The Alliance for Regenerative Medicine Announces the Appointment of Timothy D. Hunt as Chief Executive Officer

WASHINGTON, D.C. August 10, 2022

The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization representing the cell and gene therapy sector, today formally announced that its Board of Directors has appointed Timothy D. Hunt as the organizations next Chief Executive Officer. Hunt will succeed Janet Lynch Lambert, who announced in April her plan to step down as CEO and who served on the Boards Search Committee. Hunt will start at ARM on September 6.

We are excited to welcome Tim to the ARM team at such a pivotal moment for our sector, said Emile Nuwaysir, Chair of the ARM Board and Search Committee,and President and Chief Executive Officer of Ensoma, an in vivo genomic medicines company. Tims two decades of experience advocating for biotechnology companies, knowledge of the key issues facing the cell and gene therapy field, and expertise in leading teams make him the ideal choice to guide ARM in building the future of medicine. Tim has a deep philosophy of engagement with major stakeholders that will support ARM members and help bring cell and gene therapies into mainstream medical practice.

Hunt was most recently the Chief Culture and Corporate Affairs Officer at Xilio Therapeutics, a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer. Prior to that, he was the Chief Corporate Affairs Officer at CRISPR gene-editing pioneer Editas Medicine, where he led the companys global policy and government affairs, bioethics, communications, market development and human resources initiatives. He also served in executive public affairs roles at Cubist Pharmaceuticals and Biogen.

Hunt was an Advisory Group member of the Value-Based Payments for Medical Products consortium at the Duke-Margolis Center for Health Policy. He also has been a member of the Board of Directors of the non-profit organization Life Science Cares and has chaired the Ethics Committee of the American Society of Gene and Cell Therapy (ASGCT). Hunt previously served as a member of ARMs Gene Editing Task Force and on the Biotechnology Innovation Organizations Gene Editing Working Group. He received a B.A. in history and philosophy from Boston College and a J.D. from the Columbus School of Law at the Catholic University of America.

I am honored to succeed Janet as Chief Executive Officer of the Alliance for Regenerative Medicine and for the tremendous opportunity to build upon her legacy of developing ARM into the leading sector advocate and resource for the industry, said Hunt. Cell and gene therapies are already transforming patients lives, and we are on the cusp of even more breakthroughs in both rare and prevalent diseases. Our mission is both urgent and clear: to engage all our major stakeholders to ensure the patients we serve have access to the durable and potentially curative therapies of the present and future.

Tim is an excellent choice to continue to grow and strengthen this amazing organization and help realize the potential of regenerative medicine, said Lambert, whose tenure includes doubling ARMs global membership to 425 members, strengthening the organizations advocacy in the US and Europe, and building the ARM team.

Cell and gene therapies to treat blood cancers, spinal muscular atrophy, and an inherited form of blindness are approved in the US and Europe. 2022 could be a record year for new gene therapy approvals for rare disease, and regulators in the US and Europe could approve the first such therapies for hemophilia and sickle cell disease in late 2022 and 2023. More than 2,400 regenerative medicine clinical trials 60% of which targeted prevalent diseases including diabetes and cardiovascular disease were active globally at the end of 2021. ARM is committed to working with stakeholders to ensure that patients benefit from this rapidly advancing pipeline of transformative therapies.

About The Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organisation dedicated to realizing the promise of advanced therapy medicinal products (ATMPs).ARMpromotes legislative, regulatory, reimbursement and manufacturing initiativesin Europe and internationally to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-engineered therapies.Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing ATMPs.In its 12-year history,ARMhas become the global voice of the sector, representing the interests of 425+ members worldwide and 80+ members across 15 Europeancountries, including small and large companies, academic research institutions, major medical centres and patient groups.To learn more aboutARMor to become a member, visithttp://www.alliancerm.org.

Media inquiries

For more information or for media requests, please contact Stephen Majors, Senior Director of Public Affairs for ARM, atsmajors@alliancerm.org.

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The Alliance for Regenerative Medicine Announces the Appointment of Timothy D. Hunt as Chief Executive Officer - GlobeNewswire

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COVID-19 came with plenty of mysteries, some of which have been resolved, and many that haven't. One mystery since the beginning of the pandemic was why children seemed much less susceptible to the virus than adults. For that and more research news, continue reading.

Why Kids May Have More Protection Against COVID-19

Generally, children are less at risk of COVID-19 infection than adults - not immune, but less likely to be infected and less likely to have severe disease. But why?

Researchers at theUniversity of Queensland, Australia,suggestthat children's nasal lining, or the nasal epithelium, inhibits infection and replication, particularly of the original Wuhan wild-type strain of SARS-CoV-2 and the Delta variant. However, the Omicron variant and its subvariants do not seem to have the same issue. They published their research inPLOS Biology.

"We have provided the first experimental evidence that the pediatric nasal epithelium may play an important role in reducing the susceptibility of children to SARS-CoV-2," the authors wrote. "The data strongly suggest that the nasal epithelium of children is distinct and that it may afford children some level of protection from ancestral SARS-CoV-2."

They found that the wild-type virus replicated less efficiently and was linked to an increased antiviral response in the nasal epithelial cells of children. The effect was also seen with the Delta variant, but not with the Omicron. They also found that Omicron replicated better in pediatric nasal epithelial cells than the wildtype or Delta, although they caution that this was a small study and may reflect how the virus is evolving.

New Molecules Discovered for Treating Age-Related Diseases

Researchers at theHebrew University of Jerusalemhaveidentifieda group of molecules that help cells repair damaged components. Impaired mitophagy is associated with various aging-associated diseases, such as Alzheimer's and Parkinson's, as well as sarcopenia.

Augmenting mitophagy, where defective mitochondria are removed and replaced by new ones, is an emerging strategy for treating the elderly. The researchers designed and tested a family of compounds related to spermidine, a known mitophagy-promoting agent. A prototype, 1,8-diaminooctane (VL-004), was better than spermidine in its ability to induce mitophagy and protect against oxidative stress.

The researchwas publishedin the journalAutophagy. The researchers founded a biotech company, Vitalunga, that is working to develop the drug.

Unique Subset of Immune Cells Protects Against Stroke

A study from theUniversity of Pittsburgfounda subset of white blood cells, a novel subset of CD8+ regulatory-like T cells (CD8+TRLs), that appear to confer fast-acting and lasting protection against ischemic stroke in mice.

These cells were attracted to the site of ischemic injury by a unique "homing" signal produced by the damaged brain cells. The CD8+TRLs reached the brain 24 hours after the stroke, then released molecules that provide direct neuroprotective effects and knock down inflammation and secondary brain damage.

In the mice studies, the animals who received a transfusion of purified CD8+TRLs did better and recovered faster than the untreated mice over five weeks. The CD8+TRLs appear to act as early responders to alert and recruit defenses after a stroke.

Gene Therapy Shows Promise in ALS

Researchers at theUniversity of California San DiegoSchool of Medicinereportthat gene therapy in animal models of ALS measurably delayed disease onset. Although most ALS cases are of unknown cause, the mouse and rat models were of an inherited form of ALS.

The therapy involved an AAV-vector carrying synapsin-Caveolin-1 cDNA into the spinal cords of the mice. The SynCav1 protected and preserved spinal cord motor neurons and added to the mice's longevity. They speculate that SynCav1 might serve as novel gene therapy for ALS and other forms of CNS disease.

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease marked by progressive loss of motor neurons in the brain and spinal cord. It is fatal, and there are no cures.

New Therapeutic Target for Colorectal Tumors

Researchers at theTokyo University of Scienceidentifieda potential new therapeutic target for colorectal tumors.

Inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, can often lead to colorectal tumors. Innate immune receptors, such as C-type lectin receptors (CLRs), are responsible for the development of IBD. But they also play a key role in regulating gut microbiota and defending against pathogens.

One of those CLRs is a dendritic cell immunoreceptor (DCIR), responsible for maintaining the homeostasis of the immune and skeletal systems. Working with mice, the researchers found that mice without DCIR had less colitis severity and AOM-DSS-induced colorectal tumor growth. They found that using an antibody called anti-NA2 against asialo-biantennary-N-glycans (NA2), which binds to DCIR, decreased colitis symptoms and prevented colorectal tumor growth.

Two Common Viruses Associated with Alzheimer's Disease

Astudyout ofTufts Universityand theUniversity of Oxfordstrengthened the association between specific viral infections and Alzheimer's disease. Two common viruses can lie dormant in brain cells herpes simplex virus (HSV) and varicella-zoster virus (VZV); the latter is associated with shingles and chickenpox.

Researchers leveraged 3D human tissue culture models to mimic the brain and demonstrated that VZV may activate HSV to lay the groundwork for the early stages of Alzheimer's disease. HSV-1, the primary variant of HSV, when activated, leads to the accumulation of tau and amyloid-beta proteins, which are implicated in Alzheimer's disease. They published their research in theJournal of Alzheimer's Disease.

"Our results suggest one pathway to Alzheimer's disease, caused by a VZV infection which creates inflammatory triggers that awaken HSV in the brain," Dana Cairns, Ph.D., GBS12, a research associate in the Biomedical Engineering Department at Tufts, said. "While we demonstrated a link between VZV and HSV-1 activation, it's possible that other inflammatory events in the brain could also awaken HSV-1 and lead to Alzheimer's Disease."

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Research Roundup: Why Kids Have More Protection Against COVID-19 & More - BioSpace

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According toGrand View Research, the global cell therapy market was valued at $7.8 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 14.5% between 2021 and 2028.

The rising number of clinical studies for cell-based therapies and investments in the industry may have a symbiotic relationship. The industry is seeing a snowballing number of ongoingclinical trialswith funding from governments and private agencies.

Theres an arguably thin line between cell and gene therapy. Cell therapy is the transfer of intact, live cells into a patient to help lessen or cure a disease, according to theAmerican Society of Gene and Cell Therapy (ASGCT). The cells may originate from the patient (autologous cells) or a donor (allogeneic cells).

Gene therapy involves the transfer of genetic material, usually in a carrier or vector, and the uptake of the gene into the appropriate cells of the body. Some protocols use both gene therapy and cell therapy.

Companies are using thebuilding blocks of lifeand advanced technologies to improve the treatment of human diseases and disorders such as cancer, providing an alternative to traditionally relied-on drugs and surgical treatments.

Cell therapy companies like Longeveron Inc. LGVN, Biogen Inc. BIIB, Alzamend Neuro Inc. ALZN and Solid Biosciences Inc. SLDB, as a result, have gained attention for their progress in using living cells to treat previously incurable diseases and disorders.

COVID-19 has reportedly causedsignificant disruptionto the cell and gene therapy industry. The pandemic has exacerbated the woes of an industry thats had its fair share of challenges with the supply of materials and the manufacturing and logistics processes.

General investments also slowed for the industry as governments shifted focus to saving lives and reviving economies. But things are starting to pick up now that the pandemic is on a downward trend.

Regulatory bodies like the Food and Drug Administration (FDA) have been urged to be more flexible in their approval timelines to make therapies affordable. Discussions continue around access and ensuring these therapies are affordable, reimbursable and profitable for the biopharmaceutical companies that develop them.

Academic and industry collaborations are expected to continue to expand and grow with noticeable impacts on the approval of products. Partnerships among academia, global pharmaceutical companies and small biotechs are expected to continue to shape the cell and gene therapy industry.

Longeveron, a clinical-stage biotechnology company, is one example of a company in the industry that has seemingly done well even during the pandemic. The company reports developing cellular therapies for investigation in chronic aging-related and certain life-threatening conditions.

The companys lead investigational product is Lomecel-B, a cell-based therapy product, derived from culture-expanded medicinal signaling cells sourced from the bone marrow of young, healthy adult donors.

Longeveron believes using the same cells that promote formation of new blood vessels, enhance cell survival and proliferation, inhibit cell death, and modulate immune system function may result in safe and effective therapies for some of the most difficult disorders associated with aging and some medical disorders.

Longeveron is sponsoring Phase 1 and 2 clinical trials in the following indications: Aging frailty, Alzheimers disease, metabolic syndrome, acute respiratory distress syndrome and hypoplastic left heart syndrome.

The companys mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials to achieve regulatory approvals, subsequent commercialization and broad use by the healthcare community.

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Is This Company In A Special Position Even As The COVID-19 Pandemic Affects Cell-Based Therapy Industry? - Benzinga

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OHSU researchers will receive a grant to helpadvance a first-of-its-kind method to turn an individuals skin cell into an egg, with the potential to produce viable embryos. (OHSU/Christine Torres Hicks)

Scientists at Oregon Health & Science University have received significant philanthropic support to advance a first-of-its-kind method to turn an individuals skin cell into an egg, with the potential to produce viable embryos.

The technique, initially demonstrated in mice, could eventually provide a new avenue for child-bearing among couples unable to produce viable eggs of their own.

Paula Amato, M.D., professor of obstetrics and gynecology in the OHSU School of Medicine, andShoukhrat Mitalipov, Ph.D., director of the OHSU Center for Embryonic Cell and Gene Therapy. (OHSU/Christine Torres Hicks)

Even though the proof of concept in mice shows promise, significant challenges remain to be resolved before the technique could be ready for clinical trials under strict ethical and scientific oversight. Even then, Congress currently precludes the Food and Drug Administration from providing oversight for clinical trials involving genetic modification of human embryos.

Shoukhrat Mitalipov, Ph.D., (OHSU)

It will take probably a decade before we can say were ready, said Shoukhrat Mitalipov, Ph.D., director of the OHSU Center for Embryonic Cell and Gene Therapy. The science behind it is complex, but we think were on the right path.

This type of research is not funded by the National Institutes of Health, so it depends on philanthropic support. For this project, Open Philanthropy awarded $4 million over three years through the OHSU Foundation.

Paula Amato, M.D. (OHSU)

Paula Amato, M.D., professor of obstetrics and gynecology in the OHSU School of Medicine, sees the potential for an enormous benefit to families struggling to have children if the technique proves successful.

Age-related decline in fertility remains an intractable problem in our field, especially as women are delaying childbearing, said Amato, who is the principal investigator for the grant award.

The technique holds promise for helping families to have genetically related children, a cohort that includes women unable to produce viable eggs because of age or other causes, including previous treatment for cancer. It also raises the possibility of men in same-sex relationships having children genetically related to both partners.

The skin cell can come from somebody who doesnt have any eggs themselves, Amato said. The biggest implication is for female, age-related infertility. It can also come from women with premature ovarian insufficiency due to cancer treatment or genetic conditions, or from men who would be able to produce a genetically related child with a male partner.

