The NHS complaints system is v similar - it is designed to ensure that the process lasts so long that the consultant has retired on a nice pension, and that the patient who has been hurt, and their spouse, has died. It works perfectly in 99% of cases to do just that.
From this post, it appears that the MHRA aren’t fit for purpose. If they can’t process and analyse reported cases of deaths following a treatment intervention, it’s unlikely that they are able to follow up on mild or moderate side effects that would adversely affect a patient’s quality of life. From the responses of the senior staff, they don’t want to reform the MHRA to make the necessary changes to improve existing processes. This article should be in national newspapers to create enough public outcry so that the MHRA are investigated. It seems they have a similar calibre of leaders to those in the Post Office. Why is there an epidemic of poor leadership in the public sector?
I agree that this should be covered in National newspapers however I bet it would be impossible to get a mention in any of the mainstream media. What a dreadful horrific account.
Wow, I’m in awe of this good friend’s tenacity in the face of such disgraceful inefficiency and blatant lack of respect for the loss of a precious life.
I am so very sorry for the fate of your friend, and am full of admiration for your stamina and determination, battling with the MHRA to get to the bottom of it.
This is something I've often asked myself as well: "Do those who work for the MHRA ever spare a thought for the real human beings at the other end of a yellow card report? I doubt it." - and like you, I doubt this very much. To them, we're faceless and only distractions in their smooth paper- and email-shuffling working hours.
I can hear their excuses: 'these were difficult times', and 'we were all WFH, doing our best'. Gah. i wish I were Javier Milei and could shout 'afuera!' and actually do it!
Given the decades during which 'lessons which will be learned' but obviously aren't, one can't help but state that those departments must be stuffed with the barely literate.
Facebook took down all the vaccine injury groups in 2021. Following Zuck’s recent conversion to Free Speech zealot, perhaps they could all be resurrected. The wheels of justice wind slowly in the UK as the victims of the Post Office and tainted blood scandals know well. It’s doubtful any government minister will take on the battle of reforming MHRA without a noisy grass roots movement behind it.
Here’s an example of where the MHRA took on a pharmaceutical company, albeit a micro tiny one, Kappin Ltd. The timeline is
What strikes me as the most repellent aspect of this disturbing and appalling story - besides the obvious question as to whether the death of an innocent patient constitutes culpable manslaughter - is the stomach-turning belief that this 'thinkspeak' comes from the very top of all powerful entities, including various governments. Organisations are clearly rotten to the very core. They are relaxed about the disguise of potentially life-threatening, unsafe substances being injected into trusting patients, and worse still, they have colluded to persuade parents to have their children injected. Whilst there has always been an immoral imbalance of power within medicine, this is a whole new scenario. Coupled with an already high concern about antibiotic resistance, the possibility of ongoing damage to the immune systems of the majority of the population of 'compliant' countries augurs badly. Furthermore, the kind of acute inflammatory process which caused this poor lady's death has been glibly overlooked. We won't see justice while anyone who questions the status quo is labelled by the 'disinformation hunters'. Caveat emptor:it is only too clear that preventive medicine is the lowest priority of industrial-pharmaceuticals.
There is a saying in business: don’t ask a question if you are not prepared to hear the answer. It seems that the MHRA is somehow following a similar guidance: don’t look for something if you don’t want to face what you might find. Anyhow the fish alway rots from the head and it is obvious that the political mandate around the vaccines has been ignore, ignore, ignore, hide, hide, hide. Being paid by taxpayers there should be a proper follow up and consequences.
This anecdote is very depressing but not in the least surprising.
I have a few advantages via my working life (will not bore you) that makes this scenario wholly predictable, and my kitchen table rants would/could prove it !
Further to that it adds to the reasons why I was never going to be vaccinated with these products.
By the way, full marks for perseverance - great to see a kindred spirit sticking it to them.
You write: "The MHRA’s bombastic and repeated claims about what a good job they are doing could not sound more hollow.
This mess needs sorting out, but who in government has the power and the inclination to do it? From where I’m sitting, I see no one who fits that bill."
-> Sign @ukcvfamily petition to call for reform of the Vaccine Damage Payment Scheme
"Day eight seemed to make it clear that the Inquiry is not as impartial as the general public would assume; not just with Baroness Hallett’s praise to a vaccine manufacturer with the highest number of Yellow Card reports than any other, and not just because of her lead counsel’s obvious bias in his lines of questioning, but also in the admonishing of Anna Morris KC for asking a question without permission. Up until that point, the general public has likely been under the impression that any and all questions regarding a pharmaceutical product that 79% of them have received, were legitimate. It seems that is not the case."
