Alzheimer’s drug has Wall Street excited, but some researchers are still skeptical

We ought not be surprised that the Wall Street Journal went all-in with its gush-y reporting about lecanemab, the Alzheimer’s drug from Biogen that has shown promise in clinical trials where other drugs of the same class have failed. Investors are drooling.

The reversal in investor sentiment is nothing short of massive. After so many drugs targeting amyloids had failed in clinical trials in recent years, there was growing skepticism of the “amyloid hypothesis,” the idea that targeting an unusual buildup of the protein in patients’ brains should slow dementia.

The results released Tuesday were unequivocal though. The drug reduced cognitive and functional decline by 27%, compared with a placebo. The data, which haven’t yet been published in a peer-reviewed medical journal, hit all of the trial’s primary and secondary endpoints, with many analysts calling it a best-case scenario. Importantly, while the drug did show safety concerns such as brain swelling, it looked safer than other candidates now making their way through clinical trials, wrote Michael Yee of Jefferies.

The positive data make it likely that the Food and Drug Administration will grant Biogen accelerated approval in January, with full approval coming later next year. The bigger question for investors, patients and society is what the Centers for Medicare and Medicaid Services will do. Biogen’s last approved drug for the disease, Aduhelm, received the FDA nod, but CMS effectively killed its commercial prospects by restricting it due to lack of meaningful improvement in health outcomes.

Biogen’s Aduhelm is the first approved treatment for early stage Alzheimer’s patients that may be able to slow the disease. WSJ explains how the drug interacts with brain cells, and why some doctors aren’t ready to prescribe it yet.

This time will be different, with CMS unlikely to “dig in and refuse coverage” due to the highly successful clinical data, wrote Brian Skorney at Baird. With about 2 million Americans suffering from early-stage Alzheimer’s, the costs to the insurance program could be meaningful, leading to higher healthcare costs for most seniors. Just Tuesday, CMS had announced that premiums and deductibles would be declining next year due to lower-than-projected spending on Aduhelm specifically. Now, the government might find itself paying for another pricey Alzheimer’s drug instead.

Just how pricey will be another important question. Biogen has probably learned some hard lessons from the backlash it got to the Aduhelm launch at $56,000 a year, so expect it to price lecanemab at closer to $20,000.

Still, the costs—and the payoff for investors—are likely to be astronomical.

That last part really jumped out at me. They could cut the annual price by almost 2/3 and still make ungodly profits. That shows you how much money big Pharma makes when nobody is keeping tabs on the price they are charging.

And, as Caitlin Owens article in Axios notes:

Some in the research community continue to question the focus on anti-amyloid cures and say success fighting Alzheimer’s will come in combination therapies like those used for heart disease, cancer and hypertension.

“Amyloid-clearing drugs will provide an incremental benefit at best and there is still a pressing need for the next generation of drugs focused on other targets based on our knowledge of the biology of aging,” said Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation.

This is a nightmare scenario for Medicare: an expensive drug of limited benefit that will mean higher premiums for millions of Americans.

Gov’t task force recommends wide U.S. screening for anxiety disorders

In a first, a government panel recommends all adults under 65 be screen regularly for anxiety disorders.

Adults under the age of 65 should be screened for anxiety disorders and all adults should be checked for depression, a government-backed panel said, as many Americans report symptoms of these mental-health conditions following the height of the Covid-19 pandemic.

The draft guidance released Tuesday marks the first time that the United States Preventive Services Task Force has made a recommendation on screening adults for anxiety disorders. The move comes months after the task force issued similar draft guidance for children and adolescents.

“This is a really important step forward,” said Arthur C. Evans, chief executive at the American Psychological Association. “Screening for mental-health conditions is critical to our ability to help people at the earliest possible moment.”

The task force said that there wasn’t enough evidence on whether or not screening all adults without signs or symptoms ultimately helps prevent suicide. The group didn’t recommend for or against screening for suicide risk, but called for more research in the area.

The task force, a panel of 16 independent volunteer experts, issues guidance on preventive-care measures. Health insurers are often required to cover services recommended by the task force under a provision in the Affordable Care Act.

