BMJ investigation: FDA oversight of clinical trials is "grossly inadequate"
Covid-19 vaccines and drugs were developed at “warp speed” and now experts are concerned about the US Food and Drug Administration’s inadequate surveillance of clinical trial sites.
Inspections of clinical trial sites are vital to ensure the integrity of data generated in clinical trials, but only 9 out of 153 Pfizer trial sites were subject to FDA inspection prior to licensing its covid-19 mRNA vaccine. Similarly, 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected.
Notably, the FDA received a complaint from whistle-blower Brook Jackson, about misconduct at three clinical trial sites that were testing Pfizer’s covid-19 vaccine, while she was employed as a regional director. Jackson observed a range of problems including falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events. “I thought that the FDA was going to swoop in and take care of everything,” said Jackson. The FDA did not, however, inspect the trial sites in question.
Experts have criticised the FDA’s oversight of clinical trials, describing it as “grossly inadequate.”
They say the problem, which predates covid-19, is not limited to a lack of inspections, but also includes failing to proactively notify the public or scientific journals when violations are identified, effectively keeping scientific misconduct from the medical establishment.
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For paid subscribers, I have included an extended interview with Dr David Gortler (featured in The BMJ article). He was an FDA medical reviewer between 2007 and 2011 and also worked as a senior advisor to the FDA commissioner in 2019-2021.