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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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Trump Contradicts CDC Director on Vaccine Timeline

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  • CDC Director Robert Redfield said that because a COVID-19 vaccine would go to first responders and high-risk populations first, the country not start seeing immunity in the general public until the end of next year.
  • Redfield also said wearing masks is more effective than a vaccine could be and encouraged people to do so.
  • President Trump contradicted Redfield later in the day, saying that he made a mistake and misunderstood both the questions about vaccines and masks.
  • Trump said a vaccine will be ready for the entire general public by October and 100 million people would be vaccinated by the end of the year — both a date and a number most experts have said are impossible. He also said the vaccine would be more effective than masks, though he did not provide any evidence for this claim.
  • The incident sparked renewed accusations that Trump has been pressuring his health officials and scientists to rush the vaccine timeline so there is an inoculation before Election Day.

Redfield’s Testimony

President Donald Trump directly contradicted the scientific findings of the health officials in his own administration Wednesday regarding the timeline for a COVID-19 vaccine and the efficacy of face masks.

The president’s remarks came just hours after Dr. Robert Redfield, the director of the Center for Disease Control and Prevention (CDC), testified before a Senate committee. There, he said the American public will likely not see the effects of immunity effects of a vaccine until the middle of next year. He also highlighted the importance of mask-wearing in preventing further spread.

“I think there will be a vaccine that initially be available sometime between November and December, but very limited supply and will have to be prioritized,” he said. “If you’re asking me, when is it going to be generally available to the American public, so we can begin to take advantage of vaccine to get back to our regular life? I think we’re probably looking at late second quarter, third quarter 2021.” 

Redfield then went on to clarify that the vaccine will initially go to first responders and people who are at higher risk before being distributed to the wider public, a factor that he said will create a lag between when the vaccine is approved and when we will start seeing measurable public immunity.

“I think we have to assume that if we had a vaccine, say, released today, that it’s going to take us probably in the order of six to nine months to get the American public vaccinated,” he told the Senators. “And in order to have enough of us immunized, so we have immunity, I think it’s going to take us six to nine months.” 

Redfield also emphasized the importance of continuing mitigation efforts in the meantime, like hand washing, social distancing, and wearing masks.

“Face masks are the most important, powerful public health tool we have,” he said, encouraging Americans to embrace them. “I’ve said it, if we did it for six, eight, 10, 12 weeks, we’d bring this pandemic under control.”

“These actually, we have clear, scientific evidence they work, and they are our best defense,” he continued. “I might even go so far as to say that this face mask is more guaranteed to protect me against COVID than when I take a COVID vaccine.” 

Redfield’s remarks, specifically regarding the COVID-19 vaccine, have been described as by far the most detailed time frame that the leader of the main public health agency has provided in regards to a vaccine and immunity.

Last week, the CDC told health agencies that 2 million vaccine doses might be available by the end of October, with the possibility that there could be 10 to 20 million doses ready available by November and 20 to 30 million by the end of the year.

Those general timelines for both vaccine distribution and immunity put forth by the CDC are also consistent with what other top experts have said, including Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases.

“It won’t be until we get into 2021 that you’ll have hundreds of millions of doses, and just the logistics, constraints in vaccinating large numbers of people,” Fauci told CNN earlier this week.  “It’s going to take months to get enough people vaccinated to have an umbrella of immunity over the community so that you don’t have to worry about easy transmission.”

Trump Press Conference

While speaking at his press conference, Trump directly refuted Redfields remarks and provided a very different timeline for vaccine distribution.

“We’re on track to deliver and distribute the vaccine in a very, very safe and effective manner. We think we can start sometime in October,” he said. “So as soon as it is announced, we’ll be able to start. That’ll be from mid-October on. It may be a little bit later than that, but we’ll be all set.” 

“We’ll be able to distribute at least 100 million vaccine doses by the end of 2020 and a large number much sooner than that,” he added.

When asked if he agreed about Redfield’s timeline, Trump said that he did not, and that he thought the CDC director “made a mistake” in his comments.

“I called him, and he didn’t tell me that, and I think he got the message maybe confused. Maybe it was stated incorrectly,” he added.

“We’re ready to go immediately as the vaccine is announced,” Trump continued. “We will start distributing it immediately to the general public.”

“When we go, we go. We’re not looking to say, ‘Gee, in six months, we’re going to start giving it to the general public.’ No, we want to go immediately. No, it was an incorrect statement.” 

Many public health officials and experts even beyond Redfield have repeatedly disputed the president’s optimistic vaccine timeline, but Trump’s comments about vaccines are not the only remarks he made at the press conference that run counter to public health advice.

