Is Remdesivir the Coronavirus Treatment We’ve All Been Hoping For? No, But It Could Be the First Step
- 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)
Survey and Census Data Shows Record Number of Americans are Struggling Financially
Americans are choosing not to pursue medical treatment more and more frequently as they encounter money troubles.
A recent federal survey shows that a record number of Americans were worse off financially in 2022 than a year prior.
Coupled with recent census data showing pervasive poverty across much of the country, Americans are forced to make difficult decisions, like foregoing expensive healthcare.
According to a recent Federal Reserve Bureau survey, 35% of adults say they were worse off in 2022 than 2021, which is the highest share ever recorded since the question was raised in 2014.
Additionally, half of adults reported their budget was majorly affected by rising prices across the country, and that number is even higher among minority communities and parents living with their children.
According to recent census data, more than 10% of the counties in the U.S. are experiencing persistent poverty, meaning the area has had a poverty rate of 20% or higher between 1989 and 2019.
16 states report at least 10% of their population living in persistent poverty. But most of the suffering counties were found in the South — which accounts for over half the people living in persistent poverty, despite making up less than 40% of the population.
These financial realities have placed many Americans in the unfortunate situation of choosing between medical treatment and survival. The Federal Reserve study found that the share of Americans who skipped medical treatment because of the cost has drastically increased since 2020.
The reflection of this can be found in the overall health of households in different income brackets. 75% of households with an income of $25,000 or less report being in good health – compared to the 91% of households with $100,000 or more income.
See what others are saying: (Axios) (The Hill) (Federal Reserve)
Montana Governor Signs TikTok Ban
The ban will likely face legal challenges before it is officially enacted next year.
First Statewide Ban of TikTok
Montana became the first state to ban TikTok on Wednesday after Gov. Greg Gianforte (R) signed legislation aimed at protecting “Montanans’ personal and private data from the Chinese Communist Party.”
The ban will go into effect on Jan. 1, 2024, though the law will likely face a handful of legal challenges before that date.
Under the law, citizens of the state will not be held liable for using the app, but companies that offer the app on their platforms, like Apple and Google, will face a $10,000 fine per day of violations. TikTok would also be subject to the hefty daily fine.
Questions remain about how tech companies will practically enforce this law. During a hearing earlier this year, a representative from TechNet said that these platforms don’t have the ability to “geofence” apps by state.
Roger Entner, an analyst at Recon Analytics, told the Associated Press that app stores could have the capability to enforce the restriction, but it would be difficult to carry out and there would be a variety of loopholes by tools like VPNs.
Montana’s law comes as U.S. politicians have taken aim at TikTok over its alleged ties to the CCP. Earlier this year, the White House directed federal agencies to remove TikTok from government devices. Conservatives, in particular, have been increasingly working to restrict the app.
“The Chinese Communist Party using TikTok to spy on Americans, violate their privacy, and collect their personal, private, and sensitive information is well-documented,” Gov. Gianforte said in a Wednesday statement.
Criticism of Montana Law
TikTok, however, has repeatedly denied that it gives user data to the government. The company released a statement claiming Montana’s law “infringes on the First Amendment rights of the people” in the state.
“We want to reassure Montanans that they can continue using TikTok to express themselves, earn a living, and find community as we continue working to defend the rights of our users inside and outside of Montana,” the company said.
The American Civil Liberties Union condemned Montana’s law for similar reasons.
“This law tramples on our free speech rights under the guise of national security and lays the groundwork for excessive government control over the internet,” the ACLU tweeted. “Elected officials do not have the right to selectively censor entire social media apps based on their country of origin.”
Per the AP, there are 200,000 TikTok users in Montana, and another 6,000 businesses use the platform as well. Lawsuits are expected to be filed against the law in the near future.
See what others are saying: (Associated Press) (Fast Company) (CBS News)
How a Disney-Loving Former Youth Pastor Landed on The FBI’s “Most Wanted” List
“Do what is best, not for yourself, for once. Think about everyone else,” Chris Burns’ 19-year-old son pleaded to his father via The Daily Beast.
Multi-Million Dollar Scheme
Former youth pastor turned financial advisor Chris Burns remains at large since going on the run in September of 2020 to avoid a Securities Exchange Commission investigation into his businesses.
Despite his fugitive status, the Justice Department recently indicted Burns with several more charges on top of the $12 million default judgment he received from the SEC.
Burns allegedly sold false promissory notes to investors across Georgia, North Carolina, and Florida. The SEC claims he told the investors they were participating in a “peer to peer” lending program where businesses that needed capital would borrow money and then repay it with interest as high as 20%. Burns allegedly also reassured investors that the businesses had collateral so the investment was low-risk.
The SEC says that Burns instead took that money for personal use.
Burns began his adult life as a youth pastor back in 2007 before transitioning into financial planning a few years later. By 2017, he launched his own radio show, The Chris Burns Show, which was funded by one of his companies, Dynamic Money – where every week Burns would “unpack how this week’s headlines practically impact your life, wallet, and future,” according to the description. He also frequently appeared on television and online, talking about finances and politics.
The SEC alleges that he used his public appearances to elevate his status as a financial advisor and maximize his reach to investors.
His family told The Daily Beast that he became obsessed with success and he reportedly bought hand-made clothes, a million-dollar lakehouse, a boat, several cars, and took his family on several trips to Disney World. His eldest son and wife said that Burns was paying thousands of dollars a day for VIP tours and once paid for the neighbors to come along.
Then in September 2020, he reportedly told his wife that he was being investigated by the Securities Exchange Commission but he told her not to worry.
The day that he was supposed to turn over his business documents to the SEC, he disappeared, telling his wife he was just going to take a trip to North Carolina to tell his parents about the investigation. Then, the car was found abandoned in a parking lot with several cashier’s checks totaling $78,000
FBI’s Most Wanted
The default judgment in the SEC complaint orders Burns, if he’s ever found, to pay $12 million to his victims, as well as over $650,000 in a civil penalty. Additionally, a federal criminal complaint charged him with mail fraud. Burns is currently on the FBI’s Most Wanted list.
Last week, the Justice Department indicted him on several other charges including 10 counts of wire fraud and two counts of mail fraud.
“Burns is charged for allegedly stealing millions of dollars from clients in an illegal investment fraud scheme,” Keri Farley, Special Agent in Charge of FBI Atlanta, said in a statement to The Daily Beast. “Financial crimes of this nature can cause significant disruptions to the lives of those who are victimized, and the FBI is dedicated to holding these criminals accountable.”
His family maintains that they knew nothing of Burns’ schemes. His wife reportedly returned over $300,000 that he had given to her.
She and their eldest son, who is now 19, told The Daily Beast they just want Burns to turn himself in, take responsibility for his actions, and try to help the people he hurt.
“Do what is best, not for yourself, for once. Think about everyone else,” Burns’ son said in a message to his father via The Daily Beast.