Community Health Needs Assessment Implementation Strategy Now Available
 
April 8, 2021 – Lee Health’s Board of Directors recently approved the Community Health Needs Assessment Implementation Strategy and will begin executing the 2020-2023 plan, based on the needs identified in the Community Health Needs Assessment Report. 
 
The report identifies the health system’s four top priorities and the Implementation Strategy outlines methods to address these needs. The four priorities are access to healthcare services, cardiovascular and respiratory conditions (includes stroke and tobacco use), mental health and substance use disorder and nutrition, physical activity and weight (includes diabetes). 
 
Last November, Lee Health announced the release of the 2020 Community Health Needs Assessment, a systematic data-driven report that studies the health status, behaviors and needs of people living in Lee County. The purpose of the assessment is to identify major health concerns, gaps in services and other factors that may contribute to less than optimal health status for local residents.
 
“Based on the results of this process, the health system, its hospitals and community partners have worked together to develop strategies to address the highest areas of need,” said Chris Simoneau, chief foundation and development officer for Lee Health. “Implementation of programs identified in the plan are system- and community-wide and capitalize on opportunities to improve the health care delivery model and the health status of the residents of Lee County.”
 
Some program initiatives highlighted in the plan include:
 
The launch of healthy cooking demonstrations in conjunction with food distribution partners
Support community collaborations to increase behavioral health programs and services
Vaping and tobacco prevention education programs and initiatives targeting youth and young adults
Community collaborations addressing transportation as a barrier to access
Provide screenings, education and referrals in partnership with community stakeholders
Increase provider involvement in physical activity recommendation for improved health outcomes. 
 
“As a health care leader, Lee Health is committed to advancing health and wellness in the communities we serve,” said Larry Antonucci M.D., MBA, President and CEO at Lee Health. “We look forward to working with our community partners to continue to provide life-changing programs and services.”
 
The implementation plan integrates Lee Health’s mission and commitment to ongoing investments in the community to improve overall health of the community through strategic partnerships, strengthen integration and connection of health programs and services for defined populations and decrease avoidable hospital utilization and readmission.  
Not-for-profit hospitals and health systems are required to assess community health needs and provide community benefit reports annually every three years. Lee Health has been doing this for many years prior to such a requirement. 
 
Further information about the Community Health Needs Assessment and its implementation plan is available at www.leehealth.org/about-us/community-affairs/community-health-needs-assessment.
 
 
About Lee Health
Since the opening of the first hospital in 1916, Lee Health has been a health care leader in Southwest Florida, constantly evolving to meet the needs of the community. A non-profit, integrated health care services organization, Lee Health is committed to the well-being of every individual served, focused on healthy living and maintaining good health. Staffed by caring people, inspiring health, services are conveniently located throughout the community 
 
 
 
 



Study reveals how T cells in the small intestine respond to bile acids, offering localized treatment direction for a cause of chronic illness
 
April 7, 2021 – People with Crohn’s disease are typically treated with powerful anti-inflammatory medications that act throughout their body, not just in their digestive tract, creating the potential for unintended, and often serious, side effects. New research from the lab of Mark Sundrud, PhD, at Scripps Research, Florida suggests a more targeted treatment approach is possible. 
 
Crohn’s disease develops from chronic inflammation in the digestive tract, often the small intestine. More than half a million people in the United States live with the disease, which can be debilitating and require repetitive surgeries to remove irreversibly damaged intestinal tissue. 
Writing in the journal Nature on April 7, Sundrud’s team finds that certain immune cells in the small intestine have evolved a molecular sensing mechanism to protect themselves from the toxic effects of high bile acid concentrations there. This sensory mechanism can be manipulated with small drug-like molecules, they find. Treatment reduced small bowel inflammation in mice. 
 
“It seems that these immune cells, called T effector cells, have learned how to protect themselves from bile acids,” Sundrud says. “These T cells utilize an entire network of genes to interact safely with bile acids in the small intestine. This pathway may malfunction in at least some individuals with Crohn’s disease.”
 
Bile acids are made in the liver and released during a meal to help with digestion and absorption of fats and fat-soluble vitamins. They are actively recaptured at the end of the small intestine, in an area called the ileum, where they pass through layers of tissue that contain the body’s dense network of intestinal immune cells, and ultimately re-enter the blood stream for return to the liver.
 
