NEW YORK – The anti-malaria drug Hydroxychloroquine is being touted by U.S. President Donald Trump as a possible gamechanger in the fight against the coronavirus pandemic, with “very very encouraging results” in early testing.
“We know that if things don’t go as planned it’s not going to kill anybody,” Trump said on a day when the death toll in the U.S. crossed 160. There are more than 10,000 cases across the country.
Trump said in a White House briefing March 19 that he is directing the Food and Drug Administration to fast track anti-viral therapies for treating patients with COVID-19.
Trump said the drug could prove to be a “gamechanger” and if it is not, the downside risks are likely to be low.
Trump said the Food and Drug Administration has “approved” the drug for use in coronavirus cases and that early results have been very “encouraging.”
“We’ve got very very encouraging early results. And we’re going to be able to make that drug available. Almost immediately. And that’s where the FDA has been so great, they’ve gone through the approval process, it’s been approved,” Trump said.
FDA Commissioner Stephen Hahn said several approaches are under testing, including chloroquine, remdesivir and antibodies sourced from the blood of COVID-19 patients after they recover.
“We’re looking at drugs that are already approved for other indications as a potential bridge or stopgap until studies are completed on other drugs under investigation,” Hahn said.
Hahn’s remarks suggest hydroxychloroquine belongs in this “stopgap” category for now.
Chloroquine, or hydroxychloroquine, has been used to treat malaria since the 1940s and is widely available. It is often given before exposure to malaria to prevent infection, and also as treatment afterward.
“Nothing will stand in our way as we pursue any avenue to find what best works against this horrible virus,” Trump said at the White House briefing.
Hahn said 10,000 FDA scientists, doctors and staff are “working around the clock to aid the American people in this fight against the coronavirus.”
Describing himself as a “wartime president,” Trump has invoked emergency powers which allow private sector capacity to be used in responding to the coronavirus pandemic which has already killed more than 130 people in the United States.
With these emergency powers, the Trump administration can pull on the country’s installed industrial base to swiftly produce materials needed in a national crisis.
White House coronavirus response coordinator Deborah Birx cautioned that the number of people diagnosed is likely to increase dramatically in the next few days as testing capacity ramps up. It is now nearly 60 days since the first U.S. case surfaced and testing at scale remains an issue across the country till date.
Birx underlined a relatively new theme in what we know about the virus - its transmission from hard surfaces. “We’re still working out how much is by human to human transmission and how much from surfaces,” she said.
“We’ve not seen significant mortality in children,” she said.
“Don’t expose yourself to surfaces outside the home,” Birx urged Americans.
The White House task force has been calling on “younger” Americans, especially millennials, to follow the latest social distancing guidelines and stop congregating in groups. Younger Americans are also being urged to donate blood.
Hospitals, which are fearing a tidal wave of cases coming in as a result of the increased testing capacity, have been asked to cancel all elective surgeries.
India-West Staff Reporter adds:
After the press conference, many experts disagreed with the president and urged the public to keep their expectations in check since no clinical trials have been conducted to show it works against the virus, according to reports.
Trump said the drug was being “fast-tracked” by the FDA, but the agency later clarified that the drug had not yet been approved to treat COVID-19, according to Bloomberg News. “However, U.S. doctors are legally able to prescribe a drug for any illness or condition they think is medically appropriate,” it said.
Carlos Del Rio, an Emory University medical and global health professor, said contrary to the president’s claims, the drug is not readily available.
“With Trump touting today the early results of Plaquenil and saying it will be available, he clearly does not know that supplies are already limited. For the past several days, there has been a run on Plaquenil in the country. #COVID19,” he wrote on Twitter.
MSN News reports that Hahn, speaking after the president, said the FDA is considering giving chloroquine to larger populations of coronavirus patients as part of an “expanded use” testing program. “Such a trial in patients would allow the FDA to collect data to measure scientifically whether it works.”
“In the short term, we are looking at drugs that are already approved for other indications,” MSN News quoted Hahn as saying. “That’s a drug (chloroquine) 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. “We want to do that in the setting of a clinical trial, a large, pragmatic clinical trial to actually gather that information and answer that question that needs to be answered.”
However, some studies show the drug might work.
Citing findings published in the Clinical Infectious Diseases journal March 9, the New York Post reported that the drug was effective in killing the virus in lab experiments.
“(W)e predict that the drug has a good potential to combat the disease,” the study’s authors, most from the Chinese Academy of Sciences in Wuhan, wrote in a letter published in Cell Discovery March 19, said the New York Post.
According to a study published March 18, French-Polynesian researchers have already completed their own largely successful clinical trial using the drug.
“Despite its small size sample size, our survey shows that hydroxychloroquine treatment is significantly associated with viral load reduction/disappearance in COVID-19 patients and its effort is reinforced by azithromycin,” the authors wrote.