GLP-1 Drug Makers Go After Counterfeit Versions

In breaking news last week, Eli Lilly is preparing to sue several medical spas and wellness centers for allegedly selling counterfeit and compounded versions of its popular weight loss and diabetes drugs, Mounjaro and Zepbound. This issue has also been raised by Novo Nordisk, the maker of Ozempic, and health organizations, who warn that these fake products can cause serious side effects, including infections.

In an open letter on Thursday, Eli Lilly cautioned against using drugs labeled “research purposes only” or “not for human consumption,” highlighting that federal regulators have not approved oral versions of Mounjaro or Zepbound, despite some pills appearing online.

The counterfeit drugs are said to be unsafe

The company claims that some wellness centers and websites are selling unauthorized versions of these drugs made with unapproved chemicals and marketed as generic versions, even though Lilly does not produce generic versions of its drugs. These counterfeit products are dangerous because they may contain incorrect dosages, wrong medications, no medication, or a mix of several medications, posing serious health risks.

According to Lilly, fake tirzepatide — the active ingredient in Mounjaro and Zepbound — has been found to contain bacteria, high levels of impurities, and different chemicals than genuine drugs. These fake products often have safety, efficacy, and sterility issues.

The FDA does NOT approve

Counterfeiting is not limited to tirzepatide. In December, the FDA warned against using counterfeit semaglutide, the active ingredient in Ozempic and Wegovy, due to potential adverse events such as infections and abdominal pain. Since 2020, the FDA has received over 100 adverse event reports related to counterfeit tirzepatide and semaglutide, including several life-threatening cases, 19 hospitalizations, and at least two deaths.

How to spot a fake

To identify fake GLP-1 drugs, Lilly advised looking for a pink hue in the product (genuine versions are colorless), generic labeling (neither Lilly nor Novo Nordisk sells generic versions), incorrect dosages, grammatical errors on the packaging, lack of tamper-resistant features, and mismatched batch numbers.

The reason for the fakes is to meet the demand

The National Association of Boards of Pharmacy has noted that high demand and short supply of these drugs have led to the sale of substandard and falsified versions, putting patients at risk. Both Wegovy and Ozempic, as well as Zepbound and Mounjaro, have experienced shortages due to high demand. Lilly warned that fake versions of its products are also being sold online and on social media, where it does not sell genuine Mounjaro or Zepbound.

Current steps being taken by the drug makers

In its letter, Lilly also announced legal action against medspas, wellness centers, and clinics selling unapproved and counterfeit versions of its drugs. The company claims these clinics falsely market the fake products as Mounjaro and Zepbound, misuse Lilly’s clinical trial results, and deceptively use the FDA’s approval of genuine drugs to sell the counterfeits.

Lilly has previously filed similar lawsuits and settled with one company, Totality Medispa, which agreed to comply with federal law and report all adverse events to the FDA. Novo Nordisk has also filed lawsuits against nine wellness clinics for selling compounded versions of Ozempic and Wegovy, some of which contained up to 24% impure chemicals. Novo Nordisk is seeking to stop these companies from marketing and selling products claiming to contain semaglutide and is asking for compensation of up to $75,000.

Your responses and feedback are welcome!

Source: “WHO warns about fake versions of weight loss drugs Wegovy and Zepbound,” NBC News, 6/20/24
Source: “Weight-Loss Drugs Dangers Explained: Zepbound, Mounjaro Maker Warn Of Coming Counterfeit Lawsuit,” Forbes, 6/20/24
Image by sosiukin/123RF

Why Is the Most Recommended Childhood Obesity Treatment Not Readily Available?

For many U.S. parents seeking help for a child with obesity, the most widely endorsed treatment is out of reach — and it’s not the popular GLP-1 agonists like Wegovy, used for weight loss and managing diabetes.

What is the recommended childhood obesity treatment?

Leading medical groups recommend intensive behavioral counseling, spanning 26 hours within one year, to teach children and their families practical ways to eat healthier and be more active. Sounds good, right? A recent Reuters article digs into the reasons these touted programs aren’t easy to find.

And why is not widely available?

These programs are not widely accessible, with wait lists often stretching for several months. They are frequently not covered by health insurance and require a time commitment that many families find challenging, according to interviews with over a dozen doctors and parents.

No treatment option improvement is expected

Consequently, fewer than 1% of the nearly 15 million U.S. children with obesity receive this type of structured care, the U.S. Centers for Disease Control and Prevention (CDC) told Reuters. Efforts by the CDC and other organizations to expand insurance coverage have stalled, doctors involved in the process also told Reuters.

“The coverage for these programs was never good, and we’re not seeing any movement toward improvement,” said Dr. Joseph Skelton, a professor of pediatrics and obesity medicine specialist at Wake Forest University School of Medicine.

No end in sight for curbing childhood obesity

The prevalence of obesity among U.S. children has steadily increased, from 5% in 1980 to nearly 20% now, according to the CDC. It’s also a global issue. New research published by JAMA Pediatrics and based on a review of global studies revealed that the prevalence of obesity increased by 150% in the period covering 2012–2023 compared to 2000–2011, indicating that pediatric obesity and overweight conditions are increasingly common. The problem is getting worse.

