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Thursday, November 11, 2021

U.S. Postal Service Warns Vaccine Mandate Could Affect Deliveries

 The U.S. Postal Service expressed concerns on Wednesday that the Biden administration’s vaccine mandate for large companies could affect deliveries, according to Reuters.

In a financial filing, the USPS said complying with the order could lead to “labor challenges and high levels of absenteeism.” The postal service has 644,000 employees across the country.

The order “will be extremely challenging to implement and administer during the height of our peak season, particularly given its expedited schedule,” the USPS wrote in the filing.

Some employees could decide to leave, which “could cause significant business disruptions, and could adversely impact service performance and result in lower mail volume and revenue,” the postal service said.

Last week, the Department of Labor issued details about the order, which requires businesses with 100 or more employees to mandate COVID-19 vaccination or weekly testing by Jan. 4. The rules also require employers to ensure that unvaccinated employees who work in person wear masks by Dec. 5.

The 5th U.S. Circuit Court of Appeals in New Orleans is deciding whether to lift an order issued on Saturday that froze the rule temporarily, Reuters reported. States, religious organizations, and private employers have sued the federal government, claiming that it exceeded its authority in issuing the vaccine mandate.

The Postal Service is still reviewing the Biden administration’s order, David Partenheimer, a spokesman for the USPS, told Reuters on Wednesday.

“We continue to take measures to protect the health and safety of our postal workers,” he said.

https://www.webmd.com/vaccines/covid-19-vaccine/news/20211111/us-postal-service-vaccine-mandate-deliveries

New Institute Has Ties to Great Barrington Declaration

 A new think tank is promoting some old, controversial ideas about COVID-19 -- and has strong ties to the parties involved in the Great Barrington Declaration.

The Brownstone Institute for Social and Economic Research aims to evaluate the "global crisis" stemming from the policy response to the COVID-19 pandemic. Its stated mission is "constructively to come to terms with what happened, understand why, discover and explain alternative paths, and prevent such events from happening again."

It currently publishes articles that criticize COVID lockdowns, question vaccine mandates, and describe masking as "an attack on our communal life."

That may not be surprising given its strong ties to the Great Barrington Declaration, a document published last year that advocated lifting all lockdown restrictions on the young and healthy in a bid for promoting natural immunity.

All three of the scientists who were the lead authors of that declaration are senior scholars or authors at the Brownstone Institute -- and other contributors have risen to prominence for raising controversial ideas about the pandemic.

The 'Spiritual Child' of Great Barrington

Anti-lockdown rhetoric and an emphasis on "natural immunity" -- issues raised by the Great Barrington Declaration -- are topics explored by the Brownstone Institute. The institute, in fact, acknowledges its relationship to the Great Barrington Declaration, calling itself "the spiritual child" of the document.

The Great Barrington Declaration touted a strategy called "focused protection," which encouraged governments to lift lockdown restrictions on young and healthy people while continuing to restrict vulnerable groups. This strategy promoted the spread of COVID-19 in populations where it is less likely to be deadly, encouraging widespread immunity that did not depend on vaccination, the authors argued.

They added that focused protection would mitigate collateral damage of the lockdowns, such as lower childhood vaccination rates, fewer cancer screenings, increased cardiovascular illness, and a worsening mental health crisis.

The Great Barrington Declaration was widely condemned by scientists around the globe, and NIAID Director Anthony Fauci, MD, referred to it as "nonsense" and "very dangerous." However, the previous White House administration embraced it for a period of time.

The declaration was signed at a summit in Great Barrington, Massachusetts, and hosted by the American Institute of Economic Research (AIER) -- although the AIER maintained that there were no financial ties. AIER, a libertarian, free-market think tank, has a long history of denying science on climate change.

The former editorial director of the AIER, Jeffrey Tucker, helped to organize the Great Barrington Declaration, and launched the Brownstone Institute in May 2021.

In a phone interview with MedPage Today, Tucker said that AIER "in no way sponsored or backed Brownstone," but rather Brownstone really is "the child of [his] own obsession."

Family Ties

Tucker maintains that AIER had no involvement in the founding of the Brownstone Institute. Many of the organization's key scholars have been involved with either the AIER or the Great Barrington Declaration.

Martin Kulldorff, PhD, co-author of the Great Barrington Declaration, was recently named senior scientific director of the Brownstone Institute. Kulldorff is a professor of medicine at Harvard Medical School who develops epidemiological and statistical models to detect infectious disease outbreaks.

Most recently, Kulldorff has focused on natural immunity, stating that immunity derived from natural infection is stronger than that derived from vaccination. He cited a recent study from Israel that showed the benefits of immunity from past infection -- which is in opposition to findings from a recent CDC report showing that vaccine-induced immunity is more protective.

In an article published on the Brownstone Institute's website announcing Kulldorff's position, he said that "governments, universities and scientific leaders have failed us during this pandemic, resulting in the biggest public health fiasco in history."

"With the censoring of long-established public health principles, we need new organizations to safeguard public health for the future," Kulldorff added. "As part of Brownstone, I am excited to work with other scientists and the public to foster open, rigorous, and intellectual scientific debate. We cannot allow 400 years of enlightenment to end."

Kulldorff did not respond to a request for comment from MedPage Today.

Joining Kulldorff as a senior scholar at the Brownstone Institute is Jay Bhattacharya, MD, PhD, of Stanford University, who is also a co-author of the Great Barrington Declaration. Bhattacharya was an early opponent of lockdowns in March 2020, and has continued to advocate for a public health strategy that shields the vulnerable while letting the virus run free among young, low-risk groups.

Recently, Kulldorff and Bhattacharya wrote an op-ed in Newsweek criticizing Fauci's actions during the COVID-19 pandemic. They said his position on mask mandates ignored natural immunity, and that he erroneously recommended masks even though they do not work.

The pair have also worked with Florida Gov. Ron DeSantis (R) on the state's COVID-19 response. Both Kulldorff and Bhattacharya have joined DeSantis' administration at roundtable discussions on the pandemic. Bhattacharya has become a go-to expert for the administration, most recently standing as an expert witness for the state in lawsuits against its ban on mask mandates.

Sunetra Gupta, PhD, an epidemiologist at the University of Oxford and the third co-author of the Great Barrington Declaration, is also an author at the Brownstone Institute. Other authors on the site include Paul Alexander, PhD, a former HHS official under the Trump administration who reportedly sought to alter CDC reports, and George Gilder, a senior resident fellow at AIER. Vinay Prasad, MD, MPH, of the University of California San Francisco also writes articles for the organization.

Social Media Backlash

Gavin Yamey, MD, MPH, professor of global health and public policy at Duke University who has previously criticized the Great Barrington Declaration, has repeatedly blasted the Brownstone Institute on Twitter.

"The Brownstone Institute calls itself 'the spiritual child of the Great Barrington Declaration' & its Scientific Director is a GBD author," Yamey wrote. "Both push awful vaxx misinformation."

Yamey has also highlighted the organization's ties to right-wing, libertarian groups.

While Brownstone's founder Tucker admitted he has his own political biases that lean libertarian, he maintained that the site aims to publish content that represents all political backgrounds, perspectives, and ideologies.

"We need to open our minds and get insight from wherever we can find," Tucker said. "That to me is more of a priority than anything else."

The benefits of widespread masking, evidence about how lockdown restrictions flattened the curve, and COVID vaccines' high efficacy rates are not readily accessible on the Brownstone website.

https://www.medpagetoday.com/special-reports/exclusives/95601

Coloplast goes for the throat

 The third-largest medtech acquisition of the year happened with little fanfare this week. Coloplast spent €2.2bn ($2.5bn) on Atos Medical, a maker of devices for tracheostomy and laryngectomy patients, knocking ICU Medical’s purchase of Smiths Group’s medical business into fourth place. The Sweden-based Atos occupies more than 80% of the laryngectomy market, according to Coloplast, with sales last year of SEK2.2bn ($253m). Coloplast, which had a difficult 2020 as the pandemic hit its hospital business, has recovered surprisingly well, with its stock up 23% year to date. Its sales are forecast to grow at a respectable annual rate of 8% to 2026, Evaluate Medtech data show; perhaps, with the inclusion of Atos’s technology, they will grow faster still. 

Top 5 medtech M&A of 2021
Announcement dateAcquirerTargetValue ($bn)Focus
Sep 1Baxter InternationalHill-Rom10.5General hospital & healthcare supply; healthcare IT
Jan 12SterisCantel Medical4.6Endoscopy; general & plastic surgery; nephrology
Nov 8Coloplast Atos Medical2.5Ear, nose & throat; general hospital & healthcare supply
Sep 8ICU MedicalSmiths Medical (subunit of Smiths Group)2.4Anaesthesia & respiratory; patient monitoring
Mar 12RocheGenmark Diagnostics1.8In vitro diagnostics
Note: excludes Spac deals. Source: Evaluate Medtech & company release. 

https://www.evaluate.com/vantage/articles/news/snippets/coloplast-goes-throat

NeuroPace cut to Equal Weight by Morgan Stanley

 From Overweight

https://finviz.com/quote.ashx?t=NPCE

Rising costs of Covid-19 care sends Bright Health shares into tailspin

 

Shares of Bright Health stock plummeted Thursday following the company's release of its third-quarter results.

The stock closed at $4.94, down by 32% from the previous close of $7.30.

For the quarter ending Sept. 30, Bright Health Group Inc. posted a net loss of $296.7 million, or 48 cents per share, compared to a loss of $59.2 million, or 43 cents per share for the same same period last year. Revenue rose to just over $1 billion from $352 million in the year-ago quarter.

Analysts had expected a loss of 19 cents per share on revenue of $1 billion.

Bright, which went public in June, reported losses of $43 million in the second quarter.

The losses are attributed to Minneapolis-based health insurance startup's medical cost ratio (MCR) rising to 103% compared to 90.1% in the third of quarter of 2020. The ratio is found by dividing total medical expenses paid by the company by the total amount in premiums it collected.

Over 5% of this most recent ratio was caused by an unfavorable impact from Covid-19 related costs, and a 9% impact from a reduction in premium revenue due to the company being unable to capture risk adjustment on newly added members.

“Our year-to-date 2021 MCR of 90.3% represents solid performance, especially given the remarkable growth and unique factors we have experienced this year," said Cathy Smith, Bright's chief financial and administrative officer. "As a company still building to scale, we expect to see some quarterly variation in performance from time to time."

Smith added that because it's a new and rapidly growing business, population health risk is hard to gauge in the near-term, but will improve as markets and populations age. 

https://www.bizjournals.com/twincities/news/2021/11/11/bright-health-third-quarter-results.html

ReproMed Gets FDA Clearance for Hizentra® Immune Globulin Prefilled Syringes

 Repro Med Systems, Inc. dba KORU Medical Systems (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty infusion solutions that improve quality of life for patients, today announced 510k clearance for use of the KORU Medical FreedomEdge® infusion pump to deliver Hizentra® [immune globulin subcutaneous (human) 20% liquid] 20 mL prefilled syringes. Hizentra® is the most prescribed subcutaneous Ig product and the first to be available in a prefilled syringe format.

https://finance.yahoo.com/news/koru-medical-announces-fda-clearance-210000738.html

Ocugen: Covaxin phase 3 data shows 77.8% efficacy against symptomatic Covid: Lancet

One week after the World Health Organisation (WHO) granted Emergency Use Listing (EUL) to Covaxin, a prestigious medical journal Lancet has stated that the phase 3 data of India’s first indigenously developed vaccine demonstrates 77.8% efficacy against symptomatic Covid-19. Its efficacy data also demonstrates 70.8% protection against all variants of SARS-CoV-2.

Covaxin’s efficacy was arrived at through the evaluation of 130 confirmed cases, of which 24 were observed in the vaccine group and 106 cases were in the placebo group. The two-dose inactivated virus vaccine was developed from scratch in India by Bharat Biotech along with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) Pune.


The efficacy analysis showed Covaxin (BBV152) is 93.4% effective against severe symptomatic Covid-19 and offers 63.6% protection against asymptomatic Covid-19. It is also 65.2% effective against the Delta variant, 90.1% effective against the Kappa variant, Lancet said.

https://timesofindia.indiatimes.com/india/covaxin-well-tolerated-phase-3-data-shows-77-8-efficacy-against-symptomatic-covid-lancet/articleshow/87655618.cms