- Dr. Anthony Fauci said Wednesday that a recent study into remdesivir had shown positive results in decreasing the time to recovery in COVID-19 patients, though he also noted that it hadn’t shown an ability to decrease the mortality rate.
- Following the release of this information, it’s now being reported that the Food and Drug Administration will likely grant emergency use of the drug.
- Still, health officials are warning that remdesivir is not a miracle drug, though they are optimistic that it can eventually be used in combination with other drugs to create even more efficacious treatments.
FDA Likely To Approve Remdesivir for Emergency Use
White House health advisor Dr. Anthony Fauci announced Wednesday that a clinical trial of the antiviral drug remdesivir showed a “clear-cut positive effect in diminishing time to recovery” for coronavirus patients.
Speaking from the oval office, Fauci said a trial conducted by the National Institutes of Health showed that patients recovered in an average of 11 days if they were on the drug. By contrast, he said it took 15 days for those in the placebo group to recover.
It is also being reported that the Food and Drug Administration is now likely to grant emergency use authorization for remdesivir, which is manufactured by Gilead Sciences.
“As part of the FDA’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in… discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate,” FDA spokesperson Michael Felberbaum said in statement.
Though the drug has not yet shown statistically significant decreases in the mortality rate for COVID-19 patients, results from the NIH do suggest survival benefits. According to the NIH, people receiving the drug also saw a mortality rate of 8% as opposed to 11.6% in the placebo group.
As such, health officials aren’t calling remdesivir a miracle treatment; however, it is a hopeful sign that patients might not have to spend as long in the hospital. As Fauci noted, it will also become a standard of care and will guide clinicians in their approach on how to best treat COVID-19, especially since no other treatments have been approved for the disease.
“Although a 31% improvement doesn’t seem like a knockout 100%, it is very important proof of concept,” Fauci said. “What it has proven is that a drug can block this virus.”
Specifically, remdesivir works by blocking enzymes that the SARS-CoV-2 virus needs to be able to replicate. Because of that, future treatments could include a combination of remdesivir and another drug. In fact, the NIH is already moving forward on testing remdesivir with anti-inflammatory drugs.
Fauci called the study “the first truly high-powered randomized placebo controlled trial” and said about 1,090 participated in it internationally.
During his announcement, Fauci noted that the final analyses for this trial have not yet been completed. While he said he would usually hold off on releasing results of such a trial for several more days, he emphasized the importance of shifting placebo groups to the actual drug as quickly as possible.
“Whenever you have clear-cut evidence that a drug works, you have an ethical obligation to immediately let the people who are in the placebo group know so that they can have access,” Fauci said.
The trial was launched in February after the U.S. evacuated and recruited an American patient from the Diamond Princess cruise ship docked in Japan. From there, the NIH expanded the trial by recruiting other COVID-19 patients. For each of those patients, the process involved giving them either the drug or a placebo for five to 10 days.
WHO Says It’s Too Early to Comment on Remdesivir
The World Health Organization seemed to restrain some of the expectations of remdesivir’s success on Wednesday.
“Typically, you don’t have one study that will come out that will be a game changer,” said Dr. Maria Van Kerkhove, the WHO’s technical lead for the coronavirus response.
Kerkhove then explained that the WHO will generally look at multiple studies before reviewing evidence on a drug’s effectiveness.
“It can sometimes take a number of publications to determine (what) the ultimate impact of a drug is,” Dr. Mike Ryan, executive director of the WHO’s health emergencies program, said.
Other researchers have echoed similar explanations that more research will still need to be conducted with remdesivir as well as other drugs.
“We have work to do. We are looking for other therapies. This trial is going to continue,” said Dr. Andre Kalil told CNN.
Still, Kalli noted that even with that, remdesivir’s currently known benefits are quite significant, especially if patients need a ventilator.
“Four days (fewer) in a hospital is, for me as a clinician—as a clinical practitioner—it is not only significant but very meaningful,” he said.
According to The Washington Post, Eric Topol, director of the Scripps Research Translational Institute, said remdesivir “isn’t a breakthrough drug” and that it has offered a mix of good and bad results that paints a “confusing picture.” Still, he noted that it is a “good start,” calling it efficacious and safe.
