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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”Description of the frequency of side-effects
Very common greater than 1 in 10
Common 1 in 100 to 1 in 10
Uncommon [formerly ‘less commonly’ in BNF publications] 1 in 1000 to 1 in 100
Rare in 10 000 to 1 in 1000
Very rare less than 1 in 10 000
Frequency not known frequency is not defined by product literature or the side-effect has been reported from post-marketing surveillance data” my emphasis
This is from the BNF, the bible of prescribing.
https://bnf.nice.org.uk/medicines-guidance/adverse-reactions-to-drugs/
From the same publication:
“Newer drugs and vaccinesOnly limited information is available from clinical trials on the safety of new medicines. Further understanding about the safety of medicines depends on the availability of information from routine clinical practice.
The black triangle symbol identifies newly licensed medicines that require additional monitoring by the European Medicines Agency. Such medicines include new active substances, biosimilar medicines, and medicines that the European Medicines Agency consider require additional monitoring. The black triangle symbol also appears in the Patient Information Leaflets for relevant medicines, with a brief explanation of what it means. Products usually retain a black triangle for 5 years, but this can be extended if required.
Spontaneous reporting is particularly valuable for recognising possible new hazards rapidly. For medicines showing the black triangle symbol, the MHRA asks that allsuspected reactions (including those considered not to be serious) are reported through the Yellow Card Scheme. An adverse reaction should be reported even if it is not certain that the drug has caused it, or if the reaction is well recognised, or if other drugs have been given at the same time.” My emphasis added.
It’s all very well having a means of reporting adverse events but even if they were collated together, there’s a significant amount of background data that would be required for each adverse event. The adverse events would have to be stratified into life threatening, very serious, serious, minor or something similar. The medical history would be required and other medication taken.
Interestingly there is a section in the BNF that includes drug interactions, not sure where that information is sourced.
Considering that the MHRA’s self-stated mission is Being an enabler, that is, help pharmaceutical companies to sell new stuff despite adverse regulations seeking to make that needlessly difficult, that’s not exactly surprising. The only required property for medical products (of any kind) to enable them to be sold in the UK is Doesn’t kill so many people on the spot that denying causality starts to become difficult.
UK public health officials aren’t specifically seeking to kill people – after all, dead people don’t buy face coverings (requiring mandatory headstone coverings for safety from post-mortem infections would be an idea, though) – but if this or that Joe Nobody or Jane Wedontmiss happen to die while the good cause is being achieved, that’s – unfortunately – unavoidable. Neither Sir Patrick nor Sir Chris nor Dame June are going to loose any sleep over that. Getting knighted means getting righted.
Since you mention other industries that deal with safety issues, as a retired engineer that has worked in the transport field, I also find it weird that the pharmaceutical trade appear to operate on a foreign land. They do not appear to make use of the concept of “safety integrity level”, e.g. These two standards, IEC 61508 and IEC 61511 would appear to be relevant. Maybe they follow them when manufacturing their products, but who knows?
All we get are the blatant lies using the terms like “safe and effective”, with no real evidence to make a wise judgement as to the validity of this or that.
The MHRA’s safety policy is based on a very old and trusted methodology – that of human sacrifice. This methodology goes right back to the Aztecs, where it was found to be highly effective in ensuring that the sun rose the next day. For those unfamiliar with it, in simple terms, it means you sacrifice a certain number of innocent victims every day to maintain the status quo (in this case the status quo being soaring profits for Big Pharma, knighthoods and damehoods al! round for the health professionals, and a subjugated and cowering general population). I hope that provides some reassurance.
Adding a few technical points: Innocent victims is not quite correct. Those who were sacrificed were captives made during some war. Because of this, the primary (or at least most important secondary) business of all of the male Aztec population was to make war one someone to capture more people to sacrifice. This was done in form of an elaborate public procedure during which the captives would basically be skinned alive piece by piece until they died from that. Thank God these noble stone age savages weren’t white. They could have come up with something hideously cruel and useless instead which would have been a constant, mortal danger to anyone within reach!
