Christine Cotton [00:00] When the results of December 2020 are truly replicated, there is no statistical demonstration, we will say statistical evidence, that there is an effect on serious forms. For the good reason that there has not been enough in the clinical trial to prove a difference between placebo and vaccine. We have a list of people who have identified a number of potential side effects to monitor. And in this list, what we find? What we see today in reality. Mocardites, pericardites, blood clotting problems, thrombosis, neurological problems. Normally, the authorities order the products on the basis of reliable results. Now, if it is not reliable, what do we do? We review the contracts, we charge the laboratory all the undesirable effects. I would do that, and I would have all the side effects paid to the pharmaceutical laboratory. If we reproduce this way of working, i.e. sloppy tests in a very short time with messy methods, we will have only potentially ineffective or toxic products on the market.

Host [01:12] Hello Christine Cotton, thank you for accepting our invitation. You are a biostatistician, ex-DGP of a research company under contract specialized in the management of clinical trials for the pharmaceutical industry. During your career, you have worked on more than 500 clinical trials for large laboratories. You have just published a book entitled “All vaccinated, all protected, chronicles of a health disaster announced by Guy Trédaniel”, a book that combines scientific counter-investigation and testimonies of victims of serious adverse effects of Covid vaccines. For starters, maybe you could explain to us what the biostatistician profession consists of and why it plays a key role in the process of developing pharmaceuticals on the one hand, and what prompted you to undertake this scientific counter-investigation on the other hand?

Cotton [02:03] The profession of biostatistician is extremely important in the pharmaceutical industry since it is one of the stakeholders from the writing of the protocol of clinical trials or other observational surveys also, post-authorization marketing. There is always a biostatistician who makes calculations of number of subjects, that is, the number of patients to be included in a trial or in a study, post-AMM, in order to be able to conclude statistically, one will say, for clinical trials, a difference between the products. That is to say, I’m going to start from the hypothesis of effectiveness and it’s on the basis of these assumptions, on a criterion that we’re going to call the main criterion, that we’re going to define a number of subjects.

So in the case that we’re dealing with, for example, Covid vaccines, Pfizers, it’s the vaccine versus placebo. To know that we include 44,000, it is a biostatistician who made this calculation. So he writes the methodology, once we have defined the criteria of how we will analyze them, he also reflects on the criteria to be defined by the analysis that we have to do behind. That is upstream. This protocol is submitted to the health authorities who approve it or not, or have it changed, as we move on to ethics committees. If I do research on the human person who is not ethical, obviously the health agencies will refuse it to me. And then, at the time of the data collection, which was also one of my activities as CEO of a contract research company, we also managed what we call data management, data management, data collection, data cleaning until we had a database of our own, and with reliable and accurate data so that we could arrive at statistical analysis, which was also my job. That is, I know all the steps to obtain reliable data and to program the results and therefore interpret the results. If there is no biostatistician, there is no result. And contrary to what many think, it is not at all a profession of doctor to provide results of clinical trials. It is a profession of biostatistician. So a clinical report, it is then co-written by a doctor or pharmacist and the biostatistician who usually has to sign it. So we have a very heavy responsibility in the methodology, we must not be mistaken, we must not be mistaken in the analysis because obviously it could have very strong repercussions to say that a product works when it does not work and vice versa.

Host [04:32] What prompted you to finally recover the data from the Pfizer clinical trials and analyze them since at that time you had sold I believe your company?

Cotton [04:41] I sold in 2018 but I had a two-year non-competition clause. So for two years I couldn’t work for the pharmaceutical industry or at least not for my former customers. Well then it’s a bit complicated when we go back on our own to explore since the laboratories they have purchasing services, we have to get reference. So I said, I’m not even looking to work and then I’ll be back in August 2020, September 2020. Well, September 2020 was a little bit in the middle of Covid, another one. And in December, the reports came out. So I tell a little bit in my book how I did almost all this a little bit by chance finally, with people each time who are on my way and who ask me to do things I didn’t really plan to do.

Host [05:25] From the beginning of the book, you remember that a clinical trial is a long-term process, the fruit of several years of work. And you add that while some have seen in the development of these messenger RNA vaccines an unprecedented technological feat, others of which you are a part have seen it as a feasible challenge at the cost of small arrangements with the standards usually in force. What are the good practices in clinical trials and have they been followed in the trials on messenger RNA vaccines?

