Science

study:-scribes-in-ancient-egypt-had-really-poor-posture-during-work

Study: Scribes in ancient Egypt had really poor posture during work

ancient egypt, anthropology, Archaeology, bio archaeology, forensic archaeology, repetitive stress, Science / /

a scribe’s life —

There were degenerative joint changes in the spines, shoulders, knees, hips, and ankles.

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Statues depicting the high dignitary Nefer and his wife (Abusir, Egypt).

Enlarge / Statues depicting the high dignitary Nefer and his wife (Abusir, Egypt).

Martin Frouz/Czech Institute of Egyptology/Charles University.

Repetitive stress injuries are a common feature of modern life, especially for office workers who spend a good chunk of their working days at a desk typing on a computer. Apparently, scribes in ancient Egypt suffered from their own distinctive repetitive stress injuries, according to a new paper published in the journal Scientific Reports that provides fresh insights into how these scribes lived and worked during the third millennium BCE.

Egyptian kings, royal family members, and other elite people from this Fifth Dynasty era were buried in tombs in the acropolis at Abusir rather than at neighboring Giza, which by then had largely filled up thanks to all the activity during the Fourth Dynasty. The Czech Institute of Egyptology at Charles University in Prague has been conducting research at the site since 1960, leading to the discovery of nearly 200 tombs dating back to the Old Kingdom (between 2700 and 2180 BCE). The first human skeletons were excavated in 1976, and there are currently 221 Old Kingdom skeletons in the collection, 102 of which are male.

Scientists started looking into the health status and markers for specific activities in 2009, but it wasn’t until quite recently that there were enough skeletons to conduct a comprehensive study. That’s what Petra Brukner Havelková of Charles University and the National Museum in Prague, Czech Republic, and colleagues set out to do, analyzing the remains of 69 adult males of different social status and different ages at which they died.

The results show the scribes and the reference group differed in just under 4 percent of the various evaluated skeletal traits, which the authors attribute to the overall similarities in the sample (male, same age distribution, no physically demanding activities). However, the individuals identified as scribes had more degenerative joint issues clustered in several well-defined regions compared to males from other occupations, including the joint connecting the lower jaw to the skull, the right collarbone, where the right humerus meets the shoulder, the right thumb’s first metacarpal bone, where the thigh meets the knee, and all along the spine (but especially at the top). These bone changes can be indicators of repetitive stress.

Bad ergonomics?

  • Working positions of scribes. (A) cross-legged (sartorial) position, (B) kneeling-squatting position, (C) standing position. (D) Different position of the legs when sitting.

    Martin Frouz/Jolana Malátková

  • Osteoarthritis of the temporomandibular joint of a supposed family member of Khemetnu, the presumed owner of family tomb AS 79.

    Šárka Bejdová

  • Drawing indicating the most affected regions of the skeletons of scribes with higher prevalence of changes compared to reference group.

    olana Malátková

For instance, the osteoarthritis in the jaw joints may have been caused by the rush stems the scribes used to write hieroglyphics. The scribes would chew on the ends to make a brush, and whenever a pen started getting ragged or too clogged with ink, they would cut off the end and chew the next section to make a new brush.

Most scribes likely wrote with their right hands and used their left to roll papyrus into cylindrical scrolls. Writing with a rush pen required considerable dexterity, and as anyone with carpal tunnel syndrome could tell you, these sorts of repetitive motions can cause excessive stress in the hands and wrists. There were only minor wrist differences between scribes and the control group, but the significant right thumb degeneration in scribes likely corresponds to specific frequently used thumb motions and positions—probably the act of repeatedly pinching their pens, although the authors say more research is needed to make a definitive determination.

The degenerative signs noted in the cervical spines are likely due to the scribes’ typical working position. “The head had to be forward and the spine flexed, changing the center of gravity of the head and putting stress on the spine,” the authors wrote—a posture common to many modern occupations. Prolonged stretches of sitting cross-legged could also have contributed to the observed damage to the cervical spines. There were signs of stresses to the right rotator cuffs, which usually occurs when the arm is in an extended elevated position and is common among painters, for example. It’s also common in people prone to sitting for a long time and typing with unsupported arms.

As for the degenerative changes noted in the knees, hips, and ankles, the authors suggest this indicates that scribes may have sat with the left leg in a kneeling or cross-legged position and the right leg pointed upward—more of a squat or a crouch. Iconography and statues from that era frequently depict scribes in such positions, as well as standing. The authors concluded that scribes probably alternated their arm and leg positions, but the head and cervical spine were always in that stress-inducing forward position.

Where’s a good ergonomic office chair when you need one?

DOI: Scientific Reports, 2024. 10.1038/s41598-024-63549-z  (About DOIs).

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synthetic-psychedelic-found-in-candies-linked-to-seizures,-intubation

Synthetic psychedelic found in candies linked to seizures, intubation

4-AcO-DMT, candies, CDC, chocolate, diamond shruumz, fda, kava, piper methysticum, psilocybin, psychedelic, Science / /

Toxic trip —

Cases grow to 39, including 23 hospitalizations, across 20 states.

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A Diamond Shruumz chocolate bar, which comes in a variety of flavors.

Enlarge / A Diamond Shruumz chocolate bar, which comes in a variety of flavors.

The US Food and Drug Administration has identified a synthetic psychedelic compound as well as compounds from a potentially toxic plant in the Diamond Shruumz-brand microdosing candies linked to a growing number of severe illnesses nationwide that have included seizures, intubation, and admissions to intensive care units.

As of June 25, the case total has grown to 39, including 23 hospitalizations, across 20 states, the FDA and the Centers for Disease Control and Prevention reported.

It remains unclear what is in the candies and what may be causing the severe illnesses. Diamond Shruumz does not provide a full list of ingredients. The term “microdosing” and other marketing used by Diamond Shruumz suggests the candies contain a psychedelic compound, but the company does not name any. To figure it out, the FDA has been analyzing multiple samples of Diamond Shruumz-brand candies, including chocolates, gummies, and candy cones. On Tuesday, the FDA reported finding the synthetic psychedelic compound 4-AcO-DMT in the company’s Dark Chocolate Bar and its Birthday Cake Chocolate Bar.

