Where is the scrutiny and accountability with HPV vaccines?

It has taken the Time For Action team 3 months to obtain a copy of this systematic review, Serious adverse events associated with HPV vaccination, which was commissioned by the World Health Organisation (WHO) and referenced in the WHO Weekly Epidemiological Record of 14 July 2017.

The Countess of Mar asked a Parliamentary question which resulted in a copy of this review being publicly available via Hansard, after a request from us directly to the WHO received no response.

The systematic review has been referenced in a statement from the WHO, in Parliamentary responses from the UK government and on the NHS website to confirm safety of the HPV vaccines (see below).

The Time For Action team will be scrutinising this review in the New Year. In the meantime we feel it important to highlight that the WHO took the decision to exclude POTS and CRPS from the review, and instead chose to use the 2015 European Medicines Agency (EMA) review, which has been heavily criticised by prominent international scientists.

As POTS and CRPS are the two conditions most frequently flagged up in medical journals as potential safety concerns following HPV vaccination, the question is, why would they be excluded from the most recent WHO review, and more importantly, why are regulatory agencies and governments not properly scrutinising such reviews before using them to assure the public regarding safety issues?

We feel it’s important to highlight that this WHO “systematic review of serious adverse events (SAEs) following HPV vaccines” is in fact a systematic review of selected serious adverse events following HPV vaccination.

It appears that cherry picking data and cleverly designed studies and reviews, which ‘miss’ or omit specific adverse events, is a recurrent theme with HPV vaccines. Only recently Slate undertook an investigation into the flawed clinical trials of Gardasil, one of the brands of HPV vaccine. The results of their investigation formed the basis of a damning report What the Gardasil Testing May Have Missed.

“An eight-month investigation by Slate found the major Gardasil trials were flawed from the outset, however, and that regulators allowed unreliable methods to be used to test the vaccine’s safety.”

The report describes how Freedom of Information work had uncovered the “convoluted methods” used by the vaccine manufacturer to capture adverse events which made objective evaluation of side effects impossible.

“Interviews with five study participants and more than 2,300 pages of documents obtained through freedom-of-information requests from hospitals and health authorities suggest inadequacies built into Merck’s major clinical tests of Gardasil. To track the safety of its product, the drug maker used a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of its years long trials. At all other times, individual trial investigators used their personal judgment to decide whether or not to report any medical problem as an adverse event—essentially, as a potential side effect worth evaluating further. Other health issues went on a worksheet for “new medical history,” reserved for conditions that bore no relation to the vaccine. This study design put the cart before the horse, asking investigators to decide which symptoms might be side effects, rather than tracking everything in the same way.”

____________________

Instances where the WHO systematic review has been used to assure confidence in the safety of the HPV vaccines, including in relation to POTS and CRPS, despite these two conditions being excluded from the review

Extract from report of GACVS meeting of 7-8 June 2017, published in the WHO Weekly Epidemiological Record of 14 July 2017

“Also in 2017, the WHO commissioned a systematic review of serious adverse events (SAEs) following HPV vaccines. A draft was presented to GACVS at the meeting. Using the GRADE system to systematically assess the quality of evidence, the quality of evidence in the studies was considered high across randomized controlled trials. The outcomes considered were all SAEs, medically significant conditions, new onset of chronic diseases, and deaths. Data for 73 697 individuals were reviewed. Lower level studies were excluded in favour of the large body of higher level evidence available. For all outcomes, the evidence from randomized controlled trials was supported by good quality cohort studies, with no difference in rates of selected SAEs between exposed and unexposed to HPV vaccine observed.”

____________________

From the UK’s NHS website:

“Can the HPV vaccine cause long-term (chronic) conditions?

Many different clinical trials and scientific studies have looked to see if there are any links between the HPV vaccination and other conditions, including:

chronic fatigue syndrome (sometimes called ME)
complex regional pain syndrome
postural tachycardia syndrome
premature ovarian failure
Guillain-Barré syndrome

They have found no increase in cases of these conditions among girls who have been vaccinated against HPV compared to girls who have not.

The WHO Global Advisory Committee on Vaccine Safety regularly reviews the emerging international evidence on the safety of HPV vaccination. In March 2017, it issued a statement concluding that there is no evidence of any link between the HPV vaccination and these conditions.”

____________________

Parliamentary Questions referencing the WHO review

Parliamentary question asked by The Countess of Mar on 6th December 2017 and answered by Lord O’ Shaughnessy

Q: To ask Her Majesty’s Government, further to the Written Answer by Lord O’Shaughnessy on 5 December (HL3500), whether they will place a copy of the systematic review of serious adverse reactions following HPV vaccines, commissioned by the World Health Organisation, in the Library of the House.

