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US imposes strict curbs on contentious Biogen Alzheimer’s treatment

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For many years, Alzheimer’s victims have needed to take care of a debilitating illness with out the prospect of a remedy that may sluggish the relentless march of the sickness.

Such a drug seemed to be on the horizon when US regulators accepted Biogen’s Aduhelm final yr. Rivals Eli Lilly and Japan’s Eisai pushed forward with scientific trials for related therapies and mentioned they too would apply for fast-track approval from the Meals and Drug Administration.

However the way forward for this new class of medicines for a illness affecting as much as 50m individuals worldwide faces a troublesome path in the direction of widespread adoption, after the company that controls spending by government-funded well being schemes within the US imposed strict restrictions on funding the medicine.

The Facilities for Medicare & Medicaid Companies issued a proper determination on Thursday limiting reimbursement for Biogen’s drug to only a few thousand sufferers enrolled in scientific trials fairly than the estimated 6m Alzheimer’s victims within the US.

Its determination is damaging for Biogen as a result of most Alzheimer’s sufferers are aged and due to this fact coated by the government-funded Medicare programme for individuals 65 and older. The biotech group had already introduced $500mn in value cuts following a draft determination issued in January that foreshadowed restrictions on the drugs, which is priced at $28,000 a affected person per yr.

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The company, which has damaged with the conference that it ought to fund medicine accepted by the FDA, cited the remedy’s “potential for hurt”, starting from complications to mind bleeding, in addition to issues about how efficient it’s.

The choice applies not solely to Aduhelm, the primary Alzheimer’s remedy accepted since 2003, but in addition different medicines in growth based mostly on the “amyloid speculation”. The speculation holds that the illness is attributable to the build-up of a sticky plaque known as beta amyloid within the mind.

The CMS mentioned related medicine accepted below the FDA’s accelerated approval course of could be topic to the identical restrictions as Aduhelm.

Nevertheless, in a softening of its draft determination in January, the company mentioned therapies accepted by means of the FDA’s customary approval course of that confirmed proof of a scientific profit could be coated for sufferers below Medicare with out enrolment in a scientific trial.

“This long-term pathway is supposed to be nimble and reply to any new medicine on this class which might be within the pipeline and reveal scientific advantages,” mentioned Lee Fleisher, chief medical officer on the CMS.

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The pharma trade lashed out on the CMS after its draft proposal, warning that such restrictions threatened to delay remedy and discourage early analysis of Alzheimer’s. It additionally mentioned the transfer would have a “chilling impact” on analysis by corporations growing novel medicine.

“It’s actually unprecedented what CMS has carried out to suggest that you simply won’t present protection to . . . an FDA accepted medication,” Anne White, president of Lilly Neuroscience, mentioned in an interview shortly earlier than the company issued its last determination. “It is a concern you’re listening to not simply from us however from others throughout the sector.”

Biogen had warned that if the CMS didn’t amend its authentic determination, most sufferers must wait as much as 5 years for Aduhelm to change into extra broadly obtainable. By then, a lot of them can have progressed to a extra extreme stage of the illness and wouldn’t profit from the drug, it added.

“They [CMS] can take inspiration from what was carried out within the case of most cancers. We had greater than 200 medicines that have been granted accelerated approval, thereby giving sufferers and their physicians the selection,” mentioned Chirfi Guindo, an government at Biogen.

The CMS’s draft determination has prompted corporations to reassess whether or not making use of for accelerated approval is price it. In February, Lilly mentioned it might delay submitting for fast-track approval of Donanemab, which it had been anticipated to do earlier than the top of final month.

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Rachelle Doody, international head of neurodegeneration at Roche, mentioned in an interview that the corporate wouldn’t search accelerated approval for its candidate Gantenerumab. It’ll as a substitute observe the common FDA approval pathway, which suggests ready for outcomes from a late-stage trial due this yr.

Drugmakers stand to lose billions of {dollars} in income. Analysts at BMO have been forecasting Donanemab would generate virtually $5bn in annual gross sales by 2028 if accepted. At one level, Aduhelm was anticipated to generate peak yearly revenues of $9bn, in response to consensus estimates from final yr.

