Pfizer Data Manipulation- A Piece of the Puzzle
The dirty details of the fraud in Pfizer clinical trials
Brook Jackson is a clinical trial researcher based out of Texas. Back in September 2020, Brook was hired to work as a Regional Director at two out of three clinical trial sites in Texas for Pfizer’s Phase III mRNA vaccine. Ventavia is the company to which Pfizer outsourced the trials, and the company that hired Brook.
By week 3 of her employment, Brook had witnessed so many inexcusable mishaps and protocols being broken that she felt there was no option other than documenting and reporting what she was witnessing. What unfolded during her short time at Ventavia and in the months that followed is truly mind-blowing. I’ll try to capture it here, based on an interview she did yesterday with Daniel Horowitz.
The environment was one of immense pressure. Pfizer was in the race of a lifetime to be the first to market a safe and effective vaccine for Covid-19. The companies they hired out to run clinical trials were paid per patient they enrolled, and quickly. There were 1200 patients enrolled in Brook’s arm of the trial, and the team was so understaffed that it would have been impossible for the patients to all be attended to safely and properly.
After reporting the mishaps to her direct managers multiple times, and witnessing them attempting to conceal the issues rather than deal with them, Brook filed an official report with the FDA. Six hours later, she received a phone call from Ventavia saying that she was fired. Brook contacted an attorney and filed a lawsuit against Pfizer and Ventavia, which led to the case being sealed from the public for over a year and forbade Brook to speak publicly. The case has recently become unsealed, and is making its way through the courts which brings us to the list of her findings and reports (All of her public sources and documentation of evidence to support these claims are linked below):
- The temperature at which the vials of the vaccine were being kept was out of safe range for months. This should have disqualified all vaccines that were stored there.
- Family members of Ventavia employees were enrolled in the study, which is a clear conflict of interest regarding biased data reporting.
- The CEO of Ventavia and her entire family were enrolled in the study. We don’t know that they didn’t choose to be in the vaccine arm of the trial. How can they accurately report side effects?
- The patients became unblinded prematurely, contaminating the data.
- Ventavia was severely understaffed. There were 5 exam rooms, 4-5 staff members, and 40 + patients per day. It’s impossible to perform protocol properly in those conditions.
- The understaffing created an environment where it was easy and almost necessary to fabricate and falsify data. There was so much pressure that if there was a piece of data missing from a patient file, they would “just write something” to get the reports moving along.
- The rush to get through trials was so severe from Pfizer and Ventavia they pushed hard to enroll as many ppl as they could as fast as possible. Many unqualified participants were enrolled.
- The already understaffed team was also underqualified and they were not properly trained regarding vaccine storage and administration protocol.
- The receptionist at the clinic was tasked as the one person who dealt with the patients who received placebos and injected them. Brooke looked into her background and she had zero medical experience. Zero. Before Ventavia, she worked at a restaurant. Now she’s responsible for injecting people and holding critical trial data.
- At the second location as well, the vaccinator who was in charge of the unblinding had zero protocol training. Brooke discovered this after she had already injected an unknown amount of people.
- Needles were not properly disposed of and were found lying out in the open. It’s dangerous to have used needles around the employees and patients.
- A monitor came to review data and found that there was a death at the clinic that had not been reported to the proper channels. That’s inexcusable. If a patient receives an injection and dies within the time frame of the study, it is an absolute expectation that the death is to be reported to the company immediately.
- The staff members were not properly trained on the appropriate dilution ratio of the vaccine. Brook witnessed a variety of dilution levels due to unqualified and untrained workers.
- Informed Consent: The informed consent document is 26 pages of information about the trial, the vaccine, and the virus. Patients were being “informed” about the documents by a call center team. When Brooke intervened and spoke to patients herself, she realized that they were NOT properly educated, and there had been no informed consent. It took her 2 hours to explain everything to each patient, and she witnessed that the other patients had not had the courtesy of those explanations. Hundreds of trial patients were NOT appropriately informed.
- In the patient documents, there were missing signatures and missing dates. When Brook brought this to the attention of her supervisors, they told her to make a list of the issues and hand it in. She later discovered that they had filled in the dates and signed on behalf of patients rather than reaching out to the patient to do it themselves.
- There are 153 Ventavia clinical site locations in the US. Brooke worked at 2 Texas locations. Since going public, five other Ventavia employees have approached her privately to report misconduct as well.
Once Brook flagged these issues and reported them to her supervisor, there was a pause on new patient enrollment which gave Brook the sense that they were taking her seriously. However, shortly after, she got a text message from a Ventavia manager cautioning her not to tell anyone at Pfizer that they were pausing for flagged issues, but to tell Pfizer that they were right on track with the study. At this point she understood that the purpose of the pause was to clean up the issues in order to present the data to Pfizer.
Once Brooke understood what was going on she wanted out. They had a couple of calls called “Covid 1001 Cleanup Call”, and when Brooke declined to participate, the attitude towards her shifted completely.
On September 24, 2020, she was called into a meeting to discuss the pictures that she took of the issues that were apparent. The managers attacked her on the call.
On September 25, 2020, Brooke called the FDA directly and was directed to their website to file a complaint. She filed a complaint with 14 issues, beginning with the words “It is without hesitation that I’m reporting patient safety issues”.
A few hours after filing the complaint, Ventavia called and fired her. She called an attorney and filed a “false claims act” against Ventavia and Pfizer. In doing that, the case immediately went under seal, meaning she was not allowed to discuss the study, and it stayed that way for over a year. Now that the US govt has declined to open an investigation themselves, the case has become unsealed and Brook has been unsilenced.