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

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  • 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)

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Donald Trump and Eldest Three Children Hit With Fraud Lawsuit From New York AG

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AG Letitia James says that the former president “falsely inflated his net worth by billions of dollars to unjustly enrich himself.” 


Lawsuit Filed Against Trump 

New York Attorney General Letitia James announced on Wednesday that she filed a civil lawsuit against former president Donald Trump and his three eldest children over allegations that they fraudulently inflated asset valuations within the Trump Organization.

Donald Trump Jr., Eric Trump, and Ivanka Trump are all listed alongside their father in the lawsuit. Executives Jeffrey McConney and Allen Weisselberg, the latter of whom recently pled guilty to tax crimes, are also listed alongside other Trump businesses. 

“Donald Trump, with the help of his children…and senior executives at the Trump Organization, falsely inflated his net worth by billions of dollars to induce banks to lend money to the Trump Organization on more favorable terms than would otherwise have been available to the company, to satisfy continuing loan covenants, to induce insurers to provide insurance coverage for higher limits and at lower premiums, and to gain tax benefits, among other things,”  a press release announcing the lawsuit claimed. 

The Attorney General’s office claims that between 2011 and 2021, Trump and the Trump Organization made 200 false and misleading claims about asset values on annual financial statements.

The lawsuit was filed Wednesday in a State Supreme Court in Manhattan. 

“The complaint demonstrates that Trump falsely inflated his net worth by billions of dollars to unjustly enrich himself and to cheat the system, thereby cheating all of us,” James said while announcing the complaint. 

Her office is seeking to permanently ban Trump and his children from serving as an officer or director in any New York corporation and to bar Trump and his organization from entering into any New York real estate acquisitions for five years. The office is also seeking to recover $250 million in penalty payments, among other forms of relief. 

 The Office of the Attorney General has also referred the matter to the federal attorneys in New York and to the IRS for criminal investigation. 

“There aren’t two sets of laws for people in this nation: former presidents must be held to the same standards as everyday Americans,” James added in a statement on social media. 

“Trump’s crimes are not victimless,” she continued. “When the well-connected and powerful break the law to get more money than they are entitled to, it reduces resources available to working people, small businesses, and taxpayers.”

Trump Allegedly Inflated Key Assets

According to James’ release, Trump “made known through Mr. Weisselberg that he wanted his net worth on his statements to increase every year.”

“And the statements were the vehicle by which his net worth was fraudulently inflated by billions of dollars year after year,” the release continued. 

Among the assets Trump and his organization allegedly inflated was the Trump Tower Triplex, an apartment Trump allegedly claimed was 30,000 square feet when it is just around 11,000 square feet. Because of its ballooned size, the property was valued at $327 million in 2015, roughly three times as much as the sole apartment in New York City to ever sell for over $100 million at the time. 

For further comparison, the highest sale for a listing in Trump Tower at the time was only $16 million. 

Trump also allegedly claimed Mar-a-Lago was valued as high as $739 million based on the “false premise” that the property could be developed and sold for residential use. The lawsuit claims that Trump actually signed deeds donating those rights, limiting the property’s use to a social club. James and her office claim its value would fall closer to $75 million. 

Inflated Clauations Cannot Be “Excused”

“The inflated asset valuations in the Statements cannot be brushed aside or excused as merely the result of exaggeration or good faith estimation about which reasonable real estate professionals may differ,”  the lawsuit states, adding that instead, they are the result of improper methodology intentionally meant to falsely boost Trump’s net worth. 

The investigation into Trump’s alleged fraud began nearly three years ago, and the former president has repeatedly called it a politically motivated witch hunt. His attorney, Alina Habba, doubled down on that rhetoric in a statement Wednesday. 

“Today’s filing is neither focused on the facts nor the law – rather, it is solely focused on advancing the Attorney General’s political agenda,” Habba said. “We are confident that our judicial system will not stand for this unchecked abuse of authority, and we look forward to defending our client against each and every one of the Attorney General’s meritless claims.”

For his part, Trump has blasted the lawsuit on Truth Social, calling James a “fraud” and a “crime-fighting disaster.”

Trump previously tried to impede the probe but was ultimately ordered by a judge to sit for a deposition and turn over subpoenaed documents. Reports say he pled the fifth hundreds of times during his deposition. 

See what others are saying: (Bloomberg) (The Washington Post) (Reuters)

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Hurricane Fiona Causes “Catastrophic” Damage in Puerto Rico, Leaving Many Without Power

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While power has been restored to some, more than a million remain without it as continued rainfall, flooding, and landslides are expected to cause further damage across the island.


Hurricane Fiona Wreaks Havoc

Hurricane Fiona made landfall in Puerto Rico Sunday, bringing heavy rains, flooding, and landslides, while also knocking out power for the entire island and killing at least one person.

