In a time where political partisanship is at an all-time high, and even highly personal issues such as gender or sexual identity policies are moving into either right or left camps, politicians should be cautious in considering their positions on this issue.

Legislation passed this week that was tied to increasing the capacity of behavioral health care for children in the state, came with some strings attached primarily that state funding for life-altering transgender treatments for youth would be restricted. The legislation states that no money may be spent by the University Hospitals Authority for the benefit of any facility owned by the University Hospitals Authority or University Hospitals Trust performing gender reassignment medical treatment on any patient younger than 18.

The controversy swirls mostly around the University of Oklahoma Childrens Hospital, which operates a program that provides gender-affirming scope of treatment that includes using puberty blockers, managing gender-affirming hormone therapy and finding surgeons who perform gender-reassignment surgeries.

There still is so much to understand and learn about what many young people are facing when it comes to gender and sexual identity. We believe hospitals and physicians should be a part of working with children and families on those issues; however, when it comes to performing these life-altering procedures on children, there is legitimate concern in medical circles to exercise great caution.

A recent New York Times article points out that these procedures raise definite ethical questions, and some experts urge caution in treating children with puberty-blocking drugs and hormones.

The article states some clinicians have pointed to the rising demand and the turmoil of adolescent development as reasons for doctors to slow down before offering irreversible procedures. Although medical experts believe the likelihood to be small, some patients come to regret their surgeries.

This is not an issue of not trusting parents or physicians judgment regarding the needs of their children or patients, as some Democratic supporters suggest. Any type of life-altering surgery performed on a minor should be very carefully considered. We understand these issues put parents and caregivers in a sensitive position because they want to do what they can to help their children; however, children under the age of 18 do not have the judgment needed to make such drastic decisions.

Lawmakers have the right to withhold taxpayer funding for these types of programs performed at state-funded hospitals. However, outlawing or criminalizing medical facilities and professionals should not be on the table. Instead, lawmakers take the time and effort to further study the issue with care and honest consultation with physicians and families.

We are making critical coverage of the coronavirus available for free. Please consider subscribing so we can continue to bring you the latest news and information on this developing story.

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EDITORIAL: Political stances on gender reassignment treatment for minors need to be carefully considered - Enid News & Eagle

Recommendation and review posted by Bethany Smith

EL PASO, Texas, Oct. 6, 2022 /PRNewswire/ -- With more than 20 years of experience providing comprehensive healthcare and programs to Texas women, Superior HealthPlan is urging members to schedule routine appointments and screenings to help prevent breast cancer. This is part of a larger effort by Superior in support of National Breast Cancer Awareness Month in October.

"This national awareness campaign serves as an important reminder to those in need of a mammogram to contact their physician for support," said Dr. David Harmon, Chief Medical Director at Superior. "Early detection and treatment are essential in the fight against breast cancer, and we want to encourage everyone to get the care they need."

This year alone, an estimated 20,000 women in Texaswill be diagnosed with breast cancer, and nearly 3,400 of those women will die from the disease. Women older than 40 should consider beginning annual breast cancer screenings with mammograms, and potentially earlier if they have a family history of breast cancer. Below are a few ways to lower risk and take preventive steps:

Along with early prevention and other steps, Superior offers several programs and support for women. This includes Care Management specifically for women who have been diagnosed with breast cancer. This program is featured in a new videothat explores the story of Autumn, a Superior HealthPlan member who has a history of breast cancer in her family.

Superior can help members connect with their primary care physician, either through telehealth or in-person visits. Members can use the "Find a Provider" tool or call Superior at 1-800-783-5386.

For more about Superior's services and benefits, visit http://www.SuperiorHealthPlan.com.

Founded in 1999,Superior HealthPlanis a managed care company that delivers quality healthcare throughout Texas. Committed to transforming the health of the community, one person at a time, Superior supports active local involvement in all 254 Texas counties with 3,000 employees throughout the state. Superior is a wholly-owned subsidiary of Centene Corporation, a leading healthcare enterprise that is committed to helping people live healthier lives. More information on Superior can be found at http://www.SuperiorHealthPlan.com.

SOURCE Superior HealthPlan

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Superior HealthPlan Promotes Breast Cancer Screenings this October - PR Newswire

Recommendation and review posted by Bethany Smith

Hormone Replacement Therapy Market report focuses on the market size, segment size (mainly covering product type, application, and geography), competitor landscape, recent status, and development trends. Furthermore, this research report is spread across 112 Pages and provides detailed cost analysis, supply chain, exclusive information, vital statistics, trends, and competitive landscape.

The Hormone Replacement Therapy Market size to grow from USD 16398.52 million in 2021 to USD 32290.63 million by 2027, at a Compound Annual Growth Rate (CAGR) of 11.96% during the forecast period. Global Hormone Replacement Therapy market report aims at estimating the market size and growth potential of the market across different segments, such as components, deployment mode, organization size, types, application, and region. The Hormone Replacement Therapy market has been segmented into major regions: United States, Europe, China, Japan, India, Southeast Asia, Latin America, and MEA. This report covers an in-depth competitive analysis of the key players along with their company profiles, key observations, product and business offerings, recent developments, and key market strategies.

Get a sample PDF of the report at https://www.industryresearch.biz/enquiry/request-sample/21512865

The report evaluates and categorizes global vendors in the Hormone Replacement Therapy Market based on Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that helps businesses in better decision making and understanding the competitive landscape.

Which are the prominent Hormone Replacement Therapy Market players across the globe?

Top Key Players covered in the report are:

This is accomplished by current information on the most vital drivers, current trends, risks and restrictions, opportunities, and the most promising development areas. It will also help in analyzing new business strategies to execute further business expansion and growth during a forecast period.

Get A Sample PDF Of The Hormone Replacement Therapy Market Report

Short Summary About Hormone Replacement Therapy Market:

The global Hormone Replacement Therapy market size was valued at USD 16398.52 million in 2021 and is expected to expand at a CAGR of 11.96% during the forecast period, reaching USD 32290.63 million by 2027.

The report combines extensive quantitative analysis and exhaustive qualitative analysis, ranging from a macro overview of the total market size, industry chain, and market dynamics to micro details of segment markets by type, application, and region, and, as a result, provides a holistic view of, as well as a deep insight into the Cobalt Tetroxide market covering all its essential aspects.

For the competitive landscape, the report also introduces players in the industry from the perspective of the market share, concentration ratio, etc., and describes the leading companies in detail, with which the readers can get a better idea of their competitors and acquire an in-depth understanding of the competitive situation. Further, mergers and acquisitions, emerging market trends, the impact of COVID-19, and regional conflicts will all be considered.

In a nutshell, this report is a must-read for industry players, investors, researchers, consultants, business strategists, and all those who have any kind of stake or are planning to foray into the market in any manner.

Which region is expected to hold the highest market share in the Hormone Replacement Therapy Market?

Geographically, the report includes several key regions, with sales, revenue, research on production, consumption, market share, and growth rate, and forecast (2017 -2027) of the following regions:

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The report focuses on the Hormone Replacement Therapy market size, segment size (mainly covering product type, application, and geography), competitor landscape, recent status, and development trends. Furthermore, the report provides detailed cost analysis, and supply chain. Technological innovation and advancement will further optimize the performance of the product, making it more widely used in downstream applications. Moreover, Consumer behavior analysis and market dynamics (drivers, restraints, opportunities) provide crucial information for knowing the Hormone Replacement Therapy market.

Based on types, the Hormone Replacement Therapy market from 2017 to 2027 is primarily split into:

Based on applications, the Hormone Replacement Therapy market from 2017 to 2027 covers:

Whats Included in the Report

TO KNOW HOW COVID-19 PANDEMIC AND RUSSIA UKRAINE WAR WILL IMPACT THIS MARKET REQUEST SAMPLE

Some of the key questions answered in this report:

Following Chapter Covered in the Hormone Replacement Therapy Market Research:

Chapter 1 mainly defines the market scope and introduces the macro overview of the industry, with an executive summary of different market segments ((by type, application, region, etc.), including the definition, market size, and trend of each market segment.

Chapter 2 provides a qualitative analysis of the current status and future trends of the market. Industry Entry Barriers, market drivers, market challenges, emerging markets, consumer preference analysis, together with the impact of the COVID-19 outbreak will all be thoroughly explained.

Chapter 3 analyzes the current competitive situation of the market by providing data regarding the players, including their sales volume and revenue with corresponding market shares, price and gross margin. In addition, information about market concentration ratio, mergers, acquisitions, and expansion plans will also be covered.

Chapter 4 focuses on the regional market, presenting detailed data (i.e., sales volume, revenue, price, gross margin) of the most representative regions and countries in the world.

Chapter 5 provides the analysis of various market segments according to product types, covering sales volume, revenue market share, and growth rate, plus the price analysis of each type.

Chapter 6 shows the breakdown data of different applications, including the consumption and revenue with market share and growth rate, with the aim of helping the readers to take a close-up look at the downstream market.

Chapter 7 provides a combination of quantitative and qualitative analyses of the market size and development trends in the next five years. The forecast information of the whole, as well as the breakdown market, offers the readers a chance to look into the future of the industry.

Chapter 8 is the analysis of the whole market industrial chain, covering key raw materials suppliers and price analysis, manufacturing cost structure analysis, alternative product analysis, also providing information on major distributors, downstream buyers, and the impact of COVID-19 pandemic.

Chapter 9 shares a list of the key players in the market, together with their basic information, product profiles, market performance (i.e., sales volume, price, revenue, gross margin), recent development, SWOT analysis, etc.

Chapter 10 is the conclusion of the report which helps the readers to sum up the main findings and points.

Chapter 11 introduces the market research methods and data sources.

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Years considered for this report:

Detailed TOC of Hormone Replacement Therapy Market Forecast Report 2022-2027:

1 Hormone Replacement Therapy Market Overview1.1 Product Overview and Scope of Hormone Replacement Therapy Market1.2 Hormone Replacement Therapy Market Segment by Type1.2.1 Global Hormone Replacement Therapy Market Sales Volume and CAGR (%) Comparison by Type (2017-2027)1.3 Global Hormone Replacement Therapy Market Segment by Application1.3.1 Hormone Replacement Therapy Market Consumption (Sales Volume) Comparison by Application (2017-2027)1.4 Global Hormone Replacement Therapy Market, Region Wise (2017-2027)1.4.1 Global Hormone Replacement Therapy Market Size (Revenue) and CAGR (%) Comparison by Region (2017-2027)1.4.2 United States Hormone Replacement Therapy Market Status and Prospect (2017-2027)1.4.3 Europe Hormone Replacement Therapy Market Status and Prospect (2017-2027)1.4.4 China Hormone Replacement Therapy Market Status and Prospect (2017-2027)1.4.5 Japan Hormone Replacement Therapy Market Status and Prospect (2017-2027)1.4.6 India Hormone Replacement Therapy Market Status and Prospect (2017-2027)1.4.7 Southeast Asia Hormone Replacement Therapy Market Status and Prospect (2017-2027)1.4.8 Latin America Hormone Replacement Therapy Market Status and Prospect (2017-2027)1.4.9 Middle East and Africa Hormone Replacement Therapy Market Status and Prospect (2017-2027)1.5 Global Market Size of Hormone Replacement Therapy (2017-2027)1.5.1 Global Hormone Replacement Therapy Market Revenue Status and Outlook (2017-2027)1.5.2 Global Hormone Replacement Therapy Market Sales Volume Status and Outlook (2017-2027)1.6 Global Macroeconomic Analysis1.7 The impact of the Russia-Ukraine war on the Hormone Replacement Therapy Market

2 Industry Outlook2.1 Hormone Replacement Therapy Industry Technology Status and Trends2.2 Industry Entry Barriers2.2.1 Analysis of Financial Barriers2.2.2 Analysis of Technical Barriers2.2.3 Analysis of Talent Barriers2.2.4 Analysis of Brand Barrier2.3 Hormone Replacement Therapy Market Drivers Analysis2.4 Hormone Replacement Therapy Market Challenges Analysis2.5 Emerging Market Trends2.6 Consumer Preference Analysis2.7 Hormone Replacement Therapy Industry Development Trends under COVID-19 Outbreak2.7.1 Global COVID-19 Status Overview2.7.2 Influence of COVID-19 Outbreak on Hormone Replacement Therapy Industry Development

3 Global Hormone Replacement Therapy Market Landscape by Player3.1 Global Hormone Replacement Therapy Sales Volume and Share by Player (2017-2022)3.2 Global Hormone Replacement Therapy Revenue and Market Share by Player (2017-2022)3.3 Global Hormone Replacement Therapy Average Price by Player (2017-2022)3.4 Global Hormone Replacement Therapy Gross Margin by Player (2017-2022)3.5 Hormone Replacement Therapy Market Competitive Situation and Trends

4 Global Hormone Replacement Therapy Sales Volume and Revenue Region Wise (2017-2022)4.1 Global Hormone Replacement Therapy Sales Volume and Market Share, Region Wise (2017-2022)4.2 Global Hormone Replacement Therapy Revenue and Market Share, Region Wise (2017-2022)4.3 Global Hormone Replacement Therapy Sales Volume, Revenue, Price and Gross Margin (2017-2022)4.4 United States Hormone Replacement Therapy Sales Volume, Revenue, Price and Gross Margin (2017-2022)4.5 Europe Hormone Replacement Therapy Sales Volume, Revenue, Price and Gross Margin (2017-2022)4.6 China Hormone Replacement Therapy Sales Volume, Revenue, Price and Gross Margin (2017-2022)4.7 Japan Hormone Replacement Therapy Sales Volume, Revenue, Price and Gross Margin (2017-2022)4.8 India Hormone Replacement Therapy Sales Volume, Revenue, Price and Gross Margin (2017-2022)4.9 Southeast Asia Hormone Replacement Therapy Sales Volume, Revenue, Price and Gross Margin (2017-2022)4.10 Latin America Hormone Replacement Therapy Sales Volume, Revenue, Price and Gross Margin (2017-2022)4.11 Middle East and Africa Hormone Replacement Therapy Sales Volume, Revenue, Price and Gross Margin (2017-2022)

5 Global Hormone Replacement Therapy Sales Volume, Revenue, Price Trend by Type5.1 Global Hormone Replacement Therapy Sales Volume and Market Share by Type (2017-2022)5.2 Global Hormone Replacement Therapy Revenue and Market Share by Type (2017-2022)5.3 Global Hormone Replacement Therapy Price by Type (2017-2022)5.4 Global Hormone Replacement Therapy Sales Volume, Revenue and Growth Rate by Type (2017-2022)

6 Global Hormone Replacement Therapy Market Analysis by Application6.1 Global Hormone Replacement Therapy Consumption and Market Share by Application (2017-2022)6.2 Global Hormone Replacement Therapy Consumption Revenue and Market Share by Application (2017-2022)6.3 Global Hormone Replacement Therapy Consumption and Growth Rate by Application (2017-2022)

7 Global Hormone Replacement Therapy Market Forecast (2022-2027)7.1 Global Hormone Replacement Therapy Sales Volume, Revenue Forecast (2022-2027)7.1.1 Global Hormone Replacement Therapy Sales Volume and Growth Rate Forecast (2022-2027)7.1.2 Global Hormone Replacement Therapy Revenue and Growth Rate Forecast (2022-2027)7.1.3 Global Hormone Replacement Therapy Price and Trend Forecast (2022-2027)7.2 Global Hormone Replacement Therapy Sales Volume and Revenue Forecast, Region Wise (2022-2027)7.3 Global Hormone Replacement Therapy Sales Volume, Revenue and Price Forecast by Type (2022-2027)7.4 Global Hormone Replacement Therapy Consumption Forecast by Application (2022-2027)

8 Hormone Replacement Therapy Market Upstream and Downstream Analysis8.1 Hormone Replacement Therapy Industrial Chain Analysis8.2 Key Raw Materials Suppliers and Price Analysis8.3 Manufacturing Cost Structure Analysis8.3.1 Labor Cost Analysis8.3.2 Energy Costs Analysis8.3.3 RandD Costs Analysis8.4 Alternative Product Analysis8.5 Major Distributors of Hormone Replacement Therapy Analysis8.6 Major Downstream Buyers of Hormone Replacement Therapy Analysis8.7 Impact of COVID-19 and the Russia-Ukraine war on the Upstream and Downstream in the Hormone Replacement Therapy Industry

Continued

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Recommendation and review posted by Bethany Smith

Fast fashion may go easy on your wallet...but is it secretly tough on your health? Here's why one toxicology doctor says she's "most concerned" about what you and your family are putting on.

