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
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