- 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)
College Board Changes AP African American Studies After Backlash From DeSantis Amid Education Culture War
As requested by DeSantis, the College Board removed lessons on contemporary topics including Black Lives Matter, queer studies, and reparations.
College Board Rolls Out Curriculum
The College Board, which oversees Advanced Placement high school courses, announced an official curriculum framework for its new, landmark Advanced Placement African American studies on Wednesday.
The announcement, made on the first day of Black History Month, has faced scrutiny for seeming to scale back a number of relevant subjects that Florida Gov. Ron DeSantis (R) and other state education officials had criticized.
In January, DeSantis said that the new course would be banned in Florida unless changes were made, arguing that a draft version of the course was “woke.”
Education officials claimed that the class, which had been in the making for nearly a decade, violated a recent state law dubbed the Stop WOKE Act. The legislation regulates public school instruction on race by banning critical race theory and any education that describes some groups as oppressed and others as privileged based on race or sex.
Democrats denounced DeSantis’ action as a political stunt and urged the College Board to maintain its principles.
According to reports, many historical topics like slavery largely remain intact from the previous draft. However, important contemporary issues like Black Lives Matter, affirmative action, queer studies, reparations, and intersectionality — all of which Florida leaders objected to — were removed from curriculum requirements and are no longer part of the AP exam.
Instead, those areas of study have been downgraded to be part of a list of options students can pursue for a mandatory research project. The College Board also added a new research project idea to that list that will certainly please the right: “Black conservatism.”
It has additionally been reported that the organization pulled names of multiple Black authors the state education officials had flagged as problematic, including many famous and pioneering Black scholars who wrote about critical race theory, the queer experience, and Black feminism.
The College Board defended itself against criticism in a press release announcing the changes, claiming that the process of developing the framework “has operated independently from political pressure.”
DeSantis’ Ongoing Culture War
DeSantis’ attempts to influence the national curriculum of an AP course are just his latest in a much broader effort to control what is and is not taught in public schools.
Just one day before the College Board announced the revised course, the governor outlined what The New York Times described as “his most aggressive swing yet at the education establishment.”
Specifically, he proposed a massive overhaul to higher education in the state that would defund and eliminate diversity and equity programs, mandate courses on Western civilization, and reduce tenure protections that are essential to ensure professors have freedom of expression.
Furthermore, the effects of another law DeSantis signed last year are now just beginning to materialize. The policy, which went into effect this July, requires every school book to be age-appropriate, “free of pornography,” and “suited to student needs.”
To follow those guidelines, school books have to be approved by a certified media specialist who has undergone specific training.
Notably, the law also states that teachers can be charged with third-degree felonies if they “knowingly or unknowingly” give students access to a book that the specialists say is harmful — meaning that they could face up to five years in prison and a $5,000 fine.
Last month, the state education department clarified that the rule does not just apply to school libraries, but also to any books a teacher keeps in their classroom too.
Multiple outlets reported this week that records they obtained show at least two school districts have now directed teachers to either remove their books or hide them until review to avoid the possibility of going to jail.
See what others are saying: (The New York Times) (The Washington Post) (The Associated Press)
Biden Announces Plan to End COVID Emergency in May
The decision would drastically change the government’s long-standing pandemic response and shift Americans’ access to COVID-related services.
Emergency Declarations at an End
In a statement Monday, The White House announced that it would be ending the COVID national emergency and public health emergency declarations on May 11.
The move will entirely restructure the federal government’s response to the pandemic to treat it as endemic and upend policies that have been in place for the last three years. Although more than 500 people in the U.S. are still dying from COVID on average each day — which is around two times the number of daily deaths during a bad flu season — life has largely returned to normal.
Most Americans are vaccinated, and even President Joe Biden himself said the pandemic was “over” back in September. The new announcement comes in part as a response to resolutions Republicans brought to the House floor last week that would end the declarations immediately.
“An abrupt end to the emergency declarations would create wide-ranging chaos and uncertainty throughout the health care system — for states, for hospitals and doctors’ offices, and, most importantly, for tens of millions of Americans,” the White House argued.
Lapses in Coverage and Care
Federal officials decided that a phase-out would make more sense because the U.S. has come to rely on several systems and benefits under the emergencies.
One of the most significant changes that will have the biggest impact on Americans in their day-to-day lives is access to COVID tests, treatments, and vaccines that have been free throughout the pandemic.
Once the emergencies end, a very complex wave of changes will take place that differs from person to person depending on their insurance — or lack thereof — and even possibly what state they live in.
Currently, people with private health insurance or Medicare coverage have been allowed eight free COVID tests a month and insurers had to cover those tests, even if they were administered out of network.
Once the emergency ends, some Americans will have to pay out of pocket, as well as for antiviral COVID treatments like Paxlovid.
Notably, it has been reported that vaccines will still be included for all those people covered by both private and public insurance. That, however, may not be the case for those without insurance — a group that is also more likely to be the most affected by rising costs for tests and treatments.
