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Sunday, July 2, 2023

UK to overhaul planning to meet net zero targets

 Britain is planning to overhaul the country's planning system to make it easier to install overhead cables and pylons, the Department for Energy Security and Net Zero said on Sunday, a move to help the government reach its net zero targets.

A spokesperson for the department said the government had increased the amount of renewable energy capacity connected to the grid by 500% since 2010 but wanted to do more.

"We want to go further as part of our plans to power up Britain with cleaner, cheaper and more secure homegrown energy.

"That is why we're working to cut the time it takes to connect projects, building upon work already under way by network operators and (regulator) Ofgem," the spokesperson said, confirming a report in the Sunday Telegraph newspaper.

Plans are expected to be brought forward later this year.

Last month, the Climate Change Committee of legislators said Britain had lost its position as a global leader on climate action and was not doing enough to meet its mid-century net zero target.

https://www.marketscreener.com/news/latest/Britain-planning-to-overhaul-planning-to-meet-net-zero-targets--44249034/

Small business owner reveals the true cost of 'Bidenomics'

 President Biden has adopted the term "Bidenomics" to tout his economic policies ahead of the 2024 election. While the president remains confident in his economic plan, critics like one Georgia small business owner insist inflation is still "hurting" Americans. 

"I don't know where he's looking. He's not looking on Main Street. He's not looking at small business because we're hurting. It hasn't gotten any better for us," Manuel's Tavern owner Brian Maloof said.

On "America Reports" Wednesday, the Atlanta restaurant owner detailed how his near-seventy-year-old restaurant has had to embrace historic price increases to keep doors open.

"So being an independent restaurant, we can take really quick action. We purposely delayed. That's important that you understand we purposely delayed our price increases because I wanted to believe that the transitory inflation I talked about was real, and I did not want to be a business that was in some panic-driven, price increase, unnecessary situation and putting a burden on our customers," Maloof explained. "So we delayed that to our detriment because when Jerome Powell spoke to Congress and said we need to stop using the phrase transitory, to be honest, the floodgates opened."

Despite claims during the pandemic and in the early months following, many economists claimed inflation was only a transitory issue. Years later, inflation remains a problem for American families with consumer prices up 15% from January 2021. 

The inflation problem forced many small businesses like Manuel's Tavern to pass costs on to consumers. In order to survive, Maloof raised prices across the menu at the Atlanta staple by about 6.5%. 

Maloof explained that his restaurant was starting to see "double-digit percentage increases" on critical services from utilities to even accounting. 

"What shocked us was that the mathematical formula we used to set prices, it wasn't working anymore. So we have these equations and they've worked for over 50 years, and now they weren't working," he said. "That was really surprising to me. That was a big indication to me that the entire landscape of business had changed, that the fundamentals, the bedrock of how this economic engine works, has been blown up. It's just it's just gone."

Beyond Manuel's Tavern, the overall economy is still hurting business despite some improvements with food costs. 

"There's been some small improvements in food cost. I will say that. That's been a good thing," Maloof said. "But the labor shortage is real. Customer spending is down and people have gotten tight because their expenses are way up. Utilities and insurance for them. Rent, in a lot of cases from my employees. I hear that constantly now. I have employees coming to me telling me about $400 a month increases in their rent. So that's real. And it's hurting everyone."

Earlier this month, the Labor Department released the May Consumer Price Index which put inflation at 4% year over year.

Although inflation has cooled from a peak of 9.1%, it remains about more than double the pre-pandemic average and well above the Federal Reserve's 2% target rate.

Consumers continued to see some reprieve in May in the form of lower energy costs, which fell 3.6% over the course of the month and are down 11.7% compared to the same time last year. 

Other price gains proved persistent and stubbornly high in May: Shelter costs, which account for about 40% of the core inflation increase, rose 0.6% for the month and are up 8% over the past year. Used vehicle prices, meanwhile, increased 4.4% last month – the same as in April. 

Grocery prices, a visceral reminder of inflation for many Americans, accelerated again in May: Food costs jumped 0.2% in May after falling the previous two months. 

While President Biden continues to celebrate his economic success, business owners like Maloof and everyday Americans feel the pressure of persistent inflation and worry about inflation's far-reaching consequences.

Maloof added he hopes other business owners and local leaders will speak up about the "disconnect" between "BIdenomics" and the reality for most Americans.