A: The Global Advisory Committee on Vaccine Safety (GACVS) provides independent, authoritative, scientific advice to the World Health Organization (WHO) on vaccine safety issues. The GACVS public summary report dated 14 July 2017 states that it was presented with a draft of a systematic review of serious adverse events following human papillomavirus (HPV) vaccines that had been commissioned by WHO and summarises its findings. This found no difference in rates of selected serious adverse events between those exposed and unexposed to HPV vaccine. A copy of the systematic review, Serious adverse events associated with HPV vaccination, is attached. (Emphasis ours)

____________________

Parliamentary question asked by The Countess of Mar on 22nd November 2017 and answered by Lord O’ Shaughnessy

Q:  To ask Her Majesty’s Government whether they intend to place a copy of the systematic review of serious adverse reactions following HPV vaccines, commissioned by the World Health Organisation, in the Library of the House.

A: The World Health Organization’s Global Advisory Committee on Vaccine Safety publishes a summary outcome of its vaccine safety reviews on a six-monthly basis. The outcome of the Committee’s most recent review of human papillomavirus (HPV) vaccine safety was published on 14 July 2017. A copy of the Weekly epidemiological record is attached, which summarises the latest six month review. This review found no new adverse events of concern for HPV vaccine based on many very large, high quality studies. (Emphasis ours)

____________________

Parliamentary question asked by Baroness Tonge on 5th September 2017 and answered by Lord O’ Shaughnessy

Q:  To ask Her Majesty’s Government what risks associated with the human papilloma virus vaccination have been identified and recorded.

A:  As with all vaccines and medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) closely monitors the safety of human papillomavirus (HPV) vaccine. The MHRA takes advice from the Government’s independent expert advisory body, the Commission on Human Medicines (CHM), when evaluating the risks and benefits of medicines and vaccines.

The possible side effects of HPV vaccine are documented in full in the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL). A copy of the SmPC and PIL are attached. The possible side effects are identified based on evaluation of data from pre-licensure clinical trials and continuous review of safety data accumulated during post-marketing use. The type and frequency of possible side effects of HPVvaccine are broadly similar to those of most types of vaccine routinely offered to adolescents and adults. These are most commonly injection site reactions and sore arm, low grade fever, muscle aches, headaches, tiredness and nausea, which are short lasting. The CHM has advised that available evidence does not support a link between HPV vaccination and chronic illnesses and that the benefits in protecting against cervical cancer and other HPV-related disease outweigh the possible known side effects of the vaccines.

Extensive reviews of HPV vaccine safety have also been undertaken by various independent health bodies/authorities worldwide, such as the US Centre for Disease Control and Prevention and the World Health Organization (WHO). These have similarly concluded that evidence does not support a link between HPVvaccine and the development of a range of chronic illnesses. Most recently, in July 2017, the WHO’s Global Advisory Committee on Vaccine Safety concluded that it has found no new adverse events of concern for HPVvaccine based on many very large, high quality studies. (Emphasis ours)

____________________

References:

WHO commissioned systematic review: Serious adverse events associated with HPV vaccination, February 2017
http://timeforaction.org.uk/wp-content/uploads/2017/12/Serious-adverse-events-associated-with-HPV-vaccination-WHO-Feb-2017.pdf

WHO Weekly epidemiological record of 14th July 2017
http://www.who.int/vaccine_safety/committee/topics/hpv/June_2017/en/

Nodic Cochrane: Complaint filed to the European Medicines Agency over maladministration related to safety of the HPV vaccines
http://nordic.cochrane.org/news/complaint-filed-european-medicines-agency-over-maladministration-related-safety-hpv-vaccines

Slate: What the Gardasil Testing May Have Missed, 17th December 2017
https://slate.com/health-and-science/2017/12/flaws-in-the-clinical-trials-for-gardasil-made-it-harder-to-properly-assess-safety.html

NHS Website: HPV vaccine safety
https://www.nhs.uk/Conditions/vaccinations/Pages/hpv-vaccine-cervarix-gardasil-safety.aspx

Parliamentary question asked by The Countess of Mar on 6th December 2017
http://www.parliament.uk/business/publications/written-questions-answers-statements/written-question/Lords/2017-12-06/HL3941/

Parliamentary question asked by The Countess of Mar on 22nd November 2017
http://www.parliament.uk/business/publications/written-questions-answers-statements/written-question/Lords/2017-11-22/HL3500/

Parliamentary question asked by Baroness Tonge on 5th September 2017
http://www.parliament.uk/business/publications/written-questions-answers-statements/written-question/Lords/2017-09-05/HL1340/