The Big Pharma companies made a last-ditch effort asking a U.S. appeals court to reconsider their lawsuits against the Inflation Reduction Act’s Medicare drug price negotiations, which they contend infringe on their constitutional rights.
AstraZeneca, Bristol Myers Squibb and Johnson & Johnson last week appeared before a U.S. Court of Appeals for the Third Circuit panel of judges in a bid to revive their legal challenge to the Inflation Reduction Act’s Drug Price Negotiation Program, according to media reports.
Lawyers for the companies took aim at the constitutionality of the Medicare program, insisting that the drug negotiations violate several of the companies’ core constitutional rights. According to the court minutes, each pharma was given 20 minutes to lay out its arguments before the panel, focusing on one constitutional issue. The U.S. government’s lawyers were also allotted 20 minutes to provide the counterpoints to the legal claims.
Jones Day lawyer Yaakov Roth in an argument for BMS claimed that the drug price negotiations do not give the pharma companies an opportunity to negotiate. Instead, the program is akin to a “gun to the head” since non-participation is met with either steep fines or losing access to the Medicare market, according to Reuters.
Roth argued that the Inflation Reduction Act (IRA) Drug Price Negotiation Program violates the companies’ Fifth Amendment right to due process and against the unlawful seizure of property by the government without proper compensation.
Covington & Burling’s Kevin King, representing J&J subsidiary Janssen Pharmaceuticals, focused on the First Amendment and arguing that the term “maximum fair price”—which the negotiation program uses to refer to the final agreed-upon drug prices—is misleading. The label implies that the companies have agreed the new pricing is fair, even if that isn’t the case.
Government lawyer Catherine Padhi countered the industry’s arguments, insisting that the negotiations are voluntary and that the government is free to leverage its purchasing power to secure the best deals it can for Medicare beneficiaries.
Padhi maintained that “maximum fair price” is a “statutory term of art”—wording that carries specific legal meaning and “does not reflect a subjective value judgment.” Besides, as King conceded after being questioned by Judge Arianna Freeman, companies are not precluded from putting out their own statements to announce that the IRA prices are not fair, according to Endpoints News.
It is yet clear where the appeals judges lean and whether the legal complaints will be taken forward. While the panel sometimes pushed back on the government’s line of argument, pointing out that it may be taking advantage of the huge Medicare market to essentially force companies to comply, the judges noted that industry simply wants the unencumbered benefits of the government’s business and free market pricing.
Wednesday’s appeals hearing is the latest development in the industry’s unsuccessful attempt to block the IRA. Last month, a New Jersey district court threw out Novartis’ legal challenge, which made similar constitutional arguments as those by BMS, J&J and AstraZeneca. In August 2024, an Ohio judge similarly dismissed the U.S. Chamber of Commerce’s lawsuit, arguing that the association does not have standing to bring the case against the government.
However, in September, the Pharmaceutical Research and Manufacturers of America (PhRMA) scored a rare win as the Fifth Circuit Court of Appeals ruled in the trade group’s favor, sending its complaint against the IRA back to a lower Texas court.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP) ("NLS"), a biopharmaceutical company, and Kadimastem Ltd. (TASE: KDST.TA") ("Kadimastem"), a clinical-stage cell therapy company developing and manufacturing "off-the-shelf" allogeneic cell products for the treatment of neurodegenerative diseases and potential cure of diabetes, announced today that they have entered into a definitive merger agreement (the "Merger Agreement") to combine the two companies to focus on advancing NLS' promising, first-in class Dual Orexin Agonist platform ("DOXA") and Kadimastem's allogenic cell therapy program with its clinical assets (mainly targeting diabetes and amyotrophic lateral sclerosis (ALS), with Phase 2a studies that are planned to be initiated in the U.S. following the closing of the transaction). Following the closing of the transactions contemplated by the Merger Agreement (the "Closing"), NLS intends to divest its other legacy assets (including the Mazindol ER but excluding the DOXA platform), and the net proceeds of any such disposition, after deducting certain costs, fees, and expenses as set forth in a contingent value agreement (the "CVR Agreement"), will be distributed to NLS's shareholders and warrant holders, subject to the terms of the Merger Agreement and the CVR Agreement. At the Closing, pursuant to the terms of the Merger Agreement, NLS will issue shares of its common stock to Kadimastem's shareholders based on an initial target fully diluted share split, post transaction, of 85% to Kadimastem stakeholders and 15% to NLS stakeholders, in exchange for 100% of Kadimastem's issued and outstanding shares. The target fully diluted share split of 85% / 15% is subject to adjustment pursuant to the terms of the Merger Agreement, including as a result of estimated closing cash of NLS and Kadimastem and estimated closing indebtedness of NLS. Based on the cash balance of NLS following its most recent successful financing transaction, the parties currently estimate the fully diluted share split at the Closing will be 80% to Kadimastem stakeholders and 20% to NLS stakeholders. The boards of directors of Kadimastem and NLS have unanimously approved this transaction and expect it to close in January 2025, pending approval of each of NLS' and Kadimastem's shareholders, as well as other customary closing conditions, including Nasdaq approval.
