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Sometimes there are no words to take away her sons pain.

So Marie wraps her arms around her child and cries with him.

A few times a week, the 11-year-old breaks down, overwhelmed with the adversity he faces as a transgender boy. His peers, his mother said, have called him gross, stupid and a pervert.

The Penobscot County fifth-grader also suffers from gender dysphoria, a psychological condition that causes distress for those whose gender identity does not match their birth-assigned sex.

He despises the feminine body he sees when he looks in the mirror. He has pulled his hair out, cut himself and banged his head against the wall.

Its heartbreaking, his mother said. I validate him as much as I can, so that he knows at the end of the day that its not about him. He is not whats wrong.

Fred J. Field

/

For The Maine Monitor

A study recently released by the Williams Institute at UCLA estimated there were 5,900 adults 18 and older in Maine and 1,200 children aged 13-17 who identified as transgender.

The states transgender adolescents, according to the 2019 Maine Integrated Youth Health Survey, were twice as likely to have been bullied at school and four times as likely to have been threatened or injured with a weapon. Half of them had considered suicide compared to 15 percent of their non-transgender peers.

It can be really scary and isolating coming out, said Aiden Campbell, a transgender male who works at OUT Maine, an LBGTQ advocacy organization.

Living as a transgender youth in a largely rural state can be especially difficult. Medical and mental health resources are hard to come by, and growing up as a trans kid in a small town or school can be lonely and heartbreaking.

They may be the only one coming out in their school or town, said Campbell, who endured bullying before he transitioned and became the sole transgender student at Cony High in Augusta.

Campbell tried to end his life in 2012, believing he would never be loved or accepted.

I know what it feels like to be in a dark place and feel really lonely, he said. But kids shouldnt think suicide is the answer they have to turn to because they dont feel accepted.

Along with the struggle to fit in at school, at home or in their community, Maine transgender youths and their families are reeling from the heavy number of political attacks nationally.

More than 100 bills targeting transgender people have been proposed in other state legislatures since 2020, according to the American Civil Liberties Union. The bills include banning transgender students from playing girls or womens sports, using bathrooms that match their gender identity and criminalizing gender-affirming treatment for children.

Maines legislature has defeated proposed anti-trans laws in recent years, but the states Republican party amended its platform during its April convention to call for a ban on discussing transgender identity in schools. Former Republican Gov. Paul LePage, who is running for re-election, has supported laws restricting transgender rights.

Though Democratic Gov. Janet Mills has a history of voting for LBGTQ rights, advocates recently criticized her for removing a teacher-made video from the Maine Department of Educations website that discussed gender identity and same-sex relationships and was intended for kindergarten students. After the video was used in a Republican attack ad, Mills and the DOE eliminated it from the state website, saying the lesson plan was not age-appropriate for kindergartners.

The push to ban discussions about LBGTQ students in the classroom and to restrict their rights and medical treatment, frightens Marie, who is being identified by her middle name to protect her sons privacy.

I have a lot of feelings and fears about these laws, she said. To not get my son treatment is criminal. There is substantially higher risk of him committing suicide if he doesnt get help. And I will do anything I can to make sure that doesnt happen.

When parents like Marie seek resources for their children, they often turn to advocacy groups like Maine Transgender Network or OUT Maine, which offer online support groups, workshops and links to medical and mental health professionals.

Medical care is typically provided at the states two pediatric gender clinics, in Portland and Bangor. The Gender Clinic at Barbara Bush Childrens Hospital at Maine Medical Center opened in 2015 because of a growing need to treat adolescents who had to travel out of state for services. The clinic has 1,000 patients ranging in age from 3 to 25 from Maine and New Hampshire, said the clinic program manager, Brandy Brown.

While most of the patients are between ages 14 and 19, there are some who are pre-kindergarten or in grade school.

With most of our young patients, the parents have a lot of questions, Brown said. Theyre here for support and guidance.

Younger pre-teen patients, Brown said, are generally exploring their gender with social transitions such as wearing clothes that may not align with their birth-assigned sex. Sometimes they also choose to rename themselves.

In the third grade, Maries son began altering his appearance to diminish his female characteristics.

He had these long waist-length curls and he shaved one side, Marie said. And then he slowly worked up (his head) until all of the sides were shaved and he just had a bit of hair on top.

At age 9, he told his mother, I think Im a boy.

The dark-haired, sensitive child did not waver in his chosen identity, Marie said. He changed his name and appearance in the spring of 2020 when his school went to remote learning during the pandemic. When he began attending a new school in the fourth grade in the fall, he dressed in baggy pants and shirts. His classmates, his mother said, accepted him as a boy.

Most of the kids in the class were new to him, said Marie. At that time the transition was pretty easy.

But a few students who knew him before began teasing him, Marie said. Others in the class also taunted him after her son explained, I was born a girl but now Im a boy.

It was a constant barrage, Marie said. Hes got a shaky self-esteem so if he is having a bad day, hes taking it out on himself.

His emotions, Marie said, pour out in a stream of self-hate.

Im ugly, he tells his mother. Im fat. Im stupid. Im not good enough. Nobody loves me. I wish I was dead.

He also continued to hurt himself, Marie said, cutting and scratching his arms until he left scars.

Fred J. Field

/

For The Maine Monitor

Marie sought help for her son at Northern Light Eastern Maine Medical Center Gender Clinic in Bangor, which opened in 2017 and currently has 200 patients. The clinics psychologist and endocrinologist a doctor who specializes in the bodys glands and the hormones they make evaluated Maries 11-year-old child and determined he had gender dysphoria.

While not all clinic patients receive medical treatment, doctors prescribed puberty blockers for Maries son, she said, to ease his distress. The medication suppresses hormones that would cause changes like breast development and menstruation.

He is very conscious of how his body looks and cries at the sight of it, Marie said. He wears these oversized T-shirts and loose baggy clothing to try and hide it. We were fortunate that he could start treatment before his puberty progressed.

Puberty blockers, explained Dr. Mahmuda Ahmed, the Bangor clinics lead pediatric endocrinologist, delay puberty and give children time to see if their gender identity is long lasting. The medication, Ahmed added, is also given to non-transgender youth experiencing early or precocious puberty.

The World Professional Association for Transgender Health supports the use of puberty blockers, and the countrys top medical associations, including the American Academy of Pediatrics, the American Medical Association and the American Psychiatric Association, also endorse some forms of treatment for transgender youth.

When it comes to puberty blockers, though, critics argue more research is needed to understand the medications effect on a patients fertility and bone density.

Once the blockers are stopped, an adolescents body begins to produce hormones again. Pausing the production of estrogen and testosterone hormones provides relief to children whose biological bodies do not align with their gender identity, said Dr. Anna Mayo, a psychologist who evaluates patients at the Bangor clinic.

All of a sudden your body is changing in ways that dont match your identity and that can be a really distressing time in a childs life, said Mayo.

When a transgender child does not receive treatment and undergoes puberty that conflicts with their identity, the results can be dire, said Susan Maasch, director of Trans Youth Equality Foundation, a Portland-based nonprofit that provides education and support for transgender youth and their families.

Kids begin to give up hope, Maasch said. They become destructive, do badly in school. Inevitably they fall into a deep dark place and need mental health services, or worse and they take their own life.

Gender-affirming care for adolescents is controversial in many states, and conservative groups like the Christian Civic League of Maine assert that such medical treatment harms youth. But Ahmed points to several studies, including a recent report published in the Journal of Adolescent Health, which found treatment of patients with forms of gender dysphoria lowered moderate or severe depression and decreased suicidal thoughts and attempts.

Often, doctors say, families have questions about medical research on transgender youth and are hesitant to seek treatment that will change their childs appearance. Sometimes children alternate between divorced parents who disagree on care or social transitioning a child with clothing and name changes.

The kids are stuck in the middle suffering, said Maasch. I have one child now where the mother accepts her (as a transgender girl) and the dad doesnt. Besides suffering depression, a kid who shows up to school one day dressed as a boy and then later dressed as a girl is more vulnerable and more likely to be harassed.

Fred J. Field

/

For The Maine Monitor

Maine and most states do not have laws governing transgender pediatric care. Maines gender clinics follow the World Professional Association for Transgender Health guidelines. Depending on what provider they see, a youth can receive puberty blockers with only one parents consent. But surgery to alter a childs body or hormone replacement therapy which can feminize or masculinize an adolescents secondary sexual characteristics like facial hair and breast formation requires both parents permission.

In recent years, gender-affirming care for adolescents has become a controversial issue. As of March, according to the Williams Institute, 15 states have restricted access to treatment or are proposing laws to do so. Some of the bills criminalize medical care, and impose penalties on healthcare providers and families if they access puberty blockers, hormone therapy or surgery for a transgender child.

Concerned about the political battle over medical treatment for transgender minors, the AMA has urged governors to veto legislation that would prohibit care, saying it is a dangerous intrusion into the practice of medicine.

Forgoing gender-affirming care, the AMA wrote in a 2021 letter to the National Governors Association, can have tragic health consequences, both mental and physical.

Laws to criminalize care for transgender minors disturbs Marie, but it is not a topic she discusses with her son, knowing it will upset him.

We dont talk about whats going on in Texas (and other states) right now because I have a lot of feelings about it and a lot of fear, Marie said.

Though Marie has primary custody of her son, her ex-husband, she said, does not support gender-affirming care and continues to call their child by his feminine birth name. The slight, referred to as dead-naming among transgender people, is painful, explained Marie son, who has chosen the new middle name Lion to represent his courage.

You just try to keep telling yourself that you know who you are, said Lion. I try to talk to my dad about it, but it just escalates and gets into a fight.

When his father calls him by his birth name or refers to Lion as she or her, the fifth-grader tries to not let the pain affect him.

I try to stick up for myself, he said. I try to be like Batman or the Green Lantern, tough like them.

Last Christmas, Lions father wrote both his feminine birth name and his new masculine chosen name on gift tags for his presents. The gesture gave Lion hope.

Maybe things will get better, he said.

A child caught in the middle of a familys polarizing views frequently experiences trauma, said Carmen Leighton, a mental health counselor who specializes in treating LBGTQ youth.

Often we see a divide in the family, which can be very destructive, said Leighton, a therapist at Higher Ground Services in Brewer. And every time it falls on a trans kid who feels like, I know that this is my truth, my identity, but its causing all of this conflict, so its my fault.

Parents often wrestle with fear and grief, Leighton said, when they try to understand why their childs birth sex does not align with their chosen identity.

Its the fear of the unknown and its the grief of I birthed this person and gave them this name, Leighton said. And then this grief that Im losing my daughter or Im losing my son and theyre becoming someone that I may not recognize anymore.

Fred J. Field

/

For The Maine Monitor

As transgender children become teenagers, they tend to arrive at the Portland clinic with more complex problems and needs, said Erin Belfort, a child and adolescent psychiatrist. Roughly 65 percent of the youth referred to Belfort have a mental health diagnosis such as depression, anxiety or thoughts of suicide. Some have been hospitalized after suicide attempts.

Trying to navigate adolescence is hard enough, Belfort said. But trying to do so in a world that doesnt see you as you see yourself, especially if you dont have support at home, is incredibly stressful and traumatizing for kids.

Belfort sees youths from every Maine county, including the states rural pockets, where kids may struggle to find acceptance.

Though Maines non-discrimination laws protect all students to ensure they learn in a safe environment, transgender youths experiences vary depending on which schools they attend, Belfort said.

Kids who go to arts academies feel like they have great community and people really celebrate their identities, Belfort said. Then I have kids too who dont feel safe going to school with other students who are wearing (Make America Great Again) hats and driving their pickup trucks with a shotgun in the back.

While schools try to prevent bullying and harassment, it still happens, Belfort said.

The lack of mental health services throughout Maine and especially in rural areas makes it difficult for families to get their children help if they are feeling isolated or rejected.

After an initial evaluation, Belfort and doctors at the Bangor clinic refer patients to mental health providers in the community. But wait lists are long, especially in counties like Washington, Franklin and Piscataquis.

One of our primary challenges is finding mental health clinics, said Dr. Mayo, of the Bangor clinic. We have patients waiting more than six months to find providers.

Marie feels fortunate she was able to get her son treatment for his gender dysphoria. She is also grateful that Lions counselor is trained in the specific needs and trauma of transgender youth.

Its so hard to find trans competent care and people that really understand these kids, Marie said.

Fred J. Field

/

For The Maine Monitor

Lion will likely continue taking puberty blockers until he turns 15, Marie said. Then it is unclear whether he will be able to receive hormone therapy to further transition his body.

If his father does not consent, Lion must wait until turning 18.

For now, hes grateful that the medication is giving him the chance to be a regular boy who loves baseball and likes to draw.

Asked to describe himself, he quickly answers, Im smart, brave and competitive, yeah, and kind.

The 11-year-old wishes people would just stop being mean to him and others who are different.

I want acceptance for me and for everybody, he said. Like racism, too. I wish it would all stop.

This series was financially supported by The Bingham Program and the Margaret E. Burnham Charitable Trust. We encourage you to share your thoughts on this series by visiting this page.

This story was originally published byThe Maine Monitor.The Maine Monitor is a local journalism product published by The Maine Center for Public Interest Reporting, a nonpartisan and nonprofit civic news organization.

Gender Dysphoria: Mayo Clinic says gender dysphoria is the feeling of discomfort or distress that might occur in people whose gender identity differs from their sex assigned at birth or sex-related physical characteristics. Transgender and gender-diverse people might experience gender dysphoria at some point in their lives. However, some transgender and gender-diverse people feel at ease with their bodies, with or without medical intervention. The American Psychiatric Associations Psychiatry.org says gender dysphoria is clinically significant distress or impairment related to a strong desire to be of another gender, which may include desire to change primary and/or secondary sex characteristics. Not all transgender or gender diverse people experience dysphoria.

Transgender: the Mayo Clinic says transgender is an umbrella term used to capture the spectrum of gender identity and gender-expression diversity. Gender identity is the internal sense of being male, female, neither or both. Similarly, The American Psychiatric Association says transgender is An umbrella term describing individuals whose gender identity does not align in a traditional sense with the gender they were assigned at birth. GLAAD (formerly known as the Gay and Lesbian Alliance Against Defamation) describes transgender as An adjective to describe people whose gender identity differs from the sex they were assigned at birth. It is important to note that being transgender is not dependent upon physical appearance or medical procedures.

Transgender man: GLAAD says a man who was assigned female at birth may use this term to describe himself. Some may prefer to simply be called men, without any modifier. Use the term the person uses to describe their gender.

Read this article:
The Journey To Be Me: The heartbreak, hope and courage of a Maine transgender child - Maine Public

If you stopped breastfeeding (chestfeeding), it may not be too late to try again. Thats true even if youve avoided breastfeeding completely and have never done it. The challenging process of relactation can take weeks or even months to produce milk. But if youre interested in giving it another go, the process of relactating is both possible and beneficial for your babys health.

Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services.Policy

Pediatrician and breastfeeding medicine specialist Heidi Szugye, DO, IBCLC, shares why you may want to try relactation and how you can make that process easier with a few simple tips.

During relactation, you train your body to produce milk after not lactating for a period of time. Its possible to relactate if you havent produced breast milk in weeks, months or even years. And while some may think relactation is a modern concept, the practice has been around for hundreds of years. During natural disasters, emergencies or when mothers died during childbirth, it was often customary for other mothers to step in and help.

Interest in relactation has peaked since the recent infant formula shortage, and although its been around for years, Dr. Szugye is quick to point out that relactation has its challenges.

People either underestimate or overestimate the time and effort it takes to relactate, says Dr. Szugye. Some people think the process is easier than it actually is, but it doesnt just happen overnight. Its not impossible, but it takes a lot of time, effort and support.

If you choose not to breastfeed your infant and you dont stimulate your breasts after your baby is born, your breast milk will dry up typically 14 to 21 days after delivery.

You need that suckling or stimulation of the breast to tell the body to continue to make more milk. The emptying of the breasts themselves tells your body to make more, explains Dr. Szugye.

When that milk is left alone in your breasts, a specific protein builds up and acts as an inhibitor causing breast milk production to stop. Fortunately, you may be able to restart breast milk production later on when you feel the time is right.

Parents may stop initial breastfeeding for a variety of reasons. If mom is in the ICU or having medical issues after birth, breastfeeding may be more difficult. Some parents who experience postpartum depression may initially be overwhelmed by breastfeeding challenges but, once treated, find they want to try again. Parents who have to return to work sooner than later may also find breastfeeding difficult when they have to go back to the office. Lastly, if your baby is born prematurely or is sick and needs surgery after delivery, it may be hard to directly breastfeed initially.

Mothers who didnt breastfeed initially may change their minds down the line and want to breastfeed their baby or provide their baby with breast milk, says Dr. Szugye. There are also more unique situations, too, where maybe a mom had a biological child they breastfed previously but now they want to breastfeed an adopted child, so they desire to relactate.

Before you begin relactation, its important to set goals and expectations and to recognize that it takes a lot of patience and support. Dr. Szugye advises seeing a lactation consultant or breastfeeding medicine specialist to understand why you stopped breastfeeding and help you with the process of relactation.

If you faced challenges with breastfeeding initially and that led you to stop breastfeeding, these challenges may resurface when you try to relactate, says Dr. Szugye. For example, if you had an issue with the baby latching onto your breast or producing enough breast milk, those issues may happen again, so we want to make sure we can support you and work through those challenges and troubleshoot.

To reproduce milk, your breasts need to be stimulated and your body needs to know youre removing milk so that it can produce more. You can do this with a number of techniques.

You can begin trying to relactate with your baby directly, but if they have trouble latching onto your breast or theyre a bit older, this may be difficult to do. You never want to force your baby to feed because this can backfire and turn them away from wanting to suckle. Plus, you wont produce milk right away, so this process will take time and require your continued use of formula or donor milk until you begin milk production.

You cant go cold turkey from feeding a baby formula to putting them to the breast. Youre not going to be producing enough for the baby, from a nutritional standpoint, right away, notes Dr. Szugye.

To increase your babys ability to latch onto your breast and begin suckling, you can do the following:

To provide additional nutrition, you can supplement with a bottle, tube and syringe, or use a supplemental nursing system that has a tube connected to a bag of formula or donor milk. You can wear this tube like a necklace or attach it to your breast so your baby gets used to the act of suckling for milk in the right location.

In addition, you may want to try hand-expressing milk from your breasts. You can do this by making a C-hold with your thumb and index finger and compressing your breast from behind the nipple to simulate what a baby would do when suckling.

Once you begin producing milk, you can then turn to a pump to handle larger volumes, or use both simultaneously.

It can become a little tedious to hand express when you start getting bigger volumes of breast milk, but you can combine hand expression with pumping or hands-on pumping, says Dr. Szugye.

Relactation doesnt happen overnight. Youll need to stimulate your breasts for 10 to 15 minutes on each side at least eight to 10 times every day. At least one of these sessions should be done at night or early morning when prolactin, the hormone that helps with milk production, is at its highest.

It takes weeks or months to build up a supply, says Dr. Szugye. Sometimes, it can take weeks just to get drops of milk.

This can sound discouraging and feel daunting, especially given the daily requirements. If youre able to stick with it, in most cases, youll start getting drops of milk after two to four weeks.

