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  • Press Release Announcing 2024 Cohort

    Source: By: Tech4Eva Team Femtech rising in importance as Tech4Eva enters its 4th round The only Swiss based and Global FemTech accelerator,Tech4Eva, is entering its fourth round with another record number of applications. In its 2024 edition, the start-up acceleration program of Groupe Mutuel and the EPFL Innovation Park is supporting 17 start-ups from a wide range of fields, such as Menstrual & Maternal health, reproductive medicine, wellbeing or oncology for women. Among them are 2 start-ups from Switzerland. 189 companies from 45 countries applied for the fourth edition of the only Femtech acceleration program for start-ups in Switzerland - a new record and almost 29% more than last year. From the innovative companies offering solutions for women's health, 17 participants from 11 countries were selected. “We are very proud to be co-hosting the fourth edition of Tech4Eva. The importance of the Femtech sector is growing, but in many areas women's health is still underestimated or under-researched,” said Jérôme Mariéthoz, Head of Health and Pensions for Private Individuals at Groupe Mutuel. “By partnering with these innovative companies, we are emphasizing our commitment to raising awareness and adding value for our female customers.” The participating companies follow the equity-free program for six months and are closely supported by 40+ mentors who help them develop their business plan and go-to-market strategy and meet investors. They also become part of the growing Tech4Eva Femtech community. This year, we choose to scale more mature high-tech Femtech start-ups in developed healthcare systems, leveraging on the vast business network and Industrial expertise of EPFL Innovation Park. We encourage more forward looking corporates and foundations to join our initiative as partners to take care of numerous high potential projects coming from global south countries, to make a global impact on healthcare, comments Lan Zuo Gillet, Co-Founder and Director of Tech4Eva, and Deputy Managing Director, EPFL Innovation Park. This year's participants will present solutions for general women's health, reproductive medicine, pregnancy, postpartum, menopause and menstruation.  2 of them are from Switzerland and both active in Prevention/Oncology for women cancers: Calico Biosystems - www.calicobiosystems.com Calico Biosystems is a drug testing platform that predicts reliably the efficacy of anti-cancer drugs at the pre-clinical stage in cancer patients with the goal to deliver to women with cancer potent and affordable drugs. HeroSupport - https://www.herosupport.care/ HeroSupport SA is advancing radiation therapy treatment through the integration of 3D printing and surface scanning technology, a fast expanding new market. It provides comprehensive solutions for radiation oncology professionals, enabling precise and personalized treatments while enhancing patient experience. Selected International start-ups include: Ablatus Therapeutics - Luna https://lunatreatment.com/;Babyndex www.babyndex.eu/en/; CareNX Innovations www.carenx.com; CC Diagnostics www.cc-diagnostics.com; Cosm Medical www.cosm.care/; DeepLook Medical www.deeplookmedical.com/; EndoCure EndoCure.tech; Galena Innovations www.galenainnovations.com; Hamonia Healthcare www.harmoniahealthcare.com/;Hormona www.hormona.io; Mamotest www.mamotest.com; Namida www.namidalab.com;SinReglas www.sin-reglas.mx; Vital Start Health www.vitalstarthealth.com; andVivoSensMedical www.vivosensmedical.com This year's edition also features a novelty: Debiotech, a new partner of Tech4Eva, is offering technical support in the form of CHF 100,000 worth of in-kind services to a Tech4Eva start-up company, so that it can develop its solution together with the company. The winner of the prize is Ablatus Therapeutics - Luna. Congratulations! Laurent-Dominique Piveteau CEO of Debiotech commented: The project by Ablatus impressed us with the elegance of its solution and the real benefit it represents for patients suffering from a very disabling condition. This project is perfectly in line with what has driven the company for over 30 years: patient-centered innovation. But we would also like to congratulate all the candidates for the Debiotech Prize. The high quality of the projects identified by Tech4Eva made our selection task particularly difficult. On May 13, the fourth edition of Tech4Eva kicked off with a public event in Bern under the theme “Innovation with Impact”. The keynote was given by Laura Santos Carreras, Team Section Lead in Medical Technology at Helbling. She explained why strategic partnerships and the creation of a development roadmap are crucial to take Femtech projects from research to market launch. More information on the selected start-ups can be found here: https://www.tech4eva.ch/startups About Harmonia Healthcare Harmonia is a highly specialized women's health platform that combines cutting edge functional medicine treatment with science-backed resolution for underdiagnosed, undertreated and otherwise dismissed female-specific diseases. Initially focused on hyperemesis gravidarum, Harmonia's physician-lead research, diagnostic and treatment programs result in superior health outcomes and subsequently enhanced wellbeing and quality of life. For more information on Harmonia and hyperemesis gravidarum, or to learn if you might be suffering from hyperemesis gravidarum, visit www.harmoniahealthcare.com or connect with us on Instagram at @harmoniahealthcare.

  • Hyperemesis gravidarum theories dispelled by recent research: a paradigm change for better care and outcomes

