MHRA's BAFFLING RESPONSE REGARDING VACCINE SAFETY

 

My on-going communication with the British drug regulator, the MHRA, has hit a bit of a roadblock. This isn't due to any lack of response, it's more to do with MHRA language that is meaningless and excessively abstruse. It's utter nonsense.

In early January, I requested information from the MHRA regarding their Yellow Card Reporting System, moreover, for reports filed for adverse reactions to the COVID-19 vaccines.

Their initial response needed clarification such was its ambiguity.

In a nutshell, the MHRA was telling me that a reporter, like you or I, could have a family member take a vaccine and some weeks later suffer heart problems and die. After talking with a GP or a heart specialist we can then decide if the vaccine played a part in the death of a loved one or not. We can make our own minds up whether we think the vaccine caused the death or whether the death appeared out of nowhere and isn't vaccine related.

The rub being, if we conclude it wasn't vaccine related, the MHRA will agree with us. However, if we believe the death to be vaccine related, the MHRA won't agree with us because, "In any individual case it is very difficult, if not impossible, to determine whether the reported drug or vaccine was causal, contributory or simply coincidental." (See Yellow Card Reporting System Shown the Red Card)

The MHRA responding to FOIAs often throw up more questions than answers, none more so in this instance.

The MHRA told me they assess "Yellow Card reports using an internal follow up algorithm to determine whether any additional information such as test results, other drugs and/or medical history is required."

So, I asked what algorithm software they use. I was told, in a rather short email, the following:

"We can confirm that this is not a software algorithm."

To my knowledge, an algorithm is a process or set of rules to be followed in calculations or other problem-solving operations, especially by a computer. So, I pursued this further and asked the MHRA:

From: Bob Fiddaman

Sent: 24 January 2022 18:31

To: Pharmacovigilanceservice <Pharmacovigilanceservice@mhra.gov.uk>

Subject: Re: GENQ-00150010 Follow up questions

Thank you.

Presumably then, it's a process or set of rules?

Could you please forward me this process and/or set of rules.

Thanks

--

Their reply, received this morning , has left me bamboozled.

from: Pharmacovigilanceservice <Pharmacovigilanceservice@mhra.gov.uk>

to: Bob Fiddaman

date: Jan 31, 2022, 7:09 AM

Dear Mr Fiddaman,

The process around follow up is dependent on a number of factors, including the level of information within the original Yellow Card report and the specific issue reported. The follow up process doesn’t fall under a specific procedure and is assessment specific, therefore we are unable to provide you with the defined process or set of rule you have requested.

Kind regards,

Pharmacovigilance Service Team 

Vigilance and Risk Management of Medicines Division

Medicines and Healthcare Products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

--

I have to say, this seems, to me at least, the MHRA are being deliberately obtuse.

To recap:

If you suspect the COVID-19 vaccine caused a death of a loved one, the MHRA will tell you it is very difficult, if not impossible, to determine whether the reported drug or vaccine was causal, contributory or simply coincidental. But, if you change your mind and say you don't think the vaccine caused the death of a loved one, the MHRA will accept this.

Moreover, the MHRA use an internal follow up algorithm to determine whether any additional information such as test results, other drugs and/or medical history is required. However, this isn't software and it "doesn’t fall under a specific procedure and is assessment specific." They won't tell me how it works or, if indeed, it actually does. They cannot provide me with the defined process or set of rule(s).

The MHRA are in the habit of labelling question-askers 'vexatious', the definition of which is: causing or tending to cause annoyance or frustration.

Tell me, who is being vexatious here? Who is having their cake and eating it too?

Bob Fiddaman

Freedom Convoy | Ontario - The Power of Truckers and Music

 

This blog offers its full support to the truckers currently standing up for humanity across Canada.

Now watch the video.

