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Politics

Choose calls Jan. 6 an ‘rebel,’ bars ‘Cowboys for Trump’ founder

A New Mexico judge Tuesday declared that the Jan. 6 riot in the Capitol was a “riot” because he ruled that Otero County Commissioner and founder of Cowboys for Trump Couy Griffin be removed from office must be because he took part in the attack.

Griffin is barred from holding federal or state office for life — including his current role as district commissioner, from which he will be ousted “effective immediately,” Judge Francis Matthew ruled.

Griffin was “constitutionally disqualified” from those positions as of Jan. 6, 2021, the judge concluded.

That day, a violent mob of supporters of former President Donald Trump stormed the US Capitol, forcing lawmakers to leave their chambers and disrupting the transfer of power to President Joe Biden. Griffin was convicted in March of a misdemeanor for violating the restricted Capitol grounds.

The riot and the planning and incitement that led to it “constituted a ‘rebellion'” under the 14th Amendment, Matthew wrote in the New Mexico 1st Circuit Court decision.

The ruling was the first time a court had found that the Capitol riot met the definition of a riot, according to the government nonprofit watchdog group CREW, which represented the plaintiffs who filed the suit to disqualify Griffin.

“This decision makes clear that all current or former officials who took an oath to defend the US Constitution and then participated in the riot of 6.

Griffin told CNN later Tuesday that he had been ordered to clean up his desk.

“I’m shocked, just shocked,” Griffin told CNN. “I really didn’t feel like the state was going to attack me like that. I don’t know where to go from here.”

According to CREW, Matthew’s ruling is also the first time since 1869 that a court has disqualified an officer under Section 3 of the 14th Amendment.

This section, known as the disqualification clause, prohibits any person from holding any civil or military office at the federal or state level of the United States if they are “participating in an insurrection or rebellion against the same, or offering aid or consolation to the enemies thereof.” have done.”

Griffin did not enter the Capitol itself or commit any violence during the January 6 riots, but he did participate and his actions “supported the riot,” Matthew judged.

“By joining the mob and trespassing on unauthorized Capitol property, Mr. Griffin helped delay the Congressional election certification process,” the judge wrote. Griffin’s presence “helped to overwhelm law enforcement” and he “instigated, encouraged and helped normalize violence” during the riot, Matthew ruled.

In addition, the judge dismissed as “unfounded” the arguments put forward by Griffin, who represented himself in the case.

Griffin’s attempts to “clean up his actions are without merit and are at odds with the evidence presented by the plaintiffs, given that he himself has not presented any evidence in his own defense,” Matthew wrote.

His arguments in court were “not credible and amounted to nothing more than trying to put lipstick on a pig,” added the judge.

Griffin was arrested less than two weeks after the Capitol riot. He was found guilty in March and on June 17 was sentenced to a two-week prison term along with a $3,000 fine and community service.

Griffin, a Republican and vocal Trump supporter, has repeated the former president’s false claims that the 2020 election results were marred by widespread fraud.

He and the other two GOP members who make up the Otero County Commission have refused to confirm recent primary election results, reportedly citing conspiracy theories about Dominion voting machines. The commission ultimately voted 2 to 1 to confirm the primary findings, with Griffin voting no.

In 2019, Griffin founded Cowboys for Trump, a group that hosted pro-Trump horseback riding parades.

Bookbinder called Tuesday’s ruling “a historic victory for accountability for the January 6 insurgency and efforts to disrupt the peaceful transfer of power in the United States.”

“Protecting American democracy means ensuring those who violate their oath to the Constitution are held accountable,” he said.

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Health

Firms rising extra cautious about delta variant, earnings calls present

A sign describes entry restrictions at a JLL office in the Aon Center in Chicago, Illinois, USA on Thursday, June 24, 2020.

Christopher Dilts | Bloomberg | Getty Images

When the reporting season started in earnest in mid-July, few companies asked questions or mentioned the Covid Delta variant.

That changed as new Covid-19 cases increased and the Centers for Disease Control and Prevention changed their stance on masks for vaccinated people, according to a CNBC analysis of transcripts of calls.

