'Patients With Obesity Shed Pounds With Drug-Free Capsule'

 Use of an oral biodegradable drug-free capsule led to more weight loss among patients with overweight or obesity compared with placebo, according to the randomized RESET trial.

Among 279 patients, mean change in body weight from baseline to week 24 was -6.6% for those using the Epitomee capsule compared with -4.6% for those on placebo (P<0.01), reported Jamy D. Ard, MD, of Wake Forest University School of Medicine in Winston-Salem, North Carolina, at the ObesityWeekopens in a new tab or window annual meeting.

Moreover, 56% of those using the Epitomee capsule lost at least 5% of their body weight compared with 44% of those on placebo (P<0.0001), which exceeded the predefined threshold of 35%, and 27% and 11%, respectively, lost at least 10% of their body weight (P<0.002).

The Epitomee capsule -- which was cleared by the FDA in Septemberopens in a new tab or window for weight management -- is a novel shape-shifting device made up of absorbent polymers and bonding materials that self-expands in the stomach, creating a super-absorbent gel-based structure of 97% water and 3% polymers that takes up space, Ard explained.

Once it expands into a triangular shape in the stomach, it remains rigid for several hours and mimics solid food digestion, reducing appetite and affecting satiety signaling, before collapsing and dissolving in the small intestine. Unlike a gastric balloon, the patient can administer it themselves, and the intervention is short term.

"This is a novel option to add to the treatment array for patients who may not be interested in a systemic drug treatment," Ard told MedPage Today. "This treatment is designed to be used with a lifestyle intervention, so it is important to advise patients on a healthy diet and program of physical activity."

Because the treatment was found to be safe and well-tolerated, "it can be used for a wide variety of patients, even those who might not tolerate other medications or have contraindications for those medications," Ard added. Though this trial lasted only 6 months, the results were promising enough to support study of longer-term effects, he noted.

The double-blind trial enrolled 279 participants with a body mass index (BMI) of 27-40 and without diabetes between September 2020 and January 2023 from nine U.S. sites. Across the two groups, mean age was 49, 79-80% were women, 65-70% were white, and 21-24% were Black.

Of the participants, 45-48% had Class I obesity and 38-39% had Class II obesity. Mean BMI was 34.

The 138 participants in the Epitomee group took the capsule twice daily with 2 cups of water 30 minutes before meals while 141 took placebo; both groups received the same lifestyle intervention program. Similar proportions of participants in the Epitomee arm (39.1%) and placebo arm (35.5%) had prediabetes, and 2.2% and 0.7% had diabetes, respectively.

In both groups, 14% of patients discontinued the trial early, including 1.5% of the Epitomee group and 3.6% of the placebo group due to an adverse event. Nearly all of the remaining participants (96.2% and 98.3%, respectively) had treatment adherence.

The researchers also compared early responders, defined as those losing at least 2% of body weight at week 8. The 77 early Epitomee responders lost an average 9.3% of body weight at 8 weeks compared with 6.9% of the 73 early-responder placebo participants (P<0.0001). Within these subgroups, 40% of Epitomee participants and 18% of placebo participants lost at least 10% of their body weight (P<0.01), though the proportions who lost at least 5% were not significantly different.

At 24 weeks, Epitomee participants' systolic blood pressure fell an average 3.7 mm Hg compared with baseline (P<0.0001), and placebo participants' fell 2.8 mm Hg (P<0.0001), while diastolic blood pressure fell an average of -1.5 mm Hg (P<0.01) and -1.3 mm Hg (P<0.05). Even bigger reductions were seen in participants in both groups who had abnormal blood pressure at baseline (systolic blood pressure: -8.0 and -6.5, P<0.0001 for both; diastolic blood pressure: -3.8 mm Hg [P<0.0001] and -3.2 mm Hg [P<0.01]).

Among participants with prediabetes, those using Epitomee experienced an average 27.9% drop in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline, compared with a 8% drop in placebo participants (P<0.01) at 24 weeks. Epitomee participants also saw a larger percentage drop in insulin from baseline (-28.2%) compared with placebo participants (-7.4%, P<0.01).

