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Wednesday, May 31, 2023

Tenax Gets Patent OK for Oral Levosimendan (TNX-103) in Pulmonary Hypertension

 

  • Once granted, this patent will provide intellectual property protection until December 2040, and may qualify for additional U.S. patent term extension beyond 2040
  • There are currently no FDA approved treatments for PH-HFpEF, a condition affecting more than 1,600,000 North Americans, with estimates indicating a prevalence of more than 2,000,000 patients by 2030
  • Once granted, this patent will significantly broaden Tenax’s U.S. intellectual property (IP) protection for a market with the potential to generate billions in future estimated annual sales
  • Acting as both a potassium ATP channel activator and a calcium sensitizer, levosimendan is the only drug to show significant improvement in the 6-minute walk endpoint in this large patient population (Phase 2 HELP Study)
  • Tenax intends to initiate a Phase 3 trial using this daily, oral formulation in 2023

House passes debt-ceiling bill, shifting focus to Senate

 The House voted Wednesday night to approve a bill that would raise the debt ceiling for more than two years, giving the Senate just days to do the same before the US potentially runs out of money to pay its bills.

The vote was 314-117, with more Democrats than Republicans offering their approval. There were 71 Republicans opposed and 46 Democrats who voted against it.

The concessions needed to get the deal done proved to be unpopular with certain members on both sides of the aisle, complicating efforts to squeeze legislation through Congress before a default on US debt. Treasury Secretary Janet Yellen has warned that day could come as early as Monday.

“Every great nation that overextends itself has collapsed,” House Speaker Kevin McCarthy said in a speech before the votes were counted Wednesday night.

President Biden in a statement praised “Speaker McCarthy and his team for negotiating in good faith.”

The agreement, he added, "is a bipartisan compromise. Neither side got everything it wanted."

The centerpiece of the legislation negotiated by McCarthy and Biden is a cap on federal spending. It would hold spending flat for 2024 and impose new limits for 2025 without touching Social Security or Medicare while boosting spending on the military by 3%.

The legislation would also increase work requirements in order to qualify for food assistance, an incentive for people to find jobs.

In exchange, the nation’s borrowing limit would be boosted for more than two more years. That would take the full faith and credit of the US off the negotiating table through the next presidential election and give the markets an extended breather on an issue that regularly threatens economic chaos.

Some House Republicans wanted the spending cuts to be deeper, as proposed in a separate piece of legislation passed by GOP lawmakers in April.

But Republican Rep. Patrick McHenry, who was on McCarthy's negotiating team, called it 'the most conservative spending package during my time in Congress," adding that "for the first time in a debt-limit negotiation, the US will spend less money than it did the year before."

The bill now requires 60 votes in the Senate, where Democrats hold a slim 51-49 majority. One challenge there is whether a vote can happen quickly or not.

It can if all 100 senators agree, setting up a vote before the end of the week. But any one senator can choose to hold things up for days with amendment votes.

At least one Republican senator, Mike Lee, has warned that he might offer resistance. On Wednesday he called the bill a “fake response to burdensome debt” and said he “will emphatically vote no.”

He pledged to file "a bunch of amendments" but also suggested he wouldn't hold up the bill past Monday as long as votes are held on his amendments.

Senator Rand Paul has also said he wants a vote on deeper spending cuts.

Senate Majority Leader Chuck Schumer has told members that they should be prepared for “potential Friday and weekend votes” because of ‘the time it may take to process the legislation in the Senate without cooperation.”

Senate Minority Leader Mitch McConnell has asked his colleagues to “swiftly” approve the bill.

“The deadline to raise the debt ceiling is rapidly approaching, and the likelihood of triggering a negative market reaction with severe economic consequences will only increase as we approach the precipice,” Business Roundtable CEO Joshua Bolten said in a statement after the House vote.

