Uncategorized
FDA’s Anti-Ivermectin “You Are Not A Horse” Post Remains Up As Court Order Deadline Looms
FDA’s Anti-Ivermectin "You Are Not A Horse" Post Remains Up As Court Order Deadline Looms
Authored by Matthew Lysak via The Epoch Times,
Eleven…
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Authored by Matthew Lysak via The Epoch Times,
Eleven days after a court-ordered settlement required the U.S. Food and Drug Administration (FDA) to remove all social media and directives regarding ivermectin, a webpage and its most infamous post remains online, advising people against the use of the popular drug.
After years of controversy over using ivermectin to fight COVID-19, the FDA agreed to remove its social media posts urging people to stop using the drug, according to a settlement filed with federal court in southern Texas dated March 21.
The agency has already removed a page that said: “Should I take ivermectin to prevent or treat COVID-19? No.”
However, its Aug. 21, 2021, post on X (formerly Twitter)—in which the FDA wrote:
“You are not a horse. You are not a cow. Seriously y’all. Stop it”—continues to remain live on the social media platform.
At the time of publication, the post had been reposted more than 67,000 times.
Further, a page on the agency’s website titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” also remains live, in which the agency states that the “FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals.” The page also says no data exist showing ivermectin to be effective against COVID-19, despite studies that show the drug to be effective against the disease.
Dr. Mary Talley Bowden, a practitioner in Texas and founder of the Coalition of Health Freedom, told The Epoch Times that she believes the agency is delaying the inevitable to avoid further public ridicule.
“My guess is they’re hoping all the negative publicity over the case will die down, and they can quietly remove them without as many people noticing,” said Dr. Bowden, who was among a group of doctors who initially filed a lawsuit against the FDA.
“We have three years of false propaganda to overcome regarding ivermectin,” she added.
According to the terms outlined in the settlement, the agency has 21 days to “delete and not republish” web pages and several media posts, including an April 26, 2022, social media post that reads: “Hold your horses y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”
In exchange for removing the posts and webpages, doctors who sued the agency are dismissing their claims, the filing states.
An FDA spokesperson was not immediately available for comment but had previously told The Epoch Times in an email that the agency “has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old.”
Ivermectin has been around for decades but became the center of controversy in 2020 after medical opinion became divided over its effectiveness as a treatment for COVID-19. In the aftermath, many pharmacists refused to fill prescriptions for the medication.
By 2023, the issue had made its way into a courtroom in a case brought by Dr. Bowden and other medical professionals when, on Aug. 8, a lawyer representing the FDA confirmed that doctors were free to prescribe ivermectin to treat COVID-19.
“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, told the U.S. Court of Appeals for the 5th Circuit.
Despite statements from the FDA affirming that right to doctors, many pharmacists nationwide continue to refuse to fill prescriptions for ivermectin issued to patients for the treatment of COVID-19, according to Dr. Bowden.
In most cases, according to Dr. Bowden, individual pharmacists aren’t to blame and often only carry out orders from corporate leadership. However, she claims to have also seen examples where pharmacists prevented her patients from getting their medication because of their own “personal agenda.”
Further, the longer the FDA posts remain up, the more difficult it is for physicians to ensure that patients receive the care needed, according to Dr. Bowden, who added that a pharmacist refused to fill an ivermectin prescription she had written last week.
“I’ve treated over 6,000 COVID patients using a combination of medications, including ivermectin,” said Dr. Bowden. “All of my patients who received early treatment are alive and well.
“The sooner they remove the posts, the better, but we have a lot of work to do to reeducate the public,” she added.
The FDA has until April 11 to delete the remaining posts, according to the settlement.
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Humana tumbles, UnitedHealth and CVS slide on Medicare Advantage hit
The health insurance sector took yet another blow Tuesday as investors see narrowing near-term profits.
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Humana (HUM) shares fell sharply in early Tuesday trading, while rivals UnitedHealth UNH and CVS Health (CVS) traded firmly in the red, as the health insurance industry received yet another blow to its 2024 profit forecasts.
All three major health insurance groups have trailed the broader market this year, with Humana down nearly 25%, amid concern that profit margins will be hit by a surge in medical costs tied to a rise in elective procedures. Those procedures had been delayed by the covid pandemic.
UnitedHealth's medical-cost ratio, a key industry metric, rose nearly 3 percentage points, to 85%, over the final three months of last year, suggesting that a larger portion of its collected premiums were paid out on insurance claims.
Humana said its benefit-expense ratio rose more than 3 percentage points, to 90.7% over the 2023 fourth quarter compared with the year-earlier period. It also was up more than 3 percentage points from third-quarter 2023 levels.
The group noted "elevated Medicare Advantage utilization trends," which it said "further increased in 4Q23, driven by higher-than-anticipated inpatient utilization, primarily for the months of November and December, as well as a further increase in noninpatient trends, predominantly in the categories of physician, outpatient surgeries and supplemental benefits."
Humana health cost warning
Humana in fact sought to mitigate those pressures late last year when it unveiled merger talks with Cigna Group (CI) , noting that the group "continued to experience an increase in covid admissions in the third quarter."
