OPEN LETTER

To: Rt Hon Jeremy Hunt MP, Secretary of State for Health and Social Care

22nd February 2018

Dear Mr Hunt

We write to you as parents of girls who have reported serious suspected side effects with the HPV vaccination – both Cervarix and Gardasil brand of HPV vaccine. Whilst we appreciate that the vaccination has been given to millions of girls without apparent adverse reaction, the issue of our daughters’ chronic illnesses has been raised with regulatory authorities and politicians since 2009 – with Crispin Blunt MP speaking in the House in May 2009 (less than a year after the deployment of the HPV vaccination) and saying:

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 …”

 “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.”

 “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.”

 “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’.”

Many of the statements you made in the House of Commons yesterday, when you announced the Medicines and Medical Devices Safety Review, resonate completely with the campaigns that are being run by parents and patients in the Time For Action and other HPV vaccination groups in the UK and across the world.

“I pay particular tribute to those who have responded to such experiences not just with understandable anger, but with resolute determination to campaign for change on behalf of others. Many of them have met Ministers and Members to share their concerns.”

We have met with Shadow Health Ministers Andrew Gwynne and Luciana Berger; we held a Lobby in Parliament in October 2017 and have individually met with very many MPs throughout the UK. A case for lack of informed consent has been taken to the Ombudsman. In 2014 Russell Brown MP asked Jane Ellison, then Minister for Health, to attend the APPG and meet families who had been affected – she declined to do this. Dr Sarah Wollaston MP, and Chair of the Health Committee, was also asked to attend the APPG and she declined saying she had a conflict of interest as a GP. In January 2016 we met with Lord O’Shaughnessy and representatives from the MHRA and Public Health England. On Tuesday we sent a representative to a meeting on HPV vaccine safety at the MHRA chaired by CEO Dr Ian Hudson.

From data released under the Freedom of Information Act, we have compiled this graph below, to show that the number of chronic illnesses reported for the HPV vaccination is far higher than for any other vaccination, and it is only given to girls (approx. half the population), yet replies given to parliamentary questions state that the reactions reported are as for any other vaccination.

 

Mr Hunt, you also included in your statement yesterday,

We must acknowledge that the response to these issues from those in positions of authority has not always been good enough. Sometimes the reaction has felt too focused on defending the status quo, rather than addressing the needs of patients, and as a result patients and their families have spent too long feeling that they were not being listened to, making the agony of a complex medical situation even worse

Teenage girls are not being listened to – by MPs or by medical professionals. They are very frequently told their medical problems are psychological or sent away with anxiety medication. There is a very real problem of doctors not wanting to speak out about possible vaccination issues and this needs to be addressed. Healthcare professionals are regularly assured by the MHRA and Health ministers that there are no safety concerns with the HPV vaccine, and many doctors are not recognising adverse reactions.

The Swine Flu vaccination was shown to cause Narcolepsy in some children, but it took clinicians in Scandanavia to raise the alarm. The MHRA’s early warning system did not pick up the safety signal. We know there are hospitals in the UK where doctors must be aware of possible issues with the HPV vaccination because we see groups of girls photographed on hospital wards with naso-gastric feeding tubes on social media with comments about the vaccination; because there are consultants that refer to ‘our HPV girls’; and because many of our daughters have been seen at the same hospitals, with the same symptoms and the same story. Yet none of these doctors are raising concerns with regulatory authorities and the MHRA are not consulting specialists within the medical disciplines relating to the highest number of adverse reaction types.

As with Valproate, the HPV issues extend beyond the UK. There is legal action in courts in Japan, Columbia, France, Spain, Germany and Ireland that we know of. Up to 1st February 2018, 382 claims have been filed in the US Vaccine Court; 121 compensated; 147 dismissed; 114 in progress.

You said yesterday,

To do better in the future, we need to ensure that patient voices are bought to the table as systematically and consistently as other voices in the system, so today I have asked Baroness Julia Cumberlege to conduct a review into what happened in each of these three cases, including whether the processes pursued to date have been sufficient and satisfactory, and to make recommendations on what should happen in future. She will assess, first, the robustness and speed the of processes followed by the relevant authorities and clinical bodies to ensure that appropriate processes were followed when safety concerns were raised; secondly, whether the regulators and NHS bodies did enough to engage with those affected to ensure their concerns were escalated and acted upon; thirdly, whether there has been sufficient co-ordination between relevant bodies and the groups raising concerns; and fourthly, whether we need an independent system to decide what further action may be required either in these cases or in the future.”

The experience of families involved with mesh, Valproate, Primodos and other medical products has not been sufficient or satisfactory. The processes of Yellow Card reporting do not reflect severity or duration of symptoms and there is insufficient long-term follow-up to detect chronic illnesses. The reality is that, despite concerns that we have raised, the MHRA have no idea how many girls have become ill after HPV vaccination and are years later unable to attend school or employment.

An individual follow-up of patients reporting serious adverse events in the Netherlands showed that in 2016 there were 288 girls who had not recovered:

We absolutely need an independent system for dealing with reported side effects of medications and medical products and this should be separate from the licensing authority.

“Patients and their families have had to spend too much time and energy trying to access, lobby and influence NHS leaders and Ministers to get a hearing for their concerns”

We would reiterate that this has been especially difficult when raising issues with a vaccination. The mesh, Valproate and Primodos campaigns have received a lot of media exposure but we have found that despite talking to all of the mainstream media and preparing many articles with journalists, the stories are almost always pulled at the last minute. There would appear to be a media blackout in our case.

The position of the MHRA within the EMA has also caused problems for those of us campaigning to get attention for our daughters’ illnesses – not least because the MHRA led on the EMA 2015 safety review of POTS and CRPS as possible side effects of the HPV vaccination. The process and conclusion of this review was criticised by independent scientists across the world; the leading researchers in autonomic neurology in the USA were not consulted; a recent Cochrane publication has revealed that less than 50% of the clinical trial data was included, and the pharmaceutical companies were not required to follow-up reports that lacked sufficient information.  A recent Slate article revealed that women who took part in clinical trials did report side effects very similar to those suffered by our daughters but these were recorded as ‘new medical history’ and not ‘adverse events’ and the EMA had commented that this was ‘sub-optimal’ but it was still allowed to happen. The Nordic Cochrane Group made a complaint to the EU Ombudsman about the conduct of this review and the outcome was that the Ombudsman could not make a ruling on the scientific aspects, so many questions remain outstanding.

The WHO have effectively sidelined concerns raised by articles published by authors at the Uppsala Monitoring Centre that highlighted clusters of symptoms that have been reported at a higher rate than for any other vaccination, even when excluding reports from Japan and Denmark that might have been influenced by media bias. The WHO commissioned a Systematic Review of side effects that reported in 2017 and this is referenced to show the safety of the HPV vaccination – only when reading closely, you will find that this publication reports on ‘selected’ side effects and specifically excludes POTS and CRPS.

We would, therefore, respectfully ask that you instruct Baroness Cumberlege to include the HPV vaccination in the forthcoming review and request that we be allowed to input our experiences into the review.

Finally we would like to thank Lord O’Shaughnessy and the Countess of Mar for the assistance they have provided to us this far.

 

On behalf parents and families of

Time for Action – UK Families Affected by HPV Vaccination