- 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)
Wisconsin Police Deny Planting Evidence in Viral Video, Release Their Own Body Cam Footage
The footage police released shows that during a search, officers found a corner tear from a plastic bag inside a backseat passenger’s pocket. An officer then discarded it into the car after determining that it was empty.
Viral Video Appears To Show Officer Planting Evidence
The Caledonia Police Department in Wisconsin has responded to a viral cell phone video that appears to show an officer planting a small plastic baggie inside of a car during a traffic stop.
The now-viral footage was posted to Facebook by a man who goes by GlockBoy Savoo.
The user, who also filmed the clip, wrote in his post’s caption that the officer did this “just to get a reason to search the car” and said the cop didn’t know he was being recorded by the passenger.
Police Shut Down Accusations With Their Own Footage
After that video spread across social media, many were outraged, calling the Caledonia police dirty for seemingly planting evidence. All the outrage eventually prompted the department to announce an investigation Saturday.
Within hours, the department provided an update, claiming that officers didn’t actually plant any evidence or do anything illegal.
Police shared a lengthy summary of events, along with two body camera clips from the incident. That statement explained that the driver of the vehicle was pulled over for going 63 in a 45mph zone.
Two passengers in the backseat who were then spotted without seatbelts were asked to identify themselves and step out of the car. During a search of one passenger’s pockets, an officer pulled out “an empty corner tear” from a plastic baggie.
Police claim the corner tear did not contain any illegal substances, though they said this type of packaging is a common method for holding illegal drugs.
In one body cam clip, an officer can be heard briefly questioning the backseat passenger about the baggie. Then, that piece of plastic gets handed off to different officers who also determined it as empty before the officer in the original viral video discarded it into the back of the car.
The officer can also be seen explaining where the plastic came from to the passenger recording him.
“Aye, bro you just threw that in here!” the front seat passenger says, as heard in his version of the events.
“Yeah, cause it was in his pocket and I don’t want to hold onto it. It’s on their body cam that they took it off of him…I’m telling you where it came from, so. It’s an empty baggie at the moment too, so,” the officer replies.
The department went on to explain that while it would discourage officers from discarding items into a citizen’s car, this footage proves that evidence was not planted.
Authorities also noted that no arrests were made in this incident and the driver was the only one issued a citation for speeding. The statement added that since four officers were present at the scene, police have more than six hours of footage to review but they promised to release the footage in full in the near future.
See what others are saying: (Heavy)(CBS 58) (Milwaukee Journal Sentinel)
Medical Groups, Local Leaders Push for Healthcare Workers and Public Employees To Get Vaccinated
The move comes as COVID cases have nearly quadrupled in the last month due to the rapid spread of the highly infectious delta variant.
Increased Calls for Mandatory Vaccinations in Certain Sectors
More than 50 of America’s largest medical groups representing millions of healthcare workers issued a statement Monday calling for employers of all health and long-term care providers to require mandatory COVID-19 vaccinations.
The groups, which included the American Medical Association, the American Nurses Association, and 55 others, cited contagious new variants — including delta — and low vaccination rates.
“Vaccination is the primary way to put the pandemic behind us and avoid the return of stringent public health measures,” they wrote.
The call to action comes as new COVID cases have almost quadrupled during the month of July, jumping from just around 13,000 infections a day at the beginning of this month to more than 50,000.
While the vast majority of new infections and hospitalizations are among those who have not received the vaccines, many healthcare workers remain unvaccinated. According to data collected by the Centers for Medicare and Medicaid Services, over 38% of nursing home staff were not fully vaccinated as of July 11.
An analysis by WebMD and Medscape Medical News found that around 25% of hospital workers who were in contact with patients had not been vaccinated by the end of May when vaccinations became widely available.
In addition to calls for medical professionals to get vaccinated, some local leaders have also begun to impose mandates for public employees as cases continue spiking.
Last month, San Francisco announced that it was requiring all city workers to get vaccinated. Also on Monday, New York City Mayor Bill de Blasio said that all municipal employees — including police officers and teachers — must either get the jab or agree to weekly testing by the time school starts in September.
Dr. Fauci Says U.S. Officials Are Considering Revising Mask Guidance for Vaccinated People
Numerous top U.S. health officials have applauded efforts by local leaders to mitigate further spread of the coronavirus, including the nation’s top infectious disease expert, Dr. Anthony Fauci, who confirmed Sunday that federal officials are actively considering whether to revise federal masking guidelines to recommend that vaccinated Americans wear face coverings in public settings.
In May, the Centers for Disease Control and Prevention said people who are vaccinated do not need to mask in public. Although that was a non-binding recommendation, many states and cities that had not already lifted restrictions on masking began to do so shortly after.
But now, local leaders in areas seeing big spikes have begun reimposing mask mandates — even for those who are vaccinated — including major counties like Los Angeles and St. Louis.
In his remarks Sunday, Fauci also emphasized that, despite claims from many conservatives, those efforts are in line with the federal recommendations, which leave space for local leaders to issue their own rules.
While Fauci and other top U.S. public health officials have encouraged local governments to take action, Republican lawmakers in several states are taking steps to limit the ability of local leaders and public health officials to take certain mitigation measures.
According to the Network for Public Health Law, at least 15 state legislatures have passed or are considering bills to limit the legal authority of public health agencies — and that does not even include unilateral action taken by governors.
Some of the leaders of states suffering the biggest spikes have banned local officials from imposing their own mask mandates, like Arkansas, which has the highest per capita cases in the country right now, as well as Florida, which currently ranks third.
Notably, some of the laws proposed or passed by Republicans could go beyond just preventing local officials from trying to mitigate surges in COVID cases and may have major implications for other public health crises.
For example, according to The Washington Post, a North Dakota law that bans mask mandates applies to other breakouts — even tuberculosis — while a new Montana law also bars the use of quarantine for people who have been exposed to an infectious disease but have not yet tested positive.
See what others are saying: (The Washington Post) (The New York Times) (The Guardian)
Couple Slammed Over Slavery-Themed Pre-Wedding Photoshoot
Many have expressed outrage at the duo for trying to romanticize slavery while others were left completely dumbfounded by the entire ordeal.
Photoshoot Goes Viral
A couple has come under fire after sharing images on Instagram from their slavery-themed pre-wedding photoshoot.
The photos show a Black man in shackles looking deeply into his white fiancé’s eyes before she works to releases him.
“1842. Days passed and everything changed, our love got stronger and stronger, he was no longer a slave, he was part of the family,” the post’s caption reads.
To indicate his transition from “slave” to family, a fourth image shows him wearing a long coat and top hat with well-shined shoes, as opposed to the white shirt, trousers, and straw hat he wore in the previous images.
Social Media Users React
It’s not immediately clear who these people are since the social media handle is redacted in the images circulating online.
Still, many have expressed outrage at the duo for trying to romanticize slavery while others were left just completely dumbfounded by this entire ordeal. Some also directed criticism at the photographer who agreed to the shoot, along with the hundreds of Instagram users who liked the original posts.
To see people romanticize this shit is infuriating – these people are too much. There is no such thing as slave consent and the sexual abuse of male slaves was real.— Nurse Elise 🌒 (@EliseRootedMind) July 21, 2021
There were three people there counting the photographer and not one thought should we? And over 1400 people hit the like button? And it’s part 2 like there’s more? I so want to be at the wedding when minister asks if anybody objects.— Randi Pro Democracy (@RandiKinman) July 21, 2021