Covid-19 Hydroxychloroquine

Uporabnik damirj je napisal:

Boljša je, ker je manj zgoljufana.

Klikni za razširitev

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

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.

Klikni za razširitev

• 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.

Klikni za razširitev