Reimbursement rate to increase 397% per day effective January 1, 2025
New rate expected to encourage adoption of ultrafiltration therapy in the outpatient setting
Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage medical device company committed to transforming the lives of people with fluid overload, is pleased to announce that the Centers for Medicare and Medicaid Services (CMS) will reassign the Aquadex ultrafiltration code to the outpatient reimbursement level most consistent with administration of ultrafiltration therapy and cost of treatment. Effective January 1, 2025, the payment rate will increase 397% from $413 to $1,639 per day.
Turn the crank of social media / search (SM/S) and you get highly profitable Digital Addiction and social destabilization leading to disorder and breakdown.
The extremely profitable inner workings of digital addiction are complex, but the business model is simple: collect user data and sell it to advertisers. The more users you addict, oops I mean attract, and the more time they spend on your platform, the more money you make.
The raison d'etre of social media / search (SM/S) is to collect user data to sell to the highest bidder. To maximize profits, the SM/S platforms stimulate users to post more content and spend more time "engaging" (i.e. creating user data) on their platform.
There are three mechanisms to accomplish this goal:
1. Financial incentives. By offering users a tiny share of the third of the trillion dollars in revenue (of just the top three platforms), users are incentivized to post more content, and optimize that content o attract more views / engagement by other users.
The share earned by the few who attract an audience of millions is substantial, but the modest revenues shared with users posting content follows a power law distribution: a handful make millions, a few make $100,000 or more annually, a small circle make a middle class living ($60,000 annually), and the vast "long tail" earn a pittance at best.
Your song received hundreds of thousands of downloads? Thank you for the content and engagement. Here is your share of the revenues generated: $17. Your content attracted thousands of views, here's your share of advert revenue: $73.
The share is a pittance, but it's enough to drive a Darwinian frenzy that optimizes extremism and clickbait. This extremism can be measured, and as a result of the frenzied competition for attention, extremism is off the charts, with predictably destabilizing social consequences.
2. Self-worth incentives. Given the structure of everyday life, the vast majority of us have little influence or power in the status quo. (For many of us, our power lies not in the status quo but in opting out of the status quo.) Given the zeitgeist of our market-driven global economy, we observe others gaining visibility and income within the digital realm of social media. Since anyone with a phone or laptop / tablet can get online, this digital road to fame and fortune is open to all. This is in marked contrast with the real world, which is characterized by few pathways to fame and fortune, or even being noticed.
I'm worthy of attention is a powerful manifestation of selfhood: if I attract attention / engagement, I'm somebody. Without attention / engagement, I'm nobody.
This self-worth incentive is amplified by glorifying the few winners in the free-for-all competition for attention. No wonder it's called the Attention Economy: attention = user data = trillions in revenue.
3. Optimizing addiction. The mechanisms of addiction are fairly well understood, and these mechanisms function with profitable precision in endless scrolls of feeds and posts and algorithms that amplify clickbait and extremism, for these arouse base emotions that then increase "engagement," i.e. collecting more user data.
The net result is Digital Addiction and social destabilization. Turn the crank of social media / search (SM/S) and you get highly profitable Digital Addiction and social destabilization leading to disorder and breakdown.
It's the same tired and debunked arguments over and over again from the open border cheerleaders. Legacy media dinosaurs, still clinging to the last vestiges of their once vast prehistoric kingdom, have consistently defended mass immigration and common sense border security.
