Minneapolis police have issued an arrest warrant for a suspect known as “Umbrella Man” who was filmed smashing the windows of an auto parts dealership on May 27, two days after the police killing of George Floyd. Video of the “Umbrella Man” went viral after protesters in Minneapolis confronted and filmed him while he was in the act of smashing several windows of an AutoZone store. Investigators say the man is a white supremacist who sought to provoke violence against protesters. The term “Umbrella Man” was coined on social media as people guessed at his identity, with some protesters speculating he was actually a member of the police force.
According to a search warrant, the man is associated with the “Aryan Cowboys,” which the Anti-Defamation League lists as a White supremacist prison and street gang. The warrant does not label them as a White supremacist group, but describes them as a “known prison gang out of Minnesota and Kentucky.” A Minneapolis arson investigator wrote in the search warrant affidavit that the man also spray painted the words “free sh*t for everyone zone” on the doors of the AutoZone. Not long after he smashed in the windows, looting began, and a bit later the AutoZone was set on fire, the affidavit said.
“This was the first fire that set off a string of fires and looting throughout the precinct and the rest of the city,” Sgt. Erika Christensen, wrote in the affidavit. “Until the actions of the person your affiant has been calling ‘Umbrella Man,’ the protests had been relatively peaceful. The actions of this person created an atmosphere of hostility and tension. Your affiant believes that this individual’s sole aim was to incite violence.”
Police identified the 32-year-old suspect through a tip last week but the suspect has not been named. Minneapolis police spokesman John Elder told the Associated Press he could not confirm the name of the person involved, but said the investigation remains open and active. The tipster told the investigator that the man was a member of the Hells Angels biker gang who “wanted to sow discord and racial unrest by breaking out the windows and writing what he did on the double red doors.” Police matched him to photos a Muslim woman took when she was harassed during an encounter with the Aryan Cowboy Brotherhood, while eating burgers with her young daughter in Stillwater in June.
The riots spread to other parts of Minneapolis and led to Minneapolis’ 3rd Precinct burning down, and according to Minnesota Gov. Tim Walz, resulted in $500 million in property damage. At least two people died — one a man who was fatally shot at a Minneapolis pawnshop and another man whose burned body was found in the ruins of another pawnshop.
Protests against police brutality and systemic racism continue in cities across the country in the wake of Floyd’s death. The Black Lives Matter movement has drawn tens of millions into the streets to participate in protests taking place every day since May. The protests have been plagued with violence from the start. They continue to push for police reform and an end to systemic inequalities around race. It has led to radical reform in recent months in many states and the faces of those they continue to seek justice for continue to change as more police shootings occur.
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The son of a federal judge in New Jersey has died after a gunman opened fire on their home in North Brunswick. Judge Esther Salas was unharmed in the shooting that killed her 20-year-old son Daniel Anderl and critically injured her husband. Roy Den Hollander, a self-proclaimed anti-feminist lawyer, is the primary suspect in the fatal shooting that took place at Salas’ New Jersey home a Sunday evening. Daniel Salas, who had just turned 20, was an only child and studying law to follow in his parents’ footsteps. He graduated cum laude with honors from St. Joseph’s High School in 2018 and was enrolled at The Catholic University of America in Washington, D.C.
Hollander allegedly posed as a FedEx employee when he approached Salas’ home and shot her husband, Mark Anderl, and her son, Daniel Anderl, 20, before escaping in a car, according to sources. Daniel Anderl died from his injuries, and Mark Anderl was critically injured and rushed to the hospital. Salas was unharmed. Hollander was found dead by police in an apparent suicide the next day, according to investigators.
Preliminary indications are that the husband answered the door and was shot multiple times; the son came running to the door and was shot as well before the gunman fled, the sources said. Judge Salas was believed to be in the basement at the time of the shooting, and she was not injured. Hollander was found dead of an apparent suicide the day after the shooting.
The only interaction Hollander and Salas had was a civil rights lawsuit filed in 2019. A female teenager sued the Selective Service System five years ago because she could not register for the male-only draft. In her most recent opinion on the case, filed in spring 2019, Salas sided with part of the plaintiff’s argument, allowing the lawsuit to move forward. The plaintiff’s attorney at the time was Roy Den Hollander. That civil rights suit appears to be the only time Hollander argued before Salas in court. Hollander was replaced last June as the female plaintiff’s lawyer in the lawsuit. A managing partner for Boies Schiller Flexner said that Hollander asked the law firm to take over the case because he was terminally ill. In Hollander’s autobiography published on his personal website, he wrote that he was diagnosed with melanoma in 2018.