This is where the GLP-1 drugs come in

According to new research, the number of young people in the US prescribed GLP-1 agonist drugs, such as Wegovy and Ozempic, for weight loss and diabetes increased by 594.4% over the past three years. The most notable increase in prescriptions was observed among young women and adolescent girls.

Last year, the American Academy of Pediatrics updated its obesity management guidelines, recommending that in addition to behavior and lifestyle interventions for the entire family, weight loss medications are suitable for children aged 12 and older.

Clinical trials involving intensive behavioral programs for children and found that, on average, children lost 5.7 pounds. In contrast, Wegovy and similar drugs have resulted in a more dramatic weight loss — 15% or more of body weight in clinical trials. This significant weight loss, coupled with a lack of insurance coverage for counseling, may lead more families to consider these medications in the future.

Are GLP-1 medications safe for children?

In short, more research is needed. Many doctors and parents are cautious about using the medication due to the lack of data on its potential impact on a child’s development and other long-term risks.

Some doctors argue that increased use of Wegovy among youth will make it even more critical for children to learn healthy eating habits for the long term. They are concerned that relying solely on the drugs could lead to nutritional deficiencies or eating disorders.

Dr. Thomas Robinson, a professor of pediatrics and director of the Center for Healthy Weight at Stanford Medicine Children’s Health in Palo Alto, California, said:

Many of us believe it would make sense to offer behavioral counseling along with the drug. These drugs are very effective at reducing weight and health risks, but you don’t all of a sudden adopt a healthy diet or become more physically active.

Your responses and feedback are welcome!

Source: “Weight-loss options for children are hard to come by,” Reuters, 6/17/24
Source: “Prescriptions for weight loss, diabetes drugs for young people leaped 600% since 2020, study says,” CNN, 5/23/24
Image by Omar Lopez on Unsplash

GLP-1 Drugs Prompt New Food Offerings

The success of new obesity and diabetes drugs is evident in grocery store aisles. We’ve written before about how the rise of GLP-1 medications is reshaping consumer habits and posing challenges to various sectors of the food and beverage industry.

For one, a Morgan Stanley report predicted that the consumption of sweet and salty snacks could drop by as much as 3% through 2035, causing concern in the food industry. Food companies are reacting accordingly by launching new and reformulated products to cater to the growing number of people using drugs like Novo Nordisk’s Ozempic and Wegovy. Experts believe this trend could significantly alter American diets.

How GLP-1 drugs can lead to nutritional deficiencies

GLP-1 medications, which help reduce hunger and increase feelings of fullness, can lead to nutritional deficiencies because people on these drugs tend to eat less overall. This decreased appetite can result in insufficient intake of essential vitamins, minerals, fiber, and protein.

Specifically, reduced protein intake can lead to muscle loss, while lower consumption of fruits, vegetables, whole grains, beans, seeds, and nuts can limit the intake of important antioxidants, vitamins, and minerals, as well as fiber, which is crucial for blood sugar stabilization, cholesterol management, and digestive health.

To counteract these potential deficiencies, it is important for patients on GLP-1 medications to follow a well-balanced and nutrient-dense eating plan. This includes ensuring adequate intake of macronutrients (proteins for muscle preservation and satiety, carbohydrates for energy and fiber, and fats for vitamin absorption and brain function) and micronutrients (vitamins and minerals). Healthcare professionals recommend tailoring your dietary needs based on personal factors such as age, weight, medical history, and activity levels.

GLP-1-friendly food offerings

Several big food manufacturers stand out. Nestlé, owner of brands like Stouffer’s and DiGiorno Pizza, recently introduced a new line of frozen foods with smaller portions and more protein to counteract muscle loss associated with GLP-1s. This move is seen as a “logical reaction” to the GLP-1 boom, and competitors are expected to follow suit.

The line, called Vital Pursuit, is “high in protein, a good source of fiber, contain[s] essential nutrients, and they are portion-aligned to a weight-loss medication user’s appetite,” the company said. It’s also affordable as it’s sold for $4.99 or less. Items include sandwich melts, pizzas, and bowls with whole grains or protein pasta.

According to Reuters, General Mills is already offering high-protein versions of Annie’s Mac and Cheese and Betty Crocker baking mixes with lower sugar and sodium. And Conagra, which owns brands like Healthy Choice and Slim Jim, is considering smaller-portion frozen foods and sees potential in its protein- and fiber-rich snacks.

Nutrition experts say these new products cater well to GLP-1 users’ needs. These products may also benefit those who stop taking GLP-1s within a year and struggle to maintain weight loss, as well as consumers who are not on GLP-1s but want to reduce calories and sugar or increase protein intake.

A smaller-portion trend

Writer Tina Reed, in her recent article for Axios, reported that Hank Cardello, a former food executive and now a consumer health expert at Georgetown University, suggested that changing perceptions of portion sizes could positively impact American diets. This trend was evident at the recent Sweets & Snacks Expo, where many products were marketed as “minis” or “bites.”

Hank Cardello said:

Once it gets up in that neighborhood, food companies have to pay attention. They have to, otherwise they’re walking away from business. You can’t sell king-size X, Y, and Z to this crowd.