Between July 13 and Thursday, 142 S&P 500 companies out of 410 that reported quarterly earnings mentioned the Delta variant by name or answered a question about it in their earnings calls. Only 15% of those mentions came before July 27 – the same day the CDC said fully vaccinated people should wear masks in areas with high indoor transmission rates. New Covid cases also rose steadily as the highly contagious Delta variant became the dominant strain of the virus in the USA

The US reports a seven-day average of more than 109,000 new cases as of August 5, nearly 28% more than a week ago, according to Johns Hopkins University.

For the most part, executives said their companies did not see any significant business impact with the rise in new cases.

Becton, Dickinson & Co., a medical device company, was one of the few to report changes in consumer behavior and told analysts that fewer elective surgeries have been performed in some US states in recent weeks due to the variant. For the week ending August 1, 72% of beds in intensive care units in the United States were occupied, according to Johns Hopkins data.

But some companies with a more global footprint say it’s a different story outside of the US.

“An uneven recovery from the pandemic and an increasing delta variant in many countries around the world have once again shown us that the road to recovery will be a winding road,” said Apple CEO Tim Cook at the company’s conference call on April 27th. July.

Booking Holdings, the parent company of Kayak and OpenTable, said bookings were down 22% in July compared to 2019, a bigger decrease than the 13% decrease in June.

“In Europe, we noticed reductions in overnight stays in several of our most important countries, including Germany, France and Italy, in July,” said Booking CFO David Goulden on Wednesday at the company’s conference call.

Other companies reported supply chain disruptions as Covid cases accelerated in Asia and Europe. For example, rail operator Norfolk Southern said the Delta variant is affecting its suppliers in Southeast Asia.

“We have a couple of factories that source parts from Southeast Asia and due to manufacturing issues there, they had to bring forward scheduled production shutdowns later this year,” said chief marketing officer Alan Shaw on the company’s conference call on July 28th. “And that has now had an impact on our production and our volumes.”

The Delta variant has also led some companies to issue more conservative projections, although most companies said they don’t expect any further lockdowns in the US.

Abiomed, a medical device maker, told analysts on its conference call Thursday that the lower end of its full-year revenue forecast sees “some persistent unevenness” from the variant, even though the company raised its outlook.

Beyond Meat, which is not part of the S&P 500, said restaurant operators are more conservative with their food orders due to the uncertainty created by the Delta variant, as well as work-related challenges.

“For us, the main feature of the third quarter, and our forecast is simply a lack of visibility,” said CEO Ethan Brown on Thursday.

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Politics

Greg Abbott Calls Texas Particular Session, in New Voting Rights Struggle

Gov. Greg Abbott of Texas on Thursday called a new special session of the Legislature that is set to begin on Saturday, renewing Republican efforts to overhaul the state’s elections and putting pressure on Democratic lawmakers who left the state for Washington last month to block the legislation.

Mr. Abbott, a Republican, stuck to his pledge “to call special session after special session,” releasing a 17-item agenda for the Republican-controlled Legislature with a new voting bill at the top. The list also included a host of other conservative goals, like restricting abortion access, limiting the ways that students are taught about racism and tightening border security.

His announcement sent national attention swinging back to a hotel in downtown Washington, where several dozen Democrats from the Texas House of Representatives are grappling with a familiar question: Stay or go back?

The Texas Democrats are torn over how much is left for them to accomplish in Washington, with some moderate members of the caucus believing that their point has been made. But more progressive members are pushing to stay in Washington and continue to call attention to voting rights, at least while the U.S. Senate remains in session.

“I’ve been very clear, as it relates to me, that as long as Congress is in town, working on voting rights, I will be here in Washington, D.C., advocating for voting rights,” said State Representative Trey Martinez Fischer, a Democrat who was one of the organizers of the initial flight from Austin.

President Biden’s administration, by contrast, appeared to suggest that it would support a return to Texas by the state lawmakers.

“Certainly, the president believes that, one, they’ve been outspoken advocates and champions of voting rights,” Jen Psaki, the White House press secretary, said at a news conference, adding that if the legislative calendar “required them to be there, we would support that.”

The lawmakers’ stay in Washington has amounted to a prolonged period of limbo; their trip has delayed Republicans’ attempt to pass an election bill, but it remains unlikely that it will be a fatal blow.

