Many of our regular audience will know that UK Column has been hot on the heels of the MHRA since the rollout of the Covid–19 vaccines. We will continue to keep them under intense scrutiny.
As we were broadcasting the news last Friday, a very important letter to the MHRA, sent over three months ago, was released by the All-Party Parliamentary Group on Pandemic Response and Recovery. Thank you to everyone who alerted me to it; I have never had so many people alerting me to one topic in such a short space of time. I am very grateful that many feel that UK Column has been instrumental in shining a light on the MHRA, who have been lurking in a very dark corner. We have been reporting on their board meetings since the get-go and I have personally attended almost all of them. I thank everyone who gives UK Column accreditation for keeping the public informed. Do No Harm—they don’t appear to have received that memo yet.
This is the reason why I have chosen to reproduce a large portion of the letter beneath, highlighting in bold some specific points of significance. However, due to the detail and length of the original letter, I have had to omit some of it. The whole letter, ‘Raising Concerns about the MHRA’, can be found here. Please do read and share far and wide.
I am very relieved to see so many of the points that we have been trying to raise for so long aired in this communication by MPs. Now, finally, our voices may have been heard, recognised and addressed in Parliament. I hope and pray that all those who have been injured by pharmaceuticals, medical devices and blood products will be properly recognised, respected and compensated.
It would be wonderful to hope that in some way, UK Column has helped raise public awareness and shone a light in a very murky place. There is a whole library of material and articles focusing on the MHRA that can be found on the UK Column website.
Thank you to the experts and parliamentarians who signed the letter beneath, and also those behind the scenes who worked so incredibly hard; you know who you are.
[Released] 9 February 2024
Steve Brine MP
Health and Social Care Committee,
House of Commons,
London, SW1A 0AA
Letter by email
SENT: 24 October 2023
Dear Steve,
We write regarding serious concerns about the approach of the Medicines and Healthcare Products Regulatory Agency (MHRA) to patient safety and also problems in a system that, far from protecting patients, continues to put them at serious risk.
The most recent examination of patient safety failings, the Independent Medicines and Medical Devices Safety Review (IMMDS), in its thorough investigation of Primodos, sodium valproate and pelvic mesh, brought a number of these concerns to the fore. Within the scope of what it was asked to examine, it found the response of the healthcare system was not sufficiently robust, speedy or appropriate, causing patients to suffer, in some cases, life-changing or fatal, avoidable harm. We also heard from solicitor Peter Todd, who is acting for 74 individuals who have suffered thrombosis or thrombocytopenia after Covid–19 vaccination.
The evidence leads us to believe that serious patient safety concerns persist beyond even the findings of the IMMDS review. We also believe that the MHRA is at the heart of these far wider endemic failings, and that those cited in this letter merely represent the tip of a sizeable iceberg of failure.
Two aspects of the system which were of particular concern emerged:
The Yellow Card Scheme
Research has shown that a significant number of hospital admissions are caused or complicated by ADRs (16.5%), while analysis of inpatient stays has shown that 15% of patients experience one or more ADRs, with half being either definitely or possibly avoidable.
Under-reporting hinders the ability to detect signals and assign causation. The cost to patient safety of such an unreliable system can be measured in the needless fatalities, the considerable burden on the quality of life for survivors and a £2.2 billion strain on NHS England alone.
In 2018, the MHRA “estimated that only 10% of serious reactions and between 2% and 4% of non-serious reactions are reported.”
Conflicts of Interest and Transparency
The 2004-5 House of Commons Health committee report The Influence of the Pharmaceutical Industry found, “The MHRA was unusual in being one of few European agencies where the operation of the medicines regulatory system was funded entirely by fees derived from services to industry (drug regulatory agencies in other countries are more often only partly funded by licence fees). The MHRA’s activities are 60% funded through licensing fees paid by those seeking marketing approvals and 40% through an annual service fee, also paid by the industry” and that it “failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate.”
The MHRA continues to be primarily funded by income from fees for sales of products and regulatory services: the breakdown sees 50% fees for services, 25% industry periodic fees and 25% Department funding. The fact that in March 2022, Dame June Raine, Chief Executive of the MHRA, boasted of the agency’s transition from “the watchdog to the enabler” does little to quell suspicions of conflicts and the implications for patient safety and cannot be overlooked.
Lack of transparency, a similarly long-standing problem, and not surprising given the inherent symbiosis with conflicts of interest, can be demonstrated by the MHRA’s responses to Freedom of Information (FOI) requests.
Between 2008 and 2017, only 41% of requests were successful. Since 2019, the number of requests has seen a substantial increase from 609 to 1609 in 2021, likely due to concerns about the regulation of Covid-19 vaccinations, but so has the poor response, with 76% of these requests answered outside the 20 working days statutory response time. Often exemptions were applied or vague or evasive responses were received.
