Health
Concerns Remain for ‘Viagra for Women’ Twice Rejected by FDA

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. Sprout Pharmaceuticals, the makers of the twice-rejected pill intended to boost libido in women, will make a third attempt this week at convincing regulators to approve the drug as the first prescription treatment for low sexual desire in women. A panel of FDA experts will discuss the drug at a public meeting Thursday, June 4, 2015 before voting on whether to recommend its approval.(AP Photo/Allen G. Breed, File)
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
OPINION: Your Voice and Vote Impact the Quality of Your Health Care
One of the most dangerous developments we’re seeing now? Deep federal cuts are being proposed to Medicaid, the life-saving health insurance program that covers nearly 80 million lower-income individuals nationwide. That is approximately 15 million Californians and about 1 million of the state’s nearly 3 million Black Californians who are at risk of losing their healthcare.

By Rhonda M. Smith, Special to California Black Media Partners
Shortly after last year’s election, I hopped into a Lyft and struck up a conversation with the driver. As we talked, the topic inevitably turned to politics. He confidently told me that he didn’t vote — not because he supported Donald Trump, but because he didn’t like Kamala Harris’ résumé. When I asked what exactly he didn’t like, he couldn’t specifically articulate his dislike or point to anything specific. In his words, he “just didn’t like her résumé.”
That moment really hit hard for me. As a Black woman, I’ve lived through enough election cycles to recognize how often uncertainty, misinformation, or political apathy keep people from voting, especially Black voters whose voices are historically left out of the conversation and whose health, economic security, and opportunities are directly impacted by the individual elected to office, and the legislative branches and political parties that push forth their agenda.
That conversation with the Lyft driver reflects a troubling surge in fear-driven politics across our country. We’ve seen White House executive orders gut federal programs meant to help our most vulnerable populations and policies that systematically exclude or harm Black and underserved communities.
One of the most dangerous developments we’re seeing now? Deep federal cuts are being proposed to Medicaid, the life-saving health insurance program that covers nearly 80 million lower-income individuals nationwide. That is approximately 15 million Californians and about 1 million of the state’s nearly 3 million Black Californians who are at risk of losing their healthcare.
Medicaid, called Medi-Cal in California, doesn’t just cover care. It protects individuals and families from medical debt, keeps rural hospitals open, creates jobs, and helps our communities thrive. Simply put; Medicaid is a lifeline for 1 in 5 Black Americans. For many, it’s the only thing standing between them and a medical emergency they can’t afford, especially with the skyrocketing costs of health care. The proposed cuts mean up to 7.2 million Black Americans could lose their healthcare coverage, making it harder for them to receive timely, life-saving care. Cuts to Medicaid would also result in fewer prenatal visits, delayed cancer screenings, unfilled prescriptions, and closures of community clinics. When healthcare is inaccessible or unaffordable, it doesn’t just harm individuals, it weakens entire communities and widens inequities.
The reality is Black Americans already face disproportionately higher rates of poorer health outcomes. Our life expectancy is nearly five years shorter in comparison to White Americans. Black pregnant people are 3.6 times more likely to die during pregnancy or postpartum than their white counterparts.
These policies don’t happen in a vacuum. They are determined by who holds power and who shows up to vote. Showing up amplifies our voices. Taking action and exercising our right to vote is how we express our power.
I urge you to start today. Call your representatives, on both sides of the aisle, and demand they protect Medicaid (Medi-Cal), the Affordable Care Act (Covered CA), and access to food assistance programs, maternal health resources, mental health services, and protect our basic freedoms and human rights. Stay informed, talk to your neighbors and register to vote.
About the Author
Rhonda M. Smith is the Executive Director of the California Black Health Network, a statewide nonprofit dedicated to advancing health equity for all Black Californians.
Activism
OPINION: Supreme Court Case Highlights Clash Between Parental Rights and Progressive Indoctrination
At the center of this controversy are some parents from Montgomery County in Maryland, who assert a fundamental principle: the right to shield their children from exposure to sexual content that is inappropriate for their age, while also steering their moral and ethical upbringing in alignment with their faith. The local school board decided to introduce a curriculum that includes LGBTQ+ themes — often embracing controversial discussions of human sexuality and gender identity.

