You might have read my previous articles which were critical of MHRA’s safety management under the pseudonym Nick Denim.
It’s time to reveal that I was a Senior Civil Servant in the Ministry of Defence (MOD). I was responsible for the safety and effectiveness of ammunition used by the Armed Forces. The same as MHRA is supposed to do for medicines. I am therefore well qualified to comment on MHRA.
If you haven’t already seen it, have a look at a report I co-authored about MHRA. It’s available on the Perseus Group website. It details a litany of problems with MHRA’s safety management and raises a whole host of questions.
This article covers a couple of further issues which have surfaced since the report was completed.
Who watches the MHRA?
In MOD, there are individuals responsible for managing the safety and effectiveness of all products. I was responsible for ammunition. Others are responsible for the safety and effectiveness of aircraft, ships, submarine nuclear reactors and so on. But there is a separate safety regulator: the Defence Safety Regulator. It writes the rules for managing safety and ensure adherence. This separation seems very healthy to me. MHRA, on the other hand, is both the regulator and manages safety, meaning it makes its own rules and marks its own homework, and no one besides ill-qualified and short-lived Government ministers are responsible for checking it is doing its job competently.
I wrote to the Secretary of State for Health on March 20th 2023 to ask why the approach for medicines is organisationally different to defence equipment. One month later I received the reply that, essentially, they are too busy to answer the question. I shall be pursuing this further.
Batch Issues
Batch issues are very important in all safety critical sectors. In MOD, if we received a report of a safety incident with one of our types of ammunition we had to decide quickly what action to take. The first questions we asked and answered as soon as possible included: how long had the product been in use; had something similar happened before; and was it therefore more likely to be a manufacturing problem or a design problem. For example, something in use for 10 years with no similar incidents was more likely to be a manufacturing batch issue, so let’s immediately quarantine the items from the same batch and those in adjacent batches. We would start inspecting the failed and quarantined items looking for physical defects, damaged packaging etc. We would delve into the manufacturing records to look for changes in personnel, quality control, production location, sources of supply of materials and so on. In my experience, batch issues contribute to a significant number of safety issues.
In contrast, MHRA recently admitted in an FOI reply that it does not know the batch numbers for all Yellow Card reports. Which is very odd because the internet is awash, particularly in the U.S., with analysis of ‘bad batches’ or ’hot lots’ of the Covid vaccines. MHRA excused itself for the missing batch information on the basis that it is not mandatory for the reporter to include the batch number. Yet it could quickly obtain that batch information for all Yellow Card reports linked to the Covid vaccines simply by cross-checking the name in the Yellow Card report against the NHS vaccination database. For other medicines it could do so by investigating further just the fatal and serious Yellow Card reports. That’s why it is so important for MHRA to have a proper process for investigating Yellow Card reports (it has already said that it doesn’t). At the moment, all it seems to do is stick the Yellow Card reports in a database and do statistical analysis. It’s totally inadequate and reprehensible.
Conclusion
The more we dig, the greater the concerns about MHRA’s management of the safety of medicines in the U.K. When will MPs start asking questions and debating this?
Until Nick retired a few years ago, he was a Senior Civil Servant in the Ministry of Defence responsible for the safety and effectiveness of ammunition used by the Armed Forces. He is co-author of the Perseus Group report on U.K. drugs regulator the MHRA.
Stop Press: Professor Norman Fenton has produced a new video taking apart a speech by MHRA Chief Executive June Raine late last year where she claimed once again that the MHRA’s role is changing from “watchdog” to “enabler”. He concludes that it shows the MHRA is not fit for purpose.
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