When Wendy Lanski tested positive for COVID-19 in March, her doctors did what many physicians recommended. They prescribed her hydroxychloroquine and an antibiotic. Lanski has finally recovered from the disease, but now she’s on a heart monitor for a rapid heart rate that developed soon after she left the hospital.
“I've asked every doctor under the sun—pulmonary cardiologists, internists—is it the COVID or is it the drug? And you know, nobody knows the answer.”
In Lanski’s specific case, she might not ever know what’s behind her recent heart troubles. But for everyone else worried about whether or not it makes sense to risk taking the drug, there’s increasing clarity. A new study from The Lancet of COVID-19 patients who were prescribed hydroxychloroquine shows an increased risk of death and cardiac troubles, and no improvement from the symptoms of COVID-19.
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“I think all evidence points to it being ineffective and likely unsafe,” says Dr. Joseph Ross, a professor of medicine and public health at Yale University.
So what does the study say and how close are we to a final answer on whether hydroxychloroquine is of any use in the fight against the coronavirus pandemic?
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Surviving two national crises: By the time Lanski was formally diagnosed with COVID-19, the results came as little surprise. The phone call notifying her that her test was positive came while she was in the hospital on high flow oxygen after being sent home and later admitted.
Lanski, a 9/11 survivor who had escaped the 29th floor of Tower One in the World Trade Center, now had to survive the second biggest national crisis the country has faced in the past 20 years.
Her doctors prescribed hydroxychloroquine along with an antibiotic. At the time, there was a debate about whether patients should receive a five-day or seven-day course of the drug.
“Our providers were conservative because of the risk factors and they did it for five days,” Lanski says. Throughout the treatment, she received electrocardiogram readings to monitor electrical signals from her heart in order to check for potentially dangerous arrhythmias and heart trouble.
“I was released in the hospital April 5th. I've had ongoing rapid heartbeat since then.”
COVID or chloroquine? It’s not clear whether Lanski’s rapid heartbeat is a result of the COVID-19 or a side effect from her treatment with hydroxychloroquine. She’s since consulted a cardiologist and now wears a heart monitor to check for any signs of trouble.
“It’s high tech, it’s connected to its own cell phone. It does a kind of EKG 24 hours a day. So far— knock on wood—it’s not saying anything profound,” says Lanski.
But rapid heartbeats, arrhythmias, and even more serious cardiac events have been known to occur as a side effect of the drug. In new guidance released after President Trump hyped the anti-malaria drug for use against COVID-19, the FDA has warned that it “can cause abnormal heart rhythms” and “a dangerously rapid heart rate.”
Big data: According to a new study from The Lancet, the FDA’s warning is well justified. The observational study looked back at the outcomes of 96,000 patients hospitalized with COVID-19. About 15 percent of those patients received hydroxychloroquine or chloroquine and those patients tended to do worse than those who hadn’t received the drug. The drugs were “associated with an increased hazard for clinically significant occurrence of ventricular arrhythmias and increased risk of in-hospital death with COVID-19,” according to the authors.
That’s consistent with what some other studies have shown so far. The Department of Veterans Affairs published its own observational study in April which found that those who received hydroxychloroquine were more than twice as likely to die as those who hadn’t.
Proponents of hydroxychloroquine have pushed back against observational studies and argued that data from randomized clinical trials—still forthcoming—is a more suitable basis for evaluating hydroxychloroquine against COVID-19.
“I think you can go pretty far particularly in understanding drug safety” with studies like The Lancet’s observational research, says Dr. Joseph Ross. Ross, a Yale University professor of medicine and public health, works with similar healthcare claims and outcomes databases for his research on evaluating healthcare policies and clinical decision making.
Ross points out that the studies which initially suggested hydroxychloroquine might have a role to play weren’t from that “gold standard” trial design either.
“There were basically a case series of patients who seemed to do better. Those were the things that suggested the benefit of the drug trials and these very large studies I've registered using registry data, hospital data—they are much better for ascertaining safety and effectiveness than a case series.”
Many drugs have known risks and side-effects, but in the absence of any evidence that they’re effective, that risk-benefit calculus changes. And in the case of hydroxychloroquine and COVID-19, Ross says the evidence for a lack of benefit is clear.
“I think the evidence that has come out to date strongly suggests that the drug is ineffective for this purpose and that it is likely harmful, particularly when used in combination with a macrolide [antibiotic] there. There’s no doubt about it.”
What’s next? For Wendy Lanski, the future is what’s on her mind most these days. “I'm trying to be conservative and just say, if I have a problem where there’s something to monitor or there’s a pill I’ve got to take, let’s know now,” she told The Daily Beast. “As I told my doctors, Osama bin Laden didn’t kill me, I don’t want to die from a pill or a virus.”
