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Trump’s Embrace of Unproven Drugs to Treat Coronavirus Defies Science Trump’s Embrace of Unproven Drugs to Treat Coronavirus Defies Science
(3 days later)
At a long-winded White House briefing on Friday, President Trump enthusiastically and repeatedly promoted the promise of two long-used malaria drugs that are still unproven against the coronavirus, but being tested in clinical trials.At a long-winded White House briefing on Friday, President Trump enthusiastically and repeatedly promoted the promise of two long-used malaria drugs that are still unproven against the coronavirus, but being tested in clinical trials.
“I’m a smart guy,” he said, while acknowledging he couldn’t predict the drugs would work. “I feel good about it. And we’re going to see. You’re going to see soon enough.”“I’m a smart guy,” he said, while acknowledging he couldn’t predict the drugs would work. “I feel good about it. And we’re going to see. You’re going to see soon enough.”
But the nation’s leading infectious disease expert, Dr. Anthony S. Fauci, delicately — yet forcefully — pushed back from the same stage, explaining that there was only anecdotal evidence that the drugs, chloroquine and hydroxychloroquine, may be effective.But the nation’s leading infectious disease expert, Dr. Anthony S. Fauci, delicately — yet forcefully — pushed back from the same stage, explaining that there was only anecdotal evidence that the drugs, chloroquine and hydroxychloroquine, may be effective.
“The president feels optimistic about something, has feelings about it,” said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases, emphasizing that he was a scientist. “I am saying it may be effective.”“The president feels optimistic about something, has feelings about it,” said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases, emphasizing that he was a scientist. “I am saying it may be effective.”
Mr. Trump’s boosterish attitude toward the drugs has deepened worries among doctors and patients with lupus and other diseases who rely on the drugs, because the idea that the old malaria drugs could work against the coronavirus has circulated widely in recent weeks and fueled shortages that have already left people rushing to fill their prescriptions.Mr. Trump’s boosterish attitude toward the drugs has deepened worries among doctors and patients with lupus and other diseases who rely on the drugs, because the idea that the old malaria drugs could work against the coronavirus has circulated widely in recent weeks and fueled shortages that have already left people rushing to fill their prescriptions.
“Rheumatologists are furious about the hype going on over this drug,” said Dr. Michael Lockshin, of the Hospital for Special Surgery in Manhattan. “There is a run on it and we’re getting calls every few minutes, literally, from patients who are trying to stay on the drug and finding it in short supply.”“Rheumatologists are furious about the hype going on over this drug,” said Dr. Michael Lockshin, of the Hospital for Special Surgery in Manhattan. “There is a run on it and we’re getting calls every few minutes, literally, from patients who are trying to stay on the drug and finding it in short supply.”
The moment of discord between Mr. Trump and one of the nation's most trusted authorities on the coronavirus was a clash between opinion and fact. It threw Mr. Trump’s faith in his own instincts into conflict with the careful, evidence-based approach of scientists like Dr. Fauci, who has held his position since the presidency of Ronald Reagan. Mr. Trump appeared eager to sweep aside long-established standards for evaluating drugs in order to champion the remedy he favors.The moment of discord between Mr. Trump and one of the nation's most trusted authorities on the coronavirus was a clash between opinion and fact. It threw Mr. Trump’s faith in his own instincts into conflict with the careful, evidence-based approach of scientists like Dr. Fauci, who has held his position since the presidency of Ronald Reagan. Mr. Trump appeared eager to sweep aside long-established standards for evaluating drugs in order to champion the remedy he favors.
The excitement about the drugs is based largely on reports from China and France that they seem to help patients. But researchers and Dr. Fauci have stressed that the reports are not based on carefully controlled studies, which are the only way to be sure a treatment really works.The excitement about the drugs is based largely on reports from China and France that they seem to help patients. But researchers and Dr. Fauci have stressed that the reports are not based on carefully controlled studies, which are the only way to be sure a treatment really works.
In a tweet on Saturday, Mr. Trump called attention to yet another unapproved treatment for Covid-19, this time a combination of hydroxychloroquine and azithromycin, a common anti-bacterial agent. He cited a report by French researchers in a scientific journal that was not a controlled clinical trial, and studied only 20 patients.In a tweet on Saturday, Mr. Trump called attention to yet another unapproved treatment for Covid-19, this time a combination of hydroxychloroquine and azithromycin, a common anti-bacterial agent. He cited a report by French researchers in a scientific journal that was not a controlled clinical trial, and studied only 20 patients.