    Source: By: Marlena Schoenberg Fejzo Published:May 22, 2024 Highlights Recent large studies reveal that exposure to hyperemesis gravidarum (HG) in utero is associated with not only adverse maternal/fetal outcomes but also increased risk for adverse child outcomes, including abnormal brain growth, neurodevelopmental delay, autism spectrum disorder, childhood cancer, and respiratory disorders. More attention to nutrient deficiencies and gestational weight gain is needed for HG patients. Hypersensitivity to the rise of the hormone growth and differentiation factor 15 (GDF15) during pregnancy is the main cause of nausea and vomiting (NVP) and HG. Gestational loss of appetite was likely a mechanism that provided an evolutionary advantage but is no longer necessary for humans. We are on the cusp of testing prevention methods such as priming patients with metformin to increase GDF15 prior to pregnancy to desensitize patients to its rise during pregnancy. Blocking GDF15 signaling during pregnancy may decrease symptoms, but questions remain. Abstract Nausea and vomiting (NVP) affect most pregnant women. At the severe end of the clinical spectrum, hyperemesis gravidarum (HG) can be life-threatening. The condition is fraught with misconceptions that have slowed progress and left women undertreated. Herein, recent scientific advances are presented that dispel common myths associated with HG related to maternal/offspring outcomes, etiology, and evolution. There is now strong evidence that (i) HG is associated with poor outcomes, (ii) a common cause of NVP and HG has been identified, and (iii) NVP is likely a protective evolutionary mechanism that occurs throughout the animal kingdom but is no longer necessary for human survival. Therefore, it is encouraging that we are finally on the cusp of testing treatments that may put an end to unnecessary suffering. Keywords hyperemesis gravidarum morning sickness nausea vomiting pregnancy Overview of Hyperemesis Gravidarum (HG) Most pregnancies are affected by NVP (see Glossary), and recently the main cause of NVP has been elucidated [1.]. Although given the common misnomer ‘morning sickness’, it is generally not limited to the morning [2.]. The condition affects approximately 70% of pregnancies, and over 24% of pregnant women in the USA are prescribed antiemetic medication [3., 4.]. When the condition is at the severe end of the clinical spectrum, patients are diagnosed with HG. HG affects 0.3–10.8% of pregnancies and is characterized by NVP symptoms that begin early in pregnancy and affect daily activity, with an inability to eat and drink normally usually leading to dehydration, electrolyte imbalances, and weight loss [3., 5.]. It is perplexing that the emphasis on appropriate nutrition in pregnancies for overall health of mother and baby has been historically overlooked in the case of HG. Patients are often released from hospital weighing less than when they were admitted [6.]. The condition is associated with significant undernutrition, and patients generally cannot tolerate prenatal supplements. The American College of Obstetricians and Gynecologists guidelines recommend folic acid in lieu of prenatal supplements as first-line treatment [3., 7.], suggesting that folic acid is the only essential nutrient for maternal and fetal health. Although some progress has been made by the recent addition of referral to dietician in both UK and Australia/New Zealand guidelines, implementation worldwide likely remains an issue [8., 9.]. Therefore, the multitude of poor outcomes associated with HG seem evident (Figure 1) but remain largely unrecognized by providers [7.]. Figure 1: Hyperemesis gravidarum (HG)-associated adverse outcomes. Show full caption View Large Image Figure Viewer Download Hi-res image Download (PPT) There are many myths that contribute to undertreatment and lack of progress for HG and include historical misconceptions that (i) the baby is getting everything it needs from the mother, (ii) the cause is the pregnancy hormone human chorionic gonadotropin, and (iii) only humans have NVP. This article reviews new evidence that dispels these myths and introduces recent advances showing that HG has lasting effects on the mother and child, the most likely cause is the NVP hormone growth and differentiation factor 15 (GDF15), and the condition likely gave an evolutionary advantage in the wild that is now superfluous for humans. These findings are driving development of new therapies that may make strides in eradicating one of the most common, distressing, and unnecessary pregnancy conditions. Adverse outcomes HG can be life-threatening and is associated with adverse maternal, fetal, and offspring outcomes (Figure 1). Due in part to electronic health records, it has become increasingly feasible to perform large studies on HG outcomes and, importantly, to identify children who have been exposed in utero to HG, resulting in new longitudinal data on the effects of HG. Maternal morbidity and mortality Pregnant women are still dying from HG. It was the fourth leading cause of maternal death in Botswana in 2019i, and deaths have been reported this century in the USA and UK due to thyrotoxicosis, thromboembolism, suicide, thiamin deficiency that led to brain damage/death from Wernicke’s encephalopathy, and severe electrolyte disturbances that resulted in cardiac arrest [3.]ii,iii. Therapeutic terminations occur in 6% of pregnancies [10., 11.]. Maternal vitamin K deficiency has resulted in intracranial hemorrhage/fetal demise [12.]. In our study, 26% of HG patients reported losing >15% of their prepregnancy weight, and 22% reported symptoms lasting until term, making HG a form of prolonged starvation in pregnancy with a serious psychological impact. Additionally, 26% reported suicidal ideation, 18% had full criteria for post-traumatic stress disorder, and 37% decided to never get pregnant again [13., 14., 15.]. HG is a top predictor of postpartum depression [16.]. Moreover, intense prolonged vomiting can result in retinal hemorrhage, pneumothorax, esophageal tears, and rib fractures [3.]. HG is also associated with increased risk of placental dysfunction and liver and kidney disease [3.]. Birth outcomes and offspring morbidity Offspring morbidity is also significant, with a 2.8-fold increased risk of preterm birth prior to 34 weeks, 1.4-fold increased risk of low birth weight, and a 1.2-fold increased risk of neonatal intensive care unit admission [17.]. The 2.1-fold increased risk for neural tube defects for patients unable to swallow folic acid and reports of vitamin K-deficient dysmorphology and intracranial hemorrhage are direct evidence that maternal nutrient deficiencies can have lasting effects on fetal outcome [12., 17., 18., 19.]. Importantly, the risk (4.8-fold) of small for gestational age (SGA) infants associated with HG was reportedly higher than for chronic hypertension, preeclampsia, cannabis, tobacco, cocaine, and amphetamine exposure [20.]. In a study of women hospitalized for HG, inadequate pregnancy weight gain and not regaining prepregnancy weight by weeks 13–18 were both risk factors for delivering a baby that is SGA [21.]. Child outcomes Past studies significantly linking HG to adverse child outcomes were primarily based on sample sizes <1000 cases, but recently, several large studies have been published (Figure 1) [22., 23., 24., 25., 26., 27., 28., 29., 30., 31., 32., 33., 34., 35., 36., 37., 38., 39., 40., 41.]. Among them, two large US-based retrospective cohort studies showed that in utero exposure to HG is a significant risk factor for autism spectrum disorder (ASD) [36., 37.]. Another large study reported on results from both a US-based cohort of >10 000 children and a Danish cohort of >2 million children [38.]. In the US cohort, HG-exposed offspring scored significantly higher for attention deficit/hyperactivity disorder (ADHD), depression, and social problems, with an overall increased psychiatric problem score that was 25% higher than unexposed children. In the Danish cohort, exposed children were found to have significantly increased diagnoses of behavioral and emotional disorders, ADHD, conduct disorders/oppositional defiant disorders, pervasive developmental disorders, and ASD. The authors of the US/Danish study reported decreased cortical area/volume in children exposed in utero to HG and found that abnormal neurodevelopment was mediated by reduced brain size. Fetal head growth in HG patients is positively associated with maternal weight gain at midgestation, suggesting that HG-related undernutrition in the first half of pregnancy may affect fetal brain growth and development and explain the increased risk of neurodevelopmental delay in childhood [42.]. Other adverse childhood outcomes reported recently include an increased risk of childhood cancer, including a 2.5-fold increased risk for neuroblastoma, a 1.4-fold increased risk of childhood respiratory morbidity, and an increased risk of cardiovascular disease in 3-year-olds [39., 40., 41.]. Importantly, child outcome studies that included prescriptions found that associations existed independent of medication exposures and hypothesized that nutritional deficiencies are a likely cause [25., 36., 37., 39.]. Thus, studies of adverse maternal, fetal, and child outcomes associated with HG have come to light. The new findings strongly suggest that HG can have lasting effects on the mother, can alter birth outcomes, and can be a detrimental pregnancy exposure akin to a teratogen. In the case of HG, the baby is not always getting everything it needs from the mother. NVP hormone GDF15 and NVP/HG discovery Discovery of GDF15 in pregnancy In 1997, the GDF15 gene was cloned by three groups, including one searching for highly expressed genes in the placenta that reported higher placental expression of GDF15 than any other healthy human fetal or adult tissue tested, which was higher at 8–9 weeks than at term [43., 44., 45.]. Then in 2000, detection of high levels of GDF15 in the sera of pregnant women was reported [46.]. GDF15 was subsequently measured at 12 timepoints during pregnancy and labor. The study did not find an association with labor (or preeclampsia) but revealed the pattern of GDF15 levels in healthy pregnancies. Specifically, GDF15 rises rapidly in the first trimester, steadies in the second trimester, and rises again at 24–26 weeks, with a second peak at 33–35 weeks [47.]. GDF15 and appetite loss In 2007 a discovery linking GDF15 to appetite control was published [48.]. The landmark study showed that GDF15 was overexpressed by many tumors, and circulating levels were directly proportional to cachexia-associated weight loss. In mouse models, GDF15 induced appetite and weight loss that was reversed by blocking GDF15. The study suggested lowering GDF15 as a novel treatment for cachexia (a condition with similar symptoms to HG characterized by hypophagia and weight loss) and conversely increasing GDF15 to treat obesity. In 2014, the team showed that the site of action of GDF15 was the hindbrain, with complete loss of anorectic effects following ablation [49.]. Meanwhile, pharmaceutical companies pounced on the molecule in a race to find the hindbrain-restricted receptor, and in 2017, four separate groups published the discovery of GDNF family receptor α-like (GFRAL) and the coreceptor proto-oncogene tyrosine-protein kinase receptor Ret [50., 51., 52., 53.]. Programs to develop weight loss and weight gain drugs based on these findings followed [54.]iv,v. Genetic link between GDF15 and NVP/HG Earlier in 2017 our group presented the first evidence linking GDF15 to HG using a genome-wide association study (GWAS) of >50 000 23andMe, Inc., research participants [55.]. In addition, we found significant associations with the insulin-like binding factor protein 7 (IGFBP7), the progesterone receptor, and the GDF15 receptor GFRAL [56.]. We also showed that circulating levels of GDF15 and IGFBP7 are significantly elevated in patients hospitalized at 12 weeks gestation with HG compared with patients with normal and no NVP, but levels are similar at 24 weeks gestation [57.]vi. A study posted online in late 2017 (published in 2018) further supported the finding that significantly higher levels of GDF15 are detected in pregnancies affected by more severe NVP [58.]