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FDA Allows Expanded Use of Convalescent Plasma to Treat COVID-19. Here’s What You Should Know

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  • 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)

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Trump Mocks Florida Gov. “Ron DeSanctimonious” Ahead of Possible 2024 Bid

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The former president may announce a bid to take back the White House on Nov. 14, according to his inner circle.


Trump Concocts His Latest Nickname

From “Little Marco” and “Lyin’ Ted” to “Sleepy Joe” and “Crazy Bernie,” former president Donald Trump’s nicknames for his political opponents have been known for their punchy style, but Republicans found it hard to swallow his latest mouthful for Florida Governor Ron DeSantis.

“We’re winning big, big, big in the Republican Party for the nomination like nobody’s ever seen before,” he said Saturday at a rally in Pennsylvania. “Trump at 71, Ron DeSanctimonious at 10%.”

The former president drew rebuke from some allies and conservative commentators for driving a wedge through the GOP three days before the midterm elections.

“DeSantis is an extremely effective conservative governor who has had real policy wins and real cultural wins,” tweeted The Daily Wire’s Matt Walsh. “Trump isn’t going to be able to take this one down with a dumb nickname. He better have more than that up his sleeve.”

“What an idiot,” wrote Rod Dreher, a senior editor at The American Conservative. “DeSantis is a far more effective leader of the Right than Trump was, if, that is, you expect a leader to get a lot done, rather than just talking about it and owning the libs.”

In April 2021, Trump said he would “certainly” consider making DeSantis his running mate for a potential 2024 presidential bid. But as DeSantis established himself as a credible rival to Trump, their relationship grew colder.

Last September, sources told The Washington Post that Trump had called DeSantis “ungrateful” in conversations with advisors. The former president reportedly had not spoken with the governor in months.

The Party of Trump or DeSantis?

One day after his “DeSanctimonious” jab, Trump took to the stage in Florida to support Sen. Marco Rubio’s (R) reelection campaign but grabbed more attention when he seemed to endorse DeSantis for governor.

“The people of Florida are going to reelect the wonderful, the great friend of mine, Marco Rubio to the United States Senate, and you’re going to reelect Ron DeSantis as your governor of your state,” he said to the cheering crowd.

The brief moment of support was overshadowed, however, by the conspicuous absence of DeSantis himself.

Both men held competing, contemporaneous rallies in the same state hundreds of miles apart, and multiple sources told Politico that DeSantis was not invited to Trump’s event, nor did he ask to attend.

The governor has repeatedly refused to say whether he will make a run for the presidency in 2024, but national polling consistently puts Trump ahead of him among Republicans by a wide margin.

Some recent polls, however, have shown DeSantis to lead the former president in specific states like Florida and New Hampshire.

A survey last month found that 72% of GOP voters believe DeSantis should have a great or good deal of influence in the future direction of the party, while just 64% said the same about Trump.

Sources told Axios that Trump’s inner circle is discussing a Nov. 14 announcement for his presidential campaign, timing it to capitalize on the expected post-midterm euphoria as vote counts roll in.

See what others are saying: (The New York Times) (Fox News) (Politico)

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The Midterms Are Tomorrow, But We May Not Have Results for a While. Here’s What You Need to Know

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The counting of mail-in ballots and possible legal challenges will almost certainly slow the final results.


Election Delays Expected

As Americans gear up for Election Day on Nov. 8, experts are warning that many races, including some of the most highly anticipated ones, may not have the final results in for days or even weeks.

These delays are completely normal and do not indicate that election fraud or issues with vote counting took place. However, like in 2020, former President Donald Trump and other election-denying Republicans could seize on the slow-coming returns to promote false claims to that effect.

There are a number of very legitimate reasons why it could take some time before the final results are solidified.  Each state has different rules for carrying out the election process, like when polls close and when ballots can start being counted.

There are also varying rules for when mail-in ballots can be received and counted that can extend when those votes will be tallied. That lag could seriously skew early results in many places because there has been a major rise in the number of people voting by mail.

Red Mirage, Blue Mirage

One very important thing to note is that the early returns seen on election night may not be representative of the final outcomes. 

In 2020, there was a lot of talk about a “red mirage,” which is when ballots cast on election day and favoring Republicans are reported first while mail-in ballots used more by Democrats are counted later, creating the appearance that Republicans have a much wider lead.

That phenomenon may very well take place in several key battlegrounds that not only could decide the House and the Senate but also have incredibly consequential state-wide elections of their own.

For example, in Pennsylvania and Wisconsin, election officials cannot start counting mail-in and absentee ballots until Election Day. 

Some experts have also speculated that a similar occurrence could occur in Georiga because the suburbs — which have shifted blue in recent years — report their results later than rural counties.

At the same time, there are also some states where the opposite might happen: a blue mirage that makes it seem like Democrats are doing better than they actually are.

