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

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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. 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)

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.

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California Black Media

Stakeholders Warn Lawmakers of Expanding Aging Population; Older Black Californians Included

The California Commission on Aging (CCoA) hosted its second annual forum focused on challenges facing Californians over 65 years old. Titled “Aging and Disability Issues: What Legislative Staff Need to Know for 2024,” the virtual event was organized to bring awareness to lawmakers that California’s aging adults are living longer and to emphasize the importance of developing policy to support this growing population, according to organizers.

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The discussion encompassed a range of topics including planning for long-term care, assisted living, enhancing healthcare quality, technology use, services for senior adults with disabilities, state budget considerations, and the best policies and practices to help aging adults stay healthy, active, independent, and confident.
The discussion encompassed a range of topics including planning for long-term care, assisted living, enhancing healthcare quality, technology use, services for senior adults with disabilities, state budget considerations, and the best policies and practices to help aging adults stay healthy, active, independent, and confident.

By Antonio Ray Harvey, California Black Media 

The California Commission on Aging (CCoA) hosted its second annual forum focused on challenges facing Californians over 65 years old.

Titled “Aging and Disability Issues: What Legislative Staff Need to Know for 2024,” the virtual event was organized to bring awareness to lawmakers that California’s aging adults are living longer and to emphasize the importance of developing policy to support this growing population, according to organizers.

This year’s meeting included the perspectives of gerontologists and other subject-matter experts who provided data and insights critical to informing policy.

Former Assemblymember Cheryl Brown (D-San Bernardino), who chairs the CCoA’s Executive Committee, began the discussion.

“The landscape of California is changing. Aging is changing and it’s changing California,” Brown said. “Older adults are living longer, and the cohort is becoming more ethnically diverse, underscoring the need to develop culturally, appropriate services.”

The discussion encompassed a range of topics including planning for long-term care, assisted living, enhancing healthcare quality, technology use, services for senior adults with disabilities, state budget considerations, and the best policies and practices to help aging adults stay healthy, active, independent, and confident.

The CCoA acts as the principal advocate for older Californians and as a catalyst for change that supports and celebrates Californians as they advance in age. The CCoA advises the Governor and Legislature, along with state, federal, and local agencies on programs and services that affect senior adults.

Statewide organizations that participated in the event included LeadingAge California, Disability Rights California, California Foundation for Independent Living Centers, and California Collaborative for Long-Term Services and Supports.

In addition, representatives and staff members of Choice In Aging, Age Watch Newsletter, California Elder Justice Coalition, California Association of Area Agencies on Aging, and the California Long-Term Care Ombudsman Association were presenters during the 90-minute discussion.

“In California, we know that older adults are underserved and unserved relative to their needs,” CCoA Executive Director Karol Swartzlander said. “In stark terms, we know that 4% of older adults who need service actually receive services.”

According to the California Department of Aging (CDA), California’s aging population is expected to reach an estimated 4.5 million individuals ages 60 to 69 and 4.2 million senior adults ages 70- to 79 by the year 2040, based on information from CDA’s Master Plan for Aging. 

Recognizing that the state’s 65-plus population is projected to grow to 8.6 million by 2030, Gov. Gavin Newsom issued an executive order calling for the development of the MPA.

Debbie Toth, from ChoiceInAging, said the MPA is a model of “how we can do better” to service the needs of older adults. ChoiceInAging, Toth said, “is going to be shopping accessible transportation and rate increases for adult day healthcare.

“But we need to have legislation to do it,” Toth told legislative staff members.

A 2016 California Health Report (CHR) revealed that by 2030, 18% of the state will be 65 or older. Projections in that study also indicated that 52% of these older adults would be from diverse minority groups but “no population is expected to be harder hit than African Americans,” the report stated.

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California Black Media

Asm. Akilah Weber Introduces Bill to Protect Terminally Ill Californians

On Feb. 7, Assemblymember Akilah Weber (D-La Mesa) introduced legislation, Assembly Bill (AB) 2180, designed to ensure that terminally or chronically ill people living in California can afford their life-saving medications.
If passed, the law would require California health plan providers, insurers and pharmacy benefit managers (PBMs) to count the value of financial assistance provided by subsidy programs towards a terminally ill patient’s deductible and out-of-pocket expenses.

