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Hydroxychloroquine Research Is Hampered By Politics, Furor Over The Drug : Shots – Health News – NPR

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Hydroxychloroquine, a drug used to prevent malaria and treat certain autoimmune conditions, is being studied to treat or prevent COVID-19.

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Publicity around the drug hydroxychloroquine spiked this week when President Donald Trump revealed that he’s taking it to prevent COVID-19.

All the attention on the drug in recent months is increasingly spilling into science, and making it harder for some researchers to actually study whether the drug has potential for COVID-19.

Doctors have used hydroxychloroquine for decades to treat auto-immune conditions and to prevent malaria.

While the Food and Drug Administration has given emergency use authorization for doctors to try the treatment on COVID-19 patients, the agency has also cautioned about its possibly deadly side effects.

On Wednesday, the executive director of the World Health Organization’s emergencies program, Dr. Mike Ryan echoed other leading medical experts, saying at a press briefing that hydroxychloroquine and chloroquine have “yet to be found effective in the treatment of COVID-19” or for preventing the disease.

Because of potential side effects, Ryan says the WHO advises the drug “be reserved” for use in the context of clinical trials, which are now underway in many places.

But for some researchers, running such trials is becoming more difficult because of the controversy around the drug.

Missed opportunity

Dr. Jon Giles didn’t expect to have any problems drumming up interest in his clinical trial testing if hydroxychloroquine can help prevent COVID-19.

“We were getting calls all the time from people who were interested,” says Giles, an epidemiologist and rheumatologist at Columbia University.

For his study, Giles planned to give a short course of the medication to people who were “household contacts” of COVID-19 patients. Like many of the ongoing trials, it would be randomized with a control group.

By the end of April, Giles was ready to start enrolling people. But his team ran into a problem when they started calling potential participants.

“Pretty much everybody said, Well that’s the drug that’s dangerous to your heart, or, I talked to my friends and they said don’t take it, or that I saw on TV it’s dangerous,” says Giles.

Just a month earlier, he says demand for the drug was soaring. Some patients with auto-immune conditions couldn’t even get their prescriptions filled, after President Trump spoke enthusiastically about the drug.

In April, the FDA issued a warning about using the drug for COVID-19 patients without strict medical supervision in a hospital or as part of a clinical trial. The agency had received reports of serious heart-related adverse events and death in patients with COVID-19 receiving hydroxychloroquine and chloroquine.

But the back and forth headlines and the ongoing political wrangling seemed to make people wary of the medication, Giles says, even in the context of a carefully run clinical trial.

“It became almost impossible to get anyone interested,” says Giles.

Giles says the committee overseeing his study added a new requirement: that study participants needed to have had an ECG within the last year.

As a rheumatologist, Giles knows the medication better than most doctors because he prescribes it to many of his patients.

“It’s a very, very safe drug, it’s been used for over 75 years,” he says. “When I give someone hydroxychloroquine, I don’t get an ECG or do blood monitoring.”

Giles was planning to enroll otherwise healthy people and screen out anyone who could be at risk of heart problems. But that new requirement, plus the negative press, made it too difficult to find study subjects.

He gave up on doing the study. He says it’s a missed opportunity.

“It’s not unreasonable to think that a short course of this drug might have some protective ability,” he says.

Risks and potential

The concern over cardiac risk for hospitalized patients is real, says Dr. Mark Poznansky, director of the Vaccine and Immunotherapy Center in the Infectious Disease Division of Massachusetts General Hospital. Even though the drug has been used safely to prevent malaria, he says, “that is very different from using the drug in acutely ill patients with COVID-19.”

He recently published a review of the evidence for using hydroxychloroquine to treat COVID-19 that casts doubt on its effectiveness.

“The data up to date … doesn’t make one entirely optimistic that we are going to find something different in a clinical trial,” he says.

Poznansky notes a recent study of nearly 1,400 people with moderate to severe COVID-19 found no benefit and concluded that the drug should not be routinely used on patients.

He says the drug should only be used in the context of clinical trials, “or under strict compassionate use, in order to do no harm.”

Still, Poznansky doesn’t rule out that further well-designed trials could turn up better results.

‘The virus doesn’t care about politics’

At Henry Ford Health System in Detroit, cardiologist Dr. William O’Neill says enrollment for their clinical trial studying hydroxychloroquine to prevent COVID-19 plummeted in late April.

“It really caused a huge problem for us,” O’Neill says. “It set us back probably a month.”

