By: New York Times | Published: April 2, 2020 10:59:26 pm On Saturday, the FDA took the unusual step of approving those drugs to treat hospitalized patients with coronavirus on an emergency basis, even though no significant clinical trials have yet been done.
Written by Katie Thomas
An experimental stem cell therapy derived from human placentas will begin early testing in patients with the coronavirus, a New Jersey biotech company said Thursday.
The treatment, being developed by the company Celularity, has not yet been used on any patients with symptoms of COVID-19, but it has caught the attention of Rudy Giuliani, President Donald Trumps personal lawyer. Giuliani recently featured an interview with the company founder on his website and said on Twitter that the product has real potential, while also criticizing the Food and Drug Administration for not moving more quickly to approve potential remedies.
There is no proven treatment for the respiratory disease, but several experimental approaches, including old malaria drugs and HIV antivirals, are being tested in patients around the world.
READ | Video from Japan shows how COVID-19 is getting transmitted through a third route
Celularity has also enthusiastically publicized the news of its early-stage trial for its treatment, known as CYNK-001. In an email Wednesday to a reporter, its public relations firm described a development as the first FDA approval for COVID-19 cell therapy. The agencys decision, however, merely gives a green light for its product to be used in a clinical trial, not widely prescribed to patients.
In recent weeks, the established scientific process of evaluating a drugs safety and effectiveness has been upended by Trump, who has repeatedly promoted the potential of two long-used malaria drugs that have shown mainly anecdotal evidence of helping patients. On Saturday, the FDA took the unusual step of approving those drugs to treat hospitalized patients with coronavirus on an emergency basis, even though no significant clinical trials have yet been done.
The early trial by Celularity which will primarily evaluate safety, as well as an initial look at efficacy will test its therapy in up to 86 patients with symptoms. They will receive infusions of the cell therapy in the hopes it will prevent them from developing the more severe form of the disease, Dr. Robert Hariri, Celularitys founder and chief executive, said in an interview Wednesday.
The objective here is preventative, Hariri said. If the timing of giving this can prevent those patients who have early disease from progressing to the more serious, life-threatening form, it could be a very, very useful tool.
The therapy involves using stem cells from the placenta known as natural killer cells that help protect a developing fetus or newborn from viruses that have infected the mother. Celularity has been testing these cells in cancer patients.
Hariri said the trial, which would not include a placebo control group, will take place at academic medical centers around the country. He said the company expected to see initial results about 30-60 days after the first patients receive their dose. If this study is successful, Hariri said, the company would move to a placebo-controlled study that would evaluate the drugs efficacy against the disease.
At least one outside expert said the approach could present safety risks. Paul Knoepfler, a stem cell researcher at the University of California, Davis, said that patients with coronavirus can develop severe reactions where their immune systems go too far in attacking cells in their lungs, causing damaging inflammation. Other cell therapies tested in China are designed to dampen the immune response. He said one risk with the natural killer cells is they could go in the other direction, exacerbating respiratory problems by massive killing of the patients respiratory cells.
Despite the scant evidence, Giuliani has become an early booster, interviewing Hariri on a podcast published on his website Saturday and praising the treatment on Twitter, saying, this therapy has real potential. In a tweet Saturday, he added, Lets hope FDA can recognize that their cumbersome process designed to keep us safer, if it is not altered dramatically in times of great need, can result in unimaginable loss of human life.
Around the same time, Twitter deleted a post by Giuliani that it said violated its rules. The tweet, from March 27, made unfounded claims about the malaria drug hydroxychloroquine, one of the treatments that Trump has supported.
Hariri said that he has known Giuliani for years and that the appearance on his podcast was a friendly chat between people who know each other and who share a common interest in this particular response to this disease.
He said that he has no business relationship with Giuliani, and that Giuliani is not representing him in any way, either paid or unpaid.
I dont have anything to do with what the mayor tweets or whatnot, and I dont agree or disagree with anything, he said.
Hariri said the company would follow the established process for testing whether a drug works.
We have waited for the FDA to complete their review, which they did in a heroic and quick fashion, he said.
On Wednesday evening the same day the FDA approved his trial Hariri praised the appearance by the agencys commissioner, Dr. Stephen Hahn, on the conservative Fox News talk show The Ingraham Angle.
We are fortunate to have Dr. Hahn at the helm, he tweeted.
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While more affluent parts of Nashville have had testing sites for weeks, this drive-through testing site at Meharry Medical College, in a historically African American neighborhood, experienced weeks of delays because staff couldn't acquire the needed testing supplies and gear like masks and gloves. It finally opened March 30. Ken Morris/Meharry Medical College hide caption
While more affluent parts of Nashville have had testing sites for weeks, this drive-through testing site at Meharry Medical College, in a historically African American neighborhood, experienced weeks of delays because staff couldn't acquire the needed testing supplies and gear like masks and gloves. It finally opened March 30.