Many Alzheimer’s researchers defend the CMS’s determination and are deeply sceptical in regards to the FDA’s transfer to approve Aduhelm below a fast-track course of. The medicine regulator concluded the drugs was solely “fairly doubtless” to foretell a scientific profit and mentioned additional trials have been wanted to make sure.

“[This] might be the worst drug approval determination in current US historical past,” mentioned Aaron Kesselheim, a professor at Harvard Medical Faculty. He was one among three members of a committee advising the FDA on the drug who quit in protest on the company’s approval.

Critics say there may be little conclusive proof that eradicating amyloid plaques slows the event of Alzheimer’s and warn the FDA determination might set a dangerous precedent.

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“This approval was reckless and harmful. It lowered the requirements for approving medicine for Alzheimer’s illness and that’s why you see a rush of corporations concentrating on beta amyloid within the mind,” mentioned Michael Carome, director of well being analysis at Public Citizen, a progressive think-tank.

However Alzheimer’s assist teams are involved that some sufferers, significantly minorities and people in rural areas, will likely be at an obstacle as a result of they’re much less more likely to be enrolled into scientific trials.

Final month, USAgainstAlzheimer’s, an advocacy group, launched a tv advert to marketing campaign towards the CMS draft ruling, whereas a bunch of 74 Republicans in Congress despatched a letter to the administration of Joe Biden urging it to “abandon and repurpose” the choice.

Dewayne Nash, a former household physician who has been identified with Alzheimer’s, mentioned the FDA ought to in all probability have waited for extra conclusive knowledge earlier than approving Aduhelm. However he mentioned now that the drugs is accepted, the CMS ought to pay for it.

“Alzheimer’s is like having terminal most cancers. Persons are prepared to take experimental medicine to sluggish issues, to achieve a while with household, to achieve six months, a yr or two,” mentioned Nash, who’s a participant in a scientific trial of Aduhelm.

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Congress poured billions of dollars into schools. Did it help students learn?

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Congress poured billions of dollars into schools. Did it help students learn?

Two new studies offer a first look at how much more students learned thanks to federal pandemic aid money.

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Blend Images – JGI/Jamie Grill/Tetra images RF/Getty Images

America’s schools received an unprecedented $190 billion in federal emergency funding during the pandemic. Since then, one big question has loomed over them: Did that historic infusion of federal relief help students make up for the learning they missed?

Two new research studies, conducted separately but both released on Wednesday, offer the first answer to that question: Yes, the money made a meaningful difference. But both studies come with context and caveats that, along with that headline finding, require some unpacking.

How much of a difference did the money make?

$190 billion is an enormous amount of money by any measure. But districts were only required to spend a fraction of the relief on academic recovery, by paying for proven interventions like summer learning and high-quality tutoring. So how much additional student learning did the federal aid actually buy?

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Study #1, a collaboration including Tom Kane at Harvard’s Center for Education Policy Research and Sean Reardon at Stanford’s Educational Opportunity Project, estimates that every $1,000 in federal relief spent per student bought the kind of math test score gains that come with 3% of a school year, or about six school days of learning. That’s during the 2022-23 academic year.

Improvements in reading scores were smaller: roughly three school days of progress per $1,000 in federal relief spending per student.

The federal relief “was worth the investment,” Reardon tells NPR. “It led to significant improvements in children’s academic performance… It wasn’t enough money, or enough recovery, to get students all the way back to where they were in 2019, but it did make a significant difference.”

Study #2, co-authored by researcher Dan Goldhaber at the University of Washington and American Institutes for Research, offers a similar estimate of math gains. The increase in reading scores, according to Goldhaber, appeared comparable to those math gains, though he says they’re less precise and a little less certain.

“It did have an impact,” Goldhaber tells NPR, an impact that’s “in line with estimates from prior research about how much money moves the needle of student achievement.”

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Who benefited the most?

The federal recovery dollars came in three waves, known as ESSER (Elementary and Secondary School Emergency Relief Fund) I, II and III. The first two waves were relatively small, roughly $68 billion, compared to the $122 billion of ESSER III.

