A Time For Action Statement on Extending the HPV vaccination programme to teenage boys

24th July 2018

In August 2017, Time for Action (TFA) submitted a response to the consultation by the JCVI on the deployment of the HPV vaccination to teenage boys as part of the NHS schedule. You can read our submission at the end of this statement or here.

The JCVI did not acknowledge receipt of our submission, although requested to do so, or engage with our parent/patient group in any way. Their disregard for the points made about our outstanding concerns over serious adverse reactions leaving girls with chronic, life-changing illnesses, is shameful. Following the JCVI statement last week recommending that teenage boys are included in the HPV vaccination programme, the announcement today that the Government has agreed with this recommendation, is no surprise; the JCVI recommendation was leaked to the press some time ago. We are disappointed and hope that parents of boys will research the information set out below and feel able to make an informed decision when this vaccination is offered to their sons at school.

Minutes of the JCVI held on 4th October 2017 recorded the TFA contribution, but lacked detail:

Responses were received from the Alliance for Natural Health (ANH), Anal Cancer Foundation (ACF), The Association for Cancer Surgery (BASO), British Association for Sexual Health and HIV (BASHH) British Medical Association (BMA), British Dental Association (BDA), Cancer Research UK (CRUK), Faculty of Sexual and Reproductive Healthcare (FSRH), GlaxoSmithKline (GSK), HPV Action, men and boys coalition, Merck Sharp & Dohme Ltd (MSD), National association of laryngectomee clubs, Oral Health Foundation (OHF), Royal College of General Practitioners (RCGP), The Sexual Health Charity (FPA), Stonewall, Terrence Higgins Trust (THT), Time for Action (TA)”

“Most of the responses were pro vaccination of adolescent boys and disappointed with the JCVI interim advice not to recommend a programme including boys. HPV Action represents a lot of the stakeholders and provided a comprehensive response regarding the interim decision. Many of the stakeholders followed the themes highlighted by HPV Action. Some of the responses (ANH,TA) , including personal emails, were against extending HPV vaccination to boys.”

“Correspondence against including boys

  • On grounds of vaccine safety, questioning the evidence on effectiveness, and in support of sex  education and lifestyle changes.
  • The safety concerns on girls should be resolved first and then only males at high risk should be targeted.”

https://app.box.com/s/iddfb4ppwkmtjusir2tc/file/247634612957

Members of the public might be interested to know that the JCVI and the HPV Sub-Committee did have considerable engagement with the campaign group HPV Action, including holding meetings and the sharing of confidential documents:

“The Committee noted that PHE had met with HPV Action after the Subcommittee meeting to discuss its work and provide the stakeholder with the opportunity to ask questions. PHE had also indicated to the subcommittee that it would be willing to share more details on the methodology of the assessment on a pre-publication server once final reviews were completed. It was also noted that the University of Warwick work was close to being published and an earlier draft had been shared in confidence with HPV Action.”

Further, it would seem that HPV Action is in receipt of funding from the manufacturers:

“HPV Action has launched a human papillomavirus (HPV) awareness campaign backed by pharma firm Merck Sharp and Dohme (MSD).

The group, which comprises 48 organisations who work together to reduce the health burden of HPV, was presented an education grant by MSD for Jabs for the Boys.

The campaign aims to drive awareness of diseases in men caused by HPV, and in the UK there are around 2,000 cancer cases and 48,000 genital warts cases caused by HPV in men every year.

Additionally, HPV Action has also been championing the importance of making the HPV vaccine available to men, which was the chief issue of the campaign.”

http://www.pmlive.com/pharma_news/msd_supports_jabs_for_the_boys_campaign_1214595

Time for Action are committed to ensuring that safety concerns associated with the HPV vaccines are thoroughly investigated and that adverse reactions are properly recognised, with timely and appropriate treatment options offered to patients who have been adversely affected by the vaccine. The Time for Action group feel the concerns included in its submission to the JCVI last August remain, and that these concerns have not been addressed or properly investigated before this extension of the HPV vaccination programme to teenage boys. The group will continue to ensure verified factual information and peer-reviewed scientific papers are made available to parents to help them make an informed decision on HPV vaccination.