. In addition, another study revealed that circulating GDF15 levels are significantly higher in people carrying female fetuses, and nausea was reported in 72% of women carrying a female and 42% carrying a male, providing a biological explanation for the observation of worse NVP in pregnancies with female offspring [59.]. In 2022 we published the results of our second genetic study using a separate population (>1,500 recruited through hyperemesis.org) and using a whole-exome sequencing approach [60.]. The only significant locus was again a variant in GDF15. In addition, there was only one damaging variant that occurred in greater than or equal to ten cases and no controls, a mutation in GDF15. Every participant with the mutation had at least one pregnancy with HG, strongly implicating a causal etiology for GDF15. Admittedly, the genetic studies included primarily white participants of European ancestry, and, therefore, more work must be done to determine generalizability of the results to other populations. To that end, it is important to note that recently, the lead association with the GDF15 locus was replicated in GWASs that included Asian populations [61.]. Maternal–fetal genetic interplay: a mechanism affecting recurrence Perhaps the most common question patients have following a pregnancy affected by HG is ‘will I have this again?’, and ~37% of HG patients limit family size due to fear of recurrence [15.]. Assuming a strong maternal genetic component to the condition, understanding why some patients do not have HG in every pregnancy was critical to unraveling the genetic mechanism (the exception proves the rule). Among patients carrying a rare GDF15 mutation, 18% of pregnancies were not affected by HG [1.]. It was reasoned that since GDF15 causes nausea/vomiting, the mutation must cause overexpression/activity. Therefore, it was hypothesized that patients whose fetus inherited the mutation from their mothers had greater risk for HG, while patients who inherited the wild-type variant could be protected. Surprisingly, the reverse was observed. In all pregnancies where the fetus inherited wild-type (normal) GDF15, the mother had HG, and by contrast, when the fetus inherited the mutation, the mother was less likely to be affected by the condition [1.]. Although a small sample size, this provided the first evidence for interplay between maternal and fetal genes in HG risk and the first biological explanation for why HG can occur in one pregnancy but not the next (Figure 2). However, the results provided a paradox as they suggested that the same mutation that increased HG risk in the mother reduced that risk when inherited by the fetus. The solution began to unfold in an experiment showing that the mutation did not result in an increase in GDF15 levels/activity but, by contrast, was a knockout, resulting in approximately half of the normal levels of GDF15 circulating in nonpregnant healthy people who were heterozygous carriers of the mutation [1.]. Furthermore, two additional variants in GDF15 associated with HG followed the same pattern of association with lower circulating levels in nonpregnant individuals [1.]. Figure 2: Different genetic combinations of GDF15 in the mother and fetus alter the risk of nausea and vomiting of pregnancy. Show full caption View Large Image Figure Viewer Download Hi-res image Download (PPT) A role for desensitization To understand how lower levels of a nausea/vomiting hormone can cause HG, it was then hypothesized that patients with HG, genetically predisposed to lower circulating levels of GDF15 prior to pregnancy, are hypersensitive to the rapid rise in GDF15 levels during pregnancy. Both a murine model and observation in humans supported a role for desensitization [1.]. Mice were desensitized to the aversive effects of GDF15 by administration of low-dose GDF15 prior to a high dose [1.]. In humans, conditions and substances associated with high levels of circulating GDF15 prior to pregnancy had reduced HG risk during pregnancy [1.]vii. The discovery of a role for desensitization suggests that there may be a way to prevent HG. Clinical implications The new findings that nausea/vomiting is most severe when patients have lower levels of GDF15 prior to pregnancy and higher levels during pregnancy suggests a road to prevention and treatment (Figure 3). Patients at risk for HG may be primed by raising GDF15 levels prior to pregnancy to decrease their sensitivity to GDF15 during pregnancy. One approach would be to use metformin, a drug known to increase circulating GDF15 levels that has been used to improve fertility in patients with polycystic ovarian syndrome [1.]. In addition, during pregnancy, lowering GDF15 levels, such as was presumably the result in patients whose fetuses inherited the GDF15-lowering mutation, may significantly reduce HG symptoms [1.]. The patients carrying the GDF15-knockout mutation were fertile and had healthy pregnancies/babies when the fetus inherited the mutation, presumably reducing GDF15 by half [1.]. These lived human examples suggest that reduction of GDF15 may be safe. This observation is further supported by the recent identification and characterization of human homozygous GDF15 knockouts, revealing that humans completely lacking GDF15 can exceed average life expectancy and are fertile, with no evidence of increased disease prevalence or metabolic dysfunction [62.]. Additionally, a heterozygous GDF15 knockout in the study who had three children (two who were homozygous knockouts) reported no nausea/vomiting in any pregnancy, providing support that blocking GDF15 may prevent HG (and NVP). Figure 3: From mechanism to potential therapies. Show full caption View Large Image Figure Viewer Download Hi-res image Download (PPT) However, there is evidence for pause. In a study of miscarriage, GDF15 levels at weeks 7–13 predicted fetal loss, with one-third of levels in the miscarriage cohort (although this observation is likely the consequence of abnormal placentation) [63.]. Additionally, GDF15 peaks at 33–35 weeks gestation, a time when most pregnancies are not affected by NVP [27.]. So, what is its role at this time? Some evidence suggests that in addition to NVP, GDF15 may be a T cell inhibitor, protecting the rapidly growing fetal/placental unit from maternal immune attack (although it is hard to reconcile this with the lack of a local receptor and lack of altered GDF15 levels in preeclampsia) [3., 47., 63., 64., 65., 66., 67., 68.]. Therefore, until we have a better understanding, moderate GDF15 reduction or blocking the brainstem-restricted receptor GFRAL may present less risk. Indeed, the company NGM Bio announced its plans to initiate a Phase 2 proof-of-concept study of its GFRAL inhibitor NGM120 for the treatment of HG by the end of 2024viii. GDF15 outside of pregnancy In addition to its role in pregnancy, GDF15 may be a hormone that evolved to alert nonpregnant animals/people that they are more likely to survive in a weakened state if they rest and recover rather than search for food. Support for this theory comes from studies of circulating levels of GDF15, showing that it is upregulated in numerous disease states and in response to multiple environmental stressors, including cancer; cardiovascular, kidney, mitochondrial, liver, and lung disease; thalassemia; infection; undernutrition; overnutrition; overexercise; hypoxia; and environmental toxins including cytotoxic chemotherapy, smoking, potassium depletion, and hyperthyroidism [69., 70., 71.]. Of note, undernutrition; potassium deficiency; heart, kidney, and liver stress; Helicobacter pylori infection; and hyperthyroidism are all associated with HG pregnancies and may explain, in part, the higher levels of GDF15 observed in HG patients [3.]. NVP in the animal kingdom: genetic link between placental and nonplacental animals alters evolutionary theory NVP is hypothesized to be an evolutionary adaptation to protect the fetus from teratogens during organogenesis [72., 73., 74., 75.]. This is supported by overlooked evidence of gestational nausea in the animal kingdom (Figure 4). Studies in the 1970s showed that monkeys can experience NVP and appetite disturbances in early pregnancy [76., 77.]. In addition, dogs can have early anorexia and vomiting that can be severe enough to require pregnancy terminationix. Veterinary advice for pregnant cats warns that an early lack of appetite is common, and if the cat stops eating for >1–2 days, consult the vetx. Figure 4: Gestational appetite loss, nausea, and vomiting in the animal kingdom. Show full caption View Large Image Figure Viewer Download Hi-res image Download (PPT) However, maternally ingested teratogens cannot fully explain the condition as there are also reports of lack of appetite in nonplacental animals, including birds and reptiles. Following egg laying, hens may refuse to eat and remain in their coopxi. A snake study revealed that aspic vipers stop hunting during gestation, and 12% refused a mouse placed directly in front of them [78.]. The most extreme maternal behavior is observed in the octopus, where the mother cares for her eggs without feeding until death [79.]. These examples suggest that gestational loss of appetite is a biological behavior that has evolved and is coded for by genes, whereby in some species, the benefit of complete starvation until death outweighs the risk of a hostile environment. Until modern times, finding food was no quick trip to the market but was fraught with risks, not only from ingesting teratogenic foods but also from predators, pathogens, and other environmental risks, such as extreme weather. Genes that encode a behavior that results in avoiding those risks in lieu of nutritional needs likely provide some survival advantage, which may no longer exist for modern human pregnancy. Support for this comes from the observations that approximately 30% of pregnancies are unaffected by NVP, and recently, human knockouts of GDF15 have been identified that are viable and fertile [56., 62.]. Fascinatingly, IGFBP7, the second greatest genetic risk factor associated with HG in the GWAS study, is the human homolog of the wasting factor gene imaginal morphogenesis protein-late 2 (IMPL2), which has been implicated in both diapause (dormancy) in response to environmental stress (i.e., cold temperatures) in Drosophila and in the maternal death spiral of the octopus. This finding biologically linking the behavior between placental and nonplacental species suggests that modification of evolutionary theories is required [56., 79., 80., 81., 82.]. Obviously, what the mother consumes after laying eggs cannot have a teratogenic effect on offspring, so the condition cannot have evolved solely to avoid teratogens during organogenesis, debunking the most commonly accepted explanation as the sole rationale for NVP. Concluding remarks HG increases the risk of multiple adverse outcomes for mother and offspring, and, therefore, there is a benefit to effectively preventing and/or treating HG safely to improve symptoms and nutritional intake. We now have strong biological evidence to support a causal role for GDF15 and a path for development of novel prevention and treatment methods. Even before these treatments come into clinical practice, it is important for patients to know that there has been progress in understanding their condition (see Clinician's corner). Finally, NVP and HG, probably still advantageous in the wild, are likely antiquated evolutionary mechanisms for humans. Future research should focus on (i) improving nutritional intake of HG patients and understanding nutrient roles in adverse outcomes, (ii) developing and testing therapeutics for prevention and treatment based on the new findings, (iii) understanding the mechanism of GDF15 desensitization and whether the hormone has a secondary role in pregnancy, (iv) determining the generalizability of the genetic findings in additional populations, and (v) identifying and elucidating the role of additional risk genes. While outstanding questions remain (see Outstanding questions), it is time to pave the road for clinical trials and hopefully, if safe and effective, limit or maybe even eradicate HG.

