Biogen Alzheimer’s drug hits roadblocks with some hospitals, insurers

By Deena Beasley

(Reuters) -The rollout of Biogen Inc’s Alzheimer’s drug is hitting new roadblocks as some large hospitals decide not to use it and many health insurers await coverage terms from Medicare, the U.S. health plan for people aged 65 and older, before setting their own policies.

Cleveland Clinic, one of the country’s best-known health systems, and New York’s Mount Sinai Health System on Thursday confirmed they had decided not to carry the new drug, called Aduhelm.

“The tide turned on Friday when the inspector general investigation was announced, and the potential allegation of irregularity in the FDA/Biogen relationship,” Dr. Sam Gandy, director of the Mount Sinai Center for Cognitive Health, told Reuters.

The FDA called last week for an independent federal probe into its representatives’ interactions with Biogen.

Biogen shares fell nearly 8% on Thursday, or $25.21, to $324.85. Guggenheim analyst Yatin Suneja attributed the stock slump to the decision by the two hospital systems not to use the drug.

In mid-June, the Washington, D.C., Neurology Center said it would not recommend the treatment, which is given as a monthly infusion, for any of its patients due to concerns about efficacy, safety and cost.

The U.S. Food and Drug Administration approved the drug, also known as aducanumab, in early June despite mixed clinical trial results. The agency said it was convinced that evidence of Aduhelm’s ability to clear amyloid brain plaques would benefit Alzheimer’s patients.

Biogen, which priced Aduhelm at $56,000 a year, said in a statement on Thursday that clinical data supported the drug’s approval and patients who are denied access should contact the company for help.

INSURERS ON HOLD

Insurers representing millions of American enrolled in private Medicare plans said the drug has yet to meet their bar for coverage based on the data.

UnitedHealth Group, the largest private insurer offering Medicare Advantage coverage to seniors, on Thursday said it was still reviewing the drug and awaiting input from Medicare.

“This has some way to go before we get to real clarity. So I wouldn’t guide you to expect a very rapid decision-making on this piece,” CEO Andrew Witty said.

Humana, the second largest provider of Medicare Advantage plans, also said it has not finalized coverage for Aduhelm as it awaits guidance from the Centers for Medicare and Medicaid Services (CMS).

Several Blue Cross Blue Shield health insurance plans, including those in Michigan, North Carolina and Pennsylvania, have said there is insufficient evidence of Aduhelm’s benefit for patients and they will not provide coverage for the drug.

Biogen said in a statement that the several Blues plans’ “characterization of Aduhelm as experimental and investigational is inaccurate and misleading.”

CMS on Monday began a national review process it said would take nine months to complete. Until then, the agency said coverage determinations for aducanumab are being made at the local level by 12 regional contractors.

SVB Leerink this week said a survey of 57 U.S. neurologists who treat high volumes of Alzheimer’s patients found that 44% of them would use Aduhelm in patients with early Alzheimer’s disease who have evidence of amyloid plaques.

The Wall Street firm estimates sales of the drug at $65 million this year, $1.1 billion next year and $5 billion by 2025.

The Institute for Clinical and Economic Review, an influential pricing group, was holding a meeting on Thursday of doctors, patients and other stakeholders to discuss how Aduhelm’s cost stacks up against potential benefits to patients.

(Reporting by Deena Beasley; Additional reporting by Manas Mishra in Bangalaru and Julie Steenhuysen in Chicago; Editing by Howard Goller)

Canada says U.S. ties could be undermined if Michigan shuts pipeline

By Nia Williams and David Ljunggren

CALGARY, Alberta (Reuters) -A day before Michigan’s deadline to close down a key crude oil pipeline, Canada on Tuesday issued its strongest remarks so far about the move, warning that it could undermine relations with the United States, its closest ally and trading partner.

Canadian company Enbridge Inc is preparing for a legal battle with Michigan and courting protests from environmental groups, betting it can ignore the state’s Wednesday deadline to shut down Line 5, which runs under the Straits of Mackinac.

The Canadian government, intervening in the case to back Enbridge, said in a U.S. federal court filing that Michigan had no right to act unilaterally since a 1977 Canada-U.S. pipeline treaty guarantees the free flow of oil between the two nations.

