last time that we discuss this matter. I welcome debate and discussion on this important issue.
I reiterate that the Department of Health takes great pains to ensure that its vaccination information material stresses that no vaccine is 100 per cent. safe. Because the Department of Health recognises the risks, it continues to work closely with the DWP on the vaccine damage payments scheme.
Hepatitis B vaccine is widely considered to be safe. There are known side effects, but the majority are mild, transient and uncommon. With common medical conditions, it is inevitable that some people develop symptoms after they receive a vaccine. It is completely understandable how conditions occurring shortly after vaccination can be attributed to vaccination, but the onset of symptoms after vaccination does not necessarily mean that the vaccine was responsible. Those claims have been extensively evaluated, and there is currently no good scientific evidence that hepatitis B vaccines cause long-term illnesses such as MS, rheumatoid arthritis and chronic fatigue syndrome. That position is supported by the World Health Organisation and the Centre for Disease Control and Prevention in the United States.
It is also important to reiterate that the report of a suspected adverse reaction to the hepatitis B vaccine through the yellow card scheme and its consequent inclusion in the list does not necessarily mean that a reaction was caused by the vaccine. MS was included as a possible side effect in product information, with the proviso that no causal link had been established, long before the studies found that there was no link. The only potentially serious adverse reaction attributable to the hepatitis B vaccine is anaphylaxis. Such severe allergic reactions, which can result in death, are believed to occur about once in 1.1 million doses. It may also be helpful to point out that the US vaccine injury system listed that serious adverse reaction as an adverse event to hepatitis B in its vaccine injury table.
I shall now consider the suitability of including the hepatitis B vaccine in the current vaccine damage payments scheme. It is important at the beginning to understand
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the background and rationale of the scheme. The scheme has always covered the diseases that are vaccinated against as part of the Department of Health’s routine childhood immunisation programme. Such an approach underlines the intention of successive Governments for the scheme to help those children who are-extremely rarely but regretfully-severely disabled as a result of vaccinations aimed at preserving the health and safety of the wider community.
Changes to the childhood immunisation programme are made on the recommendation of the Joint Committee on Vaccination and Immunisation. As my hon. Friend indicated, in some cases, as with vaccinations against polio, rubella, meningitis C and HPV, the scheme also covers those vaccinated up to and sometimes over 18 years of age.
Ian Stewart: I am sorry to take up the Minister’s time, but he is clearly going to be unable to answer all the points that have been raised in the debate. Will he write to me to cover all the points that he has been unable to cover in this short time?
Jonathan Shaw: I am not going to be able to say everything that I wanted to say, and I will certainly write to him with those details.
(c) 2009 Parliamentary copyright
Hansard: Cervical Cancer Vaccination Debate: House of Commons, 13 May 2009
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Cervical Cancer Vaccination
Motion made, and Question proposed, That this House do now adjourn. — (Ian Lucas.)
Mr. Crispin Blunt (Reigate) (Con): I am grateful for the opportunity to highlight concerns about the human papilloma virus vaccine Cervarix, which, contrary to Government assurances even yesterday, appears to be causing adverse reactions in a number of teenage girls, and to raise concerns about the cost-benefit analysis process that has led to that vaccination programme, the manner in which it is being delivered and the yellow card warning system.
I only became concerned about the possible side effects of the Cervarix vaccine—and, I confess, aware of the vaccine itself—when the experience of one of my constituents, Rebecca Ramagge, was brought to my attention. Rebecca’s mother came to see me at my surgery 12 days ago and told me how her daughter had fallen ill shortly after her first injection with Cervarix. Over the full course of the injections, she has gone from being a healthy sports-loving teenager who was a high achiever at school and a tournament-level tennis player, to being crippled by chronic fatigue syndrome, unable to attend school regularly and in need of help with basic tasks such as walking and eating because of the exhaustion and the muscular and joint pain from which she is now suffering.
Despite experiencing serious joint pain and illness shortly after the initial injection in September 2008, Rebecca went on to receive the two follow-up jabs as the vaccinations were administered at school. Her family doctor was therefore unaware of the listed side effects of the drug and unable to link Rebecca’s deteriorating condition to the vaccine. It was only after Rebecca was referred to a consultant paediatrician at East Surrey hospital, Dr. Jawad, that her symptoms were identified as highly consistent with a reaction to the vaccine.
