Health

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

Published

9 years ago

June 2, 2015

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..

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Activism

NAACP California-Hawaii State Convention Highlights Black Voter Engagement, and More

A Friday panel featuring NAACP Chairman Leon W. Russell and Regina Wilson, Executive Director of California Black Media, examined Project 2025, an initiative perceived as a potential threat to civil rights, healthcare access, and environmental protection. This session emphasized Project 2025’s projected impact on Black communities, noting that policies within the initiative could diminish gains in civil and environmental rights over decades. Russell and Wilson highlighted the need for vigilant monitoring and community mobilization to address these challenges.

Published

18 hours ago

November 4, 2024

Oakland Post

NAACP State Conference President Rick Callender (right) engages in a discussion on voter engagement and community advocacy with NAACP President and CEO Derrick Johnson during the 37th NAACP California-Hawaii State Convention in Los Angeles. Photo by Rich Woods.

By Bo Tefu, California Black Media

The 37th NAACP California-Hawaii State Convention concluded on Sunday, Oct 27, following four days of discussions and workshops at the Los Angeles Airport Marriott. Bringing together civil rights leaders, policymakers, and advocates from California and Hawaii, the convention operated under the theme “All In.” The participants discussed critical issues impacting Black communities, including criminal justice reform, health equity, economic empowerment, education, environmental justice, and voting rights.

On Saturday, the President’s Fireside Chat brought together NAACP President Derrick Johnson and CA/HI State Conference President Rick Callender, who discussed the urgency of voter engagement and community advocacy.

Guest speakers included Congresswoman Maxine Waters (D-CA-43), who spoke at the Women in NAACP (WIN) Labor Luncheon about the intersection of labor rights and civil rights. California State Superintendent Tony Thurmond delivered remarks at the Leadership Dinner on education equity, focusing on policies to ensure all students have access to high-quality education.

Honors were given to longtime social justice advocate and former Assemblymember Mike Davis for his work in community activism. At the same time, actor and activist Danny Glover and the Rev. Dr. Amos C. Brown received the 2024 Legacy Hall of Fame Awards, recognizing their lifelong commitments to advancing civil rights.

The convention also offered practical workshops, including “What’s On Your Ballot?,” where coalition leaders provided analyses of California propositions, explaining their potential impacts on community rights and resources. The Voter Turnout Workshop provided background and encouraged participants to promote voter turnout through community-centered outreach strategies.

Sunday’s events closed with a Prayer and Memorial Breakfast honoring the contributions of past and current civil rights leaders.

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Activism

Atty Gen Bonta: U.S. Law Mandating Emergency Care to All Patients Faces Threats

The attorney general highlighted that EMTALA is vital for ensuring that no individual is turned away from emergency services based on financial status or insurance coverage. Bonta stated that the law has been a cornerstone of emergency healthcare for decades, providing peace of mind to millions of Americans who might otherwise hesitate to seek urgent medical attention due to cost concerns.

Published

2 days ago

November 3, 2024

Oakland Post

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By Bo Tefu, California Black Media

California Attorney General Rob Bonta emphasized the critical need to protect the Emergency Medical Treatment and Labor Act (EMTALA), mandating that hospitals provide emergency care to all patients regardless of their ability to pay.

In a recent statement, Bonta highlighted the potential threats to this essential legislation amid ongoing discussions about healthcare accessibility in the U.S.

“EMTALA ensures that no one is denied access to emergency medical care, including abortion care, and this federal law is more imperative than ever following the overturn of Roe v. Wade,” said Bonta.

This decision to support the federal government’s case comes at a time when many healthcare providers are facing pressure from rising costs and legislative changes that could undermine existing protections. Bonta called on lawmakers to reinforce EMTALA’s provisions and to combat any efforts aimed at weakening the act, asserting that equitable access to emergency care is a fundamental right.

He urged state and federal governments to ensure that all Americans, particularly marginalized communities, have the necessary access to emergency services without fear of financial repercussions. The brief indicates the coalition’s commitment to healthcare equity, emphasizing that maintaining strong protections under EMTALA is crucial for safeguarding public health.

As discussions around healthcare policy continue, Bonta remains steadfast in promoting initiatives that protect emergency care access, asserting that everyone deserves timely and appropriate medical treatment in emergencies. His efforts align with ongoing legal and advocacy battles to preserve the rights established by EMTALA in the face of evolving healthcare challenges.

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Alameda County

Access Better Health with Medically Tailored Meals – Transforming Health Through Nutrition for Medi-Cal Patients

Launched in 2018, the Medically Tailored Meals pilot program was designed to help Medi-Cal patients with congestive heart failure by reducing hospital readmissions and emergency department visits by providing tailored meals meeting specific dietary needs. The program’s success in improving health outcomes and reducing costly emergency room visits encouraged the Department of Health Care Services (DHCS) to expand the Medically Tailored Meals program to all 58 counties through Medi-Cal transformation and a new set of services called Community Supports.