The new coronavirus doesn't discriminate. But physicians in public health and on the front lines say that in the response to the pandemic, they can already see the emergence of familiar patterns of racial and economic bias.
In one analysis, it appears doctors may be less likely to refer African Americans for testing when they show up for care with signs of infection.
The bio-tech data firm Rubix Life Sciences, based in Boston, reviewed recent billing information in several states, and found that an African American with symptoms like cough and fever was less likely to be given one of the scarce coronavirus tests.
Delays in diagnosis and treatment can be harmful, especially for racial or ethnic minority groups that have higher rates of certain diseases, such as diabetes, high blood pressure and kidney disease. Those chronic illnesses can lead to more severe cases of COVID-19.
On the campus of Meharry Medical College a historically black institution in Nashville drive-through testing tents sat empty for weeks, because the school couldn't acquire the necessary testing equipment and protective gear like gloves and masks.
"There's no doubt that some institutions have the resources and clout to maybe get these materials faster and easier," says Dr. James Hildreth, president of Meharry and an infectious disease specialist.
His medical school is located in the heart of Nashville, where there were no screening centers until this week.
Most of the testing in the region took place at walk-in clinics managed by Vanderbilt University Medical Center, and those are primarily located in historically white areas like Belle Meade and Brentwood, Tennessee.
Hildreth says he's observed no overt bias on the part of health care workers, and doesn't suspect any.
But he says the distribution of testing sites shows a disparity in access to medical care that has long persisted.
'I pray I'm wrong'
But if anyone should be prioritized, Hildreth says it's minority communities, where people already have more risk factors like diabetes and lung disease.
"We cannot afford to not have the resources to be distributed where they need to be," he says. "Otherwise, the virus will do great harm in some communities and less in others."
In Memphis, a heat map shows where coronavirus testing is taking place. It reveals that most screening is happening in the predominantly white and well-off suburbs, not the majority black, lower-income neighborhoods.
Rev. Earle Fisher has been warning his African American congregation that the response to the pandemic may fall along the city's usual divides.
"I pray I'm wrong," Fisher says. "I think we're about to witness an inequitable distribution of the medical resources too."
Around the nation, concentrated pockets are popping up. In Milwaukee, African Americans made up all of the city's first eight fatalities.
Wisconsin Governor Tony Evers says he wants to know why black communities seem to be hit so hard. "It's a crisis within a crisis," Evers said in a video statement.
The Centers for Disease Control and Prevention is also on the ground on the north side of Milwaukee, as well as several other hot spots, looking into the outbreak in black neighborhoods. Nationwide, it's difficult to know how minority populations are faring because the CDC isn't reporting any data on race.
A few states are releasing more demographic data, but it's incomplete. Virginia is reporting race, yet the state's report is missing that information for two-thirds of confirmed cases.
Dr. Georges Benjamin of the American Public Health Association has been pushing health officials to start monitoring race and income in the response to COVID-19.
"We want people to collect the data in an organized, professional, scientific manner and show who's getting it and who's not getting it," Benjamin says. "Recognize that we very well may see these health inequities."
The subjectivity of symptoms
Until he's convinced otherwise, Benjamin says he assumes the usual disparities are at play.
"Experience has taught all of us that if you're poor, if you're of color, you're going to get services second," he says.
The subjectivity of coronavirus symptoms is what worries Dr. Ebony Hilton the most.
"The person comes in, they're complaining of chest pain, they're complaining of shortness of breath, they have a cough, I can't quantify that," she says.
Hilton is an anesthesiologist at the University of Virginia Medical Center who has been raising concerns.
She sees problems across the board, from the way social media is being used as a primary way of educating the public to how quickly drive-through testing has expanded. The first requires internet connection. The second, a car.
Hilton says the country can't afford to overlook race, even during a swiftly moving pandemic.
"If you don't get a test, if you die, you're not going to be listed as dying from COVID," she says. "You're just going to be dead."
Our furry feline friends appear to be susceptible to catching Covid-19, the disease caused by the coronavirus called SARS-CoV-2. Even worse, the cats in the study were able to infect each other, although they showed no signs of illness.
Ferrets were also able to "catch" the virus, although it didn't appear to harm them. Dogs, on the other hand, were not susceptible, according to the study. The virus showed up in the feces of five dogs, but no infectious virus was found. Pigs, chickens and ducks were also not very hospitable places for the virus.
But there's no need for cat or ferret lovers to panic, experts say. There's no evidence their pets could get very sick or die from the novel coronavirus.
"Yes, people should embrace their pets. These researchers squirted the virus down the cats nose in high concentration, which is pretty artificial," said Dr. John Williams, chief of the division of pediatric infectious diseases at the University of Pittsburgh Medical Center Children's Hospital of Pittsburgh.