The consultant in question was astonished that nurses had administered the third injection to Rebecca when she was complaining of a recognised side effect listed in the product information as a common side effect of the vaccine. That raises the wider question that I will come to shortly, of whether school is an appropriate environment in which to vaccinate children.
Rebecca’s case is not an isolated one. Similar stories of severe reactions resulting in partial paralysis, seizures and chronic fatigue have been well featured in the national press. The vaccine support group JABS—Justice Awareness and Basic Support—has nine girls registered as suffering from severe adverse reactions to Cervarix. A solicitor who specialises in representing vaccine victims is representing six girls who are suing the makers of the vaccine, GlaxoSmithKline, under the Consumer Protection Act 1987. Yesterday however, the Minister gave me a parliamentary answer that included the following:
“To date almost one million doses of Cervarix have been given in the UK and there is no evidence to suggest that Cervarix vaccine has caused chronic fatigue syndrome, paralytic disorders or any other serious or long-term side effects.”— [ Official Report, 12 May 2009; Vol. 492, c. 706W.]
For any vaccine, it is always probable that there will be a small number of people who have an adverse reaction. However, there are serious questions to be raised about
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this vaccine and its administration, the quality of the information available about its risks, and how it has been promoted by the Government.
First, it is notoriously difficult to establish firm medical proof of a causal link between a vaccine and severe medical conditions previously unrecognised as side effects, but when a group of healthy teenagers suddenly begins to exhibit similar debilitating symptoms shortly after receiving the same vaccine, it is surely only sensible provisionally to conclude, even in the absence of concrete proof, that the common factor in all of the cases—the vaccine—is the likely cause.
I was particularly disturbed to hear from the hon. Member for Bootle (Mr. Benton) about the case of a girl who collapsed in pain hours after having the Cervarix jab in school. She has been in hospital ever since. The hospital has carried out a number of tests, but has so far been unable to establish the cause of her condition. Instead of exhausting the tests available to it by carrying out the hair trace test requested by the girl’s family—who have been told they will have to pay for it privately—it has concluded that the condition is all in the girl’s mind, a result of mental abuse by her mother who, convinced that her daughter has reacted badly to the vaccine, is projecting her conviction on to her daughter. I am told that it is now proposing to take this girl into care, but, in light of Rebecca Ramagge’s experience, I am concerned that medical professionals have resorted to accusing members of this family of suffering from psychiatric disorders while not being prepared to test their thesis exhaustively.
There is also the case referred to me by my hon. Friend the Member for Newark (Patrick Mercer) regarding his 18-year-old constituent who since having the HPV vaccination has started to suffer from frequent seizures—40 in the last nine weeks—that have left her unable to drive or to continue with her college course. Again, doctors are having difficulty diagnosing exactly what is wrong with her, and have started to hint that her problem may be mental rather than physical. There is also the case in Honiton—and my hon. Friend the Member for Tiverton and Honiton (Angela Browning) is present to listen to this debate.
I hope my constituent’s experience will provoke a reassessment of these and other cases. Unless further proof emerges of another common factor between the affected girls that could have caused their condition, surely the only responsible course of action is to admit that the vaccine may have undesirable side effects for some girls, and to ensure that the public are aware of the risk, however small, they are taking when choosing to have the vaccine. In summary, the Government’s current understanding—given to me yesterday by the Minister, I am quite sure in good faith—is flat wrong.
Secondly, it is my assessment that the public have not been provided with clear and accurate information about the risks associated with the Cervarix vaccine. GlaxoSmithKline’s product information gives a full list of undesirable effects that the vaccine might cause. Among those listed are serious conditions such as myalgia—listed as being very common—arthralgia and paraesthesia. Legal representatives of Cervarix victims point out that in many of the cases in which they are representing them, paraesthesia is so severe that the effect should be more accurately described as partial paralysis.
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The information provided to patients by the NHS, however, is much briefer and far more reassuring in tone. The NHS immunisation website lists the most common side effects as mild to moderate swelling, redness and pain at the site where the injection is given. It also lists symptoms such as slightly raised temperature, sickness, dizziness, diarrhoea and muscle aches as other mild side effects that have been reported. Without repeating the full details, I can tell the House that nowhere within this NHS information is there any indication that symptoms reported as suspected side effects have in some cases been both serious and persistent—for example, the chronic debilitating muscle and joint pain experienced by my constituent—nor does it give a full list of the symptoms. It misses out headache—although that is listed as a very common side effect—upper respiratory tract infection and paraesthesia, which are all included in the literature from GSK.
