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.
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.”
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.
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.
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.
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.
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.
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.
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.”
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.
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.
Earlier this week, the US Senate passed what’s being called the ADVANCE Act, for Accelerating Deployment of Versatile, Advanced Nuclear for Clean Energy. Among a number of other changes, the bill would attempt to streamline permitting for newer reactor technology and offer cash incentives for the first companies that build new plants that rely on one of a handful of different technologies. It enjoyed broad bipartisan support both in the House and Senate and now heads to President Biden for his signature.
Given Biden’s penchant for promoting his bipartisan credentials, it’s likely to be signed into law. But the biggest hurdles nuclear power faces are all economic, rather than regulatory, and the bill provides very little in the way of direct funding that could help overcome those barriers.
Incentives
For reasons that will be clear only to congressional staffers, the Senate version of the bill was attached to an amendment to the Federal Fire Prevention and Control Act. Nevertheless, it passed by a margin of 88-2, indicating widespread (and potentially veto-proof) support. Having passed the House already, there’s nothing left but the president’s signature.
The bill’s language focuses on the Nuclear Regulatory Commission (NRC) and its role in licensing nuclear reactor technology. The NRC is directed to develop a variety of reports for Congress—so, so many reports, focusing on everything from nuclear waste to fusion power—that could potentially inform future legislation. But the meat of the bill has two distinct focuses: streamlining regulation and providing some incentives for new technology.
The incentives are one of the more interesting features of the bill. They’re primarily focused on advanced nuclear technology, which is defined extremely broadly by an earlier statute as providing any of the following:
(A) additional inherent safety features
(B) significantly lower levelized cost of electricity
(C) lower waste yields
(D) greater fuel utilization
(E) enhanced reliability
(F) increased proliferation resistance
(G) increased thermal efficiency
(H) ability to integrate into electric and nonelectric applications
Normally, the work of the NRC in licensing is covered via application fees paid by the company seeking the license. But the NRC is instructed to lower its licensing fees for anyone developing advanced nuclear technologies. And there’s a “prize” incentive where the first company to get across the line with any of a handful of specific technologies will have all these fees refunded to it.
Winners will be awarded when they have met any of the following requirements: the first advanced reactor design that receives a license from the NRC; the first to be loaded with fuel for operation; the first to use isotopes derived from spent fuel; the first to build a facility where the reactor is integrated into a system that stores energy; the first to build a facility where the reactor provides electricity or processes heat for industrial applications.
The first award will likely go to NuScale, which is developing a small, modular reactor design and has gotten pretty far along in the licensing process. Its first planned installation, however, has been cancelled due to rising costs, so there’s no guarantee that the company will be first to fuel a reactor. TerraPower, a company backed by Bill Gates, is fairly far along in the design of a rector facility that will come with integrated storage, and so may be considered a frontrunner there.
For the remaining two prizes, there aren’t frontrunners for very different reasons. Nearly every company building small modular nuclear reactors promotes them as a potential source of process heat. By contrast, reprocessing spent fuel has been hugely expensive in any country where it has been tried, so it’s unlikely that prize will ever be given out.
Enlarge/ New research lends further credence to the “population crash” theory about Easter Island being just a myth.
Arian Zwegers/CC BY 2.0
For centuries, Western scholars have touted the fate of the native population on Easter Island (Rapa Nui) as a case study in the devastating cost of environmentally unsustainable living. The story goes that the people on the remote island chopped down all the trees to build massive stone statues, triggering a population collapse. Their numbers were further depleted when Europeans discovered the island and brought foreign diseases, among other factors. But an alternative narrative began to emerge in the 21st century that the earliest inhabitants actually lived quite sustainably until that point. A new paper published in the journal Science Advances offers another key piece of evidence in support of that alternative hypothesis.
As previously reported, Easter Island is famous for its giant monumental statues, called moai, built some 800 years ago and typically mounted on platforms called ahu. Scholars have puzzled over the moai on Easter Island for decades, pondering their cultural significance, as well as how a Stone Age culture managed to carve and transport statues weighing as much as 92 tons. The first Europeans arrived in the 17th century and found only a few thousand inhabitants on a tiny island (just 14 by 7 miles across) thousands of miles away from any other land. Since then, in order to explain the presence of so many moai, the assumption has been that the island was once home to tens of thousands of people.