Trump also refuted Redfield’s comments regarding masks being more effective than a vaccine, saying that wearing a face mask is “not more effective, by any means, than a vaccine.”

He continued to say that he spoke to Redfield about his testimony, and again offered the explanation that the CDC director misunderstood the question he was asked and that he made a mistake.

“The mask is not as important as the vaccine,” Trump said, adding that masks have “problems” and are “a mixed bag,” citing waiters at restaurants touching their masks then touching food. Notably, he did not provide any evidence for his claim that a vaccine would be more effective than universal masking.

In Redfield’s explanation of why he believed wearing a mask may be more effective than a vaccine, the CDC director pointed to the fact that a coronavirus vaccine will likely not be fully effective. Very few vaccines are close to 100% effective, and the Food and Drug Administration (FDA) has said a coronavirus vaccine will only need to be 50% effective to gain their approval.

Most experts do expect the vaccine to have slightly more efficacy than that, but not by much. By contrast, there is a growing body of evidence that shows masks are highly effective in preventing spread, and if a large majority of the public wore masks, transmission would drop significantly.

It is not unusual for Trump to cast doubt on the effectiveness of masks — despite significant evidence to the contrary — but experts have said it is dangerous to present a COVID-19 vaccine as a cure-all that will mitigate the need for other precautions.

“It is overwhelmingly likely that the first COVID-19 vaccine will not be a silver bullet. Rather, it will be one more weapon against the disease to add to our arsenal,” Mother Jones wrote Wednesday. “It’s like getting dressed for a blizzard, where each intervention—in this case, masks, social distancing, and eventually a vaccine—will work in tandem to protect you.”

Concerns Over Rushed Timeline

Trump’s remarks prompted renewed allegations that he is intentionally rushing to get a vaccine out before Election Day, and that he is pressuring or pressuring his own appointees and scientists to do so.

This is not a new idea at all, just one that Trump added more fuel to. Earlier this month, the CDC told states to begin preparing for a “large-scale” distribution of vaccines by Nov. 1 — just two days before the election.

In August, the head of the Food and Drug Administration also floated the idea of the agency using emergency authority to approve one of the three vaccines in the final stages of testing before clinical trials end. 

Both directives prompted numerous people to question whether those decisions were made because of political interference from Trump, and his most recent comments simply bolstered those claims.

While speaking at a townhall event Wednesday, Democratic nominee Joe Biden raised the possibility that Trump is pressuring his health officials to sign off on a COVID-19 vaccine they might not be confident with to get an advantage in the election. He also argued that Trump’s focus on the election calendar when it comes to the vaccine damages his credibility.

“Let me be clear: I trust vaccines. I trust the scientists. But I don’t trust Donald Trump,” he said. “And at this moment, the American people can’t either.”

“We can’t allow politics to interfere with the vaccine in any way,” Biden said later that same day. “[Trump] doesn’t have any respect for science. This is the same guy who said, inject bleach. This is the guy who said, if you want to keep hurricanes from getting to the United States, drop a nuclear weapon on them.”

Trump, for his part, has taken up a new strategy when it comes to these allegations. In his press conference Wednesday, he accused Biden of promoting what he called “anti-vaccine theories.”

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

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Trump Hosts Rally in Nevada, Defying State Rules Against Large Gatherings

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  • President Trump held an indoor rally in Henderson, Nevada, directly violating the state’s rules limiting gatherings to 50 people. It marked his first indoor rally since one in Tulsa, Oklahoma this past June, which experts say likely contributed to COVID-19 spikes in the city.
  • Pictures and videos showed thousands of people shoulder-to-shoulder, many not wearing masks, which were only required for those who would be seen on TV standing behind Trump.
  • Nevada’s governor condemned Trump for “reckless and selfish actions” that endangered lives, meanwhile, the City of Henderson threatened the venue with penalties and business license removal.
  • Trump hit back, saying he believed the rules did not apply to him, and that he was not worried about spreading the virus. His campaign also downplayed the risk of the indoor rally, saying they checked temperatures and offered sanitizers and masks.

Trump Rally

President Donald Trump held an indoor rally in Henderson, Nevada Thursday in direct defiance of his administration’s coronavirus guidelines and state-wide restrictions that limit gatherings to 50 people.

Pictures and videos from the event showed thousands of people packed into a warehouse, shoulder to shoulder. Very few masks could be seen among the crowd. According to the Associated Press, the only people required to wear face coverings were the supporters who stood directly behind Trump and whose images would be shown on TV. 

The event marked the first large indoor event the president has held since his Tulsa rally in June. The city’s top health official later said that rally “more than likely” contributed to the surge of cases Tulsa County saw in the following weeks.

