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Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia, and other serious risks, the Food and Drug Administration announced Monday. U.S. health officials said they will remove the boxed warning from more than 20 pills, patches, and creams containing hormones like estrogen and progestin, which are approved to ease disruptive symptoms like night sweats. The change has been supported by some doctorsincluding FDA Commissioner Marty Makary, who has called the current label outdated and unnecessary. But some doctors worried that the process, which led to the decision, was flawed. Health officials explained the move by pointing to studies suggesting hormone therapy has few risks when started before age 60 and within 10 years of menopause symptoms. Were challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts, Health Secretary Robert F. Kennedy Jr. said in introducing the update. The 22-year-old FDA warning advised doctors that hormone therapy increases the risk of blood clots, heart problems, and other health issues, citing data from an influential study published more than 20 years ago. Many doctorsand pharmaceutical companieshave called for removing or revising the label, which they say discourages prescriptions and scares off women who could benefit. Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, said the warnings have created a lot of hesitancy among patients. I can spend 30 minutes counseling someone about hormone-replacement therapytell them everythingbut when they fill the prescription and see that warning, they just get scared, Fleischman said. Other experts have opposed making changes to the label without a careful, transparent process. They say the FDA should have convened its independent advisers to publicly consider any revisions. Debate over the health benefits of hormone therapy continues Medical guidelines generally recommend the drugs for a limited duration in younger women going through menopause who dont have complicating risks, such as breast cancer. FDAs updated prescribing information mostly matches that approach. But Makary and some other doctors have suggested that hormone therapys benefits can go far beyond managing uncomfortable mid-life symptoms. Before becoming FDA commissioner, Makary dedicated a chapter of his most recent book to extolling the overall benefits of hormone therapy and criticizing doctors unwilling to prescribe it. On Monday, he reiterated that viewpoint, citing figures suggesting hormone-therapy reduces heart disease, Alzheimers, and other age-related conditions. With few exceptions, there may be no other medication in the modern era that can improve the health outcomes of women at a population level more than hormone replacement therapy,” Makary told reporters. The veracity of those benefits remains the subject of ongoing research and debate including among the experts whose work led to the original warning. Dr. JoAnn Manson of Harvard Medical School said the evidence for overall health benefits is not as conclusive or definitive as what Makary described. Still, removing the warning is a good step because it could lead to physicians and patients making more personalized decisions, she said. The black box is really one size fits all. It scares everyone away, Manson said. Without the black box warning, there may be more focus on the actual findings, how they differ by age and underlying health factors. Hormone therapy was once the norm for American women In the 1990s, more than 1 in 4 U.S. women took estrogen alone or in combination with progestin on the assumption thatin addition to treating menopauseit would reduce rates of heart disease, dementia, and other issues. But a landmark study of more than 26,000 women challenged that idea, linking two different types of hormone pills to higher rates of stroke, blood clots, breast cancer and other serious risks. After the initial findings were published in 2002, prescriptions plummeted among women of all age groups, including younger menopausal women. Since then, all estrogen drugs have carried the FDAs boxed warningthe most serious type. That study was misrepresented and created a fear machine that lingers to this day, Makary said. Continuing analysis has shown a more nuanced picture of the risks. A new analysis of the 2002 data published in September found that women in their 50s taking estrogen-based drugs faced no increased risk of heart problems, whereas women in their 70s did. The data was unclear for women in their 60s, and the authors advised caution. Additionally, many newer forms of the drugs have been introduced since the early 2000s, including vaginal creams and tablets that deliver lower hormone doses than pills, patches, and other drugs that circulate throughout the bloodstream. The original language contained in the boxed warning will still be available to prescribers, but it will appear lower down on the label. The drugs will retain a boxed warning that women who have not had a hysterectomy should receive a combination of estrogen-progestin due to risks of cancer in the lining of the uterus. FDA sidestepped its usual public process in reviewing warning Rather than convening one of FDA’s standing advisory committees on womens health or drug safety, Makary earlier this year invited a dozen doctors and researchers who overwhelmingly supported the health benefits of hormone-replacement drugs. Many of the panelists at the July meeting consult for drugmakers or prescribe the medications in their private practices. Two of the experts also spoke at Monday’s FDA news conference. Asked Monday why the FDA didn’t convene a formal advisory panel on the issue, Makary said such meetings are bureaucratic, long, often conflicted and very expensive. Diana Zuckerman of the nonprofit National Center for Health Research, which analyzes medical research, accused Makary of undermining the FDAs credibility by announcing the change rather than having scientists scrutinize the research at an FDA scientific meeting. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. Matthew Perrone, AP health writer