But perhaps they didn’t need tens of thousands of people to accomplish that feat. Back in 2012, Carl Lipo of Binghamton University and Terry Hunt of the University of Arizona showed that you could transport a 10-foot, 5-ton moai a few hundred yards with just 18 people and three strong ropes by employing a rocking motion. In 2018, Lipo proposed an intriguing hypothesis for how the islanders placed red hats on top of some moai; those can weigh up to 13 tons. He suggested the inhabitants used ropes to roll the hats up a ramp. Lipo and his team later concluded (based on quantitative spatial modeling) that the islanders likely chose the statues’ locations based on the availability of fresh water sources, per a 2019 paper in PLOS One.
In 2020, Lipo and his team turned their attention to establishing a better chronology of human occupation of Rapa Nui. While it’s generally agreed that people arrived in Eastern Polynesia and on Rapa Nui sometime in the late 12th century or early 13th century, we don’t really know very much about the timing and tempo of events related to ahu construction and moai transport in particular. In his bestselling 2005 book Collapse, Jared Diamond offered the societal collapse of Easter Island (aka Rapa Nui), around 1600, as a cautionary tale. Diamond controversially argued that the destruction of the island’s ecological environment triggered a downward spiral of internal warfare, population decline, and cannibalism, resulting in an eventual breakdown of social and political structures.
Challenging a narrative
Lipo has long challenged that narrative, arguing as far back as 2007 against the “ecocide” theory. He and Hunt published a paper that year noting the lack of evidence of any warfare on Easter Island compared to other Polynesian islands. There are no known fortifications, and the obsidian tools found were clearly used for agriculture. Nor is there much evidence of violence among skeletal remains. He and Hunt concluded that the people of Rapa Nui continued to thrive well after 1600, which would warrant a rethinking of the popular narrative that the island was destitute when Europeans arrived in 1722.
For their 2020 study, the team applied a Bayesian model-based method to existing radiocarbon dates collected from prior excavations at 11 different sites with ahu. That work met with some mixed opinions from Lipo’s fellow archaeologists, with some suggesting that his team cherry-picked its radiocarbon dating—an allegation he dismissed at the time as “simply baloney and misinformed thinking.” They filtered their radiocarbon samples to just those they were confident related to human occupation and human-related events, meaning they analyzed a smaller subset of all the available ages—not an unusual strategy to eliminate bias due to issues with old carbon—and the results for colonization estimates were about the same as before.
Enlarge/ Binghamton University’s Robert J. DiNapoli stands next to a rock garden on Rapa Nui, or Easter Island.
Robert J. DiNapoli
The model also integrated the order and position of the island’s distinctive architecture, as well as ethnohistoric accounts, thereby quantifying the onset of monument construction, the rate at which it occurred, and when it likely ended. This allowed the researchers to test Diamond’s “collapse” hypothesis by building a more precise timeline of when construction took place at each of the sites. The results demonstrated a lack of evidence for a pre-contact collapse and instead offered strong support for a new emerging model of resilient communities that continued their long-term traditions despite the impacts of European arrival.
Fresh evidence
Now Lipo is back with fresh findings in support of his alternative theory, having analyzed the landscape to identify all the agricultural areas on the island. “We really wanted to look at the evidence for whether the island could in fact support such a large number of people,” he said during a media briefing. “What we know about the pre-contact people living on the island is that they survived on a combination of marine resources—fishing accounted for about 50 percent of their diet—and growing crops,” particularly the sweet potato, as well as taro and yams.
He and his co-authors set out to determine how much food could be produced agriculturally, extrapolating from that the size of a sustainable population. The volcanic soil on Easter Island is highly weathered and thus poor in nutrients essential for plant growth: nitrogen, phosphorus and potassium primarily, but also calcium, magnesium, and sulfur. To increase yields, the natives initially cut down the island’s trees to get nutrients back into the soil.
When there were no more trees, they engaged in a practice called “lithic mulching,” a form of rock gardening in which broken rocks were added to the first 20 to 25 centimeters (about 8 to 10 inches) of soil. This added essential nutrients back into the soil. “We do it ourselves with non-organic fertilizer,” said Lipo. “Essentially we use machines to crush rock into tiny pieces, which is effective because it exposes a lot of surface area. The people in Rapa Nui are doing it by hand, literally breaking up rocks and sticking them in dirt.”
There had been only one 2013 study aimed at determining the island’s rock-garden capacity, which relied on near-infrared bands from satellite images. The authors of that study estimated that between 4.9 and 21.2 km2 of the island’s total area comprised rock gardens, although they acknowledged this was likely an inaccurate estimation.
Enlarge/ A map of results from the analysis of rock gardens on Easter Island.
