EXCLUSIVE: Pfizer Clinical Trial Whistleblower's Lawsuit Presses Ahead Without Government’s Help
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This is your daily Facts Matter update, and I'm your host, Roman, from The Epoch Times.
And now let's begin today's discussion by talking about Pfizer.
And to start with, I would like to remind you of a very brief quote by Joe Biden.
He said this late last year, and he specifically was referring to the national vaccine mandates that he was trying to push out.
Here's what he said.
That vaccination requirements are good for the economy.
And you know what?
He was very right.
Specifically when you look at the economy in regards to Pfizer.
That's because according to Pfizer's latest filing with the SEC, their COVID vaccine has brought them an unprecedented $36.8 billion in sales.
This makes it by far the number one top-selling pharmaceutical product ever in a single year by a very wide margin.
In fact, what's even perhaps more stark is the percentage of their business that the vaccine now represents.
Because according to their filing, Pfizer brought in about $81 billion last year, with $36.8 billion of those dollars, or roughly 45%, coming from the vaccine alone.
I guess it doesn't hurt when the populations of the entire world are quite literally being forced by their governments to take your product.
I guess you can call that a form of demand and supply.
Regardless, moving forward, Pfizer expects that this year, meaning 2022, their vaccine will generate another $32 billion worth of sales, and their new COVID pill, which was just approved by the FDA in December, is expected to generate an additional $22 billion of revenue.
And then likewise, it appears that Pfizer is looking to take their mRNA technology and expand it even further.
That's because Mr.
Albert Berla, who is Pfizer's CEO, he said that his company is planning to aggressively expand the use of mRNA technology, which is of course the same technology that's used in their COVID vaccine, to treat rare genetic diseases of the liver, different muscles, as well as the central nervous system.
And then furthermore, Mr.
Burla also said that Pfizer is hoping to reduce the time frame to produce new vaccines, saying that he's trying to get it from about three months to just two months.
And he's doing this by, among other methods, exploring a collaboration with another company, one that's called Codex DNA, in order to automate and produce mRNA.
Here's specifically what he said during an interview on CNBC. We have a very strong belief that the mRNA is a very powerful technology.
All we do, it is trying to harness this technology for the best of mankind.
So there are three more deals that we have announced, including a very important one with the Beam.
Beam is a leader in the base gene editing technology.
We did a lot of due diligence, and we believe that the base technology is a technology that has the most promise in gene editing.
And I wouldn't underestimate also the agreement that we did with Codex.
Codex has a technology that you can produce DNA, not through biological means, which is how we're doing it right now, when we are working with, for example, with our vaccines against COVID, but with this chemical.
This means that you can reduce the time of producing a very essential part of the overall manufacturing process for RNA vaccines from almost a month to a couple of days.
I guess we'll just have to wait and see whether any of their new vaccines that will be using this new type of technology will become mandatory for us Americans as well.
I'm sure that will be a big boon to business if they do.
Regardless though, besides all of these positive developments, well, Pfizer is also facing some potentially serious headwinds.
To start with, despite the fact that they are clocking in record sales with their 2022 projections just for their COVID products alone being about $54 billion, well, apparently that is not enough.
That's because these astronomical projections actually fell short of what Wall Street analysts expected, and therefore Pfizer's stock fell by about 5%.
Then, to make matters a bit worse for at least the Pfizer investors, just yesterday, the FDA decided to push back their decision on whether or not to allow kids younger than the age of five to get the Pfizer vaccine.
The FDA's reasoning was that the young kids who were part of Pfizer's clinical trial had such a low number of COVID cases overall that it made evaluating the data extremely difficult.
Now, specifically what Pfizer did in that clinical trial was they took children between the ages of six months to four years of age, and they gave them a two-dose regimen of the vaccine.
However, again, because symptomatic COVID is so rare in this particular age group, the FDA determined that the data was not enough for emergency use authorization.
Here's specifically with Dr.
Scott Gottlieb, who used to be the commissioner of the FDA, but who now sits on Pfizer's board.
Here's what he said regarding the decision.
