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With Minimal Evidence, Trump Asks F.D.A. to Study Malaria Drugs for Coronavirus With Minimal Evidence, Trump Asks F.D.A. to Study Malaria Drugs for Coronavirus
(6 days later)
President Trump on Thursday exaggerated the potential of drugs available to treat the new coronavirus, including an experimental antiviral treatment and decades-old malaria remedies that hint of promise but so far show limited evidence of healing the sick.President Trump on Thursday exaggerated the potential of drugs available to treat the new coronavirus, including an experimental antiviral treatment and decades-old malaria remedies that hint of promise but so far show limited evidence of healing the sick.
No drug has been approved to treat the new coronavirus, and doctors around the world have been desperately administering an array of medicines in search of something to help patients, especially those who are severely ill.No drug has been approved to treat the new coronavirus, and doctors around the world have been desperately administering an array of medicines in search of something to help patients, especially those who are severely ill.
The malaria drugs, chloroquine and hydroxychloroquine, are among the remedies that have been tried in several countries as the virus has spread around the world, killing at least 9,800.The malaria drugs, chloroquine and hydroxychloroquine, are among the remedies that have been tried in several countries as the virus has spread around the world, killing at least 9,800.
Both drugs have gone into short supply in the United States this month, as word has spread of their potential benefit to coronavirus patients. Manufacturers of the generic products have said they are ramping up production. One company, Teva, said it would donate millions of pills of hydroxychloroquine to hospitals, and another company, Mylan, said it would restart production of the drug.Both drugs have gone into short supply in the United States this month, as word has spread of their potential benefit to coronavirus patients. Manufacturers of the generic products have said they are ramping up production. One company, Teva, said it would donate millions of pills of hydroxychloroquine to hospitals, and another company, Mylan, said it would restart production of the drug.
Doctors in China, South Korea and France have reported that the treatments seem to help. But those efforts have not involved the kind of large, carefully controlled studies that would provide the global medical community the proof that these drugs work on a significant scale.Doctors in China, South Korea and France have reported that the treatments seem to help. But those efforts have not involved the kind of large, carefully controlled studies that would provide the global medical community the proof that these drugs work on a significant scale.
In a White House briefing Thursday, Mr. Trump said the anti-malaria drugs had shown “tremendous promise.”In a White House briefing Thursday, Mr. Trump said the anti-malaria drugs had shown “tremendous promise.”
“I think it’s going to be very exciting,” he said. “I think it could be a game changer, and maybe not.”“I think it’s going to be very exciting,” he said. “I think it could be a game changer, and maybe not.”
The drugs’ potential has been highlighted during broadcasts on one of Mr. Trump’s favorite news channels, Fox News, where hosts like Laura Ingraham, Tucker Carlson and Jeanine Pirro have trumpeted the possibility of a real treatment.The drugs’ potential has been highlighted during broadcasts on one of Mr. Trump’s favorite news channels, Fox News, where hosts like Laura Ingraham, Tucker Carlson and Jeanine Pirro have trumpeted the possibility of a real treatment.
“They’ve gone through the approval process,” Mr. Trump said of the drugs. “It’s been approved, and they did.”“They’ve gone through the approval process,” Mr. Trump said of the drugs. “It’s been approved, and they did.”
But the F.D.A. has not approved any drugs for use in the treatment of coronavirus, and the drugs were already available, to treat malaria as well as rheumatoid arthritis and lupus. To date, the F.D.A. has not added the coronavirus to the list of illnesses for which the drugs are specifically approved. Then again, doctors have been free to use both old malaria drugs for any purpose deemed appropriate.But the F.D.A. has not approved any drugs for use in the treatment of coronavirus, and the drugs were already available, to treat malaria as well as rheumatoid arthritis and lupus. To date, the F.D.A. has not added the coronavirus to the list of illnesses for which the drugs are specifically approved. Then again, doctors have been free to use both old malaria drugs for any purpose deemed appropriate.