More than 30% of adults reported having symptoms of an anxiety disorder or depressive disorder this summer, according to estimates from the federal Household Pulse Survey. The percentage of U.S. adults who received mental-health treatment within the past 12 months increased to 22% in 2021, up from 19% in 2019, according to the Centers for Disease Control and Prevention.

Mental-health screening often occurs in doctor’s offices, where patients fill out questionnaires during routine checkups or other appointments. The goal is to spot at-risk people who might not be showing obvious signs, so that the person can get the correct diagnosis and potentially get connected to care before they reach a crisis point.

As for people over 65, the article notes that “some anxiety-disorder screening questionnaires emphasize issues with sleep, pain and fatigue, which also often increase with age.” So screening older adults for those risk factors might turn up a lot of older people who are, you know, just regular old, tired and creaky.

It does strike me that they ought to come up with different a different screening regimen for older people, rather than just deciding to not issue screening recommendations as all.

Nursing homes are tossing onto the street those patients who cut too much into their bottom line

Have you ever heard of the term “facility-initiated discharges”?

I had not until I read this article in The Bulwark by Bill Lueders, writing about his mother:

Last fall, my then-97-year-old mother, Elaine Benz, was evicted from the senior living facility known as the Regency, in New Berlin, Wisconsin, where she had lived for ten years. My sister, Diane, was told on Thursday, October 28, that our mom would not be allowed to return the following morning, as planned, from a physical rehabilitation center to which she had been sent following a fall. The Regency had decided her needs had gotten too great.

It was a staffer at the rehab center and not someone from the Regency—officially ProHealth Regency Care Communities New Berlin—who broke this news to Diane. As she recalls, the staffer told her that the Regency would turn Elaine “away at the doors” if the center tried sending her back. We needed to find her a new place to live.

That’s it! That’s all it took. The facility looked for any excuse to get his mother out the door. Once out the door, they just refused to let her back in.

A 97-year-old woman!

Lueders has had to become an expert regarding this common practice as he fights to protect his mother:

But in general, I learned, there is nothing unusual about it. What happened to my mother happens to elderly people in America all the time. A facility will conclude that a patient has become too much work or is no longer a good deal financially and find a way to get rid of her. Often, as with Elaine, nursing homes and other senior care facilities evict residents while they are temporarily moved to another facility.

Nicole Shannon, a frontline attorney for the Michigan Elder Justice Initiative, told me how this sometimes works: “The nursing home will say, ‘Well, it sure seems like you need a psychiatric consult, we’re gonna send you to the hospital.’ The hospital turns around and says, ‘You know, this person does not require psychiatric care. You can go back to your nursing home now,’ and the nursing home says ‘Nope, no thanks, you’re no longer welcome here.’”

Shannon’s group has seen cases in which nursing home residents have had discharges approved for transfers to a homeless shelter, to the home of an unwilling relative, to a house that no longer existed because it had burned down, and to an apartment the person no longer rented.

On November 18, the day after we found a new place for Elaine to live, the Office of Inspector General for the U.S. Department of Health and Human Services released a forty-page report on problems regarding “facility-initiated discharges.” It noted that “discharge/eviction” was from 2013 to 2019 the single most frequent complaint recorded by the federal Long-Term Care Ombudsman Program, which operates in all fifty states and the District of Columbia.

The report says that several of the ombudsmen surveyed “volunteered that nursing homes have said that they would rather accept a deficiency or enforcement penalty than keep the resident.” Other ombudsmen “opined that stronger enforcement actions could help to reduce these discharges.”

I cannot imagine being 97 years old and essentially being told that, while you were at some bogus pretext appointment somewhere, we’ve locked you out of your home and, good luck, whatever the state can do to us is nothing compared to what it costs us to keep you in your home.

You might also want to see this article from last April detailing how Wall Street private equity has been gobbling up the nursing home industry.

We are all going to end up living in a Wall Street-owned dystopian society because, while the rest of us are wasting our time fighting about the southern border and drag queen story hours, America is being sold to the highest billionaire bidder.

Bill Lueders’ mother, Elaine Benz.

Scientists find 31,000-year-old skeleton with signs of medical amputation

The only surgery I’ve had was after some inattentive goon in an SUV made a wide right turn in front of me at a Boston intersection, which sent me flying off my Vespa and into a fire hydrant.

