Welcome to European Tribune. It's gone a bit quiet around here these days, but it's still going.
by Bernard (bernard) on Wed Dec 1st, 2021 at 07:26:54 PM EST
Weinreich et al., "REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19," 2 Dec
Covid-19-related hospitalization or death from any cause occurred in 18 of 1355 patients in the REGEN-COV 2400-mg group (1.3%) and in 62 of 1341 patients in the placebo group who underwent randomization concurrently (4.6%) (relative risk reduction [1 minus the relative risk], 71.3%; P<0.001); these outcomes occurred in 7 of 736 patients in the REGEN-COV 1200-mg group (1.0%) and in 24 of 748 patients in the placebo group who underwent randomization concurrently (3.2%) (relative risk reduction, 70.4%; P=0.002).
REGEN-COV reduced the risk of Covid-19-related hospitalization or death from any cause, and it resolved symptoms and reduced the SARS-CoV-2 viral load more rapidly than placebo. (Funded by Regeneron Pharmaceuticals and others; ClinicalTrials.gov number, NCT04425629. opens in new tab.)
archived WHO Fri Sep 24th, 2021 monoclonal approval
by Cat on Thu Dec 2nd, 2021 at 01:01:49 AM EST
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Science, A prominent virologist warns COVID-19 pill could unleash dangerous mutants. Others see little cause for alarm, 7 Nov
Molnupiravir, which Merck and Ridgeback Biotherapeutics developed from an earlier, experimental antiviral, works by interfering with viral replication, littering the viral genome with mutations until the virus can no longer reproduce.... The drug's ability to mutate RNA has raised persistent fears that it could induce mutations in a patient's own genetic material, possibly causing cancer or birth defects; studies so far have not borne out those fears.
On 30 November, a Food and Drug Administration advisory committee will review possible emergency use authorization for molnupiravir in the United States.
archived Miracle in Japan, [EMA] EU says Merck's [molnupiravir] pill can be taken in emergencies, FDA advisers narrowly endorse Merck's Covid-19 drug, molnupiravir 13-10 PF-07321332
by Cat on Sat Dec 4th, 2021 at 01:15:51 AM EST
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[SARS-CoV-2]omnicron [variant] complicates [marketing] at-home Covid pill [in USA]; UK, EU marketing omitted
The FDA will likely specify which "high risk" populations should have access to the Merck-Ridgeback Biotherapeutics pill if they contract Covid-19. That still will leave [licensed medical] doctors and other providers [of WHAT?] on the hook for making ["]judgment calls["] on whether to prescribe the pill -- and to do it within five days of a patient showing symptoms -- in order to realize the potential benefits.
supply chain controversy: US licensed pharmacists do not prescribe Rx; they compound, fulfill, dispense pharmaceutical products.
But supplies of the pill will likely be limited at first. The federal government has purchased 3.1 million courses of molnupiravir, which it will acquire between the date of FDA authorization and early next year. It has the option of purchasing an additional two million doses later, if needed.

A senior federal health official said if authorized, the pills bought by the federal government will be provided free of cost to localities[sic] that can distribute [market] them through health departments, community health centers and pharmacies [marketing channels]. "We continue to work with jurisdictions to plan for distribution and use of these products that will be consistent with clinical guidelines [medical diagnostic criteria] and recommendations for who should receive them," the official said.

