Health
Concerns Remain for ‘Viagra for Women’ Twice Rejected by FDA
MATTHEW PERRONE, AP Health Writer
WASHINGTON (AP) — The makers of a pill intended to boost sexual desire in women will try again this week to persuade regulators that the drug warrants approval after two rejections.
But a new review released by the Food and Drug Administration shows government scientists still have concerns about whether the drug’s benefits outweigh its risks. The FDA review highlights several safety issues with flibanserin, including low blood pressure and fainting spells. Those problems increased when patients combined the drug with alcohol and some other medications, according to the document.
A panel of FDA experts will discuss the drug at a public meeting Thursday, before voting on whether to recommend its approval.
The ongoing saga of Sprout Pharmaceutical’s much-debated drug illustrates the complex politics and 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 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 long overlooked by the FDA. But critics argue that drug development efforts like Sprout’s medicalize women’s sexual problems, which are often related to stress, relationship issues and other life circumstances.
“There are certainly women who have low libido and are distressed by it,” says Dr. Adriane Fugh-Berman, an associate professor at Georgetown University. “But for those women therapy is the best solution, because this is not a medical disease.”
Other critics say they would support a safe and effective drug for treating women’s libido problems, but none has yet emerged.
“If a company could show that a drug is effective based on clinically significant outcome measurements, then we’d be for it,” says Cindy Pearson, executive director of the National Women’s Health Network.
Flibanserin is the first drug to approach the issue through brain chemistry. Originally studied as an antidepressant, the pill was repurposed as a libido treatment after women in company studies reported higher levels of sexual satisfaction. But the FDA has twice rejected the drug because of lackluster effectiveness and side effects including fatigue, dizziness and nausea.
Clinicians who helped study flibanserin point out that they already prescribe other antidepressants without FDA approval to treat sexual desire disorders. They argue that those drugs, including Wellbutrin and Viibryd, carry worse side effects than flibanserin, such as agitation and seizures.
“We use them all the time for female sexual dysfunction,” says Dr. James Simon, a gynecologist who helped conduct several key studies of flibanserin. “The problem is that the side effect profile for doses that are effective for increasing desire and orgasm can be very high.”
Simon says the lack of an FDA-approved option for female sexual dysfunction means doctors must balance issues of safety and lack of insurance coverage while trying to help patients.
“We’re out there in the trenches every day trying to find a happy medium.”
It’s not entirely clear how flibanserin increases desire, but researchers point to its ability to boost dopamine — a brain chemical associated with appetite — while lowering serotonin, which is linked to feelings of satiation.
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. Company studies showed women taking flibanserin reported roughly one more sexually satisfying experience per month than women taking placebo.
The drug’s initial developer, Boehringer Ingelheim, abandoned work on the drug in 2011 and sold it to Sprout, a startup company from Raleigh, North Carolina. Sprout resubmitted the drug with additional effectiveness and safety data, but the FDA again rejected the drug in October 2013. Sprout submitted the drug yet again earlier this year after filing a formal dispute over the FDA’s second rejection.
FDA’s review posted Tuesday underscores the ongoing rift between regulators and the company. The FDA acknowledges that flibanserin resulted in statistically significant increases in sexual events and desire, while decreasing distress. But the review concludes: “The fundamental question is whether these observed placebo-corrected treatment effects outweigh the risks associated with treatment.”
The FDA will ask its expert panel whether extra safety measures — including certification for doctors who wish to prescribe the drug — should be required if the drug is approved.
The FDA is not required to follow the advice of its panelists. The agency is expected to make a decision on whether to approve the drug in August..
Copyright 2015 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Activism
Through Two Programs, Shuja Helps Others Get a Second Chance at a First-Class Life
Damon Johnson, a peer counselor who serves as the executive director of Black Men Speak and Men and Women of Color will be affected by the state’s new rules. Living with a behavioral health condition, he is an advocate and a leader. Damon, best known as Shuja, was incarcerated for 34 years and today is advocating for the rights of persons with similar lived experience and for the survival of peer-led programs like the one he manages.
By Melody Parker, Gloria Woodson, Jaleah Winn and Damon Shuja Johnson
Special to The Post
Under recently passed Proposition 1, California’s behavioral health services will be allocated $1 billion for services for the unhoused in 2026-27, Governor Gavin Newsom announced last summer.
Although some of the funds from the Mental Health Services Act were diverted to Proposition 1, individuals living with behavioral health conditions and housing challenges are maintaining hope for wellness and recovery.
Damon Johnson, a peer counselor who serves as the executive director of Black Men Speak and Men and Women of Color will be affected by the state’s new rules. Living with a behavioral health condition, he is an advocate and a leader. Damon, best known as Shuja, was incarcerated for 34 years and today is advocating for the rights of persons with similar lived experience and for the survival of peer-led programs like the one he manages.