As Ars reported previously, 4-AcO-DMT (aka 4- acetoxy-N,N-dimethyltryptamine, O-acetylpsilocin, or psilacetin) is a common synthetic tryptamine used in psychedelics and was previously suspected to be in the Diamond Shruumz candies. The psychoactive drug has a chemical structure similar to the most notable mushroom-derived psychedelic, psilocybin, as well as LSD. Though safety data on the compound is scant, it is not known to be linked to some of the severe symptoms seen in the current string of illnesses. People who use 4-Aco-DMT describe it as producing effects similar to psilocybin, but without some of the unpleasant side effects noted with natural mushrooms, such as nausea. Still, according to the CDC, some people who use it could experience nausea, vomiting, fast heart rate, anxiety, agitation, lightheadedness, or tremor.

Additionally, the FDA found three compounds from the Kava plant (Piper methysticum) in the company’s dark chocolate bar, though not the birthday-cake flavored bar. The compounds are kavalactones—desmethoxyyangonin, dihydrokavain, and kavain.

Concerning kava

Kava is a plant found on some Pacific Islands and is used in traditional herbal remedies for the treatment of anxiety, insomnia, stress, and other ailments. But, over the years, it has also occasionally been linked to severe liver toxicity. In the early 2000s, this led to warnings, withdrawals, and even bans in several countries, including Germany, Switzerland, France, Canada, and the UK. In 2002, the FDA issued an advisory of its own over the associated liver injuries, which include hepatitis, cirrhosis, and liver failure. Later that same year, researchers published case reports of 11 people (two in the US and nine in Europe) who developed liver failure after using kava products and needed subsequent liver transplants.

In an update on the illnesses linked to Diamond Shruumz candies, the CDC noted that kava can cause numbness of the mouth and skin, loss of coordination, dizziness, sedation, and gastrointestinal effects, such as nausea and vomiting. Consuming kava products alongside alcohol or drugs like benzodiazepines (e.g. Valium and Xanax) can heighten the sedative effects. But, the CDC seemed to downplay the risk of liver toxicity here, noting that it has only occasionally been associated with chronic or heavy ingestion of kava.

In all, it’s still unclear if the compounds the FDA identified in the Diamond Shruumz chocolate bars so far can explain the illnesses seen in the linked cases. The CDC lists the severe and common symptoms from those cases as including seizures, decreased level of consciousness, respiratory failure, nausea, vomiting, abdominal pain, hallucinations, uncontrolled movements, abnormal heart rate (e.g., too fast or too slow), high or low blood pressure, excessive sweating or secretions, and flushed skin.

The FDA said testing of other Diamond Shruumz products is still in progress. The agency noted that there can be differences across products and batches. In the meantime, the agency advises consumers not to eat, sell, or serve any of the company’s products and, instead, discard them.

There is still no recall of the candies. Diamond Shruumz has not responded to multiple inquiries from Ars. The FDA said Tuesday that the agency has “been in contact with the firm about a possible voluntary recall,” but to date, Diamond Shruumz has not initiated one.

Synthetic psychedelic found in candies linked to seizures, intubation Read More »

dna-based-bacterial-parasite-uses-completely-new-dna-editing-method

DNA-based bacterial parasite uses completely new DNA-editing method

biochemistry, Biology, DNA, gene editing, molecular biology, RNA, Science / /
Top row: individual steps in the reaction process. Bottom row: cartoon diagram of the top, showing the position of each DNA and RNA strand.

Enlarge / Top row: individual steps in the reaction process. Bottom row: cartoon diagram of the top, showing the position of each DNA and RNA strand.

Hiraizumi, et. al.

While CRISPR is probably the most prominent gene-editing technology, there are a variety of others, some developed before, others since. And people have been developing CRISPR variants to perform more specialized functions, like altering specific bases. In all of these cases, researchers are trying to balance a number of competing factors: convenience; flexibility; specificity and precision for the editing; low error rates; and so on.

So, having additional options for editing can be a good thing, enabling new ways of balancing those different needs. On Wednesday, a pair of papers in Nature describe a DNA-based parasite that moves itself around bacterial genomes through a mechanism that hasn’t been previously described. It’s nowhere near ready for use in humans, but it may have some distinctive features that make it worth further development.

Going mobile

Mobile genetic elements, commonly called transposons, are quite common in many species—they make up nearly half the sequences in the human genome, for example. They are indeed mobile, showing up in new locations throughout the genome, sometimes by cutting themselves out and hopping to new locations, other times by sending a copy out to a new place in the genome. For any of this to work, they need to have an enzyme that cuts DNA and specifically recognizes the right transposon sequence to insert into the cut.

The specificity of that interaction, needed to ensure the system only inserts new copies of itself, and the cutting of DNA, are features we’d like for gene editing, which places a value on better understanding these systems.

Bacterial genomes tend to have very few transposons—the extra DNA isn’t really in keeping with the bacterial reproduction approach of “copy all the DNA as quickly as possible when there’s food around.” Yet bacterial transposons do exist, and a team of scientists based in the US and Japan identified one with a rather unusual feature. As an intermediate step in moving to a new location, the two ends of the transposon (called IS110) are linked together to form a circular piece of DNA.

In its circular form, the DNA sequences at the junction act as a signal that tells the cell to make an RNA copy of nearby DNA (termed a “promoter”). When linear, each of the two bits of DNA on either side of the junction lacks the ability to act as a signal; it only works when the transposon is circular. And the researchers confirmed that there is in fact an RNA produced by the circular form, although the RNA does not encode for any proteins.

So, the research team looked at over 100 different relatives of IS110 and found that they could all produce similar non-protein-coding RNAs, all of which shared some key features. These included stretches where nearby sections of the RNA could base-pair with each other, leaving an unpaired loop of RNA in between. Two of these loops contained sequences that either base-paired with the transposon itself or at the sites in the E. coli genome where it inserted.

That suggests that the RNA produced by the circular form of the transposon helped to act as a guide, ensuring that the transposon’s DNA was specifically used and only inserted into precise locations in the genome.

Editing without precision

To confirm this was right, the researchers developed a system where the transposon would produce a fluorescent protein when it was properly inserted into the genome. They used this to show that mutations in the loop that recognized the transposon would stop it from being inserted into the genome—and that it was possible to direct it to new locations in the genome by changing the recognition sequences in the second loop.

To show this was potentially useful for gene editing, the researchers blocked the production of the transposon’s own RNA and fed it a replacement RNA that worked. So, you could potentially use this system to insert arbitrary DNA sequences into arbitrary locations in a genome. It could also be used with targeting RNAs that caused specific DNA sequences to be deleted. All of this is potentially very useful for gene editing.

Emphasis on “potentially.” The problem is that the targeting sequences in the loops are quite short, with the insertion site targeted by a recognition sequence that’s only four to seven bases long. At the short end of this range, you’d expect that a random string of bases would have an insertion site about once every 250 bases.