The caveat

Consumers might be misled by marketing claims and assume products labeled for GLP-1 users are inherently “healthy.” Experts emphasize that these drugs should be paired with exercise and a proper diet.

Whether these new products and food trends associated with the increasing use of GLP-1 drugs are here to stay, time will tell. One thing is for sure: Food manufacturers will adapt.

Your responses and feedback are welcome!

Source: “Weight-loss drugs are forcing changes to grocery store offerings,” Axios, 6/4/24
Source: “Changes in food preferences and ingestive behaviors after glucagon-like peptide-1 analog treatment: techniques and opportunities,” Nature.com, 3/7/24
Source: “Nestlé Launches Frozen Food Line for People Using GLP-1 Drugs,” Healthline.com, 5/27/24
Image by Alan Hardman on Unsplash

Can Web-Based Self-Help Interventions Help With BED?

A recent JAMA Network Open study assessed the effectiveness of web-based self-help interventions in alleviating binge eating disorder (BED). Here are some details, including the findings and the conclusions.

Why BED?

We’ve covered it many times before, but let’s recall that BED is defined as uncontrolled overeating that can lead to obesity, type 2 diabetes, and hypertension. Prolonged BED can reduce the affected person’s quality of life, negatively impact social relationships, and compromise their ability to perform their job well. Without a timely intervention, BED can become chronic and even lead to premature death.

CBT and its barriers

Some studies have demonstrated that cognitive behavioral therapy (CBT) can serve as an effective BED intervention, as well as positively affect the eating disorders bulimia nervosa and anorexia nervosa.

Unfortunately, some people with BED don’t seek in-person psychotherapy because of such barriers as treatment costs, lack of availability, and sociocultural stigma.

This is where web-based cognitive behavioral interventions come in, thanks to their ease of implementation, availability, reduced social stigma, and cost-effectiveness. This avenue has been growing in popularity for these reasons, making BED treatment more accessible.

About the study

The study involved a randomized clinical trial (RCT) to evaluate the effectiveness of a web-based cognitive behavioral self-help intervention for BED. Researchers measured changes in eating disorder symptoms, well-being, co-morbid psychopathology, self-esteem, emotion regulation, and clinical impairment. Weekly symptom monitoring and ecological momentary assessment (EMA) were used to track real-time changes in binge eating.

Participants were recruited from Germany and other German-speaking regions in Europe. Eligible participants were 18-65 years old, owned a smartphone, and were diagnosed with BED according to the DSM-5 criteria. They were randomly assigned to either a control group (waiting list) or a web-based treatment group. Assessments were conducted at baseline, six weeks (mid-treatment), and 12 weeks (post-treatment).

The intervention consisted of six mandatory modules covering psychoeducation, self-monitoring of binge eating, emotion regulation, and interactive exercises. A sequential module-access strategy was employed to engage participants in a personalized manner.

Study findings

The study found significant changes in BED patterns from baseline to 12 weeks in the intervention group. Out of 1,602 patients, 154 met the eligibility criteria and were recruited, with 77 participants in each group. The intervention group reported fewer binge-eating episodes and showed significant improvements in global eating psychopathology and clinical impairment.

Dr. Priyom Bose, Ph.D., discussing the study results, writes:

“The intervention’s efficacy exceeded or was similar to previously documented digital interventions, as well as in-person guided and unguided self-help interventions for BED.

Notably, the levels of improvement observed in the intervention group were consistent with or surpassed those associated with in-person CBT interventions, thus confirming the clinical applicability of web-based cognitive behavioral self-help interventions.”

The study noted that participants’ motivation, attitudes towards online interventions, demographic characteristics, and treatment expectations influenced the positive effects of the web-based intervention.

The bottom line

The study demonstrates that web-based cognitive behavioral self-help interventions can significantly improve the well-being of people with BED, offering a promising alternative to traditional treatments. However, the study had some limitations, including the under-representation of males and older adults, and potential biases due to the self-report design. Future research can address these limitations through methodologies like double-blind designs.

Your responses and feedback are welcome!

Source: “Web-based self-help program proves effective in treating binge eating disorder,” News-Medical.net, 5/19/24
Source: “Effectiveness of a Web-Based Cognitive Behavioral Self-Help Intervention for Binge Eating Disorder,” JAMA Network Open, 5/16/24
Image by Glenn Carstens-Peters on Unsplash

Will the Cheaper Weight Loss Regimens Replace GLP-1 Drugs?

When patients start on the latest obesity drugs, they often experience reduced food cravings and significant weight loss. However, discontinuing these drugs usually reverses these effects: cravings return, and so does the weight. For instance, within a year of stopping semaglutide — known as Wegovy or Ozempic — people typically regain about two-thirds of the weight they lost. Tirzepatide, marketed as Zepbound or Mounjaro, shows similar patterns. This has led to the medical consensus that these obesity drugs need to be taken indefinitely, perhaps for life.

For pharmaceutical companies selling these blockbuster drugs, collectively known as GLP-1 drugs after the hormone they mimic, this is a lucrative prospect. For patients, who might be paying over $1,000 a month out of pocket, it’s a different story. Most Americans simply can’t afford such ongoing expenses, as a recent article in The Atlantic outlines.