No-one with power seems to have grasped that to roll out a near-mandated medical treatment to millions is _expensive_: more expensive than they wanted to know. You don't just have to buy the treatment, administer it and keep records: to do it properly, you also have to fund, organise, practise and respond to pharmacovigilance.
In this case, they just couldn't be bothered. Were the Yellow Card staff themselves bamboozled by the endless, mind-numbing "safe and effective" mantra? Or were they actually instructed to neglect, play down and minimise adverse-effects cases? I can see how the latter actually isn't strictly necessary to explain their criminal neglect.
What enrages me is the tactic of substituting wheeling out some authoritative Spokesdroid to _say_ that something is the case, for actually making sure that that is the case.
I am often told to follow the money. In this case 79% of the funding for MHRA comes from the pharmaceutical industry, therefore it is not in their interests to make any complaints system work. Until the government funds MHRA the type of experience of this person will persist.
Seems like the government’s job is to wear out the layperson looking for answers hoping they give up. Which most do as life is gruelling enough. Im not sure i could have prevailed. Im exhausted just reading this account. Bureaucracy is demoralising.
Thank you very much for completing a Yellow Card report for a suspected side effect to a COVID-19 vaccine. Your report supports the MHRA’s ability to continuously monitor the safe and effective use of vaccines in this pandemic.
Vaccines are the most effective way to prevent infectious diseases and they save millions of lives worldwide. Like all medicines, vaccines can cause side effects. Some side effects can come to light when given to a larger number of people than took part in clinical trials however, most are mild and short-term, and not everyone gets them. The known safety profile of COVID-19 vaccines is available on the Coronavirus Yellow Card reporting site.
The Yellow Card scheme is part of our long-established UK system for collecting and monitoring information about suspected safety concerns involving medicines, vaccines, and medical devices.
What happens next? Our team will now evaluate your report, alongside others received, to determine if the suspected side effects that you have reported have affected others. A team of safety experts which includes doctors, pharmacists and scientists will continually evaluate reports and consider other information, such as medical literature and data from international medicines regulators to help ensure that the benefits of the vaccine continue to outweigh any risks.
The safety of the public comes first. Emerging safety issues will be carefully analysed, and expert advice sought from the Commission on Human Medicines (CHM). If deemed necessary, regulatory action will be taken to minimise that risk and support safe use of the vaccine. Regulatory action can include adding warnings to the product information, sending out communications to healthcare professionals and patients, and possibly restricting its use. In such an event this would be communicated to the Department of Health and Social Care, Public Health England and other public health partners in the devolved nations to inform any decisions regarding the immunisation programme.
If you’d like more information about our safety monitoring strategy please visit our website. The MHRA will produce regular summaries of the safety experience, including reports of suspected side effects, on our website.
If you are worried about a suspected side effect and need medical advice, please contact a doctor or pharmacist, or call NHS 111 in England and Scotland on 111 (text phone 18001 111); NHS Direct in Wales on 0845 46 47 (textphone 0845 606 4647).
If you have any more information about the suspected side effect, or if there are any changes to the details you provided on the Yellow Card report please e-mail yellowcard@mhra.gov.uk
If you do have any questions, please contact us via our website. Please note we cannot provide medical advice. Questions raised directly within a submitted Yellow Card report may not be responded to.
Thank you once again for your important contribution to the continuous monitoring of vaccine safety in the UK and for supporting the Yellow Card scheme.
Medicines and Healthcare products Regulatory Agency.
Any information about you has been collected by Yellowcard. This information is solely for the use of Yellowcard.
This message originated from outside of NHSmail. Please do not click links or open attachments unless you recognise the sender and know the content is safe.
What irks me is that I try to provide really detailed yellow card reports and for the more severe/fatal AEFIs I do actually get fairly timely follow-up emails, but with a list of further specific questions. I have always assumed this means they are taking a thorough approach to investigating the report, but then again invariably the answers to the questions can easily be found in my original report, which makes me wonder if they are actually reading it properly...
There is never any feedback after that on whether causality has been assessed, and if assessed whether it has been accepted. I have a sneaking suspicion they are all put down to coincidence, because causality would only ever be accepted if it is an officially accepted side effect like VITT or myopericarditis. It is all rather circular.
