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U.S. approves Leqeimb, a drug that modestly slows Alzheimer’s

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U.S. health officials on Friday approved a closely watched Alzheimer’s drug that modestly slows the brain-robbing disease, albeit with potential safety risks that patients and their doctors will have to carefully weigh.

The drug, Leqembi, is the first that’s been convincingly shown to slow the decline in memory and thinking that defines Alzheimer’s by targeting the disease’s underlying biology. The U.S. Food and Drug Administration (FDA) approved it for patients with Alzheimer’s, specifically those with mild or early-stage disease.

Leqembi, from Japan’s Eisai and its U.S. partner Biogen, is a rare success in a field accustomed to failed experimental treatments for the incurable condition. The delay in cognitive decline brought about by the drug likely amounts to just several months, but some experts say it could still meaningfully improve people’s lives.

“This drug is not a cure. It doesn’t stop people from getting worse, but it does measurably slow the progression of the disease,” said Dr. Joy Snider, a neurologist at Washington University in St. Louis. “That might mean someone could have an extra six months to a year of being able to drive.”

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Snider stressed that the medicine comes with downsides, including the need for twice-a-month infusions and possible side effects like brain swelling.

A picture of a human brain is taken by PET scan at a hospital in France in January 2019. (Fred Tanneau/AFP/Getty Images)

The FDA approval came via its accelerated pathway, which allows drugs to launch based on early results before they’re confirmed to benefit patients. The agency’s use of that shortcut approach has come under increasing scrutiny from government watchdogs and congressional investigators.

Last week, a congressional report found that FDA’s approval of a similar Alzheimer’s drug called Aduhelm — also from Biogen and Eisai — was “rife with irregularities,” including a number of meetings with drug company staffers that went undocumented.

Scrutiny of the new drug, known chemically as lecanemab, will likely mean most patients won’t start receiving it for months, as insurers decide whether and how to cover it.

The drug will cost about $26,500 US ($35,613 Cdn) for a typical year’s worth of treatment. Eisai said the price reflects the drug’s benefit in terms of improved quality of life, reduced burdens for caregivers and other factors. The company pegged its value at over $37,000 US ($49,725 Cdn) per year but said it priced it lower to reduce costs for patients and insurers. An independent group that assesses drug value recently said the drug would have to be priced below $20,600 US ($27,684 Cdn) per year to be cost-effective.

Alzheimer’s didn’t stop him from earning a university degree

After being diagnosed with Alzheimer’s at the age of 80, Ron Robert enrolled at King’s University College in London, Ont., to challenge his mind and how society treats people living with the disease.

Some six million people in the U.S. and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and daily tasks.

The FDA’s approval was based on one mid-stage study in 800 people with early signs of Alzheimer’s who were still able to live independently or with minimal assistance.

Since then, Eisai has published the results of a larger 1,800-patient study that the FDA will review to confirm the drug’s benefit, paving the way for full approval later this year.

The larger study tracked patients’ results on an 18-point scale that measures memory, judgment and other cognitive abilities. Doctors compile the rating from interviews with the patient and a close contact. After 18 months, patients receiving Leqembi declined more slowly — a difference of less than half a point on the scale — than patients who received a dummy infusion. The delay amounted to just over five months.

There is little consensus on whether that difference translates into real benefits for patients, such as greater independence.

“Most patients won’t notice the difference,” said Dr. Matthew Schrag, a neurology researcher at Vanderbilt University. “This is really quite a small effect and probably below the threshold of what we’d call clinically significant.”

Schrag and some other researchers believe a meaningful improvement would require at least a difference of one full point on the 18-point scale.

‘I have pretty serious doubts’

Leqembi works by clearing a sticky brain protein called amyloid that’s one hallmark of Alzheimer’s. But it’s not clear exactly what causes the disease. A string of other amyloid-targeting drugs have failed and many researchers now think combination treatments will be needed.

Aduhelm, the similar drug, was marred by controversy over its effectiveness.

The FDA approved that drug in 2021 against the advice of the agency’s own outside experts. Doctors hesitated to prescribe the drug and insurers restricted coverage.

 

Debating the risks, benefits of a controversial Alzheimer drug

There’s debate over whether Canada should follow the U.S.’s lead and approve a controversial drug to treat Alzheimer’s, despite concerns Aducanumab isn’t effective and can be harmful. But the uncertainty isn’t stopping some patients from wanting to try the medication.