Finding cheaper alternatives

This financial burden has prompted some doctors to get creative, developing regimens that substitute cheaper, though less well-known, alternatives. GLP-1 drugs are highly effective, promoting more rapid weight loss than any other obesity medications currently available.

However, some doctors are exploring whether these drugs need to be used permanently. “What if we use them short-term, for six months to a year, to lose 50 pounds?” asks Sarah Ro, an obesity-medicine doctor and director of the University of North Carolina Physicians Network Weight Management Program. She and other doctors are investigating transitioning patients to older, less expensive drugs for long-term maintenance.

Dr. Ro has already helped hundreds of patients make this switch out of necessity. Many of her patients in rural North Carolina lack insurance coverage for the new obesity drugs and can’t afford them out of pocket. When North Carolina’s state employee health insurance cut off coverage for GLP-1 drugs in April, Ro transitioned her patients to older medications like topiramate, phentermine, metformin, and bupropion/naltrexone, coupled with lifestyle counseling. These alternatives are generally less effective, leading to about half the weight loss of GLP-1 drugs, but are far more affordable, costing as little as $10 a month when prescribed as generics.

Retirees on Medicare lose GLP-1 drug coverage

Jamy Ard, an obesity medicine doctor at Wake Forest University School of Medicine, also had to adjust his approach for patients who lost GLP-1 drug coverage upon retiring and switching to Medicare, which currently does not cover obesity treatments. Doctors like Ard see the need for research on transitioning from GLP-1 drugs to older ones, as many patients will lose coverage at retirement age. “Now I’ve got to figure out, well, how do I treat them?” he said.

Are the alternatives safe?

Long-term data on older drugs are sparse, largely because obesity drugs weren’t profitable enough to justify expensive, long-term studies until recently. Switching from GLP-1 drugs to older medications is largely anecdotal at this point, with varying outcomes. A small minority can maintain their weight with just diet and exercise, while others find the older drugs ineffective. Dr. Ro’s experience suggests that 50% to 60% of her patients have successfully maintained weight loss using older drugs alongside lifestyle changes like cutting out fast food and sugary drinks.

A tailored trial-and-error approach is the way to go

The choice of alternative medication depends on the patient. Different drugs target different biological pathways. For example, the combination of naltrexone and bupropion reduces the pleasure of eating and is particularly effective for emotional eaters. Topiramate makes carbonated drinks unpleasant, which can help soda drinkers. Each drug has different side effects, requiring a tailored approach and sometimes trial and error to find the best fit.

Doctors are also finding that some patients can maintain their weight on lower or less frequent doses of GLP-1 drugs. Lowering the dose doesn’t save money since the pens cost the same regardless of dosage, but extending the time between doses can help stretch supplies.

Stopping completely might be a challenge

Complete discontinuation of obesity medications, GLP-1 or otherwise, is unlikely for most patients. Weight loss triggers compensatory mechanisms in the body, evolved to prevent starvation, making long-term maintenance a constant challenge. Susan Yanovski, co-director of the NIH’s Office of Obesity Research, describes long-term weight maintenance as the “holy grail” of obesity treatment.

The best maintenance strategy — whether it involves GLP-1 drugs, and at what dose — remains an individual question needing further study. “These are really good research questions,” Yanovski said, though they might not align with the pharmaceutical companies’ focus on developing new drugs.

Compounded semaglutide is announced

Hims & Hers company announced last week that it will be selling compounded semaglutide for weight loss at prices significantly lower than Wegovy and Ozempic, addressing a gap in supply. However, it’s important to note that compounded semaglutide is not FDA-approved and undergoes less extensive testing than brand-name drugs.

This compounded GLP-1 drug will be prescribed by physicians through their telehealth platform. Prices start at $79 per month for oral medication kits and $199 per month for injections, much lower than the list prices of Ozempic ($935.77) and Wegovy ($1,349.02).

However, compounded semaglutide differs from FDA-approved drugs like Wegovy and Ozempic in several key ways. Compounded medications do not undergo the rigorous FDA approval process, which ensures safety, efficacy, and quality through extensive testing. This lack of testing can lead to concerns about inconsistent potency, bioavailability, and safety.

Also, these drugs can vary in how they are absorbed and utilized by the body, potentially leading to unpredictable therapeutic outcomes. Safety concerns also arise from the sterility and cleanliness of the compounding process, which might introduce harmful contaminants if not properly managed.

The BrainWeighve app would be an ideal off ramp…

The ability to rechannel displacement into less harmless activities rather than succumbing to urges is behind the behavior modification app, BrainWeighve, currently ramping up for a trial through the University of California Los Angeles (UCLA). The trial focuses on weight loss for obese teens using a self-directed, physician-supervised program withdrawing from one problem food at a time.”

Your responses and feedback are welcome!

Source: “Ozempic Patients Need an Off-Ramp,” The Atlantic, 5/22/24
Source: “Hims & Hers Selling GLP-1 Weight Loss Drugs Like Wegovy for 85% Less: What to Know,” Healthline.com, 5/22/24
Image by Thought Catalog on Unsplash

Study Finds That Severe Childhood Obesity Can Cut Life Expectancy in Half

Severe childhood obesity can drastically reduce life expectancy, cutting it nearly in half, according to a recent global study conducted by Stradoo GmbH, a life sciences consultancy in Munich. This research provides detailed insights into how the age of onset, severity, and duration of childhood obesity affect long-term health and life expectancy.

