MHRA
This week, I will report on the latest Medicines and Healthcare products Regulatory Agency (MHRA) July 2023 board meeting. The transcript of Dame June Raine’s report below is a UK Column exclusive. Before I start, you may be interested in this article released last week from Becker News entitled, Bill Gates Appears to Have Bought Off Health Regulator That Approved His New Covid Vaccine.
With less than one hour to go before the start of their latest board meeting on 11 July, I still hadn’t received the joining link, despite a flurry of emails to the MHRA Conference organisers. This was not the first time I had not received a link: the delays have been noticeable since our friend Cheryl Grainger put Stephen Lightfoot (Chair MHRA) on the spot when asking a question regarding the data on serious adverse reactions.
The MHRA website now states that taking screen shots or video footage of the meeting is prohibited—another new command from those in high places who may be feeling vulnerable and nervous given UK Column’s coverage of all their past board meetings. Luckily, as many know, I have excellent shorthand skills. There were 67 registrations to the meeting; 26 members of the public, 25 members from industry, four from the media and twelve staff. I registered as a member of the public.
Here is Dame June Raine’s report verbatim.
Thank you for the introduction. The report, as ever, demonstrates the breadth of activities, the challenges and clearly how busy the agency is, but I think there are three key things that, perhaps to have in mind as we look at the specific items of achievement. The first is patients and the public; second, our partnerships; thirdly, people—our people, as ever, are what makes this an organisation that achieves everything in this report, but we launched the corporate plan last week and maintaining public trust is our very first priority.
I think that says a very great deal, Chair, from where I sit, to where the agency has come, given those reflections on that long journey, and I think there are a number of ways to have in mind the increased transparency and openness, our commitment to delivering public hearings around important safety issues, our aim to really involve patients and the public in all of our activities. Some of the great examples of where assessors have been listening to lived experiences for example, the people with sickle disease, who have been advising in relation to ‘gene therapy’.
And then in relation to one of the issues we have been thinking about very hard for a while, [sodium] valproate, the fact that there has been important stakeholder engagement exercises recently to help us be much more assured that now risk management will work, and of course you know there was a big public health programme about adrenaline auto injectors, again based on listening to families and their experience, so a huge amount around patients and the public.
I think the second theme is partnership working, and I know we’ll return to that later today. We have just returned from our first get-together, under our chairmanship, of [the medicine regulators of] Australia, Canada, Singapore and Switzerland to demonstrate that broader partnership at international level to accelerate innovative products coming through to patients here. And we have been looking at the Windsor Framework as a way to make sure that the whole of the UK benefits from this step forward in licensing medicines for the UK, not forgetting work on medical devices, with industry driving that ongoing work to ensure that medical devices for the Health Service are available.
The CE mark should have finished at the end of last month, but now we are continuing. So huge amount, breadth of activity all in partnership.
But I think the most important flavour I would say of this report is: our people, the fourth pillar of our Corporate Plan, a place to have a great career, where people flourish in their roles alongside a customer service environment, and I think that really will be the theme going forward. I think, as we look to be a properly focused service organisation, these are the things that will deliver. New ways of working that we want to build on following our transformation. So public trust, partnerships and our people.
But ,Chair, before I finish, I think there is one aspect of people that we really want to pause and reflect on at this moment, because it is your last meeting as Chair, and it hasn’t come up in conversation so far, and can’t go much further without our reflections. You have lead the agency through a period of absolutely unprecedented change. From that long slow evolution we have just talked about, and you’ve made this Board the focus for the strategic direction of the Agency, a clear vision and a Corporate Plan that will take us to the destination we want to reach. I think you’ve done this with great skill and commitment.
Quite a bit of ‘push and pull’, and later today we’ll have the chance perhaps to talk about that with each other and our partners. But the key point and one that really needs stating is, the Agency is now in a sound a stable position to go forward. We have just signed/approved our Annual Report and Accounts. We have a clear vision in front of us and it is all thanks, Chair, to your strong leadership, so I think we can only say in very simple terms; Thank you from all of us.
