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After Lobbying Push, Drugmaker Resubmits Women’s Sex Pill

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In this Friday, Sept. 27, 2013, file photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters. The pill has been twice rejected, but Sprout Pharmaceuticals said Tuesday, Feb. 17, 2015, it is refiling its application for flibanserin, adding new information requested by the Food and Drug Administration about how the pill affects driving ability. (AP Photo/Allen G. Breed, File)

In this Friday, Sept. 27, 2013, file photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company’s Raleigh, N.C., headquarters. The pill has been twice rejected, but Sprout Pharmaceuticals said Tuesday, Feb. 17, 2015, it is refiling its application for flibanserin, adding new information requested by the Food and Drug Administration about how the pill affects driving ability. (AP Photo/Allen G. Breed, File)

MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — The makers of a twice-rejected pill designed to boost sexual desire in women are hoping a yearlong lobbying push by politicians, women’s groups and consumer advocates will move their much-debated drug onto the market.

The ongoing saga of Sprout Pharmaceutical’s female libido drug illustrates the complicated politics and unresolved science surrounding women’s sexuality.

For decades, drugmakers have tried unsuccessfully to develop a female equivalent to Viagra, the blockbuster drug that treats men’s erectile dysfunction drug by increasing blood flow. But disorders of women’s sexual desire have proven resistant to drugs that act on blood flow, hormones and other simple biological functions.

Supporters of Sprout’s drug say women’s sexual disorders have been overlooked for too long by regulators at the Food and Drug Administration. But critics argue that women’s sexuality is too complex to be addressed by a single pill.

Sprout’s drug flibanserin is the first attempt to increase libido by acting on brain chemicals linked to appetite and mood. But the Food and Drug Administration has already twice rejected the drug because of lackluster effectiveness and side effects including fatigue, dizziness and nausea.

In an effort to break the regulatory logjam, groups sponsored by Sprout and other drugmakers have begun publicizing the lack of a “female Viagra” as a women’s rights issue.

“Women deserve equal treatment when it comes to sex,” states an online petition to the FDA organized by one such group, Even the Score, which garnered almost 25,000 supporters. The group’s corporate backers include Sprout Pharmaceuticals, Palatin Technologies and Trimel Pharmaceuticals — all companies developing drugs to treat female sexual disorders. A spokeswoman for Blue Engine Media, the public relations group for Even the Score, declined to disclose how much of the group’s funding comes from companies. The group’s nonprofit supporters include the Women’s Health Foundation, the Institute for Sexual Medicine and other organizations.

Drugmakers frequently cite a 1999 survey in the Journal of the American Medical Association that found 43 percent of U.S. women had some type of sexual dysfunction.

Sprout said Tuesday it is refiling its application for flibanserin, adding new information requested by the FDA about how the pill affects driving ability. FDA scientists requested that data after their most recent rejection of the drug, in part, due to results showing nearly 10 percent of women in company trials reported sleepiness as a side effect.

The FDA first rejected flibanserin in 2010 after a panel of expert advisers unanimously voted against the drug, saying its benefits did not outweigh its risks. The drug’s initial developer, Boehringer Ingelheim, abandoned work on the drug in 2011 and sold it to Sprout, a startup headed by a husband-and-wife team from Raleigh, North Carolina.

Sprout resubmitted the drug with additional effectiveness and safety data, but the FDA again rejected the drug in October 2013. After Sprout filed a formal dispute over the decision, FDA regulators requested the driving study and other details on the drug’s interactions with other medications.

As Sprout gathered that data, the company also enlisted support from influential allies in Washington and beyond. Last January four members of Congress, including Rep. Debbie Wasserman Schultz, D-Florida, sent a letter to the FDA, urging a careful reassessment of the drug and lamenting the lack of drug options for low female libido.

“There are 24 approved medical treatments for male sexual dysfunction and not one single treatment yet approved for the most common form of female sexual dysfunction,” states the letter, which was also signed by Rep. Louise Slaughter, D-New York, and two other Democratic congresswomen.

The talking point about the imbalance of drugs for men versus women was picked up by a coalition of seven women’s and consumer health groups who met with the FDA early last year.

“We see this not only as an important unmet women’s health issue, but an inflection point for the agency to ensure that similar standards are applied for drug approvals in conditions uniquely affecting women,” states a follow-up letter to the agency from leaders of the National Organization for Women, the National Consumers League and four other groups.

Then last October the FDA held a two-day meeting at its headquarters to get public input on the problem of female sexual dysfunction and the challenge of developing treatments.