Cotton [05:53] Oh yes, so that’s a big question. So good clinical practice is a set of regulatory documents that frame all areas of clinical trials. Whether it is the provider who will take blood samples, whether it is the investigator, that is the doctor who will recruit patients in a clinical trial, all the stakeholders who will act on his site, all the staff who will work on the trials, it frames the data collection software, they must meet certain standards. In particular, identification with passwords, etc. and traceability, all being recorded, we know who captured what, at what time, such a day, such an hour, such a second, why the data was changed, this is called the audit trail. It frames the activities of how we write an analysis plan, how we define the analysis populations, that is, when you read the Pfizer report, you have different analysis populations. We say, we will exclude such and such person. That is defined in the guidelines. In general, we don’t think like that, I’m going to define such a population. It’s all framed, it’s the ICH standards. It’s a consortium that all health agencies around the world have joined, and it’s they who maintain, write and maintain these documents, that is, they update them, update them regularly.

So, in order for a trial to be valid, each stakeholder must follow these standards. In the Clinical Pfizer trial, we have a number of serious deviations from the monitoring of these standards. Here it’s a little bit complicated to explain them. We’ll say that, for example, in pure statistical terms, when you have people in this trial that you don’t systematically do a PCR test, you don’t know whether these people have Covid or not.

Now the trial is designed so that you don’t do a PCR test for all. So that’s a major statistical bias, methodology since potentially you miss Covid cases. You see, this is the first bias that any biostat or even statistician can see, that is, you miss Covid cases since you don’t test everyone. So this is a methodological choice that is somewhere wrong. So it’s also a deviation, because when you choose your method, you’re not supposed to choose methods that create biases in the results. That is, bias is something that will distort the result. You choose a wrong method, necessarily that your results are unreliable.

But it also frames the activities on the site. If you have people, they tell you that it is double blind. That is, the doctor does not know what he is giving, the patient does not know what he is taking as a product. And that in the center, you have people who are aware and who are going to lighten it all over the halls, we don’t have to disclose what the patient has taken. Since then, it’s going to distort the life that we’re going to possibly have on links to side effects, the accountability of the treatment or not.

So all this is codified, it’s written. And if you don’t follow this procedure, your results are wrong. In fact, it’s very simple. In any trade, there are standards to be met. If you start to do blood tests by not respecting the way to dose with rotten machines, you realize that your dosage, your result will be wrong. It’s exactly the same for clinical trial results. It’s not specific to trials to have standards.

Host [09:38] You take several examples of the different biases you have found. In fact, you explain in particular that the main marker that was retained by Pfizer BioNTech to evaluate the effectiveness of protecting its vaccine, is based on neutralizing antibodies and you point out in fact that the measurement of the evolution of these antibodies after the second injection finally is subject to caution and there you have really identified a relatively important bias.

Cotton [10:09] Yes, a failure, a serious failure, we’re going to say. When you develop a vaccine and you dose the antibodies for as little time as two months after dose 2, while normally a vaccine is supposed to increase your antibodies to not catch the disease or possibly be less serious when you have it. Now, what are they doing to us? Instead of multiplying the measurements, what we could have expected, since we’re in a hurry, we’re all going to die, we’re in confinement, we’re stopping the economy, the whole world is stopping for this famous Covid, so normally you’re adding measures to get a lot of data on your antibodies. They are given two months after dose 2, and after dose up to six months after dose 2.

Host [10:54] Is it possible for you that Pfizer finally deliberately failed to measure his antibodies over this period of a few months to mask their rapid decrease or is this a mere negligence?

Cotton [11:10] It’s not possible at this level to do such negligence. When you’re at this stage of doing such negligence, it’s serious, you have to change your profession. since you’re measuring your antibodies. So, your curve, you’re starting from zero. There’s no antibodies before you take the vaccine. So, your antibodies, they’re going up. And then we see that they drop a little bit. On monkeys, the publication on monkeys, we see it too.

Host [11:34] This is the preclinical study.

Cotton [11:35] Pre-Apes Clinic, so that makes you feel that way, and then they go down a little bit, and then you don’t dose, so that’s weird, especially since December 2020, they’ve been studying a boost, and they’re planning to study a boost.

Host [11:53] So a third dose.

Cotton [11:54] That’s a third dose in case of a decrease in immunity.