Long-term impact of childhood obesity

Presented at the European Congress on Obesity (ECO) in Venice, Italy, the study findings quantified the impact of various aspects of childhood obesity on long-term health for the first time. It was led by Dr. Urs Wiedemann along with colleagues from universities and hospitals across Europe and the United States.

The researchers found that the earlier a child develops obesity, the more severe the long-term effects. For instance, a child living with severe obesity at age four, who does not lose weight, has a life expectancy of just 39 years — about half the average life expectancy.

The findings in detail

“While it’s widely accepted that childhood obesity increases the risk of cardiovascular disease and related conditions such as type 2 diabetes (T2D), and that it can reduce life expectancy, evidence on the size of the impact has been patchy,” said Dr. Wiedemann. She added:

A better understanding of the precise magnitude of the long-term consequences and the factors that drive them could help inform prevention policies and approaches to treatment, as well as improve health and lengthen life.

The researchers developed an early-onset obesity model to estimate the effect of childhood obesity on cardiovascular disease, related conditions like T2D, and life expectancy. This model included four key variables: age of obesity onset, obesity duration, irreversible risk accumulation (a measure of irreversible health effects even after weight loss), and severity of obesity.

Critical factors

The severity of childhood obesity was measured using BMI Z-scores, which indicate how much an individual’s Body Mass Index (BMI) deviates from the norm for their age and sex. For example, a four-year-old boy with a BMI Z-score of 3.5, indicating severe obesity, has a life expectancy of just 39 years if he does not lose weight.

Data for the model were drawn from 50 existing clinical studies on obesity and related comorbidities, involving over 10 million participants worldwide. Approximately 2.7 million of these individuals were between two and 29 years of age.

The risks of severe childhood obesity

The model shows that earlier onset and more severe childhood obesity elevate the likelihood of developing related health issues later in life. For instance, a child with a BMI Z-score of 3.5 at age four has a 27% likelihood of developing type 2 diabetes by age 25 and a 45% chance by age 35. In contrast, a child with a BMI Z-score of 2 at age four has a 6.5% chance of developing type 2 diabetes by age 25 and 22% by age 35.

Higher BMI Z-scores at an early age also lead to a lower life expectancy. For instance, a BMI Z-score of 2 at age four without subsequent weight reduction reduces life expectancy from about 80 years to 65 years. The life expectancy drops further to 50 years for a BMI Z-score of 2.5 and 39 years for a BMI Z-score of 3.5.

Implications for early weight loss

Comparisons with other studies and expert opinions confirmed the model’s accuracy. Moreover, the model demonstrated the positive impact of weight loss on life expectancy and long-term health. For example, a child with severe early onset obesity (BMI Z-score of 4 at age four) has a life expectancy of 37 years and a 55% risk of developing T2D by age 35. If the child loses weight, reducing the BMI Z-score to 2 by age six, life expectancy increases to 64 years, and the risk of T2D drops to 29 percent.

“The early onset obesity model shows that weight reduction has a striking effect on life expectancy and comorbidity risk, especially when weight is lost early in life,” said Dr. Wiedemann.

Addressing childhood obesity

The model has some limitations. It does not account for the causes of obesity, genetic risk factors, ethnic or sex differences, or the interactions between different comorbidities. However, the impact of childhood obesity on life expectancy is profound.

Dr. Wiedemann said:

It is clear that childhood obesity should be considered a life-threatening disease. It is vital that treatment isn’t put off until the development of type 2 diabetes, high blood pressure, or other ‘warning signs’ but starts early. Early diagnosis should and can improve quality and length of life.

The bottom line

The findings of this study underscore the urgent need for early intervention in cases of childhood obesity. Preventative measures and timely treatments are crucial to improving the long-term health and life expectancy of affected children. As our understanding of the long-term consequences of childhood obesity deepens, so too must our commitment to tackling this critical public health issue from an early age.

Your responses and feedback are welcome!

Source: “Severe childhood obesity can cut life expectancy in half,” Earth.com, 05/16/24
Source: “Young children with persistent severe obesity could have half average life expectancy, study finds,” The Guardian, 05/14/24
Image by Christopher Williams on Unsplash

New Research Highlights Importance of Sugar Source in Childhood Obesity

New research presented at the European Congress on Obesity (ECO) in Venice, Italy, has shed light on a critical aspect of childhood nutrition: the source of sugar. The study, conducted by Junyang Zou and colleagues from the University of Groningen and University Medical Center Groningen, challenges conventional wisdom regarding sugar consumption and its relationship to childhood obesity.

The type of sugar might matter more than the amount

The study, which examined data from the GEKCO Drenthe study, a longitudinal investigation tracking children born in the northern Netherlands, scrutinized the impact of sugar consumption from various sources on weight gain and the development of obesity. Surprisingly, the research suggests that the type of sugar consumed may be more influential than the total amount.