As word of the drugs’ possible effects have spread around the globe, demand has surged, with hospitals ordering the treatments in a desperate effort to treat severely ill patients.As word of the drugs’ possible effects have spread around the globe, demand has surged, with hospitals ordering the treatments in a desperate effort to treat severely ill patients.
Two large generic manufacturers, Teva and Mylan, have said they are ramping up production of hydroxychloroquine, and Teva has said it will donate millions of pills to the U.S. government. The sole manufacturer of chloroquine, Rising Pharmaceuticals, has also said it is increasing production. In addition, the German company Bayer announced this week it was donating millions of pills of chloroquine to the U.S. government and would seek approval from the F.D.A. for its products to be used in the United States.Two large generic manufacturers, Teva and Mylan, have said they are ramping up production of hydroxychloroquine, and Teva has said it will donate millions of pills to the U.S. government. The sole manufacturer of chloroquine, Rising Pharmaceuticals, has also said it is increasing production. In addition, the German company Bayer announced this week it was donating millions of pills of chloroquine to the U.S. government and would seek approval from the F.D.A. for its products to be used in the United States.
Hydroxychloroquine is especially important for people with lupus, which can be life-threatening, Dr. Lockshin said. The drug can lower the risk of dying from lupus and prevent organ damage, and is considered the standard of care. If patients stop taking it after using it regularly for a long time, they can gradually become quite ill. He said it was particularly disturbing to think that people known to benefit from the drug could lose access to it because it is being diverted to a disease for which there is no solid evidence that it actually works.Hydroxychloroquine is especially important for people with lupus, which can be life-threatening, Dr. Lockshin said. The drug can lower the risk of dying from lupus and prevent organ damage, and is considered the standard of care. If patients stop taking it after using it regularly for a long time, they can gradually become quite ill. He said it was particularly disturbing to think that people known to benefit from the drug could lose access to it because it is being diverted to a disease for which there is no solid evidence that it actually works.
“If there were justification for everyone taking it, that would be one thing,” Dr. Lockshin said. “It’s not hard to do the studies even in the midst of this crisis. We could have answers in a few weeks. But it’s being prescribed right and left.”“If there were justification for everyone taking it, that would be one thing,” Dr. Lockshin said. “It’s not hard to do the studies even in the midst of this crisis. We could have answers in a few weeks. But it’s being prescribed right and left.”
Dana Olita, 50, of Los Angeles, raced Thursday and Friday to refill her prescription for hydroxychloroquine, which she has taken for a decade to treat rheumatoid arthritis. Her pharmacist at CVS initially told her it was unavailable; then she was told on Friday that they had located enough to fill her prescription. “There are lots of people that desperately need this, and if we stop taking it, the problem to us is overwhelming,” she said.Dana Olita, 50, of Los Angeles, raced Thursday and Friday to refill her prescription for hydroxychloroquine, which she has taken for a decade to treat rheumatoid arthritis. Her pharmacist at CVS initially told her it was unavailable; then she was told on Friday that they had located enough to fill her prescription. “There are lots of people that desperately need this, and if we stop taking it, the problem to us is overwhelming,” she said.
A spokesman for CVS said the company was “closely monitoring the global pharmaceutical manufacturing environment and working with our suppliers to ensure we can continue filling prescriptions for pharmacy patients and plan members.” The company said it had adequate stocks of hydroxychloroquine but described the supply of chloroquine as “tight” and said it was taking steps to address the issue.A spokesman for CVS said the company was “closely monitoring the global pharmaceutical manufacturing environment and working with our suppliers to ensure we can continue filling prescriptions for pharmacy patients and plan members.” The company said it had adequate stocks of hydroxychloroquine but described the supply of chloroquine as “tight” and said it was taking steps to address the issue.
“I would hope that doctors would stick to the science and try to keep a cool head,” said Dr. Percio S. Gulko, chief of the division of rheumatology at the Icahn School of Medicine at Mount Sinai. “Somebody is prescribing it for people who are trying to get it, in some instances preventively. They may just be depriving the patients who do need it for an established indication, for a possibility or a speculation.”“I would hope that doctors would stick to the science and try to keep a cool head,” said Dr. Percio S. Gulko, chief of the division of rheumatology at the Icahn School of Medicine at Mount Sinai. “Somebody is prescribing it for people who are trying to get it, in some instances preventively. They may just be depriving the patients who do need it for an established indication, for a possibility or a speculation.”
