The New Weight Loss Drugs

Are they worth the risk?

Sep 30, 2023

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Seems the diabetic medication, Ozempic, is often in the news these days. It’s being used as an off-label drug for weight loss. The serious side effects of this drug, including kidney failure, are finally coming to light.

Obesity is epidemic in the US. In a National Health Statistics Report from June, 2021, among children and adolescents aged 2–19 years, the prevalence of obesity is around 19% and the prevalence of untreated or restored dental caries in one or more primary or permanent teeth was 46%, another marker for poor and poor nutrition. Among adults aged 20 and over, the age-adjusted prevalence of obesity was about 41%, severe obesity was 9%. From 1999 through March 2020, US obesity increased from 30.5% to 41.9%. During the same time, the prevalence of severe obesity increased from 4.7% to 9.2%.

Although these statistics paint a dismal picture of health (really, the lack of health) in our country, the numbers may be somewhat skewed because a person is labeled as obese primarily by a measurement called the BMI, or Body Mass Index. The BMI was introduced around 1830 by a Belgian named Lambert Adolphe Jacques Quetelet. He was a mathematician, astronomer, and statistician, not a physician. He proposed the idea of the BMI to quantify his idea of the “average man” even though the concept was developed by using the heights and weights only collected on random French and Scottish participants. Apparently, he had no particular interest in the study of obesity. Also in his many papers, Quetelet apparently never advocated for his ratio be used as a general measure of ‘body build’ or amount of fat.

It took almost 150 years for Quetelet’s original index to be popularized by researcher Ancel Keys and colleagues, claiming it was the most superior and the most direct assessment of obesity that could be used.) In his 1972 paper, Keys and colleagues proposed that Quetelet’s ratio be termed body mass index and for it to become the standard population-based form of measurement. A good review of this info can be found here.

The formula for BMI is:

BMI = weight in pounds/(height in inches x height in inches) x 703
The 703 is to convert the index from the original metric version of the formula.
At present, those with a BMI of 25 to 29.9 are considered overweight and a BMI of 30 or higher is considered obese. A BMI greater than 40 is considered severely obese and greater than 50 is referred to as super morbid obesity.

Over the years, the use of BMI to define obesity has drawn criticism:

Only height and weight are used for the calculation. These are not markers of obesity.
A high BMI does not mean an individual is overweight or obese. The BMI cannot account for the difference between muscle and fat. Because muscle is denser than fat, many athletes and bodybuilders are considered overweight according to their BMI, despite being in peak athletic health.
Repeating: Quetelet never advocated that his ratio be used as any kind of general measure of body ‘build’ or ‘fat.’

Sound familiar? Think Kerry Mullis and PCR testing. Seems modern standards use what they want, the way they want, to define the ends they are looking for.

The Truth about Ozempic

Ozempic (semaglutide) was approved in 2017 by the U.S. Food and Drug Administration (FDA) for use in adults with type 2 diabetes. The once/week injection was approved to manage blood glucose levels and HbA1c values. The medication, called a GLP-1 analogue, acts to increase the levels of a hormone called incretin, which in turn helps your body to produce more insulin.

According to research, the active ingredient in Ozempic, semaglutide, also works for weight loss even though Ozempic is not approved for this indication. However, semaglutide is approved for weight loss under the name Wegovy (see below). Ozempic has a smaller dose of semaglutide than Wegovy.

The most common side effect experienced by persons taking Ozempic is nausea. In fact, “tummy hell” is the reason most stop taking the medication or don’t stay with it. Other uncomfortable experiences include foul-smelling, “rotten egg” burps, bloating, gas pains, flatulence and uncontrollable vomiting. Some other side effects include fatigue, hair loss, dizziness, compulsive/addictive behavior and problems with vision.

Another Ozempic side effect that is rarely mentioned is referred to as “Ozempic face” where facial volume and cheek fat are rapidly depleted, resulting in wrinkles and sagging skin. Providers prescribing Ozempic seldom counsel patients about the potential impact on the face. The plastic surgery community has taken advantage of this side effect and has stepped in with dermal fillers, skin tightening techniques, and surgical interventions.

