THE BMJ – Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

Source: https://www.bmj.com/content/375/bmj.n2635

PDF: https://www.bmj.com/content/bmj/375/bmj.n2635.full.pdf

Feature BMJ Investigation

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.

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banned.video – Biggest Vaccine Whistleblower in History Exposes FDA Falsified Data in COVID Jab Trials, says Robert Barnes

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Robert Barnes of https://vivabarneslaw.locals.com/ to break down the biggest vaccine whistleblower news in history as the FDA is exposed falsifying data in COVID jab trials.

More on the news here: https://www.infowars.com/posts/whistleblower-exposes-multiple-issues-with-pfizers-covid-vaccine-trial/

Leading medical journal The BMJ has published an incendiary report exposing faked data, blind trial failures, poorly trained vaccinators, and a slow follow-up on adverse reactions in the phase-three trial of Pfizer’s Covid jab.

Central to the exposé is Brook Jackson, who, for two weeks, served as regional director at Ventavia Research Group, the company contracted to assist with the pivotal trial. She provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails supporting her concerns.

Jackson reveals that Ventavia staff who conducted quality-control checks were overwhelmed by the volume of problems they were identifying. She repeatedly informed her superiors of poor laboratory management, and patient safety and data integrity issues.

In a cited internal document from August 2020, shortly after the Pfizer trial began, a Ventavia executive identified three site staff members with whom to “go over e-diary issue/falsifying data, etc.” One employee was said to have been subsequently “verbally counseled for changing data” and “not noting late entry.”

Jackson reported her concerns to the US Food and Drug Administration (FDA), but was fired later the same day on the basis that she was “not a good fit.”

In a recording of a late September meeting provided by Jackson, in which she met with two Ventavia directors, the unwelcome prospect of an FDA inspection had been openly discussed. “We’re going to get some kind of letter of information at least, when the FDA gets here … I know it,” one said to Jackson.

Another former Ventavia employee has confirmed that the company had been expecting a federal audit of its Pfizer vaccine trial, though this did not materialize. A 2007 US Department of Health report found that, between 2000 and 2005, the FDA inspected just 1% of clinical trial sites, while, in 2020, just 50 on-site visits were conducted.

In the aforementioned recording, an executive can also be heard explaining that, when examining paperwork for trial quality control, the company wasn’t able to quantify the types and number of errors that were being identified. “In my mind, it’s something new every day,” the senior staffer says. “We know that it’s significant.”

An email sent in September to Ventavia by Icon, the research organization with which Pfizer partnered on the trial, shows Icon was dissatisfied with Ventavia’s inability to keep up with data entry queries. Icon reminded Ventavia that “the expectation for this study is that all queries are addressed within 24 hours,” noting that more than 100 queries had remained outstanding for more than three days.

Among those queries were two cases in which test subjects had “reported with severe symptoms/reactions.” According to protocol, subjects experiencing grade-three local reactions – “severe” redness, swelling, or pain at the injection site – should have been contacted. Icon asked for confirmation as to whether contact had indeed been made, so as “to ascertain further details and determine whether a site visit is clinically indicated,” and that the subjects’ forms be updated accordingly.

And Here: https://www.bmj.com/content/375/bmj.n2635

The BMJ – Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

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; NCT04816643NCT04754594NCT04955626NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.

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VAXXED TV – Andy Wakefield

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I could not shake the fatigue
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Interview recorded on May 6th, 2017 in The United Kingdom

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Study – The toxicology of mercury: Current research and emerging trends.

US National Library of Medicine
National Institutes of Health – Nov 2017

Bjørklund G – 1, Dadar M – 2, Mutter J – 3, Aaseth J – 4.
Author information
1 Council for Nutritional and Environmental Medicine, Toften 24, 8610 Mo i Rana, Norway. Electronic address: bjorklund@conem.org.
2 Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran.
3 Paracelsus Clinica al Ronc, Castaneda, Switzerland.
4 Innlandet Hospital Trust and Inland Norway University of Applied Sciences, Elverum, Norway.

Abstract
Mercury (Hg) is a persistent bio-accumulative toxic metal with unique physicochemical properties of public health concern since their natural and anthropogenic diffusions still induce high risk to human and environmental health. The goal of this review was to analyze scientific literature evaluating the role of global concerns over Hg exposure due to human exposure to ingestion of contaminated seafood (methyl-Hg) as well as elemental Hg levels of dental amalgam fillings (metallic Hg), vaccines (ethyl-Hg) and contaminated water and air (Hg chloride). Mercury has been recognized as a neurotoxicant as well as immunotoxic and designated by the World Health Organization as one of the ten most dangerous chemicals to public health. It has been shown that the half-life of inorganic Hg in human brains is several years to several decades. Mercury occurs in the environment under different chemical forms as elemental Hg (metallic), inorganic and organic Hg. Despite the raising understanding of the Hg toxicokinetics, there is still fully justified to further explore the emerging theories about its bioavailability and adverse effects in humans. In this review, we describe current research and emerging trends in Hg toxicity with the purpose of providing up-to-date information for a better understanding of the kinetics of this metal, presenting comprehensive knowledge on published data analyzing its metabolism, interaction with other metals, distribution, internal doses and targets, and reservoir organs.