"death panelists" or "equity" avengers?
In Merck's trials, however, the pill was only tested on unvaccinated adults, which makes some health experts wonder if the pills will only be available to that group. With an unvaccinated population at just over 99 million people, according to the Centers for Disease Control, three million doses is "a drop in the bucket," said Eunice Neeley [MD, PHP], a preventive medicine specialist and primary care provider based in New Orleans, Louisiana.
Carlos del Rio [MD], an executive associate dean and infectious disease specialist at the Emory School of Medicine, said that the pills "should work" against other variants because of how they stop the virus from replicating. But it will be important to collect more clinical data to be sure, he added.
If pharmacists don't participate [diagnose COVID-19], patients might have to make doctors appointments, delaying when they can begin the regimen.
novel EUA launch? From prescription pad to store shelf
To get FDA approval to change a prescription drug's classification to ["over-the-counter"] OTC [medicine], the product's manufacturer must prove its medication's safety and efficacy.11 Generally drugs can become OTC if:
  • They have low potential for misuse and abuse.
  • They are used for self-diagnosed conditions.
  • They can be used safely and effectively without a health care provider's instruction.
  • They can be adequately labeled.
In late-stage clinical trials, molnupiravir was shown to be about 30 percent effective at preventing hospitalization in at-risk patients, compared to a placebo. For comparison, [monoclonal] antibody treatments [intravenous or subcutaneous injection] that are administered in clinics and hospitals are about 70 percent effective.
The most important thing, they argue, is stopping future infections before they happen. "This will not help us out of the pandemic because it is a treatment and not a prevention," said [Dorry] Segev[MD, PhD]. "The way out of this pandemic is prevention."
too late! NEXT! ...
by Cat on Sat Dec 4th, 2021 at 05:34:41 PM EST
[ Parent ]
US drugstores squeezed by vaccine demand, staff shortages
pharmacists worry another job might soon be added to their to-do list: If regulators approve antiviral pills from drugmakers Merck and Pfizer to treat COVID-19, pharmacists may be able to diagnose infections and then prescribe pills to customers
On top of that workload and [filling] routine prescriptions, many drugstores also have been asking pharmacists to ["]counsel["] patients more generally on their health Rx dosage and adverse indications or about [medical insurance plan pricing of brand name and generic drugs for] chronic conditions like diabetes and high blood pressure.
[proprietor pharmacist Theresa] Tolle noted that it is not clear yet how pharmacists will be reimbursed for the time they take to diagnose and prescribe. That will have to be clarified, especially if cases surge again and drugstores need to add even more ["]workers["] to help [do WHAT?].
David Brailer's "consumer-patient" complaints
Sherri Brown, a city employee in Omaha, Nebraska, was searching for a vaccine booster dose, but two nearby pharmacies didn't have appointments available and a third didn't have the brand she wanted. She wound up getting a shot at a county-run clinic on Friday.
This is a marketing plan that will not end well, if it even launches this decade, and not only because Mr Murphy hasn't synthesized his own reporting: CVS Health to close hundreds of drugstores over next 3 years
archived Mon Aug 21st, 2006
by Cat on Sun Dec 5th, 2021 at 03:07:50 AM EST
[ Parent ]
market-based solutions to market-based problems
Ire over pharmacy middlemen fuels lobbying blitz
While there is little agreement among PBM opponents about what actions Congress should take, industry lobbyists are offering a menu of options for Democrats to consider, such as requiring [Pharmacy Benefit Managers] PBMs to pass on more of the rebates they negotiate with drugmakers to consumers or employers. They could also ban a common practice called spread pricing in which PBMs charge health plans [insurance carriers] more than they pay to the a pharmacy corporation dispensing a drug, and pocket the difference.
JC Scott, who leads the Pharmaceutical Care Management Association, the trade group for PBMs, said targeting his members might be good politics and take the focus off drugmakers during a critical moment in the debate, but it would not lower drug costs.
Although dozens of PBMs exist, the industry is consolidated, with three of them -- CVS Caremark, Express Scripts and OptumRx -- controlling nearly 80 percent of the prescription market. Health insurers, employers and [federal and states'] government hire PBMs to manage prescription benefits for their health [employees' commercial medical insurance group] plans -- putting them at the center of a supply chain consisting of drugmakers, insurers and pharmacies.

