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
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