Participants in both groups had significant improvements in all quality-of-life measures -- physical, physical function, psychosocial, and total score -- from baseline, but the differences between the arms were only significant in the physical function score (P<0.04).

Overall adverse event rates did not significantly differ between the groups in incidence or severity, and no serious adverse events occurred in either group. The most commonly reported adverse events aside from COVID-19 were gastrointestinal disorders, with each event occurring in ≤10% of participants, except constipation, which occurred in about 16% of placebo participants.

Ard said he was surprised that participants did not have many gastrointestinal side effects overall.

"Naturally, one might think that an oral device that is designed to work through the stomach would be associated with more side effects like nausea or reflux even," Ard noted. "This device was well tolerated and caused very few GI-related issues," which may speak to "the uniqueness of the design and engineering."

Primary Source

ObesityWeek

Source Reference: opens in a new tab or windowArd JD, et al "RESET study: Randomized, double-blind, placebo-controlled study of a novel oral hydrogel capsule for weight loss" ObesityWeek 2024.

https://www.medpagetoday.com/meetingcoverage/obesityweek/112812

US watchdog de-registers Chinese accounting firm, citing repeat violations

 The U.S. Public Company Accounting Oversight Board said on Friday ithad revoked the registration of JTC Fair Song CPA Firm becausethe Chinese company had "repeatedly" violated the agency'srules and refused to cooperate with a related investigation.

The company failed to make required filings over a multi-year period and refused to produce documents and information in response to formal demands from the U.S. accounting overseer, the agency said.

The Shenzhen, China-based company did not immediately respond to a request for comment. According to the U.S. watchdog, the company neither admitted nor denied the agency's findings but consented to a disciplinary order censuring the firm and revoking its registration.

The watchdog, which is overseen by the U.S. Securities and Exchange Commission, decided not to impose a $50,000 penalty after considering the company's financial resources, according to the statement.

U.S. and Chinese authorities in 2022 struck a landmark deal to allow the watchdog, which was created in the wake of the Enron-era corporate accounting scandals, to vet accounting firms in China and Hong Kong, a long-standing source of tension between the world's two largest economies.

"Today's order should serve as a stark reminder that firms must cooperate with the Board's investigatory process," Robert Rice, head of enforcement and investigations for the watchdog, said in a statement.

https://www.xm.com/research/markets/allNews/reuters/us-watchdog-deregisters-chinese-accounting-firm-citing-repeat-violations-53964797

DOE Completes Oil Purchases for Strategic Petroleum Reserve

 The Department of Energy said Friday it has finished buying oil to replenish the Strategic Petroleum Reserve with the latest purchase of 2.4 million barrels.

The DOE directly bought 59 million barrels of oil at an average price below $76 a barrel, compared with around $95 a barrel received for emergency sales in 2022 following the Russian invasion of Ukraine.

The department said that, counting the cancellation of 140 million barrels of mandated sales from the reserve for fiscal years 2024 through 2026, it has secured 200 million barrels for the SPR. The DOE sold 180 million barrels under the 2022 emergency declaration.

"This is smoke and mirrors to make it look OK," said Phil Flynn, senior markets analyst at the Price Futures Group. "From an oil-price standpoint, initially this is bearish because the market was under the assumption that over time the government was going to end up buying this back. Obviously they're not going to replace the oil."

The SPR held 387.2 million barrels of oil at the start of November, according to the U.S. Energy Information Administration, compared with 638.1 million barrels at the start of the Biden administration.

The DOE said Friday that the sale of oil from the reserve in 2022 "calmed global markets and protected American business and consumers with a reliable supply of fuel." It said the sales in 2022, along with releases from reserves in other countries, lowered gasoline prices by as much as 40 cents a gallon according to a Treasury Department analysis.

The department added that it has used all the funds allocated for crude purchases.

https://www.morningstar.com/news/dow-jones/202411089977/doe-completes-oil-purchases-for-strategic-petroleum-reserve

'Blinken holds calls in final Middle East diplomacy push'

 The outgoing Biden administration pressed ahead on Friday with diplomacy aimed at reaching deals to end Israel's conflicts in Gaza and Lebanon, with Secretary of State Antony Blinken speaking to counterparts in the United Arab Emirates and Saudi Arabia.

