LA County Sheriff's Department Could Lose 4,000 Employees Over COVID-19 Vaccine Mandate

 by Katabella Roberts via The Epoch Times,

The Los Angeles County Sheriff’s Department is set to lose 4,000 employees who have not been vaccinated against the CCP (Chinese Communist Party) virus, which causes COVID-19.

The LA County Board of Supervisors is set to vote on the potential termination of 18,000 employees who have not complied with the COVID-19 vaccination requirements on Tuesday, the Los Angeles County Sheriff’s Department posted on Twitter Monday.

Of those 18,000 non-compliant employees, 4,000 belong to the Sheriff’s Department.

“These are the same law enforcement professionals, fire professionals, medical & health care professionals, mental health professionals, and others who we called HERO’s just a short time ago,” the department said. “Call the Board meeting tomorrow to share your public safety concerns and stop this social experimentation!”

The Board of Supervisors began establishing a policy requiring all LA County employees to submit proof of full vaccination against COVID-19 in August 2021.

Officials said employees needed to be vaccinated in an effort to “combat the elevated risk presented by the highly transmissible Delta variant and to prepare for the County’s imminent reopening of its buildings to the public.”

A COVID-19 vaccination policy was then implemented in October and requires that all LA County employees be fully vaccinated and submit proof of vaccination unless they have been granted a medical or religious exemption.

As of Feb. 1, 2022, 81.5 percent (82,298) of LA County’s approximately 100,000 employees are fully vaccinated, Los Angeles County Supervisor Sheila Kuehl said.

More than 90 percent of those vaccinated are employed by approximately a dozen LA County departments, while less than 60 percent of the employees in the Sheriff’s Department are fully vaccinated, Kuehl said.

“Unsurprisingly, approximately 74 percent of the more than 5,000 COVID-19-related workers’ compensation claims filed by County employees as of Jan. 29, 2022, have been filed by employees in the Sheriff’s Department,” the supervisor said.

The LA County Board of Supervisors says that this data illustrate the “vaccinations’ vital role in limiting the spread of COVID-19” and the “urgent need to increase vaccination rates across the entire County workforce.”

They have agreed to “discipline the employees of any County department for noncompliance” with the COVID-19 vaccine mandate and will be suspending or terminating such employees.

The Association for Los Angeles Deputy Sheriffs in December sued the Board of Supervisors, claiming that it does not have the legal authority to suspend or fire LA County sheriff’s deputies for noncompliance with the county’s mandatory vaccination order.

But the board maintains it has the legal authority to do so.

The Epoch Times has contacted the LA County Board of Supervisors for comment.

Los Angeles County Sheriff Alex Villanueva has been a vocal critic of the county’s vaccine mandate and repeatedly said he will not force his employees to get vaccinated, while calling the issue of COVID-19 vaccines “politicized.”

In October, Villanueva said that the termination of so many Sheriff’s Department employees could have dire consequences to public safety as the department was already struggling with “barebones” staffing issues due to “defund the police” efforts.

Prior to that, the sheriff also said that forcing vaccinated individuals and those who have already contracted COVID-19 to wear masks indoors is “not backed by science and contradicts the U.S. Centers for Disease Control and Prevention (CDC) guidelines.”

https://www.zerohedge.com/political/la-county-sheriffs-department-could-lose-4000-employees-over-covid-19-vaccine-mandate

Biden faces possible trucker threat

 President Biden is facing the possibility of truck driver protests mirroring those in Canada over vaccine mandates that would come as the administration works to combat supply chain disruptions, vaccinate more Americans and strengthen the U.S. economy. 

The Department of Homeland Security (DHS) on Wednesday warned police partners of protests similar to those in Canada that it said could even disrupt the Super Bowl or the State of the Union address.

DHS “has received reports of truck drivers potentially planning to block roads in major metropolitan cities in the United States in protest of, among other things, vaccine mandates. The convoy will potentially begin in California early as mid-February, potentially impacting the Super Bowl scheduled for 13 February and the State of the Union address scheduled for 1 March,” DHS wrote in a memo shared with police partners.

Protests in Canada have created a huge political problem for Prime Minister Justin Trudeau and could become an issue for Biden soon while plans for a similar protest in Washington, D.C., next month are being made on social media. 

