From fatal eyedrops to mislabeled melatonin, why the FDA is failing the public
Key Excerpts from Article on Website of Salon
Posted: August 28th, 2023
A 2022 investigation by the journal The BMJ declared that FDA oversight of clinical trials, including those for Pfizer and Moderna's mRNA Covid-19 vaccines, was "grossly inadequate," from not conducting enough inspections to failing to alert scientific journals or the public when violations were flagged. But the issues here are not confined to behind the pharmacy counter. Dr. John Abramson, author of the recent book "Sickening: How Big Pharma Broke American Health Care and How We Can Repair It," traces the roots of issue back decades. "In 1992, when what turned out to be effective HIV drugs were stuck in the bottleneck of the FDA, they didn't have enough staff to get them through quickly enough. Many people were dying, and it was a real crisis," he explains. "The solution was that the Prescription Drug User Fee Agreement was passed. The drug companies started to pay a user fee with that was due upon application for new drug approval. And now roughly 65% of the FDA budget for overseeing human products comes from the drug and device companies. This comes with rigid timelines, and as I see from the outside, some degree of influence and obligation to the drug companies that derives from this agreement." The numbers here vary — Forbes puts that budget figure as high as 75%. Another similar conflict of interest that concerns Abramson is what he calls "the revolving door that goes between FDA and the drug industry."
Note: Read about Brook Jackson, a researcher for the Pfizer COVID-19 vaccine trials, who discovered patient safety concerns, data integrity issues, and other significant issues at her site. When she reported it to the FDA, she was fired the same day. For more along these lines, see concise summaries of deeply revealing news articles on government corruption and health from reliable major media sources.