This article is from the source 'nytimes' and was first published or seen on . It last changed over 40 days ago and won't be checked again for changes.

You can find the current article at its original source at https://www.nytimes.com/2020/06/02/health/virus-study.html

The article has changed 34 times. There is an RSS feed of changes available.

Version 9 Version 10
Scientists Question Medical Data Used in Second Coronavirus Study Scientists Question Medical Data Used in Second Coronavirus Study
(3 days later)
Since the outbreak began, researchers have rushed to publish new findings about the coronavirus spreading swiftly through the world. On Tuesday, for the second time in recent days, a group of clinicians and researchers has questioned the data used in studies in two prominent medical journals.Since the outbreak began, researchers have rushed to publish new findings about the coronavirus spreading swiftly through the world. On Tuesday, for the second time in recent days, a group of clinicians and researchers has questioned the data used in studies in two prominent medical journals.
A group of scientists who raised questions last week about a study in The Lancet about the use of antimalarial drugs in coronavirus patients have now objected to another paper about blood pressure medicines in the New England Journal of Medicine, which was published by some of the same authors and relied on the same data registry.A group of scientists who raised questions last week about a study in The Lancet about the use of antimalarial drugs in coronavirus patients have now objected to another paper about blood pressure medicines in the New England Journal of Medicine, which was published by some of the same authors and relied on the same data registry.
Moments after their open letter was posted online Tuesday morning, the editors of the N.E.J.M. posted an “expression of concern” about the paper, and said they had asked the paper’s authors to provide evidence that the data are reliable.Moments after their open letter was posted online Tuesday morning, the editors of the N.E.J.M. posted an “expression of concern” about the paper, and said they had asked the paper’s authors to provide evidence that the data are reliable.
The Lancet followed later in the day with a statement about its own concerns regarding the malarial drugs paper, saying that the editors have commissioned an independent audit of the data.The Lancet followed later in the day with a statement about its own concerns regarding the malarial drugs paper, saying that the editors have commissioned an independent audit of the data.
Both of the studies relied on an analysis of patient outcomes from a private database run by a company called Surgisphere, which says it has granular information about nearly 100,000 Covid-19 patients from 1,200 hospitals and other health facilities on six continents. Many health care data experts say they knew nothing about its existence until recently.Both of the studies relied on an analysis of patient outcomes from a private database run by a company called Surgisphere, which says it has granular information about nearly 100,000 Covid-19 patients from 1,200 hospitals and other health facilities on six continents. Many health care data experts say they knew nothing about its existence until recently.
Both papers were published in May within a few weeks of each other in highly respected medical journals that subject studies to peer review before publication. Both had considerable impact, halting clinical trials of malaria drugs around the world and providing reassurance about the risks of blood pressure medications taken by millions of patients.Both papers were published in May within a few weeks of each other in highly respected medical journals that subject studies to peer review before publication. Both had considerable impact, halting clinical trials of malaria drugs around the world and providing reassurance about the risks of blood pressure medications taken by millions of patients.
But scientists have not seen the large data set that Surgisphere says it has built, and questions about its provenance are rising in scientific circles.But scientists have not seen the large data set that Surgisphere says it has built, and questions about its provenance are rising in scientific circles.
In the open letter to the authors of the N.E.J.M. paper and to the journal’s editor, Dr. Eric J. Rubin, more than 100 clinicians, researchers and statisticians demanded more detailed information about the patient data that served as the basis of the study, and called for independent validation of the work by a third party.In the open letter to the authors of the N.E.J.M. paper and to the journal’s editor, Dr. Eric J. Rubin, more than 100 clinicians, researchers and statisticians demanded more detailed information about the patient data that served as the basis of the study, and called for independent validation of the work by a third party.
The study was said to analyze 8,910 Covid-19 patients hospitalized through mid-March at 169 medical centers in Asia, Europe and North America. The authors concluded that cardiovascular disease increased their risk of dying.The study was said to analyze 8,910 Covid-19 patients hospitalized through mid-March at 169 medical centers in Asia, Europe and North America. The authors concluded that cardiovascular disease increased their risk of dying.
