Did the Trio ‘Pfizer, Ventavia and the FDA’ Falsify Clinical Trials?


A major fraud involving pharmaceutical company Pfizer, its subcontractor, Ventavia Research Group, and the Food and Drug Administration (FDA) was revealed yesterday by the British Medical Journal.

The Contract Will Begin in the Fall of 2020

Pfizer is working “at the speed of science,” said Albert Bourla, the company’s chief executive, in 2020, so perhaps the science was moving a little too fast. A regional director who worked for the research organization Ventavia Research Group told the British Medical Journal that Ventavia, which conducted the clinical trials, falsified data, anonymized profiles, used inadequately trained vaccinators, and delayed tracking adverse events reported in the pivotal Phase III trial.

The case, uncovered by investigative journalist Paul D. Thacker for the British Medical Journal, began in the fall of 2020, when Pfizer hired a series of subcontractors to conduct clinical trials involving 44,000 people at 153 sites around the world. It involves three Ventavia sites in Texas. For some researchers testing Pfizer’s vaccine at those sites, speed may have come at the expense of data integrity and participant safety. Quality control staff were overwhelmed by the number of problems discovered. After repeatedly reporting them to Ventavia, Regional Director Brook Jackson emailed a complaint to the Food and Drug Administration (FDA).

 

 

In the letter, Jackson cited several problems she had observed:

First, she pointed to the lack of seriousness in handling the vaccines, which were not kept at the proper temperature and were mislabeled. Then, the lack of follow-up of patients was denounced. Noting that anyone who reports an adverse reaction must be contacted within 24 hours, the report mentions several people who made a report but were never contacted by phone to determine if an on-site visit was necessary.

The letter also mentions employees who were taken to task by Ventavia for reporting problems.

Just hours after sending her letter, Jackson received an email from the FDA thanking her for her concerns and telling her that she could not comment on a possible investigation. That same day, she was released from Ventavia.

But that’s not the end of the story, because before she left, Jackson took dozens of internal company documents, cell phone photos, audio recordings and emails, which she provided to the British Medical Journal.

A Troubling Lack of Accuracy

Photos showing major anomalies, such as needles thrown into a plastic bag instead of a sharps box, or vaccine packages with identification numbers printed on them, raised questions about patient anonymity.

In the recording of a late September 2020 meeting between Ms. Jackson and two directors, a Ventavia executive can be heard explaining that the company is unable to quantify the types and numbers of errors it finds when reviewing trial documents for quality control. “In my mind, there’s something new every day,” the Ventavia manager says. “We know it’s important.”

There’s also the issue of participant anonymity not being respected, particularly because printouts of drug allocation confirmations were left in participants’ files by the “unblinded” staff administering the vaccine. This allowed staff who were supposed to be “blinded” to access the records. The error was corrected two months later, while the removal of the drug assignments from the records occurred after 1,000 participants had already been enrolled.

Problems Covered Up in Regulatory Filing

A few weeks later, Pfizer submitted its emergency application to the FDA. At the Dec. 10 meeting, the problems at the Ventavia site were not mentioned, and the FDA gave the green light the next day.

In August 2021, after Pfizer’s vaccine was fully approved, the FDA released a summary of its inspections of the company’s pivotal (Phase III) trial. Nine of the 153 sites participating in the trial were inspected. Ventavia sites were not among the nine, and no inspections of sites enrolling adults took place in the eight months following the December 2020 emergency approval. An FDA inspection official noted, “The data integrity and review portion of the BIMO (Biologic Research Oversight) inspections was limited because the study was ongoing and the IND (Investigational New Drug) data needed for review and comparison were not yet available.

Testimonies proliferate

Two former Ventavia employees also testified to the BMJ, but on condition of anonymity because they feared retaliation and loss of research employment opportunities. Both confirmed Brooke Jackson’s allegations.

One of them said she had worked on more than 40 clinical trials in her career, including many large ones, but had never experienced a work environment as “chaotic” as the one at Ventavia for the Pfizer trial. According to the employee, there continued to be problems at Ventavia even after Brook Jackson left. One of the main problems was that there were not enough staff to collect samples. Laboratory confirmation of the presence of Covid 19 symptoms was the main criterion for study evaluation, the staff member said.

A second collaborator also described the environment at Ventavia as “unlike anything she has experienced in 20 years of research.” She told BMJ that shortly after Jackson was fired, Pfizer was informed of the problems at Ventavia with the vaccine trial and an audit was conducted – the federal audit the company expected while she was at Ventavia “never happened.”

These revelations hit like a bombshell, shattering the narrative that the trials were conducted with spectacular and unprecedented speed, without any concessions to rigor, safety, or scientific integrity. They also shed new light on the ways in which the efficacy and safety triumphantly proclaimed by Pfizer and its zealous facilitators were not achieved “in real life.”

The reactions (…or lack of reactions) of regulators, health authorities, and their medical and media relays will be closely watched and promise to be…eloquent.