Medicare premiums to jump in part due to pricey Alzheimer's drug

 Seniors on Medicare will have to pay more than $20 more per month extra in premiums next year, a large increase that officials in part attributed to possible coverage of a pricey and controversial new Alzheimer's drug. 

The Biden administration announced Friday that the monthly premium for Medicare Part B, which covers services like doctors office visits, will increase by $21.60, from $148.50 in 2021 to $170.10 in 2022. Officials said that is one of the largest increases in recent years. 

About half of that increase is due to contingency planning to make sure the program has enough money to pay for an expensive new Alzheimer's drug, if Medicare decides to cover it, an official at the Centers for Medicare and Medicaid Services said. 

That drug, called Aduhelm and made by the company Biogen, has drawn controversy both for its price, at $56,000 per year, and because the Food and Drug Administration approved it despite doubts from experts about its effectiveness. 

Administration officials emphasized Friday that most people on Medicare will also be getting a large cost of living increase in their Social Security payments next year, which they said would more than offset the rise in Medicare costs for many seniors. 

Still, Democrats said the news shows the need to get drug prices under control, pointing to provisions in President Biden's Build Back Better plan to lower drug costs. 

"Skyrocketing drug prices not only make it harder for seniors to afford the lifesaving drugs they need, but also drive up their health care premiums for doctor’s visits and outpatient care," House Energy and Commerce Chairman Frank Pallone Jr. (D-N.J.) said in response to the announcement.

"This double financial whammy simply cannot continue, and that’s why Congress must pass the bicameral Medicare prescription drug agreement that was included in the Build Back Better Act last week."

https://thehill.com/policy/healthcare/581379-medicare-premiums-to-jump-in-part-due-to-pricey-alzheimers-drug

Tennessee governor signs law restricting COVID-19 mandates

 Tennessee Gov. Bill Lee (R) on Friday signed into law legislation limiting the power that schools, agencies and businesses in the state have to enforce COVID-19 restrictions.

The law, which was passed through the state legislature in a special session last month, will take effect immediately and is likely to face legal challenges, The Tennessean reported.

The law restricts private businesses requiring proof of vaccination against COVID-19. In addition, it only allows schools and government entities if the there are at least 1,000 coronavirus cases for every 100,000 residents within a 14-day period. 

The news comes after several states have mounted challenges to President Biden's vaccine mandate, which requires businesses of 100 employees or more to mandate vaccines or frequent testing. 

A federal court of appeals issued a temporary stay on the mandate last weekend after a challenge from states including Texas, Louisiana, Mississippi, South Carolina and Utah. 

Lee said that he was concerned that the bill did not include a provision that allowed family members indefinite visitation with their loved ones in hospitals who are battling COVID-19, according to the outlet. He stated that he intended to meet with lawmakers earlier in the week over the concern.

However, health officials and medical workers have expressed opposition to a provision like this — they say that it would counteract mitigation methods. 

Lee noted that the rule was only to apply to end-of-life patients. 

Democrats and business groups in the state have come out against the bill in full force this week. A majority of Nashville's Metro Council members called on Mayor John Cooper (D) last week to consider all avenues, including legal methods, to "clarify the city's authority," given that the law would take away Nashville's authority to maintain its existing mask mandate, The Tennessean previously reported. 

The law follows Lee's legal battles over the last couple months over an executive order allowing parents to opt out of school mask mandates. 

https://thehill.com/homenews/state-watch/581390-tennessee-governor-signs-law-restricting-covid-19-mandates

Political pressure to vaccinate young children is unscientific and counterproductive

 The Centers for Disease Control and Prevention’s formal recommendation that children ages 5-11 receive the Pfizer-BioNTech vaccine has some parents feeling relief and others feeling anxious and suspicious. This recommendation was made based on the evidence for the vaccine; however, the ultimate decision of whether children actually receive the vaccine is, and should lie, with the parents. 

Many, including my wife and I, may choose to have their children vaccinated. As a parent, it is my responsibility to make that decision based on the facts, which show us many things but do not show us that children are at significant risk of falling seriously ill or dying from COVID. Parents should be allowed to contemplate the decision to vaccinate their children without political pressures that fail to adequately scrutinize the science, something that is becoming increasingly more difficult.

It first must be acknowledged that all illnesses are cause for concern, and all deaths, especially of children, are tragic and to be mourned. To the detriment of sound medical analysis, the campaign for mandatory, total and unanimous vaccination has become a political football used by officials and elected politicians to demonstrate their competence and imbue themselves with an aura of compassion and sophistication. The approval to vaccinate children ages 5-11 has led some to call for mandatory COVID vaccinations for our kids.

