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FDA Finds Violations and Unsanitary Conditions at Emergent J&J Plant as Lawmakers Open Investigations

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  • The Food and Drug Administration said Wednesday that it found numerous safety violations at Emergent Biosolutions, the Baltimore manufacturing plant responsible for ruining more than 15 million Johnson & Johnson Vaccines.
  • The FDA said it watched security footage of employees ignoring cross-contamination protocols and improperly handling medical waste. It also found brown and black residue on the floors and walls of the plant, respectively. 
  • Separately, top House Democrats launched an investigation into how Emergent won contracts to manufacture two COVID-19 vaccines and whether or not those contracts were the result of an improper relationship between the plant and a former Trump administration official.
  • Democrats are also investigating Emergent’s role as the country’s only provider of the anthrax vaccine in the Strategic National Stockpile.

The FDA’s Unforgiving Report

The U.S. Food and Drug Administration released a damning inspection report Wednesday on Emergent Biosolutions, the Baltimore manufacturing plant that ruined 15 million Johnson & Johnson COVID-19 vaccines.

Among a multitude of violations, inspectors workers hadn’t been properly trained. They also found that medical waste had been improperly handled, saying “such waste was transported through the warehouse before disposal and has the potential to contaminate the warehouse and adjacent areas.”

For example, it found that employees had used their gloved hands to put waste into bags, that they drug the waste through hallways, and that they even allowed it to touch walls.

Made worse was the fact that the FDA found peeling paint on the walls of several sensitive work areas, with inspectors noting that they found paint flecks all along the floors around the walls. As the agency reported, that peeling — as well as additional wall damage — “impacts the firms’ ability to adequately clean and disinfect the area.”

Moreover, inspectors said they found an unknown brown residue attached to the walls, as well as a black residue on the floor.

Through reviewing security footage, inspectors said workers repeatedly failed to follow procedures that were meant to prevent vaccine cross-contamination.

Notably, that backs up information that had been previously reported, particularly that those 15 million Johnson & Johnson vaccines were ruined because of cross-contamination with AstraZeneca’s vaccine. That said, it’s important to note that none of those vaccines were ever distributed to the public because the FDA never gave the plant approval to do so.

It’s possible that the report also describes the event that specifically led to the vaccine cross-contamination, as it mentions that through security footage, it watched an employee travel from one area of the plant where one vaccine was being made, to another area of the plant where the other vaccine was being made — all without that employee changing their protective gear. 

With that finding, the FDA said Emergent didn’t properly investigate its workers’ movements as a potential cause of contamination. More broadly, it also noted that even after the plant was made aware of the contamination, it only performed routine cleaning and didn’t take further decontamination steps.

Congress Investigates Emergent’s Role in Winning Vaccine Contracts

Alongside the FDA’s recent report, top House Democrats have now launched an investigation into how Emergent won several multi-million dollar contracts.

Those lawmakers are specifically looking into what role Dr. Robert Kadlec played in helping the company obtain the contract and if it was influenced by Kadlec’s previous role as a consultant for Emergent. 

Kadlec was the assistant secretary for preparedness and response under former President Donald Trump, and as this group of Democrats alleges, Kadlec “appears to have pushed for this award despite indications that Emergent did not have the ability to reliably fulfill the contract.”

Those Democrats went on to say that after Kadlec’s confirmation, Emergent obtained millions in contracts from his agency — including some that “were awarded without competitive bidding.” In fact, the Trump administration ultimately awarded $628 million to the plant, even though it had fallen short on federal investigations.

Emergent also reportedly tried to encourage oversight of the stockpile to be shifted from the CDC to an office under Kadlec’s control. 

“We are concerned by the costs to taxpayers and the potential impact on our nation’s vaccination efforts caused by Emergent’s failed attempts to manufacture these vaccines,” the Democrats said. 

Congress Investigates Emergent’s Role as Sole Anthrax Provider

It doesn’t end there. Those lawmakers are also looking into Emergent’s role as the country’s sole provider of the anthrax vaccine in the Strategic National Stockpile.

“Emergent has raised the government purchasing price of the anthrax vaccine by 800% since acquiring the drug in 1998,” they said. “As a result, through most of the last decade, nearly half of the SNS’s budget has been spent purchasing Emergent’s anthrax vaccine.” 

When Emergent acquired that anthrax vaccine license in 1998, the vaccine was selling for about $3.35 a dose. Today, it’s over $30.

See what others are saying: (The Washington Post) (Wall Street Journal) (CNBC)

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Conservatives are Mad at “Woke” Xbox for Minor Climate-Related Updates

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The fury comes after Xbox announced it was slightly altering existing consoles to better utilize and save energy.