Host [11:59] You also explain that the effectiveness of 95% that was announced by Pfizer-BioNTech at the end of 2020 did not mean that 95% of people were immune on the one hand and on the other hand that they were only concerned with mild or moderate symptomatic Covid cases, so there also confirmed by PCR test as you recalled. What was the effectiveness of this vaccine, therefore, all Covid cases combined, i.e. mild, moderate and serious?

Cotton [12:29] So that’s a result that wasn’t provided by the lab. If we want to know who had the Covid during the trial or who didn’t, we can know it thanks to the documents made public since there they released, by court decision, documents, there’s text, there’s what’s called individual data, i.e. patient listings. And we also have specific files that are SAS tables. So it’s the analysis software that was used to do this analysis by the staff who did the intermediate analyses and that I learned to use in 1993. It doesn’t rejuvenate me. And that I never really stopped using since I like to program. I’m a real… Not geek, but not far away.

So, I never stopped using this software. I recovered these databases and roughly modo, we manage to reproduce the result. I say roughly modo because the database itself must normally respect a format. which is standard. And when you see these files, it’s one of the most rotten databases I’ve seen in my life. So even at the database level, it’s definitely not well done. So we manage to roughly reproduce it.

So we program them. And then we can know that there was Covid or not on the basis of a criterion, which is antinucleocapside serology. So that, that tells you, you have this serology measure that is done regularly. which is measured, blood surprise, so we dose antibodies, and this serology tells you who had Covid or not. And when you recalculate the effectiveness on the basis of that criterion, you are around 55%.

So in December 2020, when they exit their criteria, 95% effectiveness which is therefore mild, symptomatic, mild or moderate, confirmed by PCR test, counted from 7 days after dose 2. If you don’t look at this, you just look who had Covid or not, placebo versus vaccine, you are at 55. Why this result is not in the clinical report? In real life, we did well, when people went to get tested. Waves were cases, they were not Covid cases, symptomatic, mild or moderate, confirmed by PCR test, since it was on the basis of the tests that we were doing the cases. You had lots of asymptomatic people. In those who were going to get tested every day, it was a case and it was creating an epidemic, a pandemic. But in clinical trials, we don’t count all the cases, since asymptomatics, we don’t look at them. So you get a result that is not at all what has been observed in reality, since you have plenty of cases in reality that you do not have in clinical trials.

Host [15:26] Especially since one of the main arguments put forward by the public authorities from the beginning of the vaccination campaigns was that these vaccines protected serious forms.

Cotton [15:36] Yes, so that’s the same thing, when we really take back the December 2020 results, there’s no statistical demonstration, we’re going to say, statistical evidence that there’s an effect on the serious forms. For the good reason that there hasn’t been enough in the clinical trial to prove a difference between placebo and the vaccine. You have one severe case for the vaccine and three for placebo, and each time in 18,000 people. So out of about 36,000 participants in the trial, you have four severe cases. So it was impossible in the trial to demonstrate any efficacy of the vaccine on severe cases. That’s statistical, actually I’m going to say it’s white, it’s black.

Host [16:21] Are the analyses that have been carried out by Pfizer in the longer term, especially after six months, which have been updated, sufficient to demonstrate better results?

Cotton [16:30] So, the six-month analysis, yes, I think it proves an effectiveness, but like me, I have shown that these criteria are not valid in their mode of reporting and in their measurements, since it is these famous methodological biases that are observed, when you have people on placebo, as soon as they have the symptoms, you test it. You have people on vaccines, you test them much less, you reduce cases.

So, you create a bias. That’s how we create biases. That is to say, we introduce elements that distort you the number of cases observed. So your result, what is it worth at the end? Whether it’s severe cases, mild or moderate cases, the result is no longer worth anything. That’s why when I wrote this expertise on the Pfizer clinical trial in terms of good clinical practice, I asked for an audit, an audit of all the participating centres of all those who recruited patients, to check every time the patient called the centre saying “I have symptoms,” was he recalled? Did we do the PCR test? Why didn’t we do it? You create biases. And that, we can really check whether there is fraud or not. That’s why I, from the beginning, don’t talk about fraud, I ask for an audit. And fraud, it will be proven when we have done the audit, by obviously competent and independent people.