Operation Warp Speed, an effort I was intimately involved in during my time as deputy secretary of the Department of Health and Human Services, produced life-saving vaccines that altered the course of the pandemic. This operation yielded COVID vaccination shots in record time to protect vulnerable populations, reopen the economy, and restore our lives to normalcy. 

When we are deciding what to do about vaccination as parents and guardians, we must keep in mind all of the risks, from COVID and all other factors. The Centers for Disease Control and Prevention’s own data shows that children ages 5-11 are one of the age groups least at-risk from COVID. They represent the fourth-lowest number of cases and just 0.028 percent of deaths from COVID, the second-lowest share of any age group, just after the cohort of ages 16-17.

This is not to be interpreted that we should advocate against vaccinating children, yet the facts tell us that children are not statistically at risk from the disease. Using inflammatory language to imply that children are among the groups seriously at risk is innumerate and false. In fact, the inaccurate assessment that COVID threatens the lives of children may lead to a genuinely dangerous devaluation of inoculation against other diseases within the childhood vaccine schedule. As pediatric and primary care offices closed down during the pandemic, up-to-date status for all recommended vaccines declined from approximately two-thirds of children to fewer than half. These vaccines include inoculations against measles, mumps and rubella (MMR) and diphtheria, pertussis, and tetanus (DTP) — both of which protect children from conditions that pose greater health risks to children than COVID-19. 

Coercing populations who are not at risk of serious illness to take the vaccine, while sacrificing progress on other, more dangerous illnesses would be a mistake. The vaccine offers some families assurances that children can spend time with their grandparents over the holidays, go to class without wearing masks or socially distancing and take part in social activities among friends whose underlying health conditions might make them more susceptible to the illness. Or as with my family, we decided that the slight risk of my children contracting COVID outweighed the even slighter risk of the vaccine. 

During my time serving as acting deputy secretary under the George W. Bush administration, I outlined what the department recommended as the duties of the federal government during a pandemic. None of these responsibilities were designed to eradicate any disease, but to reduce the peak of a pandemic to a level of cases that could be cared for. Once a pandemic spreads to the world, you cannot eradicate it; you cannot return to a state of zero, but you can mitigate the effects, develop cures and improve lives.

Waging an all-out “COVID Zero” campaign and demanding mandatory vaccination of 28 million children fails to recognize two things: 

. Emphasizing vaccination out of a mistaken goal for society to be “COVID Zero,” meaning that there could be no case of COVID in the United States (or the world), is an unattainable benchmark. The only infectious disease we have fully eradicated so far is smallpox, and it has very different characteristics. The “COVID Zero” approach forces the perfect to become the enemy of the good. In reality, it is a waste of our time, resources and efforts on an extremely unlikely campaign to prevent even a single transmission; and 

• This effort would require that we pull resources from research and development programs on vaccines for other illnesses that pose greater threats to children, including respiratory syncytial virus (RSV). RSV hospitalizes 58,000 children under age 5 in the U.S. annually. Compare that to 1,647 hospitalizations with COVID for the same age group during the entirety of the pandemic; the data simply does not support abandoning the effort to protect children from these fatal diseases for a crusade to vaccinate all children against COVID.

Approving the COVID vaccines for voluntary use is a remarkable accomplishment. However, with this new milestone of FDA’s approval of vaccines for children ages 5-11, it is paramount that we respect the parents’ right to evaluate the evidence for themselves in a calm and reasonable way.

No family should be badgered into making a decision to vaccinate — or not vaccinate — their children, and we must eliminate the malicious rhetoric from both sides of the aisle around the conversation. It detracts from the overall goal of overcoming this pandemic and instead produces more skepticism and ill will in our society.  

Eric D. Hargan was most recently Deputy Secretary of the Department of Health and Human Services after having served as acting secretary. He also served at HHS under George W. Bush. In addition to serving on the Board of Operation Warp Speed, Eric oversaw the set-up and launch of the Provider Relief Fund and other parts of the U.S. pandemic response.  Since leaving his post at HHS, Hargan has launched The Hargan Group and joined the boards of University Hospitals in Cleveland; Alio Medical; Tomorrow Health; and HealthTrackRx. Follow him on Twitter at @EricDHargan.

https://thehill.com/opinion/healthcare/581260-political-pressure-to-vaccinate-young-children-is-unscientific-and

Testimony: Holmes Offered to Buy Out Investor Seeking 'Straight Answers'

 A Theranos investor from Texas asked so many probing questions about its technology and data that Elizabeth Holmes offered to buy out the man’s stake in the company for five times its value.