So there you have it: the most important pillar of the MHRA’s new plan is their people. As I sat and watched the MHRA pitch their wares to ‘industry’, I felt sick. There was no mention of Covid–19 vaccination injuries; no mention of serious adverse reaction data, despite patient safety being included on the agenda. Along with myself, there were other UK Column viewers in attendance who submitted questions regarding safety, but all were ignored by the Board. They have to wait 18 days for an answer to come via email, if they’re lucky. Time will tell.
Without the MHRA, the NHS cannot function. It’s that simple. The NHS relies on pharmaceutical companies, biotech companies, drugs and medical devices to operate. Sick people need allopathic therapies and medicines, right? Not always, no. However, that is what the NHS has become: an enabler for snake oil merchants to peddle their poison. Watching those on the MHRA Board plumping their feathers and crowing about how fantastic their service is was nauseating, to put it mildly.
Reading between the lines, it appears the MHRA is far from ‘fine’. The Board was intent on reassuring industry—so why the need to ‘rebuild’ their reputation? Does industry have confidence in the MHRA to meet targets? Why the need to build stakeholder trust? The answer, even if they don’t want to tell you outright, is no, the industry does not have confidence in the MHRA, and yes, their reputation has been shattered. The O’Shaughnessy Review was damming in its findings. Clearly, industry has lost faith in the MHRA’s abilities to meet targets and delivery.
From the report:
We have heard from industry that the UK is viewed as an unreliable and unpredictable partner. Our approvals processes are theoretically competitive but inconsistent because of backlogs at the MHRA and unnecessary site-level approvals processes, which create delays. One major global pharmaceutical company that submitted evidence to the review said that, of the 18 European countries in which it carried out research, the UK was the second slowest for setting up clinical trials. This is clearly unacceptable for a country with our resources and ambitions.
Doesn’t look so rosy now. So what else were we told at the July 2023 Board?
Dr Alison Cave, MHRA Chief Safety Officer, was late for the meeting, apparently due to transport problems. She informed the Board that she is now meeting the Patient Safety Commissioner (PSC) every month. She also reassured us that they have a good working relationship. But when asked if the PSC was happy with the progress the MHRA is making with regard to Cumberlege Report, she meekly answered, “Hopefully.” Take from that what you will.
It would appear that the PSC wants data, but does the MHRA have it? Baroness Julia Cumberlege will probably be delighted to know that she has been invited to attend an MHRA Board meeting in the near future in order to keep her abreast of developments. I do hope she is prepared to be disappointed.
It would appear that health professionals and the public still don't know about the Yellow Card scheme. Whilst confirming that more patients were reporting than professionals, the concerns were over how to inform professionals going forward. Ironically, Dr Cave reiterated that all Yellow Cards were ‘welcome’ —poor choice of words, I feel. In summary, do the British public know about the Yellow Card system, and do they know about the MHRA? If our audience were asked, there would likely be a resounding yes.
Dame June Raine announced that artificial intelligence will be used for three main purposes from now on:
- Diagnostics
- Antimicrobial Resistance
- Dementia
The ‘uniqueness’ of the MHRA was highlighted a number of times. Why is the MHRA so unique? It’s because they have access to data that no one else has, through the NHS and your GP via CPRD, Genomics England, INNOVATE and the Yellow Card Biobank.
The subject of clinical trials always takes centre stage at an MHRA Board. There is big money in trials, and with 67 million of us in the UK to experiment on, there’s no shortage of compulsory volunteers. Dr Mark Bailey, Chief Scientific Officer at National Biological Standards and Control Laboratory assured the Board that clinical trial applications were once again on track to deliver for industry. Regarding training for clinical trials, it appears no accredited training has been sourced. It seems the MHRA is winging it and creating some training as they go along.
Although there are only 10% of vacancies available at the MHRA, it appears there is some difficulty recruiting people with Digital and Technology experience. These vacancies appear hard to fill, particularly as the MHRA makes a point of recruiting from local areas only (South Mimms, London).