Host [17:49] You also refer in your book to the charges brought by Brooke Jackson, former Regional Director of Ventavia Research Group, who worked on Phases 2 and 3 of the Pfizer-BioNTech clinical trial and who reported several violations of good clinical practice. A case that concerns I believe three sites that have included a little more than 1000 participants out of the 44,000 worldwide. Is Brooke Jackson’s testimony likely to cast suspicion on all these sites that participated in the Pfizer-BioNTech trial or even question the results of the whole trial?

Cotton [18:24] It’s obvious, because if these sites were managed in this way, there’s no reason for it to be done better in others. And it’s mostly that we have almost, we know that in Argentina, we have a lot of problems in managing the site, in managing the participants. And with this case of Augusto Roux, this lawyer who almost died during the clinical trial and who does not appear in the results, and who makes a monumental hay everywhere because he wants to make him recognize the fraud since these data have been transformed. That is to say, not only did we not postpone such as he had myocarditis or pericarditis, but absolutely deplorable blood tests, he was really between life and death the boy. And that, it does not appear in the results.

So he wants us to recognize fraud. And the center of Argentina, it is very important since it is a military hospital. In Argentina, there was only one centre that recruited patients. This is this military hospital in Buenos Aires. And this centre alone recruited 5,700 participants. So you see the major methodological bias that it introduces. If in that center, you have completely false efficiency results, completely false tolerance results. You have 5,700 out of the 36,000 results that would have been provided in December 2020. So this, of course, is a centre to be audited as a matter of urgency. And besides, the agencies should have rushed to do an audit following this case at Gustourou, which nevertheless alerted all the health agencies in the world. What’s going on? Nothing.

Host [19:56] So in fact what you’re saying is that in the end it’s enough that there are violations, good practices that are identified on a single site so that we can finally ask ourselves the question of… Well, we already know that it’s 4 sites, so Ventavia is 1000 patients, the others are 5700, it’s already nearly 7,000 people. Montavia, it was in the United States.

Cotton [20:16] It’s in the United States. After, there’s the Mady de Garé case among teenagers. That’s another site since it also makes a very serious desirable not reported as it is in the clinical report, neither in the database nor in the clinical report. So, false tolerance. It’s starting to make a lot of people. And not only when we know that we have centres that have potentially worked badly, what we can do in statistics is to reanalyse the criteria without these centres, nothing prevents us. By saying that we have a suspicion, for example, of fraud on such and such centres, we exclude these centres from the analysis. However, in the report, no result is provided without these centres. What prevented them from doing this, those three programming lines?

Host [20:59] You also explain in your book that the vials of vaccines manufactured do not contain the same ingredients as those in the clinical trial since Pfizer has changed its manufacturing process, notably reducing the proportion of RNA, called the RNA integrates. And you point out that if health agencies are normally expected to carry out quality checks to verify that the vials are in compliance with what was announced by the manufacturer at the time the marketing authorisations were issued, finally, no information has been made public at the moment regarding any checks that could have been carried out.

Cotton [21:32] So on the site of the NSM in France, so the Health Agency, they say that they do checks. However, we have never seen a report of checks.

Host [21:40] Is it a usual practice finally to modify the manufacturing process?

Cotton [21:44] In fact, it had been a blocking point for the European Agency, which had therefore been slow to give its authorisation since between the time when the United States, the IDF, gave the basis, it was the emergency authorisation, and we in Europe are the conditional marketing authorisation. Conditional, condition, it’s a health emergency for which we don’t have other treatments, etc. That’s why it’s conditional.If there had been other treatments, there wouldn’t have been a vaccine.

Host [22:14] You also explain that with regard to the figures that were announced on transmission braking, in fact these figures did not come from clinical trials but from studies carried out directly on populations, hence so-called observational or real-life studies, often retrospectively and with a much lower level of scientific evidence than that of scientific trials.

Cotton [22:37] Yes, because if we were to do real life studies to put products on the market, it would be a long time before clinical trials were done. So it’s in the HAS guide, levels of evidence, studies based on retrospective data, i.e. patients that we don’t recruit specifically for the occasion, otherwise it’s forward-looking. So, we’re going to take databases that are more or less complete, with more or less missing data, and you’re going to do your statistic on that. In the pharmaceutical industry, I’ve never done analyses like this. On perhaps more than 1,000 projects that I’ve managed, since I’ve not managed clinical trials, I’ve also managed post-market studies, observational studies, what’s called observationals. And that was… come on, maybe I’ve managed three. It was just forward-looking, that is, you recruit people for the occasion, so you control the data you want, so when you don’t have it, you try to get it, and you have people who are pretty much under the same conditions. So, of course, the numbers that are obtained from retrospective studies, they do not have the same level of evidence as clinical trial results.

