- The Food and Drug Administration issued an emergency use authorization (EUA) Sunday allowing plasma taken from recovered COVID-19 patients to be used to treat patients currently hospitalized with COVID-19.
- While President Donald Trump lauded the treatment as a “breakthrough” and said that “it has proven to reduce mortality by 35 percent,” scientists were quick to point out that the treatment may only be mildly effective.
- Still, some scientists supported the EUA as current data suggests it is safe and will show some benefit for hospitalized COVID-19 patients who are not on respirators.
- Other scientists criticized the president’s language around the treatment and urged caution since the FDA gave the authorization without first collecting data from clinical trials.
Trump Announces FDA Expansion of Plasma
The Food and Drug Administration issued an emergency use authorization (EUA) on Sunday for a treatment that will allow hospitalized COVID-19 patients to receive plasma from people who have recovered from the virus.
In a press conference, President Donald Trump hailed the treatment as a “breakthrough.”
“This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection,” he said Sunday. “It’s had an incredible rate of success.”
During his speech, the president also claimed that the treatment “has proven to reduce mortality by 35 percent.”
“Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective,” he said.
Below, Rogue Rocket has fact checked Trump’s claims and provided additional details about this treatment.
What is Plasma?
The FDA approval specifically refers to convalescent plasma, or plasma taken from a person who has recovered from a disease. In this case, it refers to those who have recovered from and now have antibodies that target the COVID-19 virus.
Plasma itself refers to the “liquid” part of the blood, which admittedly isn’t a helpful definition for most people who likely see blood as liquid to begin with. More appropriately, plasma is the part of the blood that isn’t made up by blood cells. In fact, when scientists remove blood cells, plasma appears to be a yellowish color.
But what is blood if not blood cells?
Plasma actually carries a number of other important ingredients, including water, salts, enzymes, antibodies, and other proteins.
While antibodies from plasma are transfused into patients in a number of therapies (everything from other viruses to rare, chronic conditions such as autoimmune disorders and hemophilia), it’s a little less clear how effective convalescent plasma treatments are for COVID-19 patients.
Trump: “It has proven to reduce mortality by 35 percent.”
Trump’s claim that COVID-19 convalescent plasma “has proven to reduce mortality by 35 percent” is not entirely accurate.
In reality, Trump is citing data from a special agency program which observed plasma transfusions in patients who are under 80 years old, received plasma that contained a high level of virus-fighting antibodies within three days of diagnosis, and were not on a respirator. Data suggests those patients were 35 percent more likely to be alive a month later compared to those who had received plasma with a low level of antibodies.
Still, that does not mean the treatment is “proven.” Science and the scientific process involve very precise word choices. In almost no circumstance will a reputable, single study say that it “proved” anything.
While this program has already given plasma to more than 70,000 patients, it is not a controlled study, meaning it does not contain any placebo groups. Placebo groups are vitally important for studies. For example, they can help identify potential benefits or side effects between people who do and people who don’t receive the real treatment.
In its announcement of the EUA, the FDA issued a much more nuanced description of convalescent plasma’s power than Trump offered.
“Based on scientific evidence available, the FDA concluded… this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product in hospitalized COVID-19 patients,” it said.
The FDA added that clinical trials are necessary to “definitively demonstrate safety and efficacy remain ongoing.”
Trump: “The treatment is safe and very effective.”
Data suggests that the plasma transfusions are likely safe.
In June, the Mayo Clinic published data that found the treatment was safe following transfusions in a group of 20,000 diverse patients. Nearly 40% of those patients were women; 20% African Americans; nearly 35% Hispanic and 5% Asian.
Still, the treatment is likely not as effective as Trump indicated, and many medical scientists have emphasized that point.
“I think that this could be beneficial,” Former FDA Commissioner Scott Gottlieb said. “It might be weakly beneficial. It doesn’t look like a home run, but right now we’re looking for singles and doubles. There aren’t really going to be any home runs on the horizon until we can get the other therapeutic antibodies on the market and hopefully eventually vaccines and better therapeutics.”
