FDA Allows Expanded Use of Convalescent Plasma to Treat COVID-19. Here’s What You Should Know
- 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)
White House Endorses Bipartisan Senate Bill That Could Ban TikTok
The measure does not target TikTok specifically but instead would set up a framework to crack down on foreign products and services that present a national security threat.
The RESTRICT Act
A bipartisan group of senators introduced a bill Tuesday that would allow the federal government to restrict or even outright ban TikTok and other technologies produced by foreign companies.
Under the legislation, dubbed the RESTRICT Act, the Commerce Department would have sweeping authority to identify and regulate technologies that pose a risk to national security and are produced by companies in six “foreign adversary” countries: China, Russia, Iran, Cuba, Venezuela, and North Korea.
In other words, the proposal would not explicitly ban TikTok, but instead creates a path for future prohibitions on the Chinese-owned platform.
While the bill’s text does not specifically mention TikTok, the group of senators made it clear that the app is their number one target, directing most of their criticism to the platform in statements announcing the measure.
The legislation, however, would go way beyond TikTik: it is also designed to prepare for future situations where apps or technologies from an “adversary” country become popular in the U.S.
The bill’s Democratic sponsor, Sen. Mark Warner (D-Ma.), echoed that point in his remarks Tuesday.
“Today, the threat that everyone is talking about is TikTok, and how it could enable surveillance by the Chinese Communist Party, or facilitate the spread of malign influence campaigns in the U.S.,” he said. “Before TikTok, however, it was Huawei and ZTE, which threatened our nation’s telecommunications networks. And before that, it was Russia’s Kaspersky Lab, which threatened the security of government and corporate devices.”
“We need a comprehensive, risk-based approach that proactively tackles sources of potentially dangerous technology before they gain a foothold in America, so we aren’t playing Whac-A-Mole and scrambling to catch up once they’re already ubiquitous.”
Proponents of the bill also hope that, given the broad scope of the legislation, it will gain more traction than past proposals that zeroed in on TikTok. Support for the measure was further bolstered when the White House announced it would back the move shortly after it was rolled out.
“This bill presents a systematic framework for addressing technology-based threats to the security and safety of Americans,” National Security Advisor Jake Sullivan said in a statement. “We look forward to continue working with both Democrats and Republicans on this bill, and urge Congress to act quickly to send it to the President’s desk.”
A Bumpy Road Ahead
Despite the bipartisan push, there are still some hurdles for the RESTRICT Act to overcome.
Although the legislation does not directly ban TikTok, because that is clearly its intent, the same issues with an outright prohibition still stand. One of the most serious concerns is that banning TikTok would violate the First Amendment.
There is past precedent on this front: in 2020, a federal magistrate judge blocked the Trump administration from requiring Apple and Google to take the Chinese-owned app WeChat off their app stores.
In that decision, the judge argued that the government only had “modest” evidence about the app’s risks and that removing it from app stores would “burden substantially more speech than is necessary to serve the government’s significant interest in national security.”
TikTok has emulated that argument. In a statement responding to the RESTRICT Act Tuesday, a spokesperson for the company said the legislation could “have the effect of censoring millions of Americans.”
Meanwhile, even if the act does pass, there is also the question of whether the Biden administration would decide on a full-scale ban.
Commerce Secretary Gina Raimondo would be the one responsible for overseeing the process under the bill, and while she said she said in a statement that she “welcomed” the proposal and promised to work with Congress to pass it, she has also previously expressed hesitation for a full prohibition.
On the other end of the equation, there are concerns that this measure will not ultimately get enough bipartisan support from Republicans who do want an outright ban and will refuse to accept anything that falls short of that.
While speaking with Fox News on Tuesday, Sen. Marco Rubio (R-Fl.) said the new plan did not go far enough and argued that Congress “should pass a bill that bans TikTok.”
Even if the legislation does get enough support in the Senate, its path is unclear in the GOP-held House, where it also does not yet have a companion bill. Republicans in the House recently introduced a measure that would give the president the power to unilaterally ban TikTok in the U.S.
That proposal, however, is not bipartisan like the RESTRICT Act, which will be a key test to see if legislators can find a middle ground on the matter.
See what others are saying: (The Washington Post) (Reuters) (NBC News)
What You Need to Know About Wisconsin’s Supreme Court Race — The Most Important Election in 2023
Gerrymandering, abortion, the 2024 presidential election, and much more are on the line.
An election to fill an empty seat on the Wisconsin Supreme Court that has been described as the most consequential race of 2023 has now been narrowed to two candidates after the primary Tuesday.
Liberal Milwaukee County Judge Janet Protasiewicz easily took first place, winning 46.4% of the vote with nearly all precincts reporting. In second place with 24.2% was conservative Daniel Kelly, a former Wisconsin State Supreme Court justice who was appointed by the state’s then-Republican governor in 2016 but lost his re-election in 2020.
Notably, the wide discrepancy in votes can be explained by the fact that Kelly split Republican ballots with another conservative candidate who came in a close third with 21.9%. As such, the general election is expected to be tight.
Also of note, this race is technically supposed to be non-partisan, but Protasiewicz has closely aligned herself with Democrats and Kelly has done the same with Republicans. Both parties, as well as dark money groups, have poured millions of dollars into the high-stakes election that will determine whether liberals or conservatives will have a 4-3 majority on the state Supreme Court at an incredibly consequential time.
There are a number of paramount issues at play here that have widespread implications not just for Wisconsin but America at-large.
Gerrymandering and Elections
Wisconsin is one of the most important swing states in the country: it helped decide the outcomes of both the 2016 and 2020 presidential elections, and it is the center of debates on gerrymandering and free and fair elections that have played a role in those races.
