Tag Archives: FDA

Sci-Tech

Truths And Concerns- The Miracle Drug Ozempic

Leave a comment

Ozempic: A Microcosm That Can Teach Us a Lot about Canadian Healthcare Markets Ozempic (and other GLP-1 medications) have been having their moment.

Headlines hail a “miracle drug” for weight loss , others say that’s too good to be true, and there’s even a South Park episode titled “the end of obesity.” It’s all new territory for medications for type-2 diabetes and weight loss treatment.


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.

Supplemental

Dig into the various strategies insurance providers and governments are using to manage financial risks and mitigate drug shortages.

Examine the counter-balancing industry and consumer responses that seek to maintain broad access or capitalize on the new and growing market.

Sci-Tech

Cancer Vaccine Book Details How To Make Treatment

3 Comments

The Reinvention of Coley’s Toxins by Donald H. MacAdam is a fascinating read. If you are expecting a dry and brooding book you are in for a treat because MacAdam has a dynamic flair for presenting facts and characters in an enjoyable story telling fashion.

The history leading up to the formation of MBVax is remarkable and includes robotics, human genome sequencing and electronics distribution. The twists and turns that ultimately lead to the reinvention and production of  modern day Coley’s Toxins makes for a satisfying journey- one which not only parallels the experimental nature of scientific discovery but also its necessity for serendipity.

Coley’s Toxins were invented in 1893 by Dr. William Coley when he was 29 years old. In the following 43 years Dr. Coley treated about one thousand inoperable (incurable) cancer patients with better results than would be expected for a comparable group of patients today.NYTimes Article Cancer Vaccine

Until the last pharmaceutical manufacturer ceased production in 1951, Coley’s Toxins was a mainstream cancer therapy with thousands of physicians treating many tens of thousands of patients. Outcomes were respectable but not as good as achieved by Dr. Coley.

Dr. Coley’s patients fared better than those treated by other physicians because Coley’s Toxins prepared for Dr. Coley’s personal use were more effective than the commercially available formulations.

Beginning back in 2006, the small Canadian company MBVax Bioscience produced a modern version of the formulation used by Dr. Coley and provided it free of charge to physicians anywhere in the world who could legally import the product and administer treatment.

Clinical results included complete regressions (cures) of inoperable and/or metastatic breast cancer, lymphoma, melanoma, lung cancer, esophageal cancer and stomach cancer. I worked for a time alongside Mr. MacAdam at MBVax Bioscience and based on the visits of patients being treated and planning on being treated via our vaccine, I can attest to its genuinity and appreciation.

In spite of the clinical results and the support of leading cancer researchers- medical regulators in Canada, Europe and the U.S. denied permission to commence clinical trials.

For the Silo, Jarrod Barker. 

The Reinvention of Coley’s Toxins  

Donald H. MacAdam

ISBN 978-0-9959218-2-5

$25.95 (CDN)     Volumesdirect.com

Supplemental- Whatever happened to Coley’s Toxins? 

Theory of Pets.com               Samantha Randall interviews Donald MacAdam about Coley’s Toxins as treatment for Canine Cancer

Sci-Tech

Diversity is Elusive in Rare Disease Research

Leave a comment

Only 10% of rare diseases have an FDA-approved therapy. This sobering statistic highlights why research is so imperative for patients with rare diseases. Clinical trials can be a crucial opportunity to access life-saving treatments.

However, African-American, African-Canadian and Latino patients with rare diseases face significant underrepresentation in clinical trials. This lack of representation results in drugs being developed that aren’t proven safe or effective across different populations.

A 2018 research carried out by the U.S. Census Bureau stated that out of the 12% Black or African American population across the U.S., only 2.2% had participated in clinical trials for rare diseases. Sickle cell disease is one rare disease that predominantly affects the African American community.

India has close to 50-100 million people affected by rare diseases or disorders, with almost 80% of these rare condition patients being children. As per the U.S. Census Bureau, Indian Americans constitute 1.2% of the U.S. population, which translates to 4.5 million, as of 2021, and out of the 5.8% total Asian population across the U.S., their clinical trials participation in 2018 was only 1%.

When certain groups are underrepresented, the universal right to health is jeopardized, and the economic burden of public health care rises. Inequities in clinical research participation impede applications in drug efficacy, toxicity, therapeutic indices, and other areas. Furthermore, it has the potential to raise healthcare costs.

February is “Rare Disease Month”, while February 28th is “Rare Disease Day”, and 2023 is the 40th anniversary of “The Orphan Drug Act”—a law that was passed in the United States in 1983 to facilitate the development of orphan drugs—drugs for rare diseases.

Dr. Rajasimha, Founder and Executive Chairman of IndoUSrare says, “Rare Disease Month allows the rare disease community to come together and make themselves heard.”

The future of rare disease research and treatment still requires enhanced detection techniques, dissemination of understanding concerning optimal care, and research to prevent, treat, and cure disease, and IndoUSrare collaborates with researchers in the U.S. and other western countries with their counterparts in the Indian subcontinent to engage and include the large and diverse populations of Indians in India and globally.