The talks were ultimately scrapped, however, amid concern that the Federal Trade Commission, which has taken a far more active role in challenging megamergers under the leadership of Chairwoman Lina Khan, would block the proposed $120-plus billion tie-up.
Related: UnitedHealth hit by antitrust probe and ransomware hacker report
The FTC is also continuing its probe into the three largest pharmacy-benefit managers – CVS's Caremark, Cigna's Express Scripts and UnitedHealth's OptumRx – and has warned the group of likely changes to the industry's broader regulation.
Medicare Advantage payouts flat
Further pressure was added to profit margins Tuesday when the U.S. Centers for Medicare & Medicaid Services said Medicare Advantage payments would rise only by an average of 3.7% next year.
Analysts were looking for an increase of around 4.7%, based on the CMS's January proposal of 3.7% following increases of around 1.22% each year between 2019 and 2024 to preliminary CMS figures.
The payments, which reimburse insurers for treatment of U.S. patients over age 65, will be effectively lower than current levels when adjusted for costs and inflation.
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"We see Humana as most-exposed both from its 84% revenue exposure to Medicare Advantage, and on sentiment given its challenging turnaround of the Medicare book," said Cantor Fitzgerald analyst Sarah James.
"We would also flag CVS as more exposed on sentiment than the 17% revenue exposure would imply, particularly given the outsized investor focus on 2024 Medicare Advantage margins and 2025 bid strategy for the company," she added.
Humana shares were marked 9.2% lower in premarket trading to indicate an opening bell price of $318.70 each. CVS shares slumped 5% to $75.56 each while UnitedHealth was marked 4% lower at $469.95 each.
Related: Veteran fund manager picks favorite stocks for 2024
stocks pandemic treatmentUncategorized
Gritstone bio stock drops after Phase 2 cancer vaccine data
Gritstone bio’s stock took a tumble in premarket trading Tuesday morning following mixed data from a Phase 2 study of its cancer vaccine, but it’s…
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Gritstone bio’s stock took a tumble in premarket trading Tuesday morning following mixed data from a Phase 2 study of its cancer vaccine, but it’s still moving ahead with a public offering of its stock and Phase 3 planning.
In a late Monday release, Gritstone touted the data as positive from the Phase 2 portion of its Phase 2/3 GRANITE trial of its neoantigen cancer vaccine in front-line metastatic microsatellite stable colorectal cancer (MSS-CRC). Progression-free survival favored Gritstone’s vaccine in an early trend, even though the dataset is “immature,” the company said in its presentation.
But the primary endpoint of the study — the short-term circulating tumor DNA (ctDNA) response — was described as “negative” and the data utility as “low” by Gritstone in a Monday presentation. The short-term ctDNA response analysis didn’t show a difference between study arms.
Immediately after the announcement, Gritstone priced a $32.5 million public offering of 8.3 million shares of its stock $GRTS at a price of about $1.65 per share, below its previous close. The stock tumbled as much as 33% and was trading at around $1.56 premarket Tuesday. The offering is expected to close on April 4.
The company suggested that it had made a mistake in defining the original clinical trial protocol and setting the primary endpoint.
“Pioneering new spaces carries inherent risks, and with regard to defining molecular response, we simply got it wrong,” Gritstone president and CEO Andrew Allen said in a statement. “ctDNA levels in both arms decreased on chemotherapy for longer than we anticipated, generating similar short-term molecular response rates across arms and rendering our protocol measure of ctDNA change uninformative.”
Allen added that “long-term analysis demonstrates the expected correlation of ctDNA with clinical benefit and favors GRANITE patients,” with the potential to share mature progression-free survival data in the third quarter of this year and then enter regulatory discussions regarding the Phase 3 portion of the study.
Randolph Hecht, director of the UCLA GI Oncology Program and an investigator in the GRANITE Phase 2/3 study, noted that the progression-free survival difference shows a “potential” for clinical benefit as well as a reason to move into a confirmatory Phase 3 trial.
“Furthermore, we are learning how to better analyze ctDNA continuously to study the efficacy of this novel immunotherapy,” Hecht added.
As for safety, Gritstone said that no patients discontinued due to an adverse event, and “most” adverse events were grade 1 or 2.
Earlier this year, Gritstone laid off about 40% of its staff following a delay in a Phase 2b trial (and its expected funding) of its next-gen Covid-19 vaccine. The trial won’t start until the fall of this year.
vaccine dna covid-19Uncategorized
Vaccinated People Show Long COVID-Like Symptoms With Detectable Spike Proteins: Preprint Study
Vaccinated People Show Long COVID-Like Symptoms With Detectable Spike Proteins: Preprint Study
Authored by Marina Zhang via The Epoch Times…
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Authored by Marina Zhang via The Epoch Times (emphasis ours),
Spike protein could remain in immune cells for more than 245 days following vaccination, according to a recent preprint. The study evaluated 50 patients who developed long COVID-like symptoms after the COVID-19 vaccine; none had been infected with the virus.
The authors extracted immune cells from 14 post-vaccine patients and found that 13 had spike protein in their immune cells. Asymptomatic vaccinated people had no spike present.
