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The U.S. reported yet another daily high mark for newly reported cases of COVID-19 on Thursday with nearly 188,000, according to a database kept by Johns Hopkins University.The U.S. reported at least 187,833 positive COVID-19 tests on Thursday, breaking the all-time record of 177,224 that was set six days prior, on Nov. 13.Thursday marked the eighth time in November that the U.S. broke the daily record for newly reported cases as the COVID-19 continues to spread across the country. About 2.5 million people in the U.S. have contracted the virus since the start of November.The spike in cases has led to all-time highs in hospitalizations linked to the virus. The COVID Tracking Project reports that more than 80,000 people are currently hospitalized with the virus across the country — an all-time record that surpasses even the early portions of the pandemic. According to the COVID Tracking Project, 71% of those hospitalizations occur in the Midwest and South, leading to many rural hospitals running short on resources. Some states like South Dakota and Iowa say their hospitals are at their breaking points.Thursday also saw reports of 2,000 deaths linked to the virus — the first time the U.S. has seen that many reported deaths in a single day since May 6. Since Oct. 17, daily deaths linked to COVID-19 on a seven-day rolling average have nearly doubled from about 700 a day to more than 1,300 a day. The continued spike comes amid a rash of promising news in the hope for a COVID-19 vaccine. On Friday, Pfizer announced that it had filed for Emergency Use Authorization for its vaccine candidate, two days after initial studies showed it to be 95% effective in large-scale trials. Several other drugmakers have also reported that their vaccines are on the precipice of authorization.However, health experts warn that the U.S. is in for a rough few months. Vaccines will initially need to be rationed for people in high-risk populations and health care workers. Dr. Anthony Fauci has said he believes vaccines won't be widely available until April. 2075

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 state of Oregon became the first in the nation to decriminalize small amounts of hard drugs like heroin and cocaine by overwhelmingly passing Measure 110 on Tuesday.According to The Oregonian, the measure will reduce misdemeanor drug possession to a non-criminal violation, punishable by measures similar to a traffic stop. Violators will be given a ticket and a 0 fine, or be given the option of being screened for a subtance abuse disorder.Those found with larger amounts of drugs, who would have previously been charged with a felony, will now face a misdemeanor charge. The measure also redirects tax revenue from the sale of legal marijuana in the state toward Addiction Recover Centers, where people are screened for drug use and can also receive treatment for drug addiction.Supporters of the measure say the new policy will reduce the state's jail population, and in particular, free many offenders of non-violent crimes. Supporters also say the bill will promote racial equality in the state, as drug laws disproportionately affect Black people and other people of color.Opponents of the measure say it promotes drug use and will lead to more overdose deaths and overwhelm addiction centers in the state.The Oregonian also reports that the measure received funding from many out-of-state donors, including Facebook founder and CEO Mark Zuckerberg.The Associated Press reports that the measure passed with about 60% support.In addition to decriminalizing hard drug use, Oregon also legalized the sale and recreational use of Psilocybin, or magic mushrooms. The Associated Press reports that the measure passed with 56% support. 1650

The U.S. will pay more than billion for 100 million doses of a potential Covid-19 vaccine manufactured by Johnson & Johnson.The deal is one of several large agreements between the government and pharmaceutical companies as part of Operation Warp Speed, aimed at creating, testing, manufacturing and distributing a Covid-19 vaccine quickly.The Trump administration’s deal with Johnson & Johnson, announced Wednesday, allows for the purchase of an additional 200 million doses.Johnson & Johnson’s vaccine, developed by subsidiary Janssen Pharmaceutical Companies, has shown positive preclinical results. Testing of their vaccine is currently underway with human trials in the United States and Belgium.The Johnson & Johnson vaccine testing is reportedly behind some of the more advanced-stage potential vaccines, like those from Moderna, Pfizer and AstraZeneca, which have begun phase three human trials.“We greatly appreciate the U.S. government’s confidence in, and support for, our R&D platform and efforts and the scalability of our vaccine technology. We are scaling up production in the U.S. and worldwide to deliver a SARS-CoV-2 vaccine for emergency use,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson in a statement.The company says they are committed to global access to the vaccine following approvals, and has a goal of supplying 1 billion doses globally through the end of 2021. 1493

