President Donald Trump was cautiously optimistic during a Thursday press conference addressing his temporary changes to the Food and Drug Administration (FDA) that will enable the fast-tracking of potentially lifesaving drugs in the face of the novel coronavirus scare.
Trump specifically spoke about chloroquine, a drug designed to treat malaria that has reportedly been showing promising results against COVID-19 symptoms.
Bypassing the typical months-long bureaucracy, the drug has been approved and will be made readily available to the American people “almost immediately,” the president said.
“I think it could be a game-changer, and maybe not,” Trump said at the press conference.
“I have directed the FDA to eliminate rules and bureaucracy so work can proceed rapidly, quickly, and fast,” the president added. “We have to remove every barrier.”
Officials from the FDA backed Trump’s announcement and emphasized that the agency would still first and foremost make sure all drugs released to the public are effective and safe.
With regard to chloroquine, Trump highlighted that the drug has already proven to be safe when treating malaria. “So we know if things don’t go as planned, it’s not going to kill anybody,” he said, adding that the drug has showed “very encouraging” results against COVID-19 thus far.
According to information posted by the Center for Disease Control (CDC), “Chloroquine (also known as chloroquine phosphate) is an antimalarial medicine” that is currently “available in the United States by prescription only.”
“It is sold under the brand name Aralen, and it is also sold as a generic medicine,” the CDC outlines, adding, “Chloroquine can be prescribed for either prevention or treatment of malaria.”
A clinical trial report posted February 18 connects chloroquine to combating COVID-19.
“Early data from clinical trials being performed in China has revealed that chloroquine phosphate could help treat the new coronavirus disease, Covid-19,” the report said. “China National Center for Biotechnology Development deputy head Sun Yanrong said that chloroquine, an anti-malarial medication, was selected after several screening rounds of thousands of existing drugs.”
“Data from the drug’s studies showed ‘certain curative effect’ with ‘fairly good efficacy,'” the report added.
According to Sun, the report outlined, “patients treated with chloroquine demonstrated a better drop in fever, improvement of lung CT images, and required a shorter time to recover compared to parallel groups.”
“A recent controlled clinical study conducted by Didier Raoult M.D/Ph.D, et. al in France has shown that 100% patients that received a combination of HCQ (hydroxychloroquine) and Azithromycin tested negative and were virologically cured within 6 days of treatment,” information for the open-data clinical trial reads. “In addition, recent guidelines from South Korea and China report that hydroxychloroquine and chloroquine are effective antiviral therapeutic treatments for novel coronavirus. … Ground-breaking in vitro studies demonstrate potential efficacy of hydroxychloroquine as a prophylactic for novel coronavirus infection in primate cells.”