Multiple people staffing the Tulsa event as well as some Secret Service officers tested positive for the coronavirus. Notably, former presidential candidate Herman Cain also contracted the virus just days after attending the rally, and died just weeks later. It is unknown, at least publicly, where Cain caught the virus.

Regardless, Tulsa turned out to be a major disaster for the Trump campaign, which largely took to holding smaller outdoor rallies afterward. However, in Nevada, the president wanted to go bigger — despite the 50-person gathering limit on both indoor and outdoor venues that was put in place by Gov. Steve Sisolak since May.

Pushback From Leaders

As a result, the Trump campaign received significant pushback from local leaders and other officials for trying to hold a rally that violated state-level restrictions.

According to The New York Times, the campaign decided to hold the rally indoors “after two outdoor rallies in the state were scuttled.” One of those rallies was set to be held at a Reno-Tahoe Airport hangar, but it fell through the Airport Authority sent a letter to the tenants who leased the hangar telling them that the event would violate the state limit on gatherings.

After that, according to a Trump administration official, the campaign “vetted five different outdoor venues, all of which were blocked by the governor.” 

They eventually decided on holding the rally indoors on the floor of the Xtreme Manufacturing plant, despite the fact that, according to its website, the company has “restricted meetings and gatherings to no more than 10 people in large areas.”

Last month, the owner of the venue told reporters that he was fined $11,000 by the state for violating coronavirus restrictions. The fine was in relation to a Trump campaign event and beauty pageant he held at a hotel that was attended by hundreds of people.

In a statement, City of Henderson spokesperson Kathleen Richards told reporters the city had issued both written and verbal warnings to the organizer saying that the event “as planned would be in direct violation of the governor’s COVID-19 emergency directives.”

“Large live events must be approved by the Nevada Department of Business and Industry, Division of Industrial Relations and at this time, the City has not been notified that this event has been approved,” she continued. “The City may assess a fine of up to $500 per violation of the governor’s directives as well as suspend or revoke the business license.”

Nevada Governor Goes After Trump

In a series of tweets before the rally, Gov. Sisolak personally took aim at Trump for directly ignoring the rules he had put into place to try and protect Nevadans.

“Tonight, President Donald Trump is taking reckless and selfish actions that are putting countless lives in danger here in Nevada,” he wrote. 

“Despite reports from his own White House, despite local officials in Southern & Northern Nevada reiterating to the venues the existing restrictions in State emergency directives, tonight, the President is knowingly packing thousands into an indoor venue to hold a political rally.”

Sisolak also argued that Trump failed to develop a national strategy for dealing with the pandemic, and added, “he didn’t have the guts to make tough choices — he left that to governors and the states. Now he’s decided he doesn’t have to respect our State’s laws. As usual, he doesn’t believe the rules apply to him.”

“Instead, he came into our State and blatantly disregarded the emergency directives and tough choices made to fight this pandemic and begin reopening our economy by hosting an indoor gathering that’s categorized as ‘high risk’ according to his own CDC,” he continued, accusing Trump of holding the rally for his own political gain, and saying his actions were “shameful, dangerous and irresponsible.”

Trump & Campaign Defend Rally

In a statement to the media, Trump campaign spokesperson Tim Murtaugh rejected criticisms of the rally and concerns that it was dangerous. He claimed that rallygoers were given temperature checks and that they had access to hand sanitizer and masks, which they were encouraged to wear.

“If you can join tens of thousands of people protesting in the streets, gamble in a casino, or burn down small businesses in riots, you can gather peacefully under the 1st Amendment to hear from the President of the United States,” he said.

Trump himself also seemed to echo that idea during the rally, calling Sisolak a “political hack,” and pushing back on his restrictions by telling rallygoers that he would support them “if the governor came after you” for attending his event.

He also downplayed the coronavirus multiple times, telling the crowd the U.S. was “making the last turn” in defeating the virus, and arbitrarily claiming: “We will very easy defeat the China virus.”

Notably, he did not mention the fact that COVID-19 has now claimed nearly 200,000 American lives and is still killing around 1,000 a day. 

In an interview with the Las Vegas Review-Journal after the rally, the president said that he believed he was not subject to Gov. Sisolak’s order limiting gatherings to 50 people. In fact, he blamed Sisolak for forcing him to have the event indoors.

Trump also reportedly “complained that holding the rally indoors limited the size of the crowd” and said he was not afraid of getting the coronavirus from speaking at the event.

“I’m on a stage and it’s very far away,” he said. “And so I’m not at all concerned.”

The president’s rally in Henderson is not the only time in the last week that he has openly flouted state-level rules. According to The Washington Post, while speaking during an outdoor campaign event in Winston-Salem, North Carolina on Tuesday: “Trump mocked pandemic restrictions by not wearing a mask and jeered at the state’s restrictions against outdoor gatherings of more than 50 people.”