Since there's a low number of cases overall in the clinical trial, most kids are not getting symptomatic COVID. One case in one direction or another can tip the perception of the vaccine's overall effectiveness.
And so, not getting this authorization is likely going to cost Pfizer millions of dollars in potential vaccine sales.
Just for your reference, in America, there are about 24 million kids who are below the age of 5.
So, that could have been a lot of money.
However, not all hope is lost in this direction, because according to Dr.
Peter Marks, who is the current director of the FDA Center for Biologics Evaluation and Research, he said that Pfizer needs to keep conducting their clinical trials with these kids, specifically by seeing whether a three-dose regimen of the vaccine does anything.
Here's specifically what he told reporters.
The data that we saw made us realize that we needed to see data from a third dose, as in the ongoing trial, in order to make it the term determination that we could proceed with doing an authorization.
Okay, so that was the first and second headwinds that Pfizer is facing.
Now, the third headwind has to do with the Pfizer whistleblower, specifically about how, after a full year, the U.S. federal government has chosen to not help a whistleblower in her lawsuit against Pfizer.
And so now, this whistleblower is pushing ahead with her case by herself.
Now, in order to understand what's actually happening with this case, let me lay out the details for you.
Late last year, you might remember that a whistleblower came forward, specifically a whistleblower who worked within one of the subcontractors who was involved in Pfizer's clinical research.
Now, that subcontractor in question, it's called Ventavia Research Group, and they operated several of these sites for Pfizer's Phase 3 vaccine trials back in the fall of 2020.
They were one of the companies which ran the clinical trials that eventually led to the emergency use authorization being granted for the Pfizer vaccine.
However, according to Ms. Brooke Jackson, who worked as a regional director for this company during that time, she told the British Medical Journal that the trial was riddled with many issues, including the falsification of data, unblinded patients, as well as very large delays in following up on adverse reactions.
Here's specifically what she told the British Medical Journal.
Quote, The company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in the pivotal phase three trial of the Pfizer biotech vaccine.
She further said that she brought up these problems with her superiors at the company, but she says that she was ignored and the company took no corrective actions.
And so she instead emailed her complaints over to the FDA.
However, she said that just within hours of alerting the FDA to what was happening, she was fired.
She blew the whistle to the FDA, and then a few hours later, she was let go.
And then furthermore, it appears that the FDA did not even follow up with her complaints.
They seemingly ignored her.
And then Pfizer, which reportedly knew about these potential problems over at Ventavia, such as the falsification of data, unblinded patients, as well as the long delay in addressing adverse reactions, well, Pfizer hired them again anyway to conduct four more clinical trials.
Now, actually, there were a lot of very revealing details which came out in her testimony, and we'll go through them one by one after a super quick word from today's sponsor.
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Now Roman in the studio, back to you.
And now let's head back to this case.
Prior to her stint at Ventavia, the whistleblower Ms.
Brooke Jackson has worked with clinical trials for the past 15 years, and she told the British Medical Journal, which just for your reference is one of the world's oldest and most prestigious medical journals, that during the fall of 2020, she repeatedly raised concerns with her superiors about what she was witnessing at the Pfizer vaccine trials, including, most seriously, concerns about patient safety.
Specifically, she said that she witnessed things like participants not being monitored after receiving an injection, vaccines not being stored at proper temperatures, retaliation against employees who actually raised these concerns to their supervisor, mislabeled laboratory specimen, patients who experienced adverse reactions to the vaccine not being followed up with in a timely manner, and so on and so forth.
There were quite a number of problems that she brought up.
However, she said that she felt like her complaints were being ignored, and so she began to take photos of the clinical trial environment on her phone.
Now, we don't actually have access to those photos, but according to the British Medical Journal, one of the photos showed that needles were being discarded in plastic bags instead of in a box, which is a biohazard issue.
And then in another photo, it appeared to show that packaging materials actually revealed the trial participants' ID numbers, which could mean that the trial participants were unblinded, making this trial, at least potentially, not achieve the standard of being a double-blind study.
Now, because her complaints were ignored, she took her case to the FDA. Ms.
Jackson, she emailed the FDA on September 25th of 2020, of the year 2020, with a list of 12 concerns that she had regarding the trial that she was overseeing.