This is not just about patients and their families; general practitioners, too, rely on the NHS’s information; they are not being directed to GSK’s more comprehensive data and they are therefore not looking for reactions. I know of GPs who, on the back of Rebecca’s experience, have called staff meetings to alert their colleagues, and even in the past week those GPs now believe that they too are recognising symptoms. I am told that NHS Direct has no drop-down box to guide operators to ask, in the event of these symptoms being reported, whether the patient has recently had the Cervarix vaccine.
The Medicines and Healthcare products Regulatory Agency’s latest figures show that they have received 1,602 reports of suspected reactions, including 161 recipients complaining about “pain in extremity” at the injection site. As I will explain, that is likely to be a serious understatement. In the light of this and the severe nature of some of the adverse reactions reported, I ask the Minister to consider as a matter of urgency changing the information that the Government provide GPs, families and NHS Direct, not only so that families and patients may make the informed choice to which they are entitled, but so that the potential symptoms are properly identified and linked. Failure to do that will open the Government to the charge of being simplistic at best and irresponsible at worst.
Thirdly, I am concerned about the Government’s blanket promotion of this vaccine as a silver bullet against cervical cancer. Reservations have also been expressed by some medical professionals about the thoroughness of the clinical trials, which they have claimed were too short and did not include enough girls under the age of 16, who have been the first age group to receive this vaccine as part of the Government’s national programme. Gynaecological experts such as Diane Harper, director of the gynaecologic cancer prevention research group at Dartmouth medical school, have urged for the introduction of the vaccine to be delayed, so that any future side effects have time to manifest themselves.
The Government have refused to produce any open data on the cost-benefit analysis they undertook in choosing Cervarix. Sexual health charities, such as the Terrence Higgins Trust and the Brook Advisory Service, have expressed dismay that the Government have not followed the example of nearly every other western country in choosing the rival vaccine, Gardasil, which protects against a greater variety of pre-cancerous lesions
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than Cervarix, and genital warts as well. The Government’s only public response has been that they made their decision according to “pre-agreed criteria”, which they apparently will not disclose.
The Minister of State, Department of Health (Dawn Primarolo): That is not true.
Mr. Blunt: The Minister says that that is not true. I do not know whether it is, which is why I used the word “apparently”. She will have the opportunity to reply and make that position clear. I want to make it clear that I am entirely new to this matter and have had two weeks to learn and understand it, but in that period I have grown very concerned, which is why we are having this Adjournment debate.
It is open to question whether the Government have factored in to their cost-benefit analysis the savings that they might make on the cost of treatment for genital warts. It is also unclear whether there was an adequate analysis of the costs that might be incurred through compensating the victims of adverse reactions; that would apply in respect of Gardasil as well.
Another issue that I would like the Minister to address is the actual delivery of the vaccination. A school that had a number of pupils take part in the original trials of Cervarix, St. Monica’s Roman Catholic high school in Manchester, has decided not to opt in to the nationwide vaccination programme, citing concerns about the effectiveness of the drug and the side effects it caused in a number of its pupils who underwent the trial. It also cited its opinion that school was not an appropriate environment in which to vaccinate children.
There will always be a handful of adverse reactions, some serious and some involving symptoms previously unrecognised as side effects. It would surely be much safer if vaccines were administered in an appropriate medical environment by a professional who had ready access to the recipient’s medical history and where the potential risks and side effects had been properly evaluated and discussed. That would enable the recipient and their family to have a full understanding of the potential costs and benefits of the vaccine being offered to them. I therefore ask the Government to review their current policy of administering nationwide vaccination programmes in schools. Had such an approach been the norm, it is unlikely that my constituent would ever have been given the third dose of the vaccine, which exacerbated the side effects.
HPV is most commonly spread through sexual contact and, while I am aware that a proportion of girls are sexually active from a very young age, many are not, and some parents may feel that it is unnecessary for girls to receive this vaccine so early in their teens when they are still growing quickly and experiencing rapid hormonal change. Educating girls about the dangers of HPV, how it spreads and the measures that they can take to protect themselves against it, such as using contraception, should also play a part in combating HPV. Parents should be able to access this debate to make informed choices.