Because they are detergents, bile acids can cause toxicity and inflammation if the system becomes unbalanced. The whole process is kept humming along thanks to an intricate signaling system. Receptors in the nucleus of both liver cells and intestinal barrier cells sense the presence of bile acid and tell the liver to back off on bile acid production if there’s too much, or to produce more if there aren’t enough to digest a big steak dinner, for example. 
 
Given how damaging bile acids can potentially be to cells, scientists have wondered how immune cells that live in or visit the small intestine tolerate their presence at all. Sundrud’s team previously reported that a gene called MDR1, also known as ABCB1, becomes activated when an important subset of immune cells that circulate in blood, called CD4+ T cells, make their way into the small intestine. There, MDR1 acts in transitory T cells to suppress bile acid toxicity and small bowel inflammation. 
In the new study, Sundrud’s team uses an advanced genetic screening approach to uncover how T cells sense and respond to bile acids in the small intestine to increase MDR1 activity.
 
“The basic discovery that T cells dedicate so much of their time and energy to preventing bile acid-driven stress and inflammation highlights completely new concepts in how we think about and treat Crohn’s disease,” Sundrud says. “It’s like we’ve been digging in the wrong spot for treasure, and this work gives us a new map showing where X marks the spot.”
 
The T cells contain a receptor molecule in their nucleus known as CAR, short for constitutive androstane receptor. Acting in the small intestine, CAR promotes expression of MDR1, and also plays a role in activating an essential anti-inflammatory gene, IL-10, the team found.  
“When we treated mice with drug-like small molecules that activate CAR, the result was localized detoxification of bile acids and reduction of inflammation,” Sundrud says.
 
Sundrud says exploring the therapeutic potential of CAR activation will require caution and creativity, because CAR is also critical for breaking down and eliminating other substances in the liver, including many medicines.
 
“Ultimately, the Crohn’s disease therapy that emerges from this work could be something that activates CAR locally in small intestinal T cells, or something that targets another gene that is similarly responsible for promoting the safe communication between small intestinal T cells and bile acids,” Sundrud says.
 
Also interesting, the team found that the bile acid-inflammation feedback system worked somewhat differently in the colon in concert with gut microbiome factors. While gut flora had more influence on T cell development and function in the colon, it was the nuclear receptor CAR that had more influence on inflammation in the small intestine. 
Inflammation plays both positive and negative roles in the body. It can damage tissue, but it also suppresses cancer growth and fights infections. The current anti-inflammatory treatments shut it down systemically, throughout the entire body. That can have potentially serious consequences, such as lowering resistance to infections or easing off the brake on cancer. Directing treatment for inflammatory diseases only to the affected tissue would be preferable whenever feasible, he says.  
“The roughly 50 million people living in the U.S. with some sort of autoimmune or chronic inflammatory disease are all treated the same, medically,” Sundrud says. “The holy grail would be to come up with druggable approaches to treat inflammation in only specific tissues and leave the rest of the immune cells in your body untouched, and able to fend of cancer and microbial infections.”
 
In addition to lead author Sundrud, the authors of the study, “CAR/Nr1i3 directs T cell adaptation to bile acids in the small intestine,” include first author Mei Lan Chen, plus Courtney Hegner, Yujin Liu, Jinsai Shang, Amber Eliason, HaJeung Park, Sarah A. Mosure, Laura A. Solt, Douglas J. Kojetin and Matthew E. Pipkin, all of Scripps Research, Florida; Deborah A. Schady, David D. Moore, Xiangsheng Huang, Hongtao Wang and Guohui Wang of the Baylor College of Medicine and Texas Children’s Hospital in Houston, Texas; Blake Frey and Casey Weaver of the University of Alabama at Birmingham; and Alex Rodriguez-Palacios of Case Western Reserve University in Cleveland, Ohio. 
 
The research was supported by the National Institutes of Health, R21AI119728, R01AI118931-01, U19AI109976, P01AI145815, the Crohn’s and Colitis Foundation, and the R.P. Doherty



Diabetes Research Institute Investigators Will Lead the First Site Activated for the Vertex Study
 
April 6, 2021 – Researchers with the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine and Vertex Pharmaceuticals Incorporated have initiated clinical trials for VX-880, a novel investigational cell therapy with the potential to restore normal glucose control in those suffering from type 1 diabetes (T1D) with severe hypoglycemia and impaired hypoglycemic awareness. The University of Miami Health System was the first clinical site activated for this trial. 
 
