The drug is also linked to fatal heart arrhythmia.
In April, Dr. Robin Armstrong decided to use the commonly-used malaria drug hydroxychloroquine to treat patients suffering from COVID-19 at a nursing home in Galveston, Texas. After President Trump had called the effects of the drug a "miracle," Armstrong, the medical director at The Resort at Texas City,used it on 39 consenting patients residing at the Galveston facility over the course of five days.
The initial outbreak at the home consisted of 56 patients, according to reports.All of the 39 patients included in the impromptu study had tested positive, but had not yet started showing symptoms, according to the Houston Chronicle. When it was all said and done, three patients had died, Armstrong said, but he called the move a "success story," according to the the paper.
While Armstrong said he can't be certain the drug helped patients survive, he did tell the paper, “It seems like the evidence is at least suggestive that some of that made a difference in the patients that we saw and were able to treat.”
Eleven people have died in total at the Galveston nursing home after the initial COVID-19 outbreak, but it’s not clear how many of those patients were treated with the drug. Armstrong appeared to have stopped talking to the press, as multiple requests for comment by InsideEdition.com went unanswered. Meanwhile, people in nursing homes continue to fall ill as a result of COVID-19. There have been more than 5,600 deaths in nursing-home facilities across 29 states, an investigation by NBC News in mid-April found.
While President Donald Trump has been advocating for hydroxychloroquine, even going as far as saying he is taking the drug himself, emerging studies are telling a much different story about the effectiveness of the drug for coronavirus treatment. The treatment may be questionable, but how we got here isn't.
The initial touting of hydroxychloroquine came after a doctor in Marseille, France said it was a "cure." In March, French microbiologist Didier Raoult, who founded Institut Hospitalo-Universitaire Méditerranée Infection, said he would begin testing anyone who showed up at the hospital, The New York Times reported.
Raoult is an eminent, but controversial research scientist.
The first small trial he conducted included 42 people and Raoult chose who received the placebo and who did not, which is not seen as standard in clinical research, according to Katherine Seley-Radtke, a medicinal chemist. Raoult claimed, however, after the study that he had 100% cure rate. The paper was published in the International Journal of Antimicrobial Agents (IJAA), which is run by the International Society of Antimicrobial Chemotherapy, and they have since released a statement saying, “the article does not meet the Society’s expected standard.”
Another study Raoult did, which was published without peer review and studied 80 patients, had no control group. Raoult doesn't believe a control group is always necessary when conducting research. Armstrong told the paper he’d decided to use the treatment after seeing Raoult’s study.
Seley-Radtke, who works at the University of Maryland, Baltimore County, and specializes in antiviral drug research, including for coronaviruses, said not only does the drug not prove to help patients with the virus, but the potential side effects of hydroxychloroquine can seriously harm them.
Two recent studies out of New York support Seley-Radtke’s claims. The first study was published in the Journal of the American Medical Association by Eli Rosenberg and his colleagues. It examined 1,438 patients diagnosed with the coronavirus in 25 hospital across New York from March 15 to March 28. The patients who took part in the study were given hydroxychloroquine, which is FDA-approved for the treatment of malaria, lupus, and rheumatoid arthritis, alongside the antibiotic azithromycin. The study found that neither treatment, both combined or separate, made a significant difference in “in-hospital mortality.”
The second study, by Joshua Geleris and his colleagues, treated 1,376 patients at New York-Presbyterian Hospital-Columbia University Irving Medical Center with hydroxychloroquine from March 7 to April 8. The study, which was published in the New England Journal of Medicine, found that the death rate of patients hospitalized with COVID-19 was not lower among patients who'd received the drug compared to those who did not.
The study also found the drug can cause deadly cardiac arrhythmias in patients and cited their secondary outcomes as “cardiac arrest and abnormal electrocardiogram findings.” Both studies were observational.
“The problem is we don't have a really good sense of this having any benefit. And in fact, a number of trials around the world have been stopped because of the really serious side effects of this,” Seley-Radtke told InsideEdition.com. “It can cause irregular heartbeat and arrhythmias, and cause people to have a heart attack and die.”
On April 24, the FDA released a statement acknowledging the drug could cause “potentially life-threatening heart rhythm problems," and advised the drug, which they gave Emergency Use Authorization for treatment of COVID-19, should only be used by doctors in a hospital setting or clinical trial.
Since its initial promotion, studies of hydroxychloroquine in places like Brazil have been halted due to the risk of fatal heart attack when using high dosages of the medicine on people with COVID-19.
Using the drug to treat coronavirus also means less of it is available to those who actually need it, Seley-Radtke said.
“These people who really need this medicine, can't get it,” she said. “Their supply has either run out or is running out. I know this because I've been contacted by several people who have rheumatoid arthritis and they are very concerned about their medicine because they haven't been able to get it.”
Despite the controversial nature of the decision to use the drug and studies suggesting its ineffectiveness, Trump has continued to support it. On Monday, Trump said, “I get a lot of tremendously positive news on the hydroxy and I say, hey, you know the expression I've used ... what do you have to lose?”
Trump also added he’d been taking the medicine “every day” for more than a week and that he is “still here.” It’s not clear why he is taking the drug as he has said he doesn’t have the coronavirus and hydroxychloroquine has no proven preventative benefits.
“The decision to take any drug is ultimately a decision between a patient and their doctor,” FDA Commissioner Dr. Stephen Hahn said in a statement to CNBC. “Hydroxychloroquine and chloroquine are already FDA-approved for treating malaria, lupus, and rheumatoid arthritis.”
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