Tuesday May 19, 2020
President Trump announced Monday that he is taking the drug hydroxychloroquine as protection against the novel coronavirus, despite the lack of evidence that it prevents individuals from contracting the illness and warnings from physicians that it can have deadly side effects.That timing would put the start of Trump’s drug regimen at roughly the same time as news broke that two White House staffers had tested positive for the virus, and the White House later released a letter from Trump’s in-house doctor that linked his drug regimen to one of those cases.
The president said he began taking the anti-malaria drug about 10 days ago after he told the White House physician he would like to start taking hydroxychloroquine.
“After numerous discussions he and I had for and against the use of hydroxychloroquine we concluded the potential benefit from treatment outweighed the relative risks,” White House physician Sean P. Conley wrote. He said Trump continues to test negative for the virus.
In announcing his decision to take the controversial drug, Trump offered only anecdotal testimonials as evidence that it works in any form as a treatment or preventive for the virus that has killed nearly 90,000 Americans and devastated the economy.Clinical trials, academic research and scientific analysis indicate that the danger of the drug is a significantly increased risk of death for certain patients, particularly those with heart problems.
“I think it’s good. I’ve heard a lot of good stories. And if it’s not good, I’ll tell you right. I’m not going to get hurt by it,” he told reporters at the White House, noting it has long been approved to treat malaria, rheumatoid arthritis and lupus. “It’s been around for 40 years.”
The Food and Drug Administration, in a safety alert issued April 24, warned that it had received reports that hydroxychloroquine and chloroquine could have serious side effects and that the drug should be taken under the close supervision of a doctor in a hospital setting or a clinical trial.
Trump’s decision to take the drug is the latest example of him following his impulses rather than the advice of doctors and public health experts during the pandemic. He has eschewed the recommendations of the Centers for Disease Control and Prevention to wear a face covering when social distancing is not possible. He also has questioned the benefits of widespread testing, which public health officials have called the key to mitigating the outbreak and allowing for the safe reopening of the economy.
But Trump’s support of hydroxychloroquine has perhaps been the area where he has most clearly rejected the advice of the health profession, including his own officials, while making clear he believes more in the anecdotal reports he has received from friends and supporters.
“Here we go, you ready? Here’s my evidence. I get a lot of positive calls about it,” Trump said Monday. “The only negative I’ve heard was the study where they gave it — was it the VA with, you know, people that aren’t big Trump fans gave it.”
In late April, researchers posted an analysis of the medical records of 368 male patients at Veterans Affairs hospitals nationwide and found that the rates of death in those treated with hydroxychloroquine alone or in combination with the antibiotic azithromycin were higher than in those who did not receive the drugs. While the results were from a retrospective look at outcomes rather than a randomized clinical trial, they provided some of the most detailed information available about the use of the medications on covid-19 patients.
The study found 27 percent of patients who received hydroxychloroquine died and 22 percent of those treated with the combination therapy died. That compares with 11.4 percent for those who did not receive either drug.
There is only scant evidence that hydroxychloroquine can be useful in treating covid-19, the disease caused by the virus. Humans have no natural immunity and there is not yet a vaccine, so much hope has been placed on an effective treatment to lessen symptoms and save lives.
One drug, remdesivir, has shown some early promise, and Trump has welcomed its potential use outside a clinical trial. But he has never entirely dropped his promotion of hydroxychloroquine, which has backers among Trump intimates including his personal attorney, former New York mayor Rudolph W. Giuliani.
Trump recently told a group of visitors to the Oval Office that he speaks with a number of private doctors in New York regularly about the virus and treatments, said a person who heard the comments and who spoke on the condition of anonymity to discuss the conversation.
He told reporters that he’s “had so many letters” from people who support the use of the drug.
“I want the people of this nation to feel good,” Trump said. “I don’t want them being sick. And there’s a very good chance that this has an impact, especially early on.”
Trump added that he’s taking zinc in addition to hydroxychloroquine, “and all I can tell you is, so far, I seem to be okay.”
In an interview on CNN Monday night, House Speaker Nancy Pelosi (D-Calif.) criticized Trump’s decision to use hydroxychloroquine.
“He’s our president, and I would rather he not be taking something that has not been approved by the scientists,” Pelosi said, adding that Trump should be especially careful given his “age group” and his “weight group,” which she described as “morbidly obese.”
Trump’s daily pill would be a much higher dose than typically prescribed for malaria. Because hydroxychloroquine hasn’t been studied in valid large-scale research, doctors can’t know the appropriate dose for any covid-19 patient.
