‘Masks were a softening up exercise for Plan B,’ according to a government whistleblower. He told me that while there is little appetite in the Cabinet for a full lockdown, Covid Passes are ‘oven-baked’ and ready to go.
In my opinion, the UK government’s Winter Plan was always about Plan B. It displayed a classic ‘foot-in-the-door’ strategy – the raison d’être of Plan A was to prepare you for Plan B. Now winter is upon us, and the nudges fall in a flurry of torpefying snowflakes. Worst case scenarios, big numbers, salutary stories in the media, threats and cajolements are directed at us daily. Plan B is in motion as calls for working from home are heard from the usual suspects and we hear the Cabinet is divided on Covid Passes.
This seasoned government insider plays a key role on a Covid task force and has decided to speak out now because he is disturbed by the unethical reasons for mandating masks. Firstly, ‘It’s a highly political move to reset the Johnson administration’s orientation after bad polling over sleaze and corruption. If Omicron turns out to be super-bad and the public ask what the government did about it, the answer is we implemented masks. The one-way systems, plexiglass screens and masks are to give you an illusion of the government doing something. It’s just theatre. There is no evidence base or proportionality in favour of masks.’
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 2021 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.
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
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.
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.
Provenance and peer review: commissioned; externally peer reviewed.
Competing interests: PDT has been doubly vaccinated with Pfizer’s vaccine.
This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.
* Bourla A. An open letter from Pfizer chairman and CEO Albert Bourla. Pfizer. https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla.
* Ventavia. A leading force in clinical research trials. https://www.ventaviaresearch.com/company.
* Citizens for Responsible Care and Research Incorporated (CIRCARE). http://www.circare.org/corp.htm.
* Public Citizen. Letter to Scott Gottlieb and Jerry Menikoff. Jul 2018. https://www.citizen.org/wp-content/uploads/2442.pdf.
↵Food and Drug Administration. Letter to John B Cole MD. MARCS-CMS 611902. May 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jon-b-cole-md-611902-05052021.
* Department of Health and Human Services Office of Inspector General. The Food and Drug Administration’s oversight of clinical trials. Sep 2007. https://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf.
* Food and Drug Administration. Bioresearch monitoring. https://www.fda.gov/media/145858/download.
* FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. Dec 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19.
Original article: https://www.bmj.com/content/375/bmj.n2635
Is Pfizer putting profits above lives? Public Citizen, a non-profit organization says that Pfizer can stop countries from speaking about contracts, block vaccine donations, unilaterally change delivery schedules & demand public assets as collateral. Palki Sharma tells you more.
Public Citizen reveals Pfizer’s demands:
- Waive the sovereignty of its assets abroad
- The rules of the land be not applied of Pfizer
- Take into consideration delay in vaccine delivery
- Not penalised for delaying delivery
- Exempt from all civil liability
Nine countries have been forced to make concessions to Pfizer in exchange for Covid-19 vaccine supply:
- Right to silence governments.
- Pfizer decides where the shots go.
- IP Waiver – if Pfizer is accused of intellectual property theft, governments must pay to defend Pfizer.
- Private arbitrators, not public courts, will decide disputes in secret.
- Pfizer can go after state assets to secure compensation.
- Pfizer decides on key decisions such as delivery timelines.
In this exclusive interview, Laurence Fox speaks to an NHS whistle-blower, who despite working throughout the lockdown, caring in the community, now faces the sack.
Simply because she doesn’t wish to get the vaccine. Hear her story now.
A female officer with Victoria Police, who served for 16 years, has resigned in protest against the use of police to enforce Covid-19 rules, saying in an interview that a “great majority” of her colleagues shared her sentiments.
…Some rough behavior by the police during the pandemic might be partially explained by the enforcement approach taken by Victoria Premier Daniel Andrews, Mitchell suggested. “I think that the reason, or the issue, in why perhaps police [are] feeling more emboldened to act the way they are in relation to these harsher actions is because of the messaging that comes from Dan [Andrews],” who tells the law enforcers what to do “on a daily basis,” she said.
Acting Senior Sergeant Krystle Mitchell is a sworn member of the Victoria Police in Australia. She has served Victorians for 16 years as a police officer including 6 years at Professional Standards Command – the division responsible for investigating police misconduct, corruption, discrimination and freedom of information, referring investigations to the Independent Broad-based Anti-corruption Commission (IBAC) where appropriate.
Acting Senior Sergeant Mitchell cites ethical conflicts as the reason for speaking publicly about conduct of Victoria Police officers, their Chief Commissioner – Shane Patton, their Minister – the Hon. Lisa Neville MP, and ultimately their Premier – the Hon. Daniel Andrews MP. She feels she can no longer remain silent with the division between police and community is growing, and totally ignored by the leadership of both the police and government.
Despite a promise to focus on ‘Community Policing’ and ‘Back to Basics’ policing by Shane Patton, Acting Senior Sergeant Mitchell has witnessed the opposite trajectory during the Covid-19 pandemic and is reminding her colleagues that ultimately they will individually be held accountable for their actions, and are still subject to s 462A of the Crimes Act 1958 (Vic) which forbids the disproportionate use of force.
She is also calling for Victoria Police to remain consistent to the values, ethics and decision making frameworks (such as SELF) that it used to demand of its members a mere 2 years ago.