Another issue is these drugs are expensive. Using Wegovy, Saxenda, Mounjaro, or Ozempic without insurance can cost more than $15,000 per year. Today, insurance companies tend to cover these drugs if they’re prescribed to treat diabetes, but many do not cover the drug for weight management. This high cost affects the accessibility considering many individuals may not be able to afford them, especially not over the long period of time needed to see results.

In July 2023, a suit was initiated against Novo Nordisk and Eli Lilly for gastroparesis, a condition in which the stomach empties slowly or not at all. The drugs named are Ozempic, Wegovy and Mounjaro (terzepatide – a diabetes drug; not used/approved for weight loss). Lawyers expect thousands of patients will come forward to be part of the claim. If you are a victim of these drugs, look into becoming part of the suit through this link.

On review of the package inserts for Wegovy, Contrave, and Saxenda, each lists the primary indication as a BMI > 30 or BMI >27 with a conditional comorbidities, such at hypertension, diabetes, or elevated blood lipids. Here are the key drugs now prescribed for weight loss. I’ve noted a few of the most frightening potential side effects for each drug.

This info is condensed and taken directly from the package inserts.

Wegovy (semaglutide) – approved in 2021 - weekly injection

Causes delayed gastric emptying. May impact absorption of other orally taken medications.
It is not known if Wegovyis safe and effective when taken with other prescriptions, or with over-the-counter or herbal weight loss products
May cause the following:
- Thyroid tumors, including cancer
- Pancreatitis
- Acute kidney injury, requiring dialysis
- Serious allergic reactions, including anaphylaxis
- Gallbladder problems including gall stones
Results: The mean percent change in body weight was around 5%. Greater loss was obtained with concomitant intensive lifestyle therapy after 68 weeks.

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Contrave (naltrexone 32 mg/ bupropion 360 mg) – oral tablet

Contrave is a combination of two medications: Naltrexone, an opioid antagonist, and bupropion, more commonly known as Wellbutrin) is an anti-depressant in the category of a norepinephrine reuptake inhibitor. It's not completely clear how these two medications work together to help with weight. (NOTE: the usual dose of buproprion SR for depression is 100 to 150 mg.)

The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, is not kown.

Contraindications (a few listed)

Uncontrolled hypertension
Seizure disorders
Anorexia nervosa or bulimia, or undergoing abrupt discontinuation of alcohol benzodiazepines, barbiturates, and antiepileptic drugs

WARNINGS AND PRECAUTIONS

Suicidal Behavior and Ideation
There are many drug interactions
Can cause seizure disorders

It is recommended to not take Contrave with a high fat meal as it can increase your risk of having a seizure.

Results: Of the participants who stayed on Contrave for the entire 56 weeks, the average weight loss of around 11.5%.

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Saxena (liraglutide) – approved 2014 - weekly injection

Also approved for children 12yrs and older
May cause the following:

Thyroid tumors or cancer
Pancreatitis
Gallbladder problems
Kidney impairment, including acute renal failure
Allergic reactions, including anaphylaxis
Increased risk of suicide

Results: In a clinical trial of more than 3,000 people, the majority of participants lost 5–10% of their body weight while on Saxenda. The average weight loss was 12–23 pounds over 56-weeks.

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Imcivree (setmelanotide)

Imcivree is an orphan drug. It was the first FDA-approved treatment (2020) for three rare genetic conditions that can cause or contribute to obesity. The conditions are very rare, with only around 150 reported in the medical literature for all three combined.

No studies showing long-term effects.

Considering these drugs are relatively new, studies are still in progress to identify long term side effects. As noted above, usage has been linked to serious health conditions in luding cancer, and it remains to be seen how prevalent their issue may be. While many are excited about the overall weigh reduction in the population, do the costs outweigh the benefits?

More accurate predictors of health

Since Keys and his colleagues’ classic paper (1972), body mass index (BMI) has become the standard indicator for obesity. It is use by researchers in population studies, doctors, and personal trainers. It is also used by the government in as a measure of local and regional health for allocating resources and by insurance companies to assess premiums.