County officials in California say they received additional evidence connecting Hollander to another killing. San Bernardino County authorities released new images that captured Roy Den Hollander inside two California train stations in early July around the days he’s suspected of killing Marc Angelucci. Investigators believe Hollander left New York on July 4th and arrived in at the San Bernardino train station on July 7. A second photo from inside Union Station in Los Angeles supports the claims by authorities that Den Hollander fled back to New York on July 14, three days after he drove a rental car to Angelucci’s house in Cedar Pines Park and shot him.
Officials believe Den Hollander used the same gun in both of killing of Angelucci on July 11 and the shooting of Judge Esther Salas’ son and husband in New Brunswick, New Jersey. According to sources, officials are investigating whether the attacks were grudge killings committed by Hollander after he knew he was dying.
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More than a year after launching an internal investigation into 138 employees for “inappropriate social media activity,” Customs and Border Protection — the parent agency of the Border Patrol — has removed four employees, suspended 38 without pay and disciplined an additional 27 with reprimands or counseling. Investigators from Customs and Border Protection‘s Office of Professional Responsibility determined that 63 of the cases — roughly half — were “unsubstantiated.” Six cases remain open, and the Homeland Security Department‘s inspector general is also investigating.
The office began looking into more than 60 current employees and eight former staff following reports of a secret Facebook group in which members used dehumanizing and derogatory language regarding Latina members of Congress and deceased migrants. The existence of the group, known as “I’m 10-15,” the code used by Border Patrol for migrants in custody, at one point had 9,500 members and was created in August 2016. The probe, which is not criminal, ultimately doubled the number of individuals under investigation, and included several additional private social media groups.
Most of the cases deemed unsubstantiated involved personnel who reported themselves or others as part of the groups and provided information to investigators, but whose history showed they’d never posted or been active in them. At the start of the investigation, Matthew Klein, assistant commissioner of the agency’s Office of Professional Responsibility, emphasized that the privacy of the social media groups does not protect current or former employees from disciplinary action.
Members of the secret Facebook group for current and former Border Patrol agents joked about the deaths of migrants and discussed throwing burritos at Latino members of Congress visiting a detention facility while referring to them as scum buckets. In one post, a photoshopped image depicted Congressmember Alexandria Ocasio-Cortez being sexually assaulted by President Trump. In another thread, members of the group made fun of a video of an immigrant man trying to carry a child through a raging river in a plastic bag. One group member commented, “At least it’s already in a trash bag.”
In one exchange, group members responded with indifference and wisecracks to the post of a news story about a 16-year-old Guatemalan migrant who died in May while in custody at a Border Patrol station in Weslaco, Texas. One member posted a GIF of Elmo with the quote, “Oh well.” Another responded with an image and the words “If he dies, he dies.”
Rep. Veronica Escobar, who said on Twitter she was “one of the Latina members of Congress targeted by the hateful attacks,” but she had not received information about the investigation from Customs and Border Protection. Rep. Joaquín Castro, the head of the Congressional Hispanic Caucus, reviewed the Facebook discussions and was incensed. “It confirms some of the worst criticisms of Customs and Border Protection,” said Castro. “These are clearly agents who are desensitized to the point of being dangerous to migrants and their co-workers.” He added that the agents who made the vulgar comments “don’t deserve to wear any uniform representing the United States of America.”
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There have been over 15 million confirmed coronavirus cases around the world with 618,000 deaths. Of those cases 8,500,000 have recovered. In the US there are over 4 million confirmed cases and over 145,000 have died in the 6 months since the first case was confirmed in the US. Almost 8,500,000 of the US cases have recovered. The United States has set another grim record for coronavirus infections, with more than 75,600 new cases confirmed. At least 11 states are reporting record hospitalizations, with nearly 1,000 new deaths in just 24 hours. Officials in Texas and Arizona have put out calls for refrigerated trucks, as morgues overflow with the bodies of COVID-19 patients. Texas and Florida both reported their highest death tolls of the pandemic.
As the number of new global coronavirus cases reaches record highs, the World Health Organization is warning the coronavirus outbreak will continue to worsen if governments don’t take basic public health measures. Reports the number of coronavirus deaths in Latin America has now exceeded the death toll in the United States and Canada. Researchers estimate the US will have 219,864 total Covid-19 deaths by November 1, according to the Institute for Health Metrics at the University of Washington.
