Tag Archives: Pharma

Terrifying Magnetic Mouth Clamp is a Safer Weight Loss Tool

Researchers in the United Kindom and New Zealand have developed a unique alternative to bariatric surgery—invasive medical procedures performed for weight loss purposes—with an oral magnetic locking device that limits how far the wearer can open their mouths and, in turn, the type of foods they can eat.

One of the most important skills to learn for effective long-term weight loss is a proper diet, including smaller portions. Procedures like gastric bypass surgery make this easier by physically shrinking the size of a patient’s stomach, limiting how much they can eat at every meal. But it’s an invasive procedure that comes with the same risks as any procedure that requires a patient to undergo anesthesia. It’s also expensive, often costing tens of thousands of dollars, and it’s just as complicated and expensive to reverse.

Decades ago a procedure that involved physically wiring a patient’s jaws shut was a popular alternative for weight loss, but it was permanent and came with its own challenges, including limitations on proper oral hygiene. The DentalSlim Diet Control functions in a similar manner, but less permanently. It uses magnets to power a temporary locking device that limits the wearer to opening their mouths just two millimeters, restricting them to a liquid diet without inhibiting speech or breathing in the process.

The DentalSlim is attached to the wearer’s molars by a dentist using orthodontic cement so it will never accidentally fall out, but the magnetic locking mechanism it uses means it can also be occasionally disengaged and the wearer’s dietary restrictions can be temporarily relaxed. Every patient with the DentalSlim installed also carries a special tool so the device can be quickly unlocked in an emergency. (Imagine dealing with the common side effects of a night spent bar hopping if you can only open your mouth two millimeters.)

In a trial of the device that was detailed in a study published in the British Dental Journal, seven healthy, obese patients were fitted with the device and spent 14 days following a strict low-calorie liquid diet. On average they lost a little over 14 pounds using the DentalSlim, which is impressive, but such results also require a strict adherence to the type of liquids being consumed. Sipping milkshakes for two weeks straight won’t produce similar results, but if you’re going to the trouble of having a device like the DentalSlim installed, you’re ideally committed to what’s needed to make it an effective weight loss tool.

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Journal Retracts Study That Claimed Widespread Covid-19 Vaccine Deaths

A nurse showing a container of Pfizer-BioNTech covid-19 vaccine.
Photo: Scott Olson (Getty Images)

A study looking at the impacts of covid-19 vaccination—condemned by other scientists as seriously flawed and irresponsible—has now sparked a mutiny of sorts. This past week, several well-respected researchers have resigned from their involvement in the journal that published the paper, which argued that vaccines are killing almost as many people as they’re saving from the pandemic. Today, the paper was retracted.

The study, titled “The Safety of COVID-19 Vaccinations—We Should Rethink the Policy,” was published on June 24 in the journal Vaccines and was authored by Harald Walach, Rainer J. Klement, and Wouter Aukema. Citing several sources of data, the authors argued that covid-19 vaccination was more dangerous than commonly believed, and that the benefits of inoculation only barely outweighed the risks caused by covid-19. Most egregiously, they claimed that for every “three deaths prevented by vaccination, we have to accept two inflicted by vaccination.”

The paper was uncritically shared by some on social media at first, including members of the anti-vaccination movement. But it was quickly criticized by many other scientists for its faulty assumptions, bad math, and outright misinformation.

One of the main pieces of evidence the authors presented to support their claim that the covid-19 shots are deadly, for instance, came from the Netherlands’ adverse event reporting system for their vaccines. But as Gizmodo has discussed before, these systems are designed to record any health incident, including death, that occurs after a person receives a new drug or vaccine. They don’t demonstrate that the incident occurred due to the drug—after all, a person may die for any number of unrelated reasons after receiving a vaccine—but instead are meant to flag possible signals of undiscovered side effects that could be linked to a new drug or vaccine, signals that then have to be studied further before any judgment can be made.