The windfall was distributed to schools based largely on need – specifically, based on the proportion of students living in or near poverty. The assumption being: Districts with higher rates of student poverty would need more help recovering. COVID hit high-poverty communities harder, with higher rates of infection, death, unemployment and remote schooling than in many affluent communities.

“These and other factors likely caused greater learning loss during the pandemic and dampened academic recovery,” Goldhaber writes in Study #2, pointing out that, “the Detroit, MI public school district received about $25,800 per pupil across all waves of ESSER… [while] Grosse Pointe, MI (a nearby suburb) only received about $860 per pupil.”

Here’s where the story of these federal dollars gets complicated, because the learning they appear to have bought wasn’t experienced evenly, according to Goldhaber.

In Study #2, he and co-author Grace Falken, found larger academic benefits from federal spending in districts serving low shares of Black and Hispanic students. Though he tells NPR, these patterns “do not necessarily imply that ESSER’s impacts vary because of student demographics. Rather, the results could reflect other district characteristics that happen to correlate with the student populations the districts serve.”

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Reardon and Kane did not find statistically significant evidence of this kind of variation.

Goldhaber and Falken also found that towns saw more math gains than cities, while rural areas led the way in reading growth. Interestingly, suburban districts generally experienced “smaller, insignificant impacts” from the federal spending in both subjects.

But did the money help enough?

If your standard for “enough” is a full recovery for all students from the learning they missed during the pandemic, then no, the money did not remedy the full problem.

But the researchers behind both studies say that’s an unrealistic and unreasonable yardstick. After all, Congress only required that districts spend at least 20% of ESSER III funds on learning recovery. The rest of the relief came with relatively few strings attached.

Instead, the researchers say, the money’s effectiveness should be judged by a more realistic standard, based on what previous research has shown money can and cannot buy.

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Harvard’s Tom Kane, of Study #1, points out that their results do line up with pre-pandemic research on the impact of school spending, and suggest a clear, long-term return on investment.

“These academic gains will translate into improvements in earnings and other outcomes that will last a lifetime,” Kane tells NPR.

For example, the academic gains associated with every $1,000 in per student spending would be worth $1,238 in future earnings, Kane estimates. Increased academic achievement also comes with valuable social returns, he says, including lower rates of arrest and teen motherhood.

What’s more, Reardon tells NPR, because these federal dollars disproportionately went to lower-income districts, “not only do we find that the federal investment raised test scores, but we also find that it reduced educational inequality.”

But the work’s not over.

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In Study #2, Goldhaber and Falken write, “to recover from these remaining losses, our estimates suggest schools would need between $9,000 and $13,000 in additional funds per pupil, assuming the return on those funds is similar to what we estimated for ESSER III.”

They also warn that middle-income districts could continue to struggle – because they experienced academic losses but got less federal aid.

In a presidential election year, it’s unlikely Congress will agree to send schools more money. And Goldhaber worries, as ESSER funds begin to expire this year, districts will have to cut staff.

“Some districts, particularly high poverty, high minority districts, are going to lose so much money that I think teacher layoffs are inevitable,” Goldhaber tells NPR. “So I’m worried that the funding cliff – there’s a downside that we’re not thinking hard enough about.”

The good news, says Kane, is that ESSER was a massive, “brute force” effort, and a far smaller, state-driven effort could still make a big difference, so long as it’s hyper-focused on academic interventions.

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Kane says, “It falls to states to complete the recovery.”

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Atos crisis deepens as biggest shareholder ditches rescue plan

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Atos crisis deepens as biggest shareholder ditches rescue plan

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A rescue bid for French IT services group Atos led by its largest shareholder has collapsed, casting the future of the troubled group into doubt once again.

Atos said on Wednesday that the consortium led by Onepoint, an IT consultancy founded by David Layani, had withdrawn a proposal that would have converted €2.9bn of Atos debt into equity and injected €250mn of fresh funds into the struggling company.

“The conditions were not met to conclude an agreement paving the way for a lasting solution for financial restructuring,” Onepoint said in a statement on Wednesday.

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The decision by Onepoint comes less than a month after Atos had picked its restructuring proposal over a competing plan from Czech billionaire Daniel Křetínsky. Atos said on Wednesday that Křetínsky had already indicated he wanted to restart talks.

