Nestle-partnered weight loss capsule succeeds in pivotal trial

 A weight loss capsule developed by Nestlé (NSRGY) (NSRGF) and Epitomee Medical has succeeded in a pivotal trial

Israeli company Epitomee Medical has reported success in a pivotal study of its weight loss capsule, causing its stock to soar on the Tel Aviv Stock Exchange.

This capsule, classified as a medical device, is essentially a swallowable pill that expands in the stomach, creating a sensation of satiety. Following the announcement of this success, the company's stock surged by over 70% at one stage on Monday, reaching an all-time high and achieving a market cap of over $100 million.

It's worth noting that this stock jump occurred despite the fact that the company has not yet published the full results of the experiment; it has only reported the success. The company's report lacks crucial details, such as the average weight loss observed in the experimental group compared to the control group, and it does not specify the level of statistical significance achieved in the experiment.

The criteria for success in the experiment had been predetermined, requiring that 35% of the subjects in the trial lose more than 5% of their baseline body weight. The experiment involved 279 subjects, and Epitomee has stated that the final data will be released at a later time, once received from the external company responsible for conducting and overseeing the experiment.

Epitomee next intends to seek FDA approval for the sale of this medical device via the 510(k) pathway, which permits the sale of devices with a strong resemblance to existing devices in the market (Substantially Equivalent). This approach aims to expedite the FDA approval process by leveraging the similarities to other approved devices. The company anticipates receiving approval during 2024.

The 510(k) pathway is favored by companies looking to introduce their products to the market because it generally involves a shorter approval timeline and reduced FDA oversight compared to the full approval process. However, this route has faced criticism for its relatively lenient standards, allowing medical devices to enter the American market with greater ease.

Epitomee's weight management product is a shapeshifting polymeric scaffold composed of swellable biopolymers that imitates solid food to achieve a sensation of satiety. Once it reaches the stomach, it expands into a flexible triangle, interacting with the stomach wall and activating key pathways that regulate satiety and food intake. It is then cleared out through normal bowel movements and is not absorbed by the body. The capsule is already CE cleared.

In response to Calcalist's inquiries regarding the missing details in Epitomee's report, the Israel Securities Authority responded: "The Authority does not comment on its interactions with supervised entities, and if necessary, any such interactions will be reflected in the companies' reports."

Epitomee partnered with Nestlé Health Science in the study, with the latter having the exclusive rights to commercialize the capsule globally.

https://www.calcalistech.com/ctechnews/article/rj1g1lxah

Harm of Delaying the Disenrollment of Medicaid Ineligibles

 

Key Takeaways

1. As a result of federal and state COVID policies, there were roughly 18 million ineligible Medicaid enrollees on the program as of April 1, 2023, at an annualized cost of more than $80 billion. Paying for ineligible enrollees pulls resources away from other public priorities and primarily benefits health insurance companies that administer Medicaid.
2. States could have begun removing ineligible enrollees in April. Some states started the redetermination process early and are efficiently processing removals of ineligible enrollees, but other states are acting slowly and will waste resources on Medicaid coverage for individuals who have moved out of state, have private insurance, have died, or earn too much income.
3. Total Medicaid savings would be $41 billion and state savings would be $12 billion if all states pursued an efficient redetermination process.
4. There are significant protections for enrollees mistakenly disenrolled, including three-month retroactive eligibility, hospital presumptive eligibility, and a robust appeals process.

Three actions

States could have taken three actions to protect limited resources for eligible Medicaid recipients or for other purposes:

1. Prioritize those most likely to be ineligible: reviewing eligibility prior to the unwinding period to initiate redeterminations for those most likely to be ineligible,
2. Move up the start date: beginning redeterminations earlier, and
3. Check eligibility in bigger batches: processing a greater number of redeterminations each month.

Since about two-thirds of Medicaid is financed by the federal government, such actions would also reduce wasteful federal spending and lower the deficit.

https://paragoninstitute.org/research-paper-page-gonshorowski-blase-kleinworth-cost-of-good-intentions-medicaid-redeterminations-20230717/

NEW DISCOVERIES IN CLIMATE SCIENCE

 Climate science is a wild and woolly multi-disciplinary field in which virtually every proposition is controversial. It is only the politics that is settled; the science is up for grabs.

A recent study in Climate illustrates the point, not by introducing new concepts but by measuring the obvious:

A new study published in the scientific peer-reviewed journal, Climate, by 37 researchers from 18 countries suggests that current estimates of global warming are contaminated by urban warming biases.
***
It is well-known that cities are warmer than the surrounding countryside.

We all understand this. “Chance of frost in outlying areas.”

While urban areas only account for less than 4% of the global land surface, many of the weather stations used for calculating global temperatures are located in urban areas. For this reason, some scientists have been concerned that the current global warming estimates may have been contaminated by urban heat island effects.