Federal officials celebrated their arrival in Washington, with Vice President Kamala Harris likening their departure from Texas to the voting rights march in Selma, Ala., and other famous civil rights protests of the 1960s. But the group lost momentum when several vaccinated legislators tested positive for the coronavirus.

In video chats, the Texas Democrats did their best to maintain pressure on both the White House and Democratic senators to find a path forward for federal voting legislation, and eventually coaxed more than 100 state legislators from other states to join them in Washington.

And the lawmakers’ visit to Washington has coincided with the renewal of talks toward a compromise voting bill. Eight Democratic senators, including Senator Joe Manchin III of West Virginia, have been moving closer to a final draft to be introduced later this year. What prompted the end of congressional inertia, however, is unclear, and any federal voting bill would remain unlikely to move quickly through the chambers of Congress.

So now, with the Texas Democrats confronting an uncertain future, they are debating their next moves.

If they return, they could be subject to the as-yet-untested powers of the Republican Statehouse leadership to arrest and detain any lawmakers who do not show up for a legislative session while in the state of Texas.

While Speaker Dade Phelan, a Republican, can issue arrest warrants during a session that has been gaveled in, there has never been a test of that authority when a session has been called by the governor but cannot start because enough lawmakers have declined to show up. Mr. Phelan’s office believes he has the authority to request arrest warrants and send law enforcement officers to retrieve absentee lawmakers even if the session has not started.

Back in Austin, Republican members said they had been maintaining informal discussions with their Democratic colleagues in an attempt to re-establish a quorum and get back to work. The partisan strictures in the Texas Legislature are far less rigid than those in Congress, with no dividing aisle between Republicans and Democrats. Members of the opposing parties intermingle more on the House floor and often form working friendships.

“I can tell you they’ve been going on since they left three weeks ago,” State Representative Jim Murphy of Houston, the chairman of the 83-member House Republican Caucus, said of the largely ad hoc discussions. Most of the conversations were “just personal — largely people want to know if they’re going to return,” he added. “How committed are they? Are there some that are willing to come back? Are there things that need to happen to encourage them to return?”

“I’ve done some texting, some phone calling,” he said, though “not a whole lot.”

At least nine Democrats have remained in Austin for varying reasons, though most, if not all, have embraced their colleagues’ opposition to the voting bill.

But as Democrats consider their immediate future, Mr. Abbott did add a surprise item to the agenda that, while unclear in its scope or likelihood of success, could further complicate their calculations: “Legislation relating to legislative quorum requirements.”

Katie Rogers contributed reporting.

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Health

Nursing Properties Confront New Covid Outbreaks Amid Requires Employees Vaccination Mandates

In saying last Friday that it was monitoring outbreaks at nursing homes related to the Delta variant, the C.D.C. said some measures under review would include “testing, quarantine, visitation, use of PPE and source control.”

Underscoring the concern of regulators about unvaccinated workers, Colorado just implemented a new rule that unvaccinated staff members at nursing homes must be tested for the virus, using a rapid test, every time they come to work. California is now requiring health care workers in the state to be vaccinated or undergo frequent testing.

Feelings are raw among nursing home staff and operators.

“I don’t want to lose anyone else,” said Marita Smith, administrator at Saint Anne Nursing and Rehab Center in Seattle. Eight of 32 residents died of Covid early on in the pandemic, including four who were already on hospice. Ms. Smith says the losses help explain why all 52 staff members have been vaccinated.

“I question their reason for being in the business if they don’t get it,” Ms. Smith said. “You just don’t want to turn your back.”

Some nursing home staff members resisting vaccination argue that they can protect residents without being inoculated. “I go home, stay home as much as possible, do grocery pickup instead of shopping, do a lot of hand washing. I’m not exposing myself to other people,” said Jessica M., a director of nursing at a home in Grand Junction, Colo., who is unvaccinated.

She declined to give her last name because she wasn’t authorized to speak to the media. She added that she wanted to make sure “the side effects aren’t worse than protecting someone from Covid.”

But consumer advocates and others point to the difficulties nursing homes have long had in protecting residents from infection. A government report issued in May found that nursing homes averaged three Covid outbreaks from May 2020 through January 2021, with two-thirds reporting the outbreaks began with an infected staff member testing positive.