The Medicines and Healthcare products Regulatory Agency
The mission of the MHRA is “to protect and promote public health and patient safety, by ensuring that healthcare products meet appropriate standards of safety, quality and efficacy. We keep watch over medicines and devices, and take necessary action to protect the public promptly if there is a problem.” But from regulatory approval to post marketing pharmacovigilance the MHRA has a history of failing patients and in the words of recommendation 6 of the IMMDS “needs substantial revision particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work.
We also fail to see how the spirit of the mission can be reconciled with Dr Raine’s view of her organisation as an enabler: enabler of what? The IMMDS review found that comprehensive pre-market testing, post-marketing surveillance and long-term monitoring of outcomes was “dangerous” (1.15) but what reforms of any substance have been carried out at the MHRA to make the necessary improvements?
For example, at the regulatory approval stage, does the MHRA set safety targets for licensing medicines? Post licensing, can the MHRA distinguish between suspected drug reactions and the underlying condition under treatment in determining signals of harm? The MHRA does not attempt to assess or compare the safety of different vaccines, due to inadequate reporting in the system which prevents any analysis
We know from FoI 23/379 that the MHRA only followed up some 54% of deaths reported in yellow cards as possibly linked to exposure to one of the Covid–19 vaccines.
What statistical analysis of reports is done only assesses the relative safety of the medicines and not causation of the ADR. In fact, due to the methods used in its, Disproportionality Analysis for both non-Covid and Covid vaccines the MHRA missed potential safety signals, as the findings of the Commission on Human Medicines Pharmacovigilance Expert Advisory Group report show.
Government advertisements such as these in the Daily Mirror and Netmums at the very least breached the prohibition on the use of the word “safe”. Concerns raised directly with the MHRA have been met with an habitually dismissive and evasive response.
Perhaps all of these concerns pale into comparison in the light of the House of Commons Session 2004-05 Health Committee Publication on Health - Fourth Report.
The report notes there had been no Select Committee investigation of the industry since the Select Committee report on patent medicines in 1914. “The regulatory system, the medical profession and Government have all failed to ensure that industry's activities are more clearly allied to the interests of patients and the NHS.
“The regulatory authority, which is responsible for controlling much of the behaviour of the industry has significant failings. Lack of transparency has played a major part in allowing failings to continue. The traditional secrecy in the drug regulatory process has insulated regulators from the feedback that would otherwise check, test and stimulate their policies and performance. Failure can be measured by the MHRA's poor history in recognising drug risks, poor communication and lack of public trust. Regulatory secrecy also underpins publication bias, and other unacceptable practices. The closeness that has developed between regulators and companies has deprived the industry of rigorous quality control and audit.”
The report's findings were prophetic in that they predicted the further unsafe use of drugs and the increasing medicalisation of society. Furthermore, the recommendations of this report set out the need to focus more intensely on updating drug benefit/risk profiles in the Summary of Product Characteristics, following systematic post-marketing review.
Conclusion
What conclusions are we to draw about the seeming unwillingness of a regulator, largely funded by those it regulates, to disclose data to the same public it professes to protect? It raises the serious question: is this a regulator primarily concerned with patient safety, keeping watch over medicines and devices and taking the necessary action to protect the public promptly if there is a problem? We feel compelled to conclude that the MHRA has indeed become an enabler for the pharmaceutical industry, with patient safety no longer being its primary concern.
Accumulating evidence and the IMMDS review showed the MHRA’s approach to patient safety requires a radical overhaul. In the words of Baroness Cumberlege in her correspondence of 15 December 2022 to the Committee, “your scrutiny is vital in holding the system to account”.
We urge the Health and Social Care Select Committee to launch a thorough, wide ranging and long overdue investigation into the MHRA, which has overseen and continues to oversee these issues, in a system beset by conflicts, and is often too late in detecting and acting to prevent serious harms. The human cost to the patients and the financial burden on the healthcare system is substantial and failure to act will only lead to more harm and further damage to the public’s trust.