“This case raises concerns regarding the efficacy of the historic framework upon which the U.S.-Canada relationship has been successfully managed for generations,” Ottawa said.

Michigan’s move “threatens to undermine important aspects of that cooperative international relationship”, it added.

The brief said Canada would suffer “massive and

potentially permanent disruption” from a shutdown. Line 5 brings 540,000 barrels-per-day of oil from western Canada to Ontario, Quebec, Michigan, Ohio and Indiana.

Canada has been lobbying Washington officials to keep the pipeline open in what is likely to be an election year in Canada. The White House has so far kept quiet.

“We don’t weigh in on that … it will be decided in court,” U.S. Secretary of Energy Jennifer Granholm told reporters on Tuesday when asked about the White House’s position on Line 5.

In November, Michigan Governor Gretchen Whitmer gave Enbridge six months to shut down the pipeline that runs four miles (6.4 km) along the bottom of Lake Michigan-Huron, citing fears it could rupture.

The order needs a confirmatory order from a judge to enforce it, and Enbridge and Michigan are disputing whether the issue should be heard in state or U.S. federal court.

The sides are in court-ordered mediation, with the next session scheduled for May 18.

“We will not stop operating the pipeline unless we are ordered by a court or our regulator, which we view as highly unlikely,” Enbridge spokeswoman Tracie Kenyon said in a statement this week.

Joe Comartin, Canada’s consul general in Detroit who is arguing on behalf of Ottawa, said litigation could drag on until at least 2024.

“I don’t see a court jumping the gun and ordering it closed … until the litigation and constitutional issues are resolved,” he said by phone.

Ontario estimates the city of Sarnia, across the border from Michigan, could lose 5,000 refinery and chemical plant jobs. Industry lobbyists say thousands of U.S. jobs are in danger.

Environmentalists and indigenous groups opposed to Line 5 say the potential job losses are exaggerated. They plan “Evict Enbridge” rallies in Mackinaw City, Michigan, on Wednesday and Thursday.

Michigan is reviewing what it could do if Enbridge ignores the order, said a spokeswoman for the Michigan Attorney General.

Canadian crude market forward prices suggest most traders do not expect a shutdown in coming months, but the uncertainty is concerning, said one Calgary-based market source.

(Reporting by David Ljunggren and Nia Williams; Editing by David Gregorio and Marguerita Choy)

Ford outlines further production cuts due to global chip shortage

By Ben Klayman

DETROIT (Reuters) – Ford Motor Co on Wednesday outlined another series of plant shutdowns due to the global semiconductor chip shortage, with five facilities in the United States and one in Turkey affected.

The No. 2 U.S. automaker did not outline how many vehicles would be lost in the latest actions, and reiterated it intends to provide an update of the financial impact of the chip shortage at its quarterly earnings on April 28.

The firm this month announced production cuts at plants in Chicago, Flat Rock, Michigan, and Kansas City, as well as implementing a reduced schedule at its Ohio Assembly Plant, the latest in a string of chip-related curtailments.

Ford said in March it expected the semiconductor shortage to cost between $1 billion and $2.5 billion.

The company said in addition to the chip shortage, other factors driving the shutdowns included the previously reported fire at Renesas Electronics Corp’s chip-making factory in Japan, and prior severe winter storms in Texas.

Industry officials have previously said the shortage would be worse in the second quarter than in the first.

It was not clear if supplies would recover in the third quarter and whether automakers could make up all the lost production later this year.

Many North American automakers cancelled chip orders after plants were shut for two months during the COVID-19 pandemic last year, while demand surged from the consumer electronics industry as people worked from home and played video games.

That has now left carmakers competing for chips.

Semiconductors are used extensively in cars, including to monitor engine performance, manage steering or automatic windows, and in sensors used in parking and entertainment systems.

(Reporting by Ben Klayman in Detroit; Editing by Chris Reese and Jan Harvey)

More therapeutics but no surge in vaccine for Michigan, Biden administration says

By Jeff Mason and Carl O’Donnell

WASHINGTON (Reuters) -The White House said on Monday it was prepared to send additional therapeutic treatments to the state of Michigan, which is experiencing a worrying number of COVID-19 cases, but declined to promise more vaccine as the state has sought.