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Health

Biden calls on states to supply $100 money funds for vaccination

U.S. President Joe Biden speaks during a visit to the Mack-Lehigh Valley Operations Manufacturing Facility in Macungie, Pa., July 28, 2021.

Evelyn Hockstein | Reuters

President Joe Biden on Thursday called on state and local officials to offer residents $ 100 in cash as an incentive to get a Covid-19 vaccine.

During a White House speech on Thursday afternoon, Biden cited an investigation by the University of California at Los Angeles in which about a third of those unvaccinated said a cash payment would make them more likely for an injection, according to details of the plan approved by the administration.

“The American Rescue Plan (ARP) has allocated resources to states, territories, and communities that can be used to provide incentives to increase vaccination rates to provide $ 100 to anyone who gets vaccinated,” the government said in an explanation before the speech.

Biden also announced that his government will require federal employees to demonstrate their vaccination status or undergo a series of strict safety protocols as well as other steps aimed at increasing vaccination rates.

The latest vaccine surge comes as coronavirus cases begin to rise again in the US, with the highly contagious Delta variant boosting infection rates. People infected with the Delta variant carry up to 1,000 times more viruses in their nasal passages than other strains, which, according to the federal health authorities, leads to a higher degree of transmission even among those who have been vaccinated.

Infectious disease experts have warned of a possible spike in infections in the fall season, when Americans go back into the house and employers start moving workers back to the office.

Health officials claim the Covid vaccines provide strong protection against the variant, especially against serious illness and death. Nevertheless, the rate of vaccination in the US has slowed in recent months.

Data from the Centers for Disease Control and Prevention shows that nearly 800,000 shots were recorded nationwide on Sunday, the highest single-day total in weeks, but still well below the peak.

The seven-day average of reported vaccinations rose 16% over the past week to 615,000 daily vaccinations on Thursday, compared to more than 3 million daily vaccinations reported in mid-April.

New York City Mayor Bill de Blasio recently announced that officials there will pay $ 100 to anyone who goes to a city-operated vaccination site for their first dose of a vaccine.

Biden’s comments come two days after the CDC reversed course of its previous guidelines and advised fully vaccinated Americans living in areas with high rates of Covid infection to return to wearing face masks indoors. According to a CNBC analysis, the guidelines cover about two-thirds of the US population.

While the Delta variant continues to hit unvaccinated people the hardest, some vaccinated people could carry higher amounts of the virus than previously thought and potentially transmit it to others, said CDC Director Dr. Rochelle Walensky on Tuesday. She added that the variant “behaves uniquely differently from previous virus strains”.

“This pandemic continues to pose a serious threat to the health of all Americans,” Walensky told reporters on a call.

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Health

C.D.C. Inner Report Calls Delta Variant as Contagious as Chickenpox

The Delta variant is much more contagious, is more likely to breach vaccine protection, and can cause more serious illness than any other known version of the virus, according to an internal presentation spread within the Centers for Disease Control and Prevention.

Dr. Rochelle P. Walensky, the agency’s director, admitted on Tuesday that vaccinated people with so-called breakthrough infections of the Delta variant carry just as much virus in their nose and throat as unvaccinated people and can spread it just as easily, albeit less often.

But the internal document sets out a broader and even more somber view of the variant.

The delta variant is more transmissible as the viruses that cause MERS, SARS, Ebola, the common cold, seasonal flu, and smallpox, and according to the document copied by the New York Times, it is as contagious as chickenpox.

The immediate next step for the agency is to “realize that the war has changed,” the document reads. The content was first reported by the Washington Post on Thursday evening.

The tone of the document echoes CDC scientists’ concern about the spread of Delta across the country, said a federal official who saw the research described in the document. The agency plans to publish further data on the variant on Friday.

“The CDC is very concerned about the incoming data that Delta is a very serious threat that requires action now,” the official said.

Coronavirus Pandemic and Life Expectancy in the United States

In the US, there were an average of 71,000 new cases a day as of Thursday. The new data suggests that vaccinated people spread the virus and contribute to these numbers – albeit likely to a far lesser extent than those who were not vaccinated.

Dr. Walensky has called transmission by vaccinated people a rare occurrence, but other scientists have suggested it is more common than previously thought.

