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Scientists Question Validity of Major Hydroxychloroquine Study Scientists Question Validity of Major Hydroxychloroquine Study
(7 days later)
More than 100 scientists and clinicians have questioned the authenticity of a massive hospital database that was the basis for an influential study published last week that concluded that treating people who have Covid-19 with chloroquine and hydroxychloroquine did not help and might have increased the risk of abnormal heart rhythms and death.More than 100 scientists and clinicians have questioned the authenticity of a massive hospital database that was the basis for an influential study published last week that concluded that treating people who have Covid-19 with chloroquine and hydroxychloroquine did not help and might have increased the risk of abnormal heart rhythms and death.
In an open letter to The Lancet’s editor, Richard Horton, and the paper’s authors, the scientists asked the journal to provide details about the provenance of the data and called for the study to be independently validated by the World Health Organization or another institution.In an open letter to The Lancet’s editor, Richard Horton, and the paper’s authors, the scientists asked the journal to provide details about the provenance of the data and called for the study to be independently validated by the World Health Organization or another institution.
A spokeswoman for Dr. Mandeep R. Mehra, the Harvard professor who was the paper’s lead author, said on Friday that the study’s authors had asked for an independent academic review and audit of their work.A spokeswoman for Dr. Mandeep R. Mehra, the Harvard professor who was the paper’s lead author, said on Friday that the study’s authors had asked for an independent academic review and audit of their work.
Use of the malaria drugs chloroquine and hydroxychloroquine to prevent and treat Covid-19 has been a focus of intense public attention. President Trump has promoted the promise of hydroxychloroquine, despite the absence of gold-standard evidence from randomized clinical trials to prove its effectiveness, and recently said he was taking it himself in hopes of preventing coronavirus infection.Use of the malaria drugs chloroquine and hydroxychloroquine to prevent and treat Covid-19 has been a focus of intense public attention. President Trump has promoted the promise of hydroxychloroquine, despite the absence of gold-standard evidence from randomized clinical trials to prove its effectiveness, and recently said he was taking it himself in hopes of preventing coronavirus infection.
The scientists’ challenges to The Lancet paper come at a time of increasing debate about the risks of the rush to publish new medical findings about Covid-19. The paper, published May 22, included data on tens of thousands of patients hospitalized through April 14, meaning that the authors analyzed the trove of data, wrote the paper and went through the journal’s peer review of its findings in just over five weeks, much faster than usual.The scientists’ challenges to The Lancet paper come at a time of increasing debate about the risks of the rush to publish new medical findings about Covid-19. The paper, published May 22, included data on tens of thousands of patients hospitalized through April 14, meaning that the authors analyzed the trove of data, wrote the paper and went through the journal’s peer review of its findings in just over five weeks, much faster than usual.
The experts who wrote The Lancet also criticized the study’s methodology and the authors’ refusal to identify any of the hospitals that contributed patient data, or to name the countries where they were located. The company that owns the database is Surgisphere, based in Chicago.The experts who wrote The Lancet also criticized the study’s methodology and the authors’ refusal to identify any of the hospitals that contributed patient data, or to name the countries where they were located. The company that owns the database is Surgisphere, based in Chicago.
“Data from Africa indicate that nearly 25 percent of all Covid-19 cases and 40 percent of all deaths in the continent occurred in Surgisphere-associated hospitals which had sophisticated electronic patient data recording,” the scientists wrote. “Both the numbers of cases and deaths, and the detailed data collection, seem unlikely.”“Data from Africa indicate that nearly 25 percent of all Covid-19 cases and 40 percent of all deaths in the continent occurred in Surgisphere-associated hospitals which had sophisticated electronic patient data recording,” the scientists wrote. “Both the numbers of cases and deaths, and the detailed data collection, seem unlikely.”
Another of the critics’ concerns was that the data about Covid-19 cases in Australia was incompatible with government reports and included “more in-hospital deaths than had occurred in the entire country during the study period.”Another of the critics’ concerns was that the data about Covid-19 cases in Australia was incompatible with government reports and included “more in-hospital deaths than had occurred in the entire country during the study period.”
A spokeswoman for The Lancet, Emily Head, said in an email that the journal had received numerous inquiries about the paper and had referred the questions to the authors.A spokeswoman for The Lancet, Emily Head, said in an email that the journal had received numerous inquiries about the paper and had referred the questions to the authors.
“We will provide further updates as necessary,” she said. “The Lancet encourages scientific debate and will publish responses to the study, along with a response from the authors, in the journal in due course.”“We will provide further updates as necessary,” she said. “The Lancet encourages scientific debate and will publish responses to the study, along with a response from the authors, in the journal in due course.”
On Saturday, the journal made two corrections to the study but said, “There have been no changes to the findings of the paper.”On Saturday, the journal made two corrections to the study but said, “There have been no changes to the findings of the paper.”
Dr. Sapan S. Desai, the owner and founder of Surgisphere and one of the paper’s authors, vigorously defended the findings and the authenticity and validity of the company’s database. He said official counts of coronavirus cases and deaths often lagged behind actual cases, which might explain some discrepancies.Dr. Sapan S. Desai, the owner and founder of Surgisphere and one of the paper’s authors, vigorously defended the findings and the authenticity and validity of the company’s database. He said official counts of coronavirus cases and deaths often lagged behind actual cases, which might explain some discrepancies.