Bob Fiddaman

Baby Foods Contain "Staggering Amounts" of Toxic Heavy Metals, Lawsuit Alleges

 

Baum Hedlund Aristei & Goldman, the Los Angeles law firm who recently secured jury verdicts worth an estimated $2.424 billion against the agrochemical and agricultural biotechnology corporation, Monsanto, are now honing in on the baby food manufacturing industry after filing a complaint on behalf of Plaintiffs Melissa and Lorenzo Cantabrana, who allege their young son, Noah (pictured above), was diagnosed with autism spectrum disorder (ASD) and shows signs of attention-deficit/hyperactivity disorder (ADHD) after consuming baby foods. 

The complaint alleges several companies knowingly sold baby foods that contain “dangerously high levels of toxic heavy metals. The companies (listed below) face a possible further 800 or so lawsuits as more and more parents have come forward.

The defendant companies include:

• Nurture (Happy Family Organics and HappyBABY) 

• Beech-Nut

• Hain Celestial Group (Earth’s Best Organic)

• Gerber

• Plum Organics

• Walmart Inc. (Parent’s Choice)

• Sprout Foods

A Subcommittee on Economic and Consumer Policy Committee on Oversight and Reform U.S. House of Representatives, concluded in February 2021 that “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury.”, the full report can be viewed here.

According to Baum Hedlund, these lawsuits will show that several baby food companies knowingly manufacture and sell products that contain "staggering amounts" of toxic heavy metals. According to experts, including epidemiologists, neuroscientists and toxicologists, claim the metals found, including arsenic, lead, cadmium, and mercury, are known to be severe neurotoxins with the propensity to cause lifelong brain damage and neurodevelopmental disorders, including ASD and ADHD in children.

“We believe these companies continue to show callous disregard for the health of vulnerable young children, all in the name of maximizing profits,” says Baum Hedlund attorney for the Cantabrana family, Pedram Esfandiary. “It’s been nearly a year since this explosive report was released. One would think that efforts would be made to protect kids from the known dangers of these toxic metals, but these companies have done next to nothing; they simply don’t care. This has to change, and we are confident the litigation will compensate our clients for their injuries and protect future generations from the harmful products the defendants pander as ‘food’.”

Noah was diagnosed with autism spectrum disorder ASD when he was two years and nine months old. And he shows signs of ADHD. .He is now seven years old.

As a baby and toddler, Noah consumed high amounts of baby foods manufactured by all of the defendants listed above.

“My son is facing lifelong challenges because he ate foods that we believed were safe,” says Melissa. Noah's mother. “If the labels said anything about heavy metals, I never would have fed them to Noah. Parents have a right to know what is in the foods we put on the dinner table for our kids. These companies deprived us of that right. It’s shameful and they need to be held accountable.”

You can read more about Noah's plight here.

Bob Fiddaman

11:11

 

COMING SOON

Bob Fiddaman

Yellow Card Reporting System Shown the Red Card

 

In football (Soccer), a yellow card is used by the referee to discipline players for misconduct or failing to follow the rules.

The Yellow Card Reporting Scheme (MHRA) is supposed to provide an early warning that the safety of a medicine or a medical device may require further investigation. In other words, whatever you report will be assessed and logged by the MHRA.

Up until today, I didn't think there were any caveats, imagine my surprise when I open an email from Brian Burch, Signal Assessor, Vigilance Risk Management of Medicines, MHRA, who tells me reporters of adverse events can now decide whether or not they think the medicine, device or, indeed, vaccine, caused that adverse event. Upon doing so the MHRA will then take the relevant action to reflect this on their database.

So, in a nutshell, you or I could take a vaccine and some weeks later suffer with heart problems. After talking with a GP or a heart specialist we can then decide if the vaccine played a part in the heart problem or not.

We don't, it seems, even have to talk to a healthcare professional. We can make our own minds up whether we think the vaccine caused the heart problem or whether the heart problem appeared out of nowhere and isn't vaccine related.

The MHRA will accept our final word on the matter...but only if we don't wish to lay blame on the vaccine.

If we think the vaccine did cause the adverse event, the MHRA, according to Burch, will try to determine whether the reported vaccine was causal, contributory or simply coincidental.

Here's the rub (straight from the written word of Burch)

"In any individual case it is very difficult, if not impossible, to determine whether the reported drug or vaccine was causal, contributory or simply coincidental."

