Burning Bridges, not Bridgens
HART has previously noted deficiencies in mainstream “fact-checks” — after all, who watches the watchmen? And, perhaps more pertinently, who pays the watchmen?
The response from the somewhat appalled mainstream media to Andrew Bridgen’s frank outspokenness on harms from medical interventions tells its own story, and has been very well covered elsewhere, e.g. here, here and here.
HART is pleased to see this discussion progress, and provides here a critical appraisal of an attempt to ‘fact-check’ some of Andrew Bridgen’s recent statements. We have done our own analysis of two ‘fact-check’ documents by Full Fact, who are to be thanked for highlighting one minor correction that should be made to the MP’s statements, as well as having the effect of emphasising the pertinent nature of his statements, questions and challenges.
In summary, HART finds Andrew Bridgen’s statements to be true and fair, subject to one technical correction.
AB: Andrew Bridgen
FF: Full Fact
Document 1:
https://fullfact.org/health/andrew-bridgen-vaccine-safety-debate/
AB Statement:
Serious adverse effects reported by the public after vaccination are thought to represent only 10% of the true rate of serious adverse events.
FF’s comments:
The Medicines and Healthcare products Regulatory Agency (MHRA) has specifically warned this estimate shouldn’t be used for Covid-19 vaccines, given there was high public awareness of its Yellow Card scheme.
Evidence in support of AB Statement
- Underreporting is well-documented in the literature, and cannot just be ‘waved away’ by a regulator that is part-funded by entities that stand to gain from Covid-19 vaccine deployment
- “All spontaneous reporting schemes have a problem with numbers: the MHRA (Medicines and Healthcare products Regulatory Agency) itself says that only 10% of serious reactions and 2-4% of all reactions are reported using the Yellow Card Scheme. This means that most iatrogenic morbidity goes unreported.” Extract from the Prescriber.
- The underlying link to that statement can be found here: “It is estimated that only 10% of serious reactions and between 2 and 4% of non-serious reactions are reported. Under-reporting coupled with a decline in reporting makes it especially important to report all suspicions of adverse drug reactions to the Yellow Card Scheme”:
- FF correctly point out that the government have added a rider claiming that there was high public awareness of its Yellow Card scheme, but this claim is unsupported by the evidence, as the underlying reporting rate for non-Covid-19 yellow cards FELL by 16% from 2020 to 2021, which is inconsistent with high public awareness of the scheme:
- Underreporting is a well-known phenomenon and has been consistently reported in recent decades: “the median underreporting rate in the 37 studies was 94% (82-98%). There was no significant difference between the median underreporting rates calculated for general practice and hospital studies”, see 2006 review article in ‘Drug Safety’: “Under-reporting of adverse drug reactions : a systematic review”
- Moreover, underreporting in the existing well-known early warning systems (VAERS in the USA and Yellow Card in the UK) is demonstrated by the CDC & FDA’s announcement on Friday that a near-real time safety system “met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination” yet “no other safety systems have shown a similar signal”, which is consistent with known underreporting rates.
- Additionally, many doctors have reported a reluctance to report adverse events as yellow card events, and recipients have been unaware that they can file a yellow card themselves.
- Although anecdotal, reports indicate that there are specific problems with the current yellow card reporting scheme with patients being unable to file reports:
- Comparing the number of adverse events in people actively surveyed after their booster vaccines in Israel with the numbers who had a report filed in their yellow card equivalent shows an under reporting factor far greater than 10. https://jackanapes.substack.com/p/the-israeli-ministry-of-health-actually-db7
- The MHRA have not shared their active survey data to make the same comparison for UK data.
Overall Verdict:
- AB statement consistent with evidence
- FF statement is a weak appeal to authority
AB Statement:
Pfizer vaccine trials showed a 95% relative risk reduction in the development of infection against the ancestral, more lethal strain of the virus. However, the absolute risk reduction for an individual was only 0.84%.
FF’s comments:
These figures are correct, but relative risk reduction is most commonly used to communicate vaccine effectiveness as the way in which it is calculated means it is relevant no matter how prevalent Covid-19 is in the community. Absolute risk reduction is sensitive to the prevalence of the virus, so the figure measured during the trials may be less relevant to real-world situations.
