The debate over the use of anti-malaria drug hydroxychloroquine as a possible prevention method or treatment for COVID-19 was reignited Monday after President Donald Trump said he's been taking the drug for about a week and a half.
Scientists, journalists and politicians were quick to criticize the president, pointing out the drug's ineffectiveness against the coronavirus in a few recent studies and long list of potentially dangerous side effects.
Multiple government agencies have warned against the improper use of hydroxychloroquine outside a hospital or clinical trial setting, yet the president has been touting the drug since early April often relying on anecdotal evidence for his arguments.
"You'd be surprised about how many people are taking it, especially the frontline workers, before you catch it," Trump said.
So what have we learned about hydroxychloroquine since it was first mentioned during the pandemic weeks ago? Here's everything you need to know.
What is hydroxychloroquine? What is it used for?
Hydroxychloroquine is an arthritis medicine that can also be used as a prevention or treatment of malaria, a red blood cell infection transmitted by a mosquito bite, according to the Mayo Clinic. It’s available in the U.S. under prescription only.
In addition to malaria, the drug can also be used to treat acute and chronic rheumatoid arthritis, discoid lupus erythematosus and systemic lupus erythematosus.
The Johns Hopkins Lupus Centersaid it can help control lupus by decreasing the immune system’s activity without predisposing it to infection. It can also protect against UV light and sometimes even improve skin lesions that don't respond to ointments.
Hydroxychloroquine can be administered either as a pill or by intravenous drip and is marketed under the brand name Plaquenil.
What are the side effects of taking it?
Another reason why experts are cautious about using hydroxychloroquine to treat COVID-19 is because of its numerous side effects.
"It may also be worth noting that there are over 40 side effects associated with hydroxychloroquine dosage. These include dry cough, hoarseness, fever, difficulty breathing and increased incidence of cardiac arrhythmia," said John Scott, chair of the department of pharmacology at the University of Washington School of Medicine.
The long list of common side effects of Plaquenil (hydroxychloroquine) include nausea, vomiting, stomach pain or cramps, loss of appetite, weight loss, diarrhea, dizziness, spinning sensation, headache, ringing in your ears, nervousness, irritability, skin rash, itching or hair loss.
The Mayo Clinic urges patients to contact their doctor if they experience any serious side effects, such as muscle weakness, twitching, uncontrolled movement, loss of balance or coordination, blurred vision, light sensitivity, seeing halos around lights, pale skin, easy bruising or bleeding, confusion, unusual thoughts or behavior, or seizures.
Can hydroxychloroquine prevent or treat the coronavirus?
Two recent observational studies of COVID-19 patients suggested the drug has little impact in treating the disease. The studies, while not the same as a clinical trial, suggested that the drug did not significantly reduce complications from the virus or death.
A study posted on April 23 involving 368 patients with confirmed cases of COVID-19 treated at Veterans Health Administration medical centers found there were more deaths among those given hydroxychloroquine than those receiving standard care. In addition, the drug made no difference in the need for ventilators.
The U.S. National Institutes of Health launched a large clinical trial of hydroxychloroquine given in conjunction with the antibiotic azithromycin last week. It is among multiple studies underway to see if the drug can help decrease hospitalization and death from coronavirus.
In a statement on the N.I.H. website about the study, Dr. Anthony Fauci noted that while where was anecdotal evidence that the drugs might benefit some people, "we need solid data from a large randomized, controlled clinical trial to determine whether this experimental treatment is safe and can improve clinical outcomes."
Doctors, including Fauci, have said it's impossible to know if hydroxychloroquine or chloroquine – another drug the president has pushed – is effective or safe to treat COVID-19.
A Brazilian double-blind research study published in mid-April found chloroquine to be so dangerous at high doses the trial was shut down after six days.
The study of 81 patients found one-quarter of those taking the anti-malaria medication developed potentially deadly changes in the electrical system regulating their heartbeats. While a small and imperfect study, it highlighted the compelling need for more rigorous data.
The University of Minnesotais also in the midst of a large study of whether the drug can be used prophylactically, but it will not be completed until August.