Same War, New Battlefield

Mere days after M&M canceled their “spokescandies” due to backlash from the right, led largely by Fox News’ Tucker Carlson, conservatives have found a new front for their ongoing culture war: Xbox.

Carlson spent months complaining that small character redesigns were “woke” because they made the animated anthropomorphized M&M’s — in his own words — “less sexy.” His campaign finally proved successful on Monday when the company announced it would be doing away with the spokescandies and replacing them with actress Maya Rudolph.

Conservatives, now facing a sudden dearth of non-issues to complain about, quickly found a new issue to rage against. Xbox announced in a blog post earlier this month that it is making minor updates to lower its environmental impact as part of an effort to reach Microsoft’s goal of being carbon-negative by 2030.

Now, instead of having an Xbox wake up to update games, apps, and software during random times of the night, it will do that at a time of night when a user’s local energy grid is generating the most power it can from renewable sources. 

Xbox also said it would automatically update some older consoles to a power-saving mode that aims to reduce electricity consumption when it is turned off — a feature that is already the default on newer consoles.

According to The Verge, the only difference for users is that an Xbox in power-saving mode takes around 15 seconds to boot up instead of doing so immediately as the console does in “sleep” mode. The change is a small price to pay for what the outlet described as “significant” energy savings.

Xbox Under Fire

To many leading conservative voices, the minimal shifts were just another example of “woke” culture. 

While discussing M&M’s spokescandies Tuesday morning, “Fox and Friends” co-host Ainsley Earhardt brought up Xbox’s new changes with Fox radio host Jimmy Failla.

“So Xbox has also announced that they’re going woke too, you know, because of climate change,” Earhardt said.

“I mean, it’s crazy what they’re doing, but we understand what this is. It’s not that it’s actually going to offset emissions, okay — the level of reduction is infinitesimal,”  Failla claimed, without evidence. “But they’re trying to recruit your kids into climate politics at an earlier age; make them climate conscious now.”

“Yeah, I didn’t think of that — you’re right, they’re going after the children,” Earhardt agreed, despite the fact that internal data from Microsoft shows just around 10% of Xbox owners are under the age of 18.

Other prominent conservatives also did their part to bait Americans into anger on social media, including America’s Foundation, which posted a tweet stating that “the woke brigade is after video games.”

The post linked an article from the right-wing website TheBlaze, which asserted that “Xbox will force gamers to power down to fight climate change.”  That, however, is false — Xbox has said users can switch back and change the settings any time they want

Still, top lawmakers continued to share the article and spread its false claims, including Sen. Ted Cruz (R-Tx.).

“First gas stoves, then your coffee, now they’re gunning for your Xbox,” he wrote in the post, which was flagged by Twitter and given an “added context” warning.

The same warning, however, was not placed in a very similar post by Rep. Troy Nehls (R-Tx.), who also shared the article.

“They want to take your guns. They want to take your gas stoves. And now they want to take your Xbox. What’s next?” he wrote.

See what others are saying: (The Washington Post) (The Daily Beast) (VICE)

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Washington State Launches Investigation Into Abuse at Private Special Ed. Schools

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Allegations include staff kicking a fourth-grader and dragging a child with autism around by his leg.


Abuse Allegations

Washington State’s Office of Superintendent of Public Instruction (OSPI) has launched an investigation into a system of private schools for kids with disabilities after ProPublica and the Seattle Times reported on allegations of abuse.

The series of articles focused on Northwest School of Innovative Learning (NWSOIL). NWSOIL is a set of private schools that serve 500 Washington public school students with serious disabilities. ProPublica and the Seattle Times found years of complaints from parents and school districts against NWSOIL alleging abuse, overuse of isolation rooms, and unqualified aides teaching instead of certified professionals.

One district claimed NWSOIL staff kicked a fourth-grader. Another alleged that a child with autism was dragged around by his thigh.

Many former NWSOIL employees also claim that they were pressured by their parent company to to enroll more students and skimp on basic resources, like staffing.

Investigation Launched

In a seven-page letter, OSPI reminded NWSOIL of its authority to revoke or suspend a school’s approval, meaning that it could shut NWSOIL down. 

“Given the serious nature of the allegations made in the articles, OSPI is examining what, if any, actions need to be taken with respect to Northwest SOIL’s approval to contract with Washington school districts,” Tania May, assistant superintendent for special education at OSPI, wrote in the letter.

OSPI has demanded any records of mistreatment, maltreatment, abuse, or neglect as well as documents pertaining to restraint or isolation of students and calls to the police. They are also seeking information about the student-to-teacher ratio and staff qualifications. 

