Contributor (in bold below): Nick Hunt, retired Senior Civil Servant from the Ministry of Defence who was responsible for the safety and effectiveness of a wide range of explosives
MHRA’s medicine vigilance system is broken. Take coroners’ reports. Sir Munir Pirmohamed, chairof the Commission on Human Medicines, reassured the covid inquiry that coroners report medicine-related deaths to the MHRA:
[Hugo Keith, Lead Counsel to the Covid Inquiry] Are coroners able to report the outcome of inquests directly to the MHRA or CHM [Commission on Human Medicines], or do they have to go through the Yellow Card scheme themselves?
[Munir Pirmohamed] So when the Yellow Card system was set up, it was set up for doctors and dentists and coroners, so they could report via the Yellow Card system. However, they can also write directly to the MHRA if there are particular concerns.
Those reports are called Regulation 28 Reports to Prevent Future Deaths. Raine [June Raine, CEO of the MHRA] confirmed in her written evidence that MHRA received such reports. Sadly for both of them, the system is broken.
In an FoI reply in January 2023, MHRA denied having any such coroners’ reports for the covid vaccines.
This was despite at least two coroners already having issued such reports. They just hadn’t been addressed to MHRA who were therefore oblivious. Why can’t they just tell the truth about how broken and haphazard the MHRA’s medicine vigilance is?
Contributor (in bold below): Nick Hunt, retired Senior Civil Servant from the Ministry of Defence who was responsible for the safety and effectiveness of a wide range of explosives
MHRA’s medicine vigilance system is broken. Take fatal Yellow Cards. Sir Munir Pirmohamed, chair of the Commission on Human Medicines, reassured the covid inquiry that MHRA follows up all fatal Yellow Cards.
[Hugo Keith, Lead Counsel to the Covid Inquiry] Sadly, there were a number of Yellow Card reports involving death… fatality where somebody… a member of the family had reported the death of a loved one through the Yellow Card system. Were all Yellow Card fatality reports followed up by the MHRA or the CHM, by way of going back to the reporter and following it up?
[Munir Pirmohamed] That’s correct… Every report which is of fatality is followed up by the MHRA.
Those reports are called Regulation 28 Reports to Prevent Future Deaths. Raine [June Raine, CEO of the MHRA] confirmed in her written evidence that MHRA received such reports. Sadly for both of them, the system is broken.
In an FoI reply in January 2023, MHRA denied having any such coroners’ reports
He’s actually wrong. June Raine, head of the MHRA, told the inquiry that they only follow up fatal Yellow Cards “in the generality”.
[Hugo Keith] Did you, in the generality of cases, where fatal outcomes were reported to you, take steps to follow up and try to find out what had happened?
[June Raine] Yes.
[Keith] And did that include speaking to health services?
[Raine] In the generality. There may have been cases where, if it appeared that there wasn’t an association likely, that was not done.
[Keith] All right. So your positions is that you can’t say it was done in every single case. But the expectation was, and, in general terms, a fatal outcome reported to the Yellow Card system would be researched and followed up through relevant health services.
[Raine] Generality.
[Keith] All right.
But even then, Raine was gilding the lily. In an FoI reply, MHRA said that they had followed up only about 50% of fatal Yellow Cards for the Moderna covid vaccine.
Since when was 50% in the generality? I emailed the Inquiry suggesting they get Raine and Pirmohamed to correct their evidence. The Module 4 solicitors replied, “We will consider it in the context of all the evidence obtained in the investigation.”
That’s a no then.
VII-3. The real purpose of the Inquiry Module 4 [link]
Contributor: Caroline Pover, Chair of Trustees of UKCVFamily
I realised by the end of the three weeks… different themes… kept appearing throughout… I felt the purpose, what kept coming up… there were three things… [i] the purpose is to increase clinical trials in the UK… [ii] to increase the UK’s capabilities to manufacture vaccines... And [iii] to increase the number of people who are taking vaccines. So that to me felt like the purpose of the inquiry. I don’t think the inquiry is quite what the general public think it is.
Contributor (in bold below): Dr Dean Patterson, Consultant Cardiologist
This is well past the point at which we should be thinking about why does this happen. These signals should have been picked up early.
So, if you look at the data from the MHRA Yellow Card, there have been 1500 reports of myocarditis and just over 1000 pericarditis. But we do know that drug side-effects are hugely under-reported. And there’s data suggesting about 95% of cases are not reported. And when you correct this level of under-reporting, there could be 25-40,000 people with myocarditis from the covid vaccines in the UK. If you correct using my data, it could be 50,000.
The point from my data from Guernsey is the fact that I’ve not seen covid causing myocarditis. I’ve only seen the vaccine causing myocarditis, and I’ve seen an increase in myocarditis. I’m not saying that all the cases of myocarditis I’ve seen are from the vaccine, but I think we need to honestly, critically appraise what’s going on.
We know from Fraiman that the vaccines have a serious adverse event rate based on the initial studies of 1 in 800, but we don’t have data from the boosters.
Dr Joseph Fraiman is an emergency medicine physician in New Orleans, Louisiana. Here is the paper referred to above:
Myocarditis is the poster boy because it stands out — we don’t see much of it, it’s not that common. But we know that there are other side-effects, and we’ve been hearing from Gus Dalgleish [about cancer]…
We know that there is vascular disease increasing in other major organs. We know we’re worried about stroke, we’re worried about heart failure. We know the vaccines hang around for up to six months, but nobody knows what happens when you’ve had six doses of this vaccine. We just don’t know.
The systemic effects in people who have been receiving these boosters is in my opinion leading to chronic ill-health. And it’s my firm belief that we should recall the vaccines, and that there needs to be a government-led investigation into the adverse events that are unfolding.
I’ll just make a few closing remarks. Really there’s so much has gone wrong in this process, it’s difficult to know where to start. But sometimes it helps to narrow down your list of asks into narrowly-defined points.
And I suppose that what we would be asking for, what we’re seeking going forward, is an immediate cessation of the use of mRNA products as vaccines.
We want to see a reform of the Yellow Card system, which is not fit for purpose as a post-marketing vigilance system.
And we want to see reform of the Vaccine Damage Payment System, which is a ridiculously unfair system.
We want manufacturers rather than taxpayers to be liable for the huge amount of harm that their products have caused.
We want to stop the revolving door policy between regulators and industry, which creates implicit conflicts of interest.
And we want to place the power of medical decision-making back to the individual, and stop the drift towards what I can describe as communitarianism in policy, characterised by the awful phrase used by tyrannical regimes throughout history to justify all sorts of harmful policies — “it is for the greater good”.
![[III] Exposing the UK Covid-19 Inquiry (Module 4)](https://substackcdn.com/image/fetch/w_140,h_140,c_fill,f_webp,q_auto:good,fl_progressive:steep,g_auto/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F347c54ef-43c0-4f45-adcb-ba4498b2674f_872x838.png)
