Comment // Health

Debi Evans Blog: Easter 2024

Royal Family cancer crisis

Shortly after news that the Duchess of York had received two cancer diagnoses, breast and now melanoma (skin), we heard that King Charles had also received a diagnosis of cancer. This week, the headlines are dominated with the latest news that the Princess of Wales has also been diagnosed with cancer, and is receiving a course of preventative chemotherapy. My thoughts are particularly with her young children, who will have to watch or listen to Royal correspondents across all channels globally speculate and predict what may or may not happen next. I am not a Royal correspondent, neither am I a fortune teller, so I will refrain from commenting, speculating or predicting until more facts emerge. 

MHRA Board Meeting

Last week I, along with sixty members of the public, attended the Medicines and Healthcare products Regulatory Agency (MHRA) board meeting remotely. Well done and thank you to everyone who attended. Can we get that into three figures next time? As always, the ‘One Agency’ ambition is still very much at the top of their agenda. In January, the MHRA launched its ‘International Recognition Procedure’. This allows the MHRA to partner with other countries to approve and therefore facilitate quicker access to new medicines, enabling the NHS to roll out experimental drugs to the British populace without so much as a glance:

At launch, the MHRA will partner with regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area).

Applications under IRP can be received via the MHRA website under one of two recognised routes. Time horizons for authorisations are set at 60 to 110 days—considerably shorter than the current 150-day time horizon for applications.

I have been attending MHRA board meetings since they started broadcasting them on You Tube, back in 2021. I normally refer to them as ‘bored’ meetings but the latest one was far from boring. This time, we were kept on the edge of our seats, as the information and revelations just kept on coming. Thank you to Cheryl Grainger, who joined me on UK Column Extra to dissect our findings. There was so much great information to share: what is normally an exclusive broadcast for members only, was made public. Please share that UK Column Extra link wherever you can; it’s an exclusive.

The MHRA board meetings are now well known for a preposterous amount of self-congratulatory backslapping. I recommend having some ginger to hand, just in case nausea takes over. But all is not well at the MHRA: in fact, behind closed doors, a high percentage of the staff are either miserable or sick. It’s not a great look for a medicine ‘enabler’, is it? No wonder they offer reward vouchers to those whom they deem to be doing a good job. Think of £100 or £50 reward vouchers as a virtual bunch of flowers or box of chocolates, oozed People’s Officer Liz Booth, but the icing on the cake was to be the knowledge that everyone receiving a reward voucher would also receive a handwritten letter of thanks from none other than, drum roll, please … Dame June Raine herself. I bet you are green with envy (joke), although if anyone reading my blog happens to be in receipt of one of these precious letters, we would love sight of it. Well, you can’t blame me for asking: nothing ventured, nothing gained.

Going to an MHRA board meeting is a bit like a lucky dip: you never know what you will hear or learn. My jaw did drop, however, at the last board meeting, as I learned the MHRA was sitting on a cool £4 million surplus—but I didn’t expect to hear that just two months later, the surplus had increased to £6.6 million (yes, I noted the figure, too). But why; how? According to the MHRA, it all comes down to receiving more from ‘industry’ from approvals of medicines, together with a lower wage bill as the MHRA struggles to recruit experienced or qualified staff. Doesn’t that fill you with confidence? Dr Alison Cave, Chief Safety Officer, is meeting with Dr Henrietta Hughes, Patient Safety Commissioner, to discuss the phasing-out of sodium valproate. Aside from that, I don’t see her doing much to justify that huge £195,000 salary she earns. No mention was made of serious adverse reactions from the Covid–19 jabs and neither was any mention made of Dame June’s imminent resignation as CEO of the MHRA.

I used to be able to record the board meetings and show them on UK Column News; we were never told not to. However it appears that since Cheryl was allowed to ask a question on serious adverse reactions to the board members direct, and I filmed it, we are no longer allowed to record or screenshot any part of the meeting. I cannot imagine why, considering that the MHRA professes to offer complete transparency. They wouldn’t have edited Cheryl out, would they? Perhaps we frightened them? Now I have to rely on my dusty shorthand skills to report.

