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The Senate voted to send Brett Kavanaugh to the Supreme Court on Saturday, ushering in a generational conservative majority and delivering a huge victory to President Donald Trump after a vicious confirmation battle inflamed by allegations of sexual assault against the nominee.As shrieks of "shame, shame, shame" echoed from the public galleries, divided and angry senators voted 50-48 to endorse a lifetime seat on the court for Kavanaugh. The protests underscored the vital importance of an appointment that will have sweeping consequences for some of the nation's most contested disputes over abortion, LGBT rights, the scope of presidential power and the role of religion in society.Hours later, Kavanaugh was sworn in at a private ceremony. Chief Justice John Roberts administered the constitutional oath and retired Supreme Court Justice Anthony Kennedy administered the judicial oath, according to the Supreme Court.The bitter fight over Kavanaugh now moves into the epicenter of the campaign for the midterm elections in November. Republicans are convinced it will motivate their sleepy base. Democrats believe a backlash against the GOP from women voters could help deliver the House of Representatives. And the nature of the fight over Kavanaugh will trigger recriminations inside the Senate and political reverberations outside for years to come.In the end, Republicans were able to use their stranglehold on Capitol Hill and the White House to muscle through the confirmation in a power play that reflected the momentous importance of Trump's 2016 election victory over Hillary Clinton.Still, it was a close-run thing: Kavanaugh's nomination was nearly derailed by Christine Blasey Ford's allegations that the judge assaulted her when they were teenagers in the 1980s, which sparked uproar and forced Republicans to delay the confirmation vote for a week to allow time for a supplemental FBI background check.Trump's first exuberant response to the vote came in a tweet as he flew to Topeka, Kansas for a campaign rally that is likely to become a raucous victory lap."I applaud and congratulate the U.S. Senate for confirming our GREAT NOMINEE, Judge Brett Kavanaugh, to the United States Supreme Court. Later today, I will sign his Commission of Appointment, and he will be officially sworn in. Very exciting!Kavanaugh will be sworn in as an associate justice of the Supreme Court on Saturday by Chief Justice John Roberts and the man he will replace, the Court's crucial swing vote, Anthony Kennedy.Democrats furiously accused the GOP of short-circuiting efforts to examine Ford's allegations and of rushing the nomination through while ignoring the changed political dynamics surrounding complaints of misconduct against powerful men ushered in by the #MeToo movement.Senate Minority Leader Chuck Schumer called the nomination "one of the saddest moments in the history of the Senate," and said, "this chapter will be a flashing red warning light of what to avoid."Republicans "conducted one of the least transparent, least fair, most biased processes in Senate history, slanting the table from the very beginning to produce their desired result," he added.Majority Leader Mitch McConnell described Kavanaugh as a "superstar."McConnell, who stalled Barack Obama's nomination of Merrick Garland to the court in his final year in office and for whom the new conservative majority represents a defining achievement, predicted that Democratic tactics during confirmation battle would electrify Republican voters in November."They managed to deliver the only thing we had not been able to figure out how to do, which is to get our folks fired up," McConnell said. "The other side is obviously fired up, they have been all year."Kavanaugh's confirmation leaves the Senate traumatized with Republicans and Democrats as estranged as at any time in recent memory, reflecting the cavernous divides in the country itself during a presidency that has ignited rare political passions.It represents the culmination of a decades-long project by the conservative movement to construct a like-minded majority on the Supreme Court which has been a defining and unifying cause in successive congressional and presidential campaigns.The new profile of the court immediately makes Trump a consequential president, for all of the chaos and discord that rages around his White House, and means his legacy will include an achievement that eluded previous Republican presidents -- all of whom had more authentic conservative credentials.The ferocious nature of the confirmation battle could also have an impact on the Court itself, as Kavanaugh's vehement and politicized defense of his own behavior raised questions about his temperament and whether he could genuinely be an honest broker and implementer of the law in the most sensitive cases. 4844

The stock market had its worst day in a month as virus cases surge and help for the economy from Washington remains nowhere in sight. The S&P 500 fell 1.9% Monday, deepening its losses from last week. Stocks of companies that need the virus to abate and the economy to return to normal had some of the biggest losses. Cruise lines and airlines fell sharply. Energy stocks also dropped in tandem with crude oil prices. In another sign of caution, Treasury yields pulled back after touching their highest level since June last week. Overseas markets also fell.The drop in stock value came as coronavirus cases reached peak levels in the US over the weekend, while White House chief of staff Mark Meadows proclaimed that the US would be unable to contain the spread of the virus. 788

