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Azar, Trump Mislead on FDA’s Hydroxychloroquine Decision

In a meeting at the White House, Health and Human Services Secretary Alex Azar left the misleading impression that the Food and Drug Administration’s decision to revoke its emergency use authorization of hydroxychloroquine and chloroquine for COVID-19 “removes a potential barrier” and makes it easier to access the drugs. The FDA’s action does the opposite.

Following Azar’s lead, President Donald Trump also falsely accused a journalist of asking a “very inaccurately stated question” about the FDA’s emergency use authorization, or EUA, and continued to point to unscientific anecdotal evidence to insist that hydroxychloroquine is effective against COVID-19, despite growing evidence to the contrary.

The FDA announced on June 15 that it had revoked its EUA for hydroxychloroquine and chloroquine because the drugs are “unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” and that the “known and potential benefits” of the drugs “no longer outweigh” the risks — which can include “serious cardiac adverse events and other potential serious side effects.”

The FDA had issued the EUA back in March to allow adult and some adolescent patients hospitalized with COVID-19 to obtain the drugs from the Strategic National Stockpile “when clinical trials are not available, or participation is not feasible.”

But accumulating evidence, including a large randomized controlled trial that the agency cited in its decision, has found that hydroxychloroquine does not help hospitalized COVID-19 patients. Other trials also indicate that the drug does not prevent the disease if given shortly after exposure to the coronavirus.

The political spin began at a June 15 roundtable discussion at the White House when a journalist asked Trump to respond to news of the FDA’s revocation. The reporter paraphrased the agency as saying the drugs were “no longer considered reasonable as a useful treatment for COVID.” 

Trump has misleadingly promoted hydroxychloroquine as a potential “game changer,” despite its health risks and unproven use as a COVID-19 treatment.

Azar said that the reporter’s question was not “quite accurate” because the FDA’s finding only applied to hospitalized patients. He then proceeded to suggest that revoking the EUA was a good thing because it removes a “significant misunderstanding” that the drug could only be used in a hospital setting.

The secretary stressed that the drug can still be prescribed for off-label use to treat COVID-19, saying the FDA’s decision “actually removes a potential barrier to that.”

Azar, June 15: At this point, hydroxychloroquine and chloroquine are just like any other approved drug in the United States. They may be used in hospital, they may be used in out-patient, they may be used at home — all subject to a doctor’s prescription. In fact, the FDA’s removal of the emergency use authorization takes away what had been a significant misunderstanding by many that had made people think that somehow it could only be used in a hospital setting. And we’ve tried to make that clear throughout.

It’s a drug. It’s approved in the United States. Has been for decades. If a doctor wishes to prescribe it, working with a patient, they may prescribe it for any purpose that they wish to do so.  And this actually removes a potential barrier to that.

Trump: So it actually un-complicates it —

Azar: It does.

Trump: — in a way. And I think that’s probably — your question was a very inaccurately stated question.

Reporter: No, I didn’t mean to — I didn’t mean to pose it inaccurately. I believe what it said specifically was that it’s no longer reasonable to consider it an appropriate treatment.

Azar: Only in the hospital. It said the data in the hospital setting was not supported. We continue to study in outpatient settings, as well as preventive. That data is not yet in.

While it’s true that the FDA’s decision only pertains to hospitalized patients, the reporter’s phrasing is very similar to that used in the agency’s own revocation letter.

“FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks,” wrote FDA Chief Scientist Denise M. Hinton.

Rachel Sachs, a Washington University in St. Louis law professor, told us in a phone interview that the “reasonable” language, which both the reporter and the FDA used, is part of the statute governing how the FDA can issue EUAs. 

“One of the things that the FDA has to find when it grants an EUA is that it’s reasonable to believe that the drug in question is effective for the treatment of the condition,” she said. “And so what the FDA is saying now is that based on the weight of the evidence, it’s no longer reasonable to believe that hydroxychloroquine is effective for the treatment of COVID.”

In the letter, the agency toggles between statements that are specific to hospitalized patients and others that are more general. For instance, the FDA says that upon a second review of the in vitro studies that first suggested chloroquine and hydroxychloroquine might have an ability to combat the coronavirus, it now believes the suggested doses “are unlikely to produce an antiviral effect.”

It also notes that the earlier studies that found the drugs might decrease the amount of virus patients shed “have not been consistently replicated,” and that a randomized controlled trial that more rigorously tested the idea found no difference between the proportion of those taking hydroxychloroquine and those getting the standard of care in testing negative for the virus.

That’s in addition to national guidelines that now do not recommend the use of hydroxychloroquine or chloroquine in hospitalized COVID-19 patients outside of a clinical trial, including the National Institutes of Health guidelines, which recommend against the use of the drugs outside of a trial.