But the paper also appeared to put to rest any concerns that people with high blood pressure might have about taking drugs called ACE inhibitors: Some people had wondered whether the drugs were playing a role in exacerbating the illness.But the paper also appeared to put to rest any concerns that people with high blood pressure might have about taking drugs called ACE inhibitors: Some people had wondered whether the drugs were playing a role in exacerbating the illness.
Instead, the patients taking these drugs were more likely to survive than those who were not, the authors said. (Other studies have also reported that blood pressure drugs do not make people more susceptible to infection with the coronavirus, and do not increase the risk of more severe illness.)Instead, the patients taking these drugs were more likely to survive than those who were not, the authors said. (Other studies have also reported that blood pressure drugs do not make people more susceptible to infection with the coronavirus, and do not increase the risk of more severe illness.)
In the paper published in The Lancet, the 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 antimalarial drugs and 81,000 who had not, while shielding their identities.In the paper published in The Lancet, the 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 antimalarial drugs and 81,000 who had not, while shielding their identities.
The papers concluded that use of chloroquine and hydroxychloroquine may have increased the risk of death in these patients.The papers concluded that use of chloroquine and hydroxychloroquine may have increased the risk of death in these patients.
The first author on both of the papers is Dr. Mandeep R. Mehra, a cardiovascular specialist and professor at Harvard Medical School. The second author is Dr. Sapan S. Desai, the owner and founder of Surgisphere.The first author on both of the papers is Dr. Mandeep R. Mehra, a cardiovascular specialist and professor at Harvard Medical School. The second author is Dr. Sapan S. Desai, the owner and founder of Surgisphere.
On Tuesday morning, Dr. Desai, who has vigorously defended both the studies and his database, said he and his co-authors on The Lancet study have agreed to a voluntary third-party audit done in collaboration with the journal.On Tuesday morning, Dr. Desai, who has vigorously defended both the studies and his database, said he and his co-authors on The Lancet study have agreed to a voluntary third-party audit done in collaboration with the journal.
He also said he was arranging the terms of a nondisclosure agreement that would allow the editors of the N.E.J.M. to see the data they had requested.He also said he was arranging the terms of a nondisclosure agreement that would allow the editors of the N.E.J.M. to see the data they had requested.
Dr. Desai had previously said that his contractual agreements with hospitals prevented him from disclosing any hospital-level patient data, even though it was anonymized. “Surgisphere stands behind the integrity of our studies and our scientific researchers, clinical partners and data analysts,” he said in a statement.Dr. Desai had previously said that his contractual agreements with hospitals prevented him from disclosing any hospital-level patient data, even though it was anonymized. “Surgisphere stands behind the integrity of our studies and our scientific researchers, clinical partners and data analysts,” he said in a statement.
In their letter to the N.E.J.M., critics of the work wrote: “Serious, and as yet unanswered, concerns have been raised about the integrity and provenance of these data.”In their letter to the N.E.J.M., critics of the work wrote: “Serious, and as yet unanswered, concerns have been raised about the integrity and provenance of these data.”
The letter points out “major inconsistencies” between the number of coronavirus cases recorded in some countries during the study period and the number of patient outcomes reported by the researchers over the same period.The letter points out “major inconsistencies” between the number of coronavirus cases recorded in some countries during the study period and the number of patient outcomes reported by the researchers over the same period.
In particular, they said, it is “difficult to reconcile” the Surgisphere data from the United Kingdom with government reports. The paper reported on 706 patients hospitalized with confirmed Covid-19 in just seven of the U.K.’s 1,257 National Health Service hospitals.In particular, they said, it is “difficult to reconcile” the Surgisphere data from the United Kingdom with government reports. The paper reported on 706 patients hospitalized with confirmed Covid-19 in just seven of the U.K.’s 1,257 National Health Service hospitals.
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.
