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In an interview with the Washington Post, FDA Commissioner Scott Gottlieb said that the agency is proposing a ban on menthol cigarettes citing youth and minority smoking rates. According to the New York Times, a ban on menthol cigarettes could take several years to execute. It is a move that other nations have made. Canada has already implemented such a ban, and the European Union's menthol ban goes into effect in 2020. According to the FDA, menthol may reduce the irritation and harshness of smoking. According to FDA statistics, more than half of youth smokers smoke menthols. Also, a disproportionate number of minorities smoke menthols. Studies have also suggested that using menthol makes it more difficult to quit smoking, the FDA says. There have been groups, such as the African American Tobacco Control Leadership Council, that have pushed the federal government to ban menthol cigarettes. The council's co-chair, Phillip Gardiner, told the Washington Post, "I’m sorry it has taken the FDA so long to come around but I’m glad they finally are. They should have done it 10 years ago and saved hundreds of thousands of lives."According to FDA figures, more than 19 million Americans smoke menthols.  1273

In a typical year, you might expect to see holiday decor start to crowd out the Halloween candy around mid-October. But in 2020, the holiday shopping season has felt like it started even earlier due to the changes brought about by the pandemic.Social distancing concerns have forced retailers to rethink their promotional plans, and Amazon’s rescheduled Prime Day in mid-October kicked off the seasonal incentives to shop early and often.So far it seems to have worked: Plenty of people have gotten a head start on their holiday shopping this year. Forty-two percent of holiday shoppers said they started earlier this year than they normally do, according to a November survey from the National Retail Federation and Prosper Insights & Analytics.The survey also found that 59% of holiday shoppers had already started making purchases well ahead of Black Friday. Compare that to 10 years ago, when only 38% of respondents had already gotten a running start in early November.As the holiday stretches out into a multi-month marathon, will Black Friday matter this year? Well, sort of. The holiday isn’t going anywhere—and stores won’t let you forget about it. But it’s going to look a lot different in 2020.1. Black Friday Won’t Start on Thanksgiving DayIn recent years, retailers were kicking off Black Friday by starting in-store sales nearly 24 hours early: on Thanksgiving Day itself. But pandemic concerns may have put an abrupt end to this trend.Major retailers like Kohl’s, Dick’s Sporting Goods, and Target announced as early as July that they would break their traditions of opening stores early for Black Friday and simply stay closed on Thanksgiving Day.“Let’s face it: Historically, deal hunting and holiday shopping can mean crowded events, and this isn’t a year for crowds,” Target said in a blog post outlining its holiday plans.Walmart will also be closed on Thanksgiving Day, opting instead to keep regular Wednesday hours, then reopen at 5 a.m. on Friday. It’s the first time the retail giant has opted against Thanksgiving Day hours since the 1980s.Experts say people will still shop on Thanksgiving, but will do so online. “After the pumpkin pie, they’ll go to the couch with their computer and that’s where they’ll start their Black Friday shopping,” said Rod Sides, vice chairman and U.S. leader of retail and distribution at Deloitte.Although stores may keep their locations closed or limit their hours on Thanksgiving, their websites are always open, meaning a company can still pull in revenue that day without incurring the cost of staffing stores. Retailers have seen a huge increase in online sales, after years of declining foot traffic in stores, so cutting Thanksgiving Day hours is unlikely to be a huge stretch even without coronavirus concerns.“The pandemic has made that choice [to close] a lot easier,” said Seth Basham, a retail analyst at Wedbush Securities.2. Some Retailers Are Rejecting Black FridayFor some retailers, going against the Black Friday grain is a big part of company culture.Outdoor retailer REI will be closed on Black Friday for the sixth year in a row in 2020. The co-op’s “Opt Outside” campaign closes its stores, distribution centers and call centers on Black Friday in an effort to encourage people to spend the day outside with family and friends instead of shopping.But while REI was once the outlier, it may have some company this year. Ecommerce footwear brand Allbirds will actually raise prices on Black Friday, increasing the price for every item on its website by with the spare buck going toward organizations mitigating climate change.Even stores you might not immediately think of for Black Friday savings are changing things up this year. California grocery store chain Gelson’s announced it will have reduced hours on Thanksgiving, then be closed all day on Nov. 27 to acknowledge employees’ response to the pandemic.3. Doorbusters Are DoneForget waking up at 4 a.m. to be first in line for a great deal on Black Friday. The doorbuster deal, which offers a low price for a period of just a few hours, is a thing of the past.“There will be less emphasis on doorbuster-type offers this year, because social distancing makes it harder to queue up,” said Sides. There will still be limited-time or limited-quantity offers for some sale items, but Sides expects fewer people will feel compelled to line up to access deals. Deloitte’s research shows that people are planning to start shopping later in the day if they venture out on Black Friday.Instead, retailers are encouraging people to shop during far wider discounting windows. Macy’s, for example, is promoting “All-day specials” on Black Friday, while Best Buy’s newspaper ad for Black Friday sales notes which prices are available starting on Sunday, Nov. 22, Thanksgiving Day (online) or Nov. 28.4. Deals Are Everywhere, All The TimeWhy wait for Black Friday to shop when there’s a sale around every corner?By November 10—just 10 days into what Adobe considers the start of the holiday season, .7 billion had been spent online—21% higher than the same period in 2019.Retailers of all sizes have rethought how