  • New specialty care provider Harmonia Healthcare opens clinic to treat extreme morning sickness

    Source: By Anastassia Gliadkovskaya May 10, 2024 1:10pm Harmonia Healthcare, a new provider focused on specialty women’s health, has opened a clinic in New Jersey to treat hyperemesis gravidarum (HG). HG can bring nausea and vomiting during pregnancy severe enough to prevent proper food intake and can lead to weight loss, dehydration and ultimately hospitalization. It can cause complications for mothers and their babies and is estimated to affect up to nearly 11% of pregnant women. Harmonia’s new clinic will offer evidence-based treatments and educate patients on the latest science around HG. Its offerings include medication and vitamin infusion, electrolyte replacement plans, prescription management, diagnostic bloodwork and telehealth. A second clinic is planned to open in New York City this fall. The clinic does not require referrals. Its chief scientific officer, Marlena Fejzo, Ph.D., a women’s health researcher with lived experience of HG, will also leverage her and colleagues' groundbreaking discovery of the hormone associated with the condition—GDF15—to drive innovations in prognostics, prevention and treatment. Fejzo was a 2023 Fiercest Women in Life Sciences awardee. Marlena Fejzo, Ph.D., chief scientific officer, Harmonia Healthcare (hyperemesis.org ) “We really want to fix the broken care model in women’s health and improve care,” Fejzo told Fierce Healthcare. “We hope to expand this to be the future of care for these undertreated and underdiagnosed diseases.” Harmonia’s online platform will offer educational resources and eventually telehealth, though women should still ideally first come into the clinic in person. The current status quo for women with HG is unacceptable and costly, Fejzo says. If they end up in an emergency room, they are treated with fluids or antiemetic drugs and released. But because HG causes persistent nausea and vomiting, women need persistent medication management, Fejzo argues. If they are discharged without a prescription, many will inevitably wind up back in the hospital again; 60% of women have multiple hospital visits, per Fejzo. And, while HG is starting to be diagnosed properly more often, Fejzo said, it can still be misdiagnosed or not diagnosed at all. “A lot of people think that it’s just regular nausea and vomiting and that everything’s going to be fine … when actually there are really adverse outcomes associated with HG for the mother and the baby,” Fejzo said. During a recent conference, Fejzo said she discovered ER doctors affiliated with Harvard discharge HG patients without a prescription. Their justification for it was that the medications might make them tired, and then they would have to miss work. “That’s a real misunderstanding of HG,” Fejzo said, adding that if Harvard-affiliated docs are doing it, “I assume it is common.” RELATED: New study finds cause and potential treatment for dangerous morning sickness Part of the reason Fejzo believes this is happening is due to a famous historic incident known as the thalidomide disaster. After women being treated with thalidomide for nausea had babies with birth defects, it launched a widespread hesitancy to prescribe medications during pregnancy, Fejzo said. There also remains a misguided belief that HG is psychological or resolves on its own. And because HG typically starts early in pregnancy, many women see ER docs before even seeing their obstetrician, meaning many providers may not be aware of how sick their patients have really been. Obstetricians are also generally not trained to ask their patients about their levels of nausea and vomiting—and patients, too, may not talk about it, Fejzo explained. To address this, Harmonia will be monitoring women receiving medication management and coordinating with their other providers, like OB-GYNs, midwives and doulas. The goal is to intervene as early as possible with more aggressive treatment before the condition spirals out of control. The best medications for HG being prescribed off-label include Zofran, Phenergan and Reglan, according to Fejzo. Yet doctors usually begin with doxylamine and pyridoxine, as recommended by the American College of Obstetricians and Gynecologists, which Fejzo says are “pretty much a placebo for HG.” By serving patients with HG, Harmonia will have the infrastructure in place to run clinical trials on potential new treatments, Fejzo said. She is already advising NGM Bio, which recently announced it is interested in testing its drug NGM120 in HG patients. While Fejzo doesn’t anticipate challenges with patients getting their scripts filled, Harmonia providers will educate patients on how to have conversations with pharmacists in case they do run into pushback. In recent years, pharmacists have sometimes refused to fill opioid prescriptions with doses they perceived as too high or poorly monitored by the prescriber. One of the country’s only other clinics in this space, Alabama’s Morning Sickness Clinic, claims its model has led to a 95% reduction in ER visits and a 90% decrease in total cost of care. Its co-founder, an emergency medicine physician, is one of Harmonia’s clinical advisers. Harmonia eventually hopes to expand to serve other under-researched women’s health conditions. While the company does not currently plan to pursue formal health system partnerships, it hopes that its clinics will come to be known locally as the go-to expert for these conditions. And, while it isn’t yet, Harmonia plans to be working with commercial and Medicaid insurance plans by the end of this year. About Harmonia Healthcare Harmonia is a highly specialized women's health platform that combines cutting edge functional medicine treatment with science-backed resolution for underdiagnosed, undertreated and otherwise dismissed female-specific diseases. Initially focused on hyperemesis gravidarum, Harmonia's physician-lead research, diagnostic and treatment programs result in superior health outcomes and subsequently enhanced wellbeing and quality of life. For more information on Harmonia and hyperemesis gravidarum, or to learn if you might be suffering from hyperemesis gravidarum, visit www.harmoniahealthcare.com or connect with us on Instagram at @harmoniahealthcare.

  • A Treatment Center For Morning Sickness Has Opened in Central Jersey

    Source: BY JENNIFER AMATO Published: May 7, 2024 A new healthcare center in Central Jersey has opened to offer much-needed relief to pregnant women experiencing severe nausea and vomiting. Harmonia Healthcare, a specialty women’s health platform focusing on underdiagnosed, undertreated and otherwise dismissed diseases that affect women, opened its first center in Red Bank this week, with another planned for New York City in the fall. The focus is on hyperemesis gravidarum, which is such severe vomiting that it can cause weight loss and excessive ketones in the urine and blood. Harmonia offers outpatient care and established partnerships with patients, OB/GYNs, midwives, doulas, and other healthcare and pregnancy support professionals. Other treatments include medication and vitamin infusion, electrolyte replacement plans, prescription management, bloodwork, and telehealth assistance. Harmonia’s Chief Scientific Officer Dr. Marlena Fejzo received the TIME 100 Health Award on the day of the opening in recognition of her groundbreaking research on the disease. “My personal experience with HG and the frustration with being unheard and blamed by my doctors is what motivated me to discover GDF15, the hormone responsible for hyperemesis gravidarum,” says Fejzo, who earlier this year was also named one of TIME’s Women of the Year. The economic cost of nausea and vomiting in pregnancy (NVP) in the United States totals over $1.7 billion per year—or $2.2 billion when adjusted for inflation—with ER visits being a significant contributor to this amount, according to stats provided by Harmonia. One in 4 women need meds to treat NVP, and on average miss 23 days of work per year. “HG is the leading cause of hospitalization in the first half of pregnancy, but Harmonia is implementing a proven care model that has shown a 95% reduction in ER visits and a 90% decrease in the total cost of care,” says Co-Founder and President Leslie Gautam. Currently, Harmonia’s services are available to patients in New Jersey. If you are trying to get pregnant, are pregnant or are suffering from severe nausea and vomiting or HG, contact Harmonia Healthcare; no referrals are required. The Red Bank location is at 21 E. Front St., Suite 300; headquarters are located at 555 Madison Ave., Suite 11D, New York. For more information, call 732-538-5149. About Harmonia Healthcare Harmonia is a highly specialized women's health platform that combines cutting edge functional medicine treatment with science-backed resolution for underdiagnosed, undertreated and otherwise dismissed female-specific diseases. Initially focused on hyperemesis gravidarum (severe morning sickness), Harmonia's physician-lead research, diagnostic and treatment programs result in superior health outcomes and subsequently enhanced wellbeing and quality of life. For more information on Harmonia and hyperemesis gravidarum, or to learn if you might be suffering from hyperemesis gravidarum, visit www.harmoniahealthcare.com or connect with us on Instagram at @harmoniahealthcare.