That relatively low specificity showed. At the high end, various experiments could see an insertion accuracy ranging from a close-to-being-useful 94 percent down to a positively threatening 50 percent. For deletion experiments, the low end of the range was a catastrophic 32 percent accuracy. So, while this has some features of an interesting gene-editing system, there’s a lot of work to do before it could fulfill that potential. It’s possible that these recognition loops could be made longer to add the sort of specificity that would be needed for editing vertebrate genomes, but we simply don’t know at this point.

DNA-based bacterial parasite uses completely new DNA-editing method Read More »

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Some European launch officials still have their heads stuck in the sand

ariane 6, falcon 9, Science, Space, starship / /

This is fine —

“Starship will not eradicate Ariane 6 at all.”

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The first stage of Ariane 6 rocket Europe's Spaceport in Kourou in the French overseas department of Guiana, on March 26, 2024.

Enlarge / The first stage of Ariane 6 rocket Europe’s Spaceport in Kourou in the French overseas department of Guiana, on March 26, 2024.

LUDOVIC MARIN/AFP via Getty Images

There was a panel discussion at a space conference in Singapore 11 years ago that has since become legendary in certain corners of the space industry for what it reveals about European attitudes toward upstart SpaceX.

The panel included representatives from a handful of launch enterprises, including Europe-based Arianespace, and the US launch company SpaceX. At one point during the discussion, the host asked the Arianespace representative—its chief of sales in Southeast Asia, Richard Bowles—how the institutional European company would respond to SpaceX’s promise of lower launch costs and reuse with the Falcon 9 rocket.

“What I’m discovering in the market is that SpaceX primarily seems to be selling a dream, which is good. We should all dream,” Bowles replied. “I think a $5 million launch or a $15 million launch is a bit of a dream. Personally, I think reusability is a dream. How am I going to respond to a dream? My answer to respond to a dream is, first of all, you don’t wake people up.”

To be fair to Bowles, at the time of his remarks, SpaceX had only launched the Falcon 9 five times by the middle of 2013. But his condescension was nevertheless something to behold.

Later in the discussion, Bowles added that he did not believe launching 100 times a year, something that SpaceX was starting to talk about, was “realistic.” Then, in a moment of high paternalism, he turned to the SpaceX official on the panel and said, “You shouldn’t present things that are not realistic.”

In response, Barry Matsumori, a senior vice president at SpaceX, calmly said he would let his company’s response come through its actions.

Actions do speak louder than words

Eleven years later, of course, SpaceX is launching more than 100 times a year. The company’s internal price for launching a Falcon 9 is significantly less than $20 million. And all of this is possible through the reuse of the rocket’s first stage and payload fairings, each of which have now proven capable of flying 20 or more times.

One might think that, in the decade since, European launch officials would have learned their lesson. After all, last year, the continent had to resort to launching its valuable Euclid Space Telescope on a Falcon 9 rocket. This year, because the new European Ariane 6 rocket was not yet ready after myriad delays, multiple Galileo satellites have been launched and will be launched on the Falcon 9 rocket.

Some officials have taken note. In a candid commentary last year, European Space Agency chief Josef Aschbacher acknowledged that the continent faced an “acute” launcher crisis amid the Ariane 6 delays and the rise of SpaceX as a launch competitor. “SpaceX has undeniably changed the launcher market paradigm as we know it,” Aschbacher wrote. “With the dependable reliability of Falcon 9 and the captivating prospects of Starship, SpaceX continues to totally redefine the world’s access to space, pushing the boundaries of possibility as they go along.”

But not everyone got the message, it seems.

Next month, the Ariane 6 rocket should finally make its debut. It will probably be successful. Europe has excellent technical capabilities in regard to launch. But from day one, the Ariane 6 launch vehicle will cost significantly more than the Falcon 9 rocket, which has similar capabilities, and offer no provision for reuse. Certainly, it will meet Europe’s institutional needs. But it likely will not shake up the market, nor realistically compete with a fully reusable Falcon 9.

Who really needs to be woken up?

And what about Starship? If and when SpaceX can deliver it to the market, the next-generation rocket will offer a fully reusable booster with five times the lift capacity of the Ariane 6 rocket for half its cost or less. How can Europe hope to compete with that? The European Space Agency’s director of space transportation, Toni Tolker-Nielsen—who works for Aschbacher, it should be noted—said he’s not concerned.

“Honestly, I don’t think Starship will be a game-changer or a real competitor,” he said in an interview with Space News. “This huge launcher is designed to fly people to the Moon and Mars. Ariane 6 is perfect for the job if you need to launch a four- or five-ton satellite. Starship will not eradicate Ariane 6 at all.”

In one sense, Tolker-Nielsen is correct. Starship will not change how Europe gets its small and medium-sized satellites into space. Made and launched in Europe, the Ariane 6 rocket will be a workhorse for the continent. Indeed, some European officials are going so far as to press for legislation mandating that European satellites launch on European rockets.

But to say Starship will not be a game-changer represents the same head-in-the-sand attitude displayed by Bowles a decade ago with his jokes about not waking the deluded dreamers up. In hindsight, it’s clear that the dreamers were not SpaceX or its customers. Rather, they were European officials who had lulled themselves into thinking their dominance in commercial launch would persist without innovation.

While they slumbered, these officials ignored the rise of reusability. They decided the Ariane 6 rocket should look like its expendable predecessors, with solid rocket boosters. Meanwhile, following the rise of the Falcon 9, nearly all new rocket projects have incorporated a significant reusability component. It’s no longer just SpaceX founder Elon Musk saying companies need to pursue reuse or perish. Almost everyone is.

Perhaps someone should wake Tolker-Nielsen up.

Some European launch officials still have their heads stuck in the sand Read More »

the-mythical-gryphon-was-not-inspired-by-a-horned-dinosaur,-study-concludes

The mythical gryphon was not inspired by a horned dinosaur, study concludes

cryptology, Folklore, geomyths, gryphon, mythbusting, mythical creatures, mythology, paleontology, Science / /

Fantastic beasts and where not to find them —

The mythological creatures are instead “chimeras of big cats and raptorial birds.”

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Painting of a griffin, a lion-raptor chimaera

Enlarge / Painting of a gryphon, or griffin, a lion-raptor chimera from ancient folklore.