The paper’s authors said they had analyzed data gathered from 671 hospitals on six continents that shared granular medical information about nearly 15,000 patients who had received the drugs and 81,000 who had not, while shielding their identities.The paper’s authors said they had analyzed data gathered from 671 hospitals on six continents that shared granular medical information about nearly 15,000 patients who had received the drugs and 81,000 who had not, while shielding their identities.
“What the world has to understand is that this is registry-based data,” Dr. Desai said. “We have no control over the source of the information. All we can do is report the data that is given to us.”“What the world has to understand is that this is registry-based data,” Dr. Desai said. “We have no control over the source of the information. All we can do is report the data that is given to us.”
Another group of researchers from the Barcelona Institute for Global Health also raised questions about the Surgisphere database, both with the authors and editors of The Lancet.Another group of researchers from the Barcelona Institute for Global Health also raised questions about the Surgisphere database, both with the authors and editors of The Lancet.
Updated June 24, 2020 Updated June 30, 2020
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.
Scientists around the country have tried to identify everyday materials that do a good job of filtering microscopic particles. In recent tests, HEPA furnace filters scored high, as did vacuum cleaner bags, fabric similar to flannel pajamas and those of 600-count pillowcases. Other materials tested included layered coffee filters and scarves and bandannas. These scored lower, but still captured a small percentage of particles.Scientists around the country have tried to identify everyday materials that do a good job of filtering microscopic particles. In recent tests, HEPA furnace filters scored high, as did vacuum cleaner bags, fabric similar to flannel pajamas and those of 600-count pillowcases. Other materials tested included layered coffee filters and scarves and bandannas. These scored lower, but still captured a small percentage of particles.
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.
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.
Scientists who wrote and signed the letter criticizing the study included clinicians, researchers, statisticians and ethicists from academic medical centers, including Harvard’s T.H. Chan School of Public Health, the University of Pennsylvania, Vanderbilt University and Duke University.Scientists who wrote and signed the letter criticizing the study included clinicians, researchers, statisticians and ethicists from academic medical centers, including Harvard’s T.H. Chan School of Public Health, the University of Pennsylvania, Vanderbilt University and Duke University.
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One of the signatories, Dr. Adrian Hernandez, who heads the Duke Clinical Research Institute, said the paper contained many troubling anomalies, “but the biggest thing that raised a red flag was that here was such a large database across more than 600 hospitals, and no one had really known about its existence. That was quite remarkable.”One of the signatories, Dr. Adrian Hernandez, who heads the Duke Clinical Research Institute, said the paper contained many troubling anomalies, “but the biggest thing that raised a red flag was that here was such a large database across more than 600 hospitals, and no one had really known about its existence. That was quite remarkable.”
Like several other signatories of the letter, Dr. Hernandez is involved in a clinical trial of hydroxychloroquine to see if it can protect health care workers from infection.Like several other signatories of the letter, Dr. Hernandez is involved in a clinical trial of hydroxychloroquine to see if it can protect health care workers from infection.
Allen Cheng, a professor of infectious diseases at Monash University in Melbourne, Australia, who also signed the letter, said in an email that the individual hospitals included in the database should be identified.Allen Cheng, a professor of infectious diseases at Monash University in Melbourne, Australia, who also signed the letter, said in an email that the individual hospitals included in the database should be identified.
“Ideally, the database should be made public, but if that isn’t possible, it should at least be independently reviewed and an audit performed,” he said.“Ideally, the database should be made public, but if that isn’t possible, it should at least be independently reviewed and an audit performed,” he said.
Surgisphere’s data was also the basis of a study of coronavirus patients published in The New England Journal of Medicine this month by some of the same authors, including Dr. Desai and Harvard’s Dr. Mehra, as well as for two versions of an article on the use of an antimicrobial drug to treat Covid-19 that were not published in an established medical journal.Surgisphere’s data was also the basis of a study of coronavirus patients published in The New England Journal of Medicine this month by some of the same authors, including Dr. Desai and Harvard’s Dr. Mehra, as well as for two versions of an article on the use of an antimicrobial drug to treat Covid-19 that were not published in an established medical journal.
Jennifer Zeis, a spokeswoman for The New England Journal of Medicine, said by email that the journal was aware of the questions that had been raised and was looking into them.Jennifer Zeis, a spokeswoman for The New England Journal of Medicine, said by email that the journal was aware of the questions that had been raised and was looking into them.
Dr. Mehra issued a statement Friday, saying that the paper’s authors “leveraged the data available through Surgisphere to provide observational guidance to inform the care of hospitalized Covid-19 patients” because the results of randomized clinical trials would not be available for some time.Dr. Mehra issued a statement Friday, saying that the paper’s authors “leveraged the data available through Surgisphere to provide observational guidance to inform the care of hospitalized Covid-19 patients” because the results of randomized clinical trials would not be available for some time.
Other observational studies had previously reported possible harms associated with the malaria drugs, and the Food and Drug Administration had issued a safety warning about their use. After the Lancet paper was published, the World Health Organization and other organizations suspended clinical trials of the drugs.Other observational studies had previously reported possible harms associated with the malaria drugs, and the Food and Drug Administration had issued a safety warning about their use. After the Lancet paper was published, the World Health Organization and other organizations suspended clinical trials of the drugs.