Gottlieb also pointed out that some plasma transfusions have been shown to not be effective against certain viruses.
Other scientists have been more critical of Trump’s decision to promote the drug a “breakthrough,” including Eric Topol, director of the Scripps Research Translational Institute.
“I watched this in horror,” Topol told The Washington Post. “These are basically just exploratory analyses that don’t prove anything. It’s just extraordinary to declare this as a breakthrough… All this does is jeopardize ever getting the truth.”
Following the EUA, the Infectious Diseases Society of America released a statement saying that while there are “some positive signals that convalescent plasma can be helpful in treating individuals with COVID-19,” it believes the FDA should have shown its benefits in a controlled trial before authorizing it for wider use.
Similarly, reports indicate that Dr. Anthony Fauci — among others — echoed that concern last week, urging caution and saying that the data that’s currently available is not strong enough to warrant an EUA.
In its authorization, the FDA says the plasma transfusions may lessen the severity of symptoms or shorten the length of COVID-19 illness in SOME patients.
“The FDA continues to recommend that the designs of ongoing, randomized clinical trials of COVID-19 convalescent plasma and other therapeutic agents remain unaltered, as COVID-19 convalescent plasma does not yet represent a new standard of care based on the current available evidence,” the FDA said, again stressing the need for clinical trials.
That recommendation is especially important not only to find a more effective treatment but also because plasma is limited. Since it comes from blood donations, it can’t just be made it in a lab.
Is Trump Rushing a Treatment too Quickly?
It isn’t surprising to see Trump pushing convalescent plasma. Over the last few months, Trump has repeatedly pressured the FDA to authorize a treatment ahead of the November elections.
“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump said on Twitter Saturday, just a day before the FDA issued its emergency approval of plasma. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
Because of comments like that, many scientists have said they are worried that he might be trying to force the FDA to prematurely approve a treatment.
Trump’s comments on Sunday bear a striking resemblance to similar comments he’s made regarding hydroxychloroquine, which he touted as a “game changer” despite serious concerns surrounding its safety in COVID-19 patients.
See what others are saying: (CNBC) (The Washington Post) (The Wall Street Journal)
Mnuchin To Cut Off $455 Billion In Stimulus Money and Move It Out of the Biden Administration’s Reach
- Treasury Secretary Steven Mnuchin has asked the Federal Reserve to return $455 billion in stimulus funding for key emergency lending programs when they expire at the end of the year.
- Previously, the Treasury Department was expected to extend those programs as the pandemic is still raging. Because it’s now pursuing the opposite, the Fed has rebuked Mnuchin’s decision, a rare move to see from the agency.
- Other critics have called Mnuchin’s move political, saying it appears to be a blatant attempt to hamper Biden’s transition into the White House in January.
- Still, the Fed has agreed to return the funding, and it’s now being reported that the money will be placed into an account that Mnuchin’s likely successor, Janet Yellen, will need Congressional approval to access.
Mnuchin To End Emergency Funding Without Extension
Treasury Secretary Steven Mnuchin said Thursday that he doesn’t plan to extend $455 billion in key emergency lending programs past the end of the year. Instead, he’s planning on stashing that money in a fund that his successor can’t reach without Congressional approval.
Mnuchin has asked Federal Reserve Chairman Jerome Powell to return the $455 billion in unused funding. Notably, that money is meant to fund programs stemming from the $2 trillion CARES Act — the only stimulus package Congress has agreed upon thus far. Those programs are meant to prop up the economy by providing financial assistance and loans for struggling businesses and local governments.
In his letter to Powell, Mnuchin said the Fed programs “have clearly achieved their objective” because “Markets responded positively, spreads tightened, and banks continued lending.”
While he also said that Congress will later be able to use that $455 billion for other purposes, such as PPP and grants, his decision has been so controversial that even the Fed criticized it. That’s highly unusual because the Fed isn’t usually keen on inserting itself within sensitive political issues.
