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Tuesday, October 4, 2022

The Hunt for N-Acetylcysteine: Medicine or Dietary Supplement?

 Medicine or dietary supplement? N-acetylcysteine (NAC) is marketed as both and in 2021, the supplement abruptly became difficult to find, causing distress to people who had been using it for a variety of conditions. The story behind its disappearance is one of a cat-and-mouse chase between manufacturers, advocacy agencies, and the Food and Drug Administration.

Dr Dinah Miller

NAC is a medication that was approved by the FDA in 1963. It has two FDA-approved uses: To prevent hepatotoxicity after overdose with acetaminophen, administered intravenously or by mouth, and as a mucolytic agent – previously available as Mucomyst, now available only as a generic – given by inhaler or nebulizer for pulmonary illnesses. Since the 1990s, NAC has been labeled by manufacturers as a dietary supplement. It is a derivative of the amino acid L-cysteine and a precursor to glutathione, an antioxidant.

NAC has caught the attention of psychiatrists because of claims that it may be useful in treating obsessive compulsive disorder (OCD)trichotillomania, and excoriation skin picking disorder (SPD), and as an adjunctive treatment for bipolar disorder. Studies have had small sample sizes, and the supplement has not been considered an "off label" use of an already available medication. People have purchased NAC from retail drug and big box stores, Amazon, and online companies. So what's the problem?

In July 2020, the FDA issued a warning letter to Purple Biosciences LLC, because of claims on the company's website that the product "Purple Tree," sold by Amazon, could cure hangovers that result from alcohol intoxication. The letter discussed justification for why a hangover is a disease, and goes on to note:

Based on the product label on your website, it appears that you intend to market your Purple Tree® product, which contains N-acetyl-L-cysteine (NAC), as a dietary supplement. However, even if your product labeling did not have therapeutic claims that make your product an unapproved new drug, your product could not be a dietary supplement, because it does not meet the definition of dietary supplement ... products containing that article are outside the definition of a dietary supplement, unless before such approval that article was marketed as a dietary supplement or as a food. NAC was approved as a new drug under section 505 of the Act [21 U.S.C. § 355] on September 14, 1963.

The issue here is that because NAC was first approved as a drug in 1963, it cannot be marketed as a supplement. If it had been marketed as a supplement before it was approved as a drug by the FDA, then it could remain on the market. The fact that it had been sold as a supplement since the 1990s and could be classified as an "old dietary ingredient" according to the Dietary Supplement Health and Education Act of 1994 did not seem to matter. Following the warning letter, NAC was pulled from shelves and websites.

Citizen petitions allow people and organizations to request that the FDA change their policy. During summer 2021, there were two citizen petitions – one from the Council for Responsible Nutrition (CRN) and another from the Natural Products Association (NPA) – asking that the FDA look at policy around NAC. In response, in November 2021, the FDA put out a request for more information about how long NAC had been used and if there were safety concerns, to determine if making it a lawful supplement would be appropriate. CRN promptly released a response that they were "extremely dissatisfied" and felt this was an unnecessary tactic to delay a decision. Two members of Congress wrote letters to the FDA in support of leaving NAC as an available supplement. Congressman Jeff Duncan noted that there were over 1,170 products containing NAC.

The FDA continued to issue responses. On March 31, 2022, the agency formally denied the requests of the two citizen petitions, and 3 weeks later the Guidance for Industry: Policy Regarding N-acetyl-L-cysteine was released, saying that the FDA would "... exercise enforcement discretion with respect to the sale and distribution of certain products that contain NAC." While NAC was still not considered a supplement, no safety issues had been identified to date. Thus, while the FDA investigation continues, the agency will essentially look the other way.

The agency will consider rulemaking to include NAC as a supplement, a process that may take years. In a notice of final guidance released in August 2022, the FDA reiterated, "unless we identify safety-related concerns during our ongoing review, FDA intends to exercise enforcement discretion until either of the following occurs: we complete notice-and-comment rulemaking to allow the use of NAC in or as a dietary supplement (should we move forward with such proceedings) or we deny the NPA citizen petition's request for rulemaking."