“We call on the Senate to eliminate the threat of a default by passing this bipartisan bill as soon as possible.”

https://finance.yahoo.com/news/house-passes-debt-ceiling-bill-shifting-focus-to-senate-015440568.html

U Of Colorado Declares Misgendering An "Act Of Violence"

 by Jonathan Turley,

The University of Colorado Boulder (Boulder) is under fire this week for a statement on the “Pride Office” website stating that misgendering people can be considered an “act of violence.”

The guide on pronouns is reportedly the work of students associated with the office and states that “choosing to ignore or disrespect someone’s pronouns is not only an act of oppression but can also be considered an act of violence.”

It is a familiar position for many in higher education.

Opposing viewpoints are now routinely declared to be violence. That allows professors and students to rationalize their own act of violence or censorship.

The most vivid example was recently seen at Hunter College, which is part of the CUNY system. Professor Shellyne Rodríguez recently was fired after holding a machete to the neck of a New York Post reporter and threatened to “chop you up.” However, Hunter College decided not to fire her over a prior incident in which she trashed a pro-life table run by students.

Rodríguez spotted students with pro-life material at the college. She was captured on a videotape telling the students that “you’re not educating s–t […] This is f–king propaganda. What are you going to do, like, anti-trans next? This is bulls–t. This is violent. You’re triggering my students.” Even after a remarkably polite student said that he was “sorry,” Rodríguez would have nothing of it. After all, espousing pro-life views is now “violence.” Rodríguez rejected the apology and declared “No you’re not — because you can’t even have a f–king baby. So you don’t even know what that is. Get this s–t the f–k out of here.”

Just a week earlier, a professor stopped another “violent” display of pro-life views in New York. Professor Renee Overdyke of the State University of New York at Albany shut down a pro-life display and then resisted arrest.

At the University of California at Santa Barbara, feminist studies associate professor Mireille Miller Young criminally assaulted pro-life advocates on campus, and later pleaded guilty to the crime. She was defended by faculty and students, including many who said she was “triggered” by a pro-life display and that pro-life advocates were “terrorists” who did not deserve free speech.

It is that easy. You simply declare opposing views “violent” and then you can justify your own violence as a matter of self-defense.

The Colorado controversy does not involve acts of violence over misgendering. Moreover, the guide reflects a deep-felt concern that using someone’s pronouns incorrectly, even unintentionally, leads to “dysphoria, exclusion and alienation.” There are also some positive recommendations in dealing with these difficult situations.

However, this is a university site and there are countervailing free speech costs to characterizing of opposing views on pronouns as violence. As have previously discussed how other countries are prosecuting those who “misgender.” Schools in the United States have promised disciplinary action against any misgendering despite some court cases ruling for faculty with opposing views on pronouns. Even passing out “he/his” candies can result in a university investigation.

Conservative sites like Campus Reform have reported on the Colorado controversy and sought clarification.

Universities are often presented with difficult countervailing interests. On one hand, it must maintain a welcoming and tolerant environment. On the other hand, it must protect free speech values, including the right to express unpopular views or values.

Colorado students have every right to declare misgendering as violence in their eyes, even if many of us disagree. However, the university has an obligation to clearly establish that such views are not the policy or approach of the university itself.  The site states “This information was created by students, for students. The university supports an inclusive environment.” It should state that “while the university supports an inclusive environment, the statements on this site are not official statements or policies of the university.” Otherwise, the university should address the free speech implications of declaring misgendering as a violent act.

https://www.zerohedge.com/political/university-colorado-declares-misgendering-act-violence

Ramaswamy: Musk's visit in China to oppose decoupling is 'deeply concerning'

 GOP presidential candidate Vivek Ramaswamy expressed deep concerns about Tesla CEO Elon Musk meeting with China’s foreign minister this week, saying it is risky to the U.S. when the communist country uses prominent business leaders as puppets.

On Tuesday, Musk met with China’s foreign minister in Beijing and reportedly said he was open to expanding Tesla’s business there.

In a statement, the Chinese ministry cited Musk as saying he "opposes decoupling," referring to fears the world may split into multiple markets with incompatible products.