They claim that America (and the west in general) cannot survive economically without illegal immigrants and a steady flow of non-citizens from the third world. Without them, "who will mow Republican yards and clean Republican toilets", leftists often argue. But is this true? Or, do illegal immigrants actually take far more than they contribute when it comes to the economy?
Donald Trump's proposal of mass deportation of illegal migrants should he become president has the establishment media up in arms, desperately trying to frighten their readers into believing the policy will lead to the ultimate destruction of the US.
The Guardian predicts 'disaster' should illegals in America be deported. Why a British news organization cares about US borders is not clear. However, if Trump is successful in removing illegal migrants and the economy thrives as a result, the British populace (and most of Europe) will see that example and the governments overseas won't be able to exploit the same propaganda. They state:
"US consumers are accustomed to cheap goods and services, and the economic rationale for large-scale immigration has been largely avoided. In a country that relies on a mobile, low-cost workforce, the loss of migrant workers would trigger productivity losses and a new round of inflationary pricing pressure..."
Except, Americans aren't accustomed to cheap goods and services anymore, nor are they accustomed to affordable housing. We already have crushing inflation. The inflation argument is bizarre for a number of reason; the presence of tens-of-millions of illegal immigrants in the US creates a demand explosion in every sector of the economy, which means far higher prices, especially in the home rental market.
With government subsidies being provided to so many foreigners there is also the issue of increased national spending. Around 60% of illegal immigrants access welfare programs and subsidies upon their arrival in the US. That money has to come from somewhere and it's not just tax dollars. The US has to continually print new money to feed the rising debt. Hence, more inflation.
The idea that illegal immigrants are eating up excess inflation is baseless. The only reasonable factor that supports this claim is the reality that many migrants wire their under-the-table wages out of the US to their families. But the dollars migrants remove from the system do not make up for the dollars that need to be created from thin air to support them.
If more migrants meant less inflation then the US would not be suffering from the stagflationary crisis it's facing today. The Guardian continues:
"Of the undocumented migrants, between 8 and 9 million are in the workforce doing essential jobs that Americans disproportionately don’t want to do or work in sectors where there aren’t enough workers.
Typically, that’s farm work (one third of the labor force), construction work (about one quarter) and about half of the labor force in skilled work like drywalling, plumbing and insulation..."
“Undocumented immigrants make up a huge proportion of household services, manufacturing work, kitchen staff in restaurants. Americans simply do not do those jobs, or there are not enough to go around. But if you lose those key ‘bottleneck’ workers, the native workforce also can’t do their jobs..."
Anyone can do those jobs. Low-skill labor is called low-skill for a reason; any worker can be replaced easily with minimal cost and training involved. As for farming and construction work, Americans already do those jobs in great numbers, and there are plenty of real citizens that would do those jobs for fair pay. The issue is that some industries have been able to avoid paying normal wages for workers because of the open border and cheap labor from abroad.
It's not that Americans don't want those jobs, they just don't want third world wages for those jobs. There is also a large percentage of the public that would be willing to pay slightly higher prices for better quality work, better products and better standards.
In terms of construction, there won't be as much need for new housing if illegals are booted out of the country, opening up millions of homes for rent or purchase and driving costs down. The productivity and inflation arguments are disingenuous because they don't take into account how much resources illegals actually leech from the system. If there was real demand for skilled workers outside of the US, then work visas can be offered for limited periods of time. America doesn't need to depend on an open border to secure a labor pool.
Financial outlet Bloomberg attempts to use historic arguments to support illegal immigration. They assert:
"In a working paper published this month by the National Bureau of Economic Research, a group of academics analyzed the economic fallout from a US law enacted in 1882 to expel what had been a critical workforce for Western states:
Chinese laborers, many of whom toiled to build the transcontinental railroad. The authors found the Chinese Exclusion Act wiped out more than half of manufacturing establishments in the region, doing away with scores of jobs and reducing the number of White Americans coming West in search of work by 28%. A measure of lifetime income for White workers fell as a result..."
In other words, Bloomberg is advocating for the value of near-slave labor in the past to defend near-slave labor today. Labor shortages in the late 1800's were largely due to the Civil War and the deaths of over 620,000 working age men. We don't have that problem in the US today (at least not yet). Bloomberg is also conveniently forgetting about the economic boom of 1879 to 1900 called "The Gilded Age" in which the nation's industrial might skyrocketed.
