Connect with us

U.S.

Is Remdesivir the Coronavirus Treatment We’ve All Been Hoping For? No, But It Could Be the First Step

Published

on

  • 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)

U.S.

Lincoln College to Close for Good After COVID and Ransomware Attack Ruin Finances

Published

on

Last year, 1,043 schools in the U.S. were the victim of ransomware attacks, including 26 colleges or universities, according to an analysis by Emsisoft.


One of the Only Historically Black Colleges in the Midwest Goes Down

After 157 years of educating mostly Black students in Illinois, Lincoln College will close its doors for good on Friday.

The college made the announcement last month, citing financial troubles caused by the coronavirus pandemic and a ransomware attack in December.

Enrollment dropped during the pandemic and the administration had to make costly investments in technology and campus safety measures, according to a statement from the school.

A shrinking endowment put additional pressure on the college’s budget.

The ransomware attack, which the college has said originated from Iran, thwarted admissions activities and hindered access to all institutional data. Systems for recruitment, retention, and fundraising were completely inoperable at a time when the administration needed them most.

In March, the college paid the ransom, which it has said amounted to less than $100,000. But according to Lincoln’s statement, subsequent projections showed enrollment shortfalls so significant the college would need a transformational donation or partnership to make it beyond the present semester.

The college put out a request for $50 million in a last-ditch effort to save itself, but no one came forward to provide it.

A GoFundMe aiming to raise $20 million for the college only collected $2,452 as of Tuesday.

Students and Employees Give a Bittersweet Goodbye

“The loss of history, careers, and a community of students and alumni is immense,” David Gerlach, the college’s president, said in a statement.

Lincoln counts nearly 1,000 enrolled students, and those who did not graduate this spring will leave the institution without degrees.

Gerlach has said that 22 colleges have worked with Lincoln to accept the remaining students, including their credits, tuition prices, and residency requirements.

“I was shocked and saddened by that news because of me being a freshman, so now I have to find someplace for me to go,” one student told WMBD News after the closure was announced.

When a group of students confronted Gerlach at his office about the closure, he responded with an emotional speech.

“I have been fighting hard to save this place,” he said. “But resources are resources. We’ve done everything we possibly could.”

On April 30, alumni were invited back to the campus to revisit the highlights of their college years before the institution closed.

On Saturday, the college held its final graduation ceremony, where over 200 students accepted their diplomas and Quentin Brackenridge performed the Lincoln Alma Mater.

Last year, 1,043 schools in the U.S. were the victim of ransomware attacks, including 26 colleges or universities, according to an analysis by Emsisoft.

See what others are saying: (The New York Times) (Herald Review) (CNN)

Continue Reading

U.S.

U.S. Tops One Million Coronavirus Deaths, WHO Estimates 15 Million Worldwide

Published

on

India’s real COVID death toll stands at about 4.7 million, ten times higher than official data, the WHO estimated.


One Million Dead

The United States officially surpassed one million coronavirus deaths Wednesday, 26 months after the first death was reported in late February of 2020.

Experts believe that figure is likely an undercount, since there are around 200,000 excess deaths, though some of those may not be COVID-related.

The figure is the equivalent of the population of San Jose, the tenth-largest city in the U.S., vanishing in just over two years. To put the magnitude in visual perspective, NECN published a graphic illustrating what one million deaths looks like.

At the beginning of the pandemic, the White House predicted between 100,000 and 240,000 Americans would die from the coronavirus in a best-case scenario.

By February 2021, over half a million Americans had died of COVID.

The coronavirus has become the third leading cause of death in the U.S. behind heart disease and cancer.

The pandemic’s effects go beyond its death toll. Around a quarter of a million children have lost a caregiver to the virus, including about 200,000 who lost one or both parents. Every COVID-related death leaves an estimated nine people grieving.

The virus has hit certain industries harder than others, with food and agriculture, warehouse operations and manufacturing, and transportation and construction seeing especially high death rates.

People’s mental health has also been affected, with a study in January of five Western countries including the U.S. finding that 13% of people reported symptoms of PTSD attributable to actual or potential contact with the virus.

