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The Failing MHRA Consistently Misses Safety Signals From Dangerous Medicines. Time for the Government to Act

by Nick Hunt
24 July 2023 6:10 PM

Safety professional Nick Hunt has written an open letter to the Health Secretary to raise his ongoing deep concerns about the MHRA’s regulation of medicine safety, shown most recently in the missed safety signals from the Covid vaccines.

Dear Secretary of State,

Under the Human Medicines Regulations, you are the Licensing Authority for all medicines and medical devices in the U.K.  You are, therefore, personally accountable to Parliament for their safety even if the MHRA does all the underpinning work on your behalf.

Until I retired in 2017, I was a senior Civil Servant in the Ministry of Defence responsible for licensing a wide range of explosive items as safe for Service use – everything from ‘dumb’ munitions like bullets and grenades to complex weapons like missiles and torpedoes.

I am very concerned about MHRA’s regulation of the safety of medicines and medical devices and I think you should be too. First, the MHRA does not investigate all fatal or serious Yellow Card reports of suspected side-effects. Secondly, the system of weekly statistical analysis which it relies on instead is imperfect, if not broken. 

Taking those in turn, it has been public knowledge for some time that the MHRA has no process for investigating fatal or serious Yellow Card reports and that it does not even know how many it has investigated. This was confirmed again recently in an answer to a Parliamentary Question from Esther McVey MP.

Now we find out why: June Raine confirmed in 2017 (slide 23 here) that, even before the Covid vaccines, there were already too many potential serious side-effects to investigate.  MHRA simply does not have the resources. That is apparently why it relies, instead, on statistical analysis of all Yellow Card reports to detect potential safety signals.

This is unacceptable. MHRA is licensing drugs and devices as safe knowing they’ll generate too many potential fatal or serious side-effects to investigate and relying instead on statistical analysis to pick up safety signals. That would not be acceptable in any other safety-critical sector. 

“Oh dear, we’ve had a couple of plane crashes recently but it’s within statistical norms so we won’t bother to investigate them.”

“Oh dear, we’ve had a few water leaks from nuclear power stations recently, but no more than normal, so we won’t bother investigate them.”

Really? If it is okay for the MHRA not to investigate fatal or serious Yellow Card reports, then perhaps the Government should just make all air crash and nuclear accident investigators redundant?

But it is worse than that. The system of statistical analysis which MHRA relies on instead is, itself, imperfect, if not broken. It does not know for all fatal or serious Yellow Card reports the basic but essential information like the age of the subject, medical history or the batch number of the medicine. MHRA also recently revealed that it had been missing safety signals between December 2020 and June 2022 related to all vaccines, not just the Covid ones. Add to that the serious safety issues with sodium valproate, Primodos and pelvic mesh covered by the Cumberlege Report which took years to be recognised – and then as a result of pressure from patient groups, not by MHRA’s statistical analysis. And more recently MHRA was much slower than other National regulators to react to safety issues with the AstraZeneca Covid vaccine – its statistical analysis failing yet again.

And all this is before considering any of MHRA’s other regulatory failures documented in the Perseus Report. You received a copy in April by email and hardcopy. You did not reply.

I do not expect that I will receive a reply to this either so I am publishing this as an open letter and copying it to the Patient Safety Commissioner, Baroness Cumberlege and my MP.  Perhaps one of those will be as concerned as I am about MHRA’s management of the safety of medicines and medical devices and raise the issue with you personally.

Yours sincerely

Mr. N. H. Hunt

July 23rd 2023

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.

Tags: COVID-19Dame June RaineMedicineMHRASafetyVaccine

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26 Comments
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transmissionofflame
transmissionofflame
1 year ago

Just in case anyone is interested, a small freedom-oriented political party will be engaging this evening at 7 on “X”:

Dear Member
Just a quick message to let you know that I will be on Resistance UK’s X Space, on Monday 18th March at 7pm to talk about the Freedom Alliance and the local and general elections. It would be great if you could join in the conversation. Find us at https://twitter.com/i/spaces/1djGXNZoypzxZ
Please share the link with anyone else you know on X (formerly known as Twitter) or anyone you know who is currently politically homeless. Let’s get some great discussions going!
My account and that of the Freedom Alliance is listed below if you are not already following us. We will follow you back. It would be really helpful if you could retweet our posts so more people can find out about us, too.
Looking forward to talking to you tomorrow.
For freedom!
Catherine
Leader of Freedom Alliance

25
0
DHJ
DHJ
1 year ago

“Criminal gangs make £8.2 million a day keeping asylum seekers in hotels”

Reframed.

