Spinal Dysraphism

A team of international researchers has demonstrated, for the first time in a field study, that using folic acid-fortified iodized table salt can prevent multiple severe birth defects. A team of international researchers -- including experts from the University of Central Florida and Emory University -- has demonstrated, for the first time in a field study, that using folic acid-fortified iodized table salt can prevent multiple severe birth defects. The importance of women having enough folic acid in their bodies before and during pregnancy to prevent permanent and life-threatening birth defects, such as spina bifida and anencephaly, has been known for decades. The World Health Organization recommends that all women should take supplement pills with 400 micrograms of folic acid daily, from the moment they begin attempting to conceive through the first three months of pregnancy. Mandatory staple food fortification with folic acid is a cost-effective, safe, and an equitable way to address the issue. In May 2023, the World Health Assembly adopted a resolution promoting food fortification with folic acid to accelerate the slow pace of prevention of spina bifida and other birth defects associated with low maternal folate levels at the time of early pregnancy. Yet approximately 260,000 births worldwide -- about 20 per every 10,000 births -- are still affected by spina bifida and anencephaly, contributing to a high number of stillbirths, elective pregnancy terminations, and deaths of infants and young children. The problem While folic acid has been added through mandatory staple grain food fortification in about 65 countries, including the United States, more than 100 countries have yet to implement fortification due to challenges that include limited capacity for large-scale fortification of staple grains in these regions or lack of political will. A solution A new study published Friday by JAMA Network Open showed that a solution is not only possible, many people already have it on their kitchen tables. The clinical trial showed that mixing folic acid to commercially available iodized table salt, based on the existing average daily consumption of salt, increased serum folate levels among participants to levels needed for prevention of spina bifida and anencephaly. The increase was significant, a 3.7-fold improvement before and after a four-month period of using the study salt with iodine and folic acid. "We proved that folic acid can get into the blood through salt. Hopefully countries that have not already implemented fortification programs can now look at their infrastructures and realize that salt fortification is cheap and it's really easy to add in the amount of folic acid needed to save lives," says Jogi Pattisapu, MD, the study's lead author and a neurosurgeon from UCF's College of Medicine. "It might just turn the salt a little yellow, but the participants did not mind and we know it works. What we need now is action." Why it matters Pattisapu credits the study's successful outcome to the collaborative nature of the research team, specifically the efforts and expertise of researchers from Emory University's Rollins School of Public Health and the colleagues from multiple institutions in India, who co-led the study and recruited and monitored the 83 non-pregnant women -- who were between the ages of 18-45, from four different villages in southern India -- who consumed the folic acid-fortified salt as part of their regular diet during a four-month period in 2022. India has a high prevalence of spina bifida and anencephaly. "Work was done there, by the Indian team, for their cause," Pattisapu says. "That was very important, and it is a powerful message." Even though food fortification is mandatory in the United States, the researchers say the impact of this new study could be felt globally in countries with successful salt iodization programs. "This is a global goodwill involving the health of mothers and babies. We are making sure we apply the knowledge we have," says Vijaya Kancherla, an associate professor in the Department of Epidemiology at Rollins. "These are preventable birth defects and once it happens, you cannot cure it. Surgeries and clinical care are expensive and largely not available in low- and middle-income countries. Due to that, most babies with spina bifida die globally. So, it is a human rights issue that everyone should be worried about and should strive to find alternate solutions that prevent these conditions from occurring in the first place, no matter where one is born. We show that salt has the potential to close the prevention gap now." The researchers also made it clear the study does not promote salt intake, but rather adding the necessary amount of folic acid to the table salt that residents of these regions are already consuming. If the average daily salt consumption is reduced in these regions, the concentration of folic acid would simply be increased, to meet the need. This approach is already used in grain fortification program. The researchers said at least 50 percent of the current global spina bifida cases would be prevented if the major, already existing iodized salt programs took the simple step of adding folic acid. "We now know folic acid fortification of iodized salt can prevent folate deficiency that causes spina bifida," says Godfrey Oakley Jr., MD, director of the Center for Spina Bifida Prevention at Rollins. "The stage is now set for a rapid acceleration of prevention of these birth defects in many countries"

