FDA OKs libido-boosting pill for women who have gone through menopause

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By MATTHEW PERRONE, Associated Press

WASHINGTON (AP) — U.S. health officials have expanded approval of a much-debated drug aimed at boosting female libido, saying the once-a-day pill can now be taken by women older than 65.

The announcement Monday from the Food and Drug Administration broadens the drug’s use to older women who have gone through menopause. The pill, Addyi, was first approved 10 years ago for premenopausal women who report emotional stress due to low sex drive.

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Addyi, marketed by Sprout Pharmaceuticals, was initially expected to become a blockbuster drug, filling an important niche in women’s health. But the drug came with unpleasant side effects including dizziness and nausea, and it carries a safety warning about the dangers of combining it with alcohol. The boxed warning, FDA’s most serious type, cautions that drinking while taking the pill can cause dangerously low blood pressure and fainting.

Sales of Addyi, which acts on brain chemicals that affect mood and appetite, have been limited. In 2019, the FDA approved a second drug for low female libido, an on-demand injection that acts on a different set of neurological chemicals.

Sprout CEO Cindy Eckert said in a statement the approval “reflects a decade of persistent work with the FDA to fundamentally change how women’s sexual health is understood and prioritized.” The company, based in Raleigh, North Carolina, announced the FDA update in a press release Monday.

The medical condition for a troublingly low sexual appetite, called hypoactive sexual desire disorder, has been recognized since the 1990s and is thought to affect a significant portion of American women, according to surveys. After the blockbuster success of Viagra for men in the 1990s, drugmakers began pouring money into research and potential therapies for sexual dysfunction in women.

But diagnosing the condition is complicated because of how many factors can affect libido, especially after menopause, when falling hormone levels trigger a number of biological changes and medical symptoms. Doctors are supposed to rule out a number of other issues, including relationship problems, medical conditions, depression and other mental disorders, before prescribing medication.

The diagnosis is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem.

The FDA rejected Addyi twice prior to its 2015 approval, citing the drug’s modest effectiveness and worrisome side effects. The approval came after a lobbying campaign by the company and its supporters, Even the Score, which framed the lack of options for female libido as a women’s rights issue.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

Larry Jacobs: For Kaohly Her’s first 100 days as St. Paul mayor, action and clear ambition

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The inauguration of Kaohly Vang Her as mayor of St. Paul is a moment of transformation. She is the first Hmong woman elected mayor of a major American city, a powerful testament for a community that only two generations ago arrived in Minnesota as refugees. That’s not all. Her’s defeat of an incumbent widely expected to win — and by a large margin — demonstrated that voters want to upend the city’s political establishment and its clubby back-patting and favor-trading habits.

The mayor-elect enters office at a time of crisis in Minnesota’s Capitol City. The departure of businesses and residents swelled the commercial vacancy rate downtown to among the highest in the region and well above pre-pandemic levels, reflecting a slower recovery than many peer cities.  On key indicators of downtown vitality — commercial occupancy, business activity, and tax-base stability — St. Paul has consistently lagged behind comparable mid-sized U.S. cities.  All of St. Paul is bearing the cost: as the number of downtown businesses has plummeted, pressure has shifted onto homeowners through higher property taxes.

Only a bold and ambitious launch by Mayor Her on her first days in office can create the momentum to revitalize St. Paul.

Here’s a big bang: Announce a four-year campaign to raise $400 million in public and private funds to finance downtown revitalization. The declaration will itself light up the sky and inject energy and interest into Mayor Her’s administration. The funds will, in turn, equip the mayor to incentivize the formation of partnerships and to coax change from the usual St. Paul standpatters who prefer the status quo or expect deals to secure their support.

Sound pie-in-the-sky? Not for Kaohly Her, whose 15-year career prior to public service was as a successful businesswoman in the investment and finance sector. The mayor’s unique skills can empower St. Paul to pursue what was previously unimaginable and unmistakably demonstrate Mayor Her’s ability to revitalize St. Paul.

Next up: Mayor Her needs to declare an audacious agenda for her first 100 days to stop the slide in St. Paul and launch a new era of vitality, responsiveness and economic optimism.

Here are three catalysts for change.

Open for business

Small business owners, builders, and homeowners are steamed up by the cumbersome and time-consuming process of receiving permits from the city. St. Paul’s laborious slog adds to the costs of building and chases away businesses. When businesses don’t leave the state, they may prefer Woodbury, Eagan and Roseville, which move much faster and with less hassle. Minneapolis has built a larger and more advanced permitting process, making it more “business friendly” in the eyes of property owners and developers.

Mayor Her can create a faster, simpler process in her first 100 days if she makes it a priority. She doesn’t need massive new spending or sweeping legislation to get started. On her first day, the new mayor can issue an executive order that declares a new expectation of 30-day approval for standard permits, a one-stop permit office to cut through the red tape, a new requirement that all relevant departments review applications simultaneously to avoid infuriating run-arounds, and a new Chief Permit Officer who answers directly to the mayor for meeting the new deadlines and achieving simplicity.

