Treatment with Ivermectin Associated with Decreased Mortality in COVID-19: National Federated Database

 I.Efimenko1S.Nackeeran2S.Jabori3J.A. GonzalezZamora4S.Danker3D.Singh1

DOI: https://doi.org/10.1016/j.ijid.2021.12.096

PDF: https://www.sciencedirect.com/science/article/pii/S1201971221009887/pdfft?md5=8a5e8b65ebf08e845e7adb36081b7f19&pid=1-s2.0-S1201971221009887-main.pdf

Purpose

To evaluate the difference in mortality of patients treated with ivermectin vs patients treated with remdesivir with COVID-19 in United States using TriNetX Research network, a federated EMR network of over 44 healthcare organizations and 68 million patients from US, from 2009-2021.

Methods & Materials

We retrospectively identified adults (≥18 years) with a recorded COVID-19 infection between January 1, 2020 and July 11, 2021. We compared those with recorded use of ivermectin, but not remdesivir, against those with recorded use of remdesivir, but not ivermectin. We controlled for the following demographics, comorbidities, and treatments that may affect COVID-19 survival outcomes: age, gender, race, ethnicity, nicotine use diabetes mellitus, obesity, chronic lower respiratory disease, ischemic heart diseases, tocilizumab, glucocorticoids, or ventilator use. We measured association with mortality as the primary outcome, with significance assessed at p<0.05.

Results

There were a total of 1,761,060 possible COVID-19 patients based on ICD-10 diagnostic terms and confirmatory lab results. Prior to controlling, our analysis yielded 41,608 patients who had COVID-19 resulting in two unique cohorts that were treated with either ivermectin (1,072) or remdesivir (40,536). Within the ivermectin cohort, average age was 51.9 + 17.8 years, 43% were male, 60% had glucocorticoids and 1% required ventilator support. In the remdesivir cohort, average age was 62.0 + 16.0 years, 54% were male, 64% had glucocorticoids and 2% required ventilator support. After using propensity score matching and adjusting for potential confounders, ivermectin was associated with reduced mortality vs remdesivir (OR 0.308, 95% CI (0.198,0.479)),Risk Difference -5.224%, CI (-7.079%,-3.369%), p <0.0001.

Conclusion

Ivermectin use was associated with decreased mortality in patients with COVID-19 compared to remdesivir. To our knowledge, this is the largest association study of patients with COVID-19, mortality and ivermectin. Further double-blinded placebo-controlled RCTs with large samples are required for definite conclusion. In the future, if more publications are published with the similar result to the current analyses, the certainty of evidence will increase.

https://www.sciencedirect.com/science/article/pii/S1201971221009887

GOP Says It'll Investigate Fauci If It Retakes House in 2022

 Several Republican lawmakers indicated that if the GOP regains a majority in the House of Representatives in the 2022 midterm elections, they plan to open investigations on White House COVID-19 adviser Dr. Anthony Fauci, the Epoch Times reported.

“When are we going to have accountability for Anthony Fauci?” Rep. Chip Roy (R-Texas) said on Fox News over the weekend. “Look, he’s missing right now for one reason, and one reason only: The Democrats are looking at the polls."

“It wasn’t dead Americans that made Democrats move. It wasn’t dead Americans that made Fauci go away. It was polls. And I want to hold Anthony Fauci accountable.

“And if you’re watching this, Dr. Fauci, look out because when the Americans give us control in the House of Representatives, God willing, we’re going to get some answers on behalf of the American people.”

Roy’s remark came just a few days after Rep. Jim Jordan (R-Ohio), the ranking Republican on the House Judiciary Committee, confirmed to Just The News that the GOP will attempt to investigate Fauci and other federal health officials over how they responded to the COVID-19 pandemic.

Jordan added that Republicans, namely, will attempt to obtain information from the federal government and Fauci’s agency on whether COVID-19 had its origins in a lab in Wuhan, in China’s central Hubei Province.

“That is because they knew from the get-go [that COVID-19] … likely came from a lab, [with] gain-of-function likely done, and our tax dollars were used,” Jordan said, referring to “gain-of-function,” a controversial form of research that alters an organism in a way that may enhance biological functions such as altered transmissibility, pathogenesis, and host range.

Fauci was pressed during congressional hearings last year about what some critics say are false or misleading statements about whether his agency, the National Institute of Allergy and Infectious Diseases (NIAID), as well as the National Institutes of Health (NIH), steered taxpayer money to the nonprofit EcoHealth Alliance, which provided funds to scientists at the Wuhan Institute of Virology to research bat coronaviruses.

