Last week, I attended yet another Medicines and Health products Regulatory Agency (MHRA) Board meeting, but fortunately I was joined by many other UK Column viewers and subscribers. We are growing in numbers, and the MHRA know we are watching them—so thank you for your support and attendance. I asked for your comments and you didn’t disappoint. Therefore, I would like to highlight some of your comments and observations with regard to the Board meeting.
So what did our audience members get from the November 2023 Board meeting? Attending remotely were; 42 members of the Public; 11 Industry; 9 members of staff. We are usually told how many members of Press are in attendance, but it would appear none were present or declared this time.
Our dear friend and expert, Cheryl Grainger, managed to get her question asked at the end of the Board meeting. I suspect that the Board decided they didn’t want to take the risk of putting Cheryl on live again, just in case she slipped in a question they didn’t like. Since Cheryl’s appearance in March 2023, the MHRA appear to have clamped down on filming and the taking of screenshots. I wonder why.
Cheryl’s question: How many Clinical Trials are stopped from progressing?
Below is a summary of the answer given by Dr Mark Bailey Chief Science and Innovation Officer, National Institute of Biological Standards and Control (NIBSC):
- The Agency does not have a clear answer to that question.
- The Agency doesn't collect this data so cannot comment on these reasons.
- Applications are sent back because it might not be suitable in 3% of cases.
- It is up to the sponsor to stop or pause a Clinical Trial for a whole range of entirely legitimate reasons.
The Chair (Professor Graham Cooke) asked: Should we be able to answer?
Answer: For a wider eco-system, the Lord O’Shaughnessy review asked us to capture patient recruitment, setting up centres for Clinical Trials and other aspects. (They have obviously not done this). The Chair confirmed that if it was a safety reason, then they would report it. He was reassured that safety concerns were reported.
Thank you to another of our wonderful viewers, Paul Grimer, a very experienced trained nurse, who sent me a very thorough summary. Here are a few of his observations:
Professor Graham Cook outlines (once again) terms and conditions that the MHRA do not regulate, that this is a meeting in public but not a public meeting, and then gives us a warning that abusive conduct from the public will not be tolerated. The public can’t speak in this meeting and only have a ‘chat’ facility, which apparently is not seen by anyone on the Board. I wondered what Professor Cook might be expecting of us? How any member of the public, if so minded, could get any abuse through to any particular MHRA Board member they might dislike, heaven knows.
In the chat facility, it is stated:
You are reminded that content is only sought for the MHRA to record the meeting for the purpose of publishing on Gov. UK. No content is provided for anyone to take screenshots or photographs of this meeting. Recordings of the meeting must not be downloaded or copied, or distributed to any other person or location.
Albeit that the MHRA make a recording available, we the members of the public viewing only get ‘one shot’ to get it correct, as it happens, since the MHRA have a ‘no copying restraint’. The public have no access to the original recording to check for accuracy of what was said. This is a new adjustment practice from the MHRA. Recording release dates are a gift with which the MHRA allow the agency to progress, further unhindered away from public gaze. In the past, the UK Column were allowed to put out recordings of the meetings before the ‘official’ release. However, that gap appears to have systematically been plugged. I was not allowed to copy and paste any of the chat messages as the copy/paste function was disallowed.
It seemed to me that there was a ‘compliance culture’ of compliments given by Non-Executive Board members prior to the submission of any question. Examples include; “brilliant”, “very commendable paper”, “amazing effort to eliminate backlog”.
I was struck by the rigidity of Professor Cook when he talked of the MHRA’s Mandatory Training for staff being at 89%. He says, “Mandatory means Mandatory”. The answer to that is, carrot and stick. There needs to be a ‘tick in that box’, evidencing rigidity of thought. Having worked in the NHS myself, no organisation ever gets to 100%. Some events get in the way, such as caring for family members, bereavements, ill-health, intentional avoidance because the training is often so poor and so on. Statutory Training is compulsory, for example, Fire Safety Training because this is covered by Statute. Mandatory training isn’t covered by anything other than the wish of the Employer. A bit like the Covid–19 jabs, you might say. Clearly, there appears to be some control issues of staff at stake.
Professor Cook is an Honorary Consultant of Imperial College London and is enmeshed in Biomedical Research. An ‘Honorary’ position means that you are authorised to carry out research in Hospitals, but in that role you don’t see patients clinically. You also don’t have to be employed and often aren’t employed by the host Hospital. So you have no clinical treating responsibility for outcomes other than the protocol research parameters. I find this very worrying because if it gets into the wrong hands, this could be abused. Imperial College covers 5 or so hospitals including Great Ormond Street Hospital.