Fast fashion may cycle through trends at the speed of lightbut it certainly has staying power. As PC Magazine reported this past July, the online retailer Shein dethroned Amazon as the most popular shopping app in the world. But the meteoric rise of some comparable fashion brands is troubling some health experts. In 2021, a team of researchers at the University of Toronto ran tests on some popular clothing and accessories brands. For one fast fashion brand in particular, they found that one in every five items contained unsafe levels of lead.

Why Lead May Be Lurking in Your Favorite Lipstick

And its not just fast fashionor, just leadthat areprompting concern about unsuspectedtoxins in our everyday products. The University of Toronto report also identified another group of chemicals, called phthalates,that the researchers stated were present in some of the clothing they tested. Plus, earlier this year, Environmental Protection Agency-certified labs detected PFAs (per- and polyfluorinated substances) in activewear from popular consumer brands that also may contain PFAS, according to the non-profit consumer organization Fashion FWD.

From cosmetics and soaps to plastic bottles and even our food, were surrounded by chemicals in our daily lives. But just how much should we worry about the chemicals lurking in our clothes?

GetThe Healthy @Readers Digestnewsletterfor the latest health news delivered daily

At the federal level, the US regulates only two chemicals for the fashion industrylead and phthalatesand thats only for childrens clothing. According to Fashion FWD, The Toxic Substances Control Act requires more stringent testing and oversight around chemicals used in clothing made in the US. It sounds reassuringhowever, apparel made in the US only accounts for about 3% of American fashion.

As Kelly Johnson-Arbor, MD, a medical toxicology physician and the co-medical director at the National Capital Poison Center explains: Fast fashion clothing is often manufactured in developing countries that may not have stringent standards for keeping harmful chemicals out of clothing.

This means that almost all of the clothing items in our closets and drawers are more or less unregulated, meaning were relying on retailers to self-police their factories chemical usage. And according to the 2021 Fashion Revolution Transparency Index, only 26% of the worlds major clothing brands use a Manufacturing Restricted Substances List, which aims to eliminate hazardous chemicals in their factories.

Its worth noting that back in the US, restrictions may be tightening up at the state level. In both California and New York, legislators are pushing for stricter regulation around PFAS in textile products. Federally, the US still lags miles behind the European Union, which currently restricts 33 chemicals in textiles.

Lead is often used by manufacturers for dyeing fabricsparticularly those that are brightly colored, says Trevor Cates, ND, a naturopathic physician and author of the September 2022 book,Natural Beauty Reset.

PFAS generally turn up in clothing items as a coating to make products waterproof, stain-resistant, and breathable, according to a study by the Colorado Public Interest Research Group.

Phthalates work to soften plastic and make it more durable, and so theyre sometimes spun into fabrics to make them soft and pliable, according to the Office of Science and Society at McGill University. Theyre also common in waterproof items like rain jackets, faux leather, screen-printed t-shirts, and see-through accessories, like clear shoes, bags and umbrellas.

The goal of the 1978 ban on leaded paint was implemented to prevent accidental lead ingestion, such as from kids putting paint chips in their mouths or inhaling lead-containing dust. Lead is definitely associated with adverse health effectsincluding developmental delays, Dr. Johnson-Arbor explains.

A 2018 study published in Environmental Science and Pollution Research Internationalillustrated what can happen even if lead is not consumed by mouth. The study suggested that chemicals from clothing can transfer to, penetrate and accumulate in our skin. (The study authors noted that more research was needed for a closer analysis of each specific hazardous chemical of concern.) However, a 2019 peer-reviewed study looked specifically at phthalates in infant clothing and found that clothing does play an important role in exposure to textile chemicals.

Lead is a heavy metal, Dr. Cates says. And what happens with heavy metals is that our body takes them up and stores them in our bones, our blood, and our tissues. So, while exposure to high levels of lead is dangerous (lead poisoning can cause anemia, weakness, kidney failure, brain damage and death, according to the Centers of Disease Control and Prevention)prolonged, low-grade exposure can grow problematic.

As lead stores up in our bodies, chronic symptoms can start to emerge, Dr. Cates explains. These may include abdominal pain, constipation, forgetfulness, nausea, and depression. Lead in particular has been connected to infertility, she adds. The CDC says that people with long-term exposure to lead are also at a greater risk for high blood pressure, kidney disease, and heart disease.

These symptoms can also worsen with ageespecially for women. When estrogen levels drop after menopause, bones can start to deteriorate, Dr. Cates says. The lead thats stored in the bones will then start to be released in the bloodstream, its like you become toxic all over again.

10 Surprising Health Risks that Happen After Menopause

These are known as forever chemicals,' Dr. Cates says. They persist in the environment, and they also dont easily get out of the human body.

PFAS are also considered endocrine-disrupting chemicals because they can mimic hormones in the bodyand theyre extremely common in our lives. In fact, almost all adults in the United States have some level of PFAS in their bloodstreams, says Dr. Johnson-Arbor.

The 5 Best Hormone-Safe Sunscreens, Recommended by Doctors

Dr. Cates says that since the use of PFAS became so widespread, signs of hormonal imbalances are on the rise: greater rates of thyroid disease, breast and prostate cancer, breast development in young boys and the number of women having menstrual problems.

The CDC adds that current research suggests high levels of PFAS exposure may also cause high cholesterol, low infant birth weight, changes in liver enzymes, increased risk of pre-eclampsia (high blood pressure) in pregnant women, decreased vaccine response in children and an increased risk of kidney and testicular cancer.

Phthalates are another group of endocrine-disrupting chemicals. While Dr. Johnson-Arbor emphasizes there is still plenty to learn about the health effects of phthalates (and PFAS), a 2022 review of research found strong evidence that phthalate exposure is associated with low semen quality, childhood asthma and neurodevelopment problems. The researchers said that theres also moderate evidence that phthalates can increase the risk of low infant birth weight, endometriosis, low testosterone, ADHD, Type 2 diabetes, and breast or uterine cancer.

Plus, here are 10 toxic things you didnt know you were feeding your kids

You cant sell a $4 t-shirt without cutting some health and safety corners, so Dr. Cates main recommendation to limit your chemical exposure is to avoid fast fashion retailers altogether. Look for sustainable brands that prioritize natural fabrics and materials, such as cotton, linen, hemp, silk or bamboo. And keep a lookout for chemical keywords such as stain-resistant, waterproof, and shrink-proof.

Since lead is most harmful to young children, people can avoid dressing their infants and children in fast fashion clothing to avoid childhood exposures, adds Dr. Johnson-Arbor. I am most concerned with childrens potential exposure to these chemicals, specifically lead.

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Sources

People:

Trevor Cates, ND, a naturopathic physician and author of the upcoming book Natural Beauty Reset

Kelly Johnson-Arbor, MD, a medical toxicology physician and the co-medical director at the National Capital Poison Center

Websites:

PC Magazine: "Shein Unseats Amazon as Most Downloaded US Shopping App"

CBC: "Experts warn of high levels of chemicals in clothes by some fast-fashion retailers"

Mamavation: "Non-Toxic Activewear Guide: PFAS "Forever Chemicals" in Workout Leggings & Yoga Pants"

Fashion FWD: "Going out of fashion: US apparel manufacturers must eliminate PFAS "forever chemicals" from their supply chains"

Fashion FWD: "US policies fall short"

Fashion Revolution: "Fashion Transparency Index 2021"

DLA Piper: "California and New York propose banning textiles containing PFAS; California moves to impose significant reporting obligations"

European Chemicals Agency: "Substances we don't want in our clothes"

Colorado Public Interest Research Group: "Going Out of Fashion: U.S. apparel manufacturers must eliminate PFAS 'forever chemicals' from their supply chains"

Office of Science and Society at McGill University: "Are we at risk from wearing clothing with detectable amounts of PFASs or phthalates?"

Centers for Disease Control and Prevention: "Health Problems Caused by Lead"

Centers for Disease Control and Prevention: "What are the effects of PFAS?"

Journals:

Environmental Science and Pollution Research International: "Chemicals from textiles to skin: an in vitro permeation study of benzothiazole"

Science of the Total Environment: "Phthalates in infant cotton clothing: Occurrence and implications for human exposure"

Environment International: "Human health impacts of exposure to phthalate plasticizers: An overview of reviews"

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3 Major Toxins Have Been Found in Popular Clothing BrandsHere's What to Know - The Healthy

Recommendation and review posted by Bethany Smith

Under the Cures Act, patients can access their medical results instantly, allowing them to be more active participants in their own care. But some patients have received sensitive results, including cancer diagnoses, before they can speak to their doctors, leading to "emotional and mental harm," Danielle Friedman writes for the New York Times.

To standardize how patients receive results and increase transparency, the Cures Act, which was passed in 2016, included a provision requiring all medical testing centers to release patients' results "without delay." In addition, HHS in April 2021 began to enforce a rule that made "blocking" patients from their own health information against the law, leading to fines for doctors and hospitals.

According to Friedman, the provision on medical records was intended "bring health care into the modern era" by giving "patients easy access to their medical records, empowering them to play a more active role in their care by eliminating the doctor as gatekeeper."

For the most part, patients say they appreciate being able to access their health information directly.

"I feel more in control," said Yasi Noori-Bushehri, a 32-year-old engineer who has Graves' disease, an autoimmune disorder that affects her thyroid hormone levels. In fact, Bushehri said having access to her medical information has given her confidence to ask her doctor to change her treatment plan.

Similarly, Teresa Christopherson, a 59-year-old who routinely gets updated about the status of her breast cancer online, said receiving test results ahead of time allowed her to feel more prepared before speaking with her doctor.

"You can go into the next appointment having done your homework," Christopherson said, which helped her "ask the right questions" about potential next steps.

"Everyone has the right to their own medical information in real time, not on the doctor's time," she added.

Although having instant access to medical results can be beneficial in some ways, there are times where patients have "learned about life-altering diagnoses and developmentsfrom cancer to chronic illness to miscarriagethrough emails and online portals" instead of through their doctors, who could have eased them into the information, Friedman writes.

For example, Nicki Swann, a 38-year-old professor in Oregon, learned she had colon cancer through an app after she had polyps removed. "I couldn't imagine that anything but good news would be shared in that way," she said.

Although Swann immediately called her doctor's office, the physician was unavailable at that time, and they did not speak about her diagnosis until the following week. "Any cancer diagnosis is going to cause trauma," she said. "But I think it was much worse to receive it in that way."

According to Emily Porter, an ED and sexual health physician in Texas, when difficult medical diagnoses are instantly delivered to patients online, "it cuts off any opportunity for doctors to get ahead of things."

"When information is just given in black-and-white type on MyChart, that's not the full expression of compassionate care," said Elizabeth Comen, an oncologist at Memorial Sloan Kettering Cancer Center. "Yes, it is immediate care, but it's care out of context."

"We have to honor the reality that waiting can feel impossibly hard," Comen added. "But I don't think anything replaces a doctor holding your hand and looking you in the eye and saying: 'I'm going to go through every aspect of this with you in real time. You can ask me your questions. I will read your body language. I will give you tissues. I will be there with you.'"

According to a survey of 1,000 patients from the American Medical Association (AMA), around 42% said they wanted to see their test results as soon as they were available, while 43% said they preferred to speak with their doctors first. However, among patients who preferred instant access, more than half said they would want to speak to their doctor first in the case of a "debilitating, life-limiting or terminal illness."

Currently, the medical results provision includes a "preventing harm exception" that allows doctors to delay a result, but "the bar for what counts as harm is high: The provider must be able to anticipate that the test results could lead a patient to harm himself or herself," Friedman writes. In addition, any exceptions must be requested by a patient beforehand, which may not be possible when an unexpected result is found through a routine test.

To allow providers more control over sensitive test results, AMA has urged HHS to make "common sense" exceptions to the current rule. In a statement published last month, AMA requested language be added to "explicitly allow physicians, using their professional judgment, to withhold some information if immediate or proactive release could cause a patient mental or emotional harm."

Micky Tripathi, the national coordinator for health information technology at HHS, said adjusting to having instant access to medical results "is a really big transition for all of us," but added that officials hoped the Cures Act would encourage patients to be more active in their own care and talk with their doctors about how they want to receive medical information.

Tripathi said officials hoped to see health care apps introduce more flexible options that allow providers to designate a patient's preferences on specific cases or ways to allow patients to opt out of receiving certain results right away.

For now, Friedman recommends patients who are undergoing medical tests and concerned about the potential results ask their doctors "for expectations around timing both in terms of when results might be released electronically and when you can expect to hear from the doctor's office, so you can prepare mentally and emotionally." (Friedman, New York Times, 10/3)

Read more here:
Instant access to medical records sounds like a good thing. Is it? - The Daily Briefing

Recommendation and review posted by Bethany Smith

Therapeutic developments have been aimed at enhancing outcomes for patients with metastatic hormone-sensitive prostate cancer (mHSPC), an aggressive form of prostate cancer that may rapidly become castration resistant.1 Advances in the understanding of the genomics and biological functions of prostate cancer have resulted in the emergence of several new classes of agents that have improved outcomes in men with prostate cancer, including mHSPC.1 For example, several next-generation androgen receptor (AR) signaling inhibitors have recently received expanded FDA approval to include treatment of men with mHSPC.1-5

Although clinicians have welcomed the addition of novel AR-targeted agents to the mHSPC management arsenal, they have also faced the conundrum of how to best select among them when treatment intensification is needed.

During a recent OncLive Peer Exchange, panel of experts in genitourinary cancer provided an overview of the FDA-approved novel AR-targeted agents for mHSPC, including the pivotal trials that led to their approval. They also shared the factors they consider when selecting among these agents and the rationale for using triplet therapy in some patient subgroups with mHSPC.

Targeting the androgen-signaling axis remains the most effective strategy for treating patients with prostate cancer, which can encompass multiple approaches, including targeting gonadotropin-releasing hormone to prevent release of luteinizing hormone, targeting cytochrome P450 (CYP) 17A1 to restrain androgen synthesis, and directly targeting AR transcriptional activity.1 Four AR-targeted therapies have received approval for the treatment of patients with mHSPC (Table).2-9 Of these treatments, abiraterone acetate (Zytiga) targets CYP17A1, and darolutamide (Nubeqa), enzalutamide (Xtandi), and apalutamide (Erleada) target AR transcriptional activity.1

Darolutamide is the latest AR-targeted therapy to receive expanded indication for the treatment of men with mHSPC.2 Approval for this indication was based on data from the phase 3 ARASENS trial (NCT02799602), which randomly assigned 1306 patients with mHSPC to receive darolutamide 600 mg orally twice daily plus docetaxel 75 mg/m2 intravenously every 3 weeks for up to 6 cycles (n = 651) or docetaxel plus placebo (n = 655).10 The primary end point was overall survival (OS), which was assessed in the primary analysis after 533 patients had died (229 in the darolutamide arm and 304 in the placebo arm).

The primary analysis showed a 32.5% lower risk of death in the darolutamide arm vs the placebo arm (HR, 0.68; 95% CI, 0.57-0.80; P < .001). At 4 years, the OS was 62.7% (95% CI, 58.7-66.7) in the darolutamide arm and 50.4% (95% CI, 46.3-54.6) in the placebo arm. Additionally, darolutamide was associated with significantly greater benefits than placebo for several secondary endpoints, including time to castration-resistant prostate cancer, time to pain progression, symptomatic skeletal eventfree survival, time to first symptomatic skeletal events, and time to initiation of subsequent systemic antineoplastic therapy.10

The FDA approval of enzalutamide for mHSPC was based on data from the phase 3 ARCHES trial (NCT02677896), which randomly assigned 1150 patients with mHSPC to receive enzalutamide plus androgen deprivation therapy (ADT) or placebo plus ADT. Patients were stratified by disease volume and prior docetaxel chemotherapy. The studys primary end point was radiographic progression-free survival (rPFS).