The Nordic Cochrane group highlighted the following in the concluding remarks section of the statement regarding their complaint of maladministration against the EMA:

“EMA has not respected the citizens’ rights to know about the scientific uncertainties related to the possible harms of the HPV vaccines, as envisaged in Article 6 of the EU Treaty and the Charter of Fundamental Rights of the European Union. 48 Furthermore, EMA has not lived up to the scientific standards that must be expected of the agency. Finally, EMA withheld important information from its expert committee, namely the results of EMA’s own literature searches and EMA’s interpretation of what it found. 

EMA’s procedures for evaluating the harms of medical interventions – where the companies are by and large their own judges – need to be fundamentally reworked. And all procedures, information, scientific uncertainties and internal disagreements should be made available to the public. The citizens should decide for themselves whether they think any particular vaccine, drug or other intervention is a good idea. This is not a decision an authority can make for them.”

https://nordic.cochrane.org/news/complaint-filed-european-medicines-agency-over-maladministration-related-safety-hpv-vaccines

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Time for Action submission to JCVI – August 2017

Dear JCVI members

We write in response to the consultation concerning the deployment of the HPV vaccination to teenage boys as part of the NHS schedule.

Whilst we appreciate that the vaccination may have been given to millions of girls without adverse reactions and that it may well be of health benefit to them in the future, we write as parents of girls who have developed severe, life-limiting illness within close proximity of having the HPV vaccination.  Our daughters have been ill for a long time, in some cases for 8+ years – they have had their education compromised and those older are not employable. The Government has not yet recognised the link between the vaccination and their illness, but we should point out that legal action is taking place in France, Spain, Germany, Japan, Columbia and large awards have been made by the US Vaccine Court. We believe it is only a matter of time before the Government will have to recognise that for some girls there is a serious problem with having the HPV vaccination.

We strongly feel that we were not provided with sufficient information about the vaccination prior to it being given to our daughters and, in some cases, girls were scared into having the vaccination by advertisements and stories in the press (for example Jade Goody, Michael Douglas). However, it was not communicated to them or us that more than 95% of HPV infections will clear from the body naturally with no intervention; that for most women smear tests are an effective way of avoiding cervical cancer and that there are many factors associated with lifestyle that can increase the risk of developing cervical cancer (for example: smoking, high parity, poor nutrition; long-term use of the contraceptive pill).

Outstanding issues in respect to girls are as follows, and we believe that there should be no extension to the HPV vaccination programme until these are resolved:

  • The number of reported suspected adverse reactions is very high in comparison to other vaccinations, but the vaccine is only given to girls. 30% of the reported events are categorised as serious. We don’t believe there is sufficient follow up and investigation of these reports.
  • The MHRA say there are no safety concerns but taken in the context of problems found with Pandemrix (swine flu vaccine) and Narcolepsy; problems with Primodos and Sodium Valporate; and the emerging scandal of the vaginal mesh tape injuries – we do not have confidence that the safety concerns have been sufficiently investigated by the MHRA or the EMA.
  • There is an outstanding complaint of maladministration against the EMA with the EU Ombudsman concerning the investigation into POTS/CRPS as suspected side effects of the HPV vaccination in 2015. Some very serious points were raised about why the EMA investigation was not thorough or transparent.
  • There are questions around whether the targeting of strains 16 & 18 of the HPV virus will lead to other strains becoming stronger and more virulent and possibly causing more cases of cervical cancer in the future.
  • There are questions around the efficacy of the vaccination. PHE are recruiting for a trial to look at the current antibody titres of those having had the vaccination at the start of the programme. Dr Diane Harper has recently published a paper stating that the antibody titres for HPV18 following vaccination with Gardasil are considerably lower than for Cervarix, meaning that for Gardasil protection against HPV18 may have dropped after only two years and after 5 years 35% of those in the study had no detectable HPV18 antibodies.