At the briefing on Thursday, Dr. Stephen M. Hahn, who has been the commissioner of the Food and Drug Administration for only three months, tended to walk back some of the president’s more inflated predictions that these drugs might vanquish the virus altogether.At the briefing on Thursday, Dr. Stephen M. Hahn, who has been the commissioner of the Food and Drug Administration for only three months, tended to walk back some of the president’s more inflated predictions that these drugs might vanquish the virus altogether.
He said Mr. Trump had asked the agency to look into chloroquine to fight the coronavirus, and that it was setting up a large clinical trial to evaluate the drug.He said Mr. Trump had asked the agency to look into chloroquine to fight the coronavirus, and that it was setting up a large clinical trial to evaluate the drug.
Some hospitals in the United States have already begun using the drugs for coronavirus patients, apparently reasoning that they may help and are unlikely to do harm. They are cheap and relatively safe. Laboratory studies have found that they prevent the coronavirus from invading cells, suggesting that the drugs could help prevent or limit the infection.Some hospitals in the United States have already begun using the drugs for coronavirus patients, apparently reasoning that they may help and are unlikely to do harm. They are cheap and relatively safe. Laboratory studies have found that they prevent the coronavirus from invading cells, suggesting that the drugs could help prevent or limit the infection.
Not everyone can take the drugs: They are not safe for people who suffer from heart arrhythmia, or those with impaired kidneys or liver.Not everyone can take the drugs: They are not safe for people who suffer from heart arrhythmia, or those with impaired kidneys or liver.
The University of Minnesota is conducting a study in which people who live with a coronavirus patient are being given hydroxychloroquine to find out if it can prevent the infection.The University of Minnesota is conducting a study in which people who live with a coronavirus patient are being given hydroxychloroquine to find out if it can prevent the infection.
Dr. Hahn also said that the agency was allowing sick patients to use remdesivir, the not-yet-approved antiviral drug made by Gilead. Such so-called “compassionate use” programs allow patients to take unapproved, experimental drugs if they have no other options.Dr. Hahn also said that the agency was allowing sick patients to use remdesivir, the not-yet-approved antiviral drug made by Gilead. Such so-called “compassionate use” programs allow patients to take unapproved, experimental drugs if they have no other options.
Remdesivir has already been given to patients on a compassionate-use basis, including the first coronavirus patient in the United States, who was treated in Washington State in late January.Remdesivir has already been given to patients on a compassionate-use basis, including the first coronavirus patient in the United States, who was treated in Washington State in late January.
Remdesivir is being studied in clinical trials, but the results are not available yet. It was studied to treat Ebola, but did not work well enough to be useful for that disease.Remdesivir is being studied in clinical trials, but the results are not available yet. It was studied to treat Ebola, but did not work well enough to be useful for that disease.
Dr. Hahn noted that the agency’s job was to prove that drugs were safe and effective. “What’s also important is not to provide false hope, but to provide hope,” he said.Dr. Hahn noted that the agency’s job was to prove that drugs were safe and effective. “What’s also important is not to provide false hope, but to provide hope,” he said.
Updated June 16, 2020 Updated June 22, 2020
A commentary published this month on the website of the British Journal of Sports Medicine points out that covering your face during exercise “comes with issues of potential breathing restriction and discomfort” and requires “balancing benefits versus possible adverse events.” Masks do alter exercise, says Cedric X. Bryant, the president and chief science officer of the American Council on Exercise, a nonprofit organization that funds exercise research and certifies fitness professionals. “In my personal experience,” he says, “heart rates are higher at the same relative intensity when you wear a mask.” Some people also could experience lightheadedness during familiar workouts while masked, says Len Kravitz, a professor of exercise science at the University of New Mexico.
The steroid, dexamethasone, is the first treatment shown to reduce mortality in severely ill patients, according to scientists in Britain. The drug appears to reduce inflammation caused by the immune system, protecting the tissues. In the study, dexamethasone reduced deaths of patients on ventilators by one-third, and deaths of patients on oxygen by one-fifth.The steroid, dexamethasone, is the first treatment shown to reduce mortality in severely ill patients, according to scientists in Britain. The drug appears to reduce inflammation caused by the immune system, protecting the tissues. In the study, dexamethasone reduced deaths of patients on ventilators by one-third, and deaths of patients on oxygen by one-fifth.
