Brooke Jackson, who was recently fired from her position as regional director at the Ventavia Research Group, a Pfizer contract partner, told the British Medical Journal (BMJ) that multiple trials at several research sites in Texas produced flawed results based on these poor practices.
Not only was Pfizer "slow" to report problems during the trials, but it also unblinded patients, hired on inadequately trained vaccinators, and cut corners to produce desired results rather than accurate results.
Jackson says that staff members who were involved in quality control checks became overwhelmed at the sheer volume of problems that arose because of the company's tampering with the normal standards for trials of this type.
Concerned about everything she was witnessing, Jackson tried to approach her superiors about it. She also emailed a complaint to the U.S. Food and Drug Administration (FDA) before being promptly fired that same day.
After this occurred, Jackson proceeded to send a trove of incriminating evidence to the BMJ, including internal company documents, photos, audio recordings and emails.
"One photo ... showed needles discarded in a plastic biohazard bag instead of a sharps container box," reports indicate. "Another showed vaccine packaging materials with trial participants' identification numbers written on them left out in the open, potentially unblinding participants."
Rather than take her concerns seriously when presented with the facts, Ventavia instead questioned Jackson for taking photos of the incriminating evidence.
Another problem Jackson revealed about the Pfizer contract company's trial protocols involved data entry, which was not properly maintained throughout the process.
The expectation was that all queries would be addressed within 24 hours, however there were more than 100 of them older than that, a later investigation revealed.
"Subject has reported with Severe symptoms/reactions ... Per protocol, subjects experiencing Grade 3 local reactions should be contacted," one query for two separate individuals read.
"Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate."
Upon receipt of this query, investigators should have made phone contact "to ascertain further details and determine whether a site visit is clinically indicated." Instead, nothing was done.
At least three employees at Ventavia were also identified by company executives as problematic due to suspicions that they were involved with falsifying data. One of these employees was reportedly "verbally counseled for changing data and not noting late entry."
The FDA, it was feared, might come in to conduct an audit, which apparently petrified Ventavia because it knew its protocols were not up to proper standards.
"People working in clinical research are terrified of FDA audits," stated someone named Jill Fisher who is involved with all this. "I don't know why they're so afraid of them ... You would think if there's a specific and credible complaint that they would have to investigate that."
Other problems outlined by Jackson include:
• Trial participants placed in a hallway post-injection without any monitoring by clinical staff
• Lack of timely follow-up of participants who experienced adverse events
• Deviations from protocol not being reported
• Injection vials not being stored at proper temperatures
• Mislabeled laboratory specimens
• Staff members being targeted by Ventavia for bringing up issues and problems
Jackson was told by the FDA in response to her complaints that no comment would be provided. It was later discovered that the FDA looked into just nine of the trial's 153 sites, and not a single one involving Ventavia was investigated.
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