My FOI battle against the MHRA to get the adverse drug reaction data for the COVID-19 injections
MHRA delay tactics with the FOI process: where we stand 18 months on.
In this post:
Why my initial Freedom of Information (FOI) to the MHRA back in March 2021
The Medicines and Healthcare products Regulatory Agency (MHRA): from watchdog to enabler
Prologue
In December 2020 I moved from my job as NHS community nurse educator to work as nurse “vaccinator”. I helped set up a “vaccination” centre. There, in January 2021, I started administering the Oxford-AstraZeneca Vector DNA injections.
I care about patients’ well-being, I am curious, and I am passionate about clinical research. I became concerned about the AstraZeneca (AZ) injections’ suspected adverse drug reactions (ADRs). In February 2021 there came from Norway news about blood clotting from the AZ injections. [Note: I left the “vaccination” programme in July 2021. It had become too dissonant with my personal and professional ethos. It was in contrast with my knowledge and skills. I will share more about my experience in future posts.]
This post is the first of several posts I want to share about my direct experience and research with all that is related with COVID-19.
[Updates: since first drafting this post, the MHRA adverse drug reaction data for Pfizer/BioNTech and Moderna COVID-19 vaccines is available in the US OpenVAERS. However, since AstraZeneca COVID-19 vaccine is not licensed in the US, AstraZeneca adverse drug reaction data is not available in OpenVAERS. The fight continues.]
Progress update Wednesday 9th November 2022
Latest message from Tribunal to Respondents:
Dear Sonia Taylor [ICO solicitor] and Richard Weatherhogg [MHRA lawyer],
Further to the email below and the deadline for the Open bundle after an extension of time request being the 14th September 2022, can we please have an update on the open bundle as it is stagnating the further process of the appeal.
Regards
Why my initial Freedom of Information (FOI) to the MHRA back in March 2021
The "vaccination" programme had started. At the same time, I started studying harms and benefits of the COVID-19 injections. I drew from the British Medical Journal, Office of National Statistics, NHS Digital, and the COVID-19 injection trials. I was getting more and more uncomfortable at what I was reading. Hence, I went to the MHRA adverse drug reaction internet portal, the Yellow Card System. I knew about the significance of this system from my medicine prescribing studies.
You can download ADR data for all medicines from the interactive Drug Analysis Profiles (iDAPs). But, there it states that for vaccines one has to request the data to the MHRA.
The MHRA had been sharing with the public only how many ADRs to the COVID-19 injections had occurred. I wanted the usual whole data set. It includes, among other details, gender and age of the person who experienced the ADR. I and other researchers could do more meaningful analyses with this data. For the same reason, the wonderful Dr Tess Lawrie has also urged the MHRA to share the full data set.
So I did. In February 2021, worried by the Norwegian news, I emailed the MHRA requesting the full ADR data for the COVID-19 injections. But no, sorry, not available for the COVID-19 injections. So much for the MHRA transparency blurb.
For two weeks I accepted that ADR data was not available. But, further blood clotting cases occurred in Norway. By March 2021 Norway had suspended the administration of AZ. At that point, I could no longer accept the MHRA refusal to share its data. I sent my FOI request for the full data set of COVID-19 suspected ADRs.
The Medicines and Healthcare products Regulatory Agency (MHRA): from watchdog to enabler
My FOI history demonstrates how the MHRA puts great effort in preventing transparency. I share some Tribunal documents at the end of the post. There you will read why data transparency benefit patients’ well-being. You will learn how the MHRA justifies their secrecy. Likewise, you will see how the MHRA infantilises healthcare professionals.
The MHRA no longer protects us from the interests of the pharmaceutical industry. It is the self-reported champion of the industry. Dame June Raine, MHRA Chief Executive, tours with her presentation “MHRA: watchdog to enabler”.
In the G7’s report “100 DAYS MISSION to respond to future pandemic threats” – boasting a foreword by, nonetheless, Sir Patrick Vallance and Melinda French Gates – the word “enabler” labels agencies like the MHRA. The report refers to these agencies as SRAs, Strict Regulatory Authorities. Strict and authoritative they are not.
How the FOI progressed and where we are now
The MHRA rejected my FOI. I asked for an internal review. The internal review confirmed the MHRA initial decision. I appealed to the Information Commissioner’s Office (ICO). The ICO found the case in favour of the MHRA. I asked for an ICO internal review of the decision. The ICO upheld its original decision. This brought us to early February 2022! Yes, one entire year had passed from my first naive email to the MHRA.
I was not demoralised. I immediately appealed the ICO decision at the First-tier Tribunal. The MHRA asked the Tribunal permission to join the ICO as respondent, which it granted. The tribunal set a date for a paper hearing for May 2022. Since then, we have one lawyer representing the MHRA, Mr Richard Weatherhogg. We have one solicitor, Sonia Taylor, and one paralegal, Naomi Law, from the ICO. In turns, they have requested continued postponement of the hearing date. Either the bundle was not ready. Or Dame June Raine had to produce her extensive witness statement. Or there were summer holidays to take in the MHRA and ICO offices. The last deadline for MHRA and ICO to produce the bundle for the hearing was 14 September. Have I heard from anyone? No. Last night I emailed the Tribunal for an update.
My rationale as presented to the First-tier Tribunal
There are hundreds of pages of evidence in this case. I want to share here my rationales I sent to the Tribunal. The first document is my initial letter of appeal to the Tribunal. In there, I quote the ICO decision document, which I have included. The second document is my reply to the ICO and MHRA response to my initial appeal letter. Public and commercial law barrister Jennifer Thelen wrote that response. I have included it, together with Dame June Raine’s witness statement.
I am curious to know what your thoughts are about my arguments.
Thank you.
In fact, the tribunal case was first against the ICO, as it upheld the MHRA original refusal.
The MHRA, as expected, has decided to join as second respondent in the tribunal case due to its interest in the matter.
Incidentally, the tribunal solicitation of a response from ICO and MHRA has not been satisfied yet, three weeks on. Or four? I have lost count.
I follow a few folks who post their FOIA requests on this site. Have you ever heard of it?
https://www.whatdotheyknow.com/user/joel_smalley#foi_requests
I'm in USA so our FOIA process is different. But I enjoy reading the responses from the UK Govt... what a scam this whole nightmare has been.