It's a win for the consumer who wants the supplement, and a half-win for the supplement manufacturers and their advocacy organizations who would like NAC to be an official dietary supplement. But just to be clear, the issue is one of a technicality: If NAC had been marketed as a supplement before it was a drug, it would just be a dietary supplement without all the controversy and scrutiny. It was not pulled because of a clinical concern.

For now, NAC is again readily available.

Dinah Miller is a coauthor of "Committed: The Battle Over Involuntary Psychiatric Care" (Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore. She has disclosed no relevant financial relationships.

https://www.medscape.com/viewarticle/981854

Cold Water Swims Bring Many Health Benefits

 Every Sunday from November to April Dennis Thomas starts his day by hitting the beach at Coney Island for a dip in the frigid Atlantic Ocean — no matter how low the mercury plummets.

Thomas, president of the Coney Island Polar Bear Club, says these winter swims offer more than just a bracing rush of adrenaline. He believes they're the reason that, at age 67, he is fiddle-fit physically, tack-sharp mentally, and rarely catches so much as a winter cold.

"I've been doing this for 35 years," says Thomas, a brand manager for a software company who bikes 5 miles a day. "Physically, I will say I get less winter colds than I used to. Mentally, it clears my head. It's kind of a purge and a cleansing of the mind because you can't think of anything that's troubling you when you're in water that cold."

New research out of Norway appears to confirm what Thomas and his fellow Polar Bears have long believed to be true.

A systematic review of 104 studies, by researchers from UiT The Arctic University of Norway and from the University Hospital of North Norway, found strong evidence that cold-water swims and therapies based on them offer significant physical and mental health benefits.

Taking a dip in icy-cold water cuts "bad" body fat in men, according to the analysis published in the peer-reviewed International Journal of Circumpolar Health. It also boosts the development of "good" fat that helps burn calories and combats obesity, cardiovascular disease and diabetes, the authors concluded.

James Mercer, PhD, a thermal physiology specialist from UiT who led the new research, says that many small studies over the years have hinted at the benefits of cold-water immersion. But the new review is one of the most comprehensive assessments of the benefits of cold-water swimming, bathing, showering and therapies based on exposing the body to low temperatures.

"It's very rarely that you'll meet a cold-water swimmer who thinks it's a negative activity. They all swear by it," Mercer says. 

Over the years there has been evidence that cold-water swimming can boost  your health, Mercer says. Among those benefits: Everything from increased libido to improved heart health, mental health, and more. 

Mercer says more research will help solidify the connection, "but we have to start somewhere, and what we're seeing right now, I think without doubt, is that in some areas ... indeed, there may be some potential positive effects."

Not a New Trend

Cold-water swims and therapies have been practiced for centuries in many countries with colder winter climates. 

"Ice swimming," where the frozen ice over a lake or pond has been removed to expose the water below, is so common that global organizations have sprung up around the practice: the International Ice Swimming Association and the International Winter Swimming Association.

Ice swimmers typically take the plunge into waters that are under 50° F and may even be near or just below freezing temperatures, Mercer's team reports.

Many people who engage in these activities say they believe the practice has helped them lose weight, have better mental health (and less depression), improve their immune system function, boost their circulation, and even increase their libido, among other benefits.

But the new study gives greater scientific insight into how icy-water swimming, cold showers, ice baths, and exposure to cooler water and air temperatures might drive health benefits.

For the review, Mercer's team conducted a detailed search of scientific literature on the issue, excluding studies where participants wore wet suits, experienced accidental cold-water immersion and water temperatures greater than 68 degrees. 

Among their findings:

  • Some studies showed solid evidence that cold-water swimmers often experience significant improvements in overall cardiovascular health. 

  • Cold-water immersion triggers a "shock response" that stresses the cardiovascular system and elevates the heart rate — a chief goal of high-intensity heart-healthy exercise. 

  • Ice baths and other hydrotherapies can reduce cholesterol, boost the immune system, help treat autoimmune inflammation, ease pain and speed recovery from sports injuries.

  • Cold-water swimming boosts the body's stores of so-called "brown adipose tissue" (BAT), a type of "good" body fat activated by low temperatures. BAT burns calories to maintain body heat, which can lead to weight loss, unlike "bad" white fat which stores energy and hikes obesity risks.