U.S. officials have said they will make a final push to reach deals on the conflicts, although it is unclear how much leverage they have over Israel and other actors in the region now focused on the incoming administration of former President Donald Trump.

Blinken in his calls on Friday affirmed the administration's continued desire to achieve a ceasefire in Gaza as soon as possible and a diplomatic resolution to the Israel-Hezbollah conflict in Lebanon, as well as discussing the conflict in Sudan, spokesperson Matthew Miller said.

In his call with Saudi Foreign Minister Prince Faisal bin Farhan bin Abdullah, Blinken discussed "efforts to secure the release of hostages and establish a path forward that allows Palestinians in Gaza to rebuild their lives and advance governance, security and reconstruction," Miller said.

With the UAE's Sheikh Abdullah bin Zayed Al Nahyan, Blinken "discussed efforts to achieve a diplomatic resolution in Lebanon that allows civilians on both sides of the Blue Line to return to their homes," Miller said.

On Thursday Blinken also spoke to French Foreign Minister Jean-Noel Barrot about both efforts.

https://www.aol.com/middle-east-latest-israeli-defense-115546214.html

Should Trump Use DOJ Against His Enemies?

 In the nine years since Donald Trump launched his first successful campaign for the presidency, it has become increasingly clear that America is in a state of cold civil war. Rather than politics as usual, we face a life-or-death conflict between two regimes with radically different understandings of what justice is. Nowhere has this been clearer than in the enemy regime’s relentless persecution of Donald Trump himself. The endless lawfare waged against Trump, his allies, and his supporters has required the foot soldiers of the destructive Left to trample our Constitution time after time; it has also allowed them to amass incredible power in service of their own constitution.

TJ Harker and Mark Pulliam suggest a strategy for Trump’s Department of Justice that takes these facts into account: before he can serve as a president for all Americans, before he can lead the nation into a new era, Trump must finish the war. This means, first and foremost, the swift and unflinching prosecution of those who defiled the rule of law in service to their cause.

Over the last four years, regime lawyers and government officials have repeatedly ignored the constitution, stretched the meaning of federal and state statutes, and shredded legal norms. They have investigated, prosecuted, and persecuted their political opponents. They did this to suppress those who challenged their rule and to send a message to would-be challengers. 

With Donald Trump’s election and pending inauguration (assuming no shenanigans between now and then), unpleasant things will have to be done to hold these people to account. The regime’s aggressive lawlessness will require a response. 

The response must balance the immediate need for accountability with the ultimate need for reconciliation. On the one hand, we must hold responsible those whose criminal conduct subverted our constitutional order. On the other, we must prepare to reconcile with the millions of Americans who erred grievously in supporting the regime’s lawlessness — at least with those people who are humble enough to acknowledge their error. 

Equal justice under the law, an essential feature of the rule of law, means enforcing the law in an even-handed manner. Violators must be held responsible for their actions. This is not “retribution,” any more than arresting a thief or murderer constitutes retribution. All citizens are expected to obey the law. No one is above the law. Lady Justice is depicted wearing a blindfold, not so that she can ignore lawbreaking, but so she can mete out punishment regardless of the identity of the perpetrator. Over the past four years, the regime has applied the law in a one-sided manner — punishing political opponents (sometimes by fabricating crimes or seeking disproportionate punishment) while looking the other way as agents of the regime ran roughshod over legal norms. Many Americans lost respect for our legal system due to the unfair and unjust manner in which laws were enforced and violations were condoned.

With the inauguration of President Trump to his second term, the double standard must end. Those who violated the law during the Biden administration must be held to account. This is a necessary first step to restoring the rule of law, and, just as importantly, restoring public faith in equal justice under the law.

Indeed, fashioning an appropriate response will be the most important task of Trump’s first year. It will require an attorney general with the backbone to design and implement it. Here’s a sketch of how that might look. 

