André Bercoff [00:01] To address this issue, we will re-launch another war, the famous Covid War, which has occupied us for more than two years now. Hello Christine Cotton.

Christine Cotton [00:09] Good morning, Mr. Bercoff.

Bercoff [00:12] Good morning, ma’am. I take up your own terms. You are an economist-statistical magisterium. You have 23 years of career in the pharmaceutical industry. You have a company, the CRO, the Clinical Research Organisation. And you take care of any type of trial in various therapeutic fields. So, I’ve read a lot of things and you’ve written, said a lot of things and in particular we’re going to focus on Pfizer’s essays. And I think you have a lot to say about these essays and, let’s say, some legitimacy and some consistency of these essays. Tell me.

Cotton [00:49] Just to clarify, I am no longer director of the CRO, I sold it in 2018. This is precisely what gives me this freedom of speech. I took a number of documents from Pfizer himself, that is the protocol of the clinical trial, the different clinical reports on the different populations, the over 16 years, the 12-15, the 5-11. I have taken what is called the risk management plan and which is a document that is published by the laboratory itself for certain products that we want to monitor in real life.

Bercoff [01:19] “So you took Pfizer’s documents himself, right?”

Cotton [01:21] - Pfizer’s documents, that’s it. About their own documents.

Bercoff [01:25] - All right.

Cotton [01:26] “So when we look until today, so we were told 95% effectiveness, the duration of protection, you do both doses and then everything will be fine, and there is no problem of tolerance. So until today, in fact, no one had really looked at how this famous criterion of effectiveness is collected. We had said good it was 95% but we had not considered how we measured it, we calculate it. And if we finally resume the protocol in which all this is described, the results, we realize that in fact we are missing. a number of symptomatic VOCID-19 cases which is confirmed by PCR test, which is therefore called the famous main criterion. It’s on this one that we’ve been told the 95s, and we’re missing it because there are a number of methodological biases, that is to say, elements that distort the result and in favour of the vaccine. And this is a big problem, because the famous 95s in December 2020, when we’re told that, clearly they’re wrong. So I can’t say today if it was 75, 70, 53, 45, but at least they’re fake.

Bercoff [02:37] Yes, it wasn’t the 90 announced anyway.

Cotton [02:39] So if we look at this famous duration of protection, we didn’t know too much but we were supposed to do both doses and then everything would be fine, what we look at in all the clinical reports that have been submitted is that the intermediate analyses, since the trial is in progress, since it will end in January 2023. So we do intermediate analyses, which can be common in the pharmaceutical industry, and on these intermediate analyses, we analyze the population at a time T. And then, we look at each analysis, we find that we observed the maximum population three months, with 50% of the people observed less than two months. So when you are given a possible duration of protection, we’re going to tell you everything’s okay, anyway we can’t tell you because we don’t have antibody assay data. Two months after two months.

Bercoff [03:39] Yes, we were told, you’re going to see, even the booster dose, it’s going to last at least six months, what he was telling us before, and you’re thinking, there’s no real exam beyond two months or three months at most, right?

Cotton [03:52] That’s right, when you’re told that, we can’t tell you, because anyway, there’s no dosage after that, so that’s prediction, it’s clairvoyance, but it’s not based on the results of the clinical trial. It is that this famous antibody assay, we find that what would have been interesting is that we have a dosage at three months for example after dose 2. But this dosage in the protocol, oddly, it is not expected. You have only one dosage six months after dose 2. And so we had Pfizer in September 2021 who tells us, from the Israeli studies, we find out, so conference in front of the CDC, in the United States, Center for Disease Control and Prevention.

So we tell us, well, we find that there is a decrease in antibodies. Maybe if we had had this dosage at 3 months after dose 2, we would have realized it before. So why don’t we have this dosage in the trial? Why didn’t we plan this dose in the trial? So that, already, it’s a little suspicious to say to each other, but how, why isn’t there this dosage? And so, it means that my benefit clearly, well, 95% clearly, it’s not that, my duration of protection, my antibodies, it’s not that, and it’s all the more boring that if we go back to the life of the HAS of December 2020, so the HAS, the French high health authority, what do we read in December 2020? It is stated that there is no demonstrated transmission efficiency, since this test, in its analytical criteria, in its efficacy criteria, does not purport to demonstrate an effect on transmission.

Bercoff [05:32] “Yes, it’s written nowhere, yes, that’s it.