No realistic exposure
The lab experiment used a scenario that is completely unrealistic, experts say. First, researchers forced extremely high doses of virus up the nostrils of five 8-month-old domesticated cats.
Cats in our homes or even in the wild would never be exposed to that level of virus.
"That's a whole lot more than an average human would get," said infectious disease expert Dr. William Schaffner, a professor of preventative medicine and infectious disease at Vanderbilt University School of Medicine in Nashville.
"So this is an artificial circumstance and we don't know that it happens in nature at all," Schaffner added.
Two of the five cats were euthanized six days later. Researchers found virus particles in their upper respiratory systems.
The remaining three infected cats were put into a cage adjacent to three non-infected cats. One of those three cats later tested positive for the virus, while the other two did not. Still, the researchers felt that showed the virus could be transmitted via respiratory drops.
Or did it? None of the infected cats exhibited signs of illness. And even if they did pass the virus to each other, that doesn't mean they would be able to pass it on to humans.
That's what happened nearly two decades ago with a sister coronavirus called SARS-CoV, which causes the deadly pneumonia-like respiratory disease called SARS.
Ferrets affected too
The study found ferrets were also "efficient" replicators of the virus -- meaning that the virus can easily grow and reproduce in their long, slinky bodies.
"SARS-CoV-2 can replicate in the upper respiratory tract of ferrets for up to eight days, without causing severe disease or death," the study said. The study did not look at a longer time frame.
That's good news for researchers looking for a way to test any future vaccines for SARS-CoV-2, also called the novel coronavirus.
"It's necessary to have an animal model to do initial tests of vaccines and understand how viruses cause disease. So, this will be useful to the field," Williams said.
"Ferrets are classical animals in which to study influenza -- it's been done for decades," Schaffner said. "If scientists were looking for an animal model, they would reach for the ferrets first."
What this means
Will your cat or ferret come down with coronavirus? Highly unlikely, experts say, pointing to the fact that we would certainly have heard of many cases in pets by now, considering the significant spread of the virus in the US and Europe.
Hong Kong has been quarantining animals belonging to people diagnosed with Covid-19 and have found only two cases of positive results in dogs. The dogs showed no signs of illness during the quarantine.
"Out of an abundance of caution," the AVMA suggests anyone ill with COVID-19 symptoms limit contact at this time, "until more information is known about the virus."
"Have another member of your household take care of walking, feeding, and playing with your pet," the AVMA states. "If you have a service animal or you must care for your pet, then wear a facemask; don't share food, kiss, or hug them; and wash your hands before and after any contact with them."
Would you do us a favor? Would you be willing to describe how the coronavirus is affecting your mental health? Is the combination of isolation and existential stress making you feel more depressed and anxious? Or is the family togetherness and the pause from normal life giving you a greater sense of belonging and equilibrium? How would you describe your psychological state? What are you doing to cope? If youre a mental health worker, what are you seeing out there?
If youre willing to share, please fill out the form at the end of this column. The Times may publish some responses online and Ill write another column reporting on what you say.
I ask for a couple of reasons. This is a moment that calls for deeper conversations and emotional accompaniment. Were all going through something together. Well be more resilient if we can see others experiencing it in the same way.
Also, its hard to get an accurate read on the nations psychological state right now. On the one hand, this has become a wonderful moment of national solidarity. Millions are responding with acts of generosity, finding ways to bring food to elders, hosting virtual cocktail parties. People are checking in with each other. You hear of these 50-person family reunion Zoom calls.
Our national identity is being remade in real time. What had once seemed a bitter and divided society now seems more like a nation of people finding creative ways to show up for one another.
But its also likely that something much darker is going on, especially among the less fortunate. A study by Samantha Brooks of Kings College London finds that quarantine produces a range of bad mental health outcomes, including trauma, confusion and anger.
Theres an invisible current of dread running through the world. It messes with your attention span. I dont know about you, but Im mentally exhausted by 5 p.m. every day, and I think part of the cause is the unconscious stress flowing through us.
Many people are alone, consuming media all day. Others are trapped in homes with abusers and dysfunction. Alcohol and drug use is rising. In France, reported cases of domestic violence are up by about a third.
Tyler Norris of the Well Being Trust points to a curve behind the Covid-19 curve. Every one-percentage-point increase in unemployment leads eventually to a 3.5 percent increase in opioid addiction, so the pandemics economic effects alone will exacerbate our drug and mental health problems down the road.
Psychological health in times of crisis is like a wrestling match. The situation throws stressors at you. The question is whether your coping mechanisms are strong enough to overcome them.
The pandemic spreads an existential feeling of unsafety, which registers in the neurons around your heart, lungs and viscera. It alters your nervous system, changing the way you see and perceive threat.