The program was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), which offers an expedited review process to accelerate treatments for urgent and unmet medical needs. It will evaluate the safety, tolerability and efficacy of VX-880 infusion in certain T1D patients. To be considered as a candidate for the trial, participants must have a clinical history of type 1 diabetes of at least five years, be 18-65 years of age, and have multiple episodes of severe hypoglycemia and impaired hypoglycemic awareness 12 months prior to enrollment. 
“It’s a remarkable time for T1D research efforts worldwide as this investigational treatment enters the clinic,” said Camillo Ricordi, M.D., Professor of Surgery, Director of the Diabetes Research Institute and the Cell Transplant Center at the University of Miami Miller School of Medicine, Steering Committee Chair for the VX-880 clinical trial and Principal Investigator at the University of Miami Health System clinical site. “The field’s experience with the limited cadaveric islet transplants available, where some patients have experienced prolonged insulin independence for years, provides important proof-of-concept for the potential of cell therapy to be transformative for patients living with T1D.”
 
The program’s groundbreaking work began in Dr. Doug Melton’s lab, who developed this line of insulin-producing pancreatic cells derived from stem cells. Vertex acquired Semma Therapeutics, the biotechnology company founded by Melton, in 2019.
 
Type 1 diabetes is an autoimmune disorder that occurs when the body’s immune system attacks its own insulin-producing islet cells. Once all the islets are destroyed, patients must take daily injections of insulin or use an insulin pump to replace the hormone. As one of the largest and most comprehensive research centers dedicated to curing diabetes, the Diabetes Research Institute is aggressively working to develop a biological cure by restoring natural insulin production and normalizing blood sugar levels without imposing other risks.
 
“I am grateful to the DRI team that will help with this unprecedented, first-in-human clinical trial. Representing the DRI heart of our entire translational and clinical efforts: the cGMP Advanced Cell and Biologic Product Manufacturing Facility (Dr. Elina Linetsky, Xiaojing Wang, Clarissa Lenero), the CCTP Clinical Cell Transplant Program (Dr. Rodolfo Alejandro, Dr. David Baidal, Dr. Raffaella Poggioli, Ana Alvarez) and the regulatory team (Dr. Kemraj Hirani, Luis Roque, Burlett Masters), and Dr. Prasoon P. Mohan, the UHealth interventional radiologist who will infuse the cells,” added Ricordi.
 
The University of Miami Health System was the first clinical site activated for this trial, that now also includes the University of Pennsylvania and Massachusetts General Hospital. The three clinical sites are open for enrollment, and additional sites will be activated this year. To learn visit clinicaltrials.gov.
 
 
 
 
About the Diabetes Research Institute and Foundation
The mission of the Diabetes Research Institute Foundation is to provide the Diabetes Research Institute with the funding necessary to cure diabetes now. The Diabetes Research Institute at the University of Miami Miller School of Medicine leads the world in cure-focused research. As one of the largest and most comprehensive research centers dedicated to curing diabetes, the DRI is aggressively working to develop a biological cure by restoring natural insulin production and normalizing blood sugar levels without imposing other risks. Researchers have already shown that transplanted islet cells allow patients to live without the need for insulin therapy. Some study participants have maintained insulin independence for more than 10 years. The DRI is now building upon these promising outcomes through its BioHub strategy, a multidisciplinary, three-pronged approach for addressing the major challenges that stand in the way of a cure: eliminate the need for anti-rejection drugs, reset the immune system to block autoimmunity, and develop an unlimited supply of insulin-producing cells. For more information, please visit DiabetesResearch.org or call 800-321-3437.
 
About Vertex and VX-880
For more information, please visit www.vrtx.com. 
 



BY: Nick Silverio, Founder

The Gloria M. Silverio Foundation
 
And my answer is — we save newborns from the ultimate in infant abuse, abandonment.
 
We support distressed pregnant girls and women from all walks of life. Through education, grass roots community involvement, direct assistance and our 24/7 confidential, multilingual referral helpline. To date, 332 precious newborns (two little ones this year) now have a future and lots of love with their forever family and over 5,000 women helped in their time of need. AND, most importantly there have been zero abandonments in five of the last ten years. Everyone is helped. We are never judgmental. We do not charge for any of our services. 
 
