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Deanna McLeod is a Director at Kaleidoscope Strategic, an oncology publications firm dedicated to the advancement of patient care and supporting clinicians in authoring internationally recognized peer-reviewed articles and review papers. Deanna is currently working with the Canadian Covid Care Alliance to evaluate the recently released Pfizer vaccine trial data. Deanna shares this data pointing out the inconsistencies which hide some glaring errors in their results.
On the trial’s design not representing those at imminent risk…
We know that comorbidities were at the heart; they’re the key risk factors for disease. In the real world, 95% of the people who died had at least one comorbidity. In the trial only 21% had a coexisting condition. We were supposed to be looking for an intervention that was going to reduce disease, severe disease, specifically death in elderly people with co-morbidities and these people were not well-represented. There were a lot of people who were excluded from this trial [like] people with multiple comorbidities, the immuno-compromised, pregnant women, the frail & elderly. There are just so many groups that were excluded from these trials…they’re testing in the wrong population.
On the concept of herd immunity…
Concept of mass vaccination is rooted in herd immunity. Herd immunity is what they noticed in herds and veterinary populations where the healthy ones developed immunity naturally. There were some weaker members of the herd that were unable to mount an appropriate immune response. Because the healthier people in the herd got immunity it protected the disease from spreading to the weaker members of society. Mass vaccination is this idea of if there is a group that we can’t treat on their own and they can’t mount a response then we can consider giving this agent to the herd in order to prevent transmission.
On natural immunity vs vaccine-related immunity…
We know that natural immunity is durable and long lasting and broad because we’ve been measuring it for a long time now. We also know that it works cause we’re all here, civilization is moving forward. That’s historical proof right there. What’s interesting about vaccine related immunity is that vaccine immunity is very narrow in this particular trial. The way they’re measuring this is they inject you then wait seven days and then start measuring. If you’re symptomatic and COVID positive, then you are a case. At the six-month follow-up, what is the efficacy? Interestingly, they actually didn’t report efficacy for the adults at six months. What they did was they combined the reporting of the adults with the adolescents at the point of crossover.
On the unsuccessful hunt for a real pandemic…
Death rates have stayed low throughout the third wave and now low throughout the fourth wave…the definition of a pandemic is whenever you have worldwide disease and enormous numbers of deaths, what our Ontario data is telling us right now is that we no longer have a pandemic, that there is no longer a need for emergency use measures because our death rate has been low and stable, through two waves now. We can even see that now they’re not linked to hospitalizations, which I think is encouraging.
Covid-19 vaccines and treatments: we must have raw data, now ...
Today, despite the global rollout of covid-19 vaccines and treatments, the anonymised participant level data underlying the trials for these new products remain inaccessible to doctors, researchers, and the public—and are likely to remain that way for years to come.16 This is morally indefensible for all trials, but especially for those involving major public health interventions. ...
Pharmaceutical companies are reaping vast profits without adequate independent scrutiny of their scientific claims.33 The purpose of regulators is not to dance to the tune of rich global corporations and enrich them further; it is to protect the health of their populations. We need complete data transparency for all studies, we need it in the public interest, and we need it now.
Executives usually try to avoid breaking the law overtly. They don’t like prison. Prison isn’t fun. They prefer golf. (I’m not entirely sure why.)
Of course, there are exceptions. A few executives, like Elizabeth Holmes, are frauds basically from the jump. Other will cross the line when the walls are cracking and they get desperate. But generally, well-lawyered companies prefer to look for loopholes.
If paying a physician directly to prescribe your drug is illegal, offer volume “rebates” for drugs administered directly by physicians.
Or create a “naturalistic” clinical trial - where the physician receives hundreds of dollars for filling out a one-page form every time she enrolls a patient.
Or offer a free, all-expenses paid continuing education seminar for physicians about “new treatments” at a ski area, and keep the schedule light. And hire “key opinion leaders” - other physicians - to give the seminars - you can pay them, they’re working. And pay those KOLs to “consult” with your marketing division about the best ways to promote your drug.
You get the idea. When the product is a pill that costs pennies to make and can be sold for dollars (or sometimes hundreds of dollars), there’s LOTS of money sloshing around. You just need to put it to work.
So criminal OR quasi-criminal.
And concealed OR quasi-concealed. Obviously, companies will not go out of their way to describe clearly illegal behavior - cash in bags, et cetera. Getting at that usually requires whistleblowers (another topic) and internal documents.
But public companies have strict disclosure requirements. And pharma companies have to provide data to the Food and Drug Administration both before and after their products are approved and register their human clinical trials prospectively with the National Institutes of Health (they didn’t always). And lawsuits and the discovery process can also be great sources, which is yet another reason the vaccine immunity is so problematic.
Do my eyes deceive me? More people died in the drug arm following dose 2 than in the placebo arm? What the hell? And they kept going?
Go to page 61. 3 times more AEs reported overall in the drug arm than placebo arm. 2.7 times more SEVERE AEs reported overall in the drug arm. AND THEY KEPT GOING.
A former clinical trial overseer for a contractor holding trials of Pfizer’s COVID-19 vaccine is pressing forward with a lawsuit against Pfizer and her former company despite the U.S. government declining to side with her.
Brook Jackson was fired by the contractor, Ventavia Research Group, in 2020. She came forward as a whistleblower in 2021.
Jackson filed a False Claims Act suit against Pfizer, Ventavia, and another company involved in the trial, ICON. It has been under seal for over a year, but is now public after the U.S. Department of Justice declined to intervene on behalf of Jackson.
Government lawyers did not explain the choice not to intervene and the Food and Drug Administration (FDA), which investigates alleged clinical trial fraud, did not respond to a request for comment.
The choice, though, has not deterred the whistleblower.
“We’re going to pursue the case without the help of the government,” Jackson told The Epoch Times.
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.
03/01/22
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COVID › NEWS
Judge Unseals 400 Pages of Evidence, Clears Way for Pfizer Whistleblower Lawsuit
The decision by a district court judge to unseal a complaint filed more than a year ago against multiple parties involved in Pfizer’s COVID vaccine trials allowed the lawsuit to go forward — and revealed 400 pages of exhibits used to substantiate the lawsuit’s claims.
https://nitter.pussthecat.org/Fiddaman/status/1456381472735105027?source=patrick.net#m