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  4.  » Ian Fantom: Will NEJM now withdraw the Pfizer Vaccine Trial paper?

Introduction

  • Red Flags
  • Questioning basic assumptions
  • The Public is Being Experimented on – with no Placebo group
  • The British Medical Journal Investigates
  • Pfizer Trial Update – More of the Same
  • Swedish Medics Call for Suspension of Vaccinations
  • Blinded by Science

Many people are insisting that the mRNA COVID-19 vaccines are safe, whilst various medics have been insisting that COVID-19 vaccines have not been sufficiently tested for anyone to know that. Some medics, for instance, have been pointing to long-term dangers of pathogenic priming. On one occasion I drew this to the attention of someone who had just told me he was due to have his vaccination. He was very insistant that the vaccines were safe, on the basis of a single paper in a peer-reviewed medical journal, and that all those taking part in experimental vaccinations were doing so with informed consent. I asked him to send me the link, and he kindly did. The paper appeared in the prestigeous New England Journal of Medicine on 10 December, 2020, and was headed ‘Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine’ . This was the seminal Pfizer vaccine trial paper.

Red Flags

I’m not medically qualified or experienced, but I am qualified in Physics, and I could almost immediately see some red flags in that paper. I replied, making a couple of points. He said I should approach the authors of the paper, and not him. I replied, “You were putting that paper forward saying that it showed the vaccine had been properly tested”, to which he replied, “I did. It does. It has been peer-reviewed, the trial was registered, it was published by NEJM, it has been cited over 850 times, it was accepted as part of the evidence pack for approval in multiple countries – I believe in 84 countries now. Many of those have been under an expedited approvals procedure, but some countries have approved it under their standard approvals procedures. If that’s not good enough for you, then no scientific paper will be”. Well no. If any of my professors when I was a student of Physics had had such an attitude I would have wanted to change course. As Physics students we were perfectly at liberty to challenge any scientific paper. I remember putting points to fellow students about various theories. Heisenberg’s Uncertainty Theorem could, I maintained, never be proved, because it asserts a negative. It makes intuitive sense with wave theory, but not with particle theory. The reason that physicists invented the dual theory was that the complete set of observations would not make sense with just one or the other theory. Everything depends on observation.

Einstein’s Special Theory of Relativity doesn’t conclude that nothing can travel faster than light; that is an assumption made right at the beginning – it is not a conclusion, as many people state or imply. When I read the derivation of the famous equation E = mc2 I thought “That’s a bit of a leap, isn’t it?”, and I doubted whether it was a unique solution. I was curious as to why the contraction equations were named after Lorenz if they were Einstein’s. Yet no-one told me off for doubting a peer-reviewed physics paper, which undoubtedly had more references to it than this medical paper.

I hadn’t studied the original 1905 paper in German, but instead studied a short book written by Einstein himself in Germanic English, explaining it. When eventually I realised that Einstein’s 1905 paper contained no references, and thus had not acknowledged previous work, I had to wonder about the peer reviewers, and whether they had any vested interests. Similarly, when I saw obvious red flags in the Pfizer vaccine trial paper I had to wonder about the peer-reviewers, and whether they had any vested interests. I couldn’t trace them, but I did follow up the editor-in-chief of the New England Journal of Medicine, Eric J. Rubin, MD, PhD , who had taken up that position in September 2019, three months before the COVID-19 outbreak. I found an audio interview, conducted on April 29, 2020, in which the editors discuss strategies to limit transmission of SARS-CoV-2, “as restrictions are loosened and economies restart around the world”, the editors being Eric J. Rubin, M.D., Ph.D., Lindsey R. Baden, M.D. and Stephen Morrissey, Ph.D. I found that Lindsey Baden was a co-author of another paper, ‘Efficacy and Safety of mRNA-1273 SARS-CoV-2 Vaccine’, published on 4 February, 2021, in the same journal . The disclosure statement published in a linked document   ran: “Dr. Baden reports grants from NIH/NIAID, during the conduct of the study; grants from Ragon Institute, grants from NIH/NIAID, grants from Gates Foundation, grants from Wellcome Trust, outside the submitted work; and Dr. Baden is a Deputy Editor at the New England Journal of Medicine. Dr. Baden is involved in HIV and COVID vaccine clinical trials conducted in collaboration with the NIH, HIV Vaccine Trials Network (HVTN), COVID Vaccine Prevention Network (CoVPN), International AIDS Vaccine Initiative (IAVI), Crucell/Janssen, Moderna, Military HIV Research Program (MHRP), Gates Foundation, and the Ragon Institute”. I see from Dr Baden’s CV, last updated in March 2019 that since becoming Deputy Editor of NEJM in 2005, he has had three other peer-reviewed papers in NEJM.