For the last two weeks, protests in Ottawa have shut down traffic and aggravated citizens of Canada’s capital city as truckers honk in anger over requirements that truck drivers must be fully vaccinated to be permitted entry into Canada, a requirement the U.S. government has also implemented. 

The protests have come to be seen as a reflection of fatigue with pandemic restrictions that exists around the world and is a threat to existing governments. Pandemic fatigue has been seen as a factor in Biden’s low approval ratings and the dismal outlook for Democrats in this year’s midterms.  

It’s unclear how serious plans are for a similar protest in the U.S., though groups have announced plans on social media as the Canadian protests draw more attention. 

“The People’s Convoy” group on Facebook is already plotting a “March for Freedom Convoy to DC 2022.” 

Facebook posts from organizers state that truckers will arrive in Coachella Valley in Indio, Calif., on March 4 for a rally “to defeat the unconstitutional mandates.” 

The convoy will then “roll out of California,” with details to come on forthcoming rallies.  

The protests in Canada have been linked to far-right extremism, an issue for Biden and law enforcement following the Jan. 6, 2021, attack on the U.S. Capitol.  

In Ottawa, some protesters have been seen carrying signs and flags with swastikas on them, and one reportedly danced on the Tomb of the Unknown Soldier in the city. 

Trudeau has called the protesters a “fringe majority” and associated them with the rise of misinformation online and conspiracy theories. 

In the U.S., the original group organizing demonstrations in Washington was removed from Facebook after it hit more than 100,000 members because it violated the platform’s policies about QAnon.  

The Grid reported on Tuesday that a GoFundMe page for the Canadian truckers, which raised more than $8 million before it was shuttered, could have been influenced by right-wing donors in the U.S. White House press secretary Jen Psaki this week didn’t have a comment about this reporting. 

Biden announced in October a mandate that requires essential foreign travelers who cross into the U.S. by land borders to be fully vaccinated. The mandate includes truck drivers and went into effect in January soon after Canada’s mandate went into effect. 

The White House has expressed worries about how protests might affect the free flow of goods and people across the U.S.-Canada border. Truckers this week blocked the Ambassador Bridge in Ontario, which 25 percent of trade between U.S. and Canada flows through. 

The White House is watching the situation at the bridge “very closely” and the president is focused on it, Psaki said on Wednesday. She noted that the blockage “poses a risk to the supply chain” and could disrupt automakers because parts can’t travel.  

While the protesters have been characterized as a fringe group in Canada, the vaccine mandate for truckers has received attention from Democrats and trade groups in the U.S.   

Democratic Sen. Jon Tester (Mont.) called on the Biden administration last month to halt its requirement for truck drivers entering the U.S. over concerns from farmers and ranchers that the requirement will make it more difficult for them to get supplies such as fertilizers. 

“[Tester] supports the right to peacefully protest, but shutting down the border does nothing to support Montana’s truckers, producers, or our economy, which is why these folks should stop blocking traffic and let travel resume,” a Tester spokesperson told The Hill on Wednesday. 

The Owner-Operator Independent Drivers Association, a trade group made up of more than 150,000 North American truckers, wrote to Biden on Monday requesting that professional truck drivers be exempted from the vaccination requirements for non-U.S. essential workers seeking to enter the U.S. via land ports of entry. 

A spokeswoman said the trader group supports its members' choice to legally and peacefully protest but would not officially participate as a trade association. 

“We would like for leaders in D.C. to listen to, and take action on, the concerns of truck drivers that have been expressed to them for years such as the truck parking shortage, detention time, retention of drivers and government overreach. If the U.S. does see the same situation happening here as in Canada, it is a result of Congress and current and past administrations failing truckers for too long,” said Norita Taylor, spokeswoman for the association. 

The American Trucking Associations, a trade group for the U.S. trucking industry, did not respond to a request for comment on whether it supports a possible U.S. protest. 

Samir Kapadia, the head of the trade practice at the Vogel Group, argued that if truckers in the U.S. mirror the protests seen in Canada, Biden will be criticized for any impact it has on the supply chain.

