BMJ: Whistleblower Reveals “Data Integrity Issues” in Pfizer Vaccine Trial

This article, written by Paul D. Thacker, appeared in the British Medical Journal (BMJ) earlier this week.

The whistleblower is a woman named Brook Jackson, the regional director of a company called Ventavia Research Group, the contract research company that helped Pfizer conduct its Covid vaccine trials:

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.

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.

I’m sure it’s fine. You’re a Science-Denying troglodyte if you don’t want to get quintuple-vaxxed.

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.

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.”

There’s a lot in the article, and I recommend reading it in its entirety, but I’ll try to keep this post limited to the most significant bits:

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. 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.

This now raises some questions about the whole FDA approval process in general. Given the sheer number of drugs out there being tested, how can the FDA even come anywhere close to thoroughly and sufficiently testing them all? In theory, every one should be audited meticulously by the FDA, but this is not feasible.

You’d think that the Covid vaccine trials would’ve been priority #1 for the FDA’s auditors and inspectors, not only because of the global pandemic, but because of the unprecedented speed with which the vaccines were developed and tested.

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.

One wonders what type of employee would constitute a “good fit” at Ventavia.

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.

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].”

If this was happening at just a few of the 153 trial sites, you have to wonder if it was merely an aberration–a bad egg–or if it was the norm.

And again, how are we to trust the “FDA Approved” seal of quality anymore?

How can we trust that the vaccines are “safe and effective” in light of all this? The FDA inspected 9 of the 153 test sites, and that was enough for them to concluded that the vaccine was “safe and effective”?

Neither Pfizer nor the FDA followed up on the the concerns at Ventavia, which leads one to the conclusion that they can’t credibly say the vaccine is “safe and effective.”

Vaccine approval was rammed through. The trials were a formality–it was always going to be approved no matter what actually happened during the trials. There was simply too much money at stake for Pfizer to delay the vaccine rollout because of concerns raised some obnoxious narc down in Texas.

Shut up, lady!

Or, the trials were a sham and the vaccine had been in development long before the Ventavia trials.

But that’s a whole different conversation.

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