(Photo by GEORGE FREY/AFP via Getty Images)
On Monday, the Federal Drug Administration (FDA) revoked its emergency use authorization for chloroquine and hydroxychloroquine as treatments for COVID-19. The two anti-malaria drugs were touted repeatedly as "game changers" by Trump. Last month, Trump said he had been taking hydroxychloroquine himself as a prophylactic.
Asked about the FDA's decision at the White House, Trump said, "It certainly didn’t hurt me."
In revoking its emergency authorization, which was issued March 28, the FDA said that "based on the totality of scientific evidence available, it is no longer reasonable to believe that CQ [chloroquine] and HCQ [hydroxychloroquine] may be effective in treating COVID-19." Specifically, the FDA said, "it is no longer reasonable to believe that the known and potential benefits" of the two drugs "outweigh the known and potential risks" with using the drugs to treat COVID-19.
At the time of the emergency authorization, there were no controlled clinical studies of chloroquine and hydroxychloroquine in patients with COVID-19. Now, a large clinical study of hydroxychloroquine "is being sponsored by Oxford University in the United Kingdom in collaboration with several foundations and British government agencies." The study sought to determine "the effectiveness of trial treatments in reducing all-cause mortality within 28 days." (The FDA said chloroquine and hydroxychloroquine are very similar and, therefore, it considered data about hydroxychloroquine when considering whether or not to revoke authorization for chloroquine.)
On June 5, the Oxford researchers announced they were ending the portion of the study involving hydroxychloroquine early. Why? People who received the drug were having worse outcomes than people who received standard treatment. Of the 1542 participants in the study that received hydroxychloroquine, 25.7% died. That was higher than the 23.5% mortality rate among 3132 patients that received standard care. The use of hydroxychloroquine also did not shorten the hospital stays of patients who did survive or make it less likely for them to be placed on ventilators. In a few cases, hydroxychloroquine was associated with fatal cardiac events.
The National Institute of Health recently recommended against using hydroxychloroquine or chloroquine to treat COVID-19 outside of a clinical trial. With the FDA's latest action, the use of the drugs to treat COVID-19 outside of a clinical trial is illegal.
For Trump and his allies, the FDA's decision is a political embarrassment.
Fringe medical group touted by Trump campaign sues the FDA
Trump campaign manager Brad Parscale has defended Trump's decision to promote hydroxychloroquine. He relied on the work of the Association of American Physicians and Surgeons (AAPS). It is an official-sounding name but, as Popular Information previously reported, AAPS is "a fringe group that frequently pushes scientifically-discredited views in pursuit of an ideological agenda."
AAPS claimed that hydroxychloroquine was 90% effective in treating COVID-19. This claim was not based on science but on a combination of discredited studies and self-reported observations of doctors, including celebrity physician Dr. Oz.
Previously, AAPS has claimed that HIV might not cause AIDS, Obama tricked Jews into voting for him through hypnosis, and nicotine isn't addictive.
On June 2, AAPS filed suit "against the Food and Drug Administration to end its arbitrary interference with the use of hydroxychloroquine." AAPS General Counsel Andrew Schlafly said that if everyone was allowed to take hydroxychloroquine, there would be no need for any social distancing or restrictions on mass gatherings.
Entrenched, politically biased officials at the FDA should not be allowed to interfere with Americans’ right to access medication donated to the federal government for public use. By preventing Americans’ use of HCQ as a prophylaxis, the FDA is infringing on First Amendment rights to attend religious services or participate in political events such as political conventions, town halls, and rallies in an important election year.
A recent study published in the New England Journal of Medicine found that "hydroxychloroquine did not help prevent people who had been exposed to others with Covid-19 from developing the disease."
Florida's hydroxychloroquine glut
Florida Governor Ron DeSantis (R), always eager to ingratiate himself with Trump, "said in April that the state was getting 1 million doses" of hydroxychloroquine. The announcement was made "during a press conference that came across as a commercial" for the drug as a treatment for COVID-19. DeSantis bragged that he worked with Trump and the Prime Minister of India to import the drugs for the benefit of Floridians.
I spoke to President Trump, and then he spoke to Prime Minister Modi, and Modi has made an exception for the United States. Teva is bringing more of this into the United States, they have sent a second shipment already to a Florida hospital shipped yesterday.
There is just one problem: very few people in Florida want it. As of last Thursday, just "16,100 doses have been shipped to six hospitals." That leaves more than 980,000 doses unused because "few hospitals have requested the drug."
Trump administration sends millions of doses to Brazil
Trump isn't the only international leader touting hydroxychloroquine as a treatment for COVID-19 without evidence. Brazilian President Jair Bolsonaro is also a fan.
“God is Brazilian, the cure is right here! Chloroquine is working everywhere,” Bolsonaro said in March. Bolsonaro then "ordered the armed forces to mass-produce [hydroxychloroquine] in the military’s pharmaceutical laboratory and ordered a large supply of the drug’s ingredients from India."
On May 31, the Trump administration announced, "the United States Government has delivered two million doses of hydroxychloroquine (HCQ) to the people of Brazil." According to the announcement, the drug "will be used as a prophylactic to help defend Brazil’s nurses, doctors, and healthcare professionals against the virus" and "will also be used as a therapeutic to treat Brazilians who become infected."
"Donald J. Trump and President Jair Bolsonaro having spoken twice since March, the two countries are well-positioned to continue their work together to address the coronavirus pandemic," the White House said.
Meanwhile, COVID-19 is ravaging the country. Brazil has 828,000 confirmed cases, trailing only the United States. More than 41,000 Brazilians have died from the virus. Public health experts say "rejection of the emerging scientific consensus on how to fight the pandemic…[is] one of the factors that helped tilt the country into its current health crisis."
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