WIN A 2020 FORD MUSTANG CONVERTIBLE

🧬 What Happened FDA Request: On July 18, the FDA informally asked Sarepta to voluntarily halt all U.S. shipments of its Duchenne DMD gene therapy, Elevidys—a move driven by safety concerns after three patient deaths due to acute liver failure. This included two fatalities in teenage Duchenne patients treated with Elevidys and a third in an adult patient from a different Sarepta gene therapy trial . Initial Pushback: Sarepta initially resisted, stating there were no new safety concerns for ambulatory patients (those who can walk), and maintained shipments for that group. They had previously paused shipments for non-ambulatory patients earlier in the year after two deaths . Reversal and Pause: On July 21–22, Sarepta reversed course and voluntarily paused all shipments in the U.S. by end of business Tuesday, July 22, 2025, to cooperate with the FDA, respond to inquiries, and complete a revised safety labeling for Elevidys . --- 📌 Why It Matters Safety Labeling Update: The pause allows Sarepta and the FDA time to add a stricter warning (including a new black-box liver-risk warning) and possibly implement a Risk Evaluation and Mitigation Strategy (REMS) for monitoring liver safety . Regulatory Relations: CEO Doug Ingram labeled the decision “painful,” but necessary for maintaining a collaborative and constructive relationship with the FDA . Market Impact: Sarepta’s stock plunged, falling as much as 8–5% on the news, and is down nearly 90% year to date. Analysts warn that the pause and black-box warning could severely affect Elevidys uptake and 50–61% of Sarepta's revenue . --- 🔍 What’s Next Duration of Pause: The pause could extend 3–6 months while safety data is reviewed and label changes are finalized . Potential Outcomes: Resumption: Elevidys could return under new safety protocols/label. A REMS program may be required . Market Withdrawal: Analysts caution on the possibility of permanent withdrawal if FDA's safety concerns aren't resolved . Pipeline Impact: FDA has also placed a clinical hold on Sarepta’s other gene therapy trials (including for Limb-Girdle Muscular Dystrophy) and revoked platform tech designation due to the shared AAVrh74 viral vector . --- ✅ In Summary Key Takeaway Details Pause in effect All U.S. Elevidys shipments halted since end of business July 22 Why Safety concerns after 3 liver-related deaths from same viral vector Next steps Label update, FDA review, possible REMS; uncertain pause duration Risks Potential permanent withdrawal, impact on revenue, and pipeline delays

This article originally appeared on www.statnews.com , written by Christine McSherry—a registered nurse and founder of the Jett Foundation—on June 18, 2025.

Aluminum is the third most abundant element in the Earth's crust and has a wide range of industrial and household applications. However, increasing evidence suggests that aluminum exposure may pose health risks, particularly concerning brain health and toxicity. In this article, we’ll explore what aluminum is, how it affects our bodies—especially the brain—and how it may contribute to neurodegenerative diseases like Alzheimer’s. We’ll also discuss sources of aluminum exposure, methods of testing for toxicity, and natural approaches to detoxification. 

We are incredibly honored to share that JAR of Hope has been named the 2025 Non-Profit of the Year by the Monmouth Regional Chamber of Commerce as part of their prestigious Beacon Awards . The Beacon Awards are designed to recognize organizations that exemplify outstanding community enrichment through service, leadership, and achievement. It means so much to us that both the MRCC membership and the community at large recognized the work we do and the mission we live by every day. This award is not just a recognition of our team’s efforts—it’s a reflection of the amazing community that supports us, believes in our cause, and stands with us in the fight to raise awareness, fund research, and bring hope to families affected by Duchenne Muscular Dystrophy.

As research into autism spectrum disorder (ASD) continues to evolve, one intriguing area of study is the role of the microbiome—the trillions of microorganisms living in our guts. Emerging evidence suggests that the health of our microbiome may have significant implications for children with autism, particularly in relation to gut disorders and neurological development. This blog explores the connection between the microbiome and autism, emphasizing the importance of detailed stool analyses, checking for parasites, and understanding the gut-brain relationship. What is the Microbiome? The microbiome refers to the vast community of bacteria, viruses, fungi, and other microorganisms that inhabit our digestive systems. These microorganisms play a crucial role in digestion, immunity, and even brain function. In children with autism, studies have indicated that there may be an imbalance in the microbiome, often referred to as dysbiosis. This condition can lead to gastrointestinal issues that are commonly reported in children with ASD, such as constipation, diarrhea, and abdominal pain.

A groundbreaking study published in Cell on January 23, 2020, has identified 102 genes associated with autism spectrum disorder (ASD), including 30 previously unlinked to the condition. Led by Joseph Buxbaum, director of the Seaver Autism Center for Research and Treatment at Mount Sinai, the research analyzed over 35,000 DNA samples, nearly 12,000 of which were from individuals with autism. The study leveraged advanced genetic sequencing technologies and data from the Autism Sequencing Consortium, an international collaboration of scientists sharing samples and data since 2010. By comparing genetic sequences from individuals with autism to their siblings and to unaffected individuals, the researchers identified both inherited mutations and spontaneous (de novo) genetic alterations that may contribute to ASD. Notably, the research distinguished genes more closely associated with autism from those linked to other neurodevelopmental disorders, such as intellectual and motor disabilities. This differentiation enhances our understanding of autism's molecular mechanisms and could inform the development of targeted treatments. Dr. Geraldine Dawson, director of the Center for Autism and Brain Development at Duke University, hailed the study as "one of the most important, comprehensive studies on the genetics of autism to date," emphasizing its role in elucidating the complex genetic landscape of ASD. ​ This research represents a significant step forward in autism genetics, offering hope for more personalized and effective interventions in the future. January 24, 2020 2:19 PM EST Time Magazine