they will present holiday discounts this year. Walmart, for one, is breaking its usual Black Friday deals into “Black Friday Deals for Days,” rolling out sale prices at regular intervals during the entire month of November rather than wait until Nov. 27. On days when stores open early to offer in-store savings, customers will need to wait in a socially-distanced line and employees will limit the number of people who can enter.But before the pandemic, holiday shopping was already spreading out over the long Thanksgiving weekend instead of being concentrated on Black Friday. Now, the holiday shopping season has given rise to Small Business Saturday for supporting local shops and Cyber Monday for online shopping, plus big days like Green Monday (the second Monday of December), Free Shipping Day (usually around December 15) and Super Saturday (the last Saturday before Christmas).If every day is a shopping holiday, the need to cram all your shopping into Black Friday feels unnecessary.Read more: How To Budget For Holiday Shopping When The Season Is Now Twice As LongThe Name Will Remain, Even if Black Friday’s Luster FadesIt’s not impossible for Black Friday to have a post-pandemic rebound, Sides said, but the impact of the day has already waned.“We all like the hustle and bustle a little bit, but folks have figured out they don’t need additional stress” during the holidays, Sides said. There are just as many sales taking place online as there are in stores, and not everyone who goes to their local store is actually shopping on the spot—many will choose to buy online, pick up in-store or via curbside.Basham predicted that we won’t see as much of a peak in revenue during the five-day period over Thanksgiving weekend—even for online purchases. This has already been evident with other holidays in this pandemic-adjusted year: Labor Day purchases usually concentrated into a week or less were spread out over a three-week period, Basham said. By giving shoppers a longer period of time to snag a deal, it helps retailers manage demand around those high-excitement times.And that excitement will still drive consumers. “They want a call to action,” Basham said. While the right price may be the thing that convinces a shopper to make the purchase at that moment, they still need cues on the calendar to know when to start looking for those discounts. 7523

How accurate are the coronavirus tests used in the U.S.?Months into the outbreak, no one really knows how well many of the screening tests work, and experts at top medical centers say it is time to do the studies to find out.When the new virus began spreading, the Food and Drug Administration used its emergency powers to OK scores of quickly devised tests, based mainly on a small number of lab studies showing they could successfully detect the virus.That’s very different from the large patient studies that can take weeks or months, which experts say are needed to provide a true sense of testing accuracy.The FDA’s speedy response came after it was initially criticized for delaying the launch of new tests during a crisis and after the Centers for Disease Control and Prevention stumbled in getting its own test out to states.But with the U.S. outbreak nearly certain to stretch on for months or even years, some experts want the FDA to demand better evidence of the tests’ accuracy so doctors know how many infections might be missed.There have been more than 2 million confirmed coronavirus cases in the U.S. and more than 115,000 deaths, according to data compiled by Johns Hopkins University. Cases in nearly half of U.S. states are rising.In recent weeks, preliminary findings have flagged potential problems with some COVID-19 tests, including one used daily at the White House. Faulty tests could leave many thousands of Americans with the incorrect assumption that they are virus-free, contributing to new flare-ups of the disease as communities reopen.“In the beginning, the FDA was under a lot of pressure to get these tests onto the marketplace,” said Dr. Steven Woloshin of Dartmouth College, who wrote about the issue in the New England Journal of Medicine last week. “But now that there are plenty of tests out there, it’s time for them to raise the bar.”The FDA said in a statement that it has already asked multiple test makers to do follow-up accuracy studies, although it didn’t say for how many of the more than 110 authorized screening tests. The agency also said it is tracking reports of problems. Accuracy has also been an issue with blood tests that look for signs of past infections.No screening test is 100% accurate. So details on accuracy are routinely provided for tests of all types, including seasonal flu, hepatitis, HIV and cancers. For example, rapid flu tests are known to miss 20% or more of all cases, a factor doctors weigh when treating patients who have symptoms but test negative.For now, most COVID-19 tests in the U.S. don’t give data on real-world performance, including how often the tests falsely clear patients of infection or falsely detect the virus. That information is lacking for all but a few of the roughly 80 commercial screening tests available, according to an Associated Press review.The government’s emergency authorization process “requires a lower level of evidence,” the agency said. Makers need only show that a test “may be effective” instead of the usual requirement to demonstrate “safety and effectiveness.” They would have to meet that higher threshold once the U.S. government declares the emergency over.Many of the commercial test makers submitted results from 60 samples, the minimum number required and mostly used lab-produced specimens of the virus. The FDA now recommends the use of nasal swabs or other real samples from people screened for coronavirus.Experts say larger patient studies patients are needed to assess a test’s true performance.Lab testing bears little resemblance to actual — sometimes imperfect — conditions at hospitals, clinics and testing sites noted Dr. Robert Kaplan of Stanford University.