Evidence in support of AB Statement
FF has acknowledged that the claim is correct. FF’s comment regarding prevalence of the virus is highly pertinent for a discussion about whether it was appropriate to use the Pfizer vaccine in early 2021 during the northern hemisphere respiratory disease season.
Overall Verdict:
- AB statement consistent with evidence
- The trial participants were predominantly recruited from the USA. There was a autumn 2020 wave there and in Argentina and Europe during the trial period which did not end until 14th November 2020.
- FF statement correctly puts the spotlight on whether the clinical trial results were sufficient to support a global rollout strategy.
AB Statement:
A report by the Journal of the American Medical Association, looking at Covid-19 vaccination of children under five, showed that one in 200 had an adverse event that resulted in hospitalisation.
FF’s comments:
We could not fully replicate these figures from the study in question, but in any event it’s important to note the adverse events which were reported were not proven to be caused by the vaccine. The authors of the paper found the frequency of adverse events after Covid-19 vaccination was comparable with that after non-Covid vaccination.
Evidence in support of AB Statement
- The full JAMA article is here.
- AB has conflated two separate claims:
- One in every 500 children under five years who received the Pfizer mRNA Covid vaccine were hospitalised with a vaccine injury
- One in every 200 had symptoms ongoing for weeks or months afterwards.
Overall Verdict:
- AB statement is a conflated misquote and should be corrected as follows:
- One in every 500 children under five years who received the Pfizer mRNA Covid vaccine were hospitalised with a vaccine injury
- One in every 200 had symptoms ongoing for weeks or months afterwards.
- FF has helpfully drawn attention to a misquote which should be corrected.
- The FF comments miss the point that if a medical intervention is unnecessary, then a single adverse effect (serious or non-serious) is one adverse effect too many. Also both one in 200 and one in 500 are very high for a vaccine – there were zero with the other vaccines.
- It is misleading for Full Fact to imply that the study was not detecting adverse events likely caused by the Covid vaccines. The study was designed to detect likely causality as it used a control group vaccinated with other vaccines, and the figures quoted were for adverse events over and above those experienced in the control group. The authors did claim that events were “comparable overall” to other vaccines, but this is a sleight if hand; while there were ‘just’ 0.2% more hospitalisations in the Covid vaccine group, which could be termed “comparable”, this works out at 2,000 more children hospitalised in every million vaccinated – not a small number for an intervention achieving no proven benefit. Furthermore, there were zero hospitalisations with the other vaccines.
AB Statement:
The mRNA vaccines are not safe and not effective.
FF’s comments
The vaccines used in the UK have all met the MHRA’s standards for safety and effectiveness, and it says the number of Yellow Card reports received so far is not beyond what was expected. Vaccine effectiveness has changed over the course of the pandemic, but they are still effective against hospitalisation and death.
Evidence in support of AB Statement
Not Safe
- BMJ editor Dr. Peter Doshi and colleagues found that the Pfizer and Moderna mRNA COVID-19 vaccines were associated in the randomised trials with an increased risk of serious adverse events of special interest of 10.1 events per 10,000 vaccinated for Pfizer and 15.1 events per 10,000 vaccinated for Moderna. When combined, the mRNA vaccines were associated with a risk increase of serious adverse events of special interest of 12.5 per 10,000 vaccinated.
- Dr. Kevin Bardosh and colleagues found that for every COVID-19 hospitalisation prevented in previously uninfected young adults, 18 to 98 serious adverse events occurred, including 1.7 to 3.0 booster-associated myocarditis cases in males, and 1,373 to 3,234 cases of serious injury which interferes with daily activities.
- “The U.K. drug regulator, the MHRA, did not carry out the toxicity, biodistribution and pharmacokinetics studies that are required of new drugs because of the political pressure to approve. However, nearly two years have passed since then and the MHRA has not set a deadline for the pharmaceutical companies to provide these data. The MHRA allowed the treatments to be presented as vaccines like any other when they are a novel class of agents, never before approved for human use despite the technology being around for decades (mostly because they have been dangerous and ineffective in previous human trials)”. https://www.hartgroup.org/the-way-out/:
- Approvals for children were unethical when the trial data did not show evidence of a benefit from the drug to the children themselves when there was already good evidence of short term safety issues and when long term safety data was inevitably unavailable. Approving for younger children after the arrival of Omicron was even less defensible.