If I had more time, I would wish to raise the more general point of compensation for victims of adverse reactions. There is no doubt that vaccination brings great benefits to society at large, but it also carries an inherent risk of serious reactions that will affect a
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minority. The UK’s compensation scheme has been described as “hopelessly flawed” by legal experts and leaves many with no option but to sue pharmaceutical companies under consumer protection legislation. This is an expensive and exhausting process for claimants and it sparks widespread and sometimes unfounded fears about the safety of vaccination programmes.
On the basis of what I know now, I suggest that we examine the US vaccine compensation scheme, which awards damages to successful claimants according to the severity of their injuries and the costs they are likely to incur as a result. That does away with both an arbitrary and insufficient award and an artificial extent of injury qualification.
I would like to finish by highlighting the inadequacies of our system for reporting adverse reactions to vaccines. The yellow card system operated by the MHRA is not mandatory so there is no obligation on medical staff to report reactions. Furthermore, the scheme has such a low public profile that many who suffer from a reaction after a vaccination are not aware that there is a system for reporting their experience. Indeed, I spoke to a school nurse today at random and she was unaware of the scheme. The yellow card scheme was described to me by a managing director of a pharmaceutical research company yesterday as
“one of the weakest in Europe”.
Do the Government have any plans to strengthen the current system and make it fit for purpose?
The Government have so far been determined to push on with this blanket vaccination programme while paying little heed to the serious concerns raised about the safety of the vaccine, the quality of information readily available to those considering the treatment and the possibility that promoting alternative preventive measures may be a more suitable and less risky path for some girls. I would be grateful to hear from the Minister that the Government will not continue down this incautious path based on the alarming and inaccurate information given in the parliamentary answer to me yesterday, but will take account of the experiences of my constituent and those of other hon. Members.
The Minister of State, Department of Health (Dawn Primarolo): I congratulate the hon. Member for Reigate (Mr. Blunt) on securing this debate. My thoughts are with the young people about whom he spoke. I join him and other hon. Members in wishing them a full and speedy recovery and I shall say more in a moment about the individual cases.
I shall start by sounding a caution. When we debate sensitive issues such as this, it is important to deal with the science, not the supposition, and with the evidence, not the hearsay or opinion. We should not be swayed by the lurid way in which HPV and its vaccine are sometimes portrayed in the media. We have played this game before with the MMR scare and many areas are now paying the price in an explosion in measles and mumps cases because not enough families have taken up the vaccine. I want to take this opportunity to address head on the suggestions that the HPV vaccine is not safe.
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Before licensing, Cervarix was rigorously tested and found to have minimal side-effects. Scientists conducted large-scale clinical trials, involving thousands of girls and young women, to assess its safety. Since then, several million doses of vaccine have been given around the world—including the best part of 1 million in the UK, as the hon. Gentleman said—with no new risks emerging.
There are, of course, side-effects associated with Cervarix, as there are with all vaccines, but it is important to stress that most people do not experience any side-effects whatsoever. The most common known effects from Cervarix are injection site reactions, dizziness, headache, muscle pain, nausea and upset stomach. They are normally mild and last for no more than a few days. I accept that those reactions can be unpleasant, but they are nothing compared with the symptoms of advanced cervical cancer and are a price worth paying, in my view, to save 400 lives a year.
There is a clear need to keep a watching brief, and we are continually monitoring safety so that we can quickly identify any new side-effects that might emerge. I completely reject the hon. Gentleman’s proposition that somehow our regulatory and monitoring system is weak or substandard—it is one of the best. Every week, the Medicines and Healthcare products Regulatory Agency publishes online analysis of all suspected side-effects reported through its yellow card scheme. We know that almost 1,700 suspected side-effects have been reported since the immunisation programme was first introduced, but those figures come with a caveat. That is not my personal view as an individual; it is based on the scientific evidence and advice we are given.
The figures do not necessarily mean that the vaccine caused the medical condition, only that the reporter suspected it might have. On investigation, we find that 90 per cent. of those reports—to put it into perspective, that is about 1,500 reported cases out of 1 million, or 0.0015 per cent. of total vaccines administered—either relate to the known side-effects that I have already mentioned, or they were psychogenic events: that is, symptoms linked to a fear or anticipation of the needle injection. Those psychogenic events cover a number of girls who fainted after the injection, which is a known response to all needle-based vaccinations and is running at a rate that is in line with what experts would expect.