Sound impossible? Apparently it isn’t. Cities around the country have turned around their laborious permitting systems. St. Paul can too.

Economic vitality will follow. Private developers in St. Paul, including the Ryan Companies and Schafer Richardson, along with housing nonprofits such as Aeon and CommonBond are eager to build, rehab, and reinvest. But they need a city that keeps up. Reliable 30-day approvals would jump-start stalled housing projects, accelerate storefront reopenings and return responsiveness to City Hall.

‘Safe, clean, open’ downtown

Large sections of downtown are empty, uncared for, and unsafe. Walking along Wabasha or through the skyways is unsettling. Nothing threatens St. Paul’s future more. Disgust with the city reached the point that residents have taken matters into their own hands by creating “Downtown Improvement Districts” and paying out of pocket for safety services, sidewalk cleaning and the removal of graffiti.

The experiences of the Downtown Improvement Districts along with planning by the Saint Paul Downtown Alliance hand Mayor Her a playbook for quick, visible and practical actions to reclaim downtown in her first 100 days. New lights to illuminate once dark corridors and skyways, removal of foul graffiti and the deployment of welcome ambassadors are starting points. Storefronts that sit vacant and currently generate no revenue can be converted into short-term, rent-free sites for pop-up art and restaurant operations that bring people downtown and begin to make downtown feel alive again.

Milwaukee and Detroit started to reverse their declines by making “safe, clean, and open” their new welcome mat. When streets feel lively and well-lit, crime drops. When storefronts look active, businesses return. When downtown appears cared for, residents regain trust.

Fast-tracking 3 prime targets for office-to-housing conversions

It is time for City Hall to accept the reality that the 2019 market for office space is gone – and move on. The public-private tag team of the St. Paul Downtown Alliance and the Saint Paul Downtown Development Corporation have identified three prime candidates for converting former office space into new housing: the Landmark Towers, U.S. Bank Center, and the Lowertown property on 180 East Fifth. Starting these conversions, which have empty space and flexible designs, will inject economic vitality and begin the process of bringing residents and businesses back along with downtown’s tax base.

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Mayor Her can be a catalyst for change at the beginning of her term by targeting these three prime properties for conversion, expediting the approval of early-stage plans, and encouraging developers and property owners to reach agreement.

Of course, office building conversions will require more than 100 days but the mayor can deliver visible momentum: interior demolitions, new building permits, and the erecting of inconvenient — but heartening — fencing for redevelopment.

St. Paul’s challenge isn’t simply coming up with plans. Those exist. What has been missing is energetic and resourceful leadership that makes downtown redevelopment a top priority. Transforming St. Paul’s lackadaisical permit process, cleaning up downtown and starting to convert offices to housing are realistically achievable within Mayor Her’s first 100 days. The mayor can reform the permit process by using her own authority, kick-start the clean-up by broadening the scope of the Downtown Improvement Districts and teeing up housing conversions for action.

These aren’t grand promises for someday — they’re practical steps Mayor Her can take on her first day.  Results will start to appear quickly.

Larry Jacobs, St. Paul, is director of the Center for the Study of Politics and Governance at the University of Minnesota.

 

Sabres fire general manager Kevyn Adams and promote Jarmo Kekalainen to replace him

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By JOHN WAWROW

BUFFALO, N.Y. (AP) — The Buffalo Sabres fired general manager Kevyn Adams on Monday in a move made 2 1/2 months into his sixth season, with the team sitting at the bottom of the Eastern Conference standings and already in jeopardy of extending its NHL-record playoff drought to a 15th year.

The decision was made by team owner Terry Pegula and announced in a press release.

Adams’ replacement was already with the team in Jarmo Kekalainen. The former Columbus Blue Jackets GM was hired by Adams in June to serve as a senior adviser. The 59-year-old Kekalainen is from Finland and was the NHL’s first European-born GM in spending 11 years in Columbus before being fired in February 2024.

“We are not where we need to be as an organization, and we are moving forward with new leadership within our hockey operations department,” Pegula said. “We are dedicated to building an organization that is competitive year after year, and we have fallen short of that expectation.”

The decision to fire Adams comes despite the Sabres enjoying their first three-game winning streak of the season, following a 3-1 victory at Seattle on Sunday night. Buffalo returned home after splitting a six-game road trip and is now off until hosting the Philadelphia Flyers on Thursday.

Adams has been criticized for mismanaging the team’s assets, inability to secure a franchise goalie, and failure to address a leadership void that continues to linger on a team that’s finished last in the overall standings four times and no better than 19th during its playoff drought.

Under Kekalainen, the Blue Jackets reached the playoffs five times and set a franchise record with 50 wins and 108 points in 2016-17. He previously held executive roles with the St. Louis Blues and Ottawa Senators. Kekalainen also spent three years as general manager of Jokerit in Finland’s top professional league and worked with the Finnish national team program.

“It is a great honor to be named general manager of the Buffalo Sabres,” said Kekalainen. “I am humbled to be the steward of this team and look forward to experiencing the passion that Sabres fans bring to every game.”