- The MHRA failed to notice that the total mortality in the trial was higher in the vaccination group than the placebo group, showing no evidence of an overall mortality benefit, and the serious adverse reactions were much higher in the vaccination group such that one in 800 participants were hospitalised for a non-Covid condition, which far outweighed the small reduction in Covid hospitalisations.
- Dame June Raine, the head of the U.K. drug regulator the MHRA, appeared to take a unilateral decision to change its role. She said “the Covid pandemic has catalysed the transformation of the regulator from a watchdog to an enabler.”
- The regulator receives 86% of its funding from industry fees. In 2005, the House of Commons’ health committee expressed concerns regarding the U.K. drug regulator that pharmaceutical funding could lead the agency to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies”. Do we want a regulator which sees itself as an enabler of pharmaceutical companies?
- At the outset, the MHRA set out an excellent plan for safety monitoring of the Covid vaccines which was required because of the minimal safety data from trials and the planned extensive rollout. It described this as a four part system of “proactive vigilance… to rapidly detect, confirm, characterise and quantify any new risks that were not detected in clinical trials”. “However, the only publications from the MHRA in the last two years on safety have been the Yellow Card reports and even these do not divulge the number of people affected or the seriousness of the reports.”
Not Effective
- A recent study found an increased risk of COVID-19 with higher numbers of prior vaccine doses, a result consistent with the findings of other studies
- A study in 2022 found no evidence of a reduction in overall mortality in the mRNA vaccine trials.
- Additionally, recent data show no evidence of a benefit to the vaccinated regarding hospitalisations. One recent study from Oxford found waning effectiveness against hospitalisation and death into potentially negative territory within a few months of vaccination.
Overall Verdict:
- AB statement is based on a well-supported evidence base
- FF statements are not adequately supported by real-world evidence
Document 2:
https://fullfact.org/blog/2023/jan/andrew-bridgen-mps-false-claims-put-lives-at-risk/
AB Statement:
Contradictory evidence was issued on two separate days. One piece of advice said that pregnant and breastfeeding women could have the vaccine, and then another Government body said that that was not safe and that it did not recommend it.
FF’s comments:
It is not clear what Mr Bridgen was referring to but it may be the fact that there was some confusion when an old government document from December 2020 was widely circulated online. This document reflected the information known when it was originally published, saying “sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time”, However, the web page appeared as though it had been updated in August 2022, causing some people to suggest the government had now changed its advice for pregnant women. That document had not been recently updated. It was in a group of documents, one of which was updated on 16 August and had nothing to do with vaccines in pregnancy.
We fact checked a false claim about mRNA vaccines made by Mr Bridgen during Prime Minister’s Questions on 7 December. Mr Bridgen said that mRNA vaccines “are not recommended for pregnant women or those who are breastfeeding.
We wrote to Mr Bridgen to inform him that what he said was not true and to ask him to correct this claim but he did not do this. Full Fact supporters in his constituency of North West Leicestershire also wrote to Mr Bridgen to ask him to correct the record in relation to this claim.
Evidence in support of AB Statement
- A recent public controversy focused on MHRA advice updated on 16 August 2022 stating in the toxicity conclusions that “sufficient reassurance of safe use of the vaccine (mRNA BNT162b2 / Pfizer/BioNTech) cannot be provided at the present time” and “women who are breastfeeding should also not be vaccinated”.
- The government and the RCOG (Royal College of Obstetricians and Gynaecologists) were very quick to express their concerns about the circulation of this apparent misinformation and to reinforce their advice that pregnant women should get vaccinated. This document was originally from December 2020, and so the claim is that this section is outdated.
- The question remains why this section was not amended if this document was recently updated. The answer is of course because there is nothing to update it with: studies regarding genotoxicity, carcinogenicity, reproductive and developmental toxicity, prenatal and postnatal development have still not been conducted:
- Furthermore, caution should always be exercised in pregnancy because of potential for long term effects that cannot be known at this stage. Even if intervention reduces the risk from covid in pregnant women the absolute risk to an individual is low and exposing large numbers of pregnant woman and foetuses to a novel product is not justified.
