GLP-1 Drugs and Celebrities

In the old days, meaning the late 60s and early 70s, adherents of the fat acceptance movement could be found at public protests, throwing diet books and pictures of Twiggy into bonfires, as if they were draft cards. Nowadays, writer Shane O’Neill suggests, the National Association to Advance Fat Acceptance has mellowed into a group that aspires to influence legislation and end discrimination. Other people with similar feelings have gravitated to the more ambitious and militant Body Positivity movement.

For instance, when activist Virgie Tovar received partnership offers from various weight-loss companies, she notified her Instagram followers, “I don’t want Ozempic.” Tovar is not alone in that sentiment. Many people feel that too many body-positive and fat-positive influencers have transmogrified into advocates for weight loss. Their followers feel betrayed. The reporter describes the internet talk show, “It’s Bigger Than Me” produced by pharmaceutical giant Novo Nordisk.

Of course, the drug company has a justification:

We are not here to denounce body positivity or detract in any way from the strides we, as a community, have made in inclusivity. The reality is that two truths exist — obesity can impact health, but the discrimination, stigma and shame experienced by people living with obesity for their weight is also very real.

Meanwhile, if there is one thing the average American loves more than weight loss, that other thing is celebrity worship. A shocking number of average folk want — nay, demand — to know which famous people are using the trendy GLP-1 drugs, for how long, and why, or why not. And how many pounds they have lost, and how often they throw up, or stay home because they are afraid they will throw up.

It has also been open season on celebrities who say the wrong thing about other celebrities’ weight-loss drug use, whether they express criticism or approbation — and out there in the zeitgeist, there is no shortage of either.

Men are more rarely heard from

In the spring of last year, Mark Wahlberg put his feelings on the record. The actor is known for his strict fitness regime which includes rising at 2:30 AM for the first of several daily workout sessions. Wahlberg, of course, is not a normal person, having gained and lost large amounts of weight for film roles. He does it all with exercise and correct eating, saying, “You’d be surprised what you can accomplish when you’re willing to do the work.” He does not judge others harshly, but would definitely prefer them to choose the “good old-fashioned way.”

In the recent past, Wonderwall.com has contacted show biz professionals and recorded their Ozempic experiences. Sharon Osbourne reported taking an unnamed weight-loss drug for four months, feeling nauseated through most of it, and losing 30 pounds. Then in September, she appeared on a talk show and confessed, “I didn’t want to go this thin” — which, apparently, was under 100 pounds.

Actor and “internet personality” Samantha Jo took Mounjaro, and described how peaceful her inner life had become since the “food noise” quieted down, and she understood for the first time what it was like to be a normal person not constantly besieged by thoughts of eating. Jo also told the public that all the positive attention she had attracted was not always comfortable, although her audience had increased and more advertisers sought her out.

There were resentful thoughts, like, “I wasn’t good enough for you then. And the only thing that has changed about me now is my weight… I don’t see how your weight should indicate how you’re treated or if you’re worthy of respect.”

Writer and editor Samhita Mukhopadhyay stopped using Mounjaro because of the expense but also has philosophical objections. Namely, prying into the lives of celebrities as if we had the right, is just a “weird witch hunt, and all these discussions only prove how determined humans are to invent “more tools to judge each other with.”

Your responses and feedback are welcome!

Source: “New marketing push by Ozempic and others sparks body-positive backlash,” WashingtonPost.com, 02/14/24
Source: “Mark Wahlberg Is Not A Fan Of The Ozempic Weight Loss Fad,” Yahoo.com, 05/04/23
Source: “Stars Who Have Admitted,” Wonderwall.com, 09/22/23
Source: “Rocker’s Famous Wife,” Wonderwall.com, 05/08/23
Source: “Food is one of life’s great pleasures. Will weight-loss drugs end that?,” WashingtonPost.com, 10/02/23
Source: “‘You look great! Ozempic?’ The new minefields of weight-loss etiquette,” WashingtonPost.com, 06/25/24
Image by Hollywood Branded/ATTRIBUTION 2.0 GENERIC

Behavioral Therapy, Not Weight-Loss Drugs, Experts Say

The US Preventive Services Task Force (USPSTF) updated its recommendations in June for how primary care clinicians can effectively assist children with high body mass index (BMI), a standard metric used to identify obesity. The task force emphasized that extensive and intensive behavioral interventions are the most effective means for helping children achieve a healthy weight.