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The Senate was drawing closer to a vote on legislation to end the shutdown on Monday after a small group of Senate Democrats broke a 40-day stalemate late Sunday evening and voted with Republicans to move forward with reopening the government. It is unclear when the Senate will hold final votes on the bill, but Senate Majority Leader John Thune said he hopes passage will take hours, not days.” The American people have suffered for long enough. Lets not pointlessly drag this bill out, he said as the Senate opened on Monday morning. The legislation would still need to clear the House before the government could reopen. Speaker Mike Johnson urged lawmakers to start returning to Washington right now,” given travel delays, but he said he would issue an official notice for the House’s return once the Senate passes the legislation. We have to do this as quickly as possible,” Johnson said at a news conference. He has kept the House out of session since mid-September, when the House passed a bill to continue government funding. After weeks of negotiations, the moderate Senate Democrats agreed to reopen the government without a guaranteed extension of healthcare subsidies, angering many in their caucus who have demanded that Republicans negotiate with them on the Affordable Care Act tax credits that expire January 1. Thune (R-SD) promised a mid-December vote on the subsidies, but there was no guarantee of success. The final vote was 60-40. Senate Democratic Leader Chuck Schumer of New York voted against moving ahead with the package, along with all but eight of his Democratic colleagues. We will not give up the fight, Schumer said, adding that Democrats have now sounded the alarm on healthcare. Still, an end to the shutdown could still be days away if any senators object and drag out the process. Thune was still working out concerns within his Republican conference about individual provisions in the underlying spending bills. One of those Republicans, Kentucky Sen. Rand Paul, had threatened to object to a provision championed by his home state colleague, former GOP leader Sen. Mitch McConnell, to prevent the sale of some hemp-based products. Paul said he was seeking an amendment to strip the language before a final vote. President Donald Trump has not said whether he will sign the package, but told reporters at the White House Sunday evening that it looks like were getting close to the shutdown ending. 5 Democrats switch votes A group of three former governorsNew Hampshire Sen. Jeanne Shaheen, New Hampshire Sen. Maggie Hassan, and Independent Sen. Angus King of Mainebroke the six-week stalemate on Sunday when they agreed to vote to advance three bipartisan annual spending bills and extend the rest of government funding until late January. The legislation includes a reversal of the mass firings of federal workers by the Trump administration since the shutdown began on October 1. It also protects federal workers against further layoffs through January and guarantees they are paid once the shutdown is over. In addition to Shaheen, King, and Hassan, Democratic Sen. Tim Kaine of Virginia, home to tens of thousands of federal workers, also voted in favor of moving forward on the agreement. Illinois Sen. Dick Durbin, the No. 2 Democrat, Pennsylvania Sen. John Fetterman, and Nevada Sens. Catherine Cortez Masto and Jacky Rosen also voted yes. The moderates had expected a larger number of Democrats to vote with them, as 10 to 12 Democratic senators had been part of the negotiations. But in the end, only five switched their votesthe exact number that Republicans needed. King, Cortez Masto, and Fetterman had already been voting to open the government since October 1. The agreement includes bipartisan bills worked out by the Senate Appropriations Committee to fund parts of the governmentfood aid, veterans programs, and the legislative branch, among other things. Democrats call the vote a mistake Schumer, who received blowback from his party in March when he voted to keep the government open, said he could not in good faith support it after meeting with his caucus for more than two hours on Sunday. Independent Sen. Bernie Sanders of Vermont, who caucuses with the Democrats, said giving up the fight was a horrific mistake. Sen. Chris Murphy (D-CT) agreed, saying that voters who overwhelmingly supported Democrats in last week’s elections were urging them to “hold firm. House Democrats swiftly criticized the Senate. Texas Rep. Greg Casar, the chairman of the Congressional Progressive Caucus, said a deal that doesnt reduce healthcare costs is a betrayal of millions of Americans who are counting on Democrats to fight. Others gave Schumer a nod of support. House Democratic Leader Hakeem Jeffries had criticized Schumer in March after his vote to keep the government open. But he praised the Senate Democratic leader on Monday and expressed support for his leadership throughout the shutdown. The American people know we are on the right side of this fight, Jeffries said Monday, pointing to Tuesday’s election results. Healthcare debate ahead Its unclear whether the two parties would be able to find any common ground on the healthcare subsidies before a promised December vote in the Senate. House Speaker Mike Johnson (R-LA) has said he will not commit to bringing it up in his chamber. On Monday, Johnson said House Republicans have always been open to voting to reform what he called the unaffordable care act, but again did not say if they would vote on the subsidies. Some Republicans have said they are open to extending the COVID-19-era tax credits as premiums could skyrocket for millions of people, but they also want new limits on who can receive the subsidies and argue that the tax dollars for the plans should be routed through individuals. Other Republicans, including Trump, have used the debate to renew their yearslong criticism of the law and called for it to be scrapped or overhauled. By Mary Clare Jalonick and Lisa Mascaro, Associated Press Associated Press writers Seung Min Kim, Michelle Price, Stephen Groves, and Kevin Freking contributed to this report.