Gilead’s Smaller Trial
Also on Wednesday, Gilead released the results of its own study of remdesivir. In it, the company said patients who took remdisivir for five days did just as well as those who took it for 10 days.
Notably, if found to be accurate, that would mean people would not need to receive as much of the drug, making more of it available to a wider group of patients.
“The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir,” Merdad Parsey, Gilead’s chief medical officer, said. “This is particularly important in the setting of a pandemic, to help hospitals and health care workers treat more patients in urgent need of care. ”
Gilead’s study, however, was much smaller than the NIH trial as it looked at 397 patients all with “severe” cases of COVID-19. It also didn’t use a control group, a criticism that several international studies into the potential vaccines chloroquine and hydroxychloroquine have also faced.
According to Gilead, the company actively prioritized remdesivir’s manufacturing over that of a placebo early in the pandemic.
“Our goal with these studies was to answer the question of treatment duration, comparing safety and efficacy with five or 10 days of remdesivir treatment,” the company said in a statement. “A placebo control was not necessary to answer this question. The open-label study design was necessary to understand whether shortening the duration of therapy can lead to earlier discharge from the hospital.”
Gilead said it has now expanded its study to be conducted at 180 locations internationally.
See what others are saying: (CNN) (CNBC) (The Washington Post)
Viral Photo of Crowded Reopened Georgia High School Sparks Concerns
- A viral photo showing students at North Paulding High School in Georgia walking in a crowded hallway without masks has sparked widespread concerns about schools reopening safely.
- According to BuzzFeed News, there is at least one football player that has tested positive for the coronavirus, as well as several staff members.
- Students who choose to not go to school can be suspended or expelled. Additionally, students who share content criticizing the school can be punished as well, and two have already been suspended for sharing photos of crowded halls, according to BuzzFeed.
- This school is just one of many in Georgia making headlines for seeing positive COVID-19 cases. In Cherokee County, there are four schools with confirmed cases that have forced dozens of students to quarantine within their first week back.
Viral Photo in North Paulding High School
When North Paulding High School in Georgia opened back up on Monday, kids were crammed in the hallway between classes, shoulder to shoulder, many without masks.
A photo that captured one of these crowded halls quickly went viral, prompting widespread outrage as it highlighted just one of several concerns many have about schools reopening throughout the state.
Paulding County Schools Superintendent Brian Otott addressed the photo in a letter early this week, claiming that it lacked larger context. Masks are not mandatory at North Paulding, as the school district said that the choice to wear a mask is a personal one, and claim enforcing a mandate is not realistic. Otott also said that students are not passing one another in the hallway to transmit COVID-19.
Health experts, however, do not believe this is true. With such close proximity and a lack of masks, transmission in situations like this is still possible. The school’s first day also comes as both new cases and deaths in the state of Georgia are in their peak. So far, the state has had a total of 186,395 cases and 3,899 deaths.
If that photo did not spark enough concerns, there is also already at least one confirmed coronavirus case on North Paulding’s football team. According to BuzzFeed News, footballers at the school are not the only ones at risk.
Teachers told the outlet that there are positive cases among the staff, including an employee who came into contact with most teachers while they were symptomatic. Still, the school will not confirm cases among employees for privacy reasons.
“That was exactly one week ago, so we are all waiting to see who gets sick next week,” one teacher told BuzzFeed.
Most who are nervous about attending school are left with essentially no other option than to face their fears and risk infection. Virtual learning was an option for students at North Paulding, but the limited slots filled up quickly. On top of this, BuzzFeed News learned from a set of parents who wanted to keep their son home upon seeing the photo, that any student who chooses to not attend school could face suspension or expulsion.
On top of this, the school made an announcement warning students that anyone who shared negative content about the school online would face disciplinary action. According to BuzzFeed News, two students have already been suspended for sharing now-viral photos of crowded halls.
North Paulding is not the only school in the state making headlines. In Cherokee County, a second grader tested positive for the virus on the first day of school. Now, their class of 20 students will be quarantining for 14 days.
On Wednesday, officials announced that three additional schools in the county had positive cases. Those cases involved a first grader, eighth grader, and Kindergarten teacher. Several students and staff at each of these schools now must undergo a two week quarantine as well.
Statewide, school officials are concerned about what the school year will look like.