There is no question that the Urban Heat Island Effect exists. The question is, how much does it skew current temperature readings in an upward direction?

In their latest report, the IPCC estimated that urban warming accounted for less than 10% of global warming. However, this new study suggests that urban warming might account for up to 40% of the warming since 1850.

Given the IPCC’s obvious bias, I find that conclusion highly plausible.

But that’s not all:

The study also found that the IPCC’s chosen estimate of solar activity appeared to have prematurely ruled out a substantial role for the Sun in the observed warming.

One hundred percent of the energy that heats the earth–that prevents it from being a cold, dead rock–comes from the Sun. So the suggestion that variations in the Earth’s climate, which have occurred for millions of years, might relate to variations in solar activity, is an obvious one that Greenies have tried hard to obfuscate.

When the authors analysed the temperature data only using the IPCC’s solar dataset, they could not explain any of the warming since the mid-20th century. That is, they replicated the IPCC’s iconic finding that global warming is mostly human-caused. However, when the authors repeated the analysis using a different estimate of solar activity – one that is often used by the scientific community – they found that most of the warming and cooling trends of the rural data could actually be explained in terms of changing solar activity.

I don’t doubt that adding CO2 to the atmosphere has some small effect on global temperatures. But the models that are the sole basis for climate hysteria use wholly hypothetical feedback effects to transform a benign level of warming that can be accounted for scientifically into a supposedly catastrophic apocalypse. This study suggests that if we eliminate the Urban Heat Island Effect and properly account for variations in solar activity, what is left is the very modest increase in temperatures that science actually supports. (My conclusion, not necessarily that of the authors.) Or perhaps the small residual warming is due to something else entirely.

In any event, if the West actually succumbs to Green nonsense and de-industrializes and impoverishes itself, so as to yield global domination to China and India, who have no intention of doing any such thing, it will be the dumbest action by any governments in world history.

https://www.powerlineblog.com/archives/2023/09/new-discoveries-in-climate-science.php

'Musk's Father Worried About Assassination After Escalating Attacks'

 The father of Elon Musk is worried for his son's safety, after he says The New Yorker painted a target on his back with an article highlighting Elon's influence on government decisions about the war in Ukraine, and implied that a conversation Musk had with Russian President Vladimir Putin means Kremliny things are afoot.

Photo: Cyrus McCrimmon/The Denver Post/Getty Images; Anthony Harvey/Getty Images

Errol Musk, 77, told The Sun that the article was "a hit job, a shadow government-sponsored opening salvo on Elon - with one Pentagon official telling The New Yorker that Elon was treated like an "unelected official." The article also claims that Musk's "influence is more brazen and expansive" than previous "meddling of oligarchs and other monied interests in the fate of nations."

When asked by the Sun whether he feared Elon's assassination by the "shadow government," he replied "Yes," suggesting that the New Yorker article was "the artillery-like softening up of the enemy before the actual attack," according.

Interestingly, The New Yorker article came out just days before the Biden DOJ sued Musk's SpaceX for allegedly discriminating against non-US citizens (as all rocket companies and the US government tend not to do).

In July, President Joe 'The Big Guy' Biden suggested that Musk could be investigated for buying X, formerly Twitter, with the help of a Saudi Arabian conglomerate.

When asked if Musk was a threat to national security, Biden said "Elon Musk’s cooperation and/or technical relationships with other countries is worthy of being looked at.

"Whether or not he is doing anything inappropriate, I’m not suggesting that.

"I’m suggesting they’re worth being looked at and that’s all I’ll say," Biden continued, adding "There's a lot of ways."

Musk has also faced assault from censorship advocates, who have accused him of allowing a rise in hate speech and disinformation since he bought X. Musk's supporters say he's protecting freedom of speech, though many have claimed they're still being suppressed by the social media giant.

The day before the DOJ sued SpaceX, the DOJ said: "We’re currently expanding our safety and elections teams to focus on combating manipulation, surfacing inauthentic accounts and closely monitoring the platform for emerging threats.

"Our work is ongoing. These increased investments in people, policy and product will further ensure our communities have access to open, accurate and safe political discourse on X."

In May, Musk's mother scolded her son for joking about assassination.

Musk getting it from all sides

Musk has previously joked to Joe Rogan that he could be assassinated after former Russian space agency head Dmitry Rogozin made a veiled threat over Musk supplying Ukraine with Starlink satellite service last May.

Elon and Errol are reportedly estranged, with Elon once calling his father a "terrible human being." That said, earlier this year Errol said that his son is a "force for good."

https://www.zerohedge.com/political/musks-father-worried-about-assassination-after-escalating-attacks

Medivir: Promising Interim Data Of Fostrox In Combination With Lenvima In HCC

 Shares of Medivir AB (MVIR) were gaining around 11 percent in the early morning trading in Sweden after the pharmaceutical company focused on cancer treatments Monday announced promising interim safety and efficacy data, including a first complete response in phase 1b/2a HCC study with fostrox in combination with Lenvima in advanced hepatocellular carcinoma or HCC.