Yet, they will accept a patient or healthcare professional report that suggests it wasn't vaccine related.

If it's 'very difficult, if not impossible' for the MHRA to determine a casual, contributory or coincidental link, why do they assume a layperson, such as you or I, can determine if a vaccine caused or contributed to an adverse event?

Nonetheless, you or I can do the job of the MHRA (probably after speaking with our 'pro-vax' healthcare professional) - Do we have a large number of healthcare professionals who would support our inkling that the vaccine, they may have administered, caused us injury?

One has to ask, if this poor system of reporting vaccine adverse events should be shown the red card.

Anyway, here's the FOIA follow-up response Burch sent to me earlier. It comes on the back of their original reply which can be viewed here.

--

From: Pharmacovigilanceservice <Pharmacovigilanceservice@mhra.gov.uk>

To: Bob Fiddaman

Subject: GENQ-00150010

Follow up questions

Dear Mr Fiddaman,

Thank you for your recent correspondence where you asked the following:

1. Is a follow-up question/s sent to every single person who reports (via the yellow-card reporting system) an adverse reaction to the vaccine?

2. Is it the position of the MHRA that a UK citizen can determine whether or not an injury was caused by a pharmaceutical product?

Follow up questions are not sent to every single individual who reports a suspected adverse reaction to a Covid-19 vaccine. The MHRA assesses Yellow Card reports using an internal follow up algorithm to determine whether any additional information such as test results, other drugs and/or medical history is required. The MHRA will then contact the original reporter, where contact details are available and permission is granted, to request this information.

The nature of Yellow Card reporting means that reported events are not always proven side effects. The MHRA accepts reports of any suspected adverse reactions as determined by the reporter of the Yellow Card. In any individual case it is very difficult, if not impossible, to determine whether the reported drug or vaccine was causal, contributory or simply coincidental. Should a reporter of a Yellow Card, upon reflection or receipt of additional information, no longer suspect that the drug or vaccine was the cause of the adverse reaction(s) reported the MHRA accepts this information and will take the relevant action to reflect this on our database.

I hope this information is of use, please do not hesitate to contact me if I can be of any further assistance.

Yours sincerely,

Brian Burch

Signal Assessor

Vigilance Risk Management of Medicines

MHRA

--

Bob Fiddaman

 

MHRA FOIA REGARDING VACCINE INJURIES AND DEATHS

 

The following is an email response from the MHRA regarding a series of questions I posed them about vaccine injuries and deaths. Their answers (below) have prompted a follow-up email to them which is also included in this blog post.

Subject: Freedom of Information Act Request

From: Bob Fiddaman 

To: info@mhra.gov.uk

According to your weekly records, accessed 21 Dec, 2021 -

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

As of 8 December 2021, for the UK, 141,866 Yellow Cards have been reported for the COVID-19 Pfizer/BioNTech Vaccine, 239,314 have been reported for the COVID-19 Vaccine AstraZeneca, 22,270 for the COVID-19 Vaccine Moderna and 1,333 have been reported where the brand of the vaccine was not specified.

For the COVID-19 Pfizer/BioNTech Vaccine, COVID-19 Vaccine AstraZeneca and COVID-19 Vaccine Moderna the overall reporting rate is around 3 to 7 Yellow Cards per 1,000 doses administered.

In the week since the previous summary for 1 December 2021 we have received a further 2,603 Yellow Cards for the COVID-19 Pfizer/BioNTech Vaccine, 673 for the COVID-19 Vaccine AstraZeneca, 1,750 for the COVID-19 Vaccine Moderna and 26 where the brand was not specified.