Yours,
APPG on Pandemic Response and Recovery Co-chairs:
Rt Hon Esther McVey MP
Graham Stringer MP
Other signatories:
Philip Davies MP
Sammy Wilson MP
Lord Strathcarron
Baroness Foster of Oxton
Thomas Coke, the Earl of Leicester
Sir Graham Brady MP
Sir Christopher Chope MP
Jim Shannon MP
Allan Dorans MP
Simon Fell MP
Danny Kruger MP
James Grundy MP
Yvonne Fovargue MP
George Howarth MP
Chris Clarkson MP
Hannah Bardell MP
Damien Moore MP
Nick Fletcher MP
Lord Alton of Liverpool
Philip Hollobone MP
William Wragg MP
Alec Shelbrooke MP
Miriam Cates MP
Chair of ACDHPT and Secretariat for the APPG on Hormone Pregnancy Tests (Primodos)—Marie Lyon
Founder of Sling the Mesh and Secretariat for the APPG on Surgical Mesh—Kath Sansom
Professor of Evidence-Based Medicine at the University of Oxford, Director of the Centre for Evidence Based Medicine and an NHS General Practitioner working in urgent care—Professor Carl Heneghan
So there you have it: clear, easy to understand and factual. How I wish I had been there to watch Dame June Raine read that damning letter; I am presuming she has. How could anyone every hold their head up after that, least of all appear in public? I would expect to be locked up and I certainly wouldn’t be able to sleep at night. I am looking forward to the next MHRA board meeting in March. Will the contents be raised, or conveniently swept under a dirty dark carpet? I fear the latter. Maybe those registering for the March board meeting could ask that question? I certainly will; there is no agenda that should omit this.
In the meantime, my message to Dame June Raine, CEO of the MHRA, is:
Do you still feel proud of the vaccine rollout, and all the other approvals for experimental injections and therapies? Have you lied to us? Have you done your job in protecting the British population, kept us safe? Did you really read hundreds of thousands of pages of data from Pfizer, Moderna and AstraZeneca before approving the Covid-19 jab, in just a few weeks? Really? Or do I see your nose growing? Do No Harm—or is it too late? The harm continues to be done. Would Sir Alistair Breckenridge be proud of you, Dame June?
For those who couldn’t attend the MHRA board meeting in January, it has now been published on YouTube here. Please click on it, even if you choose not to watch it; every click counts and it’s free! Thank you in advance.
The Cancer Industrial Complex
How scary is it when we normalise terms such as the Cancer Industrial Complex? Yet cancer is a trillion-pound business, and the engine that drives the cancer machine has just gone up a few gears.
I cannot possibly do justice to such a gargantuan subject in one news broadcast or blog. I have decided to do a section every week on cancer. I will be covering:
- tests,
- cancer artificial intelligence,
- charities,
- surgery,
- chemotherapy,
- radiotherapy,
- behavioural science (yes, cancer has its own department),
- innovative therapies such as CAR T-cell cancer therapy,
- mRNA cancer vaccines,
- scans,
- medical devices,
- diets,
- fasting,
- GcMAF,
- palliative care,
- and, of course, parliamentary legislation.
And that is just for starters.
King Charles III’s cancer diagnosis has certainly provoked a strong reaction with the public, and many are already flocking to the NHS for the ‘Holy Grail of cancer tests’. Would they feel differently if they knew that Sir Bill Gates was the architect? Are the tests reliable? What are the chances of false positives? How might you feel if you were told you had cancer and needed major surgery, only to find that after surgery and pathology, the test was wrong and the surgery totally unnecessary?
When UK Column spoke to Professor Chris Flowers, he reported that this is exactly what can take place. Since Covid, who trusts any tests? It appears there are still many who do. How would you feel if you were wrongly told you had cancer? With an ever-increasing backlog of cancer treatment and a growing waiting list on the NHS, many are being forced to go privately for treatment, so my question is: why would the NHS be encouraging healthy people to seek a test for cancer, when there are so many waiting already for care? It makes no sense.
As I write, how many people do you know diagnosed with cancer at the moment? More than usual? Alarmingly, there are more young people being diagnosed with cancer now, but why? Sure, lockdown helped no-one, especially those waiting for cancer treatment or diagnosis. However, the sudden surge of ‘turbo’ cancer diagnoses should surely raise plenty of red Covid–19 vaccination flags—though seemingly not in all quartes. Experts would have you think the sudden surge is linked to Covid–19, but ask the unvaccinated population whether they are experiencing a sudden surge of cancer diagnoses. Are they?
How many are talking about cancer, fundraising for cancer, leaving money in their wills for cancer charities, or perhaps you are dropping off a bag of clothes to the local Cancer Research UK charity shop? Giving doesn’t mean just money; it means your belongings, treasures and time. Imagine if you opened a shop and relied on the public to stock it with ‘donations’ and staff it … for free, allowing you to flog off the donations for a massive profit with minimal outgoings, in order for you to live a luxury lifestyle. While you may think that is a ridiculous suggestion, that is exactly what is happening on British high streets under the guise of ‘charity’. But when is a charity a charity and not a business or quango?
Charity in my day was a village hall jumble sale, raising money for the local Brownie group, school or Rotary Club; it was never about supporting massive global enterprises. Every year when I was a youngster, my mum took me with her to knock on the doors of the neighbours with an Alexandra Rose Day tin. We would have a basket of pretty pink silk rose pins to give away in return for a few coins in our tins. Today, charities are asking for big bucks to support their research on cancer. As nurses in the 1970s, we were responsible for all palliative care. Today, nurses and doctors defer to McMillan Cancer Care, Marie Curie and hospices to care for those who are dying.
