The MHRA Papers - Part 13

The heavily formatted secret minutes

SUMMARY: We report on the most common expressions used to examine and discuss the evidence. The most common was “The EWG heard,” but we do not know who told them what. Secrets are forever. Do not look for “analysed.” It’s not there.

Before continuing our review of the meeting minutes of the MHRA’s ​​Commission On Human Medicines (CHM) COVID-19 Vaccines Benefit Risk Expert Working Group, which took place on 29 January 2021, we would like to point out some interesting facts.

We searched the 19 EWG formerly secret minutes (but heavily redacted in places) relating to the content of the meeting from 25 August 2020 to 3 January 2021. This is the period leading up to the release of conditional market authorisation (CMA in EMA speak) on 21 December 2020 and its UK counterpart on 1 January 2021. This procedure is called mutual recognition in regulatory speak. In the case of biologics, all registrations are handled centrally by EMA.

This, however, is only the legal authorisation to market a product under specific indications and restrictions; it is not a recommendation.

The EWG task was to examine the evidence of the effectiveness and harms of the Covid vaccines.

This is a public service of the most significant importance given the time context.

Going through the formerly secret minutes, we noticed particular quirks about the minute taking. 

So, we searched the files for specific repetitive phrases. Here is what we found:

• “The EWG heard that”…..was cited 390 times in 17 files.

• “The EWG noted that”……was cited 183 times in 16 files.

• “The EWG agreed that”........was cited 92 times in 11 file

• “The EWG discussed”..........was cited 65 times in 12 files.

• “The EWG analysed”............was cited 0 times.

• “The EWG remarked”............was cited 0 times.

• “The EWG asked”.................was cited 17 times in 3 files.

• “The EWG queried”.................was cited once in 1 file.

• “Evidence” was cited 21 times in 10 documents. 

• “Verify” was cited once in 1 file.

• “Statistical” was cited 12 times in 8 files, but it referred to the manufacturers’ analysis.

• “Independent analysis” was cited once in 1 file dated 24 December 2020:

The term “Presentation” was cited 70 times in all 19 files. One reason for this frequent use is the law enacted by the chief secret squirrel, who reminded attendees that they could not take notes or copy the presentations.

This implies that no time was allowed for analysis or reflection before or after the meeting.

The results could be due to poor note-taking, as the voices of those who had doubts about any of the subject matter were not recorded except once. All were anonymised, and the impression is one of a tightly controlled secret procedure.

None of the queries or questions are detailed (we know the EWG had 36 questions), and none of the discussions are sufficiently detailed to reconstruct a timeline (which was cited six times in four documents). None of the minutes allow us to understand the evolution of the evidence base from Phase I to Phase III trials.

This post was written by two old geezers who discuss, analyse, ask, and query everything. They do not usually note stuff, but they sometimes hear and seldom agree unless they have examined and discussed the evidence.