In the ARCHES trial, we showed that enzalutamide delays rPFS, which led to the FDA approval of that therapy, said Andrew J. Armstrong, MD, MSc, who was an ARCHES study investigator. Radiographic progression or death was reduced by 61% in the enzalutamide plus ADT arm vs the placebo plus ADT arm (HR, 0.39; 95% CI, 0.30-0.50; P < .001), and the median rPFS was not reached in the enzalutamide arm vs 19 months in the placebo arm. Benefit with enzalutamide was observed across prespecif ied subgroups, with similar benefit regardless of disease volume (ie, low vs high) and prior docetaxel use. Superiority of enzalutamide vs placebo was also shown in key secondary end points, including time to prostate-specific antigen (PSA) progression, time to initiation of new antineoplastic therapy, PSA undetectable rate, and objective response rate.11

From the 5-year data that was presented at ASCO 2022, we see that many of these men are now being treated successfully for 5-plus years, still on drug, and still going where medians havent even been reached. This is phenomenal for our patients. It emphasizes the need for survivorship, Armstrong said.

The 5-year data come from the updated OS analysis of the phase 3 ENZAMET trial (NCT02446405), which randomly assigned 1125 men to receive testosterone suppression plus open-label enzalutamide (n = 563) or a standard nonsteroidal antiandrogen therapy (ie, standard-care group; n = 562).12 Prior to randomization, up to 12 weeks of testosterone suppression and 2 cycles of docetaxel were allowed. At a median follow-up of 68 months, the HR for death was 30% lower among the enzalutamide arm vs the standard care arm. No major differences were found in enzalutamide efficacy across subgroups. Although benefit was most apparent for patients with low-volume mHSPC not deemed to require docetaxel, patients with synchronous high-volume mHSPC necessitating docetaxel still showed benefit. Exploratory analyses suggested additional benefit with triplet therapy, adding enzalutamide to testosterone suppression and docetaxel.12

Apalutamide was approved in mHSPC based on data from the phase 3 TITAN trial (NCT02489318), which randomly assigned 1052 men with mHSPC to receive apalutamide plus ADT (n = 525) or placebo plus ADT (n = 527).13 At the final OS analysis, which included a median follow-up of 44.0 months, the median treatment duration was 39.3 months with apalutamide, 20.2 months with placebo, and 15.4 months with crossover.

Apalutamide vs placebo reduced the risk of death by 35% (HR, 0.65; 95% CI, 0.53-0.79; P < .0001) and by 48% when adjusting for crossover (HR, 0.52; 95% CI, 0.42-0.64; P < .0001). The median OS was not reached in the apalutamide arm vs 52.2 months in the placebo arm. Patients who crossed over were analyzed as part of the intention-to-treat population in the placebo plus ADT group. At 48 months, the OS rates were 65.1% for patients who received apalutamide and 51.8% for those who received placebo. Updated analyses of secondary end points based on the f inal data cutoff showed apalutamide plus ADT delayed second PFS and castration resistance (P < .0001 for both).13

Data from the phase 3 LATITUDE trial (NCT01715285) supported the approval of abiraterone acetate for patients with mHSPC. Investigators randomly assigned 1199 patients with mHSPC to receive abiraterone acetate plus prednisone and ADT (n = 597) or matching placebo plus ADT (n = 602).14 Patients had not received prior chemotherapy, radiotherapy, or surgery for metastatic prostate cancer and were stratified based on the presence of visceral disease and ECOG performance status. There were 2 primary end points: OS and rPFS.

At the final OS analysis, which was performed after a median follow-up of 51.8 months, 618 deaths had occurred (275 patients in the abiraterone arm and 343 in the placebo arm). Patients in the abiraterone arm had a significantly longer OS compared with the placebo arm (53.3 months vs 36.5 months; HR, 0.66; 95% CI, 0.56-0.78; P < .0001). Analysis of OS by subgroups found an OS benefit across most subgroups, with the exception of those with an ECOG performance status of 2 and those with a Gleason score below 8. The final analysis did not include a reanalysis of the rPFS, which was 33 months (95% CI, 29.6-not reached) in the abiraterone arm versus 14.8 months (95% CI, 14.7-18.3) in the placebo arm (HR for radiographic progression or death, 0.47; 95% CI, 0.39-0.55; P < .001) in the preplanned interim analysis.14

With many novel AR-targeting therapies to select from, choosing the best one for each patient can pose a challenge for physicians. From the medical oncology perspective, I spend a lot more time taking a good medical history than maybe I was doing when there were fewer options. Especially when I meet a new patient for the first time, I spend a [significant] amount of time taking [a detailed] cardiovascular history, but also general medical health history, MaryEllen Taplin, MD, said. She explained that she looks at factors such as exercise tolerance, baseline respiratory status, and whether patients have had any falls over the past 2 years because these provide clues that help her select the best drug for each individual patient.

If I have a patient who is [older], [is] relatively sedentary, and had a fall 6 months ago, I might shy away from enzalutamide. But 1 of the other 3 choicesapalutamide, darolutamide, or abirateronemight be better for that particular patient. Ill put in the prescription and try to get the prior authorization and copay information based on that, she said. Regarding abiraterone acetate, Taplin said she would avoid it in patients with a compensated cardiac status and diabetes or trending toward diabetes.

In those with a condition such as congestive heart failure, she said, the risk of fluid retention is a contraindication in her opinion, and for patients with diabetes, she has concerns that the concomitant prednisone would affect patients glucose tolerance. For patients who are good candidates for any of the available agents, the panelists noted that decision-making usually revolves around finances. Once you find out what the co-pay is when you submit that prescription, you want to make sure your patient can afford their medication, Tanya B. Dorff, MD, said. Armstrong agreed and noted that costs among these agents may vary considerably. Paradoxically, abiraterone acetate is generic, but it has some of the hardest co-pays because there are very few assistance programs for it. Darolutamide might be easier because of co-pay assistance [access], he said.

He also suggested that COVID-19 vaccination may factor into decision-making with use of abiraterone acetate because of its concurrent administration with prednisone. A small dose of physiologic replacement prednisone would impair the vaccine efficacy, but we dont have a lot of great data there, he said.

Although mHSPC is generally considered an aggressive prostate cancer, it is still a heterogeneous disease that requires an individualized treatment approach to optimize outcomes. Patients who tend to do worse are those with high-volume, de novo metastatic disease, which is different from those who also have metastatic disease but happen to [have a recurrence] years later and theyve finished treatment, Pedro C. Barata, MD, MSc, said. He noted that patients who tend to do worse have been shown to benefit from treatment intensification approaches, such as a triplet regimen that adds docetaxel and an AR-targeted therapy to ADT, as well as strategies such as concomitant radiotherapy of the primary tumor.

To ensure he identifies patients who would benefit from treatment intensification, Barata said he sequences all patients up front. When I have [a patient with] an aggressive molecular profile, it makes me think about treatment intensification at that point, he said. Another trigger he noted is a low PSA level. Its not concurrent with the amount of disease that you see, he said.

During the discussion, Armstrong explained that an analysis of the ARCHES study found that many patients receiving enzalutamide had radiographic progression despite not showing PSA progression, a finding he noted that could be applied to any AR therapy.15 Were all used to lying back and not doing imaging very often when you see that PSA [level] go down. But we saw that approximately one-third of patients with imaging showing progression at soft tissue or new bone metastasis didnt have any rise in PSA [level] at all, and thats kind of a scary thought, he said.

Barata noted that the next step will be identifying all the patient subgroups who would benefit from treatment intensification approaches such as triplet therapy, as well as which intensification approach may be best suited to each subgroup. Ongoing studies are anticipated to help shed light on these areas.

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Novel AR-Targeted Therapies for Metastatic Hormone-Sensitive Prostate Cancer: Which One to Choose - OncLive

Recommendation and review posted by Bethany Smith

Limerick woman Fiona Robinson experienced symptoms of menopause for eight years until she finally joined up the dots and now she wants to help prevent other women from making the same mistake she did.

When she was in her mid-40s, the mum of one started to feel unusually exhausted, with aches in her ankles, but put it down to age and her busy job.

She told RSVP: I would have been very active previous to this. I played basketball and I was always on the go! I was working full-time as an executive assistant and it was very busy, I spent a lot of time on the road.

Then I started having these symptoms I was exhausted, and getting out of bed in the morning was nigh-on impossible. Id put my feet on the ground and my ankles would ache. When I did get up and go to work, after Id come home Id basically just go to bed again.

Read more: Dublin woman Catriona Doyle diagnosed with two cancers after experiencing menopause symptoms

After a while, Fiona also started to experience low motivation, anxiety and hot sweats.

She said: I went to the doctor with a list of complaints, and he took bloods but they didnt show that my symptoms were connected to oestrogen depletion. We now know that bloods arent going to give you the right answer because your hormones fluctuate so much!

One day she was playing basketball and by chance, she got chatting to a woman named Loretta Dignam, who told her that she had quit her marketing job to set up a clinic called The Menopause Hub.

She was talking about the different symptoms of menopause and perimenopause and it finally clicked, Fiona admitted.

She went into The Menopause Hub, where she got seen by a doctor who prescribed hormone replacement therapy.

I couldnt believe the difference it has made. My ability to get up and do things has definitely improved, and the sore ankles and achy bones are much better.

Weight gain has been huge for me, unfortunately. That was partly down to the fact that for so long, I just had no motivation to do anything. If I did, I was so tired the day after that I decided it wasnt worth it, or I wasnt going to do it again. Im going to see a nutritionist to see if I can balance things out.

Fiona says many women out there are in a similar position to her, and dont realise or want to believe that they are going through menopause.

She added: A lot of women dont want to recognise that they are menopausal. They are like No, dont mention that, that means Im getting old!

I know someone who came out in a rash on her chest, and she had sore, dry eyes. I said Thats oestrogen depletion and she just did not want to hear it! We can be our own worst enemies.

Im 58 now and I still have bleeds. I get told I have a lovely healthy womb and Im like Yeahit can stop working now! [laughs]"

Theres also the issue that many doctors dont have much understanding of menopause.

Its like they did a one-hour tutorial on menopause and then that was it! And then there was all the bad publicity around HRT and the inaccuracies around the links to breast cancer.

I was put on anti-depressants to try to relieve my anxiety, and I stayed on them for years, when really my anxiety was down to lack of oestrogen. Hopefully doctors are getting better educated on how to treat it and deal with menopause.

Fiona is glad that menopause is less of a taboo subject than it was, and she believes that talking about it more will help women.

If we talk about it honestly, that makes a big difference, she said. Barbara Taylor M.D. has a great quote: If it was a male issue, there would be an ATM every corner an Automatic Testosterone Machine on every corner..

Sharing her advice for others, Fiona said: Dont be afraid of menopause. You cant stop it, you cant change it, its going to happen, and you should listen to the symptoms that others have had. There are so many different help groups out there now you dont have to go through it on your own.

Visit The Menopause Hub's website here for more information.

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Limerick mum says hormone replacement therapy has changed her life after menopause - RSVP Live

Recommendation and review posted by Bethany Smith

California Gov. Gavin Newsom signed AB 2098 by Assemblyman Evan Low (D-Campbell), whichwill punish physiciansand surgeons for unprofessional conduct for advocating for the potential benefits of early treatment with off-label drugs, or those who dare to ask questions about COVID vaccine safety.

Assembly Bill 2098 puts unconstitutional restrictions on free speech by medical professionals. Under AB 2098, doctors will be subject to disciplinary actions by the Medical Board of California and the Osteopathic Medical Board of California if they do not adhere to the approved COVID treatment consensus.

Who approves the consensus, Dr. Peter Mazolewski said last week to the Globe. The medical board? Public health officials? Neither all of the members of the Medical Board nor all of Californias public health officials are licensed medical doctors.

In his signing statement, Gov. Newsom said, To be clear, this bill does not apply to any speech outside of discussions related to Covid-19 treatment within a direct physician patient relationship, as if its constitutional to limit the censorship of doctors to one medical issue. Imagine if doctors were censored over various cancer treatments or heart ailments.

The Governor of the State of California is telling the states licensed physicians that when they are treating a Covid patient, they must remain in the lane of the consensus of the CDC or CDPH treatment protocols.

Laura Powell, founder ofCalifornians for Good Governance explains in a June AB 2098 opposition letter:

There is no question that the bill is aimed at restricting speech based on its content. As such, it would be presumptively invalid and could only be upheld if the government could prove that the law is narrowly tailored to serve a compelling state interest.

Which it does not.

Physicians would be punished simply for doing what they believe is best for their patients, sharing legitimate medical information necessary for their patients to make a true risk/benefit analysis.

The bill is aimed at physicians who acknowledged the 1% mortality rate, questioned mandatory masks, school closures, and challenged the claim that the vaccine would shield patients from getting or spreading Covid. It is also aimed at physicians whochose to prescribe therapeutic treatments during COVID.

Censorship and criminalization are not the bulwarks of a free society, attorney Leigh Dundas said at the AB 2098 protest rally Friday at the State Capitol. The stark reality is if we are to remain a Constitutional Republic, then doctors must remain free to practice medicine.

Science and medicine are constantly evolving by challenging the status quo, Dundas added.

And Dundas warned that if this bill to censor Californias doctors is allowed to stand, guess who is next on the chopping block the press.

Tech entrepreneur Steve Kirsch addressed the AB 2098 protesters Friday. Im labeled a misinformation superspreader, but (Senator) Dr. Pan cant silence me because Im not a doctor.

Its [AB 2098] unconstitutional and anti-science, Kirsch continued. Tenure was created in universities to allow people to speak out without retribution. This is a special law targeted at misinformation for Covid-19, and thats not science.

As Laura Powell noted, The bill does not address the problem identified. The bills authors and supporters point to the problem of doctors who widely amplify falsehoods about Covid-19, but silencing them would violate the Constitution. To remedy the constitutional problems, it would have to be pared down to the point that it would simply duplicate existing law. Proponents are unable to cite a single example of a harm that could be prevented.

As Dr. Pete Mazolewski said, the purpose of Assembly Bill 2098is to circumvent due process against doctors over Covid misinformation conduct.

AB 2098will punish physiciansand surgeons for unprofessional conduct for advocating for the potential benefits of early treatment with off-label drugs, or those who dare to ask questions about COVID vaccine safety.

Does the Centers for Disease Control and Prevention decide approved COVID treatment consensus? EvenCDC Director Rochelle Walensky recently admittedher agencys failures during the COVID-19 pandemic during a message to her staff in August. ABC reported,To be frank, we are responsible for some pretty dramatic, pretty public mistakes. From testing, to data, to communications, Walensky said.

We know there were a lot of problems with the CDC if we speak out right now, we run the risk of losing our licenses, Dr. Mazolewski said.

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Gov. Newsom Signs Bill to Censor CA Doctors Accused of Spreading COVID Misinformation - California Globe

Recommendation and review posted by Bethany Smith

Actress Lucy Hale has been a staple in many of our guilty-pleasure television dramas, from Pretty Little Liars to Katy Keene, but do you remember when she was a brand ambassador of sorts for Bayers Kyleena, an intrauterine device (IUD)? She praised the little birth control implant, saying it was painless, simple, and a no-brainer that she wished she had tried sooner. Kyleena is a hormonal IUD, but theres also an entirely non-hormonal option out there.

Whether you know it as the copper IUD or the coil, youve probably heard about women having a little piece of metal inserted into their womb as one of the many birth control options. Often touted as the better option since we know how many complications hormonal birth control can cause conflicting research suggests that copper IUDs are actually a worse choice and that women should use hormonal IUDs as a result of lower odds of complications, discontinuation, and failure.

So, whats really going on with all of these mixed signals? Turns out there are a lot of pros and cons to IUDs which you should know before you make the choice to get one inserted.

If you opt for a hormonal IUD like Skyla, Liletta, or Mirena, you get anywhere from five to seven years of protection from pregnancy. Choosing a copper IUD like ParaGard gives you up to 12 years of protection from pregnancy. This option can be attractive because your OB/GYN inserts it, and then you can just forget about birth control upkeep. Its really a fix it and forget it method for pregnancy prevention.