“If it does turn out to be a success, we understand that there will be a need for more than has ever been available for patients with autoimmune diseases,” said Dr. David R. Karp, the president-elect of the American College of Rheumatology and chief of the rheumatic disease division at the University of Texas Southwestern Medical Center in Dallas. “We hope there will be a way for our patients to continue to access these medicines they’ve been taking for many years. Other medications can be used, but the safety profile gets much worse, and patients will likely have side effects.”“If it does turn out to be a success, we understand that there will be a need for more than has ever been available for patients with autoimmune diseases,” said Dr. David R. Karp, the president-elect of the American College of Rheumatology and chief of the rheumatic disease division at the University of Texas Southwestern Medical Center in Dallas. “We hope there will be a way for our patients to continue to access these medicines they’ve been taking for many years. Other medications can be used, but the safety profile gets much worse, and patients will likely have side effects.”
Updated June 5, 2020 Updated June 12, 2020
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.
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.
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.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.
Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.
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.
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.
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.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.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.
Judie Stein, of Sun Prairie, Wis., said she was stunned when she heard Mr. Trump pronounce the name of the drug she has taken for two years to treat rheumatoid arthritis. “When I was first prescribed this, nobody had heard of it,” said Ms. Stein, who is 59. She said she has a one-month supply of the drug and she quickly tried to refill her prescription yesterday. She has not yet received a confirmation. “If it’s readily available and has other uses, then fine, but when I say I really need it, I need it,” she said.Judie Stein, of Sun Prairie, Wis., said she was stunned when she heard Mr. Trump pronounce the name of the drug she has taken for two years to treat rheumatoid arthritis. “When I was first prescribed this, nobody had heard of it,” said Ms. Stein, who is 59. She said she has a one-month supply of the drug and she quickly tried to refill her prescription yesterday. She has not yet received a confirmation. “If it’s readily available and has other uses, then fine, but when I say I really need it, I need it,” she said.
Dr. Michael Belmont, medical director of NYU Langone Orthopedic Hospital, said a number of his lupus patients had requested 90-day prescriptions for hydroxychloroquine, rather than the usual 30 days’ worth.Dr. Michael Belmont, medical director of NYU Langone Orthopedic Hospital, said a number of his lupus patients had requested 90-day prescriptions for hydroxychloroquine, rather than the usual 30 days’ worth.
Noting that hydroxychloroquine was being widely used in coronavirus patients outside of controlled studies, he said, “It would be a shame if we use a lot of this and after all is said and done we are not able to determine with accuracy whether it had an effect or not.”Noting that hydroxychloroquine was being widely used in coronavirus patients outside of controlled studies, he said, “It would be a shame if we use a lot of this and after all is said and done we are not able to determine with accuracy whether it had an effect or not.”
Onisis Stefas, the chief pharmacy officer for Northwell Health’s 23 hospitals, said the system began stocking up on hydroxychloroquine several weeks ago. He said the drug was being given to many coronavirus patients, but that Northwell’s 10 pharmacies were also setting aside supplies for patients who had been taking it regularly for lupus or rheumatoid arthritis.Onisis Stefas, the chief pharmacy officer for Northwell Health’s 23 hospitals, said the system began stocking up on hydroxychloroquine several weeks ago. He said the drug was being given to many coronavirus patients, but that Northwell’s 10 pharmacies were also setting aside supplies for patients who had been taking it regularly for lupus or rheumatoid arthritis.
Concerned about shortages, Mr. Stefas said, “The last thing I want to happen now is that, especially since President Trump and others have been mentioning this by name, is that people will go out and ask their doctors to write prescriptions, just in case.”Concerned about shortages, Mr. Stefas said, “The last thing I want to happen now is that, especially since President Trump and others have been mentioning this by name, is that people will go out and ask their doctors to write prescriptions, just in case.”
On Friday, Mr. Trump appeared to encourage Americans to do just that, arguing that there was little downside to taking a malaria drug that is already on the market.On Friday, Mr. Trump appeared to encourage Americans to do just that, arguing that there was little downside to taking a malaria drug that is already on the market.
“If you wanted, you can have a prescription. You get a prescription,” he said. “You know the expression, what the hell do you have to lose?”“If you wanted, you can have a prescription. You get a prescription,” he said. “You know the expression, what the hell do you have to lose?”