Host [23:54] In fact, you also remember in your book that since 1995, the Pfizer group has been involved in some 40 cases that have been sentenced to pay approximately $6.5 billion in compensation, notably in the context of scientific fraud, wild clinical trials, corruption of decision-makers, dissemination of false information. And you add that these are no longer isolated cases, but ultimately a true corporate culture, even a mode of operation and a deliberate strategy.

Cotton [24:21] Well, sleep well, good people, Pfizer takes care of your health. It’s very simple, collegiate said, when you think that it would be enough for no one to buy to sell it. Well, me that’s my sentence, it’s engraved over my bed. So then it’s up to everyone, too.

Host [24:39] And according to your experience with pharmaceutical laboratories, can some large pharmaceutical laboratories possibly include, provide.

Cotton [24:50] I can’t answer that question. That’s not statistics. I, from my experience, I’ve always said, have only met serious people in this community who worked according to good clinical practice. I don’t know how many audits by audit services that were of absolute rigor, that searched everything, how we were validating our analysis programs, how we were validating our data cleanup. I never met anyone who asked me to falsify the slightest result and where I thought these people were corrupt. Never. In 23 years.

So if there are people who do malfeasance, it’s not the operations we meet in the field, it’s happening at another level. So that’s why the staff in the pharmaceutical industry need to get to know my work, because I’ve been suspended from my LinkedIn account and so I’ve lost contact with a lot of my contacts, my former colleagues in quotes, or customers, because we don’t have time to read the Pfizer tests when we work in the pharmaceutical industry. If I hadn’t sold, I would never have had time to say all of this, let alone write a report on the subject.

So these people didn’t really get to know it. There are a few people I talked to who saw them right away in particular the famous bias of not testing everyone in the squalinics, which is a major stat bias. So any statistician really can see that, but they didn’t have time to read the docs in detail. So we need the world of the pharma industry to become aware of all this, since, in fact, if we leave, if we reproduce this way of working, that is to say, sloppy tests in a very short time with messy methods, we will have on the market, from now on, only potentially ineffective or even toxic products. Since they won’t have been tested under conditions that make it possible to be sure of efficacy or tolerance, and then we go to that, that is to say, accelerated testing. It will develop.

So, accelerated testing, what does it mean when you work for the pharma industry? You have teams, you have a product, a clinical development that lasts 5 years, 10 years, right now it will last a year. You don’t think they’re going to make up half the staff of the pharma industry? So you don’t have to let those people who work really let it happen. They have to defend their job there, because there they’re sawing the branch they’re sitting in. It’s gonna hurt them when they fall.

Host [27:27] And do you think that by validating the flash development of these Covid vaccines, by providing marketing authorizations, health agencies around the world have finally opened a form of Pandora’s box?

Cotton [27:40] Yes, completely. That’s exactly what I wrote. Pandora’s box. That is, we’re doing these accelerated developments and we’re not at all sure about the safety of the people who are going to take the treatments, or whether it’s treatments or vaccines from elsewhere, or gene therapies, to trade them in the RN, DNA or I don’t know what. So we’re not at all sure about product safety anymore.

Host [28:07] So you mentioned quite a moment ago the Madhid Garey case, this young American of a dozen years who participated in Pfizer’s paediatric clinical trial in the United States and suffered from serious side effects, not all of which were reported in the final report.

Cotton [28:23] It’s important for AstraZeneca, it’s Brian Dressen. So you don’t have to say that the other vaccines, the AstraZeneca, the Janssen, are safe, it’s not true. It’s at least as toxic as the others. So here I’m not focusing on messenger RNA vaccines. I took Pfizer because it was the most administered. But I could have done exactly the same analysis on Moderna, which is also a messenger RNA. But the others, when you see the damage in terms of adverse effects, obviously there are fewer people affected since they have been given less. So, you have the impression that there are fewer adverse effects on these people, but not at all. It’s at least as bad, if it’s no more, by the way.

Host [29:03] Brian Anderson, he’s another victim of serious side effects.

Cotton [29:07] So, in the clinical trial. That is, she participated in the clinical trial AstraZeneca and she suffered from multiple neurological symptoms or she even considered putting an end to her days. But I have regular phone calls telling me that they want to put an end to their days. It’s terrible what is happening to the victims today.

