Back to School: How biopharma can reboot drug development. Access exclusive analysis here

Trump administration debate over malaria drugs for COVID-19 illustrates White House conflicts

BioCentury is providing this story for free given the urgent need for information about the COVID-19 crisis. For more analysis, sign up for our daily email.

The debate within the Trump administration over the use of hydroxychloroquine to treat COVID-19, previously reported only through leaks, broke into public view over the weekend and Monday, illustrating the White House’s chaotic decision-making processes.

Peter Navarro, director of the White House Office of Trade and Manufacturing Policy, told CNN television Monday that he strongly supports use of hydroxychloroquine both as a treatment for and prophylactic against COVID-19. “The scientific studies I have seen point to the possibility that it has both therapeutic efficacy as well as possible prophylactic efficacy.”

Navarro, who has no medical training, dismissed caution from Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases. “Doctors disagree about things all the time,” Navarro said.

The International Society of Antimicrobial Chemotherapy (ISAC), which owns the journal that published a study cited by Navarro and other proponents of hydroxychloroquine for COVID-19 has issued a statement of concern about the paper. “The ISAC Board believes the article does not meet the Society’s expected standard, especially relating to the lack of better explanations of the inclusion criteria and the triage of patients to ensure patient safety.”

Speaking to CBS News on Sunday, Fauci said the data about hydroxychloroquine “are really at best suggestive.” He added: “There have been cases that show there may be an effect and there are others to show there is no effect. So I think in terms of science, I don’t think we can definitively say it works.”

Hydroxychloroquine and chloroquine have well-documented toxicities, including causing potentially fatal cardiac events.

Navarro’s public comments, and discussions among senior White House officials that have leaked out, suggest that the President Donald Trump treats expert scientific advice from Fauci as just one of many competing, valid points of view. On Sunday, when reporters asked Fauci for his views about the hydroxychloroquine, Trump prevented Fauci from speaking and again expressed his confidence in the drug.

In contrast to Fauci, FDA Commissioner Stephen Hahn has not urged caution about recommending that the American public and physicians embrace hydroxychloroquine.

Trump and White House officials are communicating directly with Hahn about COVID-19 issues, rather than going through HHS Secretary Alex Azar who would normally serve as an intermediary.

Azar hasn’t been present at recent public White House Coronavirus Task Force briefings, and he hasn’t spoken one-on-on with Trump recently, according to administration sources.

Hahn has rejected suggestions from White House officials that he designate a senior career civil servant to head up the agency’s COVID-19 response.

The idea was to elevate the stature of an FDA non-political scientific expert, in the same way that NIH Director Francis Collins has stepped out of the limelight to allow Fauci to represent the institutes at the White House and in public.

In a move that is widely seen as bowing to pressure from Trump, FDA has issued an Emergency Use Authorization (EUA) for hydroxychloroquine and chloroquine to treat COVID-19, although the agency stated that the data supporting its use is “anecdotal” (see “FDA’s Authorization of Malaria Drugs for COVID-19 Looks Like Political Science”).

The EUA was issued more than a week after Trump incorrectly asserted that FDA had approved hydroxychloroquine and chloroquine for COVID-19.

At a press briefing Sunday, Trump called FDA’s EUA an approval, and said it justifies his belief in hydroxychloroquine. “I’m not a doctor, but I have common sense,” Trump said. “The FDA feels good about it. As you know, they’ve approved it. They gave it a rapid approval. And the reason: because it’s been out there for a long time and they know the side effects and they also know the potential.”

In addition to suggesting that the drug was “sent from heaven” to treat COVID-19 patients, Trump has repeatedly expressed belief in the efficacy of hydroxychloroquine as a prophylactic. Speaking at the White House Coronavirus Task Force briefing on Saturday, Trump asserted that “people that have lupus haven’t been catching this virus” and that COVID-19 is also less prevalent in countries where malaria is endemic.

He added: “I may take it. I’ll have to ask my doctors about that, but I may take it.”

When Trump called Hahn to the podium on Saturday, Hahn said FDA is “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.”

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE