Saturday, June 10, 2023

Crocodile’s ‘virgin birth’ is a first for science’s history books
The Conversation
June 9, 2023

Crocodile LuckyStep/Shutterstock

The first evidence of a virgin birth in crocodiles has been reported in a captive American crocodile, Crocodylus acutus, who was housed on her own for 16 years in a zoo in Costa Rica. She laid a clutch of 14 eggs, of which seven seemed viable and were artificially incubated. The eggs failed to hatch and the contents of six of them were indiscernible. But one contained a fully formed foetus, genetically identical to its mother, showing no evidence of input from any males.

This isn’t the first case of a virgin birth in the animal kingdom. Baby lizards, snakes, sharks and birds, including the California condor, have all been documented hatching from unfertilized eggs.

How do we explain virgin births?

Species can reproduce either sexually, combining genetic material from two parents, or asexually. Our ancient ancestors were asexual and essentially made clones of themselves. Plants reproduce in a similar way, including splitting, budding and fragmenting.

However, this produces lots of organisms that are genetically identical, and a lack of genetic variation means that individuals cannot adapt to changing conditions. If the environment is bad for one member of a species, it is bad for all, and could lead to extinction.

Sexual reproduction in species such as humans needs sperm to fertilize eggs and create an embryo. In terms of evolution, sexually reproducing species are thought of as being more advanced, as their offspring are genetically diverse, with unique gene combinations from their parents.

This diversity can be important if a species needs to adapt. It also reduces adverse genetic mutations, which are often associated with inbreeding (when close relatives mate).


The virgin mother was an American crocodile like this one. 
Uwe Bergwitz/Shutterstock

Virgin births are a form of asexual reproduction as they do not require genetic information from sperm. But, unlike other forms of asexual reproduction, they need an egg. Unfertilized eggs are often produced by females – you may have had unfertilised eggs for breakfast this morning from a domestic hen – and if unfertilized eggs aren’t eaten, they eventually perish. But there’s an exception. Virgin births, known as parthenogenesis, happen when an unfertilized egg develops into an embryo.

It won’t necessarily be genetically identical to the mother though – this depends on how the egg cell develops. Parthenogenic young can be either full or half clones of the mother. Half clones are produced when embryonic cells split in half before multiplying. Full clones are created when an embryo multiples whole cells.

So half clones have even less genetic diversity than full clones. Not only do they lack the genetic diversity of organisms created in sexual reproduction but they only inherit half of their mother’s genetic diversity.

Some species, termed facultative parthenogens, alternate between sexual and asexual reproduction. They rely mainly on sexual reproduction, but can use asexual reproduction if necessary.

Virgin birth, which usually results in female offspring, is thought to be triggered in several situations. For example, when there aren’t many males around. This is often reported in captive animals, including the bonnethead shark, where animals are kept in single-sex enclosures.




















Passing on genes

Even when there are males around, females may still use parthenogenesis. For example, last year a female zebra shark hatched several young with DNA that did not match any of the males in the Chicago aquarium where she lived, baffling researchers. Perhaps the female simply didn’t fancy the males she lived with.

If environmental conditions are poor, asexual reproduction involves less effort than sexual reproduction, because the female doesn’t need to waste time and energy finding a mate. For example, many cases of parthenogenesis have been discovered in geckos, snakes and lizards that live in dry and harsh climates such as high altitudes.

Female animals can also reproduce asexually to take advantage of a favorable change in conditions. The spiny-cheek crayfish is native to the US but was introduced to Europe where the climate is more moderate. It invaded many European waterways by reproducing asexually. Although many invasive species are bigger and stronger than the locals, parthenogenesis is another factor that can contribute to their success.

Genetic testing technology that can identify parthenogenesis more readily is helping researchers discover that more and more species are capable of virgin births. The revelation of parthenogenesis in the American crocodile suggests there is a common ancestral link between the archosaurs, or ruling reptiles, which include dinosaurs, pterosaurs (flying reptiles), birds and crocodiles. As parthenogenesis occurs in the birds and crocodiles, it is possible that dinosaurs had virgin births too.


The virgin mother crocodile is eerily reminiscent of a scene in Jurassic Park when scientists claim there is nothing to worry about, that they can control the park’s population by ensuring all the dinosaurs are born female, so there won’t be any young produced naturally.

But in the words of the film’s chaos theory expert, Dr Ian Malcolm (played by Jeff Goldblum): “life finds a way”.

Louise Gentle, Principal Lecturer in Wildlife Conservation, Nottingham Trent University

This article is republished from The Conversation under a Creative Commons license. Read the original article.



Alien spacecraft allegations suggest the Pentagon has approved conspiracy theories – about itself

The Conversation
June 9, 2023, 

UFO

Claims the US government has secretly retrieved crashed alien spacecraft and their non-human occupants are hardly new. They are firmly entrenched in post-war American UFO lore and conspiracy theory, inspiring the most famous narrative in ufology: the “Roswell incident

Now, however, journalists Leslie Kean and Ralph Blumenthal have injected fresh vigor into these aging claims – apparently with the Pentagon’s approval.

