And all the media attention gives us a teaching moment to help illuminate the behind-the-scenes dynamics that affect international pharmaceutical markets, insurance companies, public healthcare systems and government finances. This article summarizes the various issues that have been in the spotlight and additional posts linked in the supplemental section at the end of this article will go further behind the curtain, using Ozempic as an example, to explain the interconnected and complex economic factors and government machinery that play roles in determining the supply, demand and accessibility of pharmaceutical treatments and products, as well as broader economic responses.
First, some background.
GLP-1 receptor agonists (like Ozempic) have been used for more than 16 years to treat type 2 diabetes and for weight loss for the past nine years. Ozempic is Novo Nordisk’s brand name for a semaglutide marketed and sold for treating type 2 diabetes. Other medications in the same class include Trulicity (dulaglutide, GLP-1) and Mounjaro (tirzepatide, a dual GLP-1/GIP).
While Ozempic is heavily associated with weight loss in the media, it is NOT approved by the FDA or Health Canada as a weight-loss drug.
From the globex press release: “GlobexPharma® is thrilled to announce the launch of Ozempic Chewable Gummies for Kids®, a groundbreaking prescription treatment designed to combat obesity in children aged 1 to 5 years.”
Health Canada approved it in 2018 for adult patients with type 2 diabetes, noting that there was limited information on safety and efficacy for minors or people over age 75. The FDA has authorized it for similar purposes and also includes reducing the risk of heart attacks and strokes in type 2 diabetes patients with known heart disease.
Wegovy, a similar injectable medication containing higher amounts of semaglutide and made by the same company, is approved for weight loss in obese patients by the FDA and recently entered the Canadian market (it was approved in 2021, but only became available to consumers in May 2024). Saxenda (liraglutide, GLP1), is approved for weight management in obese pediatric patients over 12 years of age in Canada.
The class of medications is not new, their effectiveness for weight loss in non-obese patients, as well as their potential to improve fertility, reduce cardiac risks, and reduce the risk of kidney failure have all increased the attention and discussion of this class of medications.
Their growing weight-loss popularity has disrupted the market, and provides an opportunity to investigate many interrelated market dynamics including:
The incentives and potential for pharmaceutical companies to expand markets for existing products by finding new applications for them.
Similarly, off-label prescribing by physicians can provide patients access to treatments, even if a full-scale clinical trial has not been conducted.
Market expansion through new indications and off-label prescribing can create surges in demand that increase financial risks for public and private drug insurance plans.
Similarly, rapidly increasing demand increases the risk of drug shortages, at least until manufacturing capacity can expand to meet the new market demand.
Both shortages and financial risk for insurance companies can lead to restricting coverage and rationing supplies to prioritize particular patient groups.
The healthcare market and broader economy respond to these dynamics in sometimes unexpected or potentially counterproductive ways. For example, counterfeit or black market versions of the regulated medications, a proliferation of virtual services advertising directly to consumers that they can provide access, and patients failing to complete treatment due to costs or shortages. There is evidence of wider economic responses as well.
For example, Nestlé is launching a new line of frozen pizzas and pastas enriched with protein, iron, and calcium designed for people taking appetite suppressing drugs.
That’s our landscape. For The Silo, Rosalie Wyonch.
COVID Vaccination Is ‘Safe’ but Remains Clinically Untested for Pregnant Women: Health Canada
A sign is displayed in front of Health Canada headquarters in Ottawa on Jan. 3, 2014. (The Canadian Press/Sean Kilpatrick)
Nearly four years after the launch of the massive COVID-19 vaccination campaign, which included mandates and passports, the safety of the products for pregnant women remains mostly untested clinically.
Health Canada answered a series of questions from Tory MP Colin Carrie in April about the issue.
“What specific research data supported the claims that … this product may be safely administered at any stage of pregnancy?” asked Mr. Carrie in an Inquiry of Ministry.
“Please note that the vaccine manufacturers did not seek an indication for use in pregnant and lactating women and the Product Monographs included statements about the uncertainty regarding safety and efficacy in pregnancy and lactation,” answered Health Canada, which is responsible for authorizing vaccines in Canada.