It wasn’t long before scientists associated with the journal Vaccines began to protest the study’s publication. Within days, prominent scientists such as Katie Ewer, a member of the Oxford University team who helped create their now widely used covid-19 vaccine, resigned from the journal’s editorial board. A day after her resignation, the journal placed an expression of concern on the paper, meant to alert readers of the many criticisms it had received, and announced it would investigate the matter. The announcement didn’t seem to stop the bleeding, though; at last count, according to the publication Science, at least six scientists in total have resigned from positions as associate or section editors with the journal.

Finally, just today, Vaccines’ remaining editors came back with their verdict, announcing that the paper would be retracted. In their notice, they pointed to “several errors that fundamentally affect the interpretation of the findings,” including the misrepresentation of the Netherlands’ vaccine safety data. The editors also noted that the authors were asked to respond to the criticisms made of their paper, but “were not able to do so satisfactorily.” The paper was then retracted under their protest.

Even with this decision, some scientists have questioned how the paper got through the peer-review process in the first place. Two of the three reviewers were anonymous, and none brought up any of the issues that resulted in the retraction. The current fiasco isn’t the only one to have involved MDPI, the publisher of Vaccines and many other open-access journals. In its past, some scientists have accused MDPI of being a predatory publisher, more eager about the quantity than the quality of the research it publishes—criticisms that were still being made this year before the latest retracted paper.

“We have established procedures for handling all complaints about published papers, which were followed,” Damaris Critchlow, head of publication ethics at MDPI, told Gizmodo in an email. “The Editor-in-Chief and the journal conducted an investigation of the scientific concerns raised, ultimately resulting in article retraction. Our Editor-in-Chief, Editorial Board and the journal treated the investigation with utmost priority. We are in the process of consulting the Editor-in-Chief and Editorial Board to establish further ways to support our Academic Editors, who are responsible for manuscript acceptance decisions and for assessing the quality of the peer review reports.”

This debacle shouldn’t take away from the importance of confirming vaccine safety, though. We need to verify the data collected from clinical trials of any new medicine once it’s released to the public, even in the midst of a pandemic. But caution should be warranted if someone starts making extraordinary claims about safety or lack thereof—especially if those claims are based on adverse event reporting systems.

Oftentimes, adverse events aren’t related to the treatment at all, and it’s only when the risk of a particular event is plausible and higher than it would be in the general population that scientists begin to suspect a connection between the event and the drug. This has happened a few times with covid-19 vaccines, such as the now-established link between certain types of blood clots and adenovirus-based vaccines like the AstraZeneca/Oxford shots.

So far, all the risks associated with vaccination are either thought to be mild, short-lasting, or rare and manageable, and are clearly outweighed by the benefits they provide in preventing covid-19, a disease that has killed at least 4 million people worldwide in the past year and a half.

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Deaths in US Surged in 2020, Well Beyond Official Covid-19 Toll

Volunteers working on an outdoor public art installation in Washington DC. created by Suzanne Firstenberg, December 2020. The white flags are meant to represent each life lost to covid-19 in the U.S.

The covid-19 pandemic drove a horrifying surge in U.S. deaths last year, new research published Friday has shown. According to the study, over half a million more people died than would have been expected during the last 10 months of 2020. Most of these deaths were directly attributed to the viral illness, but some could also represent delays in health care and other indirect consequences of the pandemic.

From the very start, scientists and public health agencies have been tracking excess deaths—total reported deaths above the average number seen in recent years—as a way to more accurately understand the impact of the pandemic. Though countries have gotten much better at identifying covid-19 cases and related deaths over time, our official tolls are still an underestimate of the destruction it’s caused. In the U.S., studies have consistently shown a sizable gap behind excess deaths and those officially tied to covid-19.

Covid-19 may have been in the U.S. as early as late 2019, but the first peak of illness and death started by March 2020. This new study, published Friday in JAMA and led by researchers by Virginia Commonwealth University, analyzed U.S. mortality data from March 1, 2020 to January 1, 2021.