In an article for science and technology news site The Debrief, they report the US government, its allies, and defense contractors have retrieved multiple craft of non-human origin, along with the occupants’ bodies.

Additionally, they report this information has been illegally withheld from US Congress, the All-domain Anomaly Resolution Office established by the US Department of Defense in 2022 to look into UFOs, and the public.

What are the claims?

The primary source for the new claims is former US intelligence official David Grusch.

Grusch’s credentials, verified by Kean and Blumenthal, are impressive. He is a veteran of the National Geospatial-Intelligence Agency and the National Reconnaissance Office. He represented both organizations on the US government’s task force studying unidentified aerial phenomena (the official term for UFOs).


Unidentified aerial phenomena, such as this video taken by a US Navy pilot released in 2020, have been a source of renewed interest in recent years.
US Navy / Wikimedia

Grusch says the retrieved materials are:


of exotic origin (non-human intelligence, whether extraterrestrial or unknown origin) based on the vehicle morphologies and material science testing and the possession of unique atomic arrangements and radiological signatures.


Grusch’s claims are supported by Jonathan Grey, who works for the National Air and Space Intelligence Center, where he focuses on analysis of unidentified aerial phenomena. Grey told Kean and Blumenthal:
The non-human intelligence phenomenon is real. We are not alone […] Retrievals of this kind are not limited to the United States.

How credible are the claims?

Kean and Blumenthal are credible and accomplished reporters on UFOs.

In 2017, writing with Helene Cooper for the New York Times, they revealed a secret US$22 million Pentagon UFO research program. That article did much to initiate a wider rethinking about UFOs, avoiding stereotypes, stigma and sensationalism.

Most of the subsequent “UFO turn” in US defense policy and public discourse has focused on images and eyewitness testimony of anomalous airborne objects. Now, Kean and Blumenthal may have brought anomalous objects themselves – and even their supposed non-human occupants – into the conversation.

David Grusch’s claims have reached the public through a multi-pronged media effort.

Shortly after the Debrief article, Australian journalist Ross Coulthart’s interview with Grusch appeared on US news network News Nation. Former Deputy Assistant Secretary of Defense for Intelligence, Christopher Mellon, has also published an article in Politico calling for greater transparency.

This looks a lot like an orchestrated effort to convince the public (and US Congress) something much more substantial than “things in the sky we can’t explain” is going on.

Approved by the Pentagon?


Grusch seems to have followed Pentagon protocol in publishing his information. Kean and Blumenthal write Grusch:

provided the Defense Office of Prepublication and Security Review at the Department of Defense with the information he intended to disclose to us. His on-the-record statements were all “cleared for open publication” on April 4 and 6, 2023, in documents provided to us.


What does that mean? A Prepublication and Security Review is how the Pentagon confirms information proposed for public release is reviewed to ensure compliance with established national and Department of Defense policies, and to determine it:

contains no classified, controlled unclassified, export-controlled, or operational security related information.

If Grusch’s information is true, it is surely both “classified” and “operational security related”. So why would the Pentagon approve its publication?

If Grusch’s information is false, it would probably not qualify as classified or operational security related. But this raises another question: why would the Pentagon approve the publication of an unfounded conspiracy theory about itself?

Doing so would likely mislead the public, journalists, and Congress. It would also undermine the Pentagon’s own attempt to understand the unidentified aerial phenomena problem: the All-domain Anomaly Resolution Office.


An official denial

Indeed, the All-domain Anomaly Resolution Office told News Nation it:

has not discovered any verifiable information to substantiate claims that any programs regarding the possession or reverse-engineering of extraterrestrial materials have existed in the past or exist currently.

Grusch has an explanation for this apparent ignorance. When it comes to unidentified aerial phenomena investigations, he says, the US government’s left hand doesn’t know what its right is doing, with:

multiple agencies nesting [unidentified aerial phenomena] activities in conventional secret access programs without appropriate reporting to various oversight authorities.

Timothy Good’s classic 1987 exploration of UFO investigations, Above Top Secret, described similar bureaucracy.

Nested activities and segregated knowledge

The notion of “nested” unidentified aerial phenomena activities, segregating knowledge within vast bureaucracies, is partly what makes Grusch’s claims both intriguing and (for now) unverifiable.

If this is the case, organisations focusing on unidentified aerial phenomena, such as the All-domain Anomaly Resolution Office, may operate in earnest and report transparently on the best information they have. Yet they may also be deprived of information essential to their activities.

This would make them little more than PR fronts, designed to create the impression of meaningful action.

In the absence of direct experience of unidentified aerial phenomena, most of us rely on information about them to form our beliefs. Scrutinising how this information is produced and distributed is essential.

US government activity in this area will continue. Congressman James Comer, chair of the House Oversight Committee, has said he will hold a hearing on UFOs in response to Grusch’s allegations.