White House coronavirus adviser Andy Slavitt told reporters the U.S. government would work to ensure that states such as Michigan were ordering the full amount of vaccine that was available to them but said that shifting distribution was not in line with the administration’s public health strategy.

“We have to remember the fact that in the next two to six weeks, the variants that we’ve seen … in Michigan, those variants are also … present in other states,” he told reporters on a conference call.

“So our ability to vaccinate people quickly … (in) each of those states rather than taking vaccines and shifting it to playing Whack-a-Mole isn’t the strategy that public health leaders and scientists … have laid out,” he said.

Michigan Governor Gretchen Whitmer, a Democrat, has pleaded with the federal government to increase the number of vaccines allotted to her state to address a dangerous surge in cases but, despite close ties to the White House, has been rebuffed.

Whitmer was on President Joe Biden’s list of potential running mates before he chose now Vice President Kamala Harris. Michigan is a political battleground state that Biden won in 2020, helping to secure his victory over former President Donald Trump, a Republican. It is likely to be decisive in the 2024 White House race as well.

The Biden administration has highlighted an increase in vaccination rates across the country while warning Americans to continue wearing masks, maintain social distance, and follow other health protocols to prevent another major COVID-19 surge.

U.S. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said more vaccine was not the answer to Michigan’s problem. She said the state needed to “go back to basics” and shut down.

“I think if we tried to vaccinate our way out of what is happening in Michigan we would be disappointed that it took so long for the vaccine to work,” she said. “Similarly we need that vaccine in other places. If we vaccinate today we will have, you know, impact at six weeks and we don’t know where the next place … is going to be that is going to surge.”

Whitmer has faced fierce political backlash from conservatives in her Midwestern state for her COVID-19 restrictions, including armed groups entering the state capitol and a foiled plot to kidnap her. She was a frequent target of criticism from Trump.

Slavitt said that Johnson & Johnson is on track to deliver around 24 million COVID-19 shots to the United States in April whether or not it receives U.S. regulatory clearance for its Baltimore vaccine production plant, which is owned by contract manufacturer Emergent BioSciences Inc.

J&J has faced delays on vaccine shipments because of challenges at its Emergent plant, which ruined 15 million doses in recent weeks due to manufacturing error.

Jeff Zients, the White House’s COVID-19 response coordinator, said last week J&J would ship relatively few shots each week until the Emergent plant received authorization from the U.S. Food and Drug Administration.

(Reporting by Jeff Mason and Carl O’Donnell; additional reporting by Susan Heavey and Caroline HumerEditing by Chizu Nomiyama and Marguerita Choy)

Michigan coronavirus cases rise sharply, top daily tally among U.S. states

(Reuters) – Michigan topped the coronavirus daily tally among U.S. states on Monday after a steep rise in infections, about a month after the state eased restrictions when new cases showed a downward trend.

It reported 11,082 cases on Monday, which included Sunday and Monday’s case load as the state does not report on Sunday. Michigan’s daily COVID-19 tally is hovering close to its previous single-day peak of 10,140 new cases on Nov. 20.

Michigan is currently the worst affected U.S. state in terms of new cases and hospitalizations per 100,000 people in the week to April 5. It is the only state to report more than 7,000 new cases on Monday.

Following a slew of other states, Michigan began loosening restrictions around gatherings by increasing the capacity of gyms, restaurants, pubs, retail stores and entertainment venues in March.

Around the time when restrictions were eased in March, the state reported about 1,800 new infections a day. In the seven days to April 5, the average has surged to over 6,700 cases a day.

Nationwide, new virus infections were up for a third week in a row and hospitalizations also broke an 11-week streak of falling admissions.

Twenty-seven out of 50 U.S. states have reported increases in new cases in the past week compared with the previous seven days.

Last week, U.S. President Joe Biden urged states to pause reopening efforts with the head of the U.S. Centers for Disease Control and Prevention warning of “impending doom” if precautions are not taken seriously.

Vaccinations in the country hit a record for the sixth straight week and currently over 32% of the U.S. population has received at least one dose and more than 19% were fully vaccinated, according to the CDC.