The Fed has said that the programs are necessary while the pandemic rages on. In fact, it even noted the “important role” of these programs “as a backstop for our still-strained and vulnerable economy.”
The Treasury Department cannot simply reallocate that money on its own. Instead, it needs agreement from the Fed. Despite the Fed’s criticism, it ultimately gave that agreement on Friday.
Critics Blast Mnuchin’s Plan as an Attack on Biden
Top Republicans like Senate Majority Leader Mitch McConnell and Senator Patrick Toomey have backed Mnuchin’s decision. Last week, McConnell described it as “fully aligned with the letter of the law and the intent of the Congress.”
Among some Republicans, there is a concern that leaving the programs operational for too long could distort markets.
On top of that, only about $20 billion of that $455 billion has actually been used, likely because the program’s loan terms for small- and medium-sized businesses are very restrictive. Still, that’s not to say this money hasn’t been useful. As The New York Times pointed out, “Some programs calmed market conditions merely by reassuring investors.”
Connected to that and similar to the Fed’s arguments, economists are concerned that Mnuchin is pulling the plug on these programs too soon, arguing that they should not be ended before the markets have fully recovered.
The U.S. Chamber of Commerce — the largest lobbying group in the country — said that Mnuchin’s decision to end these programs “closes the door on important liquidity options for businesses at a time when they need them most.”
The chamber also added that it “unnecessarily ties the hands of the incoming administration.”
“This appears to be a political move by Team Trump to limit what President-elect Joe Biden can do next year to boost the economy, especially if Congress fails to pass a big stimulus,” Jaret Seiberg, an analyst at Cowen Inc., added.
“It’s not just closing the store down for Biden,” policy economist Ernie Tedeschi said. “It’s burning the store down.”
Mnuchin has said that this decision isn’t political. He also argued that in the “unlikely event” that these programs need to be re-established, the Fed can still request approval from other emergency funds.
Yellen Would Need Congressional Approval to Access Funds
Still, as The New York Times noted last week, this move could prevent President-elect Joe Biden’s incoming Treasury secretary from quickly restarting the efforts at scale in 2021.
That incoming secretary is expected to be Janet Yellen, who Biden chose for the role on Monday. Notably, if confirmed by the Senate, she would be the first female Treasury secretary.
On Tuesday, it was reported that Mnuchin is planning on moving that $455 billion into the Treasury’s General Fund, which means that Yellen would need Congressional approval to access any of that money.
That would then leave Yellen with only $80 billion at her discretion. While that might sound like a lot of money for the average person, it’s much less than the nearly half a trillion dollars currently set to be removed from play.
It also comes at a time where coronavirus cases are spiking, local and state governments are once again employing more restrictive lockdowns, and millions of people are set to lose their unemployment benefits at the end of the year.
Bharat Ramamurti, a Democratic member of the congressional watchdog panel overseeing the $455 billion, said on Twitter that Mnuchin’s move is illegal and that it can be reversed next year.
A spokesperson for the Treasury has asserted that Mnuchin’s move is legal under the CARES Act.
In the summer, Mnuchin initially extended the fund’s expiration date, which is why it now expires at the end of the year.
See what others are saying: (Business Insider) (Axios) (Bloomberg)
GSA Official Emily Murphy Finally Approves Biden Transition. Here’s What Comes Next
- On Monday, the head of the General Services Administration, Emily Murphy, admitted that Democrat Joe Biden is the “the apparent president-elect.”
- While this much focus isn’t usually placed on the GSA administrator, Murphy had previously refused to allow Biden’s transition team to access valuable resources ahead of his inauguration. To note, GSA transition approval does not certify Biden as the winner of the 2020 Presidential Election.
- The news comes as Biden has made several recent announcements detailing key cabinet positions, including his picks for the first female Treasury secretary and the first Latino Homeland Security secretary.
Trump Official Authorizes Transition
The U.S. government has finally begun the process of allowing President-elect Joe Biden to transition into the presidency, despite Donald Trump’s repeated refusal to concede.
On Monday, the administrator of the General Services Administration, Emily Murphy, admitted in a letter that Biden was the “the apparent president-elect.”