In the remaining 10 per cent. of cases—let us remember that we are talking about 0.00017 per cent. of the total vaccines—there is good reason to think that the reported symptoms were associated with an underlying condition or illness that the person was suffering from at the time they had their vaccination. That, in fact, appears to be the most likely interpretation for the cases reported in the media recently, including the cases in the Daily Express and Daily Mail of the young girls who were reported as suffering from partial paralysis, chronic fatigue syndrome and fits since having their vaccination. The MHRA is fully aware of those cases, several of which were reported via the yellow card scheme, and is investigating them.
As we vaccinated such a large cohort of young people, it was inevitable that a few cases would come forward where other conditions were reported as suspected side-effects even if the vaccine played no part. Indeed, the MHRA’s statistical analysis of paralytic disorders and chronic fatigue syndrome shows that the reported frequency
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of such cases is no more than—or should I say the same as—would have been expected among a similar cohort of unvaccinated teenagers. In addition, the Government’s independent advisory body, the Commission on Human Medicines, looked into the reports not just in the UK, but across the world and concluded that there are no new safety issues associated with the vaccine.
I realise that that is no consolation or comfort to the girls to whom the hon. Gentleman has drawn attention. Equally, however, it is no reason to condemn a programme that has seen more than a million teenagers receive injections with little or no reported effect.
The Government are committed to transparency and the hon. Member for Reigate can be assured that any emerging information on the possible side-effects will be fully evaluated. We will take appropriate action promptly when any true side-effects are detected but, alongside that transparency, we need to maintain public trust and confidence. The facts speak for themselves, and they remind us why we introduced the vaccine in the first place.
We know that at least half of all sexually active women will be infected by a strain of HPV in their lifetime. We know that the viruses are responsible for causing more than 99 per cent. of cervical cancer cases, and a range of other cancers. There are nearly 3,000 cases of cervical cancer each year, a third of which will prove fatal within five years, and we know that the HPV vaccine is effective in protecting young women against two HPV strains that are responsible for around 70 per cent. of those cancer cases. As a result, the vaccine could eventually prevent up to 400 deaths due to cervical cancer every year.
So the facts tell us that the Cervarix vaccine is a major breakthrough in public health, and the first vaccine that can directly prevent cancer. It would be a travesty if women were denied the potential that it offers because of scaremongering and supposition. The weight of evidence says that the vaccine is safe, effective and capable of saving thousands of lives in the years ahead.
The hon. Member for Reigate talked about lack of information. Tomorrow, I shall do him the service of referring him to my parliamentary answers detailing the conditions for the contract negotiations and on which the contracts were judged. I will not be able to give him any information that is commercially confidential, but
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the House has received a very full explanation of the matter, both in writing and in parliamentary answers to individual Members.
I believe that we should support and celebrate the saving of women’s lives from a preventable illness. I advise the hon. Member for Reigate that reports that the vaccine is not safe are incorrect, as are those suggesting that it lacks the confidence of the scientific community. I assure him that the Government, like any other, will always remain vigilant in respect of the vaccination programme.
Mr. Blunt: I have heard the Minister’s answer. On one level, I understand the requirement for an uncompromising public health message on the need for a vaccination programme, and I am not suggesting that there is a wider case against the vaccine. What I was hoping to hear from the right hon. Lady was that, as symptoms start to emerge and based on the evidence that I have presented this evening, the Government would start to think about whether those who are administering the vaccine are looking for reactions properly, because they have not been alerted to them. Any vaccination programme has a number of reactions associated with it, and the body of evidence emerges as more people are vaccinated. I have to say that I was disappointed by the tone the Minister took and the apparent lack of open-mindedness to the new evidence emerging.
Dawn Primarolo: I, too, saw the e-mail the hon. Gentleman sent to all Members of Parliament, asking for details of any cases. However, his case tonight is based on some conversations that he has had and some discussion with someone in a school about whether they were aware of something. Based on that, he has tried to advance the case that all the science, all the evidence and all the information that the Government have are not true. His central question to me, which I have answered, is why I believe that the vaccine is safe and why I believe it is appropriate to give that vaccine. I agree absolutely with the hon. Gentleman that any Government, regardless of their confidence now, would stay vigilant and look at all the reports on the vaccine—as we do monthly.
Question put and agreed to.
(c) 2009 Parliamentary copyright