From TikTok influencers talking it up to celebrities worrying about "ozempic face," drugs like Wegovy and Ozempic are being touted as weight loss miracles in a country obsessed with slimness.

But, the drugs aren't intended for cosmetic weight loss. Ozempic is approved for diabetes, and Wegovy is for people with obesity who also have weight-related conditions such as high blood pressure or high cholesterol that put them at risk of heart disease. That's millions of Americans.

And evidence shows the new class of drugs are far more effective than prior obesity medications. A landmark clinical trial published in The New England Journal of Medicine in 2021 found that the drug led to a 15% reduction in body weight, on average.

There's been such an increase in demand that an FDA database lists the medication's active ingredient, semaglutide, as "currently in shortage." Its manufacturer, Novo Nordisk, says keeping supplies stable is a priority. The company also markets Ozempic to treat diabetes, which is a lower dose of semaglutide.

But at a cost of about $1,400 a month — out of pocket when insurance doesn't cover it — many people can't afford to stay on the medication for the long term. And when people stop taking it, there's often rebound weight gain that's hard to control. In fact, a study found that most people gain back most of the weight within a year of stopping the medicine.

That's what is happening to Yolanda Hamilton from South Holland, Ill. Hamilton's doctor prescribed Wegovy because she had an elevated BMI, high blood pressure and elevated blood sugar. She lost 60 pounds and started feeling much better.

"It gave me more energy," she says, allowing her to exercise and do house chores. Her cravings for sugar subsided, and she felt satisfied from smaller meals. "I was very surprised by how good I felt," Hamilton says. The drug is administered by a once a week injection at home, which Hamilton says is easy to do.

Her Aetna insurance plan covered the cost of the medication, but when she changed jobs last fall, her new insurance plan through Blue Cross and Blue Shield of Illinois denied coverage. She now works in a hospital ER registering patients, which requires her to sit most of the day. And, after a few months of not taking the drug, she has gained back 20 pounds.

"I'm very frustrated about the weight coming back on in so little time," Hamilton says.

Blue Cross and Blue Shield of Illinois told NPR that benefits offered by employer plans can vary. "Weight-loss drugs like Wegovy may be covered, depending on the member's benefit plan," a spokesperson for the company said. Many other insurance carriers also determine coverage based on what employers are willing to cover.

Barriers to a life-changing drug

The rebound weight gain is not a surprise given how the medication works. Wegovy's active ingredient — semaglutide — is a GLP-1, or glucagon-like peptide-1, which mimics the GLP-1 satiety hormone in our bodies. When we eat, GLP-1 is released from our intestines and sends signals to our brain centers that control appetite.

"This hormone is telling your brain, I'm full, I don't need to eat anymore," explains Dr. Robert Kushner of Northwestern University, who treats Yolanda Hamilton. Kushner also serves on a Novo Nordisk medical advisory board, for which he receives an honorarium.

"What the pharmaceutical companies have done is taken this hormone that is naturally occurring and restructured it into a drug," he explains. So, it's not a surprise that when people stop taking the medicine, they start to feel hungrier, he says.

"I crave sweets," Hamilton says. And her appetite has increased. She no longer feels satisfied with small meals. "I'm losing my energy" as the weight comes back, she says.

Kushner's office is helping Hamilton appeal the insurance denial, but as she waits, she's worried that stopping the medication will also influence her blood pressure and blood sugar. "She is at risk of having these conditions worsen with regain of weight," Kushner says.

"If I gain more weight, I will be on more medications," says Hamilton. Given her long struggle with weight loss, she'd finally found something that was working.

"We're seeing a lot of patients have this rebound weight gain, and it can really be devastating," says Dr. Karla Robinson, a family physician based in Charlotte, N.C., and a medical editor at GoodRx, a company that helps people find the lowest prices for generic and brand drugs. There's no generic version of semaglutide.

"Unfortunately, being a new medication, it's one of those that is subject to the pricing of the manufacturer," Robinson says.

A representative from Novo Nordisk notes that the company offers a $500 coupon for Wegovy to reduce the cost for patients paying cash.

But, this chart from GoodRX shows the lowest price among all retailers is $1,304 per month for people paying out of pocket, which is out of reach for most people — even with a coupon.

"I do feel like Wegovy is revolutionary," Hamilton says. But she says she definitely can't afford to pay for it.

"Some of the people who need it the most are unable to access it," Robinson says, pointing out that people with low incomes experience obesity at disproportionately higher rates.

"We're talking about a huge health equity issue," she says. Black and Hispanic adults have higher rates of obesity, according to the CDC.

