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The star of the Netflix documentary "Tiger King" Joe Exotic sued the United States Justice Department Wednesday because they rejected his request for a presidential pardon.According to court documents obtained by CBS11 and Courthouse News, lawyers for Exotic, whose real name Joseph Maldonado-Passage, argued that the rejection isn't valid because Acting Pardon Attorney Rosalind Sargent-Burns didn't give his official request to President Donald Trump himself.According to the six-page complaint filed in federal court in Fort Worth, Exotic's legal team named Sargent-Burns because she allegedly never gave President Trump a formal recommendation, which according to the lawsuit, she's required to do.Currently, Maldonado-Passage is serving a 22-year prison sentence in Fort Worth after he was found guilty in April 2019 for animal cruelty and trying to hire someone to murder Carole Baskin, who's a big-cat rights activist.The complaint also names Donald Trump Jr. as a supporter, CBS11 reported. 1006

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 Tampa Police Department is searching for a young man who was caught on camera doing a skateboard trick across a custom-painted car in Ybor City.A spokesperson for the police department said the case is being investigated as a felony criminal mischief. Detectives would like to speak with Dalton Newbury as a person of interest. According to those who have shared the video that's getting thousands of shares on Facebook, it was originally posted to Instagram by the skateboarder himself. The video has since been deleted from instagram. Tampa Police obtained the video and shared it on their YouTube page. Watch the video below:  661

The World Health Organization is preparing for the "worst case scenario" as it continues to respond to the Ebola outbreak in the Democratic Republic of Congo.Peter Salama, deputy director-general of emergency preparedness and response at the WHO, said in Geneva, Switzerland, on Friday that it's "going to be tough and it's going to be costly to stamp out this outbreak."As of Wednesday, 32 people are suspected to have been infected with Ebola viral disease, including three health care workers. Eighteen of those have died, including one of the health care workers.Of the suspected cases, two have been confirmed as Ebola using laboratory tests, and 10 samples are awaiting results."The number of suspected, probable and confirmed cases is significant, so we are very concerned, and we are planning for all scenarios, including the worst-case scenario," Salama said.Ebola virus disease, which most commonly affects people and nonhuman primates such as monkeys, gorillas and chimpanzees, is caused by one of five Ebola viruses. On average, about 50% of people who become ill with Ebola die.The disease is endemic to the Democratic Republic of Congo, and this is the nation's ninth outbreak since the discovery of the virus in the country in 1976.The latest outbreak is occurring in the Bikoro health zone, 400 kilometers (about 250 miles) from Mbandaka, the capital of Equateur province.Bikoro health zone has a population of about 163,000, with three hospitals and 19 health centers, most with limited functionality, according to WHO.Given the remote location of the outbreak, Salama said, response efforts will be extremely challenging. "It is a dire scene in terms of infrastructure," he said."To give you a sense, we are talking about an area that is 280 kilometers even from the provincial capital of Equateur," he said.The WHO is working with authorities in Congo and is in discussions with the World Food Programme to arrange airlifting supplies to the affected areas. UNICEF is also making doctors available as well as sanitation and hygiene specialists to help contain the outbreak.The virus is transmitted to people from wild animals and spreads in the human population through human-to-human transmission, either through direct contact with bodily fluids such as blood or secretions or contact with materials that are contaminated with these liquids.Personal protective equipment has been sent to the affected region, and the WHO is planning to have mobile laboratories running by the weekend, after receiving approval from the country's Ministry of Health.Initial control efforts are focusing on tools such as surveillance and monitoring, safe burials and case management.Vaccines along with doctors and epidemiologists are on standby in case they are needed, according to the UN.If they are needed, "WHO is in discussions with the government and, if pertinent, will seek approval from the national regulatory authority and the Ethics Review committee to use vaccines against Ebola as part of the response," spokesman Tarik Jasarevik said.The current vaccine against Ebola is experimental and not a licensed product. Salama pointed out that its use also comes with many challenges, as the vaccine needs to be stored long-term at temperatures between minus 60 to minus 80 degrees Celsius (minus 76 to minus 112 Fahrenheit)."This is not a simple logistical effort; it's not like doing a polio campaign with oral polio vaccines, where we get it immediately out to the field. This is a highly complex sophisticated operation in one of the most difficult terrains on Earth," Salama said.Nine neighboring countries are on high alert, Salama said, but the WHO says the current risk of disease spreading to them is low.West Africa experienced the largest recorded outbreak of Ebola over a two-year period beginning in March 2014; a total of 28,616 confirmed, probable and suspected cases were reported in Guinea, Liberia and Sierra Leone, with 11,310 deaths, according to the WHO.  3999

The service academy game between Air Force and Army scheduled for Saturday at West Point, New York, was postponed Thursday due to an increase in COVID-19 cases at the Air Force Academy and the surrounding community."We are disappointed to postpone this game, but the health and safety of our cadets, staff, and the community continues to be our No. 1 priority at the Academy," Air Force Falcons Director of Athletics Nathan Pine said in a press release. "Due to the upward trends in our COVID numbers across the campus, we have paused all intercollegiate team activities."The Falcons can win the Commander-in-Chief’s Trophy with a win over Army. Air Force began the round-robin competition between the service academies with a 40-7 win over Navy on Oct. 3.The winning academy goes to the White House to receive the coveted trophy from the President.According to The Athletic's Stewart Mandel, this marks the seventh college football game this week to be postponed or canceled due to COVID.The schools are working to reschedule the game. 1044