In Florida, confirmed coronavirus cases topped 300,000 even as Disney World completed a phased reopening of its Orlando theme parks. Nearly 50 Florida hospitals said they were out of ICU beds. In Miami, hospitals have run out of regular intensive care beds, with new patients moved into converted ICUs. Governor Ron DeSantis said he was mobilizing 1,000 medical workers to fill critical staffing shortages.
California, the most populous state and the first to shut down months ago, appeared to have Covid-19 under control — only to suffer a massive resurgence and surpass New York with the most coronavirus cases in the nation. California, which now has 417,000 confirmed cases due to the recent spikes, is largely shutting down again. California Governor Gavin Newsom has a plan to halt the recent surge by ordering all indoor restaurants, wineries, movie theaters and museums to be closed again. Bars have been ordered to cease all operations. Indoor businesses have been shuttered in many areas. Newsom said the new shutdowns are needed to address the public health crisis. The Los Angeles and San Diego school districts have announced that all classes will be conducted online at the start of the school year due to the pandemic.
Covid-19 is set to become one of the leading causes of death in Los Angeles County, according to Barbara Ferrer, the county’s health director. “It’s killing more people than Alzheimer’s disease, other kinds of heart disease, stroke and COPD,” Ferrer said. Comparing Covid-19 to the flu, Ferrer said data shows Covid-19 killed twice as many people in six months as the flu did in eight months.
The city of Atlanta announced a similar plan. In New York, Governor Andrew Cuomo said schools will be allowed to reopen, but only in regions with low daily infection rates. At least 41 states have some kind of mask requirement in place or planned. In Colorado, Governor Jared Polis issued a statewide mask mandate, a week after refusing public health officials’ pleas to require facial coverings in public. Arkansas Republican Governor Asa Hutchinson issued a similar mask mandate. The CDC reports that 10 states have reported 10,000 new cases while three states each reported over 60,000 new cases in the last week.
Several vaccine trials are progressing well, and researchers say a vaccine might be publicly available by early 2021. Health and Human Services Secretary Alex Azar said any Covid-19 vaccine that’s sponsored by the US government will be free or affordable for the American public.
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As historic protests continue to sweep the country two weeks after the death of George Floyd, the Minneapolis City Council announced it would move to disband the city’s police department. Nine members of the council — a veto-proof majority — made the vow during a community rally. The vow to disband the police came just days after the Minneapolis City Council voted to ban chokeholds and neck restraints. Congress is slated to introduce reforms that include a chokehold ban, a limit on qualified immunity for officers and a restriction on military weapons. While news reporting may be bias, social media videos of police brutality toward peaceful protestors has sparked many local governments to take action as the protests continue. Although many of these reforms will be subjected to a long debate among local officials, some activists say it is a good start.
In Louisville, KY, the City Council unanimously passed “Breonna’s Law” Thursday night that banned the use of “no-knock” warrants. The legislation was named after Breonna Taylor, a 26-year-old EMT, who was killed in her home while in bed in March by Louisville police officers while executing a no-knock warrant. Louisville Mayor Greg Fischer, who suspended the use of no-knock warrants last month, said he will sign the bill. “This is one of many critical steps on police reform that we’ve taken to create a more peaceful, just, compassionate and equitable community.” The officers involved in Taylor’s death are under investigation and have been placed on administrative leave.
New York’s state legislature voted to repeal parts of a provision that shielded police disciplinary records from the public. The repeal of 50-A means that police officers across the state must disclose personnel records used to evaluate performance. Criminal justice advocates have been pushing for the repeal for years. The legislation also bans officers from using chokeholds, prohibits false race-based 911 calls and appoints the state attorney general to be an independent prosecutor in any case where an officer shoots an unarmed person. The state Senate approved the bill and the state Assembly approved it with later in the day. New York City Mayor Bill de Blasio also announced a sweeping set of reforms that would shift funding from the NYPD to other sectors of the city’s budget. De Blasio said he will work with the city council to hammer out the details over the next three weeks, but told reporters Monday that the amount would be “something substantial.”
Washington DC Mayor Muriel Bowser announced she will sign the emergency legislation passed by the City Council that bans the police from using neck restraints on suspects. The bill also bans the use of tear gas, pepper spray, rubber bullets and stun grenades to disperse protesters. The Council also passed a bill that requires the mayor to release police body camera video from any police-involved death or serious use of force within three days of the incident. The family members of the person involved in the incident will be the first to see the video, according to the bill’s language.
