Health systems are magnifying their “weight loss programs” as estimates place the global prevalence of obesity at 1 billion adults and children. Although the World Health Organization said weight loss drugs are not the sole answer to rising obesity rates, the industry for GLP-1s such as Ozempic continues to boom.
What, exactly, does “boom” mean?
The number of overdoses from Ozempic and Wegovy nearly quadrupled between 2021 and 2023, according to poison center data reported by The Los Angeles Times. Between January and November last year, 55 poison centers across the U.S. recorded nearly 3,000 calls concerning overdoses from Novo Nordisk's two approved presentations of semaglutide, Type 2 diabetes drug Ozempic and weight loss medication Wegovy. 2022 saw 1,447 calls about semaglutide, and 2021 noted 607.
The harm is escalating as off-label sales and marketing increases. America's Poison Centers said the number of overdoses is likely an undercount because reports are voluntary, the LA Times noted.
Non-pharmaceutical industries are feeling rippling effects, from junk food companies switching tactics to Walmart shoppers buying fewer calories and Weight Watchers making the drugs available through their online pharmacy after Oprah Winfrey promoted the drug widely.
And that other “boom?”
The market has already changed the economy of Denmark, where Novo Nordisk is headquartered. In late February, the country became Europe's third-most prosperous economy despite being the continent's 22nd-most populous country.
“We do not promote, suggest or encourage off-label use of our medicines,” which includes using Ozempic for weight loss.
—Novo Nordisk press statement
January 2023
Semaglutide, the active ingredient in Ozempic and Wegovy, can help manage insulin levels and induce weight loss. Ozempic is approved by the U.S. Food and Drug Administration (FDA) to treat Type 2 diabetes, and Wegovy is now approved to treat obesity. According to the manufacturer of both medications, Novo Nordisk, the average weight loss with Ozempic is 8 to 14 pounds; with Wegovy, it’s 15% of the patient’s weight.
In January 2023, after pressure about off-label sales and marketing from the press and Emergency Medicine physicians, Novo Nordisk published a statement, “We do not promote, suggest or encourage off-label use of our medicines,” which includes using Ozempic for weight loss.
What is off-label marketing? I first wrote about it in 2020 for Tarbell magazine after the former President of the United States used the White House Press Room to promote multiple drugs off-label for the treatment of Covid.
Once medical drugs and devices are approved for marketing by the FDA they can legally be used for purposes and in ways other than the ones for which they have been tested and approved. However, it is illegal for manufacturers to advertise or promote such unapproved uses of the drugs and devices. Problems and harm are further amplified when off-label use occurs among very vulnerable patient populations such as the elderly, patients with mental health disorders, pregnant women and pediatric patients.
The FDA in 1985 first green-lit drug makers to advertise medicines off-label directly to the consumer on television, but pharmaceutical companies were also expected to follow rigid rules for disclosing side effects and other information. These warnings are presented in the messaging that is read (at lightning quick speed) at the end of each ad and placed on the TV screen in a font so small, it is impossible to read. This is also the era where drug companies began renaming their medicines with slick names that were more memorable than scientific descriptions.
This combination of advertising drugs on television (DTC) while escalating off-label marketing to increase profits at any cost, has contributed to overdoses, addiction and misuse over the last 20 years especially. That celebrities like Oprah Winfrey and Lady Gaga are allowed to endorse drugs publicly without a medical license, does not help Health Literacy efforts.
In some cases, patients were hospitalized because of severe nausea, vomiting and stomach pain, according to a report from America's Poison Centers. Compounded versions of Ozempic and Wegovy might be behind the surge in calls, national officials said, because these solutions require patients to draw their own doses instead of receiving name-brand pre-filled pens.
"This is where we see a lot of errors. They end up drawing too much," Joseph Lambson, PharmD, director of the New Mexico Poison and Drug Information Center, told CNN.