Ramaswamy tweeted about his championing of Musk, but more so about his concerns about the international meeting.

"I’m breaking an unspoken rule in the GOP, but I call it like I see it: it’s deeply concerning that @elonmusk met with China’s foreign ministry yesterday to oppose decoupling and referred to the U.S. & Communist China as ‘conjoined twins,’" Ramaswamy said. "Tesla’s VP in China reposted that statement on Weibo in China, but curiously not here in the U.S."

The candidate said he has been one of the "most vocal" supporters of Musk’s work to transform Twitter, so it is a "real risk" to the U.S. when Chinese leaders take prominent business leaders and celebrities like Tim Cook, Larry Fink, Musk and LeBron James, and turn them into puppets to push communist China’s agenda forward.

"That tilts the global scales of perception in China’s favor – and sadly, it’s working," Ramaswamy said. "The U.S. needs leaders who aren’t in China’s pocket, yet Biden is just another embodiment of that same problem."

Ramaswamy is one of several Republicans seeking the party’s nomination for the White House in 2024.

He is also a health care and tech sector entrepreneur, best-selling author, conservative commentator and crusader in the culture wars.

The 37-year-old announced his candidacy in February, saying his vision centers on restoring the "national identity in America."

https://www.foxbusiness.com/politics/vivek-ramaswamy-elon-musks-visit-china-oppose-decoupling-deeply-concerning

What To Know About Berberine: Benefits, Uses and Side Effects

 Spend any time online, and you’ll be bombarded with information about the latest trendy supplements. These “all-natural” remedies promise clearer skin, restful sleep, a flat belly, improved memory … the list is endless.

The problem is that these claims often lack substantial data. It’s hard to know which ones are truly beneficial.

But berberine, a traditional Chinese medicine, may be a promising supplement.

“People are starting to look at more natural approaches and treatments. But not all ‘natural’ things are without side effects or proven effective,” says functional medicine specialist Elizabeth Bradley, MD. “But berberine, in many ways, acts similarly to medication.”

What is berberine?

Berberine is a bioactive compound — a chemical substance that can affect how humans and other living things function. It comes from plants and is part of a group of nitrogen-containing compounds called alkaloids. Other well-known alkaloids include morphine, nicotine and caffeine.

While berberine might not be as well-known as caffeine, it’s not a new substance. It’s been a staple in traditional Chinese medicine (TCM) for more than 400 years, mainly used to treat diarrhea and other gastrointestinal infections.

Research shows it may be effective for several chronic diseases, including diabetescardiovascular disorders and inflammatory diseases.

But most studies are small, not well-designed and need to be interpreted with caution. And with all supplements, the U.S. Food and Drug Administration (FDA) doesn’t regulate berberine for safety and effectiveness.

How does berberine work?

When you take berberine as a pill or powder, it enters your bloodstream and travels to your cells, binding to different molecules. But instead of producing a single change, berberine interacts with multiple targets, impacting more than one disease at a time.

“Berberine works at a cellular level and changes how cells work by turning things off and on,” Dr. Bradley explains. “Its basic interactions involve so many different processes in the body.”

It’s important to note that berberine, as with any supplement, shouldn’t replace any medical treatment. Dr. Bradley recommends speaking with a healthcare provider before starting berberine or any other supplement.

Benefits of taking berberine

The benefits of berberine show potential for anyone diagnosed with Type 2 diabetes or metabolic syndrome — a collection of risk factors that make you more likely to develop serious health issues like diabetes, heart disease and stroke.

“Berberine can help diabetes, high blood pressure and lipid levels,” notes Dr. Bradley. “Combine berberine with lifestyle changes, like losing weight, and it can positively affect those conditions.”

There’s evidence that berberine may: 

Lower and regulate blood sugar levels

The most studied benefit of berberine is its effect on blood sugar levels and diabetes. It can be taken in conjunction with medications for diabetes, but Dr. Bradley strongly cautions against using berberine in place of your diabetes medications.