I don’t know what standard procedure would be when one of the editorial board of a scientific journal is an author of a submitted paper, but surely that disclosure statement should raise a few red flags. There may be somewhere in NEJM a critical analysis of the basic assumptions made in both those papers, and in the audio interview, but I didn’t come across any. I have to wonder about any possible vested interests of the peer reviewers, too.

I looked in the other declarations of interest, linked to in the Pfizer vaccine trial paper. A total of 29 names appear in the paper as authors, out of which only seven declared that they had no competing interests. The other 22 declared an interest in Pfizer, and three declared other interests as well. At the end of the list of authors was written: “for the C4591001 Clinical Trial Group*”. Under the heading ‘Conclusions’ they gave a link to the US government’s Clinical Trials Group , stating: “(Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728. opens in new tab.)”. I followed that link to a ‘Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals’. The Brief Summary states: “This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals”. The original paper itself, under the Methods heading, describes itself as part of “an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial”. So this single paper cannot be considered to be evidence that the vaccines are safe, when it is only part of ongoing trials. The time scales given in this description, as given in the Study Design, are: “Actual Study Start Date : April 29, 2020. Estimated Primary Completion Date : October 29, 2021. Estimated Study Completion Date : April 6, 2023”. So the trial was planned to last three years, and the studies are ongoing whilst the vaccines are being rolled out to the public. Are the public properly informed when they consent to the vaccinations that the studies are still ongoing, and will not be completed until April 6, 2023? Someone recently said to me, “We all know the risks”, to which I replied, “No, we don’t”.

In the Pfizer vaccine trial paper’s Supplementary Appendix they state under ‘SARS-CoV-2 Testing Information’: “Testing for SARS-CoV-2 virus was conducted using the Cepheid Xpert Xpress SARS-CoV-2 PCR test. Testing for SARS-CoV-2 antibodies was conducting using the Roche Elecsys® Anti-SARS-CoV-2 antibody test”. They don’t state here how many cycles they apply, though this information may possibly be given elsewhere. This is crucial information, and its omission would indicate sloppy science. In any case, testing for the SARS-CoV-2 virus will of itself tell us nothing, unless it is first established that the SARS-CoV-2 virus is the cause of Covid-19, and I see no reference to any such study. Even if there was proof that the SARS-CoV-2 virus is the cause of Covid-19, its existence in the body does not prove that the person is ill; it may be that the natural immune system has successfully fought off the virus. I was also puzzled at the reference here to antibody tests, since I could see no mention in the paper of antibody tests. But in any case, the immune system is not limited to antibodies.

I wrote to US government’s Pfizer Clinical Trials Contact Center, saying:

I seek clarification on two points:

    1. I don’t see any reference in the paper itself to testing for antibodies. Was testing for antibodies employed in the trial reported in the paper?
    2. How many thermal cycles were employed in the PCR tests?

My background is in Physics and Information Science, including abstracting and indexing, rather than in medicine.

They replied: “The Contact Center is only able to provide you with general information about clinical trials or certain information that is displayed on the Pfizerclinicaltrials.com or the www.ClinicalTrials.gov websites, such as the recruitment status, location, and contact information for site locations nearest you”. So I looked up Pfizer’s Pfizer Clinical Trials website. That didn’t help, so I followed their ‘Contact’ link, which referred me to the general Pfizer contact page. I sent them the same query, quoting the clinical trial number. I had previously written to the corresponding author of the Pfizer vaccine trial paper, but that was returned as ‘undeliverable’. I also wrote to the corresponding author of their follow-up paper, asking also about the same points which applied in that paper, too. That paper had just been published, and is referred to below.