Mark Witton

The gryphon, or griffin, is a legendary creature dating back to classical antiquity, sporting the body, legs, and tail of a lion and the wings, head, and front talons of an eagle. Since the 1980s, a popular “geomyth” has spread that the griffin’s unique appearance was inspired by the fossilized skeleton of a horned dinosaur known as Protoceratops. It’s a fascinating and colorful story, but according to the authors of a new paper published in the journal Interdisciplinary Science Reviews, there is no hard evidence to support such a connection.

“Everything about griffin origins is consistent with their traditional interpretation as imaginary beasts, just as their appearance is entirely explained by them being [mythological] chimeras of big cats and raptorial birds,” said co-author Mark Witton, a paleontologist at the University of Portsmouth. “Invoking a role for dinosaurs in griffin lore, especially species from distant lands like Protoceratops, not only introduces unnecessary complexity and inconsistencies to their origins, but also relies on interpretations and proposals that don’t withstand scrutiny.”

There are representations of griffin-like creatures in ancient Egyptian art dated to before 3000 BCE, while in ancient Greek and Roman texts the creatures were associated with gold deposits in Central Asia. By the Middle Ages, griffins were common figures in medieval iconography and in heraldry. The hippogriff named Buckbeak in Harry Potter and the Prisoner of Azkaban is a related mythical creature, the product of a griffin and a mare.

It was the legendary link to Central Asian gold deposits that intrigued classical folklorist Adrienne Mayor in the 1980s. Drawing on Greek and Latin texts and related artworks, she suggested (beginning with a 1989 paper in Cryptozoology) that nomadic prospectors stumbled across fossilized skeletons of Protoceratops and brought tales of strange beaked quadrupeds to other regions as they traveled southeast along ancient trade routes. The dinosaur’s bony neck frill might have been interpreted in early illustrations as mammal-like external ears, with its beak indicating a creature that was part-bird, leading to the eventual addition of wings.

This 9th century BCE relief depicts a griffin-like monster being pursued by a deity.

Enlarge / This 9th century BCE relief depicts a griffin-like monster being pursued by a deity.

L. Gruner/Layard (1853)

Over the last 30 years, Mayor’s hypothesis has gained traction in the popular media and within certain academic circles; it’s now one of the most famous and widely touted examples of geomythology. It’s not an entirely crazy idea, even if its origins lie in the pseudoscientific field of cryptozoology. After all, people as far back as Paleolithic times certainly used fossils as decorative ornaments or talismans, and there are bona fide cases of such “geomyths”: For example, British ammonites were modified into “snake stones”; shark teeth were interpreted as snake tongues; and “winged” brachiopods became “stone swallows” in historic China.

The case for skepticism

But Witton and fellow Portsmouth paleontologist Richard Hing were skeptical because of the lack of any material evidence to support the connection between the griffin and Protoceratops. And they weren’t alone. Paleontologist Paul Sereno once dismissed Mayor’s claims as “sophomoric” and questioned her understanding of how fossils are found, identified, and interpreted, per the authors. So they set out to conduct the first detailed assessment of Mayor’s claims, re-examining historical fossil records—including the distribution of sites where Protoceratops fossils have been found—and classical sources, as well as consulting with historians and archaeologists about the supposed link.

“It is important to distinguish between fossil folklore with a factual basis—that is, connections between fossils and myth evidenced by archaeological discoveries or compelling references in literature and artwork—and speculated connections based on intuition,” said Hing. “There is nothing inherently wrong with the idea that ancient peoples found dinosaur bones and incorporated them into their mythology, but we need to root such proposals in realities of history, geography, and palaeontology. Otherwise, they are just speculation.”

The mythical gryphon was not inspired by a horned dinosaur, study concludes Read More »

nasa’s-commercial-spacesuit-program-just-hit-a-major-snag

NASA’s commercial spacesuit program just hit a major snag

collins, Science, Space, suit / /

Suit issues —

“Unfortunately Collins has been significantly behind schedule.”

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NASA astronaut Christina Koch (right) poses for a portrait with fellow Expedition 61 Flight Engineer Jessica Meir, who is inside a US spacesuit for a fit check.

Enlarge / NASA astronaut Christina Koch (right) poses for a portrait with fellow Expedition 61 Flight Engineer Jessica Meir, who is inside a US spacesuit for a fit check.

NASA

Almost exactly two years ago, as it prepared for the next generation of human spaceflight, NASA chose a pair of private companies to design and develop new spacesuits. These were to be new spacesuits that would allow astronauts to both perform spacewalks outside the International Space Station as well as walk on the Moon as part of the Artemis program.

Now, that plan appears to be in trouble, with one of the spacesuit providers—Collins Aerospace—expected to back out, Ars has learned. It’s a blow for NASA, because the space agency really needs modern spacesuits.

NASA’s Apollo-era suits have long been retired. The current suits used for spacewalks in low-Earth orbit are four decades old. “These new capabilities will allow us to continue on the ISS and allows us to do the Artemis program and continue on to Mars,” said the director of Johnson Space Center, Vanessa Wyche, during a celebratory news conference in Houston two years ago.

The two winning teams were led by Collins Aerospace and Axiom Space, respectively. They were eligible for task orders worth up to $3.5 billion—in essence NASA would rent the use of these suits for a couple of decades. Since then, NASA has designated Axiom to work primarily on a suit for the Moon and the Artemis Program, and Collins with developing a suit for operations in-orbit, such as space station servicing.

Collins exits

This week, however, Collins said it will likely end its participation in the Exploration Extravehicular Activity Services, or xEVAS, contract. On Tuesday morning Chris Ayers, general manager at Collins Aerospace, met with employees to tell them about the company’s exit from the program. A NASA source confirmed decision.

“Unfortunately Collins has been significantly behind schedule,” a person familiar with the situation told Ars. “Collins has admitted they have drastically underperformed and have overspent on their xEVAS work, culminating in a request to be taken off the contract or renegotiate the scope and their budget.”

NASA and Collins Aerospace acknowledged a request for comment sent by Ars early on Tuesday morning but as of the afternoon did not provide substantive replies to questions about this action, nor steps forward.

The agency has been experiencing periodic problems with the maintenance of the suits built decades ago, known as the Extravehicular Mobility Unit, which made its debut in the 1980s. NASA has acknowledged the suit has exceeded its planned design lifetime. Just this Monday the agency had to halt a spacewalk after the airlock had been de-pressurized and hatch opened due to a water leak in the service and cooling umbilical unit of Tracy Dyson’s spacesuit.

As a result of this problem, NASA will likely only be able to conduct a single spacewalk this summer, after initially planning three, to complete work outside the International Space Station.