Jen Kates, a senior vice president at the Kaiser Family Foundation, told The Washington Post that when the emergency declarations end, states that opted to provide Medicaid coverage for tests, treatments, and shots will lose the federal funds that matched costs at 100%.
“To me, that’s the biggest issue for the general public to think about,” she said. “The uninsured and underinsured have no guaranteed access to covid vaccines, tests or treatments.”
When it comes to vaccines, those costs could be significant. Moderna and Pfizer have both said they might charge as much as $130 per dose of vaccine once the federal government stops paying and the shots are transitioned to the private market. That figure is nearly quadruple what federal offices have paid for the doses.
The shift to the private market could happen fairly soon, especially because Republicans have refused Biden’s request that they put billions of dollars towards additional free COVID testing and shots to extend those efforts.
There could also be a spike in the number of uninsured or underinsured Americans because the $1.7 trillion spending bill passed last year ends a rule that banned states from kicking people off Medicaid, leaving millions at risk of losing coverage.
Other Possible Outcomes
Ending the declarations could also set up a battle around immigration because the Biden administration has said the move will bring an end to Title 42 — the Trump-era public health measure that placed restrictions on border crossings and other migrant policies.
Biden has previously tried to cut the program, but the Supreme Court kept it in place. House Republicans rejected the White House’s claim that the program would be terminated, arguing it is not tied to the public health emergency.
Beyond that, the termination of the declarations would require health providers to make numerous adjustments because many of the flexibilities they were allowed in a number of areas would be cut.
As a result, the administration says a phase-out of those policies over the next few months is necessary, arguing that hospitals and nursing homes “will be plunged into chaos” if they are cut immediately. House Republicans, however, are insistent on moving forward their legislation that would do just that, though the Democratic-controlled Senate could block their proposals.
See what others are saying: (The New York Times) (The Washington Post) (The Associated Press)
Conservatives are Mad at “Woke” Xbox for Minor Climate-Related Updates
The fury comes after Xbox announced it was slightly altering existing consoles to better utilize and save energy.
Same War, New Battlefield
Mere days after M&M canceled their “spokescandies” due to backlash from the right, led largely by Fox News’ Tucker Carlson, conservatives have found a new front for their ongoing culture war: Xbox.
Carlson spent months complaining that small character redesigns were “woke” because they made the animated anthropomorphized M&M’s — in his own words — “less sexy.” His campaign finally proved successful on Monday when the company announced it would be doing away with the spokescandies and replacing them with actress Maya Rudolph.
Conservatives, now facing a sudden dearth of non-issues to complain about, quickly found a new issue to rage against. Xbox announced in a blog post earlier this month that it is making minor updates to lower its environmental impact as part of an effort to reach Microsoft’s goal of being carbon-negative by 2030.
Now, instead of having an Xbox wake up to update games, apps, and software during random times of the night, it will do that at a time of night when a user’s local energy grid is generating the most power it can from renewable sources.
Xbox also said it would automatically update some older consoles to a power-saving mode that aims to reduce electricity consumption when it is turned off — a feature that is already the default on newer consoles.
According to The Verge, the only difference for users is that an Xbox in power-saving mode takes around 15 seconds to boot up instead of doing so immediately as the console does in “sleep” mode. The change is a small price to pay for what the outlet described as “significant” energy savings.
Xbox Under Fire
To many leading conservative voices, the minimal shifts were just another example of “woke” culture.
While discussing M&M’s spokescandies Tuesday morning, “Fox and Friends” co-host Ainsley Earhardt brought up Xbox’s new changes with Fox radio host Jimmy Failla.
“So Xbox has also announced that they’re going woke too, you know, because of climate change,” Earhardt said.
“I mean, it’s crazy what they’re doing, but we understand what this is. It’s not that it’s actually going to offset emissions, okay — the level of reduction is infinitesimal,” Failla claimed, without evidence. “But they’re trying to recruit your kids into climate politics at an earlier age; make them climate conscious now.”
“Yeah, I didn’t think of that — you’re right, they’re going after the children,” Earhardt agreed, despite the fact that internal data from Microsoft shows just around 10% of Xbox owners are under the age of 18.
Other prominent conservatives also did their part to bait Americans into anger on social media, including America’s Foundation, which posted a tweet stating that “the woke brigade is after video games.”
The post linked an article from the right-wing website TheBlaze, which asserted that “Xbox will force gamers to power down to fight climate change.” That, however, is false — Xbox has said users can switch back and change the settings any time they want
Still, top lawmakers continued to share the article and spread its false claims, including Sen. Ted Cruz (R-Tx.).
“First gas stoves, then your coffee, now they’re gunning for your Xbox,” he wrote in the post, which was flagged by Twitter and given an “added context” warning.
The same warning, however, was not placed in a very similar post by Rep. Troy Nehls (R-Tx.), who also shared the article.
“They want to take your guns. They want to take your gas stoves. And now they want to take your Xbox. What’s next?” he wrote.