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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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NY Gov. Cuomo Aides Reportedly Altered Nursing Home Death Toll Data

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  • Aides to New York Gov. Andrew Cuomo (D) altered a July report from the state’s Department of Health to cover up the extent of COVID-related deaths in nursing homes, according to Thursday reports from The New York Times and Wall Street Journal.
  • Last month, Cuomo admitted that his administration withheld death toll data in order to prevent a possible federal misconduct investigation. 
  • However, the new reports claim Cuomo’s staffers attempted to conceal the true numbers earlier than previously known by directly altering the DOH’s report to exclude nursing home residents who died in outside facilities.  
  • The DOH then used the incomplete number to claim New York had lower nursing home deaths than other states that included out-of-facility deaths when in reality their figures were much higher than everywhere else in the country.

New York Nursing Home Scandal Escalates

Advisers to New York Gov. Andrew Cuomo (D) allegedly re-wrote a report from health officials to conceal the number of COVID-related deaths in the state’s nursing homes, according to new reports published by The New York Times and Wall Street Journal Thursday.

Both Democrats and Republicans accused the Cuomo administration of intentionally withholding the full toll last month after his top aide, Melissa DeRosa, apologized to state legislators for refusing to provide data they requested in August. DeRosa explained that they had sidelined the request in order to prevent a possible misconduct investigation that stemmed from a similar inquiry by the Department of Justice.

Legislators and the DOJ had asked for the data after the state’s Health Department published a report in July detailing the impact of a controversial nursing home policy Cuomo had enacted at the beginning of the pandemic in March.

The policy, which Cuomo later rescinded in May, prohibited nursing homes from refusing to re-admit residents or admit new residents from hospitals solely on the basis that they had been diagnosed with COVID-19.

The directive was aimed at keeping hospital admittance low and mirrored similar actions other states had taken at the time, but many nursing home operators and legislators claimed the move had encouraged the spread of the virus amongst one of the most vulnerable populations.

The Health Department’s July report, however, found the policy was not to blame. Additionally, the agency also said the 6,432 nursing home residents that had died was lower than figures in other northeastern states when measured as a percentage of the population.

Lawmakers requested to see the data behind the report, and suspicions arose when the Cuomo administration refused to provide the information, launching a nearly six-month battle.

State Attorney General Report 

Then at the end of January, New York Attorney General Letitia James (D)  published a report claiming the administration had undercounted the nursing home deaths by the thousands, and that Cuomo’s March directive may have been responsible for higher deaths.

The Health Department’s report, James said, had left out residents who had died of COVID in outside facilities such as hospitals, but still claimed New York’s tolls were lower than other states that had counted residents who died in other places.

Shortly after James’ report, the department publicized more than 3,800 unreported deaths of nursing home residents who had died of COVID-19 in hospitals.

Cuomo refused to address the controversy for weeks, only speaking out after DeRosa’s comments leaked. During a press conference on Feb. 15, he took responsibility for not fulfilling the request for data sooner, but insisted that the nursing home deaths had always been reported correctly and transparently, arguing the difference was just a matter of “categorization.”

What the New Reports Reveal

Both Cuomo and DeRosa have maintained that they withheld the data from legislators out of concern that the Trump administration would politicize the DOJ inquiry.

However, the new reports from The Times and WSJ allege that Cuomo and his aides had actually started hiding the true numbers months earlier and directly altered the Health Department’s July report.

According to a draft of the Health Department’s July report seen by the outlets and at least half a dozen people with direct knowledge, the initial version of the report contained a chart that put the nursing home death toll at 9,250 — 50% higher than the figure that was later included in the final version.

The chart also compared the full total including residents who died in hospitals to the same totals in other states, revealing that New York’s deaths far surpassed that of all others. At the time, the state with the next-highest nursing home deaths was New Jersey with 6,150.

According to The Times, the report was rewritten by three of Cuomo’s top staffers to remove the encompassing figures, including DeRosa. None of the officials had any public health expertise. The move reportedly set off a battle with health officials working on the report and further exacerbated the already tense relationship between Cuomo and his Health Department, which eventually prompted nine top officials to leave in February.  

The governor’s office responded to the reporters in a statement Thursday night from Special Counsel Beth Garvey, who said the out-of-facility data was omitted because the Health Department “could not confirm it had been adequately verified.” 

