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Scientists Question Validity of Major Hydroxychloroquine Study Scientists Question Validity of Major Hydroxychloroquine Study
(1 day 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.
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.”
Updated May 28, 2020
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.
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.)
More than 40 million people — the equivalent of 1 in 4 U.S. workers — have filed for unemployment benefits since the pandemic took hold. One in five who were working in February reported losing a job or being furloughed in March or the beginning of April, data from a Federal Reserve survey released on May 14 showed, and that pain was highly concentrated among low earners. Fully 39 percent of former workers living in a household earning $40,000 or less lost work, compared with 13 percent in those making more than $100,000, a Fed official said.
There is an uptick in people reporting symptoms of chilblains, which are painful red or purple lesions that typically appear in the winter on fingers or toes. The lesions are emerging as yet another symptom of infection with the new coronavirus. Chilblains are caused by inflammation in small blood vessels in reaction to cold or damp conditions, but they are usually common in the coldest winter months. Federal health officials do not include toe lesions in the list of coronavirus symptoms, but some dermatologists are pushing for a change, saying so-called Covid toe should be sufficient grounds for testing.
Yes, but make sure you keep six feet of distance between you and people who don’t live in your home. Even if you just hang out in a park, rather than go for a jog or a walk, getting some fresh air, and hopefully sunshine, is a good idea.
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’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.
Charity Navigator, which evaluates charities using a numbers-based system, has a running list of nonprofits working in communities affected by the outbreak. You can give blood through the American Red Cross, and World Central Kitchen has stepped in to distribute meals in major cities.
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.