The GSA is an independent branch of the government that has the power to direct the flow of transition resources to an incoming president. Murphy’s letter now gives Biden several notable resources, including access to millions in federal funds. He and his transition team are also now able to begin holding meetings with government agencies to discuss policy changes ahead of his inauguration in January.
Usually, the GSA administrator’s role goes unnoticed following elections, but Murphy’s refusal to sign transition documents until Monday drew sharp criticism. In fact, several leading medical groups have urged President Trump to share vital COVID-19 data with Biden, a move they said could “save countless lives.”
Because of her initial refusal, many accused Murphy — who is former attorney for the Republican National Committee — of being influenced by the White House.
In her Monday letter, Murphy denied that claim.
“I have dedicated much of my adult life to public service, and I have always strived to do what is right,” she said. “Please know that I came to my decision independently, based on the law and available facts. I was never directly or indirectly pressured by any Executive Branch official — including those who work at the White House or GSA — with regard to the substance or timing of my decision.”
Murphy also noted in her letter that she had “recevie[d] threats online, by phone, and by mail directed at my safety, my family, my staff, and even my pets in an effort to coerce me into making this determination prematurely.”
As far as why Murphy took so long to sign this letter, according to The Washington Post, those close to her said she wanted more certainty before making the call. Reportedly, she wanted to see if battleground states would begin certifying their individual elections while Trump’s legal battles played out in court.
On Monday, Michigan certified its results. On Tuesday, both Pennsylvania and Nevada certified their results. In all three cases, Biden was officially declared the winner.
As The Post notes, there was also the prospect of becoming the target of Trump’s anger and the risk that he would fire her or other top aides. Only recently have multiple, major Republicans who support Trump started to break with the president and admit that it’s time for him to concede for the benefit of the country.
Trump Still Won’t Concede
Still, Trump is refusing to concede.
In a Monday tweet thanking Murphy, he said, “Our case STRONGLY continues, we will keep up the good fight, and I believe we will prevail! Nevertheless, in the best interest of our Country, I am recommending that Emily and her team do what needs to be done with regard to initial protocols, and have told my team to do the same.”
However, Trump’s legal challenges appear to be anything but strong. Case after case has failed to hold up in court, including in front of judges that Trump himself appointed.
Trump also appears to either be taking credit for Murphy’s decision to kick start Biden’s transition process or seemingly admitting that he did, in fact, pressure Murphy to hold off on signing this letter.
That comes despite the fact that The Post reported Murphy’s team told the White House Counsel’s Office on Friday that she planned to designate Biden the winner on Monday. According to the outlet, her office never received a response.
In addition to Murphy’s letter now clearing the way for Biden to access vital resources needed to begin building his government, he has also recently announced several of his cabinet picks.
On Sunday, Biden announced Antony Blinken as his secretary of state. Notably, Blinken is the former deputy secretary of state under President Obama.
Unsurprisingly, Blinken is also expected to be a massive departure from current Secretary of State Mike Pompeo. For example, Blinken has been highly critical of Trump’s “America First” policies, saying that they’ve isolated the U.S. and provided opportunities for adversaries.
Blinken is expected to help the U.S. rejoin major global agreements or organizations, such as the Paris climate accord, the Iran nuclear deal, and the World Health Organization.
On Monday, Biden has chosen Alejandro Mayorkas as his secretary of Homeland Security. Like Blinken, Mayorkas was a deputy secretary of his respective department under Obama.
He also previously served as the director of US Citizenship and Immigration Services.
As a Cuban-American, he will be the first Latino to lead the department, which is doubly notable because he’s expected to overhaul most if not all of Trump’s hardline immigration policies.
“When I was very young, the United States provided my family and me a place of refuge,” Mayorkas said on Twitter Monday. “Now, I have been nominated to be the DHS Secretary and oversee the protection of all Americans and those who flee persecution in search of a better life for themselves and their loved ones.”