Adam Dodd, Tutor, School of Communication and the Arts, The University of Queensland

This article is republished from The Conversation under a Creative Commons license. Read the original article.
AI statue designed by Michelangelo on show in Sweden

Agence France-Presse
June 9, 2023, 

The world's first Al sculpture "The Impossible Statue", on display at Stockholm's National Museum of Science and Technology
© Jonathan NACKSTRAND / AFP

A historical dream team of five master sculptors, including Michelangelo, Rodin and Takamura, have trained artificial intelligence (AI) to design a sculpture dubbed "the Impossible Statue", now on show in a Swedish museum.


"This is a true statue created by five different masters that would never have been able to collaborate in real life," said Pauliina Lunde, a spokeswoman for Swedish machine engineering group Sandvik that used three AI software programmes to create the artwork.

Shaking up traditional conceptions about creativity and art, the stainless steel statue depicts an androgynous person with the lower half of the body covered by a swath of material, holding a bronze globe in one hand.

On show at Stockholm's National Museum of Science and Technology, the statue measures 150 centimeters (4 feet 11 inches) and weighs 500 kilograms (1,100 pounds).

The idea was to create a mix of styles from five famed sculptors who each made their mark on their era: Michelangelo (Italy 1475-1564), Auguste Rodin (France 1840-1917), Kathe Kollwitz (Germany 1867-1945), Kotaro Takamura (Japan 1883-1956) and Augusta Savage (US 1892-1962).

"Something about it makes me feel like this is not made by human being," Julia Olderius, in charge of concept development at the museum, told AFP.

Visitors will note the muscular body inspired by Michelangelo, and the hand holding the globe inspired by Takamura.

Sandvik's engineers trained the AI by feeding it a slew of images of sculptures created by the five artists.

The software then proposed several images in 2D which it believed reflected key aspects from each of the artists.

"In the end we had 2D images of the sculpture in which we could see the different masters reflected.

 Then we put these 2D images into 3D modeling," Olderius said.

But is it art, or technological prowess?

"I don't think you can define what art is. It's up to every human being to see, 'this is art, this is not art'. And it's up to the audience to decide," Olderius said.

Amid debate about the role of AI in the art world, Olderius said she was optimistic.


"I don't think you have to be afraid of what AI is doing with creativity or concepts or art and design," she said.

"I just think you have to adapt to a new future where technology is a part of how we create concepts and art."

© 2023 AFP

Friday, June 09, 2023

‘From Magic Mushrooms to Big Pharma’ – a college course explores nature’s medicine cabinet and different ways of healing

The Conversation
June 9, 2023,

Psychedelic Mushrooms



Uncommon Courses is an occasional series from The Conversation U.S. highlighting unconventional approaches to teaching.

Title of course:

“From Magic Mushrooms to Big Pharma”

What prompted the idea for the course?

I’m from the foothills of the Appalachians in southern Ohio, where my Grandma Mildred would go out into the woods, which she called her medicine cabinet, to find herbs to use as medicine. I grew up to be an anthropologist, interested in how people around the world heal themselves. In the 1990s, I did my dissertation research in Ecuador and learned how Indigenous people in the Choco region used ayahuasca and other medicines from the forest to assist in the grieving process.

With the legalization of cannabis in many states and increased research on how “nontraditional” drugs can assist people with post-traumatic stress disorder, depression and addiction issues, it seemed like an opportune time to create this course. It’s part of a new interdisciplinary minor at Western Illinois University called “Cannabis & Culture” that offers students a foundation for understanding the social and cultural context, history and politics of nature-based medicine use in the United States and around the globe.

What does the course explore?

The course looks at how different peoples and cultures use nature-based medicines to heal themselves. First we establish that there are many ways of knowing the world around us, just as there are many ways to heal ourselves. Some of us rely on Western medicine, others pray, yet others turn to Indigenous or traditional ways of healing that are rooted in nature.

We talk about the ways Western medicine now seeks to validate substances that have been used for healing for centuries, like research into how ginger and turmeric can alleviate inflammation, or the ways cannabis can reduce or even eliminate some epileptic seizures.



KambĂ´ frog medicine is a shamanic medicinal ritual that originates among Amazonian tribes who use the poisonous excretion from the Phyllomedusa bicolor tree frog to cure illness. GummyBone/iStock via Getty Images Plus

We also examine how the pharmaceutical industry hasexploited Indigenous peoples’ ethnobotanical knowledgeand landscapes for monetary gain.

Using the Amazonian giant leaf frog, or kambĂ´ (Phyllomedusa bicolor), as a case study, students learn that at least 15 Indigenous groups have long histories of using the frog’s secretion for its analgesic, antibiotic and wound-healing properties. Eleven patents related to P. bicolor have been granted – all of them in rich countries. Indigenous people have not been compensated for their knowledge.

Why is this course relevant now?

The current generation of young people are open about mental health issues, and many people are looking for new ways to deal with anxiety, grief, PTSD and depression. My students can discuss their health concerns and learn about alternatives to what they may be accustomed to.

At this politically and racially polarized moment in the U.S., the course also provides the opportunity to discuss how racism, misogyny and discrimination against people of color have influenced scientific research.
What’s a critical lesson from the course?

