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Haphazard Rollout of Coronavirus Drug Frustrates Doctors Haphazard Rollout of Coronavirus Drug Frustrates Doctors
(7 days later)
When the Food and Drug Administration granted an emergency approval last week for an antiviral drug, remdesivir, to treat hospitalized coronavirus patients, many doctors were overjoyed. The drug is the first shown to be even mildly effective against the virus.When the Food and Drug Administration granted an emergency approval last week for an antiviral drug, remdesivir, to treat hospitalized coronavirus patients, many doctors were overjoyed. The drug is the first shown to be even mildly effective against the virus.
But bafflement soon followed as doctors and hospitals tried to obtain the drug. Small community hospitals with few beds received remdesivir, while medical centers besieged with cases were denied.But bafflement soon followed as doctors and hospitals tried to obtain the drug. Small community hospitals with few beds received remdesivir, while medical centers besieged with cases were denied.
Only four hospitals in Massachusetts, for example, are known to have received remdesivir: three small community hospitals and Massachusetts General, a Harvard University teaching hospital.Only four hospitals in Massachusetts, for example, are known to have received remdesivir: three small community hospitals and Massachusetts General, a Harvard University teaching hospital.
Officials at Mass General said they had not even asked for the drug. Yet other major hospitals were left out, including Boston Medical Center, which has many vulnerable African-American patients.Officials at Mass General said they had not even asked for the drug. Yet other major hospitals were left out, including Boston Medical Center, which has many vulnerable African-American patients.
“This is crazy,” said Dr. Rochelle Walensky, chief of infectious diseases at Mass General. The hospital is giving its small supply of remdesivir — 26 cases containing 40 vials each — to the state to distribute more equitably.“This is crazy,” said Dr. Rochelle Walensky, chief of infectious diseases at Mass General. The hospital is giving its small supply of remdesivir — 26 cases containing 40 vials each — to the state to distribute more equitably.
“We have no idea how this landed with us,” Dr. Walensky added. “There are people who are pretty angry that they didn’t get any.”“We have no idea how this landed with us,” Dr. Walensky added. “There are people who are pretty angry that they didn’t get any.”
Remdesivir’s approval should have been a clear win in the fight against the coronavirus, but its distribution has been tripped up by seemingly capricious decision-making and finger-pointing.Remdesivir’s approval should have been a clear win in the fight against the coronavirus, but its distribution has been tripped up by seemingly capricious decision-making and finger-pointing.
Like other drugs used in hospitals, remdesivir is supplied not by the manufacturer, Gilead Sciences, but by a wholesale distributor, in this case a company called AmerisourceBergen.Like other drugs used in hospitals, remdesivir is supplied not by the manufacturer, Gilead Sciences, but by a wholesale distributor, in this case a company called AmerisourceBergen.
After the F.D.A. granted the emergency approval, Gilead Sciences said it would donate its existing supply of the drug: 1.5 million vials, enough to treat roughly 140,000 hospitalized patients.After the F.D.A. granted the emergency approval, Gilead Sciences said it would donate its existing supply of the drug: 1.5 million vials, enough to treat roughly 140,000 hospitalized patients.
Hospitals needing the drug were told to call AmerisourceBergen to find out if they were on a list of facilities that qualified. If so, the distributor shipped the drug. If not, the hospital was denied the drug.Hospitals needing the drug were told to call AmerisourceBergen to find out if they were on a list of facilities that qualified. If so, the distributor shipped the drug. If not, the hospital was denied the drug.
That list apparently was not drawn up by AmerisourceBergen, which says on its website that hospitals “the U.S. government deems most in need will receive priority in the distribution of donated remdesivir,” adding that “neither Gilead nor AmerisourceBergen are deciding which hospitals will receive remdesivir.”That list apparently was not drawn up by AmerisourceBergen, which says on its website that hospitals “the U.S. government deems most in need will receive priority in the distribution of donated remdesivir,” adding that “neither Gilead nor AmerisourceBergen are deciding which hospitals will receive remdesivir.”
But it is not clear how federal officials came up with a list of hospitals “most in need,” or even what hospitals are on it. Criticism of the list and the rollout has been gathering steam in Washington.But it is not clear how federal officials came up with a list of hospitals “most in need,” or even what hospitals are on it. Criticism of the list and the rollout has been gathering steam in Washington.
“The fact that many of the hospitals and areas with high rates of COVID-19 cases and deaths were left out of the initial distribution raises significant questions about FEMA and HHS’ decision making,” Senator Kamala Harris, Democrat of California, said in a letter on Friday to the Federal Emergency Management Agency Administrator, Peter Gaynor, and the Secretary of Health and Human Services, Alex M. Azar II.“The fact that many of the hospitals and areas with high rates of COVID-19 cases and deaths were left out of the initial distribution raises significant questions about FEMA and HHS’ decision making,” Senator Kamala Harris, Democrat of California, said in a letter on Friday to the Federal Emergency Management Agency Administrator, Peter Gaynor, and the Secretary of Health and Human Services, Alex M. Azar II.
The White House press secretary, Kayleigh McEnany, said in a press briefing on Friday that Dr. Deborah L. Birx, the White House Coronavirus Task Force coordinator, henceforth would take a lead role in federal oversight of remdesivir allocations.The White House press secretary, Kayleigh McEnany, said in a press briefing on Friday that Dr. Deborah L. Birx, the White House Coronavirus Task Force coordinator, henceforth would take a lead role in federal oversight of remdesivir allocations.
Dr. Birx “is going to be working in consulting as to where this drug should go,” Ms. McEnany said.Dr. Birx “is going to be working in consulting as to where this drug should go,” Ms. McEnany said.
“She really has the best grasp as to how that should be distributed,” Ms. McEnany added.“She really has the best grasp as to how that should be distributed,” Ms. McEnany added.
