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Thursday, September 23, 2021

UnitedHealthcare to Offer Members 1 Year of Apple Fitness+ at No Added Cost

 UnitedHealthcare, a UnitedHealth Group (NYSE: UNH) company, has expanded its work with Apple to provide millions of members with access — at no additional cost — to Apple Fitness+, the first fitness service built entirely around Apple Watch®. This is the first such offer for Apple Fitness+ by a health insurance plan.

Starting Nov. 1, as part of their plan benefits, approximately 3 million fully insured UnitedHealthcare members in most states who own an Apple Watch can enroll with Apple Fitness+ and receive a year-long subscription at no additional cost. Employers with self-funded health plans will, starting next year, be able to purchase an "Apple Fitness Bundle," which provides a 12-month subscription to Apple Fitness+ as well as a $25 Apple digital gift card.

"Making Apple Fitness+ available to millions of UnitedHealthcare members is part of our broader effort to help people engage in their well-being and get and stay healthier," said Rebecca Madsen, chief consumer officer, UnitedHealthcare. "One way to achieve these goals is to help people enhance their fitness, with many individuals turning to on-demand and digital resources to help get or stay motivated. We are pleased to be the first health insurance plan to provide this type of access to Apple Fitness+."

For people with Apple Watch, Apple Fitness+ brings studio-style workouts and guided Meditations to iPhone, iPad, and Apple TV. Workouts and guided Meditations are led by a diverse and inclusive team of trainers whose approach is welcoming to all. Apple Fitness+ intelligently incorporates workout metrics from Apple Watch for a personalized and immersive experience that users can complete wherever and whenever it is convenient for them. Workouts are fueled by music from today’s top artists and designed to keep users motivated from start to finish, whether their workout is 5 or 45 minutes. Once activated, UnitedHealthcare members will have access to an on-demand library of over 1,200 workouts and Meditations. Workouts include High-Intensity Interval Training (HIIT), Strength, Yoga, Dance, Core, Cycling, Treadmill (for running and walking), Rowing and Mindful Cooldown, and – starting Sept. 27 – Pilates and guided Meditation.

Ideaya started at Hold by Stifel

 Target $27

https://finviz.com/quote.ashx?t=IDYA&ty=c&ta=1&p=d

Brain health paradox: Dementia rates have fallen even as drugs have failed

 Billions of dollars have been spent in pursuit of a pharmaceutical treatment for Alzheimer’s and other forms of dementia. Their fail rate through the 21st century is stuck at 100%.

The dominant story promoted by Alzheimer’s advocacy organizationspharmaceutical companies, and academic experts has been that, without a cure, aging societies will face a demographic tidal wave of dementia—a “silver tsunami” unleashing devastating socioeconomic consequences.

Yet dementia rates have actually fallen in the United StatesCanada, the United KingdomFranceSweden and the Netherlands over the past decade even though biotechnology continues to come up short. A 2020 study compiling data from those six countries from 1988 to 2015 calculated that, while the overall number of people affected by dementia is incrementally rising — as would be expected given the growing population of aging individuals — the incidence rate of dementia has consistently declined by 13% per decade and by 16% for Alzheimer’s, the most common form of dementia.

How can the dementia “tsunami” be losing momentum without effective drugs to prevent and treat the illness? And how can countries continue this somewhat paradoxical brain health trend?

We believe that looking at dementia through a population health lens provides some answers.

Older adults in the countries with decreasing dementia risk have cognitively benefited from two types of societal changes linked to overall public health improvements in the 20th century:

  • Better prevention and treatment of cardiovascular disease
  • Increased access to education

Healthier societies mean healthier hearts and heads

The human brain contains an intricate network of blood vessels, so its health is deeply intertwined with that of the heart and circulatory system. Nearly 20% of the heart’s output delivers oxygen and glucose to the brain. High blood pressure, high cholesterol, diabetes, obesity and associated metabolic syndrome, heart disease, sleep apnea, and other conditions can impair the heart and the extensive network of blood vessels in the vascular system, leading to heart attack, stroke, amputation, and more. When these conditions disrupt the flow of oxygen and nutrients to the brain, it can degrade the health and functioning of the organ and affect the mind.

Marked improvements in health care systems in high-income countries over the course of the 20th century have helped drive down the risk for cardiovascular disease, benefiting millions of aging brains.

