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FDA Approves Journavx Drug to Treat Pain Without Addiction Risk

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FDA Approves Journavx Drug to Treat Pain Without Addiction Risk

The Food and Drug Administration approved a new medication Thursday to treat pain from an injury or surgery. It is expensive, with a list price of $15.50 per pill. But unlike opioid pain medicines, it cannot become addictive.

That is because the drug, suzetrigine, made by Vertex Pharmaceuticals and to be sold as Journavx, works only on nerves outside the brain, blocking pain signals. It cannot get into the brain.

Researchers say they expect it to be the first of a new generation of more powerful nonaddictive drugs to relieve pain.

To test the drug, Vertex, which is based in Boston, conducted two large clinical trials, each with approximately 1,000 patients who had pain from surgery. They were randomly assigned to get a placebo; to get the opioid sold as Vicodin, a widely used combination pain medicine of acetaminophen (Tylenol) and hydrocodone; or to get suzetrigine.

In one trial, patients had an abdominoplasty, or tummy tuck. In the other, they had a bunionectomy. Side effects of suzetrigine reported by patients were similar to the ones reported by those taking the placebo.

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The company also submitted data from a 250-person study that assessed the drug’s safety and tolerability in patients with pain from surgery, trauma or accidents.

Suzetrigine eased pain as much as the combination opioid. Both were better than the placebo at relieving pain.

Suzetrigine’s price, though, is much higher than that of acetaminophen plus hydrocodone. Patients are expected to take two pills a day, for a total cost of $31 a day. The older drug, said Dr. John D. Loeser, an emeritus pain expert at the University of Washington, is “dirt cheap” at pennies per pill.

But suzetrigine does not have opioids’ unpleasant side effects like nausea and drowsiness, and it is nonaddictive.

“There are a number of people who, once they have an opioid, want an opioid constantly,” Dr. Loeser said.

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About 85,000 people a year become addicted after taking a prescription opioid, said Dr. David Altshuler, chief scientific officer at Vertex. It’s a small proportion of the 40 million prescribed opioids each year for acute pain — from surgery, accidents or trauma — but is nonetheless a large number, he said.

The story of suzetrigine began in the late 1990s with basic research by Dr. Stephen Waxman of Yale. He wondered how nerve cells signal pain to the brain.

Nerve cells have nine sodium channels — tiny molecular batteries — that generate electrical signals.

But, he discovered, two of those channels are only active outside the brain. One, called Nav1.7, is like the fuse for a firecracker, Dr. Waxman said. A nerve cell activates Nav1.7. That signal, in turn, activates a second channel, Nav1.8, which, he said, sends electrical signals of pain to the brain.

It seemed that a drug that could block Nav1.7 or Nav1.8 could be a potent pain medication that would have no effects on the brain, and therefore would not be addictive. (Dr. Waxman is not paid by Vertex, but does consult for other companies working on similar drugs.)

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But there was another piece of the puzzle: Were these lab results applicable to humans?

If the lab work was predictive, people with mutations that made Nav1.7 or Nav1.8 fire constantly would be in constant pain. And people with the opposite mutation — one that blocked the channels — should feel no pain.

Both sorts of mutations would be extremely rare, if they existed.

Dr. Waxman contacted pain physicians across the entire Northern Hemisphere, asking if they had patients who had constant, intractable pain that could be caused by mutations that made Nav1.7 or Nav1.8 overactive. He came up empty-handed.

Then, in 2004, the Erythromelalgia Association told him about a family in Alabama whose members were wracked with pain. Most had ended up addicted to opioids and were unable to go to school or to work. Their condition was called “Man on Fire syndrome.”

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Dr. Waxman and his colleagues found that the members of this family had a mutation in the Nav1.7 channel that made their pain nerves fire constantly.

Another group of researchers reported that a family in Pakistan whose members felt no pain had a mutation that blocked the same channel from firing. People called them firewalkers because they could walk on hot coals and feel nothing, which they did for money.

Vertex’s new drug, which blocks the Nav1.8 channel, is highly specific — the other sodium channels are left alone by the drug. Suzetrigine’s effects disappear when people stop taking the pills.

But although people with acute pain might need such a drug, there is also another group that needs pain relief but has few good options — those who have damaged nerves that cause constant pain, called peripheral neuropathic pain. That group includes people with diabetes, which can make the hands or feet hurt or go numb, among other symptoms. And it includes people with lumbosacral radiculopathy, or pinched nerves in the spine. Sciatica is one form of this condition.

In small studies, Vertex found that suzetrigine helped those with diabetic neuropathy, but was no better than placebo in those with pinched spinal nerves.

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But, Dr. Altshuler said, the company is going ahead with larger studies in both groups of patients. While analysts and researchers deemed the results disappointing in patients with pinched nerves in their spines, the company decided to proceed because there are no approved drugs for the painful condition, and because the drug is safe and “the mechanism of action is so clearly validated.”

“No one has ever helped these four million people,” he said.

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U.S. Terminates Funding for Polio, H.I.V., Malaria and Nutrition Programs Around the World

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U.S. Terminates Funding for Polio, H.I.V., Malaria and Nutrition Programs Around the World

“People will die,” said Dr. Catherine Kyobutungi, executive director of the African Population and Health Research Center, “but we will never know, because even the programs to count the dead are cut.”

The projects terminated include H.I.V. treatment programs that had served millions of people, the main malaria control programs in the worst-affected African countries and global efforts to wipe out polio.

Here are some of the projects that The New York Times has confirmed have been canceled:

  • A $131 million grant to UNICEF’s polio immunization program, which paid for planning, logistics and delivery of vaccines to millions of children.

  • A $90 million contract with the company Chemonics for bed nets, malaria tests and treatments that would have protected 53 million people.

  • A project run by FHI 360 that supported community health workers’ efforts to go door-to-door seeking malnourished children in Yemen. It recently found that one in five children was critically underweight because of the country’s civil war.

  • All of the operating costs and 10 percent of the drug budget of the Global Drug Facility, the World Health Organization’s main supply channel for tuberculosis medications, which last year provided tuberculosis treatment to nearly three million people, including 300,000 children.

  • H.I.V. care and treatment projects run by the Elizabeth Glaser Pediatric AIDS Foundation that were providing lifesaving medication to 350,000 people in Lesotho, Tanzania and Eswatini, including 10,000 children and 10,000 pregnant women who were receiving care so that they would not transmit the virus to their babies at birth.

  • A project in Uganda to trace contacts of people with Ebola, conduct surveillance and bury those who died from the virus.

  • A contract to manage and distribute $34 million worth of medical supplies in Kenya, including 2.5 million monthlong H.I.V. treatments, 750,000 H.I.V. tests, 500,000 malaria treatments, 6.5 million malaria tests and 315,000 antimalaria bed nets.

  • Eighty-seven shelters that took care of 33,000 women who were victims of rape and domestic violence in South Africa.

  • A project in the Democratic Republic of Congo that operates the only source of water for 250,000 people in camps for displaced people located in the center of the violent conflict in the east of the country.

  • Pre- and postnatal health services for 3.9 million children and 5.7 million women in Nepal.

  • A project run by Helen Keller Intl in six countries in West Africa that last year provided more than 35 million people with the medicine to prevent and treat neglected tropical diseases, such as trachoma, lymphatic filariasis, schistosomiasis and onchocerciasis.

  • A project in Nigeria providing 5.6 million children and 1.7 million women with treatment for severe and acute malnutrition. The termination means 77 health facilities have completely stopped treating children with severe acute malnutrition, putting 60,000 children under the age of 5 at immediate risk of death.

  • A project in Sudan that runs the only operational health clinics in one of the biggest areas of the Kordofan region, cutting off all health services.

