FDA Issues Emergency Authorization to Treat COVID-19 With Malaria Drugs
The U.S. Food and Drug Administration has approved the use of two malarial drugs to treat and prevent COVID-19, the respiratory infection caused by the SARS-CoV-2 coronavirus, despite only anecdotal evidence that either is proven effective in treating or slowing the progression of the disease in seriously ill patients.
Under the emergency use authorization (EUA), millions of doses will be made available to doctors' patients through a Strategic National Stockpile "to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible," announced the U.S. Department of Health and Human Services in a statement.
In laboratory studies, the oral prescription drugs have shown "activity" against coronaviruses, including SARS-CoV-2. As of now, the drugs are only approved to treat malaria and other diseases like arthritis.
"Clinical trials are needed to provide scientific evidence that these treatments are effective," adds DHHS. To determine whether either drug may be effective against the virus, a number of studies are currently ongoing. At the University of Washington, for example, researchers are working to determine whether hydroxychloroquine can prevent transmission in people exposed to the virus.
"We currently don't know if hydroxychloroquine works, but we will learn in as short a timeframe as possible what the outcome is," said principal investigator Ruanne Barnabas, associate professor of global health in the University of Washington schools of Medicine and Public Health. The Centers for Disease Control and Preventions (CDC) adds that hydroxychloroquine is available by prescription only and may react with other drugs. As such, it should be used under the discretion of a doctor.
Similarly, chloroquine phosphate is only available in the U.S. by prescription for the treatment of malaria, according to the CDC. In recent weeks, several studies aimed at understanding the efficacy and safety of chloroquine found that there is "pre-clinical evidence of effectiveness and evidence of safety from long-term clinical use."
However, neither drug has been approved yet for treating or preventing COVID-19. The CDC has warned against the misuse of chloroquine without direction of a doctor after at least two people who ingested non-pharmaceutical chloroquine phosphate – used in aquarium and available for purchase for use in aquariums and online.
On average, it takes 12 years for the FDA to approve a new drug. For existing drugs that have already undergone safety studies, that timeframe may vary. Generally, FDA approval comes in three phases: the first which tests safety in humans and lasts about a year, the second that assesses the drug's effectiveness and takes about two years, and the third which monitors and evaluates effectiveness and adverse reactions in a large population, which requires three years. The fast-track is in response to the rapidly increasing cases and death rate currently being seen in COVID-19 cases, allowing doctors and patients have access to "unapproved medical countermeasure or unapproved uses" of these measures to "prepare for and respond to chemical, biological, radiological, and nuclear threats."
"An EUA may be issued if the FDA determines that, among other criteria, the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product, and there are no adequate, approved, available alternatives. Emergency access to a medical product under an EUA is separate from use of a medical product under an investigational drug application," adds the DHHS.
The FDA concludes that the EUA will require that fact sheets be provided to healthcare providers and patients about using chloroquine phosphate and hydroxychloroquine sulfate to treat COVID-19, which includes the risks and possible drug interactions.
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French winemakers are facing devastating grape loss from the worst frost in decades, preceded by unusually warm temperatures, highlighting the dangers to the sector posed by climate change.
"An important share of the harvest has been lost. It's too early to give a percentage estimate, but in any case it's a tragedy for the winegrowers who have been hit," said Christophe Chateau, director of communications at the Bordeaux Wine Council, told CNN.
Climate change, caused by the extraction and combustion of fossil fuels, has pushed winegrowing seasons earlier, putting crops at higher risk of cold — and wildfires supercharged by climate change also threaten American vignerons and farmworkers as well.
"I think it's good for people to understand that this is nature, climate change is real, and to be conscious of the effort that goes into making wine and the heartbreak that is the loss of a crop," Jeremy Seysses of Domaine Dujac in Burgundy's Côte de Nuits told Wine Enthusiast.
As reported by Wine Enthusiast:
Last week, images of candlelit French vineyards flooded social media. Across the country, winemakers installed bougies, or large wax-filled metal pots, among the vines to prevent cold air from settling in during an especially late frost.
With temperatures in early April as low as 22°F, and following an unseasonably warm March, this year's frost damage may be the worst in history for French winegrowers. Every corner of France reports considerable losses, from Champagne to Provence, and Côtes de Gascogne to Alsace. As a result, there will likely be very little French wine from the 2021 vintage reaching U.S. shores.
