Brook Jackson

Brook Jackson, worked at Ventavia which conducted clinical trials for the Pfizer “vaccine”. She was hired as their regional director in 2020. She oversaw the research staff and ensured that data integrity and quality assurance were maintained. The “vaccine” trial was two months into enrolment when she joined. This study was observer-blind, meaning the person that was injecting was the only one aware of whether the patient was receiving the product or a placebo (saline injection). Thus the observing doctor would not affected by such knowledge in devising a treatment for the patient or diagnosing a patient. Ventavia lacked the infrastructure for enrolling more patients, as per Pfizer’s urging, and she knew they could not be safely overseen—but Pfizer pressed for more because it was in a hurry. She shadowed one of the research staff to ensure informed consent, that standard operating procedures were being followed, but what she witnessed was not full informed consent—the form was rushed through, to hasten injection. It was not a thorough process.

She was at Ventavia only 18 days before she was fired. She had documented misconduct. Much of what she documented was sloppy work, and breaches of data integrity, as well as lack of concern for patients’ welfare. She found informed consent forms that were apparently forged. She found fabrication of data. Some adverse events were not reported at all. There was an insufficient number of research staff. Staff were unsure about what to capture as adverse events. Thus the numbers on adverse events, which would be needed to prove safety to obtain Emergency Use Authorization from the FDA, were incorrect. She also found that the product was not being stored at the required temperature as detailed by Pfizer. Pfizer was in a rush, to be first to market, and tolerated these deficiencies—“money was a driving factor”. She filed a complaint with the FDA, and was then fired.

On September 25, 2020, she listed 14 problems in her FDA complaint which was then filed online. Six hours later, the Ventavia COO terminated her on the spot. From the FDA she first received a canned response. On September 29, she spoke with a FDA inspector. The inspector seemed attentive. No FDA inspectors ever went to Ventavia’s site, however. In total, the FDA only inspected six of 154 sites. She plans to raise this fact in a court case. She has a large volume of documents and audio tapes to support her case.

If she had not taken the steps she had, did Ventavia have any safeguards in place? She answers essentially in the negative—it depended on whistle blowers existing, or the FDA doing its job, or Pfizer doing its own internal audits. The FDA never investigated her allegations. To fix this system, she advocates for more oversight. The FDA failed to do its duty.

Regarding the training of staff, Jackson affirmed it was insufficient. There was also an insufficient number of staff. Making sure that the product was prepared properly, diluted, and so forth, was not attended to—staff only had retail and restaurant experience, no medical experience.

Staff were also grossly overworked; one had worked 70 hours of overtime in a two-week period. Chaos reigned.

With only six of 154 sites visited, the results of the Pfizer safety study are not reliable. Even in the inspection reports of the sites that were visited, FDA officials state they could not complete their investigations due to Covid restrictions, and the trials had not yet finished. Data integrity did not matter to Ventavia or Pfizer. Why did Pfizer include that data knowing that it was flawed?

Jackson has over two decades of experience in clinical research, and management of clinical trial sites. She has never seen misconduct like she witnessed at Ventavia. She urges for more regulatory oversight. In one example she specified how Pfizer asked for the adverse event information to be changed, so that the adverse event (heart attack leading to pneumonia) was instead blamed on Covid, which was contracted after the event.

Jackson’s lawsuit, a false claims act, was filed in January of 2021, when she realized that her claims would not be investigated. This allows her to file suit on behalf of the government, against those defrauding the government. In January of 2022, the Dept. of Justice refused to take over the case or get involved. While the explanation that followed was a bit complicated, the fact remained that the lawsuit is proceeding. Defendants were served in April of this year. August 6 is the due date for her amended complaint.

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