When a copper IUD is placed in your uterus, it acts like spermicide by decapitating sperm (yep, the IUD splits the tail from the head of the sperm) so that they cant reach your eggs. Zero chance of movement means zero chance of pregnancy, unless the IUDs effectiveness is interrupted by displacement. Since its hormone-free, once you choose to get it removed, you could hypothetically get pregnant right after removal.

When you compare an IUD to the pill or just a plain-old condom, IUDs are the most effective form of preventing pregnancy. Less than one in 100 women using an IUD will get pregnant each year, while as many as 12% of women using the pill will get pregnant and 18% of women just using condoms will get pregnant.

Lets first establish that hormone-free and side effect-free are not the same thing. Just because youre taking a pass on whichever combination of synthetic hormones other birth control methods pump into your body doesnt mean that you wont feel any symptoms related to having a piece of metal implanted in your uterus.

Nevertheless, by using a non-hormonal IUD, you wont experience those potentially lengthy detox periods when getting off birth control that leave you irregular for anywhere from a couple of weeks to a couple of years. Hormonal IUDs release low doses of hormones into your uterus, so if you opt for one, then you might still face a detox period or any of the potential complications that hormonal birth control poses.

Hormone-free and side effect-free are not the same thing.

Proponents of IUDs also believe that it can decrease your risk of endometrial cancer and cervical cancer, but the decades of data out there dont necessarily differentiate between hormonal and non-hormonal IUDs.

While a hormonal IUD can lighten your periods, a non-hormonal IUD can cause them to get heavier. In your first few months after getting an IUD inserted, you might also have irregular bleeding at unpredictable times. This heavier flow could potentially worsen backaches and cramping. While some womens periods return to a normal flow after half a year, others deal with heavy flows for much longer.

A heavy period means much more than just extra blood to take care of. If your uterine lining is too thick, you likely have developed a hormonal imbalance between estrogen and progesterone. Similarly, you might start experiencing anovulation, which is when you have a period without your body releasing an egg. Research does suggest that increased menstrual bleeding while using the IUD could decrease over time, but intermenstrual spotting over time can still be pesky.

Any OB/GYN worth their snuff will at the very least warn you that because an IUD is a physical, metal implant placed on a sensitive sex organ, you might feel some related pain. This can range from inflammation of your pelvis to full-on pelvic inflammatory disease, backaches, or feeling pain during sexual intercourse. You are also at risk of having your IUD either get stuck in your uterus or even penetrate the uterus. Though this is rare, this complication is very serious in that it can cause organ damage, scarring, and infection.

One writer, Conz Preti, shared in Insider that her copper IUD caused her constant cramping and pain during sex, all while dealing with 10-day long periods. She thought her IUD was poking into her uterus awkwardly, but after an ultrasound showed that it was still in place, her doctors sent her home.

The cramps became constant. Needing to pee made me cramp. Having one of my kids sit on my lap made me jump in pain. Regardless of whether I was ovulating, menstruating, or having penetrative sex, I was in pain, she shared.

A copper IUD doesnt necessarily introduce something foreign into your body. Our bodies need to process copper to keep other minerals like zinc and iron in balance, so you shouldnt fear a copper IUD simply because its metal. That said, if youre introducing an excess of one mineral into your body, you should be prepared for the other mineral levels to become imbalanced. This can create temporary problems like brain fog, mood swings, fatigue, depression, nausea, irritability, or cravings, just to name a few.

Our bodies need to process copper to keep other minerals like zinc and iron in balance.

One woman in a Facebook group dedicated to discussing IUD side effects shared that, among the nutrient and mineral imbalances she faced from her implant, she felt exhaustion, mood swings, migraines, cold hands/feet, dry skin, constipation, problems concentrating, spaciness, high anxiety, and even lost hair in globs. She also reported developing a rare disorder called pulmonary hypertension due to excess levels of copper in her blood.

Lets analyze one of the potential nutrient and mineral imbalances from excess copper: zinc. Your body needs zinc to work in tandem with magnesium and keep your body functioning properly. With adequate levels of zinc, youre less likely to feel stressed, your mental capacity is stronger, your mood is better regulated, and you face a higher chance of fighting off sickness and disease. That latter benefit is why, when Covid-19 began to spread, people suggested taking extra zinc to prevent infection.

After a woman gives birth, doctors may suggest the option of getting back on birth control to prevent any pregnancies so soon after the last one. Non-hormonal IUDs are a more attractive option in the eyes of physicians because they dont interrupt a womans hormone levels like the pill, patch, shot, or implant does while shes breastfeeding.

They might be even more attractive for an older mother because of the length of protection from pregnancy. If you have a geriatric pregnancy in your mid to late 30s and then have a copper IUD implanted in your uterus, youre nearly fully protected from becoming pregnant ever again since you may hit menopause around the time the IUD loses its effectiveness.

That said, having a piece of copper implanted into a major organ causes elevated levels of copper. Your bodys copper levels already increase with multiple births to create blood vessels, and this level doesnt tend to go back to normal after birth. Some women actually experience psychosis and postpartum depression thanks to elevated copper levels.

Though this isnt the case for all mothers, it does naturally lead you to wonder whether elevated copper levels play a role in certain mothers drowning their newborns, committing suicide, or engaging in any other tragic act of violence related to postpartum depression or psychosis.

There has also been talk that, since copper works well as a metal to conduct energy, the implant can potentially cause racing thoughts, insomnia, heart palpitations, and even dizziness.

Before you get too worried, contracting heavy metal toxicity from your IUD is rare. This doesnt mean youre not at risk, though. Healthy women with normal liver function can process minerals like copper, but if you have any pre-existing conditions that affect your livers ability to detox your body, then elevating your bodys copper levels can become unsafe.

Your bodys tolerance for excess copper often depends on hereditary factors. Some people are less able to metabolize and therefore effectively eliminate excess minerals from their body. If you already have a rare genetic disorder like Wilsons Disease, then your body collects copper in glands and vital organs. Again, this disorder is rare, but as life-threatening as it is, introducing extra copper into your body could be fatal.

Some people are less able to metabolize and eliminate excess minerals from their body.

Interestingly enough, some doctors and medical agencies insist that heavy metal toxicity from IUDs is either not possible or so incredibly rare that they downplay any concerns. Take Susan Rubin, associate professor for family and social medicine at Albert Einstein College of Medicine in New York, who claims: There is no such thing as copper toxicity with an IUD.

Well, similar things were said to quell fears about silicone breast implants, but we now know that breast implant illness is the real deal and not just a myth.

Though one womans negative lived experience cant negate all of the positive experiences that other women have had while on the copper IUD, its really valuable to listen to personal stories and treat them with respect.

Another otherwise healthy woman in her twenties got a copper IUD placed because she didnt want to use hormonal birth control and felt no adverse symptoms beyond a heavier period. Suddenly, she started experiencing panic attacks and numbness in her limbs. Her symptoms only went that far, but other women like Olivia Bowden had increasingly severe migraines, panic attacks, memory loss, and reported having issues processing information while on the IUD.

I thought I was getting schizophrenia, or Alzheimers. I started hearing voices in my head. It was always two men chatting to each other, kind of like TV or radio presenters, but I couldn't quite make out what they were saying, Bowden shared.

While there are certainly strong reasons to use a non-hormonal IUD as your preferred form of birth control and the odds of potential complications are in your favor, we shouldnt ignore the risks that these implants pose to your body. However, you dont have to entirely sacrifice side effect-free, effective birth control options. A more natural way to prevent pregnancy with no added side effects whatsoever is trying out Fertility Awareness Methods. These methods are effective without the need for extra pharmaceuticals, and if you try it out, you might even feel more empowered by understanding how your body naturally works.

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Read more here:
Are IUDs Just As Bad As The Pill? Let's Take A Look At The Pros And Cons - Evie Magazine

Recommendation and review posted by Bethany Smith

For women and people assigned female at birth (AFAB), taking care of your health requires more than an annual physical. You should also visit a womens health specialist like an Ob/Gyn, midwife or nurse practitioner each year to keep healthy. More than just a checkup for your breasts/chest and reproductive organs; well-woman exams can also help you develop rapport with a womens health specialist.

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Well-women exams are important for a number of reasons. No. 1 is that they help you to establish care with a specialist so that if there is a problem down the road, you have a provider that you know and feel comfortable talking to, says Ob/Gyn Amanda Elbin, MD.

That comfort level is important, too, especially because many of us may not feel comfortable talking with just anyone about issues down there.

When you have a level of comfort with a provider, its easier to talk openly about sensitive issues, notes Dr. Elbin. Its important to be able to talk with a healthcare provider about your sexual health, your reproductive wishes, abnormal discharge or whatever your concerns may be. So, having regular check-ins helps to make sure youre comfortable with having those discussions when you need to.

We spoke with Dr. Elbin about who needs well-women exams and what you can expect from these annual visits.

Your womens health specialist is your partner in screening for issues like breast cancer, ovarian cancer and cervical cancer that arent a part of a regular physical exam.

The American College of Obstetricians and Gynecologists states that the importance of these preventative care visits go beyond screening for physical abnormalities. Regular visits to a specialist can help you navigate all the other nuances that come with life. That can include things like:

So much of your health is impacted by things outside of your bodys physical functioning, Dr. Elbin says. In addition to screening for physical changes, a lot of what we talk about is your mental health whats going on in your life, how are your relationships. We spend a lot of time working with people and figuring out how we can help them be their best well-rounded, whole person.

Dr. Elbin explains that these appointments are recommended each year for anyone with female anatomy (regardless of their gender identity, and including cisgender women, non-binary people with female anatomy and transgender men). They can also be helpful for anyone who identifies as a woman (regardless of their anatomy).

For women who dont have a vagina, a womans health specialist can work with their primary care physician, or other healthcare providers, to help with managing hormones, medication or other concerns, Dr. Elbin states. A womens health specialist can also be a trusted resource for all people to access a sensitive and welcoming healthcare environment to ask questions or get advice. You may also consider seeking out an LGBTQIA+ specialist for your care.

Well-woman exams should be a part of your regular health maintenance beginning in your teenage years and well beyond menopause.

Even beyond childbearing age, these health practitioners work with you to keep you as healthy as possible, Dr. Elbin says.

Like your annual physical, one component of an annual well-woman exam is taking stock of your current health to understand your risks for certain conditions and to screen for potential health concerns. But a primary care doctor is going to check for different issues than a womens health specialist.

During a physical, a primary care physician will be more likely to check for things like high cholesterol, high blood pressure or unusual moles on your skin.

During a well-woman exam, your healthcare provider is looking primarily for concerns related to your reproductive health, like changes to your menstrual cycle or advising you on contraception options.

Your healthcare provider may do things differently depending on your age, your health status and other factors, but typically, a well-woman visit will start with questions about your overall health. Theyll take your vital signs. And youll get into one of those oh-so-chic hospital gowns to examine your breasts and pelvic area.

Dr. Elbin says theres nothing you need to do to prepare for a well-woman exam except to bring any questions you have and be open to talking about how youre doing.

Come as you are. Theres nothing fancy that you need to do, no products that you need to use and, no, we dont care if you shave your legs. Makes zero difference to us, Dr. Elbin says. (And contrary to some popular beliefs, you can get a well-woman exam when youre on your period.)

Dr. Elbin walks us through what you can expect during a well-woman exam.

Your exam will likely start with reviewing your medical history, including your family history, to understand your current health and note any changes since your last visit.

Questions you may be asked include:

Your exam will likely include some time devoted to taking your vital signs, including your:

Your provider will also likely listen to your heart and lungs using a stethoscope and will feel your neck to check your thyroid.

During the appointment, your provider will likely perform a breast exam to check for any changes, such as lumps or swelling. In most cases, this exam will take place with you lying on a doctors table with your arm above your head. Your doctor will use their fingertips and medium pressure to check your breast tissue for any signs of concern.

If youre between the ages of 21 and 65, another part of your well-woman exam will likely be a pelvic exam. This is a screening where your healthcare specialist will look for any signs of disease in your vagina, uterus, ovaries, fallopian tubes and cervix.

During the pelvic exam, youll lie on your back with your feet in stirrups. Your healthcare provider will use a speculum to look inside your vagina to ensure things look healthy. They may also perform an exam by touch, feeling your uterus and ovaries for any signs of abnormalities.

A pelvic exam may be uncomfortable or cause some mild cramping for some people, but it shouldnt hurt.

Pap smears are recommended every three years for most women and people AFAB between the ages of 21 and 65. Your doctor may recommend them more frequently if you had abnormal Pap smear results in the past.

If its time for your pap smear, your healthcare provider will use a small brush or spatula to gently remove cells from your cervix as part of your pelvic exam. That sample will be sent for testing to check for human papillomavirus (HPV) and signs of cervical cancer.

In addition to your regularly scheduled well-woman exam, Dr. Elbin reminds you to not hesitate to reach out to a healthcare provider with other concerns between annual visits. Some common reasons to consult your Ob/Gyn or other provider include:

If anything changes out of the blue or doesnt feel right, we want to see you and make sure all is well, Dr. Elbin says.

Link:
Well-Woman Exams: Who Needs Them and What To Expect - Health Essentials

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Acute suppurative thyroiditis is a rare life-threatening endocrine emergency. The thyroid gland has rich vascularity and lymphatic drainage, has large amounts of iodine in the tissue, generates hydrogen peroxide, and is encapsulated. Owing to these factors, infection of the thyroid gland is rare. The clinical presentation of acute suppurative thyroiditis closely resembles that of subacute thyroiditis, with a differentiation possible only on fine needle aspiration cytology (FNAC). However, differentiating these two conditions is important because the management of these two conditions differs drastically. Management includes intravenous antibiotics, drainage of abscesses, and sometimes surgery may be required. Here, we present a case of thyroid abscess caused by methicillin-resistant Staphylococcus aureus (MRSA), diagnosed using FNAC of the thyroid gland and blood culture.

Inflammation of the thyroid gland referred to as thyroiditis can have various causes. Of these, acute suppurative thyroiditis although rare, is an emergency associated with a high mortality rate if left untreated. Its presentation closely resembles that of subacute thyroiditis which is a common but self-remitting condition. Acute suppurative thyroiditis comprises <1% of thyroid disease.Here, we present a case of a young male with chronic kidney disease (CKD) who was ultimately diagnosed to have acute suppurative thyroiditis.

A 23-year-old male, a diagnosed case of CKDstage 5 - on maintenance hemodialysis twice weekly, with a history of marijuana smoking with no other significant past medical history. The patient presented to the emergency with complaints of fever, which was intermittent, low grade, and undocumented, initially later progressed to high grade associated with chills and rigors in the last four days. The patient noticed a neck swelling 15 days back, progressively increasing in size associated with mild pain and difficulty in swallowing which was more for solids than liquids. The swelling was not associated with any discharge. He also complained of bilateral lower limb swelling and generalized myalgia for one week. He had a history of retrosternal, non-radiating chest pain for 7 days which was associated with palpitations and shortness of breath on exertion

On examination, pulse rate was 175/min which was irregularly irregular, blood pressure was 100/70 mmHg, respiratory rate was 24/min, saturation 100% with 12 liters of oxygen, the temperature was 102F, Glasgow coma scale (GCS) - E4V4M6, the patient was agitated. Pallor and bilateral pitting pedal edema were present on general examination. Respiratory system examination revealed bilateral basal crepitations, other system examinations were within normal limits. Local examination revealed a 105cm swelling on the right side of the neck, that was moving with deglutition, and tenderness present on palpation, but not associated with discharge, redness, or fluctuation.

An electrocardiogram suggested atrial fibrillation for which diltiazem bolus followed by infusion was given. Lung point-of-care ultrasound (POCUS) showed bilateral grouped B lines and pleural shreds with minimal pleural effusion the in lungs. Arterial blood gas revealed severe metabolic acidosis with a pH of7.12 and HCO3 of 11.3 mmol/L. The patient was started on intravenous antibiotics (ceftriaxone, clindamycin) and steroids. Urgent hemodialysis was done for anuria and severe metabolic acidosis. He was then admitted to the intensive care unit. The patient's blood investigations revealed anemia, neutrophilic leukocytosis, thrombocytopenia, hyperbilirubinemia, and deranged kidney and thyroid function tests as shown in Table 1.

Other investigations done are shown in Table 2.

