A few headlines:
Fauci: no evidence anti-malaria drug pushed by Trump works against virus/The Guardian April 6, 2020
Ignoring Expert Opinion, Trump Again Promotes Use of Hydroxychloroquine/New York Times April 5, 2020
Ohio lawmaker says she'll press crimes against humanity charge against Trump over hydroxychloroquine promotion/The Hill April 6, 2020
The above headlines are referencing the April 5 Coronavirus Task Force Press Briefing, during which President Trump and task force members discuss the anti-malaria drug hydroxychloroquine as a possible treatment for coronavirus. Here are the relevant excerpts, with some text underlined for emphasis:
President Trump: We’re just hearing really positive stories, and we’re continuing to collect the data. But I’ll just speak for myself: It’s been out for a long time. It’s a malaria drug. It’s also a drug for lupus. And there’s a — there’s a study out that people with lupus aren’t catching this horrible virus. They’re not — they’re not affected so much by it. Now, maybe that’s correct; maybe it’s false. You’re going to have to check it out.
But there’s a lot of very positive things happening with that. That’s a game changer if that’s the case. … But tremendous promise with — with what’s just been mentioned… Other drugs are also being studied in patients….
Dr. Stephen Hahn (Commissioner of the FDA): …Last week, as the President said, we issued an emergency use authorization to allow the donated hydroxychloroquine to come into the country and enter the general circulation. We are prioritizing this drug to come in for clinical trials, and also into general use for physicians, because as you know, physicians, based upon their interaction with the patients, their assessment of the risks and benefits can write a prescription for hydroxychloroquine if they think it’s appropriate for the patient. Being a physician, we do this all the time. And that assessment needs to be done between a patient and a doctor… We don’t want to provide false hope, but definitely hope. …
Question: Yeah, I mean, if you lupus [sic], do you have... a greater chance of getting coronavirus or —
Dr. Fauci: There is — right now, this is being looked at in a natural history study. We don’t have any definitive information to be able to make any comment that that — it’s an obvious good question, because it might be a way for us to get some interesting and potentially important data as to the role of those medications. But that’s something that is now being looked at, but we don’t have any data to be able to say anything definitively.
President Trump: And I hope they use the hydroxychloroquine, and they can also do it with Z-Pak, subject to your doctor’s approval, and all of that. But I hope they use it because I’ll tell you what: What do you have to lose? In some cases, they’re in bad shape. What do you have to lose? It’s been out there for a long time, and I hope they use it. And they’re going to look at the — with doctors. Work with doctors.
Bottom Line: Trump is not promoting a drug “against expert opinion”. The FDA is already prioritizing hydroxychloroquine for general use. Trump is very hopeful that hydroxychloroquine will be effective against the coronavirus, but he acknowledges studies are ongoing and that the decision to treat coronavirus with hydroxychloroquine is subject to the “doctor’s approval”. Trump’s statements are in sync with what the head of the FDA (a physician) is saying. And Dr. Fauci did not say there is “no evidence” hydroxychloroquine works against coronavirus. He said the evidence is not “definitive”, which it wouldn’t be because the clinical trials are ongoing.
The administration is basically making hydroxychloroquine available for “off-label” use by physicians, defined as “prescribing medications for indications, or using a dosage or dosage form, that have not been approved by the US Food and Drug Administration” (Wittich, Burkle et al, 2012). One could say the evidence supporting off-label use is not “definitive”, because the FDA hasn’t formally approved such use. Yet US physicians write off-label drug prescriptions “all the time”, to use Dr. Hahn’s words. For example, one study:
“…found that 78.9% of children discharged from pediatric hospitals were taking at least 1 off-label medication. …In an intensive care unit, [another study] reported that 36.2% of medication orders were for an off-label use… [In yet another study] off-label use accounted for 47% of prescriptions written” (Wittich, Burkle et al, 2012).
So is it wrong for Trump to encourage doctors to consider the off-label use of hydroxychloroquine to treat coronavirus? Of course not.
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References:
Remarks by President Trump, Vice President Pence, and Members of the Coronavirus Task Force in Press Briefing, April 4, 2020. Transcript, issued on: April 5, 2020. https://www.whitehouse.gov/briefings-statements/remarks-president-trump-vice-president-pence-members-coronavirus-task-force-press-briefing-19/
Wittich, C. M., C. M. Burkle, et al. (2012). "Ten Common Questions (and Their Answers) About Off-label Drug Use." Mayo Clinic Proceedings 87(10): 982-990. DOI: https://doi.org/10.1016/j.mayocp.2012.04.017