Part 1 of this article is here.
The CEO of the UK Government's Medicines and Healthcare products Regulatory Agency (MHRA), Dame June M. Raine, gave a recorded lecture at the All-Wales Therapeutics and Toxicology Centre at the All-Wales Medicines Strategy Group’s Twentieth Anniversary Conference. The lecture was entitled Making Medicines Safer—the Nicola Wheatley Memorial Lecture. Nicola Wheatley was a toxicology expert who died in tragic circumstances, and this was a lecture given in her memory.
The lecture can be watched here. Dame June Raine made a few notable statements at the start of the 36-minute lecture, which I will highlight in note form below:
- Her role is changing and this has been catalysed by the Covid–19 pandemic.
- Safety is the top priority and there are exciting opportunities ahead that the regulator (the MHRA) will take advantage of, with better data and new scientific methodologies.
- The MHRA’s mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe.
- Changing demographics and disease patterns, and digital transformation, are unlocking the potential of transformative medicines.
- One of the impulses for rushing things through is a belief that "we mustn’t keep patients waiting".
- mRNA technology, and how we can unlock the potential beyond the vaccines, is aided by Artificial Intelligence.
- After Brexit, the MHRA became, in Raine’s notable words, an "independent sovereign regulator" (Raine sees the MHRA as an agile and supportive regulator that is listening to patients more).
- The MHRA "team" is moving from basic science to trials, enabling scientific innovation by accelerating patient access and through strengthening patient safety and surveillance.
Aims of the MHRA as enunciated by Raine
- to have a product lifecycle approach
- to put patients first
- to be a world leader
- to be innovative
- to achieve scientific excellence
The MHRA, Raine said (and not for the first time), is now the enabler (instead of controller, watchdog and policeman) and maybe a global voice: working in partnership is at the heart of learnings from Covid.
The MHRA’s new way of working
Dame June Raine admits that these new products being rushed into use means that they are reaching patients with more uncertainties and more knowledge gaps in understanding. This, she states, is the reason that a "bedrock of safety systems" that will rapidly identify emerging risks is needed. She states the need for integrated decisions to take time out of the development pathway, thus "Making Medicines Safer".
Comment by Cheryl Grainger:
So, we rush medicines to the public and look at safety when they are in use, rather than before being used. Everything is planned to be "rushed" since 2020, completely rewriting all the normal control systems in place that are tried and tested to identify safety issues before licensing and replacing with rolling reviews and no in-person inspections of manufacturing.
The new approach is to launch as soon as possible, because Raine believes we "can’t keep patients waiting" and look for the safety issue as they emerge. The risks are assessed after launch, and in the case of the Covid–19 vaccines, after billions of doses have already been given. How can rapid development not following normal protocols on clinical trials, manufacture and distribution, make it safer?
Admitted failure in the past
At this point in the lecture, Dame June Raine surprisingly presents a study by Prof. Sir Munir Pirmohamed, who is Chair of the Committee on Human Medicines. This is a paper published in the British Medical Journal (BMJ) in 2004 looking at iatrogenic reactions that accounted for:
- 6.5% of hospital admissions;
- 0.15% of deaths;
- 72% of which are avoidable.
The CHM advises on the impact of new safety issues on the balance of risks and benefits of licenced medicines. According to a 2018 study by Johns Hopkins, more than 250,000 people in the United States die every year because of medical mistakes, making it the third leading cause of death after heart disease and cancer.
Comment by Cheryl Grainger:
There was no follow-up data presented in the lecture to show whether the rate of British medical mistakes had declined or in fact increased in the two decades since the BMJ paper. Over the last twenty years, how many deaths were iatrogenic? What is this number in the UK?
A proffered example of success
Professor Philip Routledge, Chair of the Herbal Medicines Advisory Committee from 2005 to 2020, identified that comfrey tea, which is often taken for flatulence, produced a severe reaction due to atropine. That this was spotted from just one case report is a success that resonates with Dame June Raine, as this is what science really means to her.
Dr Raine asks:
What were the learnings of the Pandemic for Safety Monitoring?
Her answer is that the MHRA has learnt:
- flexibility in its approaches,
- how to use new technologies like the Yellow Card App,
- and how to join up with colleagues.
She says that the MHRA has acquired flexibility in its regulatory function, when assessing medications for licence.
Comment by Cheryl Grainger:
There is a double standard at play here of only highlighting one problem from one treatment (comfrey tea), when there are thousands of Serious Adverse Effects and deaths from all the Covid–19 vaccines highlighted on the MHRA's own Yellow Card systems. Highly qualified scientists and medics were silenced for pointing out the dangers of mRNA and lipid nanoparticles to the human body before the launch of the Covid vaccines.