The product monographs for the widely administered COVID-19 shots from Pfizer-BioNTech and Moderna, which describe the properties, claims, indications, and conditions of use for the drug, state the unavailability of data regarding use during pregnancy.
“No data are available yet regarding the use of COMIRNATY Omicron XBB.1.5 during pregnancy,” said Pfizer-BioNTech’s monographs, both for its updated Omicron injection and its original one.
“The safety and efficacy of SPIKEVAX XBB.1.5 in pregnant women have not yet been established,” similarly say Moderna’s monographs for its updated Omicron shots and its legacy product.
Pfizer-BioNTech’s initial clinical trial for pregnant women, announced publicly in February 2021, encountered recruitment problems.
A Pfizer Canada representative told a member of the National Advisory Committee for Immunization (NACI) in April 2022 that the trial had been stopped due to slow enrolment, according to internal emails seen by The Epoch Times.
Jelena Vojicic, vaccines medical lead at Pfizer Canada, also said “it became unreasonable/inappropriate to randomize pregnant women to placebo given the amount of observational evidence that the vaccine is safe and effective, coupled with increasing number of technical committees supporting immunization of pregnant women.”
Despite hurdles, Pfizer-BionTech submitted results for a small clinical trial with 348 participants in July 2023, according to the U.S. government website ClinicalTrials.gov.
Moderna’s observational pregnancy outcome study was terminated in the fall of 2023 due to low enrolment, with ClinicalTrials.gov noting 20 enrolled participants.
Neither Pfizer nor Moderna responded to a request for comment.
While confirming there is little to no clinical trial data, Health Canada said vaccination for pregnant women was recommended based on evidence of safety and effectiveness growing from “real-world use.”
“Analysis of the data show that mRNA COVID-19 vaccines are safe for people who are pregnant or breastfeeding.”
Dr. Bernard Massie, a virologist and former National Research Council acting director general of the Human Health Therapeutic Research Center, raised doubts about the reliability of data obtained outside clinical trials, calling them “very incomplete and often biased.”
“We won’t find what we’re not looking for,” noting that real-world passive surveillance of side effects can be underrepresented by a factor of 10 and up to a 100 for lax systems.
‘Off-Label’
While Health Canada authorizes vaccines, the regulator said that NACI is responsible for formulating recommendations for public use.
“This means that NACI may provide recommendations that are broader or narrower than the conditions of use approved by Health Canada, often referred to as ‘off-label’ recommendations,” said spokesperson Anna Maddison, adding such a practice by NACI is ”not uncommon.” Ms. Maddison also noted the COVID-19 vaccines are not contraindicated in pregnant or lactating women.
At the beginning of the vaccine rollout, NACI said in December 2020 that pregnant or breastfeeding mothers “should not” in most circumstances be offered the vaccine “until further evidence is available.”
The recommendation was changed in January 2021 to “may be offered” following a risk assessment.
By May 2021, NACI had updated its recommendation for pregnant women that they “should be offered” COVID-19 mRNA shots.
To back its recommendation, NACI cited a U.S. government study of 35,000 pregnant women using data from December 2020 to February 2021.
“Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines,” said the study. It noted, however, that “more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.”
Dr. Massie questioned whether the study by government scientists was interested in finding issues with vaccination and pregnancy given that the government was promoting mass vaccination.
After the results of the study were published on April 21, 2021 in the New England Journal of Medicine, other government advisory bodies recommended COVID-19 vaccination in pregnant women.
Quebec’s government announced vaccination would be offered to pregnant women on April 27 of that year, citing a recommendation from its immunization committee which “analyzed the evolution of scientific data and recommendations in different countries.”
B.C.’s government recommendation came on May 4, 2021. “All Health Canada-approved vaccines are safe and effective, and I encourage everyone to register and receive their vaccine as soon as they are eligible. Today, this includes people who are pregnant,” said Dr. Bonnie Henry, B.C.’s provincial health officer.
‘Not’ Advertising
Dr. Philip Oldfield, who has more than three decades of experience specializing in the bioanalysis of protein/nucleic acid therapeutics and regulatory affairs, raised questions about the product monographs for vaccines saying effects on pregnancy were not tested while government bodies encourage pregnant women to be vaccinated.
