'Ivermectin still not effective or approved for COVID-19 treatment, FDA says'

 As COVID-19 cases rise across the U.S. — and a new variant emerges —misinformation about treatment or prevention of the disease perseveres. In an effort to combat a flurry of recent social media posts touting the use of deworming drug ivermectin, the FDA is reminding people why it never approved it as a COVID-19 treatment.

“Although FDA has approved ivermectin for certain uses in humans and animals, it has not authorized or approved ivermectin for use in preventing or treating COVID-19, nor has the agency stated that it is safe or effective for that use,” the FDA said on its social channels.

The FDA pointed to recently updated National Institutes of Health COVID-19 treatment guidelines, which not only don’t approve of its use but recommend against it due to inefficiency and lack of evidence.

While some studies on ivermectin as COVID-19 treatment do exist and some do testify to the drug’s efficacy, that data is overwhelmingly considered inconsistent, questionable and/or inconclusive by experts.

It’s important to remember COVID-19 is a virus, not a parasite, and would not be targeted by ivermectin being introduced in the body.

Medical experts say the data affirming ivermectin’s use for COVID-19 is insignificant compared to the amount indicating it’s useless. A previous review of 14 ivermectin studies concluded these studies were small and “few are considered high quality.” The researchers say they’re uncertain about the efficacy and safety of the drug and that “reliable evidence” doesn’t support using ivermectin for COVID-19 treatment outside of well-designed randomized trials. Meanwhile, a February 2023 review in Future Virology of some ivermectin-affirming studies explained that some used too-small pools of participants, were rushed, and ignored limitations around how ivermectin is absorbed in the body.

“It must be acknowledged that some of these studies were possibly intentionally designed to yield predetermined findings,” write the researchers.

Among many most recent studies are a Journal of the American Medical Association-published randomized ivermectin vs. placebo clinical trial which concluded there was no support for ivermectin use for patients with mild to moderate COVID-19. A February 2023 Duke University researcher-led randomized clinical trial upped the dosage from the previous ivermectin vs. placebo clinical trial — finding there was no difference in efficacy even at a higher dosage.

Other major health organizations advising against use of ivermectin for COVID-19 include: the World Health Organization, European Medicines Agency, Infectious Diseases Society of America, and the U.S. National Institutes of Health. Additionally, pharmaceutical company Merck, a manufacturer of ivermectin, says there’s “no meaningful evidence” to support its use in this way.

Back in 2021, the country’s largest doctors group, the American Medical Association, called on U.S. doctors to stop prescribing ivermectin for COVID-19 treatment.

As previously mentioned, ivermectin does have some approved uses — though knowledge of the drug and its popularity soared with the onset of the coronavirus pandemic. The FDA said back in 2021 that over 88,000 prescriptions for the drug were dispensed in a month period that year. Before the pandemic, about 3,600 ivermectin prescriptions were dispensed per year.

Some of the support for ivermectin’s COVID-19 misuse can be traced to the many conservative and media personalities who promoted ivermectin, including former Fox News host Tucker Carlson and podcast host Joe Rogan, who claimed to have taken it himself.

One vocal group behind ivermectin’s proliferation is the Front Line COVID-19 Critical Care Alliance, a group of doctors whose recommendations and treatments have been labeled “dubious.” The FLCCC is behind the website “covid19criticalcare.com,” which purports to offer “prevention and treatment protocols for COVID-19.” In addition to the use of ivermectin, it’s indicated that a person gargle with mouthwash, take vitamins and administer nasal drops containing iodine.

Among the FLCCC’s resources on ivermectin is a review published in the American Journal of Therapeutics. It’s co-authored by one member of the alliance and relies to some degree (at least 15.5%, according to academic journal Nature) on a non-peer-reviewed preprint that was withdrawn due to “ethical concerns.”

That paper allegedly studied a large sample size of COVID-19 symptomatic people and found that ivermectin significantly reduced symptoms and deaths. But academics and critics found issues related to plagiarism and data manipulation, Nature reports.

A highly-cited January 2022 study published in Cureus which claimed to find that “ivermectin was associated with significantly reduced COVID-19 infection, hospitalization, and death rates from COVID-19” was later flagged and corrected by the publisher.

In the correction, Cureus explained that “several authors failed to disclose all relevant conflicts of interest when submitting this article.” According to Cureus, all but one researcher was affiliated with the FLCCC. Additionally, at least two of the authors were found to be paid consultants for ivermectin manufacturer Vitamedic.

The alliance lists a disclaimer on its website, reading in part: “… in no way should anyone infer that we, even though we are physicians, or anyone appearing in any content on this website are practicing medicine, it is for educational purposes only.”

