Category: Newsline

The U.S. Food and Drug Administration on Wednesday approved selling the leading version of naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter.

It’s a move that some advocates have long sought as a way to improve access to a life-saving drug, though the exact impact will not be clear immediately.

Here’s a look at the issues involved.

What is Narcan?

The approved nasal spray from Gaithersburg, Maryland-based Emergent BioSolutions is the best-known form of naloxone.

It can reverse overdoses of opioids, including street drugs such as heroin and fentanyl and prescription versions including oxycodone.

Making naloxone available more widely is seen as a key strategy to control the nationwide overdose crisis, which has been linked to more than 100,000 U.S. deaths a year. The majority of those deaths are tied to opioids, primarily potent synthetic versions such as fentanyl, which can take multiple doses of naloxone to reverse.

The drug has been distributed to police and other first responders nationwide.

Advocates believe it’s important to get naloxone to the people most likely to be around overdoses, including drug users and their relatives.

The decision “represents a decisive, practical and humane approach to help people and flatten the curve of overdose deaths,” said Chuck Ingoglia of the National Council for Mental Wellbeing in a statement.

What does the FDA approval mean?

Narcan will become available over the counter by late summer, the company said.

Other brands of naloxone and injectable forms will not yet be available over the counter, but they could be soon.

Several manufacturers of generic naloxone, which is made similarly to Narcan, will now be required to file applications to switch their drugs to over the counter as part of an FDA requirement.

The nonprofit Harm Reduction Therapeutics Inc., which has funding from OxyContin maker Purdue Pharma, already has an application before the FDA to distribute its version of spray naloxone without a prescription.

How is naloxone distributed now?

Even before the FDA’s action, pharmacies could sell naloxone without a prescription because officials in every state have allowed it.

But not every pharmacy carries it. And buyers have to pay for the medication — either with an insurance co-pay or for the full retail price. The cost varies, but two doses of Narcan often go for around $50.

The drug is also distributed by community organizations that serve people who use drugs, though it’s not easily accessible to everyone who needs it.

Emergent has not announced its price, and it’s not clear yet whether insurers will continue to cover it as a prescription drug if it’s available over the counter.

FDA Commissioner Robert Califf in a statement encouraged Emergent to make the drug available “at an affordable price.”

Does making naloxone over the counter improve access?

It clears the way for Narcan to be made available in places without pharmacies — convenience stores, supermarkets and online retailers, for instance.

Jose Benitez, the lead executive officer at Prevention Point Philadelphia, an organization that tries to reduce risk for drug users through services including handing out free naloxone, said it could greatly help people who don’t seek services — or who live in places where they are not available.

Now, he said, some people are concerned about getting naloxone at pharmacies because their insurers will know they are getting it.

“Putting it out on the shelves is going to allow people just to pick it up, not have stigma attached to it,” he said.

But it remains to be seen how many stores will carry it and what the prices will be. The U.S. Centers for Medicare and Medicaid Services, or CMS, which now covers prescription naloxone for people on the government insurance programs, says that coverage of over-the-counter naloxone would depend on the insurance program. CMS has not given any official guidance.

Maya Doe-Simkins, a co-director of Remedy Alliance/For The People, which launched last year to provide low-cost — and sometimes free — naloxone to community organizations, said her group will continue to distribute injectable naloxone.

How will people learn to use Narcan?

Emergent had to conduct a study examining whether untrained people could follow directions for using Narcan.

Last month, an FDA expert panel voted to make the drug available over the counter, despite the numerous errors in using the device reported in the company study. The FDA suggested Emergent make several changes to how the directions will be displayed on the packaging and said the device could be safely used “without the supervision” of a health care worker.

Keith Humphreys, a Stanford University addiction expert, said one benefit of currently having pharmacists involved in dispensing the drug is that they can show buyers how to use it. One key thing people need to remember: Always call an ambulance for the person who has received the naloxone.

He also said there are fears that if the drug isn’t profitable as an over-the-counter option, the drugmaker could stop producing it. 
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The U.N. General Assembly adopted a landmark resolution Wednesday that will ask the International Court of Justice to issue an advisory opinion on the obligations of states under international law to protect the rights of present and future generations from the impact of climate change.

“This resolution and the advisory opinion it seeks will have a powerful and positive impact on how we address climate change and ultimately protect the present and future generations,” said Vanuatu Prime Minister Ishmael Kalsakau, whose government spearheaded the drafting and negotiations of the resolution, with a core group of 18 countries representing most corners of the world. 