The FDA did not consult the same expert panel before approving Leqembi.

While there’s “less drama,” surrounding the new drug, Schrag said many of the same concerns apply.

“Is this slight, measurable benefit worth the hefty price tag and the side effects patients may experience?” he asked. “I have pretty serious doubts.”

About 13 per cent of patients in Eisai’s study had swelling of the brain and 17 per cent had small brain bleeds, side effects seen with earlier amyloid-targeting medications. In most cases those problems didn’t cause symptoms, which can include dizziness and vision problems.

Also, several Leqembi users died while taking the drug, including two who were on blood-thinning medications. Eisai has said the deaths can’t be attributed to the drug. The FDA label warns doctors to use caution if they prescribe Leqembi to patients on blood thinners.

Insurers are likely to only cover the drug for people like those in the company study — patients with mild symptoms and confirmation of amyloid buildup. That typically requires expensive brain scans. A separate type of scan will be needed to periodically monitor for brain swelling and bleeding.

Medicare question

A key question in the drug’s rollout will be the coverage decision by Medicare, the federal health plan that covers 60 million seniors and other Americans. The agency severely restricted coverage of Aduhelm, essentially wiping out its U.S. market and prompting Biogen to abandon marketing plans for the drug.

Eisai executives said they have already spent months discussing their drug’s data with Medicare officials. Coverage isn’t expected until after the FDA confirms the drug’s benefit, likely later this year.

“Once we have a Medicare decision, then we can truly launch the drug across the country,” said Eisai’s U.S. CEO, Ivan Cheung.

Dr. Sultan Darvesh of Dalhousie University says they have created a molecule to detect the disease in the brain.

Betsy Groves, 73, of Cambridge, Mass., was diagnosed with Alzheimer’s in 2021. A former lecturer at Harvard’s school of education, she noticed she was having trouble remembering some student names and answering questions.

Her initial diagnosis, based on a cognitive examination, was later confirmed by a positive test for amyloid.

Groves says she is “more than willing” to try Leqembi, despite potential side effects and the need for infusions.

“For me, the minute that drug comes on the market — and I get my doctor’s approval — I’m going to take it,” Groves said.

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Why the golden age of flying is never coming back — and it might not be a bad thing – Yahoo News Canada

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Meal service on a 1955 Trans-Canada Airlines flight. Experts say most people associate the golden age of flying with the era when commercial aviation in Canada was regulated and airlines didn't have to cut costs to stay competitive. (Air Canada - image credit)

Meal service on a 1955 Trans-Canada Airlines flight. Experts say most people associate the golden age of flying with the era when commercial aviation in Canada was regulated and airlines didn’t have to cut costs to stay competitive. (Air Canada – image credit)

From pricey parking to pat downs at security and long lineups everywhere you turn, air travel these days can be unpleasant.

“I get on a plane now at least once a month and to me, it’s like riding on a bus in the sky. Herd me on, sit me down, get me off. They’ve taken away the lure of the travel,” said Susan Barnes, 75, of Halfmoon Bay, B.C., who has been a frequent flyer for more than half a century.

Barnes, who was a flight attendant in the 1960s and ’70s, says she remembers when flying was like a Mad Men cocktail party in the sky. She jetted around the globe pouring free champagne for passengers flying CP Air, a carrier that operated until 1986 when it was taken over by Pacific Western Airlines (PWA) and then, Canadian Airlines.

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Barnes said her job was to provide top notch treatment to every passenger, even those sitting in economy. That meant handing out hot towels before and after every meal. Breakfast, lunch and dinner were served on real china, with silverware and cloth napkins — then out came coffee, tea and a fruit basket.

Submitted by Susan BarnesSubmitted by Susan Barnes

Submitted by Susan Barnes

“We were treating these people as if they were in a first-class establishment. We just happened to be in the air,” Barnes said.

Barnes and other retired CP Air, Canadian and Air Canada flight attendants interviewed by the Cost of Living described flying back then as “a pleasure.”

It’s a far cry from the experience thousands of Canadians had with airlines this past holiday season. Staff shortages, weather issues and computer outages resulted in lost baggage, cancelled flights and stranded passengers who are now battling air carriers for compensation.