Also, as you will know it is a very onerous process. Each vaccine and batch number has to be entered separately. Now that people are onto their 8th or more vaccine that can easily take half an hour to complete a YC report. I can end up with a list of yellow cards to submit, and then try to do them in batches when I have time... but I'll admit it is getting harder to find the time, though I do try to be diligent about the more serious AEFIs. If that is my experience as someone who feels quite motivated to do this, I imagine most HCPs won't be completing them now.
To my mind this suspicion of massive under-reporting is somewhat supported by the summary of yellow card reports. For fatal events reported by healthcare professionals I or my colleagues appear to have submitted 0.23% of all fatal reports for pfizer monovalent, 0.3-0.45% for AZ, 6.45% for pfizer bivalent and 8.3% for moderna bivalent, yet I don't think there is anything particularly unusual about our practice population or rates of AEFIs. Instead it looks to me that as time goes on fewer HCPs are reporting temporally-related AEFIs.
So when the MHRA points to yellow card statistics as a way of reassuring people about safety, I know implicitly they cannot and should not do this. All they can really say is that these yellow card statistics tell us how many healthcare professionals are submitting yellow cards.
Or maybe I am completely barmy and it is all imagined.
Devastating - spineless-corrupt- words cannot describe how ineffectual our government and quangos and our medical institutions are.
Fully agree.
If you don't have the resources to "wear out the doorstep" of these lazy, obfuscating, bureaucrats, you may as well not bother.
That, of course, is what they rely on.
And if you do persist, it will turn out that any injured survivor only has a 55% disability, so, no compensation.
Sack the lot of them.
The NHS complaints system is v similar - it is designed to ensure that the process lasts so long that the consultant has retired on a nice pension, and that the patient who has been hurt, and their spouse, has died. It works perfectly in 99% of cases to do just that.
From this post, it appears that the MHRA aren’t fit for purpose. If they can’t process and analyse reported cases of deaths following a treatment intervention, it’s unlikely that they are able to follow up on mild or moderate side effects that would adversely affect a patient’s quality of life. From the responses of the senior staff, they don’t want to reform the MHRA to make the necessary changes to improve existing processes. This article should be in national newspapers to create enough public outcry so that the MHRA are investigated. It seems they have a similar calibre of leaders to those in the Post Office. Why is there an epidemic of poor leadership in the public sector?
I agree that this should be covered in National newspapers however I bet it would be impossible to get a mention in any of the mainstream media. What a dreadful horrific account.
Maybe Sarah Knapton at The Telegraph should be contacted: https://www.telegraph.co.uk/news/2024/02/27/mhra-covid-vaccine-side-effects-mps-all-party-parliamentary/
Wow, I’m in awe of this good friend’s tenacity in the face of such disgraceful inefficiency and blatant lack of respect for the loss of a precious life.
Words simply fail me!
I am so very sorry for the fate of your friend, and am full of admiration for your stamina and determination, battling with the MHRA to get to the bottom of it.
This is something I've often asked myself as well: "Do those who work for the MHRA ever spare a thought for the real human beings at the other end of a yellow card report? I doubt it." - and like you, I doubt this very much. To them, we're faceless and only distractions in their smooth paper- and email-shuffling working hours.
I can hear their excuses: 'these were difficult times', and 'we were all WFH, doing our best'. Gah. i wish I were Javier Milei and could shout 'afuera!' and actually do it!
"lessons will be learnt ......"
Given the decades during which 'lessons which will be learned' but obviously aren't, one can't help but state that those departments must be stuffed with the barely literate.
Facebook took down all the vaccine injury groups in 2021. Following Zuck’s recent conversion to Free Speech zealot, perhaps they could all be resurrected. The wheels of justice wind slowly in the UK as the victims of the Post Office and tainted blood scandals know well. It’s doubtful any government minister will take on the battle of reforming MHRA without a noisy grass roots movement behind it.