With regard to "the learnings of the pandemic", there was a failure by the MHRA to regulate and a failure to conduct proper pharmacovigilance. The constant promotion of the vaccines by the MHRA as "safe and effective" without showing evidence or data to qualify this statement is wrong.
Description of the safety system
What are "the bedrocks" of the safety systems? There are four, says Dame June Raine:
- Yellow Card Reports
In its modelling, the MHRA expected 100,000 Yellow Card reports for Covid vaccinations, as Raine admitted in the Breckenridge lecture, but actually the MHRA received 500,000.
Dr Raine states that Artificial Intelligence was used for the first time during Covid to look for signals.
We are also told that the MHRA used trained assessors.
Comment by Cheryl Grainger:
What happened to the MHRA's planned AI and grant of £1m?
How could the MHRA cope at this time with at least a fivefold increase in reports, when they were about a third of their workforce down, a fact confirmed at board meetings?
Why has the MHRA not reacted to the signal that the very large number of Covid–19 vaccine reports is far greater than the total of all reports on all conventional vaccines over the previous half-century added together? And this should not be seen in isolation, as the same unprecedented volume is seen in every Adverse Event Reporting System globally.
- Yellow Card Monitor
This is an active surveillance of specifically-identified cohorts.
Dr Raine reports that 2,000 pregnant women shared their data via the Monitor.
She is very pleased with this, as it gives the MHRA a 'denominator', but she does not divulge any details.
Comment by Cheryl Grainger:
Where is this data or its assessment? Did it pick up on the same signals that the Pfizer data analysis has shown? Why was the Monitor dropped after seven months, early in 2022?
The V-safe data that the CDC was court-ordered to release shows that 25% of the 10 million Americans who signed up to this vaccine app reported being incapacitated the day after vaccination and 7–8% presented to hospital Emergency Room. Why doesn't June Raine ever mention the deaths—and, of course, the excess deaths—that have been seen and continue to be seen since the third quarter of 2021? Fatalities are not mentioned once throughout the lecture, and perhaps she believes that if she does not talk about them, they do not exist.
- Rapid Cycle Analysis
This involves using clinical data to rapidly and repetitively answer questions of things known.
There were issues that the MHRA was expecting to test for, including Guillain-Barré Syndrome and Bell's palsy.
The MHRA wanted to be as ready as it could to provide a definitive answer.
The MHRA is working with the School of Tropical Medicine, the London School of Hygiene and the UK Health Security Agency.
Comment by Cheryl Grainger:
The bibliography of peer-reviewed research is maintained at the MHRA by CPRD and by 9 January 2023 there were only two population studies relating to thrombocytopenia (22 February and 22 October) listed.
So only one type of adverse event has been put through the ecological analysis in the last two years? This does not say much for the MHRA's commitment to use population-level data to detect a potential safety signal.
- Epidemiological Analysis
Professor Stephen Evans has produced statistical tests for signal generation from spontaneous drug reaction reports. Dame June Raine highlights this test as being employed by the MHRA to identify signals.
Comment by Cheryl Grainger:
This test is the Proportional Reporting Ratio (PPR) and only looks at new, different, unexpected Serious Adverse Effects, by looking at these vaccines compared with all other conventional vaccines. It is worth noting that in the USA, the CDC used this PPR to assess Serious Adverse Effects and would not publish its results. The Epoch Times obtained them via a Freedom of Information request. Professor Normal Fenton has assessed the data obtained, and although he does not think this is the best statistical analysis tool, the CDC analysis flagged up so many red flags for Covid vaccines that he concluded they should reconsider their decision and halt any rollouts. His analysis can be seen here.
If the MHRA is using this PPR test, then do they have results like the CDC's? Why have they not published these? Based on Dame June Raine's description of the "bedrocks of the safety system", aren't there only two possible conclusions:
- the MHRA is not doing the Covid vaccine surveillance it promised; or
- the MHRA is doing the surveillance and is not making the results publicly available?
The increased use of viral vectors
Dr Raine announces that viral vector vaccines (such as AstraZeneca and Johnson & Johnson) are going to be used in the future and will form the basis of health interventions in the future (AstraZeneca is setting up in Dublin).
Comment by Cheryl Grainger:
It is understood that the AstraZeneca Covid–19 vaccines in the UK have been phased out with no fanfare or explanation. The British Heart Foundation states that "the UK Government is not ordering future supplies of the AstraZeneca Covid–19 vaccine. Evidence shows that mRNA vaccines, Pfizer and Moderna, are more effective at boosting protection from Covid–19, so these vaccines are being recommended for the autumn booster programme". Purported evidence is referred to without a reference ever being provided.
