YESTERDAY we flagged the revelation by Dr June Raine, head of the Medicines and Healthcare products Regulatory Agency, that the agency is no longer primarily there to protect the public’s health from dodgy drugs, but to be an enabler of fast-track vaccines.
This new ‘higher purpose’ goes far to explain the MHRA’s easy dismissal of its critics. Indeed, Tennyson’s famous lines about the Light Brigade, ‘Theirs not to make reply / Theirs not to reason why / Theirs but to do and die’ can be incisively applied to the agency’s determined denial of Covid vaccine injury and fatality.
A speech by Dr Raine to her Oxford University alma mater earlier this summer demonstrates a dangerous mix of stupidity, hubris and entitlement. (The transcript and video are at the end of this post.)
Superficially, her words come over as the self-congratulatory spiel of an over-promoted functionary. But to grasp their full import, listen carefully to what she says.
Speaking of the MHRA, she says she wants to tell her audience of ‘how the Covid pandemic has catalysed the transformation of a regulator, from a watchdog to enabler’.
Watchdog to enabler? Who decreed this unilateral switch of function? What about protecting the public from potentially harmful drugs, the MHRA’s prior, vitally important, purpose? Has that been thrown to the winds?
Never mind – Dr Raine’s obeisance to the Oxford science panjandrums appears to override all. ‘I think I hardly need to say to this audience that Oxford University has made a contribution to defeating this vicious virus far beyond any other institution in the world,’ she goes on. ‘And there are millions of people alive today because of this university.’
Oxford minds were busy working, she says glowingly. And she tells of the exciting email message she received from Professor Sir Andrew Pollard late one night, two years ago.
Professor Pollard? He was Chief Investigator on the University of Oxford COVID-19 Vaccine (ChAdOx-1 n-CoV-19) trials and heavily involved in the development of a SARS-CoV-2 vaccine at Oxford.
So no conflict of purpose there, then.
‘Are you available for a brief discussion about work going on here in Oxford, which will lead to extensive interaction soon?’ asked the professor.
No questions, it seems, were asked. She explains: ‘Things were already starting, starting to prepare about that manufacture at scale, the Oxford Biomedica, that needed to be, at risk, preparing for the most massive preparation manufacture of vaccines’.
Dr Raine’s role? Was it to mitigate that risk? How important must it have been to have the regulator onside, not raising any doubts about rushed-through research and novel vaccines?
Dr Raine doesn’t anguish about where her duty lay. She makes no mention of protecting the public from risk, nor of that classic medical precautionary principle of ‘first do no harm’.
In her continuing ‘tale of two cities’ she describes the London side of her personal drama when she found herself ‘dashing into Number 10 … and being asked why a regulator was in the room?’
Why indeed? Was a regulator going to be able to do anything about this crisis? Why yes, she recounts, she could do plenty. The Prime Minister, she recalls, shot a comment to her: ‘Well, the MHRA will stop us killing people,’ to which she was immediately able to respond: ‘No, the MHRA will help you keep people alive.’ And that, hey presto, in her words, ‘is the signal of the watchdog to the enabler’.
Is Dr Raine’s investment in this belief since then why she’s consistently been able to discount the huge number of people that this new -‘not holding things up’- style MHRA has failed to thoroughly investigate and complicit therefore in all subsequent injuries and deaths?
For far from ‘maintaining independence in our decision-making’ her ‘collaboration across these boundaries as never before’ (with the Vaccine Task Force, run by co-Oxford alumni and speaker Kate Bingham, and the Joint Committee on Vaccination and Immunisation chaired by none other than Sir Andrew Pollard) cannot but have undermined it.
In Dr Raine’s words, this is how she deliberately set out to transform the MHRA’s role (my bold): ‘We tore up the rule book, and we allowed companies to immediately start juxtaposing not sequential phases of clinical trials, but overlapping, beginning the next one before the previous had been finished. And that large-scale manufacture being prepared, at risk. We did not know if any of these vaccines would be effective.
‘We spent a long time on guidelines and we decided in the end that 50 per cent efficacy would really be fine. So the data began to flow in and we began, in the middle of June, six months ahead of time, 2020, to start to prepare what safety surveillance we would need.
‘And this is where I look at Kate (Vaccine Task Force chief Kate Bingham), because Kate at that point had thought that once the purchase had been made, the approval had been signed, home and dry. And what I was able to share with you was we only really learn about benefit/risk in clinical use. And we knew that there would be a vast influx of reports of side-effects. No effective medicine or vaccine is without them.