O’Neill attributes the drop in enrollment to the FDA warning and a highly publicized study of over 300 hospitalized veterans with COVID-19. The authors of that study found the drug did not reduce the need for a ventilator and even linked hydroxychloroquine to higher death rates. However, the study wasn’t a rigorous controlled trial and the results weren’t peer reviewed.

“That was interpreted as a warning that the drug is dangerous,” says O’Neill. But he says, using it for prevention is a different matter than treating already sick patients. “Everything that we see about hydroxychloroquine suggests that the earlier you use the drug, the more likely it is to be effective.”

O’Neill says the fact that President Trump is touting this drug means it now has become a political flashpoint.

“It has made people absolutely committed to proving him wrong,” he says.

“The problem with that is this is not politics, this is life and death,” he says. “We’re talking about a treatment. Who would be rooting for us not to find a therapy, for God’s sakes?”

Multiple clinical trials involving hydroxychloroquine are underway at the University of Washington in Seattle. But Dr. Christine Johnston says recruitment has become a major challenge.

“We are hearing now from some participants that the study and the drug feel too political and they just don’t want to participate at all,” says Johnston. “As physicians, we would not do something that we thought was harmful.”

Johnston’s colleague, professor Dr. Ruanne Barnabas, is trying to recruit 2,000 patients to test whether the drug can prevent COVID-19.

“A clinical trial is the only way that we will be able to answer this question quickly and with high confidence,” she says.

Researchers at Duke University are also testing if hydroxychloroquine can be a new tool for prevention during the pandemic. But Duke professor of medicine Dr. Susanna Naggie says they need to be able to recruit enough people.

“I do worry that there are many well controlled trials that are underway where we won’t get an answer,” says Naggie. “That, I think, would be a shame.”

Another researcher conducting large trials, Dr. Wesley Self, says the coverage of hydroxychloroquine has felt a bit like an “emotional roller coaster,” which has led to more questions from patients.

“I actually find it helpful,” says Self, an emergency physician at Vanderbilt University Medical Center. We’re giving people relatively low doses of hydroxychloroquine, which we believe are quite safe. And we’re monitoring for side effects very closely.”

Self is the lead investigator of the ORCHID trial that focuses on hydroxychloroquine in treating hospitalized COVID-19 patients.

“This is a perfect situation for a clinical trial to really understand what the balance of those benefits and risks are,” he says.

Another large clinical trial is looking at whether hydroxychloroquine and the antibiotic azithromycin can keep people with COVID-19 from being hospitalized or dying.

“We think the way that this medication works, it would be better to take it early, rather than later, especially when somebody is really really sick already,” says Dr. Davey Smith, head of Infectious Diseases and Global Public Health at University of California San Diego School of Medicine.

“In reality, the virus doesn’t care about politics and science should also not care about politics,” Smith says. “I just want an answer one way or the other.”

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On Politics: Biden Ventures Out – The New York Times

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Good morning and welcome to On Politics, a daily political analysis of the 2020 elections based on reporting by New York Times journalists.

Sign up here to get On Politics in your inbox every weekday.


  • Joe Biden on Monday made his first (non-virtual) public appearance since he began sheltering in place in March. Appearing alongside his wife, Jill Biden, in matching black masks, he laid a wreath at a Delaware veterans memorial in commemoration of the holiday. “It feels good to be out of my house,” Biden told reporters. “Never forget the sacrifices that these men and women made. Never, ever, forget.” There was no formal ceremony; it was a fittingly understated return to the public eye for a candidate who has been lying low throughout the coronavirus pandemic, reappearing only here and there to give televised interviews. Even still, Biden cut a sharp contrast with President Trump, who appeared mask-less at Memorial Day events at Arlington National Cemetery and Fort McHenry National Monument; the president appeared at Fort McHenry, in Baltimore, in spite of comments from the city’s mayor, Bernard C. Young, urging him to cancel the visit.

  • If Biden’s holiday weekend closed with solemn observances, it started quite a bit differently: with an unruly interview on Friday with Charlamagne Tha God, the talk-show host and hip-hop radio D.J., in which Biden often shouted down his interviewer and finished the conversation with an unforced gaffe. After parrying a series of frank, often confrontational questions, Biden took exception when Charlamagne said he would look forward to asking “more questions” in later interviews. Biden retorted: “If you have a problem figuring out whether you’re for me or Trump, then you ain’t black.” The comments drew an immediate backlash, and Biden apologized later that day, saying, “I shouldn’t have been such a wise guy.”

