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Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial


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2021 Dec 29, 10:49am   279 views  9 comments

by Patrick   ➕follow (55)   💰tip   ignore  

https://www.bmj.com/content/375/bmj.n2635?source=patrick.net


Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Poor laboratory management
On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”

Worries over FDA inspection
Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.

At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.

Box 1
A history of lax oversight
When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of Citizens for Responsible Care and Research Incorporated (CIRCARE),3 says the agency’s oversight capacity is severely under-resourced. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. And sometimes oversight occurs too late.

In one example CIRCARE and the US consumer advocacy organisation Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants.4 Nine months later, in April 2019, an FDA investigator inspected the clinical site. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. It said, “[I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.”5

“There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials.

Ventavia and the FDA
A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial.

“People working in clinical research are terrified of FDA audits,” Jill Fisher told The BMJ, but added that the agency rarely does anything other than inspect paperwork, usually months after a trial has ended. “I don’t know why they’re so afraid of them,” she said. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. “You would think if there’s a specific and credible complaint that they would have to investigate that,” Fisher said.

In 2007 the Department of Health and Human Services’ Office of the Inspector General released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites.6 Inspections carried out by the FDA’s vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year.7

RETURN TO TEXT
The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizer’s clinical trial at Ventavia. She then reported her concerns in an email to the agency. In the afternoon Ventavia fired Jackson—deemed “not a good fit,” according to her separation letter.

Jackson told The BMJ it was the first time she had been fired in her 20 year career in research.

Concerns raised
In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then listed a dozen concerns she had witnessed, including:

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, and
Targeting of Ventavia staff for reporting these types of problems.
Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. She heard nothing further in relation to her report.

In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8

In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Other employees’ accounts
In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. One of them was one of the officials who had taken part in the late September meeting. In a text message sent in June the former official apologised, saying that “everything that you complained about was spot on.”

Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Both confirmed broad aspects of Jackson’s complaint. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial.

“I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”

She added that during her time at Ventavia the company expected a federal audit but that this never came.

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

“I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.”

A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place.

Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.


https://nitter.pussthecat.org/Fiddaman/status/1456381472735105027?source=patrick.net#m


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1   Patrick   2022 Jan 20, 5:50pm  

https://strongandfreecanada.org/iron-will/how-pfizer-falsified-their-data-in-depth-with-deanna-mcleod-analyst/?source=patrick.net


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.
2   Patrick   2022 Jan 21, 7:55am  

https://www.bmj.com/content/376/bmj.o102?source=patrick.net


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.
4   Patrick   2022 Jan 27, 7:27pm  

https://alexberenson.substack.com/p/what-has-happened-to-reporters?source=patrick.net


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.
5   Patrick   2022 Feb 2, 1:02pm  

https://jessicar.substack.com/p/i-dont-know-what-to-say?source=patrick.net

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.
6   Patrick   2022 Feb 15, 9:46pm  

https://www.ntd.com/pfizer-trial-whistleblower-presses-forward-with-lawsuit-without-us-governments-help_740039.html?source=patrick.net


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.
8   Patrick   2022 Feb 24, 3:37pm  

https://etana.substack.com/p/pfizer-data-manipulation-a-piece?source=patrick.net


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.
9   Patrick   2022 Mar 1, 5:38pm  

https://childrenshealthdefense.org/defender/judge-evidence-pfizer-whistleblower-lawsuit/?source=patrick.net


03/01/22

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.


Why did it take more than a year?

How many more people died from the vaxx because of that delay?

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