I’m retired but I worked for 20-plus years in a safety critical sector where I was legally accountable for the safety of hundreds of products which I authorised for use. So I know a robust safety management system when I see it. From what I’ve found out about the MHRA, I don’t think its safety management is as robust as those responsible for it seem to think. Consider two pieces of evidence: safety audits and the processes for investigating reports of adverse events linked to medicines including vaccines.
In the organisation in which I worked, we were subject to safety audits at least once a year. I know it’s similar in other safety critical sectors like aviation, nuclear, oil and gas and transport. But not, it turns out, in the MHRA, the organisation responsible for authorising medicines for public use.
I submitted an FOI request for a copy of MHRA’s last independent safety audit report. I was sent the two pages covering safety management from a 50-page audit report (dated February 2020) by the British Standards Institute against the requirements of ISO9001, a Quality Management standard.
Believe me, there’s a world of difference between a Quality Management audit and a Safety Management audit. First, quality is about compliance; safety is about risk. Here’s a simple example of the difference in another sector. If you’re still not convinced, consider that an ISO9001 auditor requires no knowledge, qualifications or experience in safety management. So the safety extract from the Quality audit report is just saying that the auditor had seen a selection of MHRA safety-related documents or processes, or seen evidence that they existed. The auditor can’t say whether they are the right processes for robust safety management or ask searching questions about safety. I could go on but you get the picture.
There’s another major problem. The Human Medicines Regulations – which are the legislation governing medicines for public use in the U.K. – require (Part 11, Section 180) “audit of MHRA’s pharmacovigilance system every two years”. So, not only has it been meeting that requirement with Quality audits not Safety audits, but the most recent one it sent me in May 2022 was dated February 2020. This means that it is either defaulting against the Human Medicines Regulations or it’s got someone to approve it not doing the statutory audits while it’s busy monitoring the Covid vaccines rollout. Was that the work of the Secretary of State for Health? Was Parliament informed? I’ve got another FOI pending to find out.
But, either way, a cautious person would actually want a safety audit of MHRA during the biggest and fastest vaccination programme in U.K. history.
Turning to the process for investigating individual Yellow Card reports, I asked MHRA for its internal document specifying how its staff follow up individual Yellow Card reports for adverse events from medicines. This is the process which would tell its staff which Yellow Card reports to follow up and which not, as there is obviously a spectrum of severity from sore arm to death. It replied: “The MHRA does not hold a process for investigation of individual Yellow Card reports.” However, in response to someone else’s FOI request (21/1109) MHRA outlined the steps it took to investigate individual Yellow Card reports related to myocarditis. But if, as it told me, there is no documented internal MHRA process, how do staff know what steps to take and how does the Chief Executive, Dr. June Raine, know whether or not they are taking those steps? The answer seems to be that she doesn’t, as that same FOI asked how many Yellow Card reports of deaths linked to myocarditis had been investigated. MHRA invoked a Section 12 exemption – it would take too long to find out. They don’t know. So far as I can tell, they just cooperate with Coroner’s Inquests but they have no set process for this either, so it’s all anybody’s guess.
I’ve raised these concerns with both Dr. June Raine, MHRA’s Chief Executive, and Alison Cave, MHRA’s Chief Safety Officer. But so far, no replies. For me, the lack of response just underlines my concern that MHRA’s safety management does not appear to be as robust as those responsible for it think.
I hope to follow up this article later with some observations about MHRA’s process for signal detection from the accumulation of Yellow Card reports for the Covid vaccines. At face value, it appears that MHRA’s first filter on the data is a weekly review of those types of adverse events which are more common than for other vaccines. That ‘relative’ approach seems a very peculiar way to measure safety and not how it’s done in other safety critical sectors. Then there’s the question of how MHRA rolls into that process the issue that the benefit from the Covid vaccines appears to be significantly less than when it originally authorised them for emergency use. So the risk/benefit balance is likely worse than for other vaccines. Which makes the ‘relative’ approach all the more peculiar. But I’ve got more digging to do first.
One final thought in the meantime: Has anyone else noticed that the Terms of Reference for the Covid Public Inquiry do not even mention the word ‘safety’.
Until Nick retired a few years ago, he was a Senior Civil Servant in a Government Department.
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Within the Telegraph article we find:
It didn’t need to swing. Not the first time nor the second nor the third. As Albert Einstein almost certainly didn’t point out: the definition of insanity is doing the same thing over and over and expecting a different result.
