For more than seven months Gillian Dymond has been trying to get the Medicines and Healthcare products Regulatory Authority (MHRA) to explain what it is doing to investigate the deaths and injuries occurring shortly after Covid-19 vaccination. You can read previous instalments in the saga here, here, here and here.
MY correspondence with the MHRA drags on. An acknowledgement of my last email to chief executive officer Dame June Raine arrived a few days ago, telling me that I would receive a reply ‘shortly’. Meanwhile, the weeks and months pass without any thorough investigation into the deaths and injuries reported on the Yellow Card system, and without any reassurances for the public as to the long-term safety of the injections against SARS-CoV-2 approved for emergency use by the MHRA.
Astonishingly, there appears to be no heart-searching whatsoever on the part of our regulators regarding the evolving health catastrophe which their sweeping endorsement of jabs for all above nursery age may have unleashed. Quite the opposite. Basking in the confidence of a jab well done, they rejoice and congratulate each other on their speedy ‘delivery’ to people as young as five years old of novel medications for which they have not one scrap of long-term data. Indeed, ‘speed’ and ‘delivery’ are words which crop up with disturbing frequency during MHRA board meetings, along with ‘transform’ and ‘transformation’. For the MHRA is busy transforming itself from a traditional regulatory agency into one which acts as an ‘enabler’ for new pharmaceutical products: far too busy to waste much time shedding tears over reported vaccine casualties, let alone admit any sneaking suspicion that these may be under- rather than over-reported.
As Dame June made clear in a speech she gave on Medics Day at Somerville College Oxford recently, she has absolute faith in both the efficacy and the safety of the injections. The large number of side-effects was not unexpected, she said, but, after all, no medicine or vaccine was ever 100 per cent safe. Of paramount importance was the fact that, with the advent of Covid-19, the MHRA rose to the occasion and ‘tore up the rule book’, thereby ensuring that the new medications were rolled out in time to save millions of lives.
How was this achieved? By allowing companies to juxtapose and overlap clinical trials in ‘layers of parallel working’, with regulators interacting with the developers at each stage, while emerging information was fed into further development.
What about safety surveillance? Well, said Dame June (glossing over the fact that it has previously been customary to test new medicines for years, rather than months, before pronouncing them safe), ‘We only really learn about benefit/risk in clinical use.’ Fortunately, in the case of Covid the terrorised public were only too eager to act as guinea pigs, and rushed to put the novel treatments to the test.
Dame June emphasised that after the success of this exciting new approach to regulation there can be no turning back. From now on it is full steam ahead, with regulators and developers using ‘every collaborative opportunity’ as they march arm in arm (though quite independent of each other) on their ‘Hundred Days Mission’. Their shared aim is for new vaccines to be rolled out within one hundred days of declaration of the future pandemics which are confidently expected. The process will no doubt be further speeded up by ‘tweaking’ a succession of mix-and-match mRNA vaccines into being, as described by Alexandra Latypova, an expert on drug development, at the fourth symposium of Doctors for Covid Ethics (44min 05sec in and 54 mins in), after which, as with Covid, testing will be carried out in ‘real time’ by the grateful public.
It is hard to imagine how Dame June and her MHRA team can maintain a detached attitude towards the developers with whom they rub shoulders as colleagues, or avoid a kind of parental protectiveness towards products which they are effectively helping to usher into the marketplace; but even discounting the obvious threat to independence, there is a yet more intractable problem. However skilful the speeding up of the development process, however brilliant the scientists involved, however urgent the need, one thing remains intransigent: time. Over the old enemy even the most advanced and flexible regulatory system wields no power. Only time, years and years of time, can reveal just how safe or unsafe any new medication is.
Clearly our regulators are enjoying their new role as collaborators in the creation of miracle medicines. It must, after all, be far more gratifying to be viewed as facilitators of innovation and benefactors of humanity than a lot of old spoilsports insisting that, where safety is concerned, only time will tell. But the fact remains that despite any amount of rubbish-in, rubbish-out estimates from the usual suspects at Imperial College London, it is far too early for the jabbed of the world to echo Dame June’s jubilant proclamation regarding the number of lives which her agency’s risky endorsement of unproven medications have saved.
There is already quite sufficient cause for concern. The architect of the ‘Hundred Days Mission’, Sir Patrick Vallance, has urged the MHRA to ‘make the exceptional the everyday’. Perhaps this goal has already been achieved. Until now, for instance, sudden death among healthy young men and women was an exceptional occurrence.
I hope that the abbreviated testing process, void of long-term data, which Dame June is welcoming so enthusiastically does not become the norm. Meanwhile, it is high time to bring the present experimental roll-out to an end, as requested in the following email.
Dear Dame June,
Open letter: Withdraw emergency approval for injections against SARS-CoV-2
Thank you for your acknowledgement, via your diary officer, of my e-mail to you dated 29 May, 2022. I understand that I shall be receiving a response shortly.
How shortly? Weeks and months are passing. Reports of vaccine deaths and injuries in connection with the injections against SARS-CoV-2 continue to mount. You have produced no analysis of the Yellow Card reports. You have made no risk/benefit analyses of the novel injections. The medium- to long-term dangers of these medications, authorised for emergency use only, remain unknown; we do know, however, that within a couple of months of treatment their effectiveness wanes dramatically. More and more boosters are required. Are we soon to be injected on a monthly basis?
It is now clear that in the present instance there are no grounds for the emergency use of products which have not undergone the usual years of testing. Approval under the Black Triangle label is acceptable only when no alternative treatments for an illness are available. This is not the case with Covid-19. Even before the still-experimental injections had been rushed into distribution, treatment protocols using off-label, tried and trusted medicines were being successfully employed by seasoned doctors throughout the world who recognised that it was imperative to counter the illness as early as possible and drew upon their shared experience and expertise to deal specifically with their patients’ symptoms. In addition, it was clear, well before the first jab took place, that the infection fatality rate for Covid-19 outside nursing homes did not warrant emergency measures. It is in line with the medium flu epidemics of 1957 and 1968, though, most unusually, the median age of death from this particular illness surpasses normal UK life expectancy. Healthy young people are simply not under any threat from the disease. They do, however, appear to be at some immediate risk from the injections. As yet we have no idea what future illnesses or, indeed, reproductive issues they may suffer as a result of their unnecessary medication.
SARS-CoV-2 presents us with no emergency which cannot be adequately met by protection of the vulnerable and treatment protocols using tried and trusted medicines. Please withdraw emergency authorisation for the experimental injections immediately.
Yours sincerely, etc