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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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    Valerie_London
    Valerie_London
    1 year ago

    I have just had an uncomfortable conversation with my ex, whose sister recently had a series of blot clots leading to a massive stroke at the age of 50, which has left her paralysed on one side and hospital bound for months. I went down the road of suggesting that IF the vaccine was responsible and they could prove that via scans etc, she would be eligible for the £120,000 compensation payment from the Government. He listened and promised to ask her about it when the opportunity arises.

    It turns out she didn’t want the bloody thing, but her grown up children persuaded her otherwise – she had two!

    I had to play it oh so carefully, but I feel it’s a minor victory that he at least listened and will definitely raise it with her.

    Last edited 1 year ago by Valerie_London
    117
    0
    Marcus Aurelius knew
    Marcus Aurelius knew
    1 year ago
    Reply to  Valerie_London

    It’s terrible, isn’t it… Extraordinarily effective behavioural psychology played out on a society that has never been so impressionable and gullible on matters as basic as whether or not our streets are full of the dead and dying.

    Well done. I hope they achieve some sort of restitution.

    Last edited 1 year ago by Marcus Aurelius knew
    66
    0
    ELH
    ELH
    1 year ago
    Reply to  Valerie_London

    There are many stories of adult children pressuring their parents, grand parents, aunts and uncles to take the “shots”, even in my own family. Time to become a curmugeonly old person and refuse the bossiness of younger family members.

    34
    0
    Epi
    Epi
    1 year ago
    Reply to  Valerie_London

    Well done Valerie you must have the patience of Job. My Partner was bullied into getting the jab by her youngest daughter who said “ you’re not going to be one of those anti vaxxers are you mum?”

    Luckily so far my she’s been okay thank God.

    I was banned from her ex’s house by her son as he had “problems with the unvaccinated”. We had a fairly frosty Christmas last year but avoid him as much as possible. Unforgivable really.

    5
    0
    Valerie_London
    Valerie_London
    1 year ago
    Reply to  Epi

    Thanks, I haven’t had many victories in this battle, so I take the ones I can get.

    I just don’t get the logic of those who refuse to be in the company of the unjabbed. Do you think they fear they will catch ‘unvaccinated’ if they get too close?

    3
    0
    Marcus Aurelius knew
    Marcus Aurelius knew
    1 year ago

    “Time for the government to act”

    HAHAHAHAHAHAHAHAHHHAAAAAAAAAAAAAAAAAA!

    Sorry.

    Last edited 1 year ago by Marcus Aurelius knew
    77
    0
    TheBasicMind
    TheBasicMind
    1 year ago
    Reply to  Marcus Aurelius knew

    Unfortunately at this point I rather fear these kinds of letters simply make things worse. Many of us here on the Daily Sceptic have been tracking this far more closely than this chap and there are far more powerful arguments to be made and by failing to make them, he is just adding to the uncoordinated noise that is enabling the government to ignore sceptics. The problem is the argument is so stark, many simply can’t believe it. Saying safety signals have been missed doesn’t begin to do it justice.

    The example of “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.” just lets the MHRA off the hook. The yellow card system, post covid vaccines, isn’t anything like within statistical norms; Not remotely. And the charts are easily produced to illustrate this. Plus as Norman Fenton recently revealed June Raine has been deliberately covering up the atrocious a glaring safety signals by simply, and unconscionably, excluding Covid vaccine data from the bar charts in her presentation (and, in most of the presentations she gave, not even acknowledging this had been done, and when it was acknowledge it was in small type on a different slide to the one where the data had been presented).

    indeed IMO her data presentations have been nothing short of criminal.

    I am of the view, the “missed safety signals” are so egregious, it is deliberate. In my estimation June Raine is either the world’s most stupid “clever” person, or is hopelessy lost and living in fear of what she has done, paralysed with guilt and doubt, or she is a stooge of big Pharma has a hefty sociopathic streak and simply doesn’t care. I am at a loss to understand how anything other than these options can be the case.

    The MHRA are perpetrating gaslighting of the most epic scale.

    Last edited 1 year ago by TheBasicMind
    55
    0
    ELH
    ELH
    1 year ago
    Reply to  TheBasicMind

    Have you realised that June Raine was born in 1952? Why is she still working? Why hasn’t she retired? Can all civil servants continue to work into their 70s? Does anyone know the answer to this?

    18
    0
    DevonBlueBoy
    DevonBlueBoy
    1 year ago
    Reply to  TheBasicMind

    Looking at her very smug expression when she glibly announced the ‘enabler rather than regulator’ change of MHRA strategy, my vote would go to the “world’s most stupid clever person”. She also demonstrates that a high level of functional intelligence can be easily paired with zero emotional intelligence

    5
    0
    transmissionofflame
    transmissionofflame
    1 year ago

    Well done Mr Hunt.

    Perhaps Chope or Bridgen or Swayne might be worth copying in, if not done already.

    38
    0
    JayBee
    JayBee
    1 year ago

    They have officially redefined themselves as being a big pharma enabler now.
    The regulator label is as such just a con.
    And the government is as such all-in on that shift and con, if not the main driver besides big pharma of it.
    Nothing good can and should be expected of them anymore, least of all a willingness or ability to reform back to a proper regulator.