So let me get this straight. The PM initally didn’t believe in lockdowns. Neither did the Hancock, Witty and Valance trio? Dominic Cummings – who looks abit odd and almost certainly is – contacted his mates to come up with terrifying models of apocalypse if we didn’t close the country down and impoverish and destroy great swathes of our lives and businesses and economy.
And I’m the unmasked, unvaccinated baddie? Really?
The real scandal is that the general public trusted them too much, and in effect showed a batch of group thinkers that they could get away with murder. Back in 2020, as the panic developed, I thought that it demonstrated how the German government got away with what happened in the 1930s.
A lot of people dislike or mock The Spectator but you cannot fault their willingness to give platforms to unpopular/alternative views
One of the reasons I am a subscriber. I do not mind having my assumptions/prejudices challenged – provided the arguments are well made and not woke nonsense. I think that The Spectator broadly gets this right.
The comments section to Fraser Nelson’s column (geddit?) is quite illuminating too.
The petri-dish for infection monitoring, the Diamond Princess, had all elderly passengers aboard, some 3,000 plus if memory serves. The ‘rampant,’ contained infection onboard killed 14 souls, a fatality rate of .0037. Compare and contrast the real world numbers with the woefully inaccurate tripe arrived at by Ferguson.
It had passengers and crew across the age range. It showed that many youngsters were not infected, those that were had negligible or very mild symptoms.
Those most affected and among whom the fatalities occurred were 70+.
In other words – it was a Common Cold – not even ‘flu – epidemic, milder than most.
Thanks for the steer. It prompted me to google the precise numbers. Suffice it to say, Ferguson was no nearer the real world. 3,711 pob.(Persons on board), comprising 1,045 crew, median age 36. Zero deaths, 145 infections.
Passengers, 2,666. Median age 69. 567 infections, 14 deaths, all 70s and 80s.
You’d have thought somebody somewhere would have used those numbers to temper the wildly inaccurate modelling. Obviously not.
And remember what the MSM reporting about the Diamond Princess was like. Selective with the truth comes to mind for the usual suspects, esp BBC News.
The problem with Sage/modellers is that they appear to know the square root of f. all about how virus behave, transmit and the immune system.
But there again nobody knows, or ever will know, precisely how and why some people get ill and others don’t.
For example, there is the Seattle trawler case, and the Argentinian trawler case. How did so many trawlermen, completely isolated from the outside world for weeks, “catch covid”? And also it was discovered that some actually had antibody protection to this “completely new virus”.
Then there’s the experiment in Belgium or (Holland?) nursery schools. Over three winter months one was thoroughly deep cleaned every day ie to eliminate all pathogens on toys, work surfaces etc and the other just normal cleaning. Rigorous testing proved that the deep cleaned one was virtually virus/bacteria free – the other wasn’t.
The result – virtually identical levels of sicknesss/absences (the dirty one being slightly better). I can’t find the link, but I believe it is one of Tom Jefferson’s favourites.
I’m no virus denier but surely the above blows a pretty big hole in Germ Theory – which, funnily enough is bigpharma’s God.
Much proper research is desperately needed re immunology/vaccinology, sorry, gene therapies and virus.
Won’t happen – no money in it and besides mRNA will be able to cure us all of everything.
“But there again nobody knows, or ever will know, precisely how and why some people get ill and others don’t.”
Well largely we do. It depends on the state of the immune system in each individual which depends on general state of health, age, but also every individuals physiology – genetic influence – is different to the next.
This is why real CoVid deaths were among those with weakened immune systems, 95% of whom were over 80 with one or more serious medical conditions and who were near death.
It also depends on previous exposure to pathogens. Measles was mostly not fatal to Europeans, but European colonists infected the South American natives with it in whom it was nearly always fatal, because it was a pathogen never before present in their environment.
It also depends on the level of exposure to a pathogen. (A bit like poison is a matter of dose. )
And North American natives were affected in the same way, not necessarily Measles, but at least by locally unknown bugs imported by colonists.
I accept what you say entirely, and am aware we know a lot about these matters and that’s why I used the term “precisely”.
Of the many books and articles I’ve read, mainly immunological, one particular phrase resonates often, and that is “the mechanism behind thiis is not fully understood”. Then there’s the synergy and cascades of immune responses to consider.
Thus in those many cases one simply doesn’t know how much more there is to know – you could be nearly there or miles off (study the man hours/years to discover, for example, inerferon/s). It’s what you don’t know you don’t know that’s the problem.