Host [29:28] You relay several testimonies in your book of these victims. Many of them express their dismay, their distress at the care of the doctors they went to consult, whose lack of benevolence, the fact that many refuse to consider a possible link with the vaccine. Is there any form of denial, in the end, about this issue of side effects?

Cotton [29:58] I think it’s clear, yeah. It’s the worst of all. That’s not only that we don’t treat them, but we also tell them they’re crazy. And that’s… for the victims, it’s the worst of all. So that’s why I talk to them a lot, because they don’t have anyone to talk to. Often, and in their own family, they find themselves isolated. I’ve had one this week on the phone, it’s absolutely dramatic what’s happening to this girl. We don’t know how to really help. And the family is at the end of the roll, because when we have, I don’t know, 30, 40 symptoms, we can’t get out of bed anymore, we’re empty all day, we drink 7 liters of water, we can’t eat, what? Not even 40 years old. It’s absolutely dramatic what happens to these people and it’s really for them that I wrote this book because I didn’t intend to write a book. I thought I had done enough and there were enough books on the market to not add my prose to anything that already existed. But when I was offered this book with victim testimony, it was for them that I wrote it, because it is absolutely necessary that we stop being in denial of these people, because some are agonizing at home. I said it x times, I told honourable senators, I said it wherever I went, there are people dying at home in general indifference, and that is unbearable.

Host [31:24] Do you think some of these serious side effects have been predictable?

Cotton [31:32] Yes, they were predictable because we have people who, as of October 2020, have a list of potential events to watch and we still find these presentations that are available publicly and therefore were presented on the IDF YouTube channel. So we have a whole list of people who have identified a number of potential side effects to watch for, and in this list, what do we find? Are we seeing today in reality? Muscardites, pericardites, blood clotting problems, thrombosis, neurological problems, really a riddle of disabling neurological problems, people who can no longer work, who can no longer leave their homes. So they find themselves in financial troubles, who can’t order things to take care of themselves, so they’re trying to manage themselves, they’re getting close to other victims who are agonizing like them, because everybody doesn’t care. And in hospitals, when they go to the ER once, twice, ten times, we take them more seriously, but where do they actually have to go? So we have to set up centers to treat these people, it’s imperative.

Host [32:48] and precisely what are the conditions necessary for an adverse reaction to be recognised as such at the global and individual levels? And from when can the health authorities finally decide to suspend the use of a product in the light of the data raised by the case of inviolability?

Cotton [33:04] So you have the doctors who report, who normally have the obligation to report the side effects, which many do not do. So either because of lack of time, or because they say they do not have a link, so we don’t do it. We didn’t ask them to establish the link, we asked them to report. It’s not up to them to establish the link. So there are victims who do it themselves because the doctors don’t want to do it. Once we have all these statements, there are signal calculations by the authorities, by pharmacovigilance. On the basis of these signals, we will say whether they are confirmed, potential, etc.

But it’s not because you have people who have a pathology that has been classified as a signal that for him, it’s necessarily attributable. It’s done on a case-by-case basis. So we need to restart the pharmacovigilance services to know what the status is, to ask for accountability. When you have cases, you see it in the testimony of people, it’s the same, accountability is something extremely difficult to get. Since the more cases you have attributable and the more toxic the product is proven. And the more reason you have to stop it. So there is every point in having very few people whose accountability has been recognized.

Host [34:13] So if I understand correctly, that is, on the one hand, for a health agency to be able to report that a particular adverse reaction is related to a product in a comprehensive way, there must be a mass of eventually sufficiently large reporting, it is a statistical question in quotation marks. And on the individual level, for all those who suffer from this potential adverse effect, this is yet another process where we will look on a case-by-case basis if this effect is effectively associated with the vaccine.

Cotton [34:43] After that, it obviously helps to have accountability for post-vaccinal encephalitis. When it’s recognized, it’s listed in the list of side effects. If you have the hyper rare pathology that no one has, it’s going to be even harder for you to have accountability.

Host [35:00] You also point out in your book the sometimes significant delays including the consideration by health authorities of certain adverse reactions identified by Pfizer or Moderna and incorporated in the updates of their risk management plan.