Its very hard to grasp whats going on so deep inside. All trauma is preverbal, Dr. Bessel van der Kolk writes in his book The Body Keeps the Score. Rational brain is basically impotent to talk the emotional brain out of its own reality.
The best way to combat this visceral sense of fear and disassociation is by having what Bonnie Badenoch, the author of The Heart of Trauma, calls disconfirming experiences. These are experiences of deep reciprocal attunement with others that make you feel viscerally safe.
These moments of attunement and co-regulation register in the same autonomic nervous system and overcome the fear and helplessness.
Creating these experiences takes effort. Being together is not the same as being connected, Columbia professor Martha Welch told me. She recommends that people engage in deep intentional and vulnerable conversations, in which they pause for as long as 90 seconds after something important has been said, just to let it sink in. You have to have the feelings conversation, she says.
She and the other experts I spoke with endorse anything rhythmic. Anything that will create an experience of attunement: singing, dancing, yoga, deep eye contact, daily rituals and games.
I asked the experts whether they thought it was possible to have this sort of deep, visceral attunement over the internet. They thought it was, as long you can see the other persons face and hear vocal tone. The internet is a huge variable in this pandemic, Dr. van der Kolk told me. We have a profound new way to comfort one another.
Anna Freuds famous research found that during World War II the children left in London to endure the bombings suffered less trauma than the children who were sent away from their families to the country for their safety. She determined that the physical injury is often not the harshest part of trauma; its the breakdown of relationships during and after.
Sharing your emotional state with the world is not for everybody, and people who feel fragile should take care. But if you feel like filling out the form below, you may give others somebody to relate to. You might help turn a fractious country into a resilient community.
As the coronavirus spreads across the country, millions of Americans already struggling with health and finances especially those in minority communities could bear the brunt of it.
New data released Tuesday by the Centers for Disease Control and Prevention show that COVID-19 patients with underlying health issues in the United States are more likely to need treatment in a hospital or even in an intensive care unit. They are also at higher risk of dying, according to earlier epidemiological data from both China and the U.S.
Because health and wealth in the U.S. are so often linked, the coronavirus could hit low-income populations here much harder, experts say.
The elderly are the hardest hit by the disease, accounting for about 80% of fatal cases in China and the U.S., according to CDC data.
But studies have also shown that underlying health issues such as asthma, diabetes and heart disease can also make COVID-19 more dangerous, as the disease taxes already-burdened organs.
Whenever there is a disaster, people in low-income groups always tend to be the most impacted.
Pinar Keskinocak, Georgia Institute of Technology
More than a third of American adults 105 million people are at higher risk of serious illness if they get infected with the coronavirus, according to a Kaiser Family Foundation analysis of CDC data. For most of them, their age puts them in danger: More than 76 million Americans are 60 or older. The remaining 29 million people are younger but have underlying health issues.
Age and underlying health issues go hand in hand: COVID-19 has so far been most menacing to older people with underlying illnesses. But the disease has already killed younger Americans for example, a 34-year-old California man who had asthma and a 44-year-old Louisiana woman who had unspecified underlying illnesses.
Weakened already
More than three-quarters of the COVID-19 patients who required ICU treatment in the U.S. had underlying health issues, including heart disease, diabetes and chronic lung conditions, according to the new CDC data on 6,600 cases for which underlying conditions and hospitalization status were reported. Certain underlying conditions were more likely to lead to intensive care in the hospital for instance, of the COVID-19 patients who had underlying heart disease in that same CDC analysis, 21.5% landed in the ICU.
Don't see the graphic above? Click here.
Chinese scientists have also reported that heart disease, nearly as much as age, was a reliable indicator of whether a COVID-19 patient would require advanced medical treatment. And COVID-19 patients with underlying conditions in China were also more likely to die. About 10% of Chinese patients with cardiovascular problems died. For diabetes patients, the results were similar: More than 7% died. That's compared with 0.9% of patients with no underlying illness.
Don't see the graphic above? Click here.
Doctors around the world have also reported that some patients with severe COVID-19 were having heart attacks and other heart complications while hospitalized for the coronavirus, though those reports are still anecdotal.
Other viruses that attack the lungs, such as the flu, also affect the heart, says Dr. R. Scott Stephens, who runs an intensive care unit at Johns Hopkins Hospital in Baltimore. So it makes sense that underlying heart disease would make the coronavirus more dangerous.
"We're thinking about plans for 'How do we screen patients for this? What are interventions that we can use?'" Stephens says. "It's kind of like you're on the beach waiting for the wave to hit. You just don't know when it's going to hit and how big it's going to be."
In the U.S., African Americans are far more likely to have fatal heart conditions than other groups, says Donna Spiegelman, a biostatistician and epidemiologist at the Yale School of Medicine. Researchers worry that this means the U.S. could end up with noticeable disparities in who dies from the coronavirus.