The award from Open Philanthropy will enable OHSU researchers to develop the technique in early human embryos using eggs and sperm from research donors. As with other groundbreaking research at OHSU including a gene-editing discovery that generated worldwide attention in 2017 none of the early embryos will be allowed to develop past the early blastocyst stage.

Researchers will build on a study in mice published this January in the journal Communications Biology.

The study demonstrated that it is possible to produce normal eggs by transplanting skin-cell nuclei into donor eggs from which the nuclei have been removed. Known as somatic cell nuclear transfer, the technique was famously used in 1997 to clone a sheep in Scotland named Dolly. In contrast to a direct clone of one parent, the mouse study published earlier this year required OHSU and collaborating scientists to cut the donor DNA in half and then fertilize the resulting egg with sperm to generate a viable embryo with chromosomes from both parents.

The process involves implanting the skin cell nuclei into a donor egg, and then allowing the egg to discard half its skin cell chromosomes a process similar to meiosis, when cells divide to produce sperm or egg cells. This results in a haploid egg with a single set of chromosomes with precisely half the chromosomes of the diploid skin cell with two sets of chromosomes. At just the right phase of the cell cycle, the new egg is combined with sperm chromosomes through in vitro fertilization.

An embryo then develops with the correct diploid number of chromosomes from each parent.

We had to show in the mouse that this hypothesis works, Mitalipov said. Open Philanthropy saw the implications for fertility with a new way of looking into this. The key is inducing haploidy.

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OHSU advancing first-of-its-kind strategy to overcome infertility - OHSU News

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The new report titled Hemophilia Gene Therapy Market offer by Key Players, Types, Applications, Countries, Market Size, Forecast to 2030offered by Market Research, Inc. includes a comprehensive analysis of the market size, geographical landscape along with the revenue estimation of the industry. In addition, the report also highlights the challenges impeding market growth and expansion strategies employed by leading companies in the Hemophilia Gene Therapy Market.

Hemophilia is a genetic bleeding disorder in which an individual lacks or has low levels of proteins called clotting factors. There are around 13 types of clotting factors that work with blood platelets, which are necessary for clotting process to initiate. There are three forms of hemophilia A, B, and C. Hemophilia A is the most common form and is caused due to deficiency in clotting factor VIII. Hemophilia B occurs due to deficiency of clotting factor IX and Hemophilia C is caused due to clotting factor XI deficiency. Hemophilia is incurable with current therapeutic options, which only reduces symptoms such as spontaneous bleeding in muscles and joints as well as increased risk for intracranial hemorrhage.

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This market study covers and analyzes the potential of the global Hemophilia Gene Therapy industry, providing geometric information about market dynamics, growth factors, major challenges, PEST analysis and market entry strategy analysis, opportunities and forecasts. One of the major highpoints of the report is to provide companies in the industry with a strategic analysis of the impact of COVID-19 on Hemophilia Gene Therapy market.

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The Hemophilia Gene Therapy market report includes information on the product presentations, sustainability and prospects of leading player including: BioMarin Pharmaceuticals, Inc., Spark Therapeutics, Pfizer, Inc., UniQure NV, Ultragenyx Pharmaceutical, Shire PLC Sangamo Therapeutics, Inc., and Freeline Therapeutics

Hemophilia Gene Therapy Market: Segmentation

By Type:

By Application:

Hemophilia Gene Therapy Market: Regional Analysis

All the regional segmentation has been studied based on recent and future trends and the market is forecasted throughout the prediction period. The countries covered in the regional analysis of the Global Hemophilia Gene Therapy market report are North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and Latin America.

Years Considered for the Hemophilia Gene Therapy Market Size:

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Scope of Hormone Replacement Therapy Market

The main objective of thisHormone Replacement TherapyMarket research analysis is to discover the right opportunities, provide the right investment options and evaluate some actions to be taken for business growth. It forecasts the competition level in the market for the period 2022-2030. There are a few crucial factors covered in this market study report such as identification of potential sales, risks involved in the business, and pointing out exact problems in the market. It further goes on to depict how the dangerous virus COVID-19 affected human health and the world economy and how to reduce its effects on society.

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Key Players Mentioned in the Hormone Replacement Therapy Market Research Report:Abbott, Bayer AG, Merck KGaA, Novartis AG, and Pfizer Inc.

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Product Type SegmentationEstrogen HormoneGrowth HormoneThyroid HormoneTestosterone Hormone

Application SegmentationMenopauseHypothyroidismGrowth Hormone DeficiencyMale HypogonadismOther Diseases

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North America (the United States, Canada, and Mexico)Europe (Germany, France, UK, Russia, and Italy)Asia-Pacific (China, Japan, Korea, India, and Southeast Asia)South America (Brazil, Argentina, Colombia, etc.)The Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

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Analysis supports positive lifestyle habits, such as exercising and quitting smoking, investigators say.

Menopause before aged 40 years is associated with elevated risks of atrial fibrillation (AF) and heart failure (HF), according to the results of a study published in the European Heart Journal.

In the study of more than 1.4 million women, results showed that the younger the individual is at menopause, the higher the risk of new-onset HF and AF.

Women with premature menopause should be aware that they may be more likely to develop heart failure or atrial fibrillation than their peers, Ga Eun Nam of Korea University College of Medicine, Seoul, Republic of Korea, said in a statement. This may be good motivation to improve lifestyle habits known to be linked with heart disease, such as quitting smoking and exercising.

Investigators included postmenopausal women who were aged 30 years or older and completed a National Health Interview Survey health check-up in 2009. Investigators followed up with individuals until the end of 2018 for new-onset HF and AF.

Information on demographics, health behaviors, and reproductive factors, including age at menopause and use of hormone replacement therapy, were collected.

Investigators categorized age at menopause as below aged 40, 40 to 44, 45 to 49, and 50 years or older. Premature menopause was defined as the individuals final menstrual period before the aged 40 years.

Approximately 2% of individuals had a history of premature menopause. Of these women, the average age at menopause was 36.7 years. The average age at study enrollment for women with and without a history of premature menopause was 60 and 61.5 years, respectively.

During an average follow up of 9.1 years, 3.2% developed AF and 3% of individuals developed HF.

Investigators analyzed the association between history of premature menopause and incident HF and AF after adjusting for age, smoking, alcohol, physical activity, income, body mass index, and other factors that could have affected the incidence.

They found that women who experienced premature menopause had a 33% higher risk of HF and a 9% higher risk of AF compared with those who did not.

The misconception that heart disease primarily affects men has meant that sex-specific risk factors have been largely ignored. Evidence is accumulating that undergoing menopause before the age of 40 may increase the likelihood of heart disease later in life, Nam said in the statement

Our study indicates that reproductive history should be routinely considered in addition to traditional risk factors such as smoking when evaluating the future likelihood of heart failure and atrial fibrillation, she said.

Investigators also analyzed the association between age at menopause and the incidence of AF and HF after adjusting for the same factors as in the previous analyses.

The risk of HF increased as the age at menopause decreased.

Compared with those aged 50 years and older at menopause, those aged 45 to 49, 40 to 44, and below 40 years had an 11%, 23%, and 39% greater risk of incidence HF, respectively.

Additionally, the risk of AF increased as age decreased with 4%, 10%, and 11% higher, respectively, compared with women aged 50 years and above at menopause.

Several factors could explain the associations, including changes in body fat distribution and a drop in estrogen levels, investigators said.

Reference

Premature menopause is associated with increased risk of heart problems. News release. EurekAlert. August 3, 2022. Accessed August 5, 2022. https://www.eurekalert.org/news-releases/960487

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Study Results Link Menopause Before 40 to Increase in Atrial Fibrillation, Heart Failure - Pharmacy Times

Recommendation and review posted by Bethany Smith

More than 37 million people are estimated to have chronic kidney disease (CKD), according to the CDCand 9 out of 10 people don't even know they have it. "There are a number of physical signs of kidney disease, but sometimes people attribute them to other conditions," says Dr. Joseph Vassalotti, Chief Medical Officer at the National Kidney Foundation. "Also, those with kidney disease tend not to experience symptoms until the very late stages, when the kidneys are failing or when there are large amounts of protein in the urine. This is one of the reasons why only 10% of people with chronic kidney disease know that they have it." Here are five sure symptoms of kidney disease, according to doctors. Read onand to ensure your health and the health of others, don't miss these Sure Signs You've Already Had COVID.

Unexplained fatigue could be a sign of kidney disease, doctors warn. "In addition to filtering waste, healthy kidneys make a hormone called erythropoietin (EPO), which tells your bone marrow to make red blood cells. If your kidneys aren't working as well as they should, they won't make enough of this important hormone," according to Staci Leisman, MD, kidney specialist at Mount Sinai Hospital in New York City. "As a result, you produce fewer red blood cells, which could lead to a condition called anemia."

Foamy, discolored, bloody urine could be a sign of kidney disease, doctors warn. Changes in urinationfor example, urinating more or less than usualcould also be a red flag. "Even a little blood can change the color of urine dramatically," says nephrologist Juan Calle, MD.6254a4d1642c605c54bf1cab17d50f1e

Nausea and vomiting are often reported as particularly unpleasant symptoms of kidney disease. "The earliest signs are you may get nauseated especially in the morning, or you have an appetite and you smell food and then it just turns your stomach," says nephrologist James Simon, MD. "You are actually nauseated all day, a bitter and metallic taste in your mouth. Those are the earliest signs."

High blood pressure could be a sign of kidney disease, but physicians are unsure how they are connected. "High blood pressure may be a sign of kidney disease, or it may cause it. It's the chicken-or-egg dilemma," says Dr. Calle. "Anyone who has high blood pressure and diabetes needs to be screened for kidney diseases."

Knowing the risk factors for chronic kidney disease is key for prevention. "Primary risk factors include diabetes, high blood pressure, cardiovascular disease, a family history of kidney failure and age over 60," says Leslie Spry, MD, FACP. "Secondary risk factors include obesity, autoimmune diseases, urinary tract infections, systemic infections, and kidney loss, damage, injury or infection. Taking care of overall health helps protect kidney health. Wise practices include exercising regularly, low salt diet, controlling weight, monitoring blood pressure, cholesterol and glucose levels, not smoking, drinking moderately, avoiding non-steroidal anti-inflammatory drugs (NSAIDs) and getting an annual physical."

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Sure Signs You Have Kidney Disease, Say Physicians Eat This Not That - Eat This, Not That

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According to the CDC, 37.3 million people in the U.S. have diabetes (11.3% of the population) and 96 million people aged 18 years or older have prediabetes (38.0% of the adult population).

"As recently as 50 years ago, type 2 diabetes was extremely rare. Now, around the world, the number of people with diabetes is increasing rapidly and is heading towards 643 million by 2030. This is a worldwide epidemic," says Adele Hite, PhD, MPH, RD. "In the past, type 2 diabetes was thought to be a progressive disease with no hope for reversal or remission. People were and sometimes still are taught to 'manage' type 2 diabetes, rather than to try to reverse the underlying process. But now people with type 2 diabetes can hope to regain their health." Here are five habits increasing your prediabetes risk. Read onand to ensure your health and the health of others, don't miss these Sure Signs You've Already Had COVID.

Lack of sleep is strongly linked to both diabetes and prediabetes, doctors warn. "How does poor sleep contribute to obesity, diabetes, and metabolic issues? It's known that lack of sleep raises the stress hormone cortisol and increases glucose production, which raises your blood sugar," says Tony Hampton, MD. "Studies have shown that markers of increased insulin resistance appear after just one night of partial sleep deprivation. Symptoms of prediabetes can arise with as little as five days of sleep disturbances. Blood pressure also increases with sleep deprivation."

Excessive belly fat is particularly dangerous in raising the risk of prediabetes, studies show. "Being overweight is known to increase the risk of type 2 diabetes, but this study shows that not all fat is equal: where any excess fat is stored in the body has a big impact on disease risk," says Professor Mark McCarthy, University of Oxford.

If you're overweight or obese, even minor weight loss can help lower the risk of getting prediabetes, experts say. "If you have prediabetes, losing a small amount of weight if you're overweight and getting regular physical activity can lower your risk for developing type 2 diabetes," the CDC advises. "A small amount of weight loss means around 5% to 7% of your body weight, just 10 to 14 pounds for a 200-pound person."6254a4d1642c605c54bf1cab17d50f1e

Regular exercise is important for lowering the risk of prediabetes. "Even if you don't lose weight, exercise will make you stronger and healthier," says endocrinologist Douglas Zlock, MD, medical director of the diabetes center at John Muir Health. "Healthy habits can definitely postpone the onset of diabetes even if they don't prevent it."

There is evidence that stress can impact blood sugar control, helping raise the risk of prediabetes. "Most people with type 2 diabetes know the importance of exercising regularly, eating a healthy diet, and getting plenty of rest," says Dr. Joshua J. Joseph, endocrinologist at The Ohio State Wexner Medical Center. "But stress relief is a crucial and often forgotten component of diabetes management. Whether it's a yoga class, taking a walk or reading a book, finding ways to lower your stress level is important to everyone's overall health, especially for those with type 2 diabetes."

Ferozan Mast

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Habits Secretly Increasing Your Prediabetes Risk, Say Physicians Eat This Not That - Eat This, Not That

Recommendation and review posted by Bethany Smith

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At a time when our bodily autonomy is under attack, women have become more vigilant about their basic human rights to equality, information, and the highest attainable standard of healthincluding sexual and reproductive health without discrimination. But the traditional healthcare system tends to treat the complex needs of women all wrong. It takes an acute approach rather than preventative. Disparate versus integrative. As a result, American women are suffering through a national infertility crisis and high maternal mortality (a rate of 23.8 to be exact, the worst among industrialized nations). The Covid-19 pandemic meanwhile has had lasting effects on the state of mental health for women, who are already twice as likely to experience depression and anxiety than men.

In an effort to change this, numerous founders are disrupting the wellness industry as we know it. We spoke with three who were unwilling to wait for the massive ship that is the American healthcare system to course correctone a former investment banker, another a former journalist, and the third a doctor-turned-serial entrepreneur. They recognize that, for women, innovation is a matter of life and death.

Kimberly Seals Allers, founder of Irth

(Image credit: Future)

With her first pregnancy, Kimberly Seals Allers, a former reporter at Fortune and editor at Essence, deployed her journalistic skills to research the best hospitals. But when she gave birth, her experience didnt match the glowing reviews.

I walked [into] a highly rated and best of hospital in New York City, having done months of due diligence and reading reviews, says Allers. But I left feeling disrespected, traumatized, and unseen.