For a deeper dive:
CNN, Wine Enthusiast, France24, Eater
For more climate change and clean energy news, you can follow Climate Nexus on Twitter and Facebook, sign up for daily Hot News, and visit their news site, Nexus Media News.
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Climate change could make it harder to find a good cup of coffee, new research finds. A changing climate might shrink suitable areas for specialty coffee production without adaptation, making coffee taste blander and impacting the livelihoods of small farms in the Global South.
Published in Scientific Reports on Wednesday, the study focused on regions in Ethiopia, Africa's largest coffee-producing nation. Although studies have previously documented the impact of climate change on coffee production, what's less understood is how varying climates could change the flavors of specialty coffee, the researchers wrote.
The team aimed to fill this gap. Their results provide a glimpse into how future climate change could impact local regions and economies that rely on coffee cultivation, underscoring the value of local adaptation measures.
Researchers analyzed how 19 different climate factors, such as mean temperatures and rainfall levels, would affect the cultivation of five distinct specialty coffee types in the future, the Potsdam Institute for Climate Impact Research (PIK) reported. Although researchers found that areas suitable for growing "average quality coffee" may actually increase over time with climate change, regions where specialty coffee is grown will shrink — a pending problem in light of the global demand for high-quality coffee.
"This is an issue not just for coffee lovers, but for local agricultural value creation," Abel Chemura, the study's lead author, told the PIK.
Coffee profiles rely on specific climate patterns for their unique flavors, levels of acidity and fragrances. But in a warmer climate, the coffee cherry — the fruit picked from a coffee plant — matures faster than the bean inside, making for a lower quality cup of coffee, the PIK reported.
For example, the sought-after Yirgacheffe variety of coffee, which is cultivated in southwestern Ethiopia, could lose more than 40 percent of its suitable growth area by the end of the century, PIK reported. This could impact small farms and threaten Ethiopia's economy, the researchers noted.
"If one or more coffee regions lose their specialty status due to climate change this has potentially grave ramifications for the smallholder farmers in the region," Christoph Gornott, co-author of the study, told the PIK. "If they were forced to switch to growing conventional, less palatable and bitter coffee types, they would all of the sudden compete with industrial production systems elsewhere that are more efficient." In a country where coffee exports account for nearly a third of all agricultural exports, "this could prove fatal," Gornott added.
Climate change impacts on coffee production are not unique to Ethiopia. In Columbia's mountainous coffee-growing regions, temperatures are warming by 0.5 degrees Fahrenheit every decade, according to Yale Environment 360. Extreme levels of precipitation, which are becoming more common, also impact production, as they spread insect and fungal diseases.
"In earlier times, the climate was perfect for coffee," one small farmer in Columbia told Yale Environment 360. "In the period of flowering, there was summer. During harvest, there was winter. But from 2008 onward, this changed and we now don't know when it will be summer, when the coffee will blossom."
But researchers say there are glimmers of hope, emphasizing the importance of local adaptation measures that are designed for particular climates and communities. For example, in regions where temperature is an important factor for specialty coffee cultivation, the researchers suggest improved agroforestry systems that could maintain canopy temperatures, a promising step toward sustaining the "availability and taste of one of the world's most beloved beverages and, more importantly, on economic opportunities in local communities of the Global South," Gornott concluded.
By Suzanne Cords
One day Lizzie, the first-person narrator of the novel, receives an old book as a gift, with a dedication wishing the reader to be among the survivors. Like the preppers who build bunkers and stockpile supplies in remote areas to be ready for the end of the world, Lizzie is convinced that the end of the world is definitely near in times of a threatening climate disaster.
Lizzie, who lives in New York with her husband and son, is a university campus librarian. She worries about almost everything: her brother, an ex-junkie, or her dental insurance and the future in the face of the apocalypse. She is obsessed with reading reference books and articles about climate change.
She also devours words of wisdom, including about Buddhist spirituality: "A visitor once asked the old monks on Mount Athos what they did all day, and was told: We have died and we are in love with everything." But nothing can lift her spirits.
'Lizzie Is Just Like Us'
Lizzie observes rich New Yorkers plan their move to regions that are less threatened by climate change, something she simply cannot afford. Sometimes she watches disaster movies, which lead her to worry even more.
Above all, she is a gifted observer of her fellow human beings. "Young person worry: What if nothing I do matters? Old person worry: What if everything I do, does?"