Increased pressure on Axiom

During the bidding process for the commercial spacesuit program, which unfolded in 2021 and 2022, just two bidders ultimately emerged. A unit of Raytheon Technologies, Collins was the bidder with the most experience in spacesuits, having designed the original Apollo suits, and it partnered with experienced providers ILC Dover and Oceaneering. Axiom is a newer company that, until the spacesuit competition, was largely focused on developing a private space station.

As they evaluated bids, NASA officials raised some concerns about Collins’ approach, noting that the proposal relied on “rapid acceleration of technology maturation and resolution of key technical trade studies to achieve their proposed schedule.” However, in its source selection statement, the agency concluded that it had a “high level of confidence” that Collins would be able to deliver on its spacesuits.

It is not clear what NASA will do now. One person suggested that NASA would not seek to immediately re-compete the xEVAS because it could signal to private investors that Axiom is not capable of delivering on its spacesuit contracts. (Like a lot of other companies in this capital-constrained era, Axiom Space, according to sources, has been struggling to raise a steady stream of private investment.)

Another source, however, suggested that NASA likely would seek to bring a new partner on board to compete with Axiom. The space agency did something similar in 2007 with its Commercial Orbital Transportation Services program to provide cargo to the space station. When Rocketplane Kistler could not deliver on its commitments, the agency recompeted the contract and ultimately selected Orbital Sciences. If NASA were to re-open competition, one of the bidders could be SpaceX, which has already designed a basic spacesuit to support the private Polaris Dawn mission.

Since the awards two years ago, Axiom has been making comparatively better technical progress on its spacesuit, which is based on the Extravehicular Mobility Unit design that NASA has used for decades. However, the Houston-based company has yet to complete the critical design review process, which can be demanding. Axiom is also battling a difficult supply chain environment—which is especially problematic given that NASA has not built new suits for such a long time.

NASA’s commercial spacesuit program just hit a major snag Read More »

“energy-smart”-bricks-need-less-power-to-make,-are-better-insulation

“Energy-smart” bricks need less power to make, are better insulation

bricks, green, materials science, recycling, Science, Sustainability, waste / /
Image of a person holding a bag full of dirty looking material with jagged pieces in it.

Enlarge / Some of the waste material that ends up part of these bricks.

Seamus Daniel, RMIT University

Researchers at the Royal Melbourne Institute of Technology (RMIT) in Australia have developed special “energy-smart bricks” that can be made by mixing clay with glass waste and coal ash. These bricks can help mitigate the negative effects of traditional brick manufacturing, an energy-intensive process that requires large-scale clay mining, contributes heavily to CO2 emissions, and generates a lot of air pollution.

According to the RMIT researchers, “Brick kilns worldwide consume 375 million tonnes (~340 million metric tons) of coal in combustion annually, which is equivalent to 675 million tonnes of CO2 emission (~612 million metric tons).” This exceeds the combined annual carbon dioxide emissions of 130 million passenger vehicles in the US.

The energy-smart bricks rely on a material called RCF waste. It mostly contains fine pieces of glass (92 percent) left over from the recycling process, along with ceramic materials, plastic, paper, and ash. Most of this waste material generally ends up in landfills, where it can cause soil and water degradation. However, the study authors note, “The utilization of RCF waste in fired-clay bricks offers a potential solution to the increasing global waste crisis and reduces the burden on landfills.”

What makes the bricks “energy-smart”

Compared to traditional bricks, the newly developed energy-smart bricks have lower thermal conductivity: They retain heat longer and undergo more uniform heating. This means they can be manufactured at lower firing temperatures. For instance, while regular clay bricks are fired (a process during which bricks are baked in a kiln, so they become hard and durable) at 1,050° C, energy-smart bricks can achieve the required hardness at 950° C, saving 20 percent of the energy needed for traditional brickmaking.

Based on bricks produced in their lab, they estimated that “each firing cycle led to a potential value of up to $158,460 through a reduction of 417 tonnes of CO2, resulting from a 9.5 percent reduction in firing temperature.” So basically, if a manufacturer switches from regular clay bricks to energy-smart bricks, it will end up saving thousands of dollars on its power bill, and its kilns will release less CO2 into Earth’s atmosphere. Scaled up to the estimated 1.4 trillion bricks made each year, the savings are substantial.

But brick manufacturers aren’t the only ones who benefit. “Bricks characterized by low thermal conductivity contribute to efficient heat storage and absorption, creating a cooler environment during summer and a warmer comfort during winter. This advantage translates into energy savings for air conditioning, benefiting the occupants of the house or building,” the study authors explained.

Tests conducted by the researchers suggest that the residents of a single-story house built using energy-smart bricks will save up to 5 percent on their energy bills compared to those living in a house made with regular clay bricks.

“Energy-smart” bricks need less power to make, are better insulation Read More »

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Saturn’s moon Titan has shorelines that appear to be shaped by waves

astronomy, Cassini, geology, planetary science, Saturn, Science, Titan / /

Surf the moon —

The liquid hydrocarbon waves would likely reach a height of a meter.

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Ligeia Mare, the second-largest body of liquid hydrocarbons on Titan.

Enlarge / Ligeia Mare, the second-largest body of liquid hydrocarbons on Titan.

During its T85 Titan flyby on July 24, 2012, the Cassini spacecraft registered an unexpectedly bright reflection on the surface of the lake Kivu Lacus. Its Visual and Infrared Mapping Spectrometer (VIMS) data was interpreted as a roughness on the methane-ethane lake, which could have been a sign of mudflats, surfacing bubbles, or waves.

“Our landscape evolution models show that the shorelines on Titan are most consistent with Earth lakes that have been eroded by waves,” says Rose Palermo, a coastal geomorphologist at St. Petersburg Coastal and Marine Science Center, who led the study investigating signatures of wave erosion on Titan. The evidence of waves is still inconclusive, but future crewed missions to Titan should probably pack some surfboards just in case.

Troubled seas

While waves have been considered the most plausible explanation for reflections visible in Cassini’s VIMS imagery for quite some time, other studies aimed to confirm their presence found no wave activity at all. “Other observations show that the liquid surfaces have been very still in the past, very flat,” Palermo says. “A possible explanation for this is at the time we were observing Titan, the winds were pretty low, so there weren’t many waves at that time. To confirm waves, we would need to have better resolution data,” she adds.

The problem is that this higher-resolution data isn’t coming our way anytime soon. Dragonfly, the next mission to Titan, isn’t supposed to arrive until 2034, even if everything goes as planned.

