Americans are obsessed with a class of drugs that have taken America by storm.
Jimmy Kimmel joked about it in March when he hosted the 2023 Academy Awards. Surveying an auditorium brimming with suddenly svelte Hollywood celebs: “I can't help but wonder, 'Is Ozempic right for me?'”
And once again, the drug Ozempic, which has been used for years to lower blood sugar and A1C in people with diabetes, was taking center stage because it and other drugs can cause dramatic weight loss.
Concerns about your weigh? It starts with a check-up.
There may have been some in that room who’ve been taking Ozempic “off-label” for weight loss. As USA Today reported after the Oscars, “Elon Musk and Chelsea Handler are among the few big names who have admitted to using the drug for weight loss, though Handler said she stopped using it after learning it was intended for those with diabetes. But … most celebrities who use Ozempic are likely keeping their lips sealed.”
It’s become an urgent topic because:
- The drugs are in such great demand that Type 2 diabetes patients who need them to stay healthy can’t always find them.
- Countless Americans are scrambling to find them and injecting themselves with unknown substances from questionable sources.
We asked two experts – Dr. Catherine Rolih, an endocrinologist at Novant Health Forsyth Endocrine Consultants - Highland Oaks in Winston-Salem, and Dr. Cressent Pressley, an obesity medicine physician with CoreLife Novant Health – to tell us more about this class of drugs and why some people who really need them can’t get them.
What’s the background on these drugs?
Rolih: This class of drugs, glucagon-like peptide 1 (GLP-1) agonists, has been on the market for close to 20 years. They mimic our natural GLP-1 hormone produced by the digestive system that tells the brain when you’ve had enough to eat. The drugs help you feel satisfied sooner, so you eat less.
The most effective ones – the ones that have significant weight loss as a side effect – are administered by self-injection once a week, which makes it easy for users to keep up with. For my patients with diabetes, these drugs allow me to reduce the doses of their other medications, particularly insulin. Sometimes we can eliminate insulin completely.
Weight loss is a side effect of the drugs Trulicity, Ozempic and Mounjaro, which are all very similar in effect. Mounjaro, out less than a year, has probably had the biggest effect. People can achieve 20% weight loss, which is getting close to results you see with bariatric surgery.
These are revolutionary drugs for Type 2 diabetes patients, most of whom also have obesity.
Semaglutide — sold under the names Ozempic, Wegovy and Rybelsus — has benefits outside blood sugar control. It actually improves some cardiovascular outcomes. The American Diabetes Association standards of care recommendation moved up Ozempic and other drugs like it to being a first-line therapy. So, they are now standard of care for people with Type 2 diabetes.
Why the sudden popularity with drugs that have been on the market for 20 years?
Rolih: The great American obsession for women has been body size. That’s one thing driving it. You also have social media driving this tremendous interest. Increasingly, I'm having patients say, “My neighbor, my friend, whoever is on this medicine and is having great results. Can I be on it, too?”
What led to the national shortage?
Rolih: When a drug is FDA-approved, it's approved for treatment of a certain condition or illness. But once on the market, you can prescribe it for whatever you want. That’s called prescribing “off-label.” The only restrictions come from insurance companies. A lot of them say, “We'll cover Ozempic for people with Type 2 diabetes, but we won't cover it without that diagnosis.” And the cost is $1,000 to $1,500 a month.
Pressly: Ozempic was approved by the FDA in December 2017 for the treatment of diabetes. The same medication at a higher dose was approved for the treatment of obesity under the name Wegovy in June 2021. It was highly effective, and patients who struggled with obesity their whole lives were finally able to lose weight. Due to high demand and supply constraints, there was a national shortage of Wegovy by March 2022.
When Wegovy wasn’t available, physicians began prescribing Ozempic instead. Five months later, in August 2022, there was a national shortage of Ozempic as well.
What makes these drugs so effective?
Pressly: When you take semaglutide, which is a GLP-1 agonist, you feel satisfied sooner and you don’t eat as much. You also don't feel as hungry. For people who’ve had a powerful inner voice constantly telling them, “You must eat,” it’s a game changer. They can be free of that little voice, free to make the choice to eat what they want, when they want, based on what they know is healthy for them.
How are people able to get these drugs approved by insurance? I mean, my health insurer regularly denies me drugs I actually need.
Rolih: There’s paperwork that has to be done for payment for a medication to get approved by insurance. And sometimes people are untruthful on that paperwork. They’ll say they have a problem they don’t really have just to get access to the medication.
Pressly: Some insurance companies were covering Ozempic for the diagnosis of prediabetes or insulin resistance, which are common in people with obesity. Some insurance companies were covering Ozempic without requiring an associated diagnosis at all. However, in response to the shortage, the majority of insurance companies have implemented policies to prevent off-label use of Ozempic. As of April 1, prescribers must provide medical records to prove a patient has Type 2 diabetes to get Ozempic covered.