  • Clinic specializing in severe morning sickness opening in Red Bank

    Source: Published: May 6, 2024 RED BANK — Harmonia Healthcare, the specialty women's health platform focusing on underdiagnosed, undertreated and otherwise dismissed female-specific diseases including severe nausea and vomiting in pregnancy (NVP) and hyperemesis gravidarum (HG), opened its first center in Red Bank last week. A second location is planned for New York City this fall. The opening of the highly anticipated center — which will treat and innovate around HG — is led by a founding team that includes Co-Founder and President Leslie Gautam and Chief Scientific Officer Dr. Marlena Fejzo, who last week received the TIME 100 Health Award in recognition of her groundbreaking research on the disease. Harmonia said it sets itself apart with its model of providing superior outpatient medical care and fostering seamless partnerships with patients, OB/GYNs, midwives, doulas and other healthcare and pregnancy support professionals. The facility's physician-led, science-backed solutions encompass various components such as medication and vitamin infusion and electrolyte replacement plans, prescription management, diagnostic bloodwork and telehealth assistance. Harmonia's services offer a holistic approach to enhance the short- and long-term health outcomes and quality of life for both the mother and baby. "HG is the leading cause of hospitalization in the first half of pregnancy, but Harmonia is implementing a proven care model that has shown a 95 percent reduction in ER visits and a 90 percent decrease in total cost of care," said Gautam. "Harmonia patients will benefit from the insights of our best-in-class leadership team including world-leading experts in hyperemesis gravidarum. Each patient can expect to receive outpatient treatment rooted in research, patient advocacy, and compassionate care." The economic cost of nausea and vomiting in pregnancy (NVP) in the United States totals over $1.7 billion per year — or $2.2 billion when adjusted for inflation — with emergency room visits being a significant contributor to this amount, despite being an ineffective and broken care model for treating HG. One in 4 women take a pharmaceutical intervention to treat NVP, and on average miss 23 days of work per year. Through community-centered treatment, Harmonia aims to alleviate the economic burden of emergency hospital visits. "My personal experience with HG and the frustration with being unheard and blamed by my doctors is what motivated me to discover GDF15, the hormone responsible for hyperemesis gravidarum," said Fejzo, who today received the TIME 100 Health Award. Part of the publication's annual Impact Awards, the TIME 100 recognition honors those who have made a significant impact on their industries and world. Earlier this year, Fejzo's research on hyperemesis gravidarum also earned her recognition as one of TIME's Women of the Year. "The TIME recognition, as well as the opening of the center, are a demonstrable step forward for women like myself whose symptoms have been overlooked and dismissed – to our detriment," Fejzo said. "Thanks to Harmonia's team of clinicians dedicated to improving patients' lives, I look forward to the ongoing impact our shared experiences will have on the future of healthcare." Currently, Harmonia's services are available to patients in New Jersey. If you are considering pregnancy, think you are pregnant, or think you might be suffering from severe nausea and vomiting or HG, you can receive treatment at Harmonia, no referrals required. Visit www.harmoniahealthcare.com and follow them on Instagram at @harmoniahealthcare for updates on the opening of the New York location this fall. About Harmonia Harmonia is a highly specialized women's health platform that combines cutting-edge functional medicine treatment with science-backed resolution for underdiagnosed, undertreated, and otherwise dismissed female-specific diseases. Initially focused on hyperemesis gravidarum (genetically derived severe morning sickness), Harmonia's innovative, physician-led research and novel treatment programs are expected to result in superior health outcomes and subsequently enhanced wellbeing and quality of life.

  • NJ's First Severe Morning Sickness Center Opens In Red Bank

    Source: Carly Baldwin, Patch Staff Posted Mon, May 6, 2024 at 4:54 pm ET RED BANK, NJ — Hyperemesis gravidarum (HG) — also known as severe nausea and vomiting in pregnancy — is a little understood and often under-treated medical condition. But when severe morning sickness personally affected Dr. Marlena Fejzo, a research scientist, she knew she had to do something about it. Pregnant with her second child in 1999, "for weeks, all she could do was lie flat on her back, since even rolling to her side triggered debilitating nausea. Eating or drinking was out of the question, forcing her to get a home IV for nourishment. 'Every second,' she says, 'was torture,'" she told TIME magazine. She became bed-ridden and her doctor eventually ordered a feeding tube for her, but it was too late: Dr. Fejzo shared that she had lost so much weight and become so frail that she lost the baby in the first trimester. Dr. Fejzo is trained as a geneticist, but she began to dedicate her life's work to finding out why hyperemesis gravidarum occurs — what causes some women to get it, and others do not? — and what treatments can be made available to help expectant mothers so they don't have to suffer as she did. Her work led Dr. Fejzo to identify the gene that causes hyperemesis gravidarum, GDF15. Her ground-breaking research just earned her recognition as one of TIME's 2024 Women of the Year. Dr. Fejzo is also now the chief scientific officer on staff at Harmonia Healthcare, the first center for hyperemesis gravidarum treatment in New Jersey, which just opened May 1 in Red Bank. Harmonia is located on East Front Street in Red Bank. “My personal experience with HG and the frustration with being unheard and blamed by my doctors is what motivated me to discover GDF15, the hormone responsible for hyperemesis gravidarum,” said Dr. Fejzo. Co-founder Leslie Gautam says Harmonia will work with pregnant women and their OB/GYNs, midwives, doulas and other healthcare and pregnancy support professionals. The facility will offer medication, vitamin infusion and electrolyte replacement plans, prescription management, diagnostic bloodwork, and telehealth assistance. “HG is the leading cause of hospitalization in the first half of pregnancy, but Harmonia is implementing a proven care model that has shown a 95 percent reduction in ER visits and a 90 percent decrease in total cost of care,” said Gautam. “Harmonia patients will benefit from the insights of our best-in-class leadership team, including world-leading experts in hyperemesis gravidarum. Each patient can expect to receive outpatient treatment rooted in research, patient advocacy and compassionate care.” Currently, Harmonia's services are available to patients in New Jersey. If you are considering pregnancy, think you are pregnant, or think you might be suffering from severe nausea and vomiting or HG, you can receive treatment at Harmonia, no referrals required. Visit www.harmoniahealthcare.com Instagram @harmoniahealthcare The Red Bank office is their first. They plan to open a second location in New York City this fall. About Harmonia Healthcare Harmonia is a highly specialized women's health platform that combines cutting edge functional medicine treatment with science-backed resolution for underdiagnosed, undertreated and otherwise dismissed female-specific diseases. Initially focused on hyperemesis gravidarum, Harmonia's physician-lead research, diagnostic and treatment programs result in superior health outcomes and subsequently enhanced wellbeing and quality of life. For more information on Harmonia and hyperemesis gravidarum, or to learn if you might be suffering from hyperemesis gravidarum, visit www.harmoniahealthcare.com or connect with us on Instagram at @harmoniahealthcare.

