Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

my name is brooke jackson i was fired in september of 2020 for being a whistleblower i was working on pfizer's phase 3 pivotal trial on their covid19 vaccine my first day on the job was the 8th of september and from the very beginning i noticed irregularities um things that were questionable i would i would bring up the concerns to my managers and it was always we're understaffed we're really trying hard to you know make this work you know at one point when i was going through emails um there were emails from icon begging ventavia to follow up on severe adverse events that had been reported there were several emails about mislabeled specimens blood specimens and the nasal swabs there were specimens that were labeled with another participant's information it was a nightmare and on the 16th of september i stayed late in clinic one evening and i was the only one in the clinic i walked into an area where the vaccines were refrigerated or frozen rather and when i walked in i saw a biohazard bag the plastic biohazard bag contained used needles and i realized how unorganized and sloppy ventavia was was handling everything in that same room where they where they kept the vaccine the vaccine was just left out and the boxes that the vaccine came in the containers they had written the subject information on these containers so right there you know me working on the study it unblinded me to the the randomization of these patients i made note of that i took pictures i took pictures to just to document what i'd seen to show my managers it was also discovered that ventavia was unblinding participants in the study based on a directive from our ceo which was to print out the randomization scheme and put that drug assignment in everybody's chart per pfizer's protocol we should have immediately stopped enrolling but they never they never told pfizer instead they wanted us to go through each of the charts and actually take out the randomization scheme that was printed so that coupled with everything else i made the recommendation for ventavia to stop enrolling clinical trial participants in the study until we were able to let pfizer know you sent me the photos thank you and i didn't i didn't pull them up i mean not granted like that's what they're wrong i mean so i might should i not have taken the pictures the problem is is the breach of confidentiality and it was a personal sponsor information on those boxes at that point it was clear to me that i i wasn't fitting in i decided that that next morning i was gonna gonna report my company to the fda and so i did that about nine o'clock in the morning on the 25th of september and about six hours later i got a call from ventavia and was fired on the spot and told that i was not a good fit i remember investigator cannon called me and we spoke for an hour and 16 minutes to be precise i can tell you everything that we talked about it mirrored what was typed in my formal complaint to them the unblinding the safety of the clinical trial participants not monitoring them for adverse reactions they were late to report adverse events again the untrained staff the oversight by the principal investigators specifically at the fort worth location the targeting of the employees for coming forward i thought that the fda was going to swoop in and and take care of everything what i was reporting was so important [Music] you

Channel: The BMJ

Views: 2,754,411

Keywords: bmj investigates, covid-19, investigates, pfizer, the bmj, trial, vaccine

Id: RaLxhFiOBYk

Length: 6min 24sec (384 seconds)

Published: Wed Mar 16 2022

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This article and the BMJ got fact checked over this by Facebook.

The pre-eminent medical journal in the world was smeared by a social media network which hosted the livestream of the Christchurch massacre.

This is the world those in power want for us.

[u/twigman7]

Mainstream source.