Yet a high proportion of coronavirus patients hospitalized in the U.K. early on were in London, and no London borough or hospital had more than 100 confirmed cases by March 16, the critics said.Yet a high proportion of coronavirus patients hospitalized in the U.K. early on were in London, and no London borough or hospital had more than 100 confirmed cases by March 16, the critics said.
“The numbers from Turkey also appear incorrect,” the letter says, adding that the first Covid-19 case in Turkey was diagnosed at Istanbul Faculty of Medicine on March 9, and the hospital did not see another case until March 16.“The numbers from Turkey also appear incorrect,” the letter says, adding that the first Covid-19 case in Turkey was diagnosed at Istanbul Faculty of Medicine on March 9, and the hospital did not see another case until March 16.
By March 18, the Turkish Ministry of Health reported a total of 191 confirmed cases, yet Surgisphere reported data on 346 Covid-19 patients admitted by March 15 to just three Turkish hospitals.By March 18, the Turkish Ministry of Health reported a total of 191 confirmed cases, yet Surgisphere reported data on 346 Covid-19 patients admitted by March 15 to just three Turkish hospitals.
[Like the Science Times page on Facebook. | Sign up for the Science Times newsletter.][Like the Science Times page on Facebook. | Sign up for the Science Times newsletter.]
Many of the scientists who first raised concerns about the database are involved in clinical trials of chloroquine and hydroxychloroquine, and they were forced to pause the studies for safety reviews after The Lancet study was published.Many of the scientists who first raised concerns about the database are involved in clinical trials of chloroquine and hydroxychloroquine, and they were forced to pause the studies for safety reviews after The Lancet study was published.
James Watson, a senior scientist with MORU Tropical Health Network, said his unit had to immediately suspend work on a large randomized clinical trial to see if chloroquine or hydroxychloroquine can protect health care workers exposed on the job to the coronavirus from infection.James Watson, a senior scientist with MORU Tropical Health Network, said his unit had to immediately suspend work on a large randomized clinical trial to see if chloroquine or hydroxychloroquine can protect health care workers exposed on the job to the coronavirus from infection.
“I saw very quickly this paper didn’t hold up to much scrutiny at all,” he said. “We started wondering, ‘Who’s been collecting this data, and where did it come from?’ We were quite surprised to see a global study with only four authors listed and no acknowledgment of anyone else.”“I saw very quickly this paper didn’t hold up to much scrutiny at all,” he said. “We started wondering, ‘Who’s been collecting this data, and where did it come from?’ We were quite surprised to see a global study with only four authors listed and no acknowledgment of anyone else.”
The scientists then turned their attention to the paper about cardiovascular disease and blood pressure drugs that had been published in the N.E.J.M. on May 1. “We immediately thought, ‘If there’s something wrong with the database, it’s going to affect both publications,’” he said.The scientists then turned their attention to the paper about cardiovascular disease and blood pressure drugs that had been published in the N.E.J.M. on May 1. “We immediately thought, ‘If there’s something wrong with the database, it’s going to affect both publications,’” he said.
David Glidden, a professor of biostatistics at University of California, San Francisco, who reads all new publications about Covid-19 antiviral therapies as a member of a National Institutes of Health clinical guidelines panel, said he was immediately struck by the vagueness of the descriptions in both papers.David Glidden, a professor of biostatistics at University of California, San Francisco, who reads all new publications about Covid-19 antiviral therapies as a member of a National Institutes of Health clinical guidelines panel, said he was immediately struck by the vagueness of the descriptions in both papers.
There is a frenzy to publish research, he added: “Medical journals often feel pressure to be relevant and to be carrying the story that’s going to be talked about, and I think they need to be responsive to the urgency of this pandemic but also to maintain their standards, which require caution.”There is a frenzy to publish research, he added: “Medical journals often feel pressure to be relevant and to be carrying the story that’s going to be talked about, and I think they need to be responsive to the urgency of this pandemic but also to maintain their standards, which require caution.”