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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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What’s open and closed Good Friday, Easter Monday in Hamilton, Burlington and Niagara Region – Global News

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The Easter long weekend is upon us, bringing a rare four-day holiday to some in the Hamilton area. Several businesses and services will be closed on Good Friday (March 29), Easter Sunday (March 31) or Easter Monday (April 1).

Here’s a list of some things that will or will not be operating in Hamilton, Burlington and Niagara Region.

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Administrative offices: Offices are closed on Friday and Monday.

Licensing and bylaw services: Licensing and bylaw phone queue line will be closed on Friday and Monday. Service will resume on Tuesday.

Green bin, garbage and recycling: No collection on Good Friday. Friday’s pickup will occur on Saturday (March 31). Monday will be a regular collection day (April 1). The city says all materials must be at the curb by 7 a.m. Community recycling centres and transfer stations will be closed Friday and Monday.

HSR bus: Buses will operate on a Sunday/holiday schedule Friday and a regular schedule on Monday.

GO Transit: Trains and buses are operating on a Sunday schedule Friday.

ATS DARTS: Service will be operating with holiday service hours on Friday and Monday. Subscription trips on DARTS, with the exception of dialysis, are cancelled for Friday and Monday. ATS customer service will also be closed on Friday and Monday.

Ontario Works: The program, including the special supports, will be closed Friday and Monday. Phone service will resume on Tuesday.

Recreation centres: Closed on Friday and Monday.

Hamilton civic museums: Dundurn National Historic Site, the Hamilton Military Museum and the Hamilton Museum of Steam and Technology will be closed on Friday and Monday.

Tourism Hamilton visitor information centre: Closed Friday to Monday.

Hamilton Public Library: All HPL branches are closed on Good Friday, Easter Sunday and Easter Monday. Branches are open on Saturday and regular hours resume Tuesday, April 2

Social services: All Ontario Works offices, special supports and the housing services office will be closed on Friday and Monday.

Senior centres: Closed Friday and Sunday. Senior clubs will be running modified program schedules from Friday to Monday.

Arenas: Closed to public programming Friday, Sunday and Monday.

Animal services: Closed Good Friday, Sunday and Easter Monday.

Canadian Warplane Heritage Museum in Mount Hope: Open Good Friday, Saturday and Easter Sunday. Closed Easter Monday.

Burlington

Government offices: Local government such as city hall, municipal offices and facilities will be closed on Good Friday and Easter Monday.


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Administrative services: Services including parks, roads and forestry will be closed on Friday and Monday. Only snow removal and urgent services will be provided.

Animal Shelter and Control: Closed all weekend, Friday through Monday. Emergencies can be called in to 905-335-7777.

Recreation centres: Some city pools, arenas and community centres will be operational on a limited schedule. Visit burlington.ca/dropinandplay for details. Some outdoor recreation facilities will also be open, weather permitting. Visit burlington.ca/outdoorplay for more information. Tyandaga Golf Course will be closed. The tentative season opener is set for April 6.

Halton Provincial Offences Court: Closed on Friday and Monday.

Free parking: Available Friday and Monday in the downtown core in municipal lots, on-street and in the parking garage, however, the Waterfront parking lots (east and west) do not provide free parking on statutory holidays. Parking exemptions are required to park overnight on city streets and for longer than five hours. Visit burlington.ca/parkingexemptions for more.

Burlington Transit: Transit will operate a holiday schedule Sunday. The downtown transit terminal, specialized dispatch and the administration office will be closed on March 29. Monday is a regular schedule.

Niagara Region

Government offices: City halls, the Enterprise Centre and administration offices are all closed on Good Friday. Some offices, like St. Catharines, will reopen on Easter Monday.

Parks, recreation and culture services: All City recreation centres are closed on Good Friday and Easter Sunday. Administration offices are all closed on Friday. Some will be closed on Monday. St. Catharines Kiwanis Aquatics Centre is closed Friday, but open on Saturday. Seymour-Hannah Sports and Entertainment Centre is closed Friday, but open regular hours through the weekend and Monday.

Community centres: All older adult centres and arenas will either be closed or have reduced hours on Friday, Sunday and Monday.

St. Catharines Museum; Welland Canals Centre: Both facilities will be closed on Good Friday but open the rest of the long weekend between 9 a.m. to 5 p.m.

Niagara Regional Transit: Both St. Catharines and Niagara Falls buses will operate on a holiday schedule for Good Friday. Regional, Fort Erie and Welland service will not be running Friday. The agency will have regular hours on Easter Sunday and Monday.

Canada Post: No collection or mail delivery on Monday. Most post offices operated by the private sector will also be closed during business hours.