The agency’s new masking guidelines for vaccinated individuals, introduced on Tuesday, were based on information contained in the document. The CDC recommended that vaccinated people wear masks indoors in public settings in communities with high virus transmission levels.

Updated

July 31, 2021 at 11:50 p.m. ET

However, the internal document indicates that even this recommendation may not go far enough. “In view of the higher transferability and current vaccination protection, universal masking is essential,” the document says.

The agency’s data suggests that people with weak immune systems should wear masks even in places with low virus transmission. This should include vaccinated Americans who are in contact with young children, older adults, or other vulnerable people.

According to the July 24 CDC quoted in the internal presentation, there are about 35,000 symptomatic infections per week among 162 million Americans vaccinated. However, the agency does not track all mild or asymptomatic infections, so the actual incidence may be higher.

Understand the state of vaccine mandates in the United States

Infection with the delta variant produces amounts of virus in the airways that are ten times higher than in people infected with the also highly contagious alpha variant, the document says.

According to a recent study, the amount of virus in a person infected with Delta is a thousand times higher than in people infected with the original version of the virus.

The CDC document draws on data from several studies, including an analysis of a recent Provincetown, Massachusetts outbreak that began in the city after the July 4th celebrations. By Thursday, that cluster had grown to 882 cases. About 74 percent had been vaccinated, said the local health authorities.

A detailed analysis of the prevalence of the cases showed that people infected with Delta carry enormous amounts of virus in their nose and throat regardless of vaccination status, according to the CDC document.

“This is one of the most impressive examples of citizen science I’ve seen,” said Dr. Celine Gounder, an infectious disease specialist at Bellevue Hospital Center in New York. “The people involved in the Provincetown outbreak meticulously created lists of their contacts and exposures.”

Infection with the Delta variant can be more likely to lead to serious illness, the document says. Studies from Canada and Scotland found that people infected with the variant were more likely to be hospitalized, while research in Singapore suggested that they were more likely to need oxygen.

Still, the CDC’s numbers show the vaccines are highly effective at preventing serious illness, hospitalization and death in people who have been vaccinated, experts said.

“Overall, Delta is the disturbing variant that we already knew it was,” said John Moore, a virologist at Weill Cornell Medicine in New York. “But the sky is not falling and vaccinations are still very protective against the worst of the consequences.”

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Biden will put on masks indoors, calls on U.S. to do the identical

WASHINGTON – President Joe Biden and White House officials will resume wearing masks indoors when traveling to parts of the nation with high rates of covid transmission, according to updated guidelines from the Centers for Disease Control and Prevention, which include full Vaccinated individuals are encouraged to put face covers on in vulnerable areas.

“I hope all Americans living in the areas covered by the CDC guidelines will follow them; I will definitely do it when I travel to these areas, ”Biden said in a statement after the CDC issued its guidelines.

The CDC on Tuesday recommended that fully vaccinated people wear masks indoors in public places as new data shows that vaccinated people – although well protected from serious illness – can still transmit the virus to people who are sometimes not vaccinated.

“In areas of significant and high transmission, CDC recommends that fully vaccinated individuals wear masks in public, indoors, to prevent the spread of the Delta variant and to protect others. This includes schools, ”said CDC director Rochelle Walensky.

The CDC also recommended that everyone in elementary schools wear masks indoors “including teachers, staff, students and visitors regardless of vaccination status.”

Two months ago, the CDC announced to fully vaccinated people that they would no longer need to wear masks in most environments, and the White House had dubbed July 4 a “Summer of Freedom” to see progress in the fight against the Celebrating Virus.

However, the highly transmissible Delta variant has since developed into the dominant strain, which has led to a nationwide increase in infections, especially in areas with low vaccination rates. After great strides in its vaccination campaign in winter and spring, the Biden government struggled to increase vaccination rates in summer.

According to a CNBC analysis of Johns Hopkins University data, the weekly average of daily new Covid infections in the US is more than 57,000, a 65% increase from the previous week. On July 5, the seven-day average of the country’s daily new infections was just below 12,000.

In his statement on Tuesday, Biden encouraged Americans to get vaccinated.

