NIH: Critical study of Covid-19 drug shows patients respond to treatment
Preliminary data released yesterday from a closely watched, government-run trial of Gilead's remdesivir showed it was effective in Covid-19 patients. Those who were given remdesivir recovered four days faster than those who were given placebo. The decrease in mortality rate compared to placebo was not statistically significant. Anthony Fauci, the director of NIAID, which is conducting the study, said the data are a “very important proof of concept,” but cautioned they were not a “knockout.”
The preliminary results come after days of conflicting results on remdesivir's efficacy against Covid-19: While early results from Gilead's separate trial of the drug in severe Covid-19 patients showed promise, data from a trial in China showed no added benefit. NIAID's trial results are critical because the drug was tested in a large number of patients and neither the patients nor physicians knew who was getting the drug, which controlled for any unconscious biases. And following NIAID's preliminary data, the FDA is exploring an emergency use authorization for remdesivir, according to The Wall Street Journal.
The preliminary results come after days of conflicting results on remdesivir's efficacy against Covid-19: While early results from Gilead's separate trial of the drug in severe Covid-19 patients showed promise, data from a trial in China showed no added benefit. NIAID's trial results are critical because the drug was tested in a large number of patients and neither the patients nor physicians knew who was getting the drug, which controlled for any unconscious biases. And following NIAID's preliminary data, the FDA is exploring an emergency use authorization for remdesivir, according to The Wall Street Journal.
NIH announces $1.5 billion, ‘Shark Tank’-like initiative to accelerate Covid-19 testing
The NIH yesterday announced a $1.5 billion initiative aimed at speeding up the availability of diagnostics for Covid-19. The hope is that this endeavor will lead to "millions of tests" being deployed per week by late summer or fall. The initiative will rely on a "national Covid-19 testing challenge," in which researchers and inventors across the country will compete for a share of $500 million in a "Shark Tank"-style competition to move their proposed inventions forward. The National Institute of Biomedical Imaging and Bioengineering's director Bruce Tromberg tells STAT's Lev Facher that the agency, which will be coordinating the initiative, expects to select roughly five winners who will be paired with manufacturers who will mass-produce the new diagnostics.
ClinicalTrials.gov upgrade is underway
ClinicalTrials.gov was launched 20 years ago this year, and the National Library of Medicine — which maintains the website — is underway with modernizing the site. Scientific research has changed over the past two decades as has how people are expected to report to the database, acting director of ClinicalTrials.gov Rebecca Williams tells me. As a first step in the four-year modernization effort, the NLM in December solicited comments from researchers, physicians, drug companies, and others who regularly use ClinicalTrials.gov to get a sense of which areas could most use updating. Today the NLM is holding a virtual meeting to share some of this feedback, which ranged from a building a better search tool to ensuring that the language people use when reporting results is standardized. "It was very clear how much people really value ClinicalTrials.gov based on the detail in which they did comment," Williams says. By fall, the NLM plans to have a road map to implementing the changes to the database.
Inside STAT: Reopening some states heightens the risk of coronavirus surges in others
As some states loosen restrictions they placed to curb the spread of Covid-19, the emerging fear among public health experts is that infections will not only rise within those states but spread to other places as well. Opening up only some parts of the country while others are still subject to restrictions is “like having a peeing section in the swimming pool,” Jeffrey Duchin, a public health official in Seattle and King County, said during a recent panel discussion, citing a phrase someone had mentioned to him. “It doesn’t stay where you started.” Given the risk of reseeding infection in the population, businesses and areas that are looking to reopen will have to consider how they keep up with ensuring that the disease is, in fact, under control. And testing capabilities are still below where they need to be, which further complicates the problem. STAT's Andrew Joseph has more here.
Lab Chat: A non-invasive way to manipulate neurons to study behavior
Optogenetics is a field of study that involves manipulating neurons to be light-sensitive and then using light to better understand how different cells are involved in brain function. This typically involves hooking animals up to optical fibers to shine light on neurons of interest, but the process is invasive and can interfere with studying the animals' behavior. In a new study published in Neuron, researchers describe a non-invasive way to modulate neurons in the brains of mice and macaques. I spoke with Guoping Feng, a neuroscientist at MIT's McGovern Institute and a senior author of the study, to learn more.
What could you use this tool to study?
You can activate or deactivate light-sensitive neurons to see which ones control human behavior. We're focused on autism spectrum disorders and interested in how genetic mutations in neurodevelopment disorders affect the nervous system. So you can look, systematically, at how disrupted function can lead to abnormal behavior. Or, the other way around: How can we correct these defects in the genetic environment and have a long-lasting effect?
Why is it important to have a non-invasive way to do optogenetics?
Previously it was very difficult to study because mice [brains] are very small. You cannot put an optic fiber on them without having it stick out. For our interest in ASD, you would put a few mice together to study their social interactions, but with optical fibers, you would have them get tangled very easily and it would disrupt [observing] their natural behavior.
What are next the steps?
With the monkey brains, we were only able to penetrate the cortex in this study, but a lot of function is in subcortical areas. So we are going to see if we can penetrate these areas using this method.
What could you use this tool to study?
You can activate or deactivate light-sensitive neurons to see which ones control human behavior. We're focused on autism spectrum disorders and interested in how genetic mutations in neurodevelopment disorders affect the nervous system. So you can look, systematically, at how disrupted function can lead to abnormal behavior. Or, the other way around: How can we correct these defects in the genetic environment and have a long-lasting effect?
Why is it important to have a non-invasive way to do optogenetics?
Previously it was very difficult to study because mice [brains] are very small. You cannot put an optic fiber on them without having it stick out. For our interest in ASD, you would put a few mice together to study their social interactions, but with optical fibers, you would have them get tangled very easily and it would disrupt [observing] their natural behavior.
What are next the steps?
With the monkey brains, we were only able to penetrate the cortex in this study, but a lot of function is in subcortical areas. So we are going to see if we can penetrate these areas using this method.
Nearly 15% of U.S. adults say they've tried an e-cigarette
New data from the CDC show that the more than 1 in 7 U.S. adults in 2018 reported having tried an e-cigarette. Here's more the report:
- Overall trends: Nearly 15% of people in 2018 said they had ever used an e-cigarette. An estimated 3% of people reported they were current e-cigarette users.
- Cigarette smoking: Nearly 60% of those who had quit smoking cigarettes in the year prior to being surveyed reported having used an e-cigarette, as did nearly 50% of those who were current cigarette smokers.
- Demographics: Men, white adults, and those ages 18-24 were most likely to be current e-cigarette users as well as to have ever used one.
What to read around the web today
- Mind-controlled prosthetic arm enables patients to feel the objects they grip. STAT
- Juul Labs plans to cut roughly a third of its workers. The Wall Street Journal
- Dogs are being trained to sniff out coronavirus cases. The Washington Post
- Microbe mappers are tracking Covid-19's invisible traces. Wired
- A ‘sniff test’ signals consciousness after a brain injury, study shows. STAT
- Why the coronavirus is so confusing. The Atlantic
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