Good article from someone who knows his stuff. Keep digging, and good luck!
Basically June Raine is criminally negligent. I hope all those injured pursue her for damages, personally. She needs to live out the rest of her years in a bad prison, sharing a cell with cockroaches and eating cat food.
Cat food is too good for her.
Eating the roaches would be more appropriate.
Or an oubliette….
As far as I know, her organization is a bit similar to the USPTO (US Patent & Trade Office) in that it’s either completely or at least to a large degree funded by application fees paid by prospective drug sellers. As everywhere, he who pays the piper, calls the tune. That’s an nice example of small-stateism badly backfiring: A regulator supposed to operate in the interest of the public must be independent from both government and the industry it’s supposed to regulate. Raine isn’t negligent. Her income depends (at least partly) on pharmaceutical companies developing new drugs for sale. Without actually being able to sell them in the general case, nobody would (keep) invest(ing) money into this.
She obviously also isn’t overly troubled by something resembling a conscience. But for a career in either politics or the civil service, that’s pretty much a requirement.
She is responsible for their safety. She can accept payment and remain a safety watchdog. Like when you pay to sit your driving test – you do have to pass requirements or you will fail. Knowing you may fail doesn’t mean you don’t bother to learn to drive (unless you are especially shit and haven’t a chance in hell).
Driving tests are designed such that the vast majority of people will pass despite they lack both the intellectual maturity and the technical prowess necessary for unsupervised operation of such potentially deadly machines as cars happen to be. But that’s an aside.
The MHRA gets a large amount of its funding from the pharmaceutical industry. Hence, it works in the interest of the pharmaceutical industry (that’s the enabler bit). That’s the invariable outcome of such a built-in conflict of interest.
I have little doubt she has an unlimited indemnity from HMG, of the sort school governors do not get.
A pantomime dame if ever there was.As Groucho Marx might say, “She should be on the stage. There’s one leaving in half an hour.”
I’m shocked.
Never for a moment did I ever think something like this would ever happen.
For those who may be a little naive, did you ever actually think that the job of the MHRA was to find any fault whatsoever with the continuous miracle drugs produced by big pharma ?
Look at this and weep you utter bastards :-
https://www.sciencedirect.com/science/article/pii/S027869152200206X
So what is the point of a regulator that cannot regulate?
Perhaps it’s from being naive but I honestly thought the MHRA was a regulator for public safety, but it appears it’s nothing of the sort. They’re keen to promote their pharmacovigilance so if they are doing safety checks re: cvd vaccines, why aren’t these analysis in the public domain? The most egregious aspect of all of this is this impression that they’re there to regulate medicine safety (simply omit “safety” and I guess it’s accurate?). If you were to ask anyone on the street the purpose of the MHRA I’m sure they’d all say “to regulated the safety of medicines for the public”, not function to regulate the enabling of the pharmaceutical sector. If this is accurate it’s quite the revelation.
Fascinating and dispiriting. Well done for the article and the research and good luck with the FOI investigations.
Thank you for your efforts. Like Steve Kirsch in the USA, these organisations must be held to account. Few of us want to tackle that job. But is is so important because chipping away at these organisations eventually leads to findings which are less than satisfactory. Negligence is the word that comes to mind. Whoever thought of the MHRA as a negligent organisation, but there it is. The chipping away appears to show this may be exactly what is happening within the MHRA, the FDA, the CDC, the NIH. Hope the public is listening.
If they ‘had no process to follow up yellow card events’ then they should not have provided EUA for the vaccines. It’s as simple as that.
Thank you Nick Denim. Please keep digging.
Meanwhile Reiner Fuellmich opens the Grand Jury case in the Hague.
This link takes you to 18mins of summary.
https://rumble.com/v1ecssx-from-the-hague.-international-trials-day-one-crimes-against-humanity.html
Well worth a listen/watch.