“The beautiful cure” by Daniel M. Davis. 2018, if anyone’s interested. ( I am not he by the way), details history of immunological discoveries and latest research.
I would be interested to hear your, or anyone’s views om the trawler cases?
So Cummins executed a Coup d’État.
He should be put in the Tower awaiting the sensation of a short, sharp shock, from a cheap and chippy-chopper on a big black block.
It certainly seems that his hero worship for voodoo mathematical medical modellers swung the day.
I wonder how many entirely preventable deaths, injuries (mental) he and his ilk caused.
FWIW, the only thing he got right was his opinion of Hankok.
I believe the Spectator/Heneghan piece is now outside the paywall, it’s brilliant We needed a Covid inquiry – but this isn’t it | The Spectator
https://petermcculloughmd.substack.com/p/savoy-declares-independence-from
Got this from Dr Mike Yeadon’s Telegram channel. Can any of our European members verify?
“What is the point of the Covid Inquiry? It should be to establish which parts of the government’s pandemic response worked, which parts didn’t, and what to do next time. Instead, it is a farce – a spectacle of hysteria, name-calling and trivialities.”
Professor Heneghan’s opening para in his Spectator article which is superb – how on earth does this man keep up this work rate – but I have a big issue with “what to do next time” which amounts to conceding that the pandemic was real and almost invites Billy and the boys to get on with their next release.
As tof would point out – there was no pandemic.
Top class work by Professor Heneghan and at least when the pantomime whitewash is over and we have “lessons will be learned ” nobody can deny Professor Heneghan’s outright debunking.
The standard SIR model of 1927 goes up and down and has no dependencies on change of behaviour – and fits the data from India at the time, flu in an English boarding school and presumably numerous other datasets. When Covid struck the settled science was ignored.
‘When some Swedish academics started to call for lockdown based on Ferguson’s work, Giesecke agreed to go on Swedish television to debate them. As did Anders Tegnell, his protégé. They gave interviews non-stop, in the street and on train platforms, making the case for staying open. They showed it was possible to win the argument.’
Great! But, meanwhile, in Socialist Fascist Britain:
‘Broadcast content relating to the Coronavirus
Published on 23 March 2020
……..we remind all broadcasters of the significant potential harm that can be caused by material relating to the Coronavirus.
This could include:
• Health claims related to the virus which may be harmful.
• Medical advice which may be harmful.
• Accuracy or material misleadingness in programmes in relation to the virus or public policy regarding it.
We will be prioritising our enforcement of broadcast standards in relation to the above issues.
In these cases, it may be necessary for Ofcom to act quickly to determine the outcome in a proportionate and transparent manner, and broadcasters should be prepared to engage with Ofcom on short timescales.
Ofcom will consider any breach arising from harmful Coronavirus-related programming to be potentially serious and will consider taking appropriate regulatory action, which could include the imposition of a statutory sanction.’
‘Sanctions may include:
Another matter that the inquiry should be looking at: Socialist fascist state censorship.
At the beginning of the epidemic, the “case” numbers followed Farr’s Law. They were clearly not going to reach Ferguson’s estimates, if it was assumed that the mechanism of development of the epidemic was not significantly different to others. In particular, the infection had peaked before the first lockdown, especially if measured by “back working” to time of infection rather than time of case. Figures from Public Health England, published daily at the time. [NB: the sudden drop off in the last two days is an artefact of the daily reporting system and does not represent the final data for those days.]
”case’ numbers’
Yet another matter for the enquiry.
‘Until now (4 February 2022) COVID-19 cases have been reported at the individual level: every positive test taken and reported by one person has been considered part of a single case record, initiated by their first positive test.’
UK HSA
‘The Trust did run the assay for 40 cycles and cited this is standard for many PCR assays.’
PCR Testing in the UK During the SARS-CoV-2 Pandemic – Evidence from FOI Requests, April 2022
‘Infectious virus was associated with mean Ct values of 18.8 ± 3.4 (median 18.7)
Not obtaining infectious virus was associated with mean Ct values 27.1 ± 5.7 (median 27.5) (see the figure)
Samples with a Ct value below 23 yielded 91.5% of virus isolates.’
CEBM Aug. 2020
In view of the above, can we have any confidence in NHS case numbers?
Why don’t we have an inquiry into that…..oh……hang on……..
Shame the Speccie did not speak up loudly at the time.
All it seemed to want was to get rid of Boris and then get rid of Truss because she was not their preferred candidate for PM, so they attacked her until Sunak was appointed without a vote. So much for their democratic credentials.