Raj Long did attend the Board this time. Regular readers will remember Ms Long’s history and experience with the Bill and Melinda Gates Foundation. As she is the main contributor to the UK Dementia Plan, I am still trying to figure out why someone with zero medical qualifications can land a job like that. What does she know about Dementia that our qualified ‘experts’ don’t? Perhaps it has something to do with a vaccine. Ms Long, who is always keen to promote the MHRA, suggested pushing a little harder in order to achieve international acclaim and the Golden Globe for best regulator in the world. Did I really hear someone say, “Manufacturers of vaccines who are interested in working with the UK: if the stars line up, the opportunity is massive”? What opportunity—and massive for whom?
Another comment applauded the fact that the MHRA, by its own admission, is no longer a regulator but an enabler. Are you confused? I’m not. The MHRA most certainly is an enabler; it enables Big Pharma, which then enables the NHS to operate. Let’s face it, why do we turn to the NHS? To feel better, yes, but how? Through drugs and medical devices, of course. How many times have you come out of the GP’s surgery relieved you have a prescription in your hand? It feels a bit like a fait accompli. Perhaps the NHS should be renamed the NPS—National Pharmaceutical Service. After all, the MHRA enables the NHS to dish out Big Pharma’s new potions and lotions to us, whilst it also enables Big Pharma arterial direct access into the NHS.
This was Chairman Stephen Lightfoot’s last meeting, and there was the usual nauseating thanks and congratulations. In the absence of a new Chair, who has yet to be appointed, three of the Non-Executive Board Members will fill the gaps. Professor Graham Cooke will chair the meetings ad interim. To me, this means that the World Health Organisation may as well be chairing the board remotely.
So those were some of the topics discussed. However, what missed the agenda yet again were the vaccine-injured, excess deaths and serious adverse reactions. Despite UK Column members submitting relevant questions, they were ignored. Also missing from the agenda was the recent swoop by MHRA enforcement officers. Perhaps it will be on the September agenda. In the meantime, a press release reveals the following:
The Medicines and Healthcare products Regulatory Agency’s (MHRA) Criminal Enforcement Unit (CEU) seized a quantity of suspected unlicensed medical products following coordinated raids at three residential and six business premises in Bolton, Greater Manchester.
Officers from the MHRA and Greater Manchester Police seized unlicensed medical products including unlicensed versions of Botox, numbing agents and dermal fillers.
Andy Morling, MHRA Deputy Director of Criminal Enforcement, said:
Medicines like these are powerful and dangerous in the wrong hands, potentially leading to serious adverse health consequences. The criminals trading in these products are not only breaking the law, they also have no regard for your safety.
During a previous MHRA Board meeting, Andy Morling said he wanted to put a ‘ring of steel around the UK’, in order to protect the British public to keep them safe from illegal medicines and illegal online websites. Perhaps he hasn’t received the Covid–19 injection Yellow Card data from his bosses? It is also worth noting that, from the get go, there was evidence available regarding the safety of the Covid–19 vaccination and the use of Botox. The UK Column’s regular audience will know this; however, who else was warned?
On a final note, Alex Kelly dropped me a message to say that she has been blocked by the MHRA on Twitter. But for what? This is her reply:
I was posting on their vaccine tweet about when are they helping the injured and bereaved.
She also added a link to the legal fund for the vaccine injured and bereaved. For that, she got blocked. Be assured that there is much going on in the background. If the MHRA think they can continue to ignore us, they are very much mistaken. Do No Harm.
Long Vax
First Long Covid and now Long Vax. What is the difference? According to the symptoms, not a lot. Could they be one and the same? All ‘vaccines’ carry risk; that is a fact. With over 500,000 reports of serious adverse reactions and thousands of deaths, you’d think scientists and doctors would have joined the dots by now.
One symptom seen in Long Vax is Postural Orthostatic Taccycardia Syndrome (POTS). Click here for the original study. We have heard from UK CV Family that many of the vaccine injured have been diagnosed with POTS. Many suffer with dizziness or feeling faint if they change position: sitting—standing, lying—sitting. A healthy body accommodates for the sudden change in blood distribution, but those with POTS can’t, so the heart responds by pumping harder and faster to compensate. Despite the evidence and lack of investigation into serious adverse reactions to the Covid–19 injection, some clinicians are blaming anxiety when patients are presenting with symptoms of POTS.