The Supreme Court on Tuesday ruled that the Trump administration can end census field operations early, in a blow to efforts to make sure minorities and hard-to-enumerate communities are properly counted in the crucial once-a-decade tally.The decision was not a total loss for plaintiffs in a lawsuit challenging the administration’s decision to end the count early. They managed to get nearly two extra weeks of counting people as the case made its way through the courts.However, the ruling increased the chances of the Trump administration retaining control of the process that decides how many congressional seats each state gets — and by extension how much voting power each state has.The Supreme Court justices’ ruling came as the nation’s largest association of statisticians, and even the U.S. Census Bureau’s own census takers and partners, have been raising questions about the quality of the data being gathered — numbers that are used to determine how much federal funding and how many congressional seats are allotted to states.After the Supreme Court’s decision, the Census Bureau said field operations would end on Thursday.At issue was a request by the Trump administration that the Supreme Court suspend a lower court’s order extending the 2020 census through the end of October following delays caused by the pandemic. The Trump administration argued that the head count needed to end immediately to give the bureau time to meet a year-end deadline. Congress requires the bureau to turn in by Dec. 31 the figures used to decide the states’ congressional seats — a process known as apportionment.By sticking to the deadline, the Trump administration would end up controlling the numbers used for the apportionment, no matter who wins next month’s presidential election.In a statement, House Speaker Nancy Pelosi called the Supreme Court’s decision “regrettable and disappointing,” and said the administration’s actions “threaten to politically and financially exclude many in America’s most vulnerable communities from our democracy.”Associate Justice Sonia Sotomayor dissented from the high court’s decision, saying “respondents will suffer substantial injury if the Bureau is permitted to sacrifice accuracy for expediency.”The Supreme Court ruling came in response to a lawsuit by a coalition of local governments and civil rights groups, arguing that minorities and others in hard-to-count communities would be missed if the census ended early. They said the schedule was cut short to accommodate a July order from President Donald Trump that would exclude people in the country illegally from being counted in the numbers used for apportionment.Opponents of the order said it followed the strategy of the late Republican redistricting guru, Thomas Hofeller, who had advocated using voting-age citizens instead of the total population when it came to drawing legislative seats since that would favor Republicans and non-Hispanic whites.Last month, U.S. District Judge Lucy Koh in San Jose, California sided with the plaintiffs and issued an injunction suspending a Sept. 30 deadline for finishing the 2020 census and a Dec. 31 deadline for submitting the apportionment numbers. That caused the deadlines to revert back to a previous Census Bureau plan that had field operations ending Oct. 31 and the reporting of apportionment figures at the end of April 2021.When the Census Bureau, and the Commerce Department, which oversees the statistical agency, picked an Oct. 5 end date, Koh struck that down too, accusing officials of “lurching from one hasty, unexplained plan to the next ... and undermining the credibility of the Census Bureau and the 2020 Census.”An appellate court panel upheld Koh’s order allowing the census to continue through October but struck down the part that suspended the Dec. 31 deadline for turning in apportionment numbers. The panel of three appellate judges said that just because the year-end deadline is impossible to meet doesn’t mean the court should require the Census Bureau to miss it.The plaintiffs said the ruling against them was not a total loss, as millions more people were counted during the extra two weeks.“Every day has mattered, and the Supreme Court’s order staying the preliminary injunction does not erase the tremendous progress that has been made as a result of the district court’s rulings,” said Melissa Sherry, one of the attorneys for the coalition.Besides deciding how many congressional seats each state gets, the census helps determine how .5 trillion in federal funding is distributed each year.San Jose Mayor Sam Liccardo said that his city lost 0 million in federal funding over the decade following the 2010 census, and he feared it would lose more this time around. The California city was one of the plaintiffs in the lawsuit.“A census count delayed is justice denied,” Liccardo said.With plans for the count hampered by the pandemic, the Census Bureau in April had proposed extending the deadline for finishing the count from the end of July to the end of October, and pushing the apportionment deadline from Dec. 31 to next April. The proposal to extend the apportionment deadline passed the Democratic-controlled House, but the Republican-controlled Senate didn’t take up the request. Then, in late July and early August, bureau officials shortened the count schedule by a month so that it would finish at the end of September.The Senate Republicans’ inaction coincided with Trump’s order directing the Census Bureau to have the apportionment count exclude people who are in the country illegally. The order was later ruled unlawful by a panel of three district judges in New York, but the Trump administration appealed that case to the Supreme Court.The Supreme Court decision comes as a report by the the American Statistical Association has found that a shortened schedule, dropped quality control procedures, pending lawsuits and the outside politicization of some parts of the 2020 census have raised questions about the quality of the nation’s head count that need to be answered if the final numbers are going to be trusted.The Census Bureau says it has counted 99.9% of households nationwide, though some regions of the country such as parts of Mississippi and hurricane-battered Louisiana fall well below that.As the Census Bureau winds down field operations over the next several days, there will be a push to get communities in those two states counted, said Kristen Clarke, president and executive director of the Lawyers’ Committee for Civil Rights Under Law, one of the litigants in the lawsuit.“That said, the Supreme Court’s order will result in irreversible damage to the 2020 Census,” Clarke said.___Follow Mike Schneider on Twitter at https://twitter.com/MikeSchneiderAP 6792