  • Exposure to cold water or air boosts BAT's production of adiponectin, a protein that helps protect against insulin resistance, diabetes and other diseases. 

  • Cold-water immersions greatly increase insulin sensitivity and decrease insulin concentrations. This is true for both inexperienced and experienced swimmers. 

  • Winter-weather swimmers typically describe feeling "joyful" in the water, suggesting the practice has "a positive effect on mental health and brain development."

The researchers note the participants in the 104 studies varied widely. They ranged from elite swimmers and regular winter bathers to those with no previous winter swimming experience. Others were not strictly ice bathers but used cold-water immersion as a treatment after exercise. 

They added that other factors — beyond simply cold-water exposure — may play a role in the health benefits the studies observed. For instance, cold-water swimmers may be "naturally healthier" as a group and tend to live active lifestyles. They experience positive social interactions from such activities, have learned how to handle stress (often through meditation, breathing techniques and mindfulness practices), eat healthy foods and demonstrate "a positive mindset," the authors report. 

Beyond icy-water swims, Mercer says his findings also apply to cold-water therapies, such as using ice baths after sports activities, cold showers and related treatments. 

Tips to Get Started

If you'd like to give cold-water immersion a shot,  you don't need to jump in an icy lake, pond or the ocean during the winter. Amanda Alexander, ND, a naturopathic doctor with Sonoran University of Health Sciences in Tempe, AZ, and other experts recommend the following ways:

  • When showering, gradually turn the temperature of the water down, ending with cold water for 30-60 seconds. This can help blood circulate to the surface where cold water is applied and may also relieve congestion and boost energy.

  • You can also skip the warmup and go straight to a cold shower, particularly after a vigorous workout.

  • Wearing cold, wet socks also help improve blood and nutrient circulation by stimulating a pump-like effect within the circulatory and lymphatic systems, increasing vitality and speeding recovery from an acute illness with fever. 

  • Try an ice bath. Add ice to water until the temperature is 50-59 degrees F. Athletes have used ice baths for years, particular for sore muscles. Aim to stay submerged for no more than 10 to 15 minutes.

  • Swim in an unheated pool but not icy-cold water, at least for starters. 

If you do decide to give cold-water immersion a shot, Alexander, Mercer and other experts recommend talking to your doctor first if you have a heart condition or other health concerns.

It's also a good idea for beginners to ease into the practice, keep your initial experiences to just a few minutes and gradually increase your time in the water as your cold tolerance increases. In addition, be sure to warm up after any cold-water immersion to eliminate the risk for hypothermia.

"Before anyone should get involved in this they have to be aware of the negative effects and the dangers, if you're not used to this kind of activity," Mercer says. "What I'm afraid [of] is people will think they should go and jump into icy-cold water without being used to it, perhaps not realizing they might have some underlying health problem."

Even so, Mercer says he would not hesitate to recommend cold-water swimming, based on his own research.

"But with a proviso: If you do it, at least when you're starting out, don't go into the coldest water and perhaps do it with other people who know what they're doing ... because there are some risks and people could die. Ice swimming is quite high stress on the body. But all in all, we do have some clear indications that there are indeed benefits."

Lessons From a Polar Bear

Thomas, the Coney Island Polar Bear Club president, acknowledges that cold-water swimming isn't for everyone and that it's important for beginners and anyone with a pre-existing health condition to be careful.

But he's known only a few individuals who have had negative experiences or health problems during the club's regular Sunday winter swims. 

"We do encourage someone who's new to this [or] has any concerns to consult with their physician first," he says. "But in all these years, I've seen only a couple cases where people had a reaction, mild hypothermia, and I haven't seen any heart attacks."

Thomas took his first winter plunge in the 1980s after watching a group of Polar Bear swimmers jump into the ocean one wintry Sunday morning. Like many of the club's 130 members, he did it on a lark, thinking it would be a one-and-done experience only. But he enjoyed it so much he decided to keep coming back, Sunday after Sunday.

So how does he stand the cold temperatures of the water?

"People ask me that all the time — is it mind control that allows you to think it's not that cold?" he says with a laugh. "And the answer is no, it's cold every time. But it's fair to say I know what to expect, and [now] I do it for fun, to be honest." 

Thomas adds that Mercer's study findings are heartening in that they support what Polar Bear members have long suspected to be true.