He also points to passive surveillance data on vaccine adverse events collected in the United States showing over 2,000 miscarriages following COVID-19 vaccination. While this data doesn’t prove causality, it is considered largely underreported.
Dr. Oldfield said Health Canada encouraging pregnant women to get vaccinated for COVID-19 could contradict “both the law with respect to false and misleading advertisements of a drug, and contradicts the safety data found on both the Moderna and Pfizer monographs.”
The Epoch Times asked Health Canada if it is allowed by law to make recommendations about the use of products for certain populations for which the products’ monographs do not indicate safety information. The Foods and Drugs Act states that “No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.”
Health Canada spokesperson Anna Madison responded that “public health messages from a government authority that promote vaccination would not qualify as advertising of a health product.”
Despite different bodies’ recommendations for pregnant woman, NACI noted in a summer 2022 report that “uptake of COVID-19 vaccine has been lower among pregnant people compared to non-pregnant people in Canada.”
“Preliminary unpublished evidence in Ontario indicates that primary series vaccine coverage among pregnant people (71 percent) was 16 percentage points lower than in the general female population of reproductive age in Ontario by the end of 2021.”
Animal Studies
Outside of emerging real-word evidence, regulators and advisory bodies have also cited studies conducted on animals to determine the safety for pregnant women and their babies.
“Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/fetal development, parturition, or post-natal development, and human randomized clinical trials were not submitted for regulatory evaluation,” said Health Canada in responding to MP Carrie.
The NACI also cited a study conducted on rats with Pfizer’s mRNA vaccine to back its recommendation, saying no issues were encountered.
A Moderna nonclinical overview submitted to the U.S. government and obtained by legal advocacy group Judicial Watch through a lawsuit indicates the presence of “statistically significant increases” in rat offsprings with “wavy ribs and 1 or more rib nodules.”
“There were no other indicators of mRNA-1273-related developmental toxicity observed, including delayed ossification; therefore, these common skeletal variations were not considered adverse,” concluded the manufacturer.
Both Dr. Oldfield and Dr. Massie said the animal studies conducted are not proper to assess risk in humans. “Using an inappropriate species in the Developmental and Reproductive Toxicity (DART) studies would never pick up the toxic effects due to the spike protein,” said Dr. Oldfield. “The animal studies were performed using an inappropriate species (rat) which unlike humans, their ACE receptors does not bind to the vaccine generated spike protein.”
Breastfeeding
MP Carrie also raised the issue of breastfeeding in his request for information to the government, asking what specific research data there is to say that “modRNA vaccine, and consequently the spike protein, do not excrete into breast milk.”
Health Canada responded that the product monographs for authorized COVID-19 vaccines “include a statement that it is unknown whether the COVID-19 vaccine is excreted in human milk.”
“A risk to newborns/infants cannot be excluded,” it adds.
Studies have found mRNA from COVID shots does end up in breast milk, with a recent one published in the medical journal Lancet in September.
In response to previous questions, Health Canada told Mr. Carrie last year that “mRNA-encoded spike protein is only expressed transiently and at the injection site and the liver, then declines over time.”
Authors of the study published in the Lancet noted their “findings demonstrate that the COVID-19 vaccine mRNA is not confined to the injection site but spreads systemically and is packaged into [breast extracellular vesicles].”
The scientists said that since only “trace quantities” are present and a “clear translational activity is absent, we believe breastfeeding post-vaccination is safe, especially 48 h after vaccination.” They specified that since the minimum mRNA dose to elicit an immune reaction in young infants is unknown, breastfeeding mothers should consult with a health-care provider to discuss risks and benefits in the first two days after vaccination. For the Silo, Noé Chartier/Epoch Times.
Still from a classic 1963 t.v. commercial for Sanka decaffeinated Coffee. “But you can’t taste the Caffeine in any cup of coffee”. “Another fine product of General Foods – Have a whole day of it”.
I was travelling a local highway a few years ago when my friend pointed out the license plate on the rear of the car ahead of us. It read, somewhat cryptically to me at first, XLDBLDBL.