Lizzie, the U.S. author told DW, is a bit like the rest of us — well aware of the climate crisis, but because she cares and worries about so many other things, that awareness falls by the wayside. That's how she felt herself, Jenny Offill said, but the more she looked into the issue, the more she saw a need for action on her part, too.
"I also was trying to see if there was a way to make it funny, because, you know, so much of the world of prepping and imagining disaster is actually sort of strangely funny."
The novel was shortlisted for the 2020 UK's Women's Prize for Fiction and has now been released in German translation.
Climate Activist With a Vision
But then, there is also this serious, scientifically based concern about what climate change means. In the past, says Offill, artists were the ones who would predict disasters; today it's the experts, as well as the students she teaches. In the end, their fears and their justified anger motivated her to take a closer look at the issue. Today, she is a climate activist herself, and is involved in initiatives along with many other artists.
Lizzie, the heroine of Weather, hasn't gotten that far. But she voices her fears, and that's a start. "Of course, the world continues to end," says Sylvia, a mentor of Lizzie's, at one point — and commences to water her garden. There is hope after all.
Reposted with permission from Deutsche Welle.
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Court Ends Trump's Attempt to Allow Drilling in 128 Million Acres of Atlantic and Arctic Oceans
By Jake Johnson
A federal appeals court on Tuesday dealt the final blow to former President Donald Trump's attempt to open nearly 130 million acres of territory in the Arctic and Atlantic Oceans to oil and gas drilling.
In April of 2017, Trump signed an executive order aiming to undo an Obama-era ban on fossil fuel exploration in that territory, but a federal judge in Alaska ruled the move unlawful in 2019.
Though the Trump administration appealed the ruling, President Joe Biden revoked his predecessor's 2017 order shortly after taking office, rendering the court case moot. On Tuesday, the Ninth Circuit Court of Appeals agreed to dismiss the Trump administration's appeal.
"Because the terms of the challenged Executive Order are no longer in effect, the relevant areas of the [Outer Continental Shelf] in the Chukchi Sea, Beaufort Sea, and Atlantic Ocean will be withdrawn from exploration and development activities," the court said in its order.
Erik Grafe of Earthjustice, which represented a coalition of advocacy groups that challenged Trump's order, said in a statement that "we welcome today's decision and its confirmation of President Obama's legacy of ocean and climate protection."
"As the Biden administration considers its next steps, it should build on these foundations, end fossil fuel leasing on public lands and waters, and embrace a clean energy future that does not come at the expense of wildlife and our natural heritage," Grafe continued. "One obvious place for immediate action is America's Arctic, including the Arctic Refuge and the Western Arctic, which the previous administration sought to relegate to oil development in a series of last-minute decisions that violate bedrock environmental laws."
VICTORY: 9th Circuit ends fight over President Trump's illegal attempt to open up 128 million acres of Atlantic & A… https://t.co/TvYVt2F1jO— Earthjustice (@Earthjustice)1618347073.0
In January, Biden ordered a temporary pause on new oil and gas leasing on federal lands and waters, a decision environmentalists hailed as a positive step that should be made permanent.
But climate groups voiced outrage last month when the Biden administration gave career officials a green light to resume processing existing permits for drilling on public lands and waters.
"We call on President Biden to keep his promise: a full and complete ban on fracking and fossil fuel extraction on public lands. Full stop," Food & Water Watch policy director Mitch Jones said at the time. "The climate crisis requires it and he promised it."
Reposted with permission from Common Dreams.
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By 2035, every new car and truck sold in the U.S. could be an EV, a new report says.
Accelerations in technology and especially battery affordability, paired with new policy, mean the dramatic transition would save American drivers $2.7 trillion by 2050, an average savings of $1,000 per household per year.
The ramp up in EV production would also create 2 million new jobs by 2035. Battery prices have fallen 74% since 2014, and their unexpectedly rapid fall is a key driver of the cost savings.
EVs are far simpler mechanically, and more efficient, than internal combustion engine (ICE) vehicles, which translates to reduced climate pollution and lower costs for consumers.
Strengthened vehicle efficiency standards and investment in fast charging infrastructure are needed to accelerate the transition, which would prevent 150,000 premature deaths and save $1.3 trillion in health environmental costs by 2050.
For a deeper dive:
The Guardian, Fast Company, E&E, Morning Consult, Canary Media
For more climate change and clean energy news, you can follow Climate Nexus on Twitter and Facebook, sign up for daily Hot News, and visit their news site, Nexus Media News.