Many U.S. states, including Michigan, have already opened vaccinations for everyone above the age of 16.

(Reporting by Roshan Abraham and Sangameswaran S in Bengaluru; Editing by Muralikumar Anantharaman and Lisa Shumaker)

U.S. educators wrangle over school re-opening

By Brendan O’Brien and Barbara Goldberg

(Reuters) – Educators in major cities including Chicago and Philadelphia on Monday called for strong COVID-19 safety protocols in their classrooms as those and other districts pushed to re-open schools that have been closed for nearly a year.

Across the nation, school reopenings have become a red-hot topic. District officials, teachers, parents and health professionals have been debating when and how to safely re-open schools for millions of students who have been taking classes remotely for 11 months since the pandemic closed schools last spring.

In Chicago, the powerful Chicago Teachers Union was considering the school district’s proposed COVID-19 safety plan that would allow schools to begin re-opening this week. In Philadelphia, educators won an agreement to allow a mediator to decide when in-person learning could safely resume.

If approved, the agreement with Chicago Public Schools, the third largest U.S. district, would avert a threatened lock out by the district, or strike by teachers who demanded stronger safety protocols to prevent the spread of the virus in classrooms.

A deal would allow for some 67,000 students to gradually return into school buildings over the next month, starting with pre-kindergarten and special education pupils later this week.

The union’s leadership is expected to decide on Monday night whether to send its 28,000 rank and file members the district’s safety plan to for a vote on Tuesday.

In Philadelphia, the teachers union succeeded late on Sunday in reversing a district order to return some 2,000 pre-kindergarten through second grade teachers to their classrooms on Monday to prepare for students coming back on Feb. 22.

“There is a lot of uncertainty about the process of re-opening,” said Pennsylvania State Senator Nikil Saval on a Twitter video as he protested with Philadelphia teachers outside his child’s school. “We want an eventual return to schools but only when it is safe … for teachers and students.”

The Philadelphia Federation of Teachers on Twitter cheered the city’s concession to allow an independent arbitrator to decide when the district can safely resume in-person teaching.

“The mediation process is still ongoing,” the union said on Twitter.

U.S. President Joe Biden on Sunday addressed the issue on Sunday, describing school closures and their negative impact on families as a national emergency.

During a Super Bowl interview on CBS, Biden said it was time for schools to reopen if they can do it safely, with fewer people in classrooms and proper ventilation.

“I think about the price so many of my grandkids and … kids are going to pay for not having had the chance to finish whatever it was,” he said. “They are going for a lot, these kids.”

Leading health organizations, including the Centers for Disease Control and Prevention, have said there is little evidence that schools contribute to the spread of the virus, which has killed more than 460,000 people in the United States since the pandemic began.

In Michigan, more than 350 physicians and psychologists signed a letter to Ann Arbor Schools officials urging the resumption of in-person classes by March 1. They warned of the “harmful impact of delayed school reopening on our community.”

Dr. Kim Monroe, a pediatrician who helped organize the Michigan effort, told radio station WEMU, “We are seeing so much mental illness in children due to the virtual schooling.”

A gradual re-opening unfolded in Atlanta when third through fifth grade students went back to school on Monday after prekindergarten through second grade returned to schools on Jan. 25.

In New York City, in-person classes in the nation’s largest school system will resume for middle school students on Feb. 25. About half of the public school system’s 471 middle schools will offer five-day-a-week classroom learning with the remainder working toward that goal, Mayor Bill de Blasio and Schools Chancellor Richard Carranza said at a press briefing.

“If we’re in an environment where the city is overwhelmingly vaccinated, we’re able to bring school back as it was. Same physical proportions. Same number of kids in classrooms,” De Blasio said, adding he hopes to have all schools back to full-time in-person learning in the fall.

(Reporting by Brendan O’Brien in Chicago and Barbara Goldberg in Maplewood, New Jersey; Editing by David Gregorio)

Michigan’s former governor and health director charged in Flint water crisis

DETROIT (Reuters) – Michigan’s former health director was charged Thursday with involuntary manslaughter as part of a years-long criminal investigation into the crisis surrounding lead contamination of the drinking water system serving the city of Flint.