In the chat, I asked two questions:
- At 9.54: The number 20 was mentioned earlier in the patient engagement group. I asked: Please inform of the number of patient engagement groups that have been held in the previous 6 months, the number of patients on each occasion and the diversity within these patient engagement groups. Thanks.
- At 11.39: I asked: I am interested to know the number of Work Time Equivalent (WTE) equivalent staff positions with the sole remit of Health and Safety employed by MHRA? Furthermore, how is this Health and Safety resourcing kept under review? This is, in particular, with regard to Serious Accident Punishment Accidents Acts, arrangements which necessitated the attention of Health Safety Executive. Kind regards, Paul Grimer
For Question 1, presumably, I will get an email customer experience answer.
For Question 2, the first part of the question was read out. The answer: 6 WTE MHRA staff employed solely on Health and Safety staff but, no information to hand on those staff members who have a Health and Safety role as a side-part of their MHRA employment. There was no information forthcoming on how this would be kept under review since this part of my question was not read out. Similarly, the SAPA arrangement necessitating the attention of the Health and Safety Executive wasn’t read out either.
I find it concerning that the MHRA runs its own Level 4 Biological laboratory, goodness knows what private/public partnership Bio-Labs are being set up across the UK.
Paul was not the only UK Column viewer to attend and report back to us. Thank you to Malcolm who attended his first MHRA Board meeting. Here are his comments:
Just listening to the MHRA meeting (my first)—regarding the matter of sharing information with other regulators in order to speed up approval of new medicines.
I am sure you picked up on this—but I noticed that they said there is currently NO direct communication between MHRA and other regulators—rather, they will be relying on information that other regulators have shared with companies. What?!
The reason given is that if they do it for us, they would have to “do it for everyone”. I fell off my chair laughing at that point. What a gloriously wonderful get-out-of-jail-free card for when things go wrong further down the line.
So to wrap things up, the MHRA Board meeting was nothing more than an opportunity for the MHRA to talk about themselves and pat each other on the back. The delight over clearing clinical trial application backlogs was palpable, I could almost hear industry cheering and the ker’ching of the cash landing in the MHRA’s bank account. Dame June is very excited about all things associated with ‘stem cells’, but not a word was said about serious adverse reactions from Covid–19 vaccinations. Mention was made of reports of a rise in cases of ‘wild polio’, but again, no mention of vaccine derived Polio.
We did learn that the Patient Safety Commissioner has been invited to a future Board meeting. However, before we all get too hopeful, I don’t anticipate her wishing to address serious adverse reactions from the Covid–19 jab. Dr Hughes' blog appears to focus on safety, but not the safety of vaccines. Another takeaway was the MHRA’s new refreshed ‘People’s Strategy’, for which they have appointed a new People’s Officer, Liz Booth, who is keen to implement a ‘reward’ scheme for staff for public recognition. Dame June Raine introduces the People’s Strategy as another enabling tool, this time to ‘enable their people to flourish’. Clearly, this was never designed to benefit patients but rather to focus on their people, in order to attract and retain the best people, develop exceptional people and people leaders, value diversity and promote well-being and inclusion. I got the impression that one of their primary goals is to promote the MHRA as being a truly great place to work. In just six months, they have appointed 120 new members of staff. However, there was no mention of how many staff had left in the same period.
After enduring 2 hours and 30 minutes of the MHRA Board putting on an act for the camera, it all came to a close at 12 midday when they scuttled off for lunch before the afternoon private Board meeting. So what do they discuss in the later meeting that they can’t discuss in public? For those of you who are kicking themselves because you missed out on this Board meeting, there is always next time. Pencil these dates into your diary for the New Year: Tuesday 16 January 2024 and Tuesday 19 March 2024.
Stories in Brief
WHO Pandemic Preparedness Treaty – UK James Roguski
Thank you so much to James Roguski, who emailed me this week. James has been a warrior and commentator on the World Health Organisation’s plans to rule the world. It seems the WHO are aiming to call the shots for all countries to act in lockstep with their orders should we happen to have another ‘emergency’ health situation. Roguski's latest Sub Stack, entitled “Unravelling the Knots in Your Mind”, shines a light on the inner workings of public servants and those who may be responsible for such a failure. A good question to ask is, who is Sir Philip Barton?