Over the course of the semester, students begin to recognize that there is no one right way of healing. More importantly, there is no one right way of being human. It is my hope that students leave seeing that everything is connected, integrally linked to humanity’s relationship to nature.


In some parts of the U.S., cannabis is now just another agricultural crop. 

What materials does the course feature?

Scientific materials provided by the Multidisciplinary Association for Psychedelic Studies, a nonprofit that provides some of the only scientific research on psychedelics in the U.S. and promotes awareness of these drugs

How to Change your Mind,” by Michael Pollan and the accompanying Netflix series
Work of ethnobotanist Mark Plotkin, including his Ted Talk “What the people of the Amazon know that you don’t

What will the course prepare students to do?


Studying how different cultures approach problems that plague all humans, like being sick and healing our ill, demonstrates to students that there are many ways the world over to solve problems. This course views different approaches not as a problem to be overcome but as a resource that can yield new ways of thinking and new opportunities – a definite advantage in the professional world. I hope students also learn to become advocates for their own health and well-being.

Heather McIlvaine-Newsad, Professor of Anthropology, Western Illinois University

This article is republished from The Conversation under a Creative Commons license. Read the original article.
Commentary: Do we face nuclear confrontation? The erosion of agreements has heightened the risk

2023/06/08
Drew Angerer/Getty Images North America/TNS

You may not know it from watching cable news, going grocery shopping or doing any other mundane chore of daily life, but the world is at an increased risk of nuclear confrontation. That’s at least the assessment of National Security Adviser Jake Sullivan, who delivered a speech at the Arms Control Association last week about a multidecade arms control structure that is gradually losing its sturdiness.

The system of nuclear agreements and risk-reduction measures spurred on by the 1962 Cuban missile crisis “has begun to erode,” Sullivan told the group. His boss, President Joe Biden, was even more dramatic in October when he told a Democratic Party fundraiser that the chances of nuclear Armageddon were at their highest since that high-stakes gambit six decades earlier when President John F. Kennedy and Soviet leader Nikita Khrushchev stared each other down for 13 long days in October.

While discussions about nuclear proliferation are often subject to hysteria, troubling developments have led Biden and Sullivan to these worrisome conclusions. Russian President Vladimir Putin is in the process of deploying tactical nuclear warheads, Iskander-M missiles and nuclear-capable Su-25 aircraft to his ally Belarus. North Korean leader Kim Jong Un is pressing forward with his own nuclear development plans, including but not limited to the miniaturization of nuclear warheads, the testing of military reconnaissance satellites and the production of solid-fueled intercontinental ballistic missiles.

Meanwhile, China’s nuclear modernization remains in full swing, with the Pentagon estimating that Beijing’s nuclear arsenal could reach 1,500 warheads by 2035 if its current pace is maintained. And let’s not forget that the New START accord, the last major nuclear agreement between Washington and Moscow, is no longer operable; last week, the U.S. responded to Russia’s February withdrawal from the deal by limiting the usual information it sends to the Russians.

All of this sounds frightening to those who study nuclear weapons for a living. It’s clearly frightening to the Biden administration as well; otherwise, a senior U.S. security official wouldn’t have spent part of his day delivering an address on the topic.

Fortunately, the White House has a plan to deal with all of this. Unfortunately, the plan has very poor odds of success.

According to the U.S. Nuclear Posture Review, Washington’s strategy relies on two planks: modernizing the U.S. nuclear weapons apparatus to ensure that deterrence holds and exploring new nuclear transparency and risk-reduction measures to manage or, better yet, downgrade nuclear rivalry between the U.S. and its adversaries.

“Mutual, verifiable nuclear arms control offers the most effective, durable and responsible path to reduce the role of nuclear weapons in our strategy and prevent their use,” the strategy states. Sullivan reiterated those points last week, reminding everyone in the room that the U.S. is willing to get back to the table with Russia on developing a new arms control framework and enter nuclear talks with China without preconditions.

It takes more than one party for diplomacy to work, however. And as sober-minded as the Biden administration wants to be with one of the most important subjects on the planet, it’s largely talking to itself. Russia, China and North Korea are at best uninterested in pursuing a nuclear dialogue with the U.S.

The three countries all have their own reasons for staying away from the negotiating table.

For China, it’s partly a matter of basic arithmetic. From where Beijing sits, it doesn’t make a whole lot of sense to enter into bilateral nuclear talks with a country whose nuclear arsenal is nearly 13 times the size of its own. The U.S. has more than 5,200 nuclear warheads in its inventory to China’s 410, according to a Federation of American Scientists assessment.

The Chinese are already at a massive disadvantage numerically, which means any mutual weapons reductions wouldn’t alter the overall picture for the country. It should therefore be no surprise why Beijing would dismiss Washington’s offer to talk. Sadly, there is unlikely to be any U.S.-China nuclear reduction negotiations unless one of two things occurs: Washington drops to Beijing’s level or Beijing rises to Washington’s.