Once a star of France’s tech scene, Atos is racing to strike a restructuring deal by next month as it struggles under its €4.8bn debt burden. It has cycled through multiple chief executives over the past three years and its shares have collapsed. They were down 12 per cent in early trading on Wednesday.

Atos also said it had received a revised restructuring proposal from a group of its bondholders.

“Discussions are continuing with the representative committee of creditors and certain banks on the basis of this proposal with a view to reaching an agreement as soon as possible,” the company said. 

Jean-Pierre Mustier, former chief executive of Italian lender UniCredit, was installed as chair in October 2023 and given the task of putting Atos on a stable footing for the future. Since his appointment, several efforts to stabilise Atos through asset sales have fallen apart.

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If talks with Křetínsky do restart, it will mark the Czech businessman’s third attempt to do a deal with Atos after an earlier plan to buy its lossmaking legacy business unravelled.

One of the people close to the talks said creditors had not necessarily become more receptive to Kretinsky’s plan given it cutting a larger chunk of the group’s debt.

The crisis at Atos has prompted the French government to intervene. It is currently seeking to acquire three parts of Atos that are deemed of importance to national security for up to €1bn.

Atos said on Wednesday it had concluded a deal with the French state that would give it so-called “golden shares” in a key Atos subsidiary, Bull SA. The agreement also gives the government the right to acquire “sensitive sovereign activities” in the event a third party acquired 10 per cent of the shares — or a multiple thereof — in either Atos or Bull.

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New Jersey gamer flew to Florida and beat fellow player with hammer, say police

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New Jersey gamer flew to Florida and beat fellow player with hammer, say police

An online gamer from New Jersey recently flew to Florida, broke into the home of a fellow player with whom he had feuded digitally but never met in person, and tried to beat him to death with a hammer, according to authorities.

The allegations leveled by the Nassau county, Florida, sheriff’s office against 20-year-old Edward Kang constitute an extreme example of a phenomenon that academics call “internet banging” – which involves online arguments, often between young people, that escalate into physical violence.

As Bill Leeper, the local sheriff, told it, Kang and the man he is suspected of attacking became familiar with each other playing the massively multiplayer online role-playing game ArcheAge.

The Korean game is supposed to no longer be available beginning Thursday, its publisher announced in April, citing a “declining number of active players”, as ABC News reported. But prior to the cancellation, Kang and the other player became locked in some sort of “online altercation”, Leeper said at a news briefing Monday.

Kang then informed his family that he was headed out of town to meet a friend he had made through gaming, Leeper recounted. The sheriff said Kang flew from Newark, New Jersey, to Jacksonville, Florida, and booked himself into a hotel near his fellow gamer’s home early Friday morning.

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He had allegedly bought a hammer and a flashlight at a local hardware store, receipts for which deputies later found in Kang’s hotel room.

By early Sunday, Kang purportedly had put on black clothes, gloves and a mask, and he went into his target’s home through an unlocked door. He waited for the victim to get up to take a bathroom break from gaming – and then battered him with the hammer, Leeper said.

The alleged victim managed to wrestle Kang to the ground while screaming for help. The victim’s stepfather woke up after hearing the screams, rushed to his stepson’s side, helped take Kang’s hammer away and restrained him until deputies were called and they arrived, according to Leeper.

Deputies found blood at the home’s entrance and in the bedroom of the victim, Leeper added. The sheriff said the victim was brought to a hospital to be treated for “severe” head wounds while deputies jailed Kang on counts of attempted second-degree murder and armed burglary.

Leeper accused Kang of telling deputies that he carried out the violent home invasion because he believed the target to be “a bad person online”. Kang also allegedly asked investigators how much prison time was associated with breaking and entering as well as assault.

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Attempted second-degree murder alone can carry up to 15 years. Leeper quipped that his only answer to Kang was: “It will be a long time before you play video games.”

Striking a more serious tone, Leeper urged people to be vigilant about and report to authorities any suspicious online behavior aimed at them. He also mentioned the importance of locking one’s home.

“This … serves as a stark reminder of the potential real-world consequences of online interaction,” Leeper said.

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