BERRY on pharma fraud during vaccine trials:
“[I have been] asked if there have been any valid
concerns raised about Pfizer clinical trials,
about poor design or data falsification…
And the answer is no, actually.”
(2-14-22 BOCC meeting)
FACT CHECK:
Last February, Dr. Berry answered a question about whether or not there was the possibility of fraud in Pfizer’s (still ongoing) clinical trials. “[T]he answer is no, actually,” she said.
According to Dr. Berry, these “were very high quality trials,” and they have been “very heavily scrutinized.” She also pooh-poohed the suggestion that any degree of fraud could have occurred, proclaiming that no “valid concerns… about poor design or data falsification” had been documented.
Enter Brook Jackson
A Certified Clinical Research Professional with almost two decades of experience in a clinical trial setting, Brook Jackson joined Ventavia Research Group in 2020 as a Regional Director. Ventavia had been contracted to carry out clinical research on Pfizer’s vaccine before Jackson signed on, and she began noticing issues as soon as she started work there.
When she brought concerns such as “failure to preserve blinding,” “vaccine dilution errors,” “patient safety issues,” “enrollment and injection of ineligible trial participants,” and “falsification of data” to her supervisors, no actions were taken to remedy the situation. Jackson ultimately related the issues to the FDA, but not without repercussions: just hours after talking with the FDA under supposed confidentiality as a whistleblower, Ventavia contacted Jackson to inform her that she was “not a good fit” for the company and that she was fired.
Brook Jackson was fired from Pfizer contractor Ventavia after bringing safety concerns to the attention of her superiors and the FDA. Watch the BMJ’s 6-minute video of her story.
Refusing to be silenced, Jackson proceeded to file a legal complaint against Ventavia and Pfizer under the False Claims Act (FCA), contending, among other wrongs, that “Pfizer… represented that the clinical trial would comply with all applicable laws and regulations [but that] Defendants violated… multiple FDA regulations when conducting the clinical trial, rendering this certification false.” The 81-page complaint is accompanied by 29 exhibits spanning an additional 551 pages, including emails and text messages, Pfizer source documents, photos of HIPAA and other violations during clinical trials, blood draw data, and lists of errors and deficiencies.
The FCA allows whistleblowers to sue the defendants on behalf and/or with the intervention of the federal government. Suits brought under the FCA are sealed so that the government can investigate the allegations without the defendant’s knowledge. After a period of several months had elapsed with little communication from the government (more on this in a moment), Jackson decided to share her information with the British Medical Journal (BMJ), one of the world’s preeminent and most highly regarded medical publications, despite her case being under seal.
On November 2, 2021, the BMJ published an investigative piece focused on the incident at Ventavia, noting that “Revelations of poor practices at [Ventavia] raise questions about data integrity and regulatory oversight.” The BMJ’s publication enumerates half a dozen specific concerns identified by Jackson:
- Participants placed in a hallway after injection and not being monitored by clinical staff
- Lack of timely follow-up of patients who experienced adverse events
- Protocol deviations not being reported
- Vaccines not being stored at proper temperatures
- Mislabelled laboratory specimens
- Targeting of Ventavia staff for reporting these types of problems.
In its interview with Jackson, the BMJ included a photo Jackson took of a “plastic biohazard bag [that] contained used needles” which should have been disposed of in a sharps box.
(Meta’s fact checker Lead Stories quickly responded by decrying the coverage done by the “British Medical Association’s news blog.” Citing as evidence to rebut the claims of fraud were spokespeople from both Ventavia and Pfizer, the former alleging that “no part of [Jackson’s] responsibilities concerned the clinical trials at issue.”)
Jackson’s case was sealed for more than a year, until early 2022 when the government elected not to intervene in the case. Pfizer filed a motion to dismiss the case in part on the grounds that “the complaint alleges FDA was the victim of ‘fraud’ even though the agency has known about [Jackson’s] allegations for years, has not withdrawn the [vaccine] approvals in question, and continues to express confidence in the data underlying those approvals.” Therefore, even if the court were to find that Pfizer had committed fraud, it wouldn’t matter because the government would have bought their product anyway.
On October 4, the federal government then made a curious move when it submitted a statement of interest supporting Pfizer’s motion to dismiss the case: “[Jackson]’s complaint lacks factual allegations that would support a plausible claim that Ventavia’s clinical trial violations masked problems with the vaccine that were so serious that FDA would have withheld or withdrawn its authorization of the vaccine had it known the truth, such that Pfizer’s subsequent claims for Government payment for the vaccine could be rendered ‘false or fraudulent’ under the FCA.”
Jackson’s attorneys responded on October 27, characterizing the government’s response as an “unusual pleading.” “[T]he government sought this court’s extraordinary seal powers over this case for a substantial time period because of how seriously they took the pleadings as fully legally sufficient as plead…. Had the government truly believed… that [Jackson]’s complaint was devoid of evidence, they would never have required such ample time to investigate.”