  • Speaking to MSNBC’s Joy Reid on Sunday, Charlamagne warned that Biden might be taking black voters for granted. “The apology is cool, but the best apology is actually a black agenda,” he said. “On top of possible Russian interference and voter suppression, Dems have to worry about voter depression, and that’s people staying home on Election Day because they just aren’t enthused by the candidate.” But he told my colleague Annie Karni that Trump had no shot at winning over his vote.

  • Trump urged governors on Friday to exempt churches and other places of worship from stay-at-home orders, saying the pandemic shouldn’t keep people stuck at home any longer. “The governors need to do the right thing and allow these very important, essential places of faith to open right now,” he said at a quickly arranged news conference. The issue may soon be decided by the Supreme Court: On Sunday, a Southern California church asked the justices to hear its appeal of a lower court’s decision forcing it to abide by the state’s stay-at-home order. The Democratic governor, Gavin Newsom, is following a multi-step process to return California to normal activity; churches are currently required to remain closed.

  • The president is threatening to take the “N.C.” out of “R.N.C.” (Or, technically speaking, vice versa.) In a series of tweets that drove at the partisan divide over reopening, Trump warned on Monday that Republicans might move their national convention, scheduled for August in Charlotte, N.C. Trump said Roy Cooper, the state’s Democratic governor, was in a “Shutdown mood,” and lamented that Cooper was “unable to guarantee that by August we will be allowed full attendance” at the Spectrum Center. The Democratic National Committee has laid out a series of contingency plans for a scaled-back convention in response to the pandemic, and Republicans are quietly working to do the same, though Trump has not publicly endorsed the idea of a pared-down convention.


Credit…Erin Schaff/The New York Times

Former Vice President Joe Biden, with his wife, Jill Biden, laid a wreath at Veterans Memorial Park at the Delaware Memorial Bridge in New Castle.


The White House sent Congress a nationwide virus testing strategy on Sunday that more or less rejects the idea that a national strategy is needed at all.

The document, which the Trump administration was required to submit by a stimulus bill passed last month, puts into writing two things that the administration had long made clear. First, it remains states’ responsibility to figure out how to acquire and administer tests. Second, the president thinks that enough tests are already available, despite many governors’ and health officials’ statements to the contrary.

Democratic leaders responded on Monday, saying the White House’s report was an attempt to “reject responsibility and dump the burden onto the states,” and accusing Trump of trying to “paint a rosy picture about testing while experts continue to warn the country is far short of what we need.”

Our science and global health reporter Apoorva Mandavilli covered the news, and she agreed to answer a few questions for us, explaining what this report will (and won’t) do to help states address testing shortfalls.

Hi, Apoorva. What exactly does this report signify?

The Trump administration said last month that it considered the states responsible for setting and meeting testing goals and for coming up with an overall testing strategy that works for each state. With this report, it’s making that stance official. It’s telling the states: We’ll support and encourage you, and even provide some supplies, but ultimately this is your responsibility. And that sets up an everyone-for-themselves, “Hunger Games”-style competition between states.

Doesn’t it make sense for each state to identify and manage its own public health needs?

To a certain extent, yes. States have always managed their own public health, but they have traditionally received enormous amounts of guidance and support from the federal government. So they have not had to develop a ton of expertise on their own. This move essentially represents the federal government “walking away from that partnership in the middle of a pandemic,” Dr. Ashish Jha, director of the Harvard Global Health Institute, told me. States also can’t negotiate international supply chains on their own.

What about the testing numbers?

The report also said that by focusing only on people likely to be positive, the country should be able to get by with 300,000 tests a day. There are no epidemiologists I know of who would agree with that. Most models suggest at least a million tests per day, ranging up to as many as 100 million, depending on whether you want to just bring down the number of infections a little or suppress the outbreak entirely.


The fighters of the suffrage movement frequently flouted laws and norms about how women were expected to behave in public in order to achieve the passage of the 19th Amendment.

Today’s public spotlight looks very different. How do modern women in the public eye draw on the lessons of the past to make a better present and future? What barriers have they felt, broken, ignored and challenged? Join us on Tuesday as we search for answers.

Special guests include Representative Debra Haaland of New Mexico and Reshma Saujani, founder and chief executive of Girls Who Code and author of “Brave, Not Perfect.” Hosted by Monica Drake, assistant managing editor of The Times.

On Politics is also available as a newsletter. Sign up here to get it delivered to your inbox.

Is there anything you think we’re missing? Anything you want to see more of? We’d love to hear from you. Email us at onpolitics@nytimes.com.