  • Hyperemesis gravidarum specialist argues for greater investment in women’s health

    Source: By Dr. Marlena Fejzo May 2, 2024 Over 20 years ago, during my second pregnancy, I experienced a debilitating case of hyperemesis gravidarum (HG). Often given the misnomer morning sickness, the symptoms of nausea and vomiting are rarely limited to the morning, and with HG, are usually nonstop. The experience, one of the most horrific of my life, was made worse due to skepticism and derision from the healthcare professional who was supposed to be protecting me. Even today, this remains a common tale for women, with myriad studies showing that women’s pain is more likely to be discounted than their male counterparts and their symptoms ignored. Over the last two decades, I have made it my mission to ensure that my experience becomes an outlier, rather than the norm—generating knowledge which will lead to better treatments for HG and, most recently, launching Harmonia Healthcare, a specialty women’s healthcare platform focusing on commonly dismissed female-specific diseases. It is unconscionable that so little time and funding goes into women’s diseases, with only 1% of investment into healthcare research and innovation going toward female-specific conditions beyond oncology, according to a recent McKinsey study. For too long, women’s suffering has been ignored—and I’m so thrilled to be a part of research and innovation that will have an impact on improving reproductive health. Related: Research has FINALLY pinpointed the cause of severe morning sickness Approximately 14% of all pregnancies are affected by severe nausea or HG, with over one-third of HG pregnancies resulting in premature delivery, miscarriage, stillbirth or termination. The economic cost of nausea and vomiting in pregnancy in the US totals over $1.7 billion per year. Emergency room visits, a main contributor to this sum, represent a broken care model for HG treatment. The same study found that women with nausea and vomiting during pregnancy lost an average of 23 days of work, while their partner lost more than three days on average. In the future, this will no longer be the case due to new treatments that Harmonia plans to implement, which will be grounded in my research. Related: Hyperemesis Gravidarum researcher Dr. Marlena Fejzo is on a mission to understand women’s health My battle with HG was one of the most challenging periods of my life. Faced with constant nausea, I was unable to eat or drink without throwing up, and was put on an IV drip. My doctor at the time was dismissive, even noting that women often claimed these symptoms as a method to seek attention. I was too weak to advocate for myself, and it wasn’t until I had not kept any food down for over a month and tried 7 different medications at once, that a feeding tube was inserted. It was too late; I lost the baby. I tore through medical journals, searching for information on what had happened to me, but few studies existed on this devastating disease. Driven by my own suffering and a desire to ensure better care for women in the future, I embarked on a quest to discover the root cause of HG and validate the experiences of countless women who, like me, had been disregarded. Related: How to cope with hyperemesis gravidarum (HG), from a mama who’s going through it My experience with HG and suggestion by my doctor that I was purposely exaggerating symptoms is an experience that likely rings true with many women, whose very real pain and suffering is often dismissed, leading to an unacceptable number of women in crisis throughout the country. I spent the following two decades dedicated to the research of HG, identifying its causes and now searching for innovative treatments. Most recently, I helped to launch Harmonia as its Chief Scientific Officer. Harmonia, which opened its first center in New Jersey this May, will be a game-changer for HG patients by offering them better care now while simultaneously developing innovative methods to improve care in the future. I’ve also been advising, collaborating and directing research with the HER Foundation since 2001. Related: 5 tips on how to manage hyperemesis gravidarum A familial aggregation study I led found that if a patient’s sister had HG, they had a 17-fold increased risk of having it themselves. I worked with genetics company 23andMe, Inc. to conduct a genetic study, which found that the greatest genetic risk factor for the disease was a variant of the nausea and vomiting hormone gene GDF15. In a second study, I used an alternate genetic technique and found a rare mutation in GDF15 in some HG patients, providing further evidence for a causal role for GDF15. Most recently, I partnered with an international team of researchers and discovered that people with HG are predisposed to having lower levels of GDF15 prior to pregnancy, making them hypersensitive to the rise of the hormone during pregnancy. In addition to new predictive capabilities, this opens healthcare providers up to innovative new treatments, as raising a patient’s GDF15 levels prior to pregnancy has the potential to prevent HG. Harmonia endeavors to predict, prevent and treat HG with its extremely knowledgeable and versatile team. The center is grounded in the research I’ve helped generate on the condition, but the true stars are our incredible group of patient advocates and leading clinicians. Our approach will combine cutting-edge treatments with compassionate care, offering solace to those who have long suffered in silence. It is paramount to our mission that in addition to innovative treatments, we are providing concierge care and a team of health advocates to our patients, so they no longer have to advocate for themselves while battling a debilitating disease. Related: Hyperemesis gravidarum is about so much more than just morning sickness Our mission extends beyond mere treatment; it encompasses a commitment to research, innovation, and advocacy. We—along with other revolutionary centers, like The Morning Sickness & HG Clinic of Birmingham, AL—stand at the forefront of a movement, championing the cause of women’s health and challenging the status quo that has long relegated conditions like HG to the shadows. Harmonia’s expert-led research, diagnostic and treatment programs will result in superior health outcomes. It is my hope that with our centers, no one experiencing pregnancy will ever have to go through what I went through, and we will play a critical role in improving wellbeing and quality of life for women. About Harmonia Healthcare Harmonia is a highly specialized women's health platform that combines cutting edge functional medicine treatment with science-backed resolution for underdiagnosed, undertreated and otherwise dismissed female-specific diseases. Initially focused on hyperemesis gravidarum, Harmonia's physician-lead research, diagnostic and treatment programs result in superior health outcomes and subsequently enhanced wellbeing and quality of life. For more information on Harmonia and hyperemesis gravidarum, or to learn if you might be suffering from hyperemesis gravidarum, visit www.harmoniahealthcare.com or connect with us on Instagram at @harmoniahealthcare.

  • Kate Middleton and Amy Schumer suffered from extreme morning sickness. This women’s health platform wants to treat it

    Source: By: SARAH BREGEL 03-29-2024 Harmonia, a New Jersey center for treating hyperemesis gravidarum (HG), is the passion project of a doctor who lost her own pregnancy to the illness. Fifteen years ago, I was pregnant with my first child and severely sick. Everyone referred to it as “morning sickness”—albeit a rough case—but I knew it was more than that. I threw up constantly and had very little strength. Opening my eyes, climbing out of bed, and putting clothes on my body felt like the most painful thing I’d ever done. Some days, I couldn’t do it at all. After the first trimester came and went and I was still losing weight, my sickness was finally acknowledged at the doctor’s office. Prior to that, my complaints were met with mere head nods. I was told that the sickness was completely normal, and that pregnant women experience varying levels of nausea—nobody really knows why—but that it was nothing to worry about. By week 18, I had lost more than 20 pounds, spurring the nurse to double-check my chart. “That can’t be right!” she said, as I stood on the scale and waited for something to click. Finally, I was put on a prescription nausea medication that enabled me to keep down food and water. Since then, I’ve learned that my ordeal has a name: hyperemesis gravidarum (HG) or extreme morning sickness. And while 18 weeks is a long time to vomit profusely—it feels like an eternity when you’re experiencing it—my case of HG was a more mild one by comparison. Over the years, I have spoken to many women who were hospitalized on and off throughout their pregnancies, or even had to have feeding tubes placed in their bellies to deliver nutrients. I’ve also talked to women who lost their pregnancies due to the illness. Still, many people don’t even know what HG is. Celebrities like Kate Middleton and Amy Schumer brought some much-needed attention to the illness after they both experienced it, but the condition is devastatingly understudied, and therefore, extraordinarily misunderstood. However, that’s perhaps finally beginning to change because someone—unsurprisingly, a woman who suffered through the condition herself—did the research and found answers. MOVED TO THE CAUSE Twenty-five years ago, Dr. Marlena Fejzo, a geneticist at the University of Southern California Keck School of Medicine, was pregnant with her second child and so ill with HG that she couldn’t move without vomiting. Ultimately, her condition led to her losing the pregnancy. Even during her immense suffering, doctors told her that the nausea was in her head, even asserting that she must be seeking attention. After that experience, Fejzo got to work, dedicating the past two decades to studying the illness. “Following my own battle with HG, I scoured medical journals for information on why I’d been so sick, and came up empty-handed,” she tells Fast Company. Given her personal experience, she knew how important this research was to ensure women wouldn’t continue to be “dismissed” by their providers. She wanted them to have better treatment options than IVs and Zofran, which, for many women, have little to no effect. Those decades of research paid off. Last year, Fejzo published her findings in the journal Nature. The study confirmed that the hormone GDF15 was responsible for why some women developed HG. The amount of hormone circulating in a woman’s blood during pregnancy, and how much exposure she had to it, would determine how ill she became. Women with HG had significantly higher GDF15 levels during pregnancy than those who had no symptoms. The research also offered an interesting lead. According to the study, women who had a rare blood disorder, which gave them high levels of the hormone prior to pregnancy, rarely experienced nausea while pregnant. They were, essentially, less sensitive to the surge of hormones brought by a pregnancy because they’d already been exposed to high levels of it. The case that exposure therapy can be impactful was further supported by promising lab tests on mice, who lost their appetite less from the hormone after previous exposure to it. THE BIRTH OF HARMONIA Thanks to Fejzo’s research, there will undoubtedly be greater understanding surrounding HG—such as what causes it, and even just that it’s real. But for Fejzo, that was just the start. Next, she wanted to develop practical plans for treatment that could help women experience safer, healthier, and less debilitating pregnancies. Fejzo is now cofounding a new women’s healthcare platform for HG sufferers called Harmonia Healthcare, along with Leslie Gautam, who will serve as president while Fejzo will be the chief scientific officer. Harmonia will become the first-ever treatment center for hyperemesis gravidarum when its first location opens its doors next month in New Jersey. A second location will arrive in New York later this year. The care will be cutting edge. Fejzo says it will combine “the latest in functional-medicine treatments with science-backed resolutions.” She explains that the care will be outpatient and include infusions, electrolyte replacement, prescription care, diagnostic blood work, and home support. But another important mission of Harmonia’s will be “researching new ways to identify people at most risk for HG, and [playing] a critical role in clinical trials testing new methods to prevent and treat HG based on the root cause.” Despite her groundbreaking work, it isn’t lost on Fejzo that treatment took too long to arrive. She says that’s in part because health issues that primarily impact women are understudied. “Women have been historically underrepresented in healthcare,” she says. “Many women’s conditions are still in the dark ages when it comes to understanding the root cause and ways to diagnose and treat them.” As for me, four years after my first pregnancy, I went through the sickness again during my second pregnancy—this time, with a small child to chase around. Knowing what to anticipate, I started medication a few days after I found out I was expecting. But early on, the sickness was so powerful that the medicine had no effect. At five weeks to the day, I started vomiting profusely. I was terrified. For four months, I nibbled on crackers and sometimes sucked on frozen fruit. I wore SeaBands around my wrists and gnawed on ginger chews, and sprinkled drops of lavender everywhere (to this day, I still hate the smell of lavender). None of it helped—but thankfully, once I hit the 18-week mark, the medication eventually made it possible for me not to suffer. As someone who herself felt baffled by the lack of treatment for HG—just like Fejzo during her own pregnancy—it does feel dark, helpless, and desperate. It’s terrifying to be sick when nobody around you has answers. Now, I can’t help but feel immense gratitude for Fejzo’s dedication to a cause that will help so many women—perhaps one day, even my own daughter—to never feel trapped in that darkness again. ABOUT THE AUTHOR Sarah Bregel is a writer, editor, and single mom living in Baltimore, Maryland. She's contributed to NYMag, The Washington Post, Vice, In Style, Slate, Parents, and others. More