This impacted her earliest memories of motherhood. I blamed myself completely, unaware that people are not being treated the same way even in the same place.

According to a White House statement issued on its first Maternal Health Day of Action in 2021, the U.S. has the highest maternal mortality rate of any wealthy nation. For women of color, the reality is stark. According to the CDC, Black, American Indian, and Alaska Native women are two to three times more likely to die from pregnancy-related complications than white women. The pregnancy-related mortality rate for Black women with at least a college degree was 5.2 times that of their white counterparts.

So in February 2021, Allers launched Irth, an app that seeks to equalize the experience of delivering a child by giving women a central platform for rating and reviewing hospitals, OB-GYNs, and other pre- and post-natal care providers. Think of it like Yelp, but for childbirth, aimed at helping Black and Brown women access the best prenatal, birthing, postpartum, and pediatric services.

It started as a mommy-son project. Her youngest child, Michael, then a 13-year-old coding enthusiast, created the apps wireframes and soon, the duo started going to pitch competitions. I had this idea for an app and thought this would be a great way to bridge our worlds, says Allers. In 2018, they went to an MIT hackathon related to birth and breastfeeding and won the Media for Change award. There, they met an MIT engineer who went on to build Irths prototype, which enabled Allers to get more grant funding. To date, Allers has raised more than $850,000 in grants. I'm really proud of our origin story, she says.

Were turning our anonymized reviews into qualitative data...to give every Black birthing person a five-star experience while bringing life into the worldwhich is what we all deserve.

Earlier this year, she was invited to meet with Tim Cook during Apples Worldwide Developers Conference, where Apple recognizes trailblazing creators uplifting their communities through technology. Apple also featured Irth in a spotlight (opens in new tab) on the App Store to grow awareness. It was an incredible platform to share about Irth and our mission to remove the bias from birth, says Allers.

To date, Irth has more than 20,000 users and reviews from 48 states. Allers is most alarmed by the frequency at which women of color are going through similarly poor experiences, such as hearing negative comments from care providers about family size or marital status. There were too many reviews from fathers saying they were referred to as Mr. Baby Daddy while supporting their partner; Black women being coerced and admonished about birth control while in active labor, says Allers.

Right now, according to Allers, the number-one negative experience being reported on the Irth app nationwide is: "My requests for help were ignored or refused."Such medical racism has resulted in disrespect and death. A common thread in every maternal death story is that too many hospitals want to dismiss or explain away these reports of pain, instead of taking them seriously.

Irth has its sights on reform. The team of just 15 employees recently launched pilot programs with five hospitals to improve patient care for Black mothers. Allers says the hardest work is being done at the community level, encouraging more women of color to submit reviews. After all, it will take sheer volume to sound the alarm bells on one of the biggest failures of the countrys healthcare system.

Were turning our anonymized reviews into qualitative data to teach providers, payers, and hospitals how to give every Black birthing person a five-star experience while bringing life into the worldwhich is what we all deserve.

Rebecca Parekh, ceo and cofounder of The Well.

(Image credit: Future)

Step into The Well's New York City flagship, and one might wonder whether theyve entered a luxurious retreat in Montauk or Malibu. But smack in the middle of Manhattan, visitors to The Well can book meditation classes in a glowing white dome, access body treatments rooted in Traditional Chinese Medicine and Ayurveda, or try their hand at hydrotherapy, aromatherapy, meditation, and more.

Rebecca Parekh, cofounder and CEO, says the very premise of her business is to integrate holistic health into the urbanite's day-to-dayand that meant building a geographically accessible hub to promote such a lifestyle.

Our original business was a physical business and were remaining true to that because were passionate about the in-person experience and offering integrated wellness in big, busy cities, she says. Its not a common mindset in this Web3, Metaverse-obsessed startup world.

Burnout in her previous career led Parekh to rediscover the importance of holistic health. "I was an investment banker and was not modeling a wellness lifestyle; when it comes to getting swept into hustle-culture, I got disconnected," says Parekh, who worked at Deutsche Bank for 10 years. Her mom encouraged her to simply cook more and practice yoga daily. Parekh ultimately left banking, transitioning to work as Executive Director of the Global Foundation for Eating Disorders, and then COO for Deepak Chopra Radical Wellbeing.

She began envisioning a business that would promote health on a grander scale and on a daily basis. In 2016 she teamed up with cofounders Sarrah Hallock and Kane Sarhan to begin fundraising for The Well. It opened its nearly 15,000-square-foot Manhattan flagship, complete with a full-service restaurant and retail shop in September 2019just six months before the pandemic made in-person experiences practically obsolete.

Parekh and cofounders began offering digital wellness classes and services, such as a three-part webinar focused on how to ease the anxiety of returning to office work and the outside world after months in lockdown. It also focused on e-commerce for its line of vitamins, supplements, and personal care goods.

Although The Well nimbly pivoted to digital during the pandemic, its cofounders never abandoned their commitment to physical locations and products. Through a partnership with Auberge Resorts Collection, the company continued to invest in its second location at The Mayflower Inn & Spa in Connecticut, which opened in November 2020, then its third spot, Hacienda AltaGracia, in Costa Rica in 2021.

To date, The Well employs about 100 people and has raised roughly $50 million in venture capital. After surviving Covid-19 closures, the brand is set for expansion: Parekh says The Well will likely open two more locations by the end of the year, and confirmed the company is working on projects in Mexico, Miami, London, and Aspen.

While it grows via brick-and-mortar, the company is staying grounded in an industry driven by fads. Parekh credits The Wells medical and nutrition teams with vetting everything, from services offered to ingredients served in the restaurant. The rigorous standards are set forth by Frank Lipman, M.D., Chief Medical Officer and a renowned voice in integrative and functional medicine. He went from quack to guru, as [mainstream] folks are now believing in what hes been talking about for quite some time, says Parekh.

And in an industrywellnessthat can mean many things and nothing at once, The Well filters out fads by making sure each service fits within the brands key pillars: nutrition, body work, skincare, lifestyle, community, and, a newly added category: emotional wellbeing.

We focus on meeting people where they are at in their wellness journeys, says Parekh. Whether youre sick or not we believe yoga is medicine, along with the food we eat.

Parsley Health founder and CEO, Dr. Robin Berzin.

(Image credit: Future)

Just 13 percent of healthcare CEOs are femaleand even fewer are M.D.s. But Dr. Robin Berzin has defied these odds. In 2011, the graduate of Columbia Universitys College of Physicians and Surgeons cofounded Cureatr, an app that streamlines communication with physicians. That experience with health-tech inspired her to launch Parsley Health in 2016this time as a solo female founder.

Parsley Health is a functional medicine company that takes a preventive approach to chronic disease management. It uses a holistic snapshot of a patients sleep, fitness, nutrition, family history, and mental health to determine the best regimens and health protocols.

When we look at the body as an integrated systemrather than isolated partswere able to implement the right solution at the right time.

It has served tens of thousands of patients nationwide via telehealth, in addition to in-person clinics in New York City and Los Angeles. We have independent data showing that Parsley's approach to care improves health while reducing specialist referrals and prescription drug use, Dr. Berzin says. According to company data, by year two, patients have reduced their referrals to specialists by 77 percent. Those previously on chronic medications see a 65 percent reduction in prescription drug use.

We closely monitor their health to ensure that their concerns were heard, their treatments were working, and, ultimately, that we were measurably putting them on a path to feeling better, says Dr. Berzin. She points to the initial visitwhich takes 75 minutes, five times longer than the average appointment with a primary care physicianas the real changemaker.

Last year was a big one for Dr. Berzin. In response to the wellness wave sparked by Covid-19, she grew telehealth from seven states in 2020 to a nationwide operation in early 2021. She also raised a Series C round of venture capital, bringing the total raised to date to more than $100 million. She finished writing her first book, State Change (opens in new tab).

Last but not least, she welcomed her third child. In August 2021, she posted a beaming Instagram photo of herself just three weeks before giving birth, and wrote I convinced myself at 39 that I was too old to get pregnant easily, even though of course I know better. I help women beat the fertility odds every freaking day at work!

With a female physician and a mother of three at the helm, Parsley Health is a family practice with an emphasis on transforming womens healthcare. Its programs are designed to support women throughout their reproductive lifecycle: pre-conception, fertility, pregnancy, and postpartum. Last month, the company announced the launch of comprehensive menopause care.

Menopause affects more than 55 million American women and yet 73 percent of these women will suffer in silence without treatment. Perimenopause symptoms can start as early as age 45 while menopause can last for a decade. And, too often, according to Darcy McConnell, M.D., Director of Medical Affairs at Parsley Health, older women experience age-related conditions that are misattributed to menopause. For example, bloating and weight gain are often blamed on hormones, but can actually be due to high cortisol levels, leading to incorrect treatments.

Parsley Healths menopause protocol will deviate from the traditional practice of defaulting to hormone replacement therapy (HRT), which, according to Cancer.gov, is linked to numerous side effects including vaginal bleeding, dementia, and breast cancer. Parsley Healths holistic model instead takes a closer look at a womans metabolic health and mental health to offer a comprehensive system for monitoring multiple causes and conditions.

Dr. Berzin says Parsley Health aims to connect the dots, which traditional, patriarchal medicine has failed to do: When we look at the body as an integrated systemrather than isolated partswere able to implement the right solution at the right time, which halts the cycle of frustration women experience when theyre stuck in the revolving door of specialist referrals and prescription drugs.

(Image credit: Kanya Iwana / Brittany Holloway-Brown)

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Excerpt from:
The CEOs Disrupting and Democratizing Women's Health - Marie Claire

Recommendation and review posted by Bethany Smith

Data from the Phase 3 SPIRIT program showed MYFEMBREE reduced menstrual pain and non-menstrual pelvic pain in premenopausal women with endometriosis, and a loss of mean bone mineral density of less than 1% from baseline through one year of treatment Myovant and Pfizer will continue to jointly commercialize MYFEMBREE, with product available immediately Myovant to host conference call and webcast on Monday, August 8, 2022, at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time

BASEL, Switzerland and NEW YORK, [August 5] (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months. The approval is supported by one-year efficacy and safety data, including 24-week data from the Phase 3 SPIRIT 1 and SPIRIT 2 trials, which were published in The Lancet, and the first 28 weeks of an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2. MYFEMBREE also is approved for heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. Myovant and Pfizer will continue to jointly commercialize MYFEMBREE in the U.S. and product is available immediately.

Endometriosis is a painful, chronic disease with limited therapies to manage symptoms, said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. The new MYFEMBREE indication helps advance our mission to redefine care for women by helping address a disease with high unmet need, giving women and physicians a new meaningful treatment option to manage moderate to severe pain associated with endometriosis.

This approval is an important milestone reflecting Pfizer and Myovants commitment to womens health in areas of significant unmet need, said James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer. We look forward to making MYFEMBREE available to women with endometriosis and broadening their options in managing this complex disorder.

MYFEMBREE offers an effective, once-daily treatment option for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months. Endometriosis is a serious chronic condition that requires long-term interventions. Optimization of medical therapies is the recommended treatment paradigm. 1,2,3 MYFEMBREE introduces an option for up to two years of pharmacological management of moderate to severe pain associated with endometriosis in pre-menopausal women.

The data from the SPIRIT studies showed the clinical benefit that relugolix combination therapy can have on moderate to severe pain associated with endometriosis and how it can impact patients, said Linda Giudice, M.D., Ph.D., Distinguished Professor at the University of California, San Francisco (UCSF), and Chair, SPIRIT Program Steering Committee. This newly approved option for patients with pain from endometriosis offers the convenience of one pill taken once daily with a mean change in bone mineral density of <1% that did not appear to worsen at 12 months of treatment; however, monitoring is recommended.

This approval is supported by one-year data from the Phase 3 SPIRIT program, which included two 24-week multi-national clinical studies (SPIRIT 1 and SPIRIT 2) in more than 1,200 women with pain associated with endometriosis, as well as the first 28 weeks of an open-label extension study to assess its longer-term use. Overall, these studies showed MYFEMBREE reduced menstrual pain and non-menstrual pelvic pain with a loss of mean bone mineral density of less than 1% from baseline through one year of treatment.4

SPIRIT 1 and 2 each met their co-primary endpoints with 75% of women in the MYFEMBREE group in both studies achieving a clinically meaningful reduction in dysmenorrhea compared with 27% and 30% of women in the placebo groups at Week 24, respectively (both p <0.0001). For non-menstrual pelvic pain, treatment with MYFEMBREE demonstrated a clinically meaningful reduction in pain in 59% and 66% of women, compared with 40% and 43% of women in the placebo groups (p < 0.0001). Adverse reactions occurring in at least 3% of women treated with MYFEMBREE and greater than placebo were: headache, vasomotor symptoms, mood disorders, abnormal uterine bleeding, nausea, toothache, back pain, decreased sexual desire and arousal, arthralgia, fatigue, and dizziness.The open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2 showed mean bone mineral density loss of less than 1% from baseline through one year of treatment; some patients (19.7%) had losses >3%. Annual bone density measurement is recommended while treating women for endometriosis.

MYFEMBREE is available immediately to patients with moderate to severe pain associated with endometriosis with a prescription from their healthcare provider. Myovant and Pfizer also are committed to supporting women in the U.S. who are prescribed MYFEMBREE throughout their treatment journeys. The MYFEMBREE Support Program provides access support services, including insurance benefits checks, prior authorization support, co-pay support for commercially insured patients, and patient assistance for qualifying uninsured patients. Program terms and conditions apply. For more information and additional resources, please contact 833-MYFEMBREE (833-693-3627), 8 a.m. 8 p.m. Eastern Time, Monday Friday.

Myovant Conference CallMyovant will hold a conference call on Monday, August 8, 2022, at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time to discuss the FDA approval of MYFEMBREE for the management of moderate to severe pain associated with endometriosis. Investors and the general public may access the live webcast here. The live webcast can also be accessed by visiting the companys investor relations page of Myovants website at: https://investors.myovant.com/.

Endometriosis can also impact general physical, mental, and social well-being, requiring a multi-disciplinary approach to care. Approximately 190 million women suffer from symptoms of endometriosis globally.5 In the U.S., there are approximately 7.5 million premenopausal women with endometriosis and approximately 75-80 percent of them are symptomatic.6,7,8,9 Many women with pain associated with endometriosis are not able to manage their pain symptoms with current treatment options, underscoring the high unmet need for this disease.10 It can take between four and eleven years to get an endometriosis diagnosis11,12,13 and for some women, current treatment options do not provide relief.14

About MYFEMBREEMYFEMBREE (relugolix, estradiol, and norethindrone acetate) is a once-daily oral treatment approved by the U.S. Food and Drug Administration for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months. It is also currently available in the U.S. for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. MYFEMBREE contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethindrone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen.