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Recently, New York Times opinion columnist Ross Douthat moderated a debate on the Interesting Times podcast between Helen Andrews and Leah Libresco Sargeant, two conservative critics of modern feminism. The podcast received major blowback, starting with (but not ending with) the fact that the original headline of the conversation was “Did Women Ruin the Workplace?” Quickly, after the predictable backlash hit, the headline was changed to “Did Liberal Feminism Ruin the Workplace?” But the diversion didn’t help the conversation’s case all that much. While the headline was softened to perhaps dress up the discussion as an urgent political issue, mostly, it felt like intellectualized sexisma debate about women’s rightswhen the real question should be, wait, why are they up for debate anyway? If you could make it through the whole podcast, good on you. In truth, the question “Did women ruin the workplace?” felt like it was just waiting for Dolly Parton, Lily Tomlin, and Jane Fonda to burst through the office door and tie it to its desk chair. All About “Wokeness” Mainly, the debate revolved around wokeness. It started with Andrews, who recently wrote an article called The Great Feminization that criticizes women as being emotional and lacking logic, started talking about “wokeness” at work, and suggested that women are to blame for its presence in the office, noting that “the pathology in our institutions known as wokeness is distinctively feminine and feminized.” Andrews continued: “And that, in a very literal sense, our institutions have gone woke because there are more women in them than there used to be.” She also went on to talk about the uptick in sex scandals being reported, and how backward she finds it that we’re “suddenly” expected to “believe all women” regardless of how credible many of them can surely not be. The very boys club argument seemed to suggest that women in the workplace are complaining about innocent flirtations or, men just being men. For Andrews, the platform felt like a continuation of her article. She also talked about female toxicity, which she explained means things like gossiping, being unable to “deal with conflict directly,” and a host of other dated stereotypes she claimed are female traits. Sargeant pushed back on Andrews’ rhetoric several times, but she had her own troubling views about women in the workplace, too. Her take seemed to be more about the idea that no one should really expect total fulfillment at work, and if that’s the case, then women really shouldn’t bring their “woke feminism” ideas to work in the first place. “I think we make a mistake in seeing the workplace as the primary space we work out our cultural foibles,” Sergeant explained. Predictable Outrage The podcast did genuinely feel like it was better suited for an era when objectifying women at work was totally cool, a lack of DEI (another topic the guests railed into), and policies protecting women simply didn’t exist rather than an era where many are pushing to obliterate women’s rights in the office (and everywhere). Of course, like the overt sexism in even posing the question “Did Women Ruin the Workplace?”, the response has been just as direct. Almost instantly, the response pieces started circulating, critiquing, not just the host of the podcast, or its guest, but NYT for running such a clearly anti-woman article, which asked whether women ruined the workplace with all of their incessant needs, like to be viewed as equal human beings and all. In a Vanity Fair response piece, journalist Kenneal Patterson pressed that such a question is ludicrous in today’s world, and showcases fear around “the encroachment of liberal feminism in the workplace.” Patterson suggests that women are essentially being coerced into standards of womanhood dictated “by the patriarchy.” Patterson continued, “Women are losing the rights to their bodies, dignities, and beliefs every day. Starting an article with the headline Did Liberal Feminism Ruin the Workplace? does nothing more than appeal to those who try to keep lower-income women oppressed and drive young people into a tradwife future that keeps them caged.” On X, the podcast is being slammed, too. In a reshare of the article, X user and author Jess Davies wrote, “Dunno, I think the men who created hostile working environments through sexual harassment, sexist behaviours, unfair promotions and being inconsiderate of basic needs like maternity, childcare and womens health ruined the workplace.”Davies added, “But sure, its womens fault for speaking up.” Who did women ruin the workplace for? Surely, there may be a ton of people who do believe that women have ruined the workplace simply by being in them and demanding to be respected and treated fairly. So, a better question, perhaps, would be, who did they ruin it for? Surely, not their employers because in many regards, women are killing it at work. While glaring pay gaps still exist, women are outpacing men in terms of education, they hold an ever-rising share of high paying occupations, and, according to recent findings, are often held to higher standards than men in CEO roles, too. And while the tradwife trope may be preferred by men and certain groups of women, most modern women want to work. In fact, labor force participation has been rising for young women at the same time it is falling for young men. Women surely may have complicated the workplace for those who are worried about women getting ahead, who fear diversity, or who don’t want the boys club to change. As far as ruining it goes, were still waiting for the case to be made.
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