In 2017, the latest year for which data are available, African Americans died from heart disease at a rate of 208 per 100,000, while whites died at a rate of 169 per 100,000. Other racial and ethnic groups' rates were even lower.
"I would expect there would be racial and ethnic disparities simply based on the disease burden that is already present," says Leonard Friedman, a professor of health policy and management at George Washington University.
Don't see the graphic above? Click here.
The coronavirus could also exacerbate regional disparities, as heart disease takes a greater toll on some areas of the country than others. The map above shows that Appalachia, rural northwest Mississippi and eastern Michigan, including Detroit, are among areas with high percentages of Medicare recipients hospitalized for heart disease.
Low-income health struggles
In the U.S., people who struggle financially often struggle to stay healthy. The coronavirus could attack their lives at all angles, experts say: They are more likely to have underlying health issues, putting them at higher risk of serious complications and death. They are more likely to have jobs that do not allow them to work from home, increasing their likelihood of being exposed to the virus. And they are more likely to be underinsured, potentially keeping them from seeking treatment until it's too late.
"You start with those underlying conditions, and then each layer of this is just going to magnify that further," says Jon Zelner, a University of Michigan epidemiologist. "You may see disparities in who dies and who becomes ill."
During the 1918 Spanish flu pandemic, people who lived in Chicago neighborhoods with low literacy rates were more likely to die than people living in neighborhoods with high literacy rates, according to a 2016 study published by the National Academy of Sciences.
"Whenever there is a disaster," says Pinar Keskinocak, a professor at Georgia Institute of Technology who specializes in infectious disease modeling, "I think unfortunately people with low income and in low-income groups always tend to be the most impacted."
People in rural areas may have to travel farther to reach a doctor or a hospital with a ventilator if they find themselves short of breath with the coronavirus, but they aren't the only ones with barriers to accessing health care. Studies have shown that low-income people in urban areas also struggle to get to their doctor.
"Low-income populations are going to be hit regardless of where they live, rural or urban," says Julie Swann, an industrial engineering professor at North Carolina State University who has helped build models predicting how pandemics could spread. "If someone is not able to get in early enough to get appropriate care, then their situation could escalate, and they could end up in the hospital."
Don't see the graphic above? Click here.
But rural areas often do have weaker defenses against public health crises. The map above shows places the CDC says are more vulnerable to "stresses on human health" because of a combination of factors including poverty, education levels, housing quality and other issues like lack of access to transportation.
Counties along the border with Mexico, wide swaths of the South and sparsely populated areas in Alaska stand out as just a few of the places with few tools to fight the coronavirus.
Many rural hospitals have shuttered after years of financial hardship, and the ones that remain open often have small staffs without the layers of specialized doctors and critical care nurses found at urban hospitals.
"We can only imagine, but you can think about bringing your mother or grandmother to the emergency room and it being literally filled with people and having to wait outside for hours before you're even seen by somebody," says Spiegelman, the Yale epidemiologist. "And maybe even some people would even die while they're waiting."
The actress and wife of "Good Morning America anchor George Stephanopoulos, took to Instagram with the news on Wednesday, writing: "I have tested positive for the Corona Virus. I've never been sicker. High fever. Horrific body aches. Heavy chest. I'm quarantined from my family. This is pure misery. #stayhome"
Wentworth is home with Stephanopoulos and their two daughters, but is self-isolating in a separate room.
She called into "GMA" Thursday to say "First of all, thank you for all your well-wishes" and joked, "You know I'm feverish if I'm allowing myself to go on national television with no makeup on."
She explained how she started to feel ill while out walking her dog.
"What started was I had a real tightness in my chest. I was walking my dog Cooper, and I just felt very, very winded and I assumed, of course, it was because I never work out and I'm out of shape, but it was it was too heavy for that," she said via video from bed.
Wentworth said she wasn't feeling great, then she got a fever.
"And it wasn't until the fever started that I realized this can't be a common summer cold," she said. "I went and got tested ... which was three days ago, and now I've had high fevers, sort of 101, 103."
Suffering also from achy joints and flu-like symptoms, she advised that the "things that help are Tylenol, chicken soup. I took some hot baths when I had chills and I have two dogs that sleep on my bed with me."
She also warned people to stay home.
Stephanopoulos is the only one who is going in the room to help Wentworth, he said on "GMA."
"I have to get a little bit close sometimes to take her temperature and do the oxygen test and I bring her food," he said. "I'm definitely being careful in wiping down and wearing gloves. I have not been wearing a mask."
This dynamic has played out over the past few weeks, and was on full display again during the White House briefing on Tuesday. Trump said the drugs might be a "total game-changer" and implied that good news from clinical trials was just days away, only to be corrected by the nation's top infectious disease expert, who steered clear of glowing superlatives and said the research will take months, "at very best."
