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9.32 pm
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
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 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.
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, but 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 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 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.
9.47 pm
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.
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
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.
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