Although recent studies have highlighted the success of weight-loss drugs and surgical procedures for children, and the American Academy of Pediatrics endorses these methods as viable options, they are not included in the USPSTF’s current recommendations. The task force’s call for a significant number of hours dedicated to behavioral interventions has frustrated some healthcare providers, who find these guidelines unrealistic or problematic.

Recommendations overview

The latest recommendations from the USPSTF — a volunteer panel of independent medical experts —advise clinicians to offer intensive behavioral interventions to children aged six and older with a high BMI or to refer them to such services.

BMI for children is calculated differently than for adults, though both use height and weight to estimate mass. For adults, a BMI of 30 or higher indicates obesity, whereas for children, a high BMI is defined as being at or above the 95th percentile for their age and sex. This means a child’s BMI is higher than 95% of peers of the same age and gender, according to CDC growth charts. Parents can use the CDC’s online calculator to estimate their child’s body fat percentage.

The USPSTF’s recommended interventions include self-monitoring, goal-setting, supervised physical activity, instruction in healthier eating, and limits on screen time. These interventions should be tailored to fit the patient and their family and should involve at least 26 hours per year, including supervised physical activity.

Research reviewed by the USPSTF indicates that children in intensive programs typically experience modest weight loss and BMI reduction within six months to a year. Greater success was noted in those who spent more time with clinicians and included physical activity in their regimen.

Significance of the recommendations

High BMI in children can lead to severe and potentially life-threatening health issues, such as diabetes, respiratory problems, bone and joint issues, liver conditions, skin problems, high blood pressure, and high cholesterol, which can lead to heart disease. Obesity also exposes children to bullying, affecting their emotional well-being and self-esteem.

Approximately 20% of US children have a high BMI, with obesity rates tripling over the past four decades. The USPSTF recommendations guide primary care providers on effective preventive care, influencing insurance coverage decisions. Under the Affordable Care Act, preventive services graded A or B by the task force must be covered by private insurers; the new child obesity recommendations received a B grade.

Practical challenges

Dr. Susma Vaidya, a pediatrician running a weight loss clinic at Children’s National Hospital in Washington, acknowledges the importance of intensive behavioral intervention but views the 26-hour annual recommendation as impractical. She said:

“We lack the infrastructure to provide such intensive therapy,” noting the challenges for providers, parents, and children in committing to this time frame, which may only yield minimal BMI improvements.

Dr. Mona Sharifi, an associate professor at Yale School of Medicine, who contributed to the American Academy of Pediatrics guidelines on managing childhood obesity, appreciates the emphasis on behavioral treatments. However, she notes that little progress has been made since the 2010 and 2017 recommendations, and access to these treatments remains poor, possibly worsened by the pandemic.

Lack of surgical recommendations

Some doctors also criticize the USPSTF’s decision not to include surgical options. Despite the American Academy of Pediatrics considering bariatric surgery a viable option, the task force did not review the latest research, viewing surgery as outside the primary care scope.

Medication recommendations

The USPSTF also refrained from recommending weight-loss drugs, citing insufficient evidence. While studies on medications like liraglutide, semaglutide, orlistat, phentermine, and topiramate showed larger BMI reductions compared to placebos, long-term effects and potential harms remain unclear, according to task force member Dr. John Ruiz.

Dr. Vaidya argues that these FDA-approved medications have transformed her practice, helping children who struggled with lifestyle interventions alone. “The role of pharmacotherapy cannot be understated,” she said, noting that these drugs can facilitate adherence to lifestyle modifications.

And pharma companies agree

Companies producing popular weight loss injections like Ozempic and Mounjaro are beginning to test versions for children as young as six years old who struggle with obesity.

Eli Lilly announced its intention to start clinical trials with Mounjaro for children aged 6-11. Novo Nordisk, the maker of Ozempic, reported it is in phase three of testing Saxenda, a version of its drug for children aged 6-12.

However, experts stress that lifestyle and behavior modifications should be the primary focus of treatment. The weight loss injections can cost up to $1,500 and may not be covered by insurance. The studies are expected to span several years.