  • A project serving more than 144,000 people in Bangladesh that provided food for malnourished pregnant women and vitamin A to children.

  • A program run by the aid agency PATH, called REACH Malaria, which protected more than 20 million people from the disease. It provided malaria drugs to children at the start of the rainy season in 10 countries in Africa.

  • A project run by Plan International that provided drugs and other medical supplies, health care, treatment of malnutrition programming, and water and sanitation for 115,000 displaced or affected by the conflict in northern Ethiopia.

  • More than $80 million for UNAIDS, the United Nations agency, which funded work to help countries improve H.I.V. treatment, including data collection and watchdog programs for service delivery.

  • The President’s Malaria Initiative program called Evolve, which did mosquito control in 21 countries by methods that include spraying insecticide inside homes (protecting 12.5 million people last year) and treating breeding sites to kill larvae.

  • A project providing H.I.V. and tuberculosis treatment to 46,000 people in Uganda, run by the Baylor College of Medicine Children’s Foundation, Uganda.

  • Smart4TB, the main research consortium working on prevention, diagnostics and treatment for tuberculosis.

  • The Demographic and Health Surveys, a data collection project in 90 countries that were crucial and sometimes the only sources of information on maternal and child health and mortality, nutrition, reproductive health and H.I.V. infections, among many other health indicators. The project was also the bedrock of budgets and planning.

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    Mass firings across NOAA and National Weather Service ignite fury from scientists worldwide

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    Mass firings across NOAA and National Weather Service ignite fury from scientists worldwide

    As federal job eliminations struck the National Oceanic and Atmospheric Administration and the National Weather Service on Thursday, scientists and environmental advocates denounced the cuts, saying they could cause real harm to Americans.

    The full extent of the layoffs across NOAA were not immediately clear, but Democratic legislators said hundreds of scientists and experts had been notified of terminated employment. NOAA — which includes the National Hurricane Center and the Tsunami Warning Center — is the latest in a string of federal agencies targeted for cuts by Elon Musk’s Department of Government Efficiency.

    “Musk’s sham mission is bringing vital programs to a screeching halt,” U.S. Rep. Jared Huffman (D-San Rafael), the ranking member of the House Natural Resources Committee, wrote in a statement Thursday. “People nationwide depend on NOAA for free, accurate forecasts, severe weather alerts, and emergency information. Purging the government of scientists, experts, and career civil servants and slashing fundamental programs will cost lives.”

    Susan Buchanan, a spokesperson for NOAA, declined to comment on the cuts, saying in a statement that the agency would not be discussing personnel matters, “per long-standing practice.”

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    “NOAA remains dedicated to its mission, providing timely information, research and resources that serve the American public and ensure our nation’s environmental and economic resilience,” Buchanan said. “We continue to provide weather information, forecasts and warnings pursuant to our public safety mission.”

    Several people who identified themselves as NOAA or weather service employees wrote on social media that they, or family members, had received an email Thursday notifying them that they had been terminated. It appeared that many were considered probationary employees, meaning they were recently hired or promoted.

    NOAA’s Great Lakes Environmental Research Labratory posted on X that it would be ending its public communication services “due to a reduction in staff.” It wasn’t immediately clear how other operations might suffer, but scientists across the globe worried there could be dangerous effects. NOAA agencies provide key alerts and forecasts during weather emergencies and monitor for extreme events, such as hurricanes, tsunamis and dangerous fire weather.

    “The fact of the matter is that the private sector, as it presently exists, simply cannot quickly spin up to fill any void left by substantial dismantling of NOAA and/or the NWS,” Daniel Swain, a UCLA climate scientist said in a statement on social media. “The now-confirmed and rumored additional cuts to come at NOAA/NWS are spectacularly short-sighted, and ultimately will deal a major self-inflected wound to the public safety of Americans and the resiliency of the American economy to weather and climate-related disasters.”