Nexstar reached out to the FLCCC for comment and will update as it responds.

As of Friday, many recent popular ivermectin-promoting Facebook posts have been flagged as False Information and debunked by independent fact-checkers.

The FDA reiterated this week that Americans should talk to their health care providers about available COVID-19 treatment options and vaccines, which have been proven to be effective.

https://thehill.com/policy/healthcare/4159388-ivermectin-still-not-effective-or-approved-for-covid-19-treatment-fda-says/

Pentagon deploys close to 700 personnel to fight fires in Hawaii

 The Pentagon has deployed nearly 700 personnel and 140 U.S. Coast Guard responders to Hawaii to help combat the wildfires still spreading across the Pacific island state, according to the latest update.

U.S. defense officials on Friday pledged to continue its efforts in fighting the wildfires until the blazes are fully extinguished and to help with cleanup efforts in the wake of the disaster.Already, the Army has deployed CH-47 Chinooks to suppress fires while the U.S. Army Corps of Engineer is working to remove debris. The Navy and Air Force are also supporting the response across the state.

Federal military responders are assisting the Federal Emergency Management Agency (FEMA), the Hawaii National Guard and other state and local emergency personnel in battling the fires.

The military is focused on missions to carry supplies and resources across the island, carry out aerial fire suppression and fuel distribution operations, and establish support facilities, among others.

Brig. Gen. Stephen Logan, who is leading the response operation under Joint Task Force 5-0 under U.S. Indo-Pacific Command, said the “combined strength of our military and civilian partners is making a significant impact on the ground.”

“I’m immensely proud of every individual contributing to these efforts,” Logan said in a call with reporters on Friday. “We will continue to support and aid local, state and federal authorities and partners, ensuring that we offer the best possible support in the days and weeks ahead.”

The task force was formed on Aug. 11 and has reached full operational capacity after President Biden activated the military to respond to the wildfires. Biden is expected to visit Hawaii next week.

The wildfires are primarily blazing on the island of Maui, which has been devastated by the conflagration, with more than 2,000 homes damaged or destroyed and more than a hundred people dead.

Firefighters and emergency responders have now extinguished two fires in Maui but have yet to contain two fires. The Kula fire in upcountry Maui is 80 percent contained and the Lahaina fire is 90 percent contained as of Friday, according to the county.

https://thehill.com/homenews/state-watch/4159383-pentagon-deploys-close-to-700-personnel-to-fight-fires-in-hawaii/

Genes May Explain Why 20% Of People Who Get COVID-19 Are Asymptomatic: Study

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

Scientists recently discovered a gene variant that may explain why 20 percent of people who get COVID-19 never develop symptoms.

In a recent study published in Nature, researchers theorized that human leukocyte antigen (HLA) genes may be the reason some people are asymptomatic when they test positive for COVID-19.

According to the authors, HLA genes play a significant role in viral infections by helping the immune system recognize infected or foreign cells and are the most medically important region of the human genome.

To determine whether HLA gene variants are associated with asymptomatic COVID-19, researchers enrolled 24,947 bone marrow donors over a nine-month study period, as gene sequencing is a prerequisite for being a tissue or organ donor and recipient, and genetic information was already available.

Participants used a smartphone app to track positive COVID-19 tests and daily symptoms, including fever, chills, and mild symptoms such as scratchy throat or runny nose. Each week volunteers noted whether they had taken a COVID-19 test, and each month reported whether hospitalization had occurred.

During the study period, 1,428 unvaccinated individuals reported a positive COVID-19 test, with 20 percent of individuals reporting no symptoms. Further analysis revealed a specific HLA-B*15:01 variant was “significantly overrepresented” in asymptomatic individuals compared to symptomatic individuals.

Those who carried two copies of this variant—one passed down by each parent—were more than eight times more likely to remain asymptomatic than those carrying other genotypes. Researchers confirmed their findings in two other groups of people.

The authors then examined the effect HLA-B*15:01 had on T cells—a type of white blood cell that helps the immune system recognize germs and fight disease, including SARS-CoV-2.

Analyzing T cells donated by HLA-B*15:01⁺ people before the pandemic, researchers discovered that T cells in asymptomatic participants reacted to a specific piece of SARS-CoV-2 spike protein, enabling the virus to enter the cells as if they had previously encountered the virus. Additional experiments showed that T cells with the specific HLA variant responded aggressively to an almost identical spike protein fragment from two seasonal coronaviruses associated with common colds.