Beneath are two excerpts from the board meeting that you may find interesting. The reports are verbatim.

Dame June Raine, CEO, MHRA: March 19 board meeting report—

Well, thank you very much indeed. And I'm sure colleagues will have, as you said, read the paper. And clearly, it has been a very busy start to the year, with important progress. The point I'd like to highlight, as we work as One Agency, is our relentless focus on our Return to Green project, as we look to regain perhaps some of the lost momentum after Covid and with the transformation changes and return to statutory timeframes for performance.

I'd like to highlight how well Regulatory Connect is progressing as we launch, by the end of this month, Track My Case and Check My Data; so that will greatly help companies follow progress. And our international recognition procedure is now bedding in. I think we heard just this morning how many applications are coming, and are split 50-50 with innovative and generic products: something the Board has been following.

I'd like to highlight the immense variety of science and research undertaken at our science campus. We're used to expecting flu vaccines, for example, coming through. But clearly, a grant that funds antimicrobial resistance work is very timely and important alongside our work on diagnostics. And I think the Board will have noted quite a few examples where our end-to-end process takes something like dementia work, neurodegeneration. We've got everything from the biomarkers through to the products coming through, and then the post-marketing surveillance. So a real, if you like, proof that a One Agency model is working in practice.

Safety is always our first priority. It was really good that our four Chief Medical Officers chose to reinforce the need to comply with the valve rate safety restrictions. And clearly, we're going to be delving into the Yellow Card system for the genetic clues to adverse reaction susceptibility as an important project with Genomics England. So really, I wanted to just highlight our number one, if you like, focus on our efficiency and effectiveness, our new ways of working being embedded in our regulatory connect system that replaces our legacy technology, and the commitment of all our staff to working together.

And I think, while there's a lot of change in the air, what doesn't change is that commitment of all our staff. And I know the Board would want to join me in thanking staff for their commitment to keep putting patients first. So just some words of introduction. I'm really happy to explore some of the items in more detail. I know it's a long report. No, it isn't. It's always sort of reflecting the breadth of work that's going on. So thank you.

Now for a short piece from Raj Long, Non-Executive Director, MHRA and UK Health and Security Agency—who is with the Bill and Melinda Gates Foundation. At this point, I would like to remind readers that Raj Long is both the architect and author of the UK Dementia Strategy. But who is Raj Long? Great question: there is minimal information about her, but we do know that she is neither a Consultant Geriatrician nor a Consultant Neurologist or specialist in neurodegenerative disease. And yet despite all that, the UK Government has accepted her paper and adopted it within the NHS!

The subject of misinformation is high on most departmental and agency agendas; I cannot imagine why. This is what Raj Long had to say, verbatim.

Just to add to that it was really interesting to see the FDA Commissioner's perspective the night before the meeting, when we were discussing misinformation and all of the rest of it at the dinner. I think one thing that comes across is: misinformation is very invasive.

We tend to see it in one area or two areas, but actually it's much wider. The impact of misinformation ranges from vaccine hesitancy—not taking medicines and vaccines and products is an example—right through to questioning safety on very specific areas like Valproate.

I would like to suggest that we look at it first in a very strategic big-picture perspective and then target down to what would be the two or three priorities we want to hit first. Because, if I can use the expression, you can't boil the ocean here on misinformation. It won't work. We won't have the resources, but we need to be very specific. 

And I would like to finish that comment with saying: it doesn't matter how innovative we are and creating all the different regulatory pathways—all of that, manufacturing, accelerating manufacturing—if patients don't want to take the products because they don't trust the system. I think that has to be the underlying premise when we're looking at misinformation.

Because that's the impact it has: distrust. And two areas, I think, we need to think [about] when we're communicating science, particularly on safety: it's really important to step back and see who is communicating to who.

The messenger is equally important to the content of the message, so that you have the right impact. And that varies quite a bit in different settings. So just some insight into looking at misinformation. Thank you.