These improvements don’t exist in a vacuum. They are the result of specific political and economic decisions that have improved population health.

Since the devastation of the two world wars and the Great Depression in between them, every country in which dementia rates are falling — excluding the United States — has legally obligated the state to extend health care coverage to all citizens. Elders in those countries have enjoyed lifespan access to clinical care, which has been instrumental in managing and preventing vascular illnesses.

Smoking cessation programs, like the Federal Cigarette Labeling and Advertising Act of 1966 and the Public Health Cigarette Smoking Act of 1969 in the U.S., have also been major contributors to better health. In the 1960s, 42% of U.S. adults smoked compared to only 14% in 2019. The success of these public health efforts in the U.S., Canada, and Western Europe has corresponded with decreased risk of the vascular diseases that can elevate dementia risk.

Lowering lead levels in the air and water has also been good for the heart and the brain. The U.S. was a global leader in this effort in the mid-20th century. Under the Clean Air Act, first enacted in 1963, lead was gradually phased out of gasoline sold in the country, reducing the environmental burden of this heavy metal — a known neurotoxin and risk factor for dementia — from vehicle exhaust and dropping collective lead levels in the blood of Americans by more than 80% between the 1970s and 1990s. In addition to damaging neurons and synapses at the molecular level, lowering IQ, creating emotional disturbances, and reducing academic achievement, lead exposure is also a major risk-factor for cardiovascular disease. Success reducing lead from the environment has benefited brains and vascular systems of countless citizens across the last 50 years.

Learning to reduce dementia risk

The other major societal pattern that has helped lower dementia rates — increased access to education — is also a population health success story.

One observation in nearly all of the multi-country studies showing reductions in dementia risk is a consistent rise in total years of education among older adults. In the U.S., for example, the percentage of adults ages 65 and older with a high school diploma increased from 40% in 1960 to 90% in 2020, and those with college degrees increased from 8% to nearly 37%. These cumulative years of education appear to now be conferring a strong protective effect on dementia risk for millions of people.

This finding is consistent with what is known as the cognitive reserve hypothesis — the notion that intellectual stimulation across the lifespan can, through mechanisms that aren’t yet fully-understood, render the brain more resilient to neuropathologies that accumulate with age.

In the U.S., rising education rates for current elders are directly linked to governmental interventions like the GI Bill, which provided subsidies for returning veterans to attend colleges and universities. More than 10 million World War II veterans took advantage of this opportunity, though this benefit was not equitably distributed, as Black veterans were barred from attending many public universities in the segregationist 1940s and 1950s. Veterans of subsequent wars continued benefiting from the GI Bill, while the Cold War intensified the expansion and subsidization of colleges. The introduction of Pell Grants in the 1970s expanded enrollment for students in financial need.

Thanks to these state interventions, between 1945 and 1975, the number of undergraduate students in U.S. colleges and universities increased five-fold and graduate students nine-fold.

A tangled road ahead

These positive brain health trends may soon begin reversing due to the reorganization of Western societies over the last several decades around radical free-market principles. This bipartisan shift, which is commonly referred to as neoliberalism or market fundamentalism, began in the 1970s in response to the crisis of stagflation and international oil shocks. It has transitioned the government’s role from capital control, redistribution, and public investment, as was generally the commitment of Western states during the post-Depression and post-World War II period in the mid-20th century, to facilitating global capital mobility, market expansion and deregulation, decreased taxation of the wealthy, deunionization, and cutting and privatizing public goods and services.

As Western states have gradually placed greater faith in the efficiency of markets while reducing public commitments to citizens, the societal conditions of the mid-20th century that had produced a robust middle class, improved public health, and ultimately engineered progress on dementia have deteriorated. Whereas cardiovascular disease declined in the post-war period, the U.S. is now experiencing a resurgence of chronic disease, with 6 in 10 Americans living with at least one chronic condition. Eighty million Americans are either uninsured or underinsured. And millions are coping, or trying to cope, with rising rates of depressionanxiety, and day-to-day financial worry in a deeply unequal, debt-burdened country characterized by declining population health, rising deaths of despair (from suicide, overdose, and alcoholism), and falling lifespans.

None of this bodes well for brain health.