People with Type 2 diabetes often have high blood glucose levels (hyperglycemia), which can happen if:

  1. Your body doesn’t have enough insulin, a hormone that lowers blood sugar by signaling cells to take glucose from your blood.
  2. Cells are insulin resistant, meaning they don’t respond to insulin when it signals them to take glucose from your blood.

Insulin resistance is to blame for more than 80% of glucose issues with Type 2 diabetes. High blood glucose levels can lead to severe health conditions, including eye diseasefoot problemsgum disease and heart disease. But berberine regulates how glucose is processed to help get your blood sugar under control. It increases the amount of insulin your body produces and decreases cell resistance, resulting in lower blood sugar.

“Berberine helps with two things,” Dr. Bradley says. It improves:

  • Your insulin resistance, to increase glucose movement into your cells.
  • How your cells use glucose.

Cause weight loss

Early research indicates that berberine may help reduce body fat. In one small clinical trial that looked at treating nonalcoholic fatty liver disease, participants who took berberine every day for three months experienced significant weight loss.

Berberine differs from herbal weight loss products, which often lack substantial data. Its effect on weight loss stems from its impact on insulin and glucose. When most people think of insulin, they think of blood sugar management. But insulin also regulates fat and protein metabolism.

“If you have insulin resistance, the cells don’t have enough glucose, making you feel hungry — there’s improper signaling going on,” explains Dr. Bradley. As you continue eating to satisfy your hunger, your body stores excess blood glucose as fat.

But berberine improves how cells respond to insulin (insulin sensitivity), promoting better movement of glucose into cells (glucose uptake). It also impacts how glucose gets used. Once your cells have their glucose, you feel less hungry, so you eat less.

Berberine also activates an enzyme called AMP-activated protein kinase (AMPK). AMPK exists in every cell. Its primary job is to regulate metabolism, helping control how your body breaks down and uses energy. But AMPK can also influence body fat composition and plays a critical role in regulating your appetite.

It’s important to note that Dr. Bradley says that more studies on how berberine affects weight loss are needed.

Reduce the risk of heart disease

Your blood contains fatty substances (lipids) directly related to your heart health. Having high levels of some of those lipids — cholesterol (hyperlipidemia) and triglycerides — increases your risk of heart disease.

Research shows that berberine may lower lipid levels. Studies focusing on berberine and heart health also show that the supplement can raise good (HDL) cholesterol while lowering total cholesterol, bad (LDL) cholesterol and blood triglycerides.

But lowering lipid levels isn’t the only way berberine may protect your heart. Research indicates that using both berberine and hypertension medication lowered blood pressure more than medication alone.

And Dr. Bradley says, don’t forget that diabetes, obesity and high blood pressure are all risk factors for heart disease. When berberine improves those factors, it can directly affect your heart health.

Increase ’good’ gut bacteria

Your gut microbiota — the microorganisms in your digestive tract — interact positively and negatively with many of your body’s systems. It can improve immune responses and help prevent inflammatory diseases. But an imbalance in gut bacteria — more bad bacteria than good — is associated with many diseases, including diabetes, cardiovascular disease and cancer.

A review of research shows that keeping gut microbiota balanced can also reduce your risk of colon cancerinflammatory bowel disease (IBD) and obesity.

Berberine may help balance or regulate intestinal health by reducing harmful bacteria and encouraging good bacteria to grow. It also provides your gut with protection.

“Berberine helps improve how the gut barrier works,” clarifies Dr. Bradley. “We’re finding that it protects the intestinal barrier from all these inflammatory things happening in the body.”