WHO.int, "Medicines Reimbursement Policies in Europe" (2018), 200pp

An increasing number of countries in the WHO European Region have concluded managed entry agreement (MEAs). These are contractual arrangements between a pharmaceutical company and a public payer that enable reimbursement of a medicine, subject to specified conditions. A variety of different types of MEAs exist, which can be classified, in principle, as either finance-based (such as simple discounts or price-volume agreements) or performance-based (linked to health outcomes); the former are applied more frequently. Common indications covered by an MEA are oncology, rheumatology, hepatitis C and diabetes. In general, MEAs tend to be confidential - at least those aspects relating to the prices and discount arrangements.
Federal and states' HHS agencies underwrite expense of CMS price schedules for Medicare and Medicaid beneficiares enrolled public insurance plans, administered by commercial insurers licensed by the states.
archived Tue Jan 30th, 2018
by Cat on Sun Dec 5th, 2021 at 06:57:46 PM EST
[ Parent ]
by Cat on Sun Dec 5th, 2021 at 07:11:30 PM EST
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The symptom that tells you you've caught omicron
"Many of those infected have reported having a scratchy throat as opposed to a sore throat."
by Cat on Wed Dec 15th, 2021 at 06:01:31 PM EST
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South Korean Dictator Dies, Western Media Resurrects a Myth
General Chun Doo Hwan was the corrupt military dictator that ruled Korea from 1979-1988, before handing off the presidency to his co-conspirator General Roh Tae Woo.  Chun took power in a coup in 1979, and during his presidency he perpetrated the largest massacre of Korean civilians since the Korean war. He died on November 23rd, in pampered, sybaritic luxury, impenitent and arrogant to the very last breath. ...
by Cat on Sat Dec 4th, 2021 at 01:43:41 AM EST
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Means, motive, and opportunity wrought by technology translated from 3000-year-old cuneiform chronicles.
by Cat on Sun Dec 5th, 2021 at 06:06:02 PM EST
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Occam's reciprocating saw
"'It's a little fascinating with detector finds that you can imagine quite a lot', Prentz said."
by Cat on Mon Dec 6th, 2021 at 07:47:58 PM EST
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We are only at the start of a change in military technology putting the introduction of indirect fire artillery, the machine gun, and barbed wire - aka 'The First World War'

The Air and Missile War in Nagorno-Karabakh: Lessons for the Future of Strike and Defense

As numerous recent reports have argued, these [drones] were game-changing. Azerbaijani drones provided significant advantages in ISR as well as long-range strike capabilities. They enabled Azerbaijani forces to find, fix, track, and kill targets with precise strikes far beyond the front lines. UAVs were operationally integrated with fires from manned aircraft and land-based artillery but also frequently used their own ordinance to destroy various high-value military assets. Open-source reporting suggests that drones contributed to disabling a huge number of Armenian tanks, fighting vehicles, artillery units, and air defenses. Their penetration of Nagorno-Karabakh's deep rear also weakened Armenian supply lines and logistics, facilitating later Azerbaijani success in battle.

The Armenian military was the standard Cold War mix of tanks and armored infantry backed by artillery.  Azerbaijani drones ripped it to hell and gone.

But the Military Industrial Complex marches on:

Yet while drones played a large role in this conflict, their capabilities ought not be exaggerated. These platforms are very vulnerable to air defenses that are designed to counter them--defenses Armenia did not have in adequate numbers.

And elan and Will to Combat can overcome machine gun fire.


She believed in nothing; only her skepticism kept her from being an atheist. -- Jean-Paul Sartre

by ATinNM on Sat Dec 11th, 2021 at 04:09:01 PM EST
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The conflict also provides yet another reminder about the importance of passive defense. We see this time and time again with both sides operating out in the open, static or moving slowly; poorly camouflaged; and clumped in tight, massed formations.
Pretty much describes a carrier group, I wonder when the various navies will notice.
by asdf on Sat Dec 11th, 2021 at 05:42:07 PM EST
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That's the $64,000 question.  My guess?  They'll notice and come-up with some BS about why it doesn't matter.

She believed in nothing; only her skepticism kept her from being an atheist. -- Jean-Paul Sartre
by ATinNM on Mon Dec 13th, 2021 at 09:00:22 PM EST
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Christianity continues to decline among US adults
according to a Pew Research Center survey released Tuesday.

Currently, self-identified Christians of all types make up about 63% of the population. This includes Protestants, Catholics, members of the Church of Jesus Christ of Latter-day Saints and Orthodox Christians. That number is down 12 points from 75% in 2011, a continuation of a downward spiral in the 21st century.

According to the study, about three-in-10 adults (29%) identify as religious "nones," people who describe themselves as atheists, agnostics or "nothing in particular" when asked about their religious identity
The decline in Protestantism is equal between evangelicals - believers who describe themselves as born again - and non-evangelical, with both sects seeing a 6-point decline. In contrast, Catholics have held steady after suffering a downward trend between 2007 and 2014. Gorski believes immigration is holding that number firm.