For full prescribing information including Boxed Warning and patient information, please click here.Indications and UsageMYFEMBREE is indicated in premenopausal women for the management of: Heavy menstrual bleeding associated with uterine leiomyomas (fibroids) Moderate to severe pain associated with endometriosisLimitations of Use: Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS Estrogen and progestin combination products, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events. MYFEMBREE is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension.

CONTRAINDICATIONSMYFEMBREE is contraindicated in women with any of the following: high risk of arterial, venous thrombotic, or thromboembolic disorder; pregnancy; known osteoporosis; current or history of breast cancer or other hormone-sensitive malignancies; known hepatic impairment or disease; undiagnosed abnormal uterine bleeding; known hypersensitivity to components of MYFEMBREE.

WARNINGS AND PRECAUTIONSThromboembolic Disorders: Discontinue immediately if an arterial or venous thrombotic, cardiovascular, or cerebrovascular event occurs or is suspected. Discontinue at least 4 to 6 weeks before surgery associated with an increased risk of thromboembolism, or during periods of prolonged immobilization, if feasible. Discontinue immediately if there is sudden unexplained partial or complete loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis as these have been reported with estrogens and progestins.

Bone Loss: MYFEMBREE may cause a decrease in bone mineral density (BMD) in some patients, which may be greater with increasing duration of use and may not be completely reversible after stopping treatment. Consider the benefits and risks in patients with a history of low trauma fracture or risk factors for osteoporosis or bone loss, including medications that may decrease BMD. Assessment of BMD by dual-energy X-ray absorptiometry (DXA) is recommended at baseline in all women. During treatment, periodic DXA is recommended for women with heavy menstrual bleeding due to uterine fibroids; in those with moderate to severe endometriosis pain, annual DXA is recommended. Consider discontinuing MYFEMBREE if the risk of bone loss exceeds the potential benefit.Hormone-Sensitive Malignancies: Discontinue MYFEMBREE if a hormone-sensitive malignancy is diagnosed. Surveillance measures in accordance with standard of care, such as breast examinations and mammography are recommended. Use of estrogen alone or estrogen plus progestin has resulted in abnormal mammograms requiring further evaluation.

Suicidal Ideation and Mood Disorders (Including Depression): Evaluate patients with a history of suicidal ideation, depression, and mood disorders prior to initiating treatment. Monitor patients for mood changes and depressive symptoms including shortly after initiating treatment, to determine whether the risks of continuing therapy with MYFEMBREE outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate. Advise patients to seek immediate medical attention for suicidal ideation and behavior and reevaluate the benefits and risks of continuing MYFEMBREE. Gonadotropin-releasing hormone receptor antagonists, including MYFEMBREE, have been associated with mood disorders (including depression) and suicidal ideation. Hepatic Impairment and Transaminase Elevations: Steroid hormones may be poorly metabolized in these patients. Instruct women to promptly seek medical attention for symptoms or signs that may reflect liver injury, such as jaundice or right upper abdominal pain. Acute liver test abnormalities may necessitate the discontinuation of MYFEMBREE use until the liver tests return to normal and MYFEMBREE causation has been excluded.

Gallbladder Disease or History of Cholestatic Jaundice: Discontinue MYFEMBREE if signs or symptoms of gallbladder disease or jaundice occur. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, assess the risk-benefit of continuing therapy. Studies among estrogen users suggest a small increased relative risk of developing gallbladder disease.

Elevated Blood Pressure: For women with well-controlled hypertension, monitor blood pressure and stop MYFEMBREE if blood pressure rises significantly.

Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy: Advise women to use non-hormonal contraception during treatment and for one week after discontinuing MYFEMBREE. Avoid concomitant use of hormonal contraceptives. MYFEMBREE may delay the ability to recognize pregnancy because it alters menstrual bleeding. Perform testing if pregnancy is suspected and discontinue MYFEMBREE if pregnancy is confirmed.

Risk of Early Pregnancy Loss: MYFEMBREE can cause early pregnancy loss. Exclude pregnancy before initiating and advise women to use effective non-hormonal contraception.

Uterine Fibroid Prolapse or Expulsion: Advise women with known or suspected submucosal uterine fibroids about the possibility of uterine fibroid prolapse or expulsion and instruct them to contact their physician if severe bleeding and/or cramping occurs.

Alopecia: Alopecia, hair loss, and hair thinning were reported in phase 3 trials with MYFEMBREE. Consider discontinuing MYFEMBREE if hair loss becomes a concern. Whether the hair loss is reversible is unknown.

Effects on Carbohydrate and Lipid Metabolism: More frequent monitoring in MYFEMBREE-treated women with prediabetes and diabetes may be necessary. MYFEMBREE may decrease glucose tolerance and result in increased blood glucose concentrations. Monitor lipid levels and consider discontinuing if hypercholesterolemia or hypertriglyceridemia worsens. In women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations in triglycerides levels leading to pancreatitis. Use of MYFEMBREE is associated with increases in total cholesterol and LDL-C.

Effect on Other Laboratory Results: Patients with hypothyroidism and hypoadrenalism may require higher doses of thyroid hormone or cortisol replacement therapy. Use of estrogen and progestin combinations may raise serum concentrations of binding proteins (e.g., thyroid-binding globulin, corticosteroid-binding globulin), which may reduce free thyroid or corticosteroid hormone levels. Use of estrogen and progestin may also affect the levels of sex hormone-binding globulin, and coagulation factors.

Hypersensitivity Reactions: Immediately discontinue MYFEMBREE if a hypersensitivity reaction occurs.

ADVERSE REACTIONS: Most common adverse reactions for MYFEMBREE (incidence 3% and greater than placebo) were: Heavy menstrual bleeding associated with uterine fibroids: vasomotor symptoms, abnormal uterine bleeding, alopecia, and decreased libido. Moderate to severe pain associated with endometriosis: headache, vasomotor symptoms, mood disorders, abnormal uterine bleeding, nausea, toothache, back pain, decreased sexual desire and arousal, arthralgia, fatigue, and dizziness.

These are not all the possible side effects of MYFEMBREE.

DRUG INTERACTIONS: P-gp Inhibitors: Avoid use of MYFEMBREE with oral P-gp inhibitors. If use is unavoidable, take MYFEMBREE first, separate dosing by at least 6 hours, and monitor patients for adverse reactions. Combined P-gp and Strong CYP3A Inducers: Avoid use of MYFEMBREE with combined P-gp and strong CYP3A inducers.

LACTATION: Advise women not to breastfeed while taking MYFEMBREE.

About Myovant SciencesMyovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, Myovant has executed five successful Phase 3 clinical trials across oncology and womens health leading to three regulatory approvals by the U.S. Food and Drug Administration (FDA) for men with advanced prostate cancer, women with heavy menstrual bleeding associated with uterine fibroids, and pre-menopausal women with moderate to severe pain associated with endometriosis, respectively. Myovant also has received regulatory approvals by the European Commission (EC) and the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) for women with symptomatic uterine fibroids and for men with advanced hormone-sensitive prostate cancer. Myovant has a supplemental New Drug Application under review with the FDA for updates to the United States Prescribing Information (USPI) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of MYFEMBREE in premenopausal women with heavy menstrual bleeding due to uterine fibroids for up to two years. Myovant also is conducting a Phase 3 study to evaluate the prevention of pregnancy in women with uterine fibroids or endometriosis. Myovant also is developing MVT-602, an investigational oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Pharma Co., Ltd., is Myovants majority shareholder. For more information, please visit http://www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Pfizer: Breakthroughs That Change Patients LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.Pfizer.com. In addition, to learn more, please visit us on http://www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Myovant Sciences Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this press release, forward-looking statements include, but are not limited to, all statements reflecting Myovant Sciences expectations, including: statements regarding Myovants aspiration to redefine care for women and for men; the expectations regarding the continued commercialization of MYFEMBREE by Myovant and Pfizer jointly in the U.S. and the timeline of product availability; the expectations that MYFEMBREEs indication helps advance Myovants mission to redefine care for women by helping address a disease with high unmet need, giving women and physicians a new meaningful treatment option to manage moderate to severe pain associated with endometriosis in Dr. Arjona Ferreiras quote; the expectation of making MYFEMBREE available to women with endometriosis and broadening their options in managing this complex disorder in Dr. Rusnaks quote; and the expectations of the MYFEMBREE Support Program for patients and the features of such program.Myovant Sciences forward-looking statements are based on managements current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions, and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements, including unforeseen circumstances or other disruptions to normal business operations arising from or related to the COVID-19 pandemic and the conflict in Ukraine. Myovant Sciences cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could materially affect Myovant Sciences operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to, the risks and uncertainties listed in Myovant Sciences filings with the United States Securities and Exchange Commission (SEC), including under the heading Risk Factors in Myovant Sciences Quarterly Report on Form 10-Q filed on July 27, 2022, as such risk factors may be amended, supplemented, or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for Myovant Sciences management to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on the forward- looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

Pfizer Disclosure NoticeThe information contained in this release is as of August 5, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg), a new indication in the U.S. for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, and a collaboration between Pfizer and Myovant Sciences to develop and commercialize relugolix in advanced prostate cancer and womens health, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of MYFEMBREE; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when applications may be filed for any other potential indications for MYFEMBREE; whether and when regulatory authorities may approve any such applications for MYFEMBREE that may be pending or filed, which will depend on myriad factors, including making a determination as to whether the products benefits outweigh its known risks and determination of the products efficacy and, if approved, whether MYFEMBREE will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of MYFEMBREE; whether our collaboration with Myovant Sciences will be successful; uncertainties regarding the impact of COVID-19 on Pfizers business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

1American Society for Reproductive Medicine (ASRM), Treatment of pelvic pain associated with endometriosis: a committee opinion. Fertil Steril. 2014;101(4):927-35.2Becker CM et al. ESHRE guideline: endometriosis, Human Reproduction Open. 2022 Feb 26;2022(2): hoac009. 3Taylor HS et al. Endometriosis is a chronic systemic disease: clinical challenges and novel innovations. Lancet 2021;397(10276):839-52 4Giudice LC, et al. Lancet. 2022 Jun; 399(10343): 2267-2279. 5Adamson, G. et al. Journal Endometriosis. 2010; 2:3-66US census 2019 (table 1; approx. 75 million women in the US ages 15-49). Available online at https://data.census.gov/cedsci/table?q=United%20States&t=Age%20and%20Sex7Shafrir. Best Pract Res Clin Obstet Gynaecol. 2018 Aug; 51:1-15 8Fuldeore Gynecol Obstet Invest. 2017;82:453-461 9Bulletti J Asist Reprod Genet 201010Becker CM, et al. Fertil Steril. 2017 Jul;108(1):125-136. 11Zondervan KT, et al. NEJM. 2020;382(13):12441256 12Nnoaham KE et al. Fertil Steril. 2011;96(2):366.e8373.e8 13Ballard K et al. Fertil Steril. 2006;86:1296301 14Soliman et al. J Womens Health. 2017. 26(7): 788-797

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Myovant Sciences and Pfizer Receive U.S. FDA Approval of MYFEMBREE, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated...

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Pancreatic cancer is considered one of the deadliest cancers because it's difficult to diagnose and is oftentimes discovered in later stages when treatment isn't effective. According to the American Cancer Society, "About 62,210 people (32,970 men and 29,240 women) will be diagnosed with pancreatic cancer. About 49,830 people (25,970 men and 23,860 women) will die of pancreatic cancer. Pancreatic cancer accounts for about 3% of all cancers in the US and about 7% of all cancer deaths." While genetics and age do play a role in the risk of pancreatic cancer, so do unhealthy habits. Eat This, Not That! Health spoke with Dr. Michael Chuong, medical director of Proton Therapy, physician director of MRI-Guided Radiation Therapy, and director of Radiation Oncology Clinical Research at Miami Cancer Institute, part of Baptist Health South Florida who shares ways to help lower your risk of pancreatic cancer. Read onand to ensure your health and the health of others, don't miss these Sure Signs You've Already Had COVID.

Dr. Chuong says, "The pancreas is an organ in the upper abdomen that is responsible for making digestive enzymes and also regulating blood sugar by secreting hormones such as insulin. Pancreatic cancer is the 4th most common cause of cancer-related death in the United States. The death rates are especially high because pancreatic cancers are usually not diagnosed until advanced stages when cancer cells have already spread to other organs."

Dr. Chuong explains, "The main risk factors for pancreatic cancer include smoking, a diet high in saturated fats and processed meats, obesity, physical inactivity, and chronic pancreatitis. About 5-10% of individuals diagnosed with pancreatic cancer have a genetic predisposition and may have others in their family also diagnosed with the same disease."

According to Dr. Chuong, "Pancreatic cancer forms when changes, also known as mutations, occur in the DNA of normal pancreas cells leading to uncontrolled growth that the body cannot control. The exact mechanisms behind the cause of these changes are largely unknown although are thought to be caused by environmental, dietary, and sometimes hereditary factors."

"The only known cure for pancreatic cancer is surgery, which is usually only effective when pancreatic cancer is diagnosed at an early stage," Dr. Chuong says. "Some patients with advanced pancreatic cancer who are not initially candidates for surgery might eventually become eligible depending on how their cancer responds to chemotherapy and sometimes also radiation therapy."6254a4d1642c605c54bf1cab17d50f1e

Dr. Chuong states, "The most common symptoms of pancreatic cancer include unintentional weight loss, loss of appetite, upper abdominal pain, jaundice (yellowing of the skin and eyes), dark urine, and clay-colored stools. If you develop these symptoms, then seek immediate medical attention."

"Cigarettes contain carcinogens that have been directly linked to an increase in developing pancreatic cancer," Dr. Chuong tells us.

Dr. Chuong emphasizes, "Exercise regularly and maintain a healthy weight. Obesity is a known risk factor for pancreatic cancer."

Dr. Chuong advises, "Develop healthy eating patterns that include plenty of fruits, vegetables, and whole grains. Avoid eating large quantities of processed meats and highly processed foods. Also, avoid heavy alcohol consumption that can result in chronic pancreatitis, which is a risk factor for developing pancreatic cancer."

Heather Newgen

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Simple Ways to Avoid Pancreatic Cancer, Say Doctors Eat This Not That - Eat This, Not That

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For medical professionals working in reproductive health care and the patients they serve the Supreme Courts decision to overturn Roe v. Wade worsened an already confusing maelstrom for providing care. Although there is consensus among the scientific community that birth control and abortion are critical forms of medical care that help manage medical conditions and save lives, the politics of reproductive health care are beyond fraught. Not only are doctors afraid to provide evidence-based care (theyre trying to squeeze in phone calls to their lawyers between appointments with anxious patients) but patients may now be afraid to be honest with their doctors.