Nor does the fact that trends toward increasing years of education are expected to level off for future aging Americans who have faced the barrier of soaring tuition costs in marketized higher education (underwritten by Wall Street) during a 40-year stretch of wage stagnation for the working class. And as has been tragically observed in cities like Flint, Michigan, and in Cleveland, Ohio, which we have both called home, the U.S. is dealing with a widespread lead crisis stemming from its aging water pipe infrastructure and the neoliberal austerity policies that have gutted regulatory oversight and cut spending on public goods and public health.

Alzheimer’s, a heterogeneous syndrome entangled with aging, is not likely curable via single-drug approaches. That will probably be the case for other age-related dementias as well. That’s why it is critical that we again reorder population-level structures, institutions, and social processes so they benefit the bodies and brains of future generations. A healthier society in which everyone is guaranteed nutritious food, safe drinking water, living-wage jobs, safe neighborhoods, quality health care, safe and affordable housing, higher education, and adult learning opportunities — in essence, a renewed 21st century commitment to broader prosperity, public health, and prevention — will be the best way to promote brain health and keep the dementia “tsunami” under control.

Daniel R. George is associate professor of Humanities and Public Health Sciences at Penn State College of Medicine. Peter J. Whitehouse is professor of Neurology at Case Western Reserve University. They are the authors of “American Dementia: Brain Health in an Unhealthy Society” (Johns Hopkins University Press, 2021).

https://www.statnews.com/2021/09/23/the-brain-health-paradox-dementia-rates-have-fallen-even-as-drugs-have-failed/

Biogen reps banned from D.C.-area neurology clinics over Aduhelm

 Biogen has certainly faced an uphill battle trying to convince physicians to prescribe the drugmaker’s highly scrutinized Alzheimer’s disease drug Aduhelm. It doesn't make it any easier if clinics won’t even let the company's sales reps through the front door. 

But that’s the case at the Neurology Center in Washington, D.C., which has gone so far as to ban Biogen employees from entering their seven office locations in response to the controversy shrouding the company’s new med. 

“Biogen representatives should not enter or engage staff, physicians or patients,” according to an image of one of the clinic’s signs posted to Twitter, which Fierce Pharma has confirmed with the center. 

The warning is just the latest example of the frosty reception Aduhelm has received since scoring an FDA nod in June. That accelerated approval, as well as Biogen’s immediate decision to price the treatment on the high end of Wall Street’s expectations, has sparked fiery criticism and even a few federal investigations.

Part of those inquiries are related to the company's reportedly cozy relationship with regulators ahead of Aduhelm’s approval. The FDA signed off on the treatment despite its divergent late-stage trial results and an overwhelming down vote from the agency’s own advisory committee. Three of those members later resigned in protest. 

Given Aduhelm’s hefty price tag—an average of $56,000 annually per patient—and its murky clinical benefits, the Neurology Center’s physicians have agreed to avoid administering the drug until its controversies are clarified, according to a note on its website

“We weren’t going to have that at all. We weren’t going to engage it,” a center spokesperson told Fierce Pharma when asked about the clinic's sign. 

For its part, Biogen has itself acknowledged Aduhelm’s rollout has been even more gradual than the Cambridge, Massachusetts-based company would've liked.

At a Morgan Stanley healthcare event earlier this month, CEO Michel Vounatsos said there's "clearly too much confusion, misinformation and controversy surrounding our data and the approval process." 

When asked about the center’s sign, a Biogen spokesperson told Fierce Pharma the company encourages any patient denied care to contact the company for help, adding that it remains “committed to supporting access to Aduhelm for all appropriate patients.”

Although just one example, the Neurology Center’s stance could reflect a bigger problem for Biogen, which has more neurology meds than just Aduhelm, Mizuho analyst Salim Syed wrote in a note to clients on Wednesday. Syed pointed out that it was the first time he saw a clinic categorically blocking the company from entering.

Aduhelm still "remains commercially volatile at best,” Syed wrote. And even after the company’s investor R&D day, where it spent four hours and 133 slides laying out its pipeline, the drugmaker did not present a "clear case for growth" outside of its key Alzheimer's drug, according to the note.

https://www.fiercepharma.com/marketing/do-not-enter-biogen-reps-banned-from-d-c-area-neurology-clinics-over-controversial

CDC Panel Eyes Delaying Booster Jabs Decision By 1 Month To 'Wait For More Evidence'

 Last night, the FDA - as expected - authorized the emergency use of booster doses of the Pfizer-BioNTech mRNA jab for patients over the age of 65, the immuno-compromised, and the occupationally vulnerable.