42
-1
stewart
stewart
1 year ago

Putin is going to be in power for nearly 30 years and Stalin was in power for nearly 30 years, so Putin has become Stalin.

Thanks Telegraph for that insightful and profound piece of analysis. We’d be lost without you.

69
-6
Jon Garvey
Jon Garvey
1 year ago
Reply to  stewart

The late Queen Elizabeth must have been double-plus Stalin.

49
-1
Heretic
Heretic
1 year ago
Reply to  stewart

It seems they were just pointing out the Tiny Tatar’s desperate attempt to imitate his hero Stalin.

Last edited 1 year ago by Heretic
2
-9
Free Lemming
Free Lemming
1 year ago

“Why it’s Tony Blair’s fault if you can’t buy a house”

It’s a symptom of unchecked capitalism, which promotes personal wealth through property purchase over compassion. i.e. a system that breeds greed. I don’t know what the actual number is, but, amongst the people I know, about one in four have at least one property that is being used to generate income. The private rental market has created a price-fixing monopoly that has artificially inflated house prices and rent, and suffocated the aspirations of an entire generation. We don’t talk about this though – or if we do, we angrily refute the point – because, well, many people have bought a second property for exactly that reason. And who wants to think of themselves as selfish? Each property ‘pension’, ‘nest egg’, whatever you want to call it, is one less home for someone else. But who cares about that right? As long as I’m alright Jack.

27
-15
prod_squadron
prod_squadron
1 year ago
Reply to  Free Lemming

Central banks messed around with interest rates, lowering them to near zero. People couldn’t earn interest anymore. Interest would have been their income. The dot com bubble and the 2008 financial crisis frightened people out of the stock market. Dividends would have been their income. Property looked like the safest option.

33
0
DHJ
DHJ
1 year ago
Reply to  prod_squadron

In the late 1990’s and early 2000’s, interest rates were far from zero but banks were offering exceptionally large mortgages. This allowed people to overbid for properties that they were desperate to buy which forced the housing prices up. Properties were not worth the prices being paid for them.

As with furlough, this “credit” was marketed almost like it was free money and not the debt that it is.

11
-2
DHJ
DHJ
1 year ago
Reply to  DHJ

Anyone buying or selling property at the time knew properties were not worth what they were selling for as did anyone who watched Property Ladder, Location, Location, Location or Grand Designs.

8
-1
Free Lemming
Free Lemming
1 year ago
Reply to  prod_squadron

Maybe the safest option for those that have already acquired a certain amount of wealth, yes. Safe and moral are two different things however. Using personal wealth to increase personal wealth, by directly further impoverishing the less wealthy, isn’t something I’ll be considering.

6
-5
prod_squadron
prod_squadron
1 year ago
Reply to  Free Lemming

Yes but then they’d be the ones who would be impoverished if they self-abnegated in order to prevent others from being impoverished. If you give away your wealth to someone, do they immediately have to give it away to someone else in a game of hot potato, in case they are accused of being safe but immoral?

9
0
soundofreason
soundofreason
1 year ago
Reply to  Free Lemming

Oh those evil rentiers.

I know, let’s make it illegal to privately own and rent out a property. Only the state may own properties for rent. That will, no doubt, make it far cheaper and easier for those who can’t afford buying to rent somewhere to live. The state will enforce the minimal standard of rental property on itself, of course and ensure there’s a supply.

If you inherit a house and don’t intend to live in it, you have to sell it to the state. Properties left empty will be requisitioned by the state.

We already charge capital gains tax on ‘second homes’, perhaps it should be at a flat rate of 90%? That should deter the evil property speculators.

Sheesh.

25
-1
DS99
DS99
1 year ago
Reply to  Free Lemming

My vague memory here is that back in the 1980’s and 1990s we used to talk about 2.5 or 3 x our income for a mortgage. I think some adjustment in mortgage lending rates meant that calculation was thrown out of the window and people could borrow way beyond their means. After that, property went sky high. But at the same time, the population has expanded and far more people live alone. It’s a whole cluster of things here FL – not just greedy capitalists.

I’m not personally a fan of owning a second property, mainly because I don’t like the idea of it or the maintenance.