    Last edited 1 year ago by JayBee
    56
    0
    huxleypiggles
    huxleypiggles
    1 year ago

    There is not a cat in hell’s chance of an official response and there are a few reasons why. Senior members of the UK Government will have known from the outset that these injections were designed to maim and kill. It is therefore inconceivable that the UK alone would be allowed to act on the safety signals as the international repercussions would destroy ALL the globalist plans and their next “pandemic” would be dead before it had started. The boot really would be on the other foot. The likes of Bozo, Handicock, Whitless and the rest would be lucky to escape with what remains of their useless lives.

    This letter is good, right and proper but it will be ignored. From our enemies point of view it has to be.

    82
    -1
    Castorp
    Castorp
    1 year ago

    We now know very well that there’s a sinister, psychopathic, evil element within the Deep State apparatus that has, with great deviousness, actively been seeking to murder us.

    The name for this is premeditated democide. Treason of the highest order.

    Let us act with the zest and urgency that this realisation requires.

    41
    -1
    Castorp
    Castorp
    1 year ago
    Reply to  Castorp

    Sources to peer-reviewed, published papers:

    1) Moderna was granted a US patent on a key part of SARS-COV-2 in 2016:
    https://www.frontiersin.org/articles/10.3389/fviro.2022.834808/full

    2) Meta-analysis of the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults shows they cause more harm than good and are associated with a rate of serious adverse events of 1 in 800:
    https://pubmed.ncbi.nlm.nih.gov/36055877/

    Evidence of deep state-organised psy-ops:
    https://dailysceptic.org/2023/04/28/state-covid-propaganda-destroyed-publics-ability-to-consent-to-vaccines-chairman-of-uk-council-for-psychotherapy/

    Big Brother Watch report on the secretive government units spying on free speech:
    https://bigbrotherwatch.org.uk/wp-content/uploads/2023/01/Ministry-of-Truth-Big-Brother-Watch-290123.pdf

    26
    0
    Freddy Boy
    Freddy Boy
    1 year ago

    Off Piste but just watching a podcast by Rood Awakening called The Secret Journey of BAAL !! Devil worship is alive & kicking 😔

    15
    0
    George L
    George L
    1 year ago

    The MHRA misses safety signals because its paid to look the other way. I’d have thought that was pretty obvious, especially after the last couple of years..

    As the the old saying goes.. You’re not going to get someone to tell the truth if their salary and pension depend on them not telling it..

    45
    0
    Freddy Boy
    Freddy Boy
    1 year ago

    Trevor Francis 69 has died of a heart attack , my boyhood hero 😭

    19
    0
    huxleypiggles
    huxleypiggles
    1 year ago
    Reply to  Freddy Boy

    And his jab status was?

    10
    0
    Freddy Boy
    Freddy Boy
    1 year ago
    Reply to  huxleypiggles

    He lived in Spain ,will we find out if he got Jabs to travel ?

    12
    0
    huxleypiggles
    huxleypiggles
    1 year ago

    https://www.technocracy.news/biden-launches-permanent-office-of-pandemic-preparedness-and-response-policy/

    Here we go, getting ready for the next one.

    20
    0
    huxleypiggles
    huxleypiggles
    1 year ago

    https://www.technocracy.news/cbdcs-as-a-weapon-to-debank-the-banked/

    “The vast power that a CBDC would place in the hands of a nation state or its central bank points in the direction of an unprecedented level of financial surveillance, censorship, and potentially debanking the banked whenever it may serve certain political objectives. Thus, it is hardly an understatement to say that we are at a crossroads for civilization.”

    CBDC’s most definitely DO represent a “crossroads for civilisation.”

    “You will own nothing and be very unhappy” really does emanate from CBDC’s.

    Last edited 1 year ago by huxleypiggles
    29
    0
    mariawarmth
    mariawarmth
    1 year ago

    I saw a friend yesterday who had a heart attack at 51. She said you were right about it all and she blames the jabs but can’t prove it. We were both brought to tears. She was fit and healthy before. And totally on board but was too busy working and looking after family to read and investigate.
    She knows now.Sad.

    47
    0
    JeremyP99
    JeremyP99
    1 year ago

    I FoI’ed MHRA early 2021 to ask whether they considered the new jabs to be

    a) Experimental

    b) Gene Therapy.

    They replied NO to both.

    I then sent them documents from the NIH in USA which flagged the jabs as experimental, and documents from Moderna which confirmed their jabs were gene therapy.

    I noted that this meant that either the MHRA was lying, or Moderna and the NIH.

    Oddly, I got no response.

    28
    0
    huxleypiggles
    huxleypiggles
    1 year ago
    Reply to  JeremyP99

    Good work.

    13
    0
    JohnnyDollar
    JohnnyDollar
    1 year ago

    Government to Act? They’re in on it . It’s like trusting a child molester to babysit ! This how trustworthy they all are

    13
    0
    Epi
    Epi
    1 year ago

    Good letter, but I do wish people wouldn’t refer to themselves as Mr, it’s a curtesy title unless of course one happens to be a surgeon.

    1
    0

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