"We've heard a lot of anecdotal evidence through the years, small research studies and such," he says. "Anyone who does this truly believes it brings them some sort of benefits in it, whether it's physical, mental, spiritual ... or something like that. So I'm not surprised that science is starting to back that up."

Sources:

Dennis Thomas, president, Coney Island Polar Bear Club. 

James Mercer, PhD, thermal physiology specialist, UiT The Arctic University of Norway.

International Journal of Circumpolar Health: "Health effects of voluntary exposure to cold water — a continuing subject of debate."

Amanda Alexander, ND, associate professor of naturopathic medicine, Sonoran University of Health Sciences, Tempe, AZ. 

Taylor & Francis Group: "An icy swim may cut 'bad' body fat, but further health benefits unclear — review of current science suggests."

https://www.medscape.com/viewarticle/981840

Sore Throat Becoming Dominant COVID Symptom

 Having a sore throat is becoming a dominant symptom of COVID-19 infection, with fever and loss of smell becoming less common, according to recent reports in the U.K.

The shift could be a cause of concern for the fall. As the main symptoms of the coronavirus change, people could spread the virus without realizing it.

"Many people are still using the government guidelines about symptoms, which are wrong," Tim Spector, a professor of genetic epidemiology at King's College London, told The Independent.

Spector co-founded the COVID ZOE app, which is part of the world's largest COVID-19 study. Throughout the pandemic, researchers have used data from the app to track changes in symptoms.

"At the moment, COVID starts in two-thirds of people with a sore throat," he said. "Fever and loss of smell are really rare now, so many old people may not think they've got COVID. They'd say it's a cold and not be tested."

COVID-19 infections in the U.K. increased 14% at the end of September, according to data from the U.K.'s Office for National Statistics. More than 1.1 million people tested positive during the week ending Sept. 20, up from 927,000 cases the week before. The numbers continue to increase in England and Wales, with an uncertain trend in Northern Ireland and Scotland.

The fall wave of infections has likely arrived in the U.K., Spector told The Independent. Omicron variants continue to evolve and are escaping immunity from previous infection and vaccination, which he expects to continue into the winter.

But with reduced testing and surveillance of new variants, public health experts have voiced concerns about tracking the latest variants and COVID-19 trends.

"We can only detect variants or know what's coming by doing sequencing from PCR testing, and that's not going on anywhere near the extent it was a year ago," Lawrence Young, a professor of virology at the University of Warwick, told The Independent.

"People are going to get various infections over the winter but won't know what they are because free tests aren't available," he said. "It's going to be a problem."

COVID-19 cases are also increasing across Europe, which could mark the first regional spike since the BA.5 wave, according to the latest data from the European CDC. (In the past, increases in Europe have signaled a trend to come in other regions.)

People ages 65 and older have been hit the hardest, the data shows, with cases rising 9% from the previous week. Hospitalizations remain stable for now, although 14 of 27 countries in the European region have noted an upward trend.

"Changes in population mixing following the summer break are likely to be the main driver of these increases, with no indication of changes in the distribution of circulating variants," the European CDC said.

For now, most COVID-19 numbers are still falling in the U.S., according to a weekly CDC update published Friday. About 47,000 cases are being reported each day, marking a 13% decrease from the week before. Hospitalizations dropped 7% and deaths dropped 6%.

At the same time, test positivity rose slightly last week, from 9.6% to 9.8%. Wastewater surveillance indicates that 53% of sites in the U.S. reported a decrease in virus levels, while 41% reported an increase last week.

The CDC encouraged people to get the updated Omicron-targeted booster shot for the fall. About 7.5 million Americans have received the updated vaccine. Half of the eligible population in the U.S. hasn't received any booster dose yet.

"Bivalent boosters help restore protection that might have gone down since your last dose – and they also give extra protection for you and those around you against all lineages of the Omicron variant," the CDC wrote. "The more people who stay up to date on vaccinations, the better chance we have of avoiding a possible surge in COVID-19 illness later this fall and winter."

https://www.medscape.com/viewarticle/981849

Are Friday Drug Safety Alerts Deadly?

 What happens if a drug safety alert goes out and no one pays attention?