Then I looked again and realized this automobile owner had created a move-able billboard, and perhaps loving tribute, to the most popular and recognizable coffee brand in the country, Tim Hortons [ Tim Hortons is in fact so popular, that there is even a font based on its paper cup lettering– / CP ]
The “Canadian” coffee giant now owned by American corporation Burger King and a presence in the U.S.A. since 2012, made the move of super-sizing its retail coffee format a few years ago. The small was now called an extra-small, and was the same price as the old small. The old medium was now a small, the large was a medium and so on. You paid the same price for the same amount of Joe, you just call it by a different name. And for 20 cents extra, that XL double-double now got you 24 oz of coffee. That’s 3 full cups.
“What is how many pints is three cups of coffee equal to?”
Now, I love coffee as much as the next person. Maybe more. I enjoy sampling the near infinite combinations of blends and roasts from the various growing regions of the world, much like wine. But, as with alcohol, I have found that moderation in my coffee intake is key to my mental, emotional—even physical—health.
Steve Martin as Rigby Reardon in Dead Men Don’t Wear Plaid: “You need a cup of my famous Java”
Is anyone reading this old enough to remember when a cup of coffee used to literally be a cup of coffee: around 8 ounces (the amount in the Tim Horton’s extra-small)? But as our conception of “large” becomes ever larger, it’s like food, like so many things, excess becomes easier.
This trend is actually an American-style sizing format that’s been in place south of the border for years. Remember when Starbucks came north? Remember when you thought the Venti was an outrageous amount of coffee? That’s 20 oz., just so we’re clear. What will come to us next? The $3.99 All-You-Can-Eat Breakfast Buffet? Just how many sausages can you eat in an hour? How many do you want to eat? And for the record, Starbucks has the 31oz. size for its iced drinks called the Trenta.
That’s a lot of beverage. Trenta, in Italian, means 30.
Excess coffee consumption, according to Health Canada, can have results from irritability and sleep disturbances to muscle tremors, nausea and mood swings, says a CBC News article from February 2010 (www.cbc.ca/news/health). In more extreme cases: irregular heartbeat, vomiting, diarrhea—even convulsions.
Coffee’s high antioxidant content may also be responsible for a host of health benefits: decreased susceptibility to some cancers and type-2 diabetes, and increased cardiovascular health and memory function in older adults. But Health Canada also suggests that 400mg of caffeine should be the maximum daily adult dose—the amount contained in about 3 cups, or 24oz, of coffee.
Frankly, I think there is enough rage, anxiety and insomnia in our culture without people regularly downing two or three 24oz javas every day. It’s not that everyone is going to do that. It wouldn’t even be bad for everyone. Just for most of us. So I believe a note of caution is in order: as with anything, think before you drink. – For the Silo,Alan Gibson.
Canada just moved from having enough doses to vaccinate every Canadian, into a surplus position.
This also means that Canada reached a new very problematic milestone. Doses are going bad in Canada, while desperate people, including frontline health workers in Africa, are still struggling to get access to vaccines.
None of us are safe until all of us are safe. We know this pandemic isn’t truly over until it is over everywhere. Canada MUST share more of our excess doses now. Canada MUST resist the urge to offer 3rd dose “boosters” to healthy Canadians (some of whom are getting them in order to vacation in the Caribbean) while nurses in Senegal are still unprotected.
We have more than enough vaccines, others don’t.
Africa is facing a COVID-19 crisis, cases are surging and the continent is heading towards a global catastrophe. Over the last month deaths from COVID in Africa have increased 80%. Only roughly 3% of Africans have received the first shot, and the continent is not on track to vaccinate 10% of its population by the end of the year. The WHO’s Bruce Aylward said this should be “a scar on all of our consciences.”
Canada is the country that has ordered the most vaccines per person: counting optional purchases, enough to vaccinate each Canadian 5 times. Unless the excess doses are shared right now, we could end-up throwing away millions of doses while most of the rest of the world remains unvaccinated. This is a scandal that we cannot let happen.
Vaccines being discarded is not a theoretical concern. In addition to the 300,000 doses from Johnson and Johnson that were discarded due to a manufacturing issue, thousands of Astra Zeneca doses have already been wasted in Canada because they could not be used before their expiry dates. With this vaccine barely been used in anymore, there may be thousands more sitting in freezers or the garbage, and provinces are coy about how many they may be throwing away. The same is starting to happen with Moderna, with pharmacists unable to put some of the doses they have in arms.