This, along with a summer of major travel disruptions due to COVID-19 labour shortages, has the federal government promising to overhaul Canada’s airline passenger bill of rights.

If you’ve been caught in that tangled web of travel chaos, you may be asking yourself what happened. Experts say it comes down to costs, and competition — and that we’re unlikely to ever return to that golden age of flying.

Keeping prices competitive meant airlines had to be more ruthless about the bottom line, said Fred Lazar, an associate professor of economics at York University.

“Here’s a fare, it gets you a seat from A to B. Anything else costs more.”

Carrier competition

What most Canadians remember as the golden age of flying was the era when commercial aviation was regulated, explained Lazar. It was a time when airlines didn’t have to cut costs to stay competitive, because the federal government didn’t allow them to compete with one another.

“So it was essentially the government saying this is where you can fly, when you can fly and these are the prices.”

Up until 1986, the two big players were private carrier CP Air and government-owned Air Canada (formerly Trans-Canada Airlines), said Lazar, and the government did not allow much overlap on routes.

In the absence of competition, experts say Canadian carriers were guaranteed to attract customers and make money, which meant they could afford to offer perks on their flights to passengers.

According to Julie LeBlond Parker, who started as a flight attendant for CP Air in 1968, airlines also invested in their staff. She received extensive training in “decorum” and “finesse” before taking to the sky.

“The service was based on old European service. It was a very high standard,” said LeBlond Parker, who now lives in South Surrey, B.C.

Domestic and international flight prices, 1959 vs. 2023

But the golden age of air travel was also out of reach for many Canadians. Fare schedules from collectors and the archives of the Canada Aviation and Space Museum reveal that throughout the 1940s, ’50s and ’60s, flying was incredibly expensive.

In 1950, a return flight on Trans-Canada Airlines from Vancouver to Johannesburg, South Africa, cost over $21,000 when adjusted for inflation. Flying Toronto to Vancouver in 1962 on CP Air was roughly $1,900.

With prices like that, LeBlond Parker, said the regulars on her flights were business travellers, not vacationers. Leisure travellers were usually newlyweds, couples and families embarking on a once-in-a-lifetime trip.

“What was really amazing about it is that they all dressed up. They probably got a new outfit just to fly because it was special. It was a very special thing.”

City of Vancouver ArchivesCity of Vancouver Archives

City of Vancouver Archives

Goodbye blankets, hello bargains

Barry Prentice, the director of the Transport Institute at the University of Manitoba, said Canadians saw a “tremendous drop” in airfares south of the border when the U.S. deregulated its airlines in 1978.

“They went from $700 to $200, or something. And everybody in Canada was sitting there, you know, wondering, ‘well, why don’t we have that?'”

WATCH | Is air travel broken?

Prentice said the Canadian government followed the U.S., loosening its grip on the airline industry throughout the 1980s and ’90s. During that time, Air Canada became privatized and more carriers entered the Canadian market. As competition ramped up, airfares went down.

But that’s not the only reason flying became cheaper, explained Prentice.

Advances in aviation technology meant planes became more fuel efficient and larger, which increased air cargo and passenger capacity. Prentice said that — along with the 1980s oil glut, brought down the price per seat.

Even when crude prices rebounded, legacy airlines like Air Canada couldn’t go back to charging passengers as much for flights as they did before deregulation because they were up against the à la carte pricing model of no-frills carriers, said Lazar.

Submitted by Julie LeBlond ParkerSubmitted by Julie LeBlond Parker

Submitted by Julie LeBlond Parker

“Many people said, ‘We didn’t have to pay for bags, we got food for free, we didn’t have to pay for earphones,” Lazar said.

“Well now, in the lowest-fare categories, you do, because the airlines want to compete with the ultra low-cost carriers. And that’s the only way they can do it.”

Lazar, who has also worked as a consultant for Qantas, Air Canada and Porter Airlines, said stripping away the luxuries and packing more seats on planes is a “major contributing factor to making flying in economy much less comfortable and attractive, yet much more affordable.”

Snafus at security

While Canadians often blame airlines for a lousy flying experience, chaos at airport security and gates can also contribute to the overall unpleasantness of air travel. Experts say that’s because airports aren’t designed for the realities of today’s travel.

Between 1973 and 2008, Anthony Wade-Cooper was a flight attendant for CP Air, Canadian and Air Canada. He says before 9/11, he could make it from the check-in counter to the gate in 20 minutes.