Two days after his reentry to the community, Shuja began work as an outreach coordinator for Black Men Speak. Within a year, Shuja was promoted and later appointed to director after the loss of former Black Men Speak Executive Director Joe Anderson.
A native of North Oakland, Shuja was raised in an all-women household after his grandfather was murdered. Though dealing with his own grief, the loss caused Shuja to become the “man of the family.”
His grandmother’s nurturing helped him to overcome the trauma of his grandfather’s death which, “gave him a foundation as a child.” He recalls fond memories of his childhood, like riding a new bike he received for the holidays. “My friends and myself spent meaningful time together as children,” he said. “Together, we would build go-carts, climb trees, have rock fights and find worms, crabs and bees.”
But his trauma impacted his childhood and led to his being impacted by the system. Shuja grew up mostly in detention halls and prison.
Besides directing Black Men Speak! (BMS!)/Men and Women of Color (MWOC), he is also the director of a self-help center in Oakland. There, Shuja and the peer workers provide support to the unhoused. He coordinates a digital literacy program, co-facilitates trainings for peer support specialists, organizes a service animal resource, provides peer support and directs speakers’ bureaus.
BMS! and MWOC are programs increasing wellness and recovery by sharing stories of hope and journeys to meaningful living. Members have authored presentations and spoken to audiences on topics such as post-traumatic stress disorder, family, community violence, self-worth, spirituality, and mental health, alternative therapies, eight dimensions of wellness, reentry, single parenting and health.
The members have been featured nationally and locally, at trainings and conferences and throughout Alameda County Behavioral Health Care services. The organization has been in operation for over a decade.
It all began in 2009 and received nonprofit status in 2012. The group developed from Peers Organizing Community Change, formerly known as Pool of Consumer Champions (POCC), originally established as an all-men’s committee.
The committee co-founders Dewitt Buckingham and Darnell Livingston organized men with experience in the public mental health system for a speaker’s bureau. This was the consensus of the committee after a process facilitated by Katrina Killian, Steven Bucholtz, Sally Zinman and Jaleah Winn.
The committee and facilitators composed the following mission. The BMS!/MWOC mission is “to inform and enlighten the mental health community and the general public about issues concerning men and women of color suffering from mental health and substance abuse challenges, through storytelling thereby promoting ad increasing wellness, recovery, and freedom.”
Shuja has a vision and plans for the organization. “BMS!/MWOC will be sustained with the funding of $1.5 million for capacity building to hire people to pay salaries for staff.”
Currently, BMS!/MWOC has volunteers assisting the programs. Funding will enable the enhancement, increase in self-help services and provide for outings and meals. “We want exposure as when adults and children have taken the free BART rides to go to places outside of Oakland that they never traveled,” Shuja said. “We want to go to Africa. More influential communities can travel, and we need the same opportunity.”
Despite several barriers that are facing Shuja and the organization, he is determined to fulfill the nonprofit’s mission. “There is money. Children wear $200 shoes. We want to teach financial literacy, not to be a slave but how to buy and how to keep. BMS! needs some rich friends and we also need friends who have know-how. We need support from private and public sectors.
“BMS! is one of the only Black organizations in ACBHCS. Today we have the SB 803, Peer Support Specialist bill that will enable us to bill Medicaid/Medi-Cal and only two full-time staff. We do not have the support of the community.”
Shuja is honored to be a participant in advocacy for legislation to improve the lives of peers and is not discouraged by changes to statewide policies. The current changes coming down the pike with Prop 1 are motivating him to work more diligently for the rights of behavioral health clients.
“This is about employment and empowerment and authenticity. The unhoused can be asked about hope and faith. I had to have faith and hope every day that I awakened in prison. I would have died in prison, but I had hope, faith and peer support and it manifested.
“My first reentry job is to go back to my family and save them and if this is repeated among families then we will have wellness and community. Kids raise themselves today. Today, grown folks cannot be in kids’ business. We want to do better. How can we bring back the good of the past?”
Today, the good of the past is coming back with the work of Black Men Speak! Men and Women Of Color. All support is welcome. Black Men Speak and Men and Women of Color welcome contributions and invitations to collaborate. In order to contact the program staff please reach out to 510-969-5086 or shuja@blackmenspeak.org.
Activism
A Student-Run Group Is Providing Critical Support Services to Underserved Residents
During his three years volunteering at the program, Resource Director Zain Shabbir, says he noticed that many of the people who come in do not know how to navigate social services support systems, particularly online. This knowledge deficit, Shabbir says, is due to age or limited exposure to technology.
Part 2
By Magaly Muñoz
Resource Director Zain Shabbir is a jack-of-all-trades at the Suitcase Clinic, a student-run resource center that provides health and other services to underserved residents of Berkeley and surrounding areas.
Shabbir was once a clinic director. Now, he manages the General Clinic, floating around when case managers need assistance. And he has big plans for a new initiative.