Your responses and feedback are welcome!

Source: “To help children with high BMI, expert panel recommends 26 hours of behavior coaching — but not weight-loss drugs,” CNN, 6/18/24
Source: “Ozempic, Mounjaro manufacturers testing weight loss drugs for kids,” MSN, undated
Image by Food Photographer | Jennifer Pallian on Unsplash

More Interesting Things About GLP-1 Receptor Agonists

For DiabetesJournals.org, Deborah Hinnen wrote, “Proper patient selection and education can assist in achieving positive treatment outcomes.” The writer is talking about the utility of the GLP-1 drugs in treating diabetes, but the same can be said of their use to fight obesity. Patient selection implies that some people, even if they could greatly benefit from any particular treatment, are just not suited to it for other reasons.

Education is paramount in any case. We hope that the patient will take any words that come directly from the physician’s mouth as gospel, and strive to obey “doctor’s orders” to the best of their understanding and ability.

But during office visits, patients are often not at their psychological best. They are worried about how to rearrange their lives to accommodate the new demands made upon them and their families. They are concerned about expenses, and thinking ahead to the possibility that today’s prescription might not help at all, and there will be rough times in store.

Sometimes they have what we used to quaintly call a “mental block” against absorbing certain items of information. An adult patient will sometimes bring along a friend to pay attention and take notes. For a minor individual, of course, there is a good chance that a parent will be present — which is not guaranteed to be a solution, as the attention span and comprehension depth of a parent or guardian can never be taken for granted, either.

Reinforcements

In an office setting, no matter what the doctor says or forgets to say, in the best-case scenario other staff members will make every effort to assure that the instructions and warnings are understood. They will ask if the patient has any questions, or needs clarification about anything. They might hand out a printed information sheet, or directions to a helpful online resource. Of course, even then, there is no guarantee that the helpful information will be pursued or assimilated.

The “I” word

Of more immediate interest is a recent report with the word “injury” in its title: “Acute Kidney and Liver Injury Associated With Low-Dose Liraglutide in an Obese Adolescent Patient.” This paper originates with four members of the Faculty of Medicine at the Hebrew University of Jerusalem. The complete work is accessible for a fee.

The brief summary version begins by recalling that liraglutide was approved in 2020 for people aged 12 through 18, as an adjunctive therapy for weight management “in combination with a reduced-calorie diet and increased physical activity.” It goes on to say,

Although reports in adults have suggested a link between liraglutide and adverse effects including hepatic injury and acute kidney injury (AKI), these effects have not previously been reported among adolescents treated with liraglutide for weight loss.

The cause for alarm was the experience of a 17-year-old boy afflicted with class III obesity, which is the more recent enlightened term for what used to be called morbid obesity. He had been using liraglutide (at its lowest recommended dose) for three months, and consequently experienced not only significant appetite loss, and weight loss, but a sensation of melancholy. By the standard of the Adverse Drug Reaction Probability Scale, it seemed clear that the liraglutide was also responsible for the injury to his liver and kidneys.

After being off the medication for a month, his kidney issue had settled down and his liver enzymes had reverted to normal, and there was an improvement in his mood. The authors note,

Our report highlights the importance of vigilance in monitoring for these potential adverse effects among adolescents treated for obesity with any dose of liraglutide.

Liraglutide had been approved in 2010 as antidiabetic therapy for adults. A document from that year states that some rodent study results were troubling, but there was no firm evidence of adverse effects on humans. Reports of several different conditions, like pancreatitis, appeared here and there, but in very small numbers, and the evidence to connect the cases with the drug was just not there.

Your responses and feedback are welcome!

Source: “Glucagon-Like Peptide 1 Receptor Agonists for Type 2 Diabetes,” DiabetesJournals.org, 2017
Source: “Acute Kidney and Liver Injury Associated With Low-Dose Liraglutide in an Obese Adolescent Patient,” AAP.org, 06/12/24
Source: “Weighing Risks and Benefits of Liraglutide — The FDA’s Review of a New Antidiabetic Therapy,” NEJM.org, 03/04/10
Image by the healthy blog/Public Domain

Unlocking the Potential of GLP-1 Agonists Beyond Diabetes and Weight Loss

Initially developed for diabetes treatment, GLP-1 agonists have gained significant attention for their weight-loss benefits. The success of GLP-1 medications like Ozempic, Wegovy, Mounjaro, and Zepbound has spurred a wave of research exploring their potential beyond diabetes and weight loss.