The need for precision medicine in the reproductive health care sphere has never been greater: for much of the country, the risks of unwanted pregnancy are exacerbated by abortion legislation and unscientific political rhetoric around birth control.

More than 47 million American women aged 15-49 were using contraceptives as of 2019, and nearly 30% have tried five or more methods of birth control. The top reason for discontinuing the use of hormonal contraceptives like the pill? Side effects. Because of this, the use of less effective methods of birth control, such as withdrawal, have increased exponentially.

There are a wealth of options when it comes to birth control almost 200 hormonal medications on U.S. markets but doctors rely on the CDCs MEC plus a haphazard method of trial and error when it comes to prescribing patients. The gap in research and data when it comes to disorders that differentially impact women exacerbates this. When it comes to reproductive health disorders its even more glaring: although one in three women will have severe reproductive health issues in her life, less than 2.5% of publicly funded medical research has focused on female reproductive health disorders.

Its no wonder that theres increasing resistance to birth control. The combination of bad personal experiences resulting from an insufficient standard of care with a social climate of misconception and stigma has led many to write off contraceptives entirely.

It can be challenging for patients to separate fact from fiction when it comes to reproductive health care. Missouri lawmakers falsely claimed that IUDs were abortifacients as a way to undermine birth control funding. Several states have advanced legislation known as heartbeat bills that purport to ban abortions beginning when the fetuss heart starts beating, but the laws actually ban it before the embryo has even developed into a fetus, let alone has a heartbeat. If patients solely listened to their political leaders, some of whom do not seem to understand the basics of reproductive systems, they would be in major trouble. Medical professionals are urgently needed to combat misinformation and help patients to understand the complex realities of accessing birth control, and can do so by taking advantage of the benefits of precision medicine.

Using precision medicine can help doctors capitalize on the life-changing benefits of hormonal birth control and avoid dangers for high risk patients through analyzing the patients hormones, genetic makeup and other biological markers to make informed choices about which medicine to prescribe. Our dynamic hormone ranges and genetics are unique to each of us; birth control should not be one size fits all. A form of birth control that could worsen acne for one woman would help alleviate it for another. Some of these differences, like the presence of thrombogenic mutations can be the difference between life or death, and yet, these genetic risk factors arent routinely screened prior to prescribing contraceptives. And hormonal birth control, when prescribed accurately, can have a range of impactful health benefits beyond preventing pregnancy: it can help regulate the menstrual cycle, alleviate cramps, PMS and anemia; clear up acne, and is often prescribed for a range of other reproductive health issues. Beyond birth control, moving towards precision medicine in reproductive health care can also alert physicians to potential problems down the road and improve the depth and accuracy of patient care overall.

Even though the waves of legislation impeding reproductive health care access are daunting, this is actually a moment of tremendous options when it comes to contraceptives. The tools and resources are out there for physicians to respond to this challenging time and be galvanized by the urgent needs of patients. Doctors working in reproductive health care have a major task before them, but can be the leaders in advancing the standard of care for birth control, and demanding their patients continued right to the best birth control for their bodies.

Photo:FotografiaBasica, Getty Images

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Reproductive healthcare is under attack. Precision medicine is more important than ever - MedCity News

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Heavy periods after 40 (also called menorrhagia) may be common and perfectly normal for many people but, at least until menopause begins, they can be hugely disruptive to daily life and cause discomfort, embarrassment, and stress to those experiencing them. While the world has become a lot more open to talking about menstruation, this is one part of the cycle thats often left hidden.

In my South Asian culture, periods are taboo full stop. Its a subject for mothers and aunts ears only, never to be discussed outside the home and never to be discussed in front of men, so I grew up never talking about the subject and only my mother knows how much pain Ive been in over the years. When I hit my 40s, my periods got worse and now, I have a heavy one every month that makes me feel sick and keeps me in bed with a hot water bottle. Its not something thats spoken about in mainstream media and South Asian women often feel ashamed to talk about it to anyone but their friends.

If youre suffering from painful and heavy periods, whether you're experiencing perimenopause symptoms or not, youre not alone. Here, we speak to several women who noticed changes in their periods after 40, and with insights from Dr Danielle Russell (opens in new tab), a leading GP specializing in womens health, we explain why heavy periods after 40 with clots are normal, the causes, and when to seek help.

Unfortunately, yes, heavy periods after 40 with clots are normal and its common for women to experience this, explains Dr Russell, as heavy periods are caused by a drop in progesterone levels.

Its something that women over 40 tend to experience regularly as this is the age when many begin experiencing early menopause symptoms, when the body stops releasing eggs. For example, one study by the University of Michigan School of Public Health (opens in new tab) looked at women aged between 42 and 52 and found that almost 80% would consider the blood flow during their period to be heavy, with more than 90% having periods that lasted longer than they did before.

The drop in progesterone leaves relatively more estrogen to thicken up the lining of the womb so that there is more to shed during a period, Dr Russell says. Cycles can also become irregular during this time, so a skipped or delayed period leaves more time for the lining of the womb to thicken up.

This lining also becomes very vascular, she continues, making clots more likely. "During heavy flow days, usually during the first few days of the period, there is more blood present that coagulates in the uterus and vagina, and this comes out as clots."

(Image credit: Getty Images)

Just because its normal in many cases, it doesnt mean its not very difficult and no one should have to deal with the symptoms unmanaged. When I went to see my GP about heavy periods after 40, they told me it was perfectly normal to experience the changes and to keep an eye on it if it lasts longer than seven days or the clotting gets worse - and Im not the only one.

Laura Hitchcock, 48, is the editor of Dorsets Blackmore Vale and had long-but-normal periods until the birth of her third child, at which point everything changed. I suffered menorrhagia and it never really stopped. There was awful bleeding but thankfully no pain, ever, with clots for years. My fourth child four years later didnt ease things up much, she tells woman&home.

Im still waiting for the alleged light periods of aging and perimenopause. I dont have to take tranexamic and mefenamic acid now, but I always double-up super-plus Tampax, plus nighttime pads, change them every couple of hours, and I have three days of hideous bleeding. Its graphic, horror-film level, every single month. Then after this, there are another four days of what I think most women my age would call a heavy period.

(Image credit: Getty Images)

Its a situation that Irem, who is 51 and lives in Newcastle Upon Tyne, can relate to as shes always suffered with medium to heavy periods, but in the last five years, its become ridiculously heavy. So much so that I use three packets of bedtime ones in my seven to 10-day period. From day one, I'm exhausted. It's an effort to get up, get ready, and do life. The constant checking youre not leaking, especially when you work in an office full of men and no women. You dont have that support of pointing behind and whispering am I ok?!, she says.

Its not just something that happens on the lead up to perimenopause and menopause though. Some people experience heavy periods throughout their life, like Sarupa Shah, 49, from London. I have always suffered from heavy periods and clots, with my first one every lasting for three months, aged 13. Ive always had severe cramps, clotting, and heavy and tender boobs with it too, she says.

(Image credit: Getty Images)

Ive worn a tampon and pads for years and still have accidents. Recently, I had to do a long trip in the car so I just sat on a towel, just in case. I also prefer to wear leggings and trousers when I have my period as it feels safer, like its holding everything in place.

Shah, like myself and most others who experience these heavy periods, wants more conversation about periods as its still seen as taboo. I dont think we talk about period health enough or understand that it isnt a light flow for most women and we carry so much shame about it like as women theres something wrong with us.

Yes, there are treatment options available for heavy periods, including the Mirena coil, hormone replacement therapy (HRT), or non-hormonal options like tranexamic acid or non-steroidal anti-inflammatory tablet.

Non-invasive treatment options are widely available and its these that seem to have the most effect. Tablets such as tranexamic acid or non-steroidal anti-inflammatory tablets are beneficial, Dr Russell says. If these options have been tried unsuccessfully, then there are more drastic treatment options such as surgery.

Tranexamic acid is a commonly used medicine to help control bleeding of various types, including dental and nose bleeds, as well as menstrual bleeding. It normally comes in tablet form, the NHS (opens in new tab) explains, but it's also available in liquid, mouthwash, and injection forms.

Lesley Bourne, 50, from Buckinghamshire, originally had a Mirena coil (another treatment option) fitted for her heavy periods but it stopped working, leading to a heavy bleed and a trip to the emergency room one evening. Here, she wasn't seen by the gynecologist. Instead, she was given tranexamic acid and sent home.

Two days later I started clotting and went to A&E again, only to be told Im menopausal and its common. Then I went to my GP to have the coil taken out but that wasnt possible, so now I finally have a gynecologist appointment next month. But its taken three referrals and Im taking norethisterone to stop the bleeding, but I still lose a clot of blood here and there and get crampy pains.

Norethisterone is another drug used in the treatment of adverse gynecological issues, confirms the National Institute for Healthcare and Excellence (opens in new tab), but this is a progesterone hormone replacement.

Other options include the Mirena coil, also known as the hormone coil, which is placed in the uterus and acts to thin the lining of the womb so there is less to shed, explains Dr Russell. The Mirena coil has the added bonus that it can also be used as contraception and as part of HRT if needed.

Unfortunately, the coil doesnt work for everyone. It was the treatment that Bourne found beneficial when she had it fitted four years ago for heavy periods and it worked to begin with, as her periods stopped completely. But when the coil stopped working, she lost a lot of blood. They were big huge clots and only stopped after two hours, then two days later it started again. Only it was worse and it wouldnt stop, she tells woman&home.

Hormone replacement therapy (HRT) can also be used to balance hormones, which can then help with the control of periods and other symptoms of perimenopause, Dr Russell says.It's traditionally a treatment for those experiencing menopause, but has its uses here as well for those experiencing heavy periods as it also boosts low hormone levels.

A review by the University of Edinburgh (opens in new tab) confirms this, following an examination of multiple studies using the method. They found that HRT was effective at reducing menopausal symptoms with 'add-back' hormones.

Ultimately though, if youre struggling with heavy periods after 40, its best to discuss the options with your doctor to see which might be best for you.

(Image credit: Getty Images)

Millions of people around the world experience heavy periods after 40 around the world, which means you shouldnt have to put up with pain or discomfort if youre experiencing them. There is usually an underlying pathology for heavy periods, explains Dr Hina Pathak Sra, a consultant gynecologist at Harley Street's Cosmebeaut (opens in new tab).

You should see a doctor about heavy periods after 40 with clots if:

Any woman above the age of 40 years old with a change in their bleeding pattern or anyone who starts having heavy periods should see a GP to be referred to a gynecologist to organize an ultrasound scan to check endometrial thickness [thickness of the lining of the womb] and have an endometrial biopsy [biopsy of the lining of the womb]. This is to rule out any adverse changes on the endometrial cells, Dr Pathak says.

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Heavy periods after 40 with clots: Causes and treatment | Woman & Home | - Woman & Home

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More women are turning to medical cannabis to seek relief from menopause and perimenopause symptoms, research suggests.

For instance, a 2020 study shows that about 1 in 4 female veterans use cannabis to treat menopause symptoms.

And now, new research, recently published in the journal Menopause, suggests that the number of both menopausal and perimenopausal women using medical cannabis for symptom relief could be much higher.

This study suggests that medical cannabis use may be common in midlife women experiencing menopause-related symptoms, said Dr. Stephanie Faubion, medical director of the North American Menopause Society, in a press release.

Still, experts caution that the effects of cannabis on menopause symptoms like anxiety, depression, sleep, and pain have not yet been fully established.

Healthcare professionals should query their patients about the use of medical cannabis for menopause symptoms and provide evidence-based recommendations for symptom management, Faubion added.

The new study involved more than 250 perimenopausal and postmenopausal women who were recruited through targeted ads about womens health and cannabis use.

Over 83% of study participants said they regularly used cannabis to treat menopause-related symptoms, which was defined by researchers as at least once per month.

The study shows that cannabis was most commonly used to ameliorate sleep and mood or anxiety issues. The majority of participants (84%) said they smoked cannabis for symptom relief, with 78% of participants reporting the use of edibles.

Despite the seemingly positive findings, the study has a built-in bias since participants were recruited because of their interest in cannabis.

Theres no value in terms of its numbers or validity, Dr. Felice Gersh, an OB-GYN and founder of the Integrative Medical Group in Irvine, California, told Healthline.

But it does bring up the important subject about the suffering that women go through in menopause with no assistance from the medical establishment.

Gersh said that very few of her patients report using cannabis to treat menopause symptoms.

I call cannabis green medicine, Gersh said. This is a potential tool, but we have no data on efficacy or safety. It really is a medication that should be talked about with a physician, and patients should realize that there are more tested options, like hormone therapy.

According to Gersh, the new research has possibly overestimated the use of cannabis.

Still, a prior 2020 study suggests that 1 in 4 female veterans used cannabis to treat menopause. In fact, the researchers found that more women were using cannabis to treat menopause symptoms than were using hormone therapy or other traditional types of menopause symptom management.

This is disturbing because hormone therapy is the most effective therapy we have for menopause symptoms, and the benefits typically outweigh the risks for women in their 50s and within 10 years of menopause, Faubion told Healthline. Cannabis, on the other hand, is not a proven therapy for menopause.

Dr. Aaron Gelfand, an OB-GYN at ChoicePoint, an addiction treatment center in New Jersey, explained that numerous physiological systems are thought to be influenced by the endocannabinoid system, which is activated by plant-based cannabinoids like CBD and THC. These systems include:

According to Gelfand, cannabis is also used to help treat anxiety and depression, sleep, and even vaginal dryness among menopausal women.

The amygdala is responsible for emotions, behavior, and motivation, Gelfand told Healthline. During menopause, all of these are heightened. Upon taking cannabis in any form, the response is suppressed, causing less anxiety and depression.

Still, Gelfand said using cannabis to aid sleep may have mixed results in people experiencing menopause.

While THC usually has a sedative effect, it can also have a stimulating impact on certain users, particularly those who are new to [cannabis] use or who are taking greater amounts, he explained. In these circumstances, smoking [cannabis] before bed may make it harder to fall asleep.

Conversely, Gelfand said that at smaller doses, CBD seems to encourage alertness. At greater concentrations, however, CBD may induce sleepiness.

As for treating vaginal dryness, Gelfand pointed out that the use of CBD-containing products in the vaginal or vulvar tissues has not been supported by any well-controlled clinical research.