Here’s an example of where the MHRA took on a pharmaceutical company, albeit a micro tiny one, Kappin Ltd. The timeline is
Evotrox Oral Solutions licensed 2006
MHRA investigation commenced 2008
Marketing authorisation terminated 2013
Kappin Ltd directors pleaded guilty 2023
Press release published March 2024
https://www.gov.uk/government/news/disgraced-company-director-convicted-of-falsifying-medicine-quality-data
What strikes me as the most repellent aspect of this disturbing and appalling story - besides the obvious question as to whether the death of an innocent patient constitutes culpable manslaughter - is the stomach-turning belief that this 'thinkspeak' comes from the very top of all powerful entities, including various governments. Organisations are clearly rotten to the very core. They are relaxed about the disguise of potentially life-threatening, unsafe substances being injected into trusting patients, and worse still, they have colluded to persuade parents to have their children injected. Whilst there has always been an immoral imbalance of power within medicine, this is a whole new scenario. Coupled with an already high concern about antibiotic resistance, the possibility of ongoing damage to the immune systems of the majority of the population of 'compliant' countries augurs badly. Furthermore, the kind of acute inflammatory process which caused this poor lady's death has been glibly overlooked. We won't see justice while anyone who questions the status quo is labelled by the 'disinformation hunters'. Caveat emptor:it is only too clear that preventive medicine is the lowest priority of industrial-pharmaceuticals.
There is a saying in business: don’t ask a question if you are not prepared to hear the answer. It seems that the MHRA is somehow following a similar guidance: don’t look for something if you don’t want to face what you might find. Anyhow the fish alway rots from the head and it is obvious that the political mandate around the vaccines has been ignore, ignore, ignore, hide, hide, hide. Being paid by taxpayers there should be a proper follow up and consequences.
This anecdote is very depressing but not in the least surprising.
I have a few advantages via my working life (will not bore you) that makes this scenario wholly predictable, and my kitchen table rants would/could prove it !
Further to that it adds to the reasons why I was never going to be vaccinated with these products.
By the way, full marks for perseverance - great to see a kindred spirit sticking it to them.
You write: "The MHRA’s bombastic and repeated claims about what a good job they are doing could not sound more hollow.
This mess needs sorting out, but who in government has the power and the inclination to do it? From where I’m sitting, I see no one who fits that bill."
-> Sign @ukcvfamily petition to call for reform of the Vaccine Damage Payment Scheme
https://petition.parliament.uk/petitions/701729
Read this and see the videos: https://www.ukcvfamily.org/post/over-2-000-families-adversely-affected-by-covid-19-vaccination-provide-evidence-to-the-covid-inquiry
"Day eight seemed to make it clear that the Inquiry is not as impartial as the general public would assume; not just with Baroness Hallett’s praise to a vaccine manufacturer with the highest number of Yellow Card reports than any other, and not just because of her lead counsel’s obvious bias in his lines of questioning, but also in the admonishing of Anna Morris KC for asking a question without permission. Up until that point, the general public has likely been under the impression that any and all questions regarding a pharmaceutical product that 79% of them have received, were legitimate. It seems that is not the case."
https://x.com/ukcvfamily/status/1882854550073204972
Horrific story.
No-one with power seems to have grasped that to roll out a near-mandated medical treatment to millions is _expensive_: more expensive than they wanted to know. You don't just have to buy the treatment, administer it and keep records: to do it properly, you also have to fund, organise, practise and respond to pharmacovigilance.
In this case, they just couldn't be bothered. Were the Yellow Card staff themselves bamboozled by the endless, mind-numbing "safe and effective" mantra? Or were they actually instructed to neglect, play down and minimise adverse-effects cases? I can see how the latter actually isn't strictly necessary to explain their criminal neglect.
What enrages me is the tactic of substituting wheeling out some authoritative Spokesdroid to _say_ that something is the case, for actually making sure that that is the case.
I am often told to follow the money. In this case 79% of the funding for MHRA comes from the pharmaceutical industry, therefore it is not in their interests to make any complaints system work. Until the government funds MHRA the type of experience of this person will persist.
What a truly sorry saga. Good for the writer to persevere and challenge the institutions.
It is truly inhuman how the writer was treated.
I have been following the VAERS system in the USA and the time between a vaccine death and it appearing on the system can be years…
A toxic mix of incompetence and bureaucracy. It is impossible for anyone to receive the attention they deserve.
Seems like the government’s job is to wear out the layperson looking for answers hoping they give up. Which most do as life is gruelling enough. Im not sure i could have prevailed. Im exhausted just reading this account. Bureaucracy is demoralising.
Andy Morling, MHRA deputy director of criminal enforcement, said: “Public safety is our number one priority…...” Erm…..really Mr Morling ?
https://www.independent.co.uk/news/uk/mhra-interpol-data-botox-nhs-b2487375.html
30 January 2024
Here is what I received back from my last Yellow Card report. Soothing bromides
This TTE article shows how different reality is from what is stated
Yellowcard
Thank you for your report of a suspected side-effect to a COVID-19 vaccine.