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

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Court Blocks Trump’s Attempt to Prevent Undocumented Immigrants From Being Counted in the Census

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  • A federal court in New York has blocked an order from President Trump that would have excluded noncitizen immigrants from 2020 Census totals used to allocate seats in the House of Representatives based on population counts.
  • In the decision, a three-judge panel ruled that Trump’s memo violated federal law and that he had exceeded his authority by proposing it.
  • The ruling comes in the same week that another federal judge temporarily blocked the Trump administration’s efforts to cut the census count short by a full month, despite the fact that in-person counting started late due to the pandemic.
  • Numerous experts and senior Census Bureau officials have said that cutting the count short will result in highly inaccurate census data.

Court Blocks Trump Order

A three-judge federal court panel in New York decided unanimously on Thursday to block a memorandum signed by President Donald Trump to exclude undocumented immigrants from being counted in the census for reapportionment — the process of reallocated Congressional seats based on the population count.

The memo, issued by Trump on July 21, directed the Census Bureau to calculate the number of congressional seats each state is allocated without including undocumented immigrants in that count. To do so, the bureau would have to produce two counts: one of U.S. citizens and one of noncitizen immigrants.

That order sparked eight legal challenges around the country. The ruling resolves two of those lawsuits which were brought to the Federal District Court in Manhattan: one by a group of local governments and the United States Conference of Mayors, and another by a coalition of advocacy groups.

Both groups argued that Trump’s memo would lead to a less accurate census count and cause some states to lose representation. Numerous reports and studies have found that excluding the undocumented immigrant population from census totals would lead to millions being left out of the population totals used for reapportionment.

As a result, states with large immigrant populations like California and Texas would lose House seats. Meanwhile, states that are projected to lose a seat after the 2020 census, like Alabama, would actually end up gaining one.

The Judge’s Ruling

In their decision, the judges ruled that Trump had exceeded his authority under federal law with his proposal, and effectively blocked the Commerce Department, which houses the Census Bureau, from including information about the number of noncitizen immigrants in their reports to the president after the count is completed.

Specifically, the court said the president’s order violated the law “in two clear respects.” First, it went against a federal law that requires only one count of population totals and makes two counts illegal. Second, the judges wrote that Trump’s order “violates the statute governing reapportionment because, so long as they reside in the United States, illegal aliens qualify as ‘persons’ in a ‘state’ as Congress used those words.”

However, the panel also decided that they did not need to consider a second claim regarding the constitutionality of Trump’s order.

“Because the President exceeded the authority granted to him by Congress by statute, we need not, and do not, reach the overlapping, albeit distinct, question of whether the Presidential Memorandum constitutes a violation of the Constitution itself,” they wrote in their opinion.

Notably, the judges also specified in their ruling that they were not preventing the Trump administration from “continuing to study whether and how it would be feasible to calculate” those numbers to allow the Commerce Secretary to comply with the memo if a higher court overturns their decision. 

That is quite significant because the ruling is widely expected to be appealed to the Supreme Court, and if they decide to overturn it, the lawfully collected data could still be used to exclude undocumented immigrants from being counted in reapportionment.

Other Legal Battles

The court’s decision came just hours after a separate ruling from a different federal judge regarding yet another legal challenge to a recent decision made by the Trump administration concerning the census.

In that ruling, U.S. District Judge Lucy Koh ordered the Trump administration to provide internal documents in connection to its abrupt and shocking decision in August to end the 2020 Census count a full month earlier than originally planned.

Under existing law, state population totals collected through the census that will be used for reapportionment must be given to the president by Dec. 31 of the census year. However, due to delays in collecting in-person census data because of the pandemic, the White House had earlier agreed to delay the delivery of those totals until April 2021. 

But in August, the administration made an abrupt reversal and instead ordered the count to be cut short a month so that the original deadline could be met and the totals could be sent to Trump by the end of the year.

The surprising and perplexing decision to not only meet the original deadline, but to also cut short a count that had already started late, appeared to entirely contradict previous remarks from numerous senior Census Bureau officials, who had warned that the agency could no longer provide accurate counts by the end of the year due to coronavirus-related delays and restrictions.

As a result, many feared that the administration’s decision — which was widely viewed as an attempt to ensure that Trump would still have the ability to control the census totals even if he lost his re-election — would drastically skew the census data and make it so inaccurate it would become essentially unusable.

Last week, Judge Koh temporarily blocked the Census Bureau from ending the count early until a hearing set for Sept. 17. Right now, it is unclear how Thursday’s ruling from the three federal judges will impact the legal battle over the census count timeline.

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

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