A May whistleblower complaint alleged that the FDA’s emergency authorization of chloroquine and hydroxychloroquine came about as a result of political pressure from the White House.
because of numerous problems, including failing to include the outcomes of patients on the drugs who died or were hospitalized. The review also cited a small Chinese trial of 30 patients that showed the drugs had little to no effect on patient outcomes, and a letter from Chinese scientists that said it was effective – but was not backed up with any data.
The document also reviewed the risks posed by the millions of doses of the drugs that were donated for use in the US. Analyzing the 1 million chloroquine tablets donated to the US by Bayer Pharmaceuticals, the review noted they were made at never-inspected factories in India with “a low reputation for quality.” The pills were made by a manufacturer in India whose other factories had failed previous FDA inspections.
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