This week, Houston-based money manager Alan Eisenman testified in the ongoing Elizabeth Holmes fraud trial that he sought “straight answers” about the company’s work for several years. According to the Dallas Morning News, Eisenman, a financial planner, had a $1.2 million stake in the company. He is the latest witness to testify in the criminal trial that Holmes did not give straight answers about the company’s technology to investors or potential partners.

Earlier this month, immunology expert Constance Cullen testified that when she met with Holmes while a member of the Schering-Plough team, the Theranos CEO did not give straight answers. Cullen described Holmes as “cagey.” A former Pfizer scientist also testified that when he met with Holmes regarding a potential partnership between the companies, she provided him with “evasive non-informative answers” to his questions.

During his testimony this week, Eisenman said when he first invested in the start-up in 2006, Holmes made big promises about potential investors and expected capabilities of the blood-testing technology. Those big promises have been shown to be a pattern from Holmes as she sought cash flow from investors. Eisenman testified that Holmes hinted that Oracle Corp. co-founder Larry Ellison intended to invest $20 million into her company. She also said the company was eyeing strong revenue streams in the hundreds of millions of dollars and a potential initial public offering as early as 2008.

Those pie-in-the-sky promises she gave to Eisenman were similar to predictions she made to the wealthy Devos family when it intended to invest in Theranos. Three weeks ago, a representative for the family that co-founded Amway testified that when Holmes was wooing the family, they were provided revenue projections predicting a $230 million profit in 2015 on $990 million in revenue. Based on Holmes’ sales pitch, the Devos family invested $100 million into Theranos.

In the early days of Theranos, Eisenman said that Holmes was responsive to his questions, but as time went on, she became more and more annoyed with his probes that she offered to buy out his stake at five times its value.

“We don’t do quarterly calls with our other investors, many of whom invested much greater amounts than you did,” Holmes wrote to Eisenman in a 2010 email, according to the Dallas Morning News report. “We recognize you have been an investor for some time, and if we proceed with the transaction we are proposing we can provide you with a 5x return on your investment in Theranos.”

After that, Eisenman testified that he attempted to find out information from other stakeholders, but apparently, that upset Holmes even more. Even though he was disappointed about the lack of information coming from Holmes, Eisenman said he considered upping his investment into the company in 2013. That was, of course, warmly greeted by Theranos management.

However, just a few years later, when the Theranos house of cards began to crumble, Eisenman said he reached out to leadership again, particularly over the disturbing reports regarding the company’s partnership with Walgreens and questions over the failures of the blood-testing technology. Those questions were met with hostility from management and a notice that future emails sent by Eisenman would be addressed to the company’s legal team.

CNBC reported that after more than two months of testimony from investors and Theranos whistleblowers who testified about data manipulation, the prosecution is expected to rest in the ongoing fraud trial sometime next week. 

https://www.biospace.com/article/investor-questions-frustrated-elizabeth-holmes-so-much-she-offered-to-buy-him-out-testimony-reveals/

Moderna: Vaccine mRNA Sequence Was Selected Without NIH Input

 In a rebuttal to the National Institutes of Health’s claims on its COVID-19 patents, Moderna said Moderna scientists exclusively selected its RNA sequence. Also, the company said the sequence was selected with Moderna technology and without the input of NIH scientists.

On Thursday, Moderna issued a response to claims that the government should be listed as co-patent owners of the mRNA vaccine developed by the company. In its statement, Moderna said it recognizes the “substantial role” that scientists from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the NIH helmed by Dr. Anthony Fauci, has played in the development of the vaccine. Moderna said the contributions made by the NIH are highly valued. The company said it has included the NIAID scientists on some patent applications for research where they have made “inventive contributions.”

Moderna said it does not agree that NIAID scientists co-invented claims to the mRNA sequence of its COVID-19 vaccine. The company said when it selected the mRNA sequence, it was done so without the input of government scientists “who were not even aware of the mRNA sequence until after the patent application had already been filed.” Therefore, according to the company, only their scientists could be listed as inventors on those claims. Additionally, the company cited strict rules related to U.S. patent law regarding who could be listed as an inventor on the patent.