Youll want to work with a lactation consultant and pediatrician to keep an eye on your babys weight and growth during this period. Youll also need to supplement the lack of breast milk with formula or donor milk until youre able to produce enough milk on your own. In some cases, your doctor may recommend medications or supplements to help with milk production.

While relactating, youll want to focus on getting enough sleep, staying hydrated and reducing stress as much as possible because all of these things can affect milk production. If youre able to get additional help around the house during this time, that can also be beneficial.

Its almost like having a newborn all over again, says Dr. Szugye.

Here are some additional resources that can be helpful when considering relactation:

See the original post here:
How To Reintroduce Lactation After Stopping Breastfeeding - Health Essentials from Cleveland Clinic

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In 2020, for the first time, medication abortions accounted for more than half of all abortions in the United States. Thats after the pandemic led the FDA to lift a restriction that had required doctors to dispense Mifepristone, one of the two pills used to induce abortion, in person.

The pills are approved to terminate a pregnancy that is up to 10 weeks along. The pills can be taken at home and they cause similar symptoms to spontaneous miscarriage.

If the U.S. Supreme Court overturns Roe v. Wade, which is expected this month, abortion will likely become illegal in about half of the states. But abortion pills could wind up in a legal gray area approved at the federal level by the FDA, but subject to state-level abortion bans.

And because they will remain available in neighboring states that allow abortion and through online suppliers, they offer a potential workaround for anyone who wants an abortion but doesnt have the resources to travel to a state where it is legal. In Texas, for example, the number of people ordering abortion pills from an online telemedicine service tripled after state legislators passed an abortion ban in 2021.

States are already moving to limit access to medication abortion, and the FDA has sent warning letters to some of the online telemedicine companies that have tried to develop workarounds to state-level regulations.

In Oregon, a state with no restrictions on abortion, the pills are available at a wide variety of hospitals and clinics, or through telehealth appointments. Medication abortions account for about 70% of those provided by the two Planned Parenthood affiliates in Oregon, which are responsible for more than half of all abortions statewide.

To put together this guide, we spoke with two experienced obstetrician-gynecologists, the type of doctor who typically provides prenatal care and delivers babies, about abortion pills.

Oregon Health & Science Universitys Dr. Maureen Baldwin has been part of clinical trials of telemedicine abortion where a medical provider meets with and evaluates a patient via videoconference before and during the pandemic.

Dr. Paula Bednarek is an associate professor of obstetrics and gynecology at OHSU and the medical director of Planned Parenthood Columbia-Willamette.

Both doctors are supporters of abortion rights.

Using pills to end an unwanted pregnancy, or to manage a miscarriage, is known as a medication abortion. The most effective method uses two drugs: Mifepristone and Misoprostol.

Mifepristone, originally known as RU-486, is taken first. It blocks progesterone, a hormone thats needed to continue a pregnancy.

The second medication, Misoprostol, is generally taken at least 24 hours later. It starts contractions and prompts the body to expel the pregnancy. (This medication is also sometimes used to induce labor at the end of a full-term pregnancy.)

Each medication has been used individually to induce abortion, but they are most effective when taken in combination at nine weeks or less. When a pregnancy is less than seven weeks along, there is a less than 1% chance of a pregnancy continuing after following the two-step protocol, according to Baldwins research. After seven weeks, the chance of a pregnancy continuing rises incrementally. In the tenth week of pregnancy, the chance of a pregnancy continuing is about 8%.

Medication abortion is used to end pregnancies that are less than 10 weeks, or 70 days along, counted from the last day of the most recent period.

Its also an option that can help manage pregnancy loss when the process of miscarrying has started but hasnt completed naturally.

Medication abortion can be used at any point after getting a positive pregnancy test, around 4 weeks.

In a clinical or hospital setting under medical supervision, medication abortion can sometimes be used to end a pregnancy that is further than 10 weeks along. There is a higher risk of significant and dangerous bleeding after 10 weeks.

There are relatively few risk factors that make the procedure unsafe for people seeking an abortion in early pregnancy. Medication abortion is not used for people with a known allergy to Mifepristone, certain bleeding disorders, suspected ectopic pregnancy, chronic adrenal failure, or people on chronic steroid therapy. It is also not used when someone has gotten pregnant with an IUD in place.

Yes, but only if those people are physically located in Oregon for their appointment or telehealth appointment.

That is part of how all telemedicine is regulated. Providers have to be licensed in the state where the patient is located and follow the laws of the state where the patient is located.

The patient also needs an Oregon mailing address if they plan to receive pills by mail.

In the United States, getting Mifepristone requires a consultation and prescription from a doctor or health professional.

In Oregon, that can happen in person, or through telemedicine over the phone or online.

First, a doctor evaluates the patient to confirm how far along they are in pregnancy and to determine if there are any reasons the procedure might not be safe for a particular patient.

Baldwin says in most cases, an ultrasound isnt necessary.

We know from a lot of research that patients who have been recording their periods are very accurate in knowing how far along they are, she said.

Patients can pick up the medication in person at a doctors office or Planned Parenthood clinic, or have the medication mailed to them. Its not yet available in retail pharmacies.

After taking the second medication, Misoprostol, the patient may feel nauseous and throw up. They will have a lot of bleeding and cramping.

The length of time it takes to pass the pregnancy tissue can vary. It can be a very fast process, 90 minutes overall. Or, the bleeding and pain can last a few days and come and go in waves.

Standard care includes a follow-up evaluation to ensure the pregnancy tissue has all been passed.

At OHSU, for example, there are three options: a self-evaluation and home pregnancy test a few weeks afterward, an ultrasound in a clinic following the abortion, or blood tests for pregnancy hormone levels before and after the procedure.

Some people really want to have a visual, Baldwin said. In fact, we know that a lot of people come to emergency departments after a medication abortion for reassurance actually that the pregnancy has completed, she said.

Abortions are available at all Planned Parenthood health centers, at many private obstetrics and gynecology practices and in the Kaiser Permanente, OHSU, and Legacy Health systems.

Providence Health Services provides medical and surgical abortions for patients experiencing miscarriage, pregnancy loss, or a life-threatening emergency, along with resources to cope with the loss. Providence will not provide induced or elective abortions. Providence patients who are Oregon Health Plan members can access abortion through a different provider, regardless of the reason, by calling Oregon Health Plan client services at 1-800-273-0557.

Neither the Indian Health Service nor Veterans Affairs provide abortions, due to the Hyde Amendment, a law that restricts federal funding for abortion.

Federally Qualified Health Centers. which provide primary care to low-income, uninsured, rural and historically disadvantaged populations, also do not provide abortions, due to congressional restrictions. They do provide referral services for abortions and other options for their patients.

All of these services will continue to remain legal in Oregon unless state legislators change the laws here, which seems unlikely given the political make-up of the state government right now.

Boxes of the drug mifepristone line a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., on Wednesday, March 16, 2022. The drug is one of two used together in "medication abortions." According to Planned Parenthood, mifepristone blocks progesterone, stopping a pregnancy from progressing.

Allen G. Breed / AP

Mifepristone was invented in France and was first approved by the FDA for abortion, in combination with Misoprostol, in 2000.

Misoprostol is FDA approved to treat ulcers. Its used for abortions and, at a lower dose, for labor induction. The medications uses in gynecology are included in the labeling for Mifepristone and are considered safe by the American College of Obstetricians and Gynecologists.

The FDA regulates Mifepristone more tightly than most drugs and collects more complete safety data on it. Since 2011, the FDA has added what is known as a Risk Evaluation and Mitigation Strategy (REMS) to the drug. Doctors who prescribe it have to follow some special record-keeping practices and report any cases of complications, and patients who take it have to sign a form saying theyve been informed of the risks.

In December 2021, the FDA rolled back some prior restrictions on the drug. As a result, by the end of 2022, it may be available in some retail pharmacies.

Some may prefer being able to have an abortion in the comfort of their home. Some people may feel it is less invasive, or more natural, than a surgical procedure. Medication abortion via telehealth may be easier for those who live in parts of the state without a nearby abortion provider.

It is also easier to book an appointment for a medication abortion, according to Bednarek. Surgical abortions are only available in some Planned Parenthood locations in Oregon, on specific days of the week.

There is a similar safety profile for medication abortion and surgical abortion for early pregnancy. Surgical abortions do have advantages. They are more predictable and over more quickly, with less bleeding.

If somebody wants to have sedation and be asleep and have it be less pain and be over with more quickly and not have to experience the process of the abortion, that is an option with surgical abortion, Baldwin said.

A persons pain level can vary based on their prior experience with pregnancy, birth, or pregnancy loss. It can also vary based on how far along a pregnancy is. For some people, the cramping may be as painful as labor contractions. For others, it is more like bad period cramping.

Ibuprofen, a heating pad, and a warm bath or shower can be effective in helping patients manage the most significant cramping, which typically lasts in the 4-6 hour range.

People should not take aspirin. It can cause them to bleed more.

Some patients may want stronger pain medication.

We talk with patients and we provide whatever pain medicine they feel that they need, which might include a prescription for a narcotic pain medicine, but most often over-the-counter medicines are really effective, said Bednarek.

There can be a physical and emotional recovery process afterward, that can vary with the circumstances that surround a persons choice to get abortion care. Some feel relief. Others feel sadness. Many feel lots of things all at once.

Abortions, including medication abortions, are generally safe procedures.

In 2018, the National Academies of Sciences, Engineering, and Medicine convened an expert committee to review the practice of abortion in the United States. The committees final report reads: Legal abortionswhether by medication, aspiration, D&E, or inductionare safe. Serious complications are rare and occur far less frequently than during childbirth. Safety is enhanced when the abortion is performed as early in pregnancy as possible.

(Aspiration is a procedure that involves suctioning out pregnancy tissue. The term D&E stands for dilation and evacuation, and involves dilating the cervix and surgically removing pregnancy tissue.)

During a minority of medication abortions, less than 5%, complications arise.

The most common complication is that it doesnt work. In that case, a follow-up surgical abortion is required.

Rarely, in less than 1% of cases, medication abortions can cause more serious and even fatal complications. These include prolonged heavy bleeding, infections and sepsis, and ruptured ectopic pregnancies.

In an extremely small number of cases, medication abortion has been linked to infection with clostridum sordellii, a particularly dangerous type of bacterial infection thats also a rare complication of miscarriage and childbirth. It can trigger toxic shock syndrome and can be hard to diagnose because patients may have an infection without a fever.

According to the Mifepristone label, people should contact their provider or seek help if they have:

In the US, medication abortion has an associated mortality rate of less than 1 in 100,000, according to the Kaiser Family Foundation. The mortality rate associated with giving birth is 23.8 deaths per 100,000 live births, according to the CDC. In the United States, there are more deaths annually due to accidental Tylenol overdoses than from all types of abortion.

Thats also safe, according to research conducted during the pandemic.

A study published in 2021 looked at more than 50,000 patients in the United Kingdom who received medication abortions. One group had received the pills at an in-person clinic visit that included an ultrasound. The other group received the pills by mail, after a telehealth consultation.

The study found no evidence of worse outcomes linked to telemedicine abortion. It found telemedicine abortion had significant advantages. Patients had shorter waiting times and there was a 40% increase in the number of abortions provided at 6 weeks gestation or less.

The FDA warns against purchasing Mifepristone and Misoprostol outside of the American medical system.

For someone living in Oregon, often. Medication abortion is covered by the Oregon Health Plan and by many private insurance plans. It is not covered for tribal members who get care through the Indian Health Service, nor to veterans who get care through the VA, due to the Hyde Amendment.

It is not covered for people on a Providence Health Plan.

If everyone in the United States has access to abortion pills and quality information on how to use them, and when to seek help, it could reduce some of the medical risks associated with a return to illegal abortions. In short, the pills may make illegal or self-managed abortions safer than they were in 1973.

In terms of what options are for self-managed abortions were a world away from where we were, Bednarek said.

There is some evidence, for example, that the availability of Misoprostol in some Caribbean, Latin American, and African countries has reduced maternal mortality from unsafe abortions.

Self-managed abortion may carry significant legal risks. In some states with laws that oppose abortion, prosecutors have filed homicide charges against people who tried to end their pregnancies outside the medical system. And in Pennsylvania, a mother who bought abortion pills online for her daughter was sentenced to 18 months in prison for violating state abortion regulations.

Bednarek says in states where Planned Parenthood cannot legally provide medication abortion, it can provide information to anyone who has obtained pills outside the regular health care system.

If patients call us with questions and need help, we are here to support them at any point through their process, she said.

Anyone who has started the process outside the health care system and is experiencing complications or warning signs can also get help at Planned Parenthood.

We can still do an ultrasound, we can help them with additional medications or an aspiration procedure if thats part of whats needed, we can evaluate them for ectopic pregnancy, Bednarek said. Patients should not feel worried that they will be judged or turned in or something like that.

See the rest here:
Medication abortions are easy to access in Oregon, but how do they work? - Oregon Public Broadcasting

For effective, long-lasting birth control, its hard to beat an IUD, a.k.a. intrauterine device, for foolproof pregnancy protection. An IUD can live in your uterus for up to 12 years, protecting you from unwanted pregnancy with more than 99% effectiveness. IUDs are safe and reliable, but is there a catch? We talked to OB-GYNs about how this semi-mysterious method of birth control works, and what you should be aware of before having one put in your body.

Credit: Reviewed / Getty Images / flocu

This T-shaped contraceptive method is inserted directly into the uterus so there's no need for timely phone reminders or painful injections.

Made of plastic and/or copper, IUDs are semi-flexible, T-shaped devices no bigger than the size of a small sugar packet. Theyre inserted by a gynecologist and have two short strings attached at the bottom, which makes removal less arduous when it comes time to do so. The FDA currently approves of five devices: Paragard, Mirena, Kyleena, Liletta, and Skyla.

There are two types of IUDs you can get: hormonal and non-hormonal. Mirena, Kyleena, Liletta, and Skyla are hormonal IUDs, while Paragard is hormone-free. Both hormonal and non-hormonal IUDs prevent pregnancy by damaging or killing sperm, making it more difficult for them to swim to and fertilize an egg.

Its important to note that IUDs dont protect against sexually transmitted infections (STIs), so you should still use condoms to protect yourself and your partner during intercourse.

Depending on the type you get, IUDs prevent pregnancy in one of two ways. The hormone-free Paragard IUD uses a small amount of copperapproximately 176 mg, per the FDAto weaken sperm by creating an inhospitable environment in your uterus that isnt sperm-friendly. Conversely, hormone-based Mirena, Kyleena, Liletta, and Skyla use progestin, an artificial hormone similar to progesterone, to thicken cervical mucus and even prevent ovulation, or the releasing of an egg from the ovary. Thicker mucus can block or trap sperm to prevent it from fertilizing an egg, and preventing ovulation means theres no egg to fertilize to begin with.

Though Paragard, Mirena, and Liletta start working right away, youll want to wait at least 24 hours before having sex or inserting objects, such as tampons or sex toys, into your body. The same applies with Skyla and Kyleena, which take one week to become fully effective, unless insertion happens during the week following your period. (So remember to use a backup method of birth control for those seven days.) The copper Paragard can also be used as emergency contraception and is 99% effective at preventing unwanted pregnancy if implanted up to five days after having unprotected sex.

The benefits of either type of IUD are that they are long-acting, reversible contraception and can be left in place for several years, says Dr. Carolyn Ross, MD, OB-GYN, and Stix medical advisor.

Credit: Reviewed / Getty Images / Lalocracio

Both non-hormonal and hormonal IUDs contribute to pregnancy prevention within the uterus.

Hormonal IUDs are smaller than the copper option, making insertion somewhat easier. Its typical to experience spotting for a few months after insertion, but after that, a hormonal IUD often makes periods lighter and less painful, and can even stop you from getting your period altogether, which could be beneficial for those who suffer from heavy, painful periods.

Like other methods of hormone-based birth control, hormonal IUD side effects may include acne, headaches, irregular bleeding, mood changes, and cramping. And because the progestin is localized to your uterus, any positive side effects, such as clearer skin or reduced unwanted hair growth, from previous birth control methods like the pill may subside.

If youve had negative experiences with the pill or other types of hormonal contraception, the appeal of a copper IUD is almost undeniable. Effective for 12 years, it lasts the longesta great bang for your pregnancy-prevention buck.

However, the extended protection might be overkill for anyone in the 40-plus crowd, and a progestin-emitting option may be more cost-effective for anyone (depending on your insurance), so chat with your OB-GYN about your family-planning options.

One of the biggest cons, though? Your monthly flow may be heavier and steadier. Copper IUDs can cause heavy periods and cramping, especially in the first six months. Though that typically improves with timeand periods may eventually end entirely while the IUD is in placethis can be a deal-breaker for new IUD users. If the intense side effects from a copper IUD dont subside after six months, call your doctor to talk about your options.

Yes, but the chances are extremely slimless than 1%, to be exact. And because its a set it and forget it method of birth control, theres no risk of using it incorrectlyno more having to set alarms to remember to take your birth control pill at the same time every day.

An IUD remains effective from three to 12 years, depending on the makeup or dose of hormone used. With an effectiveness of 12 years, Paragard lasts the longest, while Mirena and Liletta work for seven, Kyleena for five, and Skyla for three.

While even three years might seem like an eternity for anyone who suspects their desire to get pregnant may change, you dont need to leave yours in the entire time to make it worth your while. And your ability to conceive returns almost immediately with removal.

Depending on your insurance or lack thereof, the price of an IUD can range anywhere from $0 to $1,300, but usually there is no cost, thanks to the Affordable Care Acts birth control mandate. Most insurance plans cover all forms of birth control, including IUDs, but they may only cover certain brands, so check with your insurance provider to see what options are available. If you dont have insurance, you wont automatically pay over a grandvisiting a Title X clinic such as Planned Parenthood can help reduce the cost.

Credit: Reviewed / Getty Images / Uffoow

Normal sensations after IUD insertion are cramping, slight lower back pain, and even some light bleeding.

Unlike most other forms of birth control, you must get your IUD placed and removed at your doctors office. During the insertion, your doctor or nurse will use a speculum to open your cervix and place the IUD in your uterus. You may receive medicine to help soften your cervix and be advised to take over-the-counter painkillers like ibuprofen ahead of your appointment. The process usually takes less than five minutes, and patients typically report cramping during the procedure, the severity of which can vary from person to person, according to Dr. Ross.

If youre nervous about feeling lightheaded or dizzy after insertion, ask your partner or a trusted friend or family member to come with you so they may drive you home. Its normal to experience cramping throughout the day following an IUD insertiona good heating pad and some ibuprofen can help alleviate this.

After getting your IUD placed, youll be able to feel the strings poking out of your cervix into the top of your vagina with your fingers. Your doctor may recommend feeling forbut not pulling onthose strings once a month to make sure the IUD hasnt slipped or moved. This is a rare occurrence, but can happen during the first three months following insertion.

The removal process is significantly easier. Your doctor will use forceps to clasp and pull on the IUD strings. As the IUD comes up against the cervix, the arms of the T-shaped device will fold up, and the IUD will slide out through the cervix and vagina. Patients may experience spotting after getting an IUD removed, and it may take a few months for your period to return to normalbut because your ability to get pregnant can return immediately, be aware that youll need to use another form of birth control right away if youre not quite ready to conceive.