“Together we will send a loud and clear message, not only around the world but far into the future: On this very day, the peoples of the United Nations, acting through their governments, decided to leave aside differences and work together to tackle the defining challenge of our times: climate change,” Kalsakau said.

More than 130 countries joined in co-sponsoring the resolution, which was adopted by consensus. While most of the world’s top emitters of greenhouse gases, including China and the United States, were noticeably absent from the co-sponsors, they did not prevent the adoption by consensus. 

The United States, which noted the Biden administration’s ambitious climate action to meet commitments consistent with keeping global warming to within the 1.5 degrees Celsius goal, said it has “serious concerns” that an ICJ opinion could hurt rather than help collective efforts to reach climate targets.

“We believe that launching a judicial process, especially given the broad scope of the questions, will likely accentuate disagreements and not be conducive to advancing our ongoing diplomatic and other processes,” U.S. delegate Nicholas Hill told the assembly. “In light of this, the United States disagrees that this initiative is the best approach for achieving our shared goals and takes this opportunity to reaffirm our view that diplomatic efforts are the best means by which to address the climate crisis.”

Japan and Germany are among the world’s top greenhouse gas emitters, and they joined as co-sponsors. Germany was also among the 18 countries that shepherded the initiative.

“Germany hopes that this initiative will contribute to further strengthen international cooperation, which is key for achieving the Paris Agreement’s objectives,” Ambassador Antje Leendertse said of the 2015 climate accord. 

The Pacific Island nation of Vanuatu’s very existence is threatened by rising sea levels. It is currently recovering from the devastation earlier this month of two Category 4 tropical cyclones in less than five days.

Kalsakau was clear that the effort is not intended to be a contentious one, nor is it a lawsuit. The authors also do not expect the Hague-based court to create new obligations on states, only to uphold existing ones. While the ICJ is the United Nation’s principal judicial organ, its decisions are not binding but carry considerable weight and can become part of what’s known as customary law.

“We believe the clarity it will bring can greatly benefit our efforts to address the climate crisis and could further bolster global and multilateral cooperation and state conduct in addressing climate change,” the prime minister said. 

U.N. Secretary-General Antonio Guterres welcomed the action, warning time is running out for nations to act boldly to fight global warming.

“This is the critical decade for climate action,” he told the assembly. “It must happen on our watch.”

The resolution began in 2019 as the brainchild of students from Vanuatu, which is among several small island states that are suffering the effects of the climate crisis but has contributed little to causing it.

“I don’t want to show a picture to my child one day of my island. I want my child to be able to experience the same environment, the same culture I grew up in,” Cynthia Houniuhi, president of Pacific Islands Students Fighting Climate Change, told reporters in a briefing ahead of the vote.

Human Rights Watch welcomed the resolution, saying it is a powerful demonstration of effective multilateral diplomacy led by a state from the Global South on behalf of people at risk.

“The overwhelming support for Vanuatu’s resolution is a major step toward gaining clarity on the legal obligations of states most responsible for climate change,” said HRW’s Environment and Human Rights director Richard Pearshouse. “It’s also important to focus — through the lens of human rights — on the obligations to protect those communities suffering most acutely.” 
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A joint project between Sudanese and Israeli scientists to study the unique resilience of Red Sea coral reefs has stalled due to red tape [bureaucratic delays], according to those involved. The project has been hailed not only for protecting coral reefs but also for normalizing Israel-Sudan relations. Henry Wilkins reports from Port Sudan, Sudan.
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The French ship the Plastic Odyssey is on a world tour to show how billions of tons of plastic waste is affecting the ocean. Allison Fernandes has this story from the Port of Dakar in Senegal. Salem Solomon narrates.
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Electricity generated from renewables surpassed coal in the United States for the first time in 2022, the U.S. Energy Information Administration announced Monday.

Renewables also surpassed nuclear generation in 2022, after first doing so last year.

Growth in wind and solar significantly drove the increase in renewable energy and contributed 14% of the electricity produced domestically in 2022. Hydropower contributed 6%, and biomass and geothermal sources generated less than 1%.

“I’m happy to see we’ve crossed that threshold, but that is only a step in what has to be a very rapid and much cheaper journey,” said Stephen Porder, a professor of ecology and assistant provost for sustainability at Brown University.

California produced 26% of the national utility-scale solar electricity followed by Texas with 16% and North Carolina with 8%.

The most wind generation occurred in Texas, which accounted for 26% of the U.S. total followed by Iowa (10%) and Oklahoma (9%).

“This booming growth is driven largely by economics,” said Gregory Wetstone, president and CEO of the American Council on Renewable Energy. “Over the past decade, the levelized cost of wind energy declined by 70%, while the levelized cost of solar power has declined by an even more impressive 90%.

