Hydroxychloroquine: What You Need To Know About The Drug That Trump Keeps Pushing
President Trump claimed he has been taking the malaria medication. Meanwhile, the FDA has warned against taking it outside of clinical trials or hospitals.
At some points during the coronavirus outbreak, hydroxychloroquine has been all Americans hear about. President Trump has touted the anti-malaria drug as a “cure” for the deadly virus at press briefings, to the chagrin of the nation’s leading infectious disease doctor, Anthony Fauci, who has contradicted the President in real time.
Trump even claimed during a May 18 press conference that he's been taking hydroxychloroquine.
"A lot of good things have come out about [hydroxychloroquine], a lot of good things have come out,” he said. “The frontline workers — many, many are taking it. I happen to be taking it ...‘Cause I think it’s good, I’ve heard a lot of good stories.”
Pres. Trump says he is taking hydroxychloroquine to prevent symptoms should he get coronavirus— NowThis (@nowthisnews) May 18, 2020
The FDA issued a warning against using hydroxychloroquine outside of clinical trials or hospitals, citing reports of ‘serious heart rhythm problems’ in patients https://t.co/GQoxquYhww pic.twitter.com/Yz9obNu9ga
Searches for the drug spiked online in early April, and it was promoted in now-deleted tweets from Brazilian president Jair Bolsanaro, among other right-wing figures. A man in Arizona died after ingesting a small amount of chloroquine phosphate used to clean fish tanks, mistaking the similarly named substance as the same drug touted by Trump. On April 21, President Trump was asked at a press briefing about a new study of 368 Veterans Affairs patients with COVID-19 that found “no evidence” the drug works. “We’ll be looking at it,” the President said he had not seen the report. “We’ll have a comment on it.”
As of May 18, there are no proven safe and effective therapies or imminent promising vaccines for the coronavirus, which has infected more than 4.7 million people worldwide and caused more than 90,100 deaths in the United States. For weeks, doctors in various states have been giving hydroxychloroquine – a well-known, longtime drug related to chloroquine that is used to prevent malaria and to treat lupus and rheumatoid arthritis— to COVID-19 patients at various stages of the virus. Doctors in the U.S. can prescribe drugs that haven’t been approved for a specific disease, like COVID-19, in what’s called “off-label prescribing.”
The FDA on April 24 issued a warning against using hydroxychloroquine outside of clinical trials or hospitals.
"The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin," the FDA wrote.
Doctors who spoke with NowThis on background said there are differences in how hospital systems are using the drug, which have varied, from only patients in dire condition to any patient living in a COVID-19 hotspot with a confirmed infection and no contradicting medical conditions. Doctors have become more aware of the dangers or futility of using the drug, especially in combination with the antibiotic azithromycin, commonly known as a Z-pack.
“The world is desperate for medicines for COVID-19,” Dr. Mildred Solomon, a bioethicist and social science researcher at The Hastings Center, told NowThis. “If we grasp at straws, we will squander the chance to learn what works, and we could turn a pandemic into pandemonium.”
So how did hydroxychloroquine become one of the most popular unproven “cures” in the room?
The drug was pedaled by Fox News, electric car and space hype man Elon Musk, and a television doctor. Conservative supporters pushed ads for the drug in tweets and on Facebook. President Trump’s personal lawyer and former New York City mayor Rudy Giuliani became another booster.
That mix of internet-meets-reality-TV publicity didn’t bode well for actual scientific understanding of the drug, one reason why doctors including Fauci have repeatedly called for randomized clinical trials. As Joan Donovan, director of the technology and social change research project at Harvard’s Shorenstein Center, told the Guardian: “When someone who is newsworthy or notable that has an enormous network on social media tweets about something that could be as path-breaking as a medicine that could treat coronavirus, everyone is going to pay attention no matter if that person has expertise or not.”
The President made his first public appraisal of hydroxychloroquine during a coronavirus task force briefing on March 19, and Google searches for the drug spiked around April 7 as his comments continued. Within the following days, patients who use the drug to treat lupus, which affects 1.5 million Americans, reported shortages.
Earlier this year, several studies in countries including China, France, and the U.S. produced mixed results, none of which inspired the National Institute of Health to recommend hydroxychloroquine for COVID-19 — promising lab studies do not often guarantee effectiveness in infected people. As more studies have been published, more questions have been raised about the safety of using the drug.