If Gersh were to recommend cannabis for menopause symptom relief, she said she prefers hemp-based products like CBD over products containing THC, the main psychoactive ingredient found in cannabis.

CBD and other cannabinoids like THC bind with receptors in the brain that are associated with memory, cognitive function, and pain.

Women who are going through menopause often find relief from common symptoms of menopause for exactly that reason, Mitchell H. Stern, president and CEO of California-based cannabis producer Burning Bush Nurseries told Healthline.

Some CBD brands have begun to cater to the unique needs of this emerging market by infusing their products with things like hibiscus, sage, and other natural herbs that have been helping menopausal women find relief for thousands of years, he added.

Experts have cautioned that the purported benefits of using cannabis to treat menopausal symptoms require further study.

While there has not been adequate research into the use of cannabis for menopausal symptoms, I would be reluctant to advise the use of cannabis with THC for this purpose, Dr. David Culpepper, clinical director of Telehealth company LifeMD, told Healthline.

In my experience, most of the anti-inflammatory and other health benefits patients receive from cannabis products come not from THC, but from CBD, which is a benign, non-psychoactive compound. Its possible that women using cannabis for menopause are reaping the benefits of the CBD, while unnecessarily intoxicating themselves with THC.

As with other experts, Culpepper recommended that people experiencing menopause try CBD to help relieve their symptoms instead of cannabis products containing THC.

The proliferation of medical cannabis in the United States has contributed to an increasing number of menopausal and perimenopausal women using the drug to treat their associated symptoms.

But some experts say these numbers may be overestimated, and caution that research on safety and effectiveness is still limited.

Until more rigorous research is conducted, experts recommend hormone therapy as a first-line treatment or may suggest trying CBD products as an alternative.

If you are experiencing symptoms associated with menopause or perimenopause, ask your doctor about the safest treatment options available to help you find relief.

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Cannabis Increasingly Used for Menopause Symptom Relief. Is It Safe? - Healthline

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Wilmington, Delaware, United States, Aug. 09, 2022 (GLOBE NEWSWIRE) -- Transparency Market Research Inc. - The value of the global endocrine testing market stood at US$ 5.5 Bn in 2018. The global market study on endocrine testing expects the market to rise at a CAGR of 6.4% during the forecast period, from 2019 to 2027. The global market for endocrine testing is expected toexpand faster asmetabolic and endocrineproblems become more common. The marketis also anticipated to develop as diabetes prevalence rise across the globe.

Endocrine glands, which are a component of the endocrine system, produce hormones right into the bloodstream. Testing is done to check the levels of endocrine hormones in biological samples, including luteinizing hormone,follicle stimulating hormone, insulin,estradiol, and many others. These tests assist identify deviations in hormone secretion, such as hypersecretion or hyposecretion, which can lead to endocrine illnesses such asmenopause, infertility, thyroid dysfunction, and variousother conditions. Ongoing trends of the endocrine testing market

Endocrine testing has increased as a result of a number of illnesses, including various forms of diabetes and PCOS and it is also expected to present positive endocrine testing market outlook. For instance, a study reported in Current Diabetes Reports found a substantial increase in the incidence of PCOS and diabetes. Therefore, the rise in endocrine and metabolic diseases is a major driver that is predicted to fuel the expansion of the globalendocrine testing market in the years to come.

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Global Endocrine Testing Market: Key Players

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Hyperbaric Oxygen Therapy Devices Market: The global hyperbaric oxygen therapy devices market is expected to reach the value of US$ 7.3 Bn by the end of 2028.

IBD (Ulcerative Colitis and Crohn's Disease) Treatment Market: The global IBD (ulcerative colitis and Crohn's disease) treatment market was valued at ~US$ 15.5 Bn in 2018 and is projected to expand at a CAGR of ~6% from 2019 to 2027.

Hemophilia Treatment Drugs Market: The global hemophilia treatment drugs market was valued at US$ 9,500 Mn in 2017 and is anticipated to reach US$ 15,000 Mn by 2026, expanding at a CAGR of 5% from 2018 to 2026.

Critical Limb Ischemia Treatment Market: The global critical limb ischemia treatment market is driven by rise in prevalence of critical limb ischemia. Growth of the market is also attributed to increase in awareness about critical limb ischemia and rich product pipeline.

Menopausal Hot Flashes Treatment Market: Growing population of elderly women worldwide coupled with rise in menopausal hot flashes symptoms is a major factor responsible for the growth of global menopausal hot flashes treatment market.

Substance Abuse Treatment Market: The global substance abuse treatment market is anticipated to cross US$ 23.1 Bn by 2031. The global market is projected to grow at a CAGR of 8.5% from 2022 to 2031.

Glioblastoma Multiforme Treatment (GBM) Market: The global glioblastoma multiforme (GBM) treatment market is expected to reach the value of US$ 3.72 Bn by the end of 2028.

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See the rest here:
Endocrine Testing Market is Estimated to Progress at a CAGR of 6.4% during the Forecast Period, notes TMR Study - GlobeNewswire

Recommendation and review posted by Bethany Smith

Ruth M. ORegan, MD, professor, chair, Charles Ayrault Dewey Professorship of Medicine, Department of Medicine, the University of Rochester, physician-in-chief, Strong Memorial Hospital, associate director, Education and Mentoring, the Wilmot Cancer Institute at University of Rochester, discusses the development of oral selective estrogen receptor degraders (SERDs) in hormone receptor (HR)positive breast cancer.

The randomized phase 3 EMERALD trial (NCT03778931) evaluated the oral SERD elacestrant vs standard endocrine therapy in pretreated patients with advanced or metastatic estrogen receptorpositive, HER2-negative breast cancer. Data from the study showed an advantage for the oral SERD over standard therapy, ORegan says. Although it was a modest difference, elacestrant appeared to have efficacy in HR-positive breast cancer harboring ESR1mutations, ORegan adds.

The development of elacestrant and other oral SERDs could provide a treatment advantage over the SERD fulvestrant, which is administered through intramuscular injection, ORegan notes. Additionally, oral SERDs won't have the same bioavailability issues as fulvestrant, and evaluating these agents further will be crucial, ORegan explains. Adjuvant studies are being planned with oral SERDs, though there have not been much compelling data in the metastatic setting, and there are adverse effects, such as gastrointestinal toxicity, that need to be considered. ORegan adds.

Ultimately, oral SERDs would represent a more convenient treatment option for patients, ORegan continues. In the early phase setting, encouraging data have been observed for the combination of oral SERDs with CDK4/6 inhibitors, and these regimens could be further explored in the future, ORegan concludes.

Read the original post:
Dr. O'Regan on the Development of Oral SERDs in Breast Cancer - OncLive

Recommendation and review posted by Bethany Smith

Ohio Congressmen Troy Balderson and Bill Johnson visited Ohio Universitys Athens campus today to tour facilities and learn more about OHIO's myriad contributions to Appalachian Ohio and the state through research, innovation, engagement, and experiential learning.

OHIO, which was designated anational public R1 research universityin 2022, provides more than 28,000 students with opportunities to access a high-quality education not just in the classroom but also through hands-on service to the community. During their visit, Balderson and Johnson learned more about OHIOs world class research programs, discussed how OHIO is adapting its curriculum in order to meet the career needs of students on the regional campuses, and gained insight into how OHIO Is a leader in a health education and outreach.

Ohio University is deeply committed to the success of our students and the communities we serve, Ohio University President Hugh Sherman said. I am grateful to Congressman Balderson and Congressman Johnson for taking time to discuss the Universitys many contributions, through its statewide footprint, to help uplift the region and state.

During their visit, the two Congressmen toured theInstitute for Sustainable Energy and the Environment (ISEE),theInstitute for Corrosion and Multiphase Technology (ICMT), theEdison Biotechnology Institute (EBI), and spoke with faculty leaders in each of the labs, as well as from theHealth Collaborative.

While visiting the ISEE, Balderson and Johnson heard fromJason Trembly, professor of mechanical engineering and director of the ISEE, about the institutes national leadership in developing transformational techniques to convert coal, coal waste, and carbon ore into high-performance, safe, carbon sequestered products for building and energy applications. According to Trembly, these materials transform pre-incineration coal waste long thought to be a worthless, noxious liability that is littered across Appalachia from a century of mining into useful products that our country needs to grow, all while creating manufacturing jobs in impoverished, former coal communities.

Trembly also attributes part of the ISEEs success to the partnerships established across the Appalachian Region including those with CONSOL Energy (Canonsburg, Pa.), Engineered Profiles (Columbus, Ohio), CFOAM (Triadelphia, W.Va), Koppers (Pittsburgh, Pa.), Omnis Energy (Greene Co., Pa.), AmeriCarbon (Morgantown, W.Va), and General Motors (Detroit, Mich.).

Next, the Congressmen visited the ICMT to speak with Russ College professor and director of the institute,Srdjan Nesic, about the institutes innovative research that is helping to slow down corrosion, creating job opportunities for the region, and expanding experiential learning opportunities to students from undergraduate to doctoral level.

The ICMT has been advancing research in corrosion for 30 years. A largescale operation, the institute is a training ground for undergraduate and graduate students. The size of a football field, the ICMT is one of the largest research facilities of its kind in the world and partners with some of the worlds leading oil and gas, chemical, and engineering companies such as Exon Mobile and Shell, to predict and resolve their corrosion problems to help keep oil and gas production and transportation efficient, reliable, and safe.

For our students, it is an incredible opportunity to get to work and learn firsthand in a large, world-class research facility such as this, Nesic explained. We have one of the biggest operations in the world for corrosion research and partnerships with industry giants that students have the ability to connect with and present to. It is a lot of practical and experiential work that helps prepare them for jobs in the industry all over the world.

One of the biggest innovations to come out of the ICMT is a software package,MULTICORP, that provides new capabilities and enhancements to allow researchers and scientists to significantly expand the scope of internal pipeline corrosion analyses and help them find better solutions.

Also during their visit, the Congressmen visited the EBI to learn fromDr. John Kopchick, Goll-Ohio Eminent Scholar and professor of molecular biology and principal investigator at EBI, about how the institute implements research for the discovery of novel human therapeutics, therapeutic targets, and diagnostics, as well as the importance of protection of the intellectual property that result in patents. He explained how the EBI discovered a growth hormone receptor antagonist which is now an FDA approved drug called Somavert that has been marketed worldwide for patients with a rare growth hormone condition called acromegaly and has yielded more than $110 million in royalties to Ohio University that is used to advance the discovery process and help train undergraduate, graduate, and medical students.

Having our guests see first-hand the excitement, commitment, and dedication of the students and research scientists to their particular projects allows them better understand and appreciate the enthusiasm, passion, and devotion that permeates EBI and its mission, Kopchick said. Reading about an institute/program is one thing; seeing it in action is very distinctive and special.

Kopchick alone has mentored over 300 undergraduate and 35 graduate students, 42 post-doctoral fellows, and many international visiting scientists/clinicians on the basics of molecular and cellular biology and the precise protocol used in experiments.

Following their time at OHIO and in the EBI, many graduates remain in the Athens, Southern Ohio, or state of Ohio to practice medicine and further their research, while others go on to continue their education or take their knowledge from OHIO across the world. According to Kopchick, regardless of where graduates end up, they remain the best ambassadors, spreading the word of the research enterprises and advancements being made at OHIO and in the EBI all over the globe.

The Congressmen also heard from leaders at OHIOsHeritage College of Osteopathic Medicine,College of Health Sciences and Professions, and theVoinovich School of Leadership and Public Serviceabout their efforts to make health care more easily accessible throughout the region.

As a top producer of health professionals in the state, OHIO -- which has been named among the top 10 largestSchools of Nursingin the country andOhios top provider of primary care physicians--serves its community and the surrounding region through outreach programs likeMobile Health Clinicsand theDiabetes Institutewhere patient education and care delivery programs help improve treatment for those in Appalachia with diabetes.

OHIO is also a founding member of theOhio Alliance for Innovation in Population Health, which brought together multiple universities and agencies to tackle some of the states largest population health challenges including health care access, low birth weight, infant mortality, addiction issues and more. In addition to tackling addiction through Ohio Alliance, the Voinovich School has also partnered with county Alcohol, Drug Addiction and Mental Health boards, prevention providers, among many others, to coordinatea new statewide center of excellenceto help expand prevention resources, training and support.

As educators, we believe we have a role to play in building and supporting community leaders and strengthening local economies, especially in underserved and rural parts of the state, Sherman added. I hope the conversations and experiences that were had today shed light on the need to continue to advance education, research, and service.

For more information onOhio University and its contributions to the region and experiential learning, visithttps://www.ohio.edu/forward.

Read more from the original source:
Ohio Congressmen Balderson and Johnson get firsthand look at OHIO's contributions to region through research, outreach, and experiential learning -...

Recommendation and review posted by Bethany Smith

Music icon and Grease star Olivia Newton-John passed away on Monday at the age of 73, according to an announcement made by her husband, John Easterling, on Facebook.

Though Newton-John may be best remembered for her singing and acting talents, she was also a fierce advocate for breast cancer, openly sharing her own battle with the disease while working to raise awareness and funds to further education and treatments.

Newton-John first found a lump in her breast in 1992. After being diagnosed with breast cancer, she was treated and went into remission.

In 2013, her breast cancer returned in her shoulder, followed by her back in 2017.

In September 2018, she revealed she was receiving treatment for cancer at the base of her spine.

Olivia has been a symbol of triumphs and hope for over 30 years sharing her journey with breast cancer, Easterling wrote in his announcement.

Despite her challenges, Newton-John thrived while living with breast cancer for three decades.

In addition to inspiring others with the story of her breast cancer journey, Newton-John helped raise funds in 2008 to build the Olivia Newton-John Cancer and Wellness Centre in Melbourne, Australia, which continues to sponsor global research into plant medicine and cancer.

Since Newton-Johns first diagnosis in the 1990s, breast cancer detection and treatment methods have seen many advancements.

Dr. Peter Schmid, medical director at Perci Health, an online platform that gives people access to multidisciplinary cancer specialists, says breast cancer survival rates have more than doubled in the past 40 years.

He notes that 76% of people with breast cancer now live 10 or more years, according to research by Cancer Research UK.

This is because cancer detection has improved, and treatment has become more targeted, resulting in more people being able to have the relevant treatment, he explains.

For metastatic breast cancer, where the cancer has spread to other parts of the body, the 10-year survival rates are lower depending on how advanced your cancer is, he adds. However, the good news is that new treatments are becoming available even for those with very advanced disease.