Contrary to common assumptions, the study found that the overall quantity of sugar consumed during early childhood did not correlate with weight status at age 10 or 11. However, the source of sugar emerged as a significant factor.

Zou elaborated:

The high consumption of sugary foods is considered a risk factor for childhood overweight and obesity and so children are advised to consume less sugar-rich foods, such as confectionery, cakes and sugar-sweetened drinks, and eat more fruit and unsweetened dairy products, such as milk and yogurt.

But while fruit and unsweetened dairy products are considered healthy, they contain high amounts of intrinsic sugars — sugar that occurs naturally in the food, rather than being added. We wanted to know if the source of sugar, added versus intrinsic, as well as the amount, affects the likelihood of developing overweight or obesity.

The research underscores the importance of distinguishing between intrinsic sugars and added sugars found in processed treats and beverages. While both fruit and unsweetened dairy products contain intrinsic sugars, they also offer essential nutrients and may confer protective effects against obesity.

Study results in more detail

Drawing upon data from the GECKO Drenthe study — an extensive longitudinal investigation tracking children born between 2006 and 2007 in the northern Netherlands — Zou and colleagues meticulously analyzed the dietary habits of 817 children who maintained a healthy weight at age 3. The findings yielded compelling insights into the diverse sources of sugar and their distinct effects on weight status.

On average, these children consumed 112 grams of sugar daily, comprising a blend of natural and added sugars. Among the primary sources identified were sugar-sweetened beverages, dairy products, sugary snacks, and fruits. Surprisingly, while total sugar intake at age 3 did not exhibit a significant correlation with BMI at ages 10 and 11, the source of sugar emerged as a critical determinant of weight status.

Notably, children who derived a higher proportion of their sugar intake from whole fruits demonstrated lower BMI scores and experienced less weight gain as they approached adolescence. Similarly, those who consumed more sugars from unsweetened liquid dairy products, such as milk, exhibited a reduced risk of developing obesity or overweight status.

Conversely, sugar intake from sugary snacks was associated with higher BMI scores, underscoring the detrimental impact of added sugars found in processed foods. Despite the study’s observational nature, the findings offer valuable insights into the nuanced relationship between sugar consumption and childhood obesity.

The bottom line

The research presented at the ECO highlights the critical role of sugar sources in the development of obesity during childhood. It also underscores the imperative of reevaluating dietary recommendations to prioritize nutrient-rich sources of sugar, such as fruits and unsweetened dairy products, while minimizing the consumption of sugary snacks and beverages. By empowering parents, healthcare professionals, and policymakers with evidence-based insights, we can chart a course toward a healthier future for our children — one sweet choice at a time.

Your responses and feedback are welcome!

Source: “Understanding the role of sugar sources in development of childhood obesity,” News-Medical.net, 05/13/24
Source: “Kids’ Obesity Risk Depends on Source of Sugar, Not the Amount,” Newsweek, 05/13/24
Image by Myriam Zilles on Unsplash

Semaglutide and Psychiatric Risk

Weight gain and its associated health risks often pose significant challenges for people with psychiatric disorders. The intersection of mental health and physical well-being necessitates careful consideration of treatment options, particularly when addressing weight management.

Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, gained FDA approval in 2017 for the treatment of type 2 diabetes. It operates by mimicking the GLP-1 hormone, which regulates insulin production and influences food intake and reward mechanisms within the brain. The medication, renowned for its efficacy in weight loss, has recently come under scrutiny for its potential psychiatric side effects, prompting clinicians and patients to reevaluate its role in managing obesity, particularly in people living with serious mental illness.

The APA poster on psychiatric comorbidities

Heidi Anne Duerr, MPH, reported for Psychiatric Times on a case study that was presented at the 2024 American Psychiatric Association Annual Meeting. The study shed light on the complexities of using semaglutide in patients with psychiatric comorbidities.

Presented in the poster titled “Semaglutide-Induced Suicidal Ideation in a Patient with Psychiatric Comorbidities: A Case Report,” study author Raju Kakarlapudi and colleagues recounted the upsetting experience of a 42-year-old female patient dealing with morbid obesity and type 2 diabetes mellitus alongside bipolar I disorder and posttraumatic stress disorder (PTSD).

The patient’s difficult journey

Bariatric surgery, a common weight loss intervention, was deemed unsuitable due to the patient’s psychiatric history. Consequently, semaglutide, marketed as Ozempic, emerged as a viable alternative to help the patient manage weight. However, within a mere three weeks of starting the medication, the patient started exhibiting “significant psychiatric disturbances including abrupt behavioral alterations and protracted nihilistic delusions.” Disturbingly, she even attempted self-strangulation on multiple occasions. Subsequent discontinuation of semaglutide led to the disappearance of these behavioral changes.

Additional research uncovered this

Kakarlapudi and colleagues said that…

The primary aim [was] to augment awareness regarding the potential adverse effects associated with Ozempic utilization, both among the general populace and within the psychiatric community.

Kakarlapudi et al. conducted an extensive literature review using Google Scholar, uncovering approximately 60 documented cases of suicidal ideation and seven suicide attempts linked to semaglutide use. Interestingly, many patients reported an improvement in depression upon discontinuation of the drug, suggesting a potential association between semaglutide and depressive symptoms that could precipitate suicidal ideation.