In the letter, OSPI claims that all of this was previously unknown to them as well as to police, Child Protective Services, and local school districts. They are asking NWSOIL for an explanation as to why the allegations were not reported. 

NWSOIL defended itself in a public statement.

“Use of restraints and seclusion are always used as a last response when a student is at imminent risk of hurting themselves or others, it said. “We strongly deny any allegation that we understaff and/or pressure staff to increase admissions in order to maximize profits.” 

Washington state representatives are considering a reform bill that will give them more oversight on the publicly funded system of private special education schools. 

In this legislation, OSPI and at least one district that sends students to this program would be required to visit before approving the contract. It would also standardize district agreements with programs like NWSOIL, including financial safeguards to make sure funds are being used appropriately.

See the full series: (ProPublica) (The Seattle Times)

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Mass Shootings in Half Moon Bay, Oakland Rock California

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Just since Saturday, at least 19 people have been killed and 17 have been injured in mass shootings in California.


California Sees Third Attack in Under a Week

Two California localities experienced separate mass shootings Monday, just days after an attacker killed 11 and injured nine others in a suburb of Los Angeles.

The first of the most recent shootings took place in Half Moon Bay, a small coastal town about 30 miles outside of San Francisco, where a gunman killed seven and critically injured an eighth at two different locations.

According to authorities, police were dispatched to the first location around 2:20 pm and found four people shot to death and a fifth victim also suffering gunshot wounds. Shortly after, three more people were found dead at another site nearby.

About two hours later, police discovered the suspect in his car in the parking lot of a San Mateo County Sheriff’s Office substation with a semiautomatic handgun in the vehicle that officials later confirmed he had purchased legally.

Sheriff Christina Corpus said the man was taken into custody “without incident” and is “fully cooperating.” He has been identified as a 66-year-old Half Moon Bay resident of Asian descent.

Currently, the gunman’s motive is unknown, but the Sheriff told reporters Monday that both of the locations he targeted were nurseries, and it has since been reported that they were mushroom farms.

“All evidence we have points to this being an instance of workplace violence. The Mountain Mushroom Farm, the first location, is where the subject was employed,” Corpus said in a press conference Tuesday, though she added that, so far, the “only known connection between the victims and the suspect is that they may have been coworkers.”

As of writing, it remains unclear why he targeted the second location. A mushroom farm called Concord Farms has told reporters that it was the site of the second shooting — which a law enforcement official confirmed to The Washington Post.

In a statement to the media, a spokesperson said the farm had “no past knowledge” of the alleged gunman or his possible motives. Little has been released about the victims, though Corpus said Tuesday they were all adults and a “mixture of Asian and Hispanic descent,” some of whom were migrants. 

Authorities had previously stated that, because people both live and work on the farms, children were among those who witnessed the shooting. However, on Tuesday, one official walked that back and said while children were indeed in the vicinity, police do not have information about specific witnesses.

Just hours after the violence in Half Moon Bay, seven people were injured, and one other was killed during a shooting at a gas station in Oakland. Very little has been reported about the incident, but police have said that the shooting was “between several individuals.”

Renewed Calls for Gun Control

Californians continue to reel from the rapid succession of mass shootings in a state known for its strict gun control laws.

According to Everytown for Gun Safety, a nonprofit that advocates against gun violence, the state ranks No. 1 in the country for gun law strength. An analysis led by the organization found that California has the sixth-lowest rate of gun ownership and the eighth-lowest gun death rate.

Many of California’s top lawmakers have argued that the state’s relatively low gun violence statistics emphasize the need for more federal regulations.

“The Second Amendment’s becoming a suicide pact,” Gov. Gavin Newsom (D) told CBS News in an interview.

“We’ll continue to find whatever loopholes we can and continue to lead the national conversation on gun safety reform. And the data bares out. It works. It saves lives,” he continued. “California’s 37% lower than the death rate of the rest of the nation, and yet, with all that evidence, no one on the other side seems to give a damn. I can’t get anything done in Congress.”

Following the Monterey Park shooting, U.S. Sen. Diane Feinstein (D-Ca.), alongside other Democratic colleagues, introduced two gun control bills in the upper chamber. The first would ban assault weapons, while the second aims to raise the minimum age to purchase assault weapons from 18 to 21.

President Joe Biden quickly threw his support behind the measures, urging Congress to pass them.

“The majority of the American people agree with this commonsense action,” he said in a statement Monday. “There can be no greater responsibility than to do all we can to ensure the safety of our children, our communities and our nation.”

Editor’s Note: At Rogue Rocket, we make it a point to not include the names and pictures of mass murders, suspected mass murderers, or those accused of committing violent crimes who may have been seeking attention or infamy. Therefore, we will not be linking to other sources, as they may contain these details.

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