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The White House privately warned the mayors of 11 major U.S. cities on Wednesday that they need to take "aggressive" steps to control COVID-19 outbreaks, the Center for Public Integrity reports.The warning came from Dr. Deborah Birx, the response coordinator for the White House Coronavirus Task Force. In the call, which the Center for Public Integrity included "hundreds of emergency managers and other state and local leaders," she identified 11 cities that are seeing an increase in the percentage of positive COVID-19 tests they've taken in recent weeks. Those cities were Baltimore, Cleveland, Columbus, Indianapolis, Las Vegas, Miami, Minneapolis, Nashville, New Orleans, Pittsburgh and St. Louis.“When you first see that increase in test positivity, that is when to start the mitigation efforts,” she said in a recording obtained by Public Integrity. “I know it may look small and you may say, ‘That only went from 5 to 5-and-a-half [percent], and we’re gonna wait and see what happens.’ If you wait another three or four or even five days, you’ll start to see a dramatic increase in cases.”The Center for Public Integrity also published a seven-minute segment of the conference call.Public Integrity · Dr. Deborah Birx CallIt's unclear who provided the Center for Public Integrity with the recording, which was closed to the press. The outlet also reported that it's unclear which local governments were on the call, which was hosted by the White House Office of Intergovernmental Affairs. Officials in Cleveland told the outlet that they were not on the call.Birx's call came the day after President Donald Trump resumed his daily coronavirus briefings. During those briefings, Trump encouraged the nations to wear a mask when in public — a significant shift after he refused to do so in public appearances earlier this year. But Trump also seemed to downplay the severity of the virus by claiming that mortality is falling, despite figures from Johns Hopkins that show mortality increasing. 2009

The Trump campaign has filed a second lawsuit to stop ballot counting the day after the election. This time in Pennsylvania.In a release sent to supporters, the president’s campaign says they are taking several legal actions concerning Pennsylvania ballots. The first is they are “moving to intervene in the existing Supreme Court litigation over the Pennsylvania Supreme Court’s unlawful extension of the mail-in ballot receipt deadline.”Trump’s campaign is also filing suit to stop ballot counting because they claim election officials are counting and processing ballots out of sight of Republican poll observers.“In Philadelphia and elsewhere, Democrat officials forced our observers to stay 25 feet or more from the counting process, leaving no meaningful way whatsoever for our observers to do their jobs,” the statement from Justin Clark, Trump’s deputy campaign manager, reads.With about 84 percent of the ballots counted, Trump leads Biden by almost 300,000 votes. This is similar language used by the Trump campaign when they said they filed in Michigan Wednesday morning. The Trump campaign says it is calling for a temporary halt in the counting in Michigan until it is given “meaningful access” in numerous locations and allowed to review ballots that already have been opened and processed. Trump is running slightly behind Democratic nominee Joe Biden in Michigan. 1387

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 US Centers for Disease Control and Prevention warned US consumers on Tuesday to not eat romaine lettuce, as it may be contaminated with E. coli.Thirty-two people, including 13 who have been hospitalized, have been infected with the outbreak strain in 11 states, according to the CDC. One of the hospitalized people developed hemolytic uremic syndrome, a potentially life-threatening form of kidney failure. No deaths have been reported.People have become sick in California, Connecticut, Illinois, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New York, Ohio and Wisconsin.The Public Health Agency of Canada has identified an additional 18 people who have become sick with the same strain of of E. coli in Ontario and Quebec.If you have any romaine lettuce at home, you should throw it away, even if you have eaten some and did not get sick, the CDC cautioned."This advice includes all types or uses of romaine lettuce, such as whole heads of romaine, hearts of romaine, and bags and boxes of precut lettuce and salad mixes that contain romaine, including baby romaine, spring mix, and Caesar salad," the CDC said in its announcement.All types and brands of romaine lettuce are suspect because no common grower, supplier, distributor or source company has been identified by the CDC.Retailers and restaurants also should not serve or sell any until more is known about the outbreak.Symptoms of E. coli infection, which usually begin about three or four days after consuming the bacteria, can include watery or bloody diarrhea, fever, abdominal cramps, nausea and vomiting, according to the CDC. Most people infected by the bacteria get better within five to seven days, though this particular strain of E. coli tends to cause more severe illness.People of all ages are at risk of becoming infected with Shiga toxin-producing E. coli, according to the US Food and Drug Administration, which is also investigating the outbreak. Children under 5, adults older than 65 and people with weakened immune systems, such as people with chronic diseases, are more likely to develop severe illness, but even healthy children and adults can become seriously ill.Illnesses started in October. This outbreak is not related to a multistate outbreak linked to romaine lettuce this summer.The-CNN-Wire 2311