The Infectious Diseases Society of America and the H.I.V. Medicine Association also have written to Vice President Mike Pence, head of the coronavirus task force, pleading for an explanation of the criteria used to allocate remdesivir. There has been no reply.The Infectious Diseases Society of America and the H.I.V. Medicine Association also have written to Vice President Mike Pence, head of the coronavirus task force, pleading for an explanation of the criteria used to allocate remdesivir. There has been no reply.
Neither Mr. Pence’s office nor AmerisourceBergen responded to requests for information about the distribution of remdesivir.Neither Mr. Pence’s office nor AmerisourceBergen responded to requests for information about the distribution of remdesivir.
Doctors treating coronavirus patients say they are flummoxed by what seems to be an unpredictable distribution system.Doctors treating coronavirus patients say they are flummoxed by what seems to be an unpredictable distribution system.
“Everyone is texting each other and saying, ‘Did you get anything?’” said Dr. Cameron Wolfe, an infectious disease specialist at Duke University Medical Center. His hospital did not receive remdesivir.“Everyone is texting each other and saying, ‘Did you get anything?’” said Dr. Cameron Wolfe, an infectious disease specialist at Duke University Medical Center. His hospital did not receive remdesivir.
Neither did the University of California, San Francisco, said Dr. Peter Chin-Hong, an infectious disease specialist there. “We understand that not everyone can get it,” he said. “But who is making the decision, and how are the decisions being made?”Neither did the University of California, San Francisco, said Dr. Peter Chin-Hong, an infectious disease specialist there. “We understand that not everyone can get it,” he said. “But who is making the decision, and how are the decisions being made?”
“There is no reason for this to be secretive,” said Dr. Daniel Kaul, an infectious disease specialist at the University of Michigan, which also has not received the drug.“There is no reason for this to be secretive,” said Dr. Daniel Kaul, an infectious disease specialist at the University of Michigan, which also has not received the drug.
“I would love to see where it is available,” Dr. Kaul added. Then he could tell family members where to transfer a patient who might need the drug.“I would love to see where it is available,” Dr. Kaul added. Then he could tell family members where to transfer a patient who might need the drug.
Conan MacDougall, professor of clinical pharmacy at U.C.S.F., has sent a survey to hospitals across the country, asking if they received the drug; with their replies, he has put together an unofficial distribution map that also includes data on hospital type, size and whether the hospitals reported being sites for remdesivir clinical trials.Conan MacDougall, professor of clinical pharmacy at U.C.S.F., has sent a survey to hospitals across the country, asking if they received the drug; with their replies, he has put together an unofficial distribution map that also includes data on hospital type, size and whether the hospitals reported being sites for remdesivir clinical trials.
He cautioned that the map only includes data from pharmacy departments and infectious disease specialists who responded to a voluntary survey. Still, the map suggests that large swaths of the country have been left out.He cautioned that the map only includes data from pharmacy departments and infectious disease specialists who responded to a voluntary survey. Still, the map suggests that large swaths of the country have been left out.
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.
On the West Coast, remdesivir went to medium-size hospitals in Los Angeles and San Mateo, Calif. In the Southeast, the only hospital to acknowledge getting remdesivir was in Nashville.On the West Coast, remdesivir went to medium-size hospitals in Los Angeles and San Mateo, Calif. In the Southeast, the only hospital to acknowledge getting remdesivir was in Nashville.
Most sites that received the drug were in the Northeast. Hard-hit cities like Detroit did not report getting the drug. The amounts sent to each hospital also were highly variable.Most sites that received the drug were in the Northeast. Hard-hit cities like Detroit did not report getting the drug. The amounts sent to each hospital also were highly variable.
“I think it illustrates that while the drug is now ‘available,’ most of the country is not currently able to access it,” Dr. MacDougall said in an email.“I think it illustrates that while the drug is now ‘available,’ most of the country is not currently able to access it,” Dr. MacDougall said in an email.
Before the clinical trial results were known, Dr. Chin-Hong said, “we could look at patients or family members in the eyes and say, ‘We don’t know if this works.’”Before the clinical trial results were known, Dr. Chin-Hong said, “we could look at patients or family members in the eyes and say, ‘We don’t know if this works.’”
Now, “we are dangling a golden apple in front of them,” just beyond reach, he said.Now, “we are dangling a golden apple in front of them,” just beyond reach, he said.
Those hospitals lucky enough to receive remdesivir are facing another problem: Which patients should get it?Those hospitals lucky enough to receive remdesivir are facing another problem: Which patients should get it?
The federal clinical trial that showed remdesivir to be effective included a range of severely ill patients, from those with low oxygen levels to those on respirators. The data have not been published, only announced by administration officials.The federal clinical trial that showed remdesivir to be effective included a range of severely ill patients, from those with low oxygen levels to those on respirators. The data have not been published, only announced by administration officials.
As a result, there are no clinical guidelines on how best to use the drug. Is it better to give the limited supply of remdesivir to the most seriously ill? Or is it better to start with patients who are less ill?As a result, there are no clinical guidelines on how best to use the drug. Is it better to give the limited supply of remdesivir to the most seriously ill? Or is it better to start with patients who are less ill?
The National Institute of Allergy and Infectious Diseases, sponsor of the trial, has not provided the data because it is still being reviewed, said Jennifer Routh, a spokeswoman.The National Institute of Allergy and Infectious Diseases, sponsor of the trial, has not provided the data because it is still being reviewed, said Jennifer Routh, a spokeswoman.
There should be a preliminary report with data in a few weeks, she added.There should be a preliminary report with data in a few weeks, she added.
Reporting was contributed by Michael Crowley from Washington.Reporting was contributed by Michael Crowley from Washington.