Safety professional Nick Hunt has written an open letter to the Health Secretary to raise his ongoing deep concerns about the MHRA’s regulation of medicine safety, shown most recently in the missed safety signals from the Covid vaccines.
Dear Secretary of State,
Under the Human Medicines Regulations, you are the Licensing Authority for all medicines and medical devices in the U.K. You are, therefore, personally accountable to Parliament for their safety even if the MHRA does all the underpinning work on your behalf.
Until I retired in 2017, I was a senior Civil Servant in the Ministry of Defence responsible for licensing a wide range of explosive items as safe for Service use – everything from ‘dumb’ munitions like bullets and grenades to complex weapons like missiles and torpedoes.
I am very concerned about MHRA’s regulation of the safety of medicines and medical devices and I think you should be too. First, the MHRA does not investigate all fatal or serious Yellow Card reports of suspected side-effects. Secondly, the system of weekly statistical analysis which it relies on instead is imperfect, if not broken.
Taking those in turn, it has been public knowledge for some time that the MHRA has no process for investigating fatal or serious Yellow Card reports and that it does not even know how many it has investigated. This was confirmed again recently in an answer to a Parliamentary Question from Esther McVey MP.
Now we find out why: June Raine confirmed in 2017 (slide 23 here) that, even before the Covid vaccines, there were already too many potential serious side-effects to investigate. MHRA simply does not have the resources. That is apparently why it relies, instead, on statistical analysis of all Yellow Card reports to detect potential safety signals.
This is unacceptable. MHRA is licensing drugs and devices as safe knowing they’ll generate too many potential fatal or serious side-effects to investigate and relying instead on statistical analysis to pick up safety signals. That would not be acceptable in any other safety-critical sector.
“Oh dear, we’ve had a couple of plane crashes recently but it’s within statistical norms so we won’t bother to investigate them.”
“Oh dear, we’ve had a few water leaks from nuclear power stations recently, but no more than normal, so we won’t bother investigate them.”
Really? If it is okay for the MHRA not to investigate fatal or serious Yellow Card reports, then perhaps the Government should just make all air crash and nuclear accident investigators redundant?
But it is worse than that. The system of statistical analysis which MHRA relies on instead is, itself, imperfect, if not broken. It does not know for all fatal or serious Yellow Card reports the basic but essential information like the age of the subject, medical history or the batch number of the medicine. MHRA also recently revealed that it had been missing safety signals between December 2020 and June 2022 related to all vaccines, not just the Covid ones. Add to that the serious safety issues with sodium valproate, Primodos and pelvic mesh covered by the Cumberlege Report which took years to be recognised – and then as a result of pressure from patient groups, not by MHRA’s statistical analysis. And more recently MHRA was much slower than other National regulators to react to safety issues with the AstraZeneca Covid vaccine – its statistical analysis failing yet again.
And all this is before considering any of MHRA’s other regulatory failures documented in the Perseus Report. You received a copy in April by email and hardcopy. You did not reply.
I do not expect that I will receive a reply to this either so I am publishing this as an open letter and copying it to the Patient Safety Commissioner, Baroness Cumberlege and my MP. Perhaps one of those will be as concerned as I am about MHRA’s management of the safety of medicines and medical devices and raise the issue with you personally.
Yours sincerely
Mr. N. H. Hunt
July 23rd 2023
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. medicines regulator the MHRA.
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