Category Archives: Hormone Replacement Therapy

The Church of Jesus Christ of Latter-day Saints is pressuring state regulators to punt a proposed ban on conversion therapy for minors back to Utah lawmakers, or change it so that therapists can keep counseling young clients about putting religious convictions over sexual identity.

The church has a certain view about what is right and good with respect to gender and sexuality, and so its really hard for me to believe that amendments such as these would not be interpreted by some clinicians as license to continue pushing their particular version of health and well-being on vulnerable youth, said Lisa Diamond, a professor of psychology and gender studies at the University of Utah.

The Utah Psychological Association also opposes the churchs suggested rule alterations, saying that they are inconsistent with peer-reviewed science and in violation of the American Psychological Associations ethics code. The conversion therapy ban under consideration would not infringe on self-determination, parental rights or religious freedoms, wrote Nanci Klein, the associations director of professional affairs.

The rule would do nothing more than regulate the practice of mental health therapy by prohibiting licensed mental health professionals from subjecting minors to an unnecessary, ineffective, and life-threatening practice, Klein wrote in an email.

So Troy Williams, executive director of Equality Utah, said he hopes state regulators dont comply with the churchs request to kick the issue back to lawmakers.

I dont know whats going to happen," he said, but I hope science prevails over politics.

The church released its opposition to the rule, as written, in a short news release Tuesday. Its Family Services, which offers mental health and other counseling, submitted a more formal statement to state officials expounding on concerns that the rule as drafted is too broad and would fail to protect religious beliefs.

About 250 therapists with Family Services work with 28,000 clients in Utah each year, the networks letter states. Seeing one of these therapists requires a referral from a congregational leader (a bishop or branch president), a stake president (a regional leader) or a mission president, and the typical client is looking for counseling that respects and accounts for their religious identity and personal faith goals.

Family Services has prohibited therapies seeking to change sexual orientation and supports protecting children and youth from abusive conversion therapy practices," according to the correspondence. However, the lengthy letter enumerates a number of objections to the current proposals wording, including language crafted to protect transgender youths from conversion techniques.

The church expresses concern that the drafted rule would prevent therapists from encouraging young people to adopt a wait-and-see approach before pursuing gender transition. The letter also takes issue with proposed language restricting mental health professionals from trying to change presentation and behaviors" expressing aspects of gender.

[I]t is easy to imagine numerous dysfunctional presentations and behaviors that express aspects of gender, such as extremes in dress, grooming, language and sexuality, states the letter, addressed to a DOPL representative.

For instance, discussing a topic such as toxic masculinity might be off-limits for a therapist, the church posits.

To a lesser degree, the church outlined the same problem with the proposed wording on sexual orientation, arguing that it is overly broad and could mute conversations about pornography addiction, abstinence and integrating religious values with other aspects of life.

Major medical and mental health groups in the state spoke in favor of the proposed rule during a lengthy public hearing last month, saying restricting conversion therapy could save lives by protecting youths from a practice linked to suicide and depression.

Research shows more than 60% of LGBT youths who go through conversion therapy attempt suicide, Klein noted.

But some therapists say they can see where the church is coming from.

Julie de Azevedo Hanks, a therapist with Wasatch Family Therapy who is a Latter-day Saint, said she can appreciate the churchs concerns but does not share them herself. The rule language, in her view, would not stifle conversations with a teen whos addicted to gay pornography or other sex-related issues.

The problem isnt that hes looking at gay pornography. Its that he is looking at pornography many hours a day, said Hanks, whos also an assistant professor of social work at Utah Valley University. And you treat that behavior. It has nothing to do with whether its gay or straight.

David Matheson, a former conversion therapist who recently came out as gay, said he also has problems with the ban now under consideration. The current language fails to reflect the complexities of sexual fluidity and gender identity, he said, and would act as a blunt instrument where nuance is needed.

Theres a lawyer now sitting in the therapists office, and he doesnt belong there, said Matheson, who still works as a therapist but has disavowed his past conversion efforts.

He did, however, explain that he disagrees with the churchs doctrines and policies on LGBTQ people, which he called inhumane.

Diamond said these positions throw into question the churchs credibility on the topic of conversion therapy. And while the churchs letter condemns conversion tactics using electric shock and nausea, researchers have found the techniques that cause most harm to gay youths involve prayer, she said.

Because youre asking God to help you. And then nothing happens, and you feel like, Oh, God has forsaken me, she said. So when we think about the harm of conversion therapy, we have to remember that harm doesnt just come from having somebody shock you. Harm comes from receiving and internalizing the message that there is something fundamentally wrong about you.

Therapists who follow the ethical guidelines for their profession have no reason to fear that the proposed DOPL rule will curtail their freedom during counseling sessions, she said.

Gayle Ruzicka, president of the Utah Eagle Forum and an ardent opponent of the current proposal, disagrees and says the measure would infringe on both parental and personal rights. Teens who are questioning their sexual or gender identities should have access to therapy that conforms with their religious beliefs, she said.

Its a parents right for their children and our right as individuals," she said, to be able to express ourselves and get the therapy that we want.

Matheson argues that gender dysphoria extreme discomfort because of a discrepancy between peoples assigned gender and the one they identify with subsides for many people who experience it in childhood and that therapists should be allowed to proceed with caution with these clients.

Therapies that encourage transitioning may be enforcing a lifelong change on a childhood issue somewhat like forcing a child to grow up to be an astronaut because thats what they wanted to be when they were 7, Matheson wrote in an email.

Diamond, on the other hand, says this wait-and-see approach would not fall under the conversion therapy ban and is standard therapeutic practice.

Its not like the average therapist is encouraging children ... to identify as trans as early as possible, she said. This field is extraordinarily cautious, because were aware of how complicated development is.

