Working WELL: Health Innovations, California's Naxalone Partnership, and Employee Engagement

This week, we'll be discussing:

• Groundbreaking research showing how circadian rhythm impacts drug efficacy and the cellular effects of exercise on the body
• California's new generic form of Naxalone, a quick background of the FDA's Naxalone approval last year
• The power of 211, serving communities nationwide
• Employee engagement hits an 11-year low. Insights on America's workforce.

Unlocking Assistance with a Simple Call: The Power of 211

• 15+ Million Referrals to help & resources were made by 211 network in 2023
• 8.1 Million people call 211 for assistance with housing, homelessness, and utility bills every year

Dialing "211" is a lifeline for individuals and families navigating the complexities of health and human service agencies across the United States. This three-digit number provides a streamlined pathway to essential resources, connecting those in need with appropriate agencies and community organizations.

211 is a vital resource for diverse demographics, including the elderly, disabled individuals, non-English speakers, those in crisis, individuals with limited reading skills, and newcomers to communities. Covering approximately 99% of the U.S. population, 211 services extend across all 50 states, the District of Columbia, and Puerto Rico.

Similar to 911, calls and texts to 211 are routed to local or regional calling centers. Trained referral specialists access comprehensive databases of resources from both private and public health and human service agencies. They match callers' needs with available resources and facilitate direct connections or referrals to appropriate assistance.

For more information or to access 211 services, visit 211.org or simply dial 211.

California Takes Action Against Opioid Crisis with New Generic Overdose Reversal Drug

In a groundbreaking move to enhance accessibility to life-saving medication,?California's CalRx? Program is set?to procure twin-packs of naloxone nasal spray at nearly half the current market price. Governor Newsom's announcement marks a significant milestone in the state's ongoing efforts to disrupt the pharmaceutical industry and make essential drugs more affordable and transparent.

Under the CalRx? Naloxone Access Initiative, Amneal Pharmaceuticals, a newly onboarded partner, has obtained U.S. FDA approval for an over-the-counter (OTC) naloxone nasal spray product. This partnership enables California to purchase CalRx-branded OTC naloxone at a reduced rate of $24 per pack, representing a 40% reduction compared to current prices. This price cut equates to a substantial increase in the state's purchasing power, allowing for the acquisition of 3.2 million twin-packs of naloxone, up from the previous 2 million.

Through its Naloxone Distribution Project, the state aims to distribute many of these packs for free to first responders, universities, and community organizations. It also hopes to make naloxone available to businesses and local governments at a?discounted rate, provided they agree not to sell it for profit.

The CalRx? Program?aims to ensure?that essential medications, including naloxone, are accessible to all Californians, regardless of their financial circumstances. This initiative will further bolster the Naloxone Distribution Project (NDP), which has already distributed over 4.1 million naloxone kits and resulted in more than 260,000 reported opioid overdose reversals.

The?first steps?were announced?in July of 2023. Governor Gavin Newsom emphasized the importance of naloxone as a life-saving medication and underscored California's commitment to combatting the opioid epidemic. The state planned to allocate $30 million to support partners in developing, manufacturing, and distributing naloxone nasal products under the CalRx label.

Naloxone nasal spray will be the first medication under the CalRx label, part of Newsom's strategy to compel drug companies to lower prices by offering more affordable alternatives. This move aligns with California's history of producing its?own?medications, such as the treatment for infant botulism since 2003.

The deal with Amneal Pharmaceuticals?is expected?to yield significant benefits, enabling California to purchase more naloxone at a lower cost. This development comes amidst a surge in opioid overdose deaths in California and nationwide, prompting urgent action to expand access to life-saving medication.

Additional medications may be added?to the pipeline in the future. The administration is pursuing a partnership with Civica to reduce the cost of insulin for California residents in need.

Did you know the FDA Approved the first Over-the-Counter Naloxone Nasal Spray last year?

While the FDA approval for Naloxone took place in March of 2023, it's worth sharing this life-saving resource when discussing Fentanyl and its impact on our communities. This approval expands access to the general public by making Naloxone an over-the-counter medication that can be purchased without a prescription.

"The U.S. Food and Drug Administration approved Narcan, 4 milligrams (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores, and gas stations, as well as online." (FDA)

Our Internal Clocks Impact the Way We Respond to Medications

A recent study from MIT, which had?potential benefits for drug development and treatment planning, found that?over 300 genes in the liver are influenced by circadian rhythms. These daily variations impact the availability of drugs in the body and the efficiency with which they are metabolized. Researchers' findings reveal that the timing of drug administration could significantly affect?the prescription's metabolism?in the liver. By utilizing miniature livers cultivated from human cell donors, researchers discovered?numerous?genes responsible for drug metabolism that follow a circadian rhythm, affecting drug availability and breakdown efficiency. For instance, the study revealed that enzymes responsible for metabolizing medications like Tylenol are more prevalent during specific times of the day.

Sangeeta Bhatia, MIT professor and senior author of the study, highlights the potential application of this discovery in optimizing drug regimens for maximum effectiveness and minimal toxicity.?Bhatia shares, "One of the earliest applications for this method could be fine-tuning drug regimens of already approved drugs to maximize their efficacy and minimize their toxicity."