    It’s unclear the exact nature of the NOAA firings, but they are likely to be subject to a legal review. A federal judge just on Thursday blocked several mass firings of probationary employees at federal agencies because they were probably carried out illegally.

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    But the mass exodus of NOAA employees shocked environmental advocates and scientists across the globe, particularly those focused on the climate, environment and meteorology.

    “Gutting NOAA will hamstring essential lifesaving programs that forecast storms, ensure ocean safety and prevent the extinction of whales and sea otters,” said Miyoko Sakashita, the oceans program director for the Center for Biological Diversity, an environmental nonprofit that works to protect wildlife. “I think most Americans want these kinds of vital government services protected, and we’ll do everything we can to defend them.”

    Juan Declet-Barreto, a senior social scientist for climate vulnerability at the Union of Concerned Scientists, a member-supported group of scientists, called the move from the Trump administration reckless for both the safety of communities and the future of climate science.

    “Decimating the nation’s core scientific enterprise, even as costly and deadly climate change impacts and extreme weather events worsen, flies in the face of logic, common sense and fiscal responsibility,” Declet-Barreto said. “NOAA’s data and science are used routinely by weather forecasters, mariners, farmers, emergency responders, businesses and everyday people across the country. Everyone in the United States relies on NOAA in their daily lives whether they realize it or not, something that will come into focus for many in the weeks and months ahead.”

    Jeff Watters, the vice president of external affairs for the Ocean Conservancy, a national nonprofit focused on improving the health of the sea, said the cuts to NOAA will hurt the ocean.

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    “The indiscriminate firing of employees is going to sabotage NOAA’s ability to do essential work that every single American relies on,” Watters said in a statement. “NOAA is the eyes and ears for our water and air — the agency tracks our weather and climate; monitors tides and surf forecasts; allows for the safe deployment and navigation of satellites, ships, and doppler radar. It acts as a first responder with its weather and hurricane emergency alerts; its tsunami warning centers; its oil spill response capabilities; its marine mammal stranding network; and its harmful algal blooms early warning systems. NOAA even keeps seafood on the table. Americans depend on NOAA each and every day, and so does the health of the ocean.”

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    Intuitive Machines’ Athena Lander Launches on Journey to the Moon

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    Intuitive Machines’ Athena Lander Launches on Journey to the Moon

    Intuitive Machines landed a robot on the moon last year. Can the Houston company do it again, but keep the spacecraft upright this time?

    The company’s second lander, named Athena, launched on Wednesday evening on a SpaceX Falcon 9 rocket from NASA’s Kennedy Space Center in Florida. It is now on an arcing path to the moon.

    The spacecraft turned itself on, but then several minutes of suspense followed when it was late to check in. Eventually, data from the probe arrived, accompanied by relief at Intuitive Machines’ mission control.

    On March 6, the spacecraft will attempt to land in Mons Mouton, a region about 100 miles from the moon’s south pole. That will be closer to the south pole than any previous spacecraft has landed.

    When Intuitive Machines’ first lander, Odysseus, set down on the moon in February last year, it managed to communicate with Earth even though it had toppled on its side. It was the first commercially operated lander to reach the moon’s surface, and the first American vehicle to land softly on the moon since Apollo 17 in 1972.

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    The main payload on Athena is a drill for NASA as part of its Commercial Lunar Payload Services program. Paying a commercial company like Intuitive Machines to take something to the moon is cheaper for NASA than designing and building its own spacecraft.

    The drill is designed to dig about three feet below the surface, pulling up lunar soil about four inches at a time and dropping it onto a pile on the surface. An instrument known as a mass spectrometer will then sniff around the drilled material for compounds like frozen water that easily transform into gases.

    The Athena lander is also carrying three robotic rovers and a small flying “hopper” that will be deployed after landing.

    The largest rover, known as the Mobile Autonomous Prospecting Platform, or MAPP, is part of a NASA-financed test of the first cellphone network on the moon. Nokia won financing from the space agency to test the technology but then needed a way to move at least one antenna some distance from the lander. So Nokia hired a company called Lunar Outpost to build the rover, which is about the size of a small dog.