There are more accurate predictors of health than BMI. A study in 2017 confirmed that it’s not the amount of fat in your body but where it's stored that may increase your risk for heart attack, stroke, and diabetes. The study looked at the differences in fat distribution patterns among overweight and obese men and women and their associated cardiometabolic risk.

People with the same BMI were found to have very different risk profiles, based on genetics, lifestyle, and diet. In addition, body composition differs between men and women, with women having proportionately more fat and men having more muscle.

A New Day for a Obesity Diagnosis

In June 2023, after its annual meeting, the House of Delegates from the American Medical Association (AMA) released a statement regarding the use of BMI as a medical standard:

The new policy was part of the AMA Council on Science and Public Health report which evaluated the problematic history with BMI and explored alternatives. The report also outlined the harms and benefits of using BMI and pointed to BMI as an imperfect way to measure body fat in multiple groups given that it does not account for differences across race/ethnic groups, sexes, genders, and age-span. Given the report’s findings, the new policy supports AMA in educating physicians on the issues with BMI and alternative measures for diagnosing obesity.... the AMA suggests that the BMI be used in conjunction with other valid measures of risk....The policy noted that BMI is significantly correlated with the amount of fat mass in the general population but loses predictability when applied on the individual level.

To assess the status of health more accurately, metabolic factors are much better predictor than BMI. These five metabolic risk factors that can more accurately assess your risk of heart disease, stroke, and diabetes. These measurements include:

Waist circumference: If a woman’s waist is more than 35 inches and more than 40 inches for a man, there is increased risk.
High blood cholesterol: A total cholesterol level higher than 240 mg/dL can pose a greater risk to health conditions.
Elevated triglycerides: Triglycerides are often a marker of the amount of simple carbohydrates (sugar) in you diet. A high level of triglycerides is over 150 mg/dL is worrisome.
High blood pressure: The upper limits of a normal blood pressure is 140/90mmHg. Having numbers that are consistently higher is considered a risk factor.
High blood sugar: A fasting blood sugar levels constantly higher than 125 mg/dL is considered abnormal and a risk factor for diabetes.

Natural solutions for weight loss

The addition these medications only adds about 10-15% total weight loss. For perspective, that means if you weigh 200 pounds, you will lose about 20-25 pounds over the course of at least a full year of risky medication.

Instead, undertaking a comprehensive lifestyle change is the best and most powerful way to achieve the physically lasting effects. The removal of what I’ve long called the Great Whites – 1) white refined sugar, 2) white flour (gluten), 3) white homogenized cow’s milk (pro-inflammatory), 4) white rice (empty calories) – and the removal of toxic additives, fast foods, and ‘bad’ saturated or trans fats, will lead to weight loss but more importantly, create a healthy life. Additionally, each day you should drink ½ your body weight (in pounds) in ounces of clean water [i.e. if you weigh 140 lbs, you should target to drink 70 ounces of water per day] , do at least 20 minutes of exercise and get at least six hours of quality sleep each night.

It is essential to have a vitamin D level of at least 80 ng/ml to lose weight. There have been many published articles on this topic. Here’s one. As a rule of thumb, it is recommended to take 1000 IU/day (0.025mg) for each 50-55 pounds (25 kg)) of body weight. You can find our Vitamin D here or Vitamin D+K for your bones here.

A supplement we recommend to balance blood sugar is Gluco-Control offered through Touchstone essentials. Exclusive enzymes target excess glucose, helping to flatten the glucose curve during and after your meal. Simply take 1 or 2 capsules an hour before a meal and feel the difference all day.

Gluco-Control reduces cravings and increases the feeling of being full. Gluco-Control has a proprietary glucose control complex, consisting of plant-based enzymes, organic mushrooms (chaga and reishi) and probiotics, which work together to support healthy blood sugar. It is vegan, gluten-free, and non-GMO. A full listing can be found in the supplement facts panel. Get your first bottle at a discount only through this link. I take it daily. You’ll be glad you did. For more information, here is our podcast and longer discussion about Gluco-Control.

There is no quick fix to weight loss; it takes time and dedication. But it’s worth it from every perspective. Don’t buy into a weight loss drug hype that actually only gives a small result for a potentially life-time of horrible health.

Dr. Tenpenny's Eye on the Evidence

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