*1.* Of the 141,866 Yellow Cards have been reported for the COVID-19

Pfizer/BioNTech Vaccine, how many have been:

A: Fatal

B: How many of the fatal reports did the MHRA follow-up with the reporter

C: What test, if any, was carried out to determine whether or not the

vaccine was the cause of death or not

*2.* Of the 239,314 that have been reported for the COVID-19 Vaccine

AstraZeneca, how many have been:

A: Fatal

B: How many of the fatal reports did the MHRA follow-up with the reporter

C: What test, if any, was carried out to determine whether or not the

vaccine was the cause of death or not

*3.* Of the 22,270  that have been reported for the COVID-19 Vaccine

Moderna, how many have been:

A: Fatal

B: How many of the fatal reports did the MHRA follow-up with the reporter

C: What test, if any, was carried out to determine whether or not the

vaccine was the cause of death or not

*4.* Of the 26 that have been reported where the brand was not

specified,  how many have been:

A: Fatal

B: How many of the fatal reports did the MHRA follow-up with the reporter

C: What test, if any, was carried out to determine whether or not the

vaccine was the cause of death or not

-- 

*Bob Fiddaman*

Author/Blogger/Researcher

--

From: Pharmacovigilanceservice <Pharmacovigilanceservice@mhra.gov.uk>

To: "fiddamanwork@gmail.com" <fiddamanwork@gmail.com>

CC: MHRA Customer Services <MHRACustomerServices@mhra.gov.uk>, FOI_Policy <FOI_Policy@mhra.gov.uk>

Subject: RE: FOI 21/1342 CSC 81313 Freedom of Information Act Request

Dear Mr Fiddaman,

Thank you for your FOI request dated 21st December 2021.

The number of fatal reports is included in the Vaccine Analysis Prints published each week. Please note that a report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the different vaccines. All reports are kept under continual review in order to identify possible new risks.

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

All Yellow Card reports we receive are promptly entered onto the MHRA's Adverse Drug Reaction (ADR) database so that they are available for a process called signal detection. During signal detection, reports are evaluated, together with additional sources of evidence, by a team of safety experts to identify any new safety issues or side effects. We apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of medication or vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern.

For the COVID-19 vaccines, we supplement this form of safety monitoring with other epidemiology studies, including data analysis on national vaccine usage, anonymised GP-based electronic healthcare records, and other healthcare data to proactively monitor safety. These combined safety data enable the MHRA to detect side effects or safety issues associated with COVID-19 vaccines. As well as confirming new risks, an equally important objective of monitoring will be to quickly rule out risks - in other words, to confirm that the vaccine is not responsible for a suspected side effect and to provide reassurance on its safety. We also take into account the international experience based on data from other countries using the same vaccines. For further information on how we use the data we collect, please view our COVID-19: vaccine surveillance strategy.

As with any serious suspected ADR, reports with a fatal outcome are fully evaluated by the MHRA to consider whether the medicine or vaccine may have caused the event or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. To ensure the comprehensive assessment of fatal reports, we follow-up all fatalities where necessary for further information.

As mentioned above, for all the fatal reports concerning COVID-19 vaccines, a follow-up letter is sent to the reporter to request further information, including a copy of the Post Mortem (PM) report and the certified Cause of Death. Once we receive this follow up information, it may change the classification of the case. In some instances, the reporter may not consider the death to be related to the COVID-19 vaccine. The classification of these cases would therefore be amended within our database and these updates reflected in the following weekly Coronavirus ADR publication.

Kind regards,

FOI Team

Vigilance and Risk Management of Medicines Division

Medicines and Healthcare Products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

---

Follow-Up response

From: Bob Fiddaman 

To: Pharmacovigilanceservice <Pharmacovigilanceservice@mhra.gov.uk>

Thank you for this information.

As a follow-up question, I am interested in the following paragraph you wrote me:

"As mentioned above, for all the fatal reports concerning COVID-19 vaccines, a follow-up letter is sent to the reporter to request further information, including a copy of the Post Mortem (PM) report and the certified Cause of Death. Once we receive this follow up information, it may change the classification of the case. In some instances, the reporter may not consider the death to be related to the COVID-19 vaccine." "The classification of these cases would therefore be amended within our database..."

Questions under the terms of the FOIA

1. Is a follow-up question/s sent to every single person who reports (via the yellow-card reporting system) an adverse reaction to the vaccine?

2. Is it the position of the MHRA that a UK citizen can determine whether or not an injury was caused by a pharmaceutical product?

Sincerely,

Bob Fiddaman

--

I'll let you know when/if they respond

Bob Fiddaman