So, getting rid of illegals means lower prices, less competition for housing, less government debt and more jobs while forcing certain industries to pay fair wages for laborers. Not to mention, less crime by default. The downsides to mass deportation are limited compared to the benefits. So why does the media so vehemently defend open borders? Because open borders allow expedient social engineering by people who desire political dominance.
If you can't force a native population to accept your world view, then why not simply replace them with people who will? As King Edward The Longshanks notes with dark relish in the movie Braveheart when devising the enslavement of Scotland: "The trouble with Scotland...is that it's full of Scots! ...If we can't get them out, we'll breed them out..."
The fastest way to eliminate political opposition from a population is to overwhelm them with foreigners with incompatible ideals and principles. Open border arguments can be distilled down to a single fallacy: "Give up your national sovereignty and identity and we'll make sure your economy doesn't collapse."
The economy is already going down; it's time to stop repeating the same mistakes that led to the decline.
Kenner, Louisiana, a suburb of New Orleans, has been dealing with a surge of sex crimes, gang violence, traffic infractions, and other crimes, due to an influx of illegal immigrants.
The latest crime reported by the Kenner Police Department on Oct. 29 involved a 17-year-old old illegal immigrant who was arrested for sex crimes involving two minors in the city. Two additional minors were also found to be abused, Police Capt. Mike Cunningham told The Epoch Times on Oct. 30.
Luis Renan Bonilla-Alfaro allegedly inappropriately touched four minors aged 4 to 13 and performed sexual acts with them in a trailer park.
Bonilla-Alfaro confessed and admitted that he filmed the acts with the minors. Kenner Police found sexually explicit videos on his phone of him and the minors.
“We have identified two additional victims, one of whom was the unidentified we found on [the] suspect’s phone,” said Cunningham. “A total of four victims, all under the age of 13, all males.”
Cunningham said the Kenner Police Dept. will be filing additional charges once forensic interviews of the two additional victims are completed.
Cunningham said they do not know when Bonilla-Alfaro crossed the border and that they “only know he came across as a family unit and there was contact with Border Patrol.”
Immigration and Customs Enforcement did not respond to a request for comment by The Epoch Times.
“With the failure that continues at our border the burden and challenges fall to the boots on the ground, local law enforcement, to keep our communities safe. As these illegal aliens migrate further east over time—the problems that were unique to Texas are now here in Louisiana,” said Kenner Police Department Chief of Police Keith Conley in an email to The Epoch Times.
“The most alarming trend I have seen since being elected Chief in 2022 is the sexual assault of juveniles by illegal aliens. Earlier this year we had an illegal alien rape a 15-year-old girl, then the next night he stabbed a man in the face.”
Another case he noted was of an illegal immigrant who raped a 14-year-old girl at knifepoint.
This latest case involves sexual offenses on boys ages 4, 7, and 8, and a fourth young boy his police department is working to identify, Conley said.
“We did have HSI [Homeland Security Investigations] put a detainer on this predator,” Conley said. “These children should never have been victimized, our borders should have been secured! This is a failure at the highest level.”
Kenner police also encountered more than a dozen members of the 18th Street Gang in the city and found they were attempting to recruit members from the local high school, Bonnabel High School, according to Cunningham.
The 18th Street Gang is a violent international gang that engages in numerous criminal activities, including murder, kidnapping, assault, robbery, firearms, and narcotics trafficking, according to the Department of Justice.
Like the violent MS-13 Gang, the 18th Street Gang recruits teenagers, and after two years of initiation, the new recruit must commit murder to become a full-fledged gang member, according to the Federal Bureau of Investigations.
Most of the 18th Street Gang members found in Kenner have been deported, Cunningham said.
The city of 70,000 has a mandatory arrest policy, which applies to anyone driving a vehicle who does not have a driver’s license and has led to several arrests a day, according to Conley. It has led to taking “some really bad people off the streets as a result,” he said.
Fraudulent temporary license plates, unlicensed and uninsured motorists, and traffic problems are more prevalent than ever before now, according to Conley, which is putting Kenner residents in danger and driving up insurance costs.
The rise in crime and traffic infractions is also draining the resources of the police department.