If you get pregnant with an IUD, youre at higher risk for having an ectopic pregnancy, in which the fertilized egg attaches outside of the uterus, typically in the fallopian tube. However, because IUDs are so effective at preventing pregnancy, those with IUDs are at less risk for this than those who are sexually active but dont use contraception.

Infection is possible from the insertion procedure, but rare. Its also possible your body will reject your IUD and expel itthis is why its important to check on those IUD strings to make sure they havent moved. Expulsion is more likely if youve never been pregnant, have heavy or prolonged periods, have previously expelled an IUD, are younger than 20, or had your IUD inserted immediately after childbirth.

Additionally, because the IUDs strings extend into the vagina, it can be risky to use most menstrual cups for period protection, as they can create a suction against the cervix, which could dislodge the IUD when the cup is removed. (Disc-style cups, like the Nixit, can be used instead, as they dont suction in place.) The strings can also make sex uncomfortable for your partner initially, as theyre stiff after insertion but soften over time. If that doesnt happen, schedule a follow-up visit with your doctor, who can trim the strings to make intercourse more comfortable.

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How does an IUD work and how long does it last? - Reviewed

When thinking about mens health, many people tend to think about heart disease or ailments that that affect men as they age, such as an enlarged prostate or prostate cancer.

But men can suffer from various health issues at any age. June is Mens Health Month and the focus is to encourage men to be proactive about healthy lifestyle choices and seek medical attention early.

When you look at men and their relationship with physicians, men dont go to the doctor enough. They wait until something is wrong, says Dr. David Thiel, a Mayo Clinic urologist.

The problem with waiting is that a man might be missing the early signs of another health issue. For example, erectile dysfunction is a common ailment that brings men to see their doctor. But Dr. Thiel notes that it may be the first indicator of a more serious health condition.

Its important for men to know, especially younger men who have erectile dysfunction, that this condition is often associated with other medical conditions such as heart disease, diabetes, blood pressure problems and the like. So erectile dysfunction may not just be erectile dysfunction, explains Dr. Thiel.

Women do a much better job of annual care for surveillance with things such as cervical cancer, breast cancer and so on. We want men to know its important for them to do the same. Its important to seek care not only when something is wrong, but also for preventive care.

While concerns about cancer bring many men to the doctor, heart attack, stroke, diabetes, and hypertension are much more prevalent in the population than prostate cancer, says Dr. Thiel.

Men should have a PSA, or prostate-specific antigen, check if not every year, every two to three years, to establish a baseline for evaluation of possibly clinically significant prostate cancer in the future. But, really, starting at age 40, men should have an annual physical, and have their blood pressure, cholesterol and blood sugar checked.

Based on age, family history and any symptoms, additional blood work to check hormone levels and a colonoscopy may be recommended. Due to rising rates of colon cancer, in 2021, the U.S. Preventive Services Task Force changed its recommendations to initiate colorectal cancer screening beginning at age 45 for both men and women.

Dr. Thiel also suggests an annual flu vaccine and making sure other immunizations are up to date.

Its important for men to look at the overall big picture of their health to ensure a longer, better quality of life, he says.

Being proactive about healthy lifestyle choices and seeking medical attention early can help men maintain their health.

Read the original here:
Men's Wellness: Being proactive, annual care key to maintaining health - LimaOhio.com

If you've experienced gender dysphoria the distressing feeling that occurs when your gender identity differs from the one you were assigned at birth you might have considered hormone-replacement therapy. Originally, HRT referred to the process of prescribing sex hormones like estrogen to people going through menopause as a way of treating symptoms such as hot flashes (a practice that has since been the subject of some controversy). But today, the term "HRT" is commonly used to describe "gender affirming hormone therapy" for "individuals who are seeking to alter their secondary sex characteristics for a more 'masculine' or more 'feminine' gender presentation," as defined by Folx, an online health and wellness provider for the LGBTQ+ community. At Folx and other gender-affirming-therapy providers, HRT involves using hormones like estrogen or testosterone to give the body a more traditionally feminine or masculine appearance to match one's gender identity.

While many trans and nonbinary people describe the medicine as life-saving, the process isn't for everyone, nor is it a requirement for trans and nonbinary people. "HRT does not make a trans person trans," stresses TikToker and professional actor Dylan Mulvaney, a trans woman who has been chronicling her self-described girlhood on the app. "If there is a trans person out there, and for whatever reason, they don't think HRT is right for them right now, or ever, we need to see them as such and respect their pronouns as such," Mulvaney adds.

The decision to start HRT is individual and can be complex. Sade Bolger, a Vermont-based activist and public-affairs organizer for Planned Parenthood, started HRT specifically testosterone therapy (or T) in May of 2017. But when he began, the decision was one of uncertainty. "When I did start T, I didn't really actually fully feel like I did know that for certain this is going to be the right thing," Bolger says. "I stepped into T in an explorative way, having seen other people who had gone through that process, and utilized it as a tool for self-discovery and self-exploration."

California-based Mulvaney echoes a similar sentiment: "The initial reason for going on HRT was just to sort of explore what that side to me was." Before beginning HRT, the actor had considered themself nonbinary for about 18 months. "But I always knew that I wanted to be more feminine," she says. "And even while I was nonbinary I knew that I loved the features on a woman, that I would love to have." Even so, she tells POPSUGAR, "I was so nervous to start [HRT] because it really is a huge decision to be potentially altering your body."

Josie Moon, another trans TikToker, also described her decision to start HRT as a tough one. Moon says she didn't know what the word "trans" meant until she was late into high school. The Nashville-based content creator got married at 24 years old, came out to her now-ex-wife as trans about two years into their marriage, and decided to get divorced just before the 2020 COVID lockdown. Through her own research, she discovered that some trans people don't take hormones. When making the choice for herself, she considered how it would affect her. "I was very concerned that even if I went on hormones at 29, it wasn't going to be enough for me to feel comfortable in my body," Moon tells POPSUGAR.

So she gathered more information, reading relevant threads on Reddit and Twitter and speaking to others in the trans community to make sure HRT was the right decision for her. "There's a subreddit called Trans timelines which shows pictures of mostly trans women but also trans men, really trans people in general before and after hormones," Moon says. "And I was like, wow, these people are the same age as me . . . and they look amazing. The results are amazing. So maybe this could work for me too." It had gotten to the point, Moon says, where she was constantly looking at these pictures and "imagining just feeling comfortable in my body and what that would look like." Now, two years on HRT, Moon is happy with her decision to start the therapy. So are Mulvaney and Bolger. "I look at myself in the mirror now and every day I get a little bit closer to finding myself to be a beautiful woman," Mulvaney says. "I think it was through the process of experiencing the changes that came alongside taking T that really kind of confirmed for me that this was what I wanted to do and who I wanted to be on the planet," says Bolger.

If you're still trying to figure out whether HRT is right for you, this explainer will help answer some of your questions, including what to ask your doctor, when to expect changes, and what side effects to be aware of.

Masculinizing or feminizing hormone therapy, also commonly referred to as hormone-replacement therapy or HRT, is a process used to "induce the physical changes in your body" caused by male or female hormones "to promote the matching of your gender identity and body (gender congruence)," per the Mayo Clinic.

Someone transitioning from male to female (MTF) would typically use feminizing hormone therapy and "be given medication to block the action of the hormone testosterone. You'll also be given the hormone estrogen to decrease testosterone production and induce feminine secondary sex characteristics," the Mayo Clinic states. In a female to male (FTM) transition with hormone therapy, "you'll be given the male hormone testosterone, which suppresses your menstrual cycles and decreases the production of estrogen from your ovaries."

The method in which those hormones are administered can vary, says Dave Usman, nurse practitioner at Radiant Health Centers, a California-based LGBTQIA+ Health and HIV care center. "It depends on the comfortability of the individual that's seeking hormone therapy," he says. For those receiving masculinizing HRT through testosterone, there are two options, Usman says. The most common route is injection. "It can be self-administered or office-administered," he says. There's also a topical gel option. For estrogen therapy, there's a pill, injectable, or patch.

Not every hospital or clinic provides gender-affirming healthcare. There are some instances in which medical providers can get exceptions, specifically hospitals and clinics with religious affiliations. It's important to do your research beforehand to ensure that you can get the care you need.

Bolger was referred to an endocrinologist after expressing to his therapist that he was considering HRT. Mulvaney recommends going to a queer health center in your area. "The great part is that they focus primarily on queer trans clients, so they are very in the know as far as treatment plans," she explains. Another good option? An informed-consent clinic, which means that a referral or therapy note is not required to receive care. (Planned Parenthood is an informed-consent clinic.) You can also receive hormone therapy online through services like Folx and Plume.

As far as cost goes, many insurance plans cover hormone therapy. For those who are uninsured or have trouble accessing hormone therapy, health centers like Radiant Health rely on contracted pharmacies that provide the medication at a low out-of-pocket cost for patients. Brands like Folx also offer an HRT care fund which distributes financial resources to an annual grant covering 12 months of hormone-replacement therapy, including prescription medication, unlimited clinical visits and messaging, and labs. Eighty percent of the Folx HRT grants are reserved for BIPOC. Eligibility starts at 18 years old, and you must live in a state where Folx is currently available.

"The first visit is mainly educating the patient, asking questions, and telling them what is expected," Usman says. "And then, once they have all the questions answered, they feel like they're ready, they're mentally and physically ready, that's when we start initiating therapy." That initiation point can be that day or weeks later. It's really about the patient's comfortability level.

Mulvaney first went to get information and ask questions about the process and then was prescribed spironolactone and estradiol. Spironolactone is a testosterone blocker and estradiol is a form of estrogen. "I went for the information, I got it, I got my mind put at ease. And then I started [the hormones] a few weeks later," Mulvaney says. She adds that she started out with a low dosage "because I was still new to it. I was nervous. I just didn't want to throw myself into it too fully quite yet."

One major conversation you should have with your provider, Mulvaney stresses, is about reproductive options, which will change during hormone therapy. Testosterone and estrogen therapy can lower your sperm count or egg production and may permanently change or stop your body's production of eggs and/or sperm altogether. So if someone is planning to undergo hormone therapy and they may want to conceive a child in the future, Usman says it's encouraged to do egg or sperm retrieval or freezing. "I actually didn't start the spironolactone until recently because I wanted to freeze my sperm first," Mulvaney says. "Being in my 20s, I just wanted to keep all my options open for the future and family planning because I don't know what that's going to look like when I'm older." But Bolger adds that not knowing what you want your reproductive options to be is OK, too. They started T when they were 19 years old. "I didn't know what I wanted to do reproduction wise I still don't. I'm 23 now, and I'm still figuring it out." But it's important that you know all of your options and make the decision that's best for you.

Everyone's timeline of changes is different, but Usman says you can start to see small physical changes as early as a month in.

"My first sort of notice was stretch marks on my booty," says Mulvaney. It was an unexpected surprise to her less than three months on HRT, in addition to a smoothing of her face and the loss of muscle mass in the chest. "I never had hard nipples before," Mulvaney says. "And now they are starting to bud."

For Bolger, the most notable initial changes were voice deepening, peach-fuzz hairs on the lip, and clitoral enlargement, which is commonly referred to as bottom growth. In terms of mood, Bolger says, "My libido pretty greatly increased and stayed kind of intense for the first couple of months into that first year." They also dealt with recurring mood swings. But this was predominantly "just during the period of time where my hormone balance was off because I was transitioning between estrogen and testosterone. And once I kind of plateaued with the T in my body, and that became the main hormone in my body, then all that stuff kind of settled out."

What's important to note is that the mental and emotional changes are just as important to address as the physical ones, and they may hit you sooner. "The first two weeks, I'm not gonna lie, were tough. I didn't feel like myself in some ways. My mind was foggy, I felt very emotional, I had some anxiety," says Mulvaney. These changes ultimately went away, or Mulvaney became accustomed to them. "I think my body learned to accept that this was the new normal and I started to feel like myself again," she says.

Therapy also helped, she adds. "I'm in therapy once a week and I have been with the same therapist for two years, it's changed my whole life and outlook on things." With HRT, you're seeing a doctor every three months or so for check-ins. "But you also need to have a support system in place that can help you with the day-to-day, because it can get pretty overwhelming," says Mulvaney.

Moon agrees that at times, the emotional aspects of HRT can become overwhelming. "When I was younger, I used to say I had three emotions angry, happy, neutral and that was just how it was," says Moon. But in starting HRT, she unlocked a new range of emotions with various depths and layers. "Angry is actually, 'I'm a little bit hungry, but I feel hurt and misunderstood and just sad in general.' And then when I was happy, I'm not just happy or euphoric, it's like, 'I'm excited about this and there's a little bit of joy about this.'" The whole process is "also a little bit bittersweet, because in transitioning, I get to be myself, but I also lost so, so much and had to rebuild," Moon says. "I think emotionally, it took me off guard."

One change that Bolger says he was the most unprepared for is the way others perceive him. "I absolutely took on male privilege," he says. "I noticed that I was being treated differently. The men in the room would shake my hand before they left. I was listened to more. There was more of a platform in a space, people kind of waited for me to have something to say." Emotionally, Bolger says it was "so weird." Because they don't identify as a man, "it was like switching from feeling misgendered on one side to feeling misgendered on the other side." He also says the transition between living the first 18 years experiencing sexism against women only then to be welcomed and respected by sexist men was "not ever in my intentions." There's this layer of complexity for nonbinary individuals, Bolger says, because T or no T, "we live in a society where people assume that you're either a man or a woman."

Another unexpected change? Anecdotally, many people on T have said that it changes their sexual attraction, especially as it pertains to men. Bolger says that being on T hasn't necessarily changed his attraction level to men but rather his comfortability level being with a man. "I felt really uncomfortable being with men, for example, when I was younger, because I knew that that would make people see me as a girl," Bolger says. Being on T changed the way people perceived them and how Bolger perceived himself. Ultimately, "T didn't make me stop loving women. T didn't make me start loving men. T didn't change anything about who I loved or who I f*cked. It changed my comfort, being in those relationships and having those experiences because of how I was feeling and perceiving myself."

Yes. "That's why we screen people initially for their past medical history and family history, because both [hormones] have side effects and adverse effects that can affect their overall health," says Usman. Hormone therapy can aggravate pre-existing depression and anxiety. Other complications include developing diabetes, high cholesterol, high blood pressure, and blood clots. If you're a chronic smoker in particular and you're on estrogen, "there's higher risk of developing blood clots," Usman says. So be sure to be honest about all of your lifestyle habits within that first meeting so that your provider can assess your needs and design a hormone-therapy plan that works best for you.

Bolger, for example, is neurodivergent. "I have ADHD. I sometimes struggle with routine, like hygiene care, because of that," Bolger says, and talking to his provider about that openly was "really important" in figuring out which form of T was right for them. For example, the topical gel has to be applied once a day. "It has to be a part of your routine and for me with my ADHD, that wasn't something that I really thought was going to be plausible," Bolger says. So he went with the weekly injections instead. Even so, Bolger experienced health complications, including ovarian cysts, which were caused by going off schedule on T, a diversion caused by his ADHD. That's why Bolger emphasizes the importance of seeking out a provider who can assess and treat your whole self someone who will be looking our for your mental, physical, and emotional health not just you as a trans person, but you as a whole human, too.

Image Source: Getty Images

Originally posted here:
Hormone-Replacement Therapy Is Life-Changing: What to Consider Before Getting Started - POPSUGAR

Ascendis Pharma

Late-breaker oral presentation of TransCon PTH Phase 3 PaTHway Trial data in adult hypoparathyroidism on Tuesday, June 14

Oral presentation of TransCon PTH Phase 2 PaTH Forward Trial Open-Label Extension Data in adult hypoparathyroidism on Monday, June 13

PaTHway Trial results represent the second consecutive successful pivotal Phase 3 trial of a TransCon product candidate

COPENHAGEN, Denmark, June 07, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that its presentations at ENDO 2022 will include oral presentations of Phase 2 and Phase 3 data for its investigational product candidate TransCon PTH in adult hypoparathyroidism (HP). During the meeting, which will be held in-person and virtually June 11-14 in Atlanta, Dr. Aliya Khan, M.D., Clinical Professor of Medicine at McMaster University and Director of the Calcium Disorders Clinic at McMaster University Medical Center, will give a late-breaker oral presentation of Phase 3 PaTHway Trial data for TransCon PTH in adult HP.

This is the first Phase 3 trial in adult hypoparathyroidism in which the majority of treated patients achieved real control of their disease that is, normalization of serum calcium, independence from conventional therapy, and a more normal patient-reported quality of life, said Dr. Khan. Additionally, TransCon PTH was generally well-tolerated with no discontinuations related to study drug, and TransCon PTH-treated patients showed a mean decrease in 24-hour urine calcium excretion into the normal range. I am hopeful that, with these encouraging results, we are closer to changing the treatment paradigm for patients living with this under-recognized and often debilitating disease.

An additional Ascendis oral presentation at ENDO 2022 will include a review of Phase 2 TransCon PTH long-term data by Dr. Bart Clarke, Professor of Endocrinology at Mayo Clinic, showing durable benefit for adult hypoparathyroidism patients treated with TransCon PTH through Week 84 of the Pathway Trial. Additionally, Ascendis posters will present new data showing the continued safety and efficacy of once-weekly TransCon hGH in children with growth hormone deficiency treated for 2.5 years in the EnliGHten Trial, and, for adults with growth hormone deficiency, new research showing low treatment rates, increased medical risks, and higher healthcare costs.

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Ascendis will also host a Medical Affairs booth (#1515) at ENDO 2022, as well as a separate booth (#1415) and events showcasing SKYTROFA (lonapegsomatropin-tcgd), the companys once-weekly treatment for pediatric growth hormone deficiency.

ENDO is one of the largest endocrine health symposiums, and we are especially pleased this year to be providing a comprehensive review of data from our second consecutive successful Phase 3 trial, said Jan Mikkelsen, Ascendis Pharmas President and Chief Executive Officer. Ascendis is deeply committed to developing products that deliver value for patients, payers and society, and we are honored to be able to partner with patients, physicians, and other specialists in our work to advance understanding and treatment of rare endocrine diseases.

Ascendis Pharma presentations and educational sessions at ENDO 2022 will include:

Hypoparathyroidism

Tuesday, June 149:45 11:15am

Late-BreakerPhase 3 PaTHway Trial: Participants Treated with TransCon PTH Achieved Independence from Conventional Therapy While Maintaining Normal Serum CalciumPresented by: Aliya Khan, M.D.

Monday, June 1311:30am 1:00pm

Oral PresentationThe PaTH Forward Trial: Efficacy and Safety of TransCon PTH Through Week 84 for Adults with HypoparathyroidismPresented by: Bart Clarke, M.D.

Saturday, June 111:00 2:00pmProduct Theater #2

EducationManaging Patients with Hypoparathyroidism: A Healthcare Professional and Patient PartnershipSpeaker: John P. Bilezikian, M.D.

Growth Hormone Deficiency

Monday, June 1312:30 2:30pmOn-site and on-demand for virtual attendees

Rapid Fire e-PosterSafety and Efficacy of Treatment with Lonapegsomatropin in Children with Growth Hormone Deficiency at Week 130 in the EnliGHten TrialPresented by: Paul Saenger, M.D.

