A hidden earthquake waiting to happen?
Fracking, long opposed by local communities starts in Lancashire and shortly after so do the earthquakes. Fracking by Cuadrilla is immediately suspended to allow investigations. It is reasonable to assume there may be a link. Pre fracking, no earthquakes. Fracking starts, earthquakes. It is also a safety issue that campaigners have long been concerned about. Either way, they stopped to conduct a safety review.
Not so in the Pharmaceutical Industry with the HPV vaccine where the party line from regulators is that the HPV vaccine, given to healthy children as a preventative measure against some cancers, is safe. Safety reviews from the European Medicines Agency (EMA) (2015) and Cochrane (2018) are often quoted by doctors with regular spots on TV (incl on Strictly), MPs and regulators as evidence of HPV vaccine safety.
The EMA 2015 safety review of the HPV vaccine focused on Postural Orthostatic Tachycardia Syndrome (POTS) and Complex Regional Pain Syndrome (CRPS). The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), led this review. The EMA vaccine safety experts concluded, in November 2015, that there was no link and hence no safety issue.
We can, however, now reveal that the MHRA knew that there was insufficient data available to fully inform the EMA safety review. An internal paper relating to Vaccine Pharmacovigilance presented by a Unit Manager to the general MHRA Board on 18th September 2015, of which we have copies, states:
“At present, good epidemiological data on the association between HPV vaccine and POTS and CRPS are lacking, and such data need to be gathered to reach an appropriate, evidence-based conclusion. Given the UK’s responsibility in leading the EU referral and safety surveillance of the vaccines used in the national immunisation programme, … agreed to explore the feasibility of undertaking an epidemiological study of the alleged association, in collaboration with experts from Public Health England (PHE). “
The Board welcomed the report. This is important given that the MHRA were leading the July 2015 – Nov 2015 EMA HPV vaccine safety review because they did not disclose the need for additional “evidence based and robust evaluation” to those who made the final decision, the EMA safety experts, the Scientific Advisory Group (SAG).
The briefing notes to the EMA vaccine safety experts is a 256 page confidential document of which we have a copy. It was issued to the EMA safety experts less than one month after the above MHRA Board meeting. There is no mention in this document of the need for a new epidemiological study identified as necessary by the MHRA. Instead, the EMA Safety committee briefing note (dated 13th October 2015) states:
“There is currently therefore not sufficiently plausible direct or indirect support for a specific autoimmune mechanism”; and
“There is not epidemiologic evidence or known potential biological mechanism for an association between the HPV vaccine and CRPS”.
The briefing note also used “observed v expected analysis” which was determined via a literature review (acknowledging the difficulties) and inferred “injection trauma” was the actual cause of HPV girls falling ill.
The good intentions and practice agreed by the MHRA Board on 18th September 2015, to “ensure appropriate and evidence-based decision-making” appears to have been set aside.
What happened in those 3 weeks for the MHRA to change its mind?
We asked the MHRA (in 2018) under the Freedom of Information Act (FOIA) to provide information on any studies on HPV vaccine safety undertaken post December 2014, and associated correspondence. In response to our FOIA the MHRA provided us with documentation, redacted emails and an explanation as to why the new epidemiological study was cancelled:
“Based on the descriptive analysis of recording of POTS in CPRD [Clinical Practice Research Datalink] … the likely limited statistical power of a CPRD study and the further advice on study feasibility and need from the EMA review, alongside the final conclusion from the EMA review that the evidence did not support a safety signal for POTS and CRPS, the MHRA took the decision not to proceed with a CPRD study at the time. The need for any study will be kept under review.”
However, in providing this reply, the MHRA were unaware of our already holding a copy of the report presented at the MHRA Board in September 2015 on Vaccine Pharmacovigilance. Despite that report containing information requested in our FOIA, the MHRA did not provide us with a copy (as we expected them to) when we raised the FOIA. As quoted above, in the meeting the MHRA Board was advised that a new epidemiological study of the alleged association between the HPV Vaccine and POTS or CRPS was required; and
“Managing this issue with timely production of robust data will ensure appropriate and evidence-based decision-making, and a clear EU consensus on risk-benefit balance of HPV vaccines.”
Additionally, email correspondence provided by the MHRA (dated 3rd September 2015) confirms this new study was “to provide an evidence-based and robust evaluation (and to help inform the EU review)”.
In summary the MHRA’s 2018 reasoning that the study was cancelled because of the EMA’s November 2015 HPV safety conclusion is: the chicken can come before the egg.
The redacted email correspondence received under FOIA does highlight email discussions on the feasibility of a study up to the 23rd September 2015. Concerns over the use of CPRD data (the system that collects generic patient data from a network of GP practices across the UK and used by the MHRA in the earlier Chronic Fatigue Syndrome (CFS) study) were raised, by an external expert, in an email dated 4th September 2015:
“the vaccination programme has been very largely school based, with no systematic recording in general practice records (and therefore not in CPRD).”
While these concerns were discussed in subsequent emails the draft protocol issued on 11th September 2015 is structured around CPRD data being used for analysis.
Reasoning from the MHRA (2018) for cancellation of the epidemiological study included the “likely limited statistical power of a CPRD study”. However, not only were such concerns analysed prior to the draft protocol for the study being issued; but the CPRD dataset was the basis for the previous study into whether or not CFS was linked to the HPV Vaccine. A study that also concluded: no link.
As CPRD data was used in the earlier study and as both datasets would be subject to the same limitations, why wouldn’t CPRD data be sufficient for a review of POTS and CRPS too? Or are the MHRA now admitting the CFS study based on CPRD data is flawed? The document of record for suspected vaccine harms in the UK is the Yellow Card System. However HPV Vaccine data isn’t publically available on the Yellow Card database but that’s another story (blog). But why hasn’t the data collated via this system been used for both studies?
The inconsistencies and parameters set around available evidence from the MHRA are curious.
There is a lot not known. What is known is that the MHRA has changed its mind about good intent and practice highlighted in the paper presented and agreed by the board in the minutes of 18th September 2015. Information has not been shared with either the public (to allow them to make an informed decision) or vaccine safety experts in the EMA when undertaking a safety review the findings of which are now much quoted by experts extolling the virtues of the vaccine.
The 18th Sept 2015 paper presented to the MHRA Board also include a stark warning about failure to conduct a new study:
“However, if not addressed properly and in a timely fashion, the issue may damage confidence in vaccine safety and have a longer-term impact on Agency and wider Government resource.”
Pre vaccine girls were healthy. Post vaccine they are not. It’s a reasonable assumption by families whose girls have fallen ill post vaccine that the vaccine may have something to do with it. But, from available evidence, the MHRA (part of the Department of Health) and responsible for the safety of our children have, to date, decided not to look.
Like pre and post fracking, is this a new earthquake waiting to happen? When it hits, and evidence is building that it will, the MHRA and the Department of Health will have no one to blame but themselves.
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