"I just hope other people speak up because something is being missed, something very fundamental," he said. "What is coming out of Washington and what's happening on Main Street, it seems like it's 180 degrees different. And I don't know where the disconnect is, but somebody needs to put it together and figure out that there's a real problem here."

https://www.foxbusiness.com/economy/small-business-owner-reveals-true-cost-bidenomics-were-hurting

New Research Paper: mRNA COVID-19 Vaccines Are Gene Therapy Products

 by Megan Redshaw, JD via The Epoch Times (emphasis ours),

Now that the pandemic has ended, researchers are urging regulatory agencies to consider the safety issues associated with the rapid approval of COVID-19 vaccines—and to correctly classify messenger RNA (mRNA) vaccines as gene therapy products (GTPs) to prevent pharmaceutical companies from bypassing regulatory standards.

According to a paper published in Nature on June 22, COVID-19 mRNA vaccines, by mode and action, are gene therapy products and should adhere to different regulatory standards. Yet U.S. and European regulatory agencies have not classified COVID-19 mRNA vaccines as gene therapy products, which has allowed them to be regulated as vaccines against infectious diseases instead of being subjected to the more stringent regulation of GTPs.

Because current regulatory guidelines either do not apply, do not mention RNA therapeutics, or do not have a widely accepted definition for these products, regulatory agencies adopted a modified and accelerated approval process for COVID-19 vaccines in the form of a “rolling review.

A rolling review is a regulatory tool typically used during a public health emergency to speed up the assessment of data for medicines or vaccines. It allows data to be reviewed as it becomes available—without the complete data package or specific controls.

This process led to broad and continuous biodistribution of mRNA COVID-19 vaccines that were not thoroughly studied and yielded tests with noncompliant results regarding purity, quality, and batch homogeneity. Manufacturers are now planning to replace classic vaccines with mRNA vaccines using the same process—starting with influenza vaccines.

Vaccines With mRNA Technology Are Gene Therapies

The Centers for Disease Control and Prevention currently defines a “vaccine” as a preparation used to stimulate the body’s immune response against diseases. However, the agency’s definition was changed in 2021 out of concern it didn’t apply to COVID-19 vaccines.

A vaccine must contain an antigen to trigger the body’s natural immune response. Pfizer and Moderna’s mRNA vaccines do not contain antigens. The active substance used to elicit an immune response in these vaccines is the mRNA—a form of nucleic acid and the genetic material of the SARS-CoV-2 virus that provides instructions to the body for producing antigens—spike proteins.

In other words, the mRNA is not the substance causing active immunization. Instead, the mRNA must be translated into protein by the cells of the person vaccinated, and that person’s immune system must produce its own antigens to trigger an immune response.

The U.S. Food and Drug Administration (FDA) states that gene therapy seeks to “modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.” Moderna’s Q2 2020 filing with the Securities and Exchange Commission acknowledged that mRNA is “considered a gene therapy product by the FDA.” In addition, BioNTech founder Ugur Sahin, in a 2014 article stated, “One would expect the classification of an mRNA drug to be a biologic, gene therapy, or somatic cell therapy.”

According to the FDA, mRNA vaccines are comparable to the TypeIA of prodrugs—substances that, after administration, are converted in the body into pharmacologically active drugs.

This “prodrug property” could suggest that additional controls should be applied in addition to those required for vaccines. However, neither the FDA nor the European Medicines Agency (EMA) have referenced these qualifications for mRNA COVID-19 vaccines.

“With a conventional vaccine, you have the antigen, and you inject it into a person, and that is the thing that your immune system looks at and says, ‘ah ha,’ we need to make antibodies, T-cells, and other immune system components to what’s being injected,” said Dr. David Wiseman, a research scientist with a background in pharmacy, pharmacology, and experimental pathology, in an interview with The Epoch Times.

The prime reaction of an mRNA vaccine is that it instructs the body how to make the antigen of interest. So, it’s similar to a prodrug, which is converted inside the body via metabolism and enzymes into the desired drug effect. The substance you’re injecting isn’t doing the final action; it leads to the thing that does the final action. With a prodrug, the molecule you inject does not get changed into the final molecule of the antigen, it simply provides instructions because it’s gene therapy.”

Wiseman said the FDA and EMA guidance and regulations that discuss gene therapy all define gene therapies “more or less” the same way. However, a number of years ago, the FDA decided to exclude vaccines for infectious diseases from its various guidance for unknown reasons, including vaccines made from gene therapy technology. Vaccines, in essence, were given their “own set of rules.”