Gary Holmes, a spokesman for the Health Department, also told reporters the agency “was comfortable with the final report and believes fully in its conclusion that the primary driver that introduced Covid into the nursing homes was brought in by staff.”

The new allegations, however, come as Cuomo is already facing mounting political pressure and calls to resign over the nursing home scandal as well as recent accusations of sexual misconduct by three women, including two former employees.

After the third woman came forward, Cuomo apologized on Wednesday for the “pain” he caused, but rejected calls for his resignation. The FBI has opened an inquiry into the nursing home scandal, and the sexual harassment allegations will soon be investigated by state Attorney General James’ office.

See what others are saying: (The New York Times) (The Wall Street Journal) (The Guardian)

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House Passes Landmark Elections Bill To Expand Voting Rights

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  • House Democrats passed the For the People Act on Wednesday, a broad voting rights bill that aims to enhance voting rights.
  • Among other measures, the legislation would mandate automatic voter registration, expand early and mail-in voting, restore voting rights to former felons, and impose new disclosure requirements for campaign donations and political advertising.
  • Democrats say the act is necessary to ensure American’s right to vote, especially as state legislatures have proposed dozens of bills that would roll back voting access and consolidate GOP power.
  • Republicans have argued that states, not the federal government, should decide how elections are run and claimed the new bill would lead to fraud that helps liberal candidates. 

House Approves For the People Act

The U.S. House of Representatives passed a sweeping elections bill Wednesday that aims to significantly expand federal voting rights all over the country.

The bill, called the For the People Act, was proposed by Democrats and passed 220 to 210 almost entirely along party lines. According to reports, if signed into law, it would be the most comprehensive enhancement of federal protections since the 1960s.

The bill contains a wide variety of provisions, but the most significant fall into two broader categories: creating uniform standards for voting and increasing financial transparency.

Regarding the voting rights standards, among other things, the bill would:

  • Weaken restrictive state voter ID laws.
  • Mandate that state governments use existing records to automatically register voters.
  • Guarantee no-excuse mail voting and at least 15 days of early voting for all federal elections.
  • Make it harder to purge voter rolls.
  • Restore voting rights to former felons.
  • End partisan gerrymandering by requiring states to appoint independent commissions to draw congressional districts.

As for what the bill aims to do regarding expanding transparency, it would:

  • Impose new disclosure requirements for “dark money” donations used to finance campaigns.
  • Create a public financing option for congressional campaigns.
  • Require presidential candidates to disclose their tax returns.
  • Require tech platforms to disclose political advertising information.

Arguments For And Against

Democrats have argued that this legislation is essential to protecting and ensuring the right to vote. 

The task, they say, is especially important now because Republican-controlled state legislatures have proposed dozens of bills that would roll back voting access as a reaction to former President Donald Trump’s loss and efforts to undermine the election. Many Republicans have used Trump’s false claims about voter fraud to promote their legislation.

Democrats have said these bills are a very transparent attempt by Republicans to consolidate their power because they know they benefit from lower voter turnout, and thus their strategy to win more races is just simply to make voting harder. As a result, Democrats have said the For the People Act is key to combatting these bills

“Everything is at stake,” House Speaker Nancy Pelosi (D-Ca.) said Wednesday. “We must win this race, this fight.”

Republicans, for their part, have argued that states, not the federal government, should make changes to how elections are run, and that the legislation would lead to fraud that benefits Democrats. 

“House Democrats do not get to take their razor-thin majority — which voters just shrunk — and use it to steamroll states and localities to try and prevent themselves from losing even more seats next time,” Senate Minority Leader Mitch McConnell (R-Ky.) said in response to the bill’s passage.

However, many have disputed that claim by noting that there is no evidence of widespread fraud that helped Democrats in the last election. By contrast, there are years of evidence that Republicans do benefit from making it harder for people to vote and gerrymandering districts, a fact that McConnell himself seemed to acknowledge by implying that Democrats win more when voting rights are expanded.

Despite Republican objections, recent polls have found that most Americans support having more voter protections. According to a January survey by Data for Progress, 67% of Americans back the For the People Act, including a majority of Republicans.

Still, the legislation is all but doomed in the Senate, which struck down an almost identical version passed by the House in 2019. While Democrats technically have a majority now, the current 50-50 split will require a minimum of 10 Republicans to join forces with all 50 Democrats to avoid the 60-vote legislative filibuster.