“Renewable energy is now the most affordable source of new electricity in much of the country,” he added.

The Energy Information Administration projected that the wind share of the U.S. electricity generation mix will increase from 11% to 12% from 2022 to 2023 and that solar will grow from 4% to 5% during the period. The natural gas share is expected to remain at 39% from 2022 to 2023, and coal is projected to decline from 20% last year to 17% this year.

“Wind and solar are going to be the backbone of the growth in renewables, but whether or not they can provide 100% of the U.S. electricity without backup is something that engineers are debating,” said Porder, of Brown University.

Many decisions lie ahead, he said, as the proportion of renewables that supply the energy grid increases.

This presents challenges for engineers and policymakers, Porder said, because existing energy grids were built to deliver power from a consistent source. Renewables such as solar and wind generate power intermittently. So battery storage, long-distance transmission and other steps will be needed to help address these challenges, he said.

The EIA report found the country remains heavily reliant on the burning of climate-changing fossil fuels. Coal-fired generation was 20% of the electric sector in 2022, a decline from 23% in 2021. Natural gas was the largest source of electricity in the U.S. in 2022, generating 39% last year compared to 37% in 2021.

“When you look at the data, natural gas has been a major driver for lowering greenhouse gas emissions from electricity because it’s been largely replacing coal-fired power plants,” said Melissa Lott, director of research for the Center on Global Energy Policy at Columbia University.

“Moving forward, you can’t have emissions continuing to go up, you need to bring them down quickly,” she added.

The Inflation Reduction Act (IRA) influenced the amount of renewable energy projects that went online in 2022, Lott said, and it’s expected to have a “tremendous” impact on accelerating clean energy projects.
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The World Health Organization says about 87% of Sudanese females between ages 15 and 49 have undergone female genital mutilation, one of the highest rates in the world. A project by the U.N. children’s agency, UNICEF, is targeting sports clubs to engage men and boys in the fight against the practice. Henry Wilkins reports from Khartoum, Sudan.
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The Webb Space Telescope has found no evidence of an atmosphere at one of the seven rocky, Earth-sized planets orbiting another star.

Scientists said Monday that doesn’t bode well for the rest of the planets in this solar system, some of which are in the sweet spot for harboring water and potentially life.

“This is not necessarily a bust” for the other planets, Massachusetts Institute of Technology astrophysicist Sara Seager, who wasn’t part of the study, said in an email. “But we will have to wait and see.”

The Trappist solar system — a rarity with seven planets about the size of our own — has enticed astronomers ever since they spotted it just 40 light-years away. That’s close by cosmic standards; a light-year is about 5.8 trillion miles. Three of the seven planets are in their star’s habitable zone, making this star system even more alluring.

The NASA-led team reported little if any atmosphere exists at the innermost planet. Results were published Monday in the journal Nature.

The lack of an atmosphere would mean no water and no protection from cosmic rays, said lead researcher Thomas Greene of NASA’s Ames Research Center.

As for the other planets orbiting the small, feeble Trappist star, “I would have been more optimistic about the others” having atmospheres if this one had, Greene said in an email.

If rocky planets orbiting ultracool red dwarf stars like this one “do turn out to be a bust, we will have to wait for Earths around sun-like stars, which could be a long wait,” said MIT’s Seager.

Because the Trappist system’s innermost planet is bombarded by solar radiation — four times as much as Earth gets from our sun — it’s possible that extra energy is why there’s no atmosphere, Greene noted. His team found temperatures there hitting 450 degrees Fahrenheit (230 degrees Celsius) on the side of the planet constantly facing its star.

By using Webb — the largest and most powerful telescope ever sent into space — the U.S. and French scientists were able to measure the change in brightness as the innermost planet moved behind its star and estimate how much infrared light was emitted from the planet.

The change in brightness was minuscule since the Trappist star is more than 1,000 times brighter than this planet, and so Webb’s detection of it “is itself a major milestone,” the European Space Agency said.

More observations are planned not only of this planet, but the others in the Trappist system. Looking at this particular planet in another wavelength could uncover an atmosphere much thinner than our own, although it seems unlikely it could survive, said Taylor Bell of the Bay Area Environmental Research Institute, who was part of the study.

Further research could still uncover an atmosphere of sorts, even if it’s not exactly like what’s seen on Earth, said Michael Gillon of the University of Liege in Belgium who was part of the team that discovered the first three Trappist planets in 2016. He did not take part in the latest study.

“With rocky exoplanets, we are in uncharted territory” since scientists’ understanding is based on the four rocky planets of our solar system, Gillon said in an email.