Jackson’s attorneys insinuate that if the government was aware of fraud by Pfizer, it could potentially abuse its power to seal the case in order to keep the case out of the public eye — something it succeeded in doing for almost a year before Jackson took her evidence to the BMJ. One can only wonder how many people would have chosen not to take the vaccine if they had known what Jackson knew when she knew it.
As of the publication of this Free Press article, the court has still not ruled on the motion to dismiss.
Jackson’s claims of wrongdoing have received a lot of press, but they aren’t the only reason to suspect fraudulent activity in Pfizer’s clinical trials.
Who is Maddie de Garay?
Earlier this month, Dr. Berry received a simple question: “Who is Maddie de Garay?” In a long-winded response where she not only failed to identify the young teenager by name, but also avoided describing any of the many problems de Garay suffered (and continues to suffer from) immediately after receiving her second Covid-19 shot as part of Pfizer’s clinical trials, Berry also managed to digress from the topic and harp on such things as “right wing talk radio.”
Maddie’s mother, Stephanie de Garay, says that “[i]n less than 24 hours of her second dose, [her previously] healthy and vibrant 12-year-old had a severe systemic adverse reaction.” In her mother’s words, Maddie is now “in a wheelchair, receives all her nutrition and medicine through a feeding tube, cannot control her neck, has constant stomach, back, neck and body pain, vision problems, tinnitus, can’t feel from the waist down, allergic reactions, dysautonomia and… her condition is declining.”
Maddie’s parents have given numerous interviews and even testified on what happened to their daughter (see videos here and here).
Stephanie de Garay testifies on her daughter’s behalf in Washington: “She had severe chest pain. The way she described it, it felt like her ‘heart was being pulled out of her neck.’”
In Pfizer’s report on its trial, there was one participant listed with an ongoing adverse event at the trial cutoff date. Maddie’s adverse events were ongoing when the trial ended, meaning that either the description of that participant, who was “eventually diagnosed with functional abdominal pain,” referred to Maddie, or that Pfizer omitted Maddie from its report to the FDA altogether. Pfizer deemed the adverse event unrelated to the individual’s injections.
Berry sent warm thoughts Maddie’s way over the airwaves noting that she “hope[s] she gets well,” but only after hammering down that “[i]t’s very difficult to say whether or not this girl was even in the trial.” This is an easily contestable claim. Perhaps one of the most convincing pieces of supporting evidence is a recorded phone call between Maddie de Garay’s parents and Dr. Robert Frenck, lead author of the study on the safety of Pfizer’s vaccine in adolescents.
When Dr. Berry then attempted to quash Maddie’s story by suggesting that “it’s just really unclear that those concerns are related to the vaccine,” it became obvious why she had opted not to describe Maddie’s condition in any detail — her paltry ‘lack of causality’ argument is utterly unconvincing and talking about Maddie’s reactions could have potentially fueled local ‘vaccine hesitancy.’
Even if Maddie’s declining physical condition was not a result of vaccination, the situation still merits investigation. To date, this has not occurred, and the de Garay family has been left to pay hundreds of thousands of dollars in medical bills out of pocket. Maddie was one of 1,131 participants in her trial who received the shot, meaning that her extremely severe adverse reaction occurred at a rate of around 884 per million.
Pfizer is accused of fraud not only in the US, but the EU, too.
These are two of the most notable instances of fraud allegations in the context of Pfizer’s Covid-19 shots, but not the only ones.
Concerns have surfaced following the court-ordered release of Pfizer’s clinical trial documents requested under FOIA by Public Health and Medical Professionals for Transparency (PHMPT). A non-profit organization comprised of international scientists and medical experts, PHMPT advocates for data relied upon by the FDA to license Covid-19 vaccines to be publicly available for independent review and analysis. After the FDA attempted to keep the data sealed for 75 years, and Pfizer intervened to also delay its exposure, the court ordered release at a rate of 55,000 pages per month starting on March 1, 2022.
With so much data being released, many eyes have been necessary to pore over the many documents. The FDA has still not yet finished producing all of Pfizer’s data, so it can be difficult to draw certain conclusions until it has released all of its publications.
Just recently, the European Public Prosecutor’s Office announced an investigation into vaccine contracts signed by the EU and Pfizer, opening up the possibility of fraudulent financial activity.
And let’s not forget Pfizer’s track record of paying out multi-million dollar settlements for fraudulent practices (see here, there and everywhere), including what was the largest health care fraud settlement in the history of the US DOJ.
Silencing the alarm and refusing to acknowledge that there even might be fraud going on in Pfizer’s clinical trials as Berry has attempted to do is disingenuous, although perhaps unsurprising given that her incessant exaltation of the vaccines over the past two years has married their two fates together.
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Kincaid Gould was born in Port Townsend in 2002. After graduating from Port Townsend High School in 2020, he attended the University of Washington to study music with a focus on the clarinet. Unable to further pursue his studies at UW due to the institution’s (unscientific) COVID-19 vaccination policies, he has returned to Port Townsend, where he enjoys running, cooking, playing music and continuing his education at home.
