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Hydroxychloroquine testing Hahn’s, FDA’s independence as countries, scientists negate use

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FDA’s decisions on hydroxychloroquine and chloroquine for COVID-19 have become a test of FDA Commissioner Stephen Hahn’s independence from political pressure, with mounting evidence of the drugs’ lack of benefit and dangerous cardiac liability. The question is whether, or when, Hahn will reverse course to protect patients and risk publicly contradicting President Donald Trump’s public and vocal support for their use.

The agency granted Emergency Use Authorization on March 28 to hydroxychloroquine and chloroquine to be used to treat hospitalized COVID-19 patients, citing “anecdotal clinical data in case series,” as the basis. According to ousted BARDA Director Rick Bright, the EUA was issued after FDA came under extraordinary pressure from Trump, HHS Secretary Alex Azar and administration supporters to grant broad, unrestricted approval to the drugs (see “Bright Shines Harsh Light On America’s COVID-19 Preparedness, FDA’s Independence”).

On April 24, FDA issued a warning cautioning against the use of the drugs for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. Trump later announced that he was taking hydroxychloroquine, which was prescribed by a White House physician.

Evidence that the drugs provide no benefit and they cause deaths in hospitalized patients has accumulated over the past month, including an observational study published May 22 in The Lancet that concluded that they are associated with “decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19.”

France, the first country to embrace use of hydroxychloroquine and chloroquine to treat COVID-19 patients, rescinded approval Wednesday. Also Wednesday, Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases, told CNN television that “the scientific data is really quite evident now about the lack of efficacy” of the drugs to treat COVID-19. He noted their cardiac toxicity. On May 25, WHO suspended the hydroxychloroquine arm of its SOLIDARITY master protocol, citing the Lancet study.

Fauci’s remarks increase pressure on Hahn to rescind the EUA or explain why it is in the public interest for COVID-19 patients to continue to be exposed to the drugs. Without such an explanation, Hahn risks questions about FDA’s objectivity that could erode confidence in its decisions (see “FDA’s Hydroxychloroquine Test”).

In an April 23 podcast interview with BioCentury, Hahn was unequivocal that he would terminate the EUA if the evidence did not hold up. In the event that trials demonstrate that hydroxychloroquine or chloroquine are not safe and effective for treating COVID-19, FDA “would absolutely use those data and we would rescind the EUA,” Hahn told BioCentury (see “FDA’s Hahn Denies Political Interference”).

In contrast to previous FDA commissioners who have sought to insulate the agency from partisan politics, Hahn has not distanced himself from political controversy. In a recent example, he retweeted on Monday a tweet from Trump that called SARS-CoV-2 “the China Virus,” a term used by the president, but one the scientific community has not espoused. FDA’s press office said it could not comment on the language.

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