All this week we have been publishing the key papers presented at The People’s Vaccine Inquiry press conference of the previous week: Dr Jonathan Engler’s on its purpose in view of Lady Hallett’s disgraceful refusal to honestly address the extent and cause of vaccine injury; Dr Elizabeth Evans on Hallett’s total disregard for medical ethics accompanying the vaccines’ authorisation and roll-out; Dr Clare Craig whose focus was not on what was said at the Hallett Inquiry about vaccine ‘safety and efficacy’ but on what was not said and Dr Ros Jones on the indefensible folly of the covid vaccine roll-out for children that Hallett also failed to address. Today Nick Hunt exposes the terrible failings go the Medical Health products and Regulatory Authority (MHRA) whose foremost statutory responsibility is to ensure medicines, medical devices and blood components meet applicable standards of safety, quality and efficacy.
I WAS a senior civil servant in the Ministry of Defence responsible for the safety and effectiveness of a wide range of explosive items for the UK Armed Forces – exactly what MHRA (the Medicines and Healthcare products Regulatory Agency is supposed to do for medicines and medical devices.
I co-wrote the Perseus Report in 2023 to document the harms caused by the Covid vaccines, the exaggerated benefits, and MHRA’s failures in safety management of medicines in general. I also co-wrote the Perseus Group’s witness statement to the Covid Inquiry.
I am disappointed but not surprised that the Inquiry decided not to call us to present our evidence. I doubt it will even publish it on its website.
Now I’ve seen the Module 4 Hearings, I believe it’s not just a case of silenced witnesses like us; it’s actually hidden truths. I want to share a few now.
Here’s one to start. It takes MHRA an average of 11 years to withdraw a medicine on safety grounds. Let that sink in. How many people go on being harmed while MHRA procrastinates? It’s appalling. But the Inquiry didn’t ask about that, did it?
Here’s another. June Raine admitted in her written evidence that MHRA do not investigate all Yellow Cards. How could they – there are so many. However, MHRA don’t even investigate just the fatal YCs. Our witness statement documented MHRA’s FOI replies confirming this. The word ‘haphazard’ springs to mind.
Incidentally, the Inquiry didn’t challenge the Chair of the Commission on Human Medicines when he falsely reassured them that MHRA does follow up all fatal Yellow Card reports.
Nor does MHRA assess causation – the likelihood that a reported adverse event was caused by the drug. Here’s a question the Inquiry should have asked – why is causation assessed in clinical trials of a drug but not after it is on the market?
Next, statistical analysis of YC reports. Various witnesses explained that instead of investigating YC reports, MHRA relies on statistical analysis of the whole YC database to generate safety signals – basically, does Medicine A have statistically more or fewer YC reports for different types of adverse event than other similar medicines?
Our written statement included evidence that this statistical process misses safety signals. But the Inquiry chose not to ask questions such as:
● To what extent do missed safety signals in YC analysis contribute to MHRA taking an average of 11 years to withdraw a medicine on safety grounds?
● What led to MHRA’s investigation in 2022 of missed safety signals across all vaccines? What were the conclusions and implications?
● Given that missed safety signals get baked into the baseline, is it the case that subsequent YC reports are less likely to trigger a safety signal?
Another key issue with the Covid vaccines was Process 1 vs Process 2: the fact that the Covid vaccines rolled out were mass-produced using a very different process to the product used in the clinical trials. They compared the quality of the two products and found some differences about which the regulators had concerns. Even more importantly, they had no comparative safety data.
To expand on that, June Raine’s written statement said that Process 2 vaccines were included in Pfizer’s Phase 3 clinical trial. True – late on they injected 250 people. But the Inquiry failed to expose the fact, confirmed by MHRA itself in a 2023 FOI reply which we documented in our written statement, that the results of that were never published. Nor did MHRA include in its advice to ministers recommending approval anything about the quality concerns, lack of comparative safety data and consequential safety risks. The Inquiry didn’t ask anything about DNA contamination in the mass-produced vaccines and the consequential risks. Nor why MHRA didn’t measure DNA contamination in its own batch testing.
Here’s another key safety issue which the Inquiry completely ignored. Pfizer, Moderna and AstraZeneca were all required to do post-authorisation safety studies by analysing NHS data on millions of people segmented by their covid vaccination status. This is to explore if the covid vaccines have increased the incidence of a long list of health conditions.
We included in our written evidence that Pfizer’s ‘Interim Report 5’ was completed in March last year; that MHRA was withholding publication; that we had obtained a summary from another source; and that it reports a significantly higher incidence of heart conditions among the covid vaccinated.
The Inquiry completely ignored that evidence. It should have asked:
● Why is MHRA still withholding publication? And note that June Raine said under oath that MHRA was not sitting on any such reports;
● Why do the Inquiry’s expert witnesses believe the increase in heart conditions is not caused by the vaccines when Pfizer itself is reporting that it is?
● Has MHRA required the covid vaccine manufacturers (or anyone else) to extend the analysis of the NHS data to other conditions like cancer where rates are known to have increased significantly since 2020? This would unravel how much was due to delayed diagnosis due to lockdown and how much, if at all, to the covid vaccines.
Zooming out, one issue which has bugged me throughout is why medicine safety is allowed to be managed differently from all other safety critical sectors. Our written statement to the Inquiry covered this in some detail.
To summarise, MHRA’s safety management is all relative:
● Approval is based on benefit being greater than risk;
● Surveillance is based on Drug A being no worse than similar drugs.
Unlike all other safety critical sectors, MHRA does not define a threshold or criteria for the suspension of a drug – i.e. how many deaths and serious injuries can be tolerated before action is taken. These criteria would obviously be different for an over-the-counter painkiller compared with a cancer drug, but the point stands – all other sectors do it that way, why not medicines? The Inquiry decided not to probe witnesses on this fundamental issue.
Instead, as adverse events accumulate MHRA updates patient information leaflets, moving known types up the probability ladder and adding new ones as they find them. The Inquiry should really have asked:
● Why was risk of death not included in the covid vaccine patient information leaflets for AstraZeneca’s until April 2021; Moderna’s until September 2023 or Pfizer’s until December 2023?
Another key difference is that, unlike all other safety critical sectors, MHRA is not subject to independent safety audit. It has a biennial quality audit of its pharmacovigilance system. But that’s a completely different thing – a quality audit looks at compliance with business processes whereas a safety audit would look at the extent of safety risks. Why is MHRA allowed to get away with that?
In summary, the Module 4 hearings hid inconvenient truths. MHRA’s safety management of the Covid vaccines was appalling. Unfortunately that’s just symptomatic of its appalling safety management of all medicines – and indeed of medical devices.
To finish, here’s a quote from Patrick Vallance in 2014 which should worry everyone: ‘In the future, medicines will come to market quicker with less data, with more research being conducted in the post-license phase.’ Unless MHRA’s safety management is completely reformed, medicine safety will continue to get worse.
