Truth about Cervarix

A modern history lesson, approx.3000 words

2008

The British government decided to introduce a new national vaccination programme. The purpose was to prevent deaths from cervical cancer in the future, of which, we were informed, the cause is mostly HPV virus infections. It was to be given in schools to 12 year old girls - also doctors' surgeries for a catch-up programme to teenage girls.

The government had a choice of 2 brand names from 2 manufacturers.

May 2008

The Department of Health, with newly printed publicity material entitled "Beating Cervical Cancer - the Facts", circulated 50,000 copies via GPs and Primary Care Trusts and posted it online. Note: the facts and figures about side effects were false. It was soon posted online by numerous NHS Trusts nationwide! Other leaflets gave even less information about known side effects and described them as

"quite mild."

Meanwhile, local authority education chiefs and PCT chiefs sent out letters to parents at the end of the summer term 2008, requesting parental consent. Note: under Gillick law, parental consent would not be required, even for 12 year olds.

The government chose Cervarix manufactured by UK company, Glaxo Smith Kline.


September 2008

The new school term began and immediately the vaccination programme began.


13 September 2008

A Surrey Primary Care Trust press release appeared in our local newspaper:

"The vaccine itself is safe, with no serious side effects reported either in clinical trials or among the hundreds of thousands of women who have received it worldwide."

18 September 2008

I wrote to the Medicines and Healthcare Products Regulatory Agency alerting them of conflicting reports about safety and side effects.



24 September 2008

National news: a school in Manchester refused the vaccinations on their premises. The letter sent out by the governing body (syndicated by local newspapers) pointed out that staff had noticed pupil absences immediately after the jabs were given in the pilot study there. It also cited its opinion that school was not an appropriate environment in which to vaccinate children.

The press changed the story to make it sound as if the decision was for religious or moral reasons.


30 September 2008

Dr Philip Bryan (Vigilance and Risk Management of Medicines (VRMM), MHRA) replied to my email, with this bald statement:

"Cervarix is not known to be associated with any serious risks."

Yet he contradicted that immediately by admitting that 'Cervarix may very rarely cause anaphylaxis' - which of course is serious. He did not mention any of the other serious or long-term risks associated with vaccines. He did not mention the European Medicines Agency's Scientific Discussion document which points out that

55 subjects were withdrawn from the study due to serious or non-serious adverse events including 33 subjects in the HPV vaccine group. (Cervarix)

and nor did he disclose that

13 foetal deaths were also reported to the Company as pregnancy outcomes.

I will add here that the definition of foetal death is

death of a foetus weighing at least 500 g or after 20 or more weeks of gestation.

1 October 2008

Through a Freedom of Information request, I established that the
Department of Health's so-called facts were indeed false and misleading by vastly understating the statistics and omitting some common side effects. They thanked me for bringing it to their attention yet they failed to remove the offending documents from the web and failed to inform health professionals or the public of the blunder. No official reference was made of any amendments until the following June (8 months later).

10 October 2008

This was a formal response from the Department for Childen, Schools and Families:

Thank you for your email of 30 September, to Ministers, about the document 'Beating cervical cancer - the facts'. I am sure you can appreciate the Ministers receive a vast amount of correspondence and are unable to respond to each one individually. On this occasion I have been asked to reply.

Immunisation Programmes are the responsibility of the Department of Health (DH), not the Department for Children Schools and Families (DCSF), and this is why your query has been passed to them to respond. The involvement of DCSF in the HPV Immunisation Programme is to encourage schools to co-operate with the DH and local Primary Care Trusts and allow the vaccinations to be given at school, but schools are not obliged to do so. In some areas, Primary Care Trusts themselves may decide that the vaccinations will not be given in schools, and will therefore make alternative arrangements.

Data on pupil absence in schools is published in a Statistical First Release (SFR). The data for Autumn Term 2007 is due to be published on 21 October 2008. This release reports on absence in maintained primary and secondary schools, city technology colleges and academies across the autumn term 2007 and spring term 2008. It is based on information collected via the School Census for the two terms combined and is published at local authority level.

We are now in the process of collecting data for the year 2007/08. This updates and supplements information published in the October release and does include information on the reasons for absence but only at local authority level and will be published in February 2009. Overall absence and persistent absence data will be published at school level in the Achievement and Attainment Tables in January.

18 October 2008

Our local paper published 2 letters in reply to Surrey PCT's Dr Ruth Milton who had stated that the Cervarix jabs are

"essential."

One of the letters was mine, saying that Dr Milton's claim may be an exaggeration and untrue anyway, since nature provides other ways of fighting viruses and cancers.



