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The drug had so many debilitating and lethal side effects that FDA, in an uncharacteristic act of civil disobedience against NIAID’s diminutive dictator, issued a black box warning. Nevertheless, desperate HIV-infected Americans rushed like doomed lemmings to take the drug. In 2010, FDA issued a statement that ddI can cause potentially a fatal liver disease called non-cirrhotic portal hypertension.126 Even with its demonstrated toxicity, Dr. Fauci used CRI parallel-track process to bypass the usual controls, to win approval for use of ddI in pregnant mothers who test positive for HIV. A 2019 study [Hleyhel et al., Environ Mol Mutagen (2019)127] found that ddI accounted for 16 percent of prescriptions for infected mothers and 30 percent of the cancers in their children. In 1996, Dr. Fauci used his expedited fast track to break another record by winning FDA approval for Merck’s HIV antiviral Crixivan; this time it took only six weeks.128 Dr. Fauci achieved that feat by allowing Merck to run Crixivan through a skeleton CRI process on a tiny cohort of ninety-seven volunteers in three groups, thereby winning the swiftest approval in history: forty-two days. That approval prompted open revolt by the AIDS community, which felt betrayed when Merck hiked up
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Robert F. Kennedy Jr. (The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health)