The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave.The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave.
So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.
Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.
A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.
The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.
Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.
States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.
Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.
If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)
Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.
The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.
If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.
If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.
As word has spread about chloroquine’s potential, demand in the United States has overwhelmed the country’s only supplier of the drug, the New Jersey generic manufacturer Rising Pharmaceuticals.As word has spread about chloroquine’s potential, demand in the United States has overwhelmed the country’s only supplier of the drug, the New Jersey generic manufacturer Rising Pharmaceuticals.
Chloroquine has been in short supply since March 9, according to the American Society of Health-System Pharmacists, which tracks drug shortages. Hydroxychloroquine, which is made by more companies, has been in shortage since Thursday.Chloroquine has been in short supply since March 9, according to the American Society of Health-System Pharmacists, which tracks drug shortages. Hydroxychloroquine, which is made by more companies, has been in shortage since Thursday.
Ira Baeringer, chief operating officer of Rising Pharmaceuticals, said his company had been tracking the use of the drug in China and elsewhere. They increased production about three weeks ago, he said, and are meeting all of their orders. But he acknowledged that pharmacies may currently have low stocks.Ira Baeringer, chief operating officer of Rising Pharmaceuticals, said his company had been tracking the use of the drug in China and elsewhere. They increased production about three weeks ago, he said, and are meeting all of their orders. But he acknowledged that pharmacies may currently have low stocks.
“We are experiencing an extraordinary demand, as you can imagine, but we are shipping to all of the orders,” Mr. Baeringer said. He noted that the product had not yet been extensively tested for coronavirus so it was unclear how well it works. “We’re really trying to understand what the need is going to be.”“We are experiencing an extraordinary demand, as you can imagine, but we are shipping to all of the orders,” Mr. Baeringer said. He noted that the product had not yet been extensively tested for coronavirus so it was unclear how well it works. “We’re really trying to understand what the need is going to be.”
On Thursday, the German manufacturer Bayer said it had donated three million tablets of chloroquine to the U.S. government for potential use as a treatment for coronavirus.On Thursday, the German manufacturer Bayer said it had donated three million tablets of chloroquine to the U.S. government for potential use as a treatment for coronavirus.
Bayer does not sell its chloroquine product in the United States, but has said it is seeking approval from the F.D.A. for it to be used on an emergency basis. Chloroquine, sold under the brand name Resochin by Bayer, was discovered by the company in 1934. Bayer said in a statement Thursday that it “appears to have broad spectrum antiviral properties and effects on the body’s immune response.”Bayer does not sell its chloroquine product in the United States, but has said it is seeking approval from the F.D.A. for it to be used on an emergency basis. Chloroquine, sold under the brand name Resochin by Bayer, was discovered by the company in 1934. Bayer said in a statement Thursday that it “appears to have broad spectrum antiviral properties and effects on the body’s immune response.”
The company said it had been in recent talks with the White House and several federal agencies to offer assistance.The company said it had been in recent talks with the White House and several federal agencies to offer assistance.
Mr. Trump has previously made unfounded predictions that the coronavirus epidemic would soon disappear. On Thursday, he appeared to enlist the malaria drugs in that effort, even though Dr. Deborah Birx, the White House's coronavirus response coordinator, said the virus could return in the fall or winter of next year.Mr. Trump has previously made unfounded predictions that the coronavirus epidemic would soon disappear. On Thursday, he appeared to enlist the malaria drugs in that effort, even though Dr. Deborah Birx, the White House's coronavirus response coordinator, said the virus could return in the fall or winter of next year.
“If they work, your numbers are going to come down very rapidly,” Mr. Trump said. “So, we’ll see what happens, but there’s a real chance that they might — they might work.”“If they work, your numbers are going to come down very rapidly,” Mr. Trump said. “So, we’ll see what happens, but there’s a real chance that they might — they might work.”
Sheila Kaplan contributed reporting.Sheila Kaplan contributed reporting.