Overall Verdict:
- AB statement is based on a well-supported evidence base
- FF statements are an appeal to authority and fail to address the detailed underlying concerns that underpin AB’s statement
AB Statement:
The Covid vaccines are “gene therapy”.
FF’s comments:
As we have written a number of times in the past, mRNA vaccines are not gene therapy.
The mRNA vaccines (Pfizer and Moderna in the UK) work by packaging instructions on how to make the spike protein on the surface of the SARS-CoV-2 virus (which causes Covid-19).
These mRNA instructions enter human cells and are used to make the spike protein, causing an immune response, which helps the body to fight off a genuine Covid-19 infection at a later date.
The mRNA from vaccines doesn’t enter the cell’s nucleus, where DNA is located, or interact with the person getting the vaccine’s DNA at all.
Gene therapy, on the other hand, involves delivering functioning DNA into the nuclei of the patient’s cells, often to cure a genetic condition.
This means that gene therapies can permanently alter someone’s DNA, with those changes being inherited by daughter cells that result if the cell divides, while mRNA is transitory and not inherited.
It isn’t cell therapy either, where new cells are introduced into a patient’s body, often using stem cell
Evidence in support of AB Statement
FF have used an inappropriate ‘straw man’ argument in an attempt to discredit a technically accurate statement from AB, who does not talk about either ‘altering DNA’ or ‘cell therapy’.
The FDA defined gene therapy in July 2018 and has not changed it since:
“Human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use. Gene therapy is a technique that modifies a person’s genes to treat or cure disease …”
The definition includes the words “or to alter the biological properties of living cells”.
The synthetic mRNA in the injections contain instructions for making various proteins, delivered into your body to instruct your cells to produce a modified form of the SARS-CoV-2 spike protein.
i.e. they “alter the biological properties of living cells for therapeutic use”.
Whether they modify your DNA is irrelevant. They don’t have to alter gene expression in order to still qualify as gene therapy, at least not per the FDA’s definition.
Moderna’s November 2018 Securities and Exchange Commission (SEC) registration statement also confirms that its mRNA injections are defined as gene therapy, clearly stating that its “mRNA [technology] is considered a gene therapy product by the FDA.”
[In] the United States, and in the European Union, mRNA therapies have been classified as gene therapy medicinal products … ~ BioNTech SEC Registration
The September 2019 SEC filing for BioNTech (its mRNA technology is used in the Pfizer vaccine) is equally clear, stating on page 21:6
“… in the United States, and in the European Union, mRNA therapies have been classified as gene therapy medicinal products …”
So, in the U.S. and Europe, mRNA therapies, as a group, are classified as “gene therapy medicinal products.”
A letter in Nature in June 2021 states:
“However, these mRNA vaccines, which have been developed and approved within a few months, signify a breakthrough in the field of gene therapy, which has battled to achieve ordinary acknowledgement due to a large number of sceptical and conservative scientists and other claimed safety and translational concerns. Although these two vaccines are not the first approved drugs utilising genetic materials as active ingredients, they are believed to be a milestone in modern medical history that may forever change pharmaceutical approaches. …
“This unprecedented achievement will also stress the crucial solutions that gene therapy may provide for many diseases. In the coming future, we expect to see a considerable effort for developing mRNA-based treatments for a wide range of diseases, e.g., hereditary disorders, type 1 Diabetes Mellitus, cancer, and HIV. Many other mRNA vaccines may also turn into reality for preventing infectious diseases and epidemics for being scalable, reproducible, versatile, and adaptable with different viruses’ variants. mRNA vaccines provide flexibility to be modified if any new virus variants may appear; thus, producing new forms of the vaccine within a few weeks. This is a great opportunity for the FDA and EMA to revise the drug development pipeline to make it more flexible and less time-consuming.”
President of Bayer’s Pharmaceuticals Division Stefan Oelrich said this at the World Health Summit in October 2021:
“We are really taking that leap [to drive innovation] – us as a company, Bayer – in cell and gene therapies… ultimately the mRNA vaccines are an example for that cell and gene therapy. I always like to say: If we had surveyed two years ago in the public – ‘Would you be willing to take a gene or cell therapy and inject it into your body?’ – we probably would have had a 95% refusal rate.”
