1 of 5 | Dr. Catherine Welford Varney, a UVA Health family medicine physician in Charlottesville, Va., who specializes in obesity medicine, says it's not fair to shift blame for diabetes drug shortages to people who need weight-loss medication. Photo courtesy of Dr. Catherine Welford Varney
WASHINGTON, Dec. 1 (UPI) -- Because of a national shortage of a weight-loss drug called Wegovy -- touted as a "game changer" when it entered the U.S. market 1 1/2 years ago -- some diabetics have found it hard to obtain another medication intended to improve blood-sugar control but helps obese people lose weight, as well.
Medical professionals say demand is surging -- fueled by social media -- for Ozempic, a Type 2 diabetes medication that can be used for effectively shedding pounds, even though it was not approved for that purpose.
"The shortage of Ozempic is very real," Dr. Paul Bradley, an Atlanta internist, told UPI in a phone interview. "My diabetic patients are getting their prescriptions, but they're being inconvenienced by having to shop [at] multiple drug stores."
Pharmacist Erin Fox told UPI in an email the situation is difficult on her end, too.
"It's a really frustrating shortage -- we know patients depend on Ozempic and the supplies are very inconsistent," said Fox, senior pharmacy director at University of Utah Health and adjunct professor at University of Utah College of Pharmacy.
She added: "It's frustrating not to have more detail about how much product you can expect to receive or when the shortage will truly be resolved."
Each brand that contains the active ingredient found in Wegovy, Ozempic and other drugs, semaglutide, is approved by the Food and Drug Administration for different conditions.
Semaglutide is in a class of drugs generally given by a weekly or daily shot. The drugs work by increasing the release of insulin and mimicking a naturally produced hormone that targets areas of the brain that regulate appetite and food intake.
Wegovy received FDA approval in June 2021 for chronic weight management in adults, and Ozempic received the FDA nod in 2017 to reduce blood sugar and heart disease risk for people with Type 2 diabetes.
Both drugs are expensive. Wegovy costs about $1,400 a month and Ozempic costs about $900, before taking insurance coverage and other factors into account. Both are made by Novo Nordisk, of Denmark.
Despite shortages, which the manufacturer says it will resolve soon, the good news is that the estimated 4 in 10 Americans who are obese and struggling to lose weight finally have highly effective prescription drugs to help them, endocrinologist Dr. Beverly Tchang said.
"The shortage is because we've never treated these patients [with obesity] before. It's not about taking medications away from people with diabetes. It's about actually treating a population that deserves to be treated -- for the first time," said Tchang, who works at Weill Cornell Medicine's Comprehensive Weight Control Center in New York City.
Chang said patients' weight loss is as important as blood-sugar control.
"When we treat obesity, we are either treating or preventing diabetes," she said.
The FDA approved Wegovy for adults with obesity who have a body mass index of 30 or greater, or overweight adults with a BMI of at least 27 who have at least one weight-related condition, such as hypertension, Type 2 diabetes or high cholesterol.
At least 50% of people who take Wegovy lose 15% of their body weight or more, with 4 in 10 patients losing 20% or more, clinical trial data show.
When it was approved, Wegovy became the first new drug treatment for chronic weight management since Saxenda, or liraglutide, debuted in December 2014. But Saxenda requires daily injections that result in less weight loss, doctors said.
That's why demand for Wegovy quickly exceeded supply, and supply chain issues made the costly product even more scarce.
By February, Novo Nordisk halted 0.25-milligram and 0.5-mg. starting doses of Wegovy and focused on supplying 2.4-mg. maintenance doses to people already taking the drug.
Then, in May, when the FDA approved a higher strength, 2-mg. dose of Ozempic -- putting it closer to Wegovy in potency -- Ozempic prescriptions took off.
Weight loss is tied to the size of a dose of semaglutide, doctors said, so Ozempic's approval at double its original dose made it more attractive as a weight-loss drug -- until it, too, ran into short supply.
Dr. Catherine Welford Varney, a UVA Health family medicine physician in Charlottesville, Va., who specializes in obesity medicine, decried efforts to blame people with obesity for creating shortages of a drug for diabetes control.
"More accurately, we need to be blaming employers and insurance companies for not covering anti-obesity medications and the pharmaceutical company for poor planning," she said, disputing Novo Nordisk's statement that "unprecedented demand" is to blame for Wegovy's prolonged scarcity.
Nationwide, 35 million people have Type 2 diabetes and 28 million of them are obese, Varney said. If only 2% were prescribed Wegovy, which is "the current rate of anti-obesity medication use, that is half a million people right there."
However, Wegovy's use would be expected to increase significantly, she said, "especially when the company offered a coupon that allowed patients to pay only $25 per month for six months for this game changer."
"There were 4.8 million prescriptions written for semaglutide in 2021 and they couldn't keep up with demand," Welford Varney said.
Novo Nordisk said in a statement it is "currently experiencing intermittent supply disruptions on various doses of Ozempic due to the combination of incredible demand coupled with overall global supply constraints."
While patients "in some areas of the country will experience delays," the company said it is making short- and long-term investments to resolve "temporary challenges."
Novo Nordisk also said it "recognizes that some healthcare providers may be prescribing Ozempic for patients whose goal is to lose weight, and it is up to their clinical discretion to choose the best treatment approach for their patients."
But the company said it does not "promote, suggest or encourage off-label use of our medicines."
As for Wegovy, Novo Nordisk said it is "on track to make all dose strengths available" in December -- though it will take a few weeks to reach pharmacies across the United States.
So what are doctors prescribing in the meantime for weight loss?
For overweight patients without diabetes, "we would consider Ozempic as an off-label medication," if they meet guidelines for BMI and have other weight-related health conditions, Tchang said.
But most commercial health insurers, once less strict about requiring a diagnosis of Type 2 diabetes for Ozempic', now will usually deny coverage unless a person has this diagnosis, she said.
If Ozempic is not available, Tchang said, she may switch diabetic patients to another semaglutide -- either Trulicity, a once-a-week injection, or Victoza, a daily injection.
"For others riding out the Ozempic shortage, there are other anti-diabetes agents we're familiar with and that have adequate insurance coverage ... that many of us are comfortable prescribing, so switching from Ozempic to another diabetes drug has fewer barriers," she said.
By contrast, she said, "For weight loss, it's, 'Maybe this [drug] will work,' but there are so many more barriers."
Another potential treatment option for type 2 diabetes -- and weight loss -- recently entered the market and is gaining ground, though.
In May, the FDA approved Eli Lilly & Co.'s injectable Mounjaro, or tirzepatide, to improve blood sugar control. The FDA has accelerated its review of the drug for weight loss.
"Mounjaro is getting picked up very well because of the SURMOUNT trial showing 20% to 25% weight loss" from using it, Tchang said. "We may use Mounjaro as an alternative to Ozempic for [patients with] diabetes and also talk about using Mounjaro off-label" in patients with obesity.
Still, Tchang isn't convinced about Mounjaro's ability to meet demand, either.
"I think Mounjaro will help meet some of the demand not being met by Ozempic or Wegovy at the moment," she said, but she expects the new drug to "also end up in shortage."
According to Tchang, some of her patients with obesity "almost feel guilty, like they're taking [a diabetes drug] away from someone. But feeling bad you're finally getting treatment -- it's a weird thing."
She added: "People with diabetes have alternatives and they just need to talk with their doctors now [to find other options] until supply catches up with demand for all patients."