By Craig J. DeLuz, Special to California Black Media Partners
In America’s schools, the tension between parental rights and learning curricula has created a contentious battlefield.
In this debate, it is essential to recognize that parents are, first and foremost, their children’s primary educators. When they send their children to school — public or private — they do not surrender their rights or responsibilities. Yet, the education establishment has been increasingly encroaching on this vital paradigm.
A case recently argued before the Supreme Court regarding Maryland parents’ rights to opt out of lessons that infringe upon their religious beliefs epitomizes this growing conflict. This case, Mahmoud v. Taylor, is not simply about retreating from progressive educational mandates. It is fundamentally a defense of First Amendment rights, a defense of parents’ rights to be parents.
At the center of this controversy are some parents from Montgomery County in Maryland, who assert a fundamental principle: the right to shield their children from exposure to sexual content that is inappropriate for their age, while also steering their moral and ethical upbringing in alignment with their faith. The local school board decided to introduce a curriculum that includes LGBTQ+ themes, often embracing controversial discussions of human sexuality and gender identity. The parents argue that the subject matter is age-inappropriate, and the school board does not give parents the option to withdraw their children when those lessons are taught.
This case raises profound questions about the role of public education in a democratic society. In their fervent quest for inclusivity, some educators seem to have overlooked an essential truth: that the promotion of inclusivity should never infringe upon parental rights and the deeply held convictions that guide families of different faith backgrounds.
This matter goes well beyond mere exposure. It veers into indoctrination when children are repeatedly confronted with concepts that clash with their family values.
“I don’t think anybody can read that and say: well, this is just telling children that there are occasions when men marry other men,” noted Justice Samuel Alito. “It has a clear moral message, and it may be a good message. It’s just a message that a lot of religious people disagree with.”
Justice Amy Coney Barrett raised a crucial point, noting that it is one thing to merely expose students to diverse ideas; it is quite another to present certain viewpoints as indisputable truths. By framing an ideology with the certainty of “this is the right view of the world,” educators risk indoctrination rather than enlightenment. This distinction is not merely academic; it speaks to the very essence of cultivating a truly informed citizenry.
Even Justice Elena Kagan expressed concern regarding the exposure of young children to certain materials in Montgomery County.
“I, too, was struck by these young kids’ picture books and, on matters concerning sexuality, I suspect there are a lot of non-religious parents who weren’t all that thrilled about this,” she said.
Justice John Roberts aptly questioned the practicality of expecting young children to compartmentalize their beliefs in the classroom.
“It is unreasonable to expect five-year-olds, still forming their worldviews, to reconcile lessons that conflict fundamentally with the teachings they receive at home,” he said.
As was noted in my previous commentary, “The Hidden Truth In The Battle Over Books In American Schools”, what lies at the heart of these debates is a moral disconnect between the values held by the majority of Americans and those promoted by the educational establishment. While the majority rightly argue that material containing controversial content of a sexual nature should have no place in our children’s classrooms, the education establishment continues to tout the necessity of exposing children to such content under the guise of inclusivity. This disregards the legitimate values held by the wider community.
Highlighted in this case that is before the Supreme Court is a crucial truth: parents must resolutely maintain their right to direct their children’s education, according to their values. This struggle is not simply a skirmish; it reflects a broader movement aimed at reshaping education by privileging a state-sanctioned narrative while marginalizing dissenting voices.
It is imperative that we assert, without hesitation, that parents are — and must remain — the primary educators of their children.
When parents enroll a child in a school, it should in no way be interpreted as a relinquishment of parental authority or the moral guidance essential to their upbringing. We must stand firm in defending parental rights against the encroaching ideologies of the education establishment.
About the Author
Craig J. DeLuz has almost 30 years of experience in public policy and advocacy. He has served as a member of The Robla School District Board of Trustees for over 20 years. He also currently hosts a daily news and commentary show called “The RUNDOWN.” You can follow him on X at @CraigDeLuz.
Activism
California Observes Third Annual Black Health Advocacy Week
On May 4, 2023, the California Assembly unanimously passed ACR 53, enacting BHEAW every first week of May. “The life expectancy at birth for Black Californians is 76.2 years of age, which is five years shorter than the state average and the lowest life expectancy of all racial and ethnic groups in California,” said Weber in a statement.

By Bo Tefu, California Black Media
California’s third annual Black Health Equity Advocacy Week (BHEAW), observed from May 5-9, reaffirmed the commitment of the state and advocates to address systemic health disparities affecting Black communities.
Assemblymember Akilah Weber (D-San Diego), who is a medical doctor and chair of the California Legislative Black Caucus (CLBC), authored the resolution that created BHEAW — the first statewide initiative of its kind focused on advancing Black health equity.
On May 4, 2023, the California Assembly unanimously passed ACR 53, enacting BHEAW every first week of May.
“The life expectancy at birth for Black Californians is 76.2 years of age, which is five years shorter than the state average and the lowest life expectancy of all racial and ethnic groups in California,” said Weber in a statement.
“This disparity is a stark reminder of the systemic and institutional factors that contribute to health inequities in communities of color,” she added.
The California Black Health Network (CBHN) led this year’s events, combining advocacy, training, and public engagement to amplify the urgency of closing health gaps for Black Californians.
The theme of this year’s observance was “We’ve Got the Power.”
“CBHN is calling on our community to step up, speak out, and get involved. Increasing the participation of Black Californians in policymaking — across the health industry and public sector — is one of the most powerful ways we can drive change and save lives,” reads a message from the organization promoting this year’s BHEAW.
“Policy change is within your power and this week we’re in Sacramento with our Health Equity Advocacy Training (HEAT) Program Cohort 3 to uplift issues impacting our community and advocate to help shape the policies and programs that will improve the health of current and future generations of Black Californians,” the message continued.
Focused on public awareness and information, this year’s BHEAW included a social media campaign, a rally and training program with vital information on medical conditions that have a disproportionate impact on Black Californians, including maternal mortality, mental health, diabetes, cancer and more.
For more information on the resolution or to join the movement, visit CBHN’s official site, www.cablackhealthnetwork.org.
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