Seattle Mayor Jenny Durkan announced short- and long-term changes to the city’s police force to address the concerns about police from residents. She said she will review the Seattle Police Department’s budget with a “special focus on listening community voices throughout the process.” Durkan has also called for an independent prosecutor at the state level to investigate and prosecute any police officers as well as updating the department’s procedures for mass protests.
New Jersey Attorney General Gurbir Grewal announced that the state will ban police departments from using chokeholds, carotid artery neck restraints or similar tactics. Grewal said their use has led to several incidents where a suspect suffered asphyxiation. The order provides an exemption “in the very limited situations when deadly force is necessary to address an imminent threat to life.”
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There are almost 8,000,000 confirmed cases of the coronavirus worldwide, with over 420,000 deaths. As many countries open up again, the World Health Organization warned the situation is getting worse globally. Nearly 75% of recent cases came from 10 countries, mostly in the Americas and South Asia, said the WHO. The WHO also said that the spread of COVID-19 by asymptomatic people appears to be rare.
Latin America remains the epicenter of the pandemic now with the highest tolls reported in Brazil, Mexico, Chile and Peru — which together account for over 1 million confirmed cases. The WHO said Central and South America have likely not reached peak transmission yet. Cuba remains announced they are closing in on the tail end of the pandemic, where infections have been on the decline for two months.
The number of confirmed coronavirus cases continues to rise in U.S. states that were among the first and most aggressive to reopen, leading some local officials to reconsider reopening plans. In Oregon, Gov. Kate Brown announced a 7-day statewide pause on further reopening as health officials study the data and try to contain budding outbreaks. In Arizona, Gov. Doug Ducey tried to reassure people that the rise in confirmed cases was expected and that the state’s hospitals have the capacity to handle a further surge.
Recent data shows 21 states have seen an increase in their average daily new Covid 19 cases this week than in the previous week. Alabama, Oregon and South Carolina are among the states with the biggest increases. Alabama saw a 92 percent change in its seven-day average, while Oregon’s seven-day average was up 83.8 percent and South Carolina’s was up 60.3 percent. Hospitalizations have risen as well. For example, Arkansas has seen a 120.7 percent increase in hospitalizations, from 92 cases to 203, since Memorial Day.
Health officials warn that mass gatherings of any type could worsen the spread of the virus, as the 2020 election heats up and nationwide protests against racism and police brutality stretch into their third week across the globe. CDC continues to study the spread and effects of the novel coronavirus across the United States. We now know from recent studies that a significant portion of individuals with coronavirus lack symptoms (“asymptomatic”) and that even those who eventually develop symptoms (“pre-symptomatic”) can transmit the virus to others before showing symptoms. This means that the virus can spread between people interacting in close proximity—for example, speaking, coughing, or sneezing—even if those people are not exhibiting symptoms.
In light of this new evidence, CDC recommends wearing cloth face coverings in public settings where other social distancing measures are difficult to maintain (e.g., grocery stores and pharmacies) especially in areas of significant community-based transmission. It is critical to emphasize that maintaining 6-feet social distancing remains important to slowing the spread of the virus. CDC is additionally advising the use of simple cloth face coverings to slow the spread of the virus and help people who may have the virus and do not know it from transmitting it to others. Cloth face coverings fashioned from household items or made at home from common materials at low cost can be used as an additional, voluntary public health measure.
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The New York Times editorial page editor James Bennet has resigned following outrage from staff and readers over the publication of an op-ed by Senator Tom Cotton about the protests called “Send in the Troops.” In a statement, The Times said that James Bennet had resigned and that Katie Kingsbury would serve as the acting editorial page editor through the November election. The deputy editorial page editor, Jim Dao, is being reassigned to the newsroom and is stepping off the masthead.
In the opinion piece, Sen. Tom Cotton, advocated for deploying the military for riots. The senator described looting in New York City as “carnivals for the thrill-seeking rich as well as other criminal elements,” and wrote that leftist ntifa movement had infiltrated protest marches despite an earlier Times article that reported Antifa involvement in the protests as misinformation. The column immediately drew backlash, with dozens of Times journalists voicing their opposition, tweeting the headline, caption and a form of the phrase “Running this puts Black @NYTimes staff in danger.”
