The medical community bible, The BMJ, has published a report exposing all kinds of failures facing the vaunted Pfizer injection that is supposed to prevent the spread of coronavirus-linked infections.
Asked to comment on the report, Pfizer’s press office e-mail server informs the questioning parties through an automated message that reads (verbatim): “The recipient’s mailbox is full and can’t accept messages now.”
The BMJ reports what it calls faked data, blind trial failures, poorly trained vaccinators, and a slow follow-up on adverse reactions in the phase-three trial of Pfizer’s concoction.
Some still call it vaccine. The expression “killer jab” has been gaining in frequency of use with unbelievable speed.
Sign of reliability: The BMJ, a medical trade journal, is published by the British Medical Association (BMA). A weekly peer-reviewed publication, the magazine enjoys full editorial freedom from the BMA. One of the world’s oldest general medical journals, it used to be called the British Medical Journal. In accord with the current fashion of abbreviations, it would become BMJ in 1988, ending up as The BMJ in 2014. End of sign of reliability.
Brook Jackson shared with The BMJ a number of internal company documents, photos, audio recordings, and e-mails.
All of them ring alarm bells to the highest degree.
The sheer volume of problems Ventavia staff encountered while conducting quality-control checks was overwhelming, The BMJ quotes Brooks Jackson as saying. And yes, she told The BMJ’s Paul D Thacker who wrote the report, she had informed her bosses about poor laboratory management, patient safety and data integrity issues on a number of occasions.
In fact, a document cited in the story shows that Ventavia management were aware of the issues. They even tasked several staff members with checking what would become known as e-diary issue/falsifying data, while one employee was instructed how to change data and avoid noting lateentries.
Telling the U.S. Food and Drug Administration (FDA) landed Brooks Jackson in the “not-a-good-fit” category: FDA must have shared her critical views with Ventavia management, and she was let go that same day.
Brooks Jackson has also provided The BMJ with a recording of a meeting during which a Ventavia director mentioned the company had not much to fear from a FDA inspection: they would be told in advance when to expect it.
Not that the FDA were too thorough: the U.S, Department of Health found out that the FDA had a peek at just one (yes: one) per cent of clinical trial sites. The situation hasn’t changed much since the original 2000 to 2005 report: the FDA found time for 50 on-site inspection visits.
Too much work, too few people?
According to a Ventavia executive, it takes too much work to say how many errors it has found. The company knows it’s way too many, but that’s about it.
And Icon, the research organization that works with Pfizer on its trial, has told Ventavia (in writing, too) that it wasn’t too happy, either. Ventavia, Icon complained, wasn’t keeping up with what it called data entry queries. Apparently, they needed their replies within 24 hours, and they didn’t like the idea that nobody had touched about a full hundred questions three days after they had been posed.
Those questions included two cases of severe symptoms/reactions.
There exists a protocol that grades so-called local reactions. Those with severe redness, swelling, or pain at the injection site were supposed to be contacted. Here’s the issue: no reply on whether these unfortunates had indeed been contacted was forthcoming.
Brooks Jackson’s communication with the FDA was terrifying. An eyewitness to such cases as “participants being placed in a hallway after injection and not being monitored by clinical staff,” and “a lack of timely follow-up of patients who experienced adverse events,” or “protocol deviations not being reported,” and “vaccines not being stored at proper temperatures,” and “mislabelled laboratory specimens,” she documented these issues. She also mentioned that staff who reported these problems ended up in trouble with Ventavia management.
The BMJ report lists a number of similar occasions, adding it had verified them with other eye-witnesses, most of whom suffered the consequences of being critical of the development.
What’s going on?
The BMJ report leaves open the question of why such “helter-skelter” practice could have been tolerated, if not demanded outright.
Another Ventavia employee’s comment deserves verbatim quotation, too: “I’ve never had to do what they were asking me to do, ever. It just seemed like something a little different from normal – the things that were allowed and expected. I don’t think it was good clean data [that the trial generated]. It’s a crazy mess.”
Pfizer knew about the problems with the vaccine trial at Ventavia but still, in the briefing document Pfizer submitted to the FDA advisory committee to support its application for emergency-use vaccine authorization, there wasn’t a single word about the Ventavia issues.
Pfizer got the FDA the authorisation the very next day.
FDA published a summary of its inspections of Ventavia’s vaccine trial sites, after it granted the jab its full authorisation. According to the summary, nine of the 153 had been inspected. Yet, none of those sites were part of Ventavia.
Not only that, The BMJ notes in its report, nobody inspected the trial sites after the December 2020 emergency authorisation.
Because “the study was ongoing, and the data required for verification and comparison were not yet available.”
Ventavia remains Pfizer’s subcontractor even now. It deals with four other clinical trials that include the use of the Covid-19 vaccine in children and young adults; another trial that involves pregnant women; yet another trial testing booster doses; and, finally, one more trial, testing a jab for respiratory syncytial virus.
As if nothing had happened.