    Lunar Outpost sold space on MAPP to other customers. One, the Massachusetts Institute of Technology, built a tiny rover called AstroAnt, which will crawl around on the top flat surface of MAPP.

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    Athena will also deploy a rover called Yaoki, built by a Japanese company, Dymon, that is a bit bigger than a Mac mini computer.

    Intuitive Machines built the hopper as part of another NASA contract. The small rocket-powered craft could offer new opportunities to explore long distances, similar to the way NASA’s Ingenuity helicopter on Mars provided a different way to explore areas not easily reached on the ground.

    On the airless moon, helicopters cannot fly, but thrusters will allow the hopper to fly long distances. It will also be carrying one of the Nokia cellphone antennas. The plan is to fly into one of the moon’s permanently shadowed craters.

    The Odysseus lander was supposed to use a laser altimeter to help guide it to the moon’s surface. But because of an oversight during the launch preparations, a safety switch for the device was never disabled, rendering that tool useless. Engineers at Intuitive Machines hurriedly rewrote their landing software to use similar measurements from an experimental NASA instrument on the spacecraft. But they missed updating one key parameter in the computer code, and the landing software ignored the data.

    The spacecraft thus landed oblivious to its exact altitude, only guessing its distance above the surface based on horizontal speed calculated from camera images and measurements of accelerations in the spacecraft’s velocity. The guesses were close enough that it did not crash, although it was still moving horizontally. The landing gear broke, and the spacecraft tipped.

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    The Athena lander is almost identical to Odysseus — each is what the company calls its Nova-C design — and Intuitive Machines officials said they had tested the laser multiple times.

    Three more separate spacecraft are riding on the Falcon 9 rocket. They are essentially taking advantage of extra payload space in the rocket for a cheaper ride to space.

    One, Lunar Trailblazer, is a lost-cost NASA mission — about $100 million — designed to measure the distribution of water on the moon from orbit.

    While Athena will make a quick one-week trip to the moon, Lunar Trailblazer will take a more leisurely, fuel-efficient path. If launch occurs on Wednesday, it will take just over four months to reach the moon. (If the launch occurs on a different day, the trajectory changes, and the journey could be as long as seven months.)

    A second spacecraft, Odin, is a microwave-size spacecraft built by the company AstroForge of California. It will head to a near-Earth asteroid to examine whether it might be full of valuable metals that could be mined in the future.

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    A third vehicle, CHIMERA GEO 1, is a spacecraft from Epic Aerospace of San Francisco designed to put small satellites in distant orbits.

    The mission on the surface is scheduled to last for less than one lunar day, or about 10 Earth days, until the sun sets. With no solar energy, the spacecraft’s batteries will run out of power.

    But in the middle of the lunar day, on March 14 at about 2 a.m. Eastern time, darkness will fall for a few minutes — an eclipse when the Earth passes between the sun and the moon.

    The solar-powered lander will have to draw power from its batteries during the eclipse but should survive.

    Athena is the third commercial lander launched toward the moon this year, although it might be the second to arrive.

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    On Jan. 15, a Falcon 9 rocket launched carrying the other two landers — Blue Ghost from Firefly Aerospace of Austin, Texas, and Resilience by Ispace of Japan.

    Blue Ghost, like Athena, is part of NASA’s CLPS program, and it is scheduled to land on March 2, ahead of Athena. It is headed toward Mare Crisium, a basin in the northeast quadrant of the near side of the moon.

    Resilience, also known as the Hakuto-R Mission 2 lander, is taking an indirect route and is expected to arrive at the moon in May. Its landing site is near the center of Mare Frigoris, or the Sea of Cold, in the moon’s northern hemisphere. This will be Ispace’s second lunar landing attempt. Its first mission, in 2023, crashed.

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