However, the FDA can “change or exclude whatever they want from regulatory guidance, but it doesn’t change the biologic definition of the product,” said Wiseman. “Since Pfizer and Moderna COVID-19 vaccines meet the definition of gene therapy, they should be handled according to gene therapy guidelines.”

mRNA COVID-19 Vaccines Bypassed Essential Studies

According to the paper, because mRNA COVID-19 vaccines were not classified as gene therapy, necessary tests required for GTPs were not performed for the following:

  • Genotoxicity.
  • Genome integration.
  • Germ-line transmission.
  • Insertional mutagenesis.
  • Tumorigenicity.
  • Embryo/fetal and perinatal toxicity.
  • Long-term expression.
  • Repeated toxicity.
  • Excretion in the environment, such as shedding through seminal fluid or breast milk.

“The long-term safety monitoring of GTPs is required over several years whereas, for vaccines, it is generally only carried out over a few weeks,” wrote Dr. Helene Banoun with the French Institute of Health and Medical Research in the paper. “This should not be acceptable, given the persistence of the drug product and the expressed protein.”

https://www.zerohedge.com/covid-19/new-research-paper-mrna-covid-19-vaccines-are-gene-therapy-products

Saturday, July 1, 2023

Coca-Cola to see less pain from looming WHO decision on aspartame, analysts say

 Coca-Cola will only see a limited impact if the world health agency classifies the artificial sweetener used in its Diet Coke, aspartame, as a possible carcinogen, thanks to its scale of production, analysts said on Friday.

Such a classification of the popular additive in July by the World Health Organization's cancer research arm could cause consumers, food companies, retailers and restaurants to decide whether to fight back or find alternatives.

But for Coca-Cola, whose low-calorie products accounted for a third of its total volumes sold in 2022, analysts said switching to a natural sweetener could be easier than many other companies that use aspartame.

"Coca-Cola has one of the best production and distribution systems globally... who have successfully navigated plenty of hurdles in the past, like sugar taxes and reformulations associated with that," said Charlie Higgs, an associate partner at Redburn Ltd, a consumer staples research firm.

In the past, beverage makers like Coca-Cola and PepsiCo have tweaked their ingredient composition to comply with evolving policy changes.

The companies had in 2012 altered their manufacturing process of the caramel coloring in their colas to meet the requirements of a California ballot initiative aiming to limit people's exposure to toxic chemicals.

Market Analyst Grzegorz Drozdz at investment firm Conotoxia Ltd said the shift from aspartame could hit the short-term profitability of Coca-Cola, but does not see a steep decline in its long-term growth due to its production history.

However, PepsiCo could get an edge over its rival as it had moved away from aspartame to a blend of sucralose and acesulfame potassium earlier, CFRA Research said.

The company first replaced the additive from some U.S. diet sodas in 2015, but brought it back in some products a year later. It again removed aspartame in 2020.

https://finance.yahoo.com/news/coca-cola-see-less-pain-170622834.html

Mexico blasts new Florida immigration law; vows to help migrants

 Mexico's government on Saturday slammed a tough new state immigration law in Florida spearheaded by Republican Governor and U.S. presidential contender Ron DeSantis, and the country vowed to help protect undocumented Mexicans in that state.

DeSantis is seeking the 2024 Republican nomination for president, and his new Florida law, which took effect on Saturday, is seen as a preview of the kind of hardline policies he would seek on immigration enforcement.

Last month, Mexican President Andres Manuel Lopez Obrador urged U.S. Latino voters to reject DeSantis, accusing the politician of trying to win votes at the expense of migrants.

According to DeSantis' website, the new law includes allocating funds to move migrants without lawful status out of the state; restricting access to ID cards; and requiring more businesses to use an electronic system to validate a person's eligibility to work.

Mexico's Foreign Ministry in a statement said the provisions could prompt discrimination and racial profiling, and give rise to hostile environments, intimidation and hate crimes.

"Criminalization is not the way to resolve the phenomenon of undocumented migration," the ministry said, describing the new measures as driven by xenophobia and white nationalism.

It added that Mexico respects U.S. legislative processes, yet views the Florida law as working against joint efforts by the U.S. and Mexico to treat migrants with respect.

Mexican consulates in the U.S. will work to inform migrants about their rights and partner with civil society groups to identify potential cases of abuse, the ministry said.

https://www.marketscreener.com/news/latest/Mexico-blasts-new-Florida-immigration-law-vows-to-help-migrants--44248792/

Suspected robber arrested after hours-long standoff at upstate gas station

 A suspected robber was arrested following an hours-long standoff at an upstate gas station, officials said.

The drama unfolded shortly around 8:50 a.m. Saturday at the Valero gas station on S. William Street in Newburgh, when an armed robber was initially believed to have taken a clerk hostage, according to reports.

Mayor Torrance Harvey told News 12 there was one alleged armed robber and one clerk inside the store and that Newburgh police, Orange County sheriff’s department, New York state troopers and SWAT teams responded to the incident.