Nick Lyon pleaded not guilty to the charges, which were linked to the deaths of nine people, at his arraignment in a Gennessee County court on Thursday, according to media reports.

Former Governor Rick Snyder and Howard Croft, Flint’s former public works director, were also arraigned, the reports said.

Michigan’s attorney general and a team of prosecutors are due to unveil the full findings of their investigation into the Flint water crisis later on Thursday morning.

Snyder was charged on Wednesday with two misdemeanor counts of willful neglect of duty for his role in a debacle that afflicted the predominantly African-American city and became emblematic of racial inequality in the United States.

Flint’s troubles began in 2014 after the city switched its water supply to the Flint River from Lake Huron to cut costs. Corrosive river water caused lead to leach from pipes, tainting the drinking water and causing an outbreak of Legionnaires’ disease.

The contamination also prompted several lawsuits from parents who said their children were showing dangerously high blood levels of lead, which can cause development disorders. Lead can be toxic and children are especially vulnerable.

A civil settlement of more than $600 million was reached with victims of the water crisis in August 2020 and is awaiting court approval.

The date of the misdemeanor offense in charging documents filed against Snyder and posted online was listed as April 25, 2014, the day the city switched water systems. Each count carries a maximum penalty of a year in jail and a $1,000 fine.

The Detroit News has reported that as many as 10 people in all faced charges stemming from the water crisis, including some former members of Snyder’s administration.

Snyder, a Republican who has been out of office for two years, was governor when the city of some 100,000 residents was under the control of a state-appointed manager in 2014. He was succeeded by Governor Gretchen Whitmer, a Democrat.

The former Wayne County prosecutor appointed in 2016 to lead the state’s investigation of the matter said then that he was looking to determine whether any officials who signed off on the change in the water system had acted criminally.

On Wednesday, the office of the state attorney general, Dana Nessel, also a Democrat, said the findings of that inquiry would be announced at a news conference on Thursday, along with Michigan Solicitor General Fadwa Hammoud and Wayne County Prosecutor Kym Worthy.

Snyder has repeatedly apologized for the state’s poor handling of the crisis, but his lawyer, Brian Lennon, has said any prosecution of the former governor would be politically motivated.

“It is outrageous to think any criminal charges would be filed against Governor Snyder. Any charges would be meritless,” Lennon said in a statement the day before the case was filed.

Nessel’s office declined to comment on the case ahead of Thursday’s news conference.

(Reporting by Daniel Trotta, Brendan O’Brien, Ben Klayman and Nathan Layne; additional reporting and writing by Steve Gorman; editing by Jonathan Oatis)

Grand jury indicts six men for Michigan governor kidnap plot

By Jonathan Allen

(Reuters) – Six men facing charges of plotting to kidnap Michigan Governor Gretchen Whitmer were indicted by a grand jury this week, the U.S. attorney’s office for western Michigan said on Thursday.

The men — Adam Fox, Barry Croft, Ty Garbin, Kaleb Franks, Daniel Harris and Brandon Caserta — were arrested and charged in October with conspiring to grab Whitmer, a Democrat, from her vacation home earlier this year.

Some of the men belong to an anti-government militia group called Wolverine Watchmen. At least one of the defendants, Fox, considered Whitmer to be a sort of tyrant because she had ordered gyms closed in the state to stem the spread of the novel coronavirus, according to prosecutors.

Obtaining the grand jury indictments, which came down on Wednesday, was a necessary step to proceed with the federal prosecutions, the U.S. attorney’s office said in a statement.

Parker Douglas, a lawyer representing Harris, said Harris had pleaded not guilty because “there was no actual conspiracy to kidnap Governor Whitmer.”

“As you can see from the indictment, the government is extremely vague regarding the alleged conspiracy’s nature, the alleged conspiracy’s object and any steps my client allegedly took to agree with the conspiracy,” Douglas wrote in an email.

Lawyers for the other defendants did not immediately respond to requests for comment.

If convicted at trial, the defendants, who are in jail after being denied bail, would face a maximum sentence of life in prison.

