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Coronavirus Patients in Limbo as Gilead Suspends Emergency Drug Access Coronavirus Patients in Limbo as Gilead Suspends Emergency Drug Access
(about 16 hours later)
Overwhelmed by demand for an experimental treatment for coronavirus, the drug maker Gilead abruptly shut down its emergency access program, leaving doctors and families scrambling for answers.Overwhelmed by demand for an experimental treatment for coronavirus, the drug maker Gilead abruptly shut down its emergency access program, leaving doctors and families scrambling for answers.
The company said it was setting up a broader access program that could try to help more people, but some said the transition is delaying remedies for very ill patients who have few options.The company said it was setting up a broader access program that could try to help more people, but some said the transition is delaying remedies for very ill patients who have few options.
“We have heard zero. We know nothing,” said Genny Allard, the mother of Jack Allard, a 25-year-old New Jersey resident who is in a medically induced coma and on a ventilator at Hackensack Meridian Health JFK Medical Center in Edison, N.J. “I’m just, like, apoplectic at this point. I have a kid who is sick and the doctor wants to give him the next medicine that is supposed to help.”“We have heard zero. We know nothing,” said Genny Allard, the mother of Jack Allard, a 25-year-old New Jersey resident who is in a medically induced coma and on a ventilator at Hackensack Meridian Health JFK Medical Center in Edison, N.J. “I’m just, like, apoplectic at this point. I have a kid who is sick and the doctor wants to give him the next medicine that is supposed to help.”
The drug, remdesivir, is being studied in several large-scale clinical trials around the world, including a huge trial announced last week by the World Health Organization. But the results have not been reported yet, and it is still unclear whether the drug works against the coronavirus. It was studied to treat Ebola, but did not work well enough against that virus.The drug, remdesivir, is being studied in several large-scale clinical trials around the world, including a huge trial announced last week by the World Health Organization. But the results have not been reported yet, and it is still unclear whether the drug works against the coronavirus. It was studied to treat Ebola, but did not work well enough against that virus.
There is no known treatment against the coronavirus. Over the last week, President Trump has repeatedly referred to remdesivir and other drugs, like two long-used malaria drugs, as potential game-changers, despite pushback by top health officials like Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases. Dr. Fauci has corrected Mr. Trump in blunt ways during the daily White House briefings, saying that there is not enough scientific evidence to prove the drugs will work against the virus.There is no known treatment against the coronavirus. Over the last week, President Trump has repeatedly referred to remdesivir and other drugs, like two long-used malaria drugs, as potential game-changers, despite pushback by top health officials like Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases. Dr. Fauci has corrected Mr. Trump in blunt ways during the daily White House briefings, saying that there is not enough scientific evidence to prove the drugs will work against the virus.
Critics of the president have complained that he is instilling false hope in a desperate public, as the disease spreads rapidly around the United States and elsewhere. Highly publicized talk of prospective cures has fueled demand for these potential treatments — threatening the longstanding supply of some of these drugs that are relied on regularly by people with lupus and other conditions.Critics of the president have complained that he is instilling false hope in a desperate public, as the disease spreads rapidly around the United States and elsewhere. Highly publicized talk of prospective cures has fueled demand for these potential treatments — threatening the longstanding supply of some of these drugs that are relied on regularly by people with lupus and other conditions.
As the virus spread to Europe and the United States, Gilead said emergency requests had “flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic.”As the virus spread to Europe and the United States, Gilead said emergency requests had “flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic.”
Remdesivir has been given on a case-by-case basis to patients in China, Japan, Europe and the United States — where it was administered to the first coronavirus patient in the country, who was treated in Washington State in late January.Remdesivir has been given on a case-by-case basis to patients in China, Japan, Europe and the United States — where it was administered to the first coronavirus patient in the country, who was treated in Washington State in late January.
Six clinical trials of remdesivir are underway around the world, and early results from trials in China could be announced by the end of next month. “By the time we get to the end of April, we should have a preliminary idea of the safety and efficacy of this medicine against coronavirus,” said Daniel O’Day, Gilead’s chief executive, in a news conference earlier this month.Six clinical trials of remdesivir are underway around the world, and early results from trials in China could be announced by the end of next month. “By the time we get to the end of April, we should have a preliminary idea of the safety and efficacy of this medicine against coronavirus,” said Daniel O’Day, Gilead’s chief executive, in a news conference earlier this month.
Gilead said it was switching to a broader program because it could not handle individual requests. “Due to overwhelming demand over the last several days, during this transition period we are unable to accept new individual compassionate use requests,” the company said on Sunday, with the exception of pregnant women and children under 18. “This approach will both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients,” the company said.Gilead said it was switching to a broader program because it could not handle individual requests. “Due to overwhelming demand over the last several days, during this transition period we are unable to accept new individual compassionate use requests,” the company said on Sunday, with the exception of pregnant women and children under 18. “This approach will both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients,” the company said.
Gilead said it was processing “previously approved” requests but did not say what the status was of requests — like Mr. Allard’s — that had been submitted but not approved.Gilead said it was processing “previously approved” requests but did not say what the status was of requests — like Mr. Allard’s — that had been submitted but not approved.