The state Supreme Court, which has had a conservative majority for the last 14 years, has been instrumental in shaping those policies, having weighed in on many of the most crucial topics and almost always siding with Republicans.
For example, in what VICE described as “arguably the most important decision the court made in recent years,” the court ruled 4-3 last year to uphold one of America’s most gerrymandered maps that gave Republicans a massive advantage.
“The maps are so gerrymandered that Republicans hold six of Wisconsin’s eight House seats and nearly two-thirds of legislative seats in the state—even though Democrats won most statewide races last year,” the outlet reported.
That ruling created something of a self-fulfilling prophecy: the conservative majority court has decided so many critical topics because the state government is deadlocked with a Republican majority in the legislature and a Democratic governor.
So, by approving a map that massively favored Republicans, the conservative court kept that system in place, ensuring that they would continue to have the final say on so many of these essential areas.
However, if Protasiewicz wins the general election, the court is all but certain to revisit the gerrymandered map. Protasiewicz, for her part, explicitly stated in a recent interview that a liberal majority could establish new election maps. Kelly, meanwhile, has said he has no interest in revisiting the maps.
A decision unfavorable to the GOP-drawn maps would have significant implications for the internal politics of Wisconsin and control of the U.S. House of Representatives, where Republicans currently hold a very slim five-seat majority.
To that point, the Wisconsin Supreme Court also plays a big role in how the state’s elections are administered and how its ten Electoral College votes will be doled out in the 2024 presidential election.
Last year, the conservative court banned absentee ballot drop boxes, and in 2014, it upheld a GOP voter ID law that studies have shown suppressed Black voters. While the court did vote against considering former President Donald Trump’s lawsuit to try and overturn the 2020 election in Wisconsin, it only did so by a thin margin of 4-3.
The court will very likely be tasked with wading into elections-related cases in the coming years. Already, it is anticipated that the justice will hear a lawsuit by a conservative group aiming to further limit voting access by banning mobile and alternate voting facilities.
Abortion and Other Important Statewide Subjects
In addition to the ramifications for America broadly, there are also plenty of paramount issues concerning the state Supreme Court that will materially impact the people of Wisconsin.
Much of the race has been centered heavily on the topic of abortion and reproductive rights because the composition of the court will almost positively determine whether or not abortion will be legal for the state’s six million residents.
Following the Supreme Court reversal of Roe v. Wade, an 1849 Wisconsin law banning abortion went back into effect. Currently, a lawsuit against the ban is winding its way through the court system, and it is all but assured that battle will eventually go before Wisconsin’s Supreme Court.
Experts and analysts say that if Kelly wins, it is essentially guaranteed that abortion will remain illegal in almost all cases. Protasiewicz, by contrast, has campaigned extensively on abortion rights and vocally supported the right to choose.
Beyond that, there are also several other major issues the court will likely rule on in the coming years. For example, Protasiewicz has also said she believes a liberal majority could reverse a 12-year-old law that basically eliminated collective bargaining for public workers. All of that is just the tip of the iceberg.
“Everything is at stake, and I mean everything: Women’s reproductive rights, the maps, drop boxes, safe communities, clean water,” Protasiewicz told VICE. “Everything is on the line.”
See what others are saying: (VICE) (The New York Times) (The Washington Post)
Republicans Want to Cut Food Stamps — Even As Pandemic-Era Programs Wind Down
Experts say cuts to food stamps could have a devastating impact on the 41 million Americans who rely on the program.
GOP Weighs SNAP Cuts in Budget
In recent weeks, top Republican lawmakers have floated several different ideas for cutting food stamp benefits.
Earlier this month, Republicans now leading the House Budget Committee flagged food stamps — formally known as the Supplemental Nutritional Assistance Program, or SNAP — as one of the ten areas they would support cuts to in their new budget proposal.
In a memo, the panel argued that stricter work requirements would “save tens of billions,” while a more rigid verification process for applicants would limit waste, fraud, and abuse. The idea comes as part of a broader effort to reduce the federal deficit.
Experts, however, say the proposed changes could result in debilitating cuts for the 41 million Americans who rely on food stamps and exacerbate an ongoing hunger crisis at a time when inflation has sent food prices rising.
SNAP provides low-income households with an average of around $230 a month for groceries. For many of those families who are also the most impacted by inflationary price increases across the board, that money is absolutely essential.
Experts have also noted that any additional cuts to SNAP would be especially harmful because Republicans are still proposing new cuts despite the fact that Congress already agreed just two months ago to end a pandemic-era program that had increased benefits in some states.
Under the pandemic policies, SNAP was expanded so households could receive maximum benefits instead of benefits based on income testing while also giving bigger payouts to the lowest-income Americans.
That expansion is now set to expire in March, and according to the anti-hunger advocacy group the Food Research and Action Center, an estimated 16 million households will see their per-person benefits drop by around $82 a month.
The Farm Bill Debate
Even if Republicans do not end up cutting SNAP in the budget, the program may still be in hot water.
While raising the debt limit is at the forefront of ongoing partisan battles at the moment, there is already a fight shaping up over another essential piece of legislation: the farm bill.
The farm bill is a package that has to be updated and reauthorized every couple of years. One of the most important legislative tasks Congress is responsible for, the farm bill includes many important subsidies and programs that are imperative to America’s food systems, farms, and much more.
SNAP is among the nutrition-based programs that fall under the purview of the farm bill, and Republicans have already tossed around the idea of cutting food stamp benefits in their ongoing negotiations.
Those debates are quite forward-looking, though it is normal for such discussions to occur early during a year in which Congress is charged with passing the farm bill. Lawmakers have until Oct. 1 to either enact a new version or agree on some kind of extension.