It would appear that the Foreign, Commonwealth & Development Office may have "neglected" to properly perform their duties. We have until 1 December 2023 to reject the amendments made to the International Health Assembly back in May 2022. But have our public servants, who are responsible for the management of these amendments, fulfilled their duties and acted with due diligence? James believes that the amendments were never submitted to Parliament as they were required to do.
Under Part 2 of the Constitutional Reform and Governance Act 2010 (CRaG) no treaty can be brought into force unless it has been laid before Parliament for 21 sitting days without either House having resolved that the UK should not demonstrate its consent to be bound.
James asks that if anyone in the UK has any evidence to show that the submissions were submitted to the Government for their consideration for 21 sitting days, please could you share it with him urgently. He can be contacted on +1 310-619-3055.
Please watch this very special UK Column News Extra broadcast on 27 November 2023, that has been made available for both members and non-members to view, in which James talks in more depth about the situation in the United Kingdom.
This week we had the displeasure of listening to Professor Sir Christopher Whitty and Professor Sir Jonathan Van Tam. It was unsettling to hear how they both wished the UK had locked down earlier and harder. Herd immunity was never an option, and he blamed communication problems for confusion:
I think if we were to go back in terms of our communication errors along the way, and there were a lot, this is firmly one of the ones where I think we didn’t help the public by having a debate that I think, quite rightly, upset and confused a lot of people.
I noted that an embarrassed Chris admitted that he was solely to blame for coining the phrase, ‘behavioural fatigue’, and a mistake for which he received a telling off from his colleagues in Behavioural Science. But how many mistakes did you make that you haven’t admitted to Sir Chris?
Sir Jonathan Van Tam took time off from his new job at Moderna to attend the Covid–19 inquiry in which he revealed shocking allegations that he and his family had received threats that their throats would be cut during lockdown. Despite police advising the family to move out, they decided to stay because of their cat. I noted, however, that no evidence from the police appeared to have been presented. The comments certainly woke up 73 year old Baroness Hallett as she expressed her horror that this sort of event could ever have taken place. She thanked him for his services to the public in such extreme times. I don’t expect those who are vaccine injured or bereaved would be thanking him. But then again, no one bothered to ask them.
Wearable smart phone
Humane have invented an ‘Artificial Intelligence pin’ involving magnets, a touchpad, a projector and batteries. The projector doubles up as a virtual touchscreen, and the display projects onto the palm of your hand. The device can be attached to your clothes. The device powered by OpenAIChatGTP-4 can perform language translation and voice messaging. In fact, it can act as your personal assistant by taking notes and reminding you of daily tasks. The cost is $699 plus $24 per month subscription to the T-Mobile network. Quite literally, you’ll have the ‘whole world at your fingertips’. However, are you prepared to merge your body with AI technology? Are you willing to forgo your privacy, choice and freedom just to have the world in your hands? I, personally, am not a willing candidate.
Lloyds Chemist soon to leave our high streets
Thanks to one of our loyal viewers, Peter, for bringing this story to my attention. As community pharmacists become the ‘lifeline’ and first point of contact for many patients, it is surprising to see that Lloyds Chemist are to close all their pharmacy branches in order to concentrate on the distribution of medicines, community healthcare and ‘specialist pharmacy’. But where does this leave patients who are finding it difficult to get an appointment with a GP in person and are now relying on their local pharmacist? Well, an online pharmacy, of course.
Iceland bans Covid–19 shots
Yes, you read that correctly. Thank you Peter for bringing this to my attention. Sasha Latypova was one of the six speakers at a conference that took place in Iceland entitled ‘Let The Science Speak’. Six weeks later, the organisers of the conference informed Latypova that the Icelandic Government had announced that, from next week, COVID-19 injections would no longer be available in Iceland. Bravo Sasha and all who took part. Her interview with UK Column can be found here.
Virtual Fracture Clinic
What exactly is a virtual fracture clinic? I had no idea they even existed until I was told I had been to one, although in fact, I hadn’t been anywhere. Are you confused? I was.