Drug makers have long run so-called “compassionate use” programs that allow patients to take unapproved, experimental drugs if they have no other options. The switch to what’s known as an “expanded access program” would allow the approvals to apply to larger groups instead of one individual at a time. These programs are often run as loose clinical trials, in which patients who did not qualify for the more stringent requirements of the trial can enroll. In addition to giving more patients access to the drug, it also allows the companies to collect data, including what dose was used, how sick the patient was and the extent that it worked. In compassionate-use programs, this type of information is usually not shared.Drug makers have long run so-called “compassionate use” programs that allow patients to take unapproved, experimental drugs if they have no other options. The switch to what’s known as an “expanded access program” would allow the approvals to apply to larger groups instead of one individual at a time. These programs are often run as loose clinical trials, in which patients who did not qualify for the more stringent requirements of the trial can enroll. In addition to giving more patients access to the drug, it also allows the companies to collect data, including what dose was used, how sick the patient was and the extent that it worked. In compassionate-use programs, this type of information is usually not shared.
“You are trying to save somebody, rescue somebody. It’s a last-ditch throwing the kitchen sink at them, and you rarely get information back,” said Dr. Art Caplan, head of the division of medical ethics at the New York University Grossman School of Medicine. He said that he was giving unpaid advice to some companies pursuing treatments for coronavirus. The shift to a broader program will allow Gilead to learn about the drug. Without it, “you don’t learn what’s going on, so you’re sort of stuck.”“You are trying to save somebody, rescue somebody. It’s a last-ditch throwing the kitchen sink at them, and you rarely get information back,” said Dr. Art Caplan, head of the division of medical ethics at the New York University Grossman School of Medicine. He said that he was giving unpaid advice to some companies pursuing treatments for coronavirus. The shift to a broader program will allow Gilead to learn about the drug. Without it, “you don’t learn what’s going on, so you’re sort of stuck.”
A Gilead spokeswoman said the company did not expect the transition to a new program would result in delays in treatment compared with how long patients were already waiting for the drug under the company’s now-ended compassionate-use program. Gilead would not provide details about the average turnaround time, but the spokeswoman said the company has been inundated with requests over the past week.A Gilead spokeswoman said the company did not expect the transition to a new program would result in delays in treatment compared with how long patients were already waiting for the drug under the company’s now-ended compassionate-use program. Gilead would not provide details about the average turnaround time, but the spokeswoman said the company has been inundated with requests over the past week.
The company has said that it has a limited supply of remdesivir, but that it is increasing production. It is also drawing on a stockpile Gilead created for use in future pandemics after Ebola outbreaks in West Africa.The company has said that it has a limited supply of remdesivir, but that it is increasing production. It is also drawing on a stockpile Gilead created for use in future pandemics after Ebola outbreaks in West Africa.
Mr. Allard, who lives in Metuchen, N.J. and is an associate at Bank of America in Manhattan, was admitted to the hospital on the night of March 16 after he had a high fever, back pain and was throwing up, his mother said. She described Mr. Allard, a former All-American lacrosse player at Bates College, as healthy and with no underlying conditions.
Updated June 22, 2020Updated 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.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.
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.)
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.
Mr. Allard, who lives in Metuchen, N.J. and is an associate at Bank of America in Manhattan, was admitted to the hospital on the night of March 16 after he had a high fever, back pain and was throwing up, his mother said. She described Mr. Allard, a former All-American lacrosse player at Bates College, as healthy and with no underlying conditions.
In New Jersey, officials announced 935 new positive cases on Monday, bringing the total to 2,844, including 27 deaths.In New Jersey, officials announced 935 new positive cases on Monday, bringing the total to 2,844, including 27 deaths.
Mr. Allard was tested Tuesday for the coronavirus, but the sample was sent to Quest Diagnostics, and his mother said the hospital never received the results.Mr. Allard was tested Tuesday for the coronavirus, but the sample was sent to Quest Diagnostics, and his mother said the hospital never received the results.
As the week went on, Mr. Allard’s condition rapidly declined, Ms. Allard said. He was placed in a medically induced coma and put on a ventilator. Ms. Allard said his doctors wanted to try remdesivir, but they needed to have a confirmed positive test showing he had the illness caused by the virus before they could seek the drug from Gilead. Finally, after the family made a flurry of calls to elected officials and others, the hospital tested him again on Saturday and received the results from another laboratory in less than six hours.As the week went on, Mr. Allard’s condition rapidly declined, Ms. Allard said. He was placed in a medically induced coma and put on a ventilator. Ms. Allard said his doctors wanted to try remdesivir, but they needed to have a confirmed positive test showing he had the illness caused by the virus before they could seek the drug from Gilead. Finally, after the family made a flurry of calls to elected officials and others, the hospital tested him again on Saturday and received the results from another laboratory in less than six hours.
His results came back positive and that night — around 10:30 — the doctor submitted her request to Gilead. By the next morning, Ms. Allard said, she was hearing that Gilead was shifting to a new system, and news stories later on Sunday confirmed her fears.His results came back positive and that night — around 10:30 — the doctor submitted her request to Gilead. By the next morning, Ms. Allard said, she was hearing that Gilead was shifting to a new system, and news stories later on Sunday confirmed her fears.
His doctor has submitted another request under the new system, but Ms. Allard now fears his treatment will be delayed. Ms. Allard said the doctor had previously treated another patient with remdesivir and the turnaround time for approval had been 48 hours.His doctor has submitted another request under the new system, but Ms. Allard now fears his treatment will be delayed. Ms. Allard said the doctor had previously treated another patient with remdesivir and the turnaround time for approval had been 48 hours.
“I feel as if we are in regulatory limbo,” Ms. Allard said. “We were good, we were following the rules, he was queued up for what the rules were as of Saturday night and we woke up Sunday and everything changed.”“I feel as if we are in regulatory limbo,” Ms. Allard said. “We were good, we were following the rules, he was queued up for what the rules were as of Saturday night and we woke up Sunday and everything changed.”