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October 25, 2023 Big Pharma News

Big Pharma

Drug Makers Now Targeting 6-Year-Olds With Popular Weight-Loss Shots

Manufacturers of the popular weight loss drugs Ozempic, Wegovy and Mounjaro are gearing up to market their drugs to children as young as 6. Experts caution that the drugs’ long-term risks are unknown and may exacerbate our “toxic diet culture.”

weight loss drugs children feature

The makers of three popular weight loss drugs, all of which have known physical and mental health risks, announced last week that they are testing the products for children as young as age 6.

Novo Nordisk, maker of Ozempic and Wegovy, and Eli Lilly, maker of Mounjaro, have approval for the drugs in the U.S. and European Union (EU) for people ages 12 and up.

Novo Nordisk is reportedly already in phase 3 trials with children 6-12, testing its Saxenda product, an older and less potent version of its bestselling drugs. Eli Lilly began recruiting children for its trials last week.

An Eli Lilly spokesperson told Bloomberg, “We are certainly committed to innovation in this space that’s going to address all segments of the population that’s affected.”

Commenting on the plans for marketing Ozempic and Mounjaro to younger children, nutritionist Carrie Lupoli told NewsNation:

“It’s scary to me that we are going down that path instead of actually working on the root cause because we know weight gain is a symptom of health and hormones. …

“This isn’t going to help us get healthier as a nation and it’s going to perseverate this ‘lose weight by any means’ mindset.”

Drugs’ mechanisms of action

Semaglutide, the active ingredient in Ozempic and Wegovy, liraglutide, the active ingredient in Saxenda, and tirzepatide, the active ingredient in Mounjaro, all belong to the class of drugs called incretin mimetics.

They are designed to mimic the body’s natural insulin-releasing hormone that people with Type 2 diabetes or obesity are either missing or have in short supply.

All three drugs function as glucagon-like peptide-1 (GLP-1) receptor agonists. The GLP-1 hormone helps regulate blood sugar levels by inducing the pancreas to release insulin, which helps the body process glucose (sugar) for energy.

The drugs attach to the same receptors as GLP-1, causing the body to release more insulin when we eat, which — unless we are insulin-resistant — lowers blood sugar levels.

Mounjaro’s tirzepatide, called a “dual co-agonist” medicine, also targets the glucose-dependent insulinotropic polypeptide (GIP) receptor, potentially providing a more robust insulin response, with greater suppression of glucagon and enhanced weight loss effects.

Dr. Ibiye Owei, assistant professor at Texas Tech University Health Sciences Center El Paso, told Healthline that semaglutide “works by making people feel full sooner … by slowing emptying the stomach so there is a feeling of satiety.”

The drugs also suppress the appetite and reduce cravings. Although the mechanisms are not fully understood, scientists point to GLP-1 receptors in various regions of the brain involved in the regulation of appetite and reward — in particular the suppression of dopamine signaling that affects the relationship between food and pleasure.

These drugs also have been shown to have other health-promoting effects, such as lowering blood pressure, improving blood flow to the heart, reducing the risk of heart attack and stroke, and protecting pancreatic cells.

The U.S. Food and Drug Administration (FDA) in 2020 approved Ozempic for reducing the risk of heart attacks and strokes.

The drugs typically come in liquid form and are self-administered weekly through injections to the belly, outer thighs, upper buttocks or the backs of the arms.

Long list of adverse effects

The FDA last month updated the warning labels listing adverse events for semaglutide (used in Ozempic, Wegovy and Rybelsus) to include the potential for developing ileus, an intestinal obstruction that can be life-threatening.

The FDA lists other adverse events for the drug, including pancreatitis, acute kidney injury, acute gallbladder disease, diabetic retinopathy complications, risk for thyroid C-cell tumors, and hypoglycemia when used alongside insulin or drugs that increase insulin secretion.

About one-third of the participants in clinical trials reported gastrointestinal (G.I.) issues, including nausea, vomiting, diarrhea, abdominal pain and constipation. Less frequent G.I. issues included dyspepsia, flatulence, gastroesophageal reflux disease, gastritis and eructation (belching).

Studies in pregnant animals showed abnormal fetal development, early pregnancy losses and smaller offspring.

More than 500 reports of anxiety, depression, suicidal thoughts

This summer, European regulators began reviewing Ozempic and Saxenda for reportedly inducing suicidal thoughts among some users.

Depression and suicidal thoughts are listed as possible side effects for Wegovy, which carries a higher dose of semaglutide than its sister drug Ozempic, which does not list these effects.

According to NPR pharmaceuticals correspondent Sydney Lupkin, FDA’s Adverse Event Reporting System (FAERS) has logged almost 500 reports of anxiety, depression or suicidal thoughts from people taking semaglutide drugs — including Ozempic.

Five of those experiencing suicidal thoughts later died.

The FDA told NPR last month it was not following the EU’s lead in reviewing reports of suicidal ideation but was monitoring the situation, saying it continued to “conclude that the benefits of these medications outweigh their risks.”

