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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The article makes a fundamental error in the first paragraph. It is increased prosperity and inventiveness which have improved the lot of the bulk of the people. This has been done by individuals alone and in voluntary association doing what Adamn Smith said they would do.
Capitalism, free enterprise or entrepreneurship (call it what you like) has produced a huge increase in peosperity and along the way many useful new products and methods have been developed. I struggle to think of a single one which has come about due to state run institutions.
For a useful account of how health has improved as income has improved this site provides a great deal of information in an accessible form:
Vaccines Did Not Save Us – 2 Centuries Of Official Statistics
“In addition to the extensive static graphs below, the following superb BBC FOUR broadcast by Professor Hans Rosling shows how health improved in step with wealth over the last 200 years “200 countries over 200 years using 120,000 numbers – in just four minutes“
The article assumes some very egregious and religious gospels which are false:
-viruses (flying) exist – they don’t
-DNA/RNA can survive outside a host – they can’t
-viruses cause measles et al – they don’t
-quackcines reduced death from diseaese – they didn’t
Too much disinformation which negates the obvious reality that your health, diet, your lack of imbibing toxins, your mental state, is your wealth.
Ferdlll, I am in general agreement with many of your posts but I am a bit thrown by your opinion on flying viruses. Are you saying that airborne viruses are not a thing, and illnesses cannot get passed on through the air?
I read a paper showing that the Spanish Flu, which did go around the world, beat any of the transport ships at the time. The Flu appeared to follow the natural climate circulation. It seemed a convincing argument. I also noted that Covid got into some Antarctic research bases despite stringent checks on staff health. Again an airborne spread seems feasible.
I suspect what got in to Antarctic research bases was a shed load of PCR tests and nothing more.
Please forgive me, but if a virus does not cause measles, what does?
Yes, a virus.
https://www.gov.uk/government/publications/national-measles-guidelines/measles-factsheet
” A reduction in inequality and evidence-based health policies have been central to this success”
Well there certainly has been a reduction of ‘evidence based medicine’. Probably to do with the power of Big Pharma and vested interests!
“most deaths during the Spanish Flu, before modern antibiotics were invented, were likely due to secondary bacterial infections.”
Some say most of the deaths were associated with the mass vaccine program at Fort Detrick. And the malnutrition from WW1.
Some say that masks made the situation worse, by providing a breeding ground for the secondary bacterial infections, which allegedly can be more problematic for the human body than the primary virus. Perhaps we should consider that respiratory viruses are pretty delicate little rubber dinghies with SAS operatives on a mission: they need exactly the right cells to invade and subvert into making more viruses; bacteria are more like aircraft-carriers that carry an entire food manufacturing machinery and weapon repair stations. The whole idea of humans being constantly at war with respiratory viruses rather in symbiosis with them might be a notion put about by BigPharma to boost sales.
Good point.
Yes. I believe that around 3 million Us soldiers were “vaccinated” against smallpox, ostensibly because the military were worried the Germans would use smallpox as a bioweapon (same as the military allegedly used it against the native Indian).
This trashed many immune systems leading to a prevalence of bacterial pneumonia.
Good old uncle sam again.
The real genius was getting it to be known as “Spanish Flu”. Fort Detrick Flu doesn’t have quite the same ring to it.
” taxpayers in the U.K. and elsewhere have been working hard to fund the 100-day vaccine programme” – how to work hard without noticing it.
That picture: Where’s the meat and dairy? Not a balanced diet.
That’s the diet that health fascists will
force on us
Excellent article. It demonstrates well that our health is (largely) within our own hands. None of which is rocket science, good diet/exercise/sleep etc. However it does need repeating to push home the message that pharmacology shouldn’t be the first port of call.
An appalling article. The author misunderstands most things. Improved health followed improved prosperity which was caused by individuals being allowed the freedom to pursue their own interests rather than following the diktats of the local lord or bishop. ‘Public money’ does not exist; it is simply money extorted by the robber state. Different people value health differently and choose to make different trade-offs.
The author is a coercive collectivist out to impose his version of what is good on everybody else. ‘I’m from Public Health and I’m here to help’ are some of the scariest words in the English language.
I agree with some of your comments though I think it’s harsh to call it an appalling article. The analysis of the deeply corrupt “public health” industry is correct – it’s the remedy we disagree on.
You and I probably agree that we can do without a “public health” industry, the author thinks it could be replaced with something actually helpful. But I think we’d just end up with mandatory broccoli eating (I love broccoli with garlic, Mrs ToF does it very well).
I think this illustrates what we are up against- even people who saw the “Covid” scam for what it was think that everything can be made better if only more sensible and honest people were put in charge. Hardly anyone wants to just get rid of vast swaths of public bodies.
Amen!
Could not have put it better myself.
Also we should not forget the whole surveillance industry setup to monitor infectious diseases around the globe. A lot of people would be out of jobs, including a lot of people working for the WHO.
Vaccines are killing millions. Autism now one in thirty-six post kids immunisation. Ask any parent with an autistic child when it started. They can pinpoint the day! mRNA covid poisons are currently killing millions but first causing horrific adverse events. Please wake up.
Over 7% of UK school age boys are autistic. That is 1 in 14. That is based on official statistics in England and official statistics for Northern Ireland. The NI stats prove it is nothing to do with better diagnosis or greater awareness. They show that 60% of the boys are non-verbal which means they are impossible to miss.
How about just admitting that vaccines NEVER solved any problems and NEVER helped reduced illness? On the contrary, the first vaccines were totally poisonous (just read the history of how the first smallpox vaccines were created and distributed) and modern day vaccines have their famous adjuvants, which are often poisonous on their own.
The immune system is amazingly complex and we have a very, very long way to go before we (if ever) completely understand every implication of attempting to modify or “assist” a minute part of it.
In the meantime, we are surely all aware of the dangers of mRNA vaccines. I cannot believe the author wrote the following, so maybe I misunderstood something:
We don’t yet know the long term consequences of causing inflammation and cell death in the ovaries of young girls, or the results of stimulating inflammation and probable cell death in a foetus in a pregnant woman. However, having given these injections to a lot of children and pregnant women, we should understand this better in the future.
The too typical argument of the medical profession: vaccines are a modern marvel and you have to be really very unlucky to die or become permanently disabled from them. Smile.
In my simple mind, the body has two main defences against pathogens: the respiratory system and the digestive system. Also, if I should have an open wound, the body is quick to seal the wound and “disinfect” the area, thus also acting to prevent pathogens entering the body.
But a vaccine directly injects a pathogen of sorts into the bloodstream, thus bypassing all bodily defences. The idea is to provoke some sort of advance warning inside the body so that, when I eventually am exposed to a particular disease, my body will react immediately to conquer that disease. But what is the difference when I encounter a disease without prior vaccination? Will my body not also immediately respond against that disease?
I think the whole idea of vaccination is completely flawed and, with it, the whole idea of the human race being eradicated by some modern “Pandemic”.
I’d be more comfortable believing in flying viruses if someone could isolate the little devils.
Saying, “If viruses don’t cause disease, then what does?” is rather like saying, “Well, if she’s not a witch, then why did the crops fail.”