Debi Evans Blog: 24 May 2023

 

Before I start, I want to thank the UK Column audience who have taken the time to attend the MHRA Board meetings. I would also like to thank everyone who has clicked into their Board meetings to record their view. Many of our viewers who do register to attend then send me their views and observations; some of them are vaccine injured, so I cannot imagine how any of them feel while watching. It is, however, very reassuring to know others are witnessing what I am watching too. So thank you for being there with me. 

 

 

The Board meeting held on 16 May 2023 was unique for many reasons, not least that it exposed them for under–performing. Performance featured a lot in this Board meeting, and what a ‘performance’ it has become. As the months have gone on, they have become more scripted and choreographed. Clearly, the members of the Board have had some type of training in how to look at the camera and how to speak directly to the public. It was never like that at the beginning.

 

The MHRA are struggling; the attitude, mood and body language have changed—it appears to show a far more defiant, defensive and, in my opinion, dangerous MHRA. A few ‘love in’s’ were observed but nowhere near as ‘gushy’ as on previous occasions. The mood appeared sombre.

 

In Wednesday’s news I reported on the latest MHRA Board meeting that it has become a regular date in my diary for the last two years. I’m very much a veteran. So much so that I know when to apply for the free tickets in order to attend. I am aware of the meeting agenda, I know to ask questions in good time and lastly, and I have become used to receiving the virtual joining link 4 days prior to the meeting. However, when I didn’t receive a joining link this time, it took one phone call and four emails to eventually receive it the afternoon prior to the meeting. Were they hoping I would forget? Or perhaps they were hoping I wouldn’t notice?

 

The meeting takes place around a horseshoe shaped table and all Board members are introduced by the Chair Stephen Lightfoot. It struck me immediately that this Board meeting was going to be different from all the others I had attended. It didn’t take long to find out why. Out of nowhere, a message popped up in zoom chat. I don’t normally bother to open chat messages, usually because they’re just a general welcome to the Board meeting. However, after receiving four messages in quick succession, my curiosity got the better of me and I clicked on them. The last message was of particular interest. It said:

 

You are reminded that consent is only sought for the MHRA to record the meeting for the purpose of publishing on GOV.UK. No consent is provided for anyone to take screenshots or photographs of this meeting. Recordings of the meeting must not be downloaded, copied, or distributed to any other location.

 

I must stress, I have never received such a message before. Why all of a sudden is this rather abrupt and unfriendly warning being sent? Could it be connected to how UK Column have been reporting on their meetings—with original footage? I would never dare to presume, it is for the public to decide. However, if we were in any way responsible, it would be a badge of honour that I’d wear with pride.

 

Fortunately for me, my mother insisted I complete a Pitman’s typing and shorthand course. I resented her determination at the time, but she said it would be a skill to ‘fall back on’ if I flunked out of my nursing training. She never believed I would complete 6 months of training, let alone the full 3 years and go on to qualify. Sad she didn’t have more faith in me, but proud that I proved her wrong. I digress. Unsure of the legality of such a ‘no recording’ request at such short notice, my pen fired into action. Since the meeting, I have checked my joining details and also emails from the MHRA, but I see no mention of such a restriction in any of the correspondence. Neither did I hear any mention of this in Stephen Lightfoot’s opening comments which include the traditional ‘housekeeping’ of introductions and order of business. In fact, I believed the meetings were a way of the MHRA maintaining transparency, encouraging members of the public to observe how they work. The meetings are held in public to enable as many of the public to view as possible. Now I have to ask the question; are the MHRA editing the original footage of the Board meeting? 

 

Perhaps their interpretation of transparency is different to mine. To be clear, this is a verbatim transcript of Stephen Lightfoot’s opening comments.

 

Welcome. If you haven’t attended a Board meeting before, I must remind you that this is a Board meeting held in public, it is not a public meeting.

 

It is also important to explain this Board is responsible for agreeing the strategic direction of the agency maintaining high standards of corporate governance and also scrutinising the performance of the MHRA, but it is equally important to say this Board does not make any regulatory decisions on any individual medicines or medical devices, and that is because the regulatory decisions themselves are made by Ministers in Department of Health and Social Care, on the recommendations of the MHRA officials who themselves are civil servants, with the additional independent advice from our expert advisory committees such as The Commission for Human Medicines.

 

In today’s meeting I must make you aware we are recording the meeting so we can publish the video on our website to provide opportunity for as many as possible to observe what Board does. Today there are 79 registered to attend, 45 members of the public, 19 from Industry, 4 from Media outlets and 11 members of staff.

 

 

It is now apparent that the MHRA are the key element to success in the UK Government’s Life Sciences plan, the ‘piece de resistance’. Without a ‘regulator’, big pharma are powerless. Without power, they are nothing, and without sick people, pharma have no customers. Without sick people, doctors have no job. Far from a National HEALTH system, it is a National Illness system. So it is in the best interest of the MHRA to keep us as unhealthy as possible.

 

However, it appears all is not going according to plan. The driving force to achieve world domination in pharmaceutical regulation is DATA. With a dense and diverse population of over 67 million and only one compulsory healthcare system (NHS), each piece of data is another jewel in the UK life science’s crown, the MHRA are under intense scrutiny and pressure to ‘perform’ and hit their targets. Data = dominance, power and control.

 

Many of our audience will remember me reporting on the importance of the CPRD and its vital links with GP’s. But what is the CPRD?

