US Strategic National Stockpile now has 66 million hydroxychloroquine pills that cannot be used for coronavirus
pharmafile | June 18, 2020 | News story | Business Services | COVID-19, chloroquine, coronavirus, hydroxychloroquine
The US is now sitting on a pile of 66 million anti-malaria pills, hydroxychloroquine and chloroquine, after they were removed from emergency approval by the FDA.
The FDA had originally approved both drugs for use in coronavirus patients on 28 March, and it was rushed to the former epicenter of the virus: New York. On 15 June, the FDA removed this emergency approval due to concerns over the health risks of using it in coronavirus patients taking it as well as the lack of proof these drugs are actually effective.
But due to the Trump administration pushing forward with acquiring this drug, as the President believed it was a “game changer” in fighting the pandemic, they now have millions of excess doses of the drug. Despite the government distributing 31 million tablets of hydroxychloroquine, 63 million tablets remain while another 3 million donated by Bayer have not been distributed.
The FDA’s withdrawal of the drug’s approval angered the White House, with Peter Navarro, Trump’s trade adviser, saying: “This is a Deep State blindside by bureaucrats who hate the administration they work for more than they’re concerned about saving American lives.” Trump himself said on the drug: “I took it and I felt good about taking it. I don’t know if it had an impact, but it certainly didn’t hurt me.”
The initial evidence that pointed to hydroxychloroquine working as a coronavirus treatment came from France, with Professor Didier Raoult’s study of 36 people. Raoult said he cured 100% of the patients but left out that six dropped out after the first six days and they either died, were transferred to the ICU or couldn’t tolerate the drug.
A study in Brazil was called off after it suffered 11 fatalities while another Chinese study showed that hydroxychloroquine did not speed up recovery from the coronavirus.
The results of another study into the use of hydroxychloroquine in COVID-19 patients has cast further doubts on its effectiveness in treating the virus. The research, titled the “Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19”, was published in The New England Journal of Medicine. The researchers concluded that: “Hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death. Randomized, controlled trials of hydroxychloroquine in patients with Covid-19 are needed.”
Dr Peter Lurie, the President of the Center for Science in the Public Interest, said that the evidence has always been flimsy for the drug’s approval: “It’s quite clear they were strong-armed into it by Navarro himself and others — not excluding radio, television talk show hosts, the president’s pals and some doctor in New York. And now they’ve got mud on their faces because they’ve belatedly come to their senses and done the right thing.”
Dr Bright, the former head of BARDA who was ousted over his pushback to hydroxychloroquine, tweeted: “The drugs should never have been brought into our country and should be destroyed. It took far too long for HHS to revoke this EUA.”
Conor Kavanagh
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