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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 San Luis Obispo County (California) Sheriff's Office confirms one of its deputies was shot early Wednesday morning in Paso Robles, California.At a Wednesday afternoon press conference, Sheriff Ian Parkinson described the incident as an “unprovoked attack on law enforcement” by a suspect “laying in ambush” at the police department in Paso Robles.According to officials, the situation began with shots fired at the Paso Robles Police Department building.San Luis Obispo County Sheriff's Office spokesperson Tony Cipolla says shots were fired at the Paso Robles Police Department building at about 3:15 a.m.The deputy was airlifted to a trauma center and is reportedly in serious but stable condition.Paso Robles police called for help from other agencies as they responded to the shooter outside, and Parkinson says the gunman shot at police cars as they entered the downtown area to assist.Officials released photos (pictured above) of a possible suspect wanted in connection with Wednesday's shooting. 1015

The winds were so strong on July 26 in Redding, California, authorities say they uprooted trees, ripped roofs off houses and downed power lines.The fast-moving Carr Fire took three family members from Ed Bledsoe that day -- his wife and two great-grandchildren."The tornado was hovering over the house," Amanda Woodley, Bledsoe's granddaughter, told CNN. "It was just a tornado fire over the house."Bledsoe had left the house earlier to go to the doctor's office, and was on the phone with his family members as the flames closed in. They believed they were safe from the fire and knew nothing of the approaching hellscape that was like nothing any of them had ever seen before.He said his son drove toward the flames in the hope of rescuing his family members. "My son said the grass wasn't on fire, the trees were getting sucked up in the air and burning," Bledsoe told CNN. "He said when he opened his doors, the leaves hit him like somebody was slapping him. He said it was sucking his breath out, and he got back in his car and tried to get out."Bledsoe was on the phone with his wife and great-grandchildren until the very end."It sucked the roof off the house and the walls fell out and the roof went right down on them," he said.The Carr Fire, now the sixth most destructive fire in California history, has consumed 121,000 acres and killed six people.Dr. Craig Clements of San Jose State University's Fire Weather Research Laboratory said there have been few observed firenadoes of this magnitude before. He says the conditions have to be perfect for something like this to occur.Firenadoes are formed from a fire's intense heat, causing the air to heat up quickly and rise rapidly. That, combined with surface winds that are obviously quite strong, creates a vortex similar to a dust devil.Clements says aside from the potentially damaging winds, a firenado like this can even pull fire in different directions.At 3:27 p.m. that day, the National Weather service sent out a statement noting that "radar indicates strong rotation located within the intense fire activity of the Carr Fire." They warned of possible wind gusts up to 50 mph."The wind went from zero wind to 40 to 60 mph winds within 15 minutes," Justin Sanchez told CNN. He said his house was consumed by the firenado. "(There was) a loud disturbing deep growling noise as it spun around in a spiral. It seemed the outside was moving around so slowly, with two-foot sized pieces of debris floating in it."Sanchez says when he and his family were about a mile and a half from his home, they looked back and could see their neighborhood consumed by it. 2631

The U.S. Department of Justice is at polling locations in 19 states to ensure federal voting rights laws are being followed. There are also thousands of people with civil rights and voting advocacy groups watching the polls. One place they're concerned about voter suppression is Dodge City, Kansas.Jose Vargas, Marilyn Horsch and Rita Schweitz all traveled to Dodge City to help voters.  "We were really angry and thought maybe there’s something we can do to help," says Schweitz, who flew in from Denver, CO.  They’re all here because they’re angry that the town’s polling place was moved, without much notice. They are calling it voter suppression.“Designed to frustrate the voter, to make people give up,” says Horsch.For years, the town’s polling place was right in the middle of Dodge City. But this year, the county election officer, citing construction projects, decided to move to a different location that is four miles away. The new location is outside city limits, and there’s no access to sidewalks and it’s cut off from public transportation.The ACLU sued Dodge City, asking a judge to force the county to open a second polling location for the town's 27,000 residents. A judge denied the request, so the ACLU emailed election officer Debbie Cox, asking for help publicizing a voter help line.The Wichita Eagle reported that Cox then sent that on to the Secretary of State's office, adding “LOL” to the email.So, volunteers like Jose Vargas, Marilyn Horsch and Rita Schweitz are offering bus rides from the old location to the new one to ensure voters get to the poll. They rented a bus to shuttle voters to ensure they’d be able to cast their votes. 1682

The US Food and Drug Administration on Thursday announced the approval of?the first generic version of EpiPen.The auto-injector pen delivers the drug epinephrine to patients experiencing a severe allergic reaction that, if untreated, could develop into the life-threatening condition of anaphylaxis. The medication is delivered into a muscle as a single dose, like a shot, through an injector pen with a spring.Allergies from food, bug bites, medications and latex can cause life-threatening reactions.The newly approved generic is made by Teva Pharmaceuticals and offers an alternative for patients who, until now, have been able to use only the brand-name EpiPen made by Mylan. It is approved in a smaller dose for children, as well.There are two other brand products on the market for a severe allergic reaction: Adrenaclick and Auvi-Q.The newly approved option made by Teva is the only approved non-brand option and can be substituted only for Mylan's EpiPen."Today's approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval," FDA Commissioner Dr. Scott Gottlieb said in a statement announcing the approval.In recent years, Mylan came under fire for a price increase that put the product out of reach for many who needed to keep the drug on hand. 1488

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