Sue Robbins, board chairwoman for Transgender Advocates of Utah, said hormone replacement therapy and sex reassignment surgeries are typically done later in life, and minors more often use hormone blockers to put a pause on puberty. The blockers give young people time to work through their feelings on gender identity, she said.

While the churchs letter speaks about the likelihood that gender confusion or dysphoria in children will fade over time, Robbins said only a tiny percentage of people who transition pursue a reversal and those few often do so because of discrimination rather than a change of feeling.

"It's all about going back into the closet," Robbins said.

The proposed changes suggested by the church would leave children vulnerable to nonaffirming therapy based on junk science, Robbins said.

LGBTQ advocates had negotiated the legislation with the churchs attorneys and public affairs office and landed on language that representatives of the Utah-based faith agreed not to oppose, Williams said. He said the proposed rule would have the same effect as the legislation negotiated with the church, and hes not sure why Family Services now objects.

I was surprised and disappointed to see a 26-page rebuttal of what we had worked so hard on, he said.

DOPL denied a request for an interview, but officials have said the rule could take effect Tuesday at the earliest. However, the agency could also take the rule back to any of its licensing boards if it believes public input warrants further review, according to an agency spokeswoman. Public notice would be required if the agency changes the proposed language.

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LDS Church says proposed 'conversion' ban would silence therapists, but its motives are under fire - Salt Lake Tribune

This report on globalBio-identical Hormone Replacement Therapy marketis a detailed research study that helps provides answers and pertinent questions with respect to the emerging trends and growth opportunities in this particular industry. It helps identify each of the prominent barriers to growth, apart from identifying the trends within various application segments of the global market.

The global market for Bio-identical Hormone Replacement Therapy continue to offer promising growth rate over the forecast period to 2025 encouraged by increase in R&D efforts of major companies in Bio-identical Hormone Replacement Therapy. The market forecast is poised to witness sustainable demand, encouraging flow of investments into the sector.

Key players cited in the report:

RevitaLife, US Compounding, Aesthetics&Wellness.

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Competitive Landscape:

Key players of the global Bio-identical Hormone Replacement Therapy market are profiled on the basis of various factors, which include recent developments, business strategies, financial strength, weaknesses, and main business. The Bio-identical Hormone Replacement Therapy report offers a special assessment of top strategic moves of leading players such as merger and acquisition, collaboration, new product launch, and partnership.

Product Segments of the Bio-identical Hormone Replacement Therapy Market on the basis of Types are:CreamsInjectionsImplanted pelletsPatchesGels

Application Segments of the Bio-identical Hormone Replacement Therapy Market on the basis of Application are:MenWomen

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Regional Segments 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.)

Full Browse the report description and TOC: https://www.marketinsightsreports.com/reports/10241516626/global-bio-identical-hormone-replacement-therapy-market-professional-survey-report-2019?source=ccsentinel&Mode=86

Highlights of TOC:

Market Overview: It starts with product overview and scope of the global Bio-identical Hormone Replacement Therapy market and later gives consumption and production growth rate comparisons by application and product respectively. It also includes a glimpse of the regional study and Bio-identical Hormone Replacement Therapy market size analysis for the review period 2019-2025.

Company Profiles: Each company profiled in the report is assessed for its market growth keeping in view vital factors such as price; Bio-identical Hormone Replacement Therapy market gross margin, revenue, production, markets served, main business, product specifications, applications, and introduction, areas served, and production sites.

Manufacturing Cost Analysis: It includes industrial chain analysis, manufacturing process analysis, the proportion of manufacturing cost structure, and the analysis of key raw materials.

Market Dynamics: Readers are provided with a comprehensive analysis of Bio-identical Hormone Replacement Therapy market challenges, influence factors, drivers, opportunities, and trends.

Market Forecast: Here, the Bio-identical Hormone Replacement Therapy report provides consumption forecast by application, price, revenue, and production forecast by product, consumption forecast by region, production forecast by region, and production and revenue forecast.

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Bio-identical Hormone Replacement Therapy Market Growing Trends and forecast 2019 to 2025 - The Chicago Sentinel

by Sam Manzella 10/25/2019

Its impossible to imagine contemporary popular music without the synthesizer. The instrument, which generates audio signals that are then converted to sound, pervades almost every modern musical genre. Pop, dance pop, hip-hop, EDM, experimentalif its based in electronica, it can be traced back to the invention of the commercial synthesizer. And yes, that includes most of the LGBTQ artists who comprise your going-out (or broody staying-in) playlists (Kim Petras or Sophie, anyone?)

But behind its familiar (though still seemingly out-of-this-world) sounds is a name you may not recognize: Wendy Carlos, an accomplished musician, recording engineer, and transgender woman whose forward-thinking use of synths helped make them ubiquitous.

Carlos, now almost 80 years old, has two Ivy League degrees, three Grammy Awards (all for her 1968 classic Switched-On Bach), and a handful of critically acclaimed film scores (for 1971s A Clockwork Orange and 1980s The Shining, among others) under her belt. Her rise to fame in the music industry began in New York City. After graduating from Columbia University with a masters degree in music composition in the 1960s, a 20-something Carlos worked alongside electronic music innovators and Columbia professors like Vladimir Ussachevsky and Otto Luening.

Leonard M. DeLessio/Corbis via Getty Images

There, she also met Robert Bob Moog, a fellow audio engineer and the namesake of the Moog synthesizer, a classic analog version of the instrument. The two became fast friends, and their working relationship spanned some 40 years.

It was a perfect fit, Carlos recalled in a blog post dedicated to Moog in 2005, after the 71-year-old synth pioneer died of cancer. He was a creative engineer who spoke music; I was a musician who spoke science. It felt like a meeting of simpatico minds, like he were my older brother, perhaps.