Dying has become big business, paid for by the public twice over: by taxation and donation. Who funded the local hospice in your area? Who is staffing the shops to raise the funds? When does volunteering become slave labour for the globalists and those charity CEOs who continue to rake in extortionate salaries courtesy of your goodwill and donations? Who is benefiting: your loved one or friend who has a diagnosis of cancer, or the CEO who runs the charity?
If there is anyone reading who would like to contribute with their stories or expert advice, we would love to hear from you. Perhaps you are a cancer nurse, end-of-life care expert or work in a hospice? Or have you recently been diagnosed with cancer? I will do my very best to include as much as I can. Please e-mail debi@ukcolumn.org and mention cancer in the subject line.
More on cancer next week.
Stories in Brief
Freedom of Information requests
Thank you to everyone who has been so busy submitting Freedom of Information requests. One of our valued members has gone above and beyond the call of duty. Does the MHRA have a private board meeting, away from prying public eyes? Yes. But are we allowed to see the minutes of this covert operation? No. The volume and content of replies received are simply staggering and there will be more to come on this in the near future. In the meantime, I recommend Big Gee’s Blog. Thank you for all you are doing.
Covid jabs come to the High Street
Roll up, roll up; the Covid jab for the over-12s is coming to your local pharmacist, courtesy of Pfizer/BioNTech (the same manufacturers responsible for the new ‘cancer’ mRNA vaccine). Boots will be rolling it out first to those who cannot get the jab on the NHS. The price will be set by individual pharmacies. Is Boots the Chemist acting as an arm of the state? I have previously e-mailed the CEO of Boots to ask that very question. I never received a reply.
Starbucks pays for staff transgender surgery
Thank you to Peter for reminding me of this. How many were aware of this article published by the Gay Times in 2018? A comprehensive care plan for the transgender community has been in place since 2012.
Starbucks health insurance plans include not only gender reassignment surgery (which had been covered since 2012), but now also a host of procedures for transgender partners in the U.S. that were previously considered cosmetic, and therefore not covered, such as breast reduction or augmentation surgery, facial feminization, hair transplants and more.
Source: Starbucks Stories
Cashless Society—Asda
With more and more retail and hospitality outlets refusing cash, we can now expect that to extend to our supermarkets and cities. Will London be the first cashless city in the UK, as is expected? Most who know me will have realised by now that I hate anything that involves apps or smartphones. However, trying to park your car using cash is getting more and more difficult. Now, Asda have announced that 82 of their stores will go cashless. Is the one near you one of them?
Home-made remedies—Ginger and raw honey recommendations from our viewers
Last week I posted an easy-to-make home-made remedy for colds, which included ginger. Thank you to one of our forum members, ‘Constellation’, who reminded me to mention that fresh ginger grated is far more effective than the ground form. They recommend that you keep it in the freezer so it is easier to grate—and if you thaw it, it starts to go off. Home-made curries, with plenty of ginger, chilli, garlic, turmeric and a touch of fresh coriander, are best to boost your defences against winter cold and flu. Please keep sending in your recommendations, and thank you so much.
Another wonderful viewer, Steve, sent me this recommendation if you are looking to purchase raw honey. He describes the honey as ‘out of this world’ and it can be bought direct from their website or from their shops in the South West of England. The owners are incredibly helpful and respond to all inquiries for advice or recommendations.
And Finally
Apologies for not covering as many stories this week; I felt it was super-important to feature the letter from the APPG. However, next week I will be addressing a couple of elephants in the room, including fluoridation of water and autism/right-wing terrorism (yes, you read that right). How many autistic people will be opening their doors to Prevent officers? Check out Brian Gerrish and me talking about Prevent in one of our latest in the series No Smoke Without Fire.
It is hard to know what to feature in my blog or on the news these days. What is important to one person may not necessarily resonate with another. One thing that we can say with certainty is that life as we remember it will never be the same again. No one person can stop what is now inevitable, but we can plan and prepare for a new future, whatever we choose that to look like. Now is the time to connect with your local community, share news, offer ideas and ways to support each other when needed. Who will your first contact be in the case of an emergency? Where will you meet if the power goes down and no-one can contact each other? Where can you access clean water from in your area? These are just a few questions, but there are many more that need addressing. The window of opportunity may be closing. No time like the present.
Did you know the rainbow used for the LBGTQ community only has six colours in it? God created the rainbow with seven. Just saying.
Until next week, God Bless and stand firm. Now is not the time to change sides.
Debi
And when ye shall see Jerusalem compassed with armies, then know that the desolation thereof is nigh. Luke 21:20
