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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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Senate Democrats To Introduce Voting Rights Bill This Week

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Republicans are expected to block the legislation, but Democratic leaders hope the GOP’s unified opposition will lay the groundwork to justify getting rid of the filibuster.


Voting Bill Set for Floor

Senate Democrats are officially set to advance their voting rights bill this week, with a procedural vote to start debate on the legislation scheduled for Tuesday.

The move comes as an increasing number of Democrats and progressive activists have begun to embrace a more watered-down version of the bill proposed by Sen. Joe Manchin (D-W.V.), the sole Democrat who opposed the initial proposal on the grounds that it was too partisan.

While Democrats have spent the weekend hashing out the final details of compromise on Manchin’s bill, which he has touted as a more bipartisan compromise, Senate Republicans have still broadly rejected it.

Minority Leader Mitch McConnell (R-Ky.), who previously opposed the initial For the People Act as too far-reaching, called Manchin’s alternative proposal “equally unacceptable” and predicted that no members of his party will vote in favor.

The legislation is all but guaranteed to fail in the chamber, where it will require all 50 Democrats and at least 10 Republicans to overcome the filibuster.

However, bringing the bill to the floor still has major utility for Democrats because it will lay the groundwork for the party to justify scrapping the filibuster entirely.

Pathway for Filibuster Reform

Specifically, if Manchin agrees to some form of the bill which Republicans then filibuster, Democrats can say they had the to votes to pass the legislation if the filibuster were removed. 

That, in turn, would bolster the Democratic argument that bipartisanship cannot be a precondition to taking actions to secure our democracy if it relies on reaching common ground with a party that they believe is increasingly and transparently committed to undermining democracy.

It would also give more ground to the Democratic claim that the GOP is abusing existing Senate rules to block policy changes that have gained wide public support following the Jan. 6 insurrection and amid the growing efforts by Republican governors and legislatures to restrict voting access in their states.

As a result, if Republicans block the legislation along party lines, Democratic leaders hope that could change objections to scrapping the filibuster voiced privately by some members and publicly by Manchin and Sen. Kyrsten Sinema (D-Az.).

This is especially true for Tuesday’s planned vote, because it is just a vote to proceed to debate, meaning that if Republicans filibuster, they will be preventing the Senate from even debating any efforts to protect democracy, including Manchin’s plan which he crafted specifically to reach a compromise with the GOP.

Whether a full party rejection would be enough to move the needle for Manchin and the other Democrats remains to be seen. Any successful overhaul of the contentious Senate rule would not only be incredibly significant for President Joe Biden’s agenda, but also for the precedent it could set.

See what others are saying: (The New York Times) (Reuters) (USA Today)

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McConnell Says He Would Block a Biden SCOTUS Nominee in 2024

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The Senate Minority Leader also refused to say whether or not he would block a hypothetical nominee in 2023 if his party overtakes the chamber’s slim majority in the midterm elections.


McConnell Doubles Down 

During an interview with conservative commentator Hugh Hewitt on Monday, Senate Minority Leader Mitch McConnell (R-Ky.) threatened to block a hypothetical Supreme Court nominee from President Joe Biden in 2024 if Republicans took control of the Senate.

“I think in the middle of a presidential election, if you have a Senate of the opposite party of the president, you have to go back to the 1880s to find the last time a vacancy was filled,” he said. “So I think it’s highly unlikely. In fact, no, I don’t think either party if it controlled, if it were different from the president, would confirm a Supreme Court nominee in the middle of an election.” 

McConnell’s remarks do not come as a surprise as they are in line with his past refusal to consider former President Barack Obama’s nomination of Merrick Garland to the court in February 2016 on the grounds that it was too close to the presidential election.

The then-majority leader received a ton of backlash for his efforts, especially after he forced through Amy Coney Barrett’s confirmation just eight days before the 2020 election. At the time, McConnell argued the two situations were different because the Senate and the president were from the same party — a claim he reiterated in the interview.

McConnell also implied he may take that stance even further in comments to Hewitt, who asked if he would block the appointment of a Supreme Court justice if a seat were to be vacated at the end of 2023 about 18 months before the next inauguration — a precedent set by the appointment of Anthony Kennedy.

“Well, we’d have to wait and see what happens,” McConnell responded.