Something like that appears to be happening at least one day of the week — and research shows that more patients could experience drug-related side effects as a result.

The Friday Effect

At the end of the work week, people mentally check out and pay less attention to the news.

For that reason, Friday has been known as the day of choice for businesses and governments to release unflattering reports about themselves.

For years, Friday was also when the US Food and Drug Administration (FDA) tended to issue its drug safety communications, researchers found.

But alerts released on a Friday were shared 34% less often on social media, were 12% to 51% less likely to be covered in print media, and were mentioned in 23% to 66% fewer news articles than alerts on other days, according to their study.

When the researchers compared how adverse event reporting and use of medications changed before and after a safety announcement from the FDA, they found that alerts on Fridays had less of an effect on medication consumption and submissions to a key drug-safety database.

The so-called "Friday Effect" is so pronounced that withholding an alert and waiting to release it the following week would be the better course of action, according study author Luis Diestre, PhD, a professor of strategy at IE Business School in Madrid, Spain. The extra attention on other days would more than make up for the delay, he said.

Avoidable Harm?

To examine whether medication safety alerts on Fridays have less of an impact, Diestre and his colleagues studied 441 FDA safety alerts from 1999 to 2016. They looked at data from the FDA's Adverse Event Reporting System (FAERS) to gauge whether alerts led to decreases in reported side effects, presumably because doctors and patients used a drug less often after learning about a new safety issue.

The FAERS database includes incidents of possible side effects associated with medications that were reported by clinicians, pharmacists, manufacturers, and patients. The agency monitors submissions for unexpected safety consequences. FAERS has various limitations, according to the FDA, such as the inclusion of unverified self-reports. As a result, the database on its own cannot be used to determine whether a drug caused a particular adverse event.

Diestre and his coauthors focused on reports of adverse events that listed a drug in a safety alert as the primary suspect and assessed whether the number of reports decreased 1, 3, and 6 months after FDA issued the alert. Did the extent of the reduction depend on whether the safety issue was announced on a Friday vs another weekday?

The answer was clear.

"[M]oving a Friday alert to any other weekday would reduce all drug-related side effects by 9% to 12%, serious drug-related complications by 6% to 15%, and drug-related deaths by 22% to 36%," they write.

The effect was smaller with larger time windows, which "is consistent with the idea that Friday alerts are disseminated more slowly, and thus it takes more time for doctors and patients to be informed," the researchers note.

Financial Influence?

The researchers also found that lobbying activity might play a role in the Friday effect. For drugmakers that lobbied the FDA, Fridays were by far the most common day for safety alerts. About one-third of their safety alerts were announced on that day.

But for companies that did not lobby the FDA, alerts were more evenly spread throughout the work week, with Thursdays equally as likely as Fridays, and Tuesdays and Wednesdays close behind.

"We do not know the extent to which firms and the FDA are aware of the Friday effect and its consequences," the study authors write. "Accordingly, why firms and the FDA behave like they do, and the ethical implications of their behavior, is something we do not and cannot answer in our study."

An Easy Fix?

Diestre and his colleagues reported their findings in 2019 in Management Science.

Anupam B. Jena, MD, PhD, a professor at Harvard Medical School, Boston, and the host of the Freakonomics, M.D. podcast, discussed the researchers' paper on his show about a year ago and revisited the issue last month.

Jena featured the study on his podcast "not only because the study's findings were so intuitive and interesting but because unlike most issues in healthcare, there seemed to be an easy fix," he told Medscape Medical News. "Don't report safety news about medical products on Fridays."

Have regulators have gotten the message?

"We checked with the FDA both during the initial broadcast and the re-broadcast and it was not clear that they were aware of the study's findings or the potential for a 'Friday effect,'" Jena said. "They continue to release alerts on Fridays the last we checked."

The FDA says it releases information as soon as possible, no matter the day of the week.

For whatever reason, however, Friday no longer seems to be as common a day for drug safety announcements.

Diestre sees that apparent trend as welcome news.

"I took a quick look at alerts announced in the last 2 to 3 years and it is true that there are not that many Friday alerts," Diestre said, adding that a careful statistical analysis would be required to confirm the observation. "I don't know if this is thanks to our paper or not, but in any case, I think this is great news given what we find in our study."

