Trump calls drug a potential ‘game-changer’ for coronavirus, but FDA says it needs study

The commissioner of the Food and Drug Administration said Thursday that the agency is considering testing an old anti-malarial pill called chloroquine on a broader pool of coronavirus patients, as President Donald Trump pushes the federal bureaucracy to cut red tape and move faster to find ways of combating the virus.

At a briefing Thursday, Trump 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 whether they can have a positive 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 the novel coronavirus. It has long been approved to prevent and treat malaria as well as to treat arthritis, and doctors have authority to prescribe it now, but there is not enough evidence of definite efficacy against the coronavirus.

FDA Commissioner Stephen 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. 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 leading 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.

Trump said that he spoke with New York Gov. Andrew M. Cuomo (D) on Wednesday night and that Cuomo was eager to have chloroquine made available to New Yorkers sickened by the novel 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, which said it discovered the drug in 1934, announced it is donating 3 million doses to the U.S. government. Although about a dozen generic and brand manufacturers have different versions of the drug approved in the United States, according to the FDA website, Bayer is not among them. The company says it is seeking an emergency authorization from the agency so the drug can be given to U.S. patients.

The drug costs as little as 30 cents a pill at retail Canadian pharmacies, according to the website PharmacyChecker.com. 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 website Drugs.com.

The FDA said in a statement later Thursday that, with interest rising in chloroquine, which is already approved not only for malaria but also for lupus and rheumatoid arthritis, it is working with manufacturers to ramp up production to prevent shortages.

“If clinical data suggests this product may be promising in treating COVID-19, we know there will be increased demand for it,” said Hahn. “We will take all steps to ensure chloroquine remains available for patients who take it to treat severe and life-threatening illnesses such as lupus.”

Chinese government guidelines for treating coronavirus patients have included chloroquine along with herbal medicines, an HIV drug that was recently shown to be ineffective in hospitalized patients, 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.

Nevan Krogan, a senior investigator at the Gladstone Institutes research foundation who is focusing on finding already approved drugs that could be rapidly repurposed to fight the coronavirus, said physicians need better data.

Krogan has been overwhelmed by public interest in anticipation of a study he plans to publish by the end of the week that will show whether 10 already approved drugs worked against the coronavirus in laboratory tests.

“I’d love to see the data” on chloroquine, Krogan said. “I’ve been bombarded with hundreds of emails saying ‘I took this and it cured me.’ It’s just so much nonsense that is out there—with a rumor mill, you’ve got to be so careful.”

U.S. officials have said a vaccine for the coronavirus is at least one year away from approval.

One experimental treatment drug that has been called the most promising by the World Health Organization is remdesivir, which was invented by Gilead Sciences.

Remdesivir has been shown to be effective against viral infections in laboratories and in animal experiments, but it failed in an Ebola trial in humans last year. It is being tested in coronavirus patients in China, the United States and elsewhere.

During the coronavirus crisis, the FDA has approved the use of remdesivir for about 250 seriously ill patients under an emergency provision of the agency’s “compassionate use” program, according to the agency. That program, formally called “expanded access,” allows the use of new, unapproved drugs outside clinical trials when no other treatments are available.

Outcomes data on the patients are reported to the agency for use in its regular review of the drug. Under the program, which has been streamlined in recent years, the FDA approves almost all the requests it receives.

But 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, an assistant professor in the division of medical ethics at New York University’s Grossman School of Medicine.

“There’s no incentive for drug companies to use it,” she added. “Their ultimate goal is to bring drugs to market, and to cut FDA out” isn’t in the companies’ interest.

Not every avenue of drug trials against the coronavirus is being pursued by the Trump administration. The administration’s restrictions on research using human fetal tissue have prevented a senior scientist at a government biomedical research laboratory from conducting his research, The Washington Post reported Wednesday.