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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 U.S. Food and Drug Administration has issued a warning about several hand sanitizer products that have been found to contain wood alcohol, which can potentially be deadly to ingest or on the skin.The FDA said the products from EskBiochem SA de CV in Mexico contain methanol, also known as wood alcohol, which can be deadly when absorbed through the skin or ingested. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death."Methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects," the FDA wrote in their statement.While anyone who puts methanol on their hands is at risk, officials say young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.On June 17, the FDA contacted Eskbiochem to recommend they remove its hand sanitizer products from the market. However, to date, the company has not taken action to remove the products from the market and the FDA is urging people to stop using them, and dispose of them properly. 1231

The state of Michigan has agreed on a 0 million settlement in lawsuits regarding the Flint Water Crisis, Attorney General Dana Nessel announced Thursday.The settlement will be given to parties who claim they were affected by the city of Flint's 2014 transition of its public water supply to the Flint River; the majority of the money will be going to settle claims filed on behalf of children.The settlement was reached by the state parties and legal counsel after 18 months of negotiations.“Providing relief for the people of Flint and resolving these long-standing legal disputes has been a top priority for me since taking office,” Nessel said in a press release. “Flint residents have endured more than most, and to draw out the legal back-and-forth even longer would have achieved nothing but continued hardship. This settlement focuses on the children and the future of Flint, and the State will do all it can to make this a step forward in the healing process for one of Michigan’s most resilient cities. Ultimately, by reaching this agreement, I hope we can begin the process of closing one of the most difficult chapters in our State’s history and writing a new one that starts with a government that works on behalf of all of its people.”The preliminary agreement specifies that about 80 percent of the net settlement fund will be spent on claims of children who were minors when first exposed to the Flint River water, with a large majority of that amount to be paid for claims of children age 6 and younger, and earmarking 2 percent to go to special education services in Genesee County. Another 18 percent of the net settlement funds are to be spent on claims of adults and for property damage. Roughly 1 percent will go toward claims for business losses.If the settlement receives final court approval, it is likely to be the largest in Michigan state government history, affecting tens of thousands of people and resolving more than a hundred cases in state and federal trial and appellate courts."Protecting all Michiganders and their access to clean water is a priority for my administration to make sure nothing like this ever happens again," Governor Gretchen Whitmer said in a press release. "What happened in Flint should have never happened, and financial compensation with this settlement is just one of the many ways we can continue to show our support for the city of Flint and its families.""We acknowledge that this settlement may not completely provide all that Flint needs, and that many will still feel justifiable frustration with a system and structure that at times is not adequate to fully address what has happened to people in Flint over the last six years. We hear and respect those voices and understand that healing Flint will take a long time, but our ongoing efforts and today’s settlement announcement are important steps in helping all of us move forward."View a summary of the settlement below:Terms of Settlement 699810 7 by WXYZ-TV Channel 7 Detroit on Scribd This story was first reported by WXYZ in Detroit, Michigan. 3079

The rumors are true - our entomologists located the first-ever #AsianGiantHornet nest in the U.S. late yesterday. Press conference at 2 p.m. pic.twitter.com/oXuE6urXff— WA St Dept of Agr (@WSDAgov) October 23, 2020 222

The Trump administration plans to raise pending tariffs on 0 billion in Chinese goods to 25% from 10%, a source familiar with discussions confirmed to CNN.The news was first reported by Bloomberg.The move, which is not finalized and could change, according to the source, comes as the United States and China remain locked in a trade war. Talks between US and Chinese officials have done little to ease tensions.The United States has already imposed 25% tariffs on Chinese goods worth billion. China immediately responded with its own tariffs on US goods worth billion.A second round of tariffs on products worth billion could take effect as soon as this week.US Trade Representative Robert Lighthizer earlier this month ratcheted up tensions when he released a list of thousands of additional Chinese exports worth 0 billion that could face 10% tariffs after a public comment period. It included fruit and vegetables, handbags, refrigerators, rain jackets and baseball gloves.Those tariffs, which might now be steeper, could go into effect as soon as September. 1108