Between those months, the team estimated that the country experienced 522,368 excess deaths, compared to the past five years. Though deaths do tend to slightly rise year after year (thanks in part to a growing population), this usually only results in an excess death jump of 1% to 2% annually. 2020, however, saw a 22.9% spike in excess deaths during that time period, the authors found.

“The 22.9% increase in all-cause mortality reported here far exceeds annual increases observed in recent years,” the authors wrote.

Just this week, data from the Centers for Disease Control and Prevention cemented that covid-19 was the third leading cause of death in the U.S. last year, with nearly 350,000 deaths officially attributed to it. In this study, the researchers calculated a similar direct death toll (378,039 deaths) from covid-19 that accounted for about 72% of the excess deaths they found.

Much of the remaining 28% could be hidden deaths from the pandemic or deaths from causes that were exacerbated from having had covid-19. The infection is suspected to raise the risk of life-threatening health problems like heart attack and stroke, as well as the risk of dying from chronic conditions like diabetes and dementia. But some uncounted deaths are also likely the result of indirect impacts from the pandemic that affected people who never even contracted the virus. There’s evidence, for instance, showing that visits to the emergency room or hospitals declined last year, especially during peaks of the pandemic.

Though no country has completely avoided the pandemic, it’s likely that the U.S. and local states could have done a much better job of preventing a substantial amount of these deaths, according to the researchers.

“Excess deaths surged in the east in April, followed by extended summer and early winter surges concentrated in southern and western states, respectively,” they wrote. “Many of these states weakly embraced, or discouraged, pandemic control measures and lifted restrictions earlier than other states.”

Other data has shown that more than 3.1 million people died in the U.S. overall last year, the sort of substantial increase from the previous year not seen since 1918, when World War I and the deadliest pandemic in recorded history were both ongoing.

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Stanford Scientists Post mRNA Sequence for Moderna Vaccine on Github

A doctor preparing a dose of Moderna vaccine in Ostrava, Czech Republic, in January 2021.
Photo: Radek Mica/AFP (Getty Images)

A group of Stanford researchers has hacked Moderna’s messenger RNA (mRNA) vaccine for the novel coronavirus, Motherboard first reported on Monday, and published its entire genetic sequence on the open-source code repository Github.

The mRNA vaccines work by delivering genetic information that allows the body’s own cells to produce a viral protein—such as a harmless, engineered version of the spike protein that the coronavirus uses to break its way into the body’s cells. When the body subsequently produces that protein, the immune system rapidly mobilizes to fight it, conducting a sort of live-fire training exercise that prepares it to fight the actual coronavirus; the actual mRNA delivered by the vaccine quickly disintegrates, but the antibodies stick around as a garrison against future infection. Per the MIT News Office, this allows for much easier and faster production than prior generations of vaccines relying on manufacturing the proteins under laboratory conditions. The mRNA sequence more or less serves as a sort of source code for the vaccine.

The documents the Stanford team published on Github include two pages of explanation and two pages containing the entire mRNA sequence for Moderna’s vaccine. Researchers wrote in the report that although Moderna’s mRNA has ended up in a large swathe of the population, scientists and medical personnel don’t have access to the actual genetic sequences involved.

“With the rollout of vaccines for COVID-19, these synthetic mRNAs have become broadly distributed RNA species in numerous human populations,” the researchers wrote. “Despite their ubiquity, sequences are not always available for such RNAs… Sharing of sequence information for broadly used therapeutics has the benefit of allowing any researchers or clinicians using sequencing approaches to rapidly identify such sequences as therapeutic-derived rather than host or infectious in origin.”

The research team told Motherboard that they didn’t “reverse engineer” the vaccine, they simply “posted the putative sequence of two synthetic RNA molecules that have become sufficiently prevalent in the general environment of medicine and human biology in 2021.”