Photos and videos posted on social media show floodwaters consuming major streets and engulfing cars. Some pictures show an entire bridge flooded, making it impassible. Other footage shows a different bridge entirely uprooted and a metal barrier ripped away from the road and floating down a river of floodwater.

Officials have said conditions are still too dangerous to fully evaluate the extent of the crisis. In remarks to the public, Puerto Rico’s governor, Pedro Pierluisi, described the damage as “catastrophic.”

He asserted that the storm has been one of the most significant since Hurricane Maria — which hit the island almost exactly 5 years ago to the day — killing more than 3,000 people, leaving many without power for months, and causing destruction that the island is still recovering from.

Pierluisi noted that Puerto Rico has received over 30 inches of rain and that some areas have even gotten more rain than during Hurricane Maria. As of Monday afternoon, the National Gaurd has led 30 rescue operations so far, saving more than 1,000 stranded residents in 25 municipalities, according to the governor.

Pierluisi also added that more than 2,000 people were in the island’s 128 shelters, with officials further saying there is plenty of shelter space for those who need it. On Sunday, President Joe Biden approved an emergency declaration for Puerto Rico, which will allow federal agencies to coordinate disaster relief.

Continued Issues As Storm Rages On

Meanwhile, Puerto Rico’s water authority has confirmed that just over 70% of the island is still without water. According to poweroutage.us, more than 1.3 million customers were still without power as of Monday morning.

The power company LUMA also stated that electricity had been restored to around 100,000 customers over the course of Sunday night, though it previously warned that the full restoration of power could take several days as the storm has created “incredibly challenging” conditions.

While Hurricane Fiona has passed through Puerto Rico, having now made landfall in the Dominican Republic, officials and experts say that heavy rains and further flooding are still to be expected for the next few days.

The National Weather Service has warned that “life-threatening and catastrophic flooding” as well as mudslides and landslides are expected to continue across the island. As a result, Pierluisi has urged Puerto Ricans Monday to remain home and in shelters so that officials can continue to respond to others in need.

He also noted that the areas most impacted by the hurricane include the southern part of the island, the southwest, and the mountains.

After moving through the Dominican Republic, Hurricane Fiona is expected to head towards Turks and Caicos Tuesday. The National Hurricane Center has said that the storm will continue to grow and by Wednesday, it is set to become a major hurricane — which means a Category 3 or higher.

See what others are saying: (The New York Times) (The Washington Post) (CNN

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Government Aid Cut Child Poverty in Half During Pandemic, Data Shows

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The reduction occurred similarly across geography, race, family type, and citizenship status.


Largest Drop in Half a Century

The United States’s child poverty rate sank to the lowest level on record last year, primarily thanks to pandemic relief measures and other government programs, according to an analysis of census data released Tuesday.

The Center on Budget and Policy Priorities analyzed data from the Census Bureau’s supplementary poverty measure, which accounts for safety net programs and tax credits as well as regional differences in the cost of living.

From around 11% in 2019, the percentage of kids living below the poverty line fell to 9.7% in 2020 and 5.2% the year after that.

In just two years, nearly 5.5 million kids were lifted from poverty, marking an almost 60% drop in the child poverty rate.

The Center’s researchers gave most credit to the federal government’s numerous interventions in the economy, from stimulus payments and the expanded child tax credit to eviction moratoriums and expanded unemployment insurance.

Without government intervention, poverty in 2020 would have experienced its second-largest recorded increase, the Center claimed, but instead, it underwent the largest single-year decline in over half a century.

Especially impactful was the expanded child tax credit, which sent up to $300 per child to households with children every month between July and December 2021.

According to the analysis, this policy alone pulled nearly three million kids out of poverty.

But the tax credit’s expansion expired at the end of the year despite Democrats’ efforts to prolong it with Biden’s signature Build Back Better bill, which was blocked by Sen. Joe Manchin (D-WV), who reportedly told colleagues he was concerned that families might use the payments to buy drugs.

Poverty Before COVID

Child poverty has fallen by 59% since 1993, when it sat at around 28%, according to another analysis published Sunday by The New York Times and the nonpartisan group Child Trends.

They found that the decline occurred across all 50 states and D.C., as well as in different levels of poverty.

It similarly affected nearly all subgroups of children, — white, Black, Asian and Hispanic, single-parent and two-parent, immigrant and non-immigrant.

The causes driving the pre-pandemic decline included general economic improvement — low unemployment, a higher labor force participation rate among single mothers, and growing state minimum wages — but the researchers pinned government welfare programs as the dominant factor.

They specifically mentioned the earned income tax credit, social security, unemployment insurance, and nutrition and housing assistance.

Despite the positive trend, more than eight million children still live below the poverty line, and that number excludes those who live just above it but still struggle to meet basic needs.

The current poverty line sits around $29,000 for a family of four in a location with typical living costs.

Moreover, disparities still persist, with Black and Latino children about three times as likely as their white peers to be poor.

See what others are saying: (Vox) (The New York Times) (The Washington Post)

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