“It should also be noted that Kenner enjoys a large Hispanic population—20-30 percent. It is leaders from this community that have reached out to my office, asking us to work towards keeping those from coming here illegally,” Conley said. “They feel that they came to this country legally to make a better life for their family–they worry that the criminal element and trends from those countries they fled from will now become more prevalent here.”
Bonilla-Alfaro so far has been charged with first-degree rape, two counts of sexual battery, two counts of pornography involving juveniles, and indecent behavior with juveniles. Additional charges are expected to be filed, according to the police.
People on the Kenner Police Department’s Facebook page expressed outrage at the crimes against the innocent children and cited the open border as the reason.
Kedin Ribera wrote, “Those who are doing bad things should be punished with the full weight of the law, but the majority of Hispanic people are dedicated to working honestly.”
“Joe Biden Kamala Harris this is what happens when you have open borders,” wrote Chad Brown.
Mauro Rene Carbajal, who indicated she is a minority, wrote, “100% in favor of close [d] borders, sorry my people may hate me for it, but it’s the only way to keep our families safe.”
Bonita Atchison Toca, in her Facebook posting, noted the increase in sexual abuse by migrants and wrote: “This right here is despicable!!!! Kamala Harris 2024 take him to your house!!!!!! This is the results of open borders!!! It’s more and more in Kenner Louisiana, horrible!”
The Epoch Times reached out to both the Trump campaign and the Harris campaign for comment on the latest crime in Kenner, as the open border is a major issue for voters this election.
“This is further proof that Kamala Harris refuses to fulfill her role as border czar, ignores the invasion of dangerous gangs like Tren De Aragua at the southern border, and has allowed her inhumane wide-open border policies to drive up crime,” RNC spokesperson Taylor Rogers said in an email to The Epoch Times.
“Thanks to failed border czar Kamala Harris, apartment complexes are being taken over by violent gangs, more than 32,5000 children are unaccounted for, and innocent victims like Jocelyn Nungaray, Laken Riley, and Rachel Morin have been brutally killed by illegal immigrants. America deserves a president that will close our border, deport illegal immigrants, protect our border patrol agents, and put America First. Kamala Harris broke our border security, but President Trump will fix it.”
Vice President Kamala Harris did not respond to a request for comment by publication time.
However, while on a September trip to the border, Harris said that if she is elected president, she will fix the immigration system and secure the border.
“As your president, I will protect our nation’s sovereignty, secure our border, and work to fix our broken system of immigration. And I will partner with Democrats, Republicans, and independents to do it,” Harris said.
Harris also said she will bar those who cross illegally from the country.
“Those who cross our borders unlawfully will be apprehended and removed and barred from reentering for five years. We will pursue more severe criminal charges against repeat violators, and if someone does not make an asylum request at a legal point of entry and instead crosses our border unlawfully, they will be barred from receiving asylum,” Harris said.
Barack Obama recycled the “very fine people” narrative yet again, despite the fact that it’s a proven hoax.
Obama made the comments during a Kamala Harris campaign rally in Milwaukee, Wisconsin.
“Maybe you’re Muslim-American or you’re Jewish-American and you’re furious about the ongoing bloodshed in the Middle East and worried about the rise of anti-semitism,” said Obama.
“Why would you place your faith in someone who instituted a so-called Muslim ban,” he added (another hoax given that it wasn’t a ‘Muslim ban’ – it only covered 8 per cent of the global Muslim population and focused on countries that were a high security risk to the United States).
Barack Obama is using the “very fine people” hoax in an attempt to appeal to Jewish Voters
Obama is smart and this is so thoroughly debunked that the only reasonable conclusion
“He said in the same statement he wasn’t talking about neo-Nazis and white nationalists, who he said should be “condemned totally.”
The “condemned totally” part of Trump’s remarks was cut out of the clip posted by the Harris campaign.
The Associated Press also admitted the hoax, noting that Trump, “Wasn’t talking about the Neo-Nazis and white nationalists in attendance.”
This is just the latest hoax that Democrats have attempted to reinvigorate over the course of the campaign.
They previously asserted that Trump said there would be a physical “bloodbath” in America if he didn’t win the election when Trump was in fact talking about the auto industry in the context of the economy.
Harris and her legacy media campaign surrogates also claimed that Trump threatened to execute Liz Cheney when in reality he was talking about making chickenhawks fight their own wars.