The U.S. regulators who will decide the fate of COVID-19 vaccines are taking an unusual step: Asking outside scientists if their standards are high enough.The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the virus. Thursday, a federal advisory committee pulls back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.“We will not cut corners, and we will only use science and data to make that determination,” FDA Commissioner Stephen Hahn pledged at a meeting of the Milken Institute Wednesday.Exactly how much data his agency needs to be sure a vaccine is safe and effective is a key question for the advisers. An even bigger one: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot -- and maybe competitors still being studied -- really work?“We can’t lose sight of the fact that it is in our societal interest to see these trials to completion,” said Dr. Luciana Borio, a former FDA acting chief scientist who will be watching the advisers’ debate.Plus, multiple vaccines are being studied -- shots made with different technologies that each have pros and cons.“The first vaccine is not necessarily the best vaccine,” cautioned Dr. M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren’t allowed to finish, it may be difficult or impossible to ever know for sure.It’s a critical moment in FDA’s 114-year history. The government has spent billions to race a vaccine through a research process that usually takes years, and FDA faces unprecedented pressure from the Trump administration, fueling public skepticism that politics could overrule science.Interest is so high, FDA is airing the meeting on YouTube. Here are some key issues the committee will discuss:HOW MUCH EVIDENCE IS NEEDED?FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include adequate numbers of people at highest risk from COVID-19 -- older adults, minorities and anyone with underlying health problems.FDA has made clear that any vaccine must be at least 50% effective. And while the studies are designed to run for two years, companies may get enough evidence the shots are protective -- in at least some people -- to stop the trials early and seek what’s called an “emergency use authorization” for wider vaccinations.Despite White House objections, the FDA told vaccine makers earlier this month not to seek that speedier review until they’ve tracked at least half their trial participants for two months. With other vaccines, that’s about the amount of time when major side effects crop up.That’s not long enough, said the head of the non-profit ECRI Institute, which reviews medical technology for hospitals and insurers. In comments submitted to the advisory committee, ECRI’s Dr. Marcus Schabacker said FDA should require six months of follow-up.“Doing any less would simply risk too much, and the consequences may be severe,” he wrote. “A weak vaccine that loses public trust could poison the well for epidemic control for many years.”WOULD EMERGENCY USE DERAIL FULL ANSWERS ABOUT VACCINES?Normally when a study ends because of evidence that a vaccine is working, the participants who got dummy shots are offered the real thing.But if FDA allows emergency use of a COVID-19 vaccine, that’s not the same as having full proof the shot works, Borio cautioned.And if the participants in the placebo group are immediately offered the real shot, researchers may not be able to get answers about all the high-risk groups in the study — or tell how long the vaccine’s protection lasts, a process expected to take many more months.But Pfizer Inc., which with Germany’s BioNTech is developing one of the leading candidates, told FDA that if it’s granted emergency use authorization, it “would have an ethical obligation” to alert study participants who got a placebo and allow them vaccine access. The company wants FDA to look into “other scientifically and statistically sound methods” to determine long-term safety and effectiveness.Pfizer’s stance is likely to face pushback. The Infectious Diseases Society of America states that FDA’s panelists “should insist” that vaccine developers “present a compelling case” for how they will complete their trials if FDA grants early authorization of their vaccine.Clearing a vaccine based on premature or faulty data “could cause more harm” by “further eroding public confidence in all vaccines,” the group said.It’s an unprecedented dilemma. The FDA has previously allowed emergency use of only one vaccine, a decades-old shot that in 2005 was authorized to prevent anthrax poisoning.This time around, multiple COVID-19 vaccines are in the pipeline. Pfizer competitor Johnson & Johnson cautioned that early FDA clearance of one vaccine could “jeopardize integrity” of other ongoing trials if patients decide to drop out to seek the first cleared shot instead.The company asked regulators to explain what options are available to ensure completion of all ongoing COVID-19 vaccine trials.WHAT ABOUT LONG-TERM SAFETY MONITORING?Even a study of 30,000 people cannot spot a side effect that only strikes 1 in 100,000. So the government is planning extra scrutiny of every COVID-19 vaccine to hit the market.At first there will be limited doses given to just certain high-risk people -- and those early recipients are to get text messages daily for the first week after vaccination, and then weekly out to six weeks, asking how they’re feeling.FDA also will be checking databases of electronic health records and insurance claims, looking for any red flags.“There’s a kind of tracking that has to take place here on a massive basis that hasn’t taken place before,” said Dr. Jesse Goodman of Georgetown University, a former director of the FDA’s vaccine and biologics center.___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. 6274