To get a better idea about possible waves on Titan a bit sooner, Palermo’s team went for inferring their presence from indirect cues. The researchers assumed shorelines on Titan could have been shaped by one of three candidate scenarios. They first assumed there was no erosion at all; the second modeled uniform erosion caused by the dissolution of the bedrock by the ethane-methane liquid; and the third assumed erosion by wave activity. “We took a random topography with rivers, filled up the basin-flooding river valleys all around the lake. Then, we then used landscape evolution computer model to erode the coast to 50 percent of its original size,” Palermo explains.

Sizing the waves

Palermo’s simulations showed that wave erosion resulted in coastline shapes closely matching those actually observed on Titan.

The team validated its model using data from closer to home. “We compared using the same statistical analysis to lakes on Earth, where we know what the erosion processes are. With certainty greater than 77.5 percent, we were able to predict those known processes with our modeling,” Palermo says.

But even the study that claimed there were waves visible in the Cassini’s VIMS imagery concluded they were roughly 2 centimeters high at best. So even if there are waves on Titan, the question is how high and strong are they?

According to Palermo, wave-generation mechanisms on Titan should work just like they do on Earth, with some notable differences. “There is a difference in viscosity between water on Earth and methane-ethane liquid on Titan compared to the atmosphere,” says Palermo. The gravity is also a lot weaker, standing at only one-seventh of the gravity on Earth. “The gravity, along with the differences in material properties, contributes to the waves being taller and steeper than those on Earth for the same wind speed,” says Palermo.

But even with those boosts to size and strength, could waves on Titan actually be any good for surfing?

Surf’s up

“There are definitely a lot of open questions our work leads to. What is the direction of the dominant waves? Knowing that can tell us about the winds and, therefore, about the climate on Titan. How large do the waves get? In the future, maybe we could tell that with modeling how much erosion occurs in one part of the lake versus another in estimated timescales. There is a lot more we could learn,” Palermo says. As far as surfing is concerned, she said that, assuming a minimum height for a surfable wave of around 15 centimeters, surfing on Titan should most likely be doable.

The key limit on the size and strength of any waves on Titan is that most of its seas are roughly the size of the Great Lakes in the US. The largest of them, the Kraken Mare, is roughly as large as the Caspian Sea on Earth. There is no such thing as a global ocean on Titan, and this means the fetch, the distance over which the wind can blow and grow the waves, is limited to tens of kilometers instead of over 1,500 kilometers on Earth. “Still, some models show that the waves on Titan be as high as one meter. I’d say that’s a surfable wave,” Palermo concluded.

Saturn’s moon Titan has shorelines that appear to be shaped by waves Read More »

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Astronomers think they’ve figured out how and when Jupiter’s Red Spot formed

astronomy, geophysics, Giovanni Cassini, great red spot, Jupiter, Science, science history / /

a long-lived vortex —

Astronomers concluded it is not the same and that Cassini’s spot disappeared in 1708.

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Enhanced image of Jupiter’s Great Red Spot, as seen from a Juno flyby in 2018. The Red Spot we see today is likely not the same one famously observed by Cassini in the 1600s.

Enlarge / Enhanced Juno image of Jupiter’s Great Red Spot in 2018. It is likely not the same one observed by Cassini in the 1600s.

The planet Jupiter is particularly known for its so-called Great Red Spot, a swirling vortex in the gas giant’s atmosphere that has been around since at least 1831. But how it formed and how old it is remain matters of debate. Astronomers in the 1600s, including Giovanni Cassini, also reported a similar spot in their observations of Jupiter that they dubbed the “Permanent Spot.” This prompted scientists to question whether the spot Cassini observed is the same one we see today. We now have an answer to that question: The spots are not the same, according to a new paper published in the journal Geophysical Research Letters.

“From the measurements of sizes and movements, we deduced that it is highly unlikely that the current Great Red Spot was the ‘Permanent Spot’ observed by Cassini,” said co-author Agustín Sánchez-Lavega of the University of the Basque Country in Bilbao, Spain. “The ‘Permanent Spot’ probably disappeared sometime between the mid-18th and 19th centuries, in which case we can now say that the longevity of the Red Spot exceeds 190 years.”

The planet Jupiter was known to Babylonian astronomers in the 7th and 8th centuries BCE, as well as to ancient Chinese astronomers; the latter’s observations would eventually give birth to the Chinese zodiac in the 4th century BCE, with its 12-year cycle based on the gas giant’s orbit around the Sun. In 1610, aided by the emergence of telescopes, Galileo Galilei famously observed Jupiter’s four largest moons, thereby bolstering the Copernican heliocentric model of the solar system.

(a) 1711 painting of Jupiter by Donato Creti showing the reddish Permanent Spot. (b) November 2, 1880, drawing of Jupiter by E.L. Trouvelot. (c) November 28, 1881, drawing by T.G. Elger.

Enlarge / (a) 1711 painting of Jupiter by Donato Creti showing the reddish Permanent Spot. (b) November 2, 1880, drawing of Jupiter by E.L. Trouvelot. (c) November 28, 1881, drawing by T.G. Elger.

Public domain

It’s possible that Robert Hooke may have observed the “Permanent Spot” as early as 1664, with Cassini following suit a year later and multiple more sightings through 1708. Then it disappeared from the astronomical record. A pharmacist named Heinrich Schwabe made the earliest known drawing of the Red Spot in 1831, and by 1878 it was once again quite prominent in observations of Jupiter, fading again in 1883 and at the onset of the 20th century.

Perhaps the spot is not the same…

But was this the same Permanent Spot that Cassini had observed? Sánchez-Lavega and his co-authors set out to answer this question, combing through historical sources—including Cassini’s notes and drawings from the 17th century—and more recent astronomical observations and quantifying the results. They conducted a year-by-year measurement of the sizes, ellipticity, area, and motions of both the Permanent Spot and the Great Red Spot from the earliest recorded observations into the 21st century.

The team also performed multiple numerical computer simulations testing different models for vortex behavior in Jupiter’s atmosphere that are the likely cause of the Great Red Spot. It’s essentially a massive, persistent anticyclonic storm. In one of the models the authors tested, the spot forms in the wake of a massive superstorm. Alternatively, several smaller vortices created by wind shear may have merged, or there could have been an instability in the planet’s wind currents that resulted in an elongated atmospheric cell shaped like the spot.

Sánchez-Lavega et al. concluded that the current Red Spot is probably not the same as that observed by Cassini and others in the 17th century. They argue that the Permanent Spot had faded by the start of the 18th century, and a new spot formed in the 19th century—the one we observe today, making it more than 190 years old.