“The unique element of this scenario is how a social protest around vaccine mandates crippled the supply chain—it wasn’t systemic. We’ve been facing supply chain constraints for almost two years, but this is the first time a social issue prompted such a significant collapse. Should this persist or U.S. truckers mimic the Canadian protests, the president will face greater scrutiny on a national level,” Kapadia said. 

https://thehill.com/homenews/administration/593580-biden-faces-possible-trucker-threat

Why NYC isn’t recording most at-home COVID tests

 You can’t catch what you don’t see. New Yorkers will remember how this saying defined the early weeks of the city’s COVID-19 pandemic, as the boroughs and the nation struggled to develop a test for the virus. Delayed or absent detection meant people showed up to hospitals with their symptoms too far advanced, raging and beyond recuperation.

Laboratory testing gradually built itself up and evolved to cope with case surges, but it is now entering a new evolutionary phase with omicron. The highly transmissible variant has propelled the use of at-home COVID-19 tests, especially when lines for in-person tests were hours long or difficult to book around the holiday season. The U.S. Postal Service will now deliver kits to your door — if you can bypass the kinks in its ordering website. Supplies have improved online and at retail stores after deep shortages. And New York City schools are handing out millions of kits to exposed students and staff as well as symptomatic people who don’t want to stand in lines during this frigid winter.

But city officials are not tracking the results of the at-home tests, unlike other counties in New York and other major cities such as Washington D.C. and Austin, Texas. As Gothamist reported last week, this rise of the home kit is contributing to the sharpest drop in conventional testing that New York City has experienced during the pandemic.

As community transmission cools off, testing numbers tend to fall, but never quite as fast as current data show. Some health experts worry this decline is part of a larger national pattern with coronavirus testing, one that could make it harder to spot new variants.

“The biggest worry that I have is that we're going to miss changes in the epidemiology of this virus because we're losing that surveillance,” Dr. Jennifer Nuzzo, a senior scholar at the Johns Hopkins Center for Health Security and the lead epidemiologist for the Johns Hopkins COVID-19 Testing Insights Initiative, told Gothamist.

A line stretches over two avenues long, as New Yorkers wait to receive free home test kits in Harlemn, December 24th, 2021.

DEBRA L ROTHENBERG/SHUTTERSTOCK

City health department and Test and Trace corps officials said they don't include at-home test results because it could muddy the city's official record keeping of COVID cases. They said at-home results couldn't be independently verified, and they believe that enough people are still heading to clinics and labs. (They’ve also recently launched a choose-your-own-adventure guide for people who are exposed and at-home testers.)

“Our current level of surveillance data accurately reflect transmission trends around the city,” Michael Lanza, a spokesperson for the city’s Department of Health and Mental Hygiene, said in an emailed statement. “The City is doing a high level of PCR and antigen testing, which allows us to gain an accurate understanding of the trajectory of the pandemic.”

Yet this winter, other jurisdictions such as Tompkins County in upstate New York potentially caught up to an extra 25% of cases by allowing their residents to report at-home test results. Translate these patterns to the five boroughs, and New York City could have spotted an additional 250,000 infections on top of the 1 million cases that have been recorded since it began handing out free home tests on December 16th. The same week, omicron became the dominant variant in the city.

We asked city officials to further explain their stance against tracking at-home results.

People won’t report when they’re negative — or would they?

The most common concern cited by city health officials has centered upon the reliability and quality of at-home testing.

Their statements expressed worries that people wouldn’t report the results because there is no requirement to do so. That could throw off the accounting of the city’s positivity rate — or what portion of tests come back with a positive result. But by definition, officials can only calculate this rate if they know how many people are taking tests overall and how many are negative, which is easy to do via clinics and labs.

But people in places recording at-home tests, such as Washington D.C., have actually been reporting their negative results, too, which health officials in the nation’s capital described as a welcome surprise.

“We want individuals to report that data to us, just so we have an understanding of who is testing positive and who is testing negative,” said Patrick Ashley, the senior deputy director for the health emergency preparedness and response administration at DC Health. The District has registered about 9,000 positives and 60,000 negatives since it began allowing people to self-report home results on October 15th.

