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Covid-19: six million doses of hydroxychloroquine donated to US despite lack of evidence

BMJ 2020; 368 doi: (Published 23 March 2020) Cite this as: BMJ 2020;368:m1166

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  1. Elisabeth Mahase
  1. The BMJ

Drug company Teva has said that it will donate more than six million doses of hydroxychloroquine sulfate tablets to hospitals across the US, to “meet the urgent demand for the medicine as an investigational target to treat covid-19.”

The company said that the drug—which is currently used to treat malaria and rheumatoid arthritis—had been requested by “US government officials to be made available for use immediately.”

Discussing the drug at a televised press conference, president Donald Trump said that it had shown “very, very encouraging early results” and incorrectly suggested that the Food and Drug Administration (FDA) had already approved it for the treatment of covid-19. The FDA has since made clear that this is not the case and that there are “no FDA-approved therapeutics or drugs to treat, cure, or prevent covid-19.”

Responding to the news, experts warned that the effect of the drug against covid-19 was “unproven” and that it was “irresponsible of the administration to not express the uncertainty around this drug.”

Speaking on the 19 March, Trump said, “The nice thing is that it’s been around for a long time, so we know that if things do not go as planned, it’s not going to kill anybody.” He said, “It’s shown very, very encouraging early results, and we’re going to be able to make that drug available almost immediately. And that is where the FDA has been so great, it’s gone through the approval process, and it has been approved.”

Hydroxychloroquine sulfate tablets are only approved by FDA for the treatment of malaria, lupus erythematosus, and rheumatoid arthritis. FDA commissioner Steven Hahn, said, “[Hydroxychloroquine] is a drug that the president has directed us to take a closer look at . . . to see if it benefits patients. 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.”

Teva said that it would ship six million tablets through wholesalers to hospitals by 31 March, and more than 10 million within a month. But concerns have been raised about the lack of evidence for this drug in the treatment of covid-19 and the potential for this move to do more harm than good.

Co-ordinating editor of the Cochrane Infectious Diseases Group, Paul Garner—from the Liverpool School of Tropical Medicine—told The BMJ, “There is absolutely no evidence that chloroquine is effective in people infected with coronavirus. The claims that this drug is an effective cure is fake news.

“It should not be given outside the context of a randomised controlled trial. This is a new infection: chloroquine could even do harm. We have to have the trials to assess this. It is irresponsible of the administration to not express the uncertainty around this drug.”

Garner said that announcing this drug as a cure could also “do harm and result in more people becoming infected, as they see the disease as less of a threat and ignore actions that could prevent its spread.”

Meanwhile, Trudie Lang, director of the Global Health Network, Nuffield department of medicine, University of Oxford, said, “Donald Trump’s comment on making chloroquine available was unhelpful because we do not yet know if it works, and using it unproven in this setting could actually slow our ability to answer that question as it would be outside of a research framework, where we can compare different drugs and answer this critical question as quickly, accurately, ethically, and safely as possible.”

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