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

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Texas Governor Will Reopen State “100%” and End Mask Mandate Against Expert Advice

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  • Texas Gov. Greg Abbott (R) said Tuesday that he was opening the state “100%” and ending the mask mandate starting March 10, against health guidance from federal officials.
  • Abbott justified his decision by noting that nearly 6 million Texans have been vaccinated and hospitalizations are down in the state.
  • Experts, however, pointed out that less than 2 million of the state’s 29 million residents are fully inoculated, and the CDC currently ranks Texas 48th for vaccination rates out of all 50 states.
  • On Tuesday alone, governors in Mississippi, Louisiana, and Michigan as well as local leaders in Chicago and San Francisco also announced plans to ease COVID-19 restrictions.

Abbott Announces Major COVID Policy Changes

Starting March 10, Texas will no longer have a state-wide mask mandate or any coronavirus-related restrictions on businesses and facilities, Gov. Greg Abbott (R) announced Tuesday.

The move represents the most expansive reopening of any state and makes Texas the largest state to lift its public masking requirement. However, it also goes entirely against the recommendation of the nation’s top experts.

During a press conference Monday, Rochelle Walensky, the director for the Centers for Disease Control and Prevention warned leaders against rolling back restrictions. She cited the fact that the recent nation-wide decline in cases has been stalling and that there has been community spread of the new variants  — three of which have been found in Texas, saying:

“With these new statistics, I am really worried about reports that more states are rolling back the exact public health measures we have recommended to protect people from COVID-19,” she said.

“Please hear me clearly: At this level of cases, with variants spreading, we stand to completely lose the hard-earned ground we have gained. These variants are a very real threat to our people and our progress,” she continued.

“Now is not the time to relax the critical safeguards that we know can stop the spread of covid-19 in our communities, not when we are so close.” 

Conditions in Texas

While cases have been declining in Texas, like most of the country, there is still a lot of data that makes Abbott’s decision especially concerning.

According to The New York Times tracker, Texas still ranks within the top ten states with the highest weekly cases per capita, reporting a weekly average of just over 7,200. Texas also has more hot-spot counties than any other state, according to Business Insider’s analysis of the Times data, which found that 10 counties have reported more than 100 cases per 100,000 residents on average over the last week. 

Notably, that number could be skewed because of the massive drop in the testing due to a recent storm that left millions without power and clean water. In fact, experts have warned that Texas could see more COVID cases in the fallout of the storm because people were forced to shelter together.

Abbott, however, did not focus on any of that in his announcement. Instead, he cited other metrics, noting that nearly 5.7 Texans have been vaccinated. He also pointed to declines in hospitalizations.

But both of these justifications are misleading. While it is true that Texas has vaccinated close to 6 million people, according to the CDC, less than 2 million out of 29 million state residents have received both doses needed to be considered fully inoculated. 

Beyond that, the CDC’s latest vaccination report ranks Texas 48th in vaccination rates out of all 50 states. Part of that is tied to the lag the state faced because of the storm, but experts still say this just proves that the state needs to be focus on catching up and vaccinating more people instead of rolling back restrictions.

To that point, public health officials have also pushed back against Abbott’s use of declining hospitalization rates as a rationale for his reopening plans. They warned that current hospitalization declines are already slowing and could reverse, and that will only get worse with reopenings.

Other States Reopen

Texas, however, is not the only state that has rolled back restrictions lately, or even just in the past 24 hours.

On Tuesday alone, the governors of Louisiana and Michigan as well as the mayors of Chicago and San Francisco all announced that they would be easing some restrictions on businesses and/or the capacity at which they operate.

Right after Abbott’s announcement, Mississippi Gov. Tate Reeves (R) made a nearly identical one with an even shorter timeline. In a tweet, he said that starting Wednesday, he would lift all county mask mandates and allow businesses to “operate at full capacity without any state-imposed rules.”

The recent easing of restrictions is part of a broader trend — and not just in states that have Republican governors or large conservative populations.

While California Gov. Gavin Newsom (D) slammed Abbott’s move as “absolutely reckless,” he has also been widely condemned by leaders in his state for recently rolling back numerous restrictions.

Over the last few weeks, the Democratic governors of Virginia, North Carolina, and New York have all also lifted or otherwise modified regulations to make them less restrictive. 

See what others are saying: (The New York Times) (The Dallas Morning News) (Business Insider)

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