Since Wegovy was approved by the FDA in 2021, some insurance plans have begun to cover the medication for people who meet the clinical prescribing guidelines. According to the FDA, people are eligible if they have a BMI of 27 or higher and also have at least one "weight-related ailment" such as hypertension, diabetes, or high cholesterol. Or they have a BMI of 30 or higher, regardless of weight-related ailments.

But insurance coverage is very spotty. Medicare does not cover Wegovy or other weight loss drugs, and many insurers follow Medicare's lead. Increasingly, there's pressure to change this. As STAT reported last week, the Moffitt Cancer Center in Florida is lobbying for legislation that would allow Medicare to pay for obesity drugs, citing the link between obesity and cancer risk. The NAACP is also registered to lobby on this issue.

In addition, the American Academy of Pediatrics has new guidance recommending that pediatricians offer weight loss drugs to adolescents 12 and older with obesity as an adjunct to behavior change and lifestyle interventions.

Long-term unknowns

But the fact that people may need to stay on Wegovy indefinitely in order to maintain the weight loss has raised concerns about long-term use. The most common side effects of the drug are GI symptoms. "Nausea, diarrhea, constipation, vomiting in some people, or heartburn," Kushner says.

He says starting with a low dose and increasing it over time can help people tolerate the drug better. There's ongoing research to evaluate the drug's effect on the cardiovascular system, which is positive so far.

But the drug does carry a black box warning because in rodent studies it caused thyroid tumors. So, Kushner says doctors need to screen patients to find out if they have a family history of a specific kind of thyroid carcinoma, or another rare condition called multiple endocrine neoplasia syndrome type 2 (MEN 2). "This would be an individual patient conversation," Kushner says. Generally, if you don't have a history of these conditions, "this medication is thought to be safe," he says.

If this sounds unsettling, it's a reminder of how high the stakes are to combat obesity. The theoretical risk of thyroid tumors may be unnerving. But doctors point to the risks of leaving obesity untreated: Heart disease is the leading cause of death in the U.S., and obesity and weight-related conditions are top risk factors.

Of course, exercise and diet modification are still the first strategies to try. But given that about 70% of Americans are overweight or obese, nearly half of adults in the U.S. have hypertension and more than 1 in 3 have pre-diabetes, doctors' groups cite an urgent need to layer on more interventions that can be helpful.

"We, as a society, are spending $173 billion in obesity-related health care costs," says Dr. Marcus Schabacker, CEO of ECRI, an independent, nonprofit group that has reviewed the evidence of new weight loss drugs.

He argues that the drugs can be part of destigmatizing obesity by treating it like any other disease that you treat with medicine. "We would not ask someone who has hypertension to just do exercises and change your diet and then you will be fine. No, we give them beta blockers. It's not different here. Exercise and diet are key components of tackling obesity, but so are medications which have proven to be effective," he says.

Copyright 2023 NPR. To see more, visit https://www.npr.org.

Transcript

STEVE INSKEEP, HOST:

Many people are talking about the weight loss drug Wegovy. It was called a major breakthrough given how well it does work to reduce body weight. But this drug is extremely expensive. And when people can't afford to stay on it, they often experience rebound weight gain that is hard to stop. NPR's Allison Aubrey has been reporting on this. Hey there, Allison.

ALLISON AUBREY, BYLINE: Good morning, Steve.

INSKEEP: Who's eligible for this drug? Who's it for?

AUBREY: Well, a lot of people are eligible. This is a drug for people who have a BMI - or body mass index - of 27 or higher and also have conditions related to obesity, so high blood pressure, high cholesterol. And that's millions of Americans. I spoke to Yolanda Hamilton. She works in a hospital ER. She's 51 years old, was struggling with pre-diabetes, hypertension. She recently lost 60 pounds on the drug, which is taken at home once a week by injection. Here she is.

YOLANDA HAMILTON: I was very surprised about how much weight I lost on Wegovy. And I was very surprised about how good I felt - gave me more energy to do other things, exercising, coming home from work and able to do house chores.

AUBREY: So she was feeling a lot better. And she lost all the weight in under a year.

INSKEEP: Is it clear that that is the normal experience, it works that well all the time?

AUBREY: Yes. This drug really started to take off after the results of a big clinical trial were published in the New England Journal of Medicine almost two years ago. It showed people who took the drug for about six months lost about 15% of their body weight. So for a 200-pound person, that's 30 pounds. I spoke to Dr. Robert Kushner of Northwestern. He's one of the researchers on the study. He also serves on an advisory board at Novo Nordisk. That's the company that markets Wegovy. He says it was surprising. Some people lost even more.