13 May 2009

Our Reigate MP, Crispin Blunt secured a Parliamentary debate, immediately after a Reigate parent raised the alarm about her daughter, Rebecca Ramagge. She is badly injured from 3 doses of Cervarix given by nurses at St Bede's School when already they had documented that she was on crutches (from arthralgia - joint pain and chronic fatigue).



This video clip is of Crispin Blunt's Cervarix speech in the House of Commons (2min:30sec)

Two years on, Rebecca still suffers very serious and long-term injuries. Paediatric consultant Dr Jawad specified the Cervarix vaccine in his formal diagnosis and stated that the link between arthralgia and vaccines is really well established. I have known and trusted Doctor Jawad since 1990 at the Royal Brompton Heart and Lung Hospital, London and at East Surrey Hospital so I respect his professional judgement. In contrast, the then-Health Minister Dawn Primarolo's pre-written speech ended insistently:

"reports that the vaccine is not safe are incorrect."

Crispin Blunt had described her Parliamentary answer as

"flat wrong."

9 June 2009

The Freedom of Information Head at the Department of Health confirmed that 50,000 copies of the faulty statistics about side effect risks had been printed and circulated, also online from May 2008 onwards. He or she informed me:

"You may be interested to learn that there were 600,000 girls and young women in the first cohorts eligible for HPV immunisation from September 2008."

What did interest me was that 600,000 girls, their teachers and their families had all been misled by false NHS statistics about the unlikelihood of side effects and a reassuring tone therein, in contrast to the official Patient Information Leaflets which are factual.

29 September 2009

Dr Ruth Milton, Director of Public Health for NHS Surrey and Alan Cottle, Head of Strategic Risk Management for Surrey County Council, sent out a letter urgently to Head Teachers in Surrey:

"HPV Vaccination in Surrey

We have all been saddened today by news about the death of a 14 year old girl in Coventry on the same day as she received her HPV vaccination...The HPV vaccination programme will continue. In the UK about 3000 women are diagnosed with cervical cancer every year and about 1000 sadly die from it. Protecting young women against this disease is vital."

The figures they quoted missed two important points about the age of the women and the need for screening. Cancer Research UK confirm:

"The fact that 957 women died of cervical cancer in 2008, with around a third of deaths being in those aged 75 and over is correct. Since 1988 when the NHS Cervical Screening Programme was set up, mortality rates have decreased by around 7% a year in the UK."

30 September 2009

The following day, I travelled to Guildford to speak on BBC Radio Surrey. PCT health consultant Ms. Ruth Hutchinson asserted via telephone that Cervarix is completely safe -

"absolutely"

she said.

My associates and I were offended by BBC interviewer Nick Walsh's dismissive and condescending attitude towards my pioneering research and professional experience in Education and for the Dept. of Health after retirement.

27 October 2009

By email, Sairah Mahmood (Pharmacovigilance scientist, MHRA) confirmed the definition of a serious reaction:

* Fatal

* Life-threatening

* Disabling

* Incapacitating

* Have resulted in, or prolonged, hospitalisation

* Medically significant

* Congenital abnormalities


FAST FORWARD past NHS Choices jubilant claim that the vaccine is

"in the clear"

after the tragedy of 14 year old Natalie Morton's sudden death after one jab.

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

FAST FORWARD past 4,445 girls with adverse events reported to the MHRA in the UK after Cervarix within 2 school year groups, and many more worldwide on the VAERS database. Some of these girls are still in hospital and disabled.

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

FAST FORWARD past the swine flu pandemic scare and a House of Commons standard note SN/SC/5164 10 November 2009. Author Dr Gavin Colthart specifies Government liability for harm caused by vaccines, and powers to impose compulsory vaccination. This raises ethico-legal questions about European Human Rights. Furthermore the burden of responsibility for home tuition during illness/injury rests on local authorities and schools - and Council tax, not the vaccine policy-making central government.

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

FAST FORWARD past several PCTs using bribery tactics - incentives to persuade pre-teenagers to have the 3 Cervarix jabs, including shopping vouchers and free beauty treatments.


>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
6 August 2010

"Summary of Product Characteristics for healthcare professionals: Text last updated 6 August 2010
Post Marketing Surveillance:
Blood and lymphatic system disorders
Lymphadenopathy
Immune system disorders
Allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema
Nervous system disorders
Syncope or vasovagal responses to injection, sometimes accompanied by tonic-clonic movements"

22 September 2010

Maxine Chambers of the MHRA stated to me:

"The advice of the MHRA remains that we are aware of no confirmed evidence that Cervarix vaccine carries long term risks..."

