For the past two-plus months, Donald Trump has repeatedly touted a malaria drug called hydroxychloroquine as a potential “game changer” in the fight against coronavirus — much to the distress of health officials. While clinical trials into the drug are underway around the world, hydroxychloroquine has not been proven to be an effective coronavirus treatment; in response to Trump’s claims otherwise, the Food and Drug Administration, which has not approved it for coronavirus patients, has had to issue multiple urgent warnings against its unsupervised use. In mid-May, the president sent doctors and experts into yet another tailspin: He said that he, personally, had been taking hydroxychloroquine as a prophylactic.
“I have been taking it for about a week and a half now and I’m still here, I’m still here,” Trump said at a meeting of restaurant executives. “I’ve heard a lot of good stories [about hydroxychloroquine] and if it’s not good, I’ll tell you right I’m not going to get hurt by it.”
What are the implications of taking this drug? Are any of the clinical studies into its use for coronavirus promising? Here’s what we know about hydroxychloroquine:
What is hydroxychloroquine?
Hydroxychloroquine is a prescription medicine that the FDA has approved for the treatment of malaria, as well as autoimmune diseases including lupus and rheumatoid arthritis. It has not been approved for treating or preventing COVID-19. It is also known under the brand name Plaquenil.
So … what exactly is its effect on coronavirus?
While some anecdotal evidence has shown that hydroxychloroquine — and chloroquine, a similar anti-malarial drug — could be effective in warding off COVID-19, there is little conclusive evidence so far. According to the New York Times, clinical trials have shown that the drug is not an effective treatment for infected patients, and two studies into its use as a prophylactic are still underway. Last month, the FDA said that hydroxychloroquine and chloroquine “have not been shown to be safe and effective for treating or preventing COVID-19,” and warned against their use outside of controlled settings.
Researchers’ interest in the drug as a possible treatment for coronavirus isn’t unfounded. Per the Times, one reason medical experts have considered the drug’s use for coronavirus treatment is that the drug suppresses the immune system, which has been shown to go into overdrive in serious cases of COVID-19. Additionally, a study published in February found that chloroquine — again, a drug similar to hydroxychloroquine — was effective at blocking the coronavirus from invading healthy cells and turning them into virus-producing factories. However, as the Times notes, “drugs that conquer viruses in test tubes or petri dishes do not always work in the human body, and studies of hydroxychloroquine have found that it failed to prevent or treat influenza and other viral illnesses.”
Is it safe to take?
If used correctly, the drug appears to be relatively safe for patients who do not have underlying health issues. However, the FDA has strongly cautioned against the use of hydroxychloroquine for coronavirus outside of a hospital or clinical-trial setting, as the drug could cause serious heart problems.
At this point, doctors and experts simply do not yet understand the full scope of the drug’s relationship to the coronavirus — but the published research thus far isn’t all that promising. On May 22, the Lancet published the largest study to date about treating coronavirus patients with hydroxychloroquine and chloroquine. Analyzing the medical records of 96,000 patients hospitalized with COVID-19 across six continents, researchers found that patients who were treated with an antimalarial were more likely to develop a heart arrhythmia, which can lead to cardiac death. In response to the findings, the World Health Organization temporarily halted its study of the drug as a potential COVID-19 treatment; days later, France became the first country to ban hospital doctors from administering hydroxychloroquine to coronavirus patients. However, in the weeks since the study was published, researchers across the country have called its data, ethics, and validity into question, and the WHO announced this week that it would resume its clinical trials.
On June 3, the results from the first controlled clinical trial of hydroxychloroquine were published in The New England Journal of Medicine. Researchers studied 821 people who had been exposed to a coronavirus patient, prescribing half hydroxychloroquine and half a placebo. Their findings: Hydroxychloroquine was not effective at preventing people from getting COVID-19.
“The take-home message for the general public is that if you’re exposed to someone with COVID-19, hydroxychloroquine is not an effective post-exposure, preventive therapy,” the study’s lead author, Dr. David Boulware, told the New York Times.
At the very least, the fervor with which Trump has pushed the drug is dangerous. In late March, a man in Arizona drank fish-tank cleaner containing chloroquine — the similar malaria drug Trump’s also spoken about — in an attempt to preventively self-medicate against the coronavirus, and died. “Trump kept saying it was basically pretty much a cure,” the man’s wife told NBC News. Additionally, as demand for the drug has risen amid Trump’s promotion, some pharmacies and hospitals have suffered shortages, which has negatively impacted those who rely on hydroxychloroquine. One such woman, a 40-year-old woman with lupus and rheumatoid arthritis, told USA Today last month that she has been rationing her pills ever since her pharmacist told her the medicine she has relied on for over a decade is back-ordered.
“When I have that medicine, I can live life normally and don’t have to think about it,” she told the outlet. “Now I have to stop and think before I even pick up my toothbrush to brush my teeth.”
What has Trump said about it?
In mid-March, not long after conservative media and “philosophers” began fixating on the drug, Trump started touting hydroxychloroquine as a potential “game changer” in the fight against coronavirus. Around this time, he falsely claimed that hydroxychloroquine had shown “very, very encouraging early results” (no clinical studies had shown this), and that the FDA had “gone through the approval process” (to this day, the FDA has not approved the drug to treat coronavirus patients). In some instances, Trump promoted taking the drug in combination with azithromycin, an antibiotic that many of us know as a Z-Pack (or Z-Pak). While a French study published in late March suggested that this combination of drugs could be effective at fighting the coronavirus, it has since been discredited.
On May 18, during a meeting with restaurant executives, Trump shocked reporters when he said that he’d started taking hydroxychloroquine after consulting the White House doctor. (In recent weeks, two White House staffers have tested positive for the virus: one of the Trump’s valets and Mike Pence’s spokeswoman.) Trump also claimed that “many, many” front-line workers are taking hydroxychloroquine. While there are a handful of clinical studies where health-care workers have been prescribed the drug to prevent against a coronavirus infection, their use has been supervised. These studies are ongoing, and results aren’t expected until August at the earliest. On May 24, Trump told Full Measure host Sharyl Atkisson that he had “just finished” taking the drugs.
Despite warnings from the FDA and the public-health community at large, Trump’s fixation on the drug has been unwavering. In fact, last week, Richard Bright, a federal agency head who led the government’s efforts to develop a coronavirus vaccine, testified to Congress that he was discharged after urging that hydroxychloroquine be vetted as a coronavirus treatment. The administration, Bright testified, wanted to bypass some parts of this standard process.
What has Trump’s doctor said?
Hours after Trump’s shocking declaration, White House physician Dr. Sean Conley wrote a letter on the subject, saying that Trump is “in good health and remains symptom-free.” Conley continued: “After numerous discussions he and I had regarding the evidence for and against the use of hydroxychloroquine, we concluded the potential benefit from treatment outweighed the relative risks.” However, the letter read as deliberately vague, and did not say one way or another if Trump was actually taking hydroxychloroquine.
On May 20, White House Press Secretary Kayleigh McEnany confirmed that Trump was taking hydroxychloroquine and that Conley had prescribed the dosage.
This post has been updated.