Now, it's the CDC's turn. The panel is preparing to wrap up a two-day meeting on Wednesday, where it is deliberating a more specific set of guidelines regarding the booster jab and who will initially be eligible, and when.

Before we get into specifics, it's worth noting that after the first day of discussion, some of the advisors were so befuddled by the rationale for boosters that they suggested putting off the CDC's decision for a month to wait for more evidence. Such a decision would probably have driven the Biden Administration crazy.

According to the AP, "the uncertainties were yet another reminder that the science surrounding boosters is more complicated than the Biden administration suggested when the president and his top aides rolled out their plan at the White House last month."

On Wednesday, "the CDC panelists heard a series of presentations Wednesday outlining the knotty state of science on boosters. On one hand, the COVID-19 vaccines continue to offer strong protection against severe illness, hospitalization and death. On the other hand, there are signs of more low-grade infections among the vaccinated as immunity wanes."

Ultimately, the function of the CDC panel is to "refine exactly who will be eligible" as Politico put it. For the booster jab, the focus will be on defining who's at "high risk". The discussions are expected to conclude Thursday afternoon.

Politico has five key takeaways from day one, and what to expect on day two (text courtesy of Politico):

The goals of vaccination might be changing:

Data from the large clinical trials used to authorize Covid-19 vaccines in the United States suggested they offered strong protection against even mild infection, raising hopes that the shots would confer so-called sterilizing immunity — preventing vaccinated people from spreading the virus.

But over time, scientists have realized that the vaccines' ability to ward off mild infection is waning, although protection against severe disease and death remains strong overall.

CDC panel member Sarah Long, a pediatrics professor at Drexel University's College of Medicine, urged her colleagues to differentiate between ensuring the vaccines prevent hospitalizations versus all infection.

"I don't think there's any hope that a vaccine, such as the ones we have, will prevent infection after the first maybe couple of weeks that you have those extraordinary immediate responses," she said.

The elderly show the clearest need for boosters at this point:

Antibodies from vaccination decrease over time among all age groups. But vaccine recipients 80 and older develop lower levels of neutralizing antibodies post-vaccination than younger adults do, said Natalie Thornburg, a respiratory virus immunology specialist at the CDC.

That means that older people's antibodies may drop to undetectable levels faster, at which point their memory immune cells play a larger role in protecting them against Covid-19. But older people also may produce fewer memory cells than younger people whose immune systems are stronger — suggesting that older people would benefit from a third vaccine dose.

Ruth Link-Gelles of the U.S. Public Health Service said current data shows significant drops in the efficacy of both the Pfizer and Moderna shots in people 65 and older in the time the Delta variant has dominated the domestic infection landscape.

But Thornburg cautioned against viewing vaccines' protection as an on-off switch. "Immunity is not simply a binary" in which individuals are either protected or not against the coronavirus, she said. Most people are able to maintain some level of cellular immunity, which is likely enough to protect vaccine recipients from severe disease even after antibody levels drop off.

Nursing-home residents face special risks, even with a boost

Boosters may not be enough to fully protect residents of nursing homes, according to modeling data presented by Rachel Slayton of the U.S. Public Health Service. While boosters may help reduce the number of cases in long-term care facilities, she said, that depends on their inherent efficacy and on the vaccination coverage among facility staff.

High community transmission will likely lead to more infections in nursing homes because staff can more easily import the virus, Slayton said. It's unclear whether booster doses could help curb transmission of the virus among vaccinated individuals.

Experts are worried about confusing the public

Members of the CDC's vaccine advisory committee expressed concerns Wednesday about green-lighting boosters from one brand over others with authorized Covid vaccines available to Americans, noting the potential for public perception and logistical issues. The panel is tasked with recommending to the CDC how the FDA's vaccine policy should be implemented in real-world settings.

Long suggested that the group wait for more information on so-called mix-and-match doses — the ability to vaccinate someone with one brand's primary series with the option for a different manufacturer's booster later — before signing off on just the Pfizer booster, asking “whether we’re willing to panic half the recipients of Moderna."

“I don’t want to jeopardize anyone," she said of delaying a booster decision. "At the same time, it’ll be very, very difficult to have a little less than half of the population who would be eligible to receive" a booster if people can only get the brand that matches their initial series.

