Christine Cotton is a biostatistician and former CEO of a contract research company specializing in clinical trial management for the pharmaceutical industry. Over the course of her career, she has worked on over 500 clinical trials for major pharmaceutical companies (Pierre Fabre, Roche, Sanofi, Aventis, Bayer, Pfizer, AstraZeneca, Ipsen, Janssen-Cilag, Virbac, etc.), as well as observational studies.
She has just published "Tous vaccinés, tous protégés? - Chronique d'une catastrophe sanitaire annoncée", published by Guy Trédaniel. The book details the deviations and methodological biases in the clinical trials of vaccines developed by Pfizer/BioNTech, but also gives a voice to the victims of serious adverse events.
"The Pfizer clinical trial shows a number of serious deviations from the standards set by the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)," says Christine Cotton.
She believes, for example, that the efficacy results announced at the end of 2020 are erroneous: "When we go back to the December 2020 results, there is no statistical proof that there is an effect on severe forms, for the good reason that there were not enough of them in the clinical trial to prove a difference between the placebo and the vaccine."
Christine Cotton also points to the management of certain sites involved in the clinical trial, notably the Buenos Aires Military Hospital, where one of the participants, Augusto Roux, a 36-year-old lawyer, suffered from serious pathologies not reported in the database: "This center recruited 5,700 participants out of some 40,000 worldwide. You can see the major methodological bias this introduces if it presents efficacy or tolerance results that are false. Health agencies should have carried out an audit in the wake of the Augusto Roux affair. But what happened? Nothing!
For Christine Cotton, the case of Maddie de Garay, a 12-year-old American girl who took part in the Pfizer/BioNTech pediatric trial and suffered serious adverse effects, not all of which were reported, also indicates that the adolescent trial "cannot claim to have reliable data concerning tolerability".
In contact with many victims of adverse drug reactions, Christine Cotton deplores the lack of consideration shown to them by healthcare professionals and public authorities: "There are people dying at home in a state of general indifference, it's unbearable. Not only are they not treated, but they're told they're crazy. For the victims, that's the worst thing of all.
"The biostatistician concludes: "If we reproduce this way of operating, with botched trials and shoddy methods, we're going to have potentially ineffective or even toxic products on the market, since they won't have been tested under conditions that would allow us to be sure of their efficacy or tolerance.
Find out more about Christine Cotton's work on her website: christinecotton.com
00:00 Introduction
02:02 What does a biostatistician do? What role does it play in vaccine development?
04:40 Why did you analyze Pfizer's clinical trial data?
05:53 Were good clinical practices respected?
11:14 Did Pfizer deliberately omit to measure neutralizing antibodies too far back in time?
12:28 How effective was Pfizer's vaccine, all Covid cases combined?
18:23 Does the testimony of whistleblower Brook Jackson cast suspicion on all clinical trial sites?
21:31 Is it usual for the manufacturer to modify the content of a vaccine after it has been granted marketing authorization?
27:38 Have health agencies opened a Pandora's box?
29:58 Is there a denial of adverse reactions among the medical profession?
31:30 Were these adverse effects foreseeable?
33:02 What are the conditions required to recognize an adverse reaction?
36:48 How reliable are clinical data for pregnant women?
39:29 What can we learn from this health crisis?
42:28 What impact will this have on the opinions of doctors and scientists?
46:33 Conclusion