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Dr. Akilah Weber (File Photo)
Dr. Akilah Weber (File Photo)

By California Black Media

 On Feb. 7, Assemblymember Akilah Weber (D-La Mesa) introduced legislation, Assembly Bill (AB) 2180, designed to ensure that terminally or chronically ill people living in California can afford their life-saving medications.

If passed, the law would require California health plan providers, insurers and pharmacy benefit managers (PBMs) to count the value of financial assistance provided by subsidy programs towards a terminally ill patient’s deductible and out-of-pocket expenses.

“When insurers and PBMs do onto count the value of copay assistance toward cost-sharing requirements, patients often experience “a copay surprise” at the pharmacy counter and may be forced to walk away without their needed medication because they cannot afford it,” wrote Weber in a statement.

Over 80 patient advocacy organizations, medical foundations and other groups applauded Weber for introducing the legislation.

“The All Copays Count in California Coalition commends Dr. Weber for championing legislation that will improve patient access to medications and protect the most vulnerable Californians from harmful and deceptive insurance schemes that raise patient costs,” said Lynne Kinst, Executive Director of Hemophilia Council of California (HCC), which is a cosponsor of the bill.

According to the HCC, an estimated 70% of patients “abandon their prescription medications when their out-of-pocket costs reach $250 or more.

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Bay Area

Who Are the Top Donors in the Alameda County District 5 Supervisor’s Race?

District 5 covers West and North Oakland and includes Emeryville, Berkeley, Piedmont and Albany. The five-member Board of Supervisors sets the county’s budget, governs its unincorporated areas, oversees the sheriff, Alameda Health System, and the mental health system. Voting in this election has already begun. Most of those living in the district will have been mailed paper ballots. Residents can also vote in person on March 5, the last day voting is open. If no candidate gets more than half of the votes, the top two candidates will face off in the general election in November.

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A ballot drop box sits in West Oakland. Feb. 12. Photo by Zack Haber 
A ballot drop box sits in WesA ballot drop box sits in West Oakland. Feb. 12. Photo by Zack Haber t Oakland. Feb. 12. Photo by Zack Haber 

About $342,500, a little less than half of the approximately $705,000 raised in the race so far, has come from just 30 sources.

By Zack Haber

Nine candidates are running to represent District 5 on the Alameda County’s Board of Supervisors.

District 5 covers West and North Oakland and includes Emeryville, Berkeley, Piedmont and Albany.

The five-member Board of Supervisors sets the county’s budget, governs its unincorporated areas, oversees the sheriff, Alameda Health System, and the mental health system.

Voting in this election has already begun. Most of those living in the district will have been mailed paper ballots. Residents can also vote in person on March 5, the last day voting is open. If no candidate gets more than half of the votes, the top two candidates will face off in the general election in November.

Candidates in Alameda County are required to report all of their campaign donations. The public can search these filings through an online portal.

Looking through the county’s campaign finance reports, we found that residents, businesses and other organizations, such as unions, have donated around $705,000 in total to all candidates as of Feb. 13. In three cases, candidates donated to their own campaigns, but we excluded these figures.

Of the nine candidates, John Bauters, the former Emeryville Mayor and current City Councilmember, has raised the most, about $167,500. Alameda County Board of Education Trustee Ken Berrick has raised about $157,500. Piedmont resident and East Bay Rental Housing Association board member Chris Moore has raised about $129,000. Oakland City Councilmember Nikki Fortunato Bas has raised about $130,000; and Berkeley City Councilmember Ben Bartlett raised about $103,500.

The other candidates, Omar Farmer, Gregory Hodge, Gerald Pechenuk and Lorrel Plimier have all raised much less than the other candidates. So far, Hodge has raised about 11,500 and Plimier has raised about $5,500. Farmer and Pechenuk haven’t reported receiving any campaign donations.

