I was struck by Professor Carl Heneghan’s comments to a House of Commons All Party Parliamentary Group reported last week. Like me, he is scathing about Medicines and Healthcare products Regulatory Agency’s (MHRA) safety management. In relation to MHRA’s strategies and proposals to improve medicine safety he said that “fine words butter no parsnips”. How true. I want to go a step further and explain why I think medicine safety will actually get worse, not better, unless MHRA learns from other safety critical sectors.
Unlike other safety-critical sectors, medicine safety is managed in relative terms, not absolute. Take aviation for example. Aircraft are designed to meet absolute safety targets such as the number of fatal incidents per million flying hours. In contrast, MHRA do not set safety targets for licensed medicines like ‘no more than x deaths or y serious adverse events’. Instead, MHRA licenses a medicine if the clinical trials data indicate that ‘the benefits outweigh the risks’. That’s a charter for collateral damage to start with.
It gets worse. In 2014, Patrick Vallance (then working for GlaxoSmithKline) told Health Ministers that “In the future, medicines will come to market quicker with less data, with more research being conducted in the post-license phase.” Imagine Airbus or Boeing telling the Transport Secretary that they intend to ignore absolute design safety targets, do less testing on new aircraft and then find the missed safety problems once they’re in service. Or nuclear power plants. Or oil/gas rigs. It would be ridiculous, but bizarrely, it’s okay for medicines.
On to the post-license phase. Other safety-critical sectors define absolute tolerable levels of in-service safety incidents and investigate them all. Not MHRA. They don’t define a tolerable level of harm, and they don’t investigate even just the fatal/serious Yellow Card reports and those involving children or pregnancy. It’s excuse is pathetic – it doesn’t have the resources (see slide 23 here). Instead, MHRA does statistical analysis of Yellow Card reports to compare the likelihood of different types of adverse events between different medicines. That’s a relative assessment of safety. And bear in mind that the vast majority of adverse events go unreported. So it’s a poor relative assessment at that. Nor does MHRA assess causation of Yellow Cards – to what extent was the reported fatal/serious adverse event caused by the medicine: definitely, probably, possibly, unlikely or not related. There are, of course, other aspects to MHRA’s pharmacovigilance but June Raine has confirmed that statistical analysis of Yellow Card reports remains “the most significant method” of its safety management (see slide 19 here).
To make matters even worse, MHRA knows that its statistical analysis misses safety signals:
a) In 2013, MHRA listed 27 medicines withdrawn on safety grounds since 1995. The average time on the market was 11 years. That’s how long it took MHRA to wake up to missed safety signals. Earlier this year, I asked MHRA to update the list to 2023 but they said it would cost too much to find the data.
b) In 2020, the Cumberlege Inquiry reported on two drugs and one medical device where MHRA missed safety signals for years. Sadly, the report’s recommendations tinkered around the edges. Indeed, the main one was the establishment of a Patient Safety Commissioner to “listen to patients” – a safety net, but it’s too late at that point anyway. There was nothing to improve the fundamentals of safety management because, as Appendix Five of the report confirms, the Inquiry had no input from those involved in managing safety in other safety critical sectors. That’s a failure soon to be repeated by the Covid Inquiry – Baroness Hallett is planning to appoint an independent vaccine safety expert but not any wider safety management experts. The Perseus Group offered to help but has so far been declined. The only glimmer of hope is that the Patient Safety Commissioner confirmed to me recently that she is “engaging beyond the healthcare sector to learn from other high-safety industries”.
c) For the Covid ‘vaccines’, MHRA admitted that it missed safety signals until mid-2022 when it changed its methods of statistical analysis. Ironically, one of those changes was to assess Covid vaccine safety against other drugs not other vaccines. But that works both ways – the safety of other drugs is now being compared against the Covid vaccines! Hands up if you think that’s a good idea.
d) MHRA’s statistical analysis uses signal detection thresholds. Setting low thresholds generates lots of potential safety signals which they don’t have the resources to investigate. Setting higher thresholds leaves more potential safety signals undetected.