“As the vaccine has been rolling out, these sequences have begun to show up in many different investigational and diagnostic studies,” Stanford scientists Andrew Fire and Massa Shoura told Motherboard by email. “Knowing these sequences and having the ability to differentiate them from other RNAs in analyzing future biomedical data sets is of great utility.”

“For this work, RNAs were obtained as discards from the small portions of vaccine doses that remained in vials after immunization; such portions would have been required to be otherwise discarded and were analyzed under FDA authorization for research use,” they added. Fire and Shoura told Motherboard that they had received permission from the FDA to collect scraps of vaccines that wouldn’t have otherwise been used from empty vials and that they’d notified Moderna in advance of their plans to publish the sequence without receiving any objection in turn.

There is a “substantial economy of scale and educational value in having the sequences available ASAP and in not having to guess where they have come from,” the two researchers told Motherboard.

Moderna’s mRNA vaccine and the competing one made by Pfizer-BioNTech were the first ones ever approved by the Food and Drug Administration. Per Motherboard, PowerDNS founder Bert Hubert was able to use publicly available data to reveal Pfizer’s mRNA sequence late last year.

As Hubert wrote in a separate blog post, however, this does not mean that anyone is going to be homebrewing either vaccine soon in a “distributed manufacturing revolution.” Hubert detailed the ridiculously complicated supply chain that powers the pharmaceutical companies’ vaccine manufacturing, which involves numerous complex ingredients, DNA and mRNA production in specialized facilities, and combining mRNA and lipids into lipid nanoparticles (LNPs), the last of which perhaps only a number of experts in the “low hundreds” know how to do. The final steps, including formulation where the LNPs are mixed with other more generic ingredients and are filled into vials, also require specialized knowledge and equipment—with subsequent distribution to patients being its own daunting technical challenge.

“Technically, the last step of the supply chain of these mRNA COVID-19 vaccines is the production of the spike protein,” Hubert concluded. “That’s what happens in the cells of your body after you receive the vaccine. You are the globally distributed vaccine manufacturing revolution.”

Joe Biden’s administration is facing pressure from some legislators to suspend patent protections on COVID-19 vaccines, according to Time, in the hopes of ensuring that profit incentives won’t get in the way of attaining levels of mass vaccination that could snuff out the pandemic. (Former FDA commissioner Scott Gottlieb, a member of the Pfizer board of directors, has argued that bottlenecks in mass vaccination lay primarily in supplies and production, not intellectual property restrictions.) The White House is still considering whether to do that, according to CNBC.

[Wired]

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These Mutant Rabbits Walk on Two Legs, and Geneticists Now Know Why

A sauteur d’Alfort rabbit walking on its front feet, the result of a genetic mutation.
Photo: S. Boucher

An entire lineage of French rabbits has been doing handstands for nearly a century. The acrobatic bunnies are not so much performing a stunt as they are a product of stunted genetics, according to a paper published this week in PLOS Genetics.

First discovered in a domesticated rabbit living in a Parisian suburb in 1935, the recessive trait is the product of a genetic mutation that could have been hidden in the animals’ genetic code for generations, only to surface then. It’s not a superpower. The rabbit variety—the “sauteur d’Alfort,” or “the Alfort jumper”—is also more likely to develop cataracts and become blind.

“The strain has been kept since then to study ocular malformations and pathological locomotion,” said co-author Miguel Carneiro, a geneticist at the University of Porto in Portugal, in an email. “Rabbits carrying this mutation would not be able to survive long in the wild due to its deleterious effects.”

The bunnies are bipedal and often blind.
Image: Carneiro et al. 2021 (Other)

The rabbits walk on all fours when moving slowly, but in a rush, turn to the handstand method. Now, a team of geneticists have identified the root of all those problems in the breed’s DNA.

