Connect with us

Community News

“Imagine the implications of that, the compliance.” FDA has already approved pills with sensors, what’s next?

Published

on

Photo by Towfiqu barbhuiya on Unsplash

BY SIMONE J. SMITH

We cannot deny it, technology has pushed global societies forward in significant ways: some positive and some negative, depending on how you look at it. We may not be comfortable with the implications of new technology, particularly in a world where our data is constantly bought and sold, and not to mention monitored by governments. As much as some of us may be against some of the new technology that is being rolled out, Silicon Valley seems intent on trying, and what once seemed impossible may soon become routine.

In 2017, the U.S. Food and Drug Administration approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records when medication was taken. The product is approved for: the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.

The digital sensor in each pill is tiny — about the size of a grain of sand. It’s made from elements found in common foods — copper, magnesium and silicon. Contact between the elements and stomach fluids trigger an electrical signal.

This is not the first time that digital medicine has been utilized. In June 2014, Proteus rang in a new era of what it called “digital medicine” in which your body’s vital signs and the medications entering your bloodstream can be tracked by computers. Software searches your body’s data for patterns in real time and reports that information to your doctors.

It sounds crazy, but the tiny computers exist. It sounds dangerous, but the company that makes them, Proteus, has tens of millions of dollars and relationships with some of the biggest drug companies in the world, including Novartis.

Reports also show that the FDA first approved Abilify in 2002 to treat schizophrenia. Since then, studies and lawsuits have blamed it for causing compulsive behaviour and other side effects in people taking it. The FDA approved the tracking system in 2012, but Abilify MyCite is its first approved use with a drug.

How does the tracker work?

A wearable patch on the patient’s body picks up the signal and relays the time and date via Bluetooth to a smartphone app. The patient can choose to automatically share this information with a doctor, family members or other caregivers.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

What are the positives of digital medicine?

Some medication can have harmful effects for the patient if pills are skipped or taken as a double dose, so if a physician or family member can be alerted immediately this would potentially be very helpful. Another thing to think about is that currently, physicians rely on self-report from the patient regarding their medication and this isn’t always accurate. Being able to properly track medication use could help physicians and family members determine what strategies actually work for aiding the person with dementia to remember to take their pills (ie. reminder phone calls, written reminders etc.).

What hazards and security issues exist with digital medicine?

In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Also noted was skin irritation at the site of the MyCite patch placement may occur in some patients.

Abilify has been associated with serious side effects.

It even carries two black box warnings, which is the FDA’s most serious warning. One warns that Abilify is not approved for elderly patients with dementia-related psychosis. The other warns of an increased risk of suicidal thinking or behavior in children, teens and young adults.

Studies have also found associations between Abilify and neuroleptic malignant syndrome, a life-threatening reaction to antipsychotic drugs, and tardive dyskinesia, which causes involuntary muscle movements of the lower face, and compulsive behaviours. In addition, there were a combined 370 lawsuits over Abilify side effects presented to a Florida federal court in 2016. The people who filed the lawsuits claim the drug caused: compulsive gambling, spending or eating along with hyper sexuality and stealing or shoplifting.

What cannot be ignored are the ethical issues inherent in this type of tracking, especially issues around privacy. Information is sent to the “cloud” and although generally we are assured that this is secure, there is always a potential for this information to be hacked. There is also the fact that this information could be used in the future by third party companies who have a vested interest in understanding big data drug consumption or tracking individuals.

Who knows what is next for us? In a clip from the World Economic Forum held in January 2018, Albert Bourla stated, “Imagine the implications of that, the compliance.”

Yes, imagine the compliance indeed!

We, as humans are guaranteed certain things in life: stressors, taxes, bills and death are the first thoughts that pop to mind. It is not uncommon that many people find a hard time dealing with these daily life stressors, and at times will find themselves losing control over their lives. Simone Jennifer Smith’s great passion is using the gifts that have been given to her, to help educate her clients on how to live meaningful lives. The Hear to Help Team consists of powerfully motivated individuals, who like Simone, see that there is a need in this world; a need for real connection. As the founder and Director of Hear 2 Help, Simone leads a team that goes out into the community day to day, servicing families with their educational, legal and mental health needs.Her dedication shows in her Toronto Caribbean newspaper articles, and in her role as a host on the TCN TV Network.

Community News

Canada is Sinking – Is there a correlation between the rising economic costs, and the siphoning of funds to other sources in Canada?