Diestre said he understands the FDA's inclination to release alerts as soon as possible, but avoiding Fridays has merit.

The FDA issues drug safety communications (DSCs) "to communicate new and emerging postmarket drug safety issues or adverse events to the public, patients, and/or healthcare professionals," according to Charles Kohler, a press officer for the agency's Center for Drug Evaluation and Research.

Notifications might include information about serious or life-threatening adverse events discovered after a drug is on the market, additional details about a known adverse event, a new contraindication, previously unknown drug interactions, or medication errors that could cause serious reactions, Kohler said.

When weighing whether to issue an alert, FDA officials consider whether information about an adverse event might alter the drug's risk-benefit balance, aid prescribing decisions, or affect a patient's decision to use a drug. Officials also look at whether there are ways to avoid or minimize harm from a drug, the strength of the evidence, and the severity of the adverse event, Kohler said.

DSCs appear on the FDA's website and can be shared on other channels such as MedWatch Safety Alerts, email newsletters, podcasts, and social and traditional media. They are "distributed to more than 500,000 subscribers to email distribution listservs and more than 1.6 million followers to FDA social media accounts," Kohler said.

Officials also work with other federal agencies like Veterans Affairs and regulatory agencies in other countries to keep them informed about safety issues, Kohler said.

"It has been our policy to issue drug-safety alerts as soon as we have all the available information," Kohler said. "Time is a critical factor in drug safety and we can't delay or hold on to critical safety information."

An Art and a Science

Joseph Ross, MD, MHS, of Yale School of Medicine, New Haven, Connecticut, appeared on the Freakonomics, M.D. episode.

While he doesn't doubt that the Friday effect is real, "I do not think that the day of the alert is nearly as important or influential as there being an alert in the first place," Ross told Medscape.

News alerts inform clinicians and pharmacists, who can notify patients. Prescriber resources and electronic health records incorporate the updated information. Eventually, professional guidelines take the safety data into account, which takes the longest and "will not be impacted by whether the alert is released on a Friday or a Monday," Ross said.

Ross's research has found that postmarket safety events are common.

Of 222 novel therapeutics approved by the FDA between 2001 through 2010, 32% were affected by a postmarket safety event, according to one study. Biologics, drugs indicated for the treatment of psychiatric disease, medications that received accelerated approval, and those that were approved close to the FDA's deadline for making an approval decision were more likely to have postmarket safety events.

G. Caleb Alexander, MD, MS, an internist and epidemiologist with Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, said risk communication is "an art and a science."

"Unfortunately, there are many risks about prescription drugs that are learned only after the drugs have been approved," he said.

Alexander has studied the impact of FDA drug safety communications, and found that it's "hard to predict what the precise effect of a given risk communication will be," he said. "Frankly, risk communications can become risks unto themselves."

He pointed to a recent FDA notification about cooking chicken in NyQuil as an example of an alert that could have unintended consequences.

"The FDA's communication about this may have elevated rather than reduced the likelihood of individuals undertaking this misadventure," Alexander said.

Diestre's study was partially funded by the Spanish Ministry of Economy and Competitiveness Project and by the European Regional Development Fund. Ross disclosed research support from the FDA and from Johnson & Johnson through Yale University. Alexander is a former chair and current member of an FDA advisory committee. Jena disclosed ties to pharmaceutical companies.

https://www.medscape.com/viewarticle/981857

Siemens Healthineers to Operate China Separately From Rest of Region

 Siemens Healthineers AG said Tuesday that it would split its Asia Pacific operations between China and the rest of the region, which will be named Asia Pacific Japan.

The German medical-equipment maker said the move was meant to "allow both China and the rest of the region to achieve their full potential."

The China region will continue to be led by Jerry Wang, while the new Asia Pacific Japan region is helmed by Vy Tran, who used to be Varian's chief compliance and quality officer, the company said.