Why was Raj Long at a US Food and Drug Administration dinner? Whom was she representing? Evidently, there is a growing concern among the ‘regulators’ that misinformation is leading to mistrust, which in turn is leading to a reduction in uptake of vaccines and some therapeutics. Raj Long is working on the premise that the public are too stupid to have figured out that ‘change agents’ or ‘trusted messengers’ are appointed to spew lies on safety and efficacy. Nice try, Raj, but we see through you.

The Clinical Practice Research Datalink (CPRD) is always a topic of conversation at board meetings. The MHRA is desperate for your data, and what better way to grab it than to be directly linked to your GP surgery. Is your surgery signed up? Do you know where your data is going? Ask your surgery and make an informed decision as to whether you are comfortable sharing your medical data with … who exactly? 

In summary, this board meeting showed the MHRA up for who they really are, what they stand for and what their direction of travel is. I think we all know enough by now to realise that the MHRA is not there to protect us, the public, those who pay their wages, from harm. In fact, it is the reverse; perhaps now is an apt time to remind everyone that MHRA is an acronym of HARM. One thing is for sure: we see them….and they see us watching them. I rest my case.

Stories in Brief

Gender Reassignment gets reassigned to GPs

Specialist gender clinics with specialist clinicians are apparently overwhelmed. What to do when demand outweighs supply? It appears the next best option is to refer patients to their family doctors for assessments, hormone treatment and referrals for gender reassignment surgery. I would like to note that the GPs I have spoken to have expressed concern that:

  1. They are not trained in gender reassignment;
  2. They are already overwhelmed with other medical conditions;
  3. They do not have the individual consultation time required in order to carry out lengthy assessments.

GPs who do nevertheless agree are to receive specialist training from a transgender centre in Nottingham. Does that fill you with reassurance? Perhaps someone could suggest specialist training for GPs on informed consent and serious adverse reactions from experimental pharmaceuticals?

Cancer mRNA human vaccine—Imperial College London

Imperial College proudly announces that the first British patients have now received an experimental mRNA cancer ‘therapy’. The treatment is called mRNA-4359. The cancers that are targeted are melanoma (the Duchess of York’s recent diagnosis), lung cancer and other ‘solid tumour’ cancers:

The Mobilize trial is run in partnership between Imperial College London and Imperial College Healthcare NHS Trust, with the first patients in the UK receiving the treatment at the National Institute for Health and Care Research (NIHR) Imperial Clinical Research Facility at Hammersmith Hospital.

Pfizer boss Albert Bourla takes pay cut

It appears that the CEO of Pfizer, Dr Albert Bourla, has been forced to take a pay cut. Could this have anything to do with the fact that no-one wants Pfizer poison any more? As the company’s revenue declined by 41%, their shares took a dive, too, plunging by 44%. And no-one is feeling the pinch more than Bourla, who has had to take a 35% hit to his salary, which fell from $33 million in 2022 to $21.6 million in 2023. Swings and roundabouts come to mind. Perhaps where he loses on the ‘vaccine swings’, he will make good on the cancer roundabouts?

Committee to Unleash Prosperity

Do you remember SPARS Pandemic 2025–2028, a futuristic scenario, written in retrospective form, of a pandemic involving a coronavirus? It appears we now have our own 2024 retrospective of the plandemic. COVID Lessons Learned: The Committee to Unleash Prosperity is an American ‘think tank’ whose aim it is to educate policymakers and the public about government policies that have been successful and unsuccessful. They claim to be non-partisan and apolitical, and that they simply exist to identify policies best suited to unleashing prosperity. 

The organisation is chaired by John Catsimatidis, the CEO of The Red Apple Group, a Fortune 500 company with an annual revenue of $5 billion. Red Apple is everything you would expect from a diverse holding company, with interests in oil refineries and biodiesel plants. Add to that Catsimatidis’ wife philanthropic wife, Margo, and you have the perfect partnership. 

