Trump Doubles Down on Off-label Malaria Drug
After touting a drug last week (see story) as already approved for treating coronavirus, president Trump has doubled down in promoting the malaria drug chloroquine for immediate use. During a 3/19 White House press briefing, Trump confusingly said that chloroquine was approved and available for use. “Normally the FDA would take a long time to approve something like that, ... and it was approved very, very quickly and it’s now approved by prescription,” adding that the drug could be a “game changer, or maybe not.”
After the briefing, FDA walked back the president’s remarks to clarify that the drug was not approved for coronavirus use. FDA commissioner Stephen Hahn had earlier said that the agency was looking at repurposing older drugs to treat or prevent coronavirus and that he believed chloroquine needs a large pragmatic clinical trial to collect data to support the expanded use.
On 3/21, Trump Tweeted that the combination of chloroquine and azithromycin has a “real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains — Thank You!” Trump said he hoped that they both will be put in use immediately, adding that “people are dying, and move fast” while tagging FDA, Hahn and other government agencies.
During a later press briefing that day, the president announced that New York was being shipped 10,000 doses of chloroquine. “We’re going to find out,” the president said. “I feel — look, I feel, as the expression goes, ‘What do we have to lose?’ Because, you know, I feel very — I feel very good about it... So we’re going to be delivering a lot of samples to New York and other places, and we’re going to find out very shortly whether or not it’s going to work.”
Vice president Mike Pence told reporters that Trump’s tweet was just reiterating the “hopefulness that he feels about this... If someone’s doctor believes that it’s appropriate, the doctor would be able to prescribe that medicine, even though that’s not indicated. That’s called an off-label use.” Pence noted that one state is collecting data on chloroquine’s use under a clinical trial “so we could study it and determine the viability of it.”
Following Pence’s remarks, National Institute of Allergy and Infectious Diseases director Anthony Fauci did not call into question the president “talking about hope for people.” Allowing off-label use in dire situations when no treatment is currently available is not unreasonable, Fauci said. As a scientist, Fauci said he prefers to see data from a well-controlled trial. “Those two things are really not incompatible, when you think about that, particularly when you’re in an arena where you don’t have anything that’s proven,” he explained. “We went through the same sort of thing with a little bit of a different twist during the HIV/AIDS epidemic until we finally developed drugs that were absolutely knockout drugs that were safe and that were effective. But in the beginning, there was that tension about that. So you really got to have a balance.”
On 3/23, Trump again promoted the drug on Twitter: “A great early result from a drug that will start tomorrow in New York and other places! The post included a link to a New York Post article about a Florida man who said he was recently on his death bed with the virus and after taking the malaria drug his symptoms have gone away. “To me, there was no doubt in mind that I wouldn’t make it until morning,” said the man. “So to me, the drug saved my life.”
Meanwhile, Fauci 3/22 told the Scientist about his workings with Trump while a member of the government’s coronavirus taskforce. Fauci said he recently voiced his objection to “appropriate people” about Trump blaming China for not telling the U.S. sooner about the virus, according to the interview. “The next time they sit down with him and talk about what he’s going to say, they will say, ‘By the way, Mr. President, be careful about this and don't say that.’ But I can't jump in front of the microphone and push him down. OK, he said it. Let's try and get it corrected for the next time.”
Asked whether during the press conferences if he disagrees with some of the statements made by Trump, Fauci said: “Well, I don't disagree in the substance. It is expressed in a way that I would not express it, because it could lead to some misunderstanding about what the facts are about a given subject.”
Asked how he was managing to not get fired, Fauci answered: “Well, that's pretty interesting because to his [Trump’s] credit, even though we disagree on some things, he listens. He goes his own way. He has his own style. But on substantive issues, he does listen to what I say.” At a 3/20 press conference, Fauci covered his face with his hand after Trump referred to the “deep State Department,” [a popular conspiracy theory]. The face cover even became an internet meme. Fauci was asked if he was criticized for the action, to which he responded “no comment.”