Photo: S. Boucher

To figure out the origins of the animal’s abnormalities, the team of geneticists and developmental biologists bred the Alfort jumper with rabbits that hop normally and sequenced the DNA of their descendants. They found the rabbits that ended up bipedal had a mutation on the first chromosome; specifically, a warped gene called RORB, which expresses a protein of the same name.

“With modern technology, it’s straightforward to go from a simple recessive disorder to finding the genes,” said co-author Leif Andersson, a geneticist at Uppsala University in Sweden, in a video call. “The expectation was there was something wrong with the spinal cord, because they don’t coordinate their forelegs and the hind legs.”

Among the Alfort jumping rabbits (perhaps a misnomer, given the bunnies have no hops), this was proven true. The RORB protein is a transcription factor, meaning it has a hand in a number of genes, which all end up being expressed in traits. The proteins are ordinarily produced in inhibitory interneurons that cease communications moving through the body. (Imagine an operator refusing to service your calls.) In the weird-walking rabbits, the interneurons either were less present or completely absent, and, in the latter case, the rabbits would overflex their hind legs, rendering them incapable of hopping.

“What’s happening when you’re moving is that you have these neurons firing all the time, and they coordinate muscle contractions and receive feedback on the balance of the different limbs,” Andersson said. “This coordination of muscle contraction is not correct in these rabbits.”

You can think, the rabbits’ handstand is not itself the mutation, but a workaround to an otherwise debilitating inhibition of the animal’s iconic means of locomotion. Andersson said the two-footed locomotion caused the animals no pain of which he was aware.

It’s not the only animal to experience gait disruption due to genetic mutations. Similar behavior was seen in mice with a RORB mutation, and previous work of Andersson’s found that a mutation in the gene DMRT3 disrupts the gait of mice and horses. (Interestingly, it is that mutation at work when you look at the different gait patterns of certain horse breeds, from Tennessee Walkers to Louisiana Fox Trotters.)

Thanks to genetic science, these mysteries can be decrypted on microscopic scales and could aid in better understanding the communication centers of our own (human) spinal cords, for medical research going forward.

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Researchers Found a Way to Send Tiny Robots Into Mouse Brains

Generations of laboratory mice like these recently became host to microscopic robot swarms.
Photo: Getty Images (Getty Images)

In a mind-bending development, a team of researchers in China have managed to treat brain tumors in mice by delivering drugs to the tissues using microscopic robots. The robots jumped from the mice’s bloodstreams into their brains by being coated in E. coli, which tricked the rodents’ immune systems into attacking them, absorbing the robots and the cancer-fighting drugs in the process.

The team’s research was published today in the journal Science Robotics. It comes on the heels of previous research by members of the same team, which saw liquid-coated nanorobots remotely propelled through the jelly-like fluid of the eye. Besides being an obvious recipe for an episode of “The Magic School Bus,” the research had obvious applications for ophthalmological research and medical treatments.

“It’s not just the blood-brain barrier,” said lead author Zhiguang Wu, a chemist at the Harbin Institute for Technology in China, in an email. “Most barriers in dense tissues are difficult obstacles to overcome in moving microrobots around a body.”

The crafts are magnetic, and the researchers use a rotating magnetic field to pull them around remotely. On microscales—we’re talking incremental movements about 1% the width of a hair—the researchers were able to make the hybrid bio-bots wend paths like in the video game Snake. They’re dubbed “neutrobots” because they infiltrate the brain in the casing of neutrophils, a type of white blood cell.

“The biggest challenge of the work was how to achieve a swarm intelligence of neutrobots,” Wu said. “Like robot swarms in the macroscale world, the micro/nanorobot swarms enable sophisticated manipulation to accomplish complex tasks.”