Cotton [05:35] “No, but it’s not… That’s it, you’re measuring a criterion, you can’t conclude anything other than on the criterion you have… – While we were told the opposite, at the beginning. – Exactly. So there, already, why were we told the opposite? That, we would have to ask the people who marched on the trays to tell us that. And above all, what do we learn in this opinion? It’s really a shame that we didn’t have this dosage at three months after visit 3, because finally the booster in December 2020 was already the study at the Pfizer laboratory. So, you see, so it’s already getting questions. And now, if we look at tolerance, we still have this observation period that is max three months. So when I’m told there’s no problem with tolerance in the IC, yes, there’s no problem over three months. And then I have this Mady de Garé case in the United States that’s a kid who participated in the 12- to 15-year-old trial and had 35 side effects that’s on a wheelchair powered by her gastric and the side effect it’s not in the clinical report. So why the effect isn’t in the shortcut?

Bercoff [06:42] While she was among the people who were tested, was that right back then?

Cotton [06:47] Exactly, she’s one of the volunteers because she really wanted to help science, supposedly, to participate in this trial. And so this effect is not postponed as in the clinical report, there are just belly words. When you see the state of the girl, you can see that she doesn’t just fuck with belly words. And so we have a sample size in the 12-15 age group, that is, a population size, and in the 5-11 age group, which is in the order of about 2000-2300 participants, that is, what is very small. And they recognize it in the report, it is insufficient to be able to find serious risks. So I have populations of children that aren’t important enough to find serious risks, so that means we’re gonna have to keep an eye on this in real life. And in my famous risk management plan, I know since I have populations that have not been included in the trial, like pregnant women who are always excluded from all clinical trials, so it’s population or enviral vaccines. So it must be people who are very monitored.

Bercoff [07:54] Wait, it’s interesting Christine Cotton, you’re thinking that in clinical trials, all clinical trials, we never tested pregnant women.

Cotton [08:06] Well, they’re being vaccinated, but they’re part of a population to be closely monitored in the risk management plan, but we didn’t test fragile patients with co-morbidity, we didn’t test immunocompromised patients, we didn’t test co-administration of vaccines, but when we fired it, we said we inject it with the flu. So there are still a lot of questions to ask since we still have to go back to the source and the source documents tell us attention to this, pay attention to this.

So here, it means that my no problem of tolerance announced, clearly it is false. It is wrong because the duration is too short, the sizes of the chanters are not enough to find the effects and I have lots of populations that have not been tested in the trial. Grosso modo, my benefit-risk ratio, which is said to be such a beneficiary in Vaxa, when I see a test of this quality, frankly, I have never seen this for 23 years of career, I have never seen an essay of such a mediocrity in terms of quality. That is, we have violations of good clinical practice, we have methodological biases everywhere that distort the results. And that means that it completely invalidates the results advanced. When you have a case like this, what do you do? We suspend the product since we put the population at risk of receiving something for which we did not… Yes, sufficiently tested and assessed long- or medium-term risk.

Bercoff [09:33] But just one thing Christine Cotton is conceived anyway, will you agree or not, because you’ve talked about young people, 5-11 years old, 11-19 years old, etc. But when you are told, wait, for the population aged 65 and over, it prevents serious risks, and indeed there are billions of people now who have been vaccinated, can’t we say, yes, but wait, there is still, you can’t throw the whole baby vaccine with the bath water of biased tests?

Cotton [10:02] What do you answer to that? It’s very simple. These studies, they have a certain methodology that needs to be examined. And then, I didn’t look into the question in detail. Is that for you, pardon?

Bercoff [10:17] and forgiveness because you have the experience, do you believe that in cases of co-morbidity, of a certain age, etc., the vaccine can be effective, what many doctors have said, including dissident doctors or dissident researchers?

Cotton [10:33] Ah no, but that’s not the question, we’re not supposed to prove the effectiveness of a product after its real-life authorisation on the basis of results biased by major violations or good clinical practice, it doesn’t exist. In the world of the pharmaceutical industry, there are dozens, hundreds of recommendations in every sense that frame all activities, and these international recommendations, that is, these LCHs, it is a consortium that publishes, updates these recommendations, they are intended to minimize the risk of error, to place on the market in particular a product that would be a risk to the population, or even to conclude that it does not work when it works. So we don’t have to argue with more or less tests on methodology, how to say, dubious, since here too, we see that we can… There we are in a world where we finally get a little bit of what we want to say about the number.

Bercoff [11:30] Yes, you say that even if there is a minimum risk, this risk must be weighed and weighed as such, and not admitted, etc. If there is…

Cotton [11:40] No, no, I’m not saying that, I’m saying the trials are biased, so it casts doubt on the full quality of the trial since we know that there are centers where we have patients, for example, who called back to report their symptoms and we never tested, so they too are not in the… The main criterion, from the moment the test is of a quality of this mediocrity, the product is immediately suspended, since we were wrong about the result. This is the way of working the pharma industry since always. In addition, we are in a case of accelerated development of the vaccine. Since we started preclinical phase 1 on animals, it was not finished, etc., etc. Yes, it is.