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As stark 100,000 deaths landmark looms, Trump pursues his political obsessions – CNN

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Yet despite, and perhaps because of, his earlier cavalier attitude, Trump spent the long holiday weekend bemoaning everything but the tragic roll call of death — while also finding time to claim he got “great reviews” for handling the crisis.
In his most politically significant maneuver, he heaped intense pressure on North Carolina’s Democratic governor to permit a normal, crowded Republican National Convention, despite fears such a mass gathering could seed virus hot spots. Trump warned he could pull the huge money-earner out of Charlotte, which was picked to play host in August.
The move came as the President intensified his push for a full reopening of the country and television footage showed packed beaches and boardwalks in some states as Memorial Day crowds fueled fears that social distancing may be breaking down.
North Carolina's Democratic governor is the target of Trump's convention push
On social media, he waged a weekend of Twitter wars against his critics, targeting a favorite foil, Barack Obama, after Trump’s return to the golf course — his 266th such trip in office — sparked calls for him to concentrate more fully on the pandemic.
And he indulged his preoccupations on his tax returns, Hillary Clinton, Fox News, slanders against MSNBC host Joe Scarborough, the Russia investigation, Joe Biden’s mental health, former Attorney General Jeff Sessions, mail-in voting in November and highlighted dangerous and unproven Covid-19 therapies promoted on conservative media he has tested himself.
In between Twitter eruptions, a mask-free Trump solemnly presided over Memorial Day ceremonies at Arlington Cemetery, and tweeted a campaign-style video of himself leading observances.
“For as long as our flag flies in the sky above, the names of these fallen warriors will be woven into its threads,” he said in a moving speech at Fort McHenry.
“For as long as we have citizens willing to follow their example, to carry on their burden, to continue their legacy, then America’s cause will never fail and American freedom will never, ever die.”
Yet the scripted solemnity and unifying patriotism only made Trump’s explosion of fury on Twitter seem even more surreal, and underlined how he finds it impossible to avoid thrusting himself into the social media feeds of Americans even for a weekend. Indeed, Trump returned to criticizing North Carolina Democratic Gov. Roy Cooper not long after returning to the White House Monday afternoon.

A surreal glimpse into a President’s mind

After three years of Trump deliberately trampling the normal codes of presidential behavior — partly to show supporters he remains an anti-elite outsider, none of this is surprising.
But that doesn’t mean it isn’t jarring, as the most wrenching moment so far approaches in the nation’s battle against a pandemic that while ebbing in terms of total deaths is trending up in 18 states, is steady in 22 and easing in 10 more. More than 98,000 people in the US have now died from the coronavirus and more than 1.6 million have been infected. More than 30 million Americans have lost their jobs and the unemployment rate is approaching Great Depression levels.
Some Americans take a holiday from social distancing and officials fear future spikes in coronavirus casesSome Americans take a holiday from social distancing and officials fear future spikes in coronavirus cases
In 50 years, Trump’s weekend Twitter blasts may come across as a startling document of a presidency rooted more than ever in personal obsessions, and incessant wars with the media and his increasing throngs of political enemies.
There was little evidence of a deeper meaning to his presidency at this stage than personal and political grievances. Also missing is a more sweeping policy framework for a potential second Trump term. And other than a relentless push to support an aggressive opening of the country, for instance in a new demand for schools to open, Trump seems far less interested in how the task can be accomplished safely — other than retweeting CDC hand washing advice — than his boiling political feuds.
No White House could have been fully prepared for the disaster and subsequent economic hollowing of this year’s pandemic. But it’s also hard to imagine a previous recent president from either party fighting it with the same campaign of denial, distraction and misinformation.
As an example, the most substantive administration action of the weekend was a report to Congress on the state of the pandemic — which turned over responsibility for a testing and tracing operation that experts say is critical to the states. The report did however include a pledge from the Federal Emergency Management Agency to send out 12.9 million swabs used in coronavirus testing to states in June.