It is worth highlighting that women are more predisposed to POTS, and we are hearing many anecdotal reports from women who have been diagnosed with POTS. This debilitating condition makes life very unpredictable and many suffering with POTS find their lives are severely impacted on a daily basis. More to come on this in the following weeks.
NHS
Junior doctors are currently in the middle of a five-day strike. Accident & Emergency and Outpatient departments are empty and eerily silent. Operating theatres are empty. Thousands have had their surgery cancelled, treatments have been put on hold and patients are having to endure a never ending life of pain, anxiety and uncertainty because the NHS said no. The current strike is due to end today, Tuesday 18 July, but this might just be the start if they refuse to accept the Government’s final offer of a pay deal, threatening to carry on strikes for as long as it takes.
This week, we will see Consultants go on strike for the first time. Ultimately, of course, it is the elderly and sickest in our communities who suffer. As a Government Minister declares that doctors are not an exceptional cause, how do the public feel? As doctors stand on picket lines, how many car horns are hooting now? Are we losing patience with junior doctors, after all, why are we paying them for a service that is clearly not fit for purpose?
As police are offered 7% pay rise, junior doctors ask why they are only getting an offer of 6% and nurses are asking why they settled on 5%. Are police worth more than doctors and nurses? Why are we paying doctors more for a lesser service than we should be receiving? It didn’t take long for nurses to show their fury at the Governments announcement. Were they fobbed off with a mere 5%? It appears they think they were.
News in Brief
Nano machines—the world’s smallest machines
Do you know what a Nano car dragster is? A nanosubmarine or even a nanorocket? These tiny machines are not science fiction, they are science fact. With hydrogen peroxide as the new fuel, anything is possible. These are tiny machines that can deliver anything, even drug transporters, around the body. And would you believe it, there are actually nano car competitions on nano size tracks. Fast and furious it may not be, however fast and curious it certainly is.
Ant Bots
Tiny robots that can sit on a human hair using nothing but light to power them! Smart micro robots that walk autonomously.
National emergency Guillain-Barré Syndrome
The Peruvian Government on Saturday (8 July 2023) declared a 90-day national emergency amid a sudden spike in cases of the rare neurological condition Guillain-Barré Syndrome (GBS).
As of now, doctors seem to be mystified. They obviously haven’t received the memo we did.
Tennis Nanotechnology
I do hope those of you who are tennis fans enjoyed Wimbledon. Congratulations to our very own home grown Henry Searle from Wolverhampton, the new Wimbledon boys singles champion. It was a typically wet year, so nothing unusual there. However, what was unusual was the mysterious disc attached to Novak Djoković’s chest. Nanotechnology invades every corner of our lives, tennis included.
According to the Taopatch website:
Taopatch is a patented wearable nanotechnology device that combines acupuncture with light therapy. It contains layers of nanocrystals, which capture your body heat and convert it into impulses of very weak light, which is then emitted onto the specific points on your body. This light stimulates your Central Nervous System and enhances its communication with the rest of your body.
Do you feel confident that nanotechnology will make you feel better? Personally, I don’t. I also noticed he was sponsored by Waterdrop, a new micro way of hydrating yourself. Whatever next? But whatever it was, it didn’t win him the tournament. Congratulations to Carlos Alcaraz for a thrilling final.
Talking of keeping hydrated, hot weather and hydration go hand in hand. They’re even naming heatwaves now! The one causing fires in Europe is called Cerberus. Wasn’t that the three headed dog who guarded Hades? Although now I see the next heatwave, Charon is on the way, Charon who ferries the dead over the River Styx. Perhaps there is a dark clue in the names. As I hear of holidaymakers cancelling their holidays abroad, I wonder why. Don’t Brits crave hot countries for summer holidays anymore?
As Canada continue to endure hundreds of wildfires, our thoughts and prayers are with all those who have lost their lives, including firefighters and those who have lost their homes. With earthquakes, volcanoes and unpredictable weather, the planet appears to be shaking.
Until next week, go safely and God bless,
Debi.
Ephesians 6:12 KJV
For we wrestle not against flesh and blood, but against principalities, against powers, against the rulers of the darkness of this world, against spiritual wickedness in high places.