Carl Lipo
Lipo et al. examined satellite imagery data collected over the last five years, not just in the near-infrared, but also short-wave infrared (SWIR) and other visible spectra. SWIR is particularly sensitive to detecting water and nitrogen levels, making it easier to pinpoint areas where lithic mulching occurred. They trained machine-learning models on archaeological field identifications of rock garden features to analyze the SWIR data for a new estimation of capacity.
The result: Lipo et al. determined that the prevalence of rock gardening was about one-fifth of even the most conservative previous estimates of population size on Easter Island. They estimate that the island could support about 3,000 people—roughly the same number of inhabitants European explorers encountered when they arrived. “Previous studies had estimated that the island was fairly covered with mulch gardening, which led to estimates of up to 16,000 people,” said Lipo. “We’re saying that the island could never have supported 16,000 people; it didn’t have the productivity to do so. This pre-European collapse narrative simply has no basis in the archaeological record.”
“We don’t see demographic change decline in populations prior to Europeans’ arrival,” Lipo said. “All the [cumulative] evidence to date shows a continuous growth until some plateau is reached. It certainly was never an easy place to live, but people were able to figure out a means of doing so and lived within the boundaries of the capacity of the island up until European arrival.” So rather than being a cautionary tale, “Easter Island is a great case of how populations adapt to limited resources on a finite place, and do so sustainably.”
Binghamton University archaeologist Carl Lipo has shed light on some of the ancient mysteries of Easter Island (Rapa Nui) through his ongoing research. Credit: Binghamton University, State University of New York
The piece of debris that fell through Alejandro Otero’s roof (right) came from a support bracket jettisoned from the International Space Station.
The owner of a home in southwestern Florida has formally submitted a claim to NASA for damages caused by a chunk of space debris that fell through his roof in March.
The legal case is unprecedented—no one has evidently made such a claim against NASA before. How the space agency responds will set a precedent, and that may be important in a world where there is ever more activity in orbit, with space debris and vehicles increasingly making uncontrolled reentries through Earth’s atmosphere.
Alejandro Otero, owner of the Naples, Florida, home struck by the debris, was not home when part of a battery pack from the International Space Station crashed through his home on March 8. His son Daniel, 19, was home but escaped injury. NASA has confirmed the 1.6-pound object, made of the metal alloy Inconel, was part of a battery pack jettisoned from the space station in 2021.
An attorney for the Otero family, Mica Nguyen Worthy, told Ars that she has asked NASA for “in excess of $80,000” for non-insured property damage loss, business interruption damages, emotional and mental anguish damages, and the costs for assistance from third parties.
“We intentionally kept it very reasonable because we did not want it to appear to NASA that my clients are seeking a windfall,” Worthy said.
The family has not filed a lawsuit against NASA, at least not yet. Worthy said she has been having productive conversations with NASA legal representatives. She said the Otero family wants to be made whole for their losses, but also to establish a precedent for future victims. “This is truly the first legal claim that is being submitted for recovery for damages related to space debris,” Worthy said. “How NASA responds will, in my view, be foundational for how future claims are handled. This is really changing the legal landscape.”
Who, exactly, is liable for space debris?
If space debris from another country—say, a Chinese or Russian rocket upper stage—were to strike a family in the United States, the victims would be entitled to compensation under the Space Liability Convention agreed to by space powers half a century ago. Under this treaty, a launching state is “absolutely” liable to pay compensation for damage caused by its space objects on the surface of the Earth or to aircraft, and liable for damage due to its faults in space. In an international situation, NASA or some other US government agency would negotiate on the victim’s behalf for compensation.
However, in this case the debris came from the International Space Station: an old battery pack that NASA was responsible for. NASA completed a multi-year upgrade of the space station’s power system in 2020 by installing a final set of new lithium-ion batteries to replace aging nickel-hydrogen batteries that were reaching end-of-life. During a spacewalk, this battery pack was mounted on a cargo pallet launched by Japan.
Officials originally planned to place pallets of the old batteries inside a series of Japanese supply freighters for controlled, destructive reentries over the ocean. But due to a series of delays, the final cargo pallet of old batteries missed its ride back to Earth, so NASA jettisoned the batteries to make an unguided reentry. NASA incorrectly believed the batteries would completely burn up during the return through the atmosphere.
Enlarge/ This cylindrical object, a few inches in size, fell through the roof of Alejandro Otero’s home in Florida in March.
Because this case falls outside the Space Liability Convention, there is no mechanism for a US citizen to seek claims from the US government for damage from space debris. So the Otero family is making a first-ever claim under the Federal Torts Claim Act for falling space debris. This torts act allows someone to sue the US government if there has been negligence. In this case, the negligence could be that NASA miscalculated about the survival of enough debris to damage property on Earth.