Discovering secondary uses for GLP-1s

The headlines are coming at us fast and hard. Just in recent weeks, we’ve read that the GLP-1 agonists may help reduce sleep apnea, reduce pancreatitis risk in obese and diabetic patients, reduce rheumatoid arthritis symptoms, and potentially even boost fertility.

In other words, these medications are changing consumer habits and industry dynamics, and people just can’t get enough of them. While the pharmaceutical industry is eagerly investigating new applications for GLP-1 drugs, some think that the real opportunity lies in precision medicine. This approach promises to open numerous commercial pathways and significantly advance personalized patient care.

Why precision medicine?

Elliott Green, the co-founder and CEO of Dandelion Health, which collects and processes clinical data for the healthcare industry, is one of the believers. In a recent article he penned for Fast Company, he opined that, as the COVID-19 pandemic taught us, rapid innovation is crucial for saving and improving lives on a large scale. However, traditional clinical trials, while scientifically rigorous, are not designed for speed and cost-effectiveness.

In Green’s opinion, the challenge is accelerating precision medicine for GLP-1 drugs by applying lessons from the pandemic to achieve near-term, data-driven insights that lead to personalized treatments and care.

Learning from oncology

It’s complicated though. Green writes:

To understand just how “blackbox” GLP-1 drugs are today, one only needs to read or listen to the news. For example, early GLP-1 studies seem to appear daily, and they point to potential issues, such as unwanted side effects in some patients, like psychiatric issues, or opportunities — like GLP-1 agonists potentially being used to treat prostate cancer one day. The key word here? Potential.

With increasing access to data and advancements in AI, healthcare providers should be able to predict which patients will benefit most from specific weight loss drugs. Similarly, pharmaceutical companies should be able to identify new, effective uses for GLP-1 formulations. While progress is being made, it is not happening quickly enough to optimize patient outcomes or confirm new applications for these drugs.

Adopting a proactive approach from oncology, where precision medicine has had a significant impact, could be transformative. Oncologists select treatments based on the genetic profile of tumors. Similarly, GLP-1 drugs could be chosen based on a digital phenotype that predicts the best response with minimal side effects.

Addressing data gaps

The challenge in bringing precision medicine to GLP-1 drugs lies in the lack of real-world data. Although there is more real-world data (RWD) than ever before, much of it remains isolated and unreadable, locked in various systems within healthcare organizations.

RWD often comes from electronic health records (EHR), claims data, and disease-specific registries. However, the most valuable data — unstructured clinical data like waveforms (e.g., ECGs) and imaging data (e.g., MRIs, CT scans) — is typically outside the EHR. This data, which constitutes over 80% of healthcare data, holds immense potential for personalizing GLP-1 care and accelerating drug development. 

Leveraging AI for precision medicine

In Green’s words,

[W]e can take these broad generalizations and turn them into more precise hypotheses to be tested, like: demonstrating GLP-1’s therapeutic effects beyond current uses, including secondary benefits derived from exploratory use or demonstrated with additional data modalities; and developing precision-medicine tools to identify patients with uncontrolled symptoms or to match patients to the right treatment plans.

The bottom line

To advance personalized weight loss treatments, there must be stronger integration of both structured and unstructured health data, and a robust approach to vetting AI algorithms trained on rich, unbiased datasets. This will provide the necessary insights for personalized patient care and help pharmaceutical companies quickly and cost-effectively explore new uses for GLP-1 drugs.

By embracing these strategies, we can drive a more personalized approach to weight loss and unlock new therapeutic potentials for GLP-1 drugs, benefiting patients and the healthcare industry alike.

Your responses and feedback are welcome!

Source: “How AI can power GLP-1’s next frontier in medicine,” Fast Company, 6/7/24
Source: “Ozempic and Wegovy May Help Reduce Rheumatoid Arthritis Symptoms,” Healthline, 6/27/24
Image by lightfieldstudios/123RF

Interesting Things About GLP-1 Receptor Agonists

Most of the research on these drugs, over the years, has been performed with an eye to their usefulness in treating Type 2 diabetes. The findings are also, obviously, pertinent to their effects when prescribed for weight loss in non-diabetic patients.