Thanks for this. I also watched the RFK Jr. video on Fauci and have been tracking what Rand Paul has also been saying, which is the same thing that RFK Jr. says. RFK Jr. and Paul are on the opposite of the political spectrum, so this isn’t about ideology, it’s about safety and fraud on a scale never seen before. If I had known in March 2021 what I know today, I never would have had the vaccine injected into my body. And that’s why they covered up all the safety issues with the trials. To prevent people from refusing the vaccine they had to hide the fact that it is dangerous. And of course, we can’t sue them for any damages.
I do not think the liability waiver covers a criminal conspiracy… The criminal conduct is very clear and criminals do not have legal protections regarding liability waivers…
The biggest problem with Allison Berry is that her opinions can effect everyone in our community, especially the commissioners who make binding decisions. So we might tend to react to what she has to say with prejudice or acceptance, depending on our own bias. We can make it about her rather than what she says, and in the same way she might make it about the preservation of her position rather than her ability to transparently present her substantiated evidence. In our complex authoritative society, talking points and sanctioned narratives might begin to hold more sway than facts.
Does she present peer reviewed factual studies to support her opinion or are her opinions based in government sponsored medical narratives? Do the community decision-making bodies check her references or just accept them? Are each of us aware of our biases towards her, the commissioners and the government/corporate narrative?
Critical thinking is the regiment that allows us to make personal decisions. To critically think we must have an open mind so we can hear accurately, have an awareness of our biases so they don’t cloud our thinking, participate in an exploration of factual information from all sides and maintain a resistance to group think.
Berry’s degree (M.D.), allows her to fulfill the requirements of her government position but not act as authoritative final view. Both she and each of us have the same ability to understand rudimentary facts and it is the lack of substantiated facts that separate her view from these two fact-filled articles. Are each of us to be swayed by her degree, position and opinions or by the facts as presented by Ana Wolpin and Kincaid Gould?
Great article and series. Thank you!
Dr. Berry’s behavior is explained by the fact that she is just following the today’s dominant mechanistic ideology. This ideology sees the universe as a giant mechanical clockwork, that is completely knowable and controllable by human “experts”. (Paraphrasing Mattias Desmet in “The Psychology of Totalitarianism”.) Those who believe in this ideology lose their humanity and morality, and are willing to commit ever greater offenses in order control the world and attempt to create a utopia. The more power a person with this ideology welds, the greater the destruction.
Look at the origin of this virus: It was created by man trying to play God in a laboratory.
Look at the actions of those in power as it spread: They were willing to destroy lives, livelihoods, and lifestyles to “control” the virus.
Look at the only acceptable “cure”: An artificial gene therapy, created with minimal (and fraudulent) testing, released to the population of the WHOLE world who were COERCED in every conceivable way to take it.
We are living in the tyranny of man’s hubris. I pray we gain humility before we destroy ourselves in a quest to become God.
I am so happy that Port Townsend people are finally seeing what is really happening. Join Del Bigtree’s ” The Highwire ” show. Thank you Port Townsend Free Press for being on top of this mess we all call life.
Thank you so much Kincaid. Great information and so well cited and written. I appreciate your hard work so much.
So, who’s ready for a “COVID pandemic amnesty”? See the recent “Atlantic” article to that effect.
And right on cue, like magic, after all these months of “emergency”, the Jefferson County Two Week Case Rate Public Health Department Dashboard dropped today from its high alert, panic-button, red zone into the moderate risk zone. However Berry & Co. were tracking their case rates stats, they exceeded the Washington State Public Health case rate data by an inexplicably insane margin. The state, as well as the CDC, has rated Jefferson County at low Covid risk for months now, yet Berry & Co just couldn’t let it go. But at last, the irony of being one of the most vaccinated counties in the state and yet still in high anxiety, red zone mode and the only county still in a declared state of emergency, finally dawned on our clueless leaders.
It would be comical, if only DrsBerry, Locke, the commissioners and all who wielded their lies and distortions as weapons hadn’t ruined so many lives.
We’ve been watching them game the system to fit whatever they think will best support their narrative du jour. When the commish extended our state of emergency, Jefferson County had the highest case rate in the state, the only county with a red alert on the state dashboard. After a radio station on the west end called out Berry for that obvious failure, within a week JeffCo’s status dropped to an innocuous yellow (bypassing orange). The state noted that no data had been submitted for the last 8 days. Today we are orange (splitting the difference), which no doubt can be used to support a range of narratives.
As you observe, it would be comical if it were not so damaging. Berry glides from one twisting narrative to the next like a slippery eel. The commish just nod with pride in approval. It’s comforting to know that there are others in our community who see through this.
Ana, thank you so much for clarifying! I just wasn’t able to square the case rates stats analysis reported on the state dashboard with JeffCo’s.
I also believe the reporting by PTFP has caught up with the crew in the courthouse. I have no doubt your words are being read and noted and that it’s not a coincidence the gas is being let off the high panic dashboard. Until they figure out a way to spin the flu and RSV into the next local emergency…