The challenge of VITT
Challenging times and issues are mentioned when Dr Raine moves on to talking about a particular signal, one that challenges all the MHRA's capabilities. Dr Raine states that Vaccine-induced Thrombocytopenia and Thrombosis (VITT), presenting as unusual clots in the brain, has an occurrence of "only 15 per million", and she asks why this is not more. She links this to her belief that the MHRA should look at the genetic predisposition of these injured people.
The recognition of VITT
Dame June Raine says that the MHRA is looking at 300 cases of thrombocytopenia, genetically, to work out how these injured people should have been managed in the first place to reduce the risk of this happening. The MHRA is looking at the mechanisms of actions such as headaches lasting more than four days, and looking at the theory of Platelet factor 4 (a small cytokine involved in coagulation) reacting with the viral vector, forming immune complexes, to understand whether this results in developing blood clots which are very difficult to treat. If so, this can be anticipated early to make active decisions about case management.
Comment by Cheryl Grainger:
A letter to the FDA regarding VITT arose from the Pfizer Document Analysis, which is based on the 451,000 pages of data submitted for application for licence. These would be the same documents that the MHRA was given. However, as the Doctors for Covid Ethics show here, the MHRA and Australia's TGA never inspected but just rubber-stamped the vaccine. The implication being made is that the MHRA need to investigate the injured to see what is genetically wrong with them rather than to undertake the bothersome investigation of what is wrong with the vaccine administered.
Why are the regulators not looking at the risk profile of the mRNA vaccines and their lack of efficacy, especially as they plan for this technology to be used continually from now on? Moderna is to invest in mRNA research and development in the UK and to build a state-of-the-art vaccine manufacturing centre with the ability to produce up to 250 million vaccines a year. What would the regulators have to see what Covid–19 vaccines do to patients for them to be declared unsafe?
This is not just being seen in the UK. Why is VigiAccess (a WHO collaborating centre) not picking up more signals, as it is supposed to gather global pharmacovigilance data? There is a disconnect between data in VigiAccess and the data submitted from regulators globally.
The Benefit/Risk Profiles
Communicating risk is going to be even more challenging and the MHRA is enlisting experts in the field. Moving on, June Raine then discusses benefit/risk ratios in terms of age. She then refers to an "elegant" model by Professor David Spiegelhalter, a former member of SAGE.
Comment by Cheryl Grainger:
How many experts is the MHRA using? How do they define an expert? Professor Spiegelhalter recently attacked MP Andrew Bridgen's speech and was involved in reporting Mark Steyn to the British government censor Ofcom, as discussed here. Investigation shows that he is prone to seemingly blind promotion of the government narrative rather than of the statistics, and his data is often out of date. It is interesting that he is referred to as an expert.
As a comparator, these are the infection survival (recovery) rates by age group:
0–19 99.9973%
20–29 99.986%
30–39 99.969%
40–49 99.918%
50–59 99.73%
60–69 99.41%
70+ 97.6% (non-institutional)
70+ 94.5% (all)
Transparency
June Raine then refers to "transparency" being very important in increasing public confidence—but, in her opinion, this carries a downside. This comes in the form of the demonstrations by "anti-vaxxers" outside the MHRA offices, causing the staff busily working inside to hide, she says, under their office desks!
Comment by Cheryl Grainger:
I find this to be a very strange linkage of facts, as it was the very lack of transparency that brought out the demonstrators. I know because I attended several of these protests—which were mainly on a Saturday, so I do not believe that many staff were inside the building, much less cowering under their desks. I challenge their claim of "transparency".
In 2004/5, a Parliamentary Health Select Committee discussed the influence of the pharmaceutical industry, and the government response is recorded here.
Page 12, Recommendation 11, states:
The Government agrees that the regulatory system should be as open and transparent as possible, and the public should have access to information on individual applications and the data supporting its authorisation. It also supports the publication of material it receives and assessments it makes on marketed medicines after initial licensing and after regulatory action has been taken.
I believe this lecture by Dame June Raine demonstrates that the MHRA is not as open or transparent as the Government wanted it to be and (based on its stonewalling of Freedom of Information requests) that it is refusing to let the public have access to information from drug licensing applications, supporting marketing authorisations, and publication of material after regulatory action.
How unsafe and ineffective is Paxlovid?