The patient was started on Tab Propranolol 60 mg 6-hourly and Tab Propylthiouracil 200 mg 4-hourly, Hydrocortisone 100 mg intravenously 8-hourly. Antibiotics were stepped up to intravenous vancomycin 500 mg alternate days and meropenem 500 mg twice daily. The patient required high flow oxygen to maintain saturation; hence, it was not feasible to transport patient for thyroid scintigraphy or iodine uptake study. A thyroid fine needle aspiration cytology (FNAC) report revealed a thyroid abscess (Figures 1,2) and the culture report did not detect any organism.

Ultrasound-guided aspiration of thyroid abscess was performed, seropurulent pus was seen and thyroid drain was inserted, and the patientimproved symptomatically. A final diagnosis of acute suppurative thyroiditis and Lower respiratory tract infection (LRTI) with sepsis, acute on CKD was made. However, the patient developed severe respiratory distress with type 1 respiratory failure, and hypotension for which he was intubated, and noradrenaline infusion was started, subsequent chest imaging revealed multiple consolidations with cavitations suggestive of hospital-acquired pneumonia.Despite all efforts, the patient succumbed to death on day 22 of admission.

The term thyroiditis refers to inflammation of the thyroid gland. Thyroiditis can be broadly classified into infectious, De Quervains, autoimmune, Riedels, and miscellaneous [1]. The thyroid gland has rich vascularity and lymphatic drainage, has large amounts of iodine in the tissue, generates hydrogen peroxide, and is encapsulated. Owing to these factors, infection of the thyroid gland is rare. Acute suppurative thyroiditis is a rare life-threatening endocrine emergency. It has a reported incidence of 0.1%-0.7% and if untreated, the disease carries a high mortality rate of around 12% [2,3]. On the other hand, subacute thyroiditis is a spontaneously remitting condition that is much more common than acute suppurative thyroiditis. It may last for weeks to several months and tends to recur. It is also referred to as granulomatous or De Quervains thyroiditis [4,5].

Multiple factors predispose patients to the development of acute suppurative thyroiditis of which immunosuppression is the most common [6]. However, pyriform sinus fistula and third and fourth branchial arch abnormalities are also important, especially in children [7,8].The clinical features, laboratory findings, and radiological features of acute suppurative thyroiditis closely resemble those of subacute thyroiditis (Table 3).

Fine needle aspiration from the thyroid tissue provides the most accurate diagnosis and can be used to differentiate these two conditions. In acute suppurative thyroiditis, the FNAC aspirate is purulent with the presence of bacteria or fungi, whereas, in subacute thyroiditis, the FNAC aspirate shows lymphocytes and macrophages with some giant cells [9].

Although these conditions closely mimic each other, certain clinical features can be used as differentiating factors. Patients with acute suppurative thyroiditis are generally immunocompromised, sicker, with severe localized thyroid pain, an associated upper respiratory infection, and lymphadenopathy [1]. Thyrotoxic presentation is seen in only 8%-12% of patients with bacterial thyroiditis [3]. We reviewed some recent articles on patients with acute suppurative thyroiditis, the important studies have been shown in Table 4.

Differentiating these conditions is extremely important as their treatment differs. While antibiotics with or without surgery are required for patients with acute suppurative thyroiditis, patients with subacute thyroiditis require only analgesics and sometimes corticosteroids. For Emergency physicians, since the results of FNAC are often not available, it is prudent that a low threshold is maintained for initiating antibiotics in patients with painful thyroid swelling since untreated acute suppurative thyroiditis is life-threatening.For serious infections, parenteral antibiotics are necessary. Microscopic examination, staining, and culture of a fine-needle aspirate help determine the best agent. Thionamides are not necessary forindividuals with thyrotoxicosis from thyroiditis because there is no excessive thyroid hormone production; nevertheless, adjuvant medications such asbeta-blockers and cholestyramine may be used to reduce symptoms or more quickly restore euthyroidism. If a thyroid abscess is found, aspiration or surgical drainage should be tried [20].Open surgery with a complete, nearly entire, or hemithyroidectomy can be utilized to relieve pressure sensations in extreme circumstances, in individuals who do not respond to suitable antibiotic therapy and drainage. Ultimately, surgical removal of the damaged thyroid lobe may be required to treat the local source of infection and inflammation if systemic indications and symptoms do not improve with initial treatment [21].

Our patient was a young male who was diagnosed case of CKD, who had a mildly painful neck swelling along with symptoms of hyperthyroidism and uremia, and who was ultimately diagnosed to have bacterial suppurative thyroiditis. Although patients with CKD suffer from an altered immune response which includes both innate and acquired immunity [22]. Our patient was on no immunosuppressant drugs. Also, the clinical presentation of our patient was more suggestive of subacute thyroiditis as compared to acute suppurative thyroiditis. Thus, this was a rare presentation of acute suppurative thyroiditis.

Rare but potentially fatal, acute suppurative thyroiditis should never be ignored.Patients may experience acute symptoms or develop a more chronic course depending on the underlying organism. Its presentation strongly resembles that of subacute thyroiditis, which is a self-remitting illness; precise diagnosisis therefore challenging in the emergency room.Thyroid abscess can have a variety of complications, including thyroid storm, internal jugular vein thrombosis, airway obstruction, tracheal or esophageal perforation, necrotizing mediastinitis, sepsis, and even death.Therefore, all patients who report to the emergency room with painful neck swellings must receive careful attention. The most accurate diagnosis is achieved by fine needle aspiration from thyroid tissue; however, ultrasound is the preferred diagnostic method in the emergency room. Treatment options include intravenous antibiotics, abscess drainage, and possibly surgery.

View post:
A Rare Case of Neck Swelling: Acute Suppurative Thyroiditis With End-Stage Renal Disease - Cureus

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Anyone who's had a headache, which is nearly everyone, knows how quickly one can ruin your day and while the first reaction might be to grab a bottle of pain reliever, there's actually many other natural remedies to try. Headaches are one of the most common types of pain we experience and can be seriously debilitating, but before you reach for an over-the-counter medication, here's seven ways to help get rid of the throbbing pain, according to experts we spoke with. Read onand to ensure your health and the health of others, don't miss these Sure Signs You've Already Had COVID.

Dr. Jacob Hascalovici MD, PhD as the Clearing Chief Medical Officer tells us, "Headaches can happen for quite a few different reasons. Stress, dehydration, genetics, illness, allergies, injuries, infections, hormone shifts, changes in the weather, certain medications, and even strong smells, among other things, can cause headaches."

Dr. Hascalovici says, "People should know that there are many different kinds of headaches, and that the various types may benefit from different treatments. With time and the right strategies, headaches usually fade away. If you have a headache after an injury, if a headache just keeps getting worse, if you have a stiff neck, and/or if you notice you can't remember things very well, can't seem to keep your thoughts straight, feel numb, slur your words, or have trouble seeing, you should seek medical attention."

Dr. Tomi Mitchell, a Board-Certified Family Physician with Holistic Wellness Strategies explains, "When you have a headache, the first thing you want to do is reach for some pain medication. But before you pop a pill, you may want to try reaching for a glass of water. That's because one of the most common causes of headaches is dehydration. When your body doesn't have enough fluids, it can cause your blood vessels to constrict, leading to pain. Drinking water helps to rehydrate your body and can often relieve headache pain. Plus, it's a natural and drug-free way to reduce pain. So next time you have a headache, reach for a glass of water before reaching for the medicine cabinet."

Dr. Mitchell says, "Headaches are a common albeit debilitating condition that various factors, including certain medications can cause. If these medications are missed or stopped abruptly, they can contribute to headaches. For example, beta-blockers and calcium channel blockers are used to prevent migraines, but if they are suddenly discontinued, they can cause rebound headaches. In addition, certain antidepressants and anti-seizure medications can also cause headaches if they are not tapered off gradually. As a result, it is important to take medications as prescribed and to consult with a physician before making any changes to one's medication regimen. By doing so, you can help to prevent the onset of headaches."

Dr. Hascalovici emphasizes, "That may sound odd, but just sitting still in a comfortable position in a dark, cool room may help drive your headache away. For additional help, you can try aromatherapy, which simply involves using candles, essential oils, or room diffusers that have therapeutic scents. Smells can have powerful effects on the body while they can trigger headaches, they can also ease them. Some people find relief from the smell of peppermint, lavender, eucalyptus, rosemary, or chamomile."

According to Dr. Hascalovici, "For some, a headache is connected to what they eat. The most frequent food culprits include chocolate, coffee, pizza, foods with MSG, foods preserved with nitrates (like lunch meats and pepperoni), and certain cheeses. Instead, try a salad, even if that doesn't sound as fun. The leafy greens can bring relief, as can nuts, hot peppers, pumpkin seeds, and cherries. Plenty of water and herbal tea is also good."

Dr. Mitchell shares, "This can trigger a headache if you are sensitive to certain scents or fragrances. Be aware of your environment. If you can leave the environment, great, or perhaps open the windows. However, if you cannot leave the environment, try to identify the source of the scent and avoid it if possible. For example, if you are sensitive to perfumes, ask people not to wear them around you. If you are sensitive to cleaning products, ask others not to use them when you are present. If you are sensitive to cigarette smoke, try to avoid smoking areas. By being aware of your surroundings and taking steps to avoid triggering scents, you can help reduce headaches."6254a4d1642c605c54bf1cab17d50f1e

Dr. Mitchell states, "Not getting enough sleep is a common cause of headaches. If you regularly work long hours or have trouble sleeping, you may be at risk for headaches. Sleep deprivation can trigger migraines and tension headaches. It can also make existing headaches worse. To help prevent headaches, it's essential to get enough sleep. Most adults need seven to eight hours of sleep per night. If you have difficulty sleeping, you can take steps to improve your sleep hygiene. Avoid caffeine and alcohol before bed, establish a regular sleep schedule, and create a relaxing bedtime routine. Getting enough sleep is essential for overall health and can help reduce your risk of headaches."

Dr. Mitchell says, "Most people have experienced being "hangry" at some point in their lives that feeling of irritability or irrational anger that seems to come out of nowhere. While it's often written off as a joke, the reality is that being hangry is a genuine phenomenon with a scientific explanation. Our blood sugar levels drop when we skip meals or go for extended periods without food. This can lead to feelings of dizziness, fatigue, and you guessed it headaches. So next time you're feeling hungry, try reaching for a snack instead of taking it out on the people around you. Chances are, it will do wonders for your headache and your mood."

Dr. Mitchell says this "doesn't constitute medical advice and by no means are these answers meant to be comprehensive. Rather, it's to encourage discussions about health choices."

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This is How to Dissolve a Headache Fast Eat This Not That - Eat This, Not That

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Robin Young has autism spectrum disorder, which, in his case, means he struggles to empathize and show love for someone else. The resident of Bodicote, England, is also a father.

This is something Ive always had. However, when I became a dad, I found that the love for my children was different, Young told Healthline. Not only was this strong feeling of love new, but it also enabled me to empathize better because I finally understood what others feel when they say they love someone.

Young the chief executive officer of workout supply company Fitness Savvy said he believes his outlook on life improved after having children and planning for their future.

People think that it is just your priorities that change when you become a parent, but it would make perfect sense that the brain goes through changes as well, Young said.

Hes likely correct, according to researchers from the University of Southern California (USC).

They say women arent the only ones who go through physical change when becoming parents. Mens brains undergo measurable changes after their babies arrive.

Thats right. They get dad brain.

Their study published in the journal Cerebral Cortex reports that some of those changes involve slight brain shrinkage. They add that brain changes in new fathers mostly affect areas linked to empathy and visual processing.

The scientists believe those changes contribute to neuroplasticity, which is the brains ability to create and form new synaptic connections to adapt to new experiences.

Becoming a parent entails changes to your lifestyle and your biology, said Darby Saxbe, the studys senior author and a professor of psychology at USCs Dornsife College of Letters, Arts, and Sciences, in a statement. And it requires new skills like being able to empathize with a nonverbal infant, so it makes sense but has not been proven that the brain would be particularly plastic during the transition to parenthood as well.

The study examined the brain scans of 40 expectant fathers 20 in the United States and 20 in Spain. Researchers also looked at a group of 17 childless fathers who were scanned in Spain.

The researchers identified that the most significant changes in the expectant fathers occurred in the cortex the brains outer layer managing attention, planning, and executive functioning.

Comparisons made before and after the babies were born showed changes where the brain processes visual information and areas that are part of the brains default mode network.

The childless men had no such changes.

This is such an important and neglected topic, Dr. Zishan Khan, a child, adolescent, and adult psychiatrist with Texas-based Mindpath Health, told Healthline.

This can be a very difficult transition for mothers and fathers, but fathers especially since they dont get the chance to carry the child during the course of pregnancy and it can sometimes take more time to truly feel connected, Khan explained. The psychological adjustment often involves having to manage the difficult sensory responses that occur when a child is crying, seemingly in pain or distress, or feeling ill.

Khan said theres a big shift in mindset for first-time parents.

Priorities must be shifted and you may not be able to find time to relax the same way you did after a long day at work or have the ability to go out with friends late into the night, Khan said. The lack of sleep can also further complicate this adjustment and fathers often experience irritability, impatience, and extreme exhaustion as a result.

Lauren Cook-McKay, a licensed marriage and family therapist as well as vice president of marketing for Connecticut-based Divorce Answers, told Healthline men go through their own hormone changes when they become fathers.

The mans cortisol and testosterone levels generally dip within the first few weeks of being a father, Cook-McKay said. This somehow makes fathers less aggressive, bringing them close to their children. New fathers also experience an increase in prolactin, oxytocin, and estradiol, which causes a man to exhibit nurturing behaviors.

The dad brain doesnt just happen overnight.

Parental psychological adjustment determines parental involvement, Cook-McKay said. Parents who have poor parental psychological adjustments tend to be less involved with their children. Engaging with an infant can help produce positive effects in terms of responsiveness and attentiveness.

Dr. Hayley Nelson is a neuroscientist, psychology professor, and founder of The Academy of Cognitive and Behavioral Neuroscience.

She told Healthline becoming a parent is a significant time for the brain, as it learns from new experiences.

Your life changes in the blink of an eye and you are now in charge of communicating with a non-verbal, seemingly helpless child, Nelson said. Its a perfect time for increased empathy, too.

Nelson said theres more research to be done on the brain effects of things such as fear, learning, and reward when becoming a father, which she said all affect mothers.

Future studies investigating brain changes in fatherhood considering hormonal changes, as well as effects from sleep deprivation and stress, could help further elucidate what is occurring in the brain after childbirth, Nelson said. Not only in the biological mother but also from the father or other caregivers, biological or not.

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'Dad Brain' and Why First-Time Fathers Develop It - Healthline

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Andrew P. Byrnes, Ph.D.

Office of Tissues and Advanced TherapiesDivision of Cellular and Gene TherapiesGene Transfer and Immunogenicity Branch

Andrew.Byrnes@fda.hhs.gov

Chief, Gene Transfer and Immunogenicity Branch

BS, MS, Yale University, Department of Molecular Biophysics and Biochemistry

PhD, Oxford University, Department of Human Anatomy

Postdoctoral Fellow, Johns Hopkins University, School of Hygiene and Public Health

Gene therapy holds great promise for treating cancer, inherited disorders, and other diseases. Gene therapy uses carriers called 'vectors' to deliver genes to tissues where they are needed. Researchers are currently investigating the safety and effectiveness of a variety of different gene therapy vectors in hundreds of clinical trials in the US.

We are studying one type of commonly-used gene therapy vector that is made from a disabled cold virus -- the adenovirus vector. While adenovirus vectors are very efficient at delivering genes, adenovirus vectors are not always easy to target to the correct tissue. In addition, adenovirus vectors can cause toxic effects that limit the amount of vector that doctors can give to patients. We are particularly interested in how to safely deliver large amounts of adenovirus vectors intravenously, with the goal of specifically targeting tumors and other tissues.

New adenovirus gene therapy vectors are tested in animals before human clinical trials begin, and it is important for both researchers and the FDA to know how well these animal studies can predict safety. Thus, another of our major goals is to develop animal models that reliably predict the safety and effectiveness of adenovirus vectors in humans.

Our studies will help us to understand the mechanisms for adenovirus vector targeting and toxicity, and the relevance of animal models to human outcomes. This new knowledge will enable researchers to design safer and more effective gene therapy vectors.