In 1964, Moog debuted his bespoke synthesizera smaller, more portable version of the hulking wall-to-wall synths that most audio technicians and recording engineers usedat NYCs annual Audio Engineering Society (AES) convention. It would graduate to become the worlds first commercial synthesizer, and Carlos would use it to record Switched-On Bach, an electronic reimagining of Johann Sebastian Bachs classical compositions. The triple-Grammy-winning classical music recordwhich sold a record-breaking 1,000,000 copiesis widely credited with meshing popular music and synths together. (Before Switched-On Bach, the instruments were mostly relegated to more experimental, less commercially successful music.)

SSPL/Getty Images

Her prestigious honors aside, Carlos was struggling. In fact, shed been struggling with gender dysphoria since childhood, and she began to feel hopeless and suicidal in college.

It wasnt until 197910 years after shed swept the Classical Musical categories at the 1969 Grammysthat she came out publicly as transgender in a Playboy magazine interview. Carlos recalled how shed felt too anxious to perform live once she began hormone replacement therapy (HRT) and had initiated her physical transition in secret. But she could no longer deny who she was. When Playboy asked if she had any idea what wouldve happened if she hadnt begun to live her life as a woman, Carlos was frank: Yes. Id be dead.

The magnitude of her announcement then is difficult to overstate. In 2019, in an era when trans issues are addressed explicitly by presidential hopefuls on the Democratic Party debate stage, an industry pioneer coming out in a mainstream magazine is cause for celebration. In 1970s America, it was not only unheard-of, but a potentially career-ending move (not to mention dangerous). The cultural conversation around transgender acceptance, much less transgender equality, was still burgeoning in LGBTQ spaces; it barely existed in cisgender, heterosexual circles.

Since her initial coming out, Carlos has rarely addressed her gender identity in interviews. (She declined to be interviewed for this story.) That may have something to do with the way her story has been told. In 1979, Playboy asked her some pretty invasive, if not genuinely curious, questions. Even after she discussed her transition in great detail, reporters and editors continued to print her deadname. But in one 1985 article in People, Carlos said she hit her stride in composing new music after opening up publicly about who she really was. The burden had been lifted; it was time to create.

The public turned out to be amazingly tolerant or, if you wish, indifferent, she told the magazine. There had never been any need of this charade to have taken place. It had proven a monstrous waste of years of my life.

Leonard M. DeLessio/Corbis via Getty Images

Carlos candor at a time when transness or gender nonconformity wasnt even on most Americans radars paved the way for a generation of LGBTQ electronic artists to come. Decades after Switched-On Bach, the Tron soundtrack, and her other contributions to 70s and 80s synth music, a new wave of queer musicians can make the kind of songs and albums they envision and love without their identities holding them back.

One of those artists is Kiran Gandhi, a.k.a. Madame Gandhi, a Los Angelesbased electronic music artist and activist who credits Carlos with changing the game for marginalized people in electronic music.

Usually, we imagine the analog synth community as a very homogenous community, she tells NewNowNext. But for Gandhia queer woman of color whose songs like The Future is Female and Top Knot Turn Up are meant to empower marginalized peoplediscovering Carlos pivotal role in the popularization of synth music was so inspiring, and such a relief. It made her want to pick up the instrument that much more.In 2018, Gandhi performed at Moogfest, an annual gathering for synth enthusiasts and music industry professionals that takes place in North Carolina, where Bob Moog spent the last 30 years of his life. She was joined onstage by a lineup of other electronic musiciansall women or gender-nonconforming peoplein honor of Carlos and Switched-On Bachs 50th anniversary.

Gandhi was thrilled that Moogfests organizers hosted a tribute to Carlos, but she was especially grateful that they paid homage to her transnessa fact she was unaware of before the event.

[Wendy Carlos] made folks who are booking festivals more intentional about reaching out to gender-nonconforming folks and queer folks and women in a way that I dont think would have happened had she not been one of the biggest contributors to electronic music, she says. So this shiftactually putting Wendy Carlos on the mapmade us musicians more open-minded to say, Oh, wow, this genre is actually not what we thought it was. Its something else. And thats really freaking cool.

Brooklyn-based writer and editor. Probably drinking iced coffee or getting tattooed.

Link:
Love Synth Pop? Thank Wendy Carlos, the Trans Woman Who Invented It. - NewNowNext

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Results demonstrated potential to reduce current dosing frequency from once-daily to a single weekly injection

MIAMI and NEW YORK, Oct. 21, 2019 (GLOBE NEWSWIRE) -- OPKO Health Inc. (OPK) and Pfizer Inc. (PFE) announced today that the global Phase 3 trial evaluating somatrogon dosed once-weekly in pre-pubertal children with growth hormone deficiency (GHD) met its primary endpoint of non-inferiority to daily GENOTROPIN (somatropin) for injection, as measured by annual height velocity at 12 months.

Top-line results from the study demonstrated that treatment with somatrogon dosed once-weekly in pre-pubertal children with GHD was non-inferior to somatropin dosed once-daily with respect to height velocity at 12 months of treatment (the primary endpoint); the least square mean was higher in the somatrogon group (10.12 cm/year) than in the somatropin group (9.78 cm/year); the treatment difference (somatrogon somatropin) in height velocity (cm/year) was 0.33 with a two-sided 95% confidence interval of the difference of (-0.39, 1.05). In addition, change in height standard deviation scores at six and 12 months, key secondary endpoints, were higher in the somatrogon dosed once-weekly cohort in comparison to the somatropin dosed once-daily cohort. Moreover, at six months, change in height velocity, another key secondary endpoint, was higher in the somatrogon dosed once-weekly cohort in comparison to the somatropin dosed once-daily cohort. These common measures of growth are employed in the clinical setting to measure the potential level of catch-up growth that subjects may experience relative to heights of age and gender matched peers.