[UPDATE 24/7/18: In reference to the complaint about the EMA to the EU Ombudsman, above, to see the latest statement on the matter from the team at the Nordic Cochrane Centre, please follow this link the News section of their website:  https://nordic.cochrane.org/news/complaint-filed-european-medicines-agency-over-maladministration-related-safety-hpv-vaccines ]

We strongly feel that the HPV vaccination is not required for the majority of boys, although it should be an option for those who are high risk, and it should not be part of the NHS vaccination schedule. Our reasons for this opinion are as follows (data from the Cancer Research website):

  • Head and neck cancer incidence is strongly related to age, with the highest incidence rates being in older males and females. In the UK in 2012-2014, on average each year half (50%) of the cases were diagnosed in people aged 65 and over.
  • 91% (93% in males and 85% in females) of oral cancer cases each year in the UK are linked to major lifestyle and other risk factors.
  • 93% of laryngeal cancer cases each year in the UK are linked to major lifestyle and other risk factors.
  • Smoking is the main avoidable risk factor for head and neck cancer, linked to an estimated 65% of oral cancer cases, and an estimated 79% of laryngeal cancer cases in the UK.
  • An estimated 91% of oral cancers in the UK are linked to lifestyle factors including smoking, alcohol (30%), and infections (13%).
  • An estimated 93% of laryngeal cancers in the UK are linked to lifestyle factors including smoking, and alcohol (25%).
  • Betel nut, smokeless tobacco, ionising radiation and certain occupational exposures can cause oral cancer.
  • Certain occupational exposures cause laryngeal cancer.
  • A diet high in fruit and vegetables may protect against head and neck cancer – insufficient fruit and vegetables intake is linked to an estimated 56% of oral cancer cases, and an estimated 45% of laryngeal cancer cases in the UK.

Additional research found these statistics:

  • More than 4 in 10 (43%) penile cancer cases in the UK each year are diagnosed in males aged 70 and over (2012-2014).
  • More than half (52%) of anal cancer cases in the UK each year are diagnosed in people aged 65 and over (2012-2014).
  • Incidence rates for anal cancer in the UK are highest in people aged 85-89 (2012-2014).
  • Incidence rates for penile cancer in the UK are highest in males aged 90+ (2012-2014).
  • Penile cancer and anal cancer in England is more common in males living in the most deprived areas.
  • The risk of penile cancer among men who smoked at diagnosis was 2.8 times that of men who never smoked. Among men who smoked at diagnosis, lifetime smoking of more than 45 pack-years of cigarettes elevated risk to 3.2 times that of men who never smoked.
  • The penile cancer risk among men who consumed two or more alcoholic drinks on average 35 days or more per year was 1.5 times that of men whose yearly average was 34 days or less.
  • The risk of penile cancer among men with five to 29 sexual partners was only 1.3 times that of men with one to four partners.
  • Men with HPV-positive tumours were more likely to report a greater lifetime number of sexual partners and a history of gonorrhoea. Although a higher percentage of men with HPV-positive tumours were found to have HSV-2 antibodies and reported smoking at diagnosis.
  • Poor personal hygiene is also a risk factor for penile cancer.

We think that most parents presented with such statistics would decline the vaccination for their teenage sons.

We have also looked at the statistics obtained from the annual report on sexual health clinics and found out that the majority of men taking the HPV vaccination between 2012 and 2016 did not complete the course:

1st dose:            6,217
2nd dose:          1,588
3rd dose:              308

Therefore only 5% of men completed the 3 dose schedule.  Perhaps before further deployment, PHE should look at the reasons for the non-completion of the course of this expensive vaccine?

We would therefore suggest that the vaccine is made available for high risk men, but that PHE should focus on educating teenage boys on the benefits of a healthy lifestyle and reduction of risk factors rather than subjecting every teenage boy to vaccination.

Yours sincerely

TIME FOR ACTION
UK Families Affected by the HPV Vaccination
 www.timeforaction.org.uk