The threat of a partial government shutdown looms over Washington with just five days to go before funding expires for several government agencies and no agreement yet between Democrats and Republicans over how to resolve a standoff over President Donald Trump's border wall demand.It now looks, however, that Congress will act to extend the rapidly-approaching December 7 deadline.A source briefed on the talks told CNN over the weekend that lawmakers are considering taking up a one-week spending bill to avoid a partial government shutdown by Friday, a move designed to put off a major showdown until after former President George H.W. Bush's funeral proceedings (Congress will be out of session for part of the week because of it).A stop-gap funding measure could temporarily delay a spending showdown. But Democrats and Republicans appeared to be at an impasse over the President's promise of a border wall, raising the question: which side will blink first?Trump wants billion in funding for the wall and Senate Republicans are now weighing the possibility of attempting to allocate billion over the next two years. Any spending bill would need at least some Democratic votes to pass, however, and could not be enacted without some degree of bipartisan support.Senate Democratic Leader Chuck Schumer said last week that Trump should either agree to enact an existing Department of Homeland Security funding bill that has bipartisan support in the Senate and would allocate .6 billion for border security or keep DHS funded for another year via a short-term spending measure known as a continuing resolution.Lawmakers passed a government spending package to fund much of the government prior to the 2018 midterm elections -- so if there is any kind of a shutdown, it would not affect all of the federal government. Funding will run out on December 7 for some government agencies, including the Department of Homeland Security.Trump has so far signaled an openness to a short-term extension. The President told reporters aboard Air Force One that he is willing to extend the deadline for funding the federal government to avoid a government shutdown."If (congressional leaders) come to talk about an extension because of President Bush's passing, I would absolutely consider it and probably give it," Trump said.But a one-week continuing resolution would do little to address the current standoff between Democrats and Republicans over wall funding.The impact of a partial shutdown would nevertheless be disruptive and would invite an immediate political backlash.Democrats and Republicans alike have both said that they don't want a shutdown as the funding deadline nears."We don't believe in shutdowns," House Democratic leader Nancy Pelosi told reporters on Friday, saying "we have to" when asked if Congress would avert a shutdown."I don't think anybody wants a government shutdown," North Carolina Republican Rep. Mark Meadows, who chairs the conservative House Freedom Caucus, said on Friday in the Capitol.But, Meadows said, "I do think that there is a real battle coming on the border wall funding," adding, "if the border wall funding is not there, it does increase the possibility of impasse that could lead to a shutdown."The President has warned that it is "possible" there could be a shutdown if Congress does not greenlight the money he wants to see allocated for the wall, which he promised on the campaign trail would be paid for by Mexico."If we don't get border security, possible shutdown," Trump told reporters last Thursday.For now, both sides are gearing up for the possibility that a partial shutdown could take place -- and are getting ready to pin the blame on the opposing party if it happens."Make no mistake: The President is the only person who holds the ultimate responsibility for a government shutdown," Schumer said in a Senate floor speech on Thursday.Republicans still control both chambers of Congress and the White House. That won't change until Democrats take control of the House of Representatives in the new Congress in January. But that won't stop Republicans from trying to cast blame on Democrats if a partial shutdown happens."I don't think the Democrats want to shut down the government over the border security issue. But they might. We'll see," Sen. John Cornyn, the No. 2 Senate Republican, told reporters last week. 4385