As many already know, I have broken my foot, again. This time, not only was I not able to get an emergency X-ray, I also had to wait for five weeks to be told my foot was broken and to be referred to the fracture clinic. As an unfortunate veteran of the fracture clinic, I waited and waited for a call to invite me to attend, but no calls ever came. Instead, a week later a letter arrived. The letter informed me that I had attended the virtual fracture clinic and a decision had been made regarding my injury. All this occurred without me being present and without me being consulted! No one bothered to ask how I was or if I needed crutches or pain management. Nobody asked if my toes were pink and moving, or if there was any swelling, or if I could manage the stairs ok. No one cared to ask, because in reality, no one cares.
I telephoned my good friend Dr Ahmad Malik, a senior orthopaedic consultant who is also one of the architects of the ‘virtual fracture clinic’. He informed me that many patients don’t actually need to be seen in person in order to make a diagnosis or to access help going forward. I will agree, a fracture clinic is not the best place to have to sit and wait while in pain, and they are always very busy with waits that go on for hours.
However, Dr Malik also informed me that a ‘virtual fracture clinic appointment’ must include a telephone conversation with the patient and one of the team, and that the final decision on care management must lie with a Consultant Orthopaedic Surgeon. I never received any such call and the letter did not say that anyone had tried to contact me. I had, in effect, received sub optimal care on a grand scale and my fate had been decided without my knowledge. Luckily for me, I could interpret the letter and was not in any pain—but what if I wasn’t? I am pleased to say that Dr Malik can be contacted here if you need a second opinion, some advice or an interpretation of diagnosis and treatment.
Two new Covid vaccines approved
It seems that the majority of Australians are choosing not to get a booster shot. The latest offerings in Covid–19 boosters and shots from Pfizer and Moderna is being met with strong resistance from the Australian population. Bravo to all our Australian brothers and sisters, likewise we are seeing a similar picture in the UK. However, the Australian Government won’t give up and are already planning a new ‘vaccine awareness’ drive. Please note that there is no mention of a ‘vaccine adverse reaction’ awareness drive. A message to Dr Albert Bourla and Stephan Bancel, we don’t want your mRNA jabs or any other jabs you may have planned for us; not now, not ever.
106.4 million US adults without a job
Apparently, 106.4 million US adults are out of work. With a population of just over 300 million, that equates to a third of the population being jobless. Of course we have to factor in the elderly and disabled, however, that is still a huge percentage of Americans out of work.
The Economic Collapse Blog states;
When a working age American is not working, the government puts that individual into one of two categories. Right now, there are only 6.5 million U.S. adults that are officially considered to be “unemployed”. But another 99.9 million U.S. adults are considered to be “not in the labor force”. So they don’t count as being “unemployed”. When you add those two numbers together, you get a grand total of 106.4 million U.S. adults that do not have a job right now.
By the time you are reading this, COP 28, hosted in the United Arab Emirates, will be in full swing. See for yourself how the UAE are performing in climate change and carbon emissions—can you see my eyebrow raising? King Charles will be there talking about carbon capture, climate change and sustainable goals. Remember, he was banned by Liz Truss from going to COP 27. This year, however, he can extend his sausage fingers into yet more climate pies.
Tesco magic tills
Nothing magical here it would seem. Customers are not impressed at Tesco’s latest attempt to track each and every one of us. This new innovation is being marketed as a ‘convenience’, but nothing could be further from the truth. Simply put, it is spying. Sensors and cameras have been positioned in nominated stores and will track how you shop, no scanning required. By weighing the shelves, all shoppers need to do is to put the item into their trolley. Do you live near a Tesco GetGo store? Would you like Tesco to ‘get gone’ with this? I would.
We are living in perilous times. The most appropriate message, in the words of Benjamin Franklin, appears to be "By failing to prepare, you are preparing to fail". Are you prepared for what may come? Do you have enough in your cupboards to feed you and your family for a month should the distribution and transport network go down? After all, you can only survive on chocolates, mince pies and sprouts for so long! Have you been stocking up on batteries for portable lights and radio’s? For young families with babies, have you got enough baby formula in stock? Pet owners take heed, pet food will be one of the first things to fly off the shelves. I am not advocating we storm our supermarkets and panic buy, but perhaps grab something extra next time you are doing a shop. Prices are going up daily, so buying now will save you pounds in the long run.
Next week, I will be highlighting some of your comments on the benefits and risks of smartphones. After asking you all on UK Column Extra if you could give up your phone, I got a lot of replies! Perhaps you will want to give them up more quickly after I reveal a few more facts about them next week. We’ll see!
Until next week,
Watch therefore: for ye know not what hour your Lord doth come. Matthew 24:42