Trump lays down a marker on Republican convention

Trump spent much of Memorial Day, fulminating against Cooper, complaining that the North Carolina governor was “unable to guarantee” the arena for the convention in August can be filled to capacity. The President is determined to deploy the full pageantry of convention season to portray a nation and economy in the full throes of what he calls a “transition to greatness.” His ambitions appear to spring from a similar mindset to his refusal to wear a mask in public to avoid undercutting his narrative of reopening.
The comparison could be striking if the Democrats hold a neutered social distanced convention or put most events online in a way that would deprive presumptive Democratic nominee Joe Biden of his big moment before a big crowd and a primetime TV audience.
Trump's Memorial Day weekend amid pandemic spent golfing, tweeting conspiracies and insultsTrump's Memorial Day weekend amid pandemic spent golfing, tweeting conspiracies and insults
Yet such a spectacle as the Republican convention seems utterly incongruous with real-world events. Sports teams that use such arenas are expecting to play without fans for at least months in a bio-secure environment. The prospect of thousands of delegates pouring into convention cities from all over the country, including coronavirus hotspots, is a huge headache for organizers. After delegates spend hours or days packed together they then could return home to cause new outbreaks.
“Unfortunately, Democrat Governor, @RoyCooperNC is still in Shutdown mood & unable to guarantee that by August we will be allowed full attendance in the Arena,” Trump tweeted Monday.
“In other words, we would be spending millions of dollars building the Arena to a very high standard without even knowing if the Democrat Governor would allow the Republican Party to fully occupy the space.”
Cooper told CNN last week that the convention would be treated like any other event and decisions would be made based on the advice of health officials, data and science.
It was not immediately clear whether Trump and the Republican National Committee are serious about pulling the convention from Charlotte. The chances or organizing such a massive event elsewhere seem slim at this late stage — especially as other major cities and arenas are also dealing with the virus.
But given that the Tar Heel State is a vital battleground in November, Trump may accrue political benefit from a base-stoking campaign against local Democrats.
North Carolina reported its biggest spike in cases on Saturday, though as is the case with each state it is sometimes hard to tell whether such rises represent a worsening epidemic or a rise in testing. It has not been one of the worst affected states, but deaths have been rising again in recent days.

Trump defends golf fix … by slamming Obama

The soap opera nature of Trump’s presidency was also reflected this weekend in his defense of his decision to play golf for the first time since March at his Virginia golf club.
The debate over presidents and their trips to the links has become a tedious ritual that sees partisans adopt positions according to which party is in power.
“Some stories about the fact that in order to get outside and perhaps, even a little exercise, I played golf over the weekend. The Fake & Totally Corrupt News makes it sound like a mortal sin,” Trump tweeted, complaining that Obama flew Air Force One to Hawaii for his annual vacation when he often played golf.
Fact check: Trump has spent far more time at golf clubs than Obama had at same pointFact check: Trump has spent far more time at golf clubs than Obama had at same point
Trump has used federal resources multiple times to fly to his resorts and golf courses. Trump’s two rounds this weekend struck critics as inappropriate during a national crisis and on a weekend when American remembers its war dead.
“Nearly 100,000 lives have been lost, and tens of millions are out of work. Meanwhile, the president spent his day golfing,” Biden wrote in a tweet accompanying an online ad Saturday.
The perennial debate over golf and presidents raises the question whether presidents should put the clubs away and foreswear other hobbies during four or eight years in office, or whether they have a right to enjoy some free time out of the bubble of the White House. President George W. Bush for instance decided not to play golf during much of his presidency fearing poor optics after sending Americans off to war.
Trump may not come under such criticism had he not been so dismissive of Obama’s afternoons on the golf course — and saying he wouldn’t have time to play golf if he was elected president.

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Politics, Security and the Unmasking of Gen. Flynn – Wall Street Journal

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Attorney General William Barr speaks in Washington, March 6.



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nicholas kamm/Agence France-Presse/Getty Images

Kimberley Strassel (“Barr vs. the Beltway,” Potomac Watch, May 15) says that U.S. intelligence agencies were “listening in on Mr. Flynn from the start.” They were listening in on Russian Ambassador Sergey Kislyak when they first heard Gen. Michael Flynn’s voice and were instantly alerted to maneuverings that were going on behind the current administration’s back. Does a national security adviser to the president really need a Miranda warning before talking to the FBI?

President Trump brought in Attorney General William Barr to rearrange the Justice Department to his liking. It’s little wonder that a highly respected judge like Emmet G. Sullivan would bring in Judge John Gleeson to help correct Mr. Barr’s overreaching abuses of justice.

Jim Walters

Iowa City, Iowa

The Michael Flynn case illustrates a disturbing fact about the American criminal justice system. Too often, the government isn’t required to prove its case in court, and instead wins by getting the defendant to plead guilty, often to a single lesser charge. Pleading guilty, even if innocent, may be the only way for a person accused of a crime to avoid a lengthy pretrial detention, a ruinously expensive legal defense and the risk of a much longer prison term if convicted after trial.

James G. Russell

Midlothian, Va.

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