For Russia, the situation is different. Unlike China, Russia is largely at parity with the U.S. — in fact, Russia’s nuclear arsenal is larger than America’s. Yet because U.S.-Russia relations are so acrimonious today, principally over the war in Ukraine, it is almost unfathomable to envision Putin greenlighting serious, substantive nuclear talks with the U.S., Ukraine’s biggest military supplier. Whereas Washington and Moscow have historically separated strategic stability from other issues of dispute, this no longer appears to be the case.

The Russians are currently using the prospect of nuclear arms talks as a way to leverage concrete changes to U.S. foreign policy. This includes reentering arms control agreements, such as New START, that have long been in effect. As Russian Deputy Foreign Minister Sergei Ryabkov said over the weekend, Moscow will return to New START only if the U.S. abandons what he called “its fundamentally hostile policy toward Russia.”

As far as North Korea is concerned, what is there to discuss? A nuclear deterrent is the ultimate insurance policy for an internationally isolated state that shares a heavily militarized border with a neighbor, South Korea, whose military is more sophisticated than its own and that considers the world’s predominant superpower its main enemy. North Korea isn’t any more likely to abandon its nuclear weapons program than the U.S. is. No amount of talk about denuclearization from State Department officials is going to change that basic dynamic.

We all like to envision a world without nuclear weapons. Reality, however, has a habit of crushing hopes and dreams.

____

ABOUT THE WRITER

Daniel DePetris is a fellow at Defense Priorities and a foreign affairs columnist for the Chicago Tribune.



AMERIKA
Editorial: Your tax dollars at work ... suppressing women

2023/06/09
Signage outside the Planned Parenthood Reproductive Health Services Center in St. Louis, Missouri on June 24, 2022. - 
ANGELA WEISS/GETTY IMAGES NORTH AMERICA/TNS

Missouri’s political leaders have already reached into the personal medical decisions of women across the state, and have attempted to reach into the ballot process to prevent the public from reversing the state’s extremist abortion ban. Now they’re also reaching into Missourians’ very pockets, in a few different ways, using tax dollars to continue to push ideologically based anti-choice messages that polls show majorities of Missourians don't want.

What exactly is the point of spending potentially more than $1 million in state funds over the next four years on a marketing campaign designed to convince women not to seek abortions, when that choice is currently almost entirely illegal in Missouri anyway? And what is the justification for spending millions more on tax credits to reimburse citizens for donations made to anti-abortion organizations that employ sometimes controversial methods?

Literally minutes after the U.S. Supreme Court overturned Roe v. Wade last year, Missouri became the first state in America to institute a sweeping new abortion ban. It is as stringent as any in the nation, banning the procedure from the moment of conception in all cases (rape and incest included), except in vaguely defined “medical emergencies.” Doctors who violate the ban can face up to 15 years in prison.

Before and since that law was enacted, the Legislature’s Republican majority has signaled its intention to get even more radical in its determination to deny women their biological autonomy. Among the more chilling ideas thrown around in the state Capitol are to prosecute women themselves, instead of just doctors; to somehow extend Missouri’s ban so that it covers Missouri women even when they leave the state; and to censor what women can see and read about abortion services. Some have even suggested abortion should be a death-penalty offense.

Mindful that this level of extremism doesn’t generally fly even in a red state like Missouri, lawmakers in the recent legislative session also attempted to rewrite the state’s rules regarding ballot referendums, to require supermajority approval instead of just a simple majority of the voters to change the state constitution.

Disingenuous explanations aside, there is no doubt the aim was to prevent Missouri’s voters from rolling back the state’s abortion ban — and there is just as little doubt they will keep trying.

But in their continuing campaign against choice, the state’s leaders aren’t only using their governmental powers. They’re also using tax funds, much of it collected from the very women whose rights they’re suppressing.

As the Post-Dispatch’s Kurt Erickson reports, one element of this is a $266,000 contract signed in April by Gov. Mike Parson’s administration for services from a Columbia marketing firm to help market the state’s existing “Alternatives to Abortion” program.

That $8.3 million program provides adoption assistance, child and infant care and other help to low-income mothers — which, it could be argued, is a virtual obligation for a state that is making young, poor women’s lives significantly harder and more dangerous with its abortion ban.

But the program also works with “pregnancy centers” of the kind that critics say mislead women into thinking they’re getting unbiased medical advice when they’re actually being coaxed to carry out pregnancies whether it’s in their best interests or not.

A look at the online presence of the program’s new marketing contractor, Choose Life Marketing, confirms it is a religiously focused organization that is as much about convincing women not to obtain abortions as it is about merely connecting them with support services. Support is one thing; proselytizing on the taxpayers’ dime is quite another. And, again, abortion is already illegal in Missouri anyway, so this is a curious way to spend public money.

If there’s an upside to the marketing contract, it’s that around $1 million in taxpayer funding to push right-wing political ideology is better than doing it with $7 million. That’s about how much Missouri taxpayers lost last year in tax credits that the state gives to people who donate money to pregnancy centers and other anti-abortion entities, according to a ProPublica analysis.