Report: Socialism attacks hurt Dems with Latinx voters, 2021
PEW | Faith Among Black [African and Caribbean immigrants], 2021

archived Tue Dec 8th, 2020, Fri Apr 5th, 2019, Fri Jul 20th, 2018, Thu Sep 6th, 2012

by Cat on Wed Dec 15th, 2021 at 05:27:21 PM EST
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NASA enlists theologians to assess how we would react to alien life
The program aims to answer questions that have baffled us since the begging of time such as what is life? What does it mean to be alive? Where do we draw the line between the human and the [a-word]? What are the possibilities for sentient life in other places?
Should NASA have given $1.1M to a theology institute?, 2016
In 2014, NASA gave $1.1 million to the Center of Theological Inquiry, an independent institution "rooted in Christian theology." The grant supports an initiative to study "the societal implications of astrobiology." Surprisingly, it took more than a year for anyone to complain.
Since 1998, part of the Astrobiology Program's role has been to address the societal implications of the field, mostly through a series of initiatives at the Library of Congress (although there's also an astrobiology-themed, NASA-funded student debate competition. Most recent topic: "Resolved: An overriding ethical obligation to protect and preserve extraterrestrial microbial life and ecosystems should be incorporated into international law.") The Library has a Chair in Astrobiology and hosts dialogues about astrobiology-and-society issues.
IMDB | Contact, 1997
by Cat on Sun Dec 26th, 2021 at 07:53:30 PM EST
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APsplainin US Catholic clergy shortage eased by recruits immigrants from Africa
Africa is the Catholic church's fastest-growing region. There, the seminaries are "fairly full," said the Rev. Thomas Gaunt, director of Georgetown University's Center for Applied Research in the Apostolate, which conducts research about the Catholic church.

It's different in the U.S. where the Catholic church faces significant hurdles in recruiting home-grown clergy following decades of declining church attendance and the damaging effects of widespread clergy sex abuse scandals.
Abanulo oversees two parishes in rural Alabama. His typical Sunday starts with an English-language Mass at Holy Family Catholic Church in Lanett, about 125 miles (200 kilometers) from Birmingham along the Alabama-Georgia state line. After that, he is driven an hour north to Wedowee, where he celebrates one Mass in English, another in Spanish.

praise be John Paul II
"He just breaks out in song and a lot of his lectures, he ties in his boyhood, and I just love hearing those stories," said Amber Moosman, a first-grade teacher who has been a parishioner at Holy Family since 1988.
Abanulo was ordained in Nigeria in 1990 and came to the U.S. in 2003 after a stint in Chad. His first U.S. role was as an associate pastor in the diocese of Oakland, California, where his ministry focused on the fast-growing Nigerian Catholic community. Since then, he has been a hospital chaplain and pastor in Nashville, Tennessee, and a chaplain at the University of Alabama.
When Maria Sheri Rukwishuro was told she was being sent from the Sisters of the Infant Jesus order in Zimbabwe to West Virginia to work as a missionary nun, she asked her mother superior, "Where is West Virginia?" She was scared, worrying about the unknowns.

"What kind of people am I going to? I'm just a Black nun coming to a white country," Rukwishuro told The Associated Press from Clarksburg, West Virginia, where she has been teaching religious education to public and Catholic school students since arriving in 2004.

Mitch O'bama School of diplomacy
Abanulo, who moved to Alabama in 2020, admits he was initially apprehensive about his latest posting, which meant exchanging a comfortable role as university chaplain for two rural parishes.

"People were telling me 'Father, don't go there. The people there are rednecks,'" he said. But after a year, and a warm reception, he says he now tells his friends, "There are no rednecks here. [There are no bluenecks.] All I see are Jesus necks."

by Cat on Mon Dec 27th, 2021 at 08:55:44 PM EST
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Today is the semi-annual celebration of the explanation of the difference between sidereal and solar time. Almost missed it!
by asdf on Wed Dec 22nd, 2021 at 12:21:04 AM EST
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