“The findings suggest that T cells in many people with HLA-B*15:01 could already recognize SARS-CoV-2 because of their prior exposure to seasonal coronaviruses,” according to the National Institutes of Health (NIH). This ability to recognize SARS-CoV-2 allowed their immune systems to respond rapidly to clear out the virus before it caused symptoms of infection.

https://www.zerohedge.com/covid-19/genes-may-explain-why-20-percent-people-who-get-covid-19-are-asymptomatic-study

SpaceX and Blue Origin are being targeted by spies from China, Russia: feds

 Chinese and Russian spies are looking to steal sensitive technology and data from US space companies including SpaceX and Blue Origin, according to a federal government communique.

The National Counterintelligence and Security Center, the FBI and the Air Force published an advisory on Friday warning that “foreign intelligence entities recognize the importance of the commercial space industry to the US economy and national security, including the growing dependence of critical infrastructure on space-based assets.”

“They see US space-related innovation and assets as potential threats as well as valuable opportunities to acquire vital technologies and expertise,” according to the advisory, the existence of which was first reported by the New York Times.

Intelligence agencies are concerned over Chinese and Russian spy agencies’ increased interest in US commercial space companies, according to the Times.

US intelligence agencies are warning SpaceX and Blue Origin that they could be targeted by Russian and Chinese spies.

Joe Marino/UPI/Shutterstock

The National Counterintelligence and Security Center, the FBI and the Air Force published an advisory on Friday.

NCSC

That is why the federal government wants companies like SpaceX and Blue Origin to tighten their security protocols — particularly in light of the fact that the US has come to depend on space firms for its technological infrastructure.

The agencies warned that US adversaries “use cyberattacks, strategic investment (including joint ventures and acquisitions), the targeting of key supply chain nodes, and other techniques to gain access to the US space industry.”

US relations with China (led by President Xi Jinping, above) have soured over the Communist nation’s military buildup in the South China Sea as well as disputes over trade.

REUTERS

American space firms are asked to be on the lookout for “indicators” that they are being “targeted,” including “unusually high cyberactivity targeting your company from unknown parties,” “requests to visit your company facilities from unknown or foreign entities,” “unsolicited offers to establish joint ventures with companies tied to foreign governments or state-owned enterprises,” and “attempts to recruit your company’s technical experts … and provision of financial incentives in exchange for proprietary information.”

Russian President Vladimir Putin’s invasion of Ukraine has led to strained ties with Washington.

POOL/AFP via Getty Images

The Post has sought comment from the governments of Russia and China as well as from SpaceX and Blue Origin.

US relations with both China and Russia have deteriorated in recent years.

Russia’s invasion of Ukraine and China’s military buildup in the South China Sea as well as threats to Taiwan have soured ties with Washington.

President Biden signed an executive order earlier this month prohibiting certain US investments in sensitive Chinese technology — a move designed to shore up national security concerns amid growing tensions between the superpowers.

https://nypost.com/2023/08/18/spacex-and-blue-origin-targeted-by-spies-from-china-russia-feds-say/

Progressive insurance sued for ‘patently unlawful’ racism for $25K grants only to black-owned businesses

 Progressive insurance, famed for its quirky commercials starring fictional saleswoman Flo, is being sued for “patently unlawful” racism for awarding exclusively black-owned businesses $25,000 — while allegedly banning white, Asian, Hispanic and owners of other backgrounds from applying.

The lawsuit — filed on behalf of Freedom Truck Dispatch owner Nathan Roberts in Ohio federal court on Wednesday — claims that Progressive racially discriminated against non-black small-business owners like Roberts for offering a five-figure award to 10 “black-owned small businesses to use toward the purchase of a commercial vehicle.”

The class-action suit, which was filed by anti-radical left group American First Legal, claimed that on May 24, Roberts, a Progressive customer, received an email “about a grant opportunity for their [Progressive’s] commercial-trucking small-business owners.”

However, “Progressive decided that only black-owned businesses would be eligible for these grants” because, according to the insurance company, “studies have shown how inequities have it harder for black entrepreneurs to access capital.”

Progressive partnered with grant administration company Hello Alice for the financial award.

The winners for the 2023 grant were announced in a press release on Tuesday, which said “Progressive is stepping in to provide funding to Black entrepreneurs to help navigate their small business journey.”

Applications for the grant have since closed, according to Hello Alice’s website, and it’s unclear if there will be another round of winners in 2024.

The Post has sought comment from Progressive and AFL.

When The Post sought to find more information on the grant on Progressive’s site, it appears that the landing page was taken down.

Roberts’ complaint called the entire scheme “racially discriminatory grantmaking,” with the “racially discriminatory requirement” to be black in order to apply.

AFL lawyer Gene Hamilton told the Daily Mail that Roberts’ case was part of a broader assault against big corporations that inject “racial considerations into every aspect of their business operations, employment practices and so much more.”