Published

6 days ago

October 29, 2024

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The program’s success in improving health outcomes and reducing costly emergency room visits encouraged the Department of Health Care Services (DHCS) to expand the Medically Tailored Meals program to all 58 counties through Medi-Cal transformation and a new set of services called Community Supports.

Medically Tailored Meals are one of 14 new services offered through Medi-Cal that provide members with access to new and improved services to get well-rounded care that goes beyond the doctor’s office or hospital.

Medically Tailored Meals: Overview

Malnutrition and poor nutrition can lead to severe health outcomes, especially among Medi-Cal patients with chronic health conditions. Medically Tailored Meals aim to improve health outcomes, reduce hospital readmissions, and enhance patient satisfaction by providing essential nutrition.

Key Features:

Post-Discharge Delivery: Meals are delivered to patients’ homes immediately following discharge from a hospital or nursing home.
Customized Nutrition: Meals are tailored to meet the dietary needs of those with chronic diseases, designed by registered dietitians (RD) or certified nutrition professionals based on evidence-based guidelines.
Comprehensive Services: Includes medically tailored groceries, healthy food vouchers, and food pharmacies.
Educational Support: Behavioral, cooking, and nutrition education is included when paired with direct food assistance.

Key Benefits:

Address Food Insecurity: Mitigates poor health outcomes linked to food insecurity.

Support Complex Care Needs: Tailored to individuals with chronic conditions.

Improve Health Outcomes: Studies show improvements in diabetes control, fall prevention, and medication adherence.

Patient Testimonial:

“My diabetes has gotten better with the meals. I’ve kept my weight down, and I feel much better now than I have in a long time. I’m one of the people this program is meant for.” — Brett

Eligibility:

Eligible Populations: Eligible Medi-Cal members include those with chronic conditions like diabetes, cardiovascular disorders, congestive heart failure, stroke, chronic lung disorders, HIV, cancer, gestational diabetes, and chronic mental or behavioral health disorders. Also, those being discharged from a hospital or skilled nursing facility or at high risk of hospitalization or nursing facility placement are also eligible.

Service Limitations: Up to two meals per day for up to 12 weeks, extendable if medically necessary. Meals eligible for reimbursement by alternate programs are not covered.

Cost Savings and Improved Health Outcomes:

Health Outcomes: Research indicates a 22% to 58% decrease in emergency department visits and a 27% to 63% decrease in inpatient admissions among Medically Tailored Meals recipients, translating to significant health care cost savings.

Project Open Hand: A Success Story

Project Open Hand has been a leader in providing Medically Tailored Meals, significantly impacting the lives of Bay Area Medi-Cal patients with chronic illnesses. Since its inception, Project Open Hand has delivered nutritious meals to individuals with diabetes, HIV, and other serious health conditions, demonstrating remarkable health improvements and cost savings.

Key Achievements:

Improved Health Outcomes: Project Open Hand’s research found a 50% increase in medication adherence among recipients of Medically Tailored Meals.

Reduced Hospitalizations: Their program showed a 63% reduction in hospitalizations for patients with diabetes and HIV.

Enhanced Quality of Life: Patients reported better health and increased energy levels.

Project Open Hand ensures that each meal is prepared using fresh, wholesome ingredients tailored to meet the specific dietary needs of its clients. By partnering with Medi-Cal managed care plans, Project Open Hand continues to provide life-saving nutrition to those who need it most.

Join Us in Our Mission

You can experience the profound impact of Medically Tailored Meals by joining the Medi-Cal Community Supports services initiative. Your involvement can make a difference in promoting your health through nutrition.

Learn More

For more information about Medically Tailored Meals and how to get involved, call the state’s Medi-Cal Health Care options at 800-430-4263 or contact your local managed care plan.

In Alameda County, Medi-Cal recipients can contact:

* Alameda Alliance for Health: 510-747-4567

* Kaiser Permanente: 855-839-7613

In Contra Costa County, Medi-Cal recipients can contact:
* Contra Costa Health Plan: 877-661-6230

* Kaiser Permanente: 855-839-7613

In Marin County, Medi-Cal recipients can contact:
* Partnership Health Plan of California: 800-863-4155

* Kaiser Permanente: 855-839-7613

In Solano County, Medi-Cal recipients can contact:
* Partnership Health Plan of California: 800-863-4155

* Kaiser Permanente: 855-839-7613
Your health and well-being are your health care provider’s top priority. Medically Tailored Meals are designed to enhance quality of life by advancing health care through the power of nutrition. Experience the benefits today, and take the first step toward a healthier you.