Amid growing evidence the drug is not effective, the FDA
announced in June that it had revoked the EUA for the drugs because they are “unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” and that the “known and potential benefits” of the drugs “no longer outweigh” the risks — which can include “serious cardiac adverse events and other potential serious side effects.”
A large randomized controlled study called RECOVERY, in the U.K.,
reported in a preprint, which hasn’t been peer-reviewed, that hydroxychloroquine wasn’t associated with reduced mortality — and was actually associated with “an increased length of hospital stay and increased risk of progressing to invasive mechanical ventilation or death.” The study said that 26.8% of the 1,561 patients given hydroxychloroquine died within 28 days, whereas 25% of patients given usual care died in that time span — a difference that was not statistically significant.
The authors wrote that “these results indicate that hydroxychloroquine is not an effective treatment for patients hospitalized with COVID-19.”
Another study
published July 16 in the
Annals of Internal Medicine — a randomized, double-blind, placebo-controlled trial that involved more than 400 participants — found that “hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19.”
There was one observational study by the Henry Ford Health System,
published in the
International Journal of Infectious Diseases on July 1, that found hydroxychloroquine was associated with lower mortality for patients hospitalized with COVID-19. But, as we’ve
explained before, the study has limitations — and it stands in contrast to multiple randomized controlled trials that have found the drug is not beneficial to hospitalized patients (and two other
observational studies).
During the press conference, Immanuel also claimed that a
2005 study “said it works.”
That study — which found that “[c]hloroquine is effective in preventing the spread of SARS-CoV in cell culture” — “is no evidence at all that it’s a cure for COVID,” Schluger said.
“That was a different coronavirus; that was the coronavirus that causes SARS,” he said. Secondly, he said, the study involved cells in test tubes. Potential drugs are evaluated in test tubes, then in animals, before they move into the three phases of clinical human trials, he said — and 90% of drug candidates that make it to human trials fail because they aren’t effective or aren’t safe.
A study in a test tube involving a different virus, Schluger added, is “not how the FDA approves drugs.”