If approved, flibanserin would be labeled for premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress. Because so many factors affect female sexual appetite, there are a number of other possible causes doctors must rule out before diagnosing the condition, including relationship problems, hormone disorders, depression and mood issues caused by other drugs like sleeping aids and pain medications.

Copyright 2015 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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NPRC Elder Justice Symposium Invites Community to Join Effort to Protect Alameda County Elders

“Two of our most vulnerable populations are elders and the disabled, and many times that combination resides in one individual,” said Tanya Dennis, lead facilitator of NPRC. “At our symposium, NPRC will bring decision makers and elders together in one space for a day to develop strategy and policy to protect and empower.”

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The National Probate Reform Coalition (NPRC) will host an Elder Justice Symposium on Friday, Sept. 25, from 9 a.m. to 5 p.m. at Oakland City Hall, bringing elders, families, advocates, policymakers and community leaders together to address elder abuse, financial exploitation and problems within probate and conservatorship systems.

The symposium is designed to inform and empower the community while developing strategies and policies to better protect Alameda County’s vulnerable elders and disabled residents.

“Two of our most vulnerable populations are elders and the disabled, and many times that combination resides in one individual,” said Tanya Dennis, lead facilitator of NPRC. “At our symposium, NPRC will bring decision makers and elders together in one space for a day to develop strategy and policy to protect and empower.”

Dennis said NPRC has drafted proposed legislation intended to make conservatorship a true last resort by adding safeguards before and after a petition is filed. Proposals include mandatory private mediation before entering probate and placement of an ombudsman in probate proceedings to advocate for the rights and interests of prospective or current conservatees.

The coalition also wants stronger protections for elders’ estates and assets, arguing that money accumulated over a lifetime should be preserved for elders, families and intended beneficiaries rather than unnecessarily depleted by court-related expenses.

NPRC meets monthly through Zoom and has expanded into a national coalition because elder abuse, financial exploitation and guardianship and conservatorship concerns extend well beyond Alameda County.

“Members share horror stories of being isolated from their parents and children, many times physically abused and overmedicated; seeing estates drained for court costs, and assets that parents spent decades saving to leave a legacy depleted instead and going to strangers,” said Venus Gist, an NPRC co-facilitator and former victim of the probate system. Gist said she spent more than $80,000 trying to protect her parents’ estate.

“Eighty thousand dollars is nothing compared to the people in our group losing millions and having to sell their businesses and homes to pay court fees,” she said.

The symposium will also examine forms of elder exploitation including telephone scams, bank fraud, identity theft, family financial abuse and exploitation by trusted individuals. Participants will learn to recognize warning signs involving caregivers, financial professionals, health and social service workers, attorneys and guardians.

NPRC is seeking a California lawmaker willing to champion legislation that strengthens elder protections and increases accountability in the conservatorship process.

The symposium follows Supervisor Nate Miley’s 23rd Annual Healthy Living Festival on Thursday, Sept. 24, at the Oakland Zoo. The free event for adults 55 and older will feature health screenings, vaccinations, nearly 100 community resource booths, lunch, entertainment and complimentary zoo admission for eligible attendees.

Dennis said the two events offer a comprehensive two-day focus on elder well-being.

“The health fair will cover the physical care of our elders, and the next day NPRC’s symposium will cover the mental and social health,” Dennis said. “Together, we are offering a comprehensive two days of care for Alameda County elders.”

Both events are free, and advance registration is recommended because space is limited. Community members, elders, families, advocates and public officials are encouraged to participate. Breakfast and lunch will be served at both events.

For registration: Sign-up is required via Supervisor Nate Miley’s Eventbrite page NPRC registration is https://www.eventbrite.com/e/elder-justice-symposium-tickets-1998385423597?aff=oddtdtcreator



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Episode 4: Grow Stronger After 50

INDIANAPOLIS RECORDER — Episode 4 of the Second Half of Life Podcast features hosts Thomas Griffin and Andrea McGordon in conversation with Joel Hungate, Assistant Vice President of Strategy & Integrated Wellbeing at Hancock Health. Hungate, a biomedical engineer, health adventurer, and Netflix-featured survivalist, discusses reinvention, personal reflection, confidence, and building lasting health beyond age 50.

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Strength doesn’t disappear when you turn 50- it evolves. Just as growth is a lifelong journey, becoming stronger happens every day. The second half of life is not the beginning of decline; it is the horizon of a stronger, healthier, more confident, and happier version of yourself.

In Episode 4 of the Second Half of Life Podcast, hosts Thomas Griffin and Andrea McGordon sit down with Joel Hungate, Assistant Vice President of Strategy & Integrated Wellbeing at Hancock Health, biomedical engineer, health adventurer, and Netflix-featured survivalist, for a compelling conversation on reinvention, personal reflection, confidence, and building lasting health after 50.