DC Health launched this tracking program after it noticed a desire among the community to adopt rapid antigen testing. The swabs became the cornerstone to tracking cases in schools, where students and parents must upload documents attesting that they’re not fibbing about the result. But the general public can report their positive or negative results without sharing photos of the test, though they have to submit their name and contact information.

Because it is an honor system, DC Health keeps a separate spreadsheet with self-reported results, and these numbers don’t factor into its official case counting or positivity records. Ashley said he and his colleagues are fully aware of the data quality issues that come with this self-reporting.

“Sometimes, we'll see people that report multiple positives,” he said. “They tested positive, and a couple of days later, they may take the test again and still report that they're positive.”

But data quality isn’t the goal here. Ashley said self-reporting offers better visibility into how the coronavirus is afflicting the community. The District committed heavily to the process, buying more than 6 million rapid antigen tests in late December to hand out for free — or about eight kits for every resident.

By contrast, New York City has issued 8.1 million kits, of which 6.6. million went to schools. That’s fewer than one kit per resident.

“We've always really wanted individuals to know their status, and we haven't shied away from making that data available,” Ashley said.

Are outbreaks missed without at-home test results?

At a recent lecture for the National Academy of Medicine, Nuzzo from Johns Hopkins predicted omicron cases would decline quickly in the U.S. — but not as fast as what has been seen in other countries.

That’s because multiple studies have shown that the coronavirus tends to spread in social clusters, rather than steadily moving through a population. So as businesses reopen and states like New Jersey drop mask mandates in schools, the virus may find new opportunities to jump between pockets of people — extending the duration of the current wave.

Thanks to vaccination and the widespread abundance of immunity, most people will be spared severe consequences. But a slow burn of cases, hospitalizations and deaths could simmer and thrive in at-risk communities, causing tens of thousands of deaths.

Read More: Why Coney Island and Brighton Beach were hit so hard by omicron

While Nuzzo supports at-home tests, she said now is a precarious time to develop blindspots in official case reporting.

“We want to understand who [these new cases] are and if the cases are occurring in a different demographic group than what we would typically expect,” she said.

Such reasoning explains why Tompkins County opted to start recording at-home test results in late December.

“It's just something that we're doing to be able to have an idea of what's going on with home tests and our community,” said Frank Kruppa, Tompkins County public health director and mental health commissioner. “Most importantly, when someone reports a positive test result to us, they get information back on what they should do for their own health around isolation.”

The county has recorded 1,550 positive self-tests since December 24th, while conventional testing documented 5,767 cases. Stated differently, the at-home program detected up to an extra 26% of cases.

New York City officials said it had kept track of some home test results, namely 30,000 positives from the 6.6 million kits that it had handed out to public school students and school staff since January 3rd.

The city admitted that these 30,000 cases had not been included in its COVID counts for schools nor in how it calculates in-school positivity. In fact, officials only know about the at-home outcomes because a positive or negative result dictates when a child or staff can return in person. And similar to Tompkins County, these at-home positives could have added an extra 21% of cases to the tally for New York City schools, which has accumulated 142,000 infections since classes resumed on January 3rd.

But if the city is open to registering some results, why not open it up to the general public?

Omicron changed the value of regular testing

Or maybe it doesn’t matter? The decline in testing numbers could be a result of “COVID fatigue,” or the general sense of Americans “learning to live with the virus.”

Though laboratory numbers are falling, New York City’s clinics are still averaging about 71,000 PCR tests and 15,000 antigen tests per day — bringing viral surveillance back to its pre-omicron levels. The city said this level of testing is still adequate and that it is also considering other metrics.

“In addition to cases, we also focus on other measures beyond case rates, like hospitalizations, deaths, and other measures of disease severity, in order to gauge the overall situation,” said Lanza from the city health department.

Yet if the official testing continues to slide, keeping track of the coronavirus could end up mimicking how officials track flu every year.

“We don't do this much testing for flu,” Nuzzo said. “We don't even count nationally adult flu cases.”

Instead, the Centers for Disease Control and Prevention focuses on flu hospitalizations from a fairly small selection of places — more than 70 counties across 14 states places — and then extrapolate a quick estimate of how many flu cases and deaths likely happened. The U.S. and other countries have been using this process to faithfully measure flu burden for a few decades.

