Brook Jackson has worked in the clincial trials field for over twenty years. Brook is a Clinical Research Auditor and Certified Clinical Research professional. Before working for Ventavia Research Group, Brook served as the Director of Operations for a multi-state clinical trial company. Brook began her employment with Ventavia on September 8, 2020 as a Regional Director on the Phase 3 trial of the Pfizer Covid-19 vaccine, supervising two of Ventavia's three clinical trial sites.
Warner Mendenhall is a lawyer of 24 years and the Principal of the Mendenhall Law Group, in Ohio, USA. He has a lot of experience representing whistle blowers in the past and is part of the legal team representing Brook Jackson in the current case against Pfizer, regarding fraud in the COVID-19 clinical trial.
In this episode we discuss the following:
- What was Brook's role as Regional Director at Ventavia.
- We discuss the basic concepts of a Phase 3 clinical trial of a drug product including what is a double blind randomised controlled trial.
- Brook outlines what she saw once she started work at Ventavia, including the following flaws in the trial process there, including:
* The unblinding of all trial participants from July to September 2020.
* Failure by Ventavia staff to follow the correct informed consent procedure.
* Failure to obtain all the signatures required from trial participants, and in some cases the forging of participant signatures.
* Failure to properly describe the adverse event reporting procedures to triallists.
* Failure to keep the drug product at the required cold temperature.
* Failure to quarantine drug product that was not kept at appropriate temperature.
* Failure to record adverse events correctly.
- Brook explains that when the unblinding error was discovered, the Ventavia staff were asked to remove the evidence and lie to Pfizer about the unblinding.
- Ventavia was understaffed and under pressure to onboard a large number of triallists. Why the rush, what is the payment criteria from Pfizer? Is Ventavia paid per triallist?
- Ventavia has been rewarded by Pfizer with 4 more contracts for clinical trials on the Pfizer Covid-19 vaccine (Covid-19 vaccine in children and young adults, pregnant women and a booster dose).
- Brook reported her concerns to Ventavia, and then anonymously also to Pfizer. After neither company acted, Brook reported her concerns to the FDA. The FDA did not inspect the Ventavia sites. Ventavia fired Brook on the same day that she made her report to the FDA.
- The Director of Operations at Ventavia contacted Brook in June 2021, she had been fired in 2021 for bringing forward the same concerns as Brook.
- Brook filed a false claims act lawsuit on January 8, 2021. The plaintiff is the United States of America, with Brook Jackson as the relator. The defendants are Ventavia, Icon and Pfizer.
- Warner Mendenhall explains the Qui Tam action.
- The lawsuit went under seal for 6 months. The US government cho