What we were told back in January

Interestingly, it was widely reported last January that health agencies in the U.S. and Europe have conducted thorough reviews and found no evidence linking thoughts of suicide or self-harm to semaglutide. The European Medicines Agency concluded after a nine-month review that there is no causal association between GLP-1 receptor agonists and suicidal thoughts or actions. Similarly, the Food and Drug Administration (FDA) in the U.S. reached a similar conclusion after examining reports to its adverse event reporting system. That only goes to show that more research is needed while we proceed with caution when it comes to using these weight loss medications.

The bottom line

The authors of the case study underscored the need for further research to elucidate the underlying mechanisms by which semaglutide may exacerbate psychiatric symptoms and precipitate suicidal ideation. By identifying specific proteins and enzymes implicated in these adverse effects, clinicians can better mitigate risks and tailor treatment strategies to individual patient needs.

Your responses and feedback are welcome!

Source: “Annual Meeting: Poster Investigates the Link Between Semaglutide and Suicidal Ideation,” Psychiatric Times, 05/07/24
Source: “Ozempic isn’t linked to suicidal thoughts, U.S. and European health agencies find,” NBC News, 4/15/24
Image by Hans Reniers on Unsplash

How GLP-1 Medications Are Changing Consumer Habits and Industry Dynamics

A paradigm shift is underway in the world of food and beverage consumption, and it’s being driven by a surprising catalyst: medications. Specifically, GLP-1 drugs, primarily used for weight loss and managing diabetes, are not only altering consumer behavior but also posing challenges to various sectors of the food industry.

Recent survey points to significant impact

A recent survey conducted by Morgan Stanley sheds light on the significant impact of GLP-1 medications on consumer spending habits, particularly in the realm of dining out and getting takeout. According to the survey, a majority of people taking GLP-1 drugs reported spending less on restaurant meals and deliveries, indicating a notable shift in their culinary preferences. In contrast, a smaller proportion indicated tightening their budgets while grocery shopping, suggesting a more nuanced effect on at-home food consumption.

Morgan Stanley analysts put it this way:

There is growing evidence that the drugs have a meaningful impact on consumer behavior and spending on groceries and restaurants… All of these dynamics suggest GLP-1 drugs’ impact across consumer sectors is set to increase as drug uptake grows and the drugs reshape behavior among a demographic group that represents a disproportionate share of calorie consumption.

Raised concerns as a consequence

The implications of this behavioral shift are reverberating across the food and beverage industry, raising concerns among stakeholders about potential revenue implications. With the market for GLP-1 drugs projected to reach a staggering $105 billion by 2030 and an estimated 31.5 million Americans expected to be on these medications by 2035, the impact on various sectors of the food industry is not to be underestimated.

However, according to CNBC, which was one of the many outlets reporting on the survey results,

[M]any food and beverage companies have reassured investors over the last few months that it’s still unclear how much those drugs will lower their revenue. Morgan Stanley also said in the survey that GLP-1s are a manageable long-term pressure on restaurants, not an “existential risk.”

Food companies survival projections

Among the most vulnerable are traditional fast-food chains and packaged food manufacturers, whose offerings often align with the high-calorie, indulgent preferences that GLP-1 medications seem to deter. Conversely, places offering healthier alternatives, such as fast-casual restaurants focusing on fresh ingredients and nutritional transparency, are better positioned to weather the storm of changing consumer habits.

In particular, brands like Cava, Chipotle, Sweetgreen, and Starbucks stand out as adaptable to the evolving consumer landscape, while legacy fast-food chains like Jack in the Box, Wendy’s, and Shake Shack may face greater pressure to innovate and cater to health-conscious clientele.

Similarly, packaged food companies like Hershey are identified as particularly vulnerable due to their reliance on traditional, calorie-dense snacks. On the flip side, companies offering healthier alternatives, such as Vital Farms and Simply Good Foods, are poised to benefit from the growing demand for nutritious options.

What foods might be out?

The survey also highlights the impact of GLP-1 medications on specific food categories, with consumers reporting reduced consumption of snacks, confections, and sugary drinks. This trend is expected to translate into a decline in the consumption of certain products, including ice cream, cakes, candies, and regular sodas, by 2035.

GLP-1 drugs are going for your vices, too

Wait, there’s more. It’s not just the food but tobacco and alcohol, too. The report suggests that users of GLP-1 drugs, including Ozempic, are reducing their consumption of tobacco and alcohol while on these medications due to appetite suppression effects. Survey data shows significant reductions in both tobacco and alcohol consumption after starting the treatment.

While caution is advised in drawing conclusions, anecdotal evidence suggests these drugs might help curb addictive behaviors. Clinical trials are underway to explore this further. Morgan Stanley predicts continued growth in the GLP-1 market, projecting a $105 billion global market by 2030, with around 31.5 million users in the U.S. by 2035.

The bottom line

The rise of GLP-1 medications is reshaping consumer habits and posing challenges to various sectors of the food and beverage industry. While some companies may face headwinds, others have the opportunity to innovate and cater to the growing demand for healthier options. As the landscape continues to evolve, adaptation and responsiveness to changing consumer preferences will be key for businesses seeking to thrive in this new era of food consumption.