I did eventually receive a reply from the corresponding author of the follow-up paper. In answer to my first query, he replied, “Serology testing was done and has been reported for the phase 1 part of the study, and serology will be done on an immunogenicity cohort from the phase 3 part of the study and will be reported in the future. I’ve attached a paper with serology data from the phase 1 part of the study”. ‘Serology’ is the scientific study of blood sera and their effects. This is mainly about antibodies. The paper which he attached was one that I had noticed before: ‘Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates’ . The results “support the selection of BNT162b2 for advancement to a pivotal phase 2–3 safety and efficacy evaluation”. I can understand that the reference to antibody testing would have related to the project as a whole, rather than to anything reported in the Pfizer trial paper in question. In response to my second query he replied: “The Cepheid Xpert Xpress SARS-CoV-2 PCR test was run for 45 cycles”. That I found worrying. Dr Tony Fauci is director of the National Institute of Allergy and Infectious Diseases (NIAID) and the Chief Medical Advisor to the President. Asked about cycle thresholds in the PCR test he replied, in an interview on July 16, 2020: “Again, a good question, and what is now sort of evolving into a bit of a standard that if you get a cycle threshold of 35 or more that the chances of it being replication confident are miniscule, so that if somebody – and you know we do we have patience and it’s very frustrating for the patients as well as the physicians. Somebody comes in and they repeat their PCR and it’s like 37 cycle threshold. But you never – you almost never can culture viruses from a 37 threshold cycle, so I think it – if somebody does come in with a 37, 38, you, even 36, you gotta say, you know, it’s just dead nucleotides, period. … I mean, when you go in – if I get my test, you know, it’s negative. When someone comes in and it’s positive they don’t give them the threshold until you go back and ask for it”. I have to wonder why he couldn’t have just said straight out: “Above 35 thermal cycles the signal to noise ratio becomes so low that the results are not significant”. The Pfizer papers were published well after Dr Fauci’s statement.

Questioning basic assumptions

Both of the papers mentioned have a short ‘Background’ introductory section. On the need for a vaccine the 2021 Baden paper states simply: “Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications”. It does not present a case for there being such a need. The complete ‘Background’ section of the 2020 Pfizer vaccine trial paper states: “Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently”. This was the story being put out by the popular press, but they were also confusing ‘dying with COVID-19’ and ‘dying of COVID-19’, at least in the UK. Eventually they were putting out figures for “deaths within 28 days of being tested positive”. Is this the normal way of linking a death with a test? Given this confusion, such a statement in a scientific journal would surely need a reference giving a source. No references were given on this. Even the statement that Covid-19 is the disease resulting from SARS-CoV-2 infection would need some justifying. This is a point of great controversy amongst medics. That controversy could be easily resolved if someone would produce a decent scientific paper showing that to be the case. Such a paper could easily be referenced. But where is it?

In the body of the Pfizer vaccine trial paper they do give a reference; the first sentence begins: “Coronavirus disease 2019 (Covid-19) has affected tens of millions of people globally 1 since it was declared a pandemic by the World Health Organization on March 11, 2020.2”. However, reference 1 does not refer to a scientific paper; it is a link to the John Hopkins University of Medicine’s Coronavirus Resource Center, which presents information for the public. Their website does present global figures, but I see no detail on the methods of assessment in that reference. In a section ‘How is COVID-19 diagnosed?’ the John Hopkins article states:

In the United States, diagnostic testing for COVID-19 involves testing for the presence of the virus in specimens obtained from patients. Almost all diagnostic testing for COVID-19 is done using PCR-based methods, which look for the genetic material of the SARS-CoV-2 virus, which causes COVID-19. These methods can only diagnose someone with COVID-19 if they are actively infected. Currently, most diagnostic tests for COVID-19 test nasopharyngeal or oropharyngeal specimens (nose or throat swabs). Recently, the FDA granted Emergency Use Authorization to a laboratory to test patients’ saliva.

However, this reference is about testing in the United States, not globally, and so tells us nothing about how the global figures are derived.