Launched in late 2021 to an observation post 1 million miles (1.6 million kilometers) away, Webb is considered the successor to the Hubble Space Telescope, orbiting Earth for more than three decades.

In the past, Hubble and the Spitzer Space Telescope scoured the Trappist system for atmospheres, but without definitive results.

“It is just the beginning, and what we can learn with the inner planets is going to be different from what we can learn from the other ones,” MIT’s Julien de Wit, who was not involved in the study, said in an email.
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Scientists have long known that wild seabirds ingest bits of plastic pollution as they feed, but a new study Monday shows the tiny particles don’t just clog or transit the stomach but can subvert its complex mix of good and bad bacteria, too.

Plastic-infested digestive tracts from two species of Atlantic seabirds, northern fulmars and Cory’s shearwaters, showed a decrease of mostly beneficial “indigenous” bacteria and more potentially harmful pathogens.

There was also an increase in antibiotic-resistant and plastic-degrading microbes, researchers reported in the journal Nature Ecology & Evolution.

The findings suggested that certain types of microplastic may be leeching chemicals that disrupt the birds’ so-called gut microbiome.

Microplastics — produced when plastic products break down in the environment — are directly and indirectly ingested across most animal food chains.

They can be found in every corner of the world, from the deepest trenches of oceans to the top of Mount Everest.

In humans, they have been detected in the blood, breast milk and placentas.

The new study supports previous findings that prolonged ingestion of microplastics causes an imbalance of healthy and unhealthy bacteria in the stomach, a condition known as gut dysbiosis.

The implications are far-reaching.

Like humans, birds have evolved with a vast network of microbes, including bacteria, that live in our bodies in communities called microbiomes.

Some microbes cause diseases, but most exist as “friendly” bacteria with a critical role in digestion, immune response and other critical functions.

“There’s a symbiosis that goes on — and that’s the case in the seabirds as well as in humans,” lead author Gloria Fackelmann of Ulm University in Germany told AFP.

Little is known about the effects of individual microbes on the body.

But overall, a growing body of research points to the harmful impacts of microplastics on animal health.

The tiny particles — less than 5 millimeters in diameter — can cause cell death and allergic reactions in humans.

Chemicals in microplastics have also been linked to increased risks of cancer, reproductive problems and DNA mutations.

The authors hope the findings in seabirds will spur related studies for humans.

“If this man-made substance could alter our microbiome, I think that should make people think,” said Fackelmann.
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Florida has captured more than 17,000 Burmese pythons since 2000, but tens of thousands more are likely roaming the Florida Everglades. That’s a concern because the reptiles, which are not native to the area, are gobbling up the competition.

“[Pythons] can take out one of our apex predators, which are alligators and crocodiles, and then it’ll take down some of the other native animals that are small mammals — some of the rats, the mice, the marsh bunnies — things that are supposed to be food for other things,” says Mike Hileman, park director of Gatorland, a theme park and wildlife preserve in Orlando. “So, they compete with our native animals, and because they’re a more dominant species, they win that battle.”

The Everglades is among the world’s most unique and delicate ecosystems. The python invasion is upsetting the fragile balance of the 6 million-square-kilometer wetlands preserve, which is home to rare and endangered species like manatees, the Florida panther and the American crocodile.

“Once a species starts reproducing in the wild, and they have a system that works for them, it’s almost next to impossible to eradicate them,” Hileman says.

Florida is grappling with the most severe invasive animal crisis in the continental United States. The invasives flourish in the state’s subtropical climate, characterized by hot, humid summers and wet, mild winters. There are more than 500 non-native plant and wildlife species in the state, some of which — like pythons — are taking over the habitat and threatening the environment.

“They form almost like a monoculture of the invasives, and when your biodiversity plummets, then the environment isn’t as able to withstand perturbations like climate change,” says Kurt Foote, a ranger with the National Park Service and natural resource management specialist at Fort Matanzas National Monument in St. Augustine. “Nature relies on variety, and when you don’t have variety, it’s just more susceptible to collapse.”

There is a flourishing reptile pet trade in Florida. In 1992, Hurricane Andrew destroyed a Burmese python breeding facility, releasing the animals into the wild. The Category 5 hurricane also leveled thousands of homes, setting numerous exotic pets free.

However, the very first Burmese python was found in the Everglades in 1979, more than a decade before Hurricane Andrew, and was probably a pet that escaped or was intentionally released by its owner. Florida residents are no longer allowed to keep Burmese pythons as pets.