“So long as COVID-19 runs rampant, there will be too many bodies in close quarters for us to co-exist in a traditional setting,” Dooly County Schools Superintendent Craig Lockhart telling the Atlanta Journal-Constitution. “We are not ready to return to in-person schooling and be highly confident that we can protect employees and students.”
But on the other side of this, there are parents and students eager to get back to in person classes, either because they trust their school district to handle things well, or because online learning at home just was not working well for them.
“There is a really strong case for trying to reopen schools because there are so many benefits, both for children, not only academic benefits but health and social-emotional health, and also for families, many of whom are trying to get back to work to restart the economy,” Charlene Wong, an assistant professor of pediatrics at the Duke School of Medicine also told the AJC.
Can Kids Spread the Virus?
Still, Wong believes that safety opening schools is complex and requires a multitude of safety measures. The risk is especially high because experts are still in the early stages of learning what role children play in spreading and getting this virus, especially in a crowded space like a school. Currently, most studies and research have not focused on children, so there is not enough data to prove anything just yet, despite the widespread belief that children are less likely to get and transmit the virus.
In fact, one case out of Georgia proves that idea wrong. One summer camp in Georgia was forced to close after there were 260 coronavirus cases on site, the majority of which came from people aged 17 and younger.
Another study done in South Korea concluded that while children nine and under do not transmit the virus as frequently as adults, the risk of them doing so still exists. That study also claims that people between the ages 10 and 19 actually spread COVID-19 at the same rate as adults.
See what others are saying: (BuzzFeed News) (Atlanta Journal-Constitution) (Washington Post)
NJ Woman Charged for Assaulting Staples Customer Who Asked Her to Correctly Wear a Mask
- New Jersey Police have charged 25-year-old Terri Thomas with second-degree aggravated assault for violently tossing a woman with a cane to the ground at a Staples store last Wednesday.
- Thomas attacked 54-year-old Margot Kagan for telling her to wear her face mask properly.
- Kagan, who police say had a liver transplant four months ago, was hospitalized and is recovering from a leg injury that required surgery as a result of the incident.
Police in New Jersey said Tuesday that they arrested and charged a woman caught on surveillance video attacking a fellow Staples customer who told her to correctly wear her mask.
The dispute happened inside a Hackensack Staples store last Wednesday when 54-year-old Margot Kagan was using the copy machine. Kagan, who police said had a liver transplant four months ago, noticed 25-year-old Terri Thomas walk by with her mask below her mouth.
Kagan told a local news station that she told Thomas, “You should really put a mask on,” and warned her that she was endangering everyone. However, the remarks made Thomas angry she reportedly began yelling.
The surveillance footage shows Thomas walking towards Kagan, who lifts her cane to keep Thomas away. Thomas then reaches for the cane and violently tosses Kagan to the ground.
Thomas walks out of view for a few seconds and when she returns, Kagan sticks her leg out to trip Thomas, but Thomas ultimately walks away unharmed and leaves the store.
Injuries and Charges
Kagan was hospitalized after the attack and police said she left with a fractured left tibia that required surgery. However, Kagan later told ABC 7 she suffered a broken knee and required a steel plate to be put in. She also claims she’s been told by doctors that she won’t be able to put weight on her leg for seven to 10 weeks.
As far as Thomas, police have charged her with second-degree aggravated assault and she was released on a summons pending a court appearance on August 24. In New Jersey, the charge is punishable by 5-10 years in jail, and fines as high as $150,000.
Hackensack police are encouraging anyone who witnessed the crime or have any information to reach out to them.
Aurora Police Apologize for Drawing Weapons on Black Family in Mistaken Stop
- Police drew guns on a Black family in Aurora, Colorado on Sunday who they believed were in a stolen vehicle, ordering the group out of the car and facedown down on the ground.
- The passengers were girls between the ages of 6 and 17 and video shows them sobbing in fear during the incident, with at least two minors in handcuffs.
- The adult female driver was able to confirm that the car was not stolen and police explained that the car had the same plate information as a car reported stolen in a different state. They also blamed the mixup on the fact that the family’s car was reported stolen earlier this year, even though Aurora police returned it back to them a day later.
- The city’s new police chief apologized and offered them therapy resources. She also said officers followed protocol but should be allowed to use discretion to deviate in situations like this and has ordered her team to look at new training practices.