Accountability

There are many examples of regime conduct that can be prosecuted under existing federal criminal statutes. These cases should be investigated, presented to grand juries for indictment, and prosecuted. For instance, 18 USC 242 makes it a federal crime to deprive somebody of a constitutional right under “color of law.” A Trump DOJ could use this statute to investigate the regime’s lawless prosecutors, government officials, and even judges. 

Consider, as just one example, the conduct of Shana Bellows. Bellows, the Maine secretary of state, used the power of her office to remove Donald Trump from the ballot in Maine. Though not a lawyer, Bellows claimed that Section 3 of the Fourteenth Amendment required her to do so. The Supreme Court smashed that pretense in Trump v. Anderson, ruling unanimously that Trump must be restored to the ballot in states where he had been removed, including Maine.  

It’s doubtful that Bellows has considered the possibility that DOJ might prosecute her. After all, the Department is staffed with regime allies, and under Merrick Garland it wouldn’t dream of doing so. But following Trump’s inauguration, Garland and his henchmen will be replaced with honest and tough prosecutors who should investigate Bellows’s conduct carefully to determine if she attempted to use her official position to deprive Maine’s citizens of the right vote for Trump — a federal felony under 18 USC 242. 

A brief review of publicly available facts shows that her conduct likely satisfies the elements of that offense. There are three: (1) The willful (2) deprivation of an individual’s constitutional right (3) while the defendant was acting under the color of law. 

The first element is what is called the mens rea, or intent. It requires proof that Bellows acted “with the particular purpose of violating” a Constitutional right or “with reckless disregard [of] the risk” that her conduct would do so. Her public statements alone prove her intent, as does the fact that she “did the rounds” on several regime-approved propaganda outlets that feted her “bravery.” A grand jury subpoena for her official email will almost certainly uncover further evidence of her intent.

Second, in removing Trump’s name from the ballot, Bellows violated numerous constitutional rights of Maine’s citizens (and of Donald Trump), including their right to vote. Prosecutors will have no difficulty proving this element and may find that Bellows violated other civil rights under the First, Fifth, Twelfth, and Fourteenth Amendments.

And, of course, Bellows was acting in her official capacity — that is, “under the color of law.” That’s how she was able to remove Trump’s name from the ballot in the first place. She had to be Maine’s secretary of state to do so. This satisfies the final element of the offense. 

The brief analysis above paints what prosecutors call a prima facie case. If the facts are what they appear to be (that is, if the facts described above are in fact true), and if prosecutors can prove them beyond a reasonable doubt, then a jury should find Bellows guilty of this felony.  That’s all there is to it. Bellows ought to hire an experienced criminal lawyer. Soon. 

Similarly, Trump’s new attorney general should investigate the members of Colorado’s Supreme Court. Late last year, the majority upheld a decision to remove Trump from the Centennial State’s ballot. Just as it is important to make an example of lawless executive branch officials, judges must be made to understand that they, too, cannot escape criminal liability merely by characterizing their criminal conduct as a legal order.

Indeed, prosecutors could look to the majority opinion itself for language to prove willful intent. Here’s the place to start: “We are also cognizant that we travel in uncharted territory.” This quote alone strongly suggests that the author of the opinion knew he was depriving Coloradoans of a fundamental civil right. After all, there is only one way in which the opinion is “uncharted”: state officials (in this case judges) used their official positions to try to subvert a national presidential election by denying half of Colorado’s citizens the right to vote. This goes to the very essence of the conduct prohibited by 18 USC 242. 

These are just a few examples. Investigations should be opened into Jack Smith, Jay Bratt, Fani Willis, Alvin Bragg, Letitia James, Alejandro Mayorkas, Jocelyn Benson, Jena Griswold, and many others. A thorough search of the United States code will likely uncover offenses they have committed, including offenses that can be proved easily. Indeed, applying the federal criminal code to their conduct will require prosecutors to do much less creative interpreting than state and federal prosecutors did in prosecuting Donald Trump, John Eastman, and Douglass Mackey, among others. 

