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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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Sen. Smith Leads Effort to “Protect Access to Abortion Care Where it is Still Legal”

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The Senator also told Rogue Rocket she supports major reforms to the Supreme Court.


Protecting Access to Medication Abortion Act

As conservative states move to limit abortion following the Supreme Court’s reversal of Roe v. Wade, Sen. Tina Smith (D-Mn.) is working to ensure access to the procedure is protected wherever it is still possible.

“What I’m working on right now is to try to protect access to abortion care where it is still legal in this country after the Supreme Court basically eviscerated this 50-year freedom,” Smith told Rogue Rocket while discussing a bill she recently introduced to safeguard access to medication abortion.

The legislation, dubbed the Protecting Access to Medication Abortion Act, would codify existing Food and Drug Administration guidelines on medication abortion pills to ensure people in states where abortion remains legal can always access them through telehealth and certified pharmacies, including mail-order pharmacies.

“What my bill would do is it would say in states where abortion is still legal, you should be able to get access to medication abortion — which is safe and is effective in the first ten weeks of pregnancy, it’s been around for over 20 years,” said Smith, who previously served as the Vice President for Planned Parenthood of Minnesota.

“You don’t need to go into the doctor to get access to it. You can do a telehealth visit and it can be mailed to your home,” she continued. “Or potentially, if you live in a place where abortion has been banned, you could go someplace — go to Minnesota, for example — where abortion is legal and get access to it there. This is a way of trying to add another layer of protection for women, people who are grappling with the loss of this fundamental freedom and control over their own body.”

“You have providers who have dedicated their lives to making sure that women have access to the health care that they need. You have states that are passing laws that criminalize doctors, criminalize women for accessing abortion care in their states. I think we have to be real, that we need to try to protect both providers and women.”

Smith Questions Legitimacy of Supreme Court

Smith also said the decision to overturn Roe undermines the Supreme Court’s legitimacy because the decision represents the views of “an extreme minority that is enforcing its will” on a majority of Americans who, as polls have consistently shown, broadly support abortion protections.

The reversal, she said, is the result of Republicans’ “concerted effort” to pack the Supreme Court with conservative justices.

“Republican senators and Republican presidents have put on the Supreme Court individuals that they knew that they could trust to overturn Roe,” the senator stated. “I think it calls into question the legitimacy of the court […] I think on a whole range of other issues where we see, you know, what looks to a lot of us like a Supreme Court that is putting its own opinions into court precedent rather than following precedent and the law.” 

Smith went on to say she supports expanding the Supreme Court and argued there are also many other ways to address the issue of legitimacy.

“Americans are seeing that the […] legitimacy of the court is deeply damaged. The question is, what do we do about it? How do we restore trust in the court?” Smith asserted. “Restoring balance to the court by adding justices is one important step, and I support that. There are other things that we could do.”

“The Supreme Court doesn’t abide by any clear responsibility to reveal who is paying for trips of Supreme Court justices or who’s behind the amicus briefs,” she added. “So there’s a level of financial transparency that doesn’t exist on the court like it does in other parts of government.”

The senator concluded by calling for action at the federal, state, and individual levels and urging Americans to take the issue to the polls this fall.

“I think that it is just important to understand that the Supreme Court has spoken, but the Supreme Court does not get the last word,” she said

“There is action that citizens can take, actions that I can take as a legislator, action that governors and attorney generals and state legislatures can take. And in a democracy — and we live in a democracy — we have to bring the power of people’s views on this forward in all the ways that we can, including at the ballot box.”

See what others are saying: (NBC News) (Reuters) (The New York Times)

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Supreme Court Rules High School Football Coach Can Pray on Field

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All of our rights are “hanging in the balance,” wrote Justice Sonia Sotomayor in a dissenting opinion.


Court’s Conservatives Break With 60 Years of History

The Supreme Court on Monday ruled in favor of a former high school football coach who lost his job after he refused to stop praying on the field at the end of games.

Joseph Kennedy, who was hired at Bremerton High School in Washington State in 2008, kneeled at the 50-yard line after games for years and prayed. He was often joined by some of his players, as well as others from the opposing team.

In 2015, the school asked him not to pray if it interfered with his duties or involved students.

Shortly after, Kennedy was placed on paid administrative leave, and after a school official recommended that his contract not be renewed for the 2016 season he did not reapply for the position.

Kennedy sued the school, eventually appealing the case to the Supreme Court.

The justices voted 6 to 3, with the liberal justices dissenting.

“Respect for religious expressions is indispensable to life in a free and diverse republic — whether those expressions take place in a sanctuary or on a field, and whether they manifest through the spoken word or a bowed head,” Justice Neil Gorsuch wrote in the majority opinion.

“Here, a government entity sought to punish an individual for engaging in a brief, quiet, personal religious observance,” he added.

Justice Sonia Sotomayor wrote a dissenting opinion.

“Today’s decision is particularly misguided because it elevates the religious rights of a school official, who voluntarily accepted public employment and the limits that public employment entails, over those of his students, who are required to attend school and who this court has long recognized are particularly vulnerable and deserving of protection,” she said.

“In doing so, the court sets us further down a perilous path in forcing states to entangle themselves with religion, with all of our rights hanging in the balance.”

The defense in the case argued that the public nature of Kennedy’s prayers put pressure on students to join him, and that he was acting in his capacity as a public employee, not a private citizen.

Kennedy’s lawyers contended that such an all-encompassing definition of his job duties denied him his right to self-expression on school grounds.