Published

on

BY ADRIAN REECE

At some point Toronto was a city that people enjoyed living in. Recent political leadership at every level of government has caused citizens to consider moving out of the country as a whole. The high cost of living, coupled with the difficulty affording housing, and remote work becoming more regular has made the rest of the world seem much more appealing for Canadians as a whole.

Many countries are offering travel perks and visas to travelers in the west, to encourage them to visit, or to even move into their countries. Costa Rica, Japan, and France currently have travel perks and have opened their borders to make it easier to enter. Specifically for Canadians and even more specifically Torontonians who work remotely, are looking to countries and cities with lower costs of living. The Canadian dollar goes far in other parts of the world.

We owe the struggling economy to a few factors. Political leadership has greatly impacted the state of Canada, immigration policies that have changed over the years have caused stress on Canadian citizens.

In 2023, the federal government released its new Immigration Levels Plan to welcome 485,000 permanent residents in 2024 and 500,000 in 2025 and 2026. This announcement came on the heels of an Environics public opinion survey revealing a significant increase in the number of Canadians who believe the country accepts too many immigrants. That marks a dramatic reversal from a year ago, when support for immigration levels stood at an all-time high.

The Trudeau led government has held true to their commitment to bring in millions of immigrants in a short span of time. Housing policy is draining the income of Canadians, and political debates do not provide any real answers towards understanding what is going on in the country. Consistent political scandals regarding Trudeau overspending, and not adhering to budgets, and using money that was originally allocated for certain things. Trudeau was audited and it was found that $123 million was given to ineligible businesses, or projects that should have never been awarded at all. This is one in a long list of Trudeau scandals that have been a part of Canada political identity for the last nine years.

Trudeau’s government has even siphoned off funds to their personal businesses, after audits by the auditor general, we have seen too many inconsistencies with the funding of the Trudeau government in misusing funds as well as money disappearing into places that it should not be going.

In June of this year, the auditor general (AG) released two reports about: improper contracting practices, conflict of interest, and funding provided for ineligible projects. What these reports brought to light is an unpleasant reality; politicians and bureaucrats in Ottawa do not always act in the best interest of Canadians.

According to the first AG report, Sustainable Development Technology Canada (SDTC), the federal agency responsible for funding green technology projects, demonstrated “significant lapses… in governance and stewardship of public funds.” Nearly 20% of the SDTC projects examined by the AG were in fact ineligible (based on the government’s own rules) for funding, with a total price tag of $59 million. There were also 90 instances where the SDTC ignored conflict of interest provisions while awarding $76 million to various projects. Indeed, the AG found 63 cases where SDTC agency directors voted in favour of payments to companies in which they had declared interest.

The second AG report focused on 97 contracts totaling $209 million awarded by the federal government to the McKinsey & Company consulting firm from 2011 to 2023. According to the AG, the government demonstrated “frequent disregard for procurement policies and guidance and that contracting practices often did not demonstrate value for money.” About 70% of these contracts were awarded non-competitively, meaning no other companies were permitted to bid on the contracts. Interesting!

These findings also follow an earlier report in February that found the federal government “repeatedly failed to follow good management practices in the: contracting, development, and implementation” of the ArriveCAN mobile app, which cost Canadian taxpayers at least $59.5 million.

Is there a correlation between the rising economic costs, and the siphoning of funds to other sources in Canada? Potentially, it will take a lot more investigation to confirm if that is really the case. However, Canadians can see that there has been a drastic change in the economy since the Trudeau government has come into power.

For governments to work there needs to be transparency, and there has been a lack there of in regard to our political leadership in the last few years. There are too many scandals and too many mishaps with money. Too many policies that do not benefit the citizenry, and not enough effort made to rectify the sinking economy.

Canada cannot continue to stay in these dire straits, we are sinking, and leadership plays a big role in the state of the country. We won’t see changes unless we demand it, we can take a page out of France’s method of protest; other countries have set a precedent of what their expectations are, and Canadians need to do the same. They need to demand change and implement strategies to achieve it. Within acceptable methods of protest there exists a strategy and method of changing the nature of Canada’s problems, but it starts with the citizenry. Coming together is the greatest power we have, and we need to utilize it.

