The Food and Drug Administration may soon be approving widespread medical use of a time-tested and relatively cheap anti-malarial drug to treat coronavirus patients in the United States.
With more than 10,000 stateside cases of the virus now confirmed, the Trump administration has scrambled in recent days to see drug testing deregulated for the purposes of quicker, more effective pandemic response — and the result may be a successful treatment in the form of chloroquine.
President Donald Trump told reporters Thursday in a White House news briefing that the drug, which he referred to as a potential “game-changer,” was reportedly producing strong results in trials involving hospitalized American patients.
“This is beyond right-to-try,” Trump said. “If treatments known to be safe in Europe, Japan or other nations are known to be effective against a virus, we’ll use that information to protect the health and safety of American people.”
“Nothing will stand in our way as we pursue any avenue to find what best works against this horrible virus,” he added.
According to The Brussels Times, chloroquine first went on the market as an anti-malarial in 1934 and was eventually used in 2004 to fight another coronavirus strain now known as SARS.
TRUMP: The FDA has approved Chloroquine to be prescribed to help treat Coronavirus.
— Benny (@bennyjohnson) March 19, 2020
Not thought to be a SARS treatment until late in the outbreak, the drug never saw clinical trial for its effectiveness in combating respiratory viruses in the coronavirus family.
The president seemed confident Thursday that the drug’s long lifespan was another factor working in its favor, indicating that it was, at the least, not known to be fatal — unlike other newly discovered treatments and drugs in the works.
“We know that if things don’t go as planned it’s not going to kill anybody,” Trump said. “When you go with a brand-new drug you don’t know that that’s going to happen.”
FDA Commissioner Dr. Stephen Hahn was more hesitant in his assessment, clarifying that the agency had not fully approved the drug for coronavirus treatment but affirming that medical professionals could prescribe it for “compassionate use” on patients willing to try experimental treatment options.
Further clinical trials would be required to determine whether the treatment was appropriate and, if so, to what degree.
“I have great hope for how we’re going to come out of this situation. What’s also important is not to provide false hope,” Hahn said.
“[Chloroquine is] a drug that the president has directed us to take a closer look at as to whether an expanded-use approach to that could be done to actually see if that benefits patients,” he added. “We want to do that in a setting of a clinical trial.”
“We need to make sure that this sea of new treatments will get the right drug to the right patient at the right dosage at the right time,” Hahn cautioned.
“As an example, we may have the right drug but it may not be in the appropriate dosage form right now and that may do more harm than good.”
In addition to his optimism regarding chloroquine, Trump was also confident regarding reports that biotechnology company Gilead Sciences has seen strong results employing its Ebola treatment remdesivir against the coronavirus, but Hahn said that drug would be “going through the normal process” for approval and will not be prescribed by doctors.
Numerous vaccines are also in the works and are on track to enter the human testing phase by late spring and early summer.
Others on the president’s coronavirus task force have publicly expressed hesitance regarding such developments, warning the public against reliance on anecdotal evidence and small-sample, initial trial results.
“Of course, there’s always anecdotal reports, and we’re trying to figure out how many anecdotal reports equal real scientific breakthroughs,” Deborah Birx, the White House’s coronavirus response coordinator, said during a Wednesday briefing, according to Bloomberg.
Regardless, medical experts close to the testing of these treatments have remained excited about the results, calling for expansion of clinical trials and further deregulation given the circumstances.
According to the Washington Examiner, a group of French virology researchers, led by infectious disease expert Didier Raoult, revealed Wednesday that a 26-patient study conducted earlier this month found infected individuals treated with chloroquine were nearly five times more likely to test negative for coronavirus within six days than those who were not.
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