And of course, it is not their effects alone that matter, but what happens when those effects combine with whatever else the patient is already taking? The professional with a prescription pad must be meticulously conscientious in recording a patient’s history, lest something important and potentially threatening slip through the net.

Regarding the currently existing GLP-1 RA meds, there are a few widely recognized contraindications. Except for oral semaglutide, the others are administered by subcutaneous injection. Some concerns do or may apply to all drugs in this class; others are so far known to only be relevant to one of them. Fortunately, many of the potential problems mainly apply to conditions that are relatively quite rare.

A very detailed report originated in 2006 and has been revised 11 times since then, now stating (among other things):

All GLP-1 agonists have been found to cause c-cell tumors in rodent models, but the human relevance has not been determined. All agents except for [two] have a black box warning for risk of thyroid C-cell tumors,

GLP-1 agonists have not been studied in patients with gastroparesis, and all drugs within this class, except for liraglutide and semaglutide, recommend against use in patients with preexisting gastroparesis.

However, their rep is mostly positive:

There is no basis for limiting the duration of treatment for GLP-1 agonists in patients using this medication for chronic weight management if it remains beneficial for weight loss and is not causing intolerable side effects.

Here are some of the caveats and cautions applicable to either the whole class, or various individual drugs. All of them are, of course, contraindicated in patients who are hypersensitive to the particular substance. All should be warned that since the drugs increase the sensation of satiety, it is quite possible that continuing to eat past the point of feeling full can cause nausea and/or vomiting.

Individual drugs are warned against for patients with existing or incipient pancreatitis, gastroparesis or inflammatory bowel disorders, renal disease, or Multiple Endocrine Neoplasia syndrome type 2. Likewise, for those who have a family history of medullary thyroid cancer.

They probably should be avoided for patients who are on tricyclic antidepressants. It should be noted that the GLP-1 receptor agonists, which are therapeutic peptides, could potentially cause the development of drug antibodies.

Another article, titled “Glucagon-like Peptide-1 (GLP-1) Receptor Agonists,” offers a very thorough comparison of the various available meds of this type. For starters, their efficacy and safety “primarily differ by their frequency of administration.” They all delay gastric emptying and increase satiety, and “There is no significant [clinically meaningful] difference in weight loss effect among the agents in the class.”

Here are other details that could be very disappointing, because none of these things match up with what their various manufacturers would have us believe:

Semaglutide is the only GLP-1 receptor agonist that is available as a once-daily oral tablet. Unlike semaglutide injection, the evidence of CV benefit using the oral route has not been definitively established. Compared to placebo, all agents, except albiglutide, significantly reduced weight and increased the risk of hypoglycemia and GI side effects. There were no clinically meaningful differences in weight loss effects, blood pressure reduction, or hypoglycemia risk among the drugs.

Your responses and feedback are welcome!

Source: “Drug Use Criteria: Glucagon-Like Peptide 1 Receptor Agonists,” Texas.gov, October 2022
Source: “Compare and Contrast the Glucagon-Like Peptide-1 Receptor Agonists (GLP1RAs),” NIH.gov, 03/27/23
Source: “Glucagon-like Peptide-1 (GLP-1) Receptor Agonists,” Elsevier.health, 04/11/22
Image by Consumerist Dot Com/ATTRIBUTION 2.0 GENERIC

More Vagus Nerve Knowledge

The previous post listed some activities of the vagus nerve as having to do with…

[…] stomach expansion, stomach contraction, gastric acid release, stomach content release into the small intestine, digestive pancreatic enzyme secretion and the sensations of both hunger and fullness.

Who is in charge of those departments? Who tells the vagus nerve what messages to convey? It now appears that the directives carried from this area of the body originate with the gut microbiome (as differentiated from, for instance, the skin microbiome).

The notion does seem rather radical, and it feels appropriate to resist the idea that just about everything we are, and do, is fundamentally determined by our colonies of gut bugs. Although we may diligently seek help from various treatment modalities, it is very likely that, where mood and behavior are concerned, the little critters are running the show.

