FDA approves treatment doctors say is the most effective weight loss drug on the market. But can it really make a difference?
Lisa Robillard has struggled with her weight since she was 10 years old.
Over the years, she has tried at least 15 fad diets advertised on magazine covers. Sometimes she lost weight, then would gain it all back, plus an additional pound or two.
“You can put somebody skinny who looks really great on a magazine cover and say they did the ‘fill-in-the-blank diet,’ but that’s unrealistic for somebody who has chronic obesity,” said Robillard, 54. “It was a constant roller coaster of gaining and losing weight … and I couldn’t figure out why it was so difficult for me.”
The Alexandria, Virginia, resident never tried to control her weight with medications until she participated in the clinical trial for a new use of the diabetes drug semaglutide. In 68 weeks she lost 63 pounds.
“With the trial, that light went up,” she said. “That was the first time I realized: ‘Wait a minute, this isn’t about willpower. There’s a physical aspect to this.’”
On Friday, the Food and Drug Administration approved the 2.4 mg dose of semaglutide – under the brand name Wegovy – that Robillard and about 800 other trial participants took as a treatment for chronic obesity. Doctors say it could become the gold standard to treat the chronic and stigmatized health condition that afflicts more than 40% of adult Americans, according to the Centers for Disease Control and Prevention.
But the drug may be hard to get for many with the disease, experts say, because of cost, lack of insurance coverage and weight bias among health care providers.
What is Wegovy and how does it work?
Semaglutide already exists at a lower dose as an anti-diabetic medication under the brand names Ozempic and Rybelsus made by the same pharmaceutical company, Novo Nordisk.
The drug has been used off label by some doctors to treat obesity, said Dr. Jamie Kane, director of Northwell Health’s Center for Weight Management, who is not affiliated with the drug company.
Semaglutide mimics a naturally occurring hormone that tells the brain when the body is full after a meal. The drug also slows down digestion so food stays in the stomach longer. The mechanisms work together to reduce appetite and increase fullness.
One of the challenges with long-term dieting and restricting calories for people who struggle with their weight is that they always feel hungry, said Dr. Rekha Kumar, medical director of the American Board of Obesity Medicine and associate professor of clinical medicine at Weill Cornell Medicine.
"This can increase longer-term adherence because it increases fullness," said Kumar, who is on the speaker’s bureau for the obesity drug Saxenda, also created by Novo Nordisk. "They can finally lose weight and feel full."
Robillard felt her cravings dissipate within the first few weeks of the trial. She was able to eat "normal-sized portions" and stopped when she felt full, something that was rare in the past.
Study trials show Wegovy is more effective than any other weight loss management drug on the market. More than 50% of the participants lost more than 15% of their body weight over 68 weeks.
Patients who take other medications on the market lose an average of 5% to 12%, said study investigator Dr. Robert Kushner, professor of medicine and medical education at Northwestern University’s Feinberg School of Medicine.
Wegovy doesn’t need to be administered as frequently as other weight loss drugs. While Saxenda for example, must be injected every day, patients taking Wegovy need only one shot a week.
“It just became a ritual,” Robillard said. “I did it in the morning and it became that day’s morning routine.”
Robillard said she had very few side effects other than some acid reflux for a couple of days when the dosage was increased. Nearly 85% of trial participants reported adverse events, more than 70% affecting the gastrointestinal tract. Side effects were mostly mild to moderate and included nausea, vomiting, and diarrhea. Constipation was another side effect, which in some some participants lasted as long as 27 days.
Kane said it’s possible for patients to develop gastroesophageal reflux disease, or GERD, a digestive condition in which stomach acid irritates the food pipe lining. That can occur as the stomach takes longer to clear food and produces more acid.
But patients can overcome the side effects as they become accustomed to the dosage. And while the drug isn’t perfect, Kane said it’s a good start.
“It will become the gold standard treatment for medically managed weight loss,” he said. “It’s a nice step, but there’s more to come in the upcoming years.”