Moderna has asked FDA to authorize its booster shot, and Johnson & Johnson has begun submitting booster data to the agency with an eye to filing an application.

Amanda Cohn of the CDC urged committee members to consider the recommendations they're making now as "interim policies" that will change as more data surfaces. The National Institutes of Health is conducting a study on mixing vaccine doses, with results expected later this year.

"This is a rapidly moving target," she said.

The booster rollout could be messy

Still, there are a number of challenges to approving only one brand's vaccine for boosting.

Immunocompromised Americans have already been permitted to seek out third doses of the Pfizer or Moderna vaccines because of concerns they may not have mounted a sufficient immune response to the first two shots. While they've been told they can receive the other brand's shot if they can't access the one they initially got, FDA isn't expected to allow mixing brands for people outside that category, which could sow further confusion.

More than 98 percent of Americans participating in a CDC safety monitoring program who have gotten additional doses stuck with the same brand they originally received. But it's unclear how many of those studied actually fell under the CDC's definition of immunocompromised since patients only have to attest to their eligibility — no doctor's note required — meaning there are few obstacles keeping people interested in boosters from acquiring them, anyway.

Declining to allow mixing Pfizer and Moderna doses beyond the immunocompromised could make administering boosters in long-term care facilities difficult if residents received different brands, said Molly Howell, an immunization program manager at the North Dakota Department of Health.

“I don’t know that it’s realistic to keep going back with different brands," she said.

* * *

Ironically, the deliberations on the booster jabs are happening during the slowest week for first-dose vaccinations since July (despite NY's mandate looming on Monday). Remember, all of the deliberation so far have  focused on the Pfizer jab. Regulators will decide on boosters for people who have received the Moderna or J&J jabs in the coming weeks. One thing we already know: Pfizer boosters won't be recommended for patients who received a different brand the first time around (though exceptions to this have already and will likely continue to be made).

https://www.zerohedge.com/covid-19/cdc-panel-considers-delaying-booster-jabs-decision-1-month-wait-more-evidence

Eargo Slammed on Criminal Probe, Withdrawn Guidance

 Eargo Inc.  (EAR  said after the bell Wednesday that it is the target of a criminal investigation by the U.S. Dept. of Justice.

The company said in an SEC filing that the investigation is “related to insurance reimbursement claims the Company has submitted on behalf of its customers covered by federal employee health plans.” It was notified of the investigation on Tuesday. Eargo said it is cooperating with the investigation.

Eargo, Inc., sells hearing aids through online stores. The company’s products range from $1,500 to $3,000. It makes a significant effort on the site to say they “May be covered by federal insurance.” In addition it breaks out its “Federal Employee program” on the site.

As a result of the investigation, Eargo said it is withdrawing its financial guidance for the fiscal year ending Dec. 31.

At the time of its last earnings report, on Aug. 12, Eargo said it was increasing its full-year net revenue guidance to between $93 million and $96 million from an earlier range of $89 million to $93 million.

In addition, Eargo said it has “been the subject of an ongoing claims audit by an insurance company that is the Company's largest third-party payor. The Company has been informed by the insurance company that the DOJ is now the principal contact related to the subject matter of the audit.”

It also said it “ intends to work with the government with the objective of validating the process to support any future claims that the Company may submit for reimbursement.”

https://www.thestreet.com/investing/eargo-slammed-on-criminal-probe-withdrawn-guidance

PAVmed Unit Lucid Diagnostics Files for IPO

 PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), a highly differentiated, multi-product, commercial-stage medical technology company, and its majority-owned subsidiary, Lucid Diagnostics Inc. ("Lucid"), announced yesterday that Lucid has publicly filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the "SEC") relating to the proposed initial public offering of its common stock. The number of shares to be offered and the price range for the offering have not yet been determined. Lucid Diagnostics intends to list its common stock on The Nasdaq Stock Market under the ticker symbol "LUCD."

Cantor Fitzgerald & Co. and Canaccord Genuity LLC will act as joint book-running managers for the proposed offering. BTIG, LLC and Needham & Co., LLC will act as co-lead managers for the proposed offering.

https://finance.yahoo.com/news/pavmed-subsidiary-lucid-diagnostics-files-133000153.html