The corollary to all of this is that those missed safety signals from all drugs down the years remain in the Yellow Card database and are incrementally baked into the baseline of MHRA’s relative statistical analysis of comparative drug safety. Day after day, the baseline of acceptability goes up and newer drugs can have more adverse events and still be considered acceptably safe because the older ones have safety issues undetected by MHRA’s statistical analysis.
It’s surely time for radical reform. We won’t though. We didn’t in 2004 when the House of Commons Health Select Committee published its report on the ‘Influence of the Pharmaceutical Industry’. We didn’t in 2009 with serious problems with Pandemrix, the Swine Flu vaccine. We didn’t after the Cumberlege Report in 2020. And we haven’t now despite the tsunami of evidence of harms from the Covid vaccines. The pharmaceutical industry is now too lucrative and too many doctors, the public and politicians are now addicted to ‘a pill for every ill’ that it now seems unstoppable. Depressing, isn’t it?
What’s the next ‘scandal’ going to be (apart from the Covid vaccines)? God knows. Perhaps it’ll be ‘SSRI antidepressants’. Serious concerns have been swirling around those for over a decade – which is, coincidentally, the average time it takes MHRA to wake up! Google ‘SSRI PSSD’ and judge for yourself.
Whatever it is, you just know there will be yet another medicine scandal along soon.
The fact is that there needs to be root and branch reform of MHRA and how it manages medicine safety. Sadly, that doesn’t seem likely – for example, the Government is already lining up to allow MHRA to rubber stamp anything licensed by the FDA or EMA. You have been warned.
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. medicines regulator the MHRA.
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“Unlike other safety-critical sectors, medicine safety is managed in relative terms, not absolute. Take aviation for example.”
Boeing was ‘allowed’ to “certify” the safety of its 373Max, with fatal consequences. But at least aviation learned and changed. Pharma-Medicine doesn’t look like it will ever learn from its mistakes.
Why would you want to “learn” when you make hundreds of billions of dollars making sh1t and only pay tens of billions of dollars in fines for your crimes?
Never has there been a time where taking personal responsibility for your health so as to not need any medicines or healthcare intervention been more imperative. We literally cannot trust any of them. Pharma, so-called regulators, doctors, nurses, the NHS as a whole, medical journals, the list goes on. They’ve all shown their true colours to anyone who bothered to open their flaming eyes over the last few years, if not before. Meanwhile, are one-pilot planes still meant to be on the cards in the future, or will it be under the control of AI? Well thank god there were some going spare on this flight;
”BREAKING NEWS: PILOT has died Inflight
Aug.14, 2023 – LATAM Airlines Flight LA505 (MIA-SCL) Miami to Santiago, Chile – 2 hours into 8hr flight, captain collapsed and died in the lavatory – plane diverted to Panama City – 3rd pilot collapse THIS WEEK!
56 year old captain pilot went into the washroom in the 2nd hour of the flight, saying he felt unwell.
Noticing that the captain had fallen in the sink, the cabin crew intervened with first aid, but the captain could not be revived.
There were 3 pilots on the plane, the remaining two diverted the plane and landed safely in Panama City, Panama, 28 minutes after pilot collapse, at 12:36AM EDT, Aug.15, 2023.
Captain was pronounced dead upon arrival.”
https://twitter.com/MakisMD/status/1691699040118083985
Bloody hell!
A slightly longer piece on the same event giving a few extra details – I was about to post it but you beat me to it!!
https://makismd.substack.com/p/pilot-died-in-flight-aug14-2023-latam
LOL, yes we ‘dumpers’ are on the same wavelength.