Schmid says some of the major advancements in breast cancer detection and treatment over the past 20 years, include improved screening programs, novel therapies such as immunotherapy, and genetic profiling.

Where screening is concerned, Schmid says 3D mammography allows for more precise images, meaning doctors can detect cancer at earlier stages.

Meanwhile, Immunotherapy using the bodys immune system to recognize and kill cancer cells has shown great results for triple-negative breast cancer, he explains.

While treatments for breast cancer have advanced greatly over the past 30 years, health experts say prevention is still the best medicine.

Theres no single cause of breast cancer. It results from a combination of the way we live our lives, our genes, and our environment, clarifies Lisa Jacques, lead cancer nurse at Perci Health.

While there are no definitive ways to prevent breast cancer, she says there are some lifestyle changes you can implement to help lower your risk.

Research has found that alcohol consumption can increase the risk of breast cancer by up to 7 to 16%.

Jacques stresses that there is no safe amount of alcohol when it comes to reducing your breast cancer risk but she advises limiting your alcohol intake to a maximum of 14 units per week. This is roughly equivalent to six pints of beer or one and a half bottles of wine per week.

Quitting smoking is also significantly beneficial.

Theres growing evidence that smoking can increase the risk of breast cancer and the risk is higher if you have a significant family history of breast cancer, Jacques points out.

However, quitting smoking can be challenging for many. Thats why Jacques advises consulting with a medical practitioner who may be able to point you in the direction of effective smoking cessation programs.

Maintaining a healthy weight is also key when it comes to lowering your breast cancer risk.

Try to stay active where possible, Jacques advises. You dont need to do high intensity workouts or pay for a gym membership. A short daily walk outside, which is low impact and free, can make all the difference.

Like many cancers, early detection can improve survival rates for cancer, and thats why checking your breasts on a regular basis is paramount.

Jacques advises checking for lumps once a month, ideally on the same day each month, by lifting your arms up and rubbing your hand around the breast in a circular motion.

Its key to know your body and know what is new or unusual. For example, you might notice a change of size, feel of the skin, notice a rash, lumps, or nipple changes, says Jacques.

You might also notice some pain. However, pain isnt always present so you shouldnt rely on this on its own, she adds.

If you do notice any changes, its imperative that you speak with your medical practitioner or oncology team.

Nevertheless, Jacques stresses the treatments available and the overall outlook for breast cancer patients today have improved by leaps and bounds, in part due to the advocacy efforts of people like Newton-John.

Many people now live long and happy lives after a cancer diagnosis, Jacques says.

Link:
Olivia Newton-John's 30-Year Cancer Journey Inspired Millions - Healthline

Recommendation and review posted by Bethany Smith

If youre going bald, youre far from alone. Nearly 70% of American men experience some amount of noticeable hair loss by their mid-30s, according to the American Hair Loss Association. By age 50, about 85% of mens hair is significantly thinning. And sure, you can always shave your head and let bygones be bygones. But many men love a full mane, making hair loss a disease of the spirit that leaves sufferers vulnerable to dropping cash on treatments that often leave them disappointed, says Spencer Kobren, founder of the American Hair Loss Association and the International Alliance of Hair Restoration Surgeons. So what causes hair loss, and is there anything you can do to prevent it?

Ninety-nine percent of all products and services that claim to stop, prevent, or treat hair loss don't work, Kobren says. He notes that social media has attracted additional medical misinformation and phony, bogus products and services. These products dont get at the root of the problem. But there are real ways to prevent hair loss, once you cut through all the BS. This is what you need to know.

The most common type of hair loss is called androgenic alopecia, which is sometimes referred to as male or female pattern baldness, depending on the sex of the person who has it. This condition, which affects about 98% of people with hair loss, is caused by a combination of genetics and levels of androgens, a type of sex hormone. The main culprit of male pattern baldness (including a receding hairline) is dihydrotestosterone, a byproduct of testosterone that shrinks hair follicles of those who are genetically predisposed, Kobren says.

Alopecia areata universalis is far rarer, with fewer than 200,000 people living with it in the United States. Its a very difficult disease to treat, Kobren says. Its exact cause is unknown. However, researchers think that the condition, which causes the complete loss of hair on the scalp and body, occurs when someones immune system mistakenly attacks the hair follicles, according to the National Institutes of Healths Genetic and Rare Diseases Information Center. This type of hair loss often results in bald patches, and their hair that regrows may stay intact or may be lost again.

Traction alopecia is hair loss caused by frequently wearing hairstyles that create a lot of pulling on the hair and scalp, such as heavy braids or tight ponytails. That causes a type of scarring alopecia. And once that happens once the scalp and the hair follicles are damaged to that degree hair no longer grows, Kobren says. As many as half of all Black women experience this type of hair loss, according to Johns Hopkins Medicine. But there are steps people can take to prevent or slow traction alopecia, such as wearing looser braids or dreadlocks and removing braids, weaves, and extensions within a certain time period (three months for braids; two months for the other styles).

If youre noticing hair loss, dont panic, Kobren says. Bring the issue up with your doctor so they can determine whats causing the hair loss and discuss treatment options with you.

If youre hoping to to manage hair loss with medication, early intervention is key, Kobren says. A few different types of medications are available, including finasteride and minoxidil. Other medications are also sometimes used off-label. Its important to buy these medications through a physician rather than purchasing them from an online supplier, because the latter could switch the type of generic you receive without telling you, which could impact the effectiveness of the treatment, Kobren notes.

Hair transplant surgery is a last resort, he says. Two types of hair restoration procedures are currently available, but 70% of people who have them end up with results that make them feel anywhere from dissatisfied to disfigured. These surgeries also typically arent covered by insurance unless the hair loss is due to a severe injury.

An alternative to treating hair loss is embracing it. Shave your head and see how you fare, if you can deal with that, Kobren says. Because the road to recovery and trying to treat hair loss, whether it's surgical procedures or even FDA-approved medication, that's a long road and it's a real commitment.

Not subscribed to Fatherlys newsletter yet? Were not mad, just disappointed.

See original here:
What Causes Hair Loss? And How To Stop Hair Loss In Its Tracks. - Fatherly

Recommendation and review posted by Bethany Smith

Researchers recommend having a low clinical threshold for the diagnosis of Hashimotos encephalopathy in patients who reveal no apparent cause for their altered mental status, given the heterogenous nature of the conditions presentation.

Plasmapheresis may be an option for patients with Hashimotos encephalopathy who are unresponsive to steroids and intravenous immunoglobin (IVIG) therapy, according to a case report published in Cureus.

Hashimotos encephalopathy is often called steroid-responsive encephalopathy associated with autoimmune arthritis (SREAT). However, the cases presented highlight the heterogenous nature of Hashimotos encephalopathy, describing 2 patients who found relief using plasmapheresis (PLEX) therapy when treatment with steroids was unsuccessful.

The first case involved a 42-year-old female patient with a past medical history of type 2 diabetes mellitus, hypertension, and hypothyroidism. The patient presented with an altered mental status following total thyroid resection for papillary thyroid cancer.

She was found comatose with an initial Glasgow Coma scale of 4 only a few hours after presenting with a normal state of health. She was electively intubated and admitted to the intensive care unit.

Extensive testing did not reveal the etiology of her acute encephalopathy. Initial evaluation for acute encephalopathy showed a normal computed tomography of the head. Infectious workup blood cultures, urine cultures, and screenings were all negative.

A complete blood count and complete metabolic panel showed no leukocytosis or metabolic derangements. Her thyroid-stimulating hormone was only mildly elevated at 5.04 MIU/L (reference range: 0.27-4.2 MIU/L); however, inflammatory markers were significantly elevated.

A lumbar puncture revealed an elevated opening pressure of 40 mmHg and a mildly elevated protein CSF concentration, but no evidence of underlying infection or oligoclonal banding. The patient underwent unremarkable magnetic resonance imaging.

A continuous electroencephalogram revealed diffuse, generalized slowing, consistent with a moderate nonspecific encephalopathy. After the patient was extubated, her persistent encephalopathy prevailed.

Further workup with a systemic autoimmune screen ruled out any cause of autoimmune cerebritis. Additional biopsies revealed nothing significant.

Subsequent treatment attempts with a course of empiric high-dose corticosteroids and IVIG therapy were futile. The patient remained encephalopathic 3 months following presentation, dependent on nasogastric feeding.

When inflammatory markers remained elevated, but a CSF autoimmune panel returned negative, physicians began to consider Hashimotos encephalopathy. Her serum theroid antibodies revealed normal titers or thyroid peroxidase antibodies but significantly elevated anti-thyroglobulin antibody 154.1 IU/mL (reference range: 0.0-0.9 IU/mL).

After a discussion across specialties, plasmapheresis (PLEX) therapy for 10 sessions was implemented.

With each session, the patient demonstrated significant improvement. By her second session, she became alert and oriented. Repeat anti-thyroglobulin antibody testing revealed significant improvement.

She was able to tolerate an oral diet, converse, and respond to commands. She was successfully discharged, with no recurrence during 2 years of follow-up.

The second case involved an 18-year-old male patient with a history of cerebral palsy. The patient presented to the hospital with a generalized tonic-clonic seizure. His caregiver stated that the patient was able to conduct a normal conversation and perform small tasks without difficulties at baseline.

Initially, the patient was successfully managed with intravenous lorazepam and midazolam. However, the patient remained encephalopathic with catatonic postures after the termination of his seizure.

The patient was unable to follow commands or speak meaningful sentences. Initial concerns for malignant catatonia were excluded by the psychiatry team.

Examination revealed no leukocytosis, anemia, or metabolic derangements. The patient had a normal TSH and free T4.

Diffuse, generalized slowing consistent with a moderate encephalopathy was observed in this patient as well. Neuroimaging with CT head and a lumbar puncture were generally unremarkable, though a minor elevation in CSF protein was noted.

For this patient, a complete serum and CSF autoimmune panel were negative, dismissing concerns about possible autoimmune encephalitis.

Physicians collected thyroid antibodies to determine whether Hashimotos thyroiditis could be excluded. The patient was found to have an elevated thyroid peroxidase antibody level of 80 IU/mL (reference range: 0-26 IU/mL), and an elevated thyroglobulin antibody of 22 IU/mL (reference range 0-0.9 IU/mL).

A decision was made to treat the patient for SREAT, or Hashimotos thyroiditis.

A course of IV methylprednisolone and subsequent IVIG therapy caused no improvement in the patients clinical status. Physicians decided to proceed with 10 sessions of PLEX therapy.

By the fourth session, the patient was more alert and less catatonic. The patient improved from a state of complete inattentiveness and disorientation to being alert and oriented to time, place, and person. He also became able to converse with his mother and returned to his functional baseline.

After tolerating all 10 sessions, the patient was discharged. The patient has not reported recurrence since discharge, according to the report.

These cases highlight the varied nature of the clinical presentation of Hashimotos encephalopathy. In both cases, a significant increase in the patients thyroid antibody titer was observed, with a negative CSF autoimmune panel and significant elevation in inflammatory markers.

Hashimotos encephalopathy is considered a rare disease, and currently has no definitive diagnostic study. As demonstrated by the 2 reported cases, the majority of neurological studies including a lumbar puncture, cEEG, and brain MRI, reveal only nonspecific findings.

Despite a majority of cases being characterized by an elevation in thyroid antibodies and a positive response to corticosteroid therapy, the authors suggest that positive thyroid antibody titers should not be reliably used in the diagnosis of Hashimotos encephalopathy. They recommend that empiric therapy be considered based on high clinical suspicion, even when initial thyroid antibody testing is negative.

Though they encourage further research assessing the benefit of long-term immunosuppression and other treatments for this patient population through randomized controlled trials, they encourage the use of PLEX therapy in certain patients.

Reference

Karan A, Nuthulaganti S R, Zhang Y, Kandah F, Gutierrez M, Reddy P. Two perplexing cases of Hashimotos encephalopathy unresponsive to steroid and intravenous immunoglobin therapy. Cureus. 2022;14(7):e26853. https://www.cureus.com/articles/101825-two-perplexing-cases-of-hashimotos-encephalopathy-unresponsive-to-steroid-and-intravenous-immunoglobulin-therapy. Published July 14, 2022. Accessed July 20, 2022.

Read the rest here:
Plasmapheresis is Viable Treatment Option for Patients with Hashimoto's Encephalopathy Nonresponsive to Steroids - Pharmacy Times

Recommendation and review posted by Bethany Smith

Premarin (or PMU) is a very common HRT drug that is derived from pregnant mares' urine. In fact, its very name stands for PREgnant MAres uRINe (via ScienceDirect).

This method of HRT production began in the 1940s, when it was discovered that estrogen taken from the urine of pregnant mares could relieve menopausal symptoms in women. The resulting industry spread rapidly throughout the northern United States and Canada, says Horsetalk in New Zealand. Today, more than 9,000,000 women take the drug to relieve menopausal symptoms that include vaginal dryness, hot flashes, and night sweats. Premarin may also prevent osteoporosis.

According to Forum Health, Premarin contains many types of equine estrogens, and only two are bio-identical to human estrogens. The others are much stronger and last longer than human estrogens, and they are suspected of having more side effects in humans.

Not surprisingly, the practice of keeping pregnant mares in small stalls for most of their one-after-another pregnancies, attached to urine bladder bags to collect all their urine, has raised the ire of animal welfare agencies. As a result, most PMU farms are now located in Canada, says Horsetalk, and overseas (via Gentle Giants Draft Horse Rescue).

Link:
Everything You Need To Know About Hormone Replacement Therapy - Health Digest

Recommendation and review posted by Bethany Smith

Hormones control nearly all of our bodily functions, from growth and development to emotions, sexual function and even sleep. But hormones, which occur naturally in our bodies, can also fuel the growth of certain breast cancers. We talked with breast medical oncologist Rachel Layman, M.D., to learn about hormone therapy for breast cancer, which can stop or slow the cancer-fueling action of hormones.

What is hormone therapy for breast cancer?

Hormone therapy is a form of treatment that deprives breast cancer of estrogen and progesterone, the two main female hormones that it needs to survive and grow.

Estrogen and progesterone are carried along in the bloodstream. When they encounter a breast cancer cell, they stick to proteins called hormone receptors on the cells surface. This connection acts as an on switch and triggers the cancer cell to grow. The goal of hormone therapy is to prevent hormones from attaching to cancer cells, which deprives the cancer cells of the fuel they need to grow.

Are all breast cancers fueled by hormones?

No, but most are. About 70% of all breast cancers depend on estrogen or progesterone for growth.