Somatrogon was generally well tolerated in the study and comparable to that of somatropin dosed once-daily with respect to the types, numbers and severity of the adverse events observed between the treatment arms. Immunogenicity testing and analysis of additional data are ongoing, and full results of the study will be submitted for presentation at a future scientific meeting.

We are very pleased to announce these favorable top-line results demonstrating the efficacy of somatrogon dosed once-weekly in the pediatric patient population with GHD, said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. Somatrogon is a new molecular entity incorporating OPKOs proprietary long-acting technology. We believe somatrogon represents a significant advance in the treatment of children with GHD compared to the current standard of one injection per day that could enhance a patients adherence to treatment and quality of life.

Were encouraged by these data and look forward to the possibility of bringing this longer-acting therapy to children. If approved, somatrogon could reduce the daily disease burden on children and their caregivers, potentially increasing treatment adherence, said Brenda Cooperstone, M.D., Chief Development Officer, Rare Disease, Pfizer Global Product Development. At Pfizer, we strive each and every day to advance treatment options that better serve the needs of patients with rare diseases.

In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product.

About the Study

The somatrogon Phase 3 trial is a randomized, open-label, active-controlled study conducted in over 20 countries. This study enrolled and treated 224 pre-pubertal, treatment-nave children with growth hormone deficiency who were randomized 1:1 into two arms: somatrogon dosed once-weekly vs daily GENOTROPIN (somatropin) for injection. The primary endpoint of the trial was height velocity at 12 months. Secondary endpoints included change in height standard deviation at six and 12 months, safety and pharmacodynamic measures. Children completing this study had the opportunity to enroll in a global, open-label, multicenter, long-term extension study, in which they were able to either continue receiving or switch to somatrogon. Approximately 95% of the patients switched into the open-label extension study and received somatrogon treatment.

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About Somatrogon

Somatrogon is a new molecular entity that contains the natural sequence of growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic hCG at the N-terminus and two copies at the C-terminus. The CTPs extend the half-life of the molecule. Somatrogon received Orphan Drug designation in the U.S. and the EU for the treatment of children and adults with growth hormone deficiency.

About Growth Hormone Deficiency

Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 people. In children, this disease can be caused by genetic mutations or acquired after birth. Because the patient's pituitary gland secretes inadequate levels of somatropin, the hormone that causes growth, his or her height may be affected, and puberty may be delayed. Without treatment, he or she will have persistent growth attenuation, a very short height in adulthood, and may experience other health problems.

About GENOTROPIN

GENOTROPIN is a man-made, prescription treatment option, approved in the United States for children who do not make enough growth hormone on their own, have the genetic condition called Prader-Willi syndrome (PWS), were born smaller than most other babies, have the genetic condition called Turner syndrome (TS) or have idiopathic short stature (ISS). GENOTROPIN is also approved to treat adults with growth hormone deficiency. GENOTROPIN is taken by injection just below the skin and is available in a wide range of devices to fit a range of individual dosing needs. GENOTROPIN is just like the natural growth hormone that our bodies make and has an established safety profile.

Important GENOTROPIN Safety Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

For the full Prescribing Information for GENOTROPIN, please visit http://labeling.pfizer.com/ShowLabeling.aspx?id=577.

GENOTROPIN Indications and Usage in the U.S.

GENOTROPIN is a prescription product for the treatment of growth failure in children:

GENOTROPIN is a prescription product for the replacement of growth hormone in adults with growth hormone deficiency (GHD) that started either in childhood or as an adult. Your doctor should do tests to be sure you have GHD, as appropriate.

About OPKO Health, Inc.

OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.OPKO.com.Pfizer Rare Disease

Rare disease includes some of the most serious of all illnesses and impacts millions of patients worldwide, representing an opportunity to apply our knowledge and expertise to help make a significant impact on addressing unmet medical needs. The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac and inherited metabolic disorders.

Pfizer Rare Disease combines pioneering science and deep understanding of how diseases work with insights from innovative strategic collaborations with academic researchers, patients, and other companies to deliver transformative treatments and solutions. We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures.

Clickhereto learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

Pfizer Inc.: Breakthroughs that change patients lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website atwww.pfizer.com. In addition, to learn more, please visit us onwww.pfizer.comand follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of October 21, 2019. Pfizer and OPKO assume no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about a product candidate, somatrogon dosed once-weekly in pre-pubertal children with growth hormone deficiency (or GHD) and Pfizers rare disease portfolio, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any jurisdictions for somatrogon; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether somatrogon will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of somatrogon; and competitive developments.

A further description of risks and uncertainties can be found in Pfizers and OPKOs respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2018 and in their respective subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors, Forward-Looking Information and Factors That May Affect Future Results, Cautionary Statement Regarding Forward-Looking Statements, as well as in their respective subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available atwww.sec.govand, as applicable,www.pfizer.com and http://www.OPKO.com.

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OPKO and Pfizer Announce Positive Phase 3 Top-Line Results for Somatrogon, an Investigational Long-Acting Human Growth Hormone to Treat Children with...

To be honest, when my spouse came out to me as a woman in April 2018, I had completely forgotten about Transparent.

The shine on the former Golden Globe-winning comedy, a show I had once adored, had tarnished, dulled by time and circumstance. September 2017 had seen both the launch of the series fourth season and a #MeToo scandal surrounding star and two-time Emmy winning actor Jeffrey Tambor, relegating the Amazon Prime Video show to a bygone era, canceled by the very age of heightened diversity and equality that it helped to usher in.

When the two-hour Musicale Finale was announced in October 2018, it barely registered. My wife was still publicly closeted. We had our hands full keeping her gender identity our little secret, and tensions were high as we moved toward hormone replacement therapy and the estrogen she so desperately needed.

It wasnt until July 2019, when Amazon announced the fall premiere date for the finale just a month after my wife had come out to the world, that I realized that Id have to reckon with the show again. A show that was now my life.

