Leaked documents have cast fresh doubts over the integrity of data arising from Pfizer’s pivotal COVID-19 vaccine trial and suggest problems at Ventavia are ongoing.
Earlier this month, whistle-blower Brook Jackson, raised serious concerns about ‘falsified data’ in Pfizer’s mRNA trial (Comirnaty) to The BMJ. The concerns were corroborated by two former Ventavia employees.
Ventavia, the Texas-based company at the centre of the controversy, released a statement claiming that, in respect of Ms Jackson, “no part of her job responsibilities concerned the clinical trials at issue.”
Undeterred, Ms Jackson fired back. Ventavia and its spokesperson Lauren Foreman, were served with a cease-and-desist letter, by attorney Robert Barnes, acting on behalf of whistle-blower, Ms Jackson.
Of Ventavia’s claims, the demand letter says:
“This statement is false. This statement impugns the reputation of my client, Brook Jackson, and falsely implies she publicly misrepresented her work on the clinical trials.”
Attorney Barnes is calling for Ventavia to immediately issue a public retraction and to “formally and publicly apologise” to Ms Jackson.
Her letter of offer for employment indicates Ms Jackson was hired as a “regional director” by Ventavia on 7 Sept 2020. She has almost two decades of experience in clinical trial co-ordination and management behind her.
Leaked documents support Ms Jackson’s observations and raise even more questions.
There were multiple examples of “laboratory processing logs” filled in by staff which contained glaring inconsistencies and anomalies in specimen handling.
Ventavia appeared to be aware of the need to make improvements and Ms Jackson was recruited for the very purpose of improving their quality control.
Among the documents is a list of Ventavia’s outstanding “action items”, which include discussions with trial co-ordinators about the integrity of data.
The list was dated 11 August 2020 and shows that Ventavia had concerns about data falsification even before Ms Jackson’s arrival.
Ms Jackson said the work environment at Ventavia was chaotic, that they were understaffed and that trial participants would be left, unmonitored in the hallway, due to a back log of visits and a lack of space.
The issues were so egregious according to Ms Jackson, that she suggested Ventavia “immediately pause the recruitment of trial participants,” in order to address the issues.
The breaches included improper informed consent forms (ICFs), unblinded staff (vaccine assignment was indicated on the forms), and mismatched signatures (according to Ms Jackson, staff would forge patient signatures if they were missing).
Ms Jackson says that when she raised her concerns with Ventavia, the environment became hostile.
After filing a formal complaint with the FDA on 25 Sept 2020, she was fired the same day.
The FDA did not investigate the site, despite receiving credible allegations of clinical trial misconduct.
The documents show that the problems were not limited to a single issue or employee, but were pervasive and persistent, putting patients at risk and likely to impact data integrity.
Leaked documents now suggest that problems with quality control in the current phase III trials were not corrected following Ms Jackson’s complaint.