You might have read my previous articles which were critical of MHRA’s safety management under the pseudonym Nick Denim.
It’s time to reveal that I was a Senior Civil Servant in the Ministry of Defence (MOD). I was responsible for the safety and effectiveness of ammunition used by the Armed Forces. The same as MHRA is supposed to do for medicines. I am therefore well qualified to comment on MHRA.
If you haven’t already seen it, have a look at a report I co-authored about MHRA. It’s available on the Perseus Group website. It details a litany of problems with MHRA’s safety management and raises a whole host of questions.
This article covers a couple of further issues which have surfaced since the report was completed.
Who watches the MHRA?
In MOD, there are individuals responsible for managing the safety and effectiveness of all products. I was responsible for ammunition. Others are responsible for the safety and effectiveness of aircraft, ships, submarine nuclear reactors and so on. But there is a separate safety regulator: the Defence Safety Regulator. It writes the rules for managing safety and ensure adherence. This separation seems very healthy to me. MHRA, on the other hand, is both the regulator and manages safety, meaning it makes its own rules and marks its own homework, and no one besides ill-qualified and short-lived Government ministers are responsible for checking it is doing its job competently.
I wrote to the Secretary of State for Health on March 20th 2023 to ask why the approach for medicines is organisationally different to defence equipment. One month later I received the reply that, essentially, they are too busy to answer the question. I shall be pursuing this further.
Batch Issues
Batch issues are very important in all safety critical sectors. In MOD, if we received a report of a safety incident with one of our types of ammunition we had to decide quickly what action to take. The first questions we asked and answered as soon as possible included: how long had the product been in use; had something similar happened before; and was it therefore more likely to be a manufacturing problem or a design problem. For example, something in use for 10 years with no similar incidents was more likely to be a manufacturing batch issue, so let’s immediately quarantine the items from the same batch and those in adjacent batches. We would start inspecting the failed and quarantined items looking for physical defects, damaged packaging etc. We would delve into the manufacturing records to look for changes in personnel, quality control, production location, sources of supply of materials and so on. In my experience, batch issues contribute to a significant number of safety issues.
In contrast, MHRA recently admitted in an FOI reply that it does not know the batch numbers for all Yellow Card reports. Which is very odd because the internet is awash, particularly in the U.S., with analysis of ‘bad batches’ or ’hot lots’ of the Covid vaccines. MHRA excused itself for the missing batch information on the basis that it is not mandatory for the reporter to include the batch number. Yet it could quickly obtain that batch information for all Yellow Card reports linked to the Covid vaccines simply by cross-checking the name in the Yellow Card report against the NHS vaccination database. For other medicines it could do so by investigating further just the fatal and serious Yellow Card reports. That’s why it is so important for MHRA to have a proper process for investigating Yellow Card reports (it has already said that it doesn’t). At the moment, all it seems to do is stick the Yellow Card reports in a database and do statistical analysis. It’s totally inadequate and reprehensible.
Conclusion
The more we dig, the greater the concerns about MHRA’s management of the safety of medicines in the U.K. When will MPs start asking questions and debating this?
Until Nick retired a few years ago, he was a Senior Civil Servant in the Ministry of Defence responsible for the safety and effectiveness of ammunition used by the Armed Forces. He is co-author of the Perseus Group report on U.K. drugs regulator the MHRA.
Stop Press: Professor Norman Fenton has produced a new video taking apart a speech by MHRA Chief Executive June Raine late last year where she claimed once again that the MHRA’s role is changing from “watchdog” to “enabler”. He concludes that it shows the MHRA is not fit for purpose.
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Norman Fenton has a great video just out, dismantling a recent speech by June Raine, head of MHRA. See https://www.youtube.com/watch?v=NbFK5KqEdoA
Apparently they are now the “enabler” rather than “controller”. Would be nice to see them “enabling” Ivermectin.
Any bets on whether Raine is a Common Purpose graduate?
Yeah I just posted it elsewhere, LOL!
Good. Worth adding that this is not the speech mentioned in section 8.1 of the Perseus report, which was March 22. This one is November 22.
Well you can’t go wrong with anything from our Prof Fenton as far as I’m concerned. I like to keep up with his latest and he’s bang on in this vid, though I didn’t sit through the entire Raine speech. The MHRA are just a dummy outfit ran by a bunch of corrupt stooges.
Quelle surprise!
Thanks for this Nick – interesting article. Hope DS does more of this kind of content – insider insights and analysis on just how terrible the whole thing has been.
So drug and vaccine safety is monitored by MHRA but no one is there to check them. And if there was someone, who would then be there to check the guys checking MHRA, to.make sure THEY are doing their job properly?
This is the problem with any bureaucracy. In the end someone is left unchecked.
There is a very simple solution. Don’t force people to take anything, give them the best info available and let them take the responsibility for themselves.
I know we live in a society in which most people don’t want to take responsibility for themselves and are constantly braying for a nanny state to make things right foe them. But the result is abuse eventually, at some point. And no amount of bureaucratic layers will solve that.
Kill Gates, Pfizer monitor the MHRA for compliance to the criminal industry’s strategy. If happy they send more money. If angry they fly to London for a meeting. Kill Gates seemed to here every month during the scamdemic.
But the sheeple felt compelled to write love letters to the Pres of Pfizer and probably Kill Gates thanking them for saving them….as they suffered blood clots, heart disease, illness, even death.
I noted that many of the references cited in the Perseus report were articles in DS. Well done, all!
I was nodding along as I read it, so relieved that people qualified in safety regulation had looked at this group and found them missing in action. I got so sick of being told that our regulators were independent and the best in the world (like so much of our world- beating crappiness; in fact just now Britain does seem to be the world leader in general uselessness, with the odd exception.)
If it is true that the MHRA lost most of its staff in austerity cuts, then they should never have been tasked with approving the jabs: they were clearly lacking the resources to do so, and all their pronouncements about scrutiny of adverse events have been dishonest.
I suppose they will not be closed down because even a Potemkin organisation will provide a facsimile of governmental oversight. Dear God – were things always this bad?
Instructive to look at all the various Regulators.
In my working life, I had, perforce, frequent dealings with many Regulators. Often they had good, sensible, conscientious people working for them. Alternatively, many lazy bunny- huggers and suchlike.
And actual outcomes? Largely disappointing. Leadership often awful thanks to appointment of political chums or those given sinacures to get them out of the way.
I think Raine first made the “enabler not regulator” comment at a speech to her alma mater, Somerville College. It was a ‘look at me, I’m so clever and I’m one of you’ smug and self congratulatory presentation so common to those with a high IQ but low EQ. Given the usual, glacial speed of the MHRA approval processes the key question is which politician pressured her to approve the “safe and effective” jabs at warp speed?
Just a thought: if the MHRA is now an ‘enabler’ rather than a watchdog, hasn’t this created a vacancy for a watchdog?