Experts Say FDA Oversight of Pfizer's Clinical Trials was Grossly Inadequate
Originally posted on Quora November 21, 2022
Regulatory documents show that only nine out of 153 Pfizer trial sites were subject to FDA inspection before licensing the mRNA vaccine. Similarly, only 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected.
Source: British Medical Journal
It appears that approval of Pfizer’s mRNA vaxx was a forgone conclusion before phase 3 trial even started. Not only did the FDA fail to inspect the majority of their trial sites, they also failed to notify the public and scientific journals of violations they identified at the few sites they inspected, such as falsified data and unblinded participants, almost as if they were bought and paid for by the same corporations they are supposed to be regulating (and aspire to get jobs through these corporations once their FDA gig is up). Apparently, this isn’t the first time they neglected their due diligence either. A 2007 HHS office of inspector general report found that the FDA audited less than 1% of clinical trial sites between 2000 and 2005 and did not maintain a database of operational clinical trial sites. A 2015 analysis of published clinical trials between 1998 and 2013, which the FDA had inspected, found that of the 57 clinical trials that had significant violations, 39% involved falsification of data, 25% under reported adverse events, 74% had protocol violations, 61% had inaccurate record keeping, and 53% failed to protect the safety of participants and violated informed consent. A Science investigation of FDA enforcement between 2008 and 2019 found that the agency rarely imposed sanctions when it found research violations and when it did warn researchers against breaking the law it neglected to conduct follow up investigations to ensure the problems were remedied. Apologists have tried to chalk this up to a lack of funding and resources despite the fact that the FDA has 18,000 employees and a $6 billion budget that dwarfs its international counterparts such as EMA, which has a measly $428 million budget 86% of which comes from user fees and surcharges, and Health Canada, which receives slightly more than 1 billion per year, and has increased 33% over the past decade.