President Donald Trump touted two drugs — including one currently on the market for other uses — that he said show “really good promise” as therapies to COVID-19. But he left the misleading impression that the drugs were “approved” to treat the coronavirus and available for “immediate delivery.”
In fact, neither of the drugs the president highlighted at a press conference on March 19 have been approved by the Food and Drug Administration for use as therapy for COVID-19, though the FDA is moving forward rapidly with clinical trials.
The FDA is “looking at drugs that are already approved for other indications,” and that doctors can currently prescribe off-label. The FDA plans to study the results of those drugs in hopes that they can be offered as “bridge” therapies as they await completion of clinical trials for a vaccine, which may take a year, FDA Commissioner Dr. Stephen Hahn said.
“We need to make sure that these — this sea of new treatments will get the right drug to the right patient at the right dosage at the right time,” Hahn said, speaking just after Trump. “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 a press release, Hahn said that while some of the therapies being investigated show “promise,” the FDA “also must ensure these products are effective; otherwise we risk treating patients with a product that might not work when they could have pursued other, more appropriate, treatments.”
Trump first mentioned chloroquine, an old drug used to prevent and treat malaria, as well as to treat rheumatoid arthritis and lupus.
Trump said it has shown “very, very encouraging early results” for use in people who have contracted the novel coronavirus. An article published in February in Nature found that the drug limited infection of the virus in cells grown in the lab, and the authors recommended it be assessed in human patients. It is currently being tested in clinical trials in China, where it is included in government guidelines for treating coronavirus patients.
Trump noted that because it has been around for a long time, its side effects are well known “so we know that … if things don’t go as planned, it’s not going to kill anybody.” The president described the drug as “a tremendous breakthrough” and a potential “game-changer.”
But he got a bit ahead of himself on the process.
“And we’re going to be able to make that drug available almost immediately,” Trump said. “And that’s where the FDA has been so great. They’ve gone through the approval process; it’s been approved. And they took it down from many, many months to immediate. So we’re going to be able to make that drug available by prescription.”
“There’s tremendous promise. And normally the FDA would take a long time to approve something like that, and it’s — it was approved very, very quickly and it’s now approved, by prescription,” Trump said.
To be clear, chloroquine is not approved by the FDA for use on people with the coronavirus.
Hahn said chloroquine is approved “for the treatment of malaria as well as an arthritis condition.” The FDA is considering an “expanded use” trial of patients in the U.S. “to actually see if that benefits patients. And again, we want to do that in the setting of a clinical trial — a large, pragmatic clinical trial — to actually gather that information and answer the question that needs to be answered and — asked and answered.”
According to an FDA press release issued after the press conference, “The FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug chloroquine, which is already approved for treating malaria, lupus and rheumatoid arthritis, to determine whether it can be used to treat patients with mild-to-moderate COVID-19 to potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease. Studies are underway to determine the efficacy in using chloroquine to treat COVID-19.”
Hahn declined to speculate how long it might take before chloroquine — provided everything goes well in the clinical trials and the drug is deemed “safe and effective” — might be approved for use for COVID-19.
“We want to make sure that this is done well and right for the American people,” Hahn said. “The president is right. With an off-the-shelf drug, we do have a lot of information about the side effects of the drug. So that really helps, in terms of expediting. But — but I want to assure you that we’re working as quickly as we can. I don’t want to speculate about a timeline at this point.”
In the meantime, if the drug show promise, the FDA says it will “engage with domestic manufacturers to ramp up production of this product to mitigate any potential supply chain pressures.”
As for remdesivir, Trump misleadingly said “that drug also has been approved or very close to approved, in that case, by the FDA.”
That drug has only been approved for a clinical trial, not for consumer use.
On Feb. 25, the National Institutes of Health announced that it had begun a clinical trial “to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19)” at the University of Nebraska.
The trial participants will be randomly assigned without their knowledge either remdesivir or a placebo.
“It was previously tested in humans with Ebola virus disease and has shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses,” NIH said.
As the president said, remdesivir was developed by Gilead Sciences Inc. Daniel O’Day, chairman and CEO of Gilead Sciences, said at a March 2 White House meeting that the company hopes to know by April if the drug works.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said that — if all goes right — the drug could be ready for mass production by June.
“[I]f the trial that Daniel is talking about proves efficacy, which you likely might know in a few months whether it’s … effective or not,” Fauci said. “If you know by June that it’s effective, then you just scale up and manufacture it, and you’re good to go.”