These hormone-dependent breast cancers are called hormone-sensitive. This means theyre either estrogen receptor positive or progesterone receptor positive, depending on which hormone they connect with. Some cancer cells have receptors for estrogen, some have receptors for progesterone, and some have receptors for both. 30% of breast cancers have no hormone receptors and dont benefit from hormone therapy.

How do hormone therapies for breast cancer work?

Hormone therapies reduce or eliminate contact between hormones and breast cancer cells in several different ways:

How and when are hormone therapy medications delivered?

Most hormone therapy drugs are taken as a daily oral pill, though a few are given as injections in the clinic.

Women usually begin hormone therapy after undergoing surgery for the removal of a breast tumor. They typically take hormone therapy drugs for at least five years and sometimes as long as 10 years after surgery, depending on how likely the cancer is to return. In some instances, hormone therapy is given before breast cancer surgery to shrink the tumor, which makes it easier to remove.

Women who arent healthy enough to withstand an operation may take hormone therapy drugs until theyre well enough to undergo surgery. The treatment wont get rid of cancer, but it can stop it from growing or shrink it until surgery can be performed.

Can hormone therapy prevent breast cancer, in addition to treating it?

Yes, women who have completed breast cancer treatment often use hormone therapy to help prevent the disease from coming back. Hormone therapy also helps lower the odds of getting cancer in the other breast.

Doctors may also recommend hormone therapy for healthy women who have a family history of breast cancer, or genetic mutations that raise their risk for the disease.

How effective is hormone therapy for breast cancer?

Clinical trials of breast cancer patients show that overall, hormone therapy cuts the risk of cancer developing or coming back in half.

What are the side effects of hormone therapy?

The potential side effects of hormone therapy depend largely on the specific drug or type of treatment. Common side effects of all hormone therapies include:

Less common, more serious side effects of some hormone therapy drugs may include:

Is hormone therapy the same as hormone replacement therapy?

No, the two are opposites. Hormone therapy blocks or removes hormones to treat breast cancer, while hormone replacement therapy adds hormones to the body to counter the effects of menopause. Hormone therapy for breast cancer is actually anti-hormone therapy or hormone-blocking therapy.

Whats your advice for people considering hormone therapy for breast cancer treatment?

Deciding on hormone therapy for breast cancer can be a complex decision. The type of therapy you receive may depend on the stage of your disease, whether youve gone through menopause, and whether you want to have children. Talk with your doctor about your options to help make the best decision for you.

Request an appointment at MD Anderson online or by calling 1-877-632-6789.

Link:
What is hormone therapy for breast cancer? - MD Anderson

Recommendation and review posted by Bethany Smith

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As transgender healthcare guidelines have been called into question by Gov. Ron DeSantis administration and multiple Florida healthcare agencies, a Brevard clinic serving the LGBTQ community is grappling to figure out a response.

Spektrum, an LGBTQ-focused clinic with an office in Orlando and in Melbourne,serves about 3,500 patients. They provide gender-affirming healthcare for all ages, which includes hormone replacement therapy, blockers, support letters for gender-affirming surgeries and mental health services.

With the Florida Department of Health, the Agency for Health Care Administration and DeSantis administration looking to potentially restrict transgender peoples access to healthcare specifically those on Medicaid and those under 18 years oldthe clinic is facing manyunknowns.

'I will never hide my child': Community members gather in Brevard to march against so-called 'Don't Say Gay' bill

Also: Pet Pride Parade in Cocoa Village in Support of LGBTQ Issues

"We have to wait until we see what sticks to the wall before we can fully plan our response, but of course we're kind of preparing for everything, said Joey Knoll, founder and CEO of Spektrum.

With so much uncertainty, the clinic is struggling to keep up with the number of patients it needsto see. Typically, they could see about 40 to 50 patients a day. But with so many people coming in with fears about whats going to happen, that number has dropped to 30.

Our patients and their families' appointments are taking longer because they're all panicking, he said. What used to just be a quick appointment we're checking your labs, things are looking good, how are you feeling, what results are you noticing? Now it's, do I need to move and what's going to happen? Am I going to get my medicine?

Transgender healthcare has been a topic of discussion for several months with a focus on gender dysphoria, which is defined by the federal government as "significant distress that a person may feel when sex or gender assigned at birth is not the same as their identity." It was previously called gender identity disorder.

Transgender healthcare was first brought into question in April, when the Florida Department of Health released a guidance seeking to "clarify evidence" regarding the treatment of gender dysphoria in anyone under the age of 18. It advised not only that medical transition should not be allowed under the age of 18, but also social transition, which can involve allowing a transgender child to go by a preferred name, pronouns and different clothing options.

Since then, the Agency for Health Care Administration released a 46-page report on June 2 titled "Generally Accepted Professional Medical Standards Determination on the Treatment of Gender Dysphoria." The six medical professionals who compiled the report said treatment for gender dysphoria which can include gender reassignment surgery, hormone replacement therapy and puberty blockers had the potential for harmful long-term effects, saying the treatments were "experimental and investigational."

At the time of the release of the report, AHCA requested Florida's Medicaid program review whether treatments for gender dysphoria met generally accepted professional medical standards, additionally arguing that treatments didn't meet the definition of "medically necessity." If this were found to be the case, low-income and adolescent transgender individuals would no longer have their treatments covered by Medicaid.

Separately, DeSantis' administration has asked the Florida Board of Medicine to review their findings and create a standard of care for "those complex and irreversible procedures" for gender dysphoria.

Since the initial release of its guidance in April, the Florida Department of Healthfiled a petition on July 28 to initiate rulemaking related to trans healthcare, saying that "children do not possess the cognitive or emotional maturity to comprehend the consequences of ... invasive and irreversible procedures."

In itsproposed standard of care, itsuggestedprocedures and treatments such as sex reassignment surgeries or anything altering primary or secondary sexual characteristics, puberty blockers, hormone replacement therapy and hormone antagonists be banned for transgender patients under the age of 18.

Friday the Florida Board of Medicine advanced aplan to ban healthcare providers from offering gender affirming treatments such as puberty blockers and hormone therapy to people under age 18.

Department of Health Secretary Joseph Ladapo arguedthe current standards of care were a departure from "the level of evidence and data surrounding this issue."

"Maybe it is effective, but the scientific studies that have been published today do not support that," he said at the Friday meeting in Fort Lauderdale. "Could that change in the future? Its possible. I think its very unlikely considering what Ive reviewed, but its possible."

Knoll, who has helped more than 10,000 people transition over the course of his career, said he believes the studies cited in the proposed guidelines have been misrepresented or twisted.

"It's outdated research that began in 1975 that talks about persisters and desisters when it comes to gender identity, failing to include the fact that in 1975, how was someone going to access gender affirming care?" he said.

Persistersreferto people who continued to identify as transgender into adulthood; desisters are those whoeventually reverted back to identifying with their gender assigned at birth.

"Maybe they are classified as a desister because they are living in their birth-assigned gender, but it could have been because they didn't have access to affirming care or a support system it doesn't mean that their gender identity wasn't real, so that's very terrible information for them to take,"Knoll said.

Sebastian Cook, a 17-year-old transgender boy from Melbourne, said the proposed changes are dehumanizing.

"It's honestly really scary, because it makes us look like we're just political objects and not real people, he said. We have feelings, we're human, and we just want to have our bodies feel and look the way that (they're) supposed to."

Cook will turn 18 in a few weeks, which should keep proposed guidelines surrounding healthcare for trans minors from applying to him. However, hes still facing uncertainty regarding covering the cost of hormone replacement therapy and is worried about how the guidelines will affect younger people.

"Gender-affirming healthcare it definitely does save lives, he said. We know what we want and we know how to achieve what we want, and that's something that will actually save our lives ...When it's restricted, it's going to cause so many more issues down the road, leading to depression and suicide and stuff like that."

Though its not clear how Spektrum will be required to proceed, Knoll, who has helped more than 10,000 people transition over the course of his career, has ideas for counteracting what he believes to be misinformation cited in the proposed guidelines.

"One of the things that we're trying to do to combat this is put together some research or get something published, but I'm not a publisher, I don't know how to do that stuff, I'm not a statistician," he said.

His goal is to gather statistics from the practice regarding transgender patients and their experiences. But without experience in publishing and a lack of resources in this area, he needsa volunteer to help.

The truth is, organizations like mine, other organizations around the state, we just don't have the bandwidth to gather this information, he said. "We just need help that's the hold up."

Finch Walker is a Breaking News Reporter at FLORIDA TODAY.Contact Walker at 321-290-4744orfwalker@floridatoday.com. Twitter:@_finchwalker

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Brevard LGBTQ clinic responds to proposed restrictions on trans healthcare - Florida Today

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A drug that has been used to slow progression of kidney and cardiovascular disease in people with type 2 diabetes may also help people with chronic kidney disease who do not have diabetes, according to findings published Monday in the European Heart Journal. Aldosterone, a hormone produced by the triangular adrenal glands, might be the key target.

In the observational study, researchers analyzed health data from 3,680 people with chronic kidney disease for nearly 10 years. Those with elevated levels of aldosterone, a crucial, salt-conserving hormone made by the adrenal glands, which sit atop the kidneys, had a higher risk of serious kidney disease progression during the study period: they are more likely to lose half their kidney function, start dialysis, or develop end-stage kidney disease.

That finding troubled Ashish Verma, a kidney specialist and assistant professor of medicine at Boston University School of Medicine, and lead author of the study. Elevated aldosterone levels are common in the general population but often fly under the radar, even in people at high risk of developing chronic kidney disease, Verma told STAT.

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Finerenoneis a nonsteroidal drug approved by the FDA for people with type 2 diabetes and chronic kidney disease. It could also help prevent kidney disease or its progression in people without diabetes, with a lower risk of causing dangerously high potassium levels than traditional therapies like spironolactone or eplerenone, Verma said.

STAT spoke to Verma via Zoom ahead of the papers publication. The interview has been edited for clarity and brevity.

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What is the relationship between aldosterone and kidney function?

Aldosterone is a hormone made by the adrenal glands that helps the body conserve water and salt. Take, for example, somebody who is dehydrated or has very low blood pressure. This hormone actually helps conserve water and salt. But if this hormone is, all the time, at a higher concentration in the body, it leads to hypertension (high blood pressure). And that can lead to damage in the kidney and in the heart.

Why did you decide to study aldosterones role in chronic kidney disease?

There were very recent, very big randomized controlled trials, published in the New England Journal of Medicine FIDELIO and FIGARO. And they used finerenone. Aldosterone acts on mineralocorticoid receptors, which finerenone blocks. They found drastic results in patients with diabetic kidney disease who have protein in the urine, which is abnormal, and who have low kidney function.

So those patients actually benefited from finerenone their kidney disease progression halted. But those patients had diabetes. I wanted to link the mechanism: Why this drug is helpful. And the other question I had was, Wait a second. Is high aldosterone only bad in people with diabetes? Or is it also bad in people do not have diabetes?

What did you find?

We found that higher aldosterone levels were associated with the progression of kidney disease, and even with going on dialysis (a sign of severe kidney disease). There was a risk for kidney disease progression with high aldosterone levels, irrespective of if you have diabetes or not.

What is known about how finerenone or similar drugs might work in people without diabetes who have chronic kidney disease?

Interestingly, there is a trial going on, the FIND-CKD trial, which is testing finerenone to halt kidney disease progression in people who do not have diabetes. So were going to know soon, maybe next year, if these drugs are associated with decreased kidney disease progression.

Older drugs, like spironolactone or eplerenone, can cause very high potassium levels in people with low kidney function (which can lead to life-threatening heart problems). So people feared always using it. And even in my clinic, if I use these drugs on patients, I test their potassium and make sure their potassium stays okay. That was one of the hindrances for using these drugs.

But now, with more evidence in front of us that high aldosterone concentration is bad, doctors should also be checking aldosterone levels in people with diabetes, people with resistant hypertension (high blood pressure that doesnt respond to three or more antihypertensive drugs, including a diuretic) or people with central obesity. Dr. [Anand] Vaidya, co-author of this study, showed in his previous publication that excess aldosterone is very common in normal populations, but we dont check for it, so its a very unrecognized disease in the general population.

Why dont doctors regularly check aldosterone levels? Is it difficult to do?

No, its not difficult. Its a very easy task that can be done in any clinic, anywhere in this country. The problem is that there are set guidelines for checking aldosterone. We check for it in people who have resistant hypertension, people who are young and have high blood pressure. But as new reports show that high aldosterone is common, I think physicians should be more motivated to check these levels in patients.

What surprised you throughout the research process?

What we found at baseline was that the lower a persons kidney function, the higher their aldosterone is. We dont know the mechanism of it. Maybe future studies will find out why that happens. Second, when somebodys kidney function is low, they tend to excrete less potassium in the urine, so potassium in the blood gets high. But we found the opposite: people who had lower kidney function and high aldosterone actually have lower potassium [in the blood], which fits the mechanism because if you have higher aldosterone, you can excrete more potassium in the urine. So it fit the mechanism that, yes, this aldosterone was pathogenic in these patients; it was not doing the work it does in healthy people.

What do you think is the biggest contribution of this research to the scientific literature and to the understanding of kidney disease?

This is the first study to show that high aldosterone is associated with kidney disease progression. No study before has shown it. There was a study using the same cohort but less follow-up time. And they used different methods. We used different methods because we removed people who were on aldosterone antagonists like spironolactone and eplerenone. We had nine years, almost 10 years, of follow-up, with 1,412 kidney events.

The second thing: the mechanism, that its not high potassium that leads to aldosterone secretion in chronic kidney disease. Its maybe the low GFR [glomerular filtration rate, a measure of kidney function] that is causing high aldosterone secretion. And the third, most important finding is that, irrespective of diabetes status, high aldosterone causes damage.

What new questions do these findings prompt for you?

The most important thing is why low GFR leads to high aldosterone. Why do people with chronic kidney disease have higher aldosterone? Why this happens, we dont know, which is very important to find out. And another thing, which is fascinating to me, and Im going to work on it in the future, is that in humans, we always postulate through animal models that high aldosterone actually leads to fibrosis in the heart and in the kidney. But nobody actually measured these markers in humans to see how it actually happens.

Are you applying any of these findings to your clinical practice?

Im actually checking aldosterone in a lot of patients I see that have high risk, like obese patients, and patients with resistant hypertension. And Im trying to put them on spironolactone to see. In Boston Medical Center, we dont have finerenone yet because its a costly drug. I think when finerenone comes to the market, Im going to start putting people on finerenone and see if it reduces their aldosterone levels.

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Aldosterone, a hormone that prevents dehydration, is linked to worsening kidney disease, study suggests - STAT

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