Among other notable picks, Biden has tapped Janet Yellen to become Treasury secretary. Previously, she served as the chair of the Federal Reserve under Obama but was not reappointed by Trump after he won the 2016 election.
If confirmed by the Senate, she would become the country’s first female Treasury secretary.
Regarding climate change, former Secretary of State John Kerry has been chosen to become the special presidential envoy for climate. Kerry will not need to be confirmed by the Senate for this role.
“This marks the first time that the [National Security Council] will include an official dedicated to climate change, reflecting the president-elect’s commitment to addressing climate change as an urgent national security issue,” the Biden transition team noted.
In addition to that, Biden has chosen Jake Sullivan as his national security adviser, a position he also held for Biden in a vice-presidential capacity during part of Obama’s second term. Sullivan played a key role in negotiations concerning the 2015 Iran nuclear deal.
See what others are saying: (NBC News) (The Washington Post) (CNN)
Press Secretary Falsely Claims Trump Wasn’t Given an “Orderly Transition of Power”
- Press Secretary Kayleigh McEnany falsely claimed that President Donald Trump was not given “an orderly transition of power” after he won the 2016 election.
- In reality, Hillary Clinton conceded defeat the day after the election, and President Obama Obama met with Trump to start work on the transition two days after. Trump himself even thanked Obama for making the transfer peaceful and smooth in his inauguration speech.
- By contrast, Trump has launched an unprecedented effort to prevent the peaceful transfer of power. He’s directed key members of his administration to block the transition process and filed dozens of lawsuits aimed at overturning election results, despite the fact that a growing number of Republicans have encouraged him to start the transition process.
Kayleigh McEnany’s Claims About Trump Transition
Press Secretary Kayleigh McEnany falsely claimed on Saturday that President Donald Trump was not given “an orderly transition of power.”
Her comments came during her first press briefing since the election was called for former Vice President Joe Biden, where she was asked about Trump’s refusal to concede and start the transition process.
“While, in 2016, President Trump became the duly elected President, many sought to undermine him, discredit him, delegitimize him, and deny his victory,” she continued. “There were no calls for unity; there were no calls for healing.”
“So while every legal vote is counted, let us not forget the inexcusable transition, or lack thereof, that President Trump had to endure in 2016 and four years into his presidency.”
McEnany’s claims are flatly wrong for a number of reasons. Trump’s opponent in the 2016 election, former Secretary of State Hillary Clinton, conceded the morning of Nov. 9, the day after the election.
“Donald Trump is going to be our president,” Clinton said in her concession speech. “We owe him an open mind and the chance to lead.”
Help From Obama
Later that same day, then-President Barack Obama also acknowledged Trump’s win and emphasized the importance of a smooth transition process. The day after that — less than 48 hours after the election had been called for Trump — the president-elect went to the White House to meet with Obama and start the transition process.
“As I said last night, my number one priority in the coming two months is to try to facilitate a transition that ensures our president-elect is successful,” Obama told reporters while sitting beside Trump.
“We want to make sure that they feel welcome as they prepare to make this transition, and most of all, I want to emphasize to you, Mr. President-elect, that we now are gunna wanna do everything we can to help you succeed,” he continued. “Because if we succeed, then the country succeeds.”
In fact, Trump himself even thanked Obama for helping to ensure the peaceful transfer of power while speaking at his inauguration.
“Every four years we gather on these steps to carry out the orderly and peaceful transfer of power, and we are grateful to President Obama and First Lady Michelle Obama for their gracious aid throughout this transition,” he said. “They have been magnificent. Thank you.”
Notably, as the Associated Press pointed out, Trump’s transition was indeed chaotic, but that was almost entirely due to Trump’s own doing. While the Trump transition team did receive standard cooperation during the transfer, they largely ignored advice and offers of help from Obama staffers.
Beyond that, Trump also fired the head of his transition, former New Jersey Gov. Chris Christie (R) and scrapped months of transition planning he had prepared over a feud between Trump’s son-in-law Jared Kushner and Christie, who in his previous role as a U.S. Attorney had put Kushner’s father in jail for tax evasion, witness tampering, and illegal campaign contributions.