Reconciliation

People who subvert our form of government, who weaponize the criminal justice system, who prosecute their political enemies must be held to account. But after examples have been made, we must go about the business of reconciliation. Acts of mercy will facilitate this. But mercy will have this effect only if the offenders understand who holds the cards. Thosewho get a pass must be made to understand that, but for the restraint of their fellow citizens, they would be prosecuted to the fullest extent of the law. 

Repairing the damage wrought by years of malicious, divisive, and destructive regime lawlessness will not be easy. The devastation is widespread. But it can be done. First with a calibrated but serious response, then with reconciliation. 

It must be clear to all Americans that, during Trump’s second term, the conservative half of the country that suffered tremendous injustice from the regime’s lawlessness suddenly had the power to exercise an awful retribution. And chose not to.

Mark Pulliam writes from East Tennessee. A Big Law veteran, he retired as a partner in a large law firm after practicing for 30 years. A contributing editor to Law & Liberty since 2015, Mark also blogs at Misrule of Law. He considers himself a fully-recovered lawyer.

TJ Harker is the General Counsel of a Knoxville, Tennessee company. Until recently, he was a federal prosecutor, where he investigated and tried national white-collar fraud and espionage matters. He recently launched Amicus Republicae on Substack

https://tomklingenstein.com/should-trump-use-doj-against-his-enemies/

UK health data ecosystem 'is hampering research'

 The UK is squandering the vast resource of NHS patient data because too many obstacles are being placed in front of researchers trying to tap into it – holding back medical advances.

That is the conclusion of the much-anticipated Sudlow Review – carried out by Professor Cathie Sudlow, chief scientist of Health Data Research (HDR) UK – which found that accessing patient data can take months or even years, hampering research into areas like dementia, cancer, and heart disease.

The review, called Uniting the UK's Health Data: A Huge Opportunity for Society, makes a number of recommendations for policymakers and healthcare leaders to unlock the unique potential of NHS data as a population-wide resource that goes back for decades and also includes related information on factors like social care, housing, and pollution.

Professor Cathie Sudlow OBE

"Far too often, research about health conditions affecting millions of people across the UK is prevented or delayed by the complexity of our data systems. We are letting patients and their families down as a result," said Sudlow.

"This review shows that getting this right holds a great prize, for our own care and for an effective NHS," she added. "We need to recognise our national health data for what they are: critical national infrastructure that can underpin the health of the nation."

The current data ecosystem includes a large number of legal checks and balances that have been introduced over the years to safeguard patient privacy, make sure data is not used for purposes like insurance or marketing, and guarantee that people can know how their data is being used.

While surveys have shown that people in the UK generally support the use of their health data with appropriate safeguards to improve lives, there are concerns about patient consent and the risk of data being surrendered to commercial enterprises, including organisations not based in the UK, which prompted millions of people to opt out of a GP data-sharing scheme that was eventually abandoned in 2021.

Those concerns were exacerbated by a decision by NHS England to award a contract worth up to £330 million to create a platform to bring together existing NHS data into a single framework with US group Palantir, whose chairman – Donald Trump ally and PayPal co-founder Peter Thiel – has said publicly he believes the NHS should be privatised.

The focus of the Sudlow Review was to map sources of health-relevant data across the UK and recommend how to best manage the data to improve health while maintaining privacy and trust.

The recommendations include the creation of a joined-up strategy to make NHS data a critical national infrastructure, backed up by a national health data service for England – including GP data – with accountable senior leadership.

The formulation of the strategy should be overseen by the Department of Health and Social Care (DHSC), with the views of "patients, public, health professionals, policymakers and politicians," taken into account, according to the document.

While those recommendations are focused on England, Sudlow also says that all four UK nations should work together on data access and governance processes to allow sharing, backed by a UK-wide system of standards and accreditation for organisations holding health and care data.

Baroness Gillian Merron, health minister for life sciences and innovation, welcomed the review, saying: "As part of our 10-Year Health Plan we will shift the NHS from analogue to digital – accelerating research through secure access to data whilst also driving growth and investment in the economy."