June Raine talks of therapeutics and the antiviral Paxlovid and discusses the use of good data to assess drug-drug interactions. Paxlovid, she states, is safer by dint of the MHRA anticipating risks. Adverse drug reactions for Paxlovid are "two in 1,000", she says.
Comment by Cheryl Grainger:
Paxlovid (nirmatrelvir/ritonavir) is discussed in this blog by Dr Jessica Rose. There is an extraordinary number of interactions with Paxlovid:
- 643 drugs interactions
- 5 disease interactions
- 2 alcohol/food interactions
Of the total drug interactions:
- 239 are major
- 364 are moderate
- 40 are minor
How can the MHRA guarantee that Paxlovid is not prescribed with other drugs that it might interact with? There are so many drug interactions this is not an easy drug to use.
For Covid–19 patients who took Paxlovid, 14.2% tested positive (again, this was days after testing negative) and 18.9% had a symptom rebound (nearly one in five). There are also contraindications with kidney and liver disease, pregnancy and anaphylaxis. Paxlovid is difficult to use and is not effective in many people.
It is strange statistical practice to say "two in 1,000" instead of "one in 500". Is this a ploy?
"Where next?"
The answer is Safety Connect, described by Dr Raine as a truly interactive database reporting tool.
16 million Britons are already registered, and the result, in buzzphrase-ese, is:
- giving data a dialogue
- where people feel part of a story
- with investigation of signals
- on a new patient journey
June Raine wants patients involved in the Risk Management Strategy, using their judgement. Risk management must be with the patient, and the question is, "What are the patients prepared to put up with?"
The expectation is this data set will grow to 60 million—with patient "lives" represented longitudinally (cradle to grave) and representatively (age, sex and ethnicity cohorts).
There is the Clinical Practice Research Datalink with over 3 billion British health consultations coded from primary care records and linked to other data sources.
Comment by Cheryl Grainger:
Many have signed with their GPs (family doctors) to opt out of sharing data. How are these contracts being honoured?
What happens if there is a fatal adverse reaction and then the dialogue stops?
Do the 16 million currently registered British patients know that their data is being used?
Can the whole of the British population now expect to have all their medical details from their birth to death stored, shared and analysed?
Pharmacogenomics
There are 100 thrombocytopenia patients on the Yellow Card Biobank who are being sequenced by Genomics England. The aim of the Biobank is to research genetic factors behind adverse drug reactions and to determine how we can use this data to reduce these incidents.
Comment by Cheryl Grainger:
My reaction to this part of the lecture is to question the assertion that the MHRA is looking at the people who get a particular Serious Adverse Effect (for example VITT), against their genetics to see what's in that person's make-up that causes a reaction, doing nothing for the people injured, and not considering it could be the vaccines themselves. These ‘vaccines’ have been manufactured with no GMP; no GDP; no QC and are inconsistent products; some batches harming more than others. The MHRA assumes it is the person's ‘fault’. They will then recommend a different regime, dose etc, rather than removing the vaccines from the market.
Who should be genetically tested?
Dr Raine states that it is very interesting that 99.5% of patients have haplotypes (a set of closely linked genetic markers or DNA variations that tend to be inherited together). Pharmacogenomics (PGx) is the study of how variations in the human genome dictate a person’s response to medications. In one study, more than 99% of people assessed had a genotype associated with a higher risk from at least one medication. This means that we should all be tested, she says.
This is for personal prescribing, so the drug event is developed in combination with genes to give safety and effectiveness. In the future, hospital services will make preparations to pick all of this up. To gain scientific validation and to benefit regulatory science, academia and clinical researchers need to use pharmacogenetics to improve patient outcomes. This gives better use of the data. June Raine uses the catchphrase "Better, Broader, Safer" to describe the envisaged use of health data for research and analysis.
The NHS poster phrase will be Data Saves Lives.
Everyone needs to be totally confident and to trust the environment of data research, Dame June Raine says.
Comment by Cheryl Grainger:
We already know that genetic data, depending on the test centre, was taken at the same time as PCR tests, but we did not know that it was being analysed and has already been shared. People need to be very wary of this and should totally distrust what is happening. They ought to consider why this data harvesting is happening. Has GDPR been overruled? What confidence do we have that data is kept where it is supposed to be kept, and to be used for what we have agreed it to be used for? Have we in our own cases always been asked for agreement? It seems that the MHRA has become about collecting data and not about protecting the recipients of therapies.
Dame June Raine’s summary
I add my thoughts below each key point made by Dame June Raine in her lecture:
- Opportunities from Brexit
The MHRA wants to become the global regulator (enabler).
- Learnings from the Pandemic
Moving to a data base of genomic mapping; people replaced by their data.
