A former testing site researcher in Texas has alleged that Pfizer’s pre-licensure BNT162b2 (also known as “Comirnaty”) COVID-19 biologic trials included falsification of data, unblinding patients, employing inadequately trained vaccinators, and delays in following up on experimental COVID vaccine adverse reaction reports.1
According to clinical trial researcher Brook Jackson, the incidences occurred during the phase III trial and were reported by Jackson to the U.S. Food and Drug Administration (FDA) after the private research group she worked for failed to investigate her concerns. Jackson, who was a regional director, was fired from Ventavia Research Group, a Pfizer subcontractor, the same day.1
The British Medical Journal (BMJ) reported that Jackson was a trained clinical researcher who, prior to her position with Ventavia, had over 15 years of experience in clinical research coordination and management.1 During the course of the investigation, Jackson provided the BMJ and other news sources with records including documents, photos, audio recordings, and emails to support her claims.1 2 3
Records of Sloppy Documentation and Falsifying Data in Pfizer Experimental COVID Vaccine Clinical Trial
Several of these records, which included emails from Ventavia staff discussing “sloppy” documentation and falsifying data in the Pfizer pre-licensure clinical trial of its experimental COVID biologic, can be seen in an article written in The Disinformation Chronicle.3Another record displayed in the article is an e-mail from Jackson to Ventavia officials outlining several issues she was seeing with the trials. Jackson ends the e-mail with “I might be in a little bit of shock.”3
In a recording of a meeting between Jackson and two Ventavia directors in September 2020, an executive can be heard discussing the company’s inability to quantify the amount of errors they were finding during the Pfizer COVID biologic clinical trial paperwork for quality control. The executive is heard saying:
In my mind, it’s something new every day. We know that it’s significant.1
According to the BMJ, additional former employees of Ventavia have also spoken out anonymously. One of these employees alleged that the company had been nervous about expecting a federal audit of its Pfizer biologic trial. This claim is supported by an e-mail Jackson provided.3
DHHS Report Concludes FDA Inspections Should Focus on Human Subject Protections
Jill Fisher, PhD, a 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, states that the FDA audits are rarely anything more than paperwork inspection that typically don’t occur until months after a clinical trial has ended.1
A 2007 Department of Health and Human Services Office of the Inspector General report entitled The Food and Drug Administration’s Oversight of Clinical Trials estimated that the FDA inspected only one percent of clinical trial sites.4 The DHHS report outlines a summary of findings including the fact that the agency is unable to even identify ongoing clinical trials because there is no clinical trial registry. Findings of the Inspector General also state:
The (FDA) centers conduct more inspections that verify clinical trial data than inspections that focus on human subject protections.4
Pharmaceutical Companies Pay FDA for Drug and Vaccine Licensure
Former HHS official Michael Carome, MD has cited concerns over the FDA’s funding which largely comes from “user fees” from the very pharmaceutical companies the FDA is legally responsible for regulating.
“Instead of a regulator and a regulated industry, we now have a partnership,” Carome stated. “That relationship has tilted the agency away from a public health perspective to an industry friendly perspective.”5
The FDA was entirely a taxpayer-funded agency until 1992 when Congress passed the Prescription Drug User Fee Act (PDUFA). The Act directed pharmaceutical companies to pay the FDA a fee to review drug and vaccine license applications. It also allowed for manufacturers to pay annual user fees to fast track experimental drug or vaccine licensure.5 6 7
FDA Approval Process Faster Than Any Other Country’s Regulatory Agency
According to an article in ProPublica, “Today the FDA approves drugs faster than any other regulatory agency in the world. ” The article goes on to point out that there are significant conflicts of interest between the FDA and pharmaceutical companies:
The FDA is increasingly green lighting expensive drugs despite little-known side effects and inconclusive evidence.8
Former FDA commissioner Scott Gottlieb, MD who encouraged fast tracking of many of these drugs and vaccines, left the FDA in 2019 and now sits on the Board of Directors for Pfizer.9
Vaccine Testing Site Not Investigated by FDA After Employees Report Violations During Pfizer COVID-19 Clinical Trials
According to the BMJ, Jackson’s e-mail to the FDA, which was sent on Sep. 25, 2020, outlines several concerns surrounding the mishandling of the Pfizer clinical trials of its experimental COVID biologic, including:
- Participants placed in a hallway and not being monitored by clinical staff following vaccination
- Lack of timely follow up with patients who experienced adverse events after being vaccinated
- Protocol deviations not being reported
- Vaccines not stored at proper temperatures
- Mislabeled laboratory specimens
- Targeting of Ventavia staff for sanctions for reporting any problems1
After Jackson reported protocol violations, she received a follow up e-mail and call from the FDA but was told that no further information could be provided. Following FDA’s approval of Pfizer’s COVID biologic, the FDA published a summary of its inspections of the trial. Of the 153 clinical trial sites, only nine were inspected. Ventavia’s sites were not listed among those inspected by FDA despite Jackson’s report directly to the FDA.1
In the summary, 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].1
Ventavia Denies Jackson’s Duties Included Clinical Trial Involvement
MedPage Today reports that Ventavia spokeswoman Lauren Foreman objected to the BMJ article and stated the company was working with an attorney. Foreman also alleged that Jackson was employed “for approximately two weeks in September 2020, and no part of her job responsibilities concerned the clinical trials.”2
Following the published MedPage Today article, Jackson provided MedPage Today a copy of an email showing that she had indeed been hired by Ventavia as a regional director to be involved with two sites for the Pfizer COVID biologic clinical trial.2 Jackson’s name is also listed on Pfizer’s clinical trial delegation log in which you can see her printed name, signature, and delegated duties.5 According to the document, Jackson had several delegated duties including investigational product accountability, maintenance of regulatory binder, and “compliance assessment of investigational product.”3
A Cease and Desist letter from Jackson’s attorney was issued to Ventavia demanding that a public retraction of the statement that Jackson was not involved in clinical trials. The legal letter states:
Point in fact, as you know, Jackson was in fact hired to be the regional director specifically for the ‘clinical trials at issue.’10
Asked by MedPage Today whether the FDA is investigating the accusations against the trials, the FDA stated in an e-mail: “Although the agency cannot comment further at this time in the ongoing matter, FDA has full confidence in the data that were used to support the Pfizer/BioNTech COVID biologic authorization and the Comirnaty approval.”2
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