Huge: Basically Trump FDA knew little to nothing about HCQ safety and the quality of the HCQ made overseas. FOIA memos show they approved it on political pressure. This seriously harms the reputation of the FDA when it’s abused like this. (Ht @JasonLeopold). #COVID19
2) “FDA documents, released publicly now for the first time, outlined what data the agency used to make the hot-button decision to allow widespread use of the drugs.
The EUA review, conducted by six FDA officials, referred to only two studies of the malaria drugs...”
The EUA review, conducted by six FDA officials, referred to only two studies of the malaria drugs...”
3) “which either showed negligible results or have since been called into question altogether. At its center was a controversial French study that claimed that it, combined w/ an antibiotic, was very effective. That study has since been retracted cuz of numerous problems’’
4) “...including failing to include outcomes of patients who died/hospitalized. The review also cited a small Chinese trial of 30 patients that showed little to no effect on outcomes, and a letter from Chinese scientists that said it’s effective– but not backed up w/ any data.”
5) This is another example why the FOIA (FREEDOM OF INFORMATION ACT) requests are among the most significant powers of a good democracy. Full article here: buzzfeednews.com/article/zahrah…
6) “The document also reviewed the risks posed by the millions of doses donated for use in the US. Analyzing the 1 million chloroquine tablets donated to the US by Bayer, the review noted they were made at never-inspected factories in India w/ “a low reputation for quality.”
7) “The pills were made by a manufacturer in India whose other factories had failed previous FDA inspections. That meant, “facilities used to manufacture this chloroquine are presumed to have even lower standards of quality.”
8) “A chemical analysis of the chloroquine pills conducted on March 27, also among the public records, indicated the tablets contained small impurities but met standards.”
9) “At least we have some hints now of what they were depending on" for the EUA, said Peter Lurie, a former FDA executive who now leads @CSPI . "It still seems to me to be a thin read and one is left with the question of whether the approval had to do w/ pressure from WH."
10) “I think it's fair to ask whether the FDA — expert in assessing drug data — should or could have spotted those issues,” Patricia Zettler, former FDA associate chief counsel. Zettler added, however, that the standard for an emergency use authorization is always low.”