Tbh I stopped checking in on Dr Makis’ substack as now all of his articles are behind paywalls and I’ve seen other writers do this more frequently too, so it just puts me off altogether. I mean, why would highly successful doctors, scientists, authors and lawyers want to sporadically put a newsletter behind a paywall? I see no point, they’re not exactly hard up! Whereas you get others who never do, such as Jessica Rose, Meryl Nass, Igor Chudov, Paul Alexander, Sasha Latypova etc. Bizarro.. :-/
I only saw it as it was posted in Dr Cartland’s channel
Yes I follow Dr Cartland’s Twitter too. He’s ace. Balls of steel.
I’m in his Telegram group & he’s another member of MD4CE – he is an absolutely wonderful man – so true, ethical & lovely with it.
One of the other aviation disasters that I can remember was one in the Alps a few years ago, where one of the pilots deliberately crashed into the mountains, having locked his boss (the chief pilot) out of the cabin. It’s possible to do that these days – an unwanted side effect of anti 9/11 precautions. Years ago (before 9/11) it was often normal for the cabin door to be left open, some of the time. At least in the USA.
Yes I remember that, John. You’re going back a number of years now but I do remember being horrified, and it did call into question the psychological assessments that pilots must undertake prior to flying and in order to keep their license. MH370 being another example, though there’s so much mystery surrounding what happened there it frustrates the hell out of me to think about it too much. Especially because a long-haul flight like that presumably had a few pilots onboard so that even if one lost the plot there’d be others to take the controls. I only like mysteries when they can be solved.
None of that is unknown or accidental.
The bugs are important features of the enabler, so that their criminal activity can remain in the dark to most and thereby continue and grow.
It’s being ignored by most, for now. Not enough people are dying for it to be “un-ignorable”. What level of carnage will be needed before the sheeple wake up?
That might be interesting comparing the jabs against a drug which they
recommendrequire to be administered to healthy people of all ages. <tumbleweed>(edited to emphasise the coercion to take the jabs)
Drug testing in future will be like those face cream ads, you know, 87% of 56 people said the fantasy chemical cocktail glop* made their skin smoother than a graphene coated banana or some such rubbish. (* small print – tested against a tub of lard and a brillo pad.)
‘Baroness Hallett is planning to appoint an independent vaccine safety expert‘ — all together now — brought to you by Pfizer!
They do not appear to use the concept of Safety Integrity Level (SIL) for any of their products. Look it up in general – often used for most systems that are manufactured for use in modern systems, including the ones installed in modern cars, etc.
To the author – as a senior civil servant, now retired, why do you think June Raine is not/has not been retired? She was born in 1950.
” It gets worse. In 2014, Patrick Vallance (then working for GlaxoSmithKline) told Health Ministers that “In the future, medicines will come to market quicker with less data, with more research being conducted in the post-license phase.”
——-
In other words, they intend using patients (ie you and me) as their guinea pigs and experimenting on us.
The only way you’ll avoid it is to reject any newly developed pharmaceutical products – which is precisely what I intend doing.
” What’s the next ‘scandal’ going to be (apart from the Covid vaccines)? God knows. Perhaps it’ll be ‘SSRI antidepressants’.”
——–
It’s already a scandal, but one they prefer not to talk about.
My late mother had a breakdown in her mid-60s. She developed anxiety, insomnia and depression. She was given sleeping pills and then anti-depressants (Fluoxetine). During the diagnosis, she had told her GP that she would never commit suicide – she couldn’t do that to her daughters.
Two years later after a dreadful downward spiral, she killed herself at the third attempt. A few years later I read a report in the newspapers that Fluoxetine (and other similar anti-depressants) were implicated in leading to suicidal tendencies.
They know damn well that these products are dangerous. But they are also very lucrative and, since Covid, far more people will be swallowing them without knowing “the unfortunate side effect” that they may end up wanting to kill themselves.
The MHRA clearly “doesn’t want to bite the hand that feeds it” even though it results in unsafe and ineffective treatments. Woefully unfit for purpose
86% funded by Big Pharma…. What could possibly go wrong?