- 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)
Katie Couric Says She Edited Ruth Bader Ginsburg Quote About Athletes Kneeling During National Anthem
Couric said she omitted part of a 2016 interview in order to “protect” the justice.
Kate Couric Edited Quote From Justice Ginsburg
In her upcoming book, journalist Katie Couric admitted to editing a quote from Supreme Court Justice Ruth Bader Ginsberg in 2016 in order to “protect” Ginsberg from potential criticism.
Couric interviewed the late justice for an article in Yahoo News. During their discussion, she asked Ginsburg about her thoughts on athletes like Colin Kaepernick kneeling for the national anthem to protest racial inequality.
“I think it’s really dumb of them,” Ginsburg is quoted saying in the piece. “Would I arrest them for doing it? No. I think it’s dumb and disrespectful. I would have the same answer if you asked me about flag burning. I think it’s a terrible thing to do, but I wouldn’t lock a person up for doing it. I would point out how ridiculous it seems to me to do such an act.”
According to The Daily Mail and The New York Post, which obtained advance copies of Couric’s book “Going There,” there was more to Ginsburg’s response. Couric wrote that she omitted a portion where Ginsburg said the form of protest showed a “contempt for a government that has made it possible for their parents and grandparents to live a decent life…Which they probably could not have lived in the places they came from.“
Couric Says She Lost Sleep Making Choice
“As they became older they realize that this was youthful folly,” Ginsberg reportedly continued. “And that’s why education is important.“
According to The Daily Mail, Couric wrote that the Supreme Court’s head of public affairs sent an email asking to remove comments about kneeling because Ginsburg had misspoken. Couric reportedly added that she felt a need to “protect” the justice, thinking she may not have understood the question. Couric reached out to her friend, New York Times reporter David Brooks, regarding the matter and he allegedly likewise believed she may have been confused by the subject.
Couric also wrote that she was a “big RBG fan” and felt her comments were “unworthy of a crusader for equality.” Because she knew the remarks could land Ginsburg in hot water, she said she “lost a lot of sleep” and felt “conflicted” about whether or not to edit them out.
Couric was trending on Twitter Wednesday and Thursday as people questioned the ethics behind her choice to ultimately cut part of the quote. Some thought the move showed a lack of journalistic integrity while others thought revealing the story now harmed Ginsburg’s legacy.
See what others are saying: (New York Post) (The Daily Mail) (Insider)
Biden Administration Orders ICE To Halt Workplace Raids
The Department of Homeland Security will now focus on targeting employers who exploit undocumented workers, instead of carrying out raids that dissuade those workers from reporting labor violations.
DHS Reverses Worksite Raid Policy
The Biden administration announced Tuesday that it was ordering Immigration and Customs Enforcement (ICE) to stop workplace raids.
The move marks a reversal from Trump administration policies that have been strongly criticized by immigration activists who argue the efforts created fear in immigrant communities and dissuaded them from reporting labor violations or exploitative employment practices.
In addition to stopping the raids, Department of Homeland Security (DHS) Secretary Alejandro Mayorkas said in a memo that the administration will refocus enforcement efforts to instead target “employers who exploit unauthorized workers, conduct illegal activities or impose unsafe working conditions.”
Mayorkas added that the immigration agencies housed in DHS will have the next 60 days to identify harmful existing policies and come up with new ones that provide better deportation protections for workers who report their employers.
In the Tuesday memo, the secretary argued that shift of focus will “reduce the demand for illegal employment by delivering more severe consequences to exploitative employers” and “increase the willingness of workers to report violations of law by exploitative employers and cooperate in employment and labor standards investigation.”
Labor Market Implications
The new policy comes at a time when the U.S. is experiencing a critical labor shortage, including in many sectors that rely on immigrant labor.
Some companies that use undocumented workers pay them wages that are far below the market rate, which is not only exploitative but also undercuts competitors.
According to Mayorkas, the pivot to employer-based enforcement will help protect American businesses.
“By exploiting undocumented workers and paying them substandard wages, the unscrupulous employers create an unfair labor market,” he said in the memo. “They also unfairly drive down their costs and disadvantage their business competitors who abide by the law.”
It is currently unclear how effective the new efforts will be, but historical precedent does not paint an optimistic picture.
The Biden administration’s efforts closely mirror a similar move by the Obama administration, which attempted to reverse workplace raids authorized under President George W. Bush by targetting those who employ undocumented workers rather than the workers themselves.
That effort, however, still led to thousands of undocumented workers being fired.
See what others are saying: (The Washington Post) (The New York Times) (ABC News)
Mom Charged for Hosting Secret Teen Parties, Pressuring Kids To Drink and Engage in Sex Acts
Investigators said some of the sex acts between teens were non-consensual and at times took place while the mother stood by laughing.
Mother Hit With Dozens of Charges
A California mother is facing 39 criminal charges after hosting a series of illegal parties for her teenage son and his mostly 14- and 15-year-old friends that regularly led to dangerous accidents and sexual assaults.
The mother, 47-year-old Shannon O’Connor, also known as Shannon Bruga, is currently awaiting extradition to Santa Clara County. According to The Mercury News, she was arrested Saturday in Ada County, Idaho, where she has a home in addition to her property in Los Gatos that is currently on the market.
Her criminal charges include 12 felony counts and 10 misdemeanor counts of child endangerment, one count of misdemeanor sexual battery, three counts of misdemeanor child molestation, and 13 misdemeanor counts of providing alcohol to minors.
“It took a lot of brave children to come forward and to untangle this deeply disturbing case,” Santa Clara County District Attorney Jeff Rosen said in a press release regarding the case. “As a parent, I’m shocked. As the DA, I’m determined to hold those adults who endanger children fully accountable to the law and our community.”
What Happened During the Parties?
Investigators claim O’Connor organized the functions, attended by as many as 20 teens, via text message and Snapchat. She would then allegedly supply the teens with alcohol and push them to binge drink, often to the point of illness or unconsciousness.
The harm that resulted from their intoxication included one teen breaking a finger and another almost drowning in a hot tub, among other serious situations.
In another instance, O’Connor let an unlicensed drunk teen drive her car. Her son and another one of his friends then hung off the back while it was moving, which caused the friend to fall, hit his head, and become unconscious for 30 seconds. He was later diagnosed with a concussion after spending the night vomiting.
O’Connor is additionally accused of manipulating and encouraging drunk teens to participate in sex acts with one another, which were sometimes non-consensual or carried out while she watched. In some cases, she allegedly laughed while the sexual acts happened or when assault victims asked her why she didn’t step in to help.
Investigators added that O’Connor required teens who attended her parties to keep them a secret. She’s even accused of helping them sneak out of their homes so she could drive them to her events. Authorities said she was found to have bullied at least one teen who she suspected of breaking the secret.
“Everyone should feel relieved this woman’s not on the street,” the parents of one assault victim told The Mercury News. “She was grooming these kids, setting them up for sexual acts, and she’s a mother and doing this to her own child. … I’ve been racking my brain trying to think what was in it for her.“