Grocery stores: Major grocery stores like Fortinos, Metro, FreshCo and No Frills will be closed on Good Friday and Easter Sunday.

Shoppers Drug Mart: Some locations in the city will be open on Good Friday and Easter Sunday, but not all. Holiday hours can be seen on the Shoppers store locator map.

Rexall: Some outlets are open on a holiday schedule, but not all. Visit the Rexall website for store hours.

Malls: All major shopping centres in Hamilton, Burlington, St. Catharines and Niagara Falls will be closed on Good Friday. Exceptions include:

  • Outlet Collection at Niagara Falls: Open from 10 a.m. to 6 p.m.
  • CF Toronto Eaton Centre: Open noon to 7 p.m.
  • Toronto Premium Outlets in Halton Hills: Open Friday from 9:30 a.m. to 7 p.m. and Sunday from 11 a.m. to 7 p.m.
  • Pacific Mall in Toronto: Open between 11 a.m. and 7 p.m.
  • Vaughan Mills will be open from 11 a.m. to 7 p.m.

In Toronto, retailers in designated tourist areas such as Yorkville, downtown Yonge, Queen’s Quay West and the Distillery District can stay open Good Friday, according to City of Toronto bylaws.

Walmart: All Walmarts in the GTHA will be closed Good Friday and Easter Sunday except the Niagara Falls Supercentre on Oakwood Drive, which is open between 7 a.m. and 11 p.m. on those days.

Alcohol

The Beer Store: All stores will be closed Good Friday and Easter Sunday.

LCBO: All stores will be closed Good Friday and Easter Sunday.

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Wine Rack: Most Hamilton locations will be closed on Good Friday and Easter Monday except for the Wilson Street West location in Ancaster and the Guelph Line outlet in Burlington.

Wilson Street will be open Noon to 5 p.m. on Good Friday and 11 a.m. to 6 p.m. on Easter Sunday. Guelph Line will open 10 a.m. to 6 p.m. on Friday and Sunday.

Tourist destinations

Niagara Falls: Some Niagara Falls attractions are closed during the early spring, including the Whirlpool Aero Car and Wildplay Whirlpool Adventure Course, and the White Water Walk.

However, some, like the Niagara City Cruises, Journey Behind the Falls, Niagara Falls History Museum and The Exchange, and the Niagara Power Station are open and will be operating on Good Friday and Easter Sunday. Hours of operation can be seen on the Niagara Parks website.

The Butterfly Conservatory will be open on Good Friday and Easter Sunday between 10 a.m. and 6 p.m.

Toronto: Most Toronto attractions are either closed or have adjusted hours on Good Friday and Easter Sunday.

  • The Hockey Hall of Fame will be open from 10 a.m. to 5 p.m.
  • The Toronto Zoo will be open from 9:30 a.m. to 6 p.m.
  • The Ontario Science Centre will be open from 10 a.m. to 5 p.m.
  • Ripley’s Aquarium will be open from 9 a.m. to 11 p.m.
  • The Art Gallery of Ontario will be open from 10:30 a.m. to 4:30 p.m.
  • The Royal Ontario Museum will be open from 10 a.m. to 5:30 p.m.
  • The Aga Khan Museum will be open from 10 a.m. to 5:30 p.m.

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CRA pausing new 'bare trust' reporting requirement just days before filing deadline – CBC News

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The Canada Revenue Agency (CRA) is hitting pause on a new “bare trust” reporting requirement with just a few days remaining before the deadline.

New reporting requirements for such trust arrangements were introduced for the 2024 tax season. Anyone with a bare trust was required to file a T3 tax return form naming the trustees, beneficiaries and settlors of each trust by April 2.

But on Thursday — with four days before the deadline to file — the CRA announced that it would be pausing the reporting measures.

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“In recognition that the new reporting requirements for bare trusts have had an unintended impact on Canadians, the Canada Revenue Agency will not require bare trusts to file a T3 … for the 2023 tax year, unless the CRA makes a direct request for these filings,” a statement released by the tax agency said.

John Oakey, a vice president with the Chartered Professional Accountants of Canada, said the government hasn’t done a great job of communicating the changes.

“There’s no advertising from the government saying these are coming. You don’t see an ad on the television. You don’t see ads in magazines,” he said.

“The only way that individuals are really finding out is from advisers, financial institutions … people that are already aware of these rules.”

No definition of ‘bare trust’ in Income Tax Act

There is no definition of a bare trust in the Income Tax Act. The CRA defines a bare trust as “arrangement under which the trustee can reasonably be considered to act as agent for all the beneficiaries under the trust with respect to all dealings with all of the trust’s property.”