Last September, more than 900 pages of documents detailing the use of federal money by EcoHealth were obtained and published by The Intercept. Critics said the documents suggest Fauci misled Congress when he said that his agency never funded gain-of-function research in the Wuhan lab.

In October, Lawrence Tabak, then the NIH’s principal deputy director, said that EcoHealth provided a five-year report on bat coronavirus research under an NIH grant, finding that “in this limited experiment, laboratory mice infected with the SHC014 WIV1 bat coronavirus became sicker than those infected with the WIV1 bat coronavirus.”

Fauci told Sen. Rand Paul (R-Ky.) during a hearing in early 2021 that he “never lied before the Congress” and that the NIH didn’t fund the research.

“You do not know what you’re talking about, quite frankly,” he told Paul at the time.

In October of last year, Fauci told ABC News that he stood by his assertion that the NIH didn’t fund gain-of-function research.

“The framework under which we have guidance about the conduct of research that we fund, the funding at the Wuhan Institute was to be able to determine what is out there in the environment, in bat viruses in China,” Fauci said. “And the research was very strictly under what we call a framework of oversight of the type of research. And under those conditions which we have explained very, very clearly, does not constitute research of gain of function of concern.”

Officials at NIAID didn’t respond by press time to a request by The Epoch Times for comment.

https://www.zerohedge.com/covid-19/gop-says-itll-investigate-fauci-if-it-retakes-house-2022

L.A. County Health Plan Fined $55M for Healthcare Failures

 L.A. Care, the nation's largest publicly operated health plan, was fined $55 million for failing to authorize care thousands of poor and at-risk members, causing health-threatening treatment delays, California regulators announced Friday.

The fines — by far the largest in state history — were levied against the Los Angeles County health plan by the state Department of Managed Health Care and the Department of Health Care Services.

"The scope and breadth of its violations indicate deep-rooted, systemic failures that threaten the health and safety of its members," said Michelle Baass, director of the California Department of Health Care Services.

In one case, a cancer patient was left without treatment despite deteriorating health, another plan member suffered "extreme pain" for over two weeks and another cancer patient who was given only six to nine months to live left the plan for another insurer because of delays, the agencies said.

"My hope is that this sends a strong message to the entire industry that the state takes very seriously protecting all consumers, but particularly our most vulnerable enrollees," said Mary Watanabe, director of the Department of Managed Health Care.

L.A. Care, also known as the Local Initiative Health Authority for Los Angeles County, has about 2.5 million members, making it the largest Medicaid plan in the state. Many of its members are low-income and rely on county hospitals, although some have access to private doctors.

The state regulatory agencies said their investigations were prompted by an article published two years ago in the Los Angeles Times, which noted that patients seeking specialty care with a referral from their primary doctor had to wait months for approval instead of the required 15-day limit for the health plan to offer appointments.

Some patients died in the meantime, the Times reported, including a 61-year-old woman with chronic kidney disease who waited 10 months to see specialists.

The health plan disclosed last year that it had a backlog of thousands of requests for authorizing health care services, and that it had found nearly 93,000 cases in which it had failed to process such requests in a timely manner.

The health plan also said it had failed to issue resolution letters in the time required for tens of thousands of grievances filed by members from 2019 through October 2021.

In a statement, L.A. Care said it had identified and self-reported the problems and had taken corrective actions, including agreeing to pay for an independent but state-approved monitor to make sure it meets state standards as quickly as possible.

The backlog of grievances will be resolved this month, L.A. Care said.

L.A. Care also said it will contest the fines, calling them "arbitrary and unnecessarily punitive."

"What the state does not seem to factor into their equation is that a financial penalty of this magnitude creates yet another financial hurdle for a public health plan that is a crucial part of the health care safety net in Los Angeles County," the statement said.

The fines were applauded by Health Access California, a consumer advocacy group.

"L.A. Care failed its patients in handling grievances, authorizing treatments, and ensuring timely access to care. Californians died as a result," said Diana Douglas, the group's policy and legislative advocacy manager. "These fines are not just merited but modest given the systemic issues and scale of the harm for tens of thousands of consumers."

https://www.medscape.com/viewarticle/969785

Weekend Catch-up Sleep May Help Fatty Liver

 People who don't get enough sleep during the week may be able to reduce their risk for nonalcoholic fatty liver disease (NAFLD) by catching up on the weekends, researchers say.