Adenovirus (Ad) vectors have shown considerable promise in animal models and are currently being used in numerous clinical trials, especially for the therapy of cancer. We are interested in improving the safety and efficacy of Ad vectors, especially when administered through the vascular system. Certain properties of Ad vectors make them hazardous to administer intravenously in large doses, and our laboratory is trying to understand and fix this problem.

One of our major areas of interest is the innate immune response to Ad vectors. These rapid responses can cause serious toxicity and may severely limit the doses of Ad vectors that are safe to use. In addition, we are also studying how cells in the liver such as Kupffer cells and hepatocytes recognize Ad, since the liver is the major site at which Ad vectors are cleared from the circulation. A better understanding of these mechanisms will help us to develop strategies to improve vector efficacy and reduce toxicity. We will also gain a better understanding of the advantages and disadvantages of using different animal species to predict the behavior of Ad vectors in humans, which is particularly relevant to the regulatory work of the FDA.

Recent work from our lab and others has shown that Ad vectors are heavily influenced by plasma proteins that rapidly opsonize the vectors after intravenous injection. We found that natural IgM antibodies bind to Ad vectors, activate complement, and reduce liver transduction. Intriguingly, the Ad hexon protein specifically binds to coagulation factor X (FX), and we found that recruitment of FX by Ad vectors protects them against neutralization by complement. These findings show that Ad vectors recruit a number of plasma proteins that interact in complex ways with each other and with cells, and that these host proteins ultimately help to determine whether the vector successfully reaches its target.

In the long run, a better fundamental understanding of Ad vector biology will facilitate the design of safer Ad vectors that are easier to target. Better animal models will be important for testing novel vectors for safety and efficacy.

02/22/2022

The rest is here:
Safety and Effectiveness of Gene Therapy | FDA

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The cutting-edge Cellaca PLX system, designed by the companys Nexcelom unit, combines best-in-class image cytometer hardware, software, validated consumables and trackable data reporting all in one system without requiring complex calibration procedures or intense training requirements. To further streamline the customer experience, optimized reagent kits with validated antibodies from PerkinElmers BioLegend business are also part of the proprietary solution.

The new offering provides researchers expanded cell sample CQA analysis options beyond flow cytometry and staining methods, which historically have required a variety of different instruments and analytical methods. By combining these capabilities, researchers can now detect multiple markers simultaneously (multiplexing) and perform immunophenotyping and viability assays in seconds with an easy-to-use, modern user interface.

"Pharmaceutical companies have invested heavily in cell and gene therapy, but they struggle to assess the complex cell samples required to meet immense scientific demands and regulatory rigor across their research and manufacturing processes," said Alan Fletcher, senior vice president, Life Sciences, PerkinElmer. "While the Cellaca PLX Image Cytometer platform is therapeutic area agnostic, it is expected to be especially beneficial for researchers working in CAR-T cell therapy who want to streamline their phenotyping of immune cells for downstream processes."

PerkinElmers Nexcelom unit is a leading provider of automated cell counting technology and image cytometry products for cell analysis, including the original and widely adopted Cellaca MX high-throughput automated cell counter. Learn more about the new platform and other image cytometry instruments and reagents at BioProcessing International East from September 27-30 in Boston where PerkinElmer is showcasing the latest innovations across its extensive Life Science and cell and gene therapy portfolio in booths 625 and 631. Product demonstrations can be scheduled here.

About PerkinElmer

PerkinElmer is a leading, global provider of end-to-end solutions that help scientists, researchers and clinicians better diagnose disease, discover new and more personalized drugs, monitor the safety and quality of our food, and drive environmental and applied analysis excellence. With an 85-year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team of more than 16,000 collaborates closely with commercial, government, academic and healthcare customers to deliver reagents, assays, instruments, automation, informatics and strategic services that accelerate workflows, deliver actionable insights and support improved decision making.

We are also deeply committed to good corporate citizenship through our dynamic ESG and sustainability programs. The Company reported revenues of approximately $5.0 billion in 2021, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available at http://www.perkinelmer.com. Follow PerkinElmer on LinkedIn, Twitter, Facebook, Instagram, and YouTube.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220926005402/en/

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PerkinElmer Unveils Industry-first Cell Analysis Solution to Streamline ...

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Allogene Therapeutics has begun the first pivotal test of an off-the-shelf cell therapy for cancer.

The biotechnology company, which has been at the forefront of a push in recent years to develop such treatments, known as allogeneic therapies and derived from donor cells, announced the start of two trials on Thursday. One will test a blood cancer drug known as ALLO-501A, while the other will evaluate a regimen Allogene uses to prepare patients for treatment. Assuming positive results, Allogene expects the studies will support approval applications for both of them.

The studies represent milestones for allogeneic cell therapies, which are meant to be more convenient alternatives to the personalized CAR-T treatments that have come to market for a handful of blood cancers. Allogene, spun out of Pfizers cell therapy work in 2018, is the largest and most advanced among the companies advancing them. Its run by former executives of Kite Pharma, which successfully developed the cell therapies now sold by Gilead Sciences.

Allogene raised more than a half a billion dollars in private financing and an initial public offering to fund its work. The company has had a bumpy ride since then, however. Its cell therapies, including ALLO-501A, have shown promise, but also face lingering questions about their durability and effectiveness compared to CAR-T treatments. The field has also gotten more competitive, with an emerging group of companies advancing therapies using different types of cells and CAR-T moving into earlier lines of care.

Additionally, Allogenes research was delayed by the unexpected finding of a chromosomal abnormality in a treated patient. The companys treatment was exonerated, but the FDA froze Allogenes programs for months during the investigation. Longtime partner Servier cut ties with the company last month as well.

The company now has the chance to prove how its technology stacks up. ALLO-501A is being tested in a Phase 2 study in patients with relapsed or refractory large B cell lymphoma, a setting for which multiple CAR-T treatments are already available.

In a research note, RBC Capital Markets analyst Luca Issi noted that its trial, ALPHA2, mimics the design of the studies underlying approvals of those treatments for lymphoma. Its a single-arm study of about 100 patients whove previously received at least two prior treatments, but not a CAR-T therapy. The study will be judged by ALLO-501As ability to induce a response. Allogene didnt disclose a bar for success, but Issi, after speaking with management, said executives believe efficacy needs to be in the range of approved CAR-T therapies.

Notably, the company is testing a single dose of the treatment, not a repeat-dosing regimen Allogene has been experimenting with to strengthen the effects of ALLO-501A. Issi indicated the decision was made for ease and convenience.

Allogenes other study, EXPAND, is a registrational trial for ALLO-647, an antibody drug the company is using to prepare patients for treatment. That study will enroll about 70 patients and have a control arm that doesnt receive Allogenes drug. Updates are expected by the end of the year, Allogene said.

Allogene shares climbed 12% in pre-market trading Friday, though at about $11, shares still trade well below their highs of about $54 apiece in 2020.

Continued here:
Allogene starts first pivotal trials of an 'off-the-shelf' cell therapy for cancer - BioPharma Dive

Recommendation and review posted by Bethany Smith

Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.

Cell and gene therapies (CGTs) offer significant advances in patient care by helping to treat or potentially cure a range of conditions that have been untouched by small molecule and biologic agents. Over the past two decades, more than 20 CGTs have been approved by FDA in the United States and many of these one-time treatments cost between US$375,00 and US$2 million a shot (1). Given the high financial outlay and patient expectations of these life-saving therapies, it is essential that manufacturers provide integrated services across the whole of the supply chain to ensure efficient biomanufacturing processes and seamless logistics to reduce barriers to uptake.

The following looks at the who, what, when, and why of biomanufacturing and logistics in CGTs in the bio/pharmaceutical industry in more detail.

According to market research, the global gene therapy market will reach US$9.0 billion by 2027 due to favorable reimbursement policies and guidelines, product approvals and fast-track designations, growing demand for chimeric antigen receptor (CAR) T cell-based gene therapies, and improvements in RNA, DNA, and oncolytic viral vectors (1).

In 2020, CGT manufacturers attracted approximately US$2.3 billion in investment funding (1). Key players in the CGT market include Amgen, Bristol-Myers Squibb Company, Dendreon, Gilead Sciences, Novartis, Organogenesis, Roche (Spark Therapeutics), Smith Nephew, and Vericel. In recent years, growth in the CGT market has fueled some high-profile mergers and acquisitions including bluebird bio/BioMarin, Celgene/Juno Therapeutics, Gilead Sciences/Kite, Novartis/AveXis and the CDMO CELLforCURE, Roche/Spark Therapeutics, and Smith & Nephew/Osiris Therapeutics.

Many bio/pharma companies are re-considering their commercialization strategies and have re-invested in R&D to standardize vector productions and purification, implement forward engineering techniques in cell therapies, and improve cryopreservation of cellular samples as well as exploring the development of off-the-shelf allogeneic cell solutions (2).

The successful development of CGTs has highlighted major bottlenecks in the manufacturing facilities, and at times, a shortage of raw materials (3). Pharma companies are now taking a close look at their internal capabilities and either investing in their own manufacturing facilities or outsourcing to contract development and manufacturing organizations (CDMOs) or contract manufacturing organizations (CMOs) to expand their manufacturing abilities (4). Recently, several CDMOsSamsung Biologics, Fujifilm Diosynth, Boehringer Ingelheim, and Lonzahave all expanded their biomanufacturing facilities to meet demand (5).

A major challenge for CGT manufacturers is the seamless delivery of advanced therapies. There is no room for error. If manufacturers cannot deliver the CGT therapy to the patient with ease, the efficacy of the product becomes obsolete. Many of these therapies are not off-the-shelf solutions and therefore require timely delivery and must be maintained at precise temperatures to remain viable. Thus, manufacturers must not only conform to regulations, but they must also put in place logistical processes and contingency plans to optimize tracking, packaging, cold storage, and transportation through the products journey. Time is of the essence, and several manufacturers have failed to meet patient demands, which have significant impacts on the applicability of these agents.

Several CAR T-cell therapies have now been approved; however, research indicates that a fifth of cancer patients who are eligible for CAR-T therapies pass away while waiting for a manufacturing slot (6). Initially, the manufacture of many of these autologous products took around a month, but certain agents can now be produced in fewer than two weeks (7). Companies are exploring new ways to reduce vein-to-vein time (collection and reinfusion) through the development of more advanced gene-transfer tools with CARs (such as transposon, CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) among others, and the use of centralized organization with standardized apheresis centers (5). Others are exploring the use of the of allogeneic stem cells including Regen Biopharma, Escape Therapeutics, Lonza, Pluristem Therapeutics, and ViaCord (7).

Several gene therapies have also been approved, mainly in the treatment of rare disease (8). Many companies are evaluating novel gene therapy vectors to increase levels of gene expression/protein productions, reduce immunogenicity and improve durability including Astellas Gene Therapies, Bayer, ArrowHead Pharmaceuticals, Bayer, Bluebird Bio, Intellia Therapeutics, Kystal Biotech, MeiraGTx, Regenxbio, Roche, Rocket Pharmaceuticals, Sangamo Therapeutics, Vertex Pharmaceuticals, Verve Therapeutics, and Voyager Therapeutics (8).

While many biopharma companies have established their own in-house CGT good manufacturing practice (GMP) operation capabilities, others are looking to decentralize manufacturing and improve distribution by relying on external contracts with CDMOs and CMOs such as CELLforCURE, CCRM, Cell Therapies Pty Ltd (CTPL), Cellular Therapeutics Ltd (CTL), Eufets GmbH, Gravitas Biomanufacturing, Hitachi Chemical Advances Therapeutic Solutions, Lonza, MasTHerCell, MEDINET Co., Takara Bio, and XuXi PharmaTech (6, 9, 10).

The top 50 gene therapy start-up companies have attracted more than $11.6 billion in funds in recent years, with the top 10 companies generating US$5.3 billion in series A to D funding rounds (10). US-based Sana Biotechnology leads the field garnering US$700 million to develop scalable manufacturing for genetically engineered cells and its pipeline program, which include CAR-T cell-based therapies in oncology and CNS (Central Nervous System) disorders (11). In second place, Editas Medicine attracted $656.6 million to develop CRISPR nuclease gene editing technologies to develop gene therapies for rare disorders (12).

Overall, CGTs have attracted the pharma industrys attention as they provide an alternative route to target diseases that are poorly served by pharmaceutical and/or medical interventions, such as rare and orphan diseases. Private investors continue to pour money into this sector because a single shot has the potential to bring long-lasting clinical benefits to patients (13). In addition, regulators have approved several products and put in place fast track designation to speed up patient access to these life-saving medicines. Furthermore, healthcare providers have established reimbursement policies and manufacturers have negotiated value- and outcome-based contracts to reduce barriers to access to these premium priced products

On the downside, the manufacture of CGTs is labor intensive and expensive with manufacturing accounting for approximately 25% of operating expenses, plus there is still significant variation in the amount of product produced. On the medical side, many patients may not be suitable candidates for CGTs or not produce durable response due to pre-exposure to the viral vector, poor gene expression, and/or the development of immunogenicity due to pre-exposure to viral vectors. Those that can receive these therapies may suffer infusion site reactions, and unique adverse events such as cytokine release syndrome and neurological problems both of which can be fatal if not treated promptly (14).

Despite the considerable advances that have been made in the CGT field to date, there is still much work needed to enhance the durability of responses, increase biomanufacturing efficiencies and consistency and to implement a seamless supply chain that can ensure these agents are accessible, cost-effective, and a sustainable option to those in need.

Cleo Bern Hartley is a pharma consultant, former pharma analyst, and research scientist.

BioPharm InternationalVol. 35, No. 10October 2022Pages: 4951

When referring to this article, please cite it as C.B. Hartley, "Growth in Cell and Gene Therapy Market," BioPharm International 35 (10) 4951 (2022).

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Growth in Cell and Gene Therapy Market - BioPharm International

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Click to Access Audio Press Release

CHICAGO, Oct. 1, 2022 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the primary results from the Phase 1/2 study evaluating the investigational gene therapy botaretigene sparoparvovec (formerly AAV-RPGR) in patients with the inherited retinal disease X-linked retinitis pigmentosa (XLRP) associated with the retinitis pigmentosa GTPase regulator (RPGR) gene. Treatment with botaretigene sparoparvovec was found to have an acceptable safety profile, and efficacy assessments in this proof-of-concept study demonstrated encouraging improvements in retinal sensitivity, visual function and functional vision.1 These findings and additional updates, including data from a Phase 1 trial of investigational gene therapy JNJ-81201887 (JNJ-1887) for patients with geographic atrophy (GA), a late-stage and severe form of age-related macular degeneration (AMD), were presented in late-breaking oral presentations today at the Retina Subspecialty Day program of the American Academy of Ophthalmology (AAO) 2022 Annual Meeting (Abstracts #30071754 and #30071749).

XLRP is a rare condition estimated to impact one in 40,000 people globally.2,3 People with XLRP have progressive vision loss, starting in childhood with night blindness.4 Over time, they lose their peripheral vision leading to legal blindness by middle age.4 Botaretigene sparoparvovec is being investigated in collaboration with MeiraGTx Holdings plc to treat patients with XLRP caused by disease-causing variants in the eye-specific form of the RPGR (RPGR ORF15) gene. Through a one-time administration, botaretigene sparoparvovec is designed to deliver functional copies of the RPGR gene to counteract the loss of retinal cells with the goal of preserving and potentially restoring vision for those living with XLRP. Currently, there are no approved treatments for XLRP.4

"Individuals living with XLRP often begin to experience symptoms in childhood, and as retinal degeneration progresses toward blindness, they can start to feel a sense of hopelessness as there are no treatments to turn to," said Michel Michaelides, B.Sc., M.B., B.S., M.D. (Res), FRCOphth, FACS, Consultant Ophthalmologist, Moorfields Eye Hospital, Professor of Ophthalmology, University College London and lead investigator. "These results from the MGT009 study are promising, as they represent the potential for botaretigene sparoparvovec to preserve vision and ultimately restore hope for these patients."