China is set to be the biggest global market in medical technology by 2030, according to Siemens Healthineer's former head of the Asia Pacific region. The country accounted for almost half of the company's revenue in the region in fiscal 2021, it said.

https://www.marketscreener.com/quote/stock/SIEMENS-HEALTHINEERS-AG-42379342/news/Siemens-Healthineers-to-Operate-China-Separately-From-Rest-of-Region-41925600/

CDC: Omicron Subvariant Ba.5 Represents 81.3% Of Total US Covid-19 Cases

 U.S. CDC SAYS OMICRON SUBVARIANT BA.4 REPRESENTS 1.1% OF TOTAL COVID-19 CASES IN THE UNITED STATES, AS OF WEEK ENDED 1 OCT, 2022

* U.S. CDC SAYS OMICRON SUBVARIANT BA.4.6 REPRESENTS 12.8% OF TOTAL COVID-19 CASES IN THE UNITED STATES, AS OF WEEK ENDED 1 OCT, 2022

* U.S. CDC SAYS OMICRON SUBVARIANT BA.5 REPRESENTS 81.3% OF TOTAL COVID-19 CASES IN THE UNITED STATES, AS OF WEEK ENDED 1 OCT, 2022

https://www.marketscreener.com/news/latest/U-S-CDC-Says-Omicron-Subvariant-Ba-5-Represents-81-3-Of-Total-Covid-19-Cases-In-The-United-States--41927851/

Four States Deploy National Guard To US-Mexico Border

 by Alice Giordano via The Epoch Times,

New Hampshire, Rhode Island, Kentucky, and Illinois are deploying several national guard units to the U.S.- Mexico border.

According to the office of New Hampshire Gov. Chris Sununu, the four states are sending 500 soldiers to help secure the border. The units will act under the command of the 941st Military Police Battalion, which already has 44 soldiers in place.

An additional 120 soldiers from the 237th Military Police Company will be deployed to set up surveillance sites along the border to block the laundering of drugs, weapons, and money into the U.S. by Mexican cartels, according to the release.

The units will cover a 250-mile stretch where illegal immigrants have been flooding into the U.S.

Lt. Col. Carla Raisler, director of public affairs for the Kentucky National Guard, told The Epoch Times that she was surprised Sununu released specific details about the deployment.

“Due to the security concerns of where the soldiers are inside the US border, we do not generally release information about the units or the size or their movements for security reasons to keep them and their families safe,” said Raisler.

In echoing Raisler’s position, Major Jarred Rickey of the Rhode Island National Guard told The Epoch Times that he could only confirm that the state is under a recent federal command to deploy National Guard units to the southwest border. He emphasized that it was only a support mission and not part of Operation Lone Star implemented by Texas Gov. Greg Abbott, a Republican, last year.

Lt. Col. Brad Leighton, public affairs officer for the Illinois National Guard, told The Epoch Times that a transportation company was being sent as part of a routine rotation to replace a guard unit that has been in place for several months. It will be keeping an aviation detachment already at the border in place.

Leighton said he couldn’t talk too much about the mission but did say it was specifically to assist border patrol with surveillance.

In August, Illinois Gov. J.B. Pritzker issued a Proclamation For Asylum Seekers declaring the state “a disaster area” based on busloads of immigrants from Central and South America arriving from Texas.

Pritzker, a Democrat, said he declared a state of emergency. In the interest of aiding the people of Illinois and the local governments responsible for ensuring public health, safety, and welfare in the wake of the influx of what he called “asylum seekers” in Illinois.

In his statement about the New Hampshire Guardsmen being deployed, Sununu called the border situation “an ongoing humanitarian crisis.”

While he didn’t elaborate in the statement about the reasons for sending National Guard troops to the border, last week Sununu expressed support for Florida Republican Gov. Ron DeSantis’s move in September to send 50 illegal border crossers to Martha’s Vineyard. It was a move that set off a hailstorm of criticism against DeSantis, with Democrats calling for his arrest for human trafficking.

Sununu called the New Hampshire guardsmen answering the call to the border “heroic men and women.”

“They answered the call to serve during the COVID pandemic, and are now answering our nation’s call—deploying to the ongoing humanitarian crisis along our southern border,” Sununu said.

According to Sununu, the two New Hampshire National Guard units will remain in place for a year at the U.S.-Mexico border.

The announcement of the deployment comes just weeks after Abbott announced he was reducing the 10,000 national guard soldiers he had in place at the southern border down to 5,000.

https://www.zerohedge.com/political/four-states-deploy-national-guard-us-mexico-border