McEnany’s blatantly false assertion appears to be an attempt to downplay and justify the unprecedented actions Trump has taken to block Biden from assuming the presidency during a pandemic, even as numerous experts warn that if the president does not start sharing COVID data with the president-elect and his transition team, cost countless lives could be lost.
In addition to Trump’s own refusal to concede, he has also directed those in his administration to play ball as well.
Most significantly, Emily Murphy, the head of the General Services Administration (GSA) — the agency tasked with handing hand transition resources off to Biden’s transition team — has refused to sign off on the process.
By contrast, the GSA under the Obama Administration gave Trump’s transition team the reins the day after the 2016 election.
Trump and his allies have also filed dozens of frivolous lawsuits in an attempt to overrule the will of American voters in key swing states. According to reports, the campaign has now either lost or withdrawn over 30 of those suits.
As their legal strategy starts to fall apart, team Trump has taken a new direction: getting Republican-controlled legislatures in states that gave the popular vote to Biden to basically overrule the will of the people by choosing a pro-Trump slate of electors to send to the electoral college.
Usually, the party of whichever candidate wins the popular vote in a given state gets to designate electors who will go to the Electoral College in December to cast the state’s electoral votes for the chosen candidate.
However, a state legislature could hypothetically claim that the results of the popular invalid and invoke their constitutional right to step in and choose a slate of electors they believe more accurately reflects the election results of their state.
Many believe that such a move would be illegal or at the very least incredibly undemocratic as it would amount to nothing more than a full-blown attempt to steal the election and defy the will of voters.
But Trump and his cronies have been pushing Republican legislators in states he lost narrowly to take this route. On Thursday, the president gathered state legislators from Michigan at the White House to pressure them to either send a slate of his electors to the Electoral College or not certify the election results at all.
The legislators appeared to deny that they would go against the will of their people because of baseless claims of fraud.
“We have not yet been made aware of any information that would change the outcome of the election in Michigan and, as legislative leaders, we will follow the law and follow the normal process regarding Michigan’s electors, just as we have said throughout this election,” they said in a statement.
Republicans Urge Trump to Start Transition
While some of Trump’s allies have continued to support the president’s tactic and spread his baseless claims and conspiracy theories about election fraud, other top Republicans lawmakers have been encouraging Trump to start the transition process.
On Saturday a federal judge in Pennsylvania rejected yet another lawsuit brought by the Trump campaign, effectively ending the president’s only attempt to challenge statewide results. After that ruling, Sen. Pat Toomey (R-Pa.) called on Trump to accept that he had lost and start the transition process.
“With today’s decision by Judge Matthew Brann, a longtime conservative Republican whom I know to be a fair and unbiased jurist, to dismiss the Trump campaign’s lawsuit, President Trump has exhausted all plausible legal options to challenge the result of the presidential race in Pennsylvania,” Toomey said in a statement, before going on to note that Trump’s loss in his follows “a series of procedural losses for President Trump’s campaign.”
On Sunday, Senators Kevin Cramer (R-Nd.) and Lisa Murkowski (R-Ak.) also followed suit.
“President Trump has had the opportunity to litigate his claims, and the courts have thus far found them without merit,” Murkowski said. “A pressure campaign on state legislators to influence the electoral outcome is not only unprecedented but inconsistent with our democratic process. It is time to begin the full and formal transition process.”
Those remarks were also echoed by Christie, who, despite being removed from Trump’s 2016 transition team, has maintained a close relationship with the president and his staff. While speaking to ABC News Sunday, the former governor called the conduct of Trump’s legal team “a national embarrassment.”
“Listen, I have been a supporter of the President’s. I voted for him twice, but elections have consequences, and we cannot continue to act as if something happened here that didn’t happen,” he said.
“If you are unwilling to come forward and present the evidence, it must mean the evidence doesn’t exist,” Christie continued. “The country is what has to matter the most. As much as I’m a strong Republican and I love my party, it’s the country that has to come first.”