Recently, the US Food and Drug Administration (FDA) authorized the emergency use of hydroxychloroquine and chloroquine for the treatment of the new crown by several former senior officials. Despite the lack of evidence, these two antimalarial drugs vigorously advocated by Trump are being used to treat the new coronavirus in the United States.
According to the report on April 7, local time on the US Science website, a former senior FDA official stated that the emergency use authorization of the two antimalarial drugs is based on weak clinical evidence. It jeopardizes the true value of studying this drug in the treatment of new coronary pneumonia. They also allege that the emergency use authorization of hydroxychloroquine and chloroquine to treat patients with new crowns on March 28 harmed the FDA ’s scientific authority, “because this does not seem to be a response to scientific evidence, but a fanatical propaganda against Trump and other politicians. Response “.
Margaret Hamburg, former FDA Commissioner, told the Science website that she was “surprised and upset” by the emergency authorization . “I understand the desire to find hope, but before encouraging widespread use, we need more evidence than at present.”
Hamberg added that it could have been in a few weeks Valuable clinical trial evidence for these two antimalarial drugs is collected internally, but emergency use authorization may make this difficult. “Providing medicines in a broader way may actually interfere with our ability to obtain the data we need.”
Luciana Borio, former acting chief scientist of the FDA (Luciana Borio) believes that emergency use authorization may be crucial in new epidemics, but only if it is credible.
President Trump has repeatedly publicized the effectiveness of hydroxychloroquine and chloroquine in the treatment of new coronary pneumonia. On March 19, Trump said at the White House news briefing that the antimalarial drug chloroquine showed “very encouraging early effects” in the treatment of new coronary pneumonia. He placed high hopes on chloroquine, “For me, this is a game changer.”
FDA Director Stephen Hahn was cautious about the effect of the drug in the treatment of new coronary pneumonia, saying that he is considering a large-scale clinical trial to test patients with new coronavirus pneumonia Chloroquine.
As clinical trials accelerate, the FDA issued an Emergency Use Authorization (EUA) on March 28 to allow hydroxychloroquine and chloroquine to treat patients with new coronary pneumonia. FDA allows drugs to be divided by doctors when appropriate and when clinical trials are not yet available or feasibleMatch and designate in-patient adolescents and adult patients.
Many experts believe that EUA may hinder the clinical trials of the above antimalarial drugs. Peter Lurie, a former FDA official, said that the EUA has weakened the motivation of volunteers to sign up for clinical trials. “Why do you have to take a 50% chance to get a placebo since you can guarantee the drugs you want? ? “
For the emergency use authorization (EUA) in response to Trump ’s urge, an FDA spokesperson told the Science website that the EUA is not a response to Trang General’s urge. Instead, the spokesperson said that the EUA was written by professionals who consulted relevant federal agencies and was based on “research in China, South Korea and France.”
According to CNN local time report on April 8th, the US Centers for Disease Control and Prevention (CDC) has removed the drugs targeting hydroxychloroquine and chloroquine The guide shortens the introduction of the two drugs, and no longer provides information about the dosage of the drug. Three days ago, the CDC released the key dose information of the new coronary pneumonia drugs chloroquine and hydroxychloroquine, writing, “Although the optimal dose and effective time of hydroxychloroquine for the treatment of new coronary pneumonia are not clear, some clinicians have already prescribed the drug Made a relevant report “. The guide was criticized by medical experts.
Prior to April 4, the White House had heated disagreements about the effectiveness of two antimalarial drugs. Peter Navarro, a senior trade adviser to the White House, said that the studies he had seen (mainly foreign studies) showed that hydroxychloroquine had a “significant therapeutic effect” on new coronary pneumonia. But Anthony Fudge, director of the National Institutes of Health ’s Institute of Allergy and Infectious Diseases, responded on the spot that there was only anecdotal evidence that hydroxychloroquine was effective against the new coronavirus.