  • When her doctor doubted the severity of her morning sickness, this geneticist and Time Woman of the Year found the cause herself

    Source: By: Renée Onque @IAMRENEEONQUE 03-28-2024 Geneticist Marlena Fejzo says she had bad morning sickness during her first pregnancy, but the symptoms she experienced during her second pregnancy in 1999 were much worse. The only time Fejzo wasn’t nauseous, she says, is when she laid “completely still and flat,” and she wasn’t able to hold down food or drinks. Fejzo was eventually diagnosed with hyperemesis gravidarum (HG), but when she talked about her symptoms with her doctor, they didn’t believe they were as bad as she described. “My doctor told me that people [say] this,” about their symptoms of HG, “usually, because they’re trying to get attention from their mothers or family members,” Fejzo tells CNBC Make It. Fejzo wasn’t exaggerating in the slightest: “It was so bad that I could not eat or move without vomiting.” Hyperemesis gravidarum is a condition that causes severe vomiting during pregnancy, and it affects around 1% to 3% of pregnant women, according to the National Health Service. Notably, the U.K.’s Princess of Wales, the former Kate Middleton, struggled with the condition for all three of her pregnancies. Fejzo says this percentage doesn’t account for the people who haven’t been diagnosed and believes the number is even higher. “I ended up on IV fluids and then my doctor tried seven different medications once and nothing helped me to be able to eat or drink anything,” she says. “It really was like a form of torture. And eventually, I was put on a feeding tube, but it was too late. I lost the baby in the second trimester.” Throughout the harrowing process Fejzo kept advocating for herself, but didn’t stop there. She went on to discover the gene that caused her severe morning sickness symptoms. Now, Fejzo is set to open her first healthcare center, Harmonia Healthcare, to support women with obscure health conditions that are often overlooked and underdiagnosed, including her own condition, hyperemesis gravidarum (HG). ‘Every single person in my study that had that mutation had hyperemesis’ Fueled by what she felt was a dismissal of her very real HG symptoms, Fejzo searched for a way to help other women living with the condition. She had a hunch that HG might be genetic and started her investigation there. “I had to show that it ran in families to suggest there was a genetic component,” she says. “I didn’t have it in my family, so I wasn’t sure.” It took two decades to find the answer. “I did a familial aggregation study and found that there was a 17-fold increased risk of having it if your sister has it,” she says. Fejzo then partnered with genetics company, 23andMe, and “asked them to put hyperemesis in their survey, and they did and then we were able to do a genetic study.” With data from nearly 50,000 responses, Fejzo and her team discovered that “the greatest genetic risk factor” for HG was a variant of a gene called GDF15. When Fejzo learned of the connection in 2020, she quit her job at UCLA where she was researching cancer, according to Time Magazine which named her one of their women of the year for 2024. Within a few years, she played a key role in the research that ended in a big discovery about hyperemesis gravidarum: “It turned out that people with HG are genetically predisposed to have lower levels of GDF15 prior to pregnancy,” Fejzo explains. “And so they are hypersensitive to the rise of this hormone during pregnancy.” “Every single person in my study that had that mutation had hyperemesis,” she adds. Now, her focus is finding ways to use this information to prevent women from experiencing the severe symptoms brought on by the condition. “Maybe we can prevent HG by increasing those levels prior to pregnancy,” Fejzo says. “And so Harmonia will be working on efforts to hopefully be able to predict and prevent HG.” Correction: This story has updated to correct the spelling of Marlena Fejzo’s name. Fejzo’s familial aggregation study found there was a 17-fold increased risk. A previous version misstated the number.

  • How Harmonia Healthcare is revolutionizing hyperemesis gravidarum care

    Source: Celeste Krewson, Assistant Editor March 18, 2024 Marlena S. Fejzo, PhD, sheds light on Harmonia Healthcare's innovative approach to tackling hyperemesis gravidarum, offering personalized care and telehealth options to address unmet patient needs and reduce emergency room visits. Marlena S. Fejzo, PhD, chief scientific officer of Harmonia Healthcare, recently discussed how Harmonia Healthcare can help patients with hyperemesis gravidarum (HG). Harmonia Healthcare was created to treat women affected by conditions with unmet need such as HG. The company has opened clinics to treat patients with the condition, who are often treated and released in the emergency room and must frequently return. Evidence-based and personal care will be employed to help patients with HG. The first clinic opened in 2023 in Birmingham, Alabama, and the care it has provided has proven to be an unmet need, leading to expanded care. Patients will receive testing to determine their personalized needs. Treatment options include intravenous fluid, supplying nutrients the patient may be deficient in, and providing medications and more frequent follow-up. According to Fejzo, a lack of follow-up causes patients to suffer at home and return to the emergency room. Telehealth appointments will also be available for patients who are too sick for in-person visits. This, alongside frequent follow-ups, will allow patients to receive the care they need before reaching a point of crisis. Fejzo believes the care provided by Harmonia Healthcare will be a game-changer, leading to clinics and centers opening across the United States and revolutionizing HG treatment. These impacts have been seen in the Alabama clinic, according to Fejzo. Progress has already been made in treating HG, with GDF15 identified as the gene responsible for the condition. Harmonia Healthcare is researching prevention and treatment methods to support patients with HG, and to test new technologies and medications in a clinic setting. Further information is included in a Q&A with Ladi Ilkhani, MD, which can be read below. Contemporary OB/GYN: What women-specific diseases are often underrepresented in health care? Ilkhani: Unfortunately, women's health has historically been underrepresented in health care. A lot of it has to do with lack of research and clinical trials for women. I believe there are various fields overlooked and under researched reproductive health, mental health, autoimmune diseases and cardiovascular health. Some specific diseases I could think of would be HG, menopause, polycystic ovarian syndrome, fibromyalgia, obesity, endometriosis just to name a few. Contemporary OB/GYN: Why was Harmonia created and how does the program function? Ilkhani: To provide care and education in the world of women’s health starting with HG with treatment protocols that have been clinically researched and proven to benefit patients as an adjunct to their prenatal care under the supervision of their ob-gyn. Contemporary OB/GYN: Please provide a brief summary of how hyperemesis gravidarum impacts patients and how they can receive aid from Harmonia. Ilkhani: HG is a severe form of nausea and vomiting during pregnancy which can lead to dehydration, weight loss, and nutritional deficiencies that can impact a patient’s overall well-being. Harmonia can aid in care by recommending certain medications for nausea, recommended dietary adjustments, and navigate a patient's care by providing additional support to them during their pregnancy. Intravenous fluids with vitamin supplementation have shown great promise. By shedding light about HG, we can encourage further research, improved medical interventions, and enhanced care for individuals affected by HG. Contemporary OB/GYN: Is there anything you would like to add? Ilkhani: Women may face varied health concerns throughout their lives especially in reproductive health. Raising awareness about HG is vital for many reasons. It can help pregnant individuals and healthcare providers recognize the severity of the disease, leading to earlier diagnosis and intervention. Increased awareness also contributes to reducing the stigma surrounding HG and promotes understanding and support for those experiencing it. About Harmonia Healthcare Harmonia is a highly specialized women's health platform that combines cutting edge functional medicine treatment with science-backed resolution for underdiagnosed, undertreated and otherwise dismissed female-specific diseases. Initially focused on hyperemesis gravidarum, Harmonia's physician-lead research, diagnostic and treatment programs result in superior health outcomes and subsequently enhanced wellbeing and quality of life. For more information on Harmonia and hyperemesis gravidarum, or to learn if you might be suffering from hyperemesis gravidarum, visit www.harmoniahealthcare.com or connect with us on Instagram at @harmoniahealthcare.