The primary endpoint of the MGT009 study (NCT03252847) was safety, with secondary endpoints measuring changes in assessments of three domains of visionretinal sensitivity, visual function and functional visionat specified time points post-treatment.1 In the study's dose escalation and expansion phases, significant sustained or increased functional improvement in each visual domain was observed in participants treated with botaretigene sparoparvovec compared to the randomized untreated control arm of the study at six months post-treatment.1

Analyses of the pooled low and intermediate dose cohorts demonstrated improvement in retinal sensitivity in the treated eyes compared to untreated eyes in the randomized concurrent control arm as measured by both full-field static perimetry and microperimetry.1 An improvement in mean retinal sensitivity as measured by static perimetry in the central 10-degree area of the retina was observed at six months in the treated eyes compared to untreated eyes in the randomized concurrent control arm [in the full analysis of pooled low and intermediate doses across adults: 1.96 decibel (dB); (95% CI: 0.59, 3.34); and in the sensitivity analysis when applying the Phase 3 criteria: 2.42 (0.91, 3.93)].1

As part of the study, patients performed a functional vision assessment using a visual mobility maze to assess their ability to navigate through simulated real-life obstacles across a broad range of controlled light. At week 26, improvement in walk time was observed between the treated eyes in the low and intermediate dose cohorts and the untreated eyes in the randomized concurrent control arm at low illumination levels (full analysis nominal p-value < 0.05 at lux 1 and lux 16; in the sensitivity analysis when applying the Phase 3 criteria nominal p-value < 0.01 at lux 1, lux 4 and lux 16).1

The safety profile of botaretigene sparoparvovec observed in MGT009 was consistent with previous reports.1 Botaretigene sparoparvovec demonstrated an adverse event (AE) profile that was anticipated and manageable.1 Most AEs were related to the surgical delivery procedure, were transient and resolved without intervention.1 There were no dose-limiting events.1 A total of three serious adverse events (SAEs) were observed in the overall Phase 1/2 MGT009 clinical study; two SAEs, which were previously reported, were observed in the dose-escalation phase of the study (n=10; one retinal detachment and one panuveitis in the low dose cohort), and a single additional SAE of increased intraocular pressure was observed in the dose escalation phase and resolved with treatment.1

"Without an approved treatment option available, people with XLRP are faced with the inevitable fate of going blind in the prime of life," said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular, Metabolism, Retina & Pulmonary Hypertension, Janssen Research & Development, LLC. "We're in a race to save sight for these patients and are encouraged by the strength of the data that we've shared so far. We look forward to advancing the clinical development of botaretigene sparoparvovec as part of our mission to preserve and potentially restore vision for these patients."

Further sensitivity analysis was conducted on study participants by applying the Phase 3 LUMEOS (NCT04671433) study eligibility criteria that corroborated the endpoints selected for the Phase 3 study.1 Currently, the LUMEOS study of botaretigene sparoparvovec for the treatment of patients with XLRP with disease-causing variants in the RPGR gene is actively dosing patients.

Phase 1 Data Evaluating JNJ-1887 in Geographic AtrophyJanssen also presented late-breaking data from a Phase 1, open-label, multicenter, dose-escalation, safety and tolerability study (NCT03144999) of a single intravitreal injection of JNJ-1887 in patients with advanced non-exudative (dry) age-related macular degeneration (AMD) with GA. GA is an irreversible condition that affects more than five million individuals worldwide.5 It has a devastating impact on GA patients' health-related quality of life, including their ability to read, drive and perform other day-to-day activities.5 In this study, patients (n=17) were sequentially enrolled at a low, intermediate and high dose without steroid prophylaxis, and all three doses of JNJ-1887 met the primary endpoint of safety over the two-year follow-up period.6 In addition, the supportive efficacy measures, including evaluation of GA lesion growth rates, showed a continual decline in lesion growth over six-month increments.6 These results are the first shared from the Company's common eye disease portfolio and indicate further evaluation of this investigational gene therapy is warranted.6

About the Phase 1/2 MGT009 Trial and Botaretigene SparoparvovecThe Phase 1/2 MGT009 trial (NCT03252847) was an open-label, multicenter dose escalation study that enrolled patients aged five years and older with X-linked retinitis pigmentosa (XLRP) caused by disease causing variants in the retinitis pigmentosa GTPase regulator (RPGR) gene at multiple sites in the United States and the United Kingdom. The primary endpoint was safety and tolerability; secondary endpoints assessed retinal sensitivity, visual function and functional vision.

The clinical study was composed of three parts: dose-escalation, pediatric dose-confirmation and an expansion phase. In the dose escalation phase, adult patients were treated at three escalating doses of botaretigene sparoparvovec; a low (2x1011 vg/mL), an intermediate (4x1011 vg/mL), and a high (8x1011 vg/mL) dose. In the expansion phase, 42 adult male patients were randomized to either immediate treatment with one of two low or intermediate doses or an untreated concurrent control arm with deferred treatment. At six months, the untreated control arm was randomized to receive either the low or intermediate treatment doses. Botaretigene sparoparvovec was administered through subretinal delivery in only one eye. The adult patients received treatment at three doses. The pediatric cohort (n=3) was only treated with an intermediate dose of botaretigene sparoparvovec.

Botaretigene sparoparvovec has been granted Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME), Advanced Therapy Medicinal Product (ATMP) and Orphan designations by the European Medicines Agency (EMA).

About the Janssen and MeiraGTx Strategic CollaborationIn January 2019, Janssen Research & Development, LLC entered into a worldwide collaboration and license agreementwith MeiraGTx Holdings plc, a clinical-stage gene therapy company, to develop, manufacture and commercialize its clinical-stage inherited retinal disease portfolio. Botaretigene sparoparvovec is being developed as part of a collaboration and license agreement. In addition to forming a research collaboration to explore new targets for other inherited retinal diseases, Janssen is working with MeiraGTx to build core capabilities in viral vector design, optimization and manufacturing.

About the Phase 1 JNJ-1887 Trial and JNJ-1887JNJ-81201887 (JNJ-1887), formerly referred to as AAVCAGsCD59, is an investigational gene therapy for the treatment of people with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). JNJ-1887 is designed to increase the expression of a soluble form of CD59 (sCD59) intended to protect retinal cells to slow and prevent disease progression. JNJ-1887 was evaluated in a Phase 1 clinical trial (NCT03144999), an open-label, single-center dose escalation study to determine the safety of JNJ-1887 in adults 50 or older with advanced dry AMD with GA. The patients were treated at three escalating doses of JNJ-1887 without steroid prophylaxis through a single intravitreal injection in one eye.

This Phase 1 study met its primary endpoint of safety in all doses of JNJ-1887 (n=17), with supportive efficacy measures including evaluation of GA lesion growth rates, which showed a continual decline in lesion growth over six-month increments.

JNJ-1887 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) and Advanced Therapy Medicinal Product (ATMP) designation by the European Medicines Agency (EMA).

About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism, & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.

Learn more at http://www.janssen.com. Follow us at@JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Dr. Michaelides is a scientific founder of, and consultant to, and has a financial relationship with MeiraGTx.

Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding botaretigene sparoparvovec and JNJ-81201887. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year endedJanuary 2, 2022, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online atwww.sec.gov,www.jnj.comor on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

References1Michaelides, M et al. Ph1/2 AAV5-RPGR (Botaretigene Sparoparvovec) Gene Therapy Trial in RPGR-associated X-linked Retinitis Pigmentosa (XLRP). Abstract #30071754. Presented at the 2022 American Academy of Ophthalmology Annual Meeting.

2Boughman JA, Conneally PM, Nance WE. Population genetic studies of retinitis pigmentosa. Am J Hum Genet. 1980;32(2):223235.

3Fishman GA. Retinitis pigmentosa. Genetic percentages. Arch Ophthalmol. 1978;96(5):822826. doi:10.1001/archopht.1978.03910050428005.

4 Wang DY, Chan WM, Tam PO, et al. Gene mutations in retinitis pigmentosa and their clinical implications. Clin Chim Acta. 2005;351(1-2):5-16.

5 Cohen, MN et al. Phase 1 Study of JNJ-81201887 Gene Therapy in Geographic Atrophy (GA) Due to Age-related Macular Degeneration (AMD). Abstract #30071749. Presented at the 2022 American Academy of Ophthalmology Annual Meeting.

6 Singh RP, Patel SS, Neilsen JS, et al. Patient-, caregiver- and eye care professional-reported burden of geographic atrophy secondary to age-related macular degeneration. Am J Ophthalmic Clin Trials. 2019;2(1):1-6.

Investor Contact:Raychel KruperOffice +1 732-524-6164rkruper@its.jnj.com

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Janssen Announces Late-Breaking Data from Two Gene Therapy Programs at the American Academy of Ophthalmology 2022 Annual Meeting - Johnson &...

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Acquisition of select PACT assets enables AmplifyBio to expand beyond safety, efficacy, and toxicology services to enable "living medicine" developers to shorten timelines and mitigate risk when moving to the clinic

WEST JEFFERSON, Ohio and SOUTH SAN FRANCISCO, Calif., Oct. 3, 2022 /PRNewswire/ --AmplifyBio, a contract research organization (CRO) focused on accelerating innovation across pharmaceutical modalities; today announced the acquisition of select assets fromPACT Pharma, Inc., a privately held biopharmaceutical company developing neoantigen-specific T cell receptor cell therapies. The deal will provide AmplifyBio with advanced characterization platforms, bioinformatics capabilities, and 40 drug development experts to enhance their cell and gene therapy service offerings. AmplifyBio will also acquire the South San Francisco advanced laboratory space.

With the acquisition of these assets, AmplifyBio aims to provide an early, consistent characterization of a treatment's purity, potency, and viability throughout the life cycle of therapeutic development. Unlike small molecules, there is no single, consistent process for cell and gene therapy companies to research, develop, and test their therapeutics. The gap that exists in characterization between the discovery phase and preclinical testing leads to material changes in a therapeutic during development, which can in turn create manufacturing inconsistencies and safety concerns during scale-up.

"Many biologics developers have adopted the phrase 'the process is the product' to describe how their therapeutic is differentiated based on a unique development process," said AmplifyBio Chief Executive Officer (CEO) and President J. Kelly Ganjei. "Rather than create our own, individual technique, AmplifyBio aims to replace that saying with a new one: 'the product is the product. Our acquisition of these assets from PACT Pharma means that cell and gene therapies can now be differentiated based on safety and efficacy profiles and specific product characteristics, not development processes."

"This deal allows PACT to retain its core intellectual property and continue our mission of developing novel, neoantigen-targeted T-Cell Therapies," added Scott Garland, PACT Pharma's CEO. "At the same time, we're working with AmplifyBio to leverage our platforms to offer a unique combination of optimization, characterization, safety and efficacy services to a wider range of clients seeking to better understand the immunology of their adoptive cell therapies."

AmplifyBio was spun out in 2021 from Battelle, a not-for-profit organization that advances science and technology to have the greatest impact on our society and economy. Following today's acquisition of the South San Francisco facility, AmplifyBio plans to add a third site in New Albany, Ohio that consists of 350,000 square feet of multi-function lab spaces. There, AmplifyBio will build on its advanced therapy services by adding capabilities for complex genotypic and phenotypic characterization analysis for late-stage development. The company expects to add additional development platforms and partnerships to become a commercial accelerator delivering safe, effective, reproducible advanced therapies to patients.

About AmplifyBioAmplifyBio is a leading preclinical CRO focused on toxicology, safety, and pharmacology testing to advance therapeutics for the betterment of human health. Spun out of Battelle in May of 2021, AmplifyBio's mission is to continue to provide exceptional CRO study services in an agile environment better suited to commercial goals and expand analytic capabilities to serve the dynamic needs of advanced therapy development. Clients of AmplifyBio enjoy the peace of mind that comes from decades of experience in GLP and non-GLP study design and execution, combined with rapid investment in technology, expertise, and infrastructure that together provide the critical components of a reliable, agile partnership.

Media Contact AmplifyBio[emailprotected]For Inquiries to PACT[emailprotected]

SOURCE AmplifyBio

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AMPLIFYBIO ACQUIRES PACT PHARMA ASSETS TO ENHANCE CELL AND GENE THERAPY CHARACTERIZATION CAPABILITIES - PR Newswire

Recommendation and review posted by Bethany Smith

Essential that patients have the information they need to make informed choices in the future

Australians with inherited retinal disease (IRD) have a strong interest in undergoing gene therapy to prevent and treat blindness but theres a critical need for education programmes to help them make informed choices about future treatments, new research shows.

IRD is the umbrella term for broad group of genetic eye conditions, including retinitis pigmentosa and Stargardts disease, that cause progressive vison loss and blindness. They are the most common cause of blindness in working-age Australians, affecting more than 13,000 people nationally.

The study, led by the Centre for Eye Research Australia and University of Melbourne,reveals the results of the first national survey asking Australians living with IRD and their carers about their knowledge and views on gene therapy.

It provides new insight into patients knowledge of emerging gene therapies, the methods used, their willingness undergo future treatments and their views on the potential costs and logistics.

The findings demonstrated the need for continuing, targeted education about the outcomes and risks of gene therapy, and the difference between clinical research and approved treatments.

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Education vital to help patients explore gene therapies for blindness: Australian study - BSA bureau

Recommendation and review posted by Bethany Smith

Demand for viral-vector-based gene therapies has risen to unprecedented levels, thanks to their potential to help treat previously incurable diseases. The two vectors most in the spotlight? Lentiviral (LV) vectors and adeno-associated viral (AAV) vectors due to the increased research and positive clinical results they are seeing across a wide range of applications, including cancer, heart disease, and hematologic and genetic disorders. The more drug developers look to expand this range of therapeutic areas, the greater the demand for commercial-scale development. So its important to understand not only how these two vectors can be applied to drug development, but also the capabilities required for scale-up that allows us to bring these innovative therapies to patients.

LV vectors are derived from the single-stranded RNA retrovirus HIV-1, and have been used extensively because of their ability to infect non-dividing cells, efficiently integrate into the host genome, carry large transgene loads, and allow for long-term transgene expression. They are predominantly used as delivery vehicles for introducing genetic modifications into cell therapies, such as CAR-T, and HSC gene therapies. Importantly, recent regulatory approvals and clinical successes with LV vectors are spurring even more interest among drug developers.

Lets look at the benefits of LV vectors in more detail:

However, LV vectors also present two major risks to safety.

The first is a risk of accidental exposure because HIV can self-replicate during manufacturing thanks to the lentiviruss high mutation and recombination rate.Though research shows that the risk is low, it remains a major safety concern for lab engineers and workers during development. Before using a lentiviral vector system, a risk assessment must be completed and documented. Typically, lentiviral vectors may be safely handled using either BSL-2 or BSL-2 enhanced controls, depending upon the risk assessment.

The second risk is the potential for oncogenes to occur in cells through insertional mutagenesis. For this reason, lentiviral vectors are predominantly used for cell therapy applications with genetic modification of cells ex-vivo. Only limited use is seen for direct in vivo therapies.

Unlike their LV cousins, AAV vectors are single-stranded DNA parvoviruses that can replicate only in the presence of helper viruses, such as the adenovirus, herpes virus, human papillomavirus, and vaccinia virus. Following several landmark approvals, AAV vectors are currently being used for in vitro, ex vivo, and in vivo research. AAV therapies predominantly target rare genetic disorders for which the patient population tends to be highly limited. As the market is so small, drug developers feel immense pressure to be first to market to commercialize their therapies.

The biological elements of AAV vectors make them a very attractive candidate for gene therapy for several reasons:

As with LV vectors, AAV vectors come with several drawbacks that affect their applications and efficiency.

Firstly, AAV vectors are limited by their restricted capacity for insertion of transgene DNA; because of their relatively small transgene size, they are unable to deliver genes larger than 4.8 kilobytes. Secondly, the generation of neutralizing antibodies against AAV in non-human primates (NHP) and humans may attenuate the curative effects of AAV-mediated gene therapies and limit the size of patient populations suitable for these therapies. Thirdly, there are several different serotypes and capsids for AAVs, all of which have different production and purification requirements and vary greatly with respect to function and efficacy. Fourthly, AAV drug products have varying degrees of empty and partially filled capsids, and these have implications for safety and efficacy. Generally, the highest possible percentage of AAV particles with the full transgene DNA is desired, and this varies significantly depending on the production method, AAV serotype, and the transgene itself. The latter two factors introduce significant manufacturing challenges for AAV therapies.