In March, French researchers published a widely cited study that included treating 26 patients with the drug; one of the French researchers appeared in a Facebook video in February that’s been viewed more than a quarter of a million times. The actual results: twenty of the patients recovered, but at least one died, three went to the intensive care unit, and two quit the study. After the study drummed up plenty of media mentions, the study’s publisher International Society of Antimicrobial Chemotherapy issued a statement weeks later discrediting it.
Researchers have called for randomized control trials, which would be standard and common procedure to minimize bias in understanding the efficacy of a drug. Given the unclear path for COVID-19 treatments, as well as the president’s continued promotion of unproven cures, here are some common questions about hydroxychloroquine.
What does the evidence show about the effectiveness of hydroxychloroquine for COVID-19?
There is no conclusive evidence that any drug can treat or prevent coronavirus. The NIH this week released a panel from doctors and other experts that “recommends against the use of hydroxychloroquine plus azithromycin for the treatment of COVID-19, except in the context of a clinical trial.” While supporters have pointed to anecdotal evidence for hydroxychloroquine’s effectiveness, that material “refers to people’s personal stories about taking the drugs and has no basis in scientific data,” as the Washington Post fact-check team put it. “It’s akin to a Yelp review.”
Scientists have repeatedly said that they need randomized clinical trials to better understand how the drug impacts COVID-19 patients. On that front, the drug company Novartis announced on April 20 that it will conduct a 450-person clinical trial on the drug in which patients will be given three options: hydroxychloroquine, the combination of hydroxychloroquine and the antibiotic azithromycin, or placebo, which science publication STAT calls “the medical gold standard.”
The study of 368 VA patients found a 28% death rate for people who used hydroxychloroquine — higher compared to the 11% death rate for people who didn’t use it. Patients who used hydroxychloroquine with azithromycin had a 22% death rate. The study was not a clinical trial, and public health experts told ABC that “that the fact that it was not randomized or peer-reviewed meant that no firm conclusions could be reached.”
More than 100 studies for the drug are underway for patients with COVID-19, according to a federal register. One doctor at the University of Minnesota told the New York Times that enrollment in his trial, which sought 1,500 participants, is slowing. Of Trump’s messaging on the drug, he said: “If he was promoting science and promoting research, we would have had an answer weeks ago.”
Does Trump have a business interest in promoting hydroxychloroquine?
The New York Times has reported that pharmaceutical companies are expected to profit if hydroxychloroquine becomes an accepted treatment. Those companies include Sanofi, a French drugmaker behind Plaquenil, the brand-name version of hydroxychloroquine — in which Trump reportedly has a small financial stake. But further reporting, analysis and fact-checks have found Trump stands to earn an insignificant amount of money from promoting the drug. Separately, wealthy Republican donors with ties to the President have larger financial investments in hydroxychloroquine drugs.
Are hospital systems already giving the drug to COVID-19 patients, and what should patients consider before taking it?
In hard-hit areas including New York, Louisiana, Massachusetts, and Illinois, doctors have been giving the drug to patients with mixed results. The bioethicist Solomon strongly recommends only using it for the most severe cases, and recommends patients “talk with their health care provider about what the health care system where they’re likely to get care is doing, recognize that there are potential harms and side effects...so far, it makes no sense for people with fairly mild disease.” She added: “It’s only being considered for people with serious complications including pneumonia.” Solomon also advised doctors to carefully record data including dosage level, how sick a person was when they took the medicine, and the different outcomes for people who received the drug versus those who didn’t, including demographic details like race. “It would be irresponsible to use this medicine without carefully documenting critical information so we can learn from it as best we can,” Solomon said.
Is the drug federally approved?
The FDA has approved the drug for lupus, malaria and rheumatoid arthritis. In a recent interview with the Washington Post, FDA commissioner Stephen Hahn said he did not feel pressure to rush an approval of the drug for treating COVID-19 patients, adding that they “use science and data to drive our decisions, always.”
What are the risks of using the drug?
The FDA has listed serious potential adverse effects of the drug including death, inpatient hospitalization or prolongation of existing hospitalization, and a congenital anomaly or birth defect. The NIH has listed potential adverse effects including cardiac problems, hypoglycemia, rash, and nausea; the institute also lists retinopathy or bone marrow suppression, but only with long-term use.
Since the evidence about its potential to treat coronavirus patients are anecdotal, patients including Rita Wilson have spoken about “extreme side effects” from chloroquine, including nausea, muscle weakness, and vertigo.