11/08/2021 / By Cassie B.
Respected medical journal the BMJ has reported on alleged data integrity issues with the clinical trials that were carried out for the COVID-19 vaccine from Pfizer and BioNTech.
The British Medical Journal’s report was based on information from a whistleblower that was backed up by others who worked on the trial. The journal wrote 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.”
A former regional director for Ventavia Research Group, Brook Jackson, provided company documents, audio recordings, emails and photos supporting her claims to the British Medical Journal. Ventavia is a company that was contracted by the pharmaceutical firms to help with the decisive trial.
According to Jackson, staff at Ventavia were overwhelmed by the volume of problems they found. She said that she repeatedly voiced her concerns to superiors about issues such as patient safety, data integrity and poor lab management.
She also reported her concerns to the FDA. Later the same day, she was fired on the grounds that she was “not a good fit.” She said it was the first time she had been fired during her 20-year research career.
Among the information provided to the journal by Jackson was a recording of a late September meeting in which she met with two directors of Ventavia to discuss a possible FDA inspection. One executive said to Jackson: “We’re going to get some kind of letter of information at least, when the FDA gets here … I know it.”
A senior executive can also be heard in the recording explaining that the company could not quantify the number and types of errors that were being identified. “In my mind, it’s something new every day,” the individual said. “We know that it’s significant.”
Another employee confirmed that the company was expecting to be subjected to a federal audit of its trial for the Pfizer vaccine, but one never materialized. From 2000 to 2005, the FDA only inspected 1 percent of clinical trial sites; in 2020, the agency only carried out 50 onsite visits overall.
The BMJ saw an email that was sent to Ventavia by a research organization that also partnered with Pfizer for the trial, ICON. The email indicates ICON was unhappy with Ventavia’s failure to keep up with data entry queries. The organization reminded Ventavia that they expected all queries to be addressed within 24 hours; more than 100 had remained outstanding at that point for more than three days. Among them were cases in which test subjects reported severe reactions.
In Jackson’s complaint to the FDA, she listed a dozen problems that she had personally witnessed. Some of the entries included “mislabeled laboratory specimens,” “participants being placed in a hallway after injection and not being monitored by clinical staff,” “vaccines not being stored at proper temperatures,” “protocol deviations not being reported” and “a lack of timely follow-up of patients who experienced adverse events” – along with staff who reported these problems being targeted by Ventavia.
Several other former employees of the company have supported Jackson’s account, many of whom have since left the company or been fired. Jackson said that an executive who was at the September meeting has since offered her an apology and confirmed that everything she complained about was “spot on.”
The BMJ confirmed several aspects of Jackson’s complaint with two former employees. One said that she had worked on more than four dozen clinical trials in her career and had never experienced a work environment like that of the Pfizer trial, which she termed as “helter skelter.”
She also said that some of the problems identified by Jackson continued after she left the company. For example, in some cases, a lack of employees meant that not all trial participants who reported COVID-19 symptoms were swapped for infection.
That employee said she was surprised by the things that were expected and allowed during the trial and added that she doesn’t believe that it generated “good clean data.”
“It’s a crazy mess,” she said.
Just one of the issues identified by these employees – such as unblinding patients, falsifying data, improper vaccine storage and failing to follow up on adverse effects – should have been enough to have the entire vaccine study tossed out. Instead, the FDA granted the vaccine full approval. Is it really surprising that so many people would rather lose their job than roll up their sleeve for this vaccine?
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