"I don't know if there is another public person whose weight struggle has been exploited as much as mine," said Winfrey in the interview, admitting she is now taking weight-loss drugs after struggling for decades, even using social media to combat the stigma with help from Mass General Brigham Dr. Fatima Cody Stanford.
December 14, 2023
Here are eight updates Becker’s Healthcare has flagged on the Type 2 diabetes drug and its market as the off-label sales and marketing increases:
1. Viking Therapeutics, a San Diego-based drugmaker, reported strong results from a phase 2 trial of its drug candidate VK2735. The therapy is a glucagon-like peptide-1 and a glucose-dependent insulinotropic polypeptide receptor agonist — the same as Zepbound (tirzepatide), Eli Lilly's weight loss drug.
In the trial, patients shed 14.7% of their body weight — a more promising result than Eli Lilly's tirzepatide and Novo Nordisk's semaglutide (Ozempic, Wegovy).
2. The FDA will likely expand the label of Wegovy, Novo Nordisk's approved weight loss drug with the same active ingredient as Ozempic. In mid-February, FDA Commissioner Robert Califf hinted that cardiovascular indications could be on Wegovy's label in 2024, Endpoints reported.
In phase 3 trials, Novo Nordisk found Wegovy reduced heart failure-related symptoms and helped patients evade 20% of major adverse cardiovascular events.
3. There's no consensus yet on when — or if — patients can keep the weight off after quitting GLP-1s. The injections cost about $1,000 for a four-week supply, though, so some patients are turning to older medications or switching to other GLP-1s.
One study The Lancet published Feb. 19 found that unhealthy weight regain can be halted with exercise. Among about 100 people with obesity, those who exercised while using a weight loss medication maintained more muscle and kept off far more of their weight after quitting the drug than people who didn't work out.
4. A clinical trial among four health systems suggested bariatric surgery is more effective for people with diabetes than medical and lifestyle interventions. The trial tracked the outcomes of 262 patients who either underwent bariatric surgery or medical/lifestyle management between 2007 and 2013.
5. Physicians are seeing an increasing number of patients who have used GLP-1s requesting plastic surgery procedures to remove sagging and excess skin. The unintended result was previously dubbed "Ozempic face" to describe the deflation in the face because of sudden weight loss.
6. Grocery spending has decreased between 6% and 9% in households with GLP-1 users, according to data from more than 90,000 U.S. households. When GLP-1 use stopped, monthly grocery spending rebounded to previous levels.
7. In 2023, about 4,000 adolescent prescriptions were written for Wegovy and Ozempic for weight loss — a rapid growth compared to years prior.
Nearly 20% of children have obesity, according to the CDC, which often causes other conditions including Type 2 diabetes, high blood pressure, asthma and joint problems.
8. Over the next four years or so, GLP-1s are expected to boost the U.S. economy by $1 trillion, according to Goldman Sachs analysts. By 2030, the anti-obesity drug market could reach $100 billion — 16 times more than its current worth.
9. Regarding “Ozempic Face,” the skin of the face loses its ability to retract after an episode of rapid weight loss due to reduced levels of elastin and collagen, which are essential for structural integrity. As a result, people taking Ozempic are reporting the following facial symptoms:
Increased signs of aging, such as more lines and wrinkles
Loss of fat, which can lead the skin to become loose and sag
A hollowed-out appearance
Lipodystrophy, which affects how the body accumulates and stores fat
Demand for these drugs will surge even higher this year as the pharmaceutical companies aggressively promote the medicines to prevent heart attacks, strokes and cardiac deaths.
What else reduces heart failure, strokes and death by obesity? Exercise and eating clean food, among many other healthy behaviors and practices that can be implemented in an effort to reduce chronic illness.
The off-label Oxy sales and marketing scheme lasted from 1999-2022. The ink on that Department of Justice settlement is not yet dry. Time will tell how long Attorneys General across the United States will allow this scheme to continue.