Researchers from InCellDx, a research company that produces panels and protocols that test for and treat long COVID and post-vaccine syndrome, authored the paper.
Their previous study published in 2022 showed that unvaccinated long-COVID patients could have spike protein persist in their immune cells for 15 months.
In both papers, the spike proteins were detected in monocytes, immune cells that circulate the body.
These findings indicate that the persistence of these spike proteins was likely the driver for the symptoms of long COVID and post-vaccine syndrome, InCellDx founder and lead study author Dr. Bruce Patterson told The Epoch Times.
“These cells bind to the blood vessels. They cause endotheliitis (inflammation of endothelium) and vascular inflammation, which I think now has been corroborated by many as being probably one of the most important pathogenic mechanisms in long COVID,” Dr. Patterson said.
Spike Protein Reservoirs
“Monocytes are scavenger cells of the immune system,” Dr. Patterson said. Monocytes function similarly to how the video game character Pac-Man does: They roam the body and gobble up proteins they come across in their way.
In long COVID, monocytes gobble up spike protein, the virus’ viral debris. In post-vaccine syndrome, the monocytes engulf spike proteins, which the body makes from the COVID-19 vaccine.
These spike proteins are then stored inside the monocytes, which causes the cells to live longer than they should. The prolonged longevity can cause inflammation, leading to various long-lasting symptoms.
In the study, Dr. Patterson and his team observed that post-vaccine patients had significantly higher monocyte levels than those without post-vaccine symptoms. The symptomatic post-vaccine patients also had a clear elevation in inflammatory biomarkers, whereas the asymptomatic patients did not.
Dr. Patterson believes that at the time of the study, viral replication or spike protein production from vaccinations was no longer occurring. Instead, the spike proteins persisted for months because they were being stored.
He reasoned that once the monocytes engulfed the spike proteins, the spike hijacked the cells’ cell death program, turning off cell death “so they become long-lived cells.”
A similar phenomenon occurs with the HIV and hepatitis C viruses.
Monocyte cells can cause inflammation. Particularly, nonclassical monocytes, which traverse the blood vessels, can lead to blood vasculature inflammation and damage.
Several studies have identified inflamed and damaged vasculature as central features of long-COVID symptoms. These patients have a high level of inflammatory chemicals, which can promote fatigue, blood clotting, immune and nervous system dysregulation, and more.
Long COVID vs. ‘Long Vax’
The recent preprint also shows how long COVID and post-vaccine syndrome may be differentiated.
While the same thing—spike protein persistence—likely causes both conditions, the conditions have slightly differing chemical profiles, especially regarding the level of interleukin-8, or IL-8.
IL-8 is a type of cytokine that aids in attracting immune cells to areas of inflammation, Dr. Patterson explained.
He said that medication that blocks these different cytokines should resolve symptoms. For example, his team found that tumor necrosis factor-alpha (TNF-alpha) is a cytokine that, when elevated, induces fatigue. Therefore, reducing that cytokine can help diminish fatigue.
Other cytokines shared between long COVID and the condition dubbed “long vax” include sCD40L and CCR5, which drive vascular inflammation. Another cytokine, IL-6, signals systemic inflammation.
Dr. Patterson explained that the two conditions’ distinct chemical profiles may be due to their different delivery mechanisms: Viral infection causes long COVID, while inoculation causes post-vaccine syndrome.
Treatment Protocol
Dr. Patterson uses the same protocol for treating long COVID and post-vaccine syndrome. Both treatments entail curbing inflammation in the blood vessels and throughout the body.
His protocol includes using maraviroc, an HIV drug, and atorvastatin, a type of statin, to target vasculature inflammation.
Maraviroc blocks CCR5, a type of inflammatory cytokine that causes blood vessel inflammation, while statins can bind to the receptors inside the blood vessels, blocking them from binding to inflammatory monocytes.
Many doctors have found successes with ivermectin, N-acetylcysteine (NAC), and nattokinase, all of which are drugs and nutraceuticals that help break down outside spike protein. However, Dr. Patterson reported the opposite in his practice. He explained that the drugs cannot target the spike protein stored inside cells.
In February, the U.S. Food and Drug Administration (FDA) approved Dr. Patterson’s clinical trial to test a maraviroc and statin combination for treating long COVID.
Long Vax Masked as Long COVID
The study findings imply that some people diagnosed with long COVID may actually be suffering from post-vaccination symptoms.
“Evidence they blame vaccine injury on ’long covid’?,” Dr. Lynn Flynn, a virology and infectious disease expert, wrote on X, citing the preprint.
Dr. Patterson said that the symptoms being reported in these post-vaccine patients “were almost identical to the symptoms in long COVID,” with the predominant symptoms being fatigue, neuropathy, brain fog, and headache. Long-COVID patients in another cohort also reported these symptoms.
“[Long vax] has a very low prevalence, but because billions of [people] are vaccinated, there’s a great number of individuals who have long vax,” he added.
Apart from post-vaccine syndrome, Dr. Patterson said that patients with an exacerbation of Lyme disease and myalgic encephalomyelitis (chronic fatigue syndrome) have also been labeled as long-COVID patients due to a symptoms-based diagnosis.
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