RelatedRelated

My day-to-day has never resembled that of the Pfefferman clan. Maura Pfefferman was well past retirement age when she came out to her family as a trans woman, long divorced from wife Shelly, with three children mired in their 30s and 40s. The Pfeffermans were affluent Los Angeles natives, whose stories were inextricably intwined with their own complicated relationships with Judaism.

It was a world completely unfamiliar to me, a Los Angeles transplant from South Dakota, as a lapsed Methodist who met the love of her life at 18 and married at 22. In 2014, Transparent was a window into a life I could never understand and impossible for me to infiltrate.

At the time, I found it an intimate and careful series, showcasing a story that few people could imagine, and doing so with artistry and empathy.

Judith Light in Transparent: Musicale Finale

Nicole Wilder / Amazon

Nowadays, I dont know how to feel about Transparent. Rather, I feel a lot of things about Transparent, most of them in direct opposition to something else.

There are valid arguments to be made about the decision to cast a cis man as a trans woman, and legitimate complaints about how the show handled the Tambor accusations. The series absolutely is limited by being about sad rich people in a community where that is the exception and not the rule.

But I adored it because its a show that opened my heart, too. There was a moment nearly a decade ago that horrifies me to this day one of those exchanges that weighs heavy with the significance of my suspicions in retrospect when I told my wife that I could never be with her if she was a woman. It was just not something my brain had the capacity to ponder.

My life was sheltered. Homogenous. As in, I didnt meet a Jewish person until my mid-20s; that kind of sheltered. I couldnt reconcile my own sexuality until I was in my 30s. As imperfect as it was, Transparent, as did Netflixs Orange is the New Black just the year before, invited my narrow band of experience to explore a wider world.

It was a glimpse at a place that I would very soon join. Its a thesis neatly stated by Judith Lights Shelly early in Transparent Season 3: When one person in a family transitions, everyone transitions.

My wifewho is very smart and pretty wrote that Transparent was never telling Mauras story. Which is good, in a way, because Mauras story is not one that creator Jill Soloway is necessarily equipped to tell. Instead, its the story of the family as a whole.

Alexandra Billings in Transparent: Musicale Finale

Amazon Studios

So, inspired by that, heres my story:

Learning that my wife was trans felt like a chiropractic adjustment that I didnt know I needed. My life was fine. Having been together for nearly 20 years, my wife and I had developed a routine that wasnt perfect, but worked for us. Her truth hit me so hard that every bone in my body trembled. My teeth loosened. My lungs deflated.

But suddenly, I could see. I understood arguments that wed been having for eons. Issues that we could never resolve, distance that felt impenetrable, and sadness that seemed bottomless. Problems with intimacy that no amount of therapy could resolve dissipated once there was no longer a retaining wall in my wifes brain, keeping her true self locked away. Instantly, there was context for a million moments that werent strange in isolation, but in retrospect, finally made sense.

But all the hindsight in the world couldnt mend my shattered heart.

For about 36 hours, I was lost. No matter how important and valuable the discovery, her words had basically ended my life. Our life. And it took time to reconcile that.

Its difficult to remember the specifics of those moments. I know I called in sick. I know I cried. Though we were operating in the utmost secrecy, Emily knew I needed someone to talk to and immediately looped in one of our closest friends, who was invaluable both then and now.

Because while I was unsurprised by the grief, the anger, the sadness, what struck me most in the first days after the revelation was how isolated I felt. Not only because my wifes identity was the most fragile of secrets, but also because it felt as though I had lost the rights to my own narrative.

As a writer, that narrative sometimes feels like all I have. Emily being a woman, instead of the man the world presumed her to be, felt as though my editor had just sent back the last 20 years of my life for a hard rewrite. In that moment, I realized why Soloways first impulse upon their father coming out as trans was to write a TV script. If you craft a lightly fictionalized narrative onto your life, it allows you to feel like you have control in a situation in which you feel powerless.

These were the things I thought about as I stared at the ceiling, sleepless. I wondered if my life was now a lie. I wondered if our love was a lie. I relitigated every fight wed ever had. I realized that if we were going to make it through this, we would need a full reckoning of our past, with consideration for the new information that had been entered into evidence in the contentious and imaginary court proceedings that was our marriage.

But what I thought about more than anything was how scared I was. No matter what I decided to do, be it move forward with Emily or leave, I would lose. It could be family or friends or opportunities, just to name a few, and more likely than not, any combination of the above. That said, if I stayed, I would keep the love of my life. And thats not nothing.

Judith Light in Transparent: Musicale Finale

Amazon Studios

The longer I sat with it, the more I realized that Emilys gender was not a disease, but a diagnosis. And there was a relatively painless cure. All we needed to do was treat her like the woman she always was. Thats it. If we did that, if we tweaked our world 15 degrees, then everything wouldnt be perfect, but it would be pretty damn close.

And I know thats a prescription that sounds so big to some people. And it is! But its also so small. It feels extremely strange to frame it in this fashion, but all things considered, our relationship was strangely primed to be able to take the transition in stride. There are plenty of significant challenges that can break relationships when a partner transitions, simply because it creates such fundamental incompatibilities that to stay together is impossible.

For instance, issues of attraction. A million years ago when we married, I was pretty sure I was straight. Rather, the part of me that was attracted to women didnt have a lot of room to explore, since I started dating my partner, like, the moment they crossed the threshold of my dorm room. By the time I realized I was, in fact, bisexual, it felt like it was too late to declare it to the world. No one cares what a long-time married white cis woman identifies as and I wasnt interested in declaring myself because the last thing I wanted to do was look like I was bandwagoning bisexuality. Emilys transition gave me license to come out publicly and, more importantly, it means that without the burden of heterosexuality, I find my wife more beautiful than ever before.

