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Weight loss drugs: As the market soars, people with diabetes pay the price

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CNN

The drug Jeremy Mitchell takes to manage his diabetes, Ozempic, has become a new weight-loss craze, and now he’s having trouble finding it.

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

Runs in your family. Her father, a double amputee, died last month aged 62 following complications from diabetes.

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

Jeremy Mitchell and family

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

After he learned he had diabetes, he lost about 50 pounds through diet and exercise. But when he took a less active job, he found he couldn’t support it. Some of the weight came back.

In May, his doctor prescribed him Ozempic, which helped him lose about 10 kilos. Its A1C dropped to 6.8%. This is still in the diabetic range, but much closer to normal, which is something under 5.7%.

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

He was able to get his doctor to write a prescription for a lower dose, but that means he will have to double the shots. He also confused his insurer, who initially refused to pay for the drug. The pharmacy then told him he would need to shell out $1,000 to buy a two-week supply. His copay is normally $5.

After negotiating with the insurance company, Mitchell was able to cover the pen, but since he’s doubling the doses, they’ll last half as long as usual.

He’s not sure what will happen when this pen runs out. He is worried about having to plead his case with the insurance company again.

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

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

“I think I’m angry not just at celebrities, but at anyone who wears this, and especially knowing there