Kim Witczak, a consumer representative to the FDA’s Psychopharmacologic Drugs Advisory Committee, told The Defender, “The FDA has a disregard for safety issues that other countries are putting on warning labels.” Witczak’s husband Woody committed suicide in 2003 after taking Zoloft.

The FDA also warned of the dangers of generic versions of Ozempic and Wegovy that have been obtained at compounding pharmacies, claiming such drugs are not FDA-approved and have generated adverse events reports.

‘We really worry about children’

Medical experts also warn about the use of these drugs with children.

Dr. Dan Cooper, a professor of pediatrics at the University of California, Irvine, School of Medicine, said, “Our major concern is the unbalanced and inappropriate reductions in calorie or energy intake” associated with these weight loss drugs, according to an article in U.S. News & World Report.

Optimal diet and exercise are critical for growing bodies, for example, building bones during childhood could lessen the later risk for osteoporosis.

Cooper expressed concern about the lack of places for children to play and exercise safely and the proliferation of unhealthy fast foods — factors that significantly affect obesity.

Dr. Archana Sadhu, an endocrinologist at Houston Methodist, in an appearance on “Elizabeth Vargas Reports” on NewsNation said, “We really worry about children because of their developing bodies … Unfortunately, most of these [semaglutide] studies are shorter term … We need long-term studies to really be proven to be safe.”

“Because these drugs are being marketed as a ‘quick fix’ and will be used more and more, we really need to be looking into the safety issues,” Witczak said.

Weight loss drugs a booming industry

The cost of the weight loss and blood sugar management drugs ranges between $936 and $1,349 for a month’s supply — 5-10 times more in the U.S. than in other wealthy nations, according to an analysis this summer by Kaiser Family Foundation.

Insurance companies and Medicare often do not pay for the medications, or copays and deductibles may make them unaffordable.

According to the New York Post, Novo Nordisk expects sales of Ozempic to exceed $3 billion and Wegovy to exceed $1 billion in the third quarter of 2023.

High demand has led to supply shortages for Wegovy, with Novo Nordisk imposing restrictions, expected to continue into next year, on starter doses of the drug. The company even suspended advertising “to avoid stimulating further demand.”

Eli Lilly’s Mounjaro posted nearly $1 billion in sales in the second quarter of 2023, up 72% from the first quarter. Demand was so high that the company also experienced supply shortages, leading to a delay in filling orders this summer.

Analysts predict annual sales of Mounjaro could reach $50 billion. Global demand for all weight loss drugs is expected to reach $100 billion by 2035.

In January, J.P. Morgan held an investor conference on healthcare opportunities. The two investment areas they highlighted were obesity and Alzheimer’s disease.

“Obesity is just a huge business opportunity,” said Witczak.

Ozempic and Mounjaro are approved for controlling blood sugar in diabetics, while Wegovy and Saxenda are approved for weight loss and weight management.

However, according to U.S. News & World Report, both Ozempic and Mounjaro are seeing significant off-label use for weight loss.

Clinical trial participants with obesity who took Mounjaro lost as much as 20.9% of their body weight over the course of the 72 weeks of treatment.

In two other trials of the drug, obese patients lost an average of 26.6% of body weight over the course of 84 weeks. However, one of the trials also involved intensive lifestyle interventions, including a low-calorie diet, exercise and weekly counseling.

The FDA is expected to approve Mounjaro for weight loss before the end of this year when it will be marketed under a different name.

Obesity trends driving popularity of weight loss drugs

The market for weight loss drugs is being driven by the increasing prevalence of childhood obesity, which in the U.S. has quadrupled since the 1980s.

According to 2017-2020 data from the Centers for Disease Control and Prevention (CDC), nearly 20% of children ages 2-19 — about 14.7 million — are obese.

Among 6- to 11-year-olds — the target market for the current drug testing — that percentage jumps to 22.2%. Hispanic and Black children experience the highest levels of obesity, at 26.2% and 24.8%, respectively, while non-Hispanic White and Asian children experience rates of 16.6% and 9.0%, respectively, according to the CDC.

A study comparing obesity trends in children ages 2-19 from 2011-2012 through 2017-2020 found that obesity increased from 16.7% to 20.9% for boys, but not for girls. The age group with the highest increase was children ages 2-5 — in other words, those who are 6-9 years old today.

Obesity rates climbed even more during the pandemic. In a study published in JAMA Pediatrics, females reportedly gained an average of 6.8 kilograms per year, 11.2% more than before the pandemic, while males averaged an increase of 6.6 kilograms per year, up 15.9%.

A study published in 2021 in the CDC’s Morbidity and Mortality Weekly Report (MMWR) found that school closures, disruptions in sleep and physical activity schedules, stress and social isolation during the pandemic resulted in an increase in obesity from 19% to 22% for children and teens, with the largest increase in younger school-aged children.

In a Harris poll survey sponsored by the American Psychological Association conducted in February 2021 of adults 18 and older, 42% reported experiencing an unwanted weight gain averaging 15 pounds since the beginning of the pandemic.