“Just because someone is an inventor on one patent application relating to our COVID-19 vaccine does not mean they are an inventor on every patent application relating to the vaccine,” Moderna said in its statement.

As BioSpace previously reported, ownership of the patents is critical for licensing deals. Co-ownership of those patents would allow the U.S. government to allow others to use the intellectual property without the consent of Moderna. That could be significant given the lack of access to vaccines in some parts of the world. It would also highlight the role government scientists played in developing the vaccine.

Moderna said its findings are supported by the NIAID’s patent filings, specifically one from February 2020 filed in conjunction with the University of Texas. Moderna said NIAID scientists claim to have invented what Moderna called “similar subject matter.” The company said as a “legal and practical matter,” the same thing cannot be claimed to have been invented twice by the same people working with two different collaborators.

“For those who would seek to twist Moderna’s good faith application of U.S. patent law into something else, nothing could be further from the truth.  Moderna remains the only company to have pledged not to enforce its COVID-19 intellectual property during the pandemic. Moreover, on September 29, Moderna offered to resolve its dispute with NIAID by making the government co-owners of those patent applications that only listed Moderna scientists as inventors, including the right as co-owners to license the patents as they see fit,” the company said in its statement.

The spat with the NIH over patents comes as the company continues to seek authorization for use in pediatric and juvenile patients under 17. The U.S. Food and Drug Administration (FDA) continues to investigate concerns of rare heart inflammation observed in teenage patients.

While the company awaits that decision, during an earnings call this week, Moderna Chief Medical Officer Dr. Paul Burton pointed to data showing its vaccine in adult patients. According to CNBC, Burton cited data from the U.S. Centers for Disease Control and Prevention (CDC) that showed fewer so-called breakthrough cases of COVID-19 in adults vaccinated with its medication compared to those with Pfizer or Johnson & Johnson’s vaccine. According to the data shared, 86 breakthrough cases per 100,000 received Moderna compared to 135 per 100,000 for the Pfizer and BioNTech vaccine.

https://www.biospace.com/article/moderna-rebuts-patent-claims-for-covid-19-vaccine-made-by-the-national-institutes-of-health/

CEO: I Am Challenging The Vaccine Mandate To Protect My Workers' Jobs

 By Angela Phillips, the CEO of the Ohio-based Phillips Manufacturing & Tower Company, which includes Shelby Welded Tube, first published in RealClearPolicy

The Biden administration has finally published its anticipated ultimatum threatening companies like mine with severe fines and penalties for not firing any employee who declines to be vaccinated against or submit to invasive weekly testing for COVID-19. The new rule promulgated by the U.S. Labor Department’s Occupational Safety and Health Administration (OSHA) under the guise of workplace safety may well bankrupt the business my father founded. So, as the CEO of the Phillips Manufacturing & Tower Company, I am joining with The Buckeye Institute to challenge OSHA’s vaccine mandate in court. Here’s why.

Phillips is a 54-year-old company based in Shelby, Ohio, that manufactures specialty welded steel tubing for automotive, appliance, and construction industries. OSHA’s emergency rule applies to companies with 100 or more employees — at our Shelby Welded Tube facility, we employ 104 people. As a family-owned business I take the health of my workers seriously — they are my neighbors and my friends. When I heard of the mandate, we conducted a survey of our workers to see what the impacts would be. It revealed that 28 Phillips employees are fully vaccinated, while antibody testing conducted at company expense found that another 16 employees have tested positive for COVID-19 antibodies and likely possess natural immunity. At least 47 employees have indicated that they have not and will not be vaccinated. Seventeen of those 47 unvaccinated workers said that they would quit or be fired before complying with the vaccine or testing mandate. Those are 17 skilled workers that Phillips cannot afford to lose.

Perhaps the Biden administration remains unaware of the labor shortage currently plaguing the U.S. labor market generally and industrial manufacturing especially. Like many companies, Phillips is already understaffed, with seven job openings we have been unable to fill. Employees already work overtime to keep pace with customer demand, working 10-hour shifts, six days a week on average. Firing 17 veteran members of the Phillips team certainly won’t help.

Accounting estimates that it will cost Phillips close to $1 million in additional overtime, and recruiting and training new employees to replace those lost to the mandate — assuming the company can find them. And that also assumes that Phillips will continue to meet existing customer orders using extra overtime for remaining employees. No easy task and not a safe assumption.

