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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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Virginia Governor’s Tip Line to Report Teachers Spammed by Trolls

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The tip line was created for parents to report educators who violate the governor’s new executive orders banning critical race theory and making masking optional.


Youngkin’s Controversial Policies

Celebrities, TikTok activists, and other social media users have been spamming an email tip line set up by Virginia Gov. Glenn Youngkin (R) intended for parents to report teachers and “divisive practices in their schools.”

The tip line was implemented after the new governor enacted several highly controversial policies targeted at public schools in the weeks since taking office.

On his first day, Youngkin signed an executive order banning so-called critical race theory (CRT) from being taught in public schools. CRT, which is largely taught in higher education institutions, is not included in Virginia’s curriculum standards. As a result, many educators and scholars have expressed concerns that the policy will be used to broadly restrict the accurate teaching of history.

Shortly after imposing the CRT ban, Youngkin further angered educators by signing an executive order making masking optional in schools. According to a recent analysis by The Washington Post, the majority of Virginia schools enrolling two-thirds of all students have actively disobeyed the order.

The email tip line, introduced Monday, is intended to report educators and schools that do not follow Youngkin’s policies.

Calls to Spam Tip Line

The tattle-on-a-teacher tip line prompted widespread criticism. Many people took to Twitter to urge other users to spam the email, including major names with massive followings, like musician John Legend.

“Black parents need to flood these tip lines with complaints about our history being silenced. We are parents too,” he tweeted. 

Several TikTok activists also encouraged their followers to bomb the tip line as well, including 21-year-old Sofia Ongele, who even launched a website that automatically generates emails to send to the line that include the name of a public school in Virginia and lyrics to a pop song.

Ongele told Insider that, so far, the website has gotten a lot of traffic, attracting about 1,500 people every 30 minutes.

These efforts are not the first time social media users, and specifically young TikTokers, have encouraged others to troll a tip line set up by conservative figures. In September, TikTokers also sent fake reports, porn, and Shrek memes to a tip line intended to report people who violated Texas’ six-week abortion ban.

See what others are saying: (The Washington Post) (Insider) (WDBJ7)

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Federal Court Throws Out Alabama Congressional Map, Citing Racial Gerrymandering

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The judges ruled that the Republican-held legislature gerrymandered the map so the state only had one Black-majority district despite Black residents composing 27% of the state’s population.


Alabama Ordered to Redraw Map

A panel of federal judges tossed Alabama’s new congressional map on Monday, ruling that the current version significantly weakens the voting power of Black residents.   

In their decision, the three judges noted that while about 27% of Alabamians are Black, the map drawn by the Republican-led legislature after the 2020 census was gerrymandered to leave just one of the state’s seven districts with a Black majority.

“Black voters have less opportunity than other Alabamians to elect candidates of their choice to Congress,” the judges wrote. “We find that the plaintiffs will suffer an irreparable harm if they must vote in the 2022 congressional elections based on a redistricting plan that violates federal law.”

As a result, the panel also ordered state lawmakers to redraw their map so that it includes “two districts in which Black voters either comprise a voting-age majority or something quite close to it.”

The legislature was given 14 days to redo their map before they appoint a special master to do so.

Ongoing Legal Battles

Shortly after the ruling, a spokesperson for Alabama Attorney General Steve Marshall said in a statement that his office “strongly disagrees with the court’s decision and will be appealing in the coming days.” 

According to reports, the matter could ultimately go to the Supreme Court, which would decide whether lawmakers can draw maps that are gerrymandered along racial lines.

The high court ruled in 2019 that federal courts do not have the power to block congressional maps that are gerrymandered to skew districts in a partisan manner unless a state’s constitution explicitly prohibits such gerrymandering. The justices did keep parts of the Voting Rights Act that ban racial or ethnic gerrymandering, which the federal panel claimed was the case in Alabama.

Alabama’s congressional map is not the only one drawn by Republicans that has been thrown out in recent weeks. Earlier this month, Ohio’s Supreme Court ordered lawmakers to redraw a map that would have given Republicans 12 congressional seats and Democrats just three despite the fact that recently the GOP has only won about 55% of the popular vote statewide.

The state’s high court ruled that the map clearly violated a constitutional amendment overwhelmingly passed by voters in 2018 that effectively banned partisan gerrymandering.

See what others are saying: (The New York Times) (The Washington Post) (AL.com)

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Supreme Court Agrees to Hear Affirmative Action Cases at Harvard and UNC

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The decision to take up the two cases marks the first time affirmative action will go before the high court’s latest conservative-majority bloc.


SCOTUS Takes on Race-Conscious Admissions, Again

The Supreme Court announced Monday that it will again consider whether race-conscious admissions programs at universities are legal in two cases that could have serious implications for affirmative action.

The two lawsuits center around admissions policies at Harvard University and the University of North Carolina at Chapel Hill (UNC), both of which were brought by the conservative nonprofit Students for Fair Admissions.

The Harvard case started in 2014 with a lawsuit that claimed the school discriminated against Asian American students by effectively creating a quota for their admission. It also alleged the school a subjective standard to measure personality traits like likability, courage, and kindness.

The Ivy League school denied the allegations, claiming the challengers used incorrect statistical analysis and broadly arguing that race-conscious policies are legal.

In the case against UNC, the group alleged that the school discriminated against white and Asian applicants by giving preference to Black, Hispanic, and Native American students.

The university, for its part, argued that its policies create more diversity among its student body, also echoing Harvard’s argument that such rules are legal under decades of Supreme Court precedents.

Past Precedent Up in the Air

Lower courts ruled in favor of both schools, finding they did indeed comply with Supreme Court decisions.

But in taking up these two cases, the high court’s conservative majority will now examine whether race-conscious admissions are legal at all. The move could decide the future of affirmative action and undermine more than four decades of precedent on the use of race in college admissions.

The last two times the high court took up cases regarding affirmative action, the justices upheld the constitutionality of race-conscious programs by slim majorities. Now, those majorities have been replaced by a conservative bloc that includes three justices appointed by former President Donald Trump.

According to reports, the justices will likely hear the cases in October. 

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

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