Brook Jackson

An insightful, engaging interview with Brook Jackson recorded during the summer of 2022.Show more

A former clinical trial auditor with 20 years experience, Brook lost her position as regional director for Ventavia, a clinical trial firm contracted by Pfizer to run clinical trials of its Covid-19 vaccine candidate, after she reported her concerns about alleged poor clinical management at the company to the US Food and Drug Administration.

Following a series of interactions with company management during her employment, Brook's position at the company was suddenly terminated hours following a submission she made directly to the FDA which outlined her concerns about the integrity of the trials underway.

NOTE: As of October 2022, the lawsuit is gathering pace, with Brook bringing participants forward "w/sworn testimony & across multiple sites that were included in efficacy analysis of the bogus EUA." (Brook Jackson, Twitter 9th October, 2022)

The significance of Brook's case is primarily in the serious questions it raises about the integrity of clinical trial findings that led to the original emergency usage authorization by the FDA of the Pfizer Covid-19 products. Other concerning revelations involve the seemingly interwoven chain of command that seem to characterize the relationship between Pfizer and the FDA. As Brook herself tweeted 9th October 2022, "Did FDA run to Pfizer or go directly to Ventavia to get me out of the way?" - one of many questions her case aims to resolve.

The core allegations in Brook's case also raise serious questions around the integrity of other trials that led to the approval of Pfizer's product - if this could happen at Ventavia, what about the other trial sites?

Brook's lawsuit was launched in January 2021. In an interview with the British Medical Journal, Brook summarized her allegations stating that Ventavia "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."

BMJ ARTICLE
https://www.bmj.com/content/375/bmj.n2635

"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"

"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.

"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"

MAKING SENSE COMMENTS: Regulatory bodies at national level around the world accepted the FDA's approval as evidence of the safety and efficacy of the product. Not only that, but contractual arrangements were entered into by most countries which allow for immunity from liability by Pfizer in the case of any litigant that might allege side effects from taking the product. But what happens to these contracts if it is proven in court that not only were corners cut during the trial process, but that the FDA colluded with Pfizer in perpetrating what amounts to a fraud. As Ed Dowd, the ex Blackrock fund manager reiterates, 'fraud vitiates all contracts'. Pfizer and the FDA would technically be liable for any damage caused by the Covid-19 products. What about the position of regulatory authories such as the EMA in Europe and NIAC in the Republic of Ireland in the event of a successful outcome to the lawsuit? And what about the role of the mainstream media? By suppressing coverage of this story, is the media simply following a pattern of behaviour which from the outset of the Pandemic made Informed Consent impossible?

So many questions - Hopefully you'll find this interview goes a long way to answering many of them.

LINKS

Litigation Details
https://cdn.locals.com/documents/47656/47656_e41yu6vd2x117dq.pdf

Brook Jackon's Website
https://www.iambrookjackson.com/

Making Sense
https://www.twitter.com/MakingSenseInfo