The indictment accuses the men of discussing kidnapping Whitmer, meeting in July in Wisconsin to practice using assault rifles, and surveilling Whitmer’s vacation home in August and September, mapping out how far it was from the nearest police station.

Some of the men also bought supplies for kidnapping, the indictment said. In September, Fox bought a Taser-style stun gun and placed a $4,000 order for explosives with someone he did not realize was, in fact, an undercover agent with the Federal Bureau of Investigation.

(Reporting by Jonathan Allen in New York; Editing by Bernadette Baum)

Trump and 17 states back Texas bid at Supreme Court

By Jan Wolfe and Andrea Shalal

WASHINGTON (Reuters) – President Donald Trump on Wednesday asked the U.S. Supreme Court to let him join a lawsuit by Texas seeking to throw out the voting results in four states, litigation that also drew support from 17 other states.

In a separate brief, lawyers for 17 states led by Missouri’s Republican Attorney General Eric Schmitt also urged the nine justices to hear the Texas lawsuit.

Trump on Wednesday vowed to intervene in the lawsuit though he did not provide details on the nature of the intervention including whether it would be by presidential campaign or the U.S. Justice Department.

Writing on Twitter, Trump said, “We will be INTERVENING in the Texas (plus many other states) case. This is the big one. Our Country needs a victory!”

The lawsuit, announced on Tuesday by the attorney general of Texas, Ken Paxton, targeted four states.

In addition to Missouri, the states joining Texas were: Alabama, Arkansas, Florida, Indiana, Kansas, Louisiana, Mississippi, Montana, Nebraska, North Dakota, Oklahoma, South Carolina, South Dakota, Tennessee, Utah and West Virginia.

The lawsuit was filed directly with the Supreme Court rather than with a lower court, as is permitted for certain litigation between states.

The Texas suit argued that changes made by the four states to voting procedures amid the coronavirus pandemic to expand mail-in voting were unlawful. Texas asked the Supreme Court to immediately block the four states from using the voting results to appoint presidential electors to the Electoral College.

Texas also asked the Supreme Court to delay the Dec. 14 date for Electoral College votes to be formally cast, a date set by law in 1887.

(Reporting by Andrea Shalal and Jan Wolfe; Editing by Tim Ahmann and Will Dunham)

U.S. judge declines to sanction Trump campaign over alleged ‘disinformation’ tactic

By Jan Wolfe

(Reuters) – A federal judge in Michigan has declined to reprimand President Donald Trump’s campaign for submitting a court document that opposing lawyers said was purposefully misleading.

In a four-page order issued on Tuesday, U.S. District Judge Janet Neff said she would not strike the disputed document from the court record. Lawyers for the city of Detroit had asked Neff to strike the document as a way of sanctioning Trump’s campaign.

“While we are disappointed that sanctions were not awarded, this is only one of many cases filed in Michigan, and we do expect these lawyers to be sanctioned by some courts for their repeated frivolous lawsuits,” David Fink, a lawyer for the city of Detroit, said in a statement.

Trump’s campaign on Nov. 19 said it was voluntarily dropping a lawsuit contesting Michigan’s election results because election officials in Wayne County “met and declined to certify the results of the presidential election.”

In fact, Republican members of the Wayne County Board of Canvassers on Nov. 17 refused at first to certify the results, but then reversed themselves after a public outcry.

Detroit’s lawyers said on Nov. 19 that the campaign included “impertinent and false language” in the filing. They did not request a monetary penalty, but said Neff had “the authority to strike materials from the record as a sanction.”

Federal law allows Trump’s lawyers to “voluntarily dismiss their claims, but it does not allow them to use a Notice of Dismissal to spread disinformation,” according to Detroit’s motion.

Mark “Thor” Hearne, the Trump campaign lawyer who submitted the document, has said the sanctions request was meritless and an attempt to score political points.

Hearne argued affidavits attached to his filing accurately explained the facts to the judge.

Neff provided little explanation for why she did not think the sanction was warranted.

“With the filing of its motion, the City of Detroit’s factual position is part of the court record, and the Court, in its discretion, declines to impose the requested sanction,” Neff wrote.

(Reporting by Jan Wolfe; Editing by Noeleen Walder and Tom Brown)