Our helpline receives over 2,000 calls annually. The callers have been as young as 13-years old and as old as 41. Our work is essential, therefore, we have worked safely every single day (24/7) since the beginning of the COVID-19 Pandemic; continuing to save lives, assist women in need and create greater awareness of this life-saving mission.
 
Fourteen precious little ones were welcomed into the world in 2020 and two little ones this year. We’ve helped all over Florida as well as many other states. That help came in the form of referrals to counseling, shelters, maternity homes, providing temporary housing, help for abuse issues, suicide calls, providing baby items and connection to Medicaid.
 
We implemented two important projects recently: The first is for a card to be given to the birth moms containing the message: Dear Birth Mother, you have given your baby a special gift, a chance for a future. Now, please take care of yourself. We can help you get a medical checkup, speak with a counselor, or answer any questions you may have. All calls are confidential. Please call us at 877-767-2229. 
 
We also created a Safe Haven for Newborns Community Service App for students to earn their required service hours from wherever they reside, in or out of the state of Florida.
 
So many wonderful life changing stories, the thousands of moms we helped, hundreds of babies that now have a future and the hopes and dreams of a forever family fulfilled.
 
What is more important and meaningful in life than saving a life, especially of a precious, innocent child, and then see the child grow; intellectually, emotionally, physically, and spiritually with the love and guidance of their forever parents.
 
In a perfect world, there would be no need for an organization such as a Safe Haven for Newborns. But, our world is far from perfect, and all we can do is try to make our piece of it a better place. We cannot save every infant and guide every troubled mother, but we can make a difference for as many as possible, and we will never stop trying. 
 
I am so grateful for the trust & confidence expressed by so many. Thank you to our Safe Haven for Newborns Ambassadors, Friends of Safe Haven who believe in our mission and to our wonderful statewide Safe Haven “partners”- Hospitals and Fire/EMS departments.
 
I leave you with the words of a local community leader who recently expressed to me that “this is God’s work."
 


 
 
 
 
 
 
 



April 6, 2021 – Golisano Children’s Hospital of Southwest Florida, in partnership with Ronald McDonald House Charities® of Southwest Florida, offers a free monthly autism spectrum disorder screening for toddlers 18 months to five years of age. 
 
The next screening will be held on Apr. 23, 2021, from 9 a.m. to 2 p.m. at the Pediatric Specialist Office, 15901 Bass Rd, Suite 102, Fort Myers.
 
It is estimated that one in every 59 children is diagnosed with some form of Autism Spectrum Disorder, making it more common than childhood cancer, juvenile diabetes and pediatric AIDS combined. 
 
Medical consultants for the project stress that an early diagnosis can make a vast difference for toddlers and their families. They say early intensive behavioral intervention can make an immense difference not just in the development of the child, but in their families as well.
 
The ASD screening is conducted by the Golisano Children’s Hospital of Southwest Florida. The screenings are administered by an Advanced Practice Registered Nurse, who has extensive training and experience in typical child development and developmental disorders. 
 
A physician referral is not required. To schedule a screening, please call 239-343-6838. 
 
About Golisano Children’s Hospital
Established in 1994, Golisano Children’s Hospital of Southwest Florida has been named a “Top Hospital” three consecutive years by The Leapfrog Group. It is the only recognized children’s hospital between Tampa and Miami. Lee Health opened the new 134-bed Golisano Children’s Hospital in May 2017, relocating the children’s hospital from the adjacent HealthPark Medical Center. It includes comprehensive pediatric services including a 24-hour pediatric emergency department, hematology-oncology unit, milk lab, Regional Perinatal Intensive Care Center, and Level II and Level III NICU with 70 private rooms. Golisano Children’s Hospital is proud to have been named Soliant’s 2018 Most Beautiful Hospital in the U.S., a recognition determined by popular vote For more information, visit GolisanoChildrensSWFL.org
 
About Ronald McDonald House Charities®
Ronald McDonald House Charities® (RMHC®), is a non-profit, 501 (c) (3) corporation that creates, finds, and supports programs that directly improve the health and well-being of children and their families. Through its global network of nearly 290 Chapters in more than 64 countries and regions, and its three core programs: the Ronald McDonald House®, the Ronald McDonald Family Room® and the Ronald McDonald Care Mobile®, keeps families with sick children close to each other and the medical care their child needs at leading hospitals worldwide. RMHC programs not only provide access to quality health care, they enable family-centered care ensuring families are fully supported and actively involved in their children’s care. For more information, visit www.rmhcswfl.org