System still using disputed drug
Cautionary advisory by FDA causes one hospital network to stop using it
One of the two major hospital systems in Central Florida is continuing to treat COVID-19 patients with the controversial anti-malarial drug hydroxychloroquine, taking its cue from a cautious advisory by the Food and Drug Administration.
But the other major system has stopped using the drug altogether, after having used it to treat patients in March and April, a decision it made because of a more dire warning from the National Institutes of Health.
The conflicting advisories and warnings from federal agencies don’t stand alone in casting doubt on the effectiveness of what was touted as a potential wonder drug against the coronavirus by President Donald Trump and Florida Gov. Ron DeSantis.
A new study this week echoed what a previous large-scale study had shown: that the drug is mostly ineffective treating COVID-19 and potentially might cause heart problems.
Kena Lewis, a spokeswoman for Orlando Health, said last week the hospital network had treated coronavirus patients with several investigative therapies, including hydroxychloroquine, azithromycin and convalescent plasma.
“We have had several patients do very well after receiving them,” Lewis said, but she added that without randomized trials testing the drug against patients not receiving the drug, it was difficult to pinpoint which drugs had helped and which didn’t.
As of Wednesday, however, Lewis said Orlando Health was following an NIH recommenda
tion in late April to only use it in the setting of clinical trials, and “we are not participating in any clinical trials at this time.”
Meanwhile, AdventHealth spokesman David Breen said the system’s hospitals were continuing to use the drug to treat COVID-19 patients, following FDA guidelines that said it could still be used in a hospital setting.
The FDA issued an advisory in late April saying the drug could cause “serious and potentially life-threatening heart rhythm problems” in COVID-19 patients. The FDA didn’t outright advise it shouldn’t be used, but it did stress that patients should be screened and monitored to reduce the risk.
AdventHealth’s clinical team has seen some positive results from patients, Breen said, “but it’s difficult to make a direct connection to the use of hydroxychloroquine.”
In the Journal of the American Medical Association study published Monday, University at Albany researchers looked at 1,438 coronavirus patients admitted to 25 New York City area hospitals between March 15 and 28.
The death rate for patients taking hydroxychloroquine was statistically insignificant to those who didn’t take the drug. But patients who took hydroxychloroquine, which has a known side effect of irregular or dangerously fast heartbeats, in combination with the antibiotic azithromycin were also more than twice as likely to suffer cardiac arrest.
Those results were similar to a New England Journal of Medicine study published Thursday.
In late March and early April, hydroxychloroquine was touted daily by Trump at White House news conferences and pushed on Fox News and other conservative outlets.
DeSantis went to extraordinary lengths to bring 1 million doses of hydroxychloroquine to the state. In March, DeSantis spoke with David Friedman, the U.S. Ambassador to Israel, about being able to acquire doses of the drug from the Israeli company Teva Pharmaceutical Industries.
Supplies at the time were scarce due to Trump’s vocal advocacy. Hospitals had either started to hoard the drug or run low on supplies.
Numerous lupus patients throughout Florida told the Orlando Sentinel they weren’t able to get the drug, which can prevent severe joint pain and organ failure for lupus and rheumatoid arthritis patients, at their local pharmacies.
While there had only been anecdotal evidence that the drug helped COVID-19 patients recover quicker – including the video testimony of one patient played at a DeSantis news conference – DeSantis said he wanted hospitals to have the drug as an option.
“I’m not a doctor. I’m not telling anyone to take it or not take it,” DeSantis said. “But I believe in the idea of a right to try.”
Both Orlando Health and AdventHealth received doses from the state supply, though only Orlando Health used any of it on COVID-19 patients.
Breen said Adventhealth’s “separately acquired supply has been adequate to meet the need.”
The state, meanwhile, is stressing that the 1 million doses that DeSantis helped divert to Florida were paid for by the individual hospital systems, not taxpayers.
“The State of Florida is not incurring costs, and is simply coordinating requests,” said Jason Mahon, a spokesman for the Division of Emergency Management.
Mahon said any hospitals that requested to receive state-acquired doses had received them by the end of April.
“Hospital systems requested access to this drug,” Mahon said. “… Whether or not hospitals use this treatment or participate in clinical trials is a decision that they make.”
In the meantime, the president has stopped talking about hydroxychloroquine, and so has DeSantis.