Weekend Update

Photo by Tomasz Filipek on Unsplash

Congress is on a State/District work break this week, which includes the Thanksgiving holiday.

Before leaving town the House of Representatives passed its own version of the social and climate spending budget reconciliation bill (H.R. 5376). The Society for Human Resource Management reports that the wide-ranging House bill

contains several provisions affecting employer-sponsored benefits. Two of the most important—a new paid-leave program and a modification of the “firewall” that has prevented employees from receiving premium tax credits to subsidize buying health plans on the Affordable Care Act (ACA) marketplace—are highlighted [in the article], along with other provisions effecting retirement savings plans and new penalties for labor law violations.

The SHRM article also notes that the bill “faces an uncertain future in the U.S. Senate.”

Meanwhile Roll Call reports that the Senate will continue next week its work on the must pass National Defense Authorization Act.

From the Delta variant front, the Wall Street Journal reports today that

Spotty U.S. data have clouded the view of just how many fully vaccinated people are getting Covid-19, landing in hospitals and dying. The Centers for Disease Control and Prevention doesn’t publish a running tally on raw breakthrough numbers. The Journal reviewed medical-record data for a total of more than 21 million fully vaccinated people, and an array of state reports, to compile its analysis. In particular, people with diabetes, chronic lung disease, kidney disease and compromised immune systems were at risk of serious outcomes from breakthrough cases, the data show. * * *

The likelihood of having a breakthrough infection was still low, though confirmed infections were more common for people with these illnesses. About 1.5% of roughly 110,000 people with chronic kidney disease had one, for example. But Truveta found about a quarter of breakthrough patients with chronic kidney disease wound up hospitalized. The likelihood of hospitalizations for people with breakthrough cases but without underlying health problems was about 7.5%.

Breakthrough deaths are hitting older people the hardest, amplifying a well-worn pandemic pattern. Exclusive data the Journal reviewed from the Epic Health Research Network, which analyzes data from the medical-record software company Epic Systems Corp., shows about 80% of breakthrough deaths among the vaccinated are in people ages 65 and older. The data included records for 19.5 million fully vaccinated people. Among all Covid-19 deaths this year, that age group represents closer to 69%, according to the CDC.

The Epic Health Research Network data also point to more severe breakthrough cases in the most vulnerable patients, who were identified using a federal measure of social and economic factors. “This is magnifying underlying health disparities that we’re seeing,” said Harvard T.H. Chan School of Public Health researcher Thomas Tsai, co-author of a study that found the most-vulnerable communities had twice the odds of hospitals with ICUs near capacity than the least-vulnerable areas, using the same federal measure.

From the substance use front, The New York Times reports today

Fentanyl is the third wave of an opioid epidemic that began in the 1990s with prescription pills, followed by exploding heroin use.

Now communities are struggling under an onslaught of fentanyl. The reasons are multilayered: As pharmaceutical companies have tightened the tap on prescription pain pills following a raft of legal losses for their role in causing the opioid epidemic, the pills have become scarce on the black market. Addicts have turned to fentanyl for their fix.

To profit off the situation, cartels and small-time manufacturers have flooded in caches of imitation pills — fentanyl tablets mimicking prescription brands. In September, the United States Drug Enforcement Administration issued a public safety alert: More than 40 percent of black-market prescription pills contain lethal amounts of fentanyl.

“Like a wolf in sheep’s clothing, these pills are lethal,” Ray Donovan, then the D.E.A’.s special agent in charge of the New York division, said in a statement.

The article concludes

In Suffolk County, [on Long Island] Odette R. Hall, the chief medical examiner, is using the new mass spectrometer to dig through deaths, to figure out whether fentanyl or its analogues were to blame — or, she fears, whatever novel drug is coming next.

“Whatever is happening on the street,” Dr. Hall said, “is always going to be a step ahead.”

From the Alzheimer’s Disease front and given all of the understandably negative news of the Biogen drug Aduhelm, Boston’s Brigham and Women’s Hospital announced last week that their researchers were

set to begin a clinical trial that will test the safety and efficacy of a new vaccine delivered nasally intended to prevent and slow the progression of Alzheimer’s disease (AD). The trial represents the culmination of nearly 20 years of research led by Howard L. Weiner, MD, co-director of the Ann Romney Center for Neurologic Diseases at the Brigham.

“The launch of the first human trial of a nasal vaccine for Alzheimer’s is a remarkable milestone,” said Weiner. “Over the last two decades, we’ve amassed preclinical evidence suggesting the potential of this nasal vaccine for AD. If clinical trials in humans show that the vaccine is safe and effective, this could represent a nontoxic treatment for people with Alzheimer’s, and it could also be given early to help prevent Alzheimer’s in people at risk.” 

The vaccine uses the immune modulator Protollin, an investigational intranasal agent that stimulates the immune system. Protollin is composed of proteins derived from bacteria and has been used safely in humans as an adjuvant for other vaccines. Protollin is designed to activate white blood cells found in the lymph nodes on the sides and back of the neck to migrate to the brain and trigger clearance of beta amyloid plaques — one of the hallmarks of AD. I-Mab Biopharma (I-Mab) and Jiangsu Nhwa Pharmaceutical (NHWA) are responsible for the development, manufacturing and commercialization of Protollin.

“For 20 years, there has been growing evidence that the immune system plays a key role in eliminating beta amyloid. This vaccine harnesses a novel arm of the immune system to treat AD,” said Tanuja Chitnis, MD, professor of Neurology at the Brigham and principal investigator of the trial. “Research in this area has paved the way for us to pursue a whole new avenue for potentially treating not only AD, but also other neurodegenerative diseases.”

Fingers and toes crossed on this one.

Reminder — The Federal Benefits Open Season ends on December 13, 2021, three weeks from tomorrow.

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