The phase 1b/2a study of first-in-class candidate drug fostrox in combination with Lenvima in HCC patients for whom current first- or second-line treatment has proven ineffective or is not tolerable is ongoing.

The company noted that central review of the 6 patients in phase 1b dose escalation part was performed. In these 6 patients, complete response was recorded in 1 patient, partial response in 2 patients, and stable disease in 2 patients read by an independent radiologist using mRECIST.

The interim results confirmed the previously announced favorable safety and tolerability profile. The company noted that no new or unexpected safety events and the combination continues to be tolerable.

The phase 2a dose expansion part of the study is ongoing and is now fully recruited. The company plans to present data from phase 1b/2a at an upcoming scientific congress.

https://www.rttnews.com/3387877/medivir-stock-up-on-promising-interim-data-of-fostrox-in-combination-with-lenvima-in-hcc.aspx

ACR: Rheumatologists Help Reduce Emergency, Hospitalization Costs

 Rheumatology care can save health systems more than $2700 per patient per year, according to a new report from the American College of Rheumatology (ACR).

In a white paper and corresponding position statement, the organization outlined how rheumatology care delivers financial benefits for health systems. The work also highlighted prior research on the positive outcomes associated with rheumatology care, including the following:

• A decline in hip and knee replacements for patients with rheumatoid arthritis after the introduction of biologics, while the total number of hip and knee replacements for patients with osteoarthritis increased

• Lower 30-day readmission rates among patients with systemic lupus erythematosus with access to a rheumatology clinic post discharge

"Many rheumatologists can attest to the value they bring to the care team at a healthcare system," said Christina Downey, MD, an assistant professor of medicine at Loma Linda University, Loma Linda, California, in a press release. She is the lead author of the white paper and chair of the ACR's Government Affairs Committee. "Our goal with the paper and position statement is to emphasize what that value looks like from a preventive and financial perspective. A rheumatologist on the care team benefits patients, practices, and the economy."

The analysis used adjusted claims insurance data to compare markets with a high vs low supply of rheumatologists. A high supply was defined as at least 1.5 rheumatologists per 100,000 population, whereas a low supply was less than this amount. On average, markets with a high supply of rheumatologists had lower emergency department (ED) and hospitalization costs per patient per year.

	ED costs	Hospitalization costs
Low Supply	$4194	$4194
High supply	$2882	$9542
Cost savings	$1312	$1450

 

Added together, high-supply rheumatology markets save on average $2762 in ED visit and hospitalization costs per patient per year.

Downey and colleagues also tallied the direct and downstream billings associated with rheumatologists, including office visits, consultations, lab testing, and radiology services. The average revenue generated per rheumatologist was $3.5 million per year.

"Emphasizing the impact rheumatologists have on the entire medical community is more important than ever, especially as we contend with an impending rheumatology workforce shortage coupled with an expected increase in patient demand for rheumatologic care," Downey said. "This paper supports our recruitment and sustainability efforts for the specialty by spotlighting the significant contributions we make every day and every year to patient outcomes, hospitals, and other healthcare practices."

https://www.medscape.com/viewarticle/996028

Birx Does 180, Says No New Mask Mandates

 When COVID-19 broker out, Dr. Deborah Birx, a former military AIDS researcher with no training, experience, or publications in epidemiology or public health policy, found herself leading a White House Task Force which would play a seminal role in dictating how the country locked down for the pandemic.

In March of 2020, Birx and Dr. Anthony Fauci were grinning like Cheshire Cats with Duper's Delight as they laid out an unprecedented lockdown and masking strategy which Birx later admitted they pulled out of their asses.

Now that we're revisiting mask mandates over the latest Covid-19 surge, Birx and Fauci are seemingly on different sides of the debate.

"We don't need to mandate," Birx told Newsmax on Saturday, in response to reports that an increasing number of hospitals and businesses are now requiring masks again.

"We need to actually empower people with the information that they need for themselves and their families because every family is different," she continued. "And by the way, outside is safe, and playgrounds are safe."

Meanwhile Fauci - the guy who was funding risky bat coronavirus research in Wuhan, China and was then put in charge of the Coronavirus response in which he had scientists scramble to create and bolster propaganda denying a lab leak - went on CNN to push for mask mandates, claiming "there have been many studies indicate the benefit of wearing masks."

Yet, Anchor Michael Smerconish brought up the Cochrane review of masks, one of umpteen studies that have all found that the face coverings do little to nothing against COVID transmission (via Summit News).

"When you’re talking about the effect on the epidemic or the pandemic as a whole, the data are less strong," Fauci said, sqirming. "There are other studies, Michael, that show at an individual level, for individuals they might be protective."

Sure Tony...

https://www.zerohedge.com/medical/trump-lockdown-tyrant-does-180-says-no-new-mask-mandates