Has SARS-CoV-2 been found to cause COVID-19? Where is the source on this? Feedback that I’ve been getting over the past year has been that there has been no scientific paper showing that COVID-19 is caused by SARS-CoV-2 or, for that matter, any other virus.

If SARS-CoV-2 does cause COVID-19, does it mean that someone infected with the virus is made ill by it? Obviously not, if they are talking about people being infected but being asymptomatic. The immune system is fighting off all sorts of pathogens all the time, so would there be anything abnormal about this? Why are they classifying perfectly healthy people as ‘COVID-19 cases’ merely on the grounds that the genetic material of the virus has been detected, irrespective of whether it has been successfully fought off? If it has been successfully fought off, then why is a vaccine needed? These are questions that I would expect to be tackled in a reference given in the paper. The technique of stating something as fact in an academic paper, and referring to another publication, which also just states the same thing as fact, without further justification, is a technique I am well familiar with from my earlier work in linguistics and related sociology. Over the past decade I have come across many such papers on ‘conspiracy theories’ in the psychological literature. Their authors seem to form a clique, patting each other on the back, and constantly avoiding the obvious possibility that people who question pseudoscientific theories may just possibly do so through logical reasoning rather than as a result of subconcious psychological suggestion.

The Public is Being Experimented on – with no Placebo group

In an ‘Adverse Effects’ section of the Pfizer vaccine trial paper they state: “Safety monitoring will continue for 2 years after administration of the second dose of vaccine”. However, in the Discussion section they state:

Although the study was designed to follow participants for safety and efficacy for 2 years after the second dose, given the high vaccine efficacy, ethical and practical barriers prevent following placebo recipients for 2 years without offering active immunization, once the vaccine is approved by regulators and recommended by public health authorities. Assessment of long-term safety and efficacy for this vaccine will occur, but it cannot be in the context of maintaining a placebo group for the planned follow-up period of 2 years after the second dose.

On 11 December, 2020, the day after the Pfizer paper had been published, the Federal Drugs Administration [FDA] in the USA distributed a press release, stating:

Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

On 10 March 2021 the German publishing company Springer published an ‘AdisInsight Report’ headed ‘BNT162b2 mRNA COVID-19 Vaccine: First Approval’ , in which they reported:

In early December 2020, [the Pfizer vaccine] BNT162b2 received a temporary emergency use authorization (EUA) in the UK and, subsequently, a series of approvals or authorizations for emergency use in Bahrain, Canada, Mexico, Saudi Arabia and the USA. Soon after, BNT162b2 received conditional marketing authorizations in Switzerland (19 December 2020) and the EU (21 December 2020) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.

Summaries were published by Springer and Pubmed . This means that the Pfizer report was an interim report, published two months after the vaccinations were complete, in a trial that was planned for two more years, but then a range of countries authorised the vaccine for public use, and so then the placebo group were given the option of receiving the vaccines, and comparisons with the placebo group had to stop. This means that only short-term ill-effects of the vaccine were studied in this placebo-controlled, observer-blind study.

I have heard of deep concerns by medics of underreporting of such short-term effects, but a greater concern has been regarding long-term effects, namely pathogenic priming, leading to cytokine storms, and the possibility of gene modification being passed on to future generations. Yet the Discussion section of the Pfizer vaccine trial paper states: “Assessment of long-term safety and efficacy for this vaccine will occur, but it cannot be in the context of maintaining a placebo group for the planned follow-up period of 2 years after the second dose”. We have to wonder just how this is to occur. That must mean that the public are being offered a vaccine whilst it is still under test, at least for long-term ill-effects. Are the public informed of this when they are offered the vaccine? I looked up Pfizer’s fact sheet for recipients and care givers as revised on 10 May 2021 . The section headed ‘WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?’ stated:

There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

* Difficulty breathing· * Swelling of your face and throat· * A fast heartbeat· * A bad rash all over your body· * Dizziness and weakness

Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include:· * severe allergic reactions· * non-severe allergic reactions such as rash, itching, * hives, or swelling of the face· * injection sitepain· * tiredness· * headache· * muscle pain· * chills· * joint pain· * fever·* injection site swelling· injection site redness· * nausea· * feelingunwell· * swollen lymph nodes (lymphadenopathy)· * diarrhea· * vomiting· * arm pain

These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials.

