New York: The US is partially stopping the use of hydroxychloroquine (HCQ), which President Donald Trump personally obtained from India, and chloroquine (CQ) to treat COVID-19, suspending it in hospital settings but allowing it elsewhere under doctor’s care.
The US Food and Drug Administration (FDA) said on Monday that it was withdrawing the emergency use authorisation (EUA) for treating coronavirus patients in hospitals with the two politically controversial anti-malarial drugs because data showed they “are unlikely to be effective” and had “serious side effects”.
But Health Secretary Alex Azar clarified that the FDA ruling was limited to hospital use with “the most extreme cases” and the medicines have not been completely banned and doctors can continue to prescribe them.
“We continue to study in out-patient settings, as well as preventive. That data is not yet in,” he added.
When Trump was asked about the FDA decision by reporters at the White House, he deferred to Azar, who said: “If a doctor wishes to prescribe it, working with a patient, they may prescribe it for any purpose that they wish to do so.
“They may be used in hospitals, they may be used in outpatient, they may be used at home, all subject to a doctor’s prescription.”
The FDA said the withdrawal of the EUA was “in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks”.
The EUA allows medication to treat an ailment on an emergency basis without a full authorisation for the specific disease for which other medicines are not available.
Even the partial restriction on HCQ use is a political victory for the Democrats who have been opposing it after trump had thrown his weight behind HCQ and had personally taken it for 14 days as a preventive for COVID-19.
House Speaker Nancy Pelosi denounced its use claiming that HCQ “has not been approved by the scientists”, even though the Indian Council of Medical Research (ICMR) National Task Force on COVID-19 has recommended that healthcare workers and others caring for coronavirus patients use HCQ as a preventive.
The FDA’s assertion that data had not shown that HCQ and CQ were effective is at odds with another development that dealt a blow to the credibility of the prestigious medical journal, The Lancet over a study that claimed HCQ was not effective and appeared to increase the risk of death because of doubts about the data used.
The Lancet had to “deeply apologise” and withdraw the much-cited study when experts questioned the reliability of the data used in the study by three Indian origin scientists and another.
Three authors of the study, Mandeep Mehra, Amit Patel and Frank Ruschitzka, conceded: “We can no longer vouch for the veracity of the primary data sources.”
The data came from a company called Surgisphere, whose CEO Sapan Desai was also listed as author of the study.
The World Health Organization that had stopped HCQ clinical trials based on The Lancet study resumed them after it was withdrawn.
Azar said that EUA that was withdrawn applied to CQ made in Pakistan that was donated by the pharmaceutical company Bayer, but did not mention the HCQ obtained from India.
Trump, who has backed the use of HCQ, personally phone Prime Minister Narendra Modi to lift a ban of HCQ exports and allow those ordered by the US before the ban to be released.
After India had decided to send the pre-ordered medicine to the US and also to supply several other countries, a reporter for a mainstream US media stirred a controversy by falsely claiming at a news conference that Modi had banned it as a retaliation for a US ban on the export of medical personal protection gear,Awhich India does not import from the US.
Caught unaware, Trump said he had not heard about it but there could be “retaliation”.
Congress Party leader Rahul Gandhi seized on it to create a controversy in India by claiming that Trump had made a threat and Prime Minister Narendra Modi had succumbed to it, even though the decision on exporting HCQ had been made earlier.