Drawing from his professional expertise and extraordinary life experiences, Joel challenges many of the myths surrounding aging and demonstrates that the years after 50 can be filled with purpose, adventure, and renewed strength.

The Door Doesn’t Shut at Your Second Half

One of the most memorable moments from the conversation came when Joel Hungate shared a simple yet profound truth:

“The door doesn’t shut at 50.”

Far too many people believe that once they reach the second half of life, opportunities begin to disappear. Joel offers a refreshing perspective, reminding viewers that age does not determine potential. Instead, the years after 50 present an opportunity to reflect on your experiences, redefine your purpose, and confidently pursue new goals.

Whether you’ve always wanted to travel, learn a new skill, improve your health, or simply become the best version of yourself, your second half is not a limitation; it’s an invitation.

Watch the first short clip here:https://drive.google.com/file/d/1uTp_tFVgb55Ux1GWmQnLRHp2YTVdl68k/view?usp=drivesdk

Find a Version of Strength Training That Works for You

When people hear the words strength training, many immediately picture lifting heavy weights in a gym. Joel Hungate believes strength looks different for everyone.

You don’t need an expensive fitness membership to become stronger. Walking after dinner, climbing stairs, carrying groceries, hiking with friends, cycling, resistance exercises, or simply staying physically active can all help build strength and preserve independence as you age.

Joel encourages people 50 and over to find a form of movement they genuinely enjoy because consistency not intensity, is what transforms health over time. One practical habit he recommends is taking a walk after dinner, a simple routine that benefits both physical health and overall wellbeing.

Watch the second short clip here:https://drive.google.com/file/d/188dzfMoEbNOxzjXxde2-j4xochFL8lHQ/view?usp=drivesdk

A Way Out of the Frailty Epidemic

Frailty has become one of the greatest health challenges affecting those over 50, yet many people don’t realize that it is not an inevitable part of aging.

During the conversation, Joel explains how maintaining muscle strength, staying active, and making intentional lifestyle choices can significantly reduce the risk of frailty while supporting healthy weight management.

Rather than accepting weakness as a normal part of growing older, he challenges listeners to adopt habits that preserve mobility, resilience, and independence for years to come.

If you’ve ever wondered how to stay strong and capable well into your later years, this conversation offers practical insights that could change the way you think about aging.

Watch the third short clip here:https://drive.google.com/file/d/13BJIGBE68IsEoA3sVaAT8UIBEpepq6A7/view?usp=drivesdk

Eating Better Isn’t the Goal for a Healthy You- Here’s What Is

One of Joel’s most thought-provoking statements during the episode was:

“When we think health is an end goal, it never works.”

Health is not a destination that we eventually arrive at, it is a lifelong journey shaped by daily decisions.

Joel explains that while nutritious eating is important, lasting health is built through a combination of purposeful movement, meaningful relationships, quality sleep, continual learning, and embracing new adventures. Healthy living is about creating a lifestyle that allows you to enjoy life, not simply following another diet.

This refreshing perspective encourages viewers to shift their focus from chasing perfection to building sustainable habits that support long-term wellbeing.

Watch the fourth short clip here:https://drive.google.com/file/d/1PjaysWUmBOTQunVBqQb6KcgKPHEUL5qM/view?usp=drivesdk

More Than a Conversation- A Blueprint for Living Stronger

Episode 4 of the Second Half of Life Podcast is more than an inspiring discussion- it is a practical guide for anyone determined to thrive after 50.

Joel Hungate shares expert insights, personal experiences, and actionable advice that challenge outdated beliefs about aging. His message is clear: strength doesn’t fade with age unless we stop investing in it.

If you’re ready to eliminate the fear of frailty, build lasting confidence, and embrace the adventure that awaits in the second half of life, this episode is one you won’t want to miss.

Watch the full episode now and discover how to grow stronger after 50.

For more, visit indianapolisrecorder.com.

The post Episode 4: Grow Stronger After 50 appeared first on Indianapolis Recorder.

Based on reporting by Indianapolis Recorder.



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Commentary

Episode 4: Grow Stronger After 50

INDIANAPOLIS RECORDER — Episode 4 of the Second Half of Life Podcast features hosts Thomas Griffin and Andrea McGordon in conversation with Joel Hungate, Assistant Vice President of Strategy & Integrated Wellbeing at Hancock Health. Hungate, a biomedical engineer, health adventurer, and Netflix-featured survivalist, discusses reinvention, personal reflection, confidence, and building lasting health beyond age 50.