While there were over 525 donations to candidates in total, of these, about $342,500 or a little less than half of the about $705,000 in total donations, came from just 30 sources. For the purposes of this article, we’ve defined these 30 donations as large donations—$5,000 or more. Bartlett, Bas, Bauters, Berrick, and Moore have received large donations, while Farmer, Hodge, Pechenuk and Plimier have not.

Below is a listing of each reported large donation, and information we could find about its source. We ordered the list in alphabetically by candidate name.

Large donations to Ben Bartlett:

Mukemmel ‘Mike’ Sarimsakci of Millbrae donated $10,000. Sarimsakci is a real estate developer and the CEO of Alterra Worldwide, a commercial real estate company. Man Hao Chen of San Francisco, CEO and founder of crop farming company Sunbber, inc., donated 5,000. Bao Le of Fremont, CEO of medical marijuana company Hemp.co, donated $5,000. Retired Berkeley resident Frank Brown donated $5,000.

Large donations to Nikki Fortunado Bas: 

Alameda Labor Council AFL-CIO Unitywhich represents about 135,000 healthcare, construction, service, education, and manufacturing workers, donated $20,000. Building and Construction Trades Council of Alameda County donated $20,000. Quinn Delaney of Piedmont, founder and the board chair of Akonadi Foundation, donated $20,000. Wayne Jordan of Piedmont, husband to Delaney, Akonadi Foundation board member, landlord and founder and president of Jordan Real Estate Investments, donated $20,000. California Working Families Party, a “grassroots party for the multiracial working class,” donated $10,000. Bas also received a $5,000 donation from the San Francisco crop farming company, Sunbber, inc. Man Hao Chen, who donated to Ben Bartlett’s campaign, is the CEO of Sunbber. IBEW Local 595, a union representing about 2,000 electric workers in Alameda and San Joaquin/Calaveras counties, donated $5,000. UA Local 342, a union representing around 4,000 workers in the pipe trades industries in Contra Costa and Alameda counties, donated $5,000.

Large donations to John Bauters:

Maryam Asefinejad of Orangevale, board member of Teranomic Software, donated $20,000. Fred J Bauters of Lisle, IL, relative of John Bauters, donated $20,000. The International Association of Firefighters Local 55 donated $11,000. State Assemblymember Buffy Wicks donated $10,000 from her reelection campaign. Nick Josefowitz of San Francisco, commissioner with the Metropolitan Transportation Commissionand co-founder of the nonprofit Permit Power, donated $10,000. Daniel Golden of Santa Monica, who works in sales at the pharmaceutical company Bausch Healthcare, donated $5,000. Marc Hedlund of Berkeley, founder of the investment company Tenuki Moves LLC and board treasurer of the nonprofits Bike East Bay and Code 2040, donated 5,000. The California YIMBY Victory Fund donated $5,000. Steven Berger of Berkeley, president of the company NYF Properties, inc. donated $5,000.

Large donations to Ken Berrick:

Megan Salazar of Richmond, director of advocacy for the Bay Area based nonprofit, Just Advocates which Ken Berrick founded, donated $13,520. Christopher Ciauri of London, England, CEO of the software company Unily, donated $17,500. Betsy Maushardt, unemployed resident of Santa Cruz, donated $10,500. Christopher Seiwald of Alameda, member of the University of San Francisco’s Board of Trustees and investor with the Berkeley Angel Network, donated 5,000.

Large donations to Chris Moore:

Quintin Anderson of Redwood City, Chief Operating Officer with Granite River Labs, donated $20,000. Madeline Moore, retired resident of Walnut Creek and relative of Chris Moore, donated $20,000.  Philip Dreyfuss of Oakland, partner with Farallon Capital Management, a San Francisco based hedge fund, donated $20,000.  Fred Morse of Piedmont, landlord with Morse Management, donated $15,000 through individual and company donations.

Justin Wallway of Oakland, landlord with JDW Enterprises, donated $10,000.

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