They don’t make it clear that the vaccine has been tested only over a two-month period, when the designated time period for those trials was to be two years after administration of the second dose of vaccine. Nor do they mention that the new vaccine applies new technology, never used before in vaccines, that it is an mRNA vaccine. Nor does it explain about the known phenomenon of ‘pathogenic priming’, and that concerns have been raised in the medical profession about the dangers of pathogenic priming at a later stage, when the natural immune system is suppressed as a result of the vaccination. Nor is there any mention of the possibility that the effects of the mRNA vaccine, both positive and negative, could be passed on from generation to generation. Does this leaflet provide adequate information on the risks involved with this vaccine? Generally speaking, people who have told me they are about to have their vaccination have been unable to tell me which vaccine they are to receive. So this is a leaflet to be read on the spot, when the person has already committed to having the vaccination, and may be under time pressure to digest the information. Are people being properly informed by a leaflet for quick reading, when authorative public figures have been widely reported as stating that the vaccines are safe?

If these trials are no longer placebo-controlled, observer-blind studies, then how is any valid assessment being made whilst the vaccines are being meted out to the public? This surely can only be done by comparing the effects on members of the public who have accepted the vaccines with those in similar situations who have not accepted the vaccines. Does this mean that the public is being experimented on? It sounds like that to me.

The British Medical Journal Investigates

Recently The British Medical Journal published a ‘BMJ Investigation’ titled ‘Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial’ . The BMJ investigation referred not directly to the Pfizer vaccine trial paper, but to the US government’s specification for the trial, as given in their Clinical Trials web page under number NCT04368728 . Their article begins: “Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight”. The trial “enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres”, the article reports. One of these contractors was Ventavia Research Group. A whistleblower wrote that Ventavia had “enrolled more than 1000 participants at three sites”.

According to the article, the whistleblower:

told the BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, [the whistleblower] Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. …

But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

On the day she expressed her concerns to the FDA, she was sacked. Out of the 153 sites taking part in the trial, only nine were inspected by the FDA, and those did not include any of the three Ventavia sites, yet subsequent Government trials continued to use Ventavia. The BMJ also gained evidence from other employees. “There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine, and author of ‘Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials’ . This must raise concerns about the quality control in other sites in the Pfizer vaccine study. If there had been reasonable reason to believe that Ventavia was an egregious rogue company, then one may have expected the FDA to have dealt seriously with Brook Jackson’s evidence. Yet there was no follow-up. One could also have expected Pfizer or the FDA to have modified their statistics, taking out any data provided by Ventavia’s three test sites, to show that that wouldn’t have made any significant difference to the results. Yet they don’t appear to have done that.

In one of my early reports following the declaration of a pandemic, headed ‘Science, Fake Science and Political Science’ , I reported on a symposium held on 1-2 April, 2015, by the The Academy of Medical Sciences, jointly with the Biotechnology and Biological Sciences Research Council (BBSRC), the Medical Research Council (MRC) and the Wellcome Trust, under the title ‘Reproducibility and reliability of biomedical research’. One attendee was the editor of The Lancet, who quoted one comment as, “A lot of what is published is incorrect”. He also referred to “a chilling state where severe restrictions on freedom of speech are placed on anyone on the government’s payroll”. One attendee had previously written a paper titled ‘Why most published research findings are false’, which at the seminar was described as ‘a seminal paper’. In the light of this, one may have expected a more cautious approach coming from the editor of NEJM in publishing the Pfizer trial paper. So whatever became of The Academy of Medical Sciences? “We are the independent body in the UK representing the diversity of medical science. Our mission is to advance biomedical and health research and its translation into benefits for society”, their website states . So shouldn’t medics in the UK be pressing them to hold another such seminar on ‘Reproducibility and reliability of biomedical research’? After all, they do state, “The UK leads the world in biomedical and health research, and is renowned for the quality of its research outputs, talent and collaborations”. So what does that say about the rest of the world?