 

 

 

The MHRA are clearly under performing. Eager to reach their targets, please their Ministerial masters and obey their owners (big pharma), they appear to be letting the side down. We know, from previous meetings and select committees, that the MHRA want data from 60 million of us—and much of it will be taken from the NHS App. Do you want it on your device?

 

 

1. Lack of clinical trial applications being received from industry to UK. This could explain AstraZeneca’s recent decision to move their new operation to Dublin, disenchanted with the UK Tax laws.
2. People are not volunteering readily for clinical trials.
3. There is not enough staff at National Institute Biological Standards to process applications.  
4. Awareness of data sharing, more choosing to opt out.
5. Increased mistrust of the MHRA from members of the public.
6. An inability to meet targets because of poor retention of staff at MHRA.

 

MHRA Board meetings always end with questions from the public, Stephen Lightfoot’s favourite part of the meeting, although I am not sure he felt that at the last Board when our good friend Cheryl Grainger had a question accepted. Finding herself just a screen away from the Board, she bravely put them on the spot. Sadly, this time we didn’t get anyone asking a question live on screen. Perhaps Cheryl spooked them last time.

 

 

Question from the public:

“Does the Board consider the performance of the MHRA to be adequate in respect of transparency and openness?”

 

Dame June Raine: 

“It is a good question, thanks to the questioner. Really, the important point is how seriously we take our performance, in being open and transparent about everything we do, because as we have just discussed in the context of the corporate plan, it’s the bedrock of public trust.

 

I’d secondly say we’ve made great strides when we think about, even today, performance statistics regularly published every month, the fact that evidence on which we make decisions is made available after a new product comes through the decision making process and in terms of that decision making, opening it up to patient involvement so there is a real differentiation in a number of levels in which we believe transparency and openness are absolutely key to the safe use of the medical products we regulate.

 

Having said all of that, the substantial progress there is a lot more to do, we are on a journey. We have talked in the last minutes about having the corporate plan first pillar, we are looking to build trust. We want to be able to do much more in terms of involving the public in hearings, for example, and I do think in terms of the evidence and information we hold, the interactive use of our vaccine safety data, all of which is geared to helping individual judgements of benefits and risks.

 

So we see this as a really important area, and there is more to do, and we are doing it with a purpose, which is ultimately these individual decisions on benefit/risk that we believe we want to support in the best way possible.”

 

Stephen Lightfoot asks Michael Whitehouse: 

“Are we doing enough around the theme of transparency and openness and is there more we can do?”

 

“Yes we are a transparent organisation. All the documents we produce are very clear about what we are seeking to achieve”. (He also added)…. “There is more to do but internationally compared to others I think we are transparent.”

 

Do you believe them? I don’t.

 

 

Stephen Lightfoot closed the meeting with:

I conclude the MAIN session (why is there another one we don’t get to see?) for Board. Thank you everyone. I remind you the purpose of the MHRA is to protect and improve public health and we will continue to do that by ENABLING scientific innovation, by ACCELERATING patient access to new safe and effective products and to strengthen our patient safety and SURVEILLANCE systems.

 

So there you have it, in a nutshell. The MHRA are, in my humble opinion, angry and exposed. Angry for being found out? Angry for not achieving their precious targets? Angry for upsetting their sponsors and funders? Angry for underestimating the intelligence of the British public? Angry people can be unpredictable. What will the MHRA do next to entice us into their web of corruption? I am not sure there is anything they can do to entice any of those reading this. Sadly, there are still millions willing to purchase snake oil from snake oil merchants. However, the people are speaking and the MHRA hear us. Angry they may be, but angry reveals the true nature of the MHRA when the mask slips.

 

I carried out my own small poll on twitter. I asked “Do you trust the MHRA to deliver and approve safe medicines in the UK?” The results are in. In total, 487 took part over 24 hours; 97% said no they did not trust the MHRA, with only 3% saying they did trust the MHRA. 

 

To starve the MHRA of power and ambition to become the gold standard of global regulators, I have a few suggestions. I believe we must refuse to enrol in clinical trials and refuse any tests if we are healthy. Lastly, we should check with our GP to ensure our data is not being shared with anyone. These are my suggestions, but everyone needs to make their own informed decision. 

 

As Stephen Lightfoot gets closer to his final day with the MHRA, after stepping down to ‘spend more time with his grandchildren’, I wonder how long it will be before we see others following his example. Rats and sinking ships come to mind. Remember, the MHRA need US more than WE need them. By refusing to share your data, you are disabling them. 

 

DIY Dentistry in the UK

 

 

The cost for an NHS check-up at the dentist has risen to £25.80 this week, as dentistry fees rise by 8.5% across the board. [. . .] More complex treatments, such as crowns, will now cost £306.80 (up from £282.80) after the charges rose for the first time since December 2020, when they were frozen due to the coronavirus pandemic. [. . .] Dental treatment is charged in ‘bands’, with higher charges for more complex dental work. You should only pay once for each course of dental treatment, so the maximum you should pay is £306.80.

 

 

 

 

 

And finally

 

Until next week, stand firm, join your own dots and keep smiling.

God Bless 

Debi 

 

John 5:24 KJV

Verily, verily, I say unto you, He that heareth my word, and believeth on him that sent me, hath everlasting life, and shall not come into condemnation; but is passed from death unto life.