I am one of the authors of the Perseus Report. In the House of Commons last week we presented the report to the Covid Vaccine Damage All-Party Parliamentary Group (APPG) at the invitation of Sir Christopher Chope MP. While we were waiting to go in, I was asked, “If you were in charge of the MHRA, what one thing would you change to stop the Covid vaccine debacle happening again?”
Good question. The Perseus Report documented a whole range of MHRA’s regulatory failures, so what to pick? I thought I’d share my answer – you never know, someone in a position of power over MHRA might actually read this!
Actually, I gave myself the liberty of picking two, not one. Because I think that, together, they would at least provide a safety net which currently doesn’t exist.
First, for every medicine at the point of licensing, MHRA should be required to predetermine the rate of tolerable fatal and serious adverse events (SAEs) for that particular medicine. Other safety-critical sectors do it. If the actual rate of SAEs in practice exceeds that threshold, use of that medicine has to be suspended pending detailed review. Again, that’s how other safety-critical sectors do it. What’s MHRA’s excuse?
The MHRA will say it’s difficult – we don’t know how many administrations of each medicine there are. Well, set up a process so that you do know – it’s important.
Then its officials may say that it can be dangerous to stop certain medicines once someone is taking them. So, continue existing prescriptions (with the informed consent of the patient) but suspend new prescriptions.
They may say, “We’ll never get the manufacturer to agree a figure”. Who cares what the manufacturer thinks – you’re the watchdog (oops, I forgot, you’re an ‘enabler’ now).
They might say, “But that will possibly mean repeated stop-starts, and public confidence will suffer”. Au contraire, MHRA. If I read it correctly, the Covid vaccine saga has already significantly reduced the confidence of a large proportion of the public and they’d actually be relieved that MHRA had finally got a grip.
But, MHRA people may say, the NHS would end up with stocks of unusable drugs. Oh dear – is that more important than continuing with unsafe drugs? Get a refund from the manufacturer.
Then they’d say, aha, it’s not just about risk, there’s benefit to consider, too. Okay, so have a predetermined benefit-risk ratio for each medicine – either instead of, or as well as, the tolerable rate of SAEs. Indeed, MHRA is fond of saying “the benefit outweighs the risk” – well then, define it quantitatively at the point of licensing. Then when potential problems emerge, we all know where we are instead of MHRA just insisting that the benefit outweighs the risk without actually quantifying it.
They’ll probably think of of other reasons I haven’t thought of but I’m confident there’ll be answers to all of them. All I know is that it’s shocking that the MHRA (and other regulators) been allowed to get away on this issue for so long.
The second essential change I’d make is to introduce personal delegations of safety to individuals in MHRA. People who are suitably qualified, experienced and trained should have personal responsibility for signing off a medicine as safe and retaining responsibility for decisions if and when problems arise in practice. In contrast, people in MHRA assess medicines for licensing in groups and they decide in groups what action to take in response to subsequent problems. No-one takes personal responsibility. When problems do occur, I picture them all looking at each other and saying, “Oh dear, perhaps we should wait for a bit more data”. “Yes, good idea, let’s commission some research.” In my job, I had a personal letter of safety delegation. I signed the licence declaring explosive items safe for the Armed Forces to use. I felt like I would end up in court if I got it wrong. I once had to ground a fleet of one aircraft type. I had to introduce limitations on use pending investigation. I had to raise the red card with one weapon system when the Generals shouted me down: “We’re in the middle of a war”. I invited them to take responsibility (in writing) for continuing. They declined.
Safety management isn’t rocket science. In all honesty, it’s beyond me why these two features, which are considered best practice in all other safety-critical sectors, aren’t already in use in medicine safety.
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: The Perseus Group Twitter account @perseusgroup_ and Nick’s account @nickhunt5 were both blocked yesterday by the MHRA @MHRAgovuk. Was it something they said?
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