ROBERT KUSHNER: One-third of individuals lost 20% or more of their body weight. Our mouths are really open. I've been involved in this field for over 40 years. We have never seen a medication that caused this amount of weight loss.

AUBREY: So unprecedented results, he says. But what some don't realize is that once people start the drug, they may need to stay on it indefinitely, Steve. Otherwise, the research shows, there's a rebound effect. People tend to gain most of the weight back within a year if they stop the medication.

INSKEEP: Meaning they would be stuck on this drug for life?

AUBREY: Potentially, yes, in order to maintain the benefits. But given the cost of the drug, Steve, which is about $1,400 a month for people paying out of pocket, not everyone can stay on the medication. Yolanda Hamilton changed jobs. And with that, her health insurance has changed. Her new plan denied coverage of the drug. And very quickly, within just a few months, she's already gained 20 pounds back.

HAMILTON: I definitely wouldn't be able to afford the Wegovy at $1,400 a month. And I'm very frustrated about the weight coming back on in so little time.

AUBREY: She says her cravings for sugar and fatty foods is back. And she's hungrier.

HAMILTON: But with the Wegovy, I had no taste for the bigger meals.

AUBREY: And that really makes sense, Steve, given how this drug works. It basically mimics a hormone in our bodies that can help us feel full. So without the drug, the weight is coming back on. And she's now at risk of developing diabetes and heart disease if she continues to gain weight.

INSKEEP: Well, some people listening to that might say, well, I really shouldn't be starting this drug. Maybe I should be trying to change my diet myself or doing a little more exercise.

AUBREY: You know, I think most people would like to lose weight by diet and exercise. But we live in a society where people are sedentary, in part due to our jobs. Yolanda Hamilton sits 8 hours a day at her job. And the unhealthiest foods are the cheapest foods.

INSKEEP: Yeah.

AUBREY: I mean, heart disease is the No. 1 cause of death in the U.S., Steve. And obesity is a big risk factor. It can shave years off someone's life. I spoke to physician Marcus Schabacker. He's CEO of ECRI. They're an independent nonprofit group that aims to make health care more equitable and more cost effective. His group has reviewed the evidence of these new weight loss drugs. He says, at a time when our society spends more than $170 billion a year on obesity-related costs, these FDA-approved medicines should be covered.

MARCUS SCHABACKER: Exercise and diet are key components of tackling obesity, but so are medications which have proven to be effective.

AUBREY: But right now, coverage of Wegovy by insurance plans is pretty spotty. Yolanda Hamilton's doctor is helping her appeal the insurance company's denial. But this is tricky to do. Medicare does not pay for Wegovy. Though, increasingly, there is pressure to change that.

INSKEEP: For now, what can people do if they are denied coverage?

AUBREY: Well, I spoke to Karla Robinson. She's a family physician who is also a medical editor at GoodRx, a company that helps people find affordable prices for generic and brand medications. She points out that since there's no generic version of these weight loss drugs, they're very expensive. And even with coupons available from Novo Nordisk, the manufacturer, for now, without broad insurance coverage, the drugs are just out of reach for many people, especially among people with low incomes, who experience obesity at disproportionately higher rates.

KARLA ROBINSON: Some of the people who need it the most are unable to access it. And so, yeah, we're talking about a huge health equity issue.

AUBREY: So there is momentum to push for change.

INSKEEP: What are the long-term safety effects of taking this drug for the rest of your life?

AUBREY: Well, no drug comes without risks or side effects. The most common side effect with Wegovy are GI symptoms, so nausea, upset stomach. Dr. Kushner says they're usually temporary, fade away after a few months for most people. There's ongoing research to evaluate effects on the cardiovascular system, which so far have been positive. But I will point out the drug does carry a warning to inform people that in animal studies, thyroid tumors developed in some animals given the drug. Now, this has not been seen in people. But the drug is relatively new. So doctors do screen patients for risk factors linked to a specific kind of thyroid cancer. So bottom line, everyone needs to weigh the risks and benefits. I mean, this drug has gotten a lot of buzz from notables. Like, Elon Musk tweeted about using Wegovy to slim down, plenty of TikTok influencers. But, Steve, this is not a drug for cosmetic weight loss. This is a drug for people whose health is at risk due to obesity.

INSKEEP: NPR's Allison Aubrey. Thanks so much.

AUBREY: Thank you, Steve.

(SOUNDBITE OF HELIOS' "VAINGLORY") Transcript provided by NPR, Copyright NPR.

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