On-site and on-demand for virtual attendees

Poster PlusEconomic Burden of Growth Hormone Deficiency in a U.S. Adult PopulationAuthored by: Alden Smith, Janna Manjelievskaia, et al

Saturday, June 1110:15 11:15amProduct Theater #3

EducationSKYTROFA (Lonapegsomatropin-tcgd): The First FDA-Approved Once-Weekly Treatment for Pediatric Growth Hormone DeficiencySpeaker: Aristides Maniatis, M.D.

About Ascendis Pharma A/SAscendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients lives. Guided by its core values of patients, science and passion, the company uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Heidelberg and Berlin, Germany; Palo Alto and Redwood City, California; and Princeton, New Jersey. Please visit http://www.ascendispharma.com to learn more.

Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis expectations regarding the potential for TransCon PTH to be a replacement therapy for adult hypoparathyroidism, (ii) Ascendis ability to apply its platform technology to build a leading, fully integrated biopharma company, and (iii) Ascendis use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers and distributors to supply TransCon hGH, the SKYTROFA Auto-Injector and other study drug for commercial sales in the U.S. and clinical studies; unforeseen safety or efficacy results in its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to commercialization of lonapegsomatropin-tcgd in the U.S., the co-pay program, and the further development of TransCon hGH, expenses related to the development and potential commercialization of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs, selling, general and administrative expenses, other research and development expenses and Ascendis business generally; delays in the development of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; Ascendis ability to obtain additional funding, if needed, to support its business activities and the effects on its business from the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis business in general, see Ascendis Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on March 2, 2022 and Ascendis other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, and SKYTROFA are trademarks owned by the Ascendis Pharma Group. June 2022 Ascendis Pharma A/S.

Read more:
Ascendis Pharma A/S Announces Two Oral Presentations Highlighting the Potential for TransCon PTH to be a Replacement Therapy for Adult...

Its probably not an exaggeration to say that every woman on the planet has, at one point or another, heard someone say, Oh, its probably just your hormones. People seem to be inclined to blame just about everything from headaches to hot flashes and all kinds of conditions in between on good old hormones.

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Sometimes itisyour hormones, though. Andhormonal imbalancescan mean more for your health than just a grumpy day or a few zits before your period. So, how can you tell when its hormones and when its something else?

Womens health specialistPelin Batur, MD, talks about a few types of hormonal imbalances commonly seen in women, including symptoms you shouldnt ignore and when to see a medical professional.

To decide whether you need hormone testing (and if so, what kind), your doctor will likely start by asking you lots of questions about your symptoms. This will help them put together the puzzle pieces of what might be going on.

The workflow in my head focuses on three questions, Dr. Batur says. First, do these symptoms sound hormonal? If so, do they sound like theyre related to estrogen, progesterone, testosterone or some other type of hormone? And finally, is it because theyre too low or too high?

Once your doctor has a sense of what might be happening, theyll figure out which tests to (or not to) run.

One symptom that indicates that you may need testing is irregular periods.

If youre having regular menstrual cycles and not having symptoms throughout the month, I dont usually start with lots of estrogen, progesterone or testosterone tests, Dr. Batur says. But if youre experiencing a lot of irregularities in your cycle, Im likely to do more testing.

We have at least 50 different hormones in our body, and very complex symptoms can arise from them, Dr. Batur says. Having too much or too little of certain hormones causes symptoms and issues with your health.

Here are some of the most common hormonal imbalances seen in people assigned female at birth (AFAB).

There are less-common hormonal imbalances, too, likeCushings syndromeandAddisons disease. Only a doctor can help identify which hormonal imbalance youre experiencing and what course of treatment is best.

Heres the thing: Hormonal imbalances can have a lot of symptoms and they can have a lot ofdifferentsymptoms, depending on which ones are at the root of your issues. Those symptoms may seem muddled or initially unrelated, and theyre not always related to hormones at all.

Hormones can cause so many symptoms, but that doesnt mean theyre always the cause of your symptoms, Dr. Batur says, so its really important to be seen by a doctor for an individualized assessment.

Here are some common symptoms of hormonal imbalances in women and what theymight signify.

Weird periods are a key sign of a hormonal imbalance.Irregular menstruationcan be a sign of perimenopause but can have a number of other causes, too, especially if youre not yet nearing menopausal age.

If your menstrual cycles are disrupted or if youre going through menopause, you should definitely come in to be seen and to talk things out, Dr. Batur advises.

If a woman comes in complaining of acne, Im concerned about potentially high levels of hormones such as testosterone, Dr. Batur says. We see this in women withpolycystic ovary syndrome. PCOS causes higher levels of male hormones called androgens (including testosterone), which can lead to acne.

If you start to notice differences in your hair whether on your head, face or someplace else, like your arms and legs it could be a sign of a hormone imbalance.

Starting to see chin hairs or a bit of a mustache? Increased testosterone can cause excess hair growth (hirsutism). This can be a symptom of PCOS or menopause, but it has other causes, too.

On the flip side, hormonal imbalances can also cause thinning hair on your head, legs and pubic region.During menopause, a drop in estrogen can lead to slower hair growth, or cause it to fall out more easily.Hypothyroidism and hyperthyroidism can cause hair loss, too. Or your hair loss may be related to something else entirely something nonhormonal.

It can be really complex to figure out, Dr. Batur says. You might assume hair loss is hormonal, but it can be related to high or low thyroid level, low estrogen, high testosterone or something else, like vitamin deficiency or lifestyle stressors.

These symptoms usually indicate that a womans hormones are lower, like the kind of dropping estrogen levels we see in perimenopause or postmenopause, Dr. Batur says. They can alsobe a side effect of some medications and treatments.

Your doctor can help you find ways tomanage your hot flashesso they dont negatively affect your quality of life.

Weight gain can be a symptom of a variety of hormonal imbalances, as well as lifestyle-related factors, so doctors use other clues about your health to get a sense of whats going on.

Difficulty losing weight is a very common problem in the United States, and its often blamed on hormones, Dr. Batur says. Sometimes, its related to high testosterone levels, like with PCOS, and menopause is associated with weight gain, too. But if you have weight gain with regular menstrual cycles, its more likely to be related to something likecortisol, thyroid, insulin or lifestyle habits.

Havent changed your lifestyle habits but have suddenly dropped 15 lbs.? This symptom is often a sign of an overactive thyroid, orhyperthyroidism. When your body produces too much thyroid hormone, your metabolism speeds up, which can cause weight loss along with rapid heartbeat, an intolerance to heat and other symptoms.

Althoughvaginal drynesscan be a sign of a few issues, its one of the most common symptoms of menopause. Your estrogen levels drop during menopause, which can to lead vaginal dryness that causesdiscomfort during sex.

The vagina is quite sensitive to lack of estrogen, Dr. Batur says. About 50% of women have vaginal dryness that may get in the way of intercourse, and it tends to get worse over time.

While its important to advocate for your health, try not to be swayed by broad, overarching claims (looking at you, social media) that insist thateveryoneneeds hormone testing or that every symptom youre experiencing is related to your hormones.

Just because youre experiencing symptoms of a hormonal imbalance doesntmean you haveahormonal imbalance. Nearly every symptom of a hormonal imbalance can have other causes, as well.

Its important to not lump everything together under hormones, and to instead break down each symptom individually, Dr. Batur advises. We have to take a deep dive to make sure were not missing anything, whether its lifestyle factors or another medical condition.

More here:
Do You Need Hormone Testing? - Health Essentials from Cleveland Clinic

Adults with obesity who undergo bariatric surgery to lose weight may roughly halve their risk of dying of cancer, a new study suggests.

For the study, researchers compared the risk of cancer diagnosis and death for more than 30,000 people with obesity, including more than 5,000 individuals who had bariatric surgery. Surgery was associated with a 32 percent lower risk of cancer and a 48 percent decreased chance of cancer-related death.

Patients can lose 20 to 40 percent of their body weight after surgery, and weight loss can be sustained over decades, said the lead study author,Ali Aminian, MD, the director of the Bariatric & Metabolic Institute at the Cleveland Clinic in Ohio, in a statement.

The striking findings of this study indicate that the greater the weight loss, the lower the risk of cancer, Dr. Aminian said.

About two in five American adults have obesity, according to the Centers for Disease Control and Prevention (CDC). And obesity increases the risk of 13 types of cancer that together account for 40 percent of all tumors diagnosed each year in the United States, according to the CDC.

In the study, those who underwent bariatric surgery lost an average of 25.5 kilograms (kg) (61 pounds [lb]) after 10 years of follow-up, compared with 2.7 kg (6 lb) without these operations.

Surgery was associated with a significantly lower risk of obesity-related cancers, including malignancies of the breast, ovaries, uterine lining, colon, liver, pancreas, and thyroid. Overall, 2.9 percent of people who had weight loss surgery developed these tumors, compared with 4.9 percent of those who didnt have operations.

Bariatric surgery was also tied to a significantly lower risk of diagnosis and death from all cancers, including tumors unrelated to obesity, the researchers reported June 3 in JAMA. After a decade, 0.8 percent of patients who had surgery died of cancer, compared with 1.4 percent in the nonsurgical group.

One limitation of the study is that the majority of the participants were female and white, so it's possible the results might be different for men and individuals of other racial and ethnic groups.

The study also wasnt a controlled experiment designed to prove whether or how weight loss surgery might directly reduce cancer risk.

Its possible that excess weight accelerates tumor growth because it causes inflammation, impairs the bodys ability to use the hormone insulin to turn sugars from food into energy, and increases the production of sex hormones that play a role in the growth of some cancers, the study team writes.

But its also possible that people who underwent surgery were healthier in other ways that helped prevent cancer, the researchers noted. They might have had healthier diets, exercised more, or been less likely to smoke than people who didnt have bariatric procedures, for example.

Original post:
Weight Loss Surgery Tied to Lower Risk of Obesity-Related Cancers - Everyday Health

Cancer impacts people all over the world. Experts are constantly evaluating how different treatments can eliminate or slow the spread of cancer

Each type of cancer is different, leading to the development of various treatment and detection methods.

A recent study that appears in The Lancet found that a specific combined treatment therapy may improve the survival rate for men with prostate cancer.

Prostate cancer is one of the most common types of cancer among men. As noted by the Centers for Disease Control and Prevention (CDC), in 2018, there were over 210,000 new cases of prostate cancer, and almost 31,500 of those with prostate cancer died of it.

As noted by the American Cancer Society, a few different methods can help detect prostate cancer. One is to do a prostate-specific antigen (PSA) blood test.

If the PSA level is higher than a specific reference point, it can indicate prostate cancer. However, there are other reasons for the PSA level to be high, so this is not a definitive diagnostic tool.

Doctors can also do a digital rectal exam to feel the prostate and note abnormal lumps. To confirm the findings of an elevated PSA or an abnormal digital rectal exam, doctors will order a biopsy of the prostate. If this confirms the presence of prostate cancer, treatment can begin.

Treatment for prostate cancer may include one or several options, such as surgery, radiation, cryotherapy, hormone therapy, immunotherapy, and chemotherapy. Researchers are still working to improve the treatment options and survival rate for people with prostate cancer.

The study in The Lancet was a randomized controlled trial. Researchers divided men with prostate cancer into three distinct treatment groups.

The study included participants that had previously had to have their prostate removed and had a certain PSA level after prostate removal. A total of 1,792 participants enrolled in the study.

Researchers sought to discover if using a specific, combined treatment method increased survival rates and decreased severe cancer progression.

They used the label freedom from progression. The three treatment groups included the three different treatment methods:

The study found that freedom from progression after 5 years was highest for those in group 3. In group 1, almost 71% of the group had freedom from progression. In group 3, the percentage was 87.4%.

These results indicate that adding short-term androgen deprivation therapy and pelvic lymph node radiotherapy to salvage prostate bed radiotherapy can help to improve survival rates among those with prostate cancer.

Study author Dr. Alan Pollack noted the following highlights to Medical News Today:

This is the first randomized study to demonstrate the incremental benefit of adding pelvic lymph node treatment to androgen deprivation therapy and standard prostate bed treatment. This is a three-arm study designed to test the intensification of treatment from standard of care prostate bed RT (PBRT), PBRT plus short term androgen deprivation therapy (STADT), and PBRT plus STADT plus pelvic lymph node treatment (PLNRT). The primary endpoint was 5-year freedom from progression [and the study] showed that overall there were incremental gains with the addition of ADT and then further gains with PLNRT.

The study authors do note that using this combined treatment method is not without risks. They point out that it could increase the risk for certain bone marrow problems. They also note that a longer follow-up time would be necessary to confirm the full effectiveness of the treatment.

Dr. Kelvin Moses, director of the Comprehensive Prostate Cancer Clinic at Vanderbilt University Medical Center, who was not involved in this study, agreed that more follow-up research is needed, but said that the results so far are promising.

He explained for MNT that [t]his study reinforces the importance of control of the pelvic lymph nodes either at the time of surgery, or in the setting of post-prostatectomy recurrence.

He added that [i]t remains to be seen if the progression benefit translates to a reduction in metastasis or death from prostate cancer, but these results are promising and can change the paradigm for treatment of biochemical recurrence.

The study authors further note that, as imaging of the prostate improves, it will impact how this treatment method is applied. But the research provides overall encouraging results that survival rates can improve for those with prostate cancer with the right kind of treatment.

Dr. Hayley Whitaker, a cancer expert at the University College of London, who was not involved in this study, was enthusiastic regarding its results:

There are several ways to treat patients with prostate cancer, but the order that different treatments are used or combining different treatments offers huge potential to prolong [the] life of men by many years.

According to her, [t]his is groundbreaking research that has the potential to make a real impact on men being treated for prostate cancer by making significant advances in combining surgery, radiotherapy, and hormone treatments.

More here:
Prostate cancer: Combination therapy shows high success rate - Medical News Today

Photo-Illustration: Josiah Whitfield; Photos: Getty

When Michelle went in for an egg-freezing consultation at a Sacramento, California, fertility clinic in February 2021, she was, in most ways, the typical egg-freezing patient. She was 36, a college-educated professional, and had spent much of her 20s and 30s focusing on her career and traveling to more than four dozen countries. Like the majority of women who seek out elective egg freezing, she was single and thought it would lighten the anxiety she felt while dating. So that its not like, Hi, okay, when do you wanna have a baby, you know? she says.

Nine months later, after a five-month recovery from ankle surgery, Michelle was ready to start the process, which entails hormone injections to stimulate egg-follicle growth; regular monitoring; and a short, 15- to 30-minute egg retrieval, during which a needle guided by ultrasound is used to gently suction out the eggs from their follicle sacs. The procedure is done underanesthesia, and after a few hours rest, patients can go home (clinics recommend doing so while accompanied by a friend or family member, to be safe). In the interim, she also had her hormone levels measured and learned that her anti-Mllerian hormone (AMH) level was lower than average for her age, a possible sign that her ovarian reserve was depleted. She was anxious to get going.

After a few false starts on the first two attempts at getting an appointment, communication and scheduling mishaps pushed her start date back by a month each time the busy clinic finally slotted her in for March, and called her back to the clinic in January to update her vitals. But just as she was gearing up to begin, she hit an unexpected roadblock. A few lines into a longemail from the nurse coordinatorin which she instructed Michelle on which vitamins and supplements to take, discussed the timing of the cycle, and counseled her to abstain from unprotected sex during the course of treatment, lay an unexpected ask: Dr. Lovely wants you to loose [sic] 9 more lbs before you can proceed with the treatment, we would like you under 262 lbs.

Michelle pushed the nurse for more information. She felt healthy and strong: She works out three to five times a week, eats nutritious food, and is a longtime member of a competitive traveling roller-derby team. The nurse pointed her to a practice bulletin from the American College of Obstetricians and Gynecologists on the management of obesity during pregnancy, of which only the abstract is visible without a subscription. The nurse also cited the bed-weight capacity in the clinics operating rooms, which Michelle found dubious (standard hospital beds support between 350 and 450 pounds.)

Put bluntly, Michelle was told she was too fat to continue.

Egg freezing today is sold as an empowering option for everyone. Fertility clinics and egg-freezing studios hammer this message home through social-media advertising aimed at under-40 women, promotional vans offering free fertility tests to passersby on the street, and wine-and-cheese informational nights held at clinics and egg-freezing studios across the country. But when it comes to women in larger bodies, some clinics draw the line, turning away patients over a certain body mass index, or BMI. Although there is no national data kept on this phenomenon, an estimated 11.7 percent of American women are considered severely obese, with a body mass index of 40 or higher.

There is little, if any, research evidence on egg freezing and weight. The vast majority of studies examine BMI and in vitro fertilization, and results from these are mixed. Some have linked overweight and obesity with fewer eggs retrieved and lower rates of pregnancy and live births, while others find no impact of a high BMI on IVF outcomes. Dr. Nicole Noyes, a reproductive endocrinologist who has published extensively on egg freezing and helped establish the egg-freezing program at NYU Langone Fertility Center, notes that higher BMIs are linked to more health risks in general. For egg freezing in particular, she cites risks such as those related to anesthesia; increased difficulty in performing the egg-retrieval procedure because of technical issues (such as suboptimal visualization on the ultrasound machine due to fatty tissue, which increases the risk of inadvertently piercing adjacent pelvic structures and causing internal bleeding); and a still rare but greater likelihood of needing surgery such as laparoscopy in case of complications.These risks combine with the potential for lower egg quality in obese women, something Noyes suspects may be due to theinfluence of an abnormal hormonal environment surrounding the developing egg, although she admits there is no known explanation for this.

The messaging is that this is the responsible thing to do, the thing that they should be doing to preserve their fertility, says Nicola Salmon, a U.K.-based fertility coach who specializes in working with larger patients. Salmon, whose job includes assuring her clients that they are worthy of care, engaging with clinicians and presenting them with research and evidence on caring for larger bodies, and screening clinics to ensure theyll provide sensitive and individualized care, is currently working with an egg-freezing patient in Texas. Salmons client, like Michelle, is ready to begin the egg-freezing process. But, by Salmons estimates, theyve reached out to at least eight or nine fertility clinics in the Texas areaabout their BMI guidelines, and none will work with them, typically citing BMI cutoffs of 40 (her clients BMI is 42). This has been a real blow to their body confidence, to how they feel in their body, Salmon says, because they feel that this option this thing that should be available to everybody has been taken away from them.

In general, complications from egg freezing for larger-bodied patients are rare: Noyes estimates she has done at least 20,000 egg retrievals in her 30-year career, and had fewer than ten bleeding-complication cases, none of which were in overweight or obese patients. In some cases, she has performed egg retrievals on larger-bodied women without anesthesia, either because the patient exceeded the anesthesiologists threshold for providing anesthesia or in order to avoid anesthesia risks. (She likens the procedure without anesthesia to having blood drawn; the puncture of the needle through the vaginal wall hurts, but most patients do well if they are prepared for that moment.) Ultimately, she says, medicine is about weighing risk versus benefits, and when risks creep up and the benefits are potentially lower, doctors ask themselves, Is the outcome worth it?