Would perhaps some of this money be better spent on women's health services that don’t come with an underlying mission of convincing them to make choices that serve someone else’s ideological agenda instead of their own health?

© St. Louis Post-Dispatch



US Chamber of Commerce sues over government's drug pricing power

Reuters
June 9, 2023

Pharmaceuticals:Drugs (AFP)


By Jonathan Stempel

(Reuters) - The U.S. Chamber of Commerce on Friday sued the federal government, challenging a new law that for the first time gives Medicare the power to negotiate drug prices with pharmaceutical companies.

In a complaint filed in federal court in Dayton, Ohio, the chamber said the pricing program violated drugmakers' due process rights under the U.S. Constitution by giving the government "unfettered discretion" to dictate maximum prices.

It also said the program would impose exorbitant penalties on drugmakers that don't accept those prices, and amounted to an ultimatum: "agree to whatever price the government names, or we'll smash up your business."

The U.S. Department of Health and Human Services, which administers Medicare through its Centers for Medicare & Medicaid Services (CMS), did not immediately respond to requests for comment.

Friday's lawsuit by the chamber, one of the most powerful U.S. business groups, came three days after Merck & Co filed a similar lawsuit in Washington, D.C.

Both lawsuits contended that price controls would force drugmakers to pull back on developing new drugs, causing long-term harm to Americans and their health.

Other drugmakers have also objected to the pricing program, which is part of last year's Inflation Reduction Act. Pricing changes following negotiations on 10 costly drugs selected by CMS would take effect in 2026.

Americans pay more for prescription drugs than prices in any other country.

The Biden administration hopes to save $25 billion annually by 2031 by having Medicare, the government health plan for people 65 and over, negotiate prices.

White House spokeswoman Karine Jean-Pierre said on Tuesday the government was confident it would win the Merck case.

"There is nothing in the Constitution that prevents Medicare from negotiating lower drug prices," she said.

The chamber also warned that allowing the pricing program would set a bad precedent.

"After all, if the government can impose price controls in the pharmaceutical industry, why not elsewhere?" Chief Policy Officer Neil Bradley said in a statement.

The case is Dayton Area Chamber of Commerce et al v Becerra et al, U.S. District Court, Southern District of Ohio, No. 23-00156.

(Reporting by Jonathan Stempel in New York; Editing by Bill Berkrot)

Shirley Ryan AbilityLab receives $8.7 Million NIH grant for first-of-its-kind bionic arm osseointegration study


Study has potential to restore sensation for those with upper-limb amputations

Grant and Award Announcement

SHIRLEY RYAN ABILITYLAB




Today, an estimated 41,000 people in the United States live with the loss of an upper limb, including hundreds of service men and women. Although significant progress has been made in the durability, control and function of upper-limb prosthetic devices, they lack complete integration into the body and, importantly, do not enable their users to feel.

Now, with the award of an $8.7 million grant from the National Institutes of Health (NIH), Shirley Ryan AbilityLab — the top-ranked physical medicine and rehabilitation hospital — and its research partners have an opportunity to significantly advance the field of bionics by applying osseointegration in a novel manner.

Osseointegration is a technique whereby a metal implant is surgically attached to a person’s residual bone. The implant then becomes an integrated extension of the body — providing a direct attachment between the bionic and residual limb. Then, a special system called e-OPRA (Enhanced Osseoanchored Prostheses for the Rehabilitation of Amputees) uses electrodes implanted into muscle to provide robust sensory feedback through peripheral nerve stimulation, restoring the feeling of touch.

The study is the first to combine osseointegration, targeted muscle reinnervation (TMR) and pattern-recognition control using implanted electromyographic (EMG) sensors. (TMR is a revolutionary surgical technique — that was developed by collaborators at Northwestern Medicine and Shirley Ryan AbilityLab — to allow those with amputations control of bionic prostheses.) It also is the first in-home trial of the e-OPRA system in people with upper-limb amputations who have had TMR surgery and use a Coapt Gen2 pattern recognition–controlled myoelectric prosthesis.  

“With this combination of novel and advanced technologies, the device should feel much more like a person’s actual limb,” said Levi Hargrove, the study’s lead researcher and director of the Regenstein Foundation Center for Bionic Medicine at Shirley Ryan AbilityLab. “This study builds on many years of our
leadership in bionic medicine, and marks a significant step forward in making this intuitive technology broadly available for the first time.”

As part of the study, Shirley Ryan Ability is partnering with Integrum, a Swedish company that invented the osseointegration technique, and Northwestern Medicine, which will implant the device and perform TMR surgery on eight research subjects. Researchers at UChicagoMedicine and Bionics Institute in Australia also will support the study.

Following the surgeries, the research team will lead two clinical trials to evaluate the comfort and function with implanted electrodes through e-OPRA — compared to and combined with the state-of-the-art clinical solution using Coapt’s Gen2 pattern recognition system — and to evaluate the effects of providing sensory feedback.

“Engineers, material scientists, neurophysiologists and surgeons have never before come together on this scale to apply osseointegration in this manner,” said Rickard Branemark, CEO and founder of Integrum AB. “We are very excited to collaborate on this important work.”