Shattered right ankle, mostly. What I remember most vividly about the incident is how the city ambulance seemed to have no suspension whatsoever, so the entire time between the accident scene and Boston Medical Center we were hitting Boston’s ubiquitous potholes. Everything in the ambulance — including my shattered ankle — would bounce violently.

What a relief it was when we arrived at the emergency room and they gave me a shot of pain killer. And then put me under for emergency surgery.

I was in that hospital bed for a couple of days and nights while they gave me shots of glorious morphine every four hours — I watched the clock closely, let me tell you.

And I remember thinking, “I cannot imagine that they used to do all of this without pain killers of any kind. Surgery without being asleep.”

Life before general anesthesia must have been grim and terrifying.

On a related note, researchers in the journal Nature have revealed that they found a very old skeleton that shows signs of pre-planned amputation that had healed:

A 31,000-year-old skeleton missing its lower left leg and found in a remote Indonesian cave is believed to be the earliest known evidence of surgery, according to a peer-reviewed study that experts say rewrites understanding of human history.

An expedition team led by Australian and Indonesian archaeologists stumbled upon the skeletal remains while excavating a limestone cave in East Kalimantan, Borneo looking for ancient rock art in 2020.

The finding turned out to be evidence of the earliest known surgical amputation, pre-dating other discoveries of complex medical procedures across Eurasia by tens of thousands of years.

By measuring the ages of a tooth and burial sediment using radioisotope dating, the scientists estimated the remains to be about 31,000 years old.

Palaeopathological analysis of the remains revealed bony growths on the lower left leg indicative of healing and suggesting the leg was surgically amputated several years before burial.

Dr Tim Maloney, a research fellow at Australia’s Griffith University who oversaw the excavation, said the discovery was an “absolute dream for an archaeologist”.

The stuff of nightmares.

California legislator who championed vaccine laws in the face of death threats has been term-limited out of office

You wanna talk about heroes? This guy is a hero.

A California lawmaker who rose to national prominence by muscling through some of the country’s strongest vaccination laws is leaving the state legislature later this year after a momentous tenure that made him a top target of the boisterous and burgeoning movement against vaccination mandates.

State Sen. Richard Pan, a bespectacled and unassuming pediatrician who continued treating low-income children during his 12 years in the state Senate and Assembly, has been physically assaulted and verbally attacked for working to tighten childhood vaccine requirements — even as Time magazine hailed him as a “hero.” Threats against him intensified in 2019, becoming so violent that he needed a restraining order and personal security detail.

“It got really vicious, and the tenor of these protests inside the Capitol building didn’t make you feel safe, yet he stood his ground,” said Karen Smith, director of the California Department of Public Health from 2015 to 2019. “Dr. Pan is unusual because he has the knowledge and belief in science, but also the conviction to act on it.”

“That takes courage,” she added. “He’s had a tremendous impact in California, and there’s going to be a hole in the legislature when he’s gone.”

The Democrat from Sacramento is leaving the Capitol because of legislative term limits that restrict state lawmakers to 12 years of service. He has overseen state budget decisions on health care and since 2018 has chaired the Senate Health Committee, a powerful position that has allowed him to shape health care coverage for millions of Californians.

Pan, 56, helped lead the charge to restore vision, dental, and other benefits to California’s Medicaid program, called Medi-Cal, after they were slashed during the Great Recession. Since then, he has pushed to expand social services to some of the most vulnerable enrollees.

You can read the rest at this link

Calif. State Sen. Richard Pan and his family.

Right-wing hopes to abolish Obamacare preventative coverage mandates for “homosexuals,” the “promiscuous”

The fine people over at poz.com have a good article about a sleeper case before a federal court in Texas that could, should it end up at the right-wing Supreme Court, force millions to pay out-of-pocket for preventative medicine that it now required to be covered under the ACA:

A group of patients and employers are arguing that the requirement is unconstitutional. They also contend that some preventive health measures violate protections under the Religious Freedom Restoration Act of 1993 that prohibit federal and state rules from unduly burdening one’s exercise of religion.