During his three years volunteering at the program, Shabbir says he noticed that many of the people who come in do not know how to navigate social services support systems, particularly online. This knowledge deficit, Shabbir says, is due to age or limited exposure to technology.
So, he teaches clients the basics of using email, writing in word documents, and backing up files to their phones.
Shabbir shared a story about an interaction he had with a woman who came in seeking help to create a template to message property owners and realtors as she was seeking housing. Until that point, the woman was composing separate messages to each listing she was interested in, and that process was taking up too much of her time. With Shabbir’s help, she created a standard template she could modify and use for each housing inquiry or application.
He’s also hoping to use the technology to help people create resumes to find jobs.
“[The intent] is to help people find work in the city or wherever they live — or help them find housing. As most are probably aware, the two really go together because for housing, you need income verification, and for a job you need housing,” Shabbir said.
Having a warm place to go and a hot meal may seem basic buy it is critical for people who are struggling, clinic leaders say.
Mark, a frequent attendee of the Tuesday clinic, told the Oakland Post that he’s been receiving services from the program for nearly 25 years.
Mark said he was able to receive a referral to dental care through the Clinic, which he’s been using for about 20 years now. He also utilized the chiropractor, a service that is no longer offered, for pain and aches he acquired over the years.
Many program participants say they visit the clinic now for services provided by Berkeley medical students, who rely on osteopathic care rather than traditional methods. Osteopathic medicine is a medical philosophy and practice that focuses on the whole person, rather than just symptoms.
Executive director Nilo Golchini said that many clinic patients tend to appreciate and trust this type of medicine over mainstream practices because of sub-standard care they have received in the past because they are homeless or poor.
Acupuncture is also an extremely popular station at the Clinic as well, with participants saying it “soothes and calms” them.
Attendees of the clinic are generally in happy spirits throughout the hours they’re able to interact with fellow residents. Some even participate in arts and crafts, moving from table to show their friends their new creations.
“It’s a program that’s going strong,” said Golchini. “There’s a space for everyone” who wants to volunteer or receive services, and they’ll keep going as long as the community needs it.
The Suitcase General Clinic is open every Tuesday from 6:30 to 9:30pm. Women’s and Youth Clinics are held every Monday from 6 to 9pm.
Activism
2024 in Review: Seven Questions for Frontline Doulas
California Black Media (CBM) spoke with Frontline Doulas’ co-founder Khefri Riley. She reflected on Frontline’s accomplishments this year and the organization’s goals moving forward.
By Edward Henderson, California Black Media
Frontline Doulas provides African American families non-medical professional perinatal services at no cost.
This includes physical, emotional, informational, psychosocial and advocacy support during the pregnancy, childbirth and postpartum period. Women of all ages — with all forms of insurance — are accepted and encouraged to apply for services.
California Black Media (CBM) spoke with co-founder Khefri Riley. She reflected on Frontline’s accomplishments this year and the organization’s goals moving forward.
Responses have been edited for clarity and length.
Looking back at 2024, what stands out to you as your most important achievement and why?
In 2024, we are humbled to have been awarded the contract for the Los Angeles County Medical Doula Hub, which means that we are charged with creating a hub of connectivity and support for generating training and helping to create the new doula workforce for the medical doula benefit that went live in California on Jan. 1, 2023.
How did your leadership and investments contribute to improving the lives of Black Californians?
We believe that the revolution begins in the womb. What we mean by that is we have the potential and the ability to create intentional generational healing from the moment before a child was conceived, when a child was conceived, during this gestational time, and when a child is born.
And there’s a traditional saying in Indigenous communities that what we do now affects future generations going forward. So, the work that we do with birthing families, in particular Black birthing families, is to create powerful and healthy outcomes for the new generation so that we don’t have to replicate pain, fear, discrimination, or racism.
What frustrated you the most over the last year?
Working in reproductive justice often creates a heavy burden on the organization and the caregivers who deliver the services most needed to the communities. So, oftentimes, we’re advocating for those whose voices are silenced and erased, and you really have to be a warrior to stand strong and firm.
What inspired you the most over the last year?
My great-grandmother. My father was his grandmother’s midwife assistant when he was a young boy. I grew up with their medicine stories — the ways that they healed the community and were present to the community, even amidst Jim Crow.
What is one lesson you learned in 2024 that will inform your decision-making next year?
I find that you have to reach for your highest vision, and you have to stand firm in your value. You have to raise your voice, speak up and demand, and know your intrinsic value.
In a word, what is the biggest challenge Black Californians face?
Amplification. We cannot allow our voices to be silent.
What is the goal you want to achieve most in 2025?
I really would like to see a reduction in infant mortality and maternal mortality within our communities and witness this new birth worker force be supported and integrated into systems. So, that way, we fulfill our goal of healthy, unlimited birth in the Black community and indeed in all birthing communities in Los Angeles and California.
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