Figure 1: A tale of two pandemics While Canada is in a very good position, some African countries are seeing an increase in cases with a very small share of their population vaccinated.
Canada has so far committed to share 30.7 million doses with COVAX, the global vaccine distribution mechanism, including a recent pledge to donate the remainder of our Astra Zeneca orders. But there has been no confirmation of when these donated vaccines might reach countries in need.
In addition, new analysis by the ONE Campaign based on data from analytics firm AirFinity shows that at the current rate, Canada will end-up with between 16 and 42 million more vaccines piling up in freezers or thrown away by Christmas, while the pandemic continues raging on in Africa and the developing world.
We not only have a moral obligation to share doses, it is in our own best interest to stop the global spread and emergence of new variants. Until then, more preventable deaths will occur and Canada’s own recovery will be threatened by a shaky global economy. According to the IMF, failing to help the developing world defeat Covid-19 could cost the global economy US$4.5 trillion.
The time to donate more doses is now. Lives depend on it.
Africa is experiencing an increasingly urgent COVID crisis and needs at least 200 million vaccine doses by the end of September to slow the spread and prevent more needless deaths. Canada should immediately transfer all incoming vaccine orders to COVAX, beyond ensuring that there are enough for every Canadians to be fully vaccinated. This should mean at least 12 million more doses shared before the end of September, and in total 16-42 million vaccines donated before the end of the year if we want to end the pandemic and avoid unimaginable waste.
It may be tempting for the Government to keep vaccines stockpiled just in case boosters may be needed. But the evidence so far on the need for boosters is far from conclusive, and many experts have warned that it would be counterproductive to start giving third doses to healthy people in rich countries while at-risk populations have not yet had their first shot in developing countries. Stockpiling a product with a short shelf life will inevitably lead to a lot of waste. In any case, Canada has already ordered up to 60 million more doses of Pfizer a year for the next 3 years in case boosters are needed.
The excess doses we have coming in the next 5 months must urgently be shared with countries in need to stem the pandemic globally. Variants spreading around the world pose a threat to Canadians. The longer we wait to vaccinate the world, the more variants we will see and the longer this vicious cycle will continue. The time to donating more doses is now. Lives depend on it.
Up to 42 million doses could go unused in Canada by Christmas
By December 2021, Canada will have received at least 92 million doses of the four vaccines currently approved by Health Canada (Moderna, Pfizer, Astra Zeneca and Johnson & Johnson). If Medicago and Novavax post positive Phase 3 results and are also approved, total supply could increase to 117 million doses. [1]
To fully vaccinate every Canadian, including children under 12 should vaccines be approved for them, 76 million doses will be required in total. These are highly optimistic projections of actual demand, since it is unlikely that 100% of the population will want to be vaccinated.
This means that between 16 and 42 million excess vaccines risk being stockpiled or wasted in Canada by the end of the year. The higher scenario means our excess vaccines would be enough to fully vaccinate everyone in a country like Burkina Faso this year. Right now, 0.01% of people are fully vaccinated in Burkina Faso. For the Silo, Justin McAuley.
Figure 2: A growing stockpile Even accounting for the already-announced donations, Canada will have millions of excess vaccines
[1] This excludes the 30 million doses already donated to Covax.
What does the ingredients list above represent? It’s taken from the label of a popular name brand soap advertised with fresh faces, and as leaving no residue on the skin. Would it surprise you? Perhaps you recognized it, but thought well it’s being sold in stores so it must be safe.
The good news is that since 2006, Canadians have been provided with mandatory labeling on personal care products. Health Canada has even gone a step further providing a “hotlist” or list of prohibited or restricted chemicals . This is a huge step above our neighbours to the south, whom currently have minimal regulation on personal care products. Canada is on the right track, but is still a few steps behind the European Union, where personal care products are held to stringent guidelines.
The bad news is that even though there are guidelines set of by Health Canada, some of the products on the market today still contain chemicals, with similar structures to those chemicals that have been restricted. And if something shares a similar structure it is likely to interact with the human body in a similar fashion, thus causing similar health concerns.