And although the FDA acknowledged that they received her list, nothing really came of it.
Apparently, they did not start any sort of an investigation.
And then, of course, just a few hours afterwards, she was subsequently fired from her job.
Now, back when Ms.
Jackson's story first broke, we here at the Epoch Times, we reached out to the FDA for comment on her case, but they only got back to us confirming that they were generally aware of the situation as it was playing out.
Here's specifically what they wrote to us late last year.
Quote, The FDA has full confidence in the data that were used to support the Pfizer-BioNTech COVID-19 vaccine authorization and the Comirnaty approval.
Now, last year, when she came forward with her allegations, Ms.
Jackson filed a False Claims Act lawsuit against Pfizer, Ventavia, as well as another company which was involved in the clinical trial, a third company called Icon.
And this lawsuit has actually been under seal for over a year while the U.S. Department of Justice was considering whether or not they should intervene in the case.
However, after a full year of them considering it, well, the U.S. Department of Justice, just a few days ago, declined to intervene on Ms.
Jackson's behalf.
Now, the government's lawyers did not actually offer an explanation as to why they decided to not help, and when we here at the Epoch Times reached out to the FDA for clarification, they did not get back to us with any comment.
Regardless though, what this means in practice is that for one, Ms.
Jackson's lawsuit is no longer under seal and instead it's all available to the public.
And then secondly, it means that Ms.
Jackson has to press forward with the lawsuit without the U.S. government's help.
She has to do it by herself.
And it appears that's exactly what she is planning to do.
Here's in fact what she told us here at the Epoch Times via email.
We are going to pursue the case without the help of the government.
She then added that even though the odds are stacked against her, quote, It's just a chance I have to take.
I just feel like somebody has to be held accountable.
Now again, since the government has declined to intervene in the case, we now have the lawsuit in hand, and here is how her lawyers describe their main argument, their main accusation, rather, in the case.
Quote, Pfizer, ICANN, and Ventavia deliberately withheld crucial information from the United States that calls the safety and efficacy of their vaccine into question.
Namely, the defendants concealed violations of both their clinical trial protocol and federal regulations, including falsification of clinical trial documents.
Due to the defendants' scheme, millions of Americans have received a misbranded vaccination, which is potentially not as effective as represented.
Furthermore, some of the more specific details have now been unsealed as well in the form of both emails as well as text message threads.
And some of these emails, they actually detail some of the alleged problems with these clinical trials, which were, by the way, observed not only by Ms.
Jackson, but by other Ventavia workers as well.
As an example, a woman named Levika Downs, she wrote an email on September 18th of 2020, which was addressed to Ms.
Jackson and another employee, that she, quote, observed boxes containing patient information left on the counter, fully exposed to anyone that entered the room could see.
And then also, Ms.
Marnie Fisher, who was Ventavia's director of operations at that time, she said on September the 21st of 2020 that, quote, An investigation found that multiple sites had left documents exposed, including a schedule with patient names on it, adverse events either not being reported correctly or at all, the vaccine and placebo not being kept locked in disorganized rooms, and informed consent errors.
And then furthermore, these newly unsealed documents, they show the Ventavia employees they were aware of, quote, Serious problems arising during the trial, including vaccine administrators who were either described as having no training and very little oversight or lacking medical certifications or background.
And according to these documents, an official from Pfizer was actually copied in on some of these emails, and he even replied to some of them, so you can't say that he wasn't aware.
Now, we here at the Epoch Times, we did reach out to both the FDA as well as Pfizer for comment, but neither of them have gotten back to us.
However, a spokesperson for Ventavia did get back to us, saying this in part.
Although Ms.
Jackson was hired to oversee certain sites and aspects of clinical trials, she was only employed with Ventavia for 18 days, and as a result, did not have the longevity with the company to complete the training for the role for which she was hired.
And so we will just have to wait and see what happens with this lawsuit as it plays itself out in court over the next several months.
Perhaps many more details will be revealed in that process.
If you'd like to read the documents for yourself, I'll throw all of them into the description box below this video for you to check out.
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