Cotton [35:13] It is a document written by the laboratories for certain products, the risk management plans. The first necessarily dates from the moment the product comes out of the market, or the emergency authorization in the United States December 2020. And then, as there are risks that are proven, we’re going to say signals that are confirmed, the lab is updating this famous risk management plan. So the risks we see, the side effects, but also this plan, it contains the missing data. And this is where we have, from the beginning, what we have in missing data cited in this plan, these are all the populations on which we do not have results.Pregnant or life-threatening women, immunocompromised patients, patients with co-morbidity, fragile patients with co-morbidity. This is where we wrote that we don’t know what the duration of protection is, that there wasn’t a trial on interaction with other vaccines, so that means that when you give products to these profiles, you give them no clinical trial results.

Host [36:16] Since you are referring to the vaccination of pregnant women, the European Medicines Agency and the WHO believe that they are part of the high priority group, they recommend that they be vaccinated, a point of view shared by the National Medicines Safety Agency in France, which indicates that pharmacovigilance has not identified any signs in pregnant and lactating women to date, and that current clinical data also do not indicate a risk for pregnant and future children, in the case of messenger RNA vaccines. What do you think? What is the reliability of these data to which the NSM refers?

Cotton [36:50] It’s always the same, you put people at risk, and that, anyway, is proven later. There are scientific publications that came out that you have this Spike protein that goes all over the baby. Besides, you’re putting yourself at risk. And then the question is, are they told, when they get vaccinated, that there is no clinical trial result? Are they given the information? I, from the beginning, do not say don’t get you vaccinated. What I want is that there is complete information. It’s up to people to take responsibility. I don’t have to say anything at the board level. I do what I want for my health. Everyone does what he wants for his. But he has to be able to establish his benefit-risk ratio. If my risk of having side effects is very high, for example, because I have a history of something and my benefit of catching Covid and ending up in the emergency room is to die from it, and my probability is very low, I don’t see my interest in getting vaccinated. So, did people have the right information to be able to make their decisions? Now, in what I’ve heard in the media since the beginning, we’ve been opening up a lot of news that isn’t the news of clinical trials.

Host [38:07] How do you explain the fact that we don’t know about any biostatisticals in the media?

Cotton [38:14] You did not invite a biostatistician in January 2021 who was going to tell you that there was no demonstrated effect on severe cases, no demonstrated effect on those over 75 years of age and that you had a whole list of people on whom there were no results, while they were the priority people to get vaccinated. That is, how to cut the grass under the foot. It’s obvious. Anyway, it’s not very complicated. Those we least invite are the ones that bother the most. There, I’ve been fighting for a little while, I’ve been working on this for two and a half years. I’m starting to have a very good idea why some people are invited and why others aren’t invited, but it’s no big deal.

Host [38:51] At the end of your book, you finally deplore a form of decriminalization of the practice of care, of dehumanization of medicine with patients who are sometimes reduced to simple figures. You also emphasize that statistics surely have a share of responsibility in this revolution. And you add that beyond the question of messenger RNA vaccines, we face a choice of life and a choice of society. What are the main lessons that you learn from this health crisis? What does it say about our society?

Cotton [39:32] Me, what I also deduce from my own life, since I tell a little bit about my life, so it’s not a book that’s boring to read, that’s one of the ways I found it to make him more friendly, we’ll say. Because it’s that anyway, living in fear, we’re going to stop ourselves from living out of fear of dying. They only have to hang themselves right now, it’s not the vein. So, if we have to do everything out of fear, sting each month because we’re afraid of it or we’re afraid of it, well, me, it’s not my way of thinking about life.

So this is the same, it’s all done as he can with what he has. There, we’re almost at a turning point, because we have these clinical trials that are turning into poubellization. I’m saying, it’s the poubellization of research. Clinical research is in the process of poubellization. That’s it. So now there’s a lot of things to do, too, not to be ill. If I smoke, for example, if I have lung cancer tomorrow, I’m just going to go after myself. I’m not going to blame myself, so I’m not going to take tons of drugs today.

For example, to avoid lung cancer, I just have to stop smoking. You see? So everyone has to take responsibility too. You have a whole bunch of diseases that can be prevented, that can be avoided. So you have to change your behaviour. Everyone has to take responsibility and stop putting his power in the hands of others. Everyone has to take back his power. So here I am not someone who puts my power in the hands of others. No one has to tell me what I have to do with my own life or my own health. It’s almost a choice, I wouldn’t say philosophical, but it’s been easy to put power back in the hands of others. We’re told what to eat, what to take as a medicine, how to dress, what else? We’re going to give me schedules to go to the toilet so soon. No, but well. Today, all the information is readily available everywhere. The proof is that I found it.

