Chers amis, voici une partie de l'article de P. THACKER dénonçant les fraudes commises par Ventavia, un sous-traitant de Pfizer pour les essais de son "vaccin" à ARN. Vous aurez accès à la totalité de l'article en utilisant la doi (digitalized object identification) sur Internet.
Mais la chose la plus intéressante, et de mon point de vue la plus significative, est la manière dont le journal le Figaro relate ce scandale. Selon ce quotidien, la fraude ne porte que sur une petite partie de l'essai, et à lire l'article, on se prend à conclure que ce n'est pas bien grave. Mais le même journal s'en prend à des prétendus essais d'antituberculeux conduits à l'IHU de Marseille Méditerranée, pour dézinguer une fois encore l'équipe de Didier RAOULT. Heureusement, les accusés ont fait litière de cette accusation portée par Mediapart qui a obtenu frauduleusement des données couvertes par le secret médical. Curieusement, il est impossible d'avoir un accès facile à l'interview dans laquelle trois collègues de Didier Raoult expliquent les raisons de l'utilisation hors AMM de quatre molécules largement utilisées pour traiter, par exemple, la lèpre (dont l'agent est le Mycobacterium leprae) pour traiter la tuberculose mutltirésistante aux médicaments classiques, dont l'agent est le Mycobacterium tuberculosis, c'est à dire une bactérie de la même famille. Voici le lien de cet interview. Vous verrez combien les ennemis de cette équipe sont de mauvaise foi au pire ou mal informés au mieux.
https://www.youtube.com/watch?v=XZuymQ5WPKo&t=17s&ab_channel=IHUM%C3%A9diterran%C3%A9e-Infection
Revenons aux essais frauduleux
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotalcovid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports
Paul D Thacker investigative journalist.
British Medical Ournal J 2021;375:n2635.
http://dx.doi.org/10.1136/bmj.n2635
In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1 But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has 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, 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.
Poor laboratory management
On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 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. Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts. In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says.“We know that it’s significant.”
Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”
Worries over FDA inspection
Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates. At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDAshowing up for an inspection. “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.
The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizer’s clinical trial at Ventavia. She then reported her concerns in an email to the agency. In the afternoon Ventavia fired Jackson—deemed “not a good fit,” according to her separation letter. Jackson told The BMJ it was the first time she had been fired in her 20 year career in research.
Aucun commentaire:
Enregistrer un commentaire