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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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California Gov. Gavin Newsom Survives Recall

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Experts say the outcome should act as a warning for Republicans who tie themselves to former President Donald Trump and attempt to undermine election results by promoting false voter fraud claims.


Recall Effort Fails

After seven months and an estimated $276 million in taxpayer money, the Republican-led effort to recall California Gov. Gavin Newsom (D) failed Tuesday.

Just under 70% of the votes have been reported as of Wednesday morning, showing that “no” on the recall received 63.9% of the vote. That’s nearly twice as many votes as “yes,” which had 36.1%.

According to The Washington Post, even if the margin narrows as more votes are counted, this still marks one of the biggest rejections of any recall effort in America over the last century.

Analysts say the historic rebuke was driven by high Democratic turnout and broader fears over resurging COVID cases.

While the Delta variant continues to push new infections to record highs in many parts of the country with lax mask rules and low vaccination rates, California, once a global epicenter of the pandemic, now has one of the highest vaccination rates and lowest new caseloads in the nation.

Newsom has continually tried to convince voters that those figures are the results of his vaccine and masking policies, which have been some of the most aggressive in the U.S. 

Given that polls showed the pandemic was the top concern for California voters, it is clear that the majority favored his policies over those of his competitors. Larry Elder, the Republican talk radio host of led the field of 46 challengers, ran on a platform of getting rid of essentially all COVID restrictions.

Newsom’s Remarks

In his victory speech Tuesday night, Newsom painted the recall’s failure not only as a win for Democratic coronavirus policies but also for Democracy at large.

“We said yes to science. We said yes to vaccines. We said yes to ending this pandemic,” he said. “We said yes to people’s right to vote without fear of fake fraud or voter suppression.” 

“I think about just in the last few days and the former president put out saying this election was rigged,” he continued. “Democracy is not a football. You don’t throw it around. That’s more like a, I don’t know, antique vase. You can drop it and smashing a million different pieces. And that’s what we’re capable of doing if we don’t stand up to meet the moment and push back.”

“I said this many, many times on the campaign trail, we may have defeated Trump, but Trump-ism is not dead in this country. The Big Lie, January 6th insurrection, all the voting suppression efforts that are happening all across this country.” 

A Warning for Republicans

Newsom’s remarks took aim at the efforts by Elder and other Republicans — including former President Donald Trump — who over the last week have claimed falsely and without evidence that voter fraud helped secured the governor’s win before Election Day even took place.

While it is currently unknown whether that narrative may have prompted more Republican voters to stay home, Newsom’s effort to cast Edler as a Trump-like candidate and the recall as an undemocratic, Republican power grab appears to have been effective.

Now, political strategists say that the outcome of the recall should serve as a warning that Republicans who pin themselves to Trump and his Big Lie playbook may be hurt more in certain states.

“The recall does offer at least one lesson to Democrats in Washington ahead of next year’s midterm elections: The party’s pre-existing blue- and purple-state strategy of portraying Republicans as Trump-loving extremists can still prove effective with the former president out of office,” The New York Times explained.

Even outside of a strongly blue state like California, analysts say this strategy will also be effective with similar candidates in battleground states like Georgia, Arizona, Missouri, and Pennsylvania, which will be essential to deciding control of the Senate.

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

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Justice Department Sues Texas Over Abortion Ban

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The department claims the Texas law violates past Supreme Court precedents on abortion and infringes on Constitutional protections.


Biden Administration Takes Aim at Texas Law

The Department of Justice sued Texas on Thursday in an attempt to block the state’s newly enacted law that effectively prohibits all abortions by banning the procedure after six weeks, before most people know they are pregnant.

The abortion law, which is the most restrictive in the country and does not provide exceptions for rape or incest, allows private citizens to take legal action against anyone who helps a person terminate their pregnancy after six weeks.

In its lawsuit, the Justice Department argued that the Texas law is unconstitutional because it violates past Supreme Court precedents through a technical loophole.

While numerous other states have passed similar laws banning abortion after about six weeks, federal judges have struck down those measures on the grounds that they are inconsistent with Roe v. Wade and subsequent Supreme Court decisions that states cannot prevent someone from seeking an abortion before a fetus can viably live outside the womb, usually around 22 to 24 weeks.

The Texas law, however, skirts the high court decisions by deputizing citizens to enforce the law rather than state government officials, taking the state out of the equation entirely and protecting it from legal responsibility.

Individuals who do so do not have to prove any personal injury or connection to those they take legal action against, which can range from abortion providers to rideshare drivers who take someone to a clinic.

If their lawsuit is successful, the citizen is entitled to a $10,000 award.

DOJ Lawsuit Targets Constitutionality

During a press conference detailing the DOJ lawsuit, Attorney General Merrick Garland referred to the enforcement mechanism as “an unprecedented” effort with the “obvious and expressly acknowledged intention” to prevent Texans from their constitutionally protected right to have an abortion.