Not surprisingly, the same cluster of functions performed by and related to the stomach, is heavily influenced by bariatric surgery, which causes a faction of professionals to wonder: Rather than subject children to the ordeal of surgery, if the same benefits can be achieved by somehow controlling the vagus nerve, why not concentrate on that? How can it be done?

The vagus nerve has been compared to an “information superhighway” that conveys messages from the gut to the brain. It seems that if we could influence the microbiota in regard to the messages they dispatch through the vagus nerve, that might help. It has even been suggested that “probiotic bacteria could be tailored to treat specific psychological diseases.”

This sounds like a great idea when the potential benefit for autistic children, for one example, is considered. They tend to become obese, because that is a side effect of the only drugs that are approved to treat their condition. This is also true of the drugs used against anxiety, epilepsy, and depression. If the body could be induced to manufacture its own meds to deal with those conditions, the results would be pretty spectacular… and apparently, thanks to the efforts of its microscopic tenants, it can.

The gut-brain axis is a thing

For DiscoverMagazine.com, Carla Delgado described how ultra-processed foods can cause inflammation in the gut, as well as in other parts of the body, and how the inflammation connects with mental symptoms of anxiety and depression. This information comes from Dr. Uma Naidoo of Massachusetts General Hospital, who is credentialed as not only a psychiatrist and nutrition specialist but also a professional chef.

Nutritional Psychiatry does not insist that correlation equals causation — however, the evidence against ultra-processed foods is quite damning. By all indications, the brain is tightly bound to the gut microbiome because of the vagus nerve connection, which is compared again to a “fast two-way highway sending signals and chemicals back and forth.” Dr. Naidoo is quoted:

We produce over 90 percent of our body’s serotonin — as well as other neurotransmitters which govern mood — outside the brain, in the gut where our food is digested and broken down into vitamins, minerals and other nutrients. This enables a natural symbiosis between food and the body’s brain chemistry.

Do emotional and mental disorders cause overeating? Obviously. Does overeating cause mental and emotional disorders? Undoubtedly. And right there in the middle of everything, facilitating the two-way communication, is the vagus nerve.

Your responses and feedback are welcome!

Source: “How Ultra-Processed Foods Can Affect Your Mental Health,” DiscoverMagazine.com, 10/24/22
Image by NIH Image Gallery/ATTRIBUTION 2.0 GENERIC

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

A Vagus Nerve Review

In the past months, the vagus nerve has been showing up quite a lot in the media. Before moving on to consider more recent theories and claims connected with this anatomical feature, it will be useful to recollect some past mentions of it in Childhood Obesity News and other sources. The vagus nerve connects the brain to the heart, lungs, digestive tract, and several other entities.

This quotation from technology writer Aaron Mamiit gives a basic explanation of what the nerve does:

Functions of the vagus nerve involve the enabling of several mechanisms in the human metabolic and gastrointestinal systems, including stomach expansion, stomach contraction, gastric acid release, stomach content release into the small intestine, digestive pancreatic enzyme secretion and the sensations of both hunger and fullness.

Some have gone so far as to call the human gut the “second brain.” It is full of the same neurotransmitters as the brain, and the vagus nerve hooks the brain and gut together as definitively as a pair of conjoined twins. Even if either party objected to such a close and codependent association, they have no choice in the matter.

When the microbiome is out of balance, it can act locally, to cause inflammatory bowel disease complete with pain, vomiting, and diarrhea. Thanks to the vagus nerve, it apparently also has the power to reach all the way up into the brain and cause reactions there, that are the loftier equivalents of pain, vomiting, and diarrhea. It has even been suggested that the “addictive personality” originates not in the mind, but in the intestines.

What’s down there anyway?

The microbiome is made up of several different kinds of organisms. Scientific efforts to sort out the bad from the good became laughable when researchers realized that disease-causing strains can, on occasion, be useful and helpful. Conversely, the most seemingly benign sorts can, under the wrong conditions, damage us.

Our tenants, the gut bugs, can manipulate behavior and mood by altering the neural signals in the vagus nerve. Their tricks include the ability to produce toxins that make us feel bad, and release chemical rewards to make us feel good, and change taste receptors (making certain foods “taste better”). Oh, and release hunger-inducing hormones.