Dr. Lynn Westphal, chief medical officer at Kindbody, a national chain of fertility and womens healthcare clinics, suggests a simpler reason many freestanding fertility clinics are only accredited to perform anesthesia on patients classified by the American Society of Anesthesiologists as having a risk score of I (a normal healthy patient) or II (a patient with mild systemic disease). People with BMIs between 30 and 40 are considered obese and fall into category II; those with BMIs over 40 are considered morbidly obese and have a risk score of III. This is why, Westphal explains, anesthesiologists at manyclinics use 40 as the cutoff for who they can and cant treat. Fertility clinics based in hospitals, which have different accreditation, have more leeway to treat a broader range of patients. For example, they are able to intubate patients if there is any airway problem, Westphal says, which is something that should not be done in a procedure room.

Michelle wasnt told any of this. Instead, the nurse suggested a change in diet for weight loss, without knowing anything about what Michelle currently eats, a clear sign, Michelle says, that this person has assumptions because of your size.

The weight loss itself didnt trouble her as much as the lack of context or at least context she found plausible for their request. Nine pounds on a large body is not a lot. I could lose nine pounds overnight if I wanted to, she says. I wasnt concerned about the amount of pounds; I was more concerned about the way they talked to me about it without any kind of explanation. She eventually got so fed up with the nurses communications that she stopped responding. By then, shed lost three months (most of December, January, and February) to their unhelpful back-and-forth. Because this process had already taken so long, it was a big risk for me to completely let go of this group that I had already worked with, Id already paid the consult for. Id have to do all of that again, she says.

This is what advocates for body-positive fertility care say is really at issue here: stigma. Jen McLellan, a childbirth educator who blogs at PlusSizeBirth.com, notes that many of the same risk factors doctors cite for high BMI are also present in women of advanced maternal age (35 and older), yet that patient population is targeted for fertility care all the time. Similarly, people with normal or low BMIs may be poor egg-freezing candidates for other reasons. Instead of using a single number as a cutoff, she advocates for evaluating patients on an individualized basis, especially in facilities that are equipped to handle patients with higher ASA scores. To make these blanket statements, when we dont have evidence to point to dramatic increased risks, to me points to a lot of weight bias, says McLellan.

Furthermore, weight stigma, and the stress experienced by people of size during their encounters with the medical system and in the world more generally, can also create unhealthy physical reactions, such as higher stress and cortisol levels, which in turn affect hormones and inflammation. Anyone who is in a bigger body that has been to their doctor, they will tell you how stressful that situation is, Salmon says. When you look at the research around weight stigma, a lot of health-care risks associated with being fat can be explained by this weight-stigma phenomenon.

Candace, a freelance web developer in San Diego, had been hoping to do IVF in Mexico, where the procedure is less expensive than in the U.S. The clinics she called, though, all had BMI limits lower than her BMI of 44. (She recalls the cap being around 35.) She called local clinics in Southern California, and eventually went in for a consultation at one for a 20-minute appointment that cost $195. The doctor took one look at her, she says, and told her she was a poor candidate for IVF. Instead he recommended she get weight-loss surgery. When she suggested freezing eggs to buy her some time to lose weight before carrying a pregnancy, he said her eggs would probably be poor quality and doing it would be a waste of money. He spent the remainder of their consult talking nonstop about her weight. Candace had brought a notebook filled with questions she had written down that she opened up at the beginning of the consultation. Once she realized she wasnt going to get any of the answers she hoped for, she closed it and resigned herself to enduring the rest of his lecture. Like Michelle, she left that appointment out her consultation fee and no closer to getting her eggs frozen.

Im receptive, because I am trying to lose weight, says Candace. It was just how it was presented to go to a fertility appointment and spend so much time on my weight. Certain people, you can just see their bias. It was less about what he said; he was being professional. It was how he was saying it.

The advice to come back after losing weight is particularly vexing for patients who feel the clock is ticking on their fertility. Especially if youre older, delaying treatment in order to lose weight is going to lower your chance of success because of the delay, says Dr. Peter Klatsky, a reproductive endocrinologist at Spring Fertility, which has locations in California, New York City, and Vancouver. At Spring Fertility, patients with BMIs over 40 may need an additional anesthesia consultation, and at 45 or over, will require the approval of a physician review committee to ensure the patients safety during the procedure. This is because it becomes harder to protect and maintain a patients airway under anesthesia, and there may be other medical risks like diabetes and cardiovascular disease that must be assessed before undergoing anesthesia, adds Klatsky.

For Beth, a 35-year-old attorney in New York City who asked that her real name not be used, weight loss had been on the agenda since she was in her 20s. She had always had irregular periods, and a series of ob-gyns told her that losing weight could help regulate her cycle. When she reached her early 30s, it occurred to her that her irregular cycle could affect her ability to get pregnant, so in the fall of 2020 she arranged to see an ob-gyn at New York University who specializes in fertility. The doctor confirmed she had polycystic ovary syndrome (PCOS), which is linked to irregular periods and weight gain. The conversation got her thinking that times a-ticking, especially because one complication of PCOS is infertility. We need to start taking a little bit of ownership here, she told herself. But when she asked about egg freezing, thats when the BMI thing became an issue. She doesnt remember what the BMI limit was, but it was far below her BMI at the time (NYU Langone Fertility Center confirmed to the Cut that 42 is the cutoff, citing anesthesia guidelines). She called around to other clinics an additional one in New York, one in Miami, one in Connecticut, and one in Utah, and was told the same thing. The first time I heard it, I dismissed it, because, like, the lawyer-asshole in me didnt really believe it. I was like, oh, its just what they said, Beth recalls. The second time I heard it, my heart definitely sank.

Beth wishes someone had warned her earlier on that her weight might be a barrier to accessing care. Its kind of the fourth quarter here, or the end of the third. To find out that theres this huge obstacle now had I known this at 30, I could have made different changes or choices, she says. But to find out now that theres a years worth of self-work that I have to do before I can even get to the plate to talk about egg quality, to even get to the plate to talk about fertility, I think thats what frustrated me. I wasnt depressed. I was mad.

Now Beth is focusing on losing weight in a healthy, sustainable way. She has stopped eating as much takeout and is snacking less often, and has dropped about 50 pounds since August. But it hasnt been an enjoyable process. I eat a ton of vegetables and bad-tasting food, she says. Im always a little bit hungry. She is giving herself until the end of this year to lose more weight, and will revisit the egg-freezing process then.

The question of whether to lose weight is itself a tricky one. Salmon notes that if losing weight were easy, many larger patients would have already done so. Going on crash diets by, say, cutting out entire food groups, is also unhealthy and may lead to poor fertility outcomes, she adds.

After her discouraging experience with the Sacramento clinic, Michelle had a lucky break. Her sister, who is also of size, referred her to Dr. Geoffrey Sher, a fertility specialist in New York, with whom shed undergone IVF (and who had never mentioned her weight during treatment). Michelle traveled to New York for the retrieval in March. At the recommendation of Sher, she chose to have the eggs fertilized with donor sperm, since frozen embryos are believed to survive the freezing and thawing process better than eggs. Although she is relieved to have two embryos frozen, when she looks back at her experience with the first clinic, Im like, Oh, yeah, that was wrong like, everything about the way that they interacted with me was wrong, she says. She worries that the bias and obstacles she encountered might discourage other larger patients altogether. What if they never get the memo that there might be better, more responsive care options out there?

If I didnt have my sister encouraging me I think some people would just let it go, says Michelle. They would just let it go because they couldnt lose the amount of weight that they were asked to, or they would let it go because they were like, I wasnt anticipating being fat-shamed today, and I dont want to deal with this.

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Behind BMI Limits in Egg-Freezing Procedures - The Cut

The average height for an adult man in the United Kingdom is 59. Meanwhile, the average height for a woman is 53. For some, heigh can make all the difference, be it in attraction or health. New research suggests taller individuals are at greater risk than others of developing a range of conditions.

Research conducted by the Mountain Regional VA Medical Centre into the impact of height on health found the taller someone is the greater their risk of peripheral neuropathy, skin infections, and bone infections.

However, they also found taller people had a reduced risk of heart disease, high blood pressure, and high cholesterol.

As a result of their analysis they concluded that height may be an unrecognised but biologically plausible risk factor for several common conditions in adults.

Their findings are published in the journal PLOS Genetics.

READ MORE:Cancer symptoms: Sudden dislike of one drink could signal cancer

While their findings are new, this isnt the first-time height has been associated with several common conditions.

In the past height has also been linked to cancer risk.

What scientists have struggled with is if someones height is what puts someone at risk or whether nutrition and socioeconomic status are more significant driving factors.

To reach to their conclusion, they used data from the VA Million Veteran Programme containing data of more than 200,000 white adults and over 50,000 black adults.

DONT MISS

Alongside confirming the findings of previous small-scale studies linking increased height to a raised risk of atrial fibrillation, they also uncovered new links.

They found taller people are at a greater risk of peripheral neuropathy, a condition where nerves in the bodys extremities become damaged.

While they believe height is an unrecognised risk factor they say more studies are needed.

Lead researcher Sridharan Ragharan added: We found evidence adult height may impact over 100 clinical traits, including several conditions associated with poor outcomes and quality of life.

Meanwhile, away from the United States, a new heart failure clinic has opened in the UK.

This clinic is different, however, as it is a joint clinic treating heart failure and diabetes.

Diabetes has become increasingly common in the 21st Century with around five million Britons living with the condition.

Based in the northern town of Gateshead, the clinic forms part of a new trial designed to streamline treatment and make life easier for patients.

Diabetes and Endocrinology Specialist Pharmacist Claire Davies said: The idea for the pilot came about because we recognised that heart failure and diabetes are closely connected if you have diabetes you are at risk of heart failure, and vice versa.

We noticed there was a gap in the service for people who had both conditions. Since the pilot launched at the end of last year, the clinic has saved time for the heart failure service through using specialist pharmacists.

Davies said the overall goal was to provide a caring patient-centred service, focusing on multiple interlinked conditions in one appointment.

Should the trial prove successful, more clinics of this kind could be opened around the country.

Read original article here

More here:
Taller people at greater risk of skin infections, says study - Verve Times

A less painful, home-grown and much cheaper version of traditional IVF is now available for Australian women hoping to have a baby.

The Royal Hospital for Women in Sydney is the first provider in Australia to offer the CAPA-IVM, a new fertility treatment for women with fewer hormone injections than traditional IVF, at a significantly lower cost.

In-vitro maturation is when eggs are matured in a lab instead of in a womans body, avoiding the need for about two weeks of hormone injections.

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While standard IVF requires women to take follicle-stimulating hormones to stimulate egg cell growth before they are removed, IVM retrieves eggs while they are still in the immature stage and brings them to maturity in cell culture.

Regular IVF is expensive because theres lots of drug costs involved. IVM uses around 80 per cent less hormones and is cheaper, around half the cost, RHWs Professor Bill Ledger said.

A woman can walk into the clinic on Monday, have two doses of hormone shots to prime the ovary and then her eggs can be collected on Thursday, he said.

He estimates around 15 per cent of women who experience fertility issues will be eligible for the new CAPA-IVM treatment.

It is ideally suitable for women under 38 who have a good egg count.

The treatment is particularly promising for women with polycystic ovaries, a condition which affects around 10-15 per cent of Australian women.

IVM has been around for years but its chances of success are slimmer since its difficult to replicate what the ovary does in a lab.

But with the new method the chances of fertility drastically improve.

CAPA switches off the progression of the egg for 24 hours. So it grows more slowly and it matures more healthily and its more fertile when you introduce it to the sperm, he explained.

Its giving us a longer window of time to work with the egg.

The improved IVM technique was developed by Belgian researchers and Australian scientist Professor Robert Gilchrist from UNSWs School of Clinical Medicine.

This is a wonderful example of the lifecycle of research and the huge difference it can make in peoples lives. It is proof that bench-to-bedside research is alive and well in Australia, Prof Gilchrist said.

A recent trial in Vietnam found pregnancy rates were the same with CAPA-IVM as they are in regular IVF, although IVF patients had more embryos to freeze.

Last year, under 200 women only accessed low-cost IVF for infertility issues and fertility preservation at the hospital, which is calling for more donations to fund its ground-breaking treatments.

The new treatment would not have been possible without public donations to the Hospitals Fertility and Medical Research Centre. To donate, click here

Originally posted here:
Aust women to access cheaper IVF treatment - 7NEWS

Remember those pesky hormones, estrogen and progesterone? They often have an effect on period bloating. According to a 2010 study published in the Exercise and Sport Sciences Reviews, estrogen and progesterone aren't only linked to sexual reproduction; they also control fluid retention and regulation within the body. So as these hormone levels fluctuate before (or during) your period, it can cause your body to retain more fluid and salt, leading to bloating.

According to Healthline, these fluctuations in hormones can also cause you to crave certain foods, especially those high in carbs and sugar. However, other hormones can cause these cravings, too. "Hormones, such as serotonin, decrease when menses start," Oluwakemi M. Edokpayi MD told Popsugar. "These decreases can change your mood, making you crave certain foods. And when you eat certain foods, serotonin and dopamine can be released, thus improving your mood."

More often than not, these treats will include an excessive amount of salt, which can cause the body to hold on to more fluid and therefore result in bloating. While you can't really control how your hormones increase and decrease during your period, you can deal with bloating by keeping an eye on your diet and making some changes.

Read more:
This Is Why You Get Bloated On Your Period - The List

Melatonin may be an over-the-counter supplement, but it can cause significant side effects.

American demand for melatonin a hormone produced by the brain that helps the body get ready for sleep has skyrocketed since the start of the COVID-19 pandemic. As demand has gone up, so have calls to poison control centers about the supplement.

The Centers for Disease Control and Prevention released a report Thursday that found calls to poison control centers about children who took too much melatonin rose by 530% in 10 years.

Though most children in the report did not experience serious side effects, some who called about melatonin overuse had heart and gastrointestinal problems. Four thousand children were hospitalized due to melatonin overuse in the last decade, and two died, according to the CDC.

Dr. Ritwick Agrawal, a sleep medicine specialist and assistant professor at Baylor College of Medicine, said "not much research" has been done on the long-term side effects of excessive melatonin supplementation. Melatonin in the body interacts with other hormones, and controls a variety of functions outside just sleep.

"Unfortunately, there is no established dose of melatonin," Rishi said. "The situation is further complicated by the fact that melatonin is sold as a supplement and United States and is not subject to rigorous oversight."

Here are five physical signs that might indicate you're taking too much melatonin.

Nausea is a common side effect of taking too much melatonin, according to Dr. Jing Wang, an assistant professor at the Icahn School of Medicine at Mount Sinai.

Dr. Muhammad Adeel Rishi, a pulmonology, sleep medicine, and critical care specialist with the American Academy of Sleep Medicine, said vomiting may also occur when taking too much of the supplement.

A typical dose of melatonin labeled on a supplement bottle is around one to five milligrams, according to Wang.

"Excess use may occur when taking more than the typical or recommended doses and/or if taking more than once per day," Wang said.

But the dose inside melatonin supplements can vary from what's written on the bottle label, Wang said. A2017 study in the Journal of Clinical Sleep Medicine found the amount of melatonin in 71% of supplements is off by a 10% margin, meaning the majority of sellers mislabel how much of the hormone is in the pill. The study also found the amount of melatonin within pills in a single jar can vary by 465%.

Taking too much melatonin can cause grogginess and sleepiness during the day,even if you've taken it at night, Agrawal said.

While there is no standard dosing for melatonin, he considers 20 to 25 milligrams a "very high dose."

Taking that much melatonin regularly can negatively alter the body's sleep cycle.

"It can actually paradoxically worsen sleep, and melatonin sometimes does not do what it's supposed to supposed to be taken for as a sleeping agent," said Agrawal. "Sometimes melatonin is just not enough."

Mood changes may indicate you've taken an excessive amount of melatonin, Wang said. These changes can include feelings of depression , mild anxiety, and irritability, according to the Mayo Clinic.

Very little research has been done on melatonin's impact on mood changes, however.

Rishi said poor balance is another side effect of melatonin overuse, while the Cleveland Clinic lists reduced alertness as a side effect of taking too much melatonin.

There have been few studies on melatonin's effect on balance. One study of 81 women with osteopenia found a one year treatment of 1 to 3 milligrams of melatonin did not affect postural balance or risk of falls.

Wang said headaches are another common side effect of melatonin overuse.

While melatonin can trigger headaches, some early research has shown it might treat migraines, Dr. Marri Horvat, a sleep disorder doctor at Cleveland Clinic, wrote. But researchers are not sure if migraines improve due to melatonin supplements or increased sleep as a result of supplementation.

Read the original post:
Melatonin: Signs you might be taking too much of the supplement - Insider

For Brian Meissner, the sore throat and fever he experienced in January when he became infected with COVID-19 were harbingers of a host of health issues to come.

Meissner, a 36-year-old resident of Chiba Prefecture, says he had received two COVID vaccine shots and was waiting for a third when he fell ill. After going to a local drive-in clinic and testing positive for the coronavirus, he was prescribed molnupiravir, an oral medication approved for COVID treatment, and was told to rest at home for two weeks.

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Long COVID takes toll as Japan patients seek answers - The Japan Times

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Alicia Morgans: Hi, I'm so excited to be here today at APCCC 2022, where I have two wonderful friends and colleagues to discuss PARP combination therapy, and thinking about how that may be, or may not quite be, ready for primetime use in clinical practice. I have Dr. Maha Hussain, who is a Professor of Medicine at Northwestern University and, of course, a GU Medical Oncologist, and Dr. Fred Saad, who is a Professor of Urology and the chair of that department at the University of Montreal. Thank you both so much for being here today.

Maha Hussain: Thank You.

Fred Saad: It's A pleasure.

Alicia Morgans: Wonderful. I know you're both very involved in these PARP trials and in PARP combinations, and I'd love to hear your thoughts. Why don't we start just briefly recapping some of the data Maha, would you mind sharing with us some of the data and then we can let Fred take the other study?

Maha Hussain: Absolutely. I think, from my end, I began with my interest in the PARP, probably around 2010 or so, when there was data coming up regarding the potential synergistic effect of targeting the PARP pathway and the androgen receptor. And so we designed clinical trials that were part of the Stand Up To Cancer at the time, which suggested some interesting trends, and then subsequently, of course, the definitive trials were done with PROfound, again, demonstrating that in the second or post-second line therapies in heavily pretreated patients preselected for DNA damage response defects, these patients benefited from PARP inhibition. One thing that's clear, is not all pathway elements or alterations are equal, and pretty much, a lot of the data positivity is in the BRCA2, however, there is certainly benefits in other HRR mutation areas.

So I do think that we have come a long way and we're looking at combination treatments, and of course, you've seen the data that was presented ASCO GU in the front-line setting. And I would say the data is very interesting, but there are a lot of subtleties that we need to go through, basically.

Alicia Morgans: Absolutely. And, Fred, would you mind just sharing a recap of the MAGNITUDE and PROpel trials, which are really the studies that looked at these combinations presented at GU ASCO 2022?