Both Sulzberger and Bennet first defended the decision to run the column but the Times reversed itself and said the column had not met editorial standards. The Times reported that Bennet said in a meeting with staff members that he had not read the essay before it was published. And the paper added an editor’s note to the top of the original column. “We’ve examined the piece and the process leading up to its publication,” said Eileen Murphy, a Times spokeswoman. “This review made clear that a rushed editorial process led to the publication of an op-ed that did not meet our standards. As a result, we’re planning to examine both short-term and long-term changes, to include expanding our fact-checking operation and reducing the number of op-eds we publish.”
Meanwhile, Stan Wischnowski, the top editor of The Philadelphia Inquirer, has also resigned days after the paper published a piece titled “Buildings Matter, Too.” The newsroom vet resigned after backlash from staff over that headline on a story that said “there could be a gaping hole in the heart of Philadelphia” amid protests over the killing of George Floyd.
Dozens of journalists signed an open letter to their editors explaining their decision to call out “sick and tired,” CNN reported. “They said they have spent ‘months and years’ trying to gain the public’s trust only to have it “eroded in an instant by careless, unempathetic decisions.” The paper issued an apology the next day. But it wasn’t just the article that played a role in Wischnowski’s resignation. Wischnowski and other editors had scheduled a staffwide Zoom meeting to discuss race at The Inquirer and the pressures in particular faced by journalists of color before the article was published.
The Zoom session started off with Wischnowski telling staffers about the strides made in diversifying its 213-member newsroom but the session turned intense and emotional. Some journalists could be seen in tears in their Zoom frames. Critics, black and white, denounced the pace of change at the paper, sharply criticizing both coverage and the racial and gender mix of the staff. Several journalists pointed out that the newspaper could muster only one male African American reporter to cover the protests and police response convulsing a city that is majority minority. Hours after the wrenching Zoom session, about 50 journalists of color signed an open letter calling for faster changes at the paper. The following day, most of the minority staff took the day off from work in protest.
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Protests erupted in Minneapolis, Minnesota after video footage of the death of George Floyd, 46, went viral. Floyd died after being arrested by police outside a shop on May 25th on a report he used a fake $20 bill to buy a pack of cigarettes from Cup Foods, a grocery store. The video shows now fired police officer, Derek Chauvin, kneeling on Mr Floyd’s neck while he was laying on his stomach in the street with his hands cuffed behind his back. Floyd can be heard repeatedly saying “Please, I can’t breathe, please, please officer don’t kill me” for the 8 minutes and 46 seconds that Officer Chauvin held him pinned to the ground with his knee on the back of Floyd’s neck.
In the video of the incident, a bystander tells the police: “You got him down. Let him breathe.” After Floyd says, “I’m about to die,” Chauvin tells Floyd to relax. The police ask Floyd: “What do you want?” Floyd repeats: “I can’t breathe.” Floyd continues: “Please, the knee in my neck, I can’t breathe.” The policemen taunt Floyd to “get up and get in the car,” to which Floyd replies: “I will… I can’t move.” Floyd also cries out: “Mama!” He then says “My stomach hurts, my neck hurts, everything hurts,” and requests water. The police do not audibly respond to Floyd. Floyd begs: “Don’t kill me.” A bystander points out that Floyd is bleeding from the nose. Another bystander tells the police that Floyd is “not even resisting arrest right now.”
The day after Mr. Floyd’s death, the Police Department fired all four of the officers involved and the Hennepin County attorney, Mike Freeman, announced murder and manslaughter charges against Derek Chauvin, the officer who can be seen most clearly in witness videos pinning Mr. Floyd to the ground. Chauvin kept his knee on Floyd’s neck for eight minutes and 46 seconds, according to the criminal complaint against him. Video show that Chauvin did not remove his knee even after Mr. Floyd lost consciousness and for a full minute after paramedics arrived at the scene. Floyd’s last words have been compared to those of Eric Garner who uttered the words “I can’t breathe” eight times before he died while being placed in a chokehold by Officer Daniel Pantaleo in July 2014.
Derek Chauvin had 18 complaints over his 19 year career as a police officer with 2 resulting in disciplinary actions. Chauvin has been the subject of several internal complaints as well. George Floyd and fired police officer Derek Chauvin knew each other before the fatal encounter. Chauvin worked outside security at a bar for 17 years while Floyd worked security inside the bar. Floyd grew up in Houston Texas and 13 years ago in 2007 he was charged with armed robbery in a home invasion in Houston In 2009 he was sentenced to five years in prison as part of a plea deal, according to court documents. In 2014 he moved to Minneapolis looking for work and a new start. Videos he posted on social media while under stay at home orders show him denouncing violence and encouraging his community to find another way.
