Posts Tagged ‘“The FDA and the Case of Ketek”’

“’Gee, they relied on a fraud for this application; we should deny it;’ but the FDA Commissioner granted it and put Ketek into the market”!

The drug involved is the antimicrobial agent Sanofi-Aventis makes called Ketek®, which has been linked to dozens of cases of liver injury!

The New England Journal of Medicine published “The FDA and the Case of Ketek” by David B. Ross, MD, PhD, which readers ought to take the time to read to understand how FDA truly has become ‘the handmaiden’ of the pharmaceutical industry and vaccine makers collectively called Big Pharma!  The NEJM article states:

A routine FDA inspection of the practices of the physician who enrolled the most patients — more than 400 — uncovered fraud, including complete fabrication of patient enrollment. The inspector notified FDA criminal investigators, and the physician is currently serving a 57-month sentence in federal prison for her actions. Inspections of nine other sites enrolling high numbers of patients revealed serious violations of trial conduct, raising substantial concerns about the overall integrity of the study. In the end, 4 of the 10 inspected sites were referred for criminal investigation. [CJF emphasis]



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