McConnell’s Calculus

Many Democrats immediately condemned McConnell’s remarks, including progressive leaders who renewed their calls to expand the court.

“Mitch McConnell is already foreshadowing that he’ll steal a 3rd Supreme Court seat if he gets the chance. He’s done it before, and he’ll do it again. We need to expand the Supreme Court,” said Sen. Ed Markey (D-Ma.).

Some also called on Justice Stephen Breyer, the oldest SCOTUS judge, to retire.

“If Breyer refuses to retire, he’s not making some noble statement about the judiciary. He is saying he wants Mitch McConnell to handpick his replacement,” said Robert Cruickshank, campaign director for Demand Progress.

Others, however, argued that the response McConnell’s remarks elicited was exactly what he was hoping to see and said his timing was calculated.

The minority leader’s comments come as the calls for Breyer to step down have recently grown while the current Supreme Court term draws near, a time when justices often will announce their retirement.

On Sunday, Rep. Alexandria Ocasio-Cortez (D-N.Y.) was asked if she thought Breyer should leave the bench while Democrats still controlled the Senate. She responded that she was “inclined to say yes.”

With his latest public statement, McConnell’s aims are twofold here: he hopes to broaden divisions in the Democratic Party between progressives and more traditional liberals, who are more hesitant to rush Breyer to retire or expand the court, while simultaneously working to unite a fractured Republican base and encourage them to turn out in the midterm elections.

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

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Gov. Abbott Says Texas Will Build Border Wall With Mexico

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The announcement follows months of growing tension between the Texas governor and President Biden over immigration policies.


Texas Border Wall 

Texas Gov. Greg Abbott (R) announced during a press conference Thursday that the state would build a border wall with Mexico, extending the signature campaign promise of former President Donald Trump.

Abbott provided very few details for the border wall plans, and it is unclear if he has the authority to build it.

While some of the land is state-owned, much of it belongs to the federal government or falls on private property.

Even if the state were able to build on federal ground, private landowners who fought the Trump administration’s attempts to take their land through eminent domain would still remain an obstacle for any renewed efforts.

During his term, Trump built over 450 miles of new wall, but most of it covered areas where deteriorating barriers already existed, and thus had previously been approved for the federal project.

The majority of the construction also took place in Arizona, meaning Abbott would have much ground to cover. It is also unclear how the governor plans to pay for the wall.

Trump had repeatedly said Mexico would fund the wall, but that promise remained unfulfilled, and the president instead redirected billions of taxpayer dollars from Defense Department reserves.

While Abbott did say he would announce more details about the wall next week, his plan was condemned as ill-planned by immigration activists, who also threatened legal challenges.

“There is no substantive plan,” said Edna Yang, the co-executive director of the Texas-based immigration legal aid and advocacy group American Gateways. “It’s not going to make any border community or county safer.”

Ongoing Feud

Abbott’s announcement comes amid escalating tensions between the governor and the administration of President Joe Biden.

Biden issued a proclamation that stopped border wall construction on his first day of office, and has since undone multiple Trump-era immigration policies. Abbott, for his part, has blamed Biden’s rollback of Trump’s rules for the influx of migrants at the border in recent months. 

Two weeks ago, the governor deployed over 1,000 National Guard members and troopers from the Texas Department of Public Safety to the border as part of an initiative launched in March to ramp up border security dubbed Operation Lone Star.

Last week, Abbott issued a disaster declaration which, among other measures, directed the Texas Health and Human Services Commission to strip the state licenses of all shelters that house migrant children and have contracts with the federal government.

The move, which federal officials have already threatened to take legal action against, could effectively force the 52 state-licensed shelters housing around 8,600 children to move the minors elsewhere.

During Thursday’s press conference, Abbott also outlined a variety of other border initiatives, including appropriating $1 billion for border security, creating a task force on border security, and increasing arrests for migrants who enter the country illegally.

“While securing the border is the federal government’s responsibility, Texas will not sit idly by as this crisis grows,” he said. “Our efforts will only be effective if we work together to secure the border, make criminal arrests, protect landowners, rid our communities of dangerous drugs and provide Texans with the support they need and deserve.”

See what others are saying: (The Texas Tribune) (The New York Times) (CNN)

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