‘But you can see the layers of parallel working that went on and that can never be turned back now. An interaction with a developer that, at each stage, looks at the protocols for the design and feeds in further important directions. So it all happened in parallel.
‘And so, by the time we were able to look at the interim analyses that was so exciting, we actually knew we were very close to an approval. And there were the data that Kate described in numbers, that separation of the curves around 12 days between the group that had been vaccinated and the placebo group that told you this was a highly effective Pfizer BioNTech vaccine.’
Highly effective? Was it ever? Hasn’t it now been proved to be one of diminishing if not negative returns, as documented weekly on this site? Like June Raine, Kate Bingham appears to be another ill-informed, unthinking, uncritical and over-confident collaborator in this quest to get the vaccine out at all costs.
Genuine enthusiasts they may have been, yet it is hard to listen to this make-believe. And from the a woman who cannot deny (from her own Yellow Card Reports) that vaccine adverse effects for Covid alone were soon to add up to more than for the last ten years of all vaccines put together, have proved way more complex than a sore throat and fatigue, and have had deadly effects.
How she can make such statements given the hindsight and knowledge of Pfizer’s negligible efficacy and the elevated risk that it trial data drops have revealed, is hard to compute.
As to her original decision. Well, ‘… bearing in mind that the side-effect profile was much as you would have expected, the sore arm and the temperature, fatigue, whatever. I sometimes wondered if it was about being a female. Did I find it difficult? But actually, it made itself.’
As to the Oxford-AstraZeneca vaccine, along comes more uncritical acclaim from Dr Raine: ‘This is the incredible story of global, a vaccine for the world, 2.5billion doses administered worldwide, well ahead of the others. And the fact that it is 183 nations, 20 manufacturing sites set up to deliver at cost.’
Since ‘that email from Andy Pollard about what Sarah Gilbert’s team were doing’ she’s suffered no doubts. ‘It is absolutely phenomenal. It’s hard to calculate how many lives were saved by that one research group alone, but probably in excess of a million as we speak. Something quite incredible. And I think more than a quarter of the ten billion doses of vaccine given worldwide are the AZT vaccine.’
Who does she think she is kidding?
Not presumably the 17 (mainly European) countries which have suspended the vaccine. Not those under-40s for whom it is now not advised. Not the families of the 81 fatalities accepted to have been caused by the vaccine according to MHRA Yellow Card reporting. Not the many, many more injured victims of this experiment.
But never mind that. Let’s get back to Oxford, where there’s been something else for Dr Raine to celebrate – the Recovery Study, the world’s biggest Covid treatment trial, co-run by professors Martin Landray and Peter Horby, no less.
Dr Raine cannot have read this article. She is full of enthusiasm: ‘Just listen to those statistics. From the first protocol to the first recruitment, nine days. And as we know, many trials fail to get enough participants. It’s well over 40,000 now.
‘Many trials don’t give results for a long time. Within 100 days, we were able to start using dexamethasone, which reduced mortality by a third. That knowledge that was available – and not even so much the things that work, but you remember all the press from the US about hydroxychloroquine, for example, convalescent plasma for example, where there had to be a real switch back from what the advice had been on the basis of robust data.
‘So here in Oxford, something to be astonishingly proud of. And I think again, it’s widely quoted by the March of ’21, the data from Recovery had saved at least a million lives.’
But again, never mind that, because: ‘The main output though was music to Patrick Vallance (the Government’s chief scientific officer). The Hundred Days Mission. He’s created it and he uses this wonderful expression that “we have to make the exceptional the everyday”’.
Dr Raine is all on board with the exceptional being the routine, believing the key to best practice is being ‘a joined-up regulator that’s using every collaborative opportunity, but maintaining independence’.
Her final words however don’t square that circle. Nor do the overblown clichés with which she rounded off her speech.
On her generous salary, frequent breaks, her soothing collaboration with the Covid science elite, June Raine might kid herself that ‘as a country, our leadership, our scientists, our great university, our NHS and, most of all, our people have all been in the superlative. . . . (that) We have been in the superlative, and if I’ve contributed to that, I’m very proud.’
We know otherwise. The saga of the Covid Vaccine pandemic response is fast turning into an unmitigated and unnecessary disaster, thanks to her and the people with whom she so uncritically collaborated.
You can read the full transcript of Dr Raine’s speech here.
You can watch a video recording of it here – starting at approximately 36 mins after Kate Bingham’s speech