The five-year grant is being funded through the NIH’s UG3 and UH3 mechanisms, which specifically are targeted to translating groundbreaking neural technologies for patients.

The award comes on the heels of another, recently funded $1.5 million U.S. Department of Defense grant for Shirley Ryan AbilityLab and its research collaborators to evaluate functional mobility, neural control and user satisfaction as they relate to osseointegration in bionic legs.

About Shirley Ryan AbilityLab

Shirley Ryan AbilityLab, formerly the Rehabilitation Institute of Chicago (RIC), is the global leader in physical medicine and rehabilitation for adults and children with the most severe, complex conditions — from traumatic brain and spinal cord injury to stroke, amputation and cancer-related impairment. The organization expands and accelerates leadership in the field that began at RIC in 1953. The quality of its care has led to the designation of “No. 1 Rehabilitation Hospital in America” by U.S. News & World Report every year since 1991. Upon opening in March 2017, the $550 million, 1.2-million-square-foot Shirley Ryan AbilityLab became the first-ever “translational” research hospital in which clinicians, scientists, innovators and technologists work together in the same space, surrounding patients, discovering new approaches and applying (or “translating”) research real time. This unique model enables patients to have 24/7 access to the brightest minds, the latest research and the best opportunity for recovery. Shirley Ryan AbilityLab is a 501 (c)(3) nonprofit organization. For more information, go to www.sralab.org

 

About Integrum

Integrum AB is a publicly traded company (INTEG B: Nasdaq First North Growth Market) based outside of Gothenburg, Sweden, with a U.S. subsidiary in San Francisco, CA. Since 1990, osseointegration, the science behind the OPRA™ Implant System, has been helping individuals with amputations enjoy a dramatically improved quality of life. Thorough surgical experience gained over more than three decades, from more than 500 surgeries, in 14 countries, has led to the development of Integrum’s system for bone-anchored prostheses — a vastly superior alternative to the traditionally used socket prosthesis. For more information, please visit www.integrum.se.

 

Ground-breaking findings bring hope for faster and better recovery after stroke


Peer-Reviewed Publication

UNIVERSITY OF GOTHENBURG

Strokerehab. 

IMAGE: REHABILITATION AFTER STROKE. view more 

CREDIT: PHOTO: UNIVERSITY OF GOTHENBURG




An effective treatment for most stroke victims — even those who, today, are unable to gain access to care within the first few hours. This is the goal of an experimental method that has been tested with great success in an international study headed by the University of Gothenburg.

The work now published in the Journal of Clinical Investigation is a multicenter study in which researchers at the Universities of Gothenburg and Cologne implemented parallel testing of an experimental stroke treatment on mice. The study was conducted in collaboration with researchers at the Czech Academy of Sciences.

By giving mice a molecule, the complement peptide C3a, in nasal drops, the scientists saw them recover motor function faster and better after stroke compared with mice that had received nasal drops with placebo. These results confirm and extend a previous study at the University of Gothenburg and the current study design further strengthens their credibility.

“We see the same positive effects in experiments done in Sweden and in Germany, which makes the results much more robust,” says Marcela Pekna, Professor of Neuroimmunology at Sahlgrenska Academy, University of Gothenburg, who led the study.

No racing against time

One crucial point is that the treatment was not initiated until seven days after the stroke. In a conceivable future, most stroke patients could thus be included — even those who do not reach hospital in time or who, for other reasons, are not helped by clot-dissolving drugs (thrombolysis) or mechanical clot removal (thrombectomy).

“With this method, there’s no need to race against the clock. If the treatment is used in clinical practice, all stroke patients could receive it, even those who arrive at the hospital too late for thrombolysis or thrombectomy. Those who have remaining disability after the clot is removed could improve with this treatment too,” Pekna says.

The study demonstrates not only very distinct positive effects, but also identifies the underlying cellular and molecular processes in the brain. Magnetic resonance imaging (MRI) showed that the treatment with C3a peptide increased the formation of new connections among nerve cells in the mouse brains.

Mechanisms clarified

Milos Pekny, Professor at the Department of Clinical Neuroscience at Sahlgrenska Academy, University of Gothenburg, participated in the study.

“Our results show,” he says, “that the C3a peptide affects the function of astrocytes — that is, cells that control many of the nerve cells' functions in both the healthy and the diseased brain — and which signals astrocytes send to nerve cells.”

Despite advances in emergency care, the most common form of stroke, ischemic stroke, is still a major cause of long-term disability, including impaired speech and mobility. The researchers emphasize that stroke treatment is not solely a matter of prompt interventions in the first hours after symptom onset.

“There is great potential for substantial improvement even at a later stage. Since the molecule was administered in nasal drops, the treatment could be given at home by relatives or the patients themselves,” Pekny says.

Timing is also of importance when it comes to the C3a peptide treatment. If the molecule is given too soon, it might increase the amount of inflammatory cells in the brain. The study also shows that the positive outcomes in experimental animals persist long after the treatment is discontinued.