Obesity carries other health risks, including high blood pressure, high cholesterol, Type 2 diabetes, respiratory problems such as asthma and sleep apnea, and joint problems.

Tackling obesity using the new weight loss drugs is not well received by everyone, however. Companies in the food industry are greatly concerned about how people eating less will affect their bottom lines.

Medicalization of obesity, ‘toxic diet culture’ and the ‘rebound effect’

The Lilly-sponsored study makes the argument that while the treatment of obesity is almost exclusively focused on making lifestyle changes, “evidence that diet and exercise prompt physiological counterregulatory mechanisms that limit weight reduction and impede weight maintenance has led to the realization that obesity is a complex multicomponent metabolic disease” that makes obesity challenging to overcome.

In other words, losing weight is hard, so bring on the drugs.

Novo Nordisk’s Chief Financial Officer Karsten Munk Knudsen took it one step further, telling CNBC that obesity is a “recognized medical disease … a chronic disease.”

Obesity, labeled a “disease” by the American Medical Association in 2013, has become increasingly “medicalized” — thus turning a condition into an industry.

The American Academy of Pediatrics (AAP), long tied to the pharmaceutical industry, in February, published guidelines for treating children and adolescents with obesity, including semaglutide and liraglutide, although they were clear to point out the need for lifestyle changes.

Another AAP article, however, asked “Are We Screening for Comorbidities and Providing Anti Obesity Medications?”

Writing for Parents magazine, Danielle Marie Holland warned about the “toxic diet culture” associated with drugs like Ozempic. She recommended parents have open and honest family discussions about health issues, self-esteem and social-media-driven “weight stigma and fatphobia” that can drive adolescents to seek quick-fix weight loss drugs.

Parents should also understand that these drugs are not a silver bullet for weight loss.

Dr. Andres Acosta, director of the nutrition obesity research program at the Mayo Clinic in Rochester, Minnesota, and an assistant professor of medicine, told U.S. News & World Report that Ozempic and similar medications generally result in a weight loss plateau at around the 3-6 month mark.

After that, diet and lifestyle changes will still be necessary to maintain one’s desired weight, he said.

Following through the long-term treatments may be a difficult discipline for teens — and keeping up with the cost may be prohibitive. When treatments stop, the lost weight can rapidly return. This has been called the “rebound effect,” which could lower self-esteem and even lead to depression.

Karin Conde-Knape, Novo Nordisk’s senior vice president of global drug discovery, told CNBC that according to company data, people discontinuing the use of an obesity drug can expect to recover 50% of their lost weight after two or three years, and almost all of it within five years.

The drugs don’t rewire “your neural networks to really define a new body weight setpoint,” she said, cautioning against the expectation of permanent weight loss.

Another study found that a year after stopping the use of semaglutide, participants regained two-thirds of the weight they had lost.

Food culture and policy expert Mark Bittman wrote on his Substack that “using Ozempic is like putting on a gas mask,” saying the drugs do not solve the problem, which he claims is the proliferation of ultra-processed foods that dominate American diets.

“It’s like someone hitting you in the head with a hammer and then feeding you a painkiller,” he wrote.

Bittman claims obesity is not a disease. He explained:

“If anything, it’s [obesity is] a social disorder, one brought about by the force-feeding of Americans (and others) with ‘food’ that’s really closer to the dictionary definition of poison: It makes you sick, not well. You don’t need to be obese to get diabetes, or cancer, or heart disease.”

The root causes of these diseases are difficult to address, he said, “Because in this system, corporations make money both ways: by seeding the causes of diseases … and then selling the so-called cures.”

Weighing potential benefits vs. unknown long-term risks

Dr. Emma Cooper, a resident in the Department of Psychiatry and Human Behavior at the University of California, Irvine, School of Medicine, expressed concern over these drugs’ impact on mental health and eating disorders in young people, both of which are on the rise, according to an article in U.S. News & World Report.

As news of these weight loss drugs takes over social media and access becomes easier, “It’s reasonable to assume … more children will engage in unsupervised use … In order to facilitate reaching societal beauty standards,” she said.

Dan and Emma Cooper are co-authors of a paper on the unintended consequences of using GLP-1 receptor agonist medications with children and adolescents.

They warn about the “increasing medicalization of pediatric conditions,” many of which, they say, result from “environmental and societal rather than biological mechanisms.”

The Coopers maintain the failure to adequately address environmental and lifestyle issues has significantly contributed to the childhood obesity epidemic.

The authors close their paper with a call to action, proposing such elements as:

  • Building multidisciplinary teams or frontline clinicians, community partners and others to address the knowledge gap in using these drugs with children and adolescents.
  • Improving the quality and accessibility of school-based physical fitness testing.
  • Working with regulatory bodies to update lifestyle intervention guidelines.
  • Training teachers, parents, coaches, primary care pediatricians and others about the appropriate uses and possible abuses of these medications.

According to The Atlantic, while some experts say weight loss drugs could pose serious health risks due to the unknown long-term physical and mental health effects in children, others say that not using them could make teens vulnerable to more serious health conditions brought on by obesity, including premature death.

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