“You’re testing people in parking lots, the patients themselves are extremely anxious and often unable to follow instructions,” said Kaplan, a former associate director of the National Institutes of Health.Kaplan and others say those differences could explain why some tests are not performing as expected.Last month, the FDA warned doctors of a potential accuracy problem with Abbott Laboratories’ rapid ID Now test, which delivers results in roughly 15 minutes. The test has been lauded by President Donald Trump and used to screen the president, his staff and visitors to the White House.The FDA alert followed a preliminary report by New York University that found Abbott’s test missed between a third to one-half of infections caught by a rival test in patients screened for the virus.Abbott rejected the findings, saying the researchers did not follow the instructions for using its test. The company pointed to alternate patient studies, including its own, that have found the test successfully detects between 91% and 95% or more of virus cases when compared to other tests.But similar problems with ID NOW’s accuracy have been flagged in preliminary reports by researchers at Stanford University, Loyola University and the Cleveland Clinic.For now, the FDA is requiring Abbott to conduct follow-up studies in several different patient groups.The FDA’s emergency standards “are still high but there is a significant difference in the body of work that what would go into a submission under the normal process,” said Abbott vice president John Hackett. “Our normal process takes years to bring these out.”Requiring bigger studies of all coronavirus tests could provide valuable information, but it could also strain the FDA’s already stretched staff and resources, said Dr. Daniel Schultz, former director of the FDA’s medical device center.Dr. Colin West of the Mayo Clinic worries doctors and patients have put too much confidence in the current crop of tests, when an unknown number of patients with COVID-19 are likely receiving false negative results.Even a modest error rate can have grave consequences during an outbreak like COVID-19. West gives the example of a test that is 95% accurate at detecting the virus and is used on 1 million people. That would still result in 50,000 people being incorrectly told that they don’t have the virus.“The negative test does not mean that I’m off the hook,” West said. “We just need to maintain that level of vigilance until we have a better sense of how good these tests really can be.”___Follow Matthew Perrone on Twitter: @AP_FDAwriter.___Follow AP pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 6604

In a news conference Wednesday afternoon, officials released new information about the seventh-grade student who shot himself at Jackson Memorial Medical School near Akron, Ohio.The shooting 203

In 2016, President Obama used the Affordable Care Act to extend federal sex discrimination protections to people who identify as transgender.But after a recent move by the Trump administration, some of those protections are now gone.“What happened with the recent Trump administration ruling is that they basically said they were taking out that definition of sex discrimination and stated that it only applied to a person’s birth sex and couldn’t be applied to their gender identity and that they were no longer going to enforce any protections on the basis of gender identity," said Dr. Eliabeth Kvach. “I think there’s something to be said, to think about what it’s like to be a person where the government says you don’t deserve to get accessible health care,” said Andrew MillerKvach and Miller both work at Denver Health in Colorado. Both call the recent rule change in DC a direct threat to the lives of transgender men and women.“We have for example, 300 patients on our list to be able to receive vaginoplasty or gender confirming surgery for transgender women. And if you’re waiting years to get that surgery and then all of a sudden you’re worried about whether your insurance is going to cover it, that is enormously psychologically devastating to people,” said Kvach.“I think that we’re already seeing that with cases coming out of hospitals denying care to transgender and non-binary folks," said Miller.“I certainly think that it is dangerous to the lives of transgender and non-binary people,” said Kvach.Denver Health is a LGBTQ+ Center of Excellence. For the health system it means any patient regardless of sexual orientation, gender identity, or other LGBTQ identification can receive treatment from any doctor for any health need“LGBTQ health care isn’t specialty care, it’s just health care,” said Miller.And while Miller is an employee at Denver Health, this is an extra important issue for him personally.“I identify as a transgender man, and as I said before, my pronouns are he, him, his. I was born female, and at a certain point in my life, I recognized that being a woman didn’t fit for me, it was like I was living this false life,” said MillerFor him, and many trans people, being called the wrong name or the wrong pronoun isn’t just a simple mistake“When we say hey, my name is Andrew, that’s what I go by, but you call me my birth name, what I hear is, 'It doesn’t matter that I told you my name.' You get to be more of an expert on me than I get to be on me. Why should I feel safe that you’re going to actually take care of me, if you can’t even call me my name?” Miller said.For trans people around the country, this rule change might mean they could be denied hormone therapy or gender reassignment surgery. Procedures the transgender and health care providers who treat them, deem medically necessary.“Medical treatment with hormones and with surgery help a person’s body align with who they are, with their gender identity,” Kvach said.But it also means they have to be worried about being denied treatment for anything from a sore throat to life saving surgery.“I’m from the south, I think about it all the time. What it would be like to go back home and have a medical emergency and not be able to get care. To be a person denied health care, and it’s terrifying,” said Miller.And that increased anxiety can lead to bad health outcomes from avoiding preventative treatment to suicide.A survey from the Trevor Project released this month shows that more than half of kids who identify as transgender and nonbinary have seriously considered suicide in the last 12 months.While this rule change may be disheartening to many, institutions like Denver Health reaffirm their commitment to treating transgender people, like people“I want folks to be able to go to the doctor and feel safe. I want my community to survive,” Miller said. 3878