"Our study revealed that people who get enough sleep have a lower risk of developing NAFLD than those who get insufficient sleep," wrote Sangheun Lee, MD, PhD, from Catholic Kwandong University College of Medicine in Incheon Metropolitan City, Republic of Korea, and colleagues, in Annals of Hepatology.

However, they cautioned that further research is needed to verify their finding.

Previous studies have associated insufficient sleep with obesity, hypertension, diabetes mellitus, and cardiovascular disease, as well as liver fibrosis.

A busy weekday schedule can make it harder to get enough sleep, and some people try to compensate by sleeping longer on weekends.

Studies so far have produced mixed findings on this strategy, with some showing that more sleep on the weekend reduces the risk for obesity, hypertension, and metabolic syndrome, and others showing no effect on metabolic dysregulation or energy balance.

Accessing a Nation's Sleep Data

To explore the relationship between sleep patterns and NAFLD, Lee and colleagues analyzed data from Korea National Health and Nutrition Examination Surveys collected from 2008 to 2019. They excluded people < 20 years of age, those with hepatitis B or C infections, liver cirrhosis or liver cancer, shift workers and others who "slept irregularly," and those who consumed alcohol excessively, leaving a cohort of 101,138 participants.

The survey didn't distinguish between sleep on weekdays and weekends until 2016, so the researchers divided their findings into two: 68,759 people surveyed from 2008 to 2015 (Set 1) and 32,379 surveyed from 2016 to 2019 (Set 2).

Set 1 was further divided into those who averaged more than 7 hours of sleep per day and those who slept less than that.

Set 2 was divided into three groups: one that averaged less than 7 hours of sleep per day and did not catch up on weekends, one that averaged less than 7 hours of sleep per day and did catch up on weekends, and one that averaged more than 7 hours of sleep throughout the week.

The researchers used the hepatic steatosis index (HSI) to determine the presence of a fatty liver, calculated as 8 × (ratio of serum alanine aminotransferase to serum aspartate aminotransferase) + body mass index (+ 2 for female, + 2 in case of diabetes). An HSI of ≥ 36 was considered an indicator of fatty liver.

Less Sleep, More Risk

Participants in Set 1 slept for a mean of 6.8 hours, with 58.6% sleeping more than 7 hours a day. Those in Set 2 slept a mean of 6.9 hours during weekdays, with 59.9% sleeping more than 7 hours. They also slept a mean of 7.7 hours on weekends.

In Set 1, sleeping ≥ 7 hours was associated with a 16% lower risk for NAFLD (odds ratio [OR], 0.84; 95% confidence interval [CI], 0.79 - 0.89).

In Set 2, sleeping ≥ 7 hours on weekdays was associated with a 19% reduced risk for NAFLD (OR, 0.81; 95% CI, 0.74 - 0.89). Sleeping ≥ 7 hours on the weekend was associated with a 22% reduced risk for NAFLD (OR, 0.78; 95% CI, 0.70 - 0.87). Compared with those who slept < 7 hours throughout the week, those who slept less than 7 hours on weekdays and more than 7 hours on weekends had a 20% lower rate of NAFLD (OR, 0.80; 95% CI, 0.70 - 0.92).

All these associations held true for both men and women.

Why Getting Your Z's May Have Hepatic Advantages

One explanation for the link between sleep patterns and NAFLD is that dysregulation of cortisol, inflammatory cytokines, and norepinephrine are associated with both variations in sleep and NAFLD onset, Lee and colleagues wrote.

They also point out that a lack of sleep can reduce the secretion of two hormones that promote satiety: leptin and glucagon-like peptide-1. As a result, people who sleep less may eat more and gain weight, which increases the risk for NAFLD.

Ashwani K. Singal, MD, MS, a professor of medicine at the University of South Dakota in Vermillion, who was not involved in the study, noted that it was based on comparing a cross-section of a population instead of following the participants over time.

"So, I think it's an association rather than a cause and effect," he told Medscape Medical News.

The authors don't report a multivariate analysis to determine whether comorbidities or other characteristics of the patients could explain the association, he pointed out, noting that obesity, for example, can increase the risk for both NAFLD and sleep apnea.

Still, he said, the paper will influence him to mention sleep in the context of lifestyle factors that can affect fatty liver disease. "I'm going to tell my patients, and tell the community physicians to tell their patients, to follow a good sleep hygiene and make sure that they sleep at least five to seven hours."