What at can you do? The good folks at the David Suzuki Foundation performed a Survey of Canadians and their use of personal care products, and from this developed a “dirty dozen” of chemicals to avoid. Results of their survey demonstrated that 80% of products contained at least one ingredient on the list, and only 20% did not contain any. By visiting the www.davidsuzuki.org and searching “What’s Inside? That Counts,” you can download your own copy of the list, or even visit the mobile site when you are out shopping.
Why does this all matter? Many of the chemicals that are found in personal care products can bio-accumulate, meaning they can increase in concentration over time, and be passed on to our next generations. There is also well documented evidence of effects within the human body caused chemicals affecting the endocrine system. Within the human body endocrine disruptors have been implicated in neurological diseases, reproductive disorders, thyroid dysfunction, immune and metabolic disorders. Cancer is also another health concern that has been linked to many of the chemicals found in personal care products.
What about my health? As a naturopathic doctor I am always thinking from a preventative medicine point of view. The more I learn, I continue to look for natural/chemical free personal care products. Also important is optimizing your body’s innate ability to remove build up of chemicals through organs such as liver, skin, and kidneys. As always, prevention is the best medicine, and becoming a savvy consumer involves reading labels and asking questions. For the Silo, Ashley Beeton Bsc. ND.
Let’s cut right to the chase: Do you know what’s in your lunch? We were curious, so we decided to investigate further.
We tested popular foods such as Cheerios, a Tim Hortons bagel, Ritz crackers and Fontaine Santé hummus and the results were overwhelming: 80 per cent of the foods tested contained the harmful chemical glyphosate. Glyphosate, Canada’s top-selling weed killer and key ingredient in Monsanto’s product Roundup, is of particular concern because of its links to cancer.
The unchecked use of glyphosate and widespread contamination of the foods that you and your children eat every day is not acceptable.
Just last month, a California court ruled that Monsanto’s glyphosate–based pesticide, contributed to an American citizen’s cancer. The court case revealed documents showing Monsanto manipulated scientific research and downplayed the risk of its products for decades. This case is just one of several thousand lawsuits against Monsanto (now owned by Bayer).
In Canada, the Pest Management Regulatory Agency (a department of Health Canada) recently reauthorized glyphosate for another 15 years. We are calling on the federal government to bring our outdated toxics and pesticide laws into the 21st century and remove harmful chemicals like glyphosate from our food. With your help, we can make this happen. For more information check out this report at whatsinyourlunch.caFor the Silo, Muhannad Malas.
Article from March , 2013 – In 1981, the World Health Organization introduced Code of Marketing for Breast-milk Substitutes. To date, 84 countries have enacted legislation making the labeling Code law in their countries. While Canada agreed and signed onto The Code and the amendments, to date it has not created any law, which would uphold this International document.
The WHO Code says, among many other items, that breast milk substitutes (including formula and infant foods) should not be directly advertised to consumers because they are sub-optimal foods to feed to babies and infants. Advertising includes newspapers, ads on Google or other websites, texting, and free samples through the mail.
Formula companies in Canada say they abide by the WHO Code by including a preamble in every commercial: “while breast milk is best…” Ask your average consumer today what they think about breast milk and formula and specifically if there is any difference. I have posed this question while working at numerous health fairs in the past 5 years. It is staggering the number of people who view breast milk and formula as having the same nutritional value. In case you do not know already, this has scientifically been proven false.
Over the past 5 years, I have written MPs and MPPs about why Canada does not uphold the WHO Code. What I heard from Health Canada directly is:
The Food Directorate of Health Canada is responsible for the development of policies, regulations and standards for all foods. The Food Directorate is also responsible for the premarket notification process for infant formulas…Manufacturers are responsible for the accuracy of information on the labels and advertisements for food and for compliance…”
This is akin to letting prisoners run the jail.
While writing my monthly (and at times weekly) concerns to government officials, I found an MP who said that, “If we were signatories to it, we should live up to it.” This was Justin Trudeau.
I am saying be politically involved. I have a stack of letters and many emails from all parties in their response to the WHO Code. It has been 30 years since Canada signed The Code. Why is it taking so long to actually do something to enforce it? Enforcing the Code would not result in taking formula off the market at all. The Code’s aim is to make healthier babies and our babies are entitled to the highest degree of health. For the Silo, Stephanie MacDonald.
