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“The nice part is it’s been around for a long time,” the US president said of anti-malaria treatment hydroxychloroquine in March. “So, we know that if things don’t go as planned, it’s not going to kill anybody.”
New evidence suggests it may be doing just that.
Data from clinical trials, academic research and scientific analysis suggests using the drug to treat Covid-19 may significantly increase the risk of death for certain people.
A study of Veterans Affairs patients hospitalised with the new illness found no benefit and higher death rates among those taking hydroxychloroquine, researchers have said.
More than 27 per cent of patients treated died, compared with an 11.4 per cent death rate in those not treated with the drugs, the Washington Post reports.
Now, drug safety experts are calling for the treatment's use to be entirely halted until more is understood about it.
“They should say, ‘We know there are harms, and until we know the benefits, let’s hold off’,” Joseph Ross, a professor of medicine and public health at Yale University, told the Post.
Another expert, Luciana Borio – who has previously served as director for medical and biodefense preparedness of the National Security Council – was just as succinct in her assessment: “I’m surprised it hasn’t been revoked yet,” she said.
The new calls come in the same week a former top vaccine official gave testimony alleging the White House pressured the Food and Drug Administration to quickly sign off on the untested drug in a flailing bid to tackle covid-19.
Rick Bright, former director of the Biomedical Advanced Research and Development Authority, told Congress on Thursday political pressure forced “dozens of federal scientists” to rush produce a protocol for approving hydroxychloroquine for widespread use.
Although in the end the FDA issued emergency authorisation for use in hospital patients only, Mr Bright said there were still major “potential risks” because there were so many unknowns.
Following the testimony, the FDA said it is continuing to evaluate use of hydroxychloroquine.
“In general, the FDA may revise or revoke an EUA under certain circumstances, including information related to linked or suspected adverse events, newly emerging data that may contribute to revision of the FDA’s initial conclusion that a product may be effective against the particular threat or a material change in the risk/benefit assessment based on evolving understanding of the disease or condition,” a statement said.
Some 86,000 people have died after being diagnosed with coronavirus in the US.