Annals of Hepatology. Published online February 20, 2022. Full text

Singal and the study authors all report no relevant financial relationships. The study was supported by the National Research Foundation of Korea.

https://www.medscape.com/viewarticle/969712

Walgreens and Labcorp Offer At-Home COVID-19 PCR Test Collection Kits At No Cost Nationwide

 Walgreens and Labcorp, a leading global life sciences company, today announced the nationwidei availability of Pixel by Labcorp®ii COVID-19 at-home collection kit, a PCR test available through Labcorp OnDemand™ at no cost to individuals who meet clinical guidelines*. Walgreens addition of the kits, which are provided in collaboration with the U.S. Department of Health and Human Services (HHS), will enable more communities to access reliable, convenient testing services when, where and how they need them.

Walgreens and Labcorp today announced the nationwide availability of Pixel by Labcorp® COVID-19 at-home collection kit, a PCR test available through Labcorp OnDemand™ at no cost to individuals who meet clinical guidelines. (Photo: Business Wire)

"Walgreens is focused on reducing barriers to health care, including cost and transportation," said John Standley, president, Walgreens. "Through our continued partnership with Labcorp and HHS, communities will have better access to convenient COVID-19 PCR testing. This is particularly important for uninsured, socially vulnerable and medically underserved populations, who continue to be among those most impacted by COVID."

How to Get a Pixel by Labcorp® COVID-19 At-Home Collection Kit

• Visit walgreens.com/covid19testing to request a Labcorp COVID-19 at-home kit at no cost for individuals 2 years of age and older.

• • Individuals scheduling a testing appointment using the Walgreens online scheduler will see a pop-up with the option to request a COVID-19 at-home collection kit.

• Individuals will then be directed to Labcorp OnDemand, a health care platform that helps individuals manage their health and make more informed decisions. Once on the platform, customers will be prompted to answer eligibility questions and request a kit.

• Completed tests can be dropped off at more than 6,000 Walgreens locations or a FedEx drop off location using the pre-paid FedEx Priority Overnight bag provided.

https://finance.yahoo.com/news/walgreens-labcorp-offer-home-covid-190000473.html

ADMA Receives FDA Approval for Fifth Plasma Collection Center, in GA

 FDA approval supports corporate goal of plasma supply self-sufficiency and ongoing revenue growth

Company positioned to meet or exceed target of 10 or more FDA-approved plasma collection centers by year-end 2023

ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that it has received U.S. Food and Drug Administration (“FDA”) approval for its fifth ADMA BioCenters plasma collection facility located in Conyers, Georgia. This plasma collection facility commenced operations and initiated source plasma collection in the third quarter of 2021. With the approval announced today, this facility is now FDA-approved to collect and introduce into interstate commerce, human source plasma for further manufacturing in the U.S.

“The successful expansion of ADMA’s plasma collection network supports the Company’s goal of plasma supply self-sufficiency and ongoing revenue growth objectives, and importantly, further solidifies the pathway towards profitability. The approval is a testament to the BioCenters team’s tireless commitment, and we thank the FDA for its efforts and expeditious review of the Conyers, GA Biologics License Application (“BLA”), which came well in advance of the agency’s targeted approval date,” said Adam Grossman, President and Chief Executive Officer of ADMA.

“ADMA now has ten plasma collection centers under its corporate umbrella at various stages, five of which are now FDA-approved to collect normal source and RSV hyperimmune plasma. The Company remains on track to have ten or more of its BioCenters locations FDA-approved by year-end 2023. ADMA’s growing internal plasma collections are currently being supplemented by third-party supply contracts as well as the yield enhancements resulting from the implementation of the Haemonetics’ NexSys Persona® system. We anticipate our encouraging plasma supply position will enable ADMA to continue to expand its customer base and grow revenues in the U.S. immunoglobulin market,” said Brian Lenz, Executive Vice President, Chief Financial Officer, and General Manager, ADMA BioCenters.

https://finance.yahoo.com/news/adma-biocenters-receives-fda-approval-210500249.html

Sanofi to Invest Around EUR1.43 Billion in France Over Next Five Years

 Sanofi SA on Monday said that it will invest around 1.43 billion euros ($1.56 billion) over the 2022-26 period in France, including EUR935 million to develop mRNA messenger technology.

The French pharmaceutical company said the plan is to provide the country with an autonomous mRNA-technology value chain, from research and development to production.

Sanofi also said it will invest EUR490 million over the course of five years to build a new bioproduction unit for multiple vaccine and biological platforms, including mRNA. Th facility is expected to be fully operational in the fourth quarter of 2025.

https://www.marketscreener.com/quote/stock/SANOFI-4698/news/Sanofi-to-Invest-Around-EUR1-43-Billion-in-France-Over-Next-Five-Years-39688833/