Overall, the industrys collective ability to successfully scale up LVV and AAV vectors faces two challenges:

i) Manufacturing each viral vector currently requires different processes, so companies cannot apply a one-size-fits-all approach to their upstream and downstream processes. Therefore, manufacturing requires immense scientific and market expertise to make the informed decisions necessary for developing a robust plan.

ii) Given the industrys limited experience with commercial-scale viral vector supply, companies need to work closely with regulatory agencies. This can be especially challenging during the transition from preclinical to commercial, where complexities arise that can cause potential delays resulting in increased costs.

As demand continues to rise, pharma companies must understand how to navigate these challenges to continue delivering their life-saving medications.

Head of Commercial Development for Viral Vector, Cell and Gene Technologies (CGT) at Lonza

She works closely with the innovation, operations, engineering, strategic marketing, and business teams to enable prioritization, strategic development and commercialization of viral vector production services for CGT. Suparnas background is in Neuroscience, and she earned her PhD in Neuropharmacology from the University of Toronto. She has over 15 years of broad pharmaceutical and CDMO experience driving innovation, drug discovery, product and service development for CNS, oncology, and cell and gene therapy.

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The Pros and Cons of Lentiviral and Adeno-Associated Viral Vectors - The Medicine Maker

Recommendation and review posted by Bethany Smith

Gene and cell-based treatment is promising solutions for the control and cure of some chronic and life-threatening diseases such as sickle-cell disease (SCD), haemophilia, blood cancers, and HIV. Most of the current gene therapy clinical trials on SCD and HIV are conducted in North America.The treatment is either by using someone elses cells or those of the patient. Gene therapy, also called genetic engineering, involves getting ones cells (a patient), improving them either by enhancing them to fight disease or as a replacement for the diseased cells and using them to treat the disease.

Unlike in agriculture where a lot of the genetic engineering is on seed, Dr Cissy Kityo, the executive director at Joint Clinical Research Centre (JCRC) says in medicine, the human seed (ova or sperm) or the embryo is not touched.Its not about engineering custom humans as this has no current ethical basis. Therefore, it presents a new treatment paradigm, Dr Kityo says.

Gene therapy is administered once in a lifetime. Therefore, for someone with HIV, that eliminates the burden of taking ARTs. It also has the potential to save the overall healthcare cost and increase the individuals productivity.Research is ongoing to ensure this treatment is effective, safe, and free from off-target effects and any contamination.

The processDr Francis Ssali, the deputy executive director in charge of clinical care and research at JCRC, says genetic modification involves a series of processes, the first of which is to collect specialised white blood cells called T-cells and blood-forming stem cells from the patients blood.These cells are then taken to a clean medical laboratory where they are counted, checked for viability, and purified. Thereafter, the gene to correct the disease is inserted into these cells and this is done by either using special enzymes called CRISPR or by the use of self-inactivating partial viruses called Lentiviral vectors. The lentiviral vector delivers the required gene into the cells without resulting in viral infection in the patients cells, he says.

The process of introducing the corrective gene into the patients cell is called transduction and it can take between four to seven days to perform in the laboratory. Once the cells have received this gene modification, they are checked for quality and safety before they are ready for reinfusion back into the patient.In some instances, the patient is given medical treatment to enable them to receive the gene therapy cells, he adds.However, Dr Ssali says the current approaches to gene-therapy cell manufacturing are labour intensive and take a relatively long time to prepare, and require a large clean laboratory space.

Thankfully, there are newer laboratory instruments that can automate this genetic engineering work in a single closed instrument, with efficiency, he says.Uganda has 1.4 million people living with HIV and 400,000 people living with sickle cells yet adherence to medicine is inconsistent for some.Some HIV-resistant viral variants have emerged which threaten the efficacy of the treatment programme. As such, genetic engineering will be a blessing.Globally, the first-generation cure trials for HIV were done, second-generation trials are coming up and there is hope that soon a short-term cure will be got.

Ugandan perspectiveIn Uganda, Dr Ssali says the hope is that by 2030, Uganda will have controlled HIV/Aids greatly and also contributed to finding a functional cure.Dr Kityo says JCRC hopes to start HIV gene therapy trials in Uganda in 2024.The other focus is technology transfer where these gene therapy products are produced where they are needed, more efficiently, and more cost-effectively. That is why there will be more compact systems rather than the large labs, she adds.

In Africa, Uganda ranks fifth among countries with sickle cell disease and whereas bone-marrow transplants can cure SCD, only 10 percent of the eligible patients can get a matched donor. Nonetheless, with gene therapy, this will not be an issue since the patients own cells are used.Thankfully, the current gene therapy treatment technologies for HIV are the same used in sickle cell cure research. That is why preparing to address HIV also works to tackle the sickle cell disease, Dr Kityo says.

The joint Clinical Research Centre is working towards building the research teams and creating the necessary infrastructure for this novel research and clinical care. Arthur Makara, the coordinator of Uganda Biotechnology and Biosafety Consortium, calls for several partnerships because even when JCRC creates these technologies, they need help to mass produce them for a bigger population. Gene therapy only works on an individual, not on the sperm or ovary. Therefore, Dr Kityo says even after treatment, a sickle cell patient will still have sickle cell gene but normal cells in their marrow and live a normal life.

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Gene therapy brings hope to people with sickle cell, HIV - Monitor

Recommendation and review posted by Bethany Smith

(Precision Vaccinations)

Encouraging news from researchers at Fred Hutchinson Cancer Center in Washingtonrecently showed that an experimental gene therapy for herpes simplex virus infectionsmaysuppressthe amount of transmissible virus.

Drs.Keith JeromeandMartine Aubert, the virologists leading the research effort, reported the innovative treatment dramatically reduced or even eliminated viral shedding in treated mice compared to controls.

During multiple experiments, the researchers found substantial reductions in oral and genital viral shedding in the treated mice, with many of those treated showing no detectable virus shed.

This is an important milestone since the U.S. FDA has not approved any herpes prevention vaccine as of October 4, 2022.

"If you ask people living with Herpes simplex virus (HSV)what they care about, what they care most about is whether they have to worry about giving this virus to someone else, and shedding is how that happens," Dr. Jerome said in a media release issued on September 26, 2022.

Previously,Jerome and Aubert reportedthat the experimental drug could eliminate more than 90% of the latent herpesvirus in nerve clusters near the faces of the mice injected with the enzyme-carrying adeno-associated viruses (AAVs).

In this new study, they describe how they have tested the therapy for the first time to treat infections in a cluster of nerves called dorsal root ganglia near the genital tract of mice.

They found the experimental therapy reduced the latent herpes virusby about97%.

These results reinforce the curative potential of gene editing for latent orofacial and genital HSV disease, and provide a framework for additional safety studies before human trials can begin, wrote these researchers in a non-peer-reviewed study published on September 26, 2022.

HSV establishes latency in ganglionic neurons of the peripheral nervous system, from which it can reactivate, causing recurrent disease and possible transmission to a new host.

Current anti-HSV therapy does not eliminate latent HSV and thus is only suppressive rather than curative.

These researchers developed a potentially curative approach to latent HSV infection and pathogenesis based on gene editing using HSV-specific meganucleases delivered by AAVvectors.

This non-human study's results demonstrated that a dual meganuclease therapy, composed of two anti-HSV-1 meganucleases delivered by a triple AAV serotype combination (AAV9, AAV-Dj/8, AAV-Rh10), can eliminate up to 97% of latent HSV DNA from ganglia in both ocular and vaginal mouse models of latent HSV infection.

Using a novel pharmacological approach to reactivate latent HSV-1 in mice with the bromodomain inhibitor JQ-1, theydemonstrated that this reduction in ganglionic viral load leads to a significant reduction of viral shedding from treatedvs. control mice, with many treated mice showing no detectable virus shedding.

In general, the novel therapy was found well tolerated, although dose-ranging studies showed hepatotoxicity at high AAV doses, consistent with previous observations in animals and humans.

Also, in agreement with previous literature, theyobserved subtle histological evidence of neuronal injury in some experimental mice, although none of the mice demonstrated observable neurological signs or deficits.

The Hutch scientists noted that this study'spositivenews is tempered by recentconcerns within the gene therapy fieldabout the potential for therapies using AAVs to cause liver and nerve damage.

Jerome and Aubert are still hopeful that they can get FDA approval to test the therapy in humans in an early-stage clinical trialbefore the end of 2023.

The work was funded by the U.S. NIH, the Caladan Foundation, and more than 1,600 individual donors. Cellectis developed the meganucleases used in this research.

Disclosure note:Fred Hutch and certain of its scientists may benefit financially from this work in the future.

PrecisionVaccinations publishes fact-checked, research-based vaccine news manually curated for mobile readers.

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Herpes Gene Therapy Further Refined in Mice - Precision Vaccinations

Recommendation and review posted by Bethany Smith

Bloomsbury Genetic Therapies launches with Seed financing of 5 million to develop potentially curative gene therapy treatments for rare neurological and metabolic diseases

London, UK, 7 October 2022 Bloomsbury Genetic Therapies Limited (Bloomsbury), a biotechnology company developing potentially curative treatments for patients suffering from rare neurological and metabolic diseases, based on clinically proven gene therapy technologies, today announced its launch with 5 million Seed financing led by UCL Technology Fund.

Bloomsburys innovative approach is designed to optimise therapeutic efficacy and safety, enable high manufacturability, accelerate development timelines and maximise regulatory success to create a pipeline of highly differentiated first- or best-in-class programs. The Companys lead programs are liver and CNS targeted gene therapies:

Liver targeted therapies: BGT-OTCD: Ornithine Transcarbamylase Deficiency (OTCD)

CNS targeted therapies: BGT-DTDS: Dopamine Transporter Deficiency Syndrome (DTDS)

BGT-NPC: Niemann-Pick Disease Type C (NPC)

BGT-INAD: Infantile Neuroaxonal Dystrophy (INAD)

These programs are underpinned by the unique medical insights derived from the internationally recognised clinics run by the companys academic founders, a deep understanding of disease biology and world-class translational science resulting from the close collaboration between Bloomsburys academic founders. Additionally, the viral vectors in the Companys programs have been designed with well-characterised adeno-associated virus (AAV) capsids that have demonstrated success in clinical and/or commercial settings. They have also been combined with innovative cassettes and routes of administration designed for optimal therapeutic effect.

Bloomsbury is developing potentially curative treatments for patients suffering from rare neurological and metabolic diseases, said Adrien Lemoine, Co-Founder & Chief Executive Officer of Bloomsbury. Our approach has been designed with a single goal in mind - to deliver the promise of gene therapy to rare disease patients by leveraging our industrys existing state-of-the art technology and we have already attracted a highly talented team of founders and experienced scientific and business professionals to the Company to that effect as we progress our first liver targeted gene therapy program, BGT-OTCD for the treatment of Ornithine Transcarbamylase Deficiency, into the clinic.

Our commitment to Bloomsbury is a great example of our strategy to seek to build truly innovative companies anchored by exceptional science and experienced teams, added Leigh Brody, Investment Manager of UCL Technology Fund. We are excited by the potential to develop best-in-class products in the gene therapy space.

Bloomsbury was founded as a spinout from UCL, and was supported by UCL Business, who helped foster the progression of these translational projects, supporting the team whilst managing the intellectual property, and making this deal possible. Bloomsbury is underpinned by world-leading gene therapy and rare disease expertise from the Companys academic founders:

After years of working relentlessly to identify and develop potential treatments for OTCD, NPC, DTDS and INAD, we are excited to have partnered with the team at Bloomsbury and are confident that these programs are in safe hands to be progressed through the development stage and towards regulatory approvals, with an ultimate goal of providing curative therapies to patients, added Professors Gissen, Kurian, Rahim and Waddington.

Senior leadership

Bloomsbury is led by Co-Founder & Chief Executive Officer, Adrien Lemoine, who brings 20 years of experience in pharma and biotech, including senior commercial, strategy and operation roles at AstraZeneca and GSK and joined the Company from Orchard Therapeutics where he served as Chief Business Officer. In this role he played a leading part in the companys fundraising efforts (Series B, Series C, NASDAQ IPO and follow-on financing) which raised over $750M and built the companys pipeline as well as setting-up Orchards discovery research efforts, alongside managing the program leadership & management function.

Alongside him on the senior leadership team are:

Board of Directors

Bloomsbury has also assembled an impressive trio of industry leaders as Independent Directors to assist management in driving the business forward; namely:

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Bloomsbury Genetic Therapies launches with Seed financing of 5 million to develop potentially curative gene therapy treatments for rare neurological -...

Recommendation and review posted by Bethany Smith

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Some of the Major Key players profiled in the study are BioMarin Pharmaceutical, Sangamo Therapeutics, Amicus Therapeutics, Roche, Pfizer, NightstaRx, MeiraGTx, Sarepta Therapeutics, Neurocrine Biosciences, Voyager Therapeutics, Asklepios Biopharmaceutical

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Various factors are responsible for the market's growth trajectory, which are studied at length in the report. In addition, the report lists down the restraints that are posing threat to the global Adeno-Associated Virus (AAV) Vector-Based Gene Therapy market. This report is a consolidation of primary and secondary research, which provides market size, share, dynamics, and forecast for various segments and sub-segments considering the macro and micro environmental factors. It also gauges the bargaining power of suppliers and buyers, threat from new entrants and product substitute, and the degree of competition prevailing in the market.

Global Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Market Segmentation:

Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Segmentation by Type:

Single-stranded AAV (ssAAV), Self-complementary AAV (scAAV).

Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Segmentation by Application:

Hemophilia, Ophthalmology, Lysosomal Storage Disorders, Neurological Disorders, Others

Key market aspects are illuminated in the report:

Executive Summary: It covers a summary of the most vital studies, the Global Adeno-Associated Virus (AAV) Vector-Based Gene Therapy market increasing rate, modest circumstances, market trends, drivers and problems as well as macroscopic pointers.

Study Analysis: Covers major companies, vital market segments, the scope of the products offered in the Global Adeno-Associated Virus (AAV) Vector-Based Gene Therapy market, the years measured and the study points.

Company Profile: Each Firm well-defined in this segment is screened based on a products, value, SWOT analysis, their ability and other significant features.

Manufacture by region: This Global Adeno-Associated Virus (AAV) Vector-Based Gene Therapy report offers data on imports and exports, sales, production and key companies in all studied regional markets

Market Segmentation: By Geographical Analysis

The Middle East and Africa (GCC Countries and Egypt)North America (the United States, Mexico, and Canada)South America (Brazil etc.)Europe (Turkey, Germany, Russia UK, Italy, France, etc.)Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

The cost analysis of the Global Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Market has been performed while keeping in view manufacturing expenses, labor cost, and raw materials and their market concentration rate, suppliers, and price trend. Other factors such as Supply chain, downstream buyers, and sourcing strategy have been assessed to provide a complete and in-depth view of the market. Buyers of the report will also be exposed to a study on market positioning with factors such as target client, brand strategy, and price strategy taken into consideration.

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Key questions answered in the report include:

who are the key market players in the Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Market?Which are the major regions for dissimilar trades that are expected to eyewitness astonishing growth for the Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Market?What are the regional growth trends and the leading revenue-generating regions for the Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Market?What will be the market size and the growth rate by the end of the forecast period?What are the key Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Market trends impacting the growth of the market?What are the major Product Types of Adeno-Associated Virus (AAV) Vector-Based Gene Therapy?What are the major applications of Adeno-Associated Virus (AAV) Vector-Based Gene Therapy?Which Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Services technologies will top the market in next 7 years?Table of Contents

Global Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Market Research Report 2022 - 2029

Chapter 1 Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Production, Revenue (Value) by Region

Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions

Chapter 6 Global Production, Revenue (Value), Price Trend by Type

Chapter 7 Global Market Analysis by Application

Chapter 8 Manufacturing Cost Analysis

Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10 Marketing Strategy Analysis, Distributors/Traders

Chapter 11 Market Effect Factors Analysis

Chapter 12 Global Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Market Forecast

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Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Market will reach at $ 543.23 mn by 2032 demand and future scope with Russia-Ukraine Crisis...

Recommendation and review posted by Bethany Smith