Fred Saad: Yeah. It was really a lot of fun being able to present the data for the first time, and it's really building on, on Maha's work on PARP inhibition and with the olaparib and the PROfound study that Maha led. Clearly, patients who have these mutations do very well when they've failed an AR-targeted therapy. And these are later lines of therapies, but even from PROfound, I think we learned that if you start earlier in these patients, they do better than delaying, because the trial allowed crossover. And patients who crossed over, didn't come close to doing as well as the patients who started earlier.

So taking that approach of saying, "Well, maybe we need to start, at the time, a first-line mCRPC," And taking into consideration some preclinical evidence that if you combine a PARP inhibitor with an AR-targeted therapy, there might be potential for synergistic effects that might lead to even better outcome. And obviously, I think we would all be convinced that patients who harbor BRCA mutations and maybe other HRR mutations would benefit from earlier introduction of these therapies.

The phase II study showed that, whether or not you had mutations, it looked like you can get benefit. It was only 140 patients, but they looked like they had benefit, and we published that a couple of years ago.

So, the PROpel study really used the strategy of saying, "Let's take all-comers with first line mCRPC who have not yet been exposed to novel hormonals, especially abiraterone, which was the backbone of the study." So, everybody in the study of 800 patients got abiraterone, which I think all of us would agree is the standard of care, or one of the standard of cares, for first-line mCRPC, and half got olaparib over and above the abiraterone. The first results were the primary endpoint of rPFS, which showed a very significant improvement in rPFS of about 8 months and a 34% reduction in progression or death. So, almost the same results as we saw with abiraterone against a pure placebo several years ago. So that was very insightful, that we were able to do better than the standard of care for now, at least in terms of rPFS.

And then in the subgroups, every subgroup appeared to gain benefit from the combination over the mono-therapeutic approach. And this included patients who had had docetaxel in the hormone-sensitive setting and, importantly, did well, even in patients without HRR mutations, which was almost 70% of the patients. Almost 30% did harbor mutations. So this is our first prospective study unselected that tells us that it's somewhere in between 25% and 30% of patients harbor mutations, of which the minority were BRCA. And those patients, obviously, it even looks like they're doing even better than the ones that are not mutated, but importantly, the non-mutated look like they were getting benefit, at least in terms of rPFS, with hazard ratios that are respectable, and we're still waiting for the updated results from that trial.

Alicia Morgans: Absolutely. And the MAGNITUDE study was interesting, looking at niraparib and abiraterone also in the first-line mCRPC setting. But in this case, the benefit was really confirmed in those patients who had BRCA1/BRCA2, but did not seem to be conferred to those patients who did not have those DNA repair defect alterations, which was interesting. So, really, those patients who had the DNA repair defect alterations, all of those included in the study, versus those who did not, those patients seemed to benefit

Fred Saad: Importantly, it was really the BRCA that was driving all the positive results, because the non-BRCA patients didn't appear to be getting much benefit. Obviously, subgroups and all the rest. And, really, the primary endpoint was the BRCA-mutated patients, where a lot of the data is supportive for looking at those patients in earlier introduction. So I think two positive studies, at least for patients that are mutated. The question that's going to be, I guess, debatable or questionable is, are we ready for the prime-time, like you asked upfront?

Alicia Morgans: Yes. And especially in that population that does not have the DNA repair defects, what's the truth there? Is it the combination allowing that sensitivity that we think may be conferred with the combination? Or is there something else going on? Is it perhaps just something that, if we follow them longer, we won't actually see that benefit? Dr. Hussain, what do you think about the non-mutated, the DNA repair defect-negative patients?

Maha Hussain: I question the value there. And this goes back to the days where we did the combination trial that was, again, part of the Stand Up To Cancer effort. Granted, not everybody got the genomic testing, because it's just the patients that had the availability of tissue. But what we saw in that trial, and just as a reminder for the audience, this was a trial that basically looked at combination abiraterone plus veliparib versus abiraterone alone in front-line metastatic castration-resistant disease. And then a large percentage of the patients who were recruited to this study, in fact, did have tissue available, or some of them underwent biopsy of metastatic disease for the purposes of this study.

What the data showed, basically, is that, again, overall, there was no advantage to the addition of veliparib with regard to the primary endpoint of this study. But when we looked at the breakdown again, this is post-hoc analysis, just for clarity, what was clear is this, is patients who had the HRR mutations or the DNA repair defects did better no matter what. So, if they were in the combo arm or the single-agent arm, did better than the patients who had intact tumors. And this is where comes up my bias, I guess, with the data from the PROpel trial. There's a lot of subtleties, of course, and different drugs are different.

I think that the another trial that we are reporting at ASCO this year looked at, again, the issue of combination versus single agent in both. So none of the phase III trials, even the control arms have always been the AR inhibitor. In our trial, again, albeit phase II trial, actually, it's AR inhibitor, PARP inhibitor, versus combination. And there's clearly trends. The issues is going to be is this. Is the sequential therapy.

That's where I think it's going to be important from both trials, PROpel and MAGNITUDE to actually see, if you have sequential therapy and people do just as well for overall survival, do you really need to subject them to the added physical, monetary, whatever cost of combination upfront versus not? My gut feeling is, like anything else, combination therapy tends to do better. So if I were to guess, I think it's going to be, at least in the HRR positive patients, there's going to be the trend of benefit there. But we'll have to see what the data looks like.

Alicia Morgans: Absolutely.

Fred Saad: Yeah. And your own PROfound, I think, would suggest that earlier appears to be better.

Maha Hussain: Yes. Yeah, yeah.

Fred Saad: So, the question is, do you need to combine? And I think for patients starting mCRPC, we need to give them the best standard of care.

Maha Hussain: Yes.

Fred Saad: Now, whether that's best standard care started in hormone-sensitive is a whole other question. And that's where the field is going.

Maha Hussain: Yes, I agree. I agree.

Fred Saad: And this is going to be the challenge in the future. How many mCRPC patients are going to not have been pre-exposed to NHTs in the past? But beyond HRR, and I think this is where we all, as a community, need to think, have we identified all the biomarkers of poor outcome? And we have biomarkers like chemotherapy in the hormone-sensitive setting, which might be growing over time. And these patients did really badly. They did as badly as the HRR-mutated patients in terms of how quickly they progress on Abi alone, and they did substantially better when they were combined to a PARP inhibitor.

We have the younger patients under 65. For some reason, they did exceptionally well with the combination compared to Abi alone. We have the patients who have visceral metastatic disease that don't do well on Abi alone that did substantially better in the combination. So I think we're going to all have to work on including, I don't think either of us would say we don't need to test genomic testing anymore. It's part of the equation of making a clear, informed, best approach for the individual.

Maha Hussain: Yes.

Alicia Morgans: Yeah.

Fred Saad: And, clearly, we won't be giving combination to everybody, but there are patients that come in and that I'm very concerned about. And I say, "These patients are not going to do well, and we need to do more than what we're doing today."

Maha Hussain: And I think what's going to confound things is the fact that you have the data from the triplets with darolutamide, the triplet with abiraterone in the hormone-sensitive space. And the question is, how does that paradigm shift? And of course there are trials in the hormone-sensitive space with PARP inhibitors and the issue, again, how does that impact things there?

I think the good problem, as I say, there are problems that are bad, there are problems that are good, the good problem is we have many choices for patients. There is a lot of investment in research in this patient population by comparison to even 10 years ago. So I do think that our job as the physicians is to actually go with what we think is the best process with regard to enhancing outcomes for patients, and clearly, quality of life and prolongation of life.

Alicia Morgans: Absolutely. And I know that both of you continue work in this space. I know, Maha, you're doing investigations into the basic biology to look for those unidentified drivers, because clinical features will only get us so far, but those expression profiles, those alterations that haven't been identified yet are in process. We're hoping Dr. Hussain can share those with us at some point in the near future. So, each of you, I'll give you a final word. Is combination therapy ready for prime-time in the clinic now? And if so, in whom? We'll give Maha the final word, so you get to answer first, Dr. Saad.

Fred Saad: I would say, yes, that it is ready for prime-time. The combination in first-line mCRPC. The low-hanging fruit are the patients with mutations, and I would go beyond BRCA, at least what we saw, but at the very least BRCA. But then I think the clinical parameters that we still don't understand why the biology of those parameters seem to indicate that the combination is better than simple abiraterone review. So I think we are ready for prime-time. I think it's going to be a question of selecting our patients that most need our help in doing better, because the reality is, many, many patients around the world are limited to first-line treatment and mCRPC, and don't go beyond that.

Alicia Morgans: Absolutely. Dr. Hussain.

Maha Hussain: I think I fully agree. I would just add to it, is that, pending the overall survival data based on the radiographic progression-free survival, I think the combination is, to me, clinically relevant, but I would say specifically in the patients who have the HRR mutations. So this is, if I were to offer it right now, I wouldn't offer it to all-comers. I would offer it to people who have the mutations. Again, pending the overall survival data.

If the overall survival data confirms the intermediate endpoint, so to speak, that would be great. The dilemma's going to be is if the overall survival data is no better. The question comes up is, how do you define risk benefit? And is sequential therapy going to be of value? And this is where our BRCA trial, again, not a phase III, small scale, but we're looking at sequential therapy crossing over and comparing front-line this versus that, and then crossing over. Will be interesting to see how that has resulted.

Alicia Morgans: Absolutely.

Maha Hussain: We're hoping to report it, hopefully, by the end of the year.

Alicia Morgans: Wonderful. Well, we will definitely catch up with you on that, and thank you both so much for sharing your thoughts on the PROpel and the MAGNITUDE data and how we think about that in clinical practice. It has truly been a pleasure.

Maha Hussain: Pleasure is ours, my dear. Thank you.

Alicia Morgans: Thank you.

Fred Saad: Thanks, Alicia.

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PARPi Combination Therapy Use in Clinical Practice - Ready for Prime-Time? - Maha Hussain and Fred Saad - UroToday

While in the United Kingdom (UK) for her masters degree in 2012, Pumla Nabacwa was referred to a fertility clinic for a certain procedure. As she waited at the reception for her turn to see the gynaecologist, she overheard two women (both aged about 35 years) talking about their struggles with infertility and how they had tried to conceive but in vain.

From the conversation, Pumla, then 28 years old, learnt that the women needed egg donors but the available ones were white. When it was her turn to see the gynaecologist, Pumla asked if she could donate her eggs.

She went through a series of tests and screening including blood work, physical and psychological health tests and after two days, she was contacted by the hospital. She had met all the criteria needed to donate and was asked to go back to the clinic at her convenience. The next day, she walked into the clinic and started the process that would last a month.

I had to put aside all my fears since my goal was to help those women and many like them that were struggling to have children. I was given hormone stimulating injections, with which I injected myself on the abdomen twice a day for 30 days and thereafter, the doctor harvested 27 eggs, she says, adding that three months later, she donated another 25 eggs.

According to Dr Edward Tamale Ssali, a gynaecologist at Womens Hospital International and Fertility Centre in Bukoto, Kampala, there are two types of donors.

One who is known to the recipient; most preferably a relative or friend or an anonymous person whose details are only known by the hospital. An anonymous donor is usually preferred in the African setting because this remains a secret between parents. In the West, the child has a right to know about the donation as soon as they turn 18 years.

Egg donation is a process in which a fertile woman donates an egg (oocyte), to another woman to help her conceive. The egg donors give eggs to a clinic for a recipient to be mixed with a partners sperm, or donor sperm, and used in assisted fertility treatment techniques such as In Vitro Fertilisation (IVF). The donor should be between 21 to 35 years of age.

The process starts with ones declaration of interest to donate the eggs. One must be willing to undergo several tests, starting with a background study where the doctor will ask questions about your family history.

The doctor will screen one for hepatitis, HIV, Sickle cell disease, hemophilia, sexually transmitted infections, chronic illnesses such as diabetes, mental health and many other diseases that can be transmitted to the child from the mother.

Dr Joseph Nsengiyumva, a gynaecologist at Bethany Womens Hospital in Kampala, says a baby girl at birth has about two million eggs but by puberty, they may have reduced to about 500. A hormonal test (ovary reserve test), before donation is also done to ensure you have more than enough eggs to donate.

In Uganda, you must have a letter from the LC1 chairman to track your criminal record, a national ID card for proof of your age, passport size photos and when all the criteria is met, the donor goes through pre-donation counselling. Then, one will sign a consent clearly stating that they are donating willingly.

I was given injections and give strict guidelines. I would self-inject after every 12 hours for a period of 30 days and would go to hospital for review twice a week. Here, an ultra sound scan would be used to see if the eggs are increasing in size and number, making them strong and viable, Pumla says.

The donor is also given fertility drugs that stimulate the ovaries to produce several eggs at once. During the donation cycle, donors stand risk of pregnancy before the eggs are retrieved. It is a good idea to avoid intercourse or use a barrier contraceptive, such as a condom.

During the cycle, the donor goes through frequent blood tests and ultrasound examinations to monitor their reactions to the medications. The hormonal stimulation process requires one to eat a healthy diet, although there are no food restrictions except for smoking and minimal alcohol consumption.

Pumla says there is a bit of discomfort since one suffers from bloating, swelling of the stomach and fluid retention due to the hormones although these stop after the eggs are harvested. On day 26, the doctor confirms the date of harvesting, which is an outpatient procedure that takes a few hours.

Dr Ssali says: Before the eggs are retrieved, the donor receives a final injection in preparation for the procedure and is put under sedation. A transvaginal ovarian aspiration is done to remove the eggs from the donors ovaries. An ultrasound probe is inserted into the vagina and a needle is used to remove the eggs from each follicle.

Eggs can also be harvested for women before they undergo chemotherapy, radiotherapy, those who have not found the right partners or are first focusing on career, frozen and made available when they need them. This, Dr Nsenyimva says, costs Shs5m.

Pumla donates her eggs free of charge. In the UK, I was given an allowance or a refund for transport costs to and from the hospital twice a week for review, and buying healthy foods.

Dr Nsengiymva says: You can only receive a donation of about Shs500,000 to Shs1m as a refund but not payment for the service. The service is paid for by the recipient who pays Shs1.5m and this is billed as part of the Shs18m to Shs22m (depending on the fertility clinic you go to) which is charged for In vitro fertilisation.

One must sign a contract stating that they do not get to know who the recipient is. In the UK, the donor remains anonymous and the child is only allowed to contact you after the age of 18. What I get to know is the number of my eggs that have been fertilised and have resulted in children, their date of birth and gender, says Pumla.

Her prayer is that at the right age, her children are told about the possibility of contacting her. She updates her information with the fertility centre every time she changes contact or residence so that she does not miss this opportunity.

See the original post:
Do you have what it takes to be an egg donor? - Monitor

If youve changed your supplement routine since the pandemic, youre not alone. According to a 2020 survey conducted by the Council for Responsible Nutrition (CRN), more than 43 percent of dietary supplement users have switched things up. Among those who updated their regimens, 91 percent reported increasing their supplement intake, either by adding new supplements, taking the same supplements more regularly, or upping their dose(s). Overall immune support and health and wellness benefits are cited as the top reasons.

But while supplements are often seen as a method to ensure you meet your daily nutritional needs, they can create problems if youre not careful. Like drugs, dietary supplements can affect the way your body functions, which can cause adverse effects in some people, according to an article published in the May 2022 issue of U.S. Pharmacist.

So, how do you know if youre overdoing it with the supplements? Read on to find out.

[In general], a supplement is something youre not getting enough of through food, says Rohit Moghe, PharmD, CDCES, a pharmacist with Trinity Health Mid-Atlantic in Philadelphia, and member of the American College of Lifestyle Medicine (ACLM).

To fill in these nutrient gaps, many people turn to gummies, capsules, powders, tinctures, and even saline solutions delivered via needle (known as IV therapy).

In the Dietary Supplement Health and Education Act of 1994, Congress defined supplements as products (other than tobacco) that are intended to supplement the diet, contains one or more dietary ingredients (including vitamins, minerals, herbs, botanicals, amino acids, or other substances) or their constituents, is intended to be taken by mouth as a pill, capsule, tablet, or liquid, and is labeled as a dietary supplement.

While many people are able to meet their nutrient needs through their diet, others may benefit from supplements. Particularly those who face a greater risk of nutrient deficiencies, including those with higher requirements (like children, adolescents, and pregnant and lactating women), those who struggle to absorb nutrients (like older adults, obese individuals, and people with chronic conditions), and those who follow a restrictive diet (like vegans and vegetarians), according to an article published in January 2018 article in Nutrients.

For example, a vitamin B12 supplement may be a good idea for older adults and people who follow a vegan or vegetarian diet. Vitamin B12 helps keep your blood and nerve cells healthy, and plays an important role in making DNA, per theNational Institutes of Health (NIH). Its found naturally in animal foods, which means vegans and vegetarians may not get enough through diet alone. Older adults may also be deficient in vitamin B12, because many dont have enough hydrochloric acid in their stomach to absorb it, according to the NIH. Therefore, both groups might benefit from a vitamin B12 supplement.

A common concern about supplements is that the industry, in general, is under-regulated. Unlike medications, supplements dont have to be approved by the U.S. Food and Drug Administration (FDA) before theyre sold or marketed.

New legislation, proposed by Senate Majority Whip Dick Durbin, a Democrat from Illinois, and Sen. Mike Braun, a Republican from Indiana, aims to improve the safety of dietary supplements by requiring manufacturers to list their products with the FDA under the Dietary Supplement Listing Act of 2022 a bipartisan initiative. The new legislation, which refers to the Dietary Supplement Health and Education Act of 1994, points out that in 1994 there were about 4,000 dietary supplements marketed in the United States, but the industry has boomed and now 50,000 to 80,000 products are available.

In the meantime, consumers cant be sure the supplements theyre taking are safe or effective.

Even if a supplement is considered generally safe, it may not be safe for you. Most vitamins and minerals have a risk of harm with dosages, and the risk is based on the individual nutrient and patient, says Ravi Tripathi, MD, medical director of critical care services for the Ross Heart Hospital at The Ohio State University Wexner Medical Center in Columbus. When it comes to supplements and risks, there is no one size that fits all, he says.

For example, people with an inherited condition called hemochromatosis have to be careful with iron supplements, as hemochromatosis causes toxic levels of iron to build up in their bodies, notes theNIH. And while most people dont get enough potassium even when diet and supplements are combined, according to theNIH, people with chronic kidney disease can develop abnormally high levels of potassium in their blood. This condition, known as hyperkalemia, can cause serious heart problems if left untreated, according to theNational Kidney Foundation.

Supplements can pose risks even in otherwise healthy people. According to theNIH, youre more likely to have side effects from dietary supplements if you take them at high doses or use many different supplements.

The symptoms from taking more supplementation that your body needs vary depending on the nutrient and the amount taken, and may only show up in blood tests. However, there are some physical signs to watch for. According to the May 2022U.S. Pharmacist article, general symptoms to look out for may include:

Why its good for you: Vitamin D (also known as the sunshine vitamin) helps your body absorb calcium, making it a key nutrient for bone health. Your body also needs vitamin D to carry messages between your brain and your body and fight off bacteria and viruses, according to the NIH.

Why you might be overdoing it: On the one hand, 40 percent of Americans are deficient in vitamin D, per blood tests (when serum levels are less than 50 nmol/L), according tofindings published in June 2018 in Cureus. The reason? Most of us arent getting enough sunlight exposure, notes the NIH. Taking a vitamin D supplement may help and the CRN survey shows this supplement is becoming more popular but its important to watch your dosage to ensure you dont get more than 100 micrograms (mcg) a day. According to the NIH, overdosing is almost always caused by taking supplements, as opposed to sunlight exposure or eating vitamin Drich foods.

