How hydroxychloroquine looms over the FDA’s credibility
Scientists have by and large moved on from the idea that the generic malaria drug hydroxychloroquine can help patients with Covid-19. But President Trump, a vocal advocate for the drug, wants it back in the equation, citing a problematic study and demanding the FDA “act now.” How the agency responds could speak volumes about its role in the ongoing crisis.
As STAT’s Matthew Herper reports, the latest support for hydroxychloroquine comes from an observational study with more than a few confounding details, which experts widely dismissed. But the White House disagrees, forcing the FDA into an uncomfortable position: If it bows to Trump and endorses hydroxychloroquine, it could undermine its authority on the much more important question of whether any of the in-development coronavirus vaccines should be approved.
“The FDA cannot afford another misstep if it wants to maintain credibility with American people, which is going to be so essential when doing a broad vaccine program, should we identify a safe and effective vaccine for Covid,” said Luciana Borio, who served as the FDA’s acting chief scientist from 2017 to 2019.
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As STAT’s Matthew Herper reports, the latest support for hydroxychloroquine comes from an observational study with more than a few confounding details, which experts widely dismissed. But the White House disagrees, forcing the FDA into an uncomfortable position: If it bows to Trump and endorses hydroxychloroquine, it could undermine its authority on the much more important question of whether any of the in-development coronavirus vaccines should be approved.
“The FDA cannot afford another misstep if it wants to maintain credibility with American people, which is going to be so essential when doing a broad vaccine program, should we identify a safe and effective vaccine for Covid,” said Luciana Borio, who served as the FDA’s acting chief scientist from 2017 to 2019.
Read more.
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