Several experts expressed bafflement that Azar — and then Trump — would object to the reporter’s question.

“That’s exactly what the FDA said,” said Dr. Neil Schluger, a pulmonologist and critical care specialist at Columbia University who has studied hydroxychloroquine for the treatment of COVID-19. “Azar’s being very misleading in that statement.”

“I thought the reporter’s question was perfect,” said Holly Fernandez Lynch, a professor of medical ethics at the University of Pennsylvania with expertise in FDA regulation. “If Azar was doing his job as a public health official, he wouldn’t have chided the reporter for how he asked the question.”

FDA Decision Doesn’t Remove ‘Potential Barrier’

Perhaps more critically, experts balked at Azar’s suggestion that removing the EUA was lifting a “potential barrier” on hydroxychloroquine’s use, when in fact, the move reduces access to the drug by eliminating the option of getting it from the national stockpile.

“He’s somehow implying that the EUA made people think you could only use this to treat COVID-19 for hospitalized patients, and now that they’ve removed the EUA, you could use it to treat COVID patients anywhere,” Schluger said of hydroxychloroquine in a phone interview. “It’s exactly the opposite of that.”

Azar is correct to say that because chloroquine and hydroxychloroquine are FDA-approved to treat other conditions, including malaria — and in the case of hydroxychloroquine, rheumatoid diseases — they can be prescribed to COVID-19 patients in what’s called off-label prescribing. 

But that has always been true. The EUA never changed that, and the revocation also does not change that.

“The EUA had no impact on whether physicians could prescribe the drug off-label, whether patients could receive it off-label,” said Sachs. “It just made it easier for hospital-based providers to obtain the drug from the stockpile and to administer it to their patients.”

It’s useful to consider exactly what the initial EUA did in the first place. As Fernandez Lynch explained, the goal was to provide a supply of chloroquine and hydroxychloroquine from the national stockpile, based on the limited evidence at the time that the drugs might work against the coronavirus.

While chloroquine and hydroxychloroquine are drugs that can be prescribed off-label, the specific chloroquine tablets donated to the stockpile were not actually FDA-approved for any use. On top of that, interstate commerce laws prevent distribution of drugs for unapproved uses, which meant that both drugs could not be legally dispensed from the national stockpile for COVID-19.

To make that distribution legal, the FDA needed to issue an EUA, which the agency decided to limit to hospitalized patients outside of clinical trials.

Azar’s argument appears to be that that specification confused people, leading some to think that the drug more broadly could only be prescribed to hospitalized patients — and that by revoking the entire EUA, that restriction was lifted.

But Sachs said that line of thinking doesn’t hold water.

“I certainly have no evidence to support the claim that people believed hydroxychloroquine was only available in the hospital setting, and that now a barrier to its use was removed,” she said. “Sec. Azar’s framing sounds like what the FDA is doing is opening up hydroxychloroquine for broader use. But that’s actually not what’s going on — they’re actually restricting one avenue for its use by withdrawing the EUA.”

Fernandez Lynch agreed, saying it was misleading for Azar to characterize the EUA revocation as a kind of easing on hydroxychloroquine.

“What they did was take away the EUA because the evidence no longer supported the EUA,” she said in a phone interview, adding that it was irresponsible as a public health official not to relay the information that led the FDA to change its mind. “Instead he went ahead and emphasized, do whatever you want under off-label prescribing — we’re going to leave this up to you.”

Contrary to Azar’s suggestion that the FDA was making it easier to get chloroquine and hydroxychloroquine for COVID-19 outpatients, the agency already came forward in late April to caution against the use of both drugs outside of hospitals or a clinical trial.

Misleading Research Summaries 

During the roundtable, Azar and Trump also gave misleading or incomplete descriptions of the evidence to date about hydroxychloroquine and COVID-19.

As he has done in the past, the president — who has claimed to have taken hydroxychloroquine to prevent COVID-19 — said he has heard “some great reports” about the drugs and suggested without evidence that the hospitalized patients who received hydroxychloroquine were going to die anyway. 

Trump, June 15: The only place we don’t get necessarily reports are coming out of Alex’s agency or wherever they come from. I don’t understand that, Alex. What is it exactly? Because I have heard — I’ve had so many people that were so thrilled with the results from hydroxy. So, what is that exactly?

Azar: Well, at your direction, we continue to study, especially in earlier phase — so a lot of the data that has come out that was more negative was people who were quite ill in the hospital.

Trump: People that were, like, seriously ill. Like, they weren’t going to make it. “Let’s give them a little hydroxy.” And then they don’t make it. And they say, “Oh, wow, maybe the president was wrong.” All I know is that we’ve had some tremendous reports. I’ve had a lot of people tell me that they think it saved their lives.

As Schluger previously told us, the majority of patients in several hydroxychloroquine studies survived, so it’s not the case that hydroxychloroquine has only been given to deathly ill patients.