“This is just so awesome,” Kennedy said in a statement following the decision. “All I’ve ever wanted was to be back on the field with my guys … I thank God for answering our prayers and sustaining my family through this long battle.”

Religious Liberty or Separation of Church and State?

Sixty years ago, the Supreme Court decided that the government cannot organize or promote prayer in public schools, and it has since generally abided by that jurisprudence.

But the court led by Chief Justice John Roberts has been increasingly protective of religious expression, especially after the confirmation of three conservative Trump-appointed judges.

Reactions to the ruling were mostly split between liberals who saw the separation of church and state being dissolved and conservatives who hailed it as a victory for religious liberty.

Americans United for the Separation of Church and State, which represented the Bremerton school district, said in a statement that the ruling “gutted decades of established law that protected students’ religious freedom.”

“If Coach Kennedy were named Coach Akbar and he had brought a prayer blanket to the 50 yard line to pray after a game,” one Twitter user said, “I’ve got a 401(k) that says this illegitimate, Christofascist SCOTUS rules 6-3 against him.”

“The people defending former Coach Kennedy’s right to kneel on the field after the game to pray – are the ones condemning Colin Kaepernick’s right to kneel on the field to protest police brutality against Black Americans,” another user wrote.

Others, like Republican Congressmember Ronny Jackson and former Secretary of State for the Trump administration Mike Pompeo, celebrated the ruling for protecting religious freedom and upholding what they called the right to pray.

“I am excited to build on this victory and continue securing our inalienable right to religious freedom,” Pompeo wrote.

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

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Rep. Schiff Urges DOJ to Investigate Trump for Election Crimes: “There’s Enough Evidence”

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“When the Justice Department finds evidence of criminal potential criminal wrongdoing, they need to investigate,” the congressman said.


Schiff Says DOJ Should Launch Inquiry

Rep. Adam Schiff (R-Ca.) told Rogue Rocket that he believes there is “certainly […] enough evidence for the Justice Department to open an investigation” into possible election crimes committed by former President Donald Trump.

Schiff, who took the lead in questioning witnesses testifying before the House committee investigating the Jan. 6 insurrection on Tuesday, said that it will be up to the DOJ to determine whether “they have proof beyond a reasonable doubt” of criminal activity, but added that an investigation must first be launched.

“Donald Trump should be treated like any other citizen,” the congressman said, noting that a federal judge in California has already ruled that Trump and his allies “likely” engaged in multiple federal criminal acts. “When the Justice Department finds evidence of criminal potential criminal wrongdoing, they need to investigate.”

“One of the concerns I have is it’s a year and a half since these events. And while […] there’s an investigation going on in Fulton County by the district attorney, I don’t see a federal grand jury convened in Atlanta looking into this, and I think it’s fair to ask why,” Schiff continued, referencing the ongoing inquiry into Trump’s attempts to overturn the election in Georgia.

“Normally, the Justice Department doesn’t wait for Congress to go first. They pursue evidence and they have the subpoena power. They’re often much more agile than the Congress. And I think it’s important that it not just be the lower-level people who broke into the Capitol that day and committed those acts of violence who are under the microscope,” he continued. “I think anyone who engaged in criminal activity trying to overturn the election where there’s evidence that they may have engaged in criminal acts should be investigated.”

Schiff Takes Aim at DOJ’s Handling of Committee Subpoenas

Schiff also expressed frustration with how the DOJ has handled referrals the committee has made for former Trump officials who have refused to comply with subpoenas to testify before the panel.

“We have referred four people for criminal prosecution who have obstructed our investigation. The Justice Department has only moved forward with two of them,” he stated. “That’s not as powerful an incentive as we would like. The law requires the Justice Department to present these cases to the grand jury when we refer them, and by only referring half of them, it sends a very mixed message about whether congressional subpoenas need to be complied with.”

As far as why the congressman thought the DOJ has chosen to operate in this manner in regards to the Jan. 6 panel’s investigation, he said he believes “the leadership of the department is being very cautious.” 

“I think that they want to make sure that the department avoids controversy if possible, doesn’t do anything that could even be perceived as being political,” Schiff continued. “And while I appreciate that sentiment […] at the same time, the rule of law has to be applied equally to everyone. If you’re so averse, […] it means that you’re giving effectively a pass or immunity to people who may have broken the law. That, too, is a political decision, and I think it’s the wrong decision.”

On the Note of Democracy

Schiff emphasized the importance of the American people working together to protect democracy in the fallout of the insurrection.

“I really think it’s going to require a national movement of people to step up to preserve our democracy. This is not something that I think Congress can do alone. We’re going to try to protect those institutions, but Republicans are fighting this tooth and nail,” he asserted. “It’s difficult to get through a Senate where Mitch McConnell can filibuster things.”

“We don’t have the luxury of despair when it comes to what we’re seeing around us. We have the obligation to do what generations did before us, and that is defend our democracy,” the congressman continued. “We had to go to war in World War II to defend our democracy from the threat of fascism. You know, we’re not called upon to make those kinds of sacrifices. We see the bravery of people in Ukraine putting their lives on the line to defend their country, their sovereignty, their democracy. Thank God we’re not asked to do that.”

“So what we have to do is, by comparison, so much easier. But it does require us to step up, to be involved, to rally around local elections officials who are doing their jobs, who are facing death threats, and to protect them and to push back against efforts around the country to pass laws to make it easier for big liars to overturn future elections.” 

“We are not passengers in all of this, unable to affect the course of our country. We can, you know, grab the rudder and steer this country in the direction that we want.”

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

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