Comparison between the Permanent Spot and the current Great Red Spot. (a) December 1690. (b) January 1691. (c) January 19, 1672. (d) August 10, 2023.

Enlarge / Comparison between the Permanent Spot and the current Great Red Spot. (a) December 1690. (b) January 1691. (c) January 19, 1672. (d) August 10, 2023.

Public domain/Eric Sussenbach

But maybe it is?

Others remain unconvinced of that conclusion, such as astronomer Scott Bolton of the Southwest Research Institute in Texas. “What I think we may be seeing is not so much that the storm went away and then a new one came in almost the same place,” he told New Scientist. “It would be a very big coincidence to have it occur at the same exact latitude, or even a similar latitude. It could be that what we’re really watching is the evolution of the storm.”

The numerical simulations ruled out the merging vortices model for the spot’s formation; it is much more likely that it’s due to wind currents producing an elongated atmospheric shell. Furthermore, in 1879, the Red Spot measured about 24,200 miles (39,000 kilometers) at its longest axis and is now about 8,700 miles (14,000 kilometers). So, the spot has been shrinking over the ensuing decades and becoming more rounded. The Juno mission’s most recent observations also revealed the spot is thin and shallow.

The question of why the Great Red Spot is shrinking remains a matter of debate. The team plans further simulations aiming to reproduce the shrinking dynamics and predict whether the spot will stabilize at a certain size and remain stable or eventually disappear like Cassini’s Permanent Spot presumably did.

Geophysical Research Letters, 2024. DOI: 10.1029/2024GL108993  (About DOIs).

Astronomers think they’ve figured out how and when Jupiter’s Red Spot formed Read More »

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Is having a pet good for you? The fuzzy science of pet ownership

Cats, Dogs, pets, Science, syndication / /

Who’s a good dog? —

It turns out the pet care industry has funded a lot of studies.

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A picture of a bull terrier on a park bench

For more than a decade, in blog posts and scientific papers and public talks, the psychologist Hal Herzog has questioned whether owning pets makes people happier and healthier.

It is a lonely quest, convincing people that puppies and kittens may not actually be terrific for their physical and mental health. “When I talk to people about this,” Herzog recently said, “nobody believes me.” A prominent professor at a major public university once described him as “a super curmudgeon” who is, in effect, “trying to prove that apple pie causes cancer.”

As a teenager in New Jersey in the 1960s, Herzog kept dogs and cats, as well as an iguana, a duck, and a boa constrictor named Boa. Now a professor emeritus at Western Carolina University, he insists he’s not out to smear anyone’s furry friends. In a blog post questioning the so-called pet effect, in 2012, Herzog included a photo of his cat, Tilly. “She makes my life better,” he wrote. “Please Don’t Blame The Messenger!”

Plenty of people believe there’s something salubrious about caring for a pet, similar to eating veggies or exercising regularly. But, Herzog argues, the scientific evidence that pets can consistently make people healthier is, at best, inconclusive—and, at worst, has been used to mislead the American public.

Few, if any, experts say Herzog is exactly wrong—at least about the science. Over the past 30 or so years, researchers have published hundreds of studies exploring a link between pet ownership and a range of hypothesized benefits, including improved heart health, longer lifespans, and lower rates of anxiety and depression.

The results have been mixed. Studies often fail to find any robust link between pets and human well-being; some even find evidence of harms. In many cases, the studies simply can’t determine whether pets cause the observed effect or are simply correlated with it.

Where Herzog and some other experts have concerns is with the way those mixed results have been packaged and sold to the public. Tied up in that critique are pointed questions about the role of industry money on the development of a small field—a trend that happens across scientific endeavors, particularly those that don’t garner much attention from federal agencies, philanthropies, and other funding sources.

The pet care industry has invested millions of dollars in human-animal interaction research, mostly since the late 2000s. Feel-good findings have been trumpeted by industry press releases and, in turn, dominated news coverage, with headlines like “How Dogs Help Us Lead Longer, Healthier Lives.”

At times, industry figures have even framed pet ownership as a kind of public health intervention. “Everybody should quit smoking. Everybody should go to the gym. Everybody should eat more fruits and vegetables. And everyone should own a pet,” said Steven Feldman, president of the industry-funded Human Animal Bond Research Institute, in a 2015 podcast interview.

The problem with that kind of argument, Herzog and other experts say, is that it gets out ahead of the evidence (and that not every person is equipped to care for a pet). “Most studies,” said Herzog, “do not show the pattern of results that the pet products industry claims.”

Is having a pet good for you? The fuzzy science of pet ownership Read More »

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NASA indefinitely delays return of Starliner to review propulsion data

Science, Space, starliner / /

You can check out any time you like —

“We are letting the data drive our decision.”

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Boeing's Starliner capsule lifts off aboard United Launch Alliance's Atlas V rocket.

Enlarge / Boeing’s Starliner capsule lifts off aboard United Launch Alliance’s Atlas V rocket.

In an update released late Friday evening, NASA said it was “adjusting” the date of the Starliner spacecraft’s return to Earth from June 26 to an unspecified time in July.

The announcement followed two days of long meetings to review the readiness of the spacecraft, developed by Boeing, to fly NASA astronauts Butch Wilmore and Suni Williams to Earth. According to sources, these meetings included high-level participation from senior leaders at the agency, including Associate Administrator Jim Free.

This “Crew Flight Test,” which launched on June 5 atop an Atlas V rocket, was originally due to undock and return to Earth on June 14. However, as engineers from NASA and Boeing studied data from the vehicle’s problematic flight to the International Space Station, they have waved off several return opportunities.

On Friday night they did so again, citing the need to spend more time reviewing data.

“Taking our time”

“We are taking our time and following our standard mission management team process,” said Steve Stich, manager of NASA’s Commercial Crew Program, in the NASA update. “We are letting the data drive our decision making relative to managing the small helium system leaks and thruster performance we observed during rendezvous and docking.”

Just a few days ago, on Tuesday, officials from NASA and Boeing set a return date to Earth for June 26. But that was before a series of meetings on Thursday and Friday during which mission managers were to review findings about two significant issues with the Starliner spacecraft: five separate leaks in the helium system that pressurizes Starliner’s propulsion system and the failure of five of the vehicle’s 28 reaction-control system thrusters as Starliner approached the station.

The NASA update did not provide any information about deliberations during these meetings, but it is clear that the agency’s leaders were not able to get comfortable with all contingencies that Wilmore and Williams might encounter during a return flight to Earth, including safely undocking from the space station, maneuvering away, performing a de-orbit burn, separating the crew capsule from the service module, and then flying through the planet’s atmosphere before landing under parachutes in a New Mexico desert.