REFERENCES:

https://www.environicsinstitute.org/projects/project-details/public-opinion-about-immigration-refugees

https://www.canada.ca/en/immigration-refugees-citizenship/news/notices/supplementary-immigration-levels-2023-2025.html

https://www.oag-bvg.gc.ca/internet/English/parl_oag_202402_01_e_44428.html

https://www.oag-bvg.gc.ca/internet/English/parl_oag_202406_06_e_44493.html

https://www.oag-bvg.gc.ca/internet/English/parl_oag_202406_e_44491.html

https://www.fraserinstitute.org/article/scathing-auditor-general-reports-underscore-political-realities

Continue Reading

Community News

The Jamaica Food and Drink Festival – where every bite tells a story, and every sip celebrates Jamaica’s vibrant soul

Published

on

BY SIMONE J. SMITH

What if I told you that Visa is offering two amazing opportunities that YOU, our loyal readers have an opportunity to take part in? For one of our lucky readers, you have a chance to:

  • Win a trip to Trinidad Carnival 2025
  • Win a trip to Jamaica

“What is this all about Simone,” you might be asking? Well, the Jamaica Food and Drink Festival (JFDF) turns 10 this year, and Visa International is thrilled to be part of the celebration once again. Welcome to the heart of Jamaica’s culinary playground – the Jamaica Food and Drink Festival, where flavours, culture, and music blend into one unforgettable celebration.

Step into the lively Craft Market downtown, where the spirit of Jamaica comes alive. Here, they celebrate the island’s rich history and vibrant flavours – an ode to the past. Guests get a chance to immerse themselves in the legacy of festival favourites like: Crisp, Chopstix, Pork Palooza, and Picante – all in one electrifying space.

Taste, sip, and groove your way through the night, reliving fond festival memories while savouring the global influences that have shaped the iconic dishes we love today – no passport required (except to travel of course)!

As the hot days turn into steamy nights, and steamy nights turn into sweltering days, what better way to close out the festivities than with one last delectable event? The finale is not just a celebration, but a reflection of Jamaica’s culinary renaissance. After four unforgettable days, guests get a chance to honour the island’s: finest chefs, mixologists, and artisans who have made this festival a true showcase of creativity and passion.

Naturally, the festival had to find accommodations that match its prestige, and the only hotels of choice this year are: The Jamaica Pegasus Hotel and The Courtleigh Hotel & Suites. At the Jamaica Pegasus Hotel, the Caribbean’s most distinguished address, you will experience the perfect blend of elegance and island charm. Nestled in the heart of New Kingston, surrounded by lush gardens and views of the Caribbean Sea, this 17-storey gem is where business meets leisure in true Jamaican style. You also have the option of immersing yourself in the timeless charm of The Courtleigh Hotel & Suites, a true jewel of Jamaica’s capital city. With spacious accommodations, award-winning dining, and all the modern comforts, it is the perfect way to end your festival experience.

Waldemar Cordero, Marketing Senior Director for Visa in the Caribbean and Central America, expressed his excitement about being involved in the festival’s decade-long run. “We’re really excited to be part of the 10th staging of the Jamaica Food and Drink Festival. It’s amazing to see how far this festival has come, and we’re proud to have been part of the journey over the last 6 years. This festival isn’t just about food, it’s about celebrating Jamaica’s rich culture and the incredible talent that drives it.”

Visa’s partnership with JFDF has grown over the years, evolving from a traditional sponsorship into a dynamic collaboration that enhances the festival experience for everyone. “Our relationship with the Jamaica Food and Drink Festival has deepened over time,” said Waldemar. “We’ve moved from simply being a sponsor to becoming the main partner, working closely with the organizers to bring fresh, exciting elements to the event each year. This time around, we’re especially excited about the initiatives we’re rolling out that will make it easier and more enjoyable for attendees to experience all that the festival has to offer.”

Visa is excited to enhance the celebration of the Jamaica Food and Drink Festival’s milestone 10th year by offering an exclusive hospitality package to Trinidad Carnival 2025. One lucky Visa cardholder who purchases festival tickets between October 16th and November 9th, 2024, will win this incredible experience. This offering includes: two economy class tickets from Kingston, Jamaica to Port of Spain, Trinidad; six nights of luxury accommodation at the Hyatt Regency; and comprehensive airport transfers and event transportation. The winner and their guest will enjoy: inclusive meals, stylish Monday Wear and Carnival Tuesday costumes, and access to premier events such as Brian Lara’s Event and PinkNicTT. Additionally, they will be treated to glamour make-up and photos. This package promises to deliver an unforgettable festival experience and celebrate the unified Caribbean culture in style.

In addition, one lucky winner from our Caribbean neighbour Trinidad and Tobago, who uses the First Citizens Bank card in Trinidad, will win a trip for two to the Food and Drink Festival in Jamaica. This is an all-expense paid trip for two with the winners to ensure the festival and enjoy scenic places in Jamaica such as Dunn’s River Falls and Port Royal. Ready for that almost winter getaway? Visit https://jafoodanddrink.com/ for more details. Good luck!