“It was just so different. You just walked into the airport and you got on a flight,” he said Wade-Cooper, who is now retired in a town called Mooloolaba on Australia’s Sunshine Coast.

Nowadays, airlines ask passengers flying domestic to arrive at the airport two hours in advance and Wade-Cooper said he often spends most of that time standing in a queue.

Brenna Owen/The Canadian PressBrenna Owen/The Canadian Press

Brenna Owen/The Canadian Press

Security snafus are also a result of a steady increase in air travel over the last decade — peaking in 2019 with nearly 163 million passengers passing through Canadian airports, according to Statistics Canada.

According to Lazar, most airports were not built for a post-9/11 world where every traveller has to take off their belt and shoes. There are also design problems when passengers arrive at gates. Lazar says some airports are designed like malls — a lot of shops and restaurants but not a lot of seating.

“There’s no place to sit. You know, if you have long delays, where are you going to go?”

But what we get in exchange for fewer perks and busier airports, said Prentice, are cheaper flights — and that means more people than ever can afford to fly. Which he thinks is a “really good thing.”

“More families can travel and, over time, families have split up wider and wider. My grandchildren are in Montreal and I’m in Winnipeg and I wouldn’t see them very often if it weren’t for air travel.”

If you’re wondering if there’s a way to get back a bit of the elegance or at least the enjoyment of flying, Lazar said you can’t expect to pay rock bottom prices.

He said the only way back to the golden age of travel is to fly first class or rent a private jet.

“Otherwise, just accept the fact that air travel is really the same as travelling on a bus. Except it gets you from A to B much more quickly.”

Air CanadaAir Canada

Air Canada

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Stock futures are little changed ahead of busy week of earnings, Fed meeting – CNBC

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Stock futures were modestly lower on Sunday evening as investors geared up for a week of key corporate earnings and a possible interest rate hike from the Federal Reserve.

Futures tied to the Dow Jones Industrial Average slipped 56 points, or about 0.2%. S&P 500 futures ticked down 0.2%, and Nasdaq 100 futures edged lower by 0.2%.

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Wall Street is coming off a winning week as the stock market’s January rally continued. The Nasdaq Composite gained 4.3% for the week, while the S&P 500 and Dow added 2.5% and 1.8%, respectively.

There are several tests this week for this 2023 rally. A busy stretch of corporate earnings season includes reports from McDonald’s and General Motors on Tuesday followed by tech giants Apple, Meta Platforms, Amazon and Alphabet later in the week.

The Federal Open Market Committee meets on Tuesday and Wednesday, when the Fed is expected to hike rates by one-quarter of a percentage point. Investors will be looking for clues about how much higher the central bank will take rates in the fight against inflation.

“Inflation has shocked the Fed to the upside; they need to be cautious not to inadvertently lower rates too early. Don’t buy into this gobbledygook about a couple of rate cuts being priced into December. For now, the Fed is only around to help in the very unlikely event of a crash landing,” David Zervos, chief market strategist at Jefferies, said in a note to clients.

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Bed Bath & Beyond falters in effort to find buyer in bankruptcy

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Bed Bath & Beyond Inc.’s efforts to find a buyer in bankruptcy have stalled, potentially putting the retailer on a path toward liquidation as it faces a Chapter 11 filing, according to people with knowledge of the matter.

The retailer is preparing to file for bankruptcy protection imminently, likely without a bidder in place for assets including its Buy Buy Baby brand, which is viewed by some as its most valuable chain, said the people, who asked not to be named discussing private company plans. They added that talks are ongoing and a buyer could still emerge.

Chapter 11 bankruptcy filings allow a company to continue operating while it hunts for a buyer or attempts to reorganize. A representative for Bed Bath & Beyond said in a statement that “we continue to work with our advisors and implement actions to manage our business as efficiently as possible as we consider all paths and strategic alternatives.”

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The Union, New Jersey-based retailer spiraled into distress following years of disappointing sales, strategic missteps, and a turnaround effort that came too late. Its troubles quickened when failure to pay suppliers crippled inventory as vendor shipments slowed. On Thursday, the company said it received a default notice tied to some credit lines.

Bed Bath & Beyond was seeking bids from third parties who would agree to buy some or all of the company’s assets in bankruptcy, Bloomberg previously reported.

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