Study – Systematic Review and Meta-analysis: When One Study Is Just not Enough

Clinical Journal of the American Society of Nephrology

Amit X. Garg*, Dan Hackam † , Marcello Tonelli ‡
– Author Affiliations
*Division of Nephrology and Department of Epidemiology and Biostatistics, University of Western Ontario, London, and †Division of Clinical Pharmacology and Toxicology, University of Toronto, and Cardiac Rehabilitation and Secondary Prevention Program, Toronto Rehabilitation Institute, Toronto, Ontario, and ‡Division of Nephrology and Department of Public Health Sciences, University of Alberta, and Institute of Health Economics, Edmonton, Alberta, Canada

Conclusions
Like all types of research, systematic reviews and meta-analyses have both potential strengths and weaknesses. With the growth of renal clinical studies, an increasing number of these types of summary publications will certainly become available to nephrologists, researchers, administrators, and policy makers who seek to keep abreast of recent developments. To maximize their advantages, it is essential that future reviews be conducted and reported properly, with judicious interpretation by the discriminating reader.

Study – The association between mercury levels and autism spectrum disorders: A systematic review and meta-analysis

Journal of Trace Elements in Medicine and Biology
Volume 44, December 2017, Pages 289-297

Abstract

Background & aims
The relationship between mercury and autism spectrum disorders (ASD) has always been a topic of controversy among researchers. This study aimed to assess the relationship between ASD and mercury levels in hair, urine, blood, red blood cells (RBC), and brain through a meta-analysis.

Methods
A systematic search was performed in several databases including PubMed, ISI Web of Science, Cochrane register of controlled trials, Google Scholar, Scopus, and MagIran until June 2017. Case-control studies evaluating concentration of total mercury in different tissues of ASD patients and comparing them to the healthy subjects (control group) were identified. Necessary data were extracted and random effects model was used to calculate overall effect and its 95% corresponding confidence interval (CI) from the effect sizes.

Results
A total of 44 studies were identified that met the necessary criteria for meta-analysis. The mercury level in whole blood (Hedges = 0.43, 95% CI: 0.12, 0.74, P = 0.007), RBC (Hedges = 1.61, 95% CI: 0.83, 2.38, P < 0.001), and brain (0.61 ng/g, 95% CI, 0.02, 1.19, P = 0.043) was significantly higher in ASD patients than healthy subjects, whereas mercury level in hair (−0.14 mg/g, 95% CI: −0.28, −0.01, P = 0.039) was significantly lower in ASD patients than healthy subjects. The mercury level in urine was not significantly different between ASD patients and healthy subjects (0.51 mg/g creatinine, 95% CI: −0.14, 1.16, P = 0.121).

Conclusions
Results of the current meta-analysis revealed that mercury is an important causal factor in the etiology of ASD. It seems that the detoxification and excretory mechanisms are impaired in ASD patients which lead to accumulation of mercury in the body. Future additional studies on mercury levels in different tissues of ASD patients should be undertaken.

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How to accept Jesus Christ as your personal Saviour

Testimony by Phil Robertson from Duck Dynasty

1 Corinthians 15 Authorized (King James) Version (AKJV)
1 Moreover, brethren, I declare unto you the gospel which I preached unto you, which also ye have received, and wherein ye stand;
2 by which also ye are saved, if ye keep in memory what I preached unto you, unless ye have believed in vain.
3 For I delivered unto you first of all that which I also received, how that Christ died for our sins according to the scriptures;
4 and that he was buried, and that he rose again the third day according to the scriptures:

Hebrews 6 Authorized (King James) Version (AKJV)
1 Therefore leaving the principles of the doctrine of Christ, let us go on unto perfection; not laying again the foundation of repentance from dead works, and of faith toward God,
2 of the doctrine of baptisms, and of laying on of hands, and of resurrection of the dead, and of eternal judgment.
3 And this will we do, if God permit.
4 For it is impossible for those who were once enlightened, and have tasted of the heavenly gift, and were made partakers of the Holy Ghost,
5 and have tasted the good word of God, and the powers of the world to come,
6 if they shall fall away, to renew them again unto repentance; seeing they crucify to themselves the Son of God afresh, and put him to an open shame.
7 For the earth which drinketh in the rain that cometh oft upon it, and bringeth forth herbs meet for them by whom it is dressed, receiveth blessing from God:
8 but that which beareth thorns and briers is rejected, and is nigh unto cursing; whose end is to be burned.