Weight-loss drugs: As the market grows, people with diabetes are paying the price

CNN
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Jeremy Mitchell’s diabetes drug, Ozempic, has become the new weight-loss fad, and now he’s having trouble finding it.

Mitchell, 39, of El Dorado, Kansas, was diagnosed with type 2 diabetes in 2020.

It’s part of his family. His father, a double amputee, died last month aged 62 after complications from diabetes.

“It worries me,” Mitchell said. “I have three children that I want to see grow up, and I want to see my grandchildren grow up, and Ozempic has helped me control my blood sugar.”

When Mitchell was diagnosed, his A1C – a long-term measure of blood sugar control – was an incredibly high 10%.

After learning he had diabetes, he lost about 50 pounds through diet and exercise. But when he accepted a less active job, he realized that he could not sustain it. Some of the weight is back again.

In May, his doctor gave him Ozempic, which helped him lose about 20 pounds. His A1C dropped to 6.8%. That’s still in the diabetic range, but much closer to normal, which is all under 5.7%.

When Mitchell recently went to pick up his refill, an automated message told him there would be a delay in picking up his standard 1-milligram syringe due to a nationwide shortage. All three other pharmacies in town told him the same thing: they had run out of that dose.

He managed to get the doctor to prescribe a lower dose, but that means he will have to double the injections. It also confused his insurance company, which initially refused to pay for the medication. The pharmacy then said it had to shell out $1,000 to pick up a two-week supply. His surcharge is usually $5.

After negotiating with the insurance company, Mitchell was able to get a pen, but since he is doubling up on injections, it will take him half as long as usual.

He is not sure what will happen when this pen runs out. He is worried that he will have to expose himself to his insurance company all over again.

All this meant hours of extra work to get what should have been a routine refill of the medicine. Mitchell wanted to know why he suddenly had to jump through so many hoops, and an internet search turned up stories of celebrities using the weight-loss drug. Mitchell was furious.

“My goal at age 39 is to try to delay insulin dependence as long as possible. I don’t want to suffer the same fate as my father,” he said.

“I guess it just pisses me off not just celebrities, but anyone who would use this, especially knowing there’s a shortage. That information has been published,” he said.

Every winter, millions of Americans end the year with ever-tightening waistlines, leading to another annual ritual: the New Year’s resolution to lose weight.

Nearly 1 in 4 Americans have pledged to live healthier in 2022, making it the number one New Year’s resolution. One in 5 said they wanted to lose weight, according to the consumer data website Statista.com.

Despite these good intentions, the weight continues to pile on. More than 2 in 5 Americans were classified as obese, with a BMI above 30, between 2017 and 2020, according to the US Centers for Disease Control and Prevention – up more than 10% from 1999-2000.

Until recently, people struggling to lose weight could count on only limited help from their medicine cabinets.

Three pills approved by the US Food and Drug Administration has resulted in an average weight loss of about 5% to 10% of total body weight in clinical trials.

In 2014, Saxenda, or liraglutide, ushered in a new era. Taken as a daily injection, it became the first in a class of drugs developed to treat diabetes to receive FDA approval for weight loss.

It belongs to a family of relatively new drugs that mimic the effects of an appetite-regulating hormone called GLP-1. These drugs work by stimulating the release of insulin, which helps lower blood sugar. They also slow down the passage of food through the intestines.

“It leaves you feeling full almost all the time,” Mitchell said of the GLP-1 agonist he takes, Ozempic. “You don’t want to eat.”

Ozempic, or semaglutide, is a more potent cousin of liraglutide. Instead of a daily injection, semaglutide is given once a week. It was approved by the FDA for the treatment of diabetes in 2017 under the brand name Ozempic and for weight loss as Wegovy in 2021.

Wegovy has become an all-out hit, fueled by celebrity mentions and social media posts showing remarkable before-and-after transformations. On Twitter, Elon Musk credit Wegovy for his recent weight loss.

Studies suggest that the drug can help people lose an average of 10% to 15% of their starting weight – a significantly greater amount than with previous drugs.

But soon after Novo Nordisk began marketing Wegovy, a shortage hit when the Brussels-based company it hired to fill the syringes was cited by the FDA for quality problems. The production of the medicine stopped, and the shortages that were supposed to be solved this year continued.

Wegovy should be taken both for weight loss and weight maintenance. Studies show that when people stop using it, the pounds they lost can be regained.

“There have been a few patients who have started Wegovy who have not been able to continue it,” said Dr. Kimberly Gudzune, medical director of the American Board of Obesity Medicine.

“And so, as a result of kind of not being able to get Wegovy, a lot of doctors started prescribing Ozempic off-label, which they’re allowed to do, to treat obesity,” she said.

As a result, many of these injectable GLP-1 mimics are now in short supply.

Except for Ozempic, the FDA lists Eli Lilly’s Mounjaro, or tirzepatide, as a deficiency, along with some strength of the drug Trulicity, i.e. dulaglutide.

“It’s really snowballed,” Gudzune said, and people with diabetes like Jeremy Mitchell are now struggling to find their medications.

Gudzune – who also treats people with diabetes – said the shortage has changed her practice. Previously, she sent prescriptions to pharmacies electronically, which is fast and reduces errors. But she can no longer do it for these injections.

“We kind of, as a group, had to go back to actually giving paper prescriptions to people, because then they can actually call and carry them from pharmacy to pharmacy to pharmacy to find places that actually have the medication that can be dispensed,” she said.

Gudzune said the shortage is especially hard on lower-income people who don’t necessarily have the means or time to visit or call a bunch of pharmacies to find their medicine.

Novo Nordisk, which makes both Ozempic and Wegovy, said in a statement that it is experiencing intermittent supply disruptions of some doses of Ozempic “due to a combination of incredible demand combined with overall global supply constraints.”

While it acknowledges that some health care providers may be prescribing Ozempic off-label for people looking to lose weight, the company “does not promote, suggest or encourage the off-label use of our medications.”

As for Wegovy, Novo Nordisk said it has taken steps to ramp up production. It expects to add a second contract manufacturing organization in the first half of 2023. Its current syringe loader has restarted production and expects to add a second location later in the year.

Novo Nordisk said it is on track to have all Wegovy dosage strengths available by the end of the year.

“We are asking healthcare providers to delay onboarding new patients to Wegovy until we confirm greater availability at the pharmacy level,” Nicole Araujo, senior manager of corporate communications, wrote in an email.

Gudzune said she was following those instructions. When people ask about weight loss drugs, she tells them to wait until the tension has subsided before taking them.

“The excitement around these drugs is a bit of a double-edged sword at the moment and I’m glad that people are excited and feel that they have an option to treat their obesity that actually makes sense,” she said.