So it’s true that not everyone was able to read these documents, to interpret them. That’s more complicated. But I mean, the information is available for everything and anything today. So if you want to find out about something, you can. So you have to stop thinking that the doctor has the truth. The evidence is that the doctors, obviously, did not read much of the documents. I don’t even know if they read the risk management plans. Maybe if they had been paid less to inject, I would have had more. I don’t know.

Host [42:21] And what kind of look do I have to take at you about the impact this health crisis could have on the voice of doctors and the scientific voice of public opinion?

Cotton [42:31] There, it’s complicated because there, as long as you’re facing a kind of censorship that doesn’t give the floor to people like me, but that keeps inviting what I call experts without expertise, it’s people, they’ve never worked in the community, they don’t understand anything, but then they’re given the floor. But again, it’s up to everyone to find out, we don’t have to watch BFM TV all day too. It’s a matter of responsibility. I think if we’ve had this problem for a very long time, we’ve given up taking on our responsibilities. We’ve cut off our businesses, we’ve made chefs, deputy heads, things. It’s no longer nobody’s fault and it’s been going on for a while, so it’s something we don’t see in SMEs because I as the boss, the responsibility was on my shoulders. The responsibility for the wrong work, the responsibility for finding contracts, the responsibility for managing, so we take full responsibility for everything we do. We’re not going to say it’s someone else’s fault. I, if my box is running, it’s my fault, it’s my fault.

So it’s the fault, we’re going to say, of the environment that’s not favorable. There are factors, of course, but I have my share of responsibility in this. It’s that I haven’t anticipated. Everyone has to take over their responsibilities. And of course when you take on your responsibilities, you can, in quotation marks, deceive yourself. So you have to take on your choices. Today, you find yourself in situations where there are a lot of people who have lost confidence in the health authorities, who have lost confidence in what we are told on TV, in journalists, in experts without expertise. And so, if we really had a national threat tomorrow, we’re going to say with a very virulent virus, with a vaccine to develop properly, but who today is going to believe that we can believe that it’s right and that we can get them vaccinated? That’s a real problem, so, but I’ve alerted senators, MPs, the NSM about this. And the fact that the victims are decredible too, that they are silenced, that they are censored, that they are not taken into account, makes the health agencies lose credibility. As soon as all these people lose all credibility, they can tell us anything, no one will listen to what they have to say. It’s very dangerous. That’s why it’s worth doing the right clinical trials, as we used to do, because it allowed us to have reliable products on the market. So, what did they choose to do? Not at all. We’re going to accelerate the development again. So tomorrow, who’s going to believe that if they take out the disease or the lambda virus and we have the bidule vaccine, who’s going to believe that this vaccine is good for it and who’s going to do it?

Host [45:25] We’ve had a trial in Germany over the last few days against BioNTech, a lawsuit brought by victims of undesirable events.

Cotton [45:34] We had been the first in France, with the complaint of poisoning, a complaint against X, where my report is included in this complaint with other reports of expertise, and for the moment, it’s closed, it’s on appeal. Since when you have a clinical trial that is badly done, then, the contracts that have been signed, where the laboratories clear themselves of the compensation of the adverse effects, what becomes? Normally, the authorities order the products on the basis of reliable results. Now, if it is not reliable, what do we do? We’ll review the contracts, we’ll charge the lab for all the side effects, and I’ll pay the pharmaceutical lab for all the side effects.

Host [46:27] So, perhaps, to conclude, what is the most important point that our listeners should remember from this interview, in your opinion?

Cotton [46:36] The most important thing is that you have to make your brain work. After a while, you have to stop believing, you have to check it. That’s what I wrote. The scientific approach is not to believe, it is to check it. So, it is eventually to download the documents, to read them for yourself, to try to understand. And that’s why I wrote this book, to popularize a little bit how clinical trials are going in general, how these clinical trials went, that’s the damage we’re seeing, to give them a way to reason. I don’t give advice to people, I don’t tell them what to do. I’m not God. I’m trying to give them a way to reason. It’s up to them to do their research and try to understand for themselves, even if there are complicated things. And then they can make an opinion, enlighten themselves. It’s still a matter of responsibility. We always go back to it.

Host [47:35] Thank you very much for your lighting, Christine Cotton.