The report tells us all we already knew four years ago. Its top-level pearls of wisdom are:

Lesson 1: Leaders Should Calm Public Fears, Not Stoke Them

Lesson 2: Lockdowns Do Not Work to Substantially Reduce Deaths or Stop Viral Circulation

Lesson 3: Lockdowns and Social Isolation Had Negative Consequences that Far Outweighed Benefits

Lesson 4: Government Should Not Pay People More Not to Work

Lesson 5: Shutting Down Schools Was a Major Policy Mistake With Tragic Effects on Children, Especially the Poor

Lesson 6: Masks Were of Little or No Value and Possibly Harmful

Lesson 7: Government Should Not Suppress Dissent or Police the Boundaries of Science

Lesson 8: The Real Hospital Story Was Underutilization

Lesson 9: Protect the Most Vulnerable

Lesson 10: Warp Speed: Deregulate But Don’t Mandate

The report concludes that the USA should halt all binding agreements with the World Health Organisation until satisfactory transparency and accountability is achieved; and that unless key institutions openly acknowledge that lockdowns, school closures, and mask/vaccine mandates were catastrophic errors that will not be repeated in the future, the American people will—and should—withhold their trust. 

And Finally

Many of you, including myself, are grieving the loss of loved ones, family, friends and pets; it’s been a tough few years. Looking forward, the situation may not get better before worsening first. It is time for us all to be strong and hold on to our faith, and each other, for what may be dark days ahead. With that in mind, I would like to share a poem with you. I hope it gives you as much comfort as it does me. 

The Ship by Rev. Luther. F. Beecher

What is dying?

I am standing on the seashore, a ship sails in the morning breeze and starts for the ocean.

She is an object of beauty and I stand watching her till at last she fades on the horizon and someone at my side says: "She is gone."

Gone!

Where?

Gone from my sight, that is all.

She is just as large in the masts, hull and spars as she was when I saw her, and just as able to bear her load of living freight to its destination.

The diminished size and total loss of sight is in me, not in her, and just at the moment when someone at my side says, "She is gone."

There are others who are watching her coming, and other voices take up a glad shout:

"There she comes!" … and that is dying.

Easter

Do you recall how the shepherds heard the news of the birth of Jesus? One of the most popular carols sung at Christmas is While Shepherds Watched their Flocks by Night. Shepherds were visited by an angel who told them that Jesus had been born that very same day. However, shepherds are only watching their flocks by night during the lambing season, and that only happens once a year: in spring. Sheep don’t give birth all year long. Comments and thoughts welcome.

Many are watching with wonder for the April 8th solar eclipse due to pass over the USA. The trajectory of the 2017 USA eclipse, laid against the trajectory in 2024, forms a cross. But where do they meet? Where do they cross? Which town in America experiences totality, when daylight becomes twilight in a matter of seconds? The answer may surprise you. 

Another exclusive for UK Column: Well done to all of those who managed to grab a copy of the Pfizer Documents Analysis Report that we advertised on Friday’s news. We had them sent exclusively from the Daily Clout in the USA and would like to thank Cheryl Grainger, Amy Kelly and UK Column team who facilitated this. We sold out very quickly, so are going to put another order in immediately. If you would like to secure your copy, please go to our website and pre-order your copy from the UK Column shop. We will get the reports out to you as soon as they arrive. Our huge thanks to Professor Chris Flowers and his 3,500 researchers, who are all working around the clock, analysing the mountain of data, in order to inform us of the truth.

British Summer Time

Also don’t forget, for those in the UK, this weekend coming is when we start British Summer Time: the days get longer and the nights shorter. Clocks will move one hour forward at 1 am on Sunday 31 March (Easter Sunday). 

Until next week; have a blessed and peaceful Easter.

God bless,
Debi

Jesus said unto her, I am the resurrection, and the life: he that believeth in me, though were dead, yet shall he live. John 11:25

Dedicated to Dr Harry Dalton (1958–2024)—a ‘Heart Sing’ doctor. One of a kind, who will be hugely missed but never forgotten