Published

on

Strength doesn’t disappear when you turn 50- it evolves. Just as growth is a lifelong journey, becoming stronger happens every day. The second half of life is not the beginning of decline; it is the horizon of a stronger, healthier, more confident, and happier version of yourself.

In Episode 4 of the Second Half of Life Podcast, hosts Thomas Griffin and Andrea McGordon sit down with Joel Hungate, Assistant Vice President of Strategy & Integrated Wellbeing at Hancock Health, biomedical engineer, health adventurer, and Netflix-featured survivalist, for a compelling conversation on reinvention, personal reflection, confidence, and building lasting health after 50.

Drawing from his professional expertise and extraordinary life experiences, Joel challenges many of the myths surrounding aging and demonstrates that the years after 50 can be filled with purpose, adventure, and renewed strength.

The Door Doesn’t Shut at Your Second Half

One of the most memorable moments from the conversation came when Joel Hungate shared a simple yet profound truth:

“The door doesn’t shut at 50.”

Far too many people believe that once they reach the second half of life, opportunities begin to disappear. Joel offers a refreshing perspective, reminding viewers that age does not determine potential. Instead, the years after 50 present an opportunity to reflect on your experiences, redefine your purpose, and confidently pursue new goals.

Whether you’ve always wanted to travel, learn a new skill, improve your health, or simply become the best version of yourself, your second half is not a limitation; it’s an invitation.

Watch the first short clip here:https://drive.google.com/file/d/1uTp_tFVgb55Ux1GWmQnLRHp2YTVdl68k/view?usp=drivesdk

Find a Version of Strength Training That Works for You

When people hear the words strength training, many immediately picture lifting heavy weights in a gym. Joel Hungate believes strength looks different for everyone.

You don’t need an expensive fitness membership to become stronger. Walking after dinner, climbing stairs, carrying groceries, hiking with friends, cycling, resistance exercises, or simply staying physically active can all help build strength and preserve independence as you age.

Joel encourages people 50 and over to find a form of movement they genuinely enjoy because consistency not intensity, is what transforms health over time. One practical habit he recommends is taking a walk after dinner, a simple routine that benefits both physical health and overall wellbeing.

Watch the second short clip here:https://drive.google.com/file/d/188dzfMoEbNOxzjXxde2-j4xochFL8lHQ/view?usp=drivesdk

A Way Out of the Frailty Epidemic

Frailty has become one of the greatest health challenges affecting those over 50, yet many people don’t realize that it is not an inevitable part of aging.

During the conversation, Joel explains how maintaining muscle strength, staying active, and making intentional lifestyle choices can significantly reduce the risk of frailty while supporting healthy weight management.

Rather than accepting weakness as a normal part of growing older, he challenges listeners to adopt habits that preserve mobility, resilience, and independence for years to come.

If you’ve ever wondered how to stay strong and capable well into your later years, this conversation offers practical insights that could change the way you think about aging.

Watch the third short clip here:https://drive.google.com/file/d/13BJIGBE68IsEoA3sVaAT8UIBEpepq6A7/view?usp=drivesdk

Eating Better Isn’t the Goal for a Healthy You- Here’s What Is

One of Joel’s most thought-provoking statements during the episode was:

“When we think health is an end goal, it never works.”

Health is not a destination that we eventually arrive at, it is a lifelong journey shaped by daily decisions.

Joel explains that while nutritious eating is important, lasting health is built through a combination of purposeful movement, meaningful relationships, quality sleep, continual learning, and embracing new adventures. Healthy living is about creating a lifestyle that allows you to enjoy life, not simply following another diet.

This refreshing perspective encourages viewers to shift their focus from chasing perfection to building sustainable habits that support long-term wellbeing.

Watch the fourth short clip here:https://drive.google.com/file/d/1PjaysWUmBOTQunVBqQb6KcgKPHEUL5qM/view?usp=drivesdk

More Than a Conversation- A Blueprint for Living Stronger

Episode 4 of the Second Half of Life Podcast is more than an inspiring discussion- it is a practical guide for anyone determined to thrive after 50.

Joel Hungate shares expert insights, personal experiences, and actionable advice that challenge outdated beliefs about aging. His message is clear: strength doesn’t fade with age unless we stop investing in it.

If you’re ready to eliminate the fear of frailty, build lasting confidence, and embrace the adventure that awaits in the second half of life, this episode is one you won’t want to miss.

Watch the full episode now and discover how to grow stronger after 50.

For more, visit indianapolisrecorder.com.

The post Episode 4: Grow Stronger After 50 appeared first on Indianapolis Recorder.

Based on reporting by Indianapolis Recorder.



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