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The Sanderson Sisters from "Hocus Pocus" are back and ready to put a spell on you this Halloween.Bette Midler, Sarah Jessica Parker, and Kathy Najimy are reuniting as The Sanderson Sisters from the cult classic "Hocus Pocus." The sisters will be treating us to a virtual event on Oct. 30. And it's all for a good cause.According to the New York Restoration Project (NYRP) website, tickets for the "In Search of the Sanderson Sisters: A Hocus Pocus Hulaween Takeover" are .All the money raised will benefit the nonprofit NYRP, which Midler started in 1995. They restore parks and plant trees in New York City.Midler tweeted a picture of all three actresses together as Winifred, Mary, and Sarah Sanderson. 715
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 Francisco 49ers released linebacker Reuben Foster on Sunday morning, hours after he was arrested on a domestic violence charge at a Tampa, Florida, hotel.Foster, 24, was arrested after Tampa Police officers responded to the Grand Hyatt hotel shortly after 9 p.m. Saturday, according to a release from the City of Tampa. The former first-round NFL draft pick was charged with one count of first-degree misdemeanor domestic violence and booked into the Hillsborough County Jail, the release says.Police said Foster's 28-year-old female companion reported that he "slapped her phone out of her hand, pushed her in the chest area, and slapped her with an open hand on the right side of her face."Officers observed a one-inch scratch on the woman's left collarbone, the release states. Investigating officers learned that Foster and the woman had lived together in the past and were in an on-again, off-again relationship over the past three years, the release says.The 49ers released Foster just hours before their scheduled game against the Tampa Bay Buccaneers.It was unclear Sunday morning whether Foster has retained an attorney.A college star at Alabama, Foster was the 31st overall pick in last year's NFL draft but has had several arrests since.He was charged with felony domestic violence in April for allegedly attacking his girflriend in February at their home, leaving her bruised and with a ruptured eardrum, the Santa Clara County District Attorney said. The charges were dismissed after the victim recanted her story, although the Santa Clara DA's office said the evidence demonstrated he "seriously hurt his girlfriend."The NFL had suspended him without pay for the first two games of this season in relation to a weapons offense and a misdemeanor drug offense which were resolved earlier this year, the 49ers said in a statement on its website."I accept the League's decision and am sorry that my mistakes have hurt my team," Foster said in July when the suspension was announced. "I have a responsibility to the 49ers, our fans and our community, and I am committed to learning from this situation and making better choices in the future. The support I have received over the last five months has been humbling, and I do not take it for granted."49ers General Manager John Lynch said at the time that they supported the league's decision to suspend Foster and hoped he had learned his lesson."Although we are disappointed that Reuben will not be with our team for the first two games of the season, we will continue to work with him on making better decisions and eliminating unnecessary distractions," Lynch said. "We are encouraged to see Reuben take responsibility for his mistakes, and hopeful that he has learned from them as well."In his two seasons with the 49ers Foster played in 16 games and recorded 84 tackles. 2850
The US surgeon general issued an advisory Thursday recommending that more Americans carry the opioid overdose-reversing drug, naloxone.The drug, commonly known as Narcan, can very quickly restore normal breathing in someone suspected of overdosing on opioids, including heroin and prescription pain medications.Dr. Jerome Adams emphasized that "knowing how to use naloxone and keeping it within reach can save a life." To make his point, Adams relied on a rarely used tool: the surgeon general's advisory. The last such advisory was issued more than a decade ago and focused on drinking during pregnancy.Adams noted that the number of overdose deaths from prescription and illicit opioids doubled in recent years: from 21,089 deaths across the nation in 2010 to 42,249 in 2016.America's top doctor attributed this "steep increase" to several contributing factors, including "the rapid proliferation of illicitly made fentanyl and other highly potent synthetic opioids" and "an increasing number of individuals receiving higher doses of prescription opioids for long-term management of chronic pain.""Research shows that when naloxone and overdose education are available to community members, overdose deaths decrease in those communities," Adams said. Naloxone is used by police officers, first responders and emergency medical techs to reverse opioid overdoses. Adams added that increasing both the availability of naloxone and effective treatment is critical to ending the opioid epidemic.Speaking at the National Prescription Drug Abuse & Heroin Summit in Atlanta on Thursday morning, Adams addressed the potential "moral conflict" felt by some people who believe that providing naloxone "doesn't make a difference," since many people with drug addictions will just "go on and misuse substances again.""Well, that would be like me saying 'I'm not gonna go do surgery on this trauma patient because they're just gonna go out and speed again,' " he said.Adams noted that in most states, people who are or who know someone at risk for opioid overdose can get trained to use naloxone properly and also may receive naloxone by "standing order" -- without a prescription -- from pharmacies or some community-based programs."No mother should have to bury their child ,and especially not when there's a life-saving medication that virtually anyone can access," Adams said. "It is for this reason that I am issuing the first Surgeon General's Advisory in 13 years."The-CNN-Wire 2484
The vast majority of domestic terror events that have taken place in 2020 were conducted by white supremacist groups and other "like-minded extremists," according to a study by the Center for Strategic & International Studies (CSIS).The CSIS, which describes itself as a "bipartisan, nonprofit policy research organization," added in its study that while there has also been an increase in terror plots conducted by "anarchist" or "anti-fascist" groups this year, they accounted for 20% of domestic terror plots.In addition, the group said the number of domestic terror incidents that have taken place in 2020 is "relatively small" compared to other periods in U.S. history.In all, the CSIS reports that 41 terrorist attacks and plots between Jan. 1 and Aug. 31 were connected to white supremacists, violent far-right groups and people who indentifty as "involuntary celibates," or "incels." Twelve attacks and plots were linked to far-left groups and anti-fascists (antifa).The think tank added that far-right groups and far-left groups were each responsible for one fatal attack in 2020.The CSIS added that left-wing and right-wing violence are often intertwined, creating a "security dilemma." Both sides have rushed to arm themselves, and the arms race "inadvertently threatens the other side.""Since it may be difficult for individuals to distinguish between offensive and defensive arms, even efforts by one side to protect itself may motivate others to arm, creating a spiral of actions that leads to violence," the CSIS said.The findings by the CSIS stand in contrast with past statements from President Donald Trump, who often conflates violence from white supremacists and other far-right groups with violence from far-left groups, like antifa.Following the "Unite the Right" rally in Charlottesville, Virginia in 2017, in which a counter-protester was killed by the member of a far-right group, Trump said during a press conference that he thought there were "very fine people" on both sides of the conflict.During the first presidential debate, when he was asked to denounce the Proud Boys, a far-right extremist group, Trump told the group to "stand back and stand by." He followed that up by saying that political violence "is a left-wing problem."Trump formally denounced the group a few days later. 2322
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