Continue Reading

Community News

Welcome to the Black Scholars Institute—where excellence thrives, and liberation is pursued

Published

on

BY SIMONE J. SMITH

At the heart of the University of Windsor’s campus, centrally located in the lower level of the CAW Student Centre, lies a space dedicated to fostering: African-Caribbean excellence, academic growth, and community empowerment: The Black Scholars Institute, or BSI.

The BSI Lounge is more than just a meeting place. It is a safe and welcoming space for African/-Caribbean faculty, staff, and students—a venue that fosters not only academic engagement, but community connection. Here, important university and local events, aligned with the Institute’s mission and values, take place.

The Black Scholars Institute is a multidisciplinary research institute—a home for African-Caribbean scholars at UWindsor. It is dedicated to advancing Black excellence and liberation through scholarship, research, and community engagement. The Institute’s work enriches teaching, learning, and social justice efforts across the University, with a focus on making an impact nationally and globally.

BSI hosts a range of weekly programs that encourage meaningful dialogue and academic collaboration. Events such as “Think Tank Thursday” provide a platform for African-Caribbean faculty and students to come together, exchange ideas, and discuss relevant research and current events. For those who are deep in their academic work, “Just Write” sessions offer dedicated time for focused writing in a supportive environment. “Coffee and Convo,” a collaboration with Leddy Library, creates space to explore Black literature and hold thought-provoking discussions around important topics.

Graduate students are invited to participate in student saloons, where they present their works-in-progress in a safe, inclusive space, where they can receive valuable feedback from peers and faculty members alike. Additionally, the “Black Research Spotlight” shines a light on the groundbreaking work of African Caribbean scholars, providing them with a platform to showcase their research and innovations.

In recognition of the challenges posed by systemic anti-Black racism, the BSI offers its members a membership with the National Center for Faculty Development and Diversity, providing on-demand access to a wealth of professional development resources. This is just one of the ways BSI ensures its scholars are well-equipped to thrive and succeed in their academic careers. As a research institute, BSI is committed to supporting Black Studies and promoting excellence in scholarships. One vital aspect of this is the awarding of grants to Black scholars. These grants are instrumental in advancing research that is often overlooked in traditional funding competitions.

While visiting the University earlier this month, I learned more about some of the challenges that have been faced in opening BSI. The establishment of this initiative was approved by the University of Windsor’s Senate on October 7th, 2022. The initiative is in alignment with the University’s commitment to the Scarborough Charter (utoronto.ca) on anti-Black racism and Black inclusion in Canadian higher education. In 2023, the University of Windsor (UWindsor) announced their new academic home that would spotlight: Black excellence, scholarship, research, and community. The inaugural Black Scholars Institute (BSI) at UWindsor, was formally launched in September 2024.

Dr. Clinton Beckford, UWindsor’s Vice President of Equity, Diversity, and Inclusion, envisions that the BSI will be the institutional home for Blackness at the University. “The establishment of a Black Scholars Institute at the University of Windsor is ground-breaking and transformative,” he says.  “It positions the University of Windsor as a post-secondary leader in intellectual thought and practice around Blackness and makes real our commitments to Black flourishing and thriving at and beyond the institution.”

The BSI will work closely with UWindsor’s Interdisciplinary and Critical Studies Department within the Faculty of Arts, Humanities and Social Sciences. Building a Black Scholars academic program represents an innovative plan of action intended to meaningfully understand UWindsor’s approach to African-Caribbean ways of knowing in Canadian universities. The expected output will enhance UWindsor’s research profile in Black Studies and feature scholarly work, special events, speakers’ series, mentorship, and more.

Dr. Camisha Sibblis, the Director at BSI, is hopeful that the institute will enrich the experiences of Black faculty at UWindsor. “We believe that the inclusion of Black peoples, ways of learning and knowledge systems are integral to the growth of our community. The establishment of the BSI is a crucial part of fulfilling the University’s Strategic Mandate Agreement (ontario.ca) and purposefully moving the institution into the future. The Institute will enhance the University’s research profile and will also establish the University as a center of excellence in Windsor-Essex and the Detroit area – a region known for its historic importance for Black people in North America.”

Welcome to the Black Scholars Institute—where excellence thrives, and liberation is pursued through scholarship, research, and community engagement.

Continue Reading

Trending