Risks: Very high levels of vitamin D can cause nausea, vomiting, muscle weakness, pain, loss of appetite, dehydration, and kidney stones, per the NIH.

Why its good for you: Iron is a mineral your body needs to make hemoglobin, a protein in red blood cells that carries oxygen throughout your body, according to theNIH. It also helps your body make hormones.

Why you might be overdoing it: Iron supplements are often recommended for younger women to help offset iron lost during menstruation. But according to theCleveland Clinic, many women continue to take supplements containing iron after menopause, when menstruation stops and iron needs decrease.

Risks: Getting too much iron can cause gastrointestinal (GI) symptoms like constipation, nausea, vomiting, abdominal pain, and diarrhea, per the NIH. Overdosing on iron can also lead to inflammation of the stomach lining and ulcers. Although rare, extremely high doses of iron (in the hundreds or thousands of milligrams) can even cause organ failure, coma, convulsions, and death, according to the NIH.

Why its good for you: According to theNIH, vitamin A is important for vision, immune health, reproduction, growth, and development.

Why you might be overdoing it: Its pretty easy for most people to score plenty of vitamin A. If you eat cereal for breakfast and carrots or sweet potatoes at lunch, and then pop a supplement for eye health, youve probably gone over the recommended amount, says the Cleveland Clinic.

Risks: High levels of vitamin A can cause severe headaches, blurred vision, nausea, dizziness, muscle aches, and coordination issues, notes the NIH.

Why its good for you: Vitamin C, also known as ascorbic acid, acts as an antioxidant, helping to protect your body from free radical damage. According to theNIH, your body also needs vitamin C to make collagen, a protein thats important for wound healing.

Why you might be overdoing it: The CRN survey found that vitamin C supplements have seen a big boost since the pandemic. However, most people can get enough vitamin C through food. In fact, 1 cup of strawberries, chopped red pepper, or broccoli will provide the daily amount needed, per Mayo Clinic.

Risks: Taking too much vitamin C can cause diarrhea, nausea, and stomach cramps, according to Mayo Clinic. Vitamin C supplements may also interact with cancer treatments like chemotherapy and radiation therapy, per the NIH. In addition, a past study found that men who took vitamin C supplements had a higher risk for developing kidney stones.

Why its good for you: Calcium is a mineral that builds and maintains strong bones. It also plays a role in nerve function, circulation, and hormone release, according to theNIH.

Why you might be overdoing it: You may be tempted to load up on calcium supplements to protect your bones, but according to theCleveland Clinic, its surprisingly easy to overdo it. Especially if youre already getting calcium from your food.

Risks: Excess calcium has been linked to constipation, kidney stones, kidney failure, heart problems, and cognitive issues, according to the Cleveland Clinic.

Experts often recommend speaking with your doctor before trying a supplement. Unfortunately, many physicians and nurse practitioners arent as knowledgeable in this area. I find many [healthcare professionals] are grossly unprepared to answer their patients questions, and they wind up telling them that supplements are a waste of money, when maybe theres a product that may actually work for your intended use, Dr. Moghe says.

If youre interested in adding a supplement to your diet, Moghe suggests talking with a physician trained in integrative medicine or nutritional medicine, a pharmacist, naturopath, or registered dietitian. You can check the directories of the National Board of Physician Nutrition Specialists and the American Board of Physician Specialties to find a healthcare professional who works for your needs.

Simple blood tests can reveal if youre deficient in specific nutrients, but the routine blood work at your annual physical doesnt typically include these tests, although some nutritional deficiencies can produce changes on these labs, according toRush University. Youll have to request these blood tests when you visit your doctor. A physician trained in integrative medicine and/or nutritional medicine, a pharmacist, naturopath, or registered dietitian may be able to offer suggestions and a tailored approach to getting the right levels of nutrients for you, and explore whether it makes sense to test for specific vitamin deficiencies given your unique lifestyle, diet, and health.

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Can You Take Too Many Supplements? - Everyday Health

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Data show MammaPrint is the first and most comprehensive FDA-cleared test for early breast cancer resulting in the ability to identify women who may be over- or under-treated if treatment decisions relied on the 21-gene assay

FLEX Trial continues to support the discovery and development of novel genomic profiles, bringing precision oncology into the clinic to improve and redefine breast cancer management

IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia, Inc., a commercial-stage company focused on improving outcomes for breast cancer patients worldwide by providing physicians and patients with next-generation diagnostic and information solutions to inform optimized treatment decision-making, today announced it will present seven posters derived from the companys FLEX Trial, the real-world, multicenter, prospective, observational breast cancer study at the American Society of Clinical Oncology Annual Meeting (ASCO) 2022.

One of Agendias posters, selected for the oral discussion session, titled Whole transcriptomic analysis of HR+ breast cancer in Black women classified as basal-type by BluePrint [Reid, S., et al.], will present findings from a racially-diverse cohort and resulting transcriptomic analyses suggesting hormone receptor-positive (HR+)/Basal tumors are biologically similar to triple-negative breast cancer (TNBC) tumors, regardless of race, demonstrating the importance of subtyping a tumors biology to determine optimal treatment course. BluePrint also identified racial disparities in the proportion of HR+/Basal tumors, showing a near doubling of such tumors among Black women, underscoring the need for diverse representation in clinical trials, a hallmark of the FLEX Trial.

Leveraging the BluePrint assay, we are able to uncover new gene expression insights for HR+/Basal breast cancer tumors, which traditionally are more aggressive, higher grade, and disproportionally impact Black women compared to White women, said Sonya Reid, MD, MPH, Department of Medicine, Vanderbilt University Medical Center. The FLEX Trials robust collection of diverse patient genomic profiles uniquely allows for sub-studies analyses like these to take place, helping researchers better support their patients from all racial and ethnic backgrounds with further classification of breast cancer tumors.

These data build on findings presented at San Antonio Breast Cancer Symposium 2021, also authored by Dr. Reid, that showed MammaPrint and BluePrint more robustly identify differences in more aggressive breast cancers in Black and White women beyond clinical factors, highlighting the fundamental importance of genomic classification and personalized treatment planning.

In addition, Agendia will present several sub-studies highlighting the FLEX Trials approach to cancer research by accelerating impactful data generation, aimed at redefining cancer care. The company believes this patient-centric design and national network of participating sites backed by Agendia will allow its investigator-initiated sub-studies to produce important results with the potential to drive science forward, like those being shared at ASCO 2022:

These new findings presented at ASCO 2022 show the breadth of the FLEX research platform to identify and evaluate the many different complexities of a breast cancer biology at diagnosis that may facilitate more precise and individualized treatment recommendations, said William Audeh, MD, Chief Medical Officer at Agendia. Agendias commitment to expanding our understanding of breast cancer to improve outcomes for women with breast cancer is astounding, exemplified by the FLEX Real World Evidence Trial. FLEX has the significant potential to broaden the application of genomic information through assays such as MammaPrint, BluePrint, and new proprietary Agendia signatures, which could lead to practice-changing models within breast cancer care aimed at improved outcomes for women with breast cancer.

Agendia will be sharing updates throughout the conference on its Twitter, Facebook and LinkedIn pages.

About Agendia

Agendia is a mission-driven, commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide. The company currently offers two commercially-available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey.

MammaPrint is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patients breast cancer recurrence risk. BluePrint is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis and potential response to systemic therapy. Together, MammaPrint and BluePrint provide a holistic view of the biology underlying an individual patients breast cancer, enabling physicians to objectively select the best treatment plan.

For more information on Agendias assays and ongoing trials, please visit http://www.agendia.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220605005052/en/

Terri ClevengerWestwicke/ICR Healthcare PRTel: 203.856.4326[emailprotected]

Source: Agendia, Inc.

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Agendia Presents Data from the FLEX Real World Evidence Trial in Seven Posters at ASCO 2022, Showcasing the Power of Its 30,000-Patient Breast Cancer...

Image: Professor John Yarnold (left), Professor Pascal Meier (middle) and Professor Clare Isacke.Credit:soora.co.uk

As research efforts become bigger and more ambitious, there is a real need to bring together researchers with diverse scientific backgrounds and perspectives to solve complex scientific problems. This type of multidisciplinary approach taken by The Breast Cancer Team at the ICR and The Royal Marsden NHS Foundation Trusthas been critical to their success in making transformational discoveries in breast cancer.

Twelve researchers from the ICR and The Royal Marsden Breast Cancer Team have been awarded the 2022 Team Science Award from the American Association for Cancer Research (AACR). The award recognises the significant contributions to the breast cancer research community made by the multidisciplinary team spanning a spectrum of discovery biology, molecular pathology, trial statistics and clinical science.

Here, we celebrate the teams tremendous achievements, which are underpinned by more than two decades of research.

In 1995, Professor Alan Ashworth, then at the ICR but now President of the UCSF Helen Diller Family Comprehensive Cancer Center, was part of a team of researchers that discovered the second breast cancer susceptibility gene, BRCA2. Building on this work, Professor Ashworth and Professor Andrew Tutt(then Ashworths MRC Clinical Training Fellow and PhD student), along with a wider group in the Ashworth lab, uncovered the important role of the BRCA2 gene in DNA damage repair revealing how it might be targeted with drugs such as carboplatin.

Together with Professor Chris Lordwho had joined the lab, and Professor Steve Jacksonsteam at the UK biotech company KuDOS, in 2005, they went on to identify the first synthetic lethal interaction between the BRCA1/2 genes and the DNA damage repairing enzyme Poly-ADP-Ribose Polymerase 1, or PARP1.

The concept of synthetic lethality is based on the dependency between a pair of cancer genes, where loss of function of either individual gene will allow the cancer cell to survive, but loss of function of both genes simultaneously will cause the cancer cell to die.

The collaboration with the KuDOS team, who had discovered a PARP inhibitor drug called olaparib, showed that blocking PARP1 caused cancer cells carrying BRCA1 or BRCA2 mutations to die. The striking results from the Ashworth lab stimulated Professor Tutt and the Ashworth group to design a Phase I clinical trial in 2008, together with ICR clinician scientist Professor Johann de Bonoand Professor Stan Kayeat The Royal Marsden, that focussed on BRCA1/2 mutation carriers.

Commenting on the discoveries, Professor Lord said, I think we knew from a very early stage that this was quite a significant finding. But at the time, we didnt fully realise that it would go all the way to actually getting approved and used worldwide. For us lab scientists and clinician scientists, these are things that we came into research to do. From an emotional perspective, it is incredibly rewarding and an enormous privilege to be able to contribute to things that actually make a difference to people.

The teams collaborative efforts pioneered the use of synthetic lethality as a new therapeutic strategy in cancer. This has had a particular impact in breast cancer, as well as in ovarian, prostate and pancreatic cancer, where PARP inhibitors are also now used.

Phase III trials with olaparib, that followed the phase II proof of concept studies led by Professor Tutt in 2010, resulted in the drugs approval in treating advanced BRCA1/2 mutated breast cancers. Olaparib was approved for breast cancer by regulators in the US, the Food and Drug Administration (FDA), in 2018, and in Europe, the European Medicines Agency (EMA), in 2019. The FDA and EMA have also approved the use of olaparib in ovarian, prostate and pancreatic cancers.

The development and approval of olaparib has transformed how advanced BRCA1/2 mutated breast cancers are treated worldwide. Olaparib is the first cancer treatment targeted against an inherited genetic fault. This breakthrough has had a huge impact on thousands of people with breast cancer, enabling patients to live longer and have a better quality of life while receiving treatment.

More recently, the results from the OlympiA trial, that was led by Professor Tutt as the Breast International Groups Global OlympiA Steering Committee Chair,revealed that adding olaparib to standard treatment for early-stage breast cancer in patients with inherited BRCA1/2 mutations can improve survival and reduce the risk of recurrence. The trial also supports testing for germline BRCA1/2 mutations, which has now been established as an important part of treatment selection in early breast cancer. The teams findings have impacted international treatment guidelines for both breast cancer therapy and genetic testing.

Professor Tutt said, This work brought together fundamental biologists, geneticists, biotech companies, early phase trials leaders and international collaborators at the phase III study stage. The award recognises the teamwork and amalgamation of skillsets required to change the way breast cancer is treated.

While the use of PARP inhibitors has been largely successful, not all patients who have inherited a faulty BRCA1 or BRCA2 gene respond to PARP inhibitors. Professors Lord and Tutt and their team are trying to understand how cancer cells become resistant to these drugs. They are uncovering ways to overcome resistance by identifying molecules that can be targeted using different drug combinations.

Developing smarter, kinder treatments for patients is a continuous cycle from the lab to the clinic and back again. Professor Lord said, Our collaboration with The Royal Marsden allows us to be a truly translational research centre. We can do biological research that informs new drug discovery projects and design of clinical trials, but we can also take observations from the clinic and feed them back into the lab where they can be dissected at a molecular level. This provides useful insight that can help to make new discoveries to overcome drug resistance.

Our researchers regularly present their latest findings at the AACR Annual Meeting in the US.

Find our more about the AACR conference

Oestrogen receptor positive, or ER+, breast cancer is the most common form of the disease it makes up about 80 per cent of cases and this is where the joint team made another major contribution recognised by the award. These cancers rely on oestrogen for their growth and can be treated using aromatase inhibitors that block the effects of the hormone.

The ICR and The Royal Marsden played a key role in the clinical development of aromatase inhibitors assessing their effectiveness over the years. The teams work in this field has been critical to understanding the biology of ER+ breast cancers and improving our knowledge of how these cancers become resistant to conventional hormone treatment.

Early trials involving Professor Mitch Dowsettfound that aromatase inhibitors were better than tamoxifen another type of hormone therapy for breast cancer at preventing the recurrence of ER+ breast cancers.

A seminal trial co-led by Professor Judith Bliss, an expert trial statistician and methodologist, demonstrated improved relapse-free survival in patients that switched to the aromatase inhibitor exemestane after two to three years of tamoxifen treatment compared with tamoxifen alone for five years. This trial played an instrumental role in changing practice guidelines for use of aromatase inhibitors in the clinic.

Professor Stephen Johnston, a consultant oncologist at The Royal Marsden, led the large-scale international MonarchE trialwhich aimed to identify new treatments that overcome resistance in ER+ breast cancer. The results showed that adding the drug abemaciclib a CDK4/6 inhibitor that prevents cell growth to hormone treatment significantly reduced the risk of the disease coming back in high-risk patients with early breast cancers.

The MonarchE trial was based on many years of research done at the ICR and The Royal Marsden and was a collaboration between both organisations, Eli Lilly and numerous international investigators. Abemaciclib was approved for adjuvant therapy by the FDA in the US in 2021 and just this month by the EMA.

Professor Bliss said, The ICR and The Royal Marsden bring together discovery science, clinical expertise and dedicated cancer specific trials methodology, which is ideal for designing scientifically robust, efficient and practice-changing clinical trials.

Professor Dowsett and his team also discovered an important biomarker Ki67, which marks newly divided cancer cells to evaluate the effectiveness of aromatase inhibitors in patients. The biomarker was subsequently developed into a test that is used to identify patients who might particularly benefit from hormone therapy.

The POETIC trialinvolved Professor Dowsett, Professor Bliss and Professor Ian Smith, and enrolled postmenopausal women who were planned to receive an aromatase inhibitor for five years following surgery. By starting the aromatase inhibitor two weeks before surgery and looking at how the Ki67 biomarker changed in patients tumours following the short-term therapy, the researchers were able to distinguish groups of patients with different risks of their cancer coming back.

Some patients started with a low level of the biomarker which stayed low after two weeks of treatment. The patients in this group had a very low chance of their cancer coming back during the next five years, with many of these patients able to be treated with aromatase inhibitor therapy alone. A minority of these patients were likely to still require chemotherapy if they exhibited certain high-risk features in their cancer.

For patients who had higher levels of the biomarker before treatment, assessing the levels again after two weeks of therapy showed that biomarker changes during that period affected the patients long-term outcome. Many of these patients had tumours that exhibited low levels of the biomarker following treatment. Patients whose biomarker levels stayed high following the brief exposure to aromatase inhibitors had the highest risk of their cancer coming back.

These findings helped to identify high-risk patients whose cancer was likely to come back and so required additional treatment above the current standard of care. This national trial engaged patients and doctors throughout the UK and helped to promote the desire for Ki67 biomarker testing as part of routine practice in the clinic.

Professor Johnston said, The pioneering work done by The Royal Marsden and the ICR is unrivalled elsewhere. Our close collaborations with the Cancer Research UK-funded Clinical Trials and Statistics Unitat the ICR and the scientists involved in the development of biomarkers made it possible to do the POETIC trial and plan the follow up POETIC-A trial, which started in 2020. These trials help to increase our understanding of the disease and how we can overcome resistance.

A measure of cancer treatment is not only how effective it is, but also how well tolerated it is by patients. Its important that research is used to find smarter and kinder treatments, and the joint team has excelled in this area.

The award recognises approaches that have led to de-escalation of breast cancer treatment. Long-standing research conducted by Professor John Yarnoldand Professor Bliss, and their wider teams, has revolutionised the way radiotherapy is delivered to people with breast cancer. This work was done in partnership with many other clinical leads at hospitals across the UK.

The findings from their clinical trials demonstrated that patients could be treated safely and effectively with fewer and bigger radiotherapy doses. Their remarkable discovery changed the treatment, for some patients, from being delivered in 25 doses over five weeks to just five doses over one week, reducing overall treatment time, the burden of that time on patients and hospital costs. This was particularly impactful during the Covid-19 pandemic when patients needed to receive treatment but minimise the time spent in hospitals.

Professor Bliss spoke about the impact of the radiotherapy trials saying, These trials investigated the balance of being able to keep recurrence rates down without causing more side effects. Our findings have been practice-changing and have had a great impact on the treatment pathways for breast cancer patients worldwide. They have also reduced inequalities by expanding access to the best treatment for patients in an impartial manner.

The team have also developed a test, known as a liquid biopsy, that detects tumour DNA circulating in the blood. By analysing samples of blood plasma from breast cancer patients to see if that tumour DNA is present, researchers can predict which patients are at risk of recurrence. This work, led by Professor Nick Turner, provides a less invasive way to assess patients and their response to therapy, avoiding the need for repeat tumour biopsies.

A recent phase II trial (plasmaMATCH), involving Professor Turner, Professor Bliss and Dr Alistair Ring, assessed the feasibility and clinical use of liquid biopsies in breast cancer patients it has shown promising results. The team have launched additional trials to further assess the potential use of liquid biopsies in guiding cancer therapy.

While most people with primary breast cancer, which hasnt spread, have a high survival rate because of the availability of effective treatments and the accessibility of tumours for surgical intervention, metastatic disease is still considered incurable.

Progress in treating advanced disease is urgently needed and the award recognised the discovery of molecular changes in breast cancer that drive some of the more aggressive behaviours in advanced breast cancer.