Last edited 1 year ago by DS99
6
0
huxleypiggles
huxleypiggles
1 year ago
Reply to  DS99

“I think some adjustment in mortgage lending rates meant that calculation was thrown out of the window and people could borrow way beyond their means.”

Sensible lending multiples were abounded and the mortgage industry adopted a new system:

Liar Loans.

Basically the buyer could declare a salary / wage of whatever they needed, the lenders accepted the figure and Bob’s your uncle. This caused much house inflation until the bubble burst and we saw the likes of Northern Rock go boobies up. Northern Rock led the way in offering mortgages at 120 – 130 % of loan to value (LTV), they really let rip. Other lenders followed suit but with not quite the same care free abandon.

I was in the industry throughout this madness. Gordon Brown presiding.

8
0
soundofreason
soundofreason
1 year ago
Reply to  DS99

Every home that someone pays rent on is owned by someone (or something) else. Councils rarely directly own properties but use arms-length housing associations. If property ownership for profit is a Bad Thing then it just leaves the state to provide homes for all these people – and I have grave doubts about the competence of government at any level to manage this efficiently.

7
-1
Dinger64
Dinger64
1 year ago

“We’re complacent about the grave threat Putin presents”

The real threat is a lot closer to home!
Rochdale, Bradford etc

Last edited 1 year ago by Dinger64
32
-1
huxleypiggles
huxleypiggles
1 year ago
Reply to  Dinger64

Too right Dinger.

12
0
Dinger64
Dinger64
1 year ago

“Macron says Western ground operations in Ukraine ‘is possible”

Ahrrr bless, he’s trying to look strong, too late, f@#k off twat!

20
-1
Dinger64
Dinger64
1 year ago

“Stunning claims of whistleblower need to go viral”

White fibrous substances!
Thank all the gods and a critical mind , I didn’t succumb to the bullying bullshyte!

15
-1
huxleypiggles
huxleypiggles
1 year ago
Reply to  Dinger64

Despite the headline I believe John O’Looney was the first funeral director to drop the bombshell about the calamari clots.

19
0
Dinger64
Dinger64
1 year ago

“Scotland’s new walk-in hate crime reporting centres”

Is there a walk in.. burglary, rape, murder, vandalism crime centre?
I seem to remember those from long ago, I think they called them ‘police stations’

I Could be wrong!

43
0
WyrdWoman
WyrdWoman
1 year ago

HART flags the Cape Byron Declaration to read and sign.

https://hartuk.substack.com/p/the-cape-byron-lighthouse-declaration

4
0
Dinger64
Dinger64
1 year ago

“Can old-fashioned tariffs slam on brakes of Chinese electric cars?”

You don’t need tariffs, if anyone even considers buying a ‘Chinese electric car’ they must be brain dead! They used to call it jap crap, now its China crap!
Import them,stock them, selling them is a different matter!

8
-2
WyrdWoman
WyrdWoman
1 year ago

Dr Mercola to make all his content freely available again, after having to restrict it for a few years due to the amount of hacking his site is subject to.

https://articles.mercola.com/sites/articles/archive/2024/03/18/mercola-articles-free-again.aspx

7
0
WyrdWoman
WyrdWoman
1 year ago

“Don’t use word ‘widows’, Lloyds chiefs tell staff at… Scottish Widows” 

Lloyds claims the word is ‘unnecessarily vivid’ and may ‘trigger unwarranted personal memories of trauma and upsetting situations’. 
It suggests using the term ‘separated’ instead.

When are they going to ban the word ‘death’ as being too ‘triggering’?

16
0
Dinger64
Dinger64
1 year ago

“Trudeau Government’s newly proposed online-speech law that could be used to punish hate crimes before they’ve been committed.”

I’ve seen that one, it stared Tom Cruise I believe!

15
0
JohnK
JohnK
1 year ago

I’m not advertising, but…. https://www.gbnews.com/news/gb-news-ofcom-presenters-complaint .

1
0
Heretic
Heretic
1 year ago

“Woke U.S. bosses tell cast to reshoot sex scenes in Jilly Cooper Rivals”

No one needs sex scenes or nudity in books or films— it’s just another type of porn = VOYEURISM. The Satanic corruption of humanity.

5
-3
transmissionofflame
transmissionofflame
1 year ago
Reply to  Heretic

I disagree with you about banning porn, but I agree with your point here, broadly speaking. Those scenes very rarely tell us anything we didn’t already know, advance the plot etc. I tend to look away from the screen when they appear.

5
0

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