Trump went even further on Tuesday, falsely suggesting that the drugs have already been proven safe. "Very powerful drug, but it's been out there for a long time," he said at the daily White House coronavirus briefing. "So, it's tested in the sense that you know it doesn't kill you."
Doctors say he's wrong, and that comments like these could have deadly consequences.
"As the dose of chloroquine goes up, it goes from being safe and effective to highly toxic, quickly," said Dr. Christopher Plowe, a renowned malaria expert at the Duke Global Health Institute. "It's very easy to overdose on chloroquine. You get above the ceiling of safety pretty quickly. There are some very serious risks here. There's quite a bit to lose, including your life."
Experts like Plowe who study these drugs, and doctors who are prescribing them, agree with the public health officials that clinical trials will tell whether Trump's optimism is well-placed.
Testing is underway, including a large study in New York, the epicenter of the US outbreak with more than 75,000 cases, the most of any state in the country. New York public health authorities have obtained at least 1 million doses of hydroxychloroquine, which will be used for a large-scale clinical trial, an official at the New York State Department of Health told CNN.
Optimism versus science
Regardless, within 48 hours, Trump sprang into action and began touting the study and the drugs, and has done so at least a dozen times in two weeks, according to a CNN analysis.
Senior Trump administration officials and public health experts followed suit, partially walking back Trump's comments with their own tempered takes, often from the very same podium.
When a journalist asked Dr. Anthony Fauci, the nation's top infectious disease expert, if these medicines could prevent Covid-19, Fauci gave a crystal-clear response: "The answer is no."
Dr. Deborah Birx, the response coordinator for the White House's coronavirus task force, said, "We're trying to figure out how many anecdotal reports equal real scientific breakthrough," when asked about the drugs.
The FDA Commissioner, Dr. Stephen Hahn, said a "large, pragmatic clinical trial" is still needed to "actually gather that information and answer the question that needs to be answered," as to whether the drugs are effective and safe to use during the worsening coronavirus pandemic.
The report said more research is needed to corroborate the French study. If those early results are accurate, "this would be the first time chloroquine or hydroxychloroquine was found to be effective for the clinical management of a viral infection," the report said, because previous clinical trials determined that the drugs had no impact on other viruses like influenza and HIV.
Balancing benefits and risks
Senior public health officials like Fauci and Hahn have said Trump wants to strike an optimistic tone to keep hope alive among Americans who are worried about their health and their paycheck. But there are risks, both to public health and in the presidential campaign unfolding in the background, in over-promising when it comes to things like drug treatments during an epidemic.
"Medical history has so many examples of treatments that people had good experiences with, and people got better, and they had great confidence in the treatment, and years later when a randomized trial was done, it turned out no better than placebo," said Plowe, the Duke expert.
Even with that uncertainty, some doctors on the frontlines say there aren't many other options.
"The FDA made a difficult decision, but they were right," Colyer told CNN. "We won't have all the hard data we want for months. But at this point, this is one of the most promising treatments out there. We need to understand all these drugs better, but we're in a unique situation."
Regardless of Trump's glowing rhetoric about the medicines, Colyer said the FDA "made a finding after reviewing all the literature" that is available, even though the research is limited.
"They've seen the plusses and the minuses and made a professional decision," he added.
CNN's Elizabeth Cohen, Brynn Gingras and Tara Subramaniam contributed to this article.
The initial guidance, issued by the I.R.S. on Monday, drew criticism from lawmakers in both parties. Representative Richard E. Neal, Democrat of Massachusetts and chairman of the House Ways and Means Committee, urged Treasury Secretary Steven Mnuchin and Social Security officials to find a solution that did not involve filing an additional return. Senator Tom Cotton, Republican of Arkansas, wrote on Twitter that he was extremely disappointed in the I.R.S.
The reversal should allow Social Security recipients to avoid filing an unexpected return, but the same cannot be said for many others who do not normally have to file.
The I.R.S. guidance acknowledged the potential complexity for low-income Americans, and the agency said it would soon offer instructions on its website for filing a 2019 tax return that contained simple, but necessary, information including their filing status, number of dependents and direct deposit bank account information.
Filing even the simplest of returns could pose challenges during a pandemic. The I.R.S. does have a free filing site, but those who lack internet access could be unable to use it because nonprofits, libraries and other places are closed. Low-income filers, however, will have until the end of the year to file and still get their stimulus payments.
The decision to require more people to file returns puzzled policy experts, who said the government had the ability to crosscheck various databases to make sure it reached everyone who was eligible, including those who would have the greatest need.
The matching part may take longer, and its legitimate for them to say that one group will get payments faster and one group will be slower, said Ms. Parrott, who worked in the federal Office of Management and Budget during the Obama administration. But to throw up their hands and say they cant do it? They have the capacity to do it, and I think they need the leadership to say that they are going to get this done.