Harvey said the law enforcers did a “major sweep” of the facility and then negotiations with the suspect took place.

Authorities were then able to free the clerk and arrest the suspect, the mayor said.

Authorities later determined there was no hostage situation, saying instead that the suspect had refused to leave the convenience store, News12 reported.

But by 10:20 a.m., officials confirmed one suspect was in custody, News12 tweeted.

Valero gas station

Mayor Torrance Harvey said the law enforcers did a “major sweep” of the facility and then negotiations with the suspect took place.
Douglas Healey
“Right now everything is clear, no problems,” advised a man who answered the phone at the Hudson View Pharmacy on nearby Lake Street at around 11:15 a.m.

The name of the suspect and the charges were not immediately released.

https://nypost.com/2023/07/01/one-arrested-following-robbery-standoff-in-newburgh-ny/

Spinal-cord injury induces an immune deficiency in patients, study finds

 Patients recovering from a severe spinal-cord injury can develop an immune deficiency that puts them at risk of developing life-threatening infections, according to a new study by researchers at The Ohio State University Wexner Medical Center and collaborators in Germany, Switzerland and Canada. The study is reported in the journal Brain.

The deficiency, called spinal cord injury-induced  syndrome, was initially identified in experimental models. The findings of this study suggest the immune deficiency also likely occurs in patients. The study of 111 patients found that monocytes,  required to fight bacterial infections, were deactivated shortly after spinal-cord injury. It also found reductions in blood levels of antibody and immunoglobulins, which are part of the body's "learned" or adaptive immunity.

Furthermore, these indicators of immune deficiency were associated with the severity to spinal-cord injury. That is, they were "neurogenic," and they add to other consequences of spinal-cord injury that also weaken the  such as being bed ridden, receiving anesthesia or undergoing surgery.

The researchers state the findings could lead to improvements in spinal-cord-injury care through staging a patient's susceptibility to infection. This would help to identify patients who are particularly immune suppressed and to the development of new treatments to reduce infection susceptibility early on.

"Infections and subsequent sepsis are the main cause of death after spinal-cord injury," said co-corresponding author Jan Schwab, MD, Ph.D., the William E. Hunt & Charlotte M. Curtis Chair and a professor of neurology and neurosciences at the Ohio State College of Medicine.

"Our study provides evidence for an immune deficiency that sets spinal-cord injured patients up to develop infections," said Schwab, who is also medical director of the Belford Center for Spinal Cord Injury and a Scholar of the Chronic Brain Injury Initiative at Ohio State.

The findings showed that the risk of developing an immune deficiency syndrome was greatest for patients with complete, higher-level injury (fourth thoracic vertebra or above), compared with patients having incomplete, lower-level injury (fifth thoracic vertebra or lower), and compared with a reference group of patients who had vertebral fracture that did not involve the spinal cord.

Complete spinal-cord injury results in total loss of motor and sensory function below the level of injury; with incomplete spinal-cord injury, some function remains below the level of the injury.

"Those patients with complete injuries and consequent loss of central nervous system control over immune system function displayed the highest odds for an immune deficiency," Schwab said.

The study involved 111 patients enrolled in the international prospective multi-center cohort study known as SCIentinel study. To detect the presence and severity of immune suppression in the blood of patients, the researchers measured the levels of a cell-surface molecule called mHLA-DR on monocytes.

A low number of mHLA-DR molecules is a recognized and quantifiable marker for monocyte deactivation and has been shown to predict susceptibility to sepsis in .

Key findings include:

  • Patients with high complete injury had the highest burden of pulmonary and , including recurrent infections;
  • Patients with infections had mHLA-DR levels below the reference value for "immune suppression" within two weeks after injury;
  • Patients with early infection (in the first or second week) had especially low mHLA-DR values in the range of "borderline immunoparalysis" already at 15 hours after injury;
  • A drop in immunoglobulin (IgG and IgA) levels after spinal-cord injury suggested depressed humoral immunity as well. This was most pronounced in high completely injured patients;
  • Both cellular and non-cellular immune defense mechanisms were compromised in spinal cord injury patients and associate with early onset of infections.

"Overall, our study suggests that a neurogenic immune deficiency syndrome drives infection susceptibility in  injury patients, and it does so in a severity-dependent manner," Schwab said.

More information: Marcel A Kopp et al, The spinal cord injury-induced immune deficiency syndrome: results of the SCIentinel study, Brain (2023). DOI: 10.1093/brain/awad092


https://medicalxpress.com/news/2023-06-spinal-cord-injury-immune-deficiency-patients.html