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 would lose weight, but then regain it, plus an extra pound or two.
“You can put some skinny guy who looks really good on a magazine cover and say he did the ‘fill-in diet’, but that’s unrealistic for someone who is chronically obese. “said Robillard, 54. “It was a constant roller coaster of weight gain and loss… and I couldn’t understand why it was so difficult for me.
The Alexandria, Va. Resident never tried to control her weight with medication until she entered the clinical trial for a new usesemaglutide, a medicine for diabetes.In 68 weeks, she lost 63 pounds.
“With the trial, that light came on,” she said. “It was the first time I realized, ‘Wait a minute, it’s not a question of willpower. There is a physical aspect to this.
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 on Friday. Doctors say socould become the gold standard for treating the chronic, stigmatized health condition that afflicts more than 40% of American adults, according to the Centers for Disease Control and Prevention.
But the drug can be difficult to obtain for many people with the disease, experts say due to the cost, lack of insurance coverage, and weight bias among healthcare providers.
What is Wegovy and how does it work?
Semaglutide already exists in a lower dose as an anti-diabetic drug under the brand names Ozempic and Rybelsus made by the same pharmaceutical company, Novo Nordisk.
The drug has alreadybeen used off-label by some doctors to treat obesity, said Dr Jamie Kane, director of the Center for Weight Management at Northwell Health, which is not affiliated with the drug company.
Semaglutide mimics a natural 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 satiety.
One of the challenges of long-term dieting and calorie restriction for people who struggle with their weight is that they are always hungry, said Dr. Rekha Kumar, medical director of the American Board of Obesity Medicine and associate professor of clinical medicine at Weill Cornell Medicine. .
“It can increase long-term adherence because it increases satiety,” said Kumar, who is part of the speaker’s bureau for obesity drug Saxenda, also created by Novo Nordisk. “They can finally lose weight and feel full.”
Robillard felt his urges dissipate in the first weeks of the trial. She was able to eat “normal sized portions” and stopped when she felt full, which was rare in the past.
Clinical trials show Wegovy is more effective than any other weight loss management drug on the market today. Over 50% of participants lost more than 15% of their body weight in 68 weeks.
Patients who take other drugs on the market lose an average of 5% to 12%, said study researcher Dr Robert Kushner, professor of medicine and medical education at the Feinberg School of Medicine. Northwestern University.
Wegovy does not need to be given as frequently as other weight loss drugs. While Saxenda, for example, needs to be injected every day, patients taking Wegovy only need one injection per week.
“It just became a ritual,” said Robillard. “I did it in the morning and it became the morning routine that day.”
Robillard said she had very few side effects other than some acid reflux for a few days when the dose was increased. Almost 85% of trial participants reported adverse events, over 70% of which affected the gastrointestinal tract. Side effects were mostly mild to moderate and included nausea, vomiting and diarrhea. Constipation was another side effect, which in some participants lasted for up to 27 days.
Kane said it was possible for patients to develop gastroesophageal reflux disease, or GERD, a digestive disease in which stomach acid irritates the lining of the food pipes. This can happen when the stomach takes longer to eliminate food and produces more acid.
However, patients can get over the side effects as they get used to the dosage. And while the drug isn’t perfect, Kane said it’s a good start.
“It will become the gold standard for medically managed weight loss,” he said. “It’s a great milestone, but there is more to come in the years to come.”
Wegovy’s prescribing information contains a boxed warning advising healthcare professionals and patients of the potential risk of thyroid C cell tumors. The FDA has stated that 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 regarding pancreatitis, gallbladder problems including gallstones, hypoglycemia, acute kidney damage, eye retinal damage, increased heart rate, and suicidal behaviors or thoughts.
Changing the Discourse on Obesity
Health experts hope that approval of treatments like Wegovy will help change the perception of obesity from a moral failure to the chronic disease it is.
“I can’t think of any other medical condition for which we blame people for their illness,” Kushner said. “It’s like thinking about going around and blaming someone for their diabetes, heart disease, or sleep apnea.”
Part of the drug’s clinical trial demonstrated a physiological component of obesity unaffected by diet and exercise.
After receiving Wegovy for 20 weeks, the 800 participants lost an average of 10.6% of their body weight. Then they were separated in a randomized controlled trial in which 535 continued to receive the treatment and 268 were replaced with a placebo.
Both groups maintained the same diet and exercise regimen, but participants who remained on the drug continued to lose an average of 7.9% of their body weight, while those on placebo gained 6. 9%.
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“The fact that these people stayed in the trial and didn’t know they had switched to a placebo and despite seeing a registered dietitian every month, they regained their body weight, it really highlights the idea that their obesity is biologically motivated and it’s not a problem of will or moral failure, ”Kushner said. “It’s really biology, and it supports the need for long-term treatment like any other chronic disease.
However, health experts still recommend a combination of diet, exercise, and medical interventions to treat chronic obesity.
“Nothing is a catch-all and that’s why this area is so complicated,” Kumar said. “There will never be one thing that works for everyone. “
Barriers to Obesity Treatment
But the benefits of Wegovy may remain beyond the reach of patients due to cost, lack of health insurance, and biases in the medical system.
“We are only treating 1.4% of the target population,” said Dr. Ethan Lazarus, president-elect of the Obesity Medicine Association, which is also part of the Saxenda speakers bureau. The drugs currently on the market “are hardly used”.
A 4-week supply of Ozempic – a lower dose of semaglutide approved for diabetic patients – costs more than $ 850, according to Novo Nordisk. A 30-day supply of the weight loss drug Saxenda costs almost $ 1,350.
Although the company has yet to set a price, Kane said that Wegovy is unlikely to be any cheaper than itslower dose counterparts.
Insurance companies are also less likely to cover obesity treatments. Although 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 of Novo Nordisk. .
“Insurance companies don’t want to pay for the more expensive things… higher end plans tend to cover more things and lower end plans tend to exclude,” Kane said.
Medicare does not currently cover obesity treatments because it classifies weight loss drugs as cosmetics, like hair loss drugs. A bill in Congress, called the “Obesity Treatment and Reduction Act of 2021,” seeks to include obesity drugs among the treatments covered by Medicare.
Medicaid coverage also depends on states with general federal guidelines, many of which focus on programs that focus on prevention rather than treatment. Meanwhile, a 2020 study found that Medicaid recipients were 27% more likely to be obese than those with commercial insurance.
Even with a full coverage plan from a private insurer, patients are less likely to see a doctor for obesity treatment due to the shame and embarrassment of weight bias,experts say.
Weight bias in the medical community manifests itself in multiple ways, ranging from ill-fitting gowns and weighing patients in public to misdiagnosing a fatal disease due to a doctor’s inability to overcome the burden. excess weight of a person.
Although the medical community recognizes obesity as a disease, health experts say some doctors are even less likely to prescribe medication and more likely to encourage themselves and exercise on their own.
Kumar hopes data showing Wegovy’s effectiveness could increase acceptance among doctors and insurance companies.
“This drug, because it is so effective, should standardize the use of anti-obesity drugs,” she said. “We really have to think of (obesity) in the context of a chronic disease model.”
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
Patient health and safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial contributions.
