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

[Jam]

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

Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open...

www.bmj.com

View: https://twitter.com/FrankGrimes_Jr/status/1455569779817865219

 

[LLight]

Since I'm too late to post this news, here is another one (don't know if he is joking):

View: https://twitter.com/RolandBakerIII/status/1455602271807365121?s=20

 

[Drareg]

Lols! It reads like the trials were done at the back of a mafia owned restaurant. The same company are now doing trial’s for the kids covid vaccine.
It’s rational for non experts to trust the experts they say, I wouldn’t take a coffee from this place let alone trust "their vaccine science".


"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. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts".

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.6 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.

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.

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)


Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial

 

[Lollipop2]

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

Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open...

www.bmj.com

View: https://twitter.com/FrankGrimes_Jr/status/1455569779817865219

WoW...

 

[Lollipop2]

@Kris

 

[Peatness]

Editor of the British Medical Journal tells the FDA about Serious Concerns over Pfizer Trial Data Integrity

And the lack of FDA oversight

nakedemperor.substack.com

View: https://twitter.com/DowdEdward/status/1514992931870240772?cxt=HHwWiMDT1e6Cq4YqAAAA