Teams Will Develop Solutions to Advance Patient Healthcare in the Pharmacy and Infusion Therapy Space BETHLEHEM, Pa., March 5, 2024 /PRNewswire/ -- B. Braun Medical Inc. (B. Braun), a leader in smart infusion therapy and pain management, today announced a collaboration agreement with Orlando Health, a nationally recognized healthcare provider with award-winning hospitals, to jointly develop innovative solutions to increase access to care for patients and clinicians. With a focus on the disruption across the pharmacy and infusion therapy landscape, the collaboration centers on early clinician feedback to identify needs and develop solutions to address those needs. "The idea behind this unique effort is getting together the right people to help bring impactful innovations to market," said Michael Schmidt, Vice President of Strategic Innovations at Orlando Health. "Our frontline clinical team members can bring both idea generation and provide quick feedback on prototypes, and B. Braun has the commercial and manufacturing know-how to bring these ideas to life. It's a true collaboration." The innovation teams that will form under the collaboration will consist of interdisciplinary colleagues from B. Braun and Orlando Health. By combining B. Braun's dedicated, cross-functional incubator team with over 200 years of commercial, technology and operational proficiency with Orlando Health's tremendous clinical and healthcare expertise, the teams can rapidly identify and develop the most promising solutions. "This collaboration provides us access to Orlando Health's broad, diverse team to help enable rapid developments with vital confirmation from clinicians on the front lines," said Mike Golebiowski, Corporate Vice President, Healthcare Strategy and Innovation at B. Braun. "Their feedback on both the need and the practicality of ideas in the early stages of the innovation cycle is invaluable to helping develop the right solution, reduce time to market and advance patient healthcare." B. Braun and Orlando Health plan to publish the various findings that come out of this collaborative, with the goal of pursuing commercialization of the technologies that have the strongest potential for adoption by other healthcare systems. About B. Braun B. Braun Medical Inc. (B. Braun) is a leader in smart infusion therapy and safe and effective pharmacy products, patient and provider safety, and sustainable health solutions. Our purpose is to help providers constantly improve patient satisfaction and outcomes. With products and services created to help healthcare professionals focus on what matters most—their patients—we're uniquely positioned to help health systems succeed now and in the future. B. Braun is headquartered in Bethlehem, Pennsylvania and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®. The company employs 8,500 people at over 30 locations across North America. Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, explore our website. About Orlando Health Orlando Health, headquartered in Orlando, Florida, is a not-for-profit healthcare organization with $9.6 billion of assets under management that serves the southeastern United States and Puerto Rico. Founded more than 100 years ago, the healthcare system is recognized around the world for Central Florida's only pediatric and adult Level I Trauma program as well as the only Adult Trauma Center in Pinellas County. It is the home of one of the nation's largest neonatal intensive care units, one of the only systems in the southeast to offer open fetal surgery to repair the most severe forms of spina bifida, the site of an Olympic athlete training facility and operator of one of the largest and highest performing clinically integrated networks in the region. Orlando Health has pioneered life-changing medical research and its Graduate Medical Education program hosts more than 350 residents and fellows. To learn more about Orlando Health, visit their website. SOURCE B. Braun Medical Inc.

SAN JUAN, Puerto Rico, Feb. 12, 2024 /PRNewswire/ -- Attorneys for Milberg Coleman Bryson Phillips Grossman ("Milberg"), Napoli Shkolnik, and Kresch Legal Services PR have filed an amended proposed class action complaint on behalf of Puerto Rico residents who claim they were injured by ethylene oxide (EtO) emissions from sterilization facilities located in the Commonwealth. Ethylene oxide is a colorless gas emitted by plants that use it to sterilize medical equipment and produce chemicals. Known to cause cancer, EtO is one of the most toxic air pollutants regulated by the Environmental Protection Agency (EPA). More than 14 million people in the U.S.—most of them residents of low-income, non-English speaking communities of color—live within five miles of a facility that emits ethylene oxide. Emissions are alarmingly prevalent in Puerto Rico, where there are seven sterilizer plants, including four of the most dangerous facilities, according to a report from the Union of Concerned Scientists. The report found that roughly 13% of Puerto Rico's neighborhoods are impacted by the release of EtO from medical facilities. "Hundreds of thousands of Puerto Ricans have, unknowingly, been breathing air poisoned by the defendants," said Environmental Attorney Wendy Kerner of Kresch Legal Services. "These corporations have chosen to use ethylene oxide at their facilities when feasible alternatives were available, causing unimaginable, yet preventable, suffering across the island." The lawsuit alleges that sterilization companies Customed, Inc., Medtronic PR, Inc., Edwards Lifesciences Technology Sarl, and Steri-Tech, Inc. have emitted large quantities of EtO into the air for decades in Puerto Rico, despite evidence of its human harms and without warning residents. The plaintiffs, suffering from ailments that include spina bifida, fibromyalgia, thyroid issues, asthma, and cancer, are seeking injury compensation as well as medical monitoring costs for Puerto Ricans affected by EtO exposure. "Corporations like the defendants often concentrate their environmental harms in communities that are the least able to fight back against them," said Milberg Senior Partner Marc Grossman. "Puerto Rico is the poorest U.S. jurisdiction, and people of color make up 99% of the population within five miles of the defendants' sterilizers." The carcinogenic and DNA-damaging effects of EtO have been widely studied and known since the 1940s and definitively known to the defendants since at least 1984, the lawsuit states. However, the defendants chose to operate their facilities and emit the dangerous gas in the densely populated areas of Añasco, Fajardo, Salinas, and Villalba. "Of particular concern in this case is the health of children and community members who may appear healthy today, but due to years of inhaling EtO emitted by the defendants are far more likely to develop potentially fatal injuries in the years to come," said Napoli Shkolnik Associate Nevin Wisnoski. "We seek what the common law has always been intended to provide through damages—compensation and deterrence. Medical monitoring for these impacted communities is a critical aspect of reaching that aim." The suit has been filed in the Federal District Court of Puerto Rico, Case Number 3:23-cv-1445. More updates will be provided as the case develops. About Milberg Coleman Bryson Phillips Grossman: For over 50 years, Milberg and its affiliates have defending the rights of victims of corporate wrongdoing and have recovered over $50 billion for clients. A pioneer in class action litigation, the firm has been recognized as leaders in the plaintiffs' bar and appointed to numerous leadership roles in prominent national mass torts and class actions. About Napoli Shkolnik: Napoli Shkolnik is an international litigation firm providing representation to persons in class action lawsuits and complex commercial cases, as well as victims of environmental contamination disasters, aviation accidents, defective prescriptions drugs and medical devices, asbestos-related illnesses, and other serious personal injury matters. About Kresch Legal Services PR: 1-800-LAW-FIRM is a team of seasoned lawyers who strongly believe in holding accountable companies that put profits over people. The firm joins forces with the nation's best law firms to pursue litigation related to personal injuries, consumer protection, environmental hazards, civil rights violations, and other matters. Media Contact: Karine Lim [email protected] SOURCE Milberg Coleman Bryson Phillips Grossman PLLC