“Today’s announcement also makes it clear that the most important protection we have against the Delta variant is vaccination. While most US adults are vaccinated, too many aren’t. Although we have seen an increase in vaccinations over the past few days, we still have to do better, ”said the President.

Biden told reporters that his government is also considering whether to give federal employees the Covid-19 vaccine, a move that comes a day after the Department of Veterans Affairs implemented such a mandate.

“That is being considered right now,” Biden said, adding that unvaccinated people are contributing to the ongoing pandemic.

“If those other 100 million people were vaccinated, we would be in a completely different world. So get vaccinated, ”said the President.

White House press secretary Jen Psaki told reporters that on Tuesday morning, Dr. Anthony Fauci, the government’s medical advisor for the coronavirus, has been briefed on the CDC’s updated guidance.

“We will of course adhere to every aspect of the CDC guidelines on masking that they are providing this afternoon,” Psaki said during a press conference.

“That means we will be ready to wear masks again if necessary,” she said.

When asked if the White House was disappointed with CDC guidelines, Psaki noted the severity of the nascent Delta variant.

“We are all dealing with an evolving virus for which there is no playbook or historical precedent,” said Psaki. “The American people should feel confident that we will continue to be guided by science and look at public health data to provide new guidance.”

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U.S. Surgeon Common Calls Covid Misinformation ‘Pressing Menace’

President Biden’s surgeon general on Thursday used his first formal advisory to the United States to warn against the dangers of health misinformation, calling it an “urgent threat to public health” and urging all Americans — and specifically tech and social media companies — to do more to curb the spread of falsehoods about Covid-19.

The official warning by Dr. Vivek Murthy is unusual; surgeons general have traditionally used their official “advisories” — short statements that call the American people’s attention to a public health issue and provide recommendations for how it can be addressed — to talk about health matters ranging from tobacco use to opioid addiction, suicide prevention and breastfeeding.

But this new advisory, contained in a 22-page report with footnotes, occurs in a more political context. Fox News hosts like Tucker Carlson and Laura Ingraham, along with their guests, are among those who have been casting doubt on Covid-19 vaccines, which studies show are highly effective at preventing death and hospitalization from the disease.

Health misinformation about social distancing, mask use, treatments and vaccines has been rampant during the coronavirus pandemic. The report is a sign that the Biden administration, faced with a steep decline in vaccination rates, is moving more forcefully to confront it. Fewer than 50 percent of Americans are fully vaccinated, and many top health experts have called for the president to do more to reach people who have yet to be get shots.

While virus numbers remain at some of the lowest levels since the beginning of the pandemic, they are once again slowly rising, fueled by the spread of the more contagious Delta variant; vaccines are effective against the variant. Counties that voted for Mr. Biden average higher vaccination levels than those that voted for Donald Trump. Conservatives tend to decline vaccination far more often than Democrats.

“Health misinformation is a serious threat to public health,” Dr. Murthy said in the report. “It can cause confusion, sow mistrust, harm people’s health, and undermine public health efforts.”

In a statement, he added, “From the tech and social media companies who must do more to address the spread on their platforms, to all of us identifying and avoiding sharing misinformation, tackling this challenge will require an all-of-society approach, but it is critical for the long-term health of our nation.”

But calling out tech and media companies is tricky business, and the White House has danced around the question of whether it would try to regulate companies like Facebook that have become platforms for health disinformation. Asked about this at her Wednesday briefing, the White House press secretary, Jen Psaki, was noncommittal.

“Obviously, decisions to regulate or hold to account any platform would certainly be a policy decision,” she said. “But in the interim, we’re going to continue to call out disinformation and call out where that information travels.”

The report is assiduously apolitical, and does not name any specific purveyors of misinformation. But it comes as some Republican leaders, concerned that the virus is spreading quickly through conservative swaths of the country, are beginning to promote vaccination and speak out against media figures and elected officials who are casting doubt on vaccines.

Health misinformation is not a recent phenomenon — and is not limited to news media. In the 1990s, the report notes, “a poorly designed study” — later retracted — falsely claimed the measles, mumps, rubella vaccine causes autism.

“Even after the retraction, the claim gained some traction and contributed to lower immunization rates over the next twenty years,” the report said.