NASA provided a form to the Otero family to submit a claim, which Worthy said they did at the end of May. NASA now has six months to review the claim. The space agency has several options. Legally, it could recompense the Otero family up to $25,000 for each of its claims based on the Federal Torts Claim Act (see legal code). If the agency seeks to pay full restitution, it would require approval from the US attorney general. Finally, NASA could refuse the claims or make an unacceptable settlement offer—in which case the Otero family could file a federal lawsuit in Florida.
Ars has sought comment from NASA about the claims made and will update this story when we receive one.
Enlarge/ Pharma interest and investment in radiotherapy drugs is heating up.
Knowable Magazine
On a Wednesday morning in late January 1896 at a small light bulb factory in Chicago, a middle-aged woman named Rose Lee found herself at the heart of a groundbreaking medical endeavor. With an X-ray tube positioned above the tumor in her left breast, Lee was treated with a torrent of high-energy particles that penetrated into the malignant mass.
“And so,” as her treating clinician later wrote, “without the blaring of trumpets or the beating of drums, X-ray therapy was born.”
Radiation therapy has come a long way since those early beginnings. The discovery of radium and other radioactive metals opened the doors to administering higher doses of radiation to target cancers located deeper within the body. The introduction of proton therapy later made it possible to precisely guide radiation beams to tumors, thus reducing damage to surrounding healthy tissues—a degree of accuracy that was further refined through improvements in medical physics, computer technologies and state-of-the-art imaging techniques.
But it wasn’t until the new millennium, with the arrival of targeted radiopharmaceuticals, that the field achieved a new level of molecular precision. These agents, akin to heat-seeking missiles programmed to hunt down cancer, journey through the bloodstream to deliver their radioactive warheads directly at the tumor site.
Use of radiation to kill cancer cells has a long history. In this 1915 photo, a woman receives “roentgenotherapy”—treatment with X-rays—directed at an epithelial-cell cancer on her face.
Wikimedia Commons
Today, only a handful of these therapies are commercially available for patients—specifically, for forms of prostate cancer and for tumors originating within hormone-producing cells of the pancreas and gastrointestinal tract. But this number is poised to grow as major players in the biopharmaceutical industry begin to invest heavily in the technology.
AstraZeneca became the latest heavyweight to join the field when, on June 4, the company completed its purchase of Fusion Pharmaceuticals, maker of next-generation radiopharmaceuticals, in a deal worth up to $2.4 billion. The move follows similar billion-dollar-plus transactions made in recent months by Bristol Myers Squibb (BMS) and Eli Lilly, along with earlier takeovers of innovative radiopharmaceutical firms by Novartis, which continued its acquisition streak—begun in 2018—with another planned $1 billion upfront payment for a radiopharma startup, as revealed in May.
“It’s incredible how, suddenly, it’s all the rage,” says George Sgouros, a radiological physicist at Johns Hopkins University School of Medicine in Baltimore and the founder of Rapid, a Baltimore-based company that provides software and imaging services to support radiopharmaceutical drug development. This surge in interest, he points out, underscores a wider recognition that radiopharmaceuticals offer “a fundamentally different way of treating cancer.”
Treating cancer differently, however, means navigating a minefield of unique challenges, particularly in the manufacturing and meticulously timed distribution of these new therapies, before the radioactivity decays. Expanding the reach of the therapy to treat a broader array of cancers will also require harnessing new kinds of tumor-killing particles and finding additional suitable targets.
“There’s a lot of potential here,” says David Nierengarten, an analyst who covers the radiopharmaceutical space for Wedbush Securities in San Francisco. But, he adds, “There’s still a lot of room for improvement.”
Atomic advances
For decades, a radioactive form of iodine stood as the sole radiopharmaceutical available on the market. Once ingested, this iodine gets taken up by the thyroid, where it helps to destroy cancerous cells of that butterfly-shaped gland in the neck—a treatment technique established in the 1940s that remains in common use today.
But the targeted nature of this strategy is not widely applicable to other tumor types.
The thyroid is naturally inclined to absorb iodine from the bloodstream since this mineral, which is found in its nonradioactive form in many foods, is required for the synthesis of certain hormones made by the gland.
Other cancers don’t have a comparable affinity for radioactive elements. So instead of hijacking natural physiological pathways, researchers have had to design drugs that are capable of recognizing and latching onto specific proteins made by tumor cells. These drugs are then further engineered to act as targeted carriers, delivering radioactive isotopes—unstable atoms that emit nuclear energy—straight to the malignant site.