Bercoff [12:23] No, criticism as fair, we find each other after a very small break, we find each other and… And we’re still with Christine Cotton, biostatistician, for 23 years, the pharmaceutical study, methodology without clinical trial. And Christine Cotton, you were actually talking about biases and biases, as they say, one can say biased, pass me the rehearsal. But in fact, so for you, there’s something that is… today, at the time we’re talking, 3 billion people have been vaccinated, we’re talking now about removing the vaccine pass, we don’t know how long, all this is suspended, do you, this whole policy, I’m not just talking about France, but about other countries, basically, what do we have? We’ve given in to what, and what should we do for you?

Cotton [13:17] I always put myself from a methodological point of view, that is to say, it is necessary for our listeners to understand that clinical trials, the results, are not doctors who give them, they are biostatisticians. He who writes the methodology of the clinical trial, who calculates the number of subjects in a trial, he is not a doctor, he is a biostatistician. It is a profession. So until today, on the plateaus, we have never heard this type of person. Epidemiologists are not biostatisticians like me, I am not an epidemiology specialist.

Bercoff [13:48] And epidemiologists don’t see patients, so it’s not doctors too.

Cotton [13:52] No, it’s really a completely different profession. Specialists, those who analyze, who do the method of clinical trials, are biostatistics.

Bercoff [14:00] We agree.

Cotton [14:03] But maybe I can’t answer that question that way. The fact is that we have standards, we have recommendations that have been implemented for decades and decades, that we follow, we have very serious audits, we have a lot of things to do to ensure a good quality of clinical trial. There, we are in an accelerated process of development and we do not take any precaution. We are putting on the market something that is intended to be administered to billions of people without any precaution. So, there is still something wrong. So then, it becomes a public health problem. And this, me, is not my field. I’m saying clinical trials, a mediocrity. I’ve never seen it before. I’ve had opinions from regulatory business colleagues, quality insurers, biostatisticians who are totally human in my life. It’s not because these people don’t show up that they don’t agree. And any good biostat that’s gonna say that, he’s probably gonna agree with me because there’s no other thing to say.

Bercoff [15:08] You’re thinking, it’s mediocre and sloppy, right?

Cotton [15:12] And it’s mediocre, sloppy, patient population followed clearly poorly, without knowing it by the Vantavia case, so these three centers, with this director in the United States who alerted about the management of these centers, it’s catastrophic. So who tells me that of all the 150 centres that have participated, so clinics, hospitals that have recruited the participants, I don’t have the double or triple that has problems, we need an audit. We have to ask Pfizer all the questions. If we wanted to know in the trial whether the participants had had Covid or not, it was enough to do a serological test.

Bercoff [15:51] And we didn’t do a serological test.

Cotton [15:54] So the participants, they go home quietly, they can contaminate their co-workers, their families, their neighbours, supposedly it’s a deadly disease, we’re in the middle of a pandemic, restriction of movement, and the lab lets its participants into their homes. Without saying anything, but be careful if they’re sick they might die or contaminate the others, but I thought it was very serious the Covid. Obviously for the lab it wasn’t that bad, since we let them go home, we don’t give them a test, we tell them you call if you’re not good, well, it’s big stuff. And then the problem is, we’ve been trying for months to justify us with more or less studies where we can, by looking at the methodology, we’ll see that we can quite question the results. It’s like I’m telling you, Mr. Bercoff, we’re going to do a survey to find out if people use the metro, that I’m 300 metres from the metro. I’m gonna have a lot of people using the subway, so see, the methods are really…

Bercoff [16:58] I’m not on the subway, but I’m looking at it outside the subway, and I’m looking at it from the outside.

Cotton [17:05] If I get into the middle of the country, I’m going to have 0% using the subway. If I get 300 meters from the subway mouth, I’m going to get 90% of it. I’m going to say, there’s 90% of the people so you see, this whole thing is a method story. And that’s why people need to understand well, seclinics are methods, and it’s extremely regulated. And all the people I’ve worked with are extremely competent people. So the question is, we’ve sent this relationship with the Verity association, with which I’m working, which lists a lot of side effects, including a number of very serious ones going to death, and so the people of the NSM have my report. So we’re eagerly waiting for the answers.

Bercoff [17:51] Well listen to these answers we’ll wait with you and we’ll resume this discussion with you. Thank you Christine Cotton because you’ve actually set the time.