Another reality of life married to a trans woman is that the aforementioned HRT effectively sterilizes her remaining sperm. Understandably, this is heartbreaking for couples who harbor hope for biological children, potentially forcing them on a path of assisted reproduction that they never planned on.

Lucky for us, I suppose, is that our marriage had already been grappling with infertility for years. We were so far along in the IVF process, actually, that mere weeks after my wife told me she was a woman, we had our first IVF transfer. While weve yet to have success and while, honestly, we have enough to deal with right now we are already veterans of this battle.

We are privileged even beyond fundamental advantages, including insurance and steady employment in ways that not all our LGBTQ sisters and brothers are, and grateful every day that our previous paths gave us challenges that prepared us for this very unique road.

So, when I revisit Transparent now, its with jaded, yet guilty, eyes. I feel intense shame at how casually the Pfeffermans storm through the world, leaving the less fortunate in their wake, rarely taking the time or effort to clean up after themselves, literally or figuratively. And practically, it feels like no one cries enough and that Maura is looked at askance too often. The show cant ever see past the idea of Tambor in a dress and so the audience is kept at arms length, making it impossible to embrace Maura as a woman.

For better or worse, this is the world, as created by Transparent.

Transparent: Musicale Finale

Erin Simkin / Amazon

To watch the shows recent finale, is to understand that even Transparent knows that there is no place for it in 2019. Its not that the musical endeavor is a failure; its far more confusing than that. The episode picks up immediately after Mauras death and shows the family exploring their grief through song, which isnt bad, but is strange.

There are things that work, however, including Shelly attempting to launch a show about the family, going so far as to cast doppelgngers for her children and to find herself a new Maura (standout and IRL trans woman Shakina Nayfack) that helps her process her pain at the death of her ex.

As a whole, the episode is slightly cracked, garish and extreme and above all else, indulgent. But caught around the edges are hints of the subtle series that used to exist. One such moment has Shelly imagining herself and Maura as young girls taking dance together, remolding their bond into something truer to themselves and so profoundly moving that I had to pause the episode. I couldnt see through my silent sobs.

This has always been the heart of conflict for a Transparent fan. Theres so much to cringe over and nearly as much raw, real emotion.

I miss Transparent in the same way that I miss my old life. My relationship wasnt better then, but I knew what it was. It was comfortable. Its hard to woo this hot new babe when months ago you were in a genial routine and could go entire weekends in the same apartment, communicating exclusively through Slack messages. Its hard to challenge what you understand about identity, when its so much easier to fall back on what youve always known.

You could watch the Transparent finale if you want, if you feel like doing so would offer you closure. But I dont think its necessary. In fact, after rewatching three seasons of the series, Im not sure we need to revisit Transparent ever again. The series isnt somewhere weve been and its not somewhere were going. It was a conduit that brought us to where we are now. Its the bridge that brought us from the transgender experience as a punchline to realizing that transgender individuals are just people, trying their best to live happy and fulfilled lives.

We live in this beautiful, fucked-up world. Where we sit and wait to see if the U.S. Supreme Court will strip protections from LGBTQ individuals, even as television is helping to guide people about the nebulous nature of gender and love.

Im grateful for Transparent and the weight it carried. For how it paved the way for shows like Pose, and how its quality injected the trans experience into mainstream conversation, opening the eyes and hearts of people around the world, including me. But using it now to try to bolster your understanding of the world around you in 2019 is like reading a safe-sex pamphlet from 1988. Its not safe. Its not smart. It may have been the best we had available at the time, but the world has moved on.

We can do better. And we will. Now its on us to make reality better than that fiction.

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Im Married to a Trans Woman. And I Miss Transparent Like I Miss My Old Life. - IndieWire

The Government has recently imposed restrictions on the parallel export of certain drugs from the UK to the EEA. At the moment, parallel imports tend to flow into the UK, where goods can be bought inexpensively in other EU member states and resold at a higher price in the UK. As the pound continues to weaken, the tide has recently turned and we are seeing more parallel exports. As a result, and particularly in response to the ABPIs call for ministers to restrict parallel exports and attempt to stem the flow of drugs out of the UK, the Government has now announced a ban on drug exports of the medicines considered to be in shortest supply across the country. The export ban lists 24 drugs in total, including 19 hormone replacement therapy drugs, adrenaline pens for severe allergies, hepatitis B vaccines and a number of contraceptives. It is not yet clear how long this ban will stay in place for.

Currently, under EU legislation, for the UK Government to impose a temporary export ban to prevent stockpiled drugs being sold out of the UK, it would need to do so on the basis of Article 36 of the Treaty on the Functioning of the European Union (TFEU). Article 36 provides that the provisions of Articles 34 and 35 (which themselves prohibit restrictions on imports and exports between Member States) shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of the protection of health and life of humans Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States.

Article 36 allows for a limited exception to the prohibition of any restrictions of the free movement of goods within the EU only where the public health justification is:

A number of EU Member States have applied to the Commission to restrict exports on the basis of Article 36, with varying success. For example, the Belgian Constitutional Court is currently considering the legitimacy of an amendment to the Medicines Act made earlier this year by the Belgian Parliament which sought to tackle medicines shortages in Belgian pharmacies.

Another recent example is Romania: on 13 September 2019, the Romanian Ministry of Health announced, as a result of a public consultation, that it would suspend the exportation of 127 medicines for a six month period. The targeted medicines all run an increased risk of shortage and are indicated for the treatment of cancer and transplant patients. The measure will be notified to the European Commission and is expected to be blessed given the short-term, targeted, nature of the proposed restriction.