And what does that say about the long-established New England Journal of Medicine, considered by many to be a respectable peer-reviewed scientific journal in the medical field. In particular, I think we should now be questioning why they have not withdrawn the Pfizer paper, in the light of the evidence now available from the BMJ’s investigation. And surely, I cannot have been the only reader of that paper to have had doubts on whether that paper had been genuinely peer-reviewed at all. So even without the BMJ report I have to wonder not only why the paper was not withdrawn, but even why it was published in the first place.

The BMJ investigation was reported by Dr John Campbell, who regularly gives video talks about COVID, and has 1.29 million subscribers on YouTube, having produced 1 877 videos. He is “a retired Nurse Teacher and A and E nurse based in England”, whose “PhD focused on the development of open learning resources for nurses nationally and internationally” . He stated in the video:

As of yet, the paper has not been retracted, and I think that’s an important point; the paper has not been retracted by the New England Journal of Medicine’. If it does of course we’ll talk about it very quickly. So what were these concerns? A revelation of poor practice at a contract research company. Pfizer’s pivotal vaccine trial raises questions about data integrity … no indication that that has been retracted.

He then goes through a list of the points made by the BMJ. For each of these he says he doesn’t like the sound of it, or that what is reported is not ideal, and spells out the reasons for it not being ideal, and makes the point that ideally it would be better for it not to have been the case. I should have thought that any one of those points would have been not just ‘not ideal’, but crippling, that it would by itself be a cause for peer reviewers to send the copy back for revision if they had been aware of these points. Certainly I should have thought that the reputation of the journal would be at stake. After 16 minutes of such explanations, John Campbell comes back to the question of retraction, stating:

Um, this paper’s not been retracted. So, um, can we assume that because this paper has not been retracted that the New England Journal of Medicine is happy that the overall, um, results and data were not compromised, uh, issues? Um, Well, I think the thing to do is: read this for yourself and see what you think. But as of now that paper has not been retracted, so I think we have to assume that the British Medical Journal are, are happy with it, and that this hasn’t fundamentally affected these issues – have not fundamentally affected the overall integrity of the data in a, uh, significant way, but, um, it would be good to hear a statement on that from the New England Journal of Medicine, um, as soon as possible. This feeds into the whole issue of trust, doesn’t it?

It does indeed. When a scientific paper is published in a peer-reviewed journal, it is being put out for assessment in the wider community, giving an opportunity for peers to criticise it and to try to reproduce the experiments. Editors and peer reviewers aren’t interested in excuses. Any mentions of what the FDA think about it, or any pressures that the FDA may be under, should be irrelevant as far as a scientific journal is concerned. He concluded the video with:

You, know, vaccines have saved untold amounts of pain, suffering and death in the world, but, but we have to have this – The scientific process has to be, uh, has to be transparent, and it has to be valid for people to trust in it, and given that some people don’t trust in vaccines anyway, really, this sort of thing doesn’t help. So, what we should have is perfect integrity all the way through, so that we can completely trust the the clinical data that we are given, but unfortunately, this puts – shall we say, shall we say, this puts questions in people’s minds.

This does indeed put questions in people’s minds, and quite legitimately, too. On first hearing this I felt confused at the way the criticisms were sandwiched between the statements on the paper not having been retracted. On my second hearing, I felt even more confused. In the meantime I had offered Dr Campbell my analysis of the Pfizer paper, though still in draft form. I didn’t receive a reply, so I thought that perhaps I ought to finish off my report on the paper: to edit it and bring in the BMJ’s report, too.

The question of trust that Dr Campbell raises was the subject of a NEJM editorial of 31 December 2020, in which Deputy Editor Dr Baden was the corresponding author . The editorial was headed ‘The FDA and the Importance of Trust’ . The editorial concluded:

Without a clear, transparent, and scientifically sound decision-making process, the trust the FDA has built and maintained over the past century is eroding. As potential therapies for Covid-19 come before the FDA for consideration, only an open, rigorous scientific process that relies on high-quality data can assure clinicians and patients that the new approaches are safe and effective. Such a process will be particularly important as the FDA considers emerging candidate SARS-CoV-2 vaccines.