It ultimately took Wu’s team eight years to actualize the microscopic robot swarms capable of bridging the gap between the rodent bloodstream in the animal’s tail, where the bots were injected, and its brain, where gliomas—tumors that emerge from the brain’s glial cells—resided. Part of the issue is that the mice’s white blood cells didn’t dig the flavor of the magnetic robots. To overcome that issue, Wu’s team coated the bots in bits of E. coli membrane, which the white blood cells easily recognize as a unwelcome invader. That made the robots much more palatable, and the white blood cells enveloped them. From inside those cells, the robots were then able to roll the cells toward the brain; a Trojan horse for the 21st century (in this case, one that benefits the residents of Troy). The neutrobots made it into the brains and were able to deliver the drug directly to the targeted tumors.

Wu said the applications of the robots are manifold, and more breakthroughs could be on the horizon. “The neutrobots are not exclusively designed for the treatment of glioma,” he said, explaining that they’re “a platform for active delivery for the therapy of various brain diseases such as cerebral thrombosis, apoplexy, and epilepsy.”

A neutrobot nestled up against a glioma tumor in a mouse brain.
Image: Zhang et al., Sci Robot. 6, eaaz9519 (2021)

Whether it’s surgery or drug delivery, robots are slowly but surely making their way into our most personal of domains. Of course, they’re still just in mouse brains for now, but future applications in humans seem increasingly likely.

“The use of neutrophils in microrobot design is a fascinating strategy for overcoming biological barriers,” wrote robotic engineers Junsun Hwang and Hongsoo Choi, who weren’t affiliated with the new work, in an accompanying article. “However, bench-to-bedside translation with respect to targeted drug delivery by neutrobots or microrobots is still some way off.”

Currently, experts lack the ability to see what the robots are doing clearly in real time, which would be vital for any medical use of the droids down the line. But in the rat race of robotics research, it’s clear that humans are pushing their inanimate swarms in the direction of progress.

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Processed Meat Linked to Increased Dementia Risk, Study Finds

Photo: Joe Raedle (Getty Images)

People’s love of processed meat might come back to bite them in the long run, new research from the UK suggests. The study found a link between greater consumption of processed meat and higher rates of Alzheimer’s disease and other forms of dementia. At the same time, it also found a possible link between eating unprocessed meats and a lower risk of dementia.

Processed meats such as bacon, jerky, and hot dogs don’t exactly have a reputation for being healthy in the first place. Other research has suggested that diets high in these foods are linked to chronic conditions such as type 2 diabetes, cardiovascular disease, and some types of cancer. Some studies have even pointed to a link between processed meats and the increased risk of neuropsychiatric symptoms, such as episodes of bipolar depression.

There’s been mixed evidence that a diet high in meat could raise a person’s risk of dementia in their later years. But according to the authors of this new study, published Monday in The American Journal of Clinical Nutrition, there’s been less work to separate out the possible dementia risk from different types of meats (processed versus not) and whether genetics may play a role in that risk.

The study relied on population data from the UK Biobank, an ongoing research project that’s collected health and genetic information from around a half million residents, ages 40 to 69, between 2006 and 2010. As part of the project, volunteers filled out a questionnaire about their diet at the start of their enrollment and in periodic online surveys for up to 16 months after. Because of the UK’s nationalized health system, the researchers were then able to track the health outcomes of these participants, including whether they developed or died from dementia.

About 2,900 cases of dementia were diagnosed in the entire group, during an average eight-year follow-up period. And when the researchers tried to account for people’s diets, they found a clear association between processed meat and the risk of dementia, but they didn’t see the correlation when it came to other types of meat.

For example, the associated risk of dementia rose by 44% for every 25 grams of processed meat eaten daily. But there was no significant link found between dementia risk and total meat consumption or between dementia risk and a person’s daily intake of chicken. Meanwhile, the associated risk of dementia actually declined slightly for those who regularly ate unprocessed red meat (cooked beef, veal, pork, etc.). The risk of dementia increased for those who carried the APOE ε4 genetic variation, as expected, but this risk wasn’t affected by meat consumption.

“Our findings suggest that consumption of processed meat may increase risk of incident dementia, and unprocessed red meat intake may be associated with lower risks,” the authors wrote.