The ACA provisions “make it impossible for these plaintiffs to purchase health insurance unless they agree to pay for preventive-care coverage that they do not want and do not need” and prevent them from buying less expensive health insurance without that coverage, they argue.

And a requirement that health plans pay for a drug that prevents HIV “forces religious employers to provide coverage for drugs that facilitate and encourage homosexual behavior, prostitution, sexual promiscuity, and intravenous drug use,” the group argues.

Neither the lawyers representing the plaintiffs in the case nor the U.S. Department of Health and Human Services (HHS), the defendant, responded to requests for comment.

The federal judge hearing the case, Reed O’Connor of the U.S. District Court for the Northern District of Texas, in 2018 struck down the Affordable Care Act as unconstitutional, only to be overturned by the U.S. Supreme Court in 2021. Supporters of the law are worried he will decide in favor of the plaintiffs in the new case.

“This judge has shown he is not shy about abolishing the entire Affordable Care Act and issuing nationwide injunctions,” said Wayne Turner, senior attorney at the National Health Law Program, which litigates on behalf of health equity and access to health care for underserved populations. O’Connor has a history of issuing nationwide injunctions involving federal laws, including the ACA.

And ACA supporters are not confident that a ruling striking down the preventive health requirements would be overturned by the conservative U.S. Court of Appeals for the 5th Circuit or ultimately by the U.S. Supreme Court, with its majority of Republican-appointed justices.

This would be a disaster in so many ways. But the extreme Right is feeling powerful now that it has a Supreme Court that will likely uphold many of its more extreme positions in court cases.

The Democrats simply must keep control of the House and Senate.

If you’re eligible for a monkeypox vaccine, please get one as soon as you are able

This article in the New York Times features people who had monkeypox. The disease is not to be trifled with:

It began as an odd-looking pimple, or perhaps as a weird rash, or maybe as a sudden wave of fatigue in the middle of a hot summer day. The doctor was stumped, or said it was not a big deal, or — just maybe — identified it right away: monkeypox.

New York City has been the epicenter of an outbreak of an old disease that has created new havoc. More than 18,000 cases have been identified across the United States, as of the end of August, and nearly 3,000 of them have been found in the city, mostly among men who have sex with men. Increased access to an effective antiviral medication called tecovirimat, or Tpoxx, and an effort to vaccinate thousands of people most at risk have led to eased symptoms for some.

But not for everyone: Infected lesions and other complications still land some patients in the hospital. Even those with mild cases are forced to isolate at home for weeks, away from family, friends and pets. Many who recover carry psychological wounds or face social stigma. 

Jeez, man, it’s just one outbreak after another, and this one — shades of 1984 — is stalking gay and bi men.

Except this time there is prevention and treatment available, though not available fast or widely enough as it should be. Let’s hope that changes.

Now that the FDA approved new COVID booster shots, when should you get one?

Now that the FDA has given the go-ahead for the “new and improved” Moderna and Pfizer booster shots, questions arise.

This article in The Atlantic covers the bases quite well.

In less than two weeks, you could walk out of a pharmacy with a next-generation COVID booster in your arm. Just a few days ago, the Biden administration indicated that the first updated COVID-19 vaccines would be available shortly after Labor Day to Americans 12 and older who have already had their primary series. Unlike the shots the U.S. has now, the new doses from Pfizer and Moderna will be bivalent, which means they’ll contain genetic material based both on the ancestral strain of the coronavirus and on two newer Omicron subvariants that are circulating in the U.S.

These shots’ new formulation promises some level of protection that simply hasn’t been possible with the original vaccines. “A bivalent vaccine will have some benefit for almost everybody who gets it,” Rishi Goel, an immunologist at the University of Pennsylvania, told me. “How much benefit that is, we’re still not exactly sure.” People who aren’t at high risk could end up only marginally more protected against severe outcomes, and no one thinks the shots will banish COVID infections for good. There is, however, a simple rule of thumb that nearly everyone can follow to maximize the uncertain gains from a shot: Wait three to six months from your last COVID infection or vaccination.

Put that rule into action, and it plays out a little differently, depending on your circumstances.

You can read the rest of the article at this link.