Yellow Card reference: GB-MHRA-APPCOVID-202105201428343350-HZVIL
Thank you very much for completing a Yellow Card report for a suspected side effect to a COVID-19 vaccine. Your report supports the MHRA’s ability to continuously monitor the safe and effective use of vaccines in this pandemic.
Vaccines are the most effective way to prevent infectious diseases and they save millions of lives worldwide. Like all medicines, vaccines can cause side effects. Some side effects can come to light when given to a larger number of people than took part in clinical trials however, most are mild and short-term, and not everyone gets them. The known safety profile of COVID-19 vaccines is available on the Coronavirus Yellow Card reporting site.
The Yellow Card scheme is part of our long-established UK system for collecting and monitoring information about suspected safety concerns involving medicines, vaccines, and medical devices.
What happens next? Our team will now evaluate your report, alongside others received, to determine if the suspected side effects that you have reported have affected others. A team of safety experts which includes doctors, pharmacists and scientists will continually evaluate reports and consider other information, such as medical literature and data from international medicines regulators to help ensure that the benefits of the vaccine continue to outweigh any risks.
The safety of the public comes first. Emerging safety issues will be carefully analysed, and expert advice sought from the Commission on Human Medicines (CHM). If deemed necessary, regulatory action will be taken to minimise that risk and support safe use of the vaccine. Regulatory action can include adding warnings to the product information, sending out communications to healthcare professionals and patients, and possibly restricting its use. In such an event this would be communicated to the Department of Health and Social Care, Public Health England and other public health partners in the devolved nations to inform any decisions regarding the immunisation programme.
If you’d like more information about our safety monitoring strategy please visit our website. The MHRA will produce regular summaries of the safety experience, including reports of suspected side effects, on our website.
If you are worried about a suspected side effect and need medical advice, please contact a doctor or pharmacist, or call NHS 111 in England and Scotland on 111 (text phone 18001 111); NHS Direct in Wales on 0845 46 47 (textphone 0845 606 4647).
If you have any more information about the suspected side effect, or if there are any changes to the details you provided on the Yellow Card report please e-mail yellowcard@mhra.gov.uk
If you do have any questions, please contact us via our website. Please note we cannot provide medical advice. Questions raised directly within a submitted Yellow Card report may not be responded to.
Thank you once again for your important contribution to the continuous monitoring of vaccine safety in the UK and for supporting the Yellow Card scheme.
Medicines and Healthcare products Regulatory Agency.
Any information about you has been collected by Yellowcard. This information is solely for the use of Yellowcard.
This message originated from outside of NHSmail. Please do not click links or open attachments unless you recognise the sender and know the content is safe.
What irks me is that I try to provide really detailed yellow card reports and for the more severe/fatal AEFIs I do actually get fairly timely follow-up emails, but with a list of further specific questions. I have always assumed this means they are taking a thorough approach to investigating the report, but then again invariably the answers to the questions can easily be found in my original report, which makes me wonder if they are actually reading it properly...
There is never any feedback after that on whether causality has been assessed, and if assessed whether it has been accepted. I have a sneaking suspicion they are all put down to coincidence, because causality would only ever be accepted if it is an officially accepted side effect like VITT or myopericarditis. It is all rather circular.
Also, as you will know it is a very onerous process. Each vaccine and batch number has to be entered separately. Now that people are onto their 8th or more vaccine that can easily take half an hour to complete a YC report. I can end up with a list of yellow cards to submit, and then try to do them in batches when I have time... but I'll admit it is getting harder to find the time, though I do try to be diligent about the more serious AEFIs. If that is my experience as someone who feels quite motivated to do this, I imagine most HCPs won't be completing them now.
To my mind this suspicion of massive under-reporting is somewhat supported by the summary of yellow card reports. For fatal events reported by healthcare professionals I or my colleagues appear to have submitted 0.23% of all fatal reports for pfizer monovalent, 0.3-0.45% for AZ, 6.45% for pfizer bivalent and 8.3% for moderna bivalent, yet I don't think there is anything particularly unusual about our practice population or rates of AEFIs. Instead it looks to me that as time goes on fewer HCPs are reporting temporally-related AEFIs.
So when the MHRA points to yellow card statistics as a way of reassuring people about safety, I know implicitly they cannot and should not do this. All they can really say is that these yellow card statistics tell us how many healthcare professionals are submitting yellow cards.
Or maybe I am completely barmy and it is all imagined.