A new study is shedding light on the potential of CBD to ease behavioral challenges in children with autism. Researchers in Israel found that cannabidiol (CBD), a non-psychoactive compound derived from cannabis, significantly improved symptoms like anxiety, aggression, and restlessness in kids on the spectrum. The peer-reviewed study, published in the journal Translational Psychiatry, followed 82 children and teens with autism who were treated with CBD-rich cannabis oil for six months. Results showed that many experienced meaningful improvements in behavior and social communication — with minimal side effects. Parents reported reduced irritability, fewer outbursts, and better sleep among participants. One mother shared that her nonverbal son began using more words and expressing emotions for the first time. While researchers emphasized that CBD isn’t a cure for autism, they believe it could be a safe and effective option to support children with challenging symptoms — especially when traditional treatments fall short. As interest in alternative therapies grows, this study adds to the growing body of research suggesting that CBD may offer a new avenue of hope for families navigating autism. Published April 8, 2025, 9:46 a.m. ET New York Post

As autism diagnoses continue to rise in the U.S., scientists are exploring innovative treatments — and one unexpected option may be a generic cancer drug. Leucovorin, typically used to reduce the side effects of chemotherapy, is showing remarkable promise in improving symptoms of autism. Over the past 13 years, Dr. Richard Frye, a pediatric neurologist, has gathered compelling evidence that leucovorin may help children with autism — including nonverbal kids who began speaking after treatment. While there’s no single “autism pill,” Frye believes leucovorin offers real hope for some families. The drug’s potential lies in its ability to bypass a condition called cerebral folate deficiency (CFD), which is linked to low levels of folate in the brain. Many children with autism have been found to carry folate receptor autoantibodies that block the brain’s folate transport. Leucovorin, a folic acid derivative, can restore folate levels despite this blockage. Frye’s early patients often showed dramatic improvements — from reduced seizures to increased communication and social interaction.  With autism now affecting about 1 in 36 children in the U.S., the need for effective treatments has never been greater. While further research is needed, leucovorin is offering a surprising and hopeful path forward.

Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition that affects communication, behavior, and social interaction. As parents of autistic children, you may often find yourself navigating a maze of information, therapies, and treatment options. One approach that has gained traction in recent years is the biomedical model, which posits that by modifying certain environmental factors, we can help improve symptoms and enhance the quality of life for autistic individuals. The Genetic Component of Autism Autism is believed to have a genetic basis, with studies indicating that certain genetic factors may predispose individuals to develop the condition. However, it’s crucial to understand that not all genetic components are set in stone. Some genetic expressions can be influenced by environmental factors, meaning that changes in the environment can potentially modify how these genes function. One such gene of interest is the **MTHFR gene**. To simplify, the MTHFR gene is responsible for producing an enzyme that helps process amino acids—the building blocks of proteins—and is essential for the body's ability to use folate (a type of B vitamin). This gene plays a significant role in the methylation process, which is involved in regulating many bodily functions, including DNA repair and detoxification. When the MTHFR gene is not functioning optimally—often due to mutations—this can lead to a variety of health issues, including problems with metabolism and mental health. In the context of autism, some researchers believe that supporting the body's methylation process through dietary changes and supplements can help address certain symptoms associated with the disorder. The Role of Environment in Modifying Autism The biomedical approach emphasizes the idea that while some genetic factors may be permanent, many are modifiable through environmental changes. This could include dietary adjustments, lifestyle modifications, and the use of specific supplements aimed at enhancing overall health and well-being. For instance, research has shown that certain dietary interventions, such as gluten-free or casein-free diets, can lead to improvements in behavior and communication skills in some children with autism. Furthermore, ensuring adequate intake of vitamins and minerals, particularly those involved in the methylation process, can support brain health and function. A study published in *The Journal of Autism and Developmental Disorders* found that children with autism who were supplemented with methylcobalamin (a form of vitamin B12) showed improvements in communication and social skills. This illustrates the potential impact of targeted nutritional support in managing autism symptoms. The Mind-Body Connection Another aspect of the biomedical approach is addressing the mind-body connection. Many doctors and scientists argue that by focusing on mental health and emotional well-being, we can facilitate better outcomes for autistic individuals. Stress, anxiety, and other emotional factors can exacerbate the challenges faced by children with autism. Therefore, therapies that promote mental wellness—such as cognitive-behavioral therapy, mindfulness, and relaxation techniques—can play a vital role in treatment. Furthermore, some researchers are investigating how gut health may influence autism symptoms. The gut-brain connection is increasingly recognized in modern medicine, and studies suggest that a healthy gut microbiome may positively impact behavior and cognitive function. This underscores the importance of a holistic approach that considers both physical and mental health. Conclusion While autism has genetic components that may be permanent, the biomedical approach offers hope for parents seeking to improve their child's condition through modifications in environment and lifestyle. By understanding the role of genes like MTHFR and the impact of nutrition and mental health, we can empower ourselves to make informed decisions about treatment options. As research continues to evolve, staying informed and connected with healthcare professionals who specialize in autism is essential. Remember, every child is unique, and what works for one may not work for another. Nevertheless, with the right support and interventions, the journey toward improved well-being for autistic individuals can be a positive and transformative experience. If you’re interested in exploring more about the biomedical approach to autism, consider connecting with professionals or support groups that focus on this area. Together, we can create a brighter future for our children.