There will be an extra layer of difficulty for people who dont normally file a return and lack a standard checking account.
Is it safe to go outside?
Even if coronavirus particles can move through the air, they would still diffuse over distance. People envision these clouds of viruses roaming through the streets coming after them, but the risk of [infection] is higher if youre closer to the source, says Linsey Marr, who studies airborne disease transmission at Virginia Tech. The outside is great as long as youre not in a crowded park.
In February, scientists in Wuhan, Chinawhere the coronavirus outbreak originatedsampled the air in various public areas, and showed that the virus was either undetectable or found in extremely low concentrations. The only exceptions were two crowded sites, one in front of a department store and another next to a hospital. Even then, each cubic meter of air contained fewer than a dozen virus particles. (No one knows the infectious dose of SARS-CoV-2that is, the number of particles needed to start an infectionbut for the original SARS virus of 2003, one study estimated somewhere between 43 and 280.)
These particles might not even have been infectious. I think well find that like many other viruses, [SARS-CoV-2] isnt especially stable under outdoor conditions like sunlight or warm temperatures, Santarpia said. Dont congregate in groups outside, but going for a walk, or sitting on your porch on a sunny day, are still great ideas.
Read: This is how we can beat the coronavirus
You could tie yourself in knots gaming out the various scenarios that might pose a risk outdoors, but Marr recommends a simple technique. When I go out now, I imagine that everyone is smoking, and I pick my path to get the least exposure to that smoke, she told me. If thats the case, I asked her, is it irrational to hold your breath when another person walks past you and you dont have enough space to move away? Its not irrational; I do that myself, she said. I dont know if it makes a difference, but in theory it could. Its like when you walk through a cigarette plume.
Indoors, experts opinions start to diverge. Consider, for example, the grocery storeone of the last vestiges of public life. There, Santarpia is far more concerned about touching shared surfaces than breathing shared air, and he makes sure to sanitize his hands before he leaves. Marr said that she tries to go when its less crowded, although thats obviously harder in a big city. Bourouibas best advice is to always keep as much distance from other people as possible, and she adds that the onus is on stores to improve their ventilation or limit the number of concurrent customers. Stores must also devise ways of protecting the people at greatest risk: the cashiers and the workers stocking shelves.
Then there are shared spaces like hallways, stairwells, and elevators in apartment buildings. Elevators pose the highest risk, Bourouiba told me, since theyre enclosed boxes with limited airflow. For stairwells and hallways, she advocated a commonsense approach: If you hear neighbors going out, and there are 10 people in the corridor right now, maybe wait and go later.
A 1960s health poster from the National Tuberculosis Association indicates that TB was still a problem in the U.S. in that decade. Universal History Archive/Universal Images Group via Getty hide caption
A 1960s health poster from the National Tuberculosis Association indicates that TB was still a problem in the U.S. in that decade.
As the world battles the deadly coronavirus, there is a lot we can learn from one of the great pandemics of recent centuries: tuberculosis.
Like the bug that has caused the newest global outbreak, TB is spread through the air. Every exhaled breath by a person with the disease can spread the tuberculosis bacteria to new individuals. TB is thought to have killed 1 billion people between 1800 and 2000. It attacks the human body more slowly than viral diseases like flu or COVID-19, but exacts a great toll. Untreated TB is a death sentence for 80 percent of those who fall ill.
Although TB still kills 4,000 people every day in poor countries, it largely disappeared in wealthy countries after the 1950s through a set of tried and tested strategies which suggests important lessons for how to stop the newest plague.
Current efforts to battle COVID-19 focus largely on reducing transmission by quarantine and physical distancing and by providing hospital care for the severely ill. But as scientists discovered with TB, the secret is not to put the everyday life of the community on indefinite hold, but rather to make it progressively safer. The focus of stopping transmission and delivering care should not only be on hospitals, but also in the communities where people live and work: their homes, schools and workplaces. Using this approach, wealthy countries turned the airborne scourge of TB from the leading cause of death at the end of the 19th century to a tiny fraction of all infections only 60 years later.
How did public health agencies, municipalities and private partners do it? Aided by a flurry of diagnostic and treatment innovations in the early to mid-20th century, they stopped TB using a community-based strategy called "search, treat and prevent."
First they searched for contacts of known patients. In communities where TB was rampant, they went house-by-house looking for people who had the disease and were transmitting it to others. "Searching" meant giving thousands of people skin tests and chest X-rays, in many cases with mobile vans.
Then they treated the sick first with food, rest and basic nursing care, and later with medicines. This was done in combination with social and financial support for those who were ill with TB. This freed people from the need to keep working to support themselves and their families, spreading the illness in the process. Finally, starting in the early 1960s, they stopped further spread of the microbe by giving preventive therapy to exposed individuals before they became sick.