- Arising from the Cumberlege Review, First Do No Harm (2020)
The MHRA needs substantial revision, particularly in relation to adverse event reporting.
- A proactive, collaborative regulatory approach
Creating or controlling a situation rather than responding to it after it has happened?
- Enable innovative products without delay
Generating a need for new preparations for the same old conditions, at speed.
- New medicines to patients and healthcare
Is speed more important than safety, efficacy and quality?
- Safety based on science (real-time safety collection)
At the time of authorisation of a medicinal product, the benefit/risk balance is judged to be positive for the target population—but not all actual or potential risks will have been identified at the time of initial authorisation. At the launch of the Covid vaccines, there were large number of Serious Adverse Effects reports being rapidly and consistently seen globally. These Covid vaccines are listed by the MHRA as Black Triangle preparations in view of their novelty and, as such, require additional safety monitoring. The Black Triangle label (▼) generally stays with the new drug (or new use of an existing drug) for at least five years, when it is then reviewed, and after this time the Black Triangle label may or may not be discontinued.
- Safety systems—bring together all relevant data
Information needs to be shared (not hidden) and regularly produced (not closed after two years). Long-term safety data is still not available.
- Accelerated access to innovative products
This happened by running the clinical trial reviews (Phases I, II and III) concomitantly in a rolling review and ignoring the safety processes embedded into the pre-2020 protocols.
New tools } for BUT ONLY IF
Data } strengthened THEY ARE WORKING
Methodologies } surveillance PROPERLY
The MHRA’s most systematic failings
The Yellow Card Reports and the pharmacovigilance talked up by Dame June Raine in this lecture are not working, as the MHRA is not acknowledging or investigating severe Adverse Drug Reactions (ADRs) and death. We also know that the US FDA (as seen from VAERS data) and the EU's EMA (as seen from EUDRA data) are operating in the same manner as the MHRA. This is failure on a global scale.
The best summary of the MHRA shortfalls in safety management is shown here, from which I pull out the main facts, which speak for themselves:
- The MHRA does not have a process for investigating individual Yellow Card reports. So how many has it investigated? (FoI 21/1109)
- The MHRA has never had a safety audit (FoI 22/562).
- The MHRA does not actively seek out real-world data, e.g. adverse events of special interest segmented by vaccination status and age. In January 2022, the MHRA did not hold such data (CSC 88243); and in August 2022, the UK Health Security Agency only held whole-population-level information on thrombosis with thrombocytopenia syndrome/TTS (FoI 22/472).
- The MHRA does not (or cannot) define the quantitative level of risk which is ‘acceptable’ as the basis of “acceptably safe” (FoI 22/390).
- The MHRA lost 20% of posts in 2021 due to funding cuts and has 20% vacancies below that new baseline (FoI 22/1007).
- The MHRA does not have a process for delegating the authority to approve medicines for public use (FoI 22/1002) or governance of individuals’ competence (qualification, experience and training) (FoI 22/1007) to MHRA officers.
- The MHRA has hidden safety data (FoI 22/1083), redacting numbers in tables on the pretext of maintaining patient confidentiality.
Autopsies are not being done, despite their being the standard investigation when new treatments are suspected of causing death. If the criteria for causality can be shown (which they can: see here and here), then why are all regulators, including the MHRA, turning a blind eye? Why is the MHRA not responding to the red flags that have been evident since January 2021?
Dr Tess Lawrie, in a letter to the MHRA in June 2021, stated:
The MHRA now has more than enough evidence on the Yellow Card system to declare the COVID–19 vaccines unsafe for use in humans.
Dr Jessica Rose stated in October 2021, based on her analysis of VAERS data:
When evidence of harm appears, we need to follow the evidence and immediately take steps to mitigate risks.
Dr Rose also stated in a Critical Appraisal of VAERS Pharmacovigilance:
With approximately 1 in every 400 individuals experiencing an adverse event (~1 in every 25,000 for death) in the context of the COVID–19 fully vaccinated population in the United States, it is therefore unclear why these injections are continuing to be used in the human population.
Closing observation
Edward Dowd has applied the reliable numbers from his vaccine damage report for the US. Operating on the assumption that 5 billion people are vaccinated globally, and extrapolating his US data to estimate the human cost worldwide, he obtains the conservatively-estimated Covid vaccination damage total of 5 million deaths, 46.5 million disabilities and 900 million injuries.
Medications are usually pulled after fewer than 50 deaths are recorded. Therefore, the only conclusion in relation to all Covid–19 vaccinations is that they should have already been stopped.