9 November 2010

Claire Tilstone (Editor, Drug Safety Update, MHRA confirmed to me:

"...our detailed 2 year safety update ... states (page 3) that "During the course of the two years, regulatory action has been taken to ensure that the product information for Cervarix adequately reflects the very rare risk of anaphylaxis"; "We are aware that the possibility of anaphylaxis, lymphadenopathy and injection-related vaso-vagal syncope was included in the product information for Cervarix last year"; "These risks are not unique to Cervarix" and "most vaccines can cause these, and hence they are not considered as newly-identified risks due to the vaccine."

This is a big set of excuses and a complete contradiction. Claire Tilstone's MHRA colleague expert senior assessor Dr Philip Bryan had reckoned two years ago that "Cervarix is not known to be associated with any serious risks" so that was blatantly an untruth and a fob-off when he replied to me. Primary Care Trust leaders had issued press releases stating the vaccine is safe and even "essential" and that was also untrue. Ex-Health Minister Primarolo had insisted to Parliament that the vaccine is safe whereas some parents, some senior medical staff and some MPs insist otherwise. Clearly they cannot all be correct. I put it to you that civil servants, the MHRA and vaccine policymakers are 'covering their backs', distorting the facts to suit themselves and collectively 'flat wrong' about safety risks.


30 November 2010

Subject: incidence, mortality and survival - cervical cancer

An extract from my email:

"...I don't know how these figures can justify the expense of the Cervarix programme indefinitely, along with the incidence of serious and long-term side effects and medical treatment, disability benefits, lost schooling, queries about effects on fertility etc., especially when there are so many other pressing needs in the health service... The basis of my initial research on this was that the figures regarding side effects were vastly understated in the DH publicity materials from 2008-9, and the benefits were exaggerated in the NHS national and PCT advertising from 2008-10. Correspondence from a former health minister, leading MPs and the ASA is on file to confirm these findings, along with my webpages, case studies online and the VAERS database.

Grace Filby

cc.Freda Birrell, www.sanevax.org

Extension work - documents on file

1. Email from Andrew Lansley MP, current Secretary of State for Health, ignoring my practical suggestion about statistical analysis of school attendance records and stating that he doesn't agree with me about my call for caution, October 2008;

2. Admission by Department of Health through my Freedom of Information request that the stated figures in the literature were wrong and understated, October 2008;

3. Letter from Mark Simmonds MP, former shadow Conservative health minister, agreeing wholeheartedly that parents have a right to accurate information about side effects, June 2009;

4. Letter from Dawn Primarolo MP, former Health Minister apologising for the mistakes in the printed literature, plus a request for my help..., June 2009;

5. Photographs of bus adverts in Redhill, Surrey bearing the locally amended caption

"Harm yourself for life"

August 2009

6. Statement from Anya Brooks regarding live BBC Radio Surrey interview, September 2009:

"I have listened on Iplayer to this broadcast concerning the HPV vaccination. I have just carried out a literature review for my Childhood and Youth Honours Degree with the Open University where I was asked to write a research project for my end of course assessment and having a 12 year old daughter, I chose the HPV vaccination. This is currently being marked.
However, during the review, one of the most important factors was that this vaccine has not been trialled enough in the age group that it is being administered to. There is minimal research on the long term effects of such a programme on young adolescent children while their bodies are still developing. Most of the research papers I reviewed were written by people who had in some way received some funds from the pharmaceutical companies that manufacture the vaccine. Government literature is both ambiguous and erroneous as Grace Filby pointed out on the breakfast show last Wednesday. There have been severe reactions from children after this vaccination, even though they are not being connected - there is not enough research or follow up medical information. The figures given for vaccination are wrong, Nick Wallis gave the percentage as 0.3 for side effects when in fact, the roll out of this vaccination is 3 injections per child and this brings the percentage up. It is approximately 1% and possibly higher, figures are hard to establish because of the gap in follow up research currently available.
Media coverage of this vaccination often misinforms the public, it does not prevent Cervical Cancer. There is still a need for cervical screening. HPV is not just transmitted sexually. The vaccine does not help those already with the HPV virus and it is possible for mothers to pass this at birth to their child - there are no tests in place to see whether children already have the virus. There are no tests to understand whether high levels of aluminium are already present in a child before injecting them with more. Research with aluminium shows that it can be attributed to Parkinsons and other medical issues. There is no conclusive understanding of long term efficacy, it has been based on clinical judgement. Although there is the idea that scaremongering happens during an early vaccination programme, it is unbelievable that issues are being ignored, misreported and we are being fobbed off with comments from the Department of Health that this vaccine is safe. No vaccine is safe as Grace Filby pointed out on Wednesday and if an organisation such as the BBC actually investigated, or at least checked out what academics already know - we would perhaps be able to give parents and children a more informed choice when making their decision about whether to opt in to this vaccination."

7. Letter from Dr Tim Crayford, Chief Medical Officer at Department for Transport ignoring my suggestions, quoting a passage from the MHRA whilst ignoring the significance of the term "recognised side effects" and stating that

"Unless and until further evidence suggests otherwise, the DfT will not therefore be developing any further policy on driving specifically in relation to this vaccine."