 As we're entering this new phase in the pandemic, we are going to have to possibly rethink how we conduct surveillance. 

 Jennifer Nuzzo, Johns Hopkins Center for Health Security

Repeating this habit for COVID-19 would essentially mean the country has collectively given up on trying to monitor the disease in real-time, which would give the coronavirus more reign to spread.

“Partly that is because we don't try to interrupt individual chains of transmission of flu like we are trying to do for COVID,” Nuzzo said. That’s less of an issue if a high abundance of people keep taking boosters or updated versions of the vaccine to thwart future variants.

The American experience with seasonal influenza teaches us that only about 50% of adults and about 60% of children take their flu vaccines annually. As a partial consequence, flu has averaged about 35,000 fatalities per year since 2010.

COVID-19’s fatality rate is still about five to 10 times higher than the flu’s. An endemic of this coronavirus will not be harmless.

“As we're entering this new phase in the pandemic, we are going to have to possibly rethink how we conduct surveillance,” Nuzzo said.

https://gothamist.com/news/why-nyc-isnt-recording-most-at-home-covid-tests-and-what-officials-could-be-missing

Anti-vax, pro-ivermectin measures advance in Kansas Senate

 Fellow Republican conservatives rallied Tuesday behind a Kansas physician-legislator who's under investigation by the state medical board, advancing his measures to protect doctors pursuing potentially dangerous treatments for COVID-19 and to weaken childhood vaccination requirements. 

As a Senate health committee member, state Sen. Mark Steffen successfully pushed a proposal that would require pharmacists to fill prescriptions of the anti-worm medication ivermectin, the anti-malaria drug hydroxychloroquine and other drugs for off-label uses as COVID-19 treatments.

 Steffen is among the Republican-controlled Legislature's biggest vaccine skeptics and a critic of how the federal government and Democratic Gov. Laura Kelly have handled the coronavirus pandemic. Steffen also successfully persuaded the Republican-dominated committee to add a proposal to make it easy for parents to claim religious exemptions from vaccine requirements at schools and day cares. Kansas requires children to be vaccinated against more than a dozen diseases, including polio and measles. 

The bill goes next to the Senate. The health committee's actions showed that fringe anti-vaccine activists have gained significant influence with GOP lawmakers.

 “This is a very dangerous bill,” said Sen. Cindy Holscher, a Kansas City-area Democrat. “It was dangerous before. It's even more dangerous now.”

 Steffen disclosed during a committee hearing last month that the State Board of Healing Arts has been investigating him since 2020 over his public statements about COVID-19. He has said the investigation is not about his care for patients as an anesthesiologist and pain-management specialist from Hutchinson, a city of 40,000 residents about 50 miles (80 kilometers) northwest of Wichita. 

The board has so far opened investigations of 50 people related to COVID-19, 32 of which remain open, said Susan Gile, its acting executive director. She said investigations are opened in response to complaints. Some conservatives want to block the board's investigations of doctors accused of spreading misinformation about COVID-19. Steffen participated in the Senate committee's debate Tuesday despite his personal stake in the legislation. Anti-vaccine activists packed the small hearing room and applauded loudly after its vote. Supporters of the measure argued that they are protecting patients' and parents' rights. 

Steffen and Thompson falsely asserted that COVID-19 vaccines and childhood immunizations are unsafe. Under the bill, a school or day care could not investigate the beliefs of a parent who claimed religious exemptions from any vaccine mandate. That mirrors a law enacted in November for workers seeking to avoid federal COVID-19 vaccine mandates. Miami’s Top 25 best-paid employees See the who earns the most in the city of Miami government READ MORE 

“All we're doing is reaffirming the people's religious rights,” said Sen. Mike Thompson, a conservative Kansas City-area Republican. Mark Tallman, a lobbyist for the Kansas Association of School Boards, said public school districts generally don't investigate people's beliefs and he's not aware of a large number of religious exemptions being denied.

 But Marcus Baltzell, a lobbyist for Kansas' largest teachers union, said the measure would make schools less safe. As for ivermectin, Steffen has said he's tried to write prescriptions but cannot get pharmacists to fill them. Kansas law allows doctors to write prescriptions for off-label uses, but the state medical board still requires doctors to do “what a reasonable physician would have done under the same or similar circumstance.”