Nutritional studies like this one have their limitations, of course. For instance, they can’t show a direct cause-and-effect relationship between any two things, only a correlation. Studying people’s diets is hard in general, since we aren’t the greatest at remembering what and how much of any given food we eat regularly. And of course, a person’s diet at 40 or 50 might still change significantly between then and the time of their dementia diagnosis years or decades later.

Any single study shouldn’t be seen as the final verdict on a topic. More research will have to be done to tease out the potential effects of a diet high in processed meats on our dementia risk and how these diets may be causing it. That said, as mentioned earlier, this wouldn’t be the first study tying processed meats to worsening health. So while the specifics still need to be worked on, it’s likely in many of our best interests to cut down on bacon or sausage anyway.

“Worldwide, the prevalence of dementia is increasing and diet as a modifiable factor could play a role,” said lead author Huifeng Zhang, a PhD student from the University of Leeds’ School of Food Science and Nutrition, in a statement released by the UK-based university. “Our research adds to the growing body of evidence linking processed meat consumption, to increased risk of a range of non-transmissible diseases.”

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Purdue Pharma reveals plan to dissolve the company and Sackler family agrees to pay $4.2 billion

As part of the proposed plan, the Sackler family has agreed to pay an additional $4.2 billion over the next nine years to resolve various civil claims.

“Today marks an important step toward providing help to those who suffer from addiction, and we hope this proposed resolution will signal the beginning of a far-reaching effort to deliver assistance where it is needed,” the Sackler family said in a statement.

The company, which makes OxyContin, called the plan “unprecedented in scope and nature” in a press release.

“The vast majority of the Debtors’ assets will be dedicated to programs to abate the opioid crisis. Billions of dollars will flow into trusts established for the benefit of states and localities, as well as other creditor groups such as Native American Tribes, hospitals, and children with a history of Neonatal Abstinence Syndrome and their guardians. Each trust will require that the funds be dedicated exclusively to opioid abatement efforts, and there will be transparency to so ensure,” court documents state.

But attorneys general across the country objected to the settlement. In a joint statement, they called Purdue a “criminal enterprise” and demanded the company admit to its role in creating the crisis.

“It falls short of the accountability that families and survivors deserve,” the statement said.

The restructuring plan is over 300 pages long. It details how the embattled pharmaceutical company plans to transfer billions of dollars and operating assets into a newly-formed company, whose stated mission is to address the country’s opioid crisis.

Purdue Pharma said in a press release that state and local governments will neither own, nor operate the new company and that more than $10 billion will be designated to “providing, at cost, millions of doses of potentially lifesaving opioid addiction treatment and overdose reversal medicines.”

Purdue Pharma’s plan will also distribute funds through two newly-established national opioid abatement trusts: the National Opioid Abatement Trust (the “NOAT”) and the Tribe Trust, which will be dedicated to resolving claims from Native American tribes.

“All value distributed to NOAT and the Tribe Trust will be exclusively dedicated to programs designed to abate the opioid crisis and for no other purpose (other than to fund administration of the programs themselves and to pay fees and costs). The Debtors believe that funding these dedicated abatement funds, while allocating significant value for distribution to holders of PI Claims, is in the best interest of creditors and of the American public,” court documents state.

A hearing to approve the plan is scheduled for April 21.

Oxycontin is among the most abused prescription drugs of all time, linking the pharmacy company to the opioid epidemic raging through the country. According to the Centers for Disease Control, 450,000 people died in the United States in the 10 years starting in 1999 from overdoses involving opioids, including prescription and illicit drugs. And about a third of those deaths in 2018 involved prescription opioids.

Purdue had allegedly paid doctors to write more opioid prescriptions, according to the three federal criminal charges the company pleaded guilty to in November. Purdue was to pay more than $8 billion and agreed to close down the company.

