adplus-dvertising
Connect with us

News

Patient safety issues halt trial for MDMA-assisted psychotherapy during Health Canada review – CBC.ca

Published

 on


Patient safety concerns uncovered during an ongoing federal review have led to the suspension of one of two clinical trials for MDMA-assisted psychotherapy currently underway in Canada.

The Phase II trial in Toronto, sponsored by a mental health charity called the Remedy Institute, was issued a non-compliant rating on June 22, according to Health Canada. 

A spokesperson told CBC in an email that the study was put on hold “due to concerns for participant safety.”

The federal regulator’s summary of a June 6 inspection identifies 12 concerns with the project, including a failure to conduct the study according to the approved protocol, problems with quality control and staff training, and a lack of informed written consent from participants.

The report card also says that medical care for the patients involved was happening without supervision from a qualified investigator.

Anne Wagner, founder of the Remedy Institute and an adjunct professor of psychology at Toronto Metropolitan University, said her organization had believed they were compliant with Health Canada regulations, but they now understand changes are necessary.

“We welcome Health Canada’s observations, and we are actively working to address them by hiring a leading regulatory compliance consultancy, revising documentation and administrative procedures, and creating better audit trail processes,” Wagner wrote in an email.

She said no study participants have been harmed.

“All participants in our study have received the safe dosages of medication approved by Health Canada and the Research Ethics Board, as well as ethical psychotherapy under the supervision of a licensed psychologist,” Wagner said.

Health Canada promised a review of all trials involving MDMA in April, following a complaint from a group of academics, study participants and journalists about alleged sexual misconduct by two investigators in Vancouver, potential flaws in the research conducted to date and reports of increased suicidal thinking from some patients.

Inspectors are still finalizing their findings about the second active MDMA study site in Montreal, where a Phase II trial sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) is underway.

However, an initial summary of a June 6 inspection of the site says “deficiencies were noted in conducting the clinical trial in keeping with good clinical practices … [and] in the completeness, accuracy or availability of the required records.”

The Health Canada spokesperson said staff have also reviewed all applications for previously authorized MDMA trials and found nothing in the plans for those studies that suggested safety problems or violations of regulatory requirements.

Complaint raised several concerns about research

The review comes at a time when psychedelic drugs are becoming increasingly mainstream and have been hailed in some corners as miracle drugs for serious psychiatric conditions.

MDMA — a recreational drug also known as ecstasy or molly — produces feelings of euphoria and enhances sensation and suggestibility. Research to date has largely focused on its potential, when combined with psychotherapy, to treat post-traumatic stress disorder.

Much of the information in the complaint that preceded the Health Canada review was obtained during research by the team behind New York magazine’s podcast “Cover Story: Power Trip,” which explores the growing field of psychedelic therapy.

Co-host Lily Kay Ross submitted the complaint to Health Canada after reviewing data from trials conducted by MAPS, speaking with experts and hearing from participants about their experiences.

Three people who participated in Canadian trials for MDMA-assisted psychotherapy told CBC they experienced escalating suicidal thoughts. (suriyachan/Shutterstock)

MAPS has characterized many of the criticisms in the complaint as inaccurate and based in part on “a lack of familiarity with the subject matter.”

The complaint alleges that MAPS improperly blended data from small study sites that used different methodologies to produce favourable results.

One of the most serious allegations is that certain participants became increasingly suicidal during the course of the trials, and those experiences weren’t all included in MAPS’s reported results.

CBC has spoken to three Canadian participants who said they experienced a sharp spike in suicidal thoughts during or immediately after the trials.

The complaint also questions whether enough was done to keep patients safe, pointing to videos of MAPS sub-investigators Dr. Donna Dryer and Richard Yensen pinning down, cuddling, spooning and blindfolding participant Meaghan Buisson during experimental sessions in Vancouver in 2015.

MAPS recorded the videos to make sure therapists were following the accepted protocol and patients were safe, but the organization says staff didn’t watch the videos until six years after they were filmed.

Yensen has admitted to having sex with Buisson after the experimental sessions ended, but while she was still enrolled in the clinical trial. She has alleged it was sexual assault, but Yensen argues the relationship was consensual.

MAPS issued a statement in 2019 acknowledging Yensen had an “inappropriate and unethical” sexual relationship with a study participant and said it was cutting ties with the couple. 

Adblock test (Why?)

728x90x4

Source link

Continue Reading

News

Looking for the next mystery bestseller? This crime bookstore can solve the case

Published

 on

WINNIPEG – Some 250 coloured tacks pepper a large-scale world map among bookshelves at Whodunit Mystery Bookstore.

Estonia, Finland, Japan and even Fenwick, Ont., have pins representing places outside Winnipeg where someone has ordered a page-turner from the independent bookstore that specializes in mystery and crime fiction novels.