The small intestine is also inhabited by enteroendocrine cells, or EECs, which are important in ways not yet fully comprehended, but we do know they influence obesity. They differentiate into about 15 kinds of cells, and each one only lives from three to five days, so they are constantly being replaced. (Their dead bodies feed the gut bugs.)

The sub-category called L cells makes glucagon-like peptide-1, more familiarly known as GLP-1, which has received a lot of publicity lately. It regulates appetite and consumption by accessing the vagus nerve to influence the brainstem and hypothalamus. Other L cells are responsible for GLP-2, active in the inflammation associated with obesity. The EECs live cheek-by-jowl with the microbiota with whom they interact in ways that are, as yet, not fully comprehended.

Your responses and feedback are welcome!

Source: “Appetite Pacemaker: Here’s How this Weight Loss Implant Works,” TechTimes.com, 01/15/15
Image by Beth Scupham/ATTRIBUTION 2.0 GENERIC

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

A Birds-Eye View of BED

VeryWellHealth.com started off the current year with an extremely detailed overview of the current state of treatment for Binge Eating Disorder (BED), including a perspective on which approaches are likely to be most effective.

(Bear in mind that simple binge eating does not include behaviors intended to cancel out the inappropriate consumption. If the person pursues a counteractive strategy like vomiting or doing exhaustive exercise, that’s a different disorder.)

Showing thorough professionalism by resisting any temptation toward sensationalism, author Heather Jones did not position the most shocking aspect right up front, but left it for the end:

[E]ating disorder treatment can range from $1,500 to $2,000 a day, depending on whether it’s outpatient or inpatient.

Fortunately, there are more affordable self-help options, to be discussed. Altogether, we are looking at a wide range of possibilities, including psychotherapy, lifestyle changes, and medication. Because eating disorders encompass so many complexities, it is recommended that a person obtain the most specialized help available.

Psychotherapy is the most common treatment, possibly because guilt is one of the most common symptoms driving people to seek help. Nobody wants to live in a perpetual state of self-disgust, and even if psychotherapy cannot immediately end the behavior, the exploration of interior states (such as the tendency toward guilt) will certainly be of overall benefit to the patient.

Branching out

As things stand, a less Freudian method — one that does not delve into the murky past — is widely regarded as the first resort. That is cognitive behavioral therapy (CBT), which Jones explains as “a type of psychotherapy that focuses on disordered or negative thinking patterns.”

Not surprisingly, the description is reminiscent of the expression “stinking thinking,” which originated with another widely used and often effective program, Alcoholics Anonymous. In addition to identifying such aberrations, CBT helps to change the wonky thoughts into positive and productive ones.

Then, there is CBT-E, or Enhanced CBT, which narrows down the general usefulness of the technique to a state of maximal helpfulness for eating disorders. Jones says that a therapist “can tailor the treatment to the specific eating disorder that a person has, as well as the unique factors in a person’s life that are contributing to the disorder.”

Here, as in so many aspects of life, the personal touch is very effective:

In one study, CBT-E had a success rate of about 66% in treating multiple eating disorders. A 2014 study showed that participants with binge eating disorder showed improvement during short-term CBT treatment and continued to improve or were stable during the four years after treatment.

It gets even better, with the added benefit that although CBT-E was formulated for adults, it is very amenable to adaptation for use with younger people. For them, as well as for other generations, there is even more good news, in the form of another variation called CBTgsh, where the three small initials stand for guided self-help.

Furthermore, the author notes that “mental health professionals can provide it even if they do not specialize in eating disorders.” It also comes with a caveat:

[R]esearchers are still unsure about the effectiveness of CBTgsh. Older studies suggested that participants with binge eating disorder had positive results from treatment with CBTgsh and that it may be beneficial for some people.

Still, we can’t have everything, and what we do have is quite a lot.

(To be continued…)

Your responses and feedback are welcome!

Source: “What is the Best Binge Eating Disorder Treatment Approach?,” VeryWellHealth.com, 01/10/24
Image by Eric Van Buskirk/ATTRIBUTION-SHAREALIKE 2.0 GENERIC

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Profiles: Kids Struggling with Weight

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The Book

OVERWEIGHT: What Kids Say explores the obesity problem from the often-overlooked perspective of children struggling with being overweight.

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.
You can contact Dr. Pretlow at:

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