“Animals can be a lot of work. The parrots are loud; they live almost 80 years. Tortoises can get really big and live 100 years. So, it’s a big commitment to have a lot of these animals,” says Kylie Reynolds, deputy director of Amazing Animals Inc., a nonprofit exotic animal preserve in St. Cloud that takes in non-native animals that were once people’s pets.

“People sometimes just go, ‘You know, it’s nice in Florida. We’ll just let it loose.’… Maybe they think their animal would be happier free. But again, they could compete for our natural resources with our native wildlife,” Reynolds says.

In addition to Burmese pythons, Florida’s most problematic invasive animals include lionfish, feral hogs, Argentine black and white tegu lizards, and Cuban tree frogs, which can be found in many parts of the state, including Fort Matanzas.

“They’re a bigger tree frog than what we have here by quite a bit, and they’re also fairly omnivorous, and they will eat the native tree frogs,” Foote says. “Like a lot of invasives, when they get here, they don’t have the things that predated them or competed with them in their homelands. They get here and without that pressure, they’re able to really breed and reproduce.”

Feral hogs, originally brought to Florida by Spanish explorers in the 1500s, cause millions of dollars’ worth of damage to crops each year. The animals, which are found statewide, disrupt the soil in areas such as Lake Apopka in Mount Dora that biologists are trying to restore.

“We’re planting native vegetation. … A lot of times, they’re rare or endemic species,” says Ben Gugliotti, land manager of Lake Apopka North Shore, a nature preserve. “The hogs will come in and root up those areas, basically destroying the planting areas that we’re trying to restore. And then also actually create a secondary opening for invasive plant species that move into those disturbed soil areas.”

Argentine black and white tegu lizards are on the mind of Cheryl Millett, manager of The Nature Conservancy’s Tiger Creek preserve in Babson Park, which sits on Florida’s oldest and highest land mass.

“It’s a biodiversity hotspot. And yeah, we have a lot of things that … don’t exist anywhere else,” Millett says. “And if we lost them here, we wouldn’t have them anymore on Earth.”

She’s most concerned about tegu lizards, which haven’t reached Tiger Creek yet but have been spotted nearby. They can grow up to 1.5 meters long.

“They found baby gopher tortoises in the guts of tegu lizards that have been found in South Florida,” Millett says. “They can eat baby gopher tortoises. I’m really worried about their potential impact here.”

Gopher tortoises are listed as federally endangered. They are a keystone species, which means they are critical to the surrounding ecosystem because they provide shelter for hundreds of other animals.

“[Tegu lizards] love gopher tortoise burrows, and they’ve been found using gopher tortoise burrows in South Florida,” Millett says. “Gopher tortoises create these burrows. They’re like 10 feet deep, and can be 30 feet long, and they harbor over 300 different species in them.”

Florida spends more than $500 million a year trying to contain invasive species and the damage they cause. Officials organize hunts, exotic pet amnesty programs, and utilize other methods to combat invasive species. But it might come down to educating the future.

“Our generation, we already have preconceived ideas. We’re lost. We’re not going to change anything,” says Hileman of Gatorland, who speaks to school groups about wildlife conservation. “We’ve got to get with the little guys, and we got to get them on the same team so they can spread that message to their kids as they get older.”
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Keep an eye to the sky this week for a chance to see a planetary hangout.

Five planets — Mercury, Jupiter, Venus, Uranus and Mars — will line up near the moon.

Where and when can you see them?

The best day to catch the whole group is Tuesday. You’ll want to look to the western horizon right after sunset, said NASA astronomer Bill Cooke.

The planets will stretch from the horizon line to around halfway up the night sky. But don’t be late: Mercury and Jupiter will quickly dip below the horizon around half an hour after sunset.

The five-planet spread can be seen from anywhere on Earth, as long as you have clear skies and a view of the west.

“That’s the beauty of these planetary alignments. It doesn’t take much,” Cooke said.

Do I need binoculars?

Maybe. Jupiter, Venus and Mars will all be pretty easy to see since they shine brightly, Cooke said. Venus will be one of the brightest things in the sky, and Mars will be hanging out near the moon with a reddish glow. Mercury and Uranus could be trickier to spot, since they will be dimmer. You’ll probably need to grab a pair of binoculars.

If you’re a “planet collector,” it’s a rare chance to spot Uranus, which usually isn’t visible, Cooke said. Look out for its green glow just above Venus.

Does this happen often?

Different numbers and groups of planets line up in the sky from time to time. There was a five-planet lineup last summer and there’s another one in June, with a slightly different makeup.

This kind of alignment happens when the planets’ orbits line them up on one side of the sun from Earth’s perspective, Cooke said.
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