“This kind of scheme to nullify the Constitution of the United States is one that all Americans — whatever their politics or party — should fear,” Garland said, adding that the provision of the law allowing civilians “to serve as bounty hunters” may become “a model for action in other areas, by other states, and with respect to other constitutional rights and judicial precedents.”

The Justice Department argued that the Texas policy violates equal protection guarantees under the 14th Amendment as well as the Constitution’s Supremacy Clause, which establishes that the Constitution and federal law generally take precedence over state law.

The lawsuit also claimed that the law interferes with the constitutional obligation of federal employees to provide access to abortion, including in cases of rape or incest, to people who are under the care of federal agencies or contractors such as those in prisons.

Both Sides See Path to Supreme Court

While proponents of abortion rights applauded the Justice Department’s legal challenge, officials in Texas defended the law and accused the Biden administration of filing the lawsuit for political reasons. 

“President Biden and his administration are more interested in changing the national narrative from their disastrous Afghanistan evacuation and reckless open border policies instead of protecting the innocent unborn,” a spokeswoman for Texas Gov. Greg Abbott (R), said in a statement. 

“We are confident that the courts will uphold and protect that right to life.”

The DOJ’s suit will now be decided by a federal judge for the Western District of Texas, based in Austin. 

Depending on how that court rules, either opponents or supporters of the abortion ban are expected to appeal the case, sending it to the conservative Fifth Circuit Court of Appeal and likely ultimately placing the matter before the Supreme Court again in a matter of months.

The Supreme Court allowed the law to go into effect by declining to approve an emergency petition to block the measure last week, but it did not rule on the constitutionality of the policy.

As a result, the Justice Department’s legal challenge could force the high court to hear another facet of the law that it has not yet considered if it decides to see the case.

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

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Texas Governor Says Rape Victims Aren’t Forced To Give Birth Because They Have 6 Weeks To Get an Abortion

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The governor also defended the six-week abortion ban’s lack of exceptions for rape and incest by saying the state will “eliminate all rapists.”


Abbott Defends Texas Abortion Law

Texas Gov. Greg Abbott (R) on Tuesday defended the state’s new controversial law that bans abortion after six weeks, before many know they are pregnant, after facing criticism that the policy does not provide exceptions for rape and incest.

During a press conference, Abbott refuted a reporter’s assertion that the law forced victims of rape and incest to carry their pregnancies to term, claiming that it “provides at least six weeks for a person to be able to get an abortion.”

“Let’s make something very clear: Rape is a crime,” the governor continued. 

“And Texas will work tirelessly to make sure that we eliminate all rapists from the streets of Texas by aggressively going out and arresting them and prosecuting them and getting them off the streets.” 

Backlash Over Remarks on Abortions at Six Week 

Abbott’s claim that rape victims would still have plenty of time to get an abortion was widely criticized by many, including Rep. Alexandria Ocasio-Cortez (D-N.Y.), who called his remarks “disgusting” in a now-viral interview on CNN

“I don’t know if he is familiar with a menstruating person’s body. In fact, I do know that he’s not familiar with a female or menstruating person’s body because if he did, he would know that you don’t have six weeks,” she said. 

“But in case no one has informed him before in his life, six weeks pregnant means two weeks late for your period,” Ocasio-Cortez continued. “Two weeks late for your period for any person, any person with a menstrual cycle, can happen if you’re stressed, if your diet changes, or for really no reason at all.” 

Those comments were echoed by a lot of other people who pointed to data from Planned Parenthood that said 85-90% of people who obtain abortions in Texas are at least six weeks into their pregnancy.

Critics Note Flaws in Abbott’s Claims About Rapists

Many also took aim at Abbott’s claim that he was going to “eliminate all rapists” by mocking the governor.

“Wait. Governor Abbott had a solution to end all RAPE and he sat on it until now?” Texas State Representative Gene Wu (D) tweeted. 

Others argued that historical evidence proves Abbott’s promise was ignorant.

According to data from the Justice Department analyzed by the Rape, Abuse & Incest National Network (RAINN), only 1 out of every 3 rapes and sexual assaults are reported. 

Source: Rape, Abuse & Incest National Network

Out of every 1,000 assaults, only 50 lead to arrest, and only 25 lead to incarceration, meaning that more than 97% of people who commit assault walk free.

Some critics also said that Abbott’s goal of getting rid of “all rapists” relied on a faulty conception of who actually perpetrates sexual crimes.

“The majority of people who are raped and who are sexually assaulted are assaulted by someone who they know,” Ocasio-Cortez told CNN. “And these aren’t just predators that are walking around the streets at night. They are people’s uncles, they are teachers, they are family friends.”

“And when something like that happens, it takes a very long time, first of all, for any victim to come forward,” she added. “And second of all, when a victim comes forward they don’t necessarily want to bring their case into the carceral system.” 

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

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