Your responses and feedback are welcome!

Source: “Most people on weight loss drugs are spending less on restaurants and takeout, survey says,” CNBC, 4/20/24
Source: “Ozempic is coming for the alcohol and tobacco industries next,” Quartz, 4/23/24
Image by Jonathan Borba on Unsplash

GLP-1 Agonist Drugs Show Promise for Treating More Conditions

GLP-1 agonist drugs like Ozempic, Wegovy, Mounjaro, and Zepbound, initially used for weight loss and diabetes, are showing promise for treating various conditions beyond their original scope. Novo Nordisk’s Ozempic and Wegovy, along with Eli Lilly’s Mounjaro and Zepbound, are leading this trend.

Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound — brand names for drugs semaglutide and tirzepatide — are far and away the most famous members of a booming class of medications known as GLP-1 agonists. These medications mimic a gut hormone called GLP-1. They were initially approved to treat diabetes and, more recently, obesity, and with more and more people using the drugs, signs of other potential benefits are starting to emerge.

For one, Novo Nordisk gathered enough data to prove this and scored approval from the Food and Drug Administration last March to add cardiovascular benefits to Wegovy’s label (experts expect Zepbound will be shown to have similar heart benefits). And earlier this month Eli Lilly issued a press release notifying the world that it was eying a label expansion for Zepbound after a late-stage trial found that the drug “meaningfully improved sleep apnea symptoms,” which means the drug “has the potential to be the first pharmaceutical treatment for the underlying disease,” according to Lilly’s senior vice president for product development Jeff Emmick.

To expand on this, Eli Lilly’s weight loss drug Zepbound has shown effectiveness in reducing obstructive sleep apnea in adults with obesity, potentially becoming the first pharmaceutical treatment for this condition. The drug led to significant reductions in sleep apnea events in two studies, with participants experiencing an average weight loss of around 20%.

These findings, though not yet peer-reviewed, indicate the drug’s potential to address a major health issue beyond weight loss. Experts believe these results could influence insurance coverage for the drug, and Lilly plans to present additional details at the American Diabetes Association conference in June and submit them to the FDA later this year.

Additionally, companies like Novo Nordisk, Eli Lilly, Boehringer, and Zealand Pharma are exploring GLP-1 drugs as a potential treatment for fatty liver disease. As a recent Forbes article points out:

Studies also indicate the GLP-1 class could potentially help with a range of brain disorders, where they potentially help boost mood, cognitive function and alleviate symptoms for conditions including Parkinson’s, Alzheimer’s, depression, bipolar disorder and anxiety, areas that have long been notorious sticking points for pharmaceutical development.

Substance use disorders and addiction is another promising avenue following reports of diminished cravings among people taking GLP-1 drugs, though scientists are still working to figure out why — the drug could feasibly act on parts of the brain and nervous system as these also produce the GLP-1 hormone or have relevant hormone receptors for it — and confirm whether the medications can indeed curb addiction.

Of course, post-approval reports are crucial, as they may reveal unforeseen negative effects. Still, the weight loss market has no indication of slowing down. On the contrary, analysts estimate that the weight loss drug market could be worth at least as much as $100 billion by 2030, with Novo Nordisk and Eli Lilly currently dominating it. These companies’ extensive data and label expansions set a high bar for competitors.

Your responses and feedback are welcome!

Source: “Drugs Like Ozempic And Mounjaro Could Treat Other Conditions — Here’s What Scientists Are Looking At,” Forbes, 04/18/24
Source: “Eli Lilly’s weight loss drug Zepbound found to reduce sleep apnea, company says,” NBC News, 04/17/24
Image by Isabella Fischer on Unsplash

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About Dr. Robert A. Pretlow

Dr. Robert A. Pretlow is a pediatrician and childhood obesity specialist. He has been researching and spreading awareness on the childhood obesity epidemic in the US for more than a decade.
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Presentations

Dr. Pretlow’s invited presentation at the American Society of Animal Science 2020 Conference
What’s Causing Obesity in Companion Animals and What Can We Do About It

Dr. Pretlow’s invited presentation at the World Obesity Federation 2019 Conference:
Food/Eating Addiction and the Displacement Mechanism

Dr. Pretlow’s Multi-Center Clinical Trial Kick-off Speech 2018:
Obesity: Tackling the Root Cause

Dr. Pretlow’s 2017 Workshop on
Treatment of Obesity Using the Addiction Model

Dr. Pretlow’s invited presentation for
TEC and UNC 2016

Dr. Pretlow’s invited presentation at the 2015 Obesity Summit in London, UK.

Dr. Pretlow’s invited keynote at the 2014 European Childhood Obesity Group Congress in Salzburg, Austria.

Dr. Pretlow’s presentation at the 2013 European Congress on Obesity in Liverpool, UK.

Dr. Pretlow’s presentation at the 2011 International Conference on Childhood Obesity in Lisbon, Portugal.

Dr. Pretlow’s presentation at the 2010 Uniting Against Childhood Obesity Conference in Houston, TX.

Food & Health Resources