Pfizer makes headlines again after some new data involving allegedly poor practices at a contract research company helping to carry out Pfizer’s covid vaccine trial raise questions about the data integrity and the regulatory oversight.
BMJ begins their piece by saying that in the autumn of 2020, Pfizer’s chairman and chief exec Albert Bourla released an open letter to billions of people all over the world who were hoping to see normality again in the world.
“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.
Data integrity and patient safety
BMJ continues and notes that researchers who were testing Pfizer’s vaccine at a few sites in Texas during that autumn, speed may have come at the cost of “data integrity and patient safety.”
It’s been revealed that the regional director who was employed at the research organization Ventavia Research Group has told The BMJ that the company did the following:
“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.”
Ventavia was notified of these problems, and the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA).
Ventavia fired her later the same day. Another vital issue that’s worth noting is the fact that Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. We strongly suggest that you take a look at The BMJ article in order to find out some pretty interesting, yet disturbing info.
Stay tuned for more corona-related news and make sure to stay safe as well.