 Pharmacists can refuse to fill any prescription based on their professional judgment. Under the bill Steffen favors, pharmacists could face disciplinary action or lawsuits for failing to fill off-label prescriptions of ivermectin to treat COVID-19.

 Dr. Steve Stites, chief medical officer at University of Kansas Health System, said the measure suggests that if a patient asks for something a doctor must give it to them. 

“That’s just wrong,” Stites said on a morning video briefing. “Your kid walks up and says, ‘Mom, Dad, I want a cookie. You have to give it to me.’ The kid doesn’t know if it’s good for him or not, right?”

 The Food and Drug Administration has approved ivermectin to treat infections of lice, roundworms and other tiny parasites in humans. The FDA has tried to debunk claims that animal-strength versions of the drug can help fight COVID-19, warning that large doses can cause nausea, vomiting, diarrhea, seizures, delirium and even death.

https://www.miamiherald.com/news/article258173728.html

Protective mutations in COVID-19

 One way in which the body combats COVID-19 is by mutating the coronavirus, making it less harmful. This built-in protective mechanism in cells has a clear connection with decreased viral load in the body, a study from the University of Gothenburg shows.

Mutations are often associated with the emergence of virus variants that are more contagious and pathogenic than their predecessors. However, the current study shows that virus mutations often work in the opposite direction.

Virology researchers at the University's Sahlgrenska Academy have mapped mutation patterns in the SARS-CoV-2 coronavirus. The results, published in the journal PNAS, indicate that the body's natural enzyme ADAR1 (adenosine deaminases acting on RNA) impairs reproduction of SARS-CoV-2.

ADAR1, found inside the cells' protective membrane, can replace the nucleotides, which are the building blocks in the RNA of the virus. Nevertheless, how ADAR1 affects the coronavirus causing COVID-19 it has been unclear to date.

Mutations that benefit us

"Our study shows that there is an inverse relationship between the viral load (the measurable amount of virus in the body) and the extent to which ADAR1 has mutated the virus. We also found that ADAR1-induced mutations are the most common type of SARS-CoV-2 mutation," says Johan Ringlander, Ph.D. student in virology at Sahlgrenska Academy and the study's first author.

In particular, the scientists noted that individual patients are often infected with more than one variant of the virus. When mutations in relatively rare virus variants were investigated, it was found that a common mutation in which one nucleotide, guanosine (G), replaces adenosine (A) significantly worsened the reproductive ability of SARS-CoV-2. These mutations are caused by the enzyme ADAR1.

Analyses of more than 200,000 virus strains from patients who were ill with COVID-19 showed that mutations caused by ADAR1 were mainly circulating in summer 2020, when transmission and mortality rates were low in Europe. When transmission and mortality rates were higher, virus variants with ADAR1-induced mutations were uncommon, probably because they were outcompeted by more infectious virus strains.

Helps to clear away

"Our results clarify how the body's cells can generate mutated virus variants. Mutations can make a virus more infectious, but in most cases the mutations we've studied make the virus weaker; instead of spreading, it's removed from infected cells. These findings suggest that ADAR1 serves as a protective mechanism used by the body to limit viral infections," Ringlander says.

Michael Kann, Professor of Clinical Virology at Sahlgrenska Academy and chief physician at Sahlgrenska University Hospital, is the main author of the article.

"When SARS-CoV-2 multiplies in the airways, inflammation occurs. Its effects include activation of ADAR1, which in turn reduces the likelihood of the virus infecting other cells. We're currently investigating whether this protective mechanism may be important in other viral infections as well," Kann says.

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Explore further

When your body doesn't recognize your own left-handed RNA

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More information: Johan Ringlander et al, Impact of ADAR-induced editing of minor viral RNA populations on replication and transmission of SARS-CoV-2, Proceedings of the National Academy of Sciences (2022). DOI: 10.1073/pnas.2112663119

https://medicalxpress.com/news/2022-02-mutations-covid-.html

CMS's Devastating Blow to American Seniors

 America's biotech companies have spent a staggering $42.5 billion developing treatments for Alzheimer's since 1995.

