The FDA recently announced that Novo Nordisk’s semaglutide GLP-1 medication (Ozempic and Wegovy) is no longer in short supply. Before this announcement, the FDA permitted compounded GLP-1 products to be sold at much lower prices to maintain supplies. But, since the FDA only allows compounded drugs to be sold while the branded forms they’re mimicking are limited, compounded GLP-1 sellers will have until April or May to take their products (which are far cheaper than their branded counterparts) off the market.
This announcement means that weight loss treatment is going to get more expensive. Compounded semaglutide medications are currently being sold at large online healthcare providers for as little as $165 per month. The decision by the FDA could raise those costs as much as 10-fold, as only expensive brands by big Pharma will be available.
What are compounded GLP-1s? You may have heard the brand names in advertisements, Mounjaro, Wegovy, Ozempic, Zepbound. Compounded GLP-1s are purported to have the same ingredients and formulas as the brand names at significantly lower prices.
GLP-1s are game changing weight loss drugs. These medications were initially developed to help people with type 2 diabetes manage their blood sugar. When weight loss was recognized as a side effect, physicians began prescribing them off label for weight loss. Now, GLP-1s are prescribed for those who qualify as overweight (with certain comorbidities) or obese based on Body Mass Index (BMI).
How do these medications work? GLP-1 drugs mimic the GLP-1 gut hormone and amplify its effects. This hormone decreases blood sugar levels and slows down the stomach. More importantly, it suppresses hunger signals by affecting the hypothalamus, known as the appetite center of the brain. People taking these drugs report experiencing little or no hunger.
The success of GLP-1 drugs for weight loss is significant. And in most cases, GLP-1 drugs are prescribed alongside lifestyle changes, like a healthy diet and physical activity, to help patients lose weight and maintain their weight long-term. Numerous clinical studies have shown they can help patients lose weight (between 17% to 23% of body weight) more effectively and maintain a healthy body weight (if they continue to take them). The use of GLP-1s has resulted in a 20% reduction in cardiovascular diseases, reduced fatty liver disorder, and reduced instances of type 2 diabetes.
The population of overweight people in America is not a small one. According to the CDC, 74% of adults are overweight based on BMI. About 43% of the population are clinically obese (BMI>30).
Recent guidelines by the CDC emphasize preventing obesity through better education about health and diet, improving food labels, and continuing programs that focus on healthy eating. These habits include adequate nutrition, reduced sugar, reduced fast food intake, recommended activity levels, and limited exposure to unhealthy stressors.
It is easy to say that overweight people are merely people who lack willpower, but the truth is that our bodies are designed to retain weight, not lose it. Scientists learned a lot about fat and weight loss after monitoring participants from the television show The Biggest Loser. Most of the poor souls who participated in that television show have gained their weight back. Not because they are weak-willed or lazy, but because the biology of their bodies is determined to return to their unhealthy weight levels.
One of the causes of their weight regain was the hormone leptin, which causes the feelings of hunger and satiety. Contestants began their weight-loss journey with normal levels of the hormone leptin. By the season’s finale, they had almost no leptin at all. In short, they were starving.
Their metabolism, regulated by the thyroid, had slowed dramatically as well. After weight loss, they needed to eat 600 fewer calories than the average person to maintain their weight. One contestant who has been working to keep his weight down; is a 295-pound man, 6 feet tall; whose metabolism has so slowed that, despite 6-8 hours of rigorous weekly strength exercise and constant feelings of starvation, he must consume 800 calories per day fewer than a typical male his size to maintain his current weight. Hardly a fair fight.
Our body uses other mechanisms to prevent us from losing weight. After losing 10% of our body weight, our muscles start using genes to exercise more efficiently, causing us to burn 20-30% fewer calories while doing the same amount of exercise.
The combined effects of low leptin levels and a slower metabolism conspired to make the contestants regain most, if not all, of the weight they’d lost. But the truly shocking part was that their leptin and metabolism levels never rebounded. The more weight a contestant lost, the slower his metabolism became. Weight regain was inevitable.
But GLP-1 medications have proven to be the game changer for these issues, and can be continued after weight loss to maintain weight. So why did the FDA eliminate the low-cost version of these medications, the compounded semaglutide injections?
The FDA allowed compounded semaglutide (GLP-1s) to be produced when there were scarcities in the branded drugs Wegovy and Ozempic. Allowing compounded semaglutides (GLP-1s) ensured that the population could get access to these medications. The FDA recently declared that these shortages no longer exist, thus paving the way for only the branded (and significantly more expensive) FDA approved drugs to be used.
The FDA expressed concerns that compounded GLP-1 drugs, which are not regulated by the FDA, could pose risks for the patient. While most of these online health organizations that supply these GLP-1 medications use FDA approved components in FDA approved labs, there is no regulation on the actual compounded product. There have been few reports of problems, but the potential exists. Branded GLP-1s (such as Wegovy, Zepbound, Ozempic), on the other hand, have undergone rigorous testing to obtain FDA approval.
For many reasons, including the costs of research and development, big pharma cannot compete with the lower priced compounded GLP-1s. The hope is that as more big pharma products are introduced (Eli Lilly is introducing a GLP-1 pill next year), competition will reduce prices. Eli Lilly recently lowered the price of its tirzepatide (another GLP-1 drug).
But, for now, this announcement significantly increases the cost of GLP-1 weight loss medicines. At this time, most insurance companies and Medicare do not cover these medications for weight loss (only for diabetes), so someone who wants to lose weight using GLP-1s must have sufficient funds to pay for this medicine. (At current prices, it would be very costly for Medicare and insurance companies to cover GLP-1s for weight management.)
Which begs the larger question. If scientists are calling obesity a disease, which they are, why is it not being treated as a disease? We have a solution for obesity that is proven to work, but without insurance and affordable prices, these treatments are only available to those who have the resources to pay for these medications. The rest must fight their biology with weight loss plans, diets, but mostly, sheer willpower. Hardly a fair fight.
Angela Rieck, a Caroline County native, received her PhD in Mathematical Psychology from the University of Maryland and worked as a scientist at Bell Labs, and other high-tech companies in New Jersey before retiring as a corporate executive. Angela and her dogs divide their time between St Michaels and Key West Florida. Her daughter lives and works in New York City.