The work was also endorsed by Professor Sir Rory Collins, chief executive of UK Biobank, who said: "We must now treat the UK's health data like the critical infrastructure that it is [and] use the […] wealth of de-identified health data carefully, securely, and to its full potential."

He added: "The implementation of the Sudlow Report recommendations will truly be a transformative moment for health research and healthcare delivery."

https://pharmaphorum.com/news/uk-health-data-ecosystem-hampering-research

Federal Agency Accuses White House Official Of Violating Hatch Act

 by Sam Dorman via The Epoch Times,

A federal investigative agency is requesting disciplinary action for Neera Tanden, who serves as one of President Joe Biden’s domestic policy advisors, over her allegedly violating a law that prohibits solicitations for partisan political candidates.

The agency, known as the U.S. Office of Special Counsel (OSC), announced the complaint on Nov. 7 while highlighting recent posts Tanden made on the social media platform X. According to the agency’s complaint, Tanden violated the Hatch Act by posting or reposting solicitations for donations to Vice President Kamala Harris’s presidential campaign, as well as multiple Democratic congressional candidates.

“Congress created a rule banning all federal employees from fundraising for political candidates,“ Special Counsel Hampton Dellinger said.

“The Hatch Act contains no escape hatch for White House officials.”

The White House did not respond to The Epoch Times’ request for comment before publishing time. According to Politico, White House spokesperson Andrew Bates said Tanden took “compliance with the Hatch Act seriously.”

Tanden served as White House staff secretary before Biden promoted her last year to be one of his domestic policy advisors. Biden had nominated her to lead his Office of Management and Budget, but she backed out amid scrutiny over other social media posts.

In its Nov. 6 complaint, the special counsel office said it notified the White House Counsel’s Office on Aug. 30 that Tanden was in violation of the Hatch Act after her post two days prior promoting four candidates for the U.S. House of Representatives.

Tanden eventually removed that post on Sept. 3 but two days later reposted a video of actor Michael Keaton asking for funds to support Sen. Bob Casey (D-Pa.) in his campaign for reelection, the complaint said. In September, subsequent posts from Tanden promoted solicitations for Democrat Lucas Kunce, who was running to unseat Sen. Josh Hawley (R-Mo.); Democratic House candidate Rebecca Cooke of Wisconsin; and Democratic House candidate Will Rollins of California.

“Each of Tanden’s three subsequent posts ... was also made after Tanden was notified that making such posts violated the Hatch Act prohibition against soliciting political contributions,” the OSC’s complaint read.

The OSC’s complaint requested that the Merit Systems Protection Board (MSPB) penalize Tanden under a federal law that outlines removal, suspension, monetary fines, or “reprimand” as potential punishments.

Bates reportedly pointed to a 2021 report wherein the special counsel office raised constitutional concerns with the MSPB disciplining individuals directly appointed by the president. That report said that OSC “may not pursue disciplinary action through the MSPB” for commissioned officers, or those appointed by the president, and Senate-confirmed presidential appointees.

For both types of appointees, the OSC said it “must report its findings to the president” and allow the president to take appropriate action.

Reporting to the president was the course of action the OSC took in response to alleged Hatch Act violations by Kellyanne Conway, former counselor to then-President Donald Trump. In 2018, the agency said it concluded its investigation into Conway.

“Considering the president’s constitutional authority, the proper course of action, in the case of violations of the Hatch Act by such officers, is to refer the violations to the president,” its report to Trump said at the time.

The OSC did not respond to The Epoch Times’ request for comment before publishing time.

The OSC announced in September that it submitted a report to Biden over an alleged Hatch Act violation by Secretary of the Navy Carlos Del Toro, who expressed support for Biden winning a second term.

The agency added that it reached settlement agreements entailing unpaid suspensions for an employee within the Department of Commerce and a U.S. attorney’s office.

“While OSC deals with some close calls in its Hatch Act enforcement, federal employees soliciting donations for a political campaign is express advocacy and a clear-cut violation,“ Dellinger said as part of the announcement. ”We urge federal employees not to cross these brightest of lines.”

https://www.zerohedge.com/political/federal-agency-accuses-white-house-official-violating-hatch-act