The EU has already made clear that, if the UK leaves the EU without a deal, parallel exports into the EU would not be possible as the UK would be outside of the single market. Ahead of Brexit, any restriction imposed by the UK on exports would need to be genuine and proportionate, meaning a temporary, targeted restriction could constitute a legitimate way of preventing the drugs stockpiles in the UK from being run down ahead of Brexit. As the precise details of the Governments new ban are still to be released, in particular its duration, it is not yet clear whether it would be deemed to be genuine and proportionate for the purposes of Article 36.

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Brexit Healthcare blog post: Recent developments on the sale of no-deal Brexit stockpiled drugs out of the UK - Lexology

Each year over 300,000 women are diagnosed with breast cancer, making it the most common form of cancer in women. Overall, it is the second most common cause of death from cancer in women exceeded only by lung cancer. There are a number of risk factors women should be aware of for breast cancer.

Aging: The aging process is the greatest risk factor for developing breast cancer. Two-thirds of all cases of invasive breast cancer occur in women over the age of 55 years. Only 12.5% of cases occur in women below the age of 45 years. So as women age, the importance of regular breast self-examinations and mammograms increases in importance.

Family History: Having one first-degree female relative (mother, sister or daughter) with breast cancer doubles your risk for developing breast cancer. Having two first-degree female relatives with breast cancer increases your risk 5-fold. Around 5% to 10% of breast cancers are due to the inheritance of abnormal genes. These genes include BRCA1, BRCA2 and CHEK2. If you have a female relative with breast cancer you should ask them if they were tested for the presence of these genes.

Body Weight: Being overweight increases your risk for developing breast cancer. If you already have had breast cancer, it increases your risk of recurrence. The increased risk is especially seen after menopause. The excess fat cells make the hormone estrogen which can encourage breast cancers to develop and grow. Eating a plant-based, whole foods diet (consisting of fresh or frozen fruits and vegetables instead of processed foods) helps to decrease the risk of breast cancer. Also, there is a lower rate of breast cancer in countries where women consume lower fat diets.

Exercise: Exercising 35-60 minutes each day reduces the risk of breast cancer. Exercise also improves survival among women who have breast cancer. Consult with your medical provider and a physical trainer on how best to start an appropriate exercise program.

Alcohol: Consuming three alcoholic beverages per week increases the risk of breast cancer by 15%. Each additional drink added to this average increases the risk by another 10% e.g. 4 drinks per week is associated with a 25% increase in risk. Alcohol raises estrogen levels and can potentially damage DNA both of which contribute to the risk of cancer.

Smoking: This increases the risk of breast cancer especially among younger, pre-menopausal women. Even second-hand smoke exposure has been associated with an increased risk of breast cancer.

Oral Contraceptive Use: Any use results in a 7% overall increase in risk. Current use causes a 24% increase in the risk of breast cancer. After a woman has been off the oral contraceptive for 10 years, the increased risk had resolved. Similarly the use of hormone replacement therapy also increases the risk of breast cancer due to the ongoing exposure of the breasts to estrogen. You should consult with your health care provider is you are considering hormone replacement therapy after menopause to assess the risks and benefits of this therapy.

Dr. Samuel Abbate has a practice in Wasilla.

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Steps women can take to prevent breast cancer - Mat-Su Valley Frontiersman

WASHINGTON None of us know when a medical emergency will affect us, Senator Bernie Sanders wrote in a tweet from Desert Springs Hospital Medical Center on Wednesday, hours after the 78-year-old Democratic candidate for president experienced one.

Mr. Sanderss emergency the sudden onset of chest pain known as angina is one that thousands of other Americans experience each year. Mr. Sanderss discomfort occurred at a campaign event on Tuesday night. Because it signaled acute heart trouble, the senator went to the hospital where doctors implanted two stents in one of the coronary arteries that nourish the heart.

Doctors often release patients who undergo such procedures in a day or two. Mr. Sanders remained in the hospital until Friday evening, when after three days of revealing few details about his condition his campaign confirmed that Mr. Sanders had suffered a heart attack.

Until then, Mr. Sanders had not disclosed whether blood and electrocardiogram tests showed he had a heart attack. The senator and his campaign have not allowed reporters to interview his doctors, though advisers have said that Mr. Sanders would be able to appear in the next Democratic debate on Oct. 15.

With respect to release of health information, President Trump has not had a medical emergency while running for or serving in office, but he disclosed few specific laboratory test results initially in his 2016 campaign. He issued a four-paragraph letter from his personal physician stating that Mr. Trump would be the healthiest individual ever elected to the presidency. Closer to the 2016 election date, Mr. Trumps doctor offered a more conventional letter that still omitted a number of details that would be part of a customary summary of a patients health.

In 2018, the doctor, Harold N. Bornstein, said that Trump aides had raided his office a year earlier and taken the presidents medical files after The Times reported that the president had taken a drug for hair growth. And this year, the White House physician pronounced Mr. Trump in very good health although the president had gained weight and is now officially obese.

The health questions hang over Mr. Sanders in part because he would become the nations oldest president by far if elected. Also, given that implanting two stents in one coronary artery is a very common procedure in American hospitals, it was puzzling that for several days he did not release more details. Mr. Sanders is a private person, no doubt, but most modern-day presidents and serious candidates for the presidency have put forward details to inform the electorate after emergency health issues.

Normally, recovery from stent placement is very quick, and patients usually go home a day or two after the procedure, said Dr. Jonathan S. Reiner, a cardiologist at George Washington University Hospital in Washington, D.C. who treated former Vice President Dick Cheney for serious heart disease for many years before, during and after his two terms of office. Dr. Reiner is not involved in Mr. Sanderss care.

Older patients and those who experience complications like heart rhythm abnormalities, heart attacks or heart failure may remain in the hospital longer. A patients condition usually determines the length of stay.

In the 2016 presidential campaign, Mr. Sanderss doctor said that the senator was in overall very good health. His ailments included gout; a mild elevation of cholesterol; an inflammation of out-pouches in the bowel known as diverticulitis; and hormone replacement therapy for an underactive thyroid gland. He had no reported history of heart disease. Tuesdays episode of angina appears to be his first such incident.

