Earlier this week, the U.S. Centers for Disease Control and Prevention removed from its website guidance telling doctors how to prescribe and treat COVID-19 patients with hydroxychloroquine and chloroquine, anti-malarial drugs recommended by President Donald Trump and later, Gov. Ron DeSantis, to treat COVID-19. the disease caused by the novel coronavirus.
The guidance originally said: “Although optimal dosing and duration of hydroxychloroquine for treatment of COVID-19 are unknown, some U.S. clinicians have reported anecdotally” on several ways to prescribe the medication of COVID-19, and listed suggested dosages.
As of Tuesday, the website no longer includes dosing information and instead says: “There are no drugs or other therapeutics approved by the U.S. Food and Drug Administration to prevent or treat COVID-19.”
Meanwhile in Florida the demand for the drug from the governor’s office continues to ramp up, while medical professionals are practicing more caution given the scant evidence of the drug’s effectiveness.
At a briefing Tuesday, the same day the CDC walked back guidance on the drug, DeSantis gave it a shout-out. He said he loosened shipments from India to free up supplies in the state, and played testimonials on the drug from Florida doctors and a patient via livestream.
A few weeks prior, Trump praised the pairing of hydroxychloroquine and azithromycin, an antibiotic, saying they “have a real chance to be one of the biggest game changers in the history of medicine.”
He has touted it at several coronavirus task force briefings since, despite hesitation from NIAID Director Anthony Fauci, who warned that making claims is premature without a clinical trial and a randomized study.
Soon after Trump’s initial announcement, the Food and Drug Administration authorized emergency use of the drug for COVID-19 patients who are severely ill and hospitalized. The order also lifted restrictions on the drug’s manufacturer to get more of the medication. The drug is often prescribed for patients with lupus.
“As this thing was first discussed in Washington and the FDA made their decision on it ... I reached out to physicians and just, you know, asked them, ‘Hey, what’s the deal with this?’ ” DeSantis said Tuesday. “We want to obviously give patients all the opportunities toward recovering.”
Israeli-based Teva Pharmaceuticals provided Florida with a shipment of hydroxychloroquine this week, following a shipment sent last month, Politico Florida reported.
Medical community skeptical
Doctors and scientists have expressed some skepticism over use of the drug, especially given the lack of research and testing from the global medical community.
“I usually don’t take medical advice from governors,” said Dr. Dushyantha Jayaweera, a physician and researcher at the University of Miami Health System and the Miller School of Medicine. “We are not under pressure from anybody.”
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Jayaweera, who is beginning his own randomized trial of 15,000 Florida health care workers and first responders in the coming weeks, said while University of Miami physicians are using hydroxychloroquine for what is called “off-label” use in COVID-19 patients, “everything is very fluid” when it comes to how patients respond.
While early studies have shown that the drug does work to reduce viral load in sick patients, the studies aren’t perfect. Patients may be receiving other types of drugs or stem cell treatments that could impact their results.
There are also risks. The potential side effects of hydroxychloroquine were highlighted by the Mayo Clinic last month, and came to light recently after a hospital in France stopped using the drug on at least one coronavirus patient after it became a “major risk” to their cardiac health.
“These are quick and dirty studies ... the general consensus is that we want to have a clinical trial,” Jayaweera said. “In the scientific community, we have to answer the basic questions.”
Because ‘there’s no other option’
Meanwhile, doctors are doing what they can to make sure as many patients as possible survive. Jayaweera said he and others use hydroxychloroquine because “there’s no other option” but that he doesn’t recommend it as a policy.
“When patients are sick you are very nervous to do a randomized control trial [of a drug],” he said. “You give the best thing you can think of for the patient because it’s an emergency.”
On Thursday, the Wall Street Journal reported that Chinese doctors who have been treating coronavirus patients with chloroquine for months say there is no clear evidence the drug is effective against COVID-19.
On a conference call hosted by the Miami Chamber of Commerce Thursday, Department of Emergency Management Director Jared Moskowitz clarified that the state is not making any recommendations when it comes to treating COVID-19 patients.
“We are leaving it up to hospitals and doctors and medical practitioners at the local level to make those decisions,” he said.
Dr. Eneida Roldan, a physician and CEO of the FIU Health Care Network who was also on the call, warned of instances where people have treated themselves with the drug, like an Arizona man who died after officials said they treated themselves with a popular fish tank additive that has the same active ingredient as the anti-malaria drug.
“You need to follow your doctor’s orders, not just going on a website and buying hydroxychloroquine,” she said.
However, she noted the drugs could help patients under the proper care of a doctor.
“There’s still a lot of unknowns, but we know for a fact that patients have done very well under the observation of a doctor,” she said.
The back-and-forth comes as a clinical trial by the National Institutes of Health began Thursday to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with COVID-19 with the first participants now enrolled in Tennessee.
James Kiley, director of the Division of Lung Diseases under the National Institutes of Health, said in a statement that while hydroxychloroquine has showed promise in a lab setting, it’s hard to know its potential efficacy in studies with patients.
“We really need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19,” he said.
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