Determining the safety and efficacy of the therapies clinicians use and patients receive is at the heart of the medical system. The FDA has been the envy of the world, setting standards for the studies it requires and then following the resulting science and data in its regulatory decisions. Today more than ever, as science is being manipulated and disregarded, it is critical that the FDA uphold its standards and its objectivity. Truth may be difficult to know, but the scientific process is our best path to knowing it. Treatments for patients should evolve as new data accumulate. But physicians and patients must be confident that any approval from the FDA is based on a careful evaluation of all the available data and that the agency’s decisions are well reasoned and objective. There should be no political interference in the FDA process. The FDA and the executive branch should not squander the trust that the agency has carefully built over many decades of hard work.

This throws the onus onto the FDA, but the issue of trust raised here relates to the NEJM and the Pfizer trial paper. The obvious conclusion is surely that any questioning of the integrity of the NEJM paper, on which the FDA has based a major decision, will undermine trust in the FDA.

Dr Campbell’s point about trust is valid, but it shouldn’t make any difference to any objective analysis of the paper. Such a consideration should be outside the scope of a scientific journal. If it’s not good science, then it’s not good science. If a paper is not good science, then it should be rejected if the journal is to maintain a good reputation within the science community. If the FDA, or any other body, are going to use such a rejected paper for any reason, then it should be made explicitly clear that the paper was not a peer-reviewed scientific paper. One should not reverse the argument, in suggesting that withdrawing the NEJM paper would undermine trust, especially when not withdrawing the paper is likely to do just that.

Pfizer Trial Update – More of the Same

On 4 November, 2021, an update of the Pfizer vaccine trial was published in NEJM, headed ‘Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months’ . The paper’s Abstract states: ‘In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-μg doses, at 21 days apart, of BNT162b2 or placebo”. So they have extended the trial down to participants aged 12 or over, and they also state that the Pfizer vaccine trial is a placebo-controlled, observer-blinded trial, when the only part of this trial in the six months described in the paper to be placebo-controlled and observer-blinded was for participants below the age of 16. Indeed, the US government’s Study Design is titled: ‘A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS’. This would give a false impression to those who just read the abstract, and don’t go into the nitty-gritty of the paper itself, and those people are likely to include most politicians and journalists, if indeed they even get that far. The Conclusions given in the Abstract were: “Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728. opens in new tab.)”. So, everything looks fine to the main opinion formers who may read only the Abstract.

However, I notice from the Supplementary Appendix that three of the investigators represent Ventavia Research Group. In the light of this, the same doubts as to the trustworthiness of the data that were expressed for Phase One of the trial must apply to the further work over the specified six month period.

Swedish Medics Call for Suspension of Vaccinations

On 5 November, 2021, three days after the BMJ article had appeared, and the day after the Pfizer update paper had appeared, a Swedish group of medics sent out a press release about an appeal signed by 16 medical researchers and practitioners to their government to suspend the Covid vaccination programme, on the basis of concerns raised in the BMJ investigation. They say that they believe that the findings of the BMJ investigation are “extremely serious”, and that they undermine confidence in Pfizer. They describe the number of reported suspected side effects as “gigantic”, with 83,744 reported suspected side effects, “which is more than ten times more than all side effects reported per year in the most recent years for all drugs and vaccines, a total of about 25,000 substances”. About twenty studies have shown that the vaccine’s effect is “very weak”. As researchers and immunologists, they are “deeply concerned”.

The group of medics which put out that press release is known as Läkaruppropet [The doctor’s call], and they had launched their activities with a medical appeal to reduce restrictions and improve the protection of risk groups, in a Declaration written and signed on March 12, 2021 by three medics, though now this Declaration has gathered not far off a thousand signatures from medical researchers and medical staff, and around ten times that number of committed citizens. The press release on that begins:

As doctors and researchers, we want to raise our voices against the harmful restrictions that are going on in Sweden. There are now political demands for a total shutdown of society. Many studies, published by the respected The Lancet, among others, show that lockdowns aimed at preventing the spread of Covid-19 are lacking in evidence. The potential benefits of shutting down society must be weighed against the documented negative effects it brings in the form of deferred care, lack of school attendance and education, physical inactivity, isolation and mental illness, deteriorating future public health, unemployment and bankruptcies.