January 2010

8. Letter from the Advertising Standards Authority confirming that wording on bus adverts "Arm yourself for life" must be changed or removed - NB the ASA requested confidentiality. The complaint against West Sussex PCT was informally resolved and listed online with no mention of the vaccine programme. January 2010

9. Correspondence from Pat Langford, Programmes Director of STEMNET, insinuating that I, as a Science & Engineering ambassador was promoting beliefs, political opinions and seeking personal gain by addressing Year 8 girls in a blog and video online. My intention as a retired science teacher was to enable girls and their parents to make an informed choice. It was necessary to attempt to redress the balance because official bodies had deprived them of accurate information and had manipulated public opinion by using dubious tactics. Every year a small number of girls are therefore going to be endangered by this vaccine programme. This is a scientific and mathematical fact, which 12 year old girls have a right to know if the programme is truly voluntary. Pat Langford accused me of presenting these views in schools which was her false assumption without any evidence. Her course of action was to censor my blog. She also censored an innocent Wiki scientific diagram of the female immune system, suitable for 12 year olds. She did not have the courtesy to reply to my response upholding the truth of the matter. September 2010

10. My NHS Choices comments that were censored by anonymous moderators. These comments include referenced scientific information from official sources. The moderators repeatedly accused me of offering medical advice. August-December 2010

11. Letter from Norman Lamb MP, former shadow Liberal Democrat Health Minister, stating his request to Health Secretary Andrew Lansley MP for a full response to my comments about health education and expenditure, 4 November 2010

12. Spreadsheet based on Cancer Research UK figures (anonymity respected)
'It will take approx. 9 years before one life is saved
It will take 28 years before 650 lives are saved as a one off
It will take 75 years before 650 lives are saved on a yearly basis."

13. Letter from Secretary of State Andrew Lansley

"There remains no evidence of any serious or long-term risks of the vaccine from other countries."

Mr Lansley does not deny that there are serious and long-term risks, however. August 2010

14. Email from Department for Education

"Any long-term absences are managed by local authorities who, along with schools, have the responsibility for ensuring that all pupils are taught and receive a suitable education. Pupils who are absent from school for long periods (e.g. illness) should be offered alternative provision, which may include home tutoring or attending an education setting elsewhere than at school."

15. Market research on behalf of the Department of Health, proving that, before the programme was introduced, parents had raised key questions about safety, side effects and potential of the vaccine to damage their children's fertility.


6 December 2010


In conclusion:

In other words, if a child is injured by Cervarix or any vaccine, the costs of all future medical care and individualised education have to be met by local authorities and local health care services, not central government. Surrey County Council's dire need for fair government funding is being made worse by their school co-operation with the Cervarix vaccine programme. I consider that local authority leaders should now reconsider their involvement in the government's Cervarix programme.


Elizabeth Grace Filby BA(Hons) CertEd FRSA
Churchill Fellow 2007
Millennium Fellow 2003


References:

NHS campaign advertising material (at a cost of £2.8 million in 2008-9) with the slogan "Arm yourself for life" was the subject of a complaint in 2010. The complaint was upheld by the Advertising Standards Authority against West Surrey Primary Care Trust. It was an informally resolved complaint and announced by the ASA although details of the complaint remain confidential. Photography with the offending slogan had previously won an award for health at the Newspaper Marketing Network on 16/9/2008.

As at 7th December 2010, the following Central London NHS and government organisations still bear this offending advertising material and misleading claims:

City of Westminster Children's Services
NHS Westminster

http://www.westminster.gov.uk/workspace/assets/publications/Children-First-magazine-Autumn09-1254910971.pdf
Quick View
Children First Magazine, Autumn 2009
False/Misleading Claim:

The side effects are mild

Westminster PCT

http://www.westminster-pct.nhs.uk/English/news-and-events/current-campaigns/NHSWCampaigns/HPV%20vaccine.aspx
Page heading
Video

http://hpv123.org/why/
False/Misleading Claim:

"It saves hundreds of women's lives each year."

False/Misleading Claim:

"Is it safe? Will there be any side effects?
The side effects are quite mild - usually just stinging and soreness in the arm that soon wears off."

http://hpv123.org/how/
False/Misleading Claim:

"Life is full of difficult decisions. Thankfully getting the HPV vaccine isn't one of them."

St Johns Wood Medical Practice, NHS Westminster

http://www.stjohnswood.nhs.uk/info.aspx?p=19
Headings:

Arm yourself for life!

Arm yourself against cervical cancer.

False/misleading claim:

"Is it safe? Will there be any side effects?
The side effects are quite mild."