"There is no data that pre-exposure prophylaxis is effective in prevention COVID-19. The study we're conducting should help us answer the question," said Mahmoud Al-Kofahi, a professor of experimental and clinical pharmacology at the University of Minnesota.
Can I take it? Can my doctor prescribe it?
It is not available over the counter at drug stores and must be prescribed by a doctor. Because it is FDA-approved for malaria and other conditions, physicians are legally free to prescribe it in any manner they want "off-label," meaning not for the reason listed on the drug's label.
The FDA explicitly warned consumers not to buy it from online pharmacies without a prescription from a health care professional.
"Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19," the FDA warned. Both can cause abnormal heart rhythms and a dangerously rapid heart rate, the statement said.
Why is Trump taking it?
The drug first came to public attention after several small, anecdotal, non-peer reviewed reports about hydroxychloroquine in China in February. None were up to the scientific gold standard of a double-blind, randomized, placebo-controlled trial that would definitively show the drug worked or not.
Trump first spoke about hydroxychloroquine given together with the antibiotic azithromycin on March 19. He went on to tout them numerous times in various media and public events.
On April 13 he announced his administration had deployed roughly 29 million doses of hydroxychloroquine from the National Stockpile. "Just recently, a friend of mine told me he got better because of the use of that, that drug," he said in a briefing.
Since late April, Trump had toned down his support of the drug, but during a roundtable discussion with restaurant executives at the White House on Monday said he's been taking the drug.
"I happen to be taking it," Trump said. "I hope to not be able to take it soon, you know, because I hope that they come up with some answer. But I think people should be allowed to."
Trump, who said he has tested negative for COVID-19, said he has been taking the drug daily for about a week and a half as an added measure to avoid getting the coronavirus. He said the White House physician "didn't recommend" hydroxychloroquine but offered it to him.
The news comes after two people in the White House, who would have been in close contact with him, tested positive for COVID-19. One was a valet to the president, the other is Vice President Mike Pence's press secretary, Katie Miller.
Trump told reporters that along with taking the drug, he is being tested for COVID-19 every couple of days. The president also said he is taking zinc and took an initial dose of the antibiotic azithromycin.
What coronavirus treatment options is the US considering?
As experts race to find a treatment for COVID-19, the experimental drug remdesivir is reportedly showing some promise. Data from a global study released at the end of April found patients given the drug recovered faster and may be less likely to die.
The study, conducted by the U.S. National Institute of Allergy and Infectious Diseases, found patients who received remdesivir had a 31% faster recovery time than those who received a placebo.
While not a "knock out," Fauci said at an Oval Office meeting the study results were "a very important proof of concept."
Remdesivir is an experimental antiviral drug from the American biotech firm Gilead Sciences, Inc. It was originally tested as a treatment for Ebola and other coronaviruses including SARS and is now being tested as a possible COVID-19 treatment. According to Scott, the drug impairs the ability of the virus to replicate.
“You’re decreasing the degree of infection so the immune system can fight. It’s like taking fuel away from the fire,” he said.
However, many scientists caution against drawing any conclusions about remdesivir. In fact, another study published the same day in the British medical journal The Lancet found no clinical benefits to the drug.
Early data from a Chinese study was prematurely posted then removed from a World Health Organization website. It did not appear to show any difference in outcomes between patients who got the drug and patients who didn’t.
Another study that has not yet been peer-reviewed found patients on a 10-day remdesivir treatment plan and a five-day treatment plan showed "similar improvement," Gilead said.
A study published April 10 in the New England Journal of Medicine found the majority of people who got the drug improved, but there was no control group.
Medical news site STAT reported early and incomplete results from a remdesivir study being conducted in Chicago. The University of Chicago issued a statement saying that “drawing any conclusions at this point is premature and scientifically unsound.”
Remdesivir is one of several drugs touted recently as possible coronavirus treatments.
Convalescent plasma and immunomodulators like tocilizumab have been given to patients with COVID-19 in clinical trials, but remdesivir is the only treatment that has been shown to have even a potential effect on the disease.
Contributing: Savannah Behrmann, N’dea Yancey-Bragg,Courtney Subramanian and John Fritze, USA TODAY. Follow Adrianna Rodriguez and Elizabeth Weise on Twitter: @AdriannaUSAT @eweise