If a short-handed Phillips cannot meet contractual production requirements due to the mandate-fueled labor shortage, then Phillips could lose customers and face significant penalties. Many Phillips customers are outside of the U.S. — primarily in Mexico — and may flock to foreign competitors or companies with fewer than 100 workers that are not subject to the mandate or the shortages it creates. And one Phillips contract, for example, imposes a $25,000 penalty for each hour that the customer is without the promised product. Such obligations and penalties help protect supply chains across the industry, but those obligations — and supply chains — may soon be broken and customers may soon go elsewhere thanks to the administration’s callous new rule.

Complying with OSHA’s vaccine mandate and testing requirements risks catastrophic financial consequences. It also means firing qualified, well-trained, hardworking employees who rely on their jobs at Phillips Manufacturing & Tower Company to feed their families and pay their mortgages — for no reason other than to avoid draconian federal fines. Indeed, these employees may very well have the natural immunity that we tested for, which studies show to be more robust and longer lasting than vaccinated immunity. OSHA has no authority to require Phillips or any other company to make such a Hobson’s choice.

OSHA’s vaccine-or-testing ultimatum is unlike any other occupational health and safety regulation inasmuch as it tries to regulate an employee’s individual decision not to receive an injection. And it does not regulate commercial activity inasmuch as employees subject to the mandate do not even pay for the vaccines.

As Biden administration officials have publicly admitted, the vaccine mandate is a brazen attempt to coerce private companies into enforcing a vaccine requirement that Washington lacks the legal authority to require. Phillips is one company unwilling to do the administration’s dirty work.  

https://www.zerohedge.com/markets/ceo-i-am-challenging-vaccine-mandate-protect-my-workers-jobs

Cassava And Cortexyme Diverge — Why One Alzheimer's Stock Is 'Back On Track'

 Alzheimer's stocks Cassava Sciences (SAVA) and Cortexyme (CRTX) diverged Thursday. An analyst says SAVA stock is "back on track," but CRTX stock skidded on a key presentation.

On the stock market today, SAVA stock jumped 4.4% to 72.43 after the company's third-quarter report. Cassava's losses grew and were deeper than expected. But the company recently began a Phase 3 study of its Alzheimer's drug, simufilam.

Meanwhile, CRTX stock crumbled 7.4% and ended the regular session at 14.57. Last month, Cortexyme shares plummeted after the company said its Alzheimer's drug missed its mark in a key study. Executives emphasized the drug did its job in specific patients.

SAVA Stock Rises As CRTX Stock Falls

The SAVA stock jump follows a 24-cent loss in the third quarter. Cassava doesn't yet have revenue.

Maxim Group analyst Jason McCarthy expects Cassava's fortunes to turn around. Recently, Cassava began a final-phase study of simufilam, an experimental Alzheimer's drug that aims to stabilize a scaffolding protein in the brain. The study will pit simufilam against a placebo for the first time. The first studies of simufilam were open-label, meaning patients knew they were receiving the drug.

Earlier this year, short sellers tried to stop Cassava's Phase 3 study. A Citizen Petition filed with the Food and Drug Administration accused Cassava of manipulating some of the data foundational to the company and the drug. Last week, the journal that published the paper in question said it didn't find any evidence of data manipulation, and SAVA stock soared.

After a "roller coaster ride of a biotech story in 2021," McCarthy kept his buy rating on SAVA stock.

"Recent events, including both initiation of the Phase 3 study and the Journal of Neuroscience validating the data in question in the Citizen Petition have driven a rise in Cassava shares," McCarthy said in a report to clients. He has a 190 price target on SAVA stock.

Alzheimer's Stocks Diverge

CRTX stock has also been on a roller-coaster ride this year.

On a single October day, shares fell nearly 77% after Cortexyme said its drug, atuzaginstat, missed its key goal in a study. Atuzaginstat targets a bacteria called P. gingivalis. The bacteria causes periodontal disease. But Cortexyme says the same bacteria, in the brain, causes Alzheimer's disease.

But the drug only benefited patients whose saliva contained the bacteria.

On Thursday, CRTX stock fell again on the full results. For all patients, Cortexyme said atuzaginstat slowed cognitive decline. But it didn't pass muster on several markers of cognition. Further, there was no benefit on a scale that measures activities of daily living.

So, as SAVA stock reversed a three-day decline, CRTX stock touched its lowest-ever point.

https://www.investors.com/news/technology/sava-stock-why-it-is-back-on-track-but-crtx-stock-is-plummeting/