While the protests started in Minnesota, they quickly spread across the globe. Demonstrators gathered in London, France, Germany, Denmark, Italy, Syria, Brazil, Ireland, Poland, Mexico, Canada and New Zealand, among other places, to protest against police brutality in solidarity with the US crowds. Demonstrators have gathered in the thousands in many major cities worldwide. Many protestors remain peaceful but their message has been marred by the violence, looting and vandalism taking place in cities across the US.
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In St. Joseph Missouri, 422 workers at a Triumph Foods pork plant have tested positive for the coronavirus and all of them were asymptomatic, according to state health officials. After nearly three dozen workers at the plant became infected last month, the Missouri Department of Health and Senior Services tested all asymptomatic workers at the plant from April 27 to May 1. The testing found that 422 of 2,367 workers tested positive despite showing no symptoms.
Those workers have been advised to self-isolate for 10 days before returning to work, according to federal health guidelines. The plant remains open, along with a mobile testing site operated by Northwest Health Services. The company just confirmed that one employee, a man in his 40s with underlying health issues has died of Covid 19. The company said he was one of the first workers to be tested and had not returned to work since April 21.
“While individuals tested during this initiative did not show COVID-19 symptoms, lab results received thus far indicate that around 17% tested positive for the virus. Of all the positive test results received thus far, over 90% have been collected from asymptomatic people,” explained Mark Campbell, CEO of Triumph Foods. Employees with positive results were notified and asked to self-isolate. The state health department began tracing measures and have confirmed that nearly 200 people were infected with Covid 19 by some of the asymptomatic Triumph workers. Meanwhile, the state continues to work to contact trace the affected employees and now those they have infected as well.
Missouri Governor Parsons issued a state wide stay at home order on April 6th yet the asymptomatic employees still infected almost 200 people in the counties they live in. Kansas City and Wyandotte County, where the new cases were confirmed, have been under stay at home orders issued by Mayor Lucas since March 24. Despite those orders being issued first and ending later than the state wide order, they still had a spike in cases due to the outbreak at Triumph Foods.
Outbreaks have become common at other meat plants across the U.S., infecting thousands of workers, leading to the closure of some plants and prompting meat shortages. Several big grocery chains this week were restricting customer purchases of meat, and Wendy’s was unable to serve hamburgers at some locations due to shortages. Other packing plants are beginning to test all employees like Triumph Foods, which industry leaders say is critical to assure employees that it’s safe to go back to work and to grow data sets to show how the virus works.
For most people, the coronavirus causes mild or moderate symptoms that clear up after two to three weeks. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia. Because the virus is still circulating through the community, it’s important to maintain social distancing, mask wearing and hand-washing, even after stay-at-home orders are lifted.
Dr. Aamina Akhtar, Mercy Hospital South chief medical officer and an infectious disease specialist said “The next two to three weeks will be telling, and will really give us an idea whether human actions will lead to an increased number of cases. Our actions today will affect the community around us. It’s a big social responsibility and I hope we are ready.”
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The Food and Drug Administration (FDA) announced the emergency use authorization for the antiviral drug remdesivir, after preliminary results from a federal trial showed the drug could speed recovery in patients infected with the coronavirus. The finding, which has not yet been peer reviewed, came after another study found no benefit for the drug in severely ill patients in China. The new results suggest a moderate improvement in the death rate of patients taking remdesivir, whose hospital stays were shortened, on average, from 15 days to 11.
The issuance of an EUA is different than FDA approval. In determining whether to issue an EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks of any unproven products with any known or potential benefits of making them available during the emergency. Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.
The emergency use authorization (EUA) allows for remdesivir to be distributed in the U.S. and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.
The EUA requires that fact sheets that provide important information about using remdesivir in treating COVID-19 be made available to health care providers and patients, including dosing instructions, potential side effects and drug interactions. The EUA is temporary and will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated. It may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.
Possible side effects of remdesivir include increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering.
The top coronavirus task force scientist Dr. Anthony Fauci welcomed news of the first potential treatment for COVID-19. The U.S. government will coordinate the donation and distribution of remdesivir to hospitals in cities most heavily impacted by COVID-19. Given the severity of illness of patients appropriate for remdesivir treatment and the limited availability of drug supply, hospitals with intensive care units and other hospitals that the government deems most in need will receive priority in the distribution of remdesivir.
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