Spacecraft has a 45-day limit

Now, the NASA and Boeing engineering teams will take some more time. Sources said NASA considered June 30 as a possible return date, but the agency is also keen to perform a pair of spacewalks outside the station. These spacewalks, presently planned for June 24 and July 2, will now go ahead. Starliner will make its return to Earth sometime afterward, likely no earlier than the July 4 holiday.

“We are strategically using the extra time to clear a path for some critical station activities while completing readiness for Butch and Suni’s return on Starliner and gaining valuable insight into the system upgrades we will want to make for post-certification missions,” Stich said.

In some sense, it is helpful for NASA and Boeing to have Starliner docked to the space station for a longer period of time. They can gather more data about the performance of the vehicle on long-duration missions—eventually Starliner will fly operational missions that will enable astronauts to stay on orbit for six months at a time.

However, this vehicle is only rated for a 45-day stay at the space station, and that clock began ticking on June 6. Moreover, it is not optimal that NASA feels the need to continue delaying the vehicle to get comfortable with its performance on the return journey to Earth. During a pair of news conferences since Starliner docked to the station, officials have downplayed the overall seriousness of these issues—repeatedly saying Starliner is cleared to come home “in case of an emergency.” But they have yet to fully explain why they are not yet comfortable with releasing Starliner to fly back to Earth under normal circumstances.

NASA indefinitely delays return of Starliner to review propulsion data Read More »

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Top FDA official overrules staff to approve gene therapy that failed trial

clinical data, clinical trials, duchenne muscular dystrophy, elevidys, fda, fda approval, gene therapy, Peter Marks, sarepta, Science / /

Internal conflict —

Peter Marks overruled three teams and two top directors.

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Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration on March 18, 2021 in Washington, DC.

Enlarge / Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration on March 18, 2021 in Washington, DC.

The Food and Drug Administration (FDA) on Thursday announced expanded approval for a gene therapy to treat Duchenne muscular dystrophy (DMD)—despite the fact that it failed a Phase III clinical trial last year and that the approval came over the objections of three of FDA’s own expert review teams and two of its directors.

In fact, the decision to expand the approval of the therapy—called Elevidys (delandistrogene moxeparvovec-rokl)—appears to have been decided almost entirely by Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research.

Elevidys initially gained an FDA approval last year, also over objections from staff. The therapy intravenously delivers a transgene that codes for select portions of a protein called dystrophin in healthy muscle cells; the protein is mutated in patients with DMD. Last year’s initial approval occurred under an accelerated approval process and was only for use in DMD patients ages 4 and 5 who are able to walk. In the actions Thursday, the FDA granted a traditional approval for the therapy and opened access to DMD patients of all ages, regardless of ambulatory status.

“Today’s approval broadens the spectrum of patients with Duchenne muscular dystrophy eligible for this therapy, helping to address the ongoing, urgent treatment need for patients with this devastating and life-threatening disease,” Marks said in the announcement Thursday. “We remain steadfast in our commitment to help advance safe and effective treatments for patients who desperately need them.”

Criticism

The move, which follows a string of controversies in recent years of the FDA issuing questionable approvals over the assessments of advisors and its own staff, has quickly drawn criticism from agency watchers.

In a blog post Friday, a notable pharmaceutical industry expert and commentator, Derek Lowe, admonished the approval. Lowe expressed concern that the agency seems to be tilting toward emotional rhetoric and the will of patient advocates over scientific and medical evidence.

“It appears that all you need is a friend high up in the agency and your clinical failures just aren’t an issue any more,” he wrote. “Review committees aren’t convinced? Statisticians don’t buy your arguments? Who cares! Peter Marks is here to deliver hot, steaming takeout containers full of Hope. … And while I realize that this may make me sound like a heartless SOB, I think this is a huge mistake that we will be paying for for a long time.”

In a comment to Stat News, former FDA chief scientist Luciana Borio echoed concerns about how decisions like this will affect the agency in the longer term.

“I don’t know what to say. Peter Marks makes a mockery of scientific reasoning and approval standards that have served patients well over decades,” said Borio, who has also opposed earlier controversial approvals. “This type of action also promotes the growing mistrust in scientific institutions like the FDA.”

Internal dissent

In a series of review documents and memos released by the FDA, the divide between Marks and agency staff is abundantly clear. A review by FDA statisticians concluded that the collective clinical trial results “do not suggest there is substantial evidence to support the effectiveness of [Elevidys] for the expanded indication to all DMD patients and do not support the conversion of accelerated to traditional approval.”

A joint review from the agency’s Clinical and Clinical Pharmacology teams likewise concluded that the “totality of the data does not provide substantial evidence of effectiveness of Elevidys for treatment of ambulatory DMD patients of any age” and that the results “argue against” expanding access.

In a memo, Lola Fashoyin-Aje, Director of the Office of Clinical Evaluation in the Office of Therapeutic Products (OTP), and Dr. Nicole Verdun, Super Office Director of the OTP, concluded that the clinical results “cast significant uncertainty regarding the benefits of treatment of DMD with Elevidys.” The two directors found the primary clinical trial endpoint results were “not statistically significant” and smaller analyses looking at secondary endpoints of specific patient measures—such as the time it takes patients to rise from the floor or walk 10 meters—were “inconclusive,” in some cases “conflicting,” and overall illustrated the “unreliability of exploratory analyses to support regulatory decision-making.”

In a memo of his own, Marks agreed that primary endpoint result of the trial—based on scores on a standardized assessment of motor function in patients—did not show a statistically significant benefit. But he argued that the secondary endpoints were convincing enough for him. Marks wrote:

Specifically, although acknowledging that the Applicant’s randomized study of Elevidys failed to meet its statistical primary endpoint … I find that the observations regarding the secondary endpoints and exploratory endpoints are compelling and, combined with other data provided in the efficacy supplement and the original [Biologics License Application], meet the substantial evidence of effectiveness standard …

If Marks had not overruled the agency’s reviewers and directors, Fashoyin-Aje wrote that she would have recommended the therapy’s maker, Sarepta, conduct “an additional adequate and well-controlled study of Elevidys in the subgroup(s) of patients for which [Sarepta] believes the effects of Elevidys to be most promising.” However, Marks’ decision to approve renders the possibility of such a trial “highly infeasible to explore in a post-approval setting,” she wrote.

Top FDA official overrules staff to approve gene therapy that failed trial Read More »