The United States’ Gross Domestic Product is expected to have a modest comeback in 2021 while unemployment will be slower to recover for years to come, according to a government projection from the Congressional Budget Office.The nonpartisan government agency that provides policy guidance for members of Congress said that unemployment is projected to remain above pre-pandemic levels through 2030.Thursday’s estimates from the CBO indicate that real GDP in 2021 will jump 4% in 2021 from 2020 after taking a projected 5.8% drop in 2020. The CBO then projects that real GDP will increase 2.9%. In years following, the GDP is expected to level off at 2.2%.But after unemployment dropped to 3.5% in 2019,, the unemployment rate is expected to be 7.6% in 2021, followed by 6.9% in 2022 and 5.9% in 2023 and 2024. Data released Thursday pegged the US unemployment rate at 11.1% in June.The CBO stresses there is uncertainty in its forecast given the pandemic.“The severity and duration of the pandemic are subject to significant uncertainty,” the CBO said. “In particular, several important epidemiological characteristics of the coronavirus remain unclear: Much still needs to be learned about its transmissibility and lethality and about the immunity conferred on people who have recovered from it. Moreover, the severity and duration of the pandemic will be affected by how various mitigation measures reduce the spread of the virus and by when vaccines and additional treatments become available—outcomes that remain highly uncertain.” 1544

The US Food and Drug Administration expanded?the list of drugs being recalled that contain valsartan. The drug is used as a component in a set of drugs used to treat heart failure and blood pressure.New to the list are some valsartan products manufactured by Hetero Labs Ltd. in India, which are labeled as Camber Pharmaceuticals Inc. Test results show that some of the products may be tainted.The FDA announced a valsartan recall in July after lab tests revealed that some drugs could have been tainted with a substance linked to higher risk of cancer. The drug had been recalled in 22 other countries. The expanded recall includes some drugs that contain valsartan and hydrochlorothisazide. Not all of the drugs containing valsartan were affected.N-nitrosodimethylamine or NDMA, the impurity the lab tests found, is considered a?possible carcinogen by the US Environmental Protection Agency. It is an organic chemical that has been used to make liquid rocket fuel, and it can be unintentionally introduced through certain chemical reactions. It's a byproduct of the manufacturing of some pesticides and fish processing.The medicines that are now a part of this expanded list?in the recall are tablets sold by AvKare, A-S Medication Solutions LLC, Bryant Ranch Prepack Inc, Camber Pharmaceuticals, Inc. H J Harkins Company, Northwind Pharmaceuticals, NuCare Pharmaceuticals Inc., Prinston Pharmaceutical Inc. (labeled as Solco Healthcare LLC), Proficient Rx LP, Remedy Repack, Teva Pharmaceuticals (labeled as Major Pharmaceuticals), Teva Pharmaceuticals USA (labeled as Actavis).The FDA also published a list of valsartan products that are not currently recalled. Only the drugs suspected of being tainted with NDMA are on the recall list. If you are taking a valsartan drug, look for the company name on your prescription bottle. If the information isn't on the label, you can call your pharmacy for those details.The recalled medicine is linked to a manufacturer in China. The substances were supplied by Zhejiang Huahai Pharmaceuticals, based in Linhai, in eastern China, which said it notified authorities as soon as it identified the impurity."We published our recall notice at midday on July 13 in China and overseas, and published the US market recall notice on July 14 Beijing time ... all the drug materials for the Chinese market were recalled by July 23," the company said in a statement to the Shanghai stock exchange last month.The FDA said on its website that it's working with drug manufacturers "to ensure future valsartan active pharmaceutical ingredients are not at risk."If you are worried that your drug could be on the recall list, talk with your doctor or pharmacist before changing any routine with your medicine. Because not all valsartan drugs are involved in the recall, they might be able to switch you to a version of the drug made by another company.If you know your drug is on the recall list, the FDA suggests you continue taking it until your doctor or pharmacist provides a replacement.To get a sense of what taking a tainted drug could mean, FDA scientists estimated that if 8,000 people took the highest dose of valsartan (320 milligrams) from the recalled batches every day for four years, there may be one additional case of cancer."The key with this is, patients should not stop taking their medication abruptly, that definitely can be harmful," Dr. Mary Ann Bauman, a representative for the American Heart Association, said in July. "You don't want to jump to any conclusions on your own about this medication, or any medication for that matter. Definitely talk with your doctor first." 3690