For 30 years, the store has been offering fans of Agatha Christie’s Hercule Poirot or Arthur Conan Doyle’s Sherlock Holmes a place to get lost in whodunits both old and new.

Jack and Wendy Bumsted bought the shop in the Crescentwood neighbourhood in 2007 from another pair of mystery lovers.

The married couple had been longtime customers of the store. Wendy Bumsted grew up reading Perry Mason novels while her husband was a historian with vast knowledge of the crime fiction genre.

At the time, Jack Bumsted was retiring from teaching at the University of Manitoba when he was looking for his next venture.

“The bookstore came up and we bought it, I think, within a week,” Wendy Bumsted said in an interview.

“It never didn’t seem like a good idea.”

In the years since the Bumsteds took ownership, the family has witnessed the decline in mail-order books, the introduction of online retailers, a relocation to a new space next to the original, a pandemic and the death of beloved co-owner Jack Bumsted in 2020.

But with all the changes that come with owning a small business, customers continue to trust their next mystery fix will come from one of the shelves at Whodunit.

Many still request to be called about books from specific authors, or want to be notified if a new book follows their favourite format. Some arrive at the shop like clockwork each week hoping to get suggestions from Wendy Bumsted or her son on the next big hit.

“She has really excellent instincts on what we should be getting and what we should be promoting,” Micheal Bumsted said of his mother.

Wendy Bumsted suggested the store stock “Thursday Murder Club,” the debut novel from British television host Richard Osman, before it became a bestseller. They ordered more copies than other bookstores in Canada knowing it had the potential to be a hit, said Michael Bumsted.

The store houses more than 18,000 new and used novels. That’s not including the boxes of books that sit in Wendy Bumsted’s tiny office, or the packages that take up space on some of the only available seating there, waiting to be added to the inventory.

Just as the genre has evolved, so has the Bumsteds’ willingness to welcome other subjects on their shelves — despite some pushback from loyal customers and initially the Bumsted patriarch.

For years, Jack Bumsted refused to sell anything outside the crime fiction genre, including his own published books. Instead, he would send potential buyers to another store, but would offer to sign the books if they came back with them.

Wendy Bumsted said that eventually changed in his later years.

Now, about 15 per cent of the store’s stock is of other genres, such as romance or children’s books.

The COVID-19 pandemic forced them to look at expanding their selection, as some customers turned to buying books through the store’s website, which is set up to allow purchasers to get anything from the publishers the Bumsteds have contracts with.

In 2019, the store sold fewer than 100 books online. That number jumped to more than 3,000 in 2020, as retailers had to deal with pandemic lockdowns.

After years of running a successful mail-order business, the store was able to quickly adapt when it had to temporarily shut its doors, said Michael Bumsted.

“We were not a store…that had to figure out how to get books to people when they weren’t here.”

He added being a community bookstore with a niche has helped the family stay in business when other retailers have struggled. Part of that has included building lasting relationships.

“Some people have put it in their wills that their books will come to us,” said Wendy Bumsted.

Some of those collections have included tips on traveling through Asia in the early 2000s or the history of Australian cricket.

Micheal Bumsted said they’ve had to learn to be patient with selling some of these more obscure titles, but eventually the time comes for them to find a new home.

“One of the great things about physical books is that they can be there for you when you are ready for them.”

This report by The Canadian Press was first published on Sept. 15, 2024.



Source link

Continue Reading

News

Labour Minister praises Air Canada, pilots union for avoiding disruptive strike

Published

 on

MONTREAL – Canada’s labour minister is praising both Air Canada and the union representing about 5,200 of its pilots for averting a work stoppage that would have disrupted travel for hundreds of thousands of passengers.

Steven MacKinnon’s comments came in a statement shared to social media shortly after Canada’s largest air carrier announced it had reached a tentative labour deal with the Air Line Pilots Association.

MacKinnon thanked both sides and federal mediators, saying the airline and its pilots approached negotiations with “seriousness and a resolve to get a deal.”

The tentative agreement averts a strike or lockout that could have begun as early as Wednesday for Air Canada and Air Canada Rouge, with flight cancellations expected before then.

The airline now says flights will continue as normal while union members vote on the tentative four-year contract.

Air Canada had called on the federal government to intervene in the dispute, but Prime Minister Justin Trudeau said Friday that would only happen if it became clear no negotiated agreement was possible.

This report from The Canadian Press was first published Sept. 15, 2024.

Companies in this story: (TSX:AC)

The Canadian Press. All rights reserved.



Source link

Continue Reading

News

As plant-based milk becomes more popular, brands look for new ways to compete

Published

 on

When it comes to plant-based alternatives, Canadians have never had so many options — and nowhere is that choice more abundantly clear than in the milk section of the dairy aisle.