So, manufacturers bypassing insurance and making these drugs so readily available – as well as possibly not-quite-truthful paperwork – have contributed to the problem. Is the shortage also at least partially a result of off-label use?
Rolih: My gut feeling is: Yes. My diabetes patients now have decreased access to the medications they need – and that are extremely effective for them – because there’s so much off-label use.
The sad result of that is that the people who have been on those drugs for diabetes for a long time – and are benefiting from them – can’t get them.
I have patients who miss a week or two – or even months – of medication because their pharmacy can't get it. Patients are switching pharmacies, using mail order, spending a lot of time and legwork just to find their medication.
What happens when a diabetes patient can’t get the drug?
Rolih: One of my patients had good control over his diabetes on this medication, and when he could no longer get it, his blood sugar went from 150 to 350, which can be a dangerous level. This is probably happening more frequently than we know.
I’ve heard there are Ozempic knockoffs. I assume people should be leery of those.
Rolih: These medications do have risks, so to get these drugs, you should go through your usual healthcare provider. Avoid the online health community. They don't have your complete medical record; they don't know your history or whether there are indications that you should not be using the medication. And they may not be as informed as you would like them to be as a prescriber. I have concerns about whether people who get these drugs online are being followed appropriately and whether they’re being put at undue risk.
What are some potential side effects of these drugs?
Rolih: There can be GI issues – nausea, vomiting, diarrhea. Some people get constipation. Pancreatitis, which is inflammation of the pancreas, is another possibility. It can be mild – or it can put you in the ICU and potentially be fatal. Another is kidney failure, particularly if you get a lot of nausea, vomiting, diarrhea and get very dehydrated.
And there’s a rare potential problem. There's a type of cancer of the thyroid called medullary thyroid cancer. I've been practicing for almost 30 years, and I’ve only had two patients with that cancer. It’s very uncommon, but it’s out there.
Is taking these drugs a long-term commitment?
Pressly: Yes. Obesity is a chronic disease (see sidebar), so even after weight is lost, medication is often required to prevent regain. The body has a metabolic setpoint. Everything in your body is going to fight to keep you there. When you lose weight, your body's interpretation is that you’re sick or not getting the nutrition you need. Your brain’s job is to keep you at this weight. These medications override your body's hormone system to get that weight down. When you remove that medication, your body will want to return to its previous setpoint.
Think about obesity as you would high blood pressure. If your blood pressure is high, and I put you on medication, your blood pressure will come down. If you stop the medication, your blood pressure will go up again. That’s because your high blood pressure didn't get cured. It got controlled.
When we use these medications for obesity, we tell patients: This is a chronic disease. And when and if you reach your healthy weight, if you want to maintain, you’re most likely going to need to stay on this medication for the rest of your life. You may be able to decrease the dosage or frequency, but it's probably going to be something you take the rest of your life.
I don't want to make it sound like losing weight without medication is impossible. You may be able to lose weight by yourself – it’s just really, really hard. When your BMI hits 30, the fat cells themselves become dysfunctional and start to alter other hormones that cause you to become more obese.
If your BMI is under 30 and you have no other diseases, you're more likely to be able to lose weight without medication. These medications were not intended for and should not be used by people with lower BMI’s who are just seeking to be thinner.
Obesity is a disease
The following is an edited interview with Dr. Cressent Pressly.
For years, everyone thought obesity was caused by eating too much and exercising too little. Over the last 30 years, research has shown that about 50% to 70% of your body size is genetic.
There are 300 different genes associated with obesity. Body size is often predetermined based on your genetics. The environment we grow up in, the medications we take, and the amount of sleep we get also make a difference in our metabolism and relationship with food.
Different bodies consume and burn calories differently. There are hormones – one being GLP-1 – that tell the body: “You've had enough to eat. You are not going to starve.” There are other hormones that drive us to eat, like ghrelin, commonly referred to as “the hunger hormone.” We evolved to have this very strong response to ghrelin, so we would obtain the food we need to survive. For some people, if they feel the slightest twinge of hunger, their brain perceives that as a real threat. It’s a compulsion patients can't control.
Obesity is associated with an increased risk of Type 2 diabetes, hypertension, heart disease, obstructive sleep apnea, osteoarthritis and cancer. Although obesity was recognized in 2013 by the American Medical Association as a disease – just like diabetes and hypertension – insurance companies don’t want to pay for doctor's visits or medications to treat obesity, because there’s still a fundamental bias in our country that says obesity is the individual’s fault.
Even after the American Cardiology Association, the American Medical Association and the National Institutes of Health all made statements that obesity is a disease and needs to be treated as such, many doctors don’t have the knowledge or resources to provide the care necessary.
Many patients with obesity are scared to seek treatment due to negative experiences they have had. Until our society acknowledges obesity as a multifactorial disease and makes treatment easily available, we will continue to see a rise in the number of people suffering from obesity and all the conditions associated with it.