FDA contradicts Trump on status of potential coronavirus drug
Donald Trump’s assertion that the Food and Drug Administration had approved an anti-malarial drug to treat patients with coronavirus was undercut by the regulator’s chief, who said the agency was still investigating whether chloroquine should be used to help infected individuals.
Mr Trump said the FDA had expedited approval of chloroquine, during a White House press conference on Thursday. Speaking from the same podium, Steven Hahn, the FDA head, contradicted Mr Trump, saying the president had “directed us to take a closer took” at whether the drug could help people with coronavirus.
“We want to do that in the setting of a . . . large pragmatic clinical trial to actually gather that information and answer the question that needs to be answered,” Mr Hahn said, indicating that the FDA had not granted approval.
The discrepancy between Mr Trump and Mr Hahn was just the latest example of the president heralding some form of progress in the war against the pandemic that had not materialised or had been greatly exaggerated.
At the White House on Thursday, Mr Trump said chloroquine would be available “almost immediately” for people.
“That’s where the FDA has been so great,” Mr Trump said. “They’ve gone through the approval process. It’s been approved.”
Mr Trump said the decision came after “very encouraging early results” and that there were no serious concerns about the drug since it was already being used as an anti-malarial medicine. He added that Andrew Cuomo, the governor of New York, had asked that his state be first in line to receive the drug.
The US president was speaking as the number of confirmed cases in the US has soared to 10,755, with 154 deaths, according to Johns Hopkins University. New York is the worst-hit US state with more than 4,000 cases.
Eric Topol, director of the Scripps Research Translational Institute, said doctors can prescribe drugs that are already on the market “off label” — for different conditions than they were originally approved for — but usually only do so after significant research papers have been written on the issue.
Mr Topol said it was “deeply troubling” to see Mr Trump promote a “false premise” about the drug to the public, when there had been no proper study to shows it worked.
“This is the most troubling thing I’ve seen in the history of biopharma in this country. If you have a president deciding whether a drug should be approved with no clue about interpreting the data,’ Mr Topol said.
“Now you have planted the seeds with family members and patients who will say ‘I need chloroquine to save my life’ and there are no data to show that at all.”
Mr Trump said remdesivir, an antiviral drug developed by Gilead, would also be available soon. But Mr Hahn said it was going through the regulatory process.
Gilead said remdesivir has not been approved anywhere in the world and has not been demonstrated as safe or effective. The spokesperson said a large number of severely ill patients have received the drug for compassionate use. The company is in discussions with regulatory agencies including the FDA to determine how to get the drug approved, if the data are positive.
A small study in France has found that chloroquine accelerated recoveries and reduced how long patients were contagious. The medicine can have serious side effects, including acute poisoning and even death if a patient overdoses. Another formulation of the drug, hydroxychloroquine, has fewer side effects.
“The nice part is it’s been around for a long time,” Mr Trump said about chloroquine. “So we know that if things don’t go as planned, it’s not going to kill anybody.”