  • Keck Med professor among Time's women of the year

    Source: By: Alexis Kayser (Email) Thursday, February 22nd, 2024 Marlena Fejzo, PhD — a geneticist and clinical assistant professor at the University of Southern California's Keck School of Medicine —  is one of Time's women of the year. Dr. Fejzo, 56, grew ill during her second pregnancy and was diagnosed with hyperemesis gravidarum (HG), a condition causing extreme nausea and vomiting in 1-3% of pregnancies. Her physician downplayed her symptoms, suggesting that many women exaggerate their pain for sympathy, Dr. Fejzo told the magazine. The physician did not prescribe a feeding tube until it was too late, and she lost the fetus. Dr. Fejzo — who received her PhD in genetics at Harvard University, and researched at the University of California campuses in both Los Angeles and San Francisco — began to research the condition. In 2020, more than two decades after her diagnosis, she published a paper in Nature Communications suggesting a genetic variant that could predispose people to HG. In 2023, her second paper in Nature reported that people with the condition have high levels of the hormone GDF15 during pregnancy, but lower-than-average levels prior to pregnancy. By supplementing high-risk patients with the hormone before pregnancy, or lowering the levels during pregnancy, physicians might be able to reduce the system-shock that causes vomiting and nausea. Dr. Fejzo is now the chief scientific officer of  Harmonia Healthcare, a specialty women's health platform that launched Feb. 21, according to a news release shared with Becker's. This year, Harmonia aims to open a HG-specific treatment center in New Jersey, and eventually hopes to expand to New York City. Dr. Fejzo is named alongside 11 other Time women of the year, including "Barbie" Director Greta Gerwig; Singer Audra Day; and Nobel Laureate Claudia Goldin, PhD.

  • Time Woman of the Year 2024: Her Doctor Dismissed Her Extreme Morning Sickness. So She Found the Gene Behind It

    Source: BY JAMIE DUCHARME FEBRUARY 21, 2024 6:23 AM EST Geneticist Marlena Fejzo had a difficult start to her first pregnancy. She suffered from nausea and vomiting, as roughly 70% of pregnant people do, but pushed through until the symptoms lessened with time. Her second pregnancy, in 1999, was another story. For weeks, all Fejzo could do was lie flat on her back, since even rolling to her side triggered debilitating nausea. Eating or drinking was out of the question, forcing her to get a home IV for nourishment. “Every second,” she says, “was torture.” Fejzo, who is now 56 and a clinical assistant professor at the University of Southern California’s Keck School of Medicine, had something more serious than typical morning sickness. She was ultimately diagnosed with hyperemesis gravidarum (HG), a condition that leads to extreme nausea and vomiting in 1% to 3% of pregnancies. But even as her doctor diagnosed her, he downplayed the situation, suggesting that many women with HG exaggerate their symptoms for sympathy. Fejzo knew he was wrong; the idea of making up such misery was ludicrous. But she “didn’t have the energy to fight.” By that point, she was bedbound and losing weight at an alarming rate. Fejzo’s physician eventually ordered a feeding tube, at around 11 weeks of pregnancy, but it wasn’t enough. Fejzo had become so frail that she lost her fetus just a few weeks later. “It was just too late,” she says. Haunted by her doctor’s dismissal and the limits of his care, Fejzo tried to learn whatever she could about HG while she recovered. That turned out to be not much at all—the condition was barely studied at the time. (Many would only learn about HG when British royal Kate Middleton was hospitalized with it during her pregnancies.) “There was so little known,” Fejzo says, but she had a hunch “there was something biological going on.” She vowed to be the one to find out what it was, both for her own sake and that of her future children, twin daughters who were later born via surrogate. “I didn’t want my daughters to have to go through that,” she says. “Or anybody else.” Fejzo was uniquely well suited to the task. She’d been interested in women’s health since her Ph.D. training in genetics at Harvard University, when she discovered two genes linked to developing potentially painful uterine growths known as fibroids. She’d gone on to research breast cancer at the University of California, San Francisco, and multiple sclerosis at the University of California, Los Angeles. Motivated by her “horrible experience” and the memory of being blamed for it, she turned her scientific expertise toward her own condition. She began by setting up an online survey to learn more about the experiences of other people who’d had HG, the results of which suggested the condition ran in families—many sufferers said their mothers or sisters had also lived through it. Even more painstakingly, Fejzo spent a decade calling people who had suffered through HG, one by one, to ask for saliva samples she could use in genetic studies down the line. She collected plenty of samples, but at first struggled to persuade funders to pay for costly genetic research. Then, in 2010, she took a 23andMe DNA test that changed everything. When Fejzo saw the survey 23andMe sends to its customers to learn more about how their genes relate to their health, it sparked an idea. She persuaded the company to include questions about HG in its survey, and by 2016 she had access to genetic data and survey responses from about 50,000 people. By analyzing that trove of data, Fejzo was able to zero in on two genes of interest. One, in particular, seemed promising: it codes for the hormone GDF15, which is linked to appetite suppression and vomiting—and which the body produces in earnest during pregnancy. In 2018, she published a paper in Nature Communications suggesting that a variant of that gene could predispose people to HG. She later bolstered that finding, discovering a rare genetic mutation that seemed to be even more strongly linked to developing HG. Spurred by those discoveries, Fejzo quit her position in a UCLA cancer laboratory in 2020 to focus on researching HG. It wasn’t difficult to leave, she says. “There’s tons of people working on cancer, and I’m one of the only people working on hyperemesis. If I stopped working on it, the road would have ended.” She wasn’t willing to let that happen. Last year, more than two decades after her harrowing experience with HG, Fejzo had another breakthrough. In a paper published in Nature, she reported that people with HG tend to have high blood levels of GDF15 during pregnancy, yet produce lower-than-average amounts of GDF15 prior to pregnancy. When GDF15 levels naturally rise after conception, the shock to the system results in HG’s relentless nausea and vomiting. That finding opens up promising avenues for treatment. Doctors could lower GDF15 levels during pregnancy. Or, if they could gradually supplement levels of the hormone in people who are not yet pregnant but deemed high-risk based on personal or family history of HG, they could feasibly smooth the transition and avoid debilitating symptoms. Fejzo is now applying for funding for a clinical trial to test whether the drug metformin—which is approved to treat Type 2 diabetes but is used off-label for numerous purposes and has been shown to raise GDF15 levels—works as a preventive therapy. It may take years to find out whether that approach works, but if it does, Fejzo will be able to act quickly. In addition to serving on the board of the Hyperemesis Education & Research Foundation, Fejzo is the chief scientific officer at a new women’s health company, Harmonia Healthcare, which this year plans to open an HG-focused treatment center in New Jersey before expanding to New York City. “I’ve been trying for so long to put an end to this,” Fejzo says, “and I think we’re finally close.” WRITE TO JAMIE DUCHARME AT JAMIE.DUCHARME@TIME.COM.

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