But they have little to show for their efforts. Despite conducting nearly 1,100 clinical trials enrolling 184,000 patients over that period, almost all those experimental drugs failed. The FDA approved just six treatments, a success rate of just 0.5%.

Thankfully, those long odds haven't forced biotech companies to abandon the field -- at least not yet. Firms have continued to invest money into Alzheimer's research, even though these projects are statistically doomed to fail, because they know that if an experimental drug does prove effective, the returns -- both for investors and society as a whole -- would be enormous.

Worryingly, a recent proposal by the federal agency that oversees Medicare could fundamentally alter that risk calculus -- and cause investment in Alzheimer's research to plummet.

Earlier this month, the federal Centers for Medicare and Medicaid Services (CMS) issued a draft "national coverage determination" that, if finalized, would severely restrict how Medicare covers an entire class of promising Alzheimer's treatments, including Aduhelm, an antibody drug targeting a protein called amyloid in the brain. The FDA granted accelerated approval to the new drug in June 2021, based on clinical trial data showing that it reduces amyloid plaques in Alzheimer's patients.

The FDA has taken similar steps before. In fact, the nation's top scientific and regulatory body created its accelerated approval pathway all the way back in 1992 to address "unmet needs for serious or life-threatening diseases." This pathway allows regulators to approve medications whose clinical benefit has yet to be demonstrated directly in patients, so long as those drugs meet so-called surrogate endpoints that are predictive of clinical benefits.

CMS oversees insurance coverage for over 100 million Americans, including millions of Alzheimer's patients. And by law, Medicare Part B must cover medicines that are "reasonable and necessary" to treat a patient, and Part B cannot decline to cover an FDA-approved drug because of its cost.

Yet CMS is proposing to deny coverage for Aduhelm and any future treatments targeting amyloid plaque, outside of a small subset of patients participating in clinical trials, because "health outcomes" have not been ascertained.

CMS's claim is technically accurate -- Aduhelm hasn't yet been proven to stall the progression of Alzheimer's.

But the claim is also tautological. The purpose of the accelerated approval process is to grant patients earlier access to medications that, based on initial data, are reasonably likely to yield positive health benefits.

CMS's second-guessing is a shocking overreach by an administrative agency primarily staffed with bureaucrats. It seeks to elbow CMS into a fundamentally scientific, medical, and regulatory question that falls squarely within the purview of FDA -- and in so doing, to overrule FDA's own approval processes.

Particularly audacious is that the proposed CMS determination covers not just Aduhelm but the entire class of Alzheimer's disease therapies that target amyloid protein. This sweeping decree effectively imposes a moratorium on scientific research and clinical trials targeting amyloid, a protein which is indisputably the core biological hallmark of Alzheimer's disease. There is no justification for anyone at CMS to be engaging in an appraisal of such far-reaching magnitude.

The proposed CMS coverage decision is also noteworthy for its absence of basic scientific rigor. At no point does CMS state which specific outcomes would constitute a "clinically meaningful difference in decline in cognition and function." This provides drug researchers -- and the FDA itself, which CMS is presuming to instruct -- with no guidance on how to proceed with the development of Alzheimer's therapies to CMS's satisfaction.

That will have a chilling effect on Alzheimer's research. If biotech companies suddenly have to worry not just about inventing effective treatments -- which was already extraordinarily difficult -- but also whether CMS officials will cover drugs that the FDA has approved, many firms will decide the risk is simply too large to bear.

Biotech companies cannot operate or raise funding in an erratic regulatory environment. The prospect of CMS transforming itself into an alternative FDA would signal the beginning of the end for our current golden age of medical innovation.

Gaurav Gupta, a physician, is the founder of the biotechnology investment firm Ascendant BioCapital.

https://www.realclearhealth.com/articles/2022/02/09/cmss_devastating_blow_to_american_seniors_111311.html

Transcript : Mirati Therapeutics, Inc. Presents at 4th Annual Guggenheim Oncology Day, Feb-09-2022 12:30 PM

 https://www.marketscreener.com/quote/stock/MIRATI-THERAPEUTICS-INC-13643861/news/Transcript-Mirati-Therapeutics-Inc-Presents-at-4th-Annual-Guggenheim-Oncology-Day-Feb-09-2022-1-37831560/