To meet growing demand, companies are investing in new products and technology to keep up with consumer tastes and differentiate themselves from all the other players on the shelf.

“The product mix has just expanded so fast,” said Liza Amlani, co-founder of the Retail Strategy Group.

She said younger generations in particular are driving growth in the plant-based market as they are consuming less dairy and meat.

Commercial sales of dairy milk have been weakening for years, according to research firm Mintel, likely in part because of the rise of plant-based alternatives — even though many Canadians still drink dairy.

The No. 1 reason people opt for plant-based milk is because they see it as healthier than dairy, said Joel Gregoire, Mintel’s associate director for food and drink.

“Plant-based milk, the one thing about it — it’s not new. It’s been around for quite some time. It’s pretty established,” said Gregoire.

Because of that, it serves as an “entry point” for many consumers interested in plant-based alternatives to animal products, he said.

Plant-based milk consumption is expected to continue growing in the coming years, according to Mintel research, with more options available than ever and more consumers opting for a diet that includes both dairy and non-dairy milk.

A 2023 report by Ernst & Young for Protein Industries Canada projected that the plant-based dairy market will reach US$51.3 billion in 2035, at a compound annual growth rate of 9.5 per cent.

Because of this growth opportunity, even well-established dairy or plant-based companies are stepping up their game.

It’s been more than three decades since Saint-Hyacinthe, Que.-based Natura first launched a line of soy beverages. Over the years, the company has rolled out new products to meet rising demand, and earlier this year launched a line of oat beverages that it says are the only ones with a stamp of approval from Celiac Canada.

Competition is tough, said owner and founder Nick Feldman — especially from large American brands, which have the money to ensure their products hit shelves across the country.

Natura has kept growing, though, with a focus on using organic ingredients and localized production from raw materials.

“We’re maybe not appealing to the mass market, but we’re appealing to the natural consumer, to the organic consumer,” Feldman said.

Amlani said brands are increasingly advertising the simplicity of their ingredient lists. She’s also noticing more companies offering different kinds of products, such as coffee creamers.

Companies are also looking to stand out through eye-catching packaging and marketing, added Amlani, and by competing on price.

Besides all the companies competing for shelf space, there are many different kinds of plant-based milk consumers can choose from, such as almond, soy, oat, rice, hazelnut, macadamia, pea, coconut and hemp.

However, one alternative in particular has enjoyed a recent, rapid ascendance in popularity.

“I would say oat is the big up-and-coming product,” said Feldman.

Mintel’s report found the share of Canadians who say they buy oat milk has quadrupled between 2019 and 2023 (though almond is still the most popular).

“There seems to be a very nice marriage of coffee and oat milk,” said Feldman. “The flavour combination is excellent, better than any other non-dairy alternative.”

The beverage’s surge in popularity in cafés is a big part of why it’s ascending so quickly, said Gregoire — its texture and ability to froth makes it a good alternative for lattes and cappuccinos.

It’s also a good example of companies making a strong “use case” for yet another new entrant in a competitive market, he said.

Amid the long-standing brands and new entrants, there’s another — perhaps unexpected — group of players that has been increasingly investing in plant-based milk alternatives: dairy companies.

For example, Danone has owned the Silk and So Delicious brands since an acquisition in 2014, and long-standing U.S. dairy company HP Hood LLC launched Planet Oat in 2018.

Lactalis Canada also recently converted its facility in Sudbury, Ont., to manufacture its new plant-based Enjoy! brand, with beverages made from oats, almonds and hazelnuts.

“As an organization, we obviously follow consumer trends, and have seen the amount of interest in plant-based products, particularly fluid beverages,” said Mark Taylor, president and CEO of Lactalis Canada, whose parent company Lactalis is the largest dairy products company in the world.

The facility was a milk processing plant for six decades, until Lactalis Canada began renovating it in 2022. It now manufactures not only the new brand, but also the company’s existing Sensational Soy brand, and is the company’s first dedicated plant-based facility.

“We’re predominantly a dairy company, and we’ll always predominantly be a dairy company, but we see these products as complementary,” said Taylor.

It makes sense that major dairy companies want to get in on plant-based milk, said Gregoire. The dairy business is large — a “cash cow,” if you will — but not really growing, while plant-based products are seeing a boom.

“If I’m looking for avenues of growth, I don’t want to be left behind,” he said.

Gregoire said there’s a potential for consumers to get confused with so many options, which is why it’s so important for brands to find a way to differentiate themselves, whether it’s with taste, health, or how well the drink froths for a latte.

Competition in a more crowded market is challenging, but Taylor believes it results in better products for consumers.

“It keeps you sharp, and it forces you to be really good at what you’re doing. It drives innovation,” he said.

This report by The Canadian Press was first published Sept. 15, 2024.



Source link

Continue Reading

Trending