Professor Clare Isacke and her teams research focuses on how breast cancer cells interact with their environment during the early stages of metastatic colonisation. They have developed new ways to study advanced breast cancer using metastasis models in mice, which has provided important insights into how breast cancer cells adapt to survive in secondary sites and evolve to resist treatment. Their discoveries about how certain cells, called cancer associated fibroblasts, nourish tumour seedlings, have revealed potential therapeutic targets for advanced breast cancer.

Professor Pascal Meierand his team, whose work centres on cell death, have discovered proteins that regulate cell survival and inflammation. They are trying to change the way cancer cells die so that it activates the immune system and helps to fight the tumour cells more effectively. Their work uncovering how breast cancer cells escape death may help to develop new strategies for cancer therapies.

Image: Picture of the winning team from the ICR and The Royal Marsden. Credit:soora.co.uk

The ICR and The Royal Marsden have a close partnership that goes back many decades, which has been particularly productive for breast cancer research. Professor Johnston said, We are a close-knit team and have worked together for over 20 years. The regular dialogue between the basic scientists who are studying the biology of the disease and clinician scientists who are translating that into better treatments for patients facilitates easy transfer of knowledge. Our collaboration advances our understanding of breast cancer and also enables clinical trials to be set up relatively seamlessly.

Professor Lord also emphasised the unique partnership between the two organisations saying, Our close collaboration means any potential opportunity to translate is not lost. This ultimately means we can get new cancer treatments out to patients quickly.

Breast Cancer Now and Cancer Research UKfunded much of the teams research at the ICR. Professor Isacke said: The partnership between the ICR and The Royal Marsden really provides the best environment to do cancer research. Its a huge credit to the Breast Cancer Now charity, which set up a dedicated research centreat the ICR and created the space for us to do our research. They have continued to fund our research and support us all these years.

Speaking about the Team Science Award, Professor Tutt said, Its an amazing honour to receive this award. The AACR is one of the worlds biggest and most prestigious cancer research organisations and for them to have recognised a UK based team for the work weve done in breast cancer is a massive achievement.

Its unusual for this to be awarded to a team outside of the US. For us to have been that team, in fact for the second time now for the ICR, is a testament to what the ICR and its clinical partners at the Royal Marsden can achieve. We want to make fundamental discoveries that improve the outlook for our patients with breast cancer, and to be recognised for that, I think is as good as it gets.

He stressed, Each named member is a figurehead for a wider team who have been involved in the work, so this victory is shared by many.

Professor Lord agreed, It really does take an entire army of people to deliver all of that work. The AACR Team Science Award neatly illustrates that if you want to achieve things that make a real difference to people who actually have cancer, it needs a multidisciplinary team and involves an enormous amount of teamwork.

The winners of the AACR Team Science Award are Professor Alan Ashworth, Professor Judith Bliss, Professor Mitch Dowsett, Professor Clare Isacke, Professor Stephen Johnston, Professor Chris Lord, Professor Pascal Meier, Dr Alistair Ring, Professor Ian Smith, Professor Nick Turner, Professor Andrew Tutt, and Professor John Yarnold.

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From bench to bedside and beyond: the team of scientists that transformed breast cancer treatment - The Institute of Cancer Research

Authorities said an arsonist likely burned down Knoxville's Planned Parenthood clinic on New Year's Eve in Dec. 2021.

KNOXVILLE, Tenn. It has been around 4 months since a Planned Parenthood medical clinic in East Knoxville was likely set on fire by an arsonist, according to the Knoxville Fire Department. It burned down on the morning of New Year's Eve in December 2021.

Leaders of the Planned Parenthood of Tennessee and North Mississippi branch said they planned to rebuild the clinic and welcome patients once again.

We will rebuild at our Cherry Street location," said Aimee Lewis, the vice president of external affairs. "We expect the design phase, which we are currently in, to take approximately 6 months and construction to take a year. While we work with our architects, builders and insurance to make this happen, we are exploring options to provide in-person services in some capacity in the meantime."

She said they are continuing to offer limited telehealth options and referrals for patients while trying to expand healthcare options by hiring more providers and staff.

In 2021, the clinic served almost 4,000 patients. More than 2,400 went to the medical facility for birth control and to test for sexually-transmitted diseases, while another 712 sought gender-affirming hormone therapy. Officials said 815 were there for abortion treatments.

The clinic had posted before burning down that it was closed for renovation "to enhance and expand our patient services."

Officials previously said they expected it would cost around $2.2 million to rebuild, in addition to the $2.2 million they had already spent on the renovation project the center burned down.

Recently, MacKenzie Scott donated a historic $275 million to support Planned Parenthood at the national level.

Regarding MacKenzie Scotts incredible generosity, Planned Parenthood of Tennessee and North Mississippi did not receive a donation," said Lewis. "However, this gift is a testament to the very strong health care network that the Planned Parenthood federation and its affiliates provide for its patients all over the country. Were excited to see what Ms. Scotts investment in our sister affiliates will do to bring care and education to the patients they serve.

Anyone with information about the arsonist or arsonists involved in the Knoxville branch's fire should reach out to KFD at 1-800-762-3017 or email them at KFDArson@Knoxvilletn.gov. They previously offered a reward of up to $10,000 for information.

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'We will rebuild' | Knoxville Planned Parenthood leader expects year-and-a-half of work to reopen clinic - WBIR.com

CULTURAL INDOCTRINATION WAR.Recently, leftist activists and their allies in the media had a big success labeling a bill passed by the Florida Legislature as the "Don't Say Gay" bill. They claimed, without evidence, that the Republican-sponsored bill would ban the mention of homosexuality in Florida schools. In fact, the bill, now signed into law by Gov. Ron DeSantis, prohibited "classroom instruction" on "sexual orientation or gender identity" by teachers or other adults in kindergarten through third grade. It also said such instruction after third grade must be "age-appropriate" or "developmentally appropriate." In other words, it specifically allowed classroom instruction on such matters after third grade. Nevertheless, LGBTQIA+ activists called the bill "Don't Say Gay." Many media outlets and commentators picked it up immediately.

Now, just a month later, the same alliance is at it again. The Alabama Legislature has passed a bill banning hormone treatment, puberty blockers, and surgery for minors who say they want to change their gender. "Minors, and often their parents, are unable to comprehend and fully appreciate the risk and life implications, including permanent sterility, that result from the use of puberty blockers, cross-sex hormones, and surgical procedures," the Republican-sponsored bill says. "For these reasons, the decision to pursue a course of hormonal and surgical interventions to address a discordance between the individual's sex and sense of identity should not be presented to or determined for minors who are incapable of comprehending the negative implications and life-course difficulties attending to these interventions." A "minor," for the purposes of this measure, is defined in Alabama law as "a person who is under 19 years of age."

So the law bans certain drastic treatments and procedures for children 18 and under. And this is the headline of the New York Times story reporting it: "Alabama Lawmakers Approve Ban on Medical Care for Transgender Youth."

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A ban on medical care? If a "transgender youth," that is, 18 or under, breaks his or her leg or catches pneumonia or is diagnosed with cancer is that person denied medical care under the new law? Would it be illegal for a doctor to treat them? Obviously not. And is there a consensus that puberty blockers, hormone treatments, amputations, and other surgeries, irreversible actions, are appropriate "medical care" for young people age 18 and under? Those are questions raised by the New York Times headline.

NPR took a slightly different route, headlining its story "Alabama Legislature votes to ban gender-affirming medical care for transgender youth." The phrase "gender-affirming" has entered wide use quite recently and is a euphemism for medical procedures not to affirm but to change one's gender. For example, this explainer from the Mayo Clinic mentions "gender affirming genital surgical procedures, such as penile inversion vaginoplasty." For its part, the New York Times article describes the Alabama law as the criminalization of "gender-affirming surgeries."

The Biden White House is fully on board. On Thursday, press secretary Jen Psaki said, "To be clear, every major medical association agrees that gender-affirming healthcare for transgender kids is a best practice and potentially lifesaving." The Alabama law, Psaki continued, "would target trans youth with tactics that threaten to put pediatricians in prison if they provide medically necessary, lifesaving healthcare."

On March 31, the Biden administration released a statement celebrating what is called the "Transgender Day of Visibility." The statement used the word "affirm" or "affirming" 29 times. Some examples: The administration pledged to strengthen federal measures to "protect transgender youth against discrimination, including when those youth seek gender-affirming care." It pledged to emphasize "the positive impact of gender-affirming care on youth mental health." It pledged to confirm that "providing gender-affirming care is neither child maltreatment nor malpractice." It pledged to create an information bank to show why "gender-affirming care ... is important to transgender, nonbinary, and other gender expansive young people's well-being." It pledged to use the Justice Department to knock down laws like Alabama's by "reaffirming that transgender children have the right to access gender-affirming health care."

And so on. You get the idea. Not surprisingly, the phrase "gender-affirming" and its variants are showing up more and more in the media discussion of puberty blockers, hormone treatments, and surgery. Such measures are also benignly described as "medical care." And who could be against medical care? Who could respond negatively to a positive word like "affirming?"

Just like the "Don't Say Gay" situation, supporters of the Florida bill and now the Alabama bill, and other bills like them around the country, face a battle of language as well as substance. And with the current administration, the activist world, and much of the media arrayed against them, it is an uphill battle.

For a deeper dive into many of the topics covered in the Daily Memo, please listen to my podcast, The Byron York Show available on the Ricochet Audio Network and everywhere else podcasts can be found. You can use this link to subscribe.

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Cultural indoctrination war - Washington Examiner

Amryt Pharma plc

Amryt Announces Positive Long-Term Safety and Efficacy Data for Mycapssa (oral octreotide) from the 2nd Year of OPTIMAL Open Label Extension Study in Acromegaly Patients

Acromegaly patients were exposed to Mycapssa during the OPTIMAL Phase 3 Trial, including its open label extension (OLE), for a maximum treatment duration of 3.2 years

Study demonstrated that 100% of evaluable patients who entered the 2nd year OLE phase of the study as responders - insulin-like growth factor 1 (IGF-1) within normal limits - maintained their long-term biochemical response at the end of the study

IGF-1 levels were stably maintained within normal limits at the end of the OLE period (mean IGF-1 levels at baseline and at the end of the OLE were 0.92 and 0.84 respectively)

Growth hormone (GH) levels also improved at the end of the OLE period (mean GH levels at baseline and at the end of the OLE were 0.79 and 0.45 respectively)

Long-term safety profile of Mycapssa during the OLE was consistent with that observed in prior studies

DUBLIN, Ireland, and Boston MA, April 13, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today presents long-term safety and efficacy data from the 2nd year open-label extension (OLE) of its global Phase 3 OPTIMAL clinical trial that compared Mycapssa (octreotide capsules) to placebo for maintenance of biochemical response in patients with acromegaly. The OPTIMAL trial supported the approval of Mycapssa in the United States for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.

Susan L Samson, MD, PhD, at Mayo Clinic (Jacksonville, Florida), and lead investigator of the OPTIMAL study commented: These data together with the recently published positive results from the 3 years OLE period of the MPOWERED Phase 3 study further supports the long-term safety and efficacy of Mycapssa (oral octreotide) in acromegaly patients who were previously biochemically controlled on monthly injectable Somatostatin Receptor Ligands (iSRLs). The data showing that 100% of responders (IGF-1 within normal limits) maintained their response at the end of the 2nd year of the OLE, confirming the durability of response over time.

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Dr. Mark Sumeray, Chief Medical Officer of Amryt, commented: The OPTIMAL 2nd year OLE data show that acromegaly patients who were switched from iSRLs to Mycapssa may benefit from a daily oral treatment based on maintenance of long-term biochemical response.

OPTIMAL Phase 3 Trial Open-Label Long-Term Safety & Efficacy Data40 patients that completed the 9 months double-blind placebo controlled (DPC) core treatment phase elected to continue treatment with Mycapssa in the OPTIMAL open label extension study (20 patients that were originally randomized to Mycapssa and 20 that were randomized to placebo). Results from the first year were published previously and demonstrated that all patients who responded to Mycapssa (IGF-1 within normal limits) during the DPC period and enrolled in the OLE (n=14) completed the 48-week period and 93% (13/14) maintained their IGF-1 response within the normal limit at the end of this period. 32 patients continued treatment into the 2nd year of the OLE (18 of those originally randomized to Mycapssa during the DPC and 14 of those randomized to placebo).

Key 2nd year study outcomes included:

31 out of 32 patients (97%) of those enrolled to the 2nd year of the OLE completed 96 weeks in the OLE period

100% of evaluable patients, who entered the 2nd year OLE phase of the study as responders (IGF-1 within normal limits; N=17), maintained their long-term biochemical response at the end of the study. The average IGF-1 levels of enrolled patients were stably maintained within the normal limits at the end of the OLE period (mean IGF-1 levels at baseline OLE and at the end of the OLE were 0.92 and 0.84 respectively).

93% of all patients who entered the 2nd year OLE phase (N=32) were responders at the end of the 96 weeks OLE

The average GH levels of enrolled patients improved at the end of the OLE period (mean GH levels at baseline OLE and at the end of the OLE were 0.79 and 0.45 respectively)

Acromegaly patients were exposed to Mycapssa during the OPTIMAL study (including its OLE phase), for a median treatment duration of 2.1 years and a maximal exposure of 3.2 years

Patients in the OLE demonstrated a median compliance rate of 98% over this period of time

The long-term safety profile of Mycapssa during the OLE, was consistent with the safety profile observed during previous studies with Mycapssa with no new safety signals with long-term exposure

About the OPTIMAL Phase 3 TrialThe OPTIMAL trial (NCT03252353) was a randomized, double-blind, placebo-controlled, nine-month Phase 3 clinical trial of octreotide capsules in 56 adult acromegaly patients whose disease was biochemically controlled by injectable somatostatin analogs (octreotide or lanreotide). Patients were randomized on a 1:1 basis, to octreotide capsules or placebo. The primary endpoint of the trial was the proportion of patients who maintained their biochemical response (IGF-1 levels 1.0 ULN), at the end of the nine-month, double-blind, placebo-controlled period. Hierarchical secondary endpoints included: (i) proportion of patients who maintain GH response at 9 months; (ii) time to loss of response; and (iii) proportion of patients requiring reversion to prior treatment. The OPTIMAL study met the primary endpoint and all secondary endpoints which led to the US approval of Mycapssa, the first oral somatostatin analog, for the long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.

FDA APPROVED INDICATION AND USAGEMycapssa delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

IMPORTANT SAFETY INFORMATIONWARNINGS AND PRECAUTIONSMycapssa can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected. Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly. Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.

The full US Prescribing Information for Mycapssa is available at http://www.mycapssa.com.

About AcromegalyAcromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. Amryt estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analog injections in the United States.

About Amryt Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.

Amryts commercial business comprises three orphan disease products metreleptin (Myalept/ Myalepta); oral octreotide (Mycapssa); and lomitapide (Juxtapid/ Lojuxta).

Myalept/Myalepta (metreleptin) is approved in the US (under the trade name Myalept) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link.

Mycapssa (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa is the first and only oral somatostatin analog approved by the FDA. Mycapssa has also been submitted to the EMA and is not yet approved in Europe. For additional information, please follow this link.

Juxtapid/Lojuxta (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid) and in the EU, Israel, Saudi Arabia and Brazil (under the trade name Lojuxta). For additional information, please follow this link.

Amryt's lead development candidate, Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (EB), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez has been selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB.

Amryts pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, and the polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders.

Amryt also intends to develop oral medications that are currently only available as injectable therapies through its Transient Permeability Enhancer (TPE) technology platform. For more information on Amryt, including products, please visit http://www.amrytpharma.com.

Forward-Looking StatementsThis announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Companys current beliefs and assumptions and are based on information currently available to management.

ContactsJoe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, ir@amrytpharma.comTim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, tim@lifesciadvisors.com

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Amryt Announces Positive Long-Term Safety and Efficacy Data for Mycapssa (oral octreotide) from the 2nd Year of OPTIMAL Open Label Extension Study in...

Your elevated hematocrit/hemoglobin might well be directly related to your TRT. If so, there are ways to address that. However, your TRT might only be partly to blame as there are other conditions that can either contribute to high hematocrit/hemoglobin or even give false readings.

Depending on your situation, here are several ways to address high levels of hematocrit/hemoglobin:

This is the most obvious solution to elevated hematocrit, but it's probably also the least popular. Hardly any man wants to use less testosterone and give up any of the increased energy, sexuality, and muscularity that the hormone has gifted him. But truth be told, a lot of men are probably taking more than they need. The standard TRT clinic dosage is 200 mg. a week, which is, frankly, equivalent to a mild steroid cycle.

A study conducted by the Department of Urology at University of California found that subcutaneous (subQ) injections (under the skin rather than into the muscle) led to higher levels of free T, along with evidence of subQ being physiologically superior to IM shots in several other important ways.

Men who received subQ injections of testosterone exhibited the following:

The second result is the kicker. Since subQ injections led to a 41% reduction in hematocrit levels, you could theoretically use the same dosage you use for intramuscular injections. Of course, given that subQ injections led to a 14% increase in total T, you might just use a lesser dosage anyhow and further reduce hematocrit while retaining all the positive effects of your TRT.

Studies have shown that testosterone creams and gels raise hematocrit less than intramuscular testosterone injections.

This is the standard go-to treatment for high hematocrit. Every pint donated has been shown to decrease hematocrit by about 3 points. Unfortunately, you'd likely have to continue to periodically donate blood if you hadn't adopted any other hematocrit-lowering strategies.

That being said, there's some evidence that hematocrit levels stabilize after donating blood five times. Whether that's universally true is unlikely.

You can donate blood to places like the Red Cross or have your doctor perform what's known as a "therapeutic blood draw." Be careful not to donate too often, though. Giving a pint of blood more than every two and a half months or so may lead to long stints of fatigue.

High hematocrit readings sometimes occur because the patient was simply dehydrated, making it appear that the concentration of red blood cells was higher than it really was.

Of course, one simple way to determine whether your high hematocrit was caused by dehydration is to do a little simple math: hematocrit must always be three times the value of hemoglobin. If it's lower (Hct<3 x Hb), you're over-hydrated. If it's higher (Hct>3 x Hb), you're dehydrated. Either way, you're getting a false value because of your hydration status.

Red meats are high in heme iron (the type of iron found only in animal tissues), which is more efficiently absorbed than non-heme iron (the type found in whole grains, nuts, seeds, legumes, and leafy greens), and ingesting it can raise hemoglobin and, subsequently, hematocrit.

Sleep apnea is a medical condition where patients suffer from fragmented sleep. They literally stop breathing from 10 to 50 seconds multiple times throughout the night.

As a result of this interrupted breathing/sleep, patients experience poor oxygen saturation, which forces the body to produce more red blood cells and more hemoglobin.

Evidence suggests that curcumin binds to ferric acid in the digestive system, thus reducing hemoglobin levels. Be sure to use micellar curcumin which is 95 times more bioavailable than regular curcumin with piperine.

If you've got high hematocrit/hemoglobin AND have high blood pressure, ask your doctor to consider switching your high blood pressure medicine to Losartan. It's been used by physicians since the early 2000s to bring down hematocrit in kidney transplant patients and patients with chronic obstructive pulmonary disease (COPD).

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TRT Side Effects: The Big One to Avoid - T NATION