The FDA last month warned against its use outside of a hospital setting or a clinical trial, just weeks after it had approved an emergency use authorization for the drug. The April 24 safety alert warned that the agency had received reports that hydroxychloroquine and chloroquine, a related drug, could have serious side effects. Among them: “potentially life-threatening heart rhythm problem,” when used for the prevention or treatment of covid-19, for which the drugs are not approved by the agency.
The FDA said the drugs, when used for covid-19, should be taken under the close supervision of a doctor in a hospital setting or a clinical trial.
The agency acknowledged that since the drug was approved for malaria and other uses, doctors are legally permitted to prescribe it for whatever purpose they choose.
The FDA declined to comment on Trump’s statement Monday.
Trump asserted that many doctors and others on the front lines of the pandemic response are taking hydroxychloroquine as a prophylactic, although he did not provide details to back up the claim.
“You’d be surprised at how many people are taking it, especially the front-line workers before you catch it,” he said.
Prescriptions for hydroxychloroquine and chloroquine surged in late March in states that had become covid-19 hot spots, as health-care workers and other Americans who heard Trump’s praise for the drug sought it out for themselves.
Among the many trials taking place involving hydroxychloroquine is a major prevention study by Duke University researchers. They will determine whether the drug is effective in preventing covid-19 among health-care workers who are exposed to the virus and in limiting the unintentional spread of the virus by people without symptoms.
Eric Topol, a cardiologist who is the director of the Scripps Research Translational Institute, said hydroxychloroquine is “completely without evidence of any benefit and, on the other hand, known risk of serious heart rhythm problems.”
He added: “All risk, no proven benefit, goes against any rational use of the drug.”
Hydroxychloroquine has a number of serious side effects, chief among them its effect on the “QT interval” — the time it takes for the heart’s electrical system to reset between contractions, which push blood into the vascular system and around the body, medical experts say.
“Hydroxychloroquine is a drug that, although it’s been around a long time, has a well-known and very serious adverse effect, namely that it causes electrical changes in the heart that predispose you to a particularly malignant type of arrhythmia that can be lethal,” said Steven Nissen, chief academic officer, at the Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute.
In recent days, enthusiasm about hydroxychloroquine has been boosted by a study, which has yet to be peer-reviewed, out of NYU Langone that looked at the combination of hydroxychloroquine, the antibiotic azithromycin and zinc supplements. It showed that patients who received the three-drug combination vs. the two drug combination of hydroxychloroquine and azythromycin were 44 percent less likely to die than the second group.
That paper has been misinterpreted as showing Trump was correct in his support of hydroxychloroquine as a treatment for covid-19.
Joseph Rahimian, a clinical instructor who specializes in infectious diseases at NYU Langone Health, who was a co-author of the study, said the study’s findings were limited to the possible promise of zinc, not hydroxychloroquine.
“There are many conclusions being made about the study that seem to suggest the article said things differently,” he said. “The article is not a commentary on President Trump’s opinions.”
He said the risk of cardiac abnormalities in people taking hydroxychloroquine — as a prophylactic or a treatment — has been known for a long time, and there are studies launched to try to assess how common they are.
Associates, not doctors, have had the most influence over Trump’s view of hydroxychloroquine.
Giuliani, in a recent interview, was dismissive of the studies done by the federal government. He said his son, Andrew Giuliani, a White House aide, had worked with him to get the drug for a police officer the men know.
Giuliani, among others, has continued to tell the president that the drug is working in New York, particularly for patients who take it early on, and said that others are running a campaign against it not based in facts.
Test results so far have been “silly,” he said, adding that a police officer friend and others in New York have recovered from the illness after taking it. “They don’t know what they’re talking about,” Giuliani, who does not have any medical training, said of doctors warning against using the drug.
“Either they want to come out with that result or misconstrue that information,” he said of government studies, adding he had taken it three times without side effects.
White House officials who requested anonymity to relate internal discussions said economic adviser Peter Navarro has continued to press the drug aggressively. He accused people who oppose it of having “blood on their hands,” in the words of one senior administration official.
On Monday, Trump described letters and calls he said he has received about the drug from doctors, referring several times to one physician from near Westchester, N.Y. He also suggested he knew full well the effect his announcement of his personal use of an unproven drug regimen would have.
“I was just waiting to see your eyes light up when I said this,” Trump told reporters. “When I announced this. Yeah, I’ve taken it for one and a half weeks now. And I’m still here. I’m still here.”