Roberts is a hard-working “small business owner fighting to create a better life for himself and his family,” Hamilton added, noting that he was denied the opportunity to receive $25,000 “solely because of the amount of pigment in his skin.”

In the 50-page lawsuit, Roberts says he wants the court to declare Progressive’s grants illegal and award him “nominal” compensation and pay his legal fees.

The class-action lawsuit was filed by anti-radical left nonprofit group American First Legal, which is headed by former senior White House advisor Stephen Miller.

Pacific Press/LightRocket via Getty Images

It’s unclear what the total sum would likely be.

Aside from being black, entrepreneurs had to have 10 or fewer employees and a turnaround below $5 million in order to apply to the grant program, which is dubbed “Driving Small Business Forward.”

Roberts did not immediately respond to The Post’s request for comment.

Progressive originally launched this program in 2022. The first iteration only allowed Hispanic business owners to apply to win a $25,000 grant.

https://nypost.com/2023/08/18/progressive-sued-for-offering-25k-grants-to-black-entrepreneurs-only/

Hochul administration illegally favored drug felons over disabled vets in legal pot initiative: judge

 New York’s troubled pot program just got burned again.

A judge ruled Friday that the Hochul administration’s problem-plagued legal-marijuana initiative will remain on ice — because the state likely illegally favored drug felons over other groups such as disabled veterans in dishing out licenses to sell ganja.

Albany state Supreme Court Judge Kevin Bryant handed down the preliminary injunction after four New York army vets sued the administration earlier this month, arguing, in part, that the state’s cannabis licensing program was unconstitutional.

The injunction, which follows a temporary order handed last week, bans Empire State regulators from awarding any more cannabis licenses, or approving any new dispensaries to open, pending a final decision in the suit.

“It is the finding of this court that [the veterans] have established a likelihood of success [of their lawsuit] on the merits by articulating meritorious constitutional arguments regarding the actions and decisions of [the state],” the judge’s ruling said.

The crux of the lawsuit alleges the state Office of Cannabis Management and state Cannabis Control Board unconstitutionally established a process that made it a requirement to have a prior marijuana-related conviction to be eligible for the first round of licenses doled out.

The move occurred despite the state’s Marijuana Regulation and Taxation Act listing disabled vets as one of five priority “social and economic equity” groups that should get at least 50% of employment opportunities in the budding pot industry.

Still, under the process, only disabled veterans who were partnered with someone with a marijuana conviction were awarded a license during the first go-round.

By doing so, the state appears to have “failed to follow the clear language of the applicable legislation,” the judge said.

The four disabled vets at the heart of the suit — Carmine Fiore, Dominic Spaccio, William Norgard and Steve Mejia — issued a joint statement in the wake of Friday’s ruling saying their “fight has always been for equal access to this new and growing industry.

Carmine Fiore is among the four vets who are suing the Hochul administration over its cannabis program.

Stephen Yang

“We believe in a robust, accessible, and thriving adult-use cannabis sector for New York state and today’s decision — by correctly recognizing the irreparable harms we are facing through the board’s and OCM’s failures to follow the law — will help put the state back on track toward achieving this goal,” they said.

“OCM has resoundingly failed to create the legal cannabis market envisioned by New York’s MRTA, in large part by keeping licenses out of the hands of service-disabled veterans and other minority groups the law prioritizes,” the group added.

The judge’s procedural ruling left legal cannabis sellers rattled — and upset the decision put a freeze on their budding industry.

“This injunction is a major problem,” Osbert Orduna, CEO of The Cannabis Place delivery service in Queens, told The Post on Friday.

The crux of the lawsuit alleges the state Office of Cannabis Management and state Cannabis Control Board unconstitutionally established a process that made it a requirement for the first licensees to have a prior marijuana-related conviction.

Getty Images

Orduna, a disabled vet whose business partner has a prior weed conviction, allowing them to open a pot home-delivery service, said he wants to expand and open a licensed cannabis store in Middle Village, Queens — but that the ruling has put those plans on hold.

“It’s not only going to delay our store opening, it’s going to delay hiring, construction and create challenges for investment,” he said.

The state’s legal cannabis program has been criticized for its slow rollout, which critics say has allowed an illegal market to thrive.

Just 21 adult-use retail dispensaries have opened nearly two and half years since the legislation was passed, with a backlog of 463 cannabis-licensed operators that have yet to begin operating.

Hochul’s office did not respond to The Post’s request for comment on the ruling.

https://nypost.com/2023/08/18/nys-troubled-pot-peddling-program-remains-on-ice-after-state-likely-illegally-favored-drug-felons-over-disabled-vets/