Of the 300+ liver genes regulated by circadian cycles that MIT's team identified, many are involved in drug metabolism and also inflammation. Additionally, the research uncovered that the liver is particularly vulnerable to infections like malaria during specific phases of the circadian cycle. Researchers observed variations in the expression of genes involved in immune responses, which impact infection rates.?This susceptibility coincides with periods of reduced production of inflammatory proteins, highlighting the importance of understanding the liver's circadian dynamics in infection susceptibility.

Bhatia shared, "The inflammatory signals are much stronger at certain times of day than others. This means that a virus like hepatitis or parasite like the one that causes malaria might be better at taking hold in your liver at certain times of the day."

Lead author Sandra March emphasizes the importance of identifying the ideal time of day for drug administration to enhance therapeutic outcomes while minimizing adverse effects. Her team suspects that the cyclical nature observed could be due to the liver's reduced response to potential threats and pathogens after meals. During this time, the liver?is exposed?to?an influx?of microorganisms, which could trigger inflammation even if they aren't?harmful.

Currently,?Bhatia's lab is capitalizing on these patterns to study infections that are typically difficult to simulate in lab-grown livers. This?includes exploring malaria infections caused by parasites other than Plasmodium falciparum. March remarks, "This is quite important for the field because just by setting up the system and choosing the right time of infection, we can increase the infection rate of our culture by 25 percent, enabling drug screens that were otherwise impractical.

This groundbreaking research, supported by various funding sources, including?MIT International Science and Technology Initiatives,?the U.S. National Cancer Institute, and the National?Institutes of Health and Research of France, opens new avenues for optimizing drug therapies and understanding the dynamics of liver function.

Source: Massachusetts Institute of Technology

Unlocking the Mysteries of Exercise: Exploring its Cellular Effects

The transformative power of exercise is now more evident than ever. In?a recent study conducted on rats, scientists with the Molecular Transducers of Physical Activity Consortium (MoTrPAC) have discovered that physical activity causes a profound and comprehensive impact on all 19 organs they examined.?This breakthrough reveals that the human body has an incredible capacity for change, and through exercise, we can unleash its full potential.

The latest research reveals that?exercise sparks cellular and molecular changes throughout the body beyond what was previously understood. By studying various tissues, including the brain, heart, and lungs, scientists observed measurable differences in each organ in conjunction with exercise. These changes helped regulate immune function and stress response and aided the control of pathways connected to inflammatory liver disease, heart disease, and tissue injury.?

Traditionally, studies on exercise?and health focused on individual organs or specific aspects. However, MoTrPAC's multi-faceted approach provides a broader perspective. By analyzing molecular changes across multiple tissues, researchers uncovered insights into conditions like liver disease and tissue injury. They found clues explaining why exercise reduces fatty liver, potentially informing future treatments.

The team aims to personalize exercise regimens based on?an individual's?health status and develop exercise-mimicking therapies for those unable to engage in physical activity. Carr, the Co-senior author of the study, shared, "This is the first whole-organism map looking at the effects of training in multiple different organs. The resource produced will be enormously valuable and has already produced many potentially novel biological insights for further exploration."

MoTrPAC, launched in 2016, combines expertise from leading institutions to illuminate the biological mechanisms underlying exercise benefits. In total, the team conducted nearly 10,000 assays to make about 15 million measurements on blood and 18 solid tissues to find out how exercise impacts our bodies. Their findings revealed that exercise influenced thousands of molecules, with the most significant alterations observed in the adrenal gland.

This gland, responsible for secreting hormones crucial for functions like immunity, metabolism, and blood pressure regulation, showed pronounced changes due to exercise. Additionally, the scientists identified sex-based disparities in various organs, particularly concerning the immune system's response over time. Notably, immune-signaling molecules specific to females exhibited fluctuations within one to two weeks of training, while those in males showed differences between four to eight weeks.

This groundbreaking research underscores the necessity of integrated studies to grasp the full scope of exercise's health benefits and paves the way for tailored treatments and exercise strategies. Available in a public repository, other

scientists will now have the opportunity to analyze the data and utilize this study for their own research.

Source: Broad Institute of MIT and Harvard

U.S. Engagement Hits 11-Year Low

A Gallup study found that employee engagement in the American workforce is at its lowest level in over a decade. The data indicates a significant disconnect between workers and their organizations, with employees reporting reduced role clarity, decreased satisfaction, and weakened ties to their company's mission.

Remote, hybrid, and younger workers are most affected. By the end of 2023, only 33% of U.S. employees were highly engaged, dropping further to 30% in Q1 2024. This decline represents a staggering 4.8 million fewer engaged employees.

"Post-pandemic engagement trends vary widely across age generations, with younger employees feeling the most detached from their work and employers but baby boomers remaining engaged" (Jim Harter, Gallup).

Employee engagement is critical as it correlates with various performance outcomes essential to organizational success, including productivity, retention, customer service, and profitability. However, the current state of engagement in the U.S. is worrying, with only 1.8 engaged employees for every actively disengaged worker.

However, some organizations have successfully prioritized workplace culture and employee well-being, boasting an impressive 70% engagement rate. Despite the challenges posed by the pandemic, these organizations have thrived by fostering hybrid work environments and prioritizing employee wellness initiatives.

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