Food and Drug Administration chief said on Thursday the agency is considering testing an old anti-malarial pill called chloroquine on a broader pool of corona virus patients, as President Trump pushes the federal bureaucracy to cut red tape and move faster to find ways of combating the virus.
Trump at a briefing Thursday said he wants to speed approvals of vaccines and treatments to fight the pandemic. There are no approved treatments, but medical investigators around the world are studying several widely available drugs, including chloroquine, to see if it could have an effect.
Trump sang the praises of chloroquine, calling it a potential “game-changer,” while seeming to stumble over the regulatory path required to give it to a broader pool of patients.
“It has shown very, very encouraging early results, and we’re going to be able to make that drug available almost immediately,” Trump said, “and that is where the FDA has been so great. It’s gone through the approval process. It’s been approved. They took it down from many months to immediate.”
But in fact, the drug has not been approved by the FDA for coronavirus. It has long been approved to prevent and treat malaria as well as treat arthritis, and doctors have authority to prescribe it now, but there is no proof it works on coronavirus.
Stephen Hahn, the FDA commissioner, 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 scientifically measure whether it works. It was not immediately clear how long it would take the FDA to design the study and get it working at trial sites around the country.
“In the short term, we are looking at drugs that are already approved for other indications,” Hahn said, citing chloroquine as the lead example. “That’s 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.
“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,” he said.
President Trump said he spoke with Democratic Gov. Andrew Cuomo of New York on Wednesday night and that Cuomo was eager to have chloroquine made available to New York patients with coronavirus.
Chloroquine is an inexpensive generic drug that has been used for 70 years against malaria and has shown promise in laboratory tests against the novel coronavirus.
It is attracting great interest as a potential treatment and is being studied in China, the United States, and Europe. Bayer AG, which said it discovered the drug in 1934, announced it was donating 3 million doses to the U.S. government.
The drug costs as little as 30 cents a pill at retail Canadian pharmacies, according to the websites. In the United States, where drug prices typically are the highest in the world, the retail price is $6.63 per tablet, according to the websites.
Chinese government guidelines for treatment of coronavirus patients have included chloroquine along with herbal medicines, an HIV drug that was recently shown to be ineffective in hospitalized patient, an influenza drug and other therapies.
“The anti-malarial chloroquine works by a plausible mechanism to block virus entry, but it’s unclear that this would have an effect” in people with coronavirus, said Angela Rasmussen, a virologist at Columbia University.
During the news conference, Trump took the opportunity to tout a different patient access program, one that has been much less successful, called “right to try.” The law was passed in 2018.
“People are living now that had no chance of living,” he said. The legislation allows desperately ill patients to use unapproved drugs after they have passed preliminary safety tests and circumvents the FDA.
But only about eight to 10 patients have used the program because many drug manufacturers are leery about providing unapproved drugs to patients without the FDA’s blessing, said Alison Bateman, House, assistant professor, division of medical ethics at NYU Grossman School of Medicine.