In the U.S., all this was made possible through an infusion of resources from national, state and local governments and by voluntary contributions from organizations like the National Tuberculosis Association, as well as employers and labor unions.
The results were stunning: "Search, treat and prevent" helped the U.S. and other wealthy countries stop TB in its tracks. A disease which had been a plague on mankind since the beginning of the modern era was brought to heel in the period from the 1950s to the 1970s fewer than 20 years.
The lesson for coronavirus? Community-focused mobilization using the "search, treat and prevent" approach could be transformative. Although physical distancing may indeed be necessary in the short term, its economic cost is devastating, particularly for those who cannot work from home or who work in industries that depend on social interaction. The dislocation caused by quarantines the destruction of social bonds and livelihoods may in the end be as harmful to health and well-being as the pandemic itself. Moreover, countries relaxing quarantines have seen transmission begin anew from carriers who are not showing symptoms.
So there is much reason to believe that physical distancing and quarantine alone will not stop the epidemic.
The announcement last Friday of a point-of-care test that can accurately diagnose the coronavirus in as little as five minutes is a game-changer. With such technology we can identify hot spots whose residents need to practice physical distancing, provide community-based care to those not sick enough to be in hospitals, and when preventive medicines, new treatments and vaccines become available deliver these tools to those who could benefit most.
After a few weeks of physical distancing, this approach would help to identify groups of individuals and even entire communities that could resume their regular economic and social life. Re-entry would require access to masks and other protective equipment for community members as these items become more available and more widespread application of tools like indirect UVC lamps in stores and closed work spaces. UVC light has been shown to kill tuberculosis, influenza, coronaviruses and other pathogens that linger in the air and on exposed surfaces in public spaces.
To implement this strategy we would need to give people access to free testing, treatment, medicines and the necessary resources to sustain themselves through any physical distancing. It would be carried out by neighborhood-based teams of professional and lay health workers trained to safely conduct screening, provide basic treatment at home, and give social and economic support to those in isolation. This is exactly what happened after 1963, when a wave of federal funding for the "approach to zero for TB" helped establish community-based health teams in every U.S. state and territory.
The organization and funding of these teams would vary in different national and local settings. In the U.S. during the 1960s and '70s, community-based TB interventions were overseen by municipal public health authorities with funding from federal, state and private sources.
Community-wide coronavirus teams would also, as health expert Dr. Joia Mukherjee has pointed out, employ thousands of people, helping to mitigate the economic impact of the pandemic.
A community-wide coronavirus strategy would require large-scale investment in manufacturing a variety of tests, personal protection equipment and UVC lighting, as well as rapid training and mobilization of community health teams. But given the potential contribution to restarting local economies put in limbo by the epidemic, the cost will be modest. We have entered a state of emergency that upends the logic of austerity that led to decades of public health cutbacks.
The federal coronavirus relief bill just signed by President Trump provides $500 million for patient tracking and data collection alone. States have also begun to open their coffers and are likely to make millions available to stop this epidemic. We have to ensure that these resources are spent on approaches that can help restore our daily lives and livelihoods.
The "search, treat and prevent" strategy that stopped TB in wealthy countries was never expanded to poor countries because of fear that it would be too difficult to do there. It would be a mistake to make this same decision with the coronavirus. This global pandemic has exposed the same truth as climate change: On an ecologically interconnected planet, piecemeal approaches are doomed. As soon as we have working models of this approach in the U.S., we should ensure that they are expanded to at-risk settings all over the world.
Using the full array of technological and programmatic tools at our disposal can help us bring the pandemic to a close with a minimum loss of life, while avoiding an economic crash that would throw millions of people around the world into poverty, with an equally devastating public health impact.
We need to lay a foundation that will ensure that when we leave our homes in weeks or months, we are better prepared and safer than when the outbreak began. The community-wide approach can ensure that we find the sick and begin the process of healing. And with the right resources, it can begin today.
Salmaan Keshavjee is a professor of global health and social medicine at Harvard Medical School and Director of the Harvard Medical School Center for Global Health Delivery. He is a physician at Boston's Brigham and Women's Hospital and senior TB specialist at the Boston-based nonprofit Partners In Health. He is a member of the Council on Foreign Relations. His twitter handle is @s_keshavjee.
Aaron Shakow is director of the Initiative on Healing and Humanity at the Harvard Medical School Center for Global Health Delivery and a research associate in the department of global health and social medicine. A historian by training, he focuses his research on the social and political history of epidemics and quarantine.
Tom Nicholson is executive director of Advance Access and Delivery, a North Carolina-based nonprofit committed to improving access to high-quality health care. He is also a research associate at Duke University's Sanford School of Public Policy in the Duke Center for International Development. He is a member of the board of directors of the Global Health Council.