What to consider before taking a berberine supplement

Dr. Bradley says berberine can be a user-friendly supplement. But there are some things to think about before adding berberine to your daily routine:

  • It isn’t regulated. Like other supplements, the FDA doesn’t review or regulate berberine. That means no one checks what’s sold to ensure it’s safe and effective. Dr. Bradley recommends choosing high-quality supplements with no added fillers.
  • It may interact with other medications. If you take prescription medication, speak to your healthcare provider before taking berberine. Be especially cautious if you take drugs that interact with the liver. Berberine can make some medicines less effective.
  • It requires a strict dosage regimen. Berberine has a short half-life of several hours — half the dose will be metabolized and eliminated from your system within a few hours. To keep blood levels stable and benefit from berberine, spread the daily dosage (up to 1.5 grams or 1,500 milligrams daily) throughout the day. Dr. Bradley recommends taking it three times a day before meals.

Side effects of berberine

Berberine is good for your gut, but ironically, its most common side effects involve the digestive system and include:

Not everyone experiences side effects, which should become tolerable if you reduce the dose.

“I usually tell patients to start slow and low,” Dr. Bradley advises. “Typical dosing is 500 milligrams (0.5 grams) three times a day before meals. But you may want to start with one dose a day and see how you handle it before slowly progressing to taking it three times a day.”


https://health.clevelandclinic.org/berberine-for-insulin-resistance-weight-loss/

COVID-19 lockdowns had same effect on memory as serving jail time: study

 Your mind isn’t playing tricks on you — the pandemic may have affected your memory.

According to a study published Wednesday in the journal PLOS One, COVID-19 lockdowns caused people to lose track of time.

Scottish researchers found people made errors when trying to remember events from 2021, findings that are consistent with memory lapses experienced by people who have served jail time.

“Remembering when past events occurred becomes more difficult as more time passes,” study co-author Arash Sahraie told SWNS. “In addition, people’s activities and emotions can influence their perception of the passage of time.”

Previous studies have linked COVID-19 infection to brain shrinkage, memory loss and “face blindness,” but Sahraie’s team was interested in learning how pandemic lockdowns affected “people’s perception of time.”

Man gazing out of window

“Restrictions imposed during the pandemic have impoverished our timescape, affecting the perception of event timelines,” study co-author Arash Sahraie said.
Getty Images

“The social isolation resulting from COVID-19 lockdowns significantly impacted people’s activities and emotions, and prior research has shown that the pandemic triggered distortions in people’s perception of time,” the University of Aberdeen professor added.

The study analyzed responses to a 2022 survey in which 277 participants were asked to match events to the years in which they took place, ranging from 2016 to 2022.

People were questioned about when major news events occurred — such as Prince Harry and Meghan Markle’s bombshell Oprah interview or the death of George Floyd. They also completed a questionnaire about their mental health.

While distant memories garnered more errors, the researchers found people’s abilities to recall 2021 events were lacking. Some respondents even matched the events to three or four years prior.

Person sitting on floor of hallway with head in hands
Researchers found that respondents had a hard time recalling when 2021 events occurred.
Getty Images/iStockphoto

The inability to accurately recall a timeline of events correlated with reports of depression, anxiety and stressful physical and mental demands, according to researchers.

“As expected, participants’ recollection of events that occurred further in the past was less accurate,” Sahraie said. “However, their perception of the timing of events that occurred in 2021 — one year prior to the survey — was just as inaccurate as for events that occurred three to four years earlier.”

“In other words, many participants had difficulty recalling the timing of events coinciding with COVID-19 lockdowns,” he added.

Kid bored doing virtual school at desk
“In other words, many participants had difficulty recalling the timing of events coinciding with COVID-19 lockdowns,” the study’s co-author said.
Christopher Sadowski
The researchers believe “anchoring” life events are vital for accurate recollection of timelines, and these were in short supply after pandemic lockdowns began in 2020.

In fact, the results “are similar to those previously reported for prison inmates,” he added.

“In a landscape, if features are not clearly discernible, it is harder to place objects/yourself in relation to other features,” he explained. “Restrictions imposed during the pandemic have impoverished our timescape, affecting the perception of event timelines.”

“We can recall that events happened, we just don’t remember when,” he added.

https://nypost.com/2023/05/31/covid-19-lockdowns-had-same-effect-on-memory-as-jail-time-study/