In cases like Mr. Sanderss, doctors perform a standard procedure known as cardiac catheterization. In it, they thread thin tubes into chambers of the heart and inject a radio-opaque dye to produce X-rays outlining the coronary arteries. For Mr. Sanders, the procedure revealed blockage in one artery; he has not said which artery. Doctors would then remove the blockage, which is usually caused by deposits of fatty substances, by inflating a tiny balloon in a tube to squash them. Implanting the stents aims at preventing development of scar tissue and recurrence of the blockage.

All presidential hopefuls strive to portray themselves in good health. When a medical event occurs, candidates and their aides, who usually have had little if any medical knowledge, often scurry to play it down to prevent damage to the leaders image.

Mr. Sanderss event is likely to renew pressure on his rivals to release their health information in a timely fashion. Although some have made pledges, they have not done so.

In recent years, most candidates have released their personal health information in statements from their doctors or through interviews. The practice grew out of retrospective analyses of the health of presidents that document how some presidents hid or lied about their health problems, often aided by their doctors. Occasionally, White House doctors have misdiagnosed a presidents heart and vascular problems.

Experts believe that President Warren Harding died of a heart attack that his doctor did not detect. Toward the end of President Franklin D. Roosevelts third term and until his death in his fourth term, his White House doctor withheld the fact that he had serious heart failure. President Dwight D. Eisenhower suffered a heart attack near the end of his first term. Examination of his older medical records has provided strong clues that he had a heart attack before he ran for president.

In 1999, former Senator Bill Bradley of New Jersey damaged his presidential campaign by not disclosing that he had a number of episodes of atrial fibrillation (a heart rhythm abnormality) before he experienced one while campaigning and had to rush to a hospital in the Bay Area with reporters trailing him.

Among the current candidates, Joseph R. Biden Jr. underwent emergency surgery in 1988 for a near-fatal ruptured berry aneurysm of an artery in his brain. He also underwent surgery to remove a second berry aneurysm. New cerebral aneurysms can develop years later in a tiny percentage of individuals who have survived one. In 2008, Mr. Bidens doctor said that he had recovered fully, and that he did not need further tests to detect a new berry aneurysm because he had done well for 20 years.

Modern medicine has enabled many individuals with heart disease and other chronic ailments to successfully run for office and fulfill their duties. Nevertheless, Mr. Sanderss stent episode is likely to renew a measure of voter interest in the health of its 2020 presidential candidates. Two other leading Democratic hopefuls are in their 70s and President Trump is 73. All of them, as well as Mr. Sanders, may well be medically fit to serve, but Americans have never faced the prospects or consequences of so many top candidates who were past the official retirement age.

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Sanders Said He Had a Common Heart Procedure. So Why the Mystery? - The New York Times

In 2009, Connecticut was the first state to pass a law that requires radiologists to notify women who have had screening mammograms if they have dense breasts. Since then, more than 30 states, including New York, have followed suit. Breast density has to do with the amount of fibrous and glandular tissues that a woman has in her breasts compared with the amount of fat. Having dense breasts is a risk factor for breast cancer. Below, Sandra Brennan, M.D., Director of Radiology at Memorial Sloan Kettering (MSK) Westchester, explains what doctors know about breast density and what steps women with dense breasts can take to increase the likelihood that any cancer they might develop is detected early.

Having dense breasts is relatively common and makes it more difficult for cancer to be picked up by a mammogram. The dense tissue looks white on the image, and that can obscure cancerous masses.

Women with dense breasts also have an elevated risk of breast cancer. The 10 percent of women who have the most-dense tissue have a risk that's four to six times higher compared with those whose breasts are the least dense. This is because glandular tissue is more likely to become cancerous. But even women with breasts that are mostly fatty can develop breast cancer.

Mostly it's just part of the body's natural makeup. Density is affected by age and hormones. Taking hormone replacement therapy will increase breast density. Conversely, taking an estrogen-receptor drug to treat breast cancer will decrease it. A woman's breasts may become less dense as she ages, but that doesn't always happen. Some women may have changes in the amount of fat in their breasts if they lose or gain weight. Women with a low body mass index tend to have dense breasts.

Tomosynthesis, also known as 3-D mammography, is better at detecting masses in dense breasts than traditional 2-D mammography. This is because it looks at the breasts in visual slices and removes some of the masking effect of the overlying dense tissue. We offer 3-D mammograms as an option for women who get screened at any of MSK's locations, including MSK Westchester.

Women with dense breasts should discuss with their doctor whether they should have supplemental screening with ultrasound. It can pick up cancers that we might not see on a mammogram in women with dense breasts.

We offer 2-D and 3-D mammography, and screening breast ultrasounds. For women at a higher breast cancer risk unrelated to their breast density, we offer breast MRIs, which can detect small tumors that are not seen on a mammogram.

For those who need a breast biopsy, we perform a number of nonsurgical procedures at MSK Westchester. These include percutaneous ultrasound-guided core biopsies, fine-needle aspirations, stereotactic breast biopsies and MRI-guided biopsies. People who are having surgery at MSK in Manhattan can have their preoperative seed localizations and sentinel node injections done at MSK Westchester.

We also offer contrast-enhanced digital mammography (CEDM) at MSK Westchester. This advanced breast-imaging technique creates a vascular map of the breast, similar to an MRI. It's a specialized procedure that highlights areas of increased blood flow that can be associated with tumor growth. MSK research has shown that CEDM is as sensitive in detecting breast cancer as breast MRI when both were compared with standard mammograms. MSK is unique among breast-screening facilities in Westchester County in offering CEDM, which is not widely available.

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What Women Should Know About Breast Density And Cancer Risk - Patch.com