“The good effect remains,” Pekna says, “and that is important. It means that this is real. And we know more about how the C3a peptide works. Our ambition is to develop the method to make it usable in clinical practice, but to get there, and especially to be able to carry out the necessary clinical trials, we need to team up with a partner in the pharmaceutical industry,” she concludes.

Astrocytes are cells that control many of the nerve cells' functions in both the healthy and the diseased brain.

CREDIT

Photo: University of Gothenburg.

Sleep apnoea link to cognitive decline raises need for targeted treatment options


Peer-Reviewed Publication

FLINDERS UNIVERSITY

Associate Professor Andrew Vakulin 

IMAGE: ASSOCIATE PROFESSOR ANDREW VAKULIN IS SEARCHING FOR SOLUTIONS TO SLEEP DISORDERS WITH THE FLINDERS HEALTH AND MEDICAL RESEARCH INSTITUTE SLEEP HEALTH GROUP. view more 

CREDIT: THE HOSPITAL RESEARCH FOUNDATION



Flinders University experts are working on better solutions for sleep apnoea to ward off a range of health risks, including cognitive decline.

Improved solutions for obstructive sleep apnoea (OSA), insomnia and other sleep disorders are being developed by the Flinders Sleep Health experts to reduce the associated negative health effects such as cardiovascular harm, diabetes, anxiety and depression and even long-term cognitive decline.

Heightened risk of cognitive function decline from undiagnosed OSA – particularly in middle-aged men living in the community – is the focus of one of the latest studies published in Sleep Health.

The study recorded the sleep patterns of more than 470 men aged from 41-87 years along side their daytime cognitive function for processing speed, visual attention, episodic memory recollection and other markers.

Measuring distinct features of brain electrical activity during non-REM sleep, called ‘sleep spindles’, the study aimed to explore if these features can serve as markers of cognitive function.

“Non-REM sleep includes light stage 1 and 2 sleep, as well as deeper stage 3 sleep which is thought to play an important role in learning and memory,” says Flinders University sleep researcher Dr Jesse Parker.

“Our study found cross-sectional associations between various domains of next-day cognitive function and several sleep spindle metrics during stage 2 and stage 3 of their sleep cycle.

“The presence and severity of OSA was an important factor in this relationship.”

While standard clinical tests for OSA may detect and help to improve this common sleep-related breathing disorder with interventions such as continuous positive airway pressure (CPAP) or specific dental devices, the condition does vary between people depending on gender, age and other factors.

Based on this latest Florey Adelaide Male Ageing Study results, the Flinders Health and Medical Research Institute Sleep Health researchers recommend long-term investigations into sleep spindle phases and OSA to improve future treatments – and to determine whether OSA interventions such as CPAP do improve sleep quality and cognitive function.

Sleep apnoea affects more than 1 billion people globally and if untreated or severe may increase the risk of dementia and Parkinson’s disease, hypertension, cardiovascular disease, anxiety and depression, reduced quality of life, traffic accidents and all-cause mortality, previous research has found. In Australia alone, the economic cost associated with poor sleep including sleep disorders has been estimated at $66 billion a year.

“Poor sleep as a result of OSA, as well as delayed sleep and body clock disruption, may lead to chronic health conditions, including cognitive impairment, poor mental health and cardiovascular disease,” says Associate Professor Andrew Vakulin, senior author on the publication and Flinders Health and Medical Research Institute (FHMRI) Sleep Health researcher.

“Highlighting the need for better treatments, our latest studies not only make more links between sleep disorders and poor health outcomes but also the need for tailored specific treatments for individual cases, including co-occurring conditions such as insomnia and sleep apnoea.

"Along with uncontrolled hypertension, this latest study also clearly links cognitive function to sleep in adult males, possibly made worse by undiagnosed moderate to severe OSA,” says Associate Professor Vakulin

The article, The association between sleep spindles and cognitive function in middle-aged and older men from a community-based cohort study (2023) by Jesse Parker, Sarah L Appleton, Robert J Adams, Yohannes Adama Melaku, Angela d’Rozario, Gary A Wittert, Sean Martin, Peter G Catcheside, Bastien Lechat, Alison Jane Teare, Barbara Toson and Andrew Vakulin has been published in Sleep Health. DOI:  10.1016/j.sleh.2023.03.007

Also, Associations of Baseline Sleep Microarchitecture with Cognitive Function After 8 Years in Middle-Aged and Older Men from a Community-Based Cohort Study (2023) published in Nature and Science of Sleep DOI: 10.2147/NSS.S401655

Acknowledgements: The work was supported by the Australian NHMRC and Hospital Research Foundation grants, as well as the ResMed Foundation, USA for the EEG analysis.

The Flinders Health and Medical Research Institute Sleep Health group is also investigating other interventions to tackle sleep apnea including a range of clinical trials of alternative drug therapies – including the publications at the links below:

From novel devices and cognitive behavioural therapy to complementary muscle, sedative and other drug treatments, the latest round of studies from Flinders Sleep Health group are exploring more targeted treatments.