UK medicines regulator puts patients at serious risk, MPs say

The All-Party Parliamentary Group (“APPG”) on pandemic response and recovery, an influential group of Members of Parliament (“MPs”), has raised “serious patient safety concerns”.

It has claimed that “far from protecting patients” the Medicines and Healthcare products Regulatory Agency (“MHRA”) operates in a way that “puts them at serious risk.”

Some 25 MPs across four parties have written to the Health Select Committee asking for an urgent investigation.

In a letter published last week to Steve Brine, MP for Winchester and Chandler’s Ford and Chair of the Health and Social Care Select Committee, the APPG said that there was reason to believe that the MHRA had been aware of post-vaccination heart and clotting issues as early as February 2021, but did not highlight the problems for several months.

“There is reason to believe the MHRA was aware of a signal for post-vaccination myocarditis and pericarditis in February 2021. However, it failed to mention myocarditis or pericarditis in safety updates in April, May and June, only alerting the public on 25 June, supposedly ‘following a thorough review of extremely rare reports of myocarditis and pericarditis after covid-19 vaccination’,” the letter signed by Graham Stringer MP stated.

The letter noted that a previous response to a Freedom of Information Act (“FoI”) request revealed that in the intervening two and a half years since knowing of post-vaccination myocarditis and pericarditis, the MHRA has not undertaken any formal epidemiological studies or instructed Pfizer and Moderna to carry any out.

The APPG also noted that the MHRA does not have a process for the investigation and follow-up of individual Yellow Card reports and cannot and does not effectively monitor them.  This information was again obtained through FoI.

In a previous letter to Brine, the APPG noted that the MHRA continues to be primarily funded by income from fees for sales of products and regulatory services. The breakdown of their funding is 50% fees for services, 25% industry periodic fees and 25% Department funding.

“The fact that in March 2022, Dame June Raine, Chief Executive of the MHRA, boasted of the agency’s transition from ‘the watchdog to the enabler’ does little to quell suspicions of conflicts and the implications for patient safety and cannot be overlooked,” they said.

Further reading: MHRA: The Big Pharma ‘enabler’ is negligent as well as incompetent, The Conservative Woman, 26 July 2023

In March 2021, when The Telegraph published an article implying a causal link between the AstraZeneca covid-19 vaccine and blot clots after Norwegian scientists suggested a possible mechanism, they “received a threatening phone call from a senior official at the MHRA warning that The Telegraph would be banned from future briefings and press notices if we did not soften the news.”

This was an “extraordinary reaction” the APPG noted. “Not one you might expect from a drug safety regulator that has learnt lessons, was genuine in its response to the review’s recommendations or puts patients first in everything it does.”

“It seems the MHRA is more concerned with putting itself, and perhaps the pharmaceutical industry, first. Protecting itself, one might say, rather than protecting and ensuring patient safety,” the letter said.

According to The Telegraph, in reply, Brine said an inquiry into patient safety is “very likely.”

MHRA Chief Executive Dame June Raine announced she would be stepping down last week.  MPs have said that her previous statement that the agency was transitioning from “watchdog to the enabler” warranted its own investigation, The Telegraph said.

You can read the APPG’s first letter to Brine dated 24 October 2023 (published 9 February 2024) HERE and their latest letter dated 11 December 2023 (published 22 February 2024) HERE.