Fifteen Million Dead

On Thursday, the World Health Organization estimated that nearly 15 million people have died from the pandemic worldwide, a dramatic revision from the 5.4 million previously reported in official statistics.

Between January 2020 and the end of last year, the WHO estimated that between 13.3 million and 16.6 million people died either due to the coronavirus directly or because of factors somehow attributed to the pandemic’s impact on health systems, such as cancer patients who were unable to seek treatment when hospitals were full of COVID patients.

Based on that range, scientists arrived at an approximate total of 14.9 million.

The new estimate shows a 13% increase in deaths than is usually expected for a two-year period.

“This may seem like just a bean-counting exercise, but having these WHO numbers is so critical to understanding how we should combat future pandemics and continue to respond to this one,” Dr. Albert Ko, an infectious diseases specialist at the Yale School of Public Health who was not linked to the WHO research, told the Associated Press.

Most of the deaths occurred in Southeast Asia, Europe, and the Americas.

According to the WHO, India counts the most deaths by far with 4.7 million, ten times its official number.

See what others are saying: (NBC) (U.S. News and World Report) (Scientific American)

Continue Reading

U.S.

Official Says Missing Alabama Convict and Corrections Officer Had a “Special Relationship”

Published

on

Authorities have also said they now believe the officer willfully helped the inmate escape.


New Information on Missing Inmate & Officer

Authorities in Alabama revealed Tuesday that Assistant Director of Corrections for Lauderdale County Vicky White, who is accused of helping a murder suspect Casey Cole White escape from jail, had a “special relationship” with the inmate.

“Investigators received information from inmates at the Lauderdale County Detention Center over the weekend that there was a special relationship between Director White and inmate Casey White,” Lauderdale County Sheriff Rick Singleton said in a statement. “That relationship has now been confirmed through our investigation by independent sources and means.”

Officials have previously said that the two are not related, despite their shared surname.

Singleton elaborated on the nature of the relationship while speaking to CNN later on Tuesday. He said it took place “outside of her normal work hours” and added that although it did not include “physical contact,” he still characterized it as “a relationship of a different nature.”

“We were told Casey White got special privileges and was treated differently while in the facility than the other inmates,” Singleton said.

Also on Tuesday, the Marshals Service issued a statement confirming that authorities believe Officer White had helped Mr. White escape. The authorities described her as a “wanted fugitive” and offered a $5,000 reward for any information on her whereabouts. Earlier this week, the Marshals Service also offered a $10,000 reward for any information that could lead to Mr. White’s capture.

Singleton echoed the belief that Officer White’s actions were intentional while speaking to Good Morning America Wednesday.

“I think all of our employees and myself included were really hoping that she did not participate in this willingly. But all indications are that she absolutely did,” he said. “We’re very disappointed in that because we had the utmost trust in her as an employee and as an assistant director of corrections.”

Mysterious Escape

Vicky White and Casey White were last seen leaving the Lauderdale County jail just after 9:30 a.m. Friday. The officer told other employees that she was taking the inmate to a mental health evaluation at a courthouse just down the road, and that she would be going to a medical appointment after because she was not feeling well.

Officials later said her actions violated an official policy that required two sworn deputies to transport people with murder charges. In 2020, Mr. White was charged with two counts of capital murder in connection to a fatal stabbing he confessed to and was awaiting his trial in Lauderdale County.

Mr. White was also serving time for what officials said was a “crime spree” in 2015 which included home invasion, carjacking, and a police chase. He had also previously tried to escape from jail, police said.

It wasn’t until 3:30 p.m. on Friday that a jail employee reported to higher-ups that he was not able to reach Officer White on her phone and that Mr. White had never been returned to his cell.

During a press conference that same night, Singleton told reporters that there had never even been a scheduled mental health evaluation. At another briefing Monday, he announced that an arrest warrant had been issued for Vicky on a charge of “permitting or facilitating an escape in the first degree.”

At the time, Singleton said it was unclear “whether she did that willingly or was coerced or threatened” but added, “we know for sure she did participate.” 

See what others are saying: (CNN) (ABC News) (NPR)

Continue Reading