Dr. Murthy is expected at Thursday’s White House briefing to discuss his report. It cites evidence of the spread of misinformation, including a study by the Kaiser Family Foundation that found, as of late May, that 67 percent of unvaccinated adults had heard at least one Covid-19 vaccine myth and either believed it to be true or were unsure of its truthfulness; and a Science Magazine analysis of millions of social media posts found that false news stories were 70 percent more likely to be shared than true stories.

Another recent study showed that even brief exposure to misinformation made people less likely to want a Covid-19 vaccine, the surgeon general said.

This is Dr. Murthy’s second turn at being surgeon general; he also served under former President Barack Obama. The position, often referred to as the “nation’s doctor,” offers little formal policymaking authority, but derives its strength from the surgeon general’s bully pulpit, and past surgeons general have made powerful impacts on the nation’s health.

Dr. Murthy’s advisory drew immediate plaudits from the American College of Obstetricians and Gynecologists, an organization that is particularly concerned about false information suggesting Covid-19 vaccines might be harmful to pregnant women. There is no evidence of that.

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FDA requires federal investigation into approval

Biogen shares fell on Friday after the head of the Food and Drug Administration called for an investigation into the recent approval of the company’s Alzheimer’s drug, Aduhelm.

Acting FDA Commissioner Dr. Janet Woodcock asked the Office of the Inspector General to investigate interactions between the US agency and Biogen representatives prior to the drug’s approval on June 7.

“I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures,” Woodcock wrote in a letter sent Friday.

Shares of Biogen fell by more than 3% after the announcement.

Biogen’s stock surged last month after the FDA approved the biotech company’s drug, the first medication cleared by US regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

That decision marked a departure from the advice of the agency’s independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At least three members of the panel have resigned in protest following the agency’s approval.

Federal regulators faced intense pressure from friends and family members of Alzheimer’s patients asking to fast-track the drug, scientifically known as aducanumab. STAT News and other media outlets reported FDA officials used a regulatory shortcut to gain approval in order to get the drug on the market sooner.

Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists expect plays a role in the devastating disease.

It’s rare for an FDA chief to call for an investigation into the agency’s own decisions. It’s the latest setback for the company and the drug, which has been controversial since it showed promise in 2016.

In March 2019, Biogen pulled development of the drug after an analysis from an independent group revealed it was unlikely to work. The company then shocked investors several months later by announcing it would seek regulatory approval for the medication after all.

When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”

Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it harder for other companies to enroll patients in their own drug trials.

Some doctors have said they won’t prescribe aducanumab because of the mixed data package supporting the company’s application.

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In a Reversal, F.D.A. Requires Limits on Who Will get Alzheimer’s Drug

When the FDA approved Aduhelm a month ago, the original label said the drug was “for the treatment of Alzheimer’s disease.” The surprisingly broad label caused a storm of concern among many Alzheimer’s experts, even those who had supported the drug’s approval.

At a forum sponsored by the Alzheimer’s Association last month that urged Aduhelm to be approved, a panel of Alzheimer’s clinics with differing views agreed on whether the drug should have been approved that its use was strong should be restricted.

Many experts say the drug’s label should not only restrict Aduhelm’s use to mild disease stages, but also require two more stringent clinical trial conditions: that suitable patients have evidence of high levels of a key protein, amyloid, in their brain, and that people with certain diseases (so-called “contraindications”) should be prevented from taking the drug or at least classified as a high-risk group, as this can lead to brain swelling and bleeding.

At the forum, Dr. Stephen Selloway, director of the Memory and Aging Program at Butler Hospital in Providence, RI, who helped conduct the Aduhelm studies and is one of the drug’s most ardent medical advocates, when he saw the label had no contraindications to his The reaction was “oy”.

On Thursday, Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, who also worked on one of the Aduhelm studies and spoke out against the approval of the drug, saying that the new labeling was neglected.

The label should have said, among other things, that people with diabetes, high blood pressure and people who take blood thinners are not allowed to take part in the clinical trials and therefore “no extent is known”. of increased risk ”for these patients.

Dr. Jason Karlawish, a co-director of the University of Pennsylvania’s Penn Memory Center, said the new label was based more on what he and other Alzheimer’s experts believe should originally have been written. But the abrupt revision of the label so soon after a much criticized approval decision was worrying, he said.