It is true, however, that nearly all of the studies have been done in hospitalized patients. 

This includes a large randomized controlled trial in the U.K. called RECOVERY that the FDA cited in its EUA revocation decision. Although the full results have not been published, the trial reported on June 5 that hydroxychloroquine did not reduce the risk of death and also did not shorten the hospital stay or offer beneficial effects on other outcomes.

According to a June 5 press release, 25.7% of the 1,542 hospitalized patients who received hydroxychloroquine died after 28 days, whereas 23.5% of the 3,132 patients who were given usual care died — a difference that was not statistically significant.

The press release concluded that the results “convincingly rule out any meaningful mortality benefit of hydroxychloroquine in patients hospitalised with COVID-19.”

From that data, plus other smaller randomized controlled trials and other rigorously performed observational studies, which we have previously reviewed, it does not appear hydroxychloroquine offers any benefit to hospitalized COVID-19 patients.

“The science is pretty straightforward on this,” said Schluger. “The data tell a pretty consistent story.”

On June 17, the World Health Organization announced that given the initial findings from its own trial, the results of the RECOVERY trial and a review of the evidence, it was suspending the hydroxychloroquine arm of its Solidarity trial, which also was evaluating the drug in hospitalized patients.

What is less clear — and where Trump and Azar may have a point — is that these results don’t necessarily rule out that hydroxychloroquine might still have some effect in milder cases or for COVID-19 prevention.

Some scientists do think it’s plausible that hydroxychloroquine could still work in these instances — even if there isn’t yet any evidence that it does. 

As Nicholas White, a professor of tropical medicine at the University of Oxford’s Centre for Tropical Medicine and Global Health and Mahidol University in Thailand, told us in an email, it’s “[m]uch easier to prevent infections growing in the body” than to get “rid of them once they have grown.”

He is helping to run a multinational randomized controlled trial with upwards of 40,000 participants to test whether chloroquine or hydroxychloroquine can prevent COVID-19 — and is concerned that some governmental decisions, including the FDA’s memo, might make it harder to complete the trials that are necessary to definitively say whether the drugs work or not.

The WHO, notably, also cautioned that its suspension decision should not apply to trials testing hydroxychloroquine’s ability to prevent COVID-19 either before or after exposure, or what is called pre- and post-exposure prophylaxis.

Still, Azar didn’t give the whole story when he said that the “data is not yet in” regarding the use of hydroxychloroquine to treat people outside of the hospital or for COVID-19 prevention. While many of these trials are in the works, at least one has reported results — and it, too, failed to identify an effect.

The University of Minnesota published the first post-exposure prophylaxis randomized controlled trial of hydroxychloroquine for COVID-19 in the New England Journal of Medicine on June 3. In the double-blind trial, more than 800 volunteers were randomized to receive hydroxychloroquine or a placebo within four days of exposure to someone with confirmed COVID-19. Nearly 12% of hydroxychloroquine participants developed a COVID-19-like illness compared with 14.3% of those getting the placebo — a difference that was not significant.

Some scientists argue that more data is needed. They have critiqued the study because it did not confirm COVID-19 infection in the vast majority of people who were exposed and went on to develop the disease — an unavoidable problem, given the lack of testing availability at the time. Others, meanwhile, have found the results largely convincing. 

Schluger called it a “pretty good study,” adding, “it’s a pretty big study — 821 patients — a randomized trial, so that’s a very high standard of evidence.”

Science magazine reported on June 9 that another post-exposure prevention trial, run out of Barcelona, Spain, did not pick up a protective effect of hydroxychloroquine. The trial included more than 2,300 people who were exposed to the coronavirus and found there was no significant difference among those who received hydroxychloroquine versus the standard care in developing COVID-19. The study’s lead investigator told Science that the results had been submitted for publication.

University of Minnesota infectious disease specialist Dr. David Boulware, who led the first published prophylaxis trial, said no studies have reported results yet for pre-exposure prophylaxis. Those studies typically involve high-risk health care workers and have been slower to enroll volunteers.

But he said the results of his university’s trial of hydroxychloroquine in outpatients had been reported to the FDA.

“Investigators from the University of Minnesota conducted a nationwide randomized clinical trial testing hydroxychloroquine for early outpatient treatment of COVID-19,” he said in an email, adding that the drug was given within four days of the start of COVID-19 symptoms. “The trial’s final results were shared with FDA on June 11, 2020 as well as with NIH, and the manuscript is presently undergoing scientific peer-review.”

“There are no positive data supporting hydroxychloroquine having a clinical benefit in humans with coronavirus,” said Boulware in response to Azar’s claim that a lot of the “more negative” data was in very ill hospitalized patients. “The FDA is fully aware of what data do exist for earlier phase treatment.”

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