British funeral undertaker John O’Looney speaks to independent journalist Lindie Naughton about all the elderly people who are supposedly dying from “covid” in care homes and hospitals.
Lindie Naughton is an Irish journalist living in Dublin. She writes regular columns on running and minority sports for the Evening Herald. She also writes for the Irish Garden and Irish Runner magazines and is a judge for the Irish Times Sportswoman of the Year awards.
“Lockdowns,” the mass quarantine of both sick and healthy people, have never before been used for disease mitigation in the modern Western world. Previously, the strategy had been systematically ruled out by the pandemic plans of the World Health Organization (WHO) and by health experts of every developed nation. So how did we get here?
Dr Sam White is a GP in the UK. He was recently suspended by the NHS for speaking out about informed consent, the safety of the vaccine and other safe and effective alternative treatments.
He is now running a campaign to promote his concerns about the vaccine and the plan to vaccinate children.
Dr Hodkinson is the CEO of Western Medical Assessments, and has been the Company’s Medical Director for over 20 years. He received his general medical degrees from Cambridge University in the UK, and then became a Royal College certified pathologist in Canada (FRCPC) following a residency in Vancouver, BC.Source: Western Medical Assessments
- Dr Hodkinson’s interview is at 2h49m.
Find out more about the Investigative Corona Committee Germany.
A shortened version of the video Session 56 has been uploaded to Bitchute by Coronavirus Plushie.
Dr. Michael Dykta, Dr. Wolfgang Wodarg, Professor Arne Burkhardt, Dr. Peter McCullough and Dr. Roger Hodkinson speak with Dr. Reiner Fuellmich on Germany’s Investigative Corona Committee Session 56.
- Dr McCullough’s is at around 1h35m.
- Dr Hodkinson’s interview is at 2h49m.
Find out more about the Investigative Corona Committee Germany.
The full video has been removed from YouTube. You can find a backup mirror below:
The ‘Speak Out’ service is available to witnesses with information about ALL aspects of the pandemic response, not just Covid death reporting. Professional legal advice will be given free-of-charge* to eligible applicants at the start of their process and everything will be fully confidential. Those with information on any Covid related practices of concern are encouraged to come forward as a matter of urgency by completing the form on the “Speak Out” page of the website below.
Go to the Covid19 Assembly Speak Out Service
James talks to the receptionist of a large NHS medical practice. She tells him the true shocking story about adverse reactions to the ‘jab’.
Please note – Nina’s name has been changed and her voice has been altered to protect her identity
Undercover filming, by BBC Panorama, at a major UK Covid testing lab has revealed how poor working practices could lead to people getting incorrect test results.
Shelley Tasker, 43, from Camborne, Cornwall, resigned from Treliske hospital
Healthcare assistant made speech outside Truro cathedral and revealed what’s been going on behind closed doors of NHS hospitals
Claims she had no work for three weeks at height of pandemic due to no patients
“I can tell you on Friday in Treliske there were three people in with Covid. No extra deaths, three – and that covers Treliske, West Cornwall and Hayle hospital…The total deaths from these three hospitals in seven months, is 76 people – that’s about ten people a month over the last seven months, and we have locked down.”
The number of prescriptions for a powerful sedative that can kill the frail doubled at the height of the coronavirus pandemic, raising fears it was used to control elderly residents in stretched care homes – or even to hasten their deaths.
Official figures show out-of-hospital prescribing of the drug midazolam increased by more than 100 per cent in April compared to previous months.
An anti-euthanasia campaigner last night said he suspected that the spike was evidence that many people had been put on end-of-life protocols or ‘pathways’.
- Non-COVID patients were put in with COVID patients, then marked with Do Not Resuscitate orders.
- Hospitals have a financial incentive to mark patients as COVID-19.
- Doctors stopped treating people as humans. Inexperienced doctors were practicing on patients.
- COVID-19 has been proven to be easily treatable with the Hydroxychloroquine/Zinc/Antibiotic protocol
- People were coming in too late due to fear.
- Patients were unnecessarily put on ventilators. “They want to use the vents.”
- Patients were put in restraints “due to laziness.”
- New York may have been hit hard because their hospitals were already struggling. They couldn’t afford to keep them open.
A frontline nurse working in New York on coronavirus patients claims the city is killing sufferers by putting them on ventilators, advocating against them
The nurse persuaded a friend, a nurse practitioner who is not working on coronavirus patients, to make the video to get the word out
‘It’s a horror movie. Not because of the disease, but the way it is being handled,’ the frontline nurse said through the friend, who only was identified as Sara NP
Sara said COVID-19 patients are placed on ventilators rather than less invasive CPAP or BiPAP machines due to fears about the virus spreading
She explained: ‘The ventilators have high pressure, which then causes barotrauma, it causes trauma to the lungs’
More than 12,000 people have died from the virus in NYC, with another 4,300 dying in other parts of the Empire State
New York emergency room doctor Cameron Kyle-Sidell stepped down this month because he didn’t want to follow the hospital’s ventilator protocol
Republican Minnesota Senator Scott Jensen told Fox News’ Laura Ingraham that Medicare pays hospitals three times as much if patients are placed on ventilators