Promising results from initial study of possible new way to stimulate memory in older adults

So, this is interesting news about a possible new way to stimulate memory in older people:

Pulsing electrical currents through the brain for 20 minutes can boost memory for older adults for at least a month, according to a new study.

Around 8 percent of people in the US get diagnosed with Alzheimer’s disease or dementia as they get older — significantly impairing their memory — and an even larger group of older adults has some degree of age-related memory loss. This new study is only a first look at a potential solution. But easy, quick treatments like this one could become even more important as the world’s population rapidly ages — especially if future research shows that it can help with more serious cognitive conditions.

The brain stimulation done in this study, published Monday in Nature Neuroscience, came from a swim cap-like device studded with electrodes positioned to deliver the electric current to specific areas of the brain. The research team was interested in two main areas: one that’s linked with working memory (which holds information temporarily and overlaps with short-term memory) and another linked with long-term memory.

The research team divided 60 participants between the ages of 65 and 88 into three groups: one group wore the device but didn’t get any electrical stimulation; the second received stimulation in the region associated with working memory; and the third received stimulation in the area associated with long-term memory. For four consecutive days, the participants received the treatment (or fake treatment) while performing a memory task where they were read a list of 20 words and asked to recall them. The researchers looked to see how often they remembered the words at the beginning of the list (long-term memory) and the end of the list (working memory).

Both working and long-term memory improved over the course of the four days, the study found. “We watched the memory improvements accumulate over time with each passing day,” said study author Robert Reinhart, a professor in the department of psychological and brain sciences at Boston University, during a press briefing. And participants still had improved memory one month later.

And it might have applications to other neurodegenerative conditions.

Too early to tell, of course.

But if it’s in Nature Neuroscience, there’s a pretty good chance that some high-caliber reviewers thought it to be interesting enough to publish in that high-impact journal.

You can read the rest of the The Verge article at this link.

America’s crisis in parenting and child care

I’ve never understood conservatives’ visceral opposition to universal child care and robust programs to make sure that parents and children get adequate nutrition and early childhood education.

If you want families to stay intact and healthy to the point that they are able to bring up children who will be law-abiding taxpayers who contribute innumerable ways to a better society, those early, formative years are the most crucial for governments to fund fully so that they are not paying for crime and prisons later.

Reporters Cassandra Robertson, Tara McGuinness and Monée Fields-White have an article in The New Republic that uses new parents Diana Apresa and her husband Michael Romo as examples of parents who, after spending the huge sums of money that having a baby costs up-front, are then faced with the no-win situation of losing all or part of one parent’s income because to take care of a child because no affordable child care options exist:

Apresa and Romo are among the more than 12 million working parents with kids younger than six—a segment of the population that contends with a unique, economic double bind: without an option for paid leave, parents must find childcare in order to work and provide for their families (right after covering the exorbitant health costs for giving birth). But skyrocketing childcare costs often mean there’s nothing left over anyway. And the government—both at the state and federal level—has often left these families behind without any comprehensive solution for this unique stage of life.

The downstream consequences of this policy failure to support families are impossible to overstate. Early childhood is a critical time—children’s brains are forming more than a million neural connections per second as they approach three years old. Research has shown how poverty and low incomes can have a significant, negative long-term impact on a child’s wellbeing, while a recent study for the Proceedings of the National Academy of Sciences found that monthly cash payments to mothers during the first year of their children’s lives led to faster brain activity, “a pattern [positively] associated with learning and development at later ages.” The impacts also matter for society at large. The earliest years of a child’s life are hugely consequential. Care and family income are critical drivers here. Yet these earliest years from zero to five—the years that arguably ought to draw the most robust policy response—are also the most vulnerable, and served by piecemeal policy interventions that are not fully funded.

It’s time for a new approach to support families.

Today, U.S. spending on early childhood education and childcare as a percent of GDP is among the lowest in OECD countries. It is one of only two that does not cover health care costs, and we are the only high-wealth country without any type of guaranteed paid leave.

Good article that examines thoroughly the options available for this country if it truly cares about children and the parents trying to raise them. It’s not just the right thing to do morally. But it will save society much grief later on. Pay now, or pay later.

You can read the rest of the article at this link.