“Perhaps the most misguided measures are those that affect children”, they say, giving some details of their concerns on this matter as well as several others. They also provide some suggestions for decisions that they think could be made today to save lives.

There are a few medical groups in the UK campaigning with similar objectives. Perhaps all such groups should be calling for the withdrawal of the NEJM Pfizer trial paper, and pressing their own governments to suspend Covid vaccinations for the same reasons. It may be difficult in the UK to build up similar numbers of signatories from medical staff, considering the “chilling state where severe restrictions on freedom of speech are placed on anyone on the government’s payroll”, as the editor of The Lancet put it.

Blinded by Science

I think one misconception that arises is that publication of a scientific paper in a peer-reviewed journal is the end of the scientific process. It is not; it is the beginning of public scrutiny. The peer review is equivalent to the triage process in an emergency ward. One can only find out whether a scientific experiment is reproducible by publishing the details and letting other specialists, with no vested interests, try to repeat the experiment. In the case of cold fusion, for instance, no-one could, and the idea was dropped. In the case of a clinical trial, other medical specialists need to examine the papers for any flaws that may have got through the reviewing process. It may, for instance, be that the fine details are correct, but that the whole experiment is based on false assumptions. It may be that a lay person spots that the emperor has no clothes on, as in Hans Christian Andersen’s ‘The Emperor’s New Clothes’. The job of journalists should be to pick up on any dissent, particularly from the peers, and pose sensible questions to the authors. Instead, we are constantly finding just the opposite, so that the public receives a false impression on the reliability of public statements made by people put forward as scientists, who may have vested interests and may even be charlatans.

The points I’ve drawn attention to in this article regarding the Pfizer research paper are things that I wouldn’t have expected to have to be studying when I graduated in Physics several decades ago. Many of these issues are hidden in the text, or glossed over, in the supposed peer reviewed paper, in such a manner that virtually no journalist will spot anything wrong. Whatever happened to scientistists in the journalism profession?

Qualified medics, who should know better, are failing to highlight these issues, except for a small minority, who are constantly being silenced by the censors. The public needs to understand this. People should be asking questions, and expecting sensible answers. Whenever there is obfuscation, or evasion, or ad hominem attacks arise, this should be taken as evidence of bad faith. Yet a culture has embedded itself in our civilisations of ‘Cooperate and don’t criticise’. Yet criticism is an essential part of any co-operation.

Yet one country has a constitution which requires referenda on major issues, and that is Switzerland, which is to hold a referendum on 28 November, 2021, on their government’s proposed Covid restrictions. At a press conference on 12 November he said said that what we’re seeing is “a global coup d’etat against democracy”. Speaking as a litigator, he stated:

You think about this. I got expelled from Instagram because of ‘vaccine misinformation’. But Instagram and Facebook cannot point to one single erroneous statement that I have ever made. Everything we post is valid, it is sourced and cited to government databases or peer review publications. When they use the terms ‘vaccine misinformation’ they are using it as a euphemism for any statement that departs from official government policies and pharmaceutical industry profit-taking. It has nothing to do with whether it’s true or false. It only has to do with what the political implications are. And who is doing this censorship? It’s government officials in league with Bill Gates with Larry Ellison, with Mark Zuckerberg, with Sergey Brin from Google, and all of these Internet titans. They have engineered not only the destruction of our democracy and our civil rights, but they have engineered the biggest shift of wealth in human history. Three point eight trillion dollars from working people to these handful of billionaires, many of them from Silicon Valley. This pandemic has impoverished the world and created five hundred new billionaires. And those are the people who are strip mining our economies, and making themselves rich. And is it a coincidence that these are the same people who are censoring criticism of the government policies and are bringing them trillions of dollars?. People aren’t stupid. We can see what’s happening. We can ask the question ‘Cui bono?’. And the answer is the people who are benefiting are the people who are squeezing away our constitutional rights and engineering the destruction of democracy worldwide.

We are being blinded by science, and this is being led by holligans and charlatans.