Such a scenario is possible in Arizona, where election officials can process mail-in ballots as soon as they receive them, and where a similar trend played out in 2020.

Other Possible Slow-Downs

Beyond all that, there are a number of other factors that could delay when results are finalized.

For example, in Georgia, candidates need to get at least 50% of the vote to win, and if none do, then the top two are sent to a run-off election on Dec. 6. That is a very real possibility for the state’s closely-watched Senate race because there is a libertarian on the ballot who could siphon enough votes from Republican Herschel Walker and Democratic Sen. Raphael Warnock to keep them both below the 50% threshold. 

In other words: if control of the Senate comes down to Georgia again — as it did in 2020 and which is a very real possibility — voters may not know the outcome until a month after the election.

Meanwhile, experts also say that legal battles over mail-in ballots could further delay results, or even go to the Supreme Court. According to The New York Times, before Election Day, over 100 lawsuits had already been filed.

In Pennsylvania, for example, the State Supreme Court ruled last week in favor of a lawsuit from Republican groups requesting that mail-in ballots that did not have dates on outer envelopes be invalidated, causing thousands of ballots to be set aside. Multiple rights groups are now suing to get that decision reversed. 

See what others are saying: (NPR) (ABC News) (Reuters)

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DHS Confirms Paul Pelosi Attacker is a Canadian National in the U.S. Illegally

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The suspect espoused many political conspiracy theories promoted by the American far-right and told investigators he wished to harm House Speaker Nancy Pelosi to send a message to other U.S. politicians.


Pelosi Attacker’s Immigration Issues

The man accused of attacking Paul Pelosi and trying to kidnap House Speaker Nancy Pelosi (D-Ca.) is a Canadian national currently residing in the United States illegally, according to a statement from the Department of Homeland Security (DHS) late Wednesday.

Law enforcement officials say the suspect embraced far-right conspiracies about U.S. politicians and told investigators he wanted to break the House Speaker’s kneecaps as a lesson to other members of Congress. 

Despite his lack of citizenship, the man also allegedly told police he was on a “suicide mission” and had a list of state and federal lawmakers he wanted to target.

In its statement to the media, DHS said that Immigration and Customs Enforcement (ICE) had lodged a “detainer” on the suspect, which is a notice the agency intends to take custody of an individual who could be deported and requests it be notified before that person is released. The detainer, however, likely will not impact the case against him, because deportations are civil proceedings that happen after criminal cases are resolved.

According to several reports, federal records indicate the suspect came to the U.S. legally via Mexico in March 2008. Canadians who travel to America for business or pleasure are usually able to stay in the country for six months without a visa. DHS told The Washington Post the Canadian citizen was admitted as a “temporary visitor” traveling for pleasure.

Before the confirmation from DHS, there was some mixed reporting on how long the suspected attacker has been in America. On Monday, an anonymous U.S. official told the Associated Press the man had legally entered in 2000 but stayed way after his visa expired.

One day later, The New York Times reported he was registered to vote in San Francisco County from 2002 to 2009, and even voted once in 2002. 

Heightened Security Concerns

The new revelation comes as lawmakers are facing increased threats, prompting conversations about safety and security with a specific focus on the role of the U.S. Capitol Police (USCP).

On Tuesday, multiple outlets reported that USCP security cameras trained on the Pelosi’s house actually captured the attack, but no one was watching. In a statement Wednesday, the agency said its command center has access to around 1,800 cameras and not all are watched constantly.

The Capitol Police also said that the Pelosi’s home is “actively” monitored “around the clock” when the Speaker is there, but not when she is in Washington.

As a result, many argued that there should be more security and surveillance for the second person in line for the presidency — especially given the threat of violence after the Jan. 6 insurrection and warnings from law enforcement ahead of the midterms.

That was echoed in a scathing letter yesterday sent to Capitol Police by Rep. Zoe Lofgren (D-Ca.), who is one of the most senior Democrats in Congress and heads the Administration Committee.

In her letter, Lofgren noted that the agency “has previously reported to the committee that the speaker receives the most threats of any member of Congress,” and asked why that protection was not extended “to the spouses and/or other family members of the congressional leaders in the presidential line of succession.”

She questioned why the USCP had turned down an offer from the FBI for some of its officers to be part of terrorism task forces investigating threats against Congressmembers and why it had not made a formal agreement with San Francisco police for a car to be posted at the Pelosi’s home 24-hours a day as had been done in the months after Jan. 6.

Lofgren also inquired why the Capitol Police did not direct more threats against lawmakers for prosecution. She noted that members of Congress received at least 9,625 threats in 2021, but just 217 were referred.

Editor’s Note: At Rogue Rocket, we make it a point to not include the names and pictures of mass murders, suspected mass murderers, or those accused of committing violent crimes who may have been seeking attention or infamy. Therefore, we will not be linking to other sources, as they may contain these details.

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