Kekalainen’s promotion comes a day after his father, Kari, died after a lengthy illness at the age of 82. Kekalainen posted a message on his Instagram account, referring to his father as his coach and idol, translated from his native Finnish.

Adams’ missteps also include second-guessing himself for failing to make a roster move to help spark the team during an 0-10-3 skid last season that essentially knocked the Sabres out of contention before Christmas.

Adams entered this season on the hottest of NHL seats and with reportedly two years left on his contract.

He long ago fell out of favor with Sabres fans, who began chanting “Fire Adams” so often the team elected to not introduce the GM as traditionally happens during Buffalo’s season opener in October. Last year, fans brought blow-up palm trees to games in response after Adams lamented the difficulty he had attracting talent to Buffalo because the city has high taxes and no palm trees.

Adams took over in June 2020 and following a last-place finish launched a major rebuilding plan that led to the team trading its top players — highlighted by the deals that sent Jack Eichel to Vegas and Sam Reinhart to Florida. After showing signs of development, and Adams proclaiming the Sabres competitive window opening, the Sabres have instead regressed over the past two seasons.

Buffalo went from finishing with 91 points and one win from ending its playoff drought in 2022-23 to 84 points the next season and 79 last year.

This season, the Sabres (14-14-4) are are once again struggling with consistency in the first half of their second season under coach Lindy Ruff, who is back for a second stint in Buffalo. The Sabres have spent much of the season hovering at .500, have been competitive at home (9-5-2) but have struggled on the road with two of their five wins coming in regulation.

This wasn’t the plan Adams laid out in closing last season by saying everything was on the table to turn the Sabres into competitors.

He opened this season with: “We need to win. And I’m fully aware of that.”

Adams, with input from Ruff, spent the summer adding grit at the expense of offense by trading two-time 20-goal-scorer JJ Peterka to Utah to acquire forward Josh Doan and hulking defenseman Michael Kesselring. The deal has had middling results. While Doan ranks second on the team with 10 goals and third with 23 points, Kesselring has been limited to playing just nine games due to injuries.

Another trade that has yet to pan out involved Buffalo and Ottawa swapping top-line centers, with the Sabres acquiring talented but injury prone Josh Norris for Dylan Cozens in March. Norris appeared in just three games before aggravating an oblique injury last year, and is limited to just six games this season.

Adams has mismanaged Buffalo’s goaltending position, starting with losing Linus Ullmark to free agency in the summer of 2021 after saying he was assured by the goalie he’d re-sign with the team in March. The Sabres have had 11 goalies start at least one game since.

The Sabres are now on their fifth GM since Darcy Regier was fired a month into the 2013-14 season.

Adams is from Buffalo, and a former NHL forward, who won a Stanley Cup title in 2006 with Carolina over his 10-season career.

He had no front-office experience and held a business role with the Sabres when replacing Jason Botterill in June 2020. Botterill’s firing was deemed a cost-cutting move, with Adams purging much of the team’s hockey infrastructure as the NHL dealt with the uncertainty of the COVID pandemic.

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AP NHL: https://apnews.com/hub/nhl

Man who tried to assassinate Trump on golf course requests attorney for sentencing

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By MIKE SCHNEIDER

ORLANDO, Fla. (AP) — A man convicted of trying to assassinate President Donald Trump on a Florida golf course last year has decided to use an attorney during the sentencing phase instead of representing himself as he did for most of the trial.

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The sentencing hearing for Ryan Routh in Fort Pierce, Florida, was pushed back from this week to early February after he requested and was granted an attorney to represent him during the sentencing and appeal phases of the trial.

The federal courtroom erupted into chaos in September shortly after jurors found Routh guilty on all counts, including attempting to kill a presidential candidate and several firearm-related charges. Routh tried to stab himself in the neck with a pen, and officers quickly dragged him out. The pen Routh used was flexible to prevent people in custody from using it as a weapon.

Prosecutors said Routh, 59, spent weeks plotting to kill Trump before aiming a rifle through shrubbery as the then-Republican presidential candidate played golf on Sept. 15, 2024, at his West Palm Beach country club.

At Routh’s trial, a Secret Service agent helping protect Trump on the golf course testified that he spotted Routh before Trump came into view. Routh aimed his rifle at the agent, who opened fire, causing Routh to drop his weapon and run away without firing a shot.

In the motion requesting an attorney, Routh offered to trade his life in a prisoner swap with inmates unjustly held in other countries and said an offer still stood for Trump to “take out his frustrations on my face.”

“Just a quarter of an inch further back and we all would not have to deal with all of this mess forwards, but I always fail at everything (par for the course),” Routh wrote.

In her decision granting Routh an attorney, U. S. District Judge Aileen Cannon chastised the “disrespectful charade” of Routh’s motion, saying it made a mockery of the proceedings. But the judge, nominated by Trump in 2020, said she wanted to err on the side of legal representation.

Cannon signed off on Routh’s request to represent himself following two hearings in July. The U.S. Supreme Court has held that criminal defendants have the right to represent themselves in court proceedings, as long as they can show a judge they are competent to waive their right to be defended by an attorney.

Routh’s former defense attorneys served as standby counsel and were present during the trial.