The company didn’t have $8 billion in cash, so Purdue agreed to dissolve itsefl and use its assets to create a new “public benefit company” controlled by a trust or similar entity designed for the benefit of the American public. The plan was swiftly criticized by dozens of state attorneys general.

The Sackler family has made a fortune off of the sales of Oxycontin. In October, the family paid $225 million in damages, but did not take responsibility for the opioid crisis.

The Sackler’s have already paid $225 million under an initial settlement framework to satisfy their civil settlement with the US Department of Justice and persons associated with the Sackler entities have agreed to be “prohibited from engaging in the manufacturing or sale of opioids, subject to exceptions to be agreed,” court documents state.

— CNN’s Chris Isidore contributed to this report.

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Rapid 3D-Printing Method Could Be the Secret to Developing 3D-Printed Organs

We may not have flying cars yet, but 3D-printed organs? That sci-fi fantasy just got one step closer to reality thanks to a rapid 3D-printing method developed by University of Buffalo engineers.

Their work was recently included in a study published in the journal Advanced Healthcare Materials, which you can read here, and is also demonstrated in the frankly unsettling gif above. This sped-up footage shows a 3D printer fully constructing an artificial hand in just 19 minutes, a task that would take six hours using conventional 3D printing methods, the team said.

“The technology we’ve developed is 10-50 times faster than the industry standard, and it works with large sample sizes that have been very difficult to achieve previously,” said the study’s co-lead author Ruogang Zhao, an associate professor of biomedical engineering at the university, in a press release Friday.

The process relies on stereolithography, a longstanding 3D-printing method that uses lasers to harden liquid resin, and jelly-like substances called hydrogels, which can absorb large quantities of water without dissolving. Hydrogels are commonly used in commercial products like contact lenses, glue, and disposable diapers, though scientists have also experimented with them in potential biomedical treatments.

According to researchers, this method is particularly suited for correctly printing all the teeny tiny details in cells with embedded blood vessel networks, something that’s expected to play a critical role in the eventual production of 3D-printed human tissue and organs.

“Our method allows for the rapid printing of centimeter-sized hydrogel models. It significantly reduces part deformation and cellular injuries caused by the prolonged exposure to the environmental stresses you commonly see in conventional 3D printing methods,” said the study’s other co-lead author, Chi Zhou, an associate professor of industrial and systems engineering at the university.

The team’s research was funded by the National Institute of Biomedical Imaging and Bioengineering and the National Institutes of Health as well as the UB School of Engineering and Applied Sciences and the Jacobs School of Medicine and Biomedical Sciences, per the press release.

The idea of 3D-printed organs still seems like futuristic mumbo jumbo to me, but I suppose if you can already eat 3D-printed meat in a 3D-printed house where you keep your 3D-printed gun, then the sky’s the limit.

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UPDATE: Jazz Pharmaceuticals to acquire GW Pharma for $7.2 billion in cash and stock, GW soars 46% premarket

Jazz Pharmaceuticals Plc
JAZZ,
+1.32%
said Wednesday it has agreed to acquire GW Pharmaceuticals Plc
GWPH,
+1.51%
in a cash-and-stock deal valued at $7.2 billion. Under the terms of the deal, Jazz Pharma will pay $200 per share in cash and $20 in stock for each share owned, or a premium of about 50% over GW’s closing price on Tuesday, and 60% over its 30-day volume weighted average price. The deal is expected to close in the second quarter, to boost profit in the first year after close and to drive double-digit revenue growth. GW is a leader in therapies based on its proprietary cannabinoid product platform to treat a number of diseases. The company was the first to receive FDA approval for a CBD-based treatment for severe forms of childhood epilepsy in its Epidiolex lead product. Jazz makes sleep medications and has a growing oncology business. GW Pharma shares soared 46% premarket after resuming trade following a halt for the news. Jazz shares were down 2.7% premarket, but have gained 11% in the last 12 months, while the S&P 500
SPX,
+1.39%
has gained 18%.

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