Anencephaly

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"

From the Middle Ages to the Enlightenment, 'monstrous births' -- malformed or anomalous fetuses -- were, to Western medicine, an object of superstition. In 19th-century America, they became instead an object of the 'modern scientific study of monstrosity,' a field formalized by French scientist Isidore Geoffroy Saint-Hilaire. This clinical turn was positioned against the backdrop of social, political, and economic activity that codified laws governing slavery, citizenship, immigration, family, wealth, and access to resources. From the Middle Ages to the Enlightenment, "monstrous births" -- malformed or anomalous fetuses -- were, to Western medicine, an object of superstition. In 19th-century America, they became instead an object of the "modern scientific study of monstrosity," a field formalized by French scientist Isidore Geoffroy Saint-Hilaire. This clinical turn was positioned against the backdrop of social, political, and economic activity that codified laws governing slavery, citizenship, immigration, family, wealth, and access to resources. In a new article published in Isis: A Journal of the History of Science Society, "Monstrosity in Medical Science: Race-Making and Teratology in the Nineteenth-Century United States," Miriam Rich demonstrates how scientific interest in monstrous births served as a mechanism for stabilizing notions of race and racial hierarchy, and shaped modern medical discourse into a project of making race. Rich presents three frameworks, or "logics of race," that structured the study of monstrous birth, beginning with the schema of development in the field of teratology. Teratology, informed by the theory of epigenesis, proposed that monstrosity was caused by an arrest in the development of a fetus before it could reach its final, more perfect form. This model was predicated on a belief in both teleological progress and a hierarchy of being. It overlapped with taxonomies of race that placed white Europeans at the top, and therefore implied a correlation between infant "monsters" and the racialized subjects who fell farther down the continuum of species. As Rich writes, "Through the scientific framework of teratological development, monstrosity gained specificity as a way to articulate the nature of racial difference -- as hierarchical, temporalized, and biologically embodied." The second logic of race articulated by Rich is that of the monster as "a race apart." The "race apart" framework proposed that monstrous births comprised their own species, distinct even from human race categories, and was supported by the fact that monsters could be born to women of any race. Rich draws upon the examples of an enslaved Black woman in Georgia and a white English woman in Philadelphia, both of whom gave birth to infants with anencephaly. As she notes, "Within a leading taxonomic cosmology of the era's medical science…the two women in these cases did not belong to the same species as one another -- but, remarkably, their monstrous infants did." Rich suggests that despite the departure this theory represents from contemporary notions of race as congenital and immanent, the "race apart" thesis was ultimately used to legitimize a system of racial hierarchy. The third and final logic of race examined in this article is that of "monstrosity as racial degeneracy." In the aftermath of Emancipation, fears on the part of white hegemony regarding the destabilized racial categories that slavery had once upheld were transmuted into fears regarding social and evolutionary decline. Since the favored model of Darwinian evolution at this time was one of progress, and the theory of teratology had conflated fetal developmental progress with whiteness, monstrous births in this period were seen as signs of atavism, and thus of regression into non-whiteness. In addition to reinforcing the racial boundaries of the late 19th-century, Rich writes, this schema of monstrosity would also pave the way for early 20th-century eugenics. In this article, Rich argues that the interpretation of monstrosity used by 19th-century scientists had significant implications for the racial caste system in the United States and for medicine as a discipline. The study of monstrous births shaped human reproduction into a site of the inscription of fixed racial difference, and embedded within modern medical discourse a practice of racial hierarchy.

ROCKAWAY, N.J. and CHARLOTTE, N.C., Nov. 1, 2022 /PRNewswire/ -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage, bioelectronic medicine company, announced today that gammaCore Sapphire™, the first and only FDA cleared non-invasive device to treat and prevent multiple types of headache pain via the vagus nerve, will be distributed and billed exclusively by Joerns Healthcare, LLC (Joerns) within select managed care health systems. "Joerns' mission is to simplify care delivery so providers can focus on patients' needs and payors can be confident that the best value-based therapies are available to their beneficiaries," said Doug Ferguson, Chief Strategy Officer at Joerns Healthcare. "Assisting in the distribution and billing of electroCore's Sapphire nVNS therapy will make it easier for managed care and other providers to ensure their patients have access to optimal therapies when and where they need them." "We are excited to be working with Joerns as we expand patient access to our therapy," commented Dan Goldberger, Chief Executive Officer of electroCore. "Joerns is a trusted partner of many large managed care companies, and this partnership enables us to expand the use of gammaCore nVNS technology for sufferers of primary headache within a self-insured managed care organization, reinforcing the company's strategy of providing patients with greater access and ease to our nVNS therapy." About Joerns Healthcare, LLC Joerns Healthcare is a healthcare technology and equipment services company focused on driving the transformation of care nationally across the post-acute continuum. We are simplifying the complex post-acute care world by providing the technology, professionals, products, and data to help streamline the process, so providers concentrate on care. Joerns brings our national service footprint, the right products, and over 130 years of expertise to help navigate the new complexities that surround accountable care and optimize patient and financial outcomes. For more information, visit Joerns.com. About electroCore, Inc. electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company's current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults. For more information, visit . About gammaCore™ gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore is self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient's neck over the vagus nerve, gammaCore stimulates the nerve's afferent fibers, which may lead to a reduction of pain in patients. gammaCore (nVNS) is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults. gammaCore is contraindicated for patients if they: Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone) Safety and efficacy of gammaCore have not been evaluated in the following patients: Adolescent patients with congenital cardiac issues Patients diagnosed with narrowing of the arteries (carotid atherosclerosis) Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy) Pediatric patients (less than 12 years) Pregnant women Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia For more information, please visit gammaCore.com Forward-Looking Statements This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the Company's business prospects through Joerns, Kaiser and other self-insured managed care organizations or other new markets or other distribution agreements and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore's business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore's results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at . Media Contacts: Joerns Healthcare Lindy Plummer [email protected] CG Capital Rich Cockrell 404-736-3838 [email protected] SOURCE Joerns Healthcare