The prescribing information for Wegovy contains a boxed warning informing health care professionals and patients about the potential risk of thyroid C-cell tumors. The FDA said Wegovy should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Wegovy also contains warnings for pancreatitis, gallbladder problems including gallstones, low blood sugar, acute kidney injury, eye retina damage, increased heart rate and suicidal behavior or thinking.
Changing the conversation about obesity
Health experts hope the approval of treatments like Wegovy will help change the perception of obesity from a moral failing to the chronic disease it is.
“I can’t think of any other medical condition where we blame people for their disease,” Kushner said. “It’s like thinking about going around and blaming someone for their diabetes or heart disease or sleep apnea.”
Part of the drug's clinical trial demonstrated a physiological component to obesity unaffected by diet and exercise.
After receiving Wegovy for 20 weeks, all 800 participants lost an average of 10.6% of their body weight. Then they were separated into a randomized, controlled trial in which 535 continued to receive treatment and 268 were switched to a placebo.
Both groups maintained the the same diet and exercise regimen, but participants who stayed on the drug continued to lose an average of 7.9% of their body weight, while those on the placebo gained 6.9%.
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“The fact that those individuals remained in the trial and did not know that they were switched to a placebo and despite seeing a registered dietician every monthly they regained their body weight, it really highlights the whole idea that their obesity is biologically driven and it’s not a problem of willpower or moral failing," Kushner said. “It really is biology, and it supports the need for long-term treatment just like any other chronic disease.”
But health experts still recommend a combination of diet, and exercise and medical interventions to treat chronic obesity.
“Nothing is a catch-all and that’s why this field is so complicated,” Kumar said. “There is never going to be one thing on its own that works for everybody.”
Barriers to obesity treatment
But the benefits of Wegovy may remain out of reach for patients because of cost, a lack of health insurance and bias in the medical system.
“We’re only treating 1.4% of the target population,” said Dr. Ethan Lazarus, president-elect of the Obesity Medicine Association, who is also on the speaker’s bureau for Saxenda. Drugs now on the market “are barely being used.”
A four-week supply of Ozempic – a lower dose of semaglutide approved for patients with diabetes – is more than $850, according to Novo Nordisk. A 30-day supply of the weight loss drug Saxenda is nearly $1,350.
Although the company has yet to set a price, Kane said it’s unlikely Wegovy will be cheaper than its lower-dose counterparts.
Insurance companies also are less likely to cover obesity treatments. Though the drug may be available in pharmacies by the end of June, Novo Nordisk is still working on reimbursement plans and coverage, said Doug Langa, executive vice president of North America Operations and president at Novo Nordisk.
“Insurance companies don’t want to pay for the more expensive stuff … the higher-end plans tend to cover more stuff and the lower end plans tend to exclude,” Kane said.
Medicare doesn’t cover treatments for obesity because it categorizes medications for weight loss as cosmetic, such as medications for hair loss. A bill in Congress called the Treat and Reduce Obesity Act of 2021 aims to include obesity medication as a covered treatment under Medicare.
Medicaid coverage also depends on states with broad federal guidelines, many of which emphasize programs that address prevention instead of treatment. Meanwhile, a 2020 study found Medicaid beneficiaries were 27% more likely to have obesity than those who had commercial insurance.
Even with a comprehensive coverage plan from a private insurer, patients are less likely to go to the doctors for obesity treatment because of shame and embarrassment, experts say.
Weight bias in the medical setting manifests itself in a myriad of ways, from having ill-fitted gowns and weighing patients in public to misdiagnosing a life-threatening illness because of a doctor’s inability to look past a person's excess weight.
Although the medical community recognizes obesity as a disease, health experts say some doctors are still less likely to prescribe medication and more likely to encouragediet and exercise alone.
Kumar hopes data showing the Wegovy's effectiveness may increase acceptance among doctors and insurance companies.
“This medicine, because it’s so effective, should normalize the use of anti-obesity medications,” she said. “We really need to think about (obesity) in the context of a chronic-disease model.”
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
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This article originally appeared on USA TODAY: Weight loss: FDA approves highly effective drug treatment for obesity