Police in Aurora, Colorado apologized Monday for drawing weapons on a Black family after mistaking their car for another stolen vehicle.
On Sunday, August 2, Brittney Gilliam decided to take her 6-year-old daughter, 12-year-old sister, and 14 and 17-year-old nieces out to get their nails done. Gilliam told CNN that her niece had just gotten back in the car after looking to see if the nail salon they wanted to go to was open. At this point, she and the girls were parked in a parking lot with the car turned off.
That’s when Aurora police pulled up behind the vehicle with guns drawn. Then, police allegedly yelled at the group to put their hands out of the window and get out of the car.
She said the family exited the vehicle and were told to lay face down on the ground. At that time, police handcuffed Gilliam, her 12-year-old sister, and 17-year-old niece. Gilliam claims that police would not explain why she was pulled over until she was handcuffed. Then, they pulled her away to verify her claim that the car was not stolen as the children remained on the ground.
A bystander named Jennifer Wurtz began recorded the incident after the family was handcuffed. The footage is about 12 and a half minutes long, but a shorter minute in a half-second clip went viral on Twitter. That clip shows the minors facedown on the floor sobbing as police try to keep onlookers away.
Eventually, police sit the children up and in the longer video, Wurtz can be heard pressing the officers about why they had drawn guns on children.
Police repeatedly asked her to stop interfering, however, they did say she had the right to film. Wurtz stopped pointing the phone towards the scene, but continued to criticize the stop and asked for the officers’ names.
As frustration from onlookers grew, one officer explained that this was a “high-risk stop” and that police were following procedure.
The onlookers were still angry about the policy being used against children and became angrier after learning that the car was in fact, not stolen.
What Caused the Confusion?
As far as what the mixup actually was, Gilliam explained that she had reported her car stolen in February, but that case was cleared up. In fact, her attorney told CNN that when her vehicle was stolen, it was actually returned to her the next day by Aurora police.
In a statement late Monday, Intern Chief of Police Vanessa Wilson said that after the stop, police realized the car Gilliam was driving was not stolen. Instead, another vehicle with the same plate information but from a different state had been. The Associated Press reported that the vehicle was a motorcycle from Montana.
In her statement, Wilson said “The confusion may have been due, in part, to the fact that the stopped car was reported stolen. After realizing the mistake, officers immediately unhandcuffed everyone involved, explained what happened and apologized.”
“I have called (Gilliam’s) family to apologize and to offer any help we can provide, especially for the children who may have been traumatized by yesterday’s events,” she continued. “I have reached out to our victim advocates so we can offer age-appropriate therapy that the city will cover.”
Outrage and Apology
Still, that did little to put the community at ease, especially since the incident comes amid widespread frustration over how Black people are treated by police. Frustrations are especially high in Aurora, where police have faced security for the 2019 death of Elijah McClain. McClain was an unarmed Black man who was stopped by officers as he walked home after he was reported as a suspicious person in a ski mask.
During the confrontation, officers placed him in a chokehold and paramedics injected him with ketamine to sedate him. He then suffered a heart attack in the ambulance and was declared brain dead days later before being taken off life support.
Just last month, two officers were fired for reenacting the chokehold in a photo near the memorial site for Elijah McClain A third officer was fired for not alerting supervisors about the photo while a fourth resigned before a disciplinary hearing about the incident.
So this latest incident piled on the existing outrage against the local department and police policies in general. And many, including Gilliam, felt that the stolen car mixup did not justify how the young girls were treated.
“That’s police brutality,” she told KUSA. “There’s no excuse why you didn’t handle it a different type of way. … You could have even told them, ‘Step off to the side let me ask your mom or your auntie a few questions so we can get this cleared up.’ ”
In her statement, Chief Wilson confirmed that a suspect in a stolen vehicle is a high-risk stop, and said officers followed procedures they are trained to carry out. However, she added that the department, “must allow our officers to have discretion and to deviate from this process when different scenarios present themselves.”
Wilson added that an internal investigation into this incident has been opened and said she had directed her team to look at new practices and training. Her promises to reexamine department practices are especially significant because that same Monday night, Aurora’s city council voted to make Wilson the city’s permanent police chief.