Moderna’s submission to the U.S. Government in June 2020, made the request for its vaccine not to be classified as gene therapy as that would give it a bad press and could complicate approval. It said (emphasis ours):
“Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism. In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products, or may require safety testing like gene therapy products. …
“Regulatory requirements governing gene and cell therapy products have evolved and may continue to change in the future, and the implications for mRNA-based therapies are unknown. For example, the FDA has established the Office of Tissues and Advanced Therapies within CBER to consolidate the review of gene therapy and related products, and convenes the Cellular, Tissue and Gene Therapies Advisory Committee to advise CBER on its review. In the European Union, mRNA has been characterised as a Gene Therapy Medicinal Product. In certain countries, mRNA therapies have not yet been classified or any such classification is not known to us, specifically, in Japan, the Pharmaceuticals and Medical Devices Agency has not taken a position on the regulatory classification. Notwithstanding the differences between our mRNA investigational medicines and gene therapies, the classification of some of our mRNA investigational medicines as gene therapies in the United States, the European Union, and potentially other countries could adversely impact our ability to develop our investigational medicines, and could negatively impact our platform and our business. For instance, a clinical hold on gene therapy products across the field due to risks associated with altering cell DNA irreversibly may apply to our mRNA investigational medicines irrespective of the mechanistic differences between gene therapies and mRNA.”
Moderna is evidently keen to distinguish its mRNA-based product from “gene therapies” on the basis that it doesn’t alter cell DNA irreversibly, but that distinction is one the company is pushing for, not one that already exists.
The wider point that could be made is that drug companies would presumably like to see these mRNA technologies classed as vaccines as they allow the side-stepping of steps that would otherwise be required in the approval process. For example, from the BNT162b2 Module 2.4. Nonclinical Overview:
- “No secondary pharmacodynamics studies were conducted with BNT162b2.”
- “No safety pharmacology studies were conducted with BNT162b2 as they are not considered necessary for the development of vaccines according to the WHO guideline”
- “Nonclinical studies evaluating pharmacodynamic drug interactions with BNT162b2 were not conducted as they are generally not considered necessary to support development and licensure of vaccine products for infectious diseases”
- “Pharmacokinetic studies have not been conducted with BNT162b2 and are generally not considered necessary to support the development and licensure of vaccine products for infectious diseases”
- “No PK drug interaction studies have been conducted with BNT162b2.”
- “A separate single-dose toxicity study with BNT162b2 has not been conducted.”
- “No genotoxicity studies are planned for BNT162b2 as the components of the vaccine construct are lipids and RNA and are not expected to have genotoxic potential”
- “Carcinogenicity studies with BNT162b2 have not been conducted as the components of the vaccine construct are lipids and RNA and are not expected to have carcinogenic or tumorigenic potential. Carcinogenicity testing is generally not considered necessary to support the development and licensure of vaccine products for infectious diseases”
- “Phototoxicity studies with BNT162b2 have not been conducted.”
- “Stand-alone immunotoxicity studies with BNT162b2 have not been conducted.”
- “Mechanistic studies with BNT162b2 have not been conducted.”
Overall Verdict:
- AB statement is correct and well-evidenced
- FF statements are an inappropriate ‘straw man’ that has been constructed to incorrectly widen AB’s specific statement into a more general statement that can be rebutted by its subsequent statements (which, on a standalone basis, are not incorrect, just not relevant in response to AB’s statement).
HART comment: many people jump to the conclusion that ‘gene therapy’ means manipulation of DNA. Language matters. It may be helpful to refer to these as “injected genetic therapy products” rather than “gene therapy” to avoid the above straw man being used as an inappropriate rebuttal for the use of the term.
Conclusion
Andrew Bridgen’s statements were all well evidenced apart from a minor mistake conflating the long term symptoms with hospitalisation after children had been vaccinated. The Full Fact claims are not backed by evidence, use appeals to authority or are based on a ‘straw man’ argument. Full Fact has declared itself a fair arbiter of debate and yet has demonstrably backed one side of this debate without providing evidence to support its case. The actual facts speak for themselves.