Unlike express trusts, where people seek out a lawyer to create a trust, bare trusts can happen almost accidentally — when a parent cosigns a mortgage for a child and becomes partial owner, or when an aging parent puts their kids down as partial owners of their house in anticipation of an impending death.

Oakey said a bare trust could also be something as simple as a shared bank account.

“If I put my name on [my parents’] bank account in order to help them pay their bills, that creates a trust relationship,” he said.

“I have no real control over the asset. I still have to adhere to their wishes. All I’m doing is acting as an agent on their behalf to do whatever they want me to do.”

In those cases, the bare trust does not earn any money for the trustee to report in a given tax year.

Even though Canadians wouldn’t have been taxed on a trust’s value, failure to report being a member of a bare trust could have resulted in a fine of $2,500, or five per cent of the value of all property in the trust, whichever is higher.

The requirement was meant as a way to crack down on tax avoidance. Corporations and wealthy individuals sometimes hold properties in bare trusts so they can avoid paying property transfer taxes. Oakey said the move was also likely an effort to crack down on money laundering.

The CRA said it would be working to “to further clarify its guidance on this filing requirement” over the coming months.

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Economy grows more than expected, keeping the Bank of Canada 'on its toes' – Financial Post

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January GDP strongest monthly growth in a year

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The Canadian economy surprised to the upside in January, posting its strongest monthly growth in a year, which could keep the Bank of Canada “on its toes,” say economists.

Real gross domestic product (GDP), which measures the value of goods and services produced during a specific time frame, edged up by 0.6 per cent in January, according to Statistics Canada, beating analysts’ expectations of 0.4 per cent. The agency also expects a 0.4 per cent rise in GDP during February.

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“To put that two-month flurry of growth into perspective, the combined one per cent gain is as much as the economy grew in the entire 12 months of 2023,” Bank of Montreal chief economist Douglas Porter said in a note. “After a prolonged lull through much of last year … the economy looks to have caught some strong tailwinds early this year.”

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The rise in GDP was due to broad-based growth in 18 of the 20 sectors measured by Statistics Canada.

The public sector, which includes education, health care and social assistance and public administration, increased 1.9 per cent in January, following two consecutive monthly declines. Education, which grew by six per cent, was the largest contributor to the country’s growth as activity rebounded from strikes by public sector workers in Quebec late last year.

Manufacturing fully recouped December’s decline in growth with a 0.9 per cent rise in January. A sudden drop in temperature in mid-January in parts of Canada contributed to increased activity in the utilities sector, which rose by 3.2 per cent, its highest growth rate since January 2022.

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The real estate and rental sector grew for a third consecutive month — by 0.4 per cent — on higher resale activity. The Greater Toronto Area, Hamilton-Burlington and most markets in Ontario’s Greater Golden Horseshoe contributed to the growth.

The information and cultural services sector, which includes the motion picture and sound recording industry, also grew for the third consecutive month, as activity continued to ramp up following the end of a strike by the Screen Actors Guild – American Federation of Television and Radio Artists in November.

These “robust” figures could pose a difficult challenge for the Bank of Canada, Toronto-Dominion Bank economist Marc Ercolao said in a note.

While the central bank has received “solid evidence” in the past two months that inflation is cooperating, “strong GDP data prints” such as today’s will “keep them on their toes,” said Ercolao, who expects the first interest rate cut to take place in July.

On the labour front, Statistics Canada said there were 632,100 job vacancies in January, down 34,800, or 5.2 per cent, from November. Vacancies in the manufacturing sector declined by 10.2 per cent to 37,500, the lowest level since September 2017.

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Monthly payroll increases were recorded in 13 of 20 sectors, led by retail trade, manufacturing and finance. But these gains were offset by a 0.3 per cent decline in construction.

The number of employees receiving pay and benefits from their employers, as measured by payroll employment, rose for the first time in the retail trade after four consecutive monthly declines.

Despite the strong start to the year, some economists expressed caution, especially regarding February’s GDP estimate.

Claire Fan, an economist at the Royal Bank of Canada, said the “substantially stronger-than-expected” numbers are partially driven by one-off factors such as the ending of the Quebec teachers’ strike, so growth isn’t likely to be sustained in the coming months.

“We’ve learned to take the advance estimates (February) with a grain of salt as they have been highly revision prone,” she said, while retaining RBC’s assessment of a weak economic backdrop.

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BMO’s Porter said Canada experienced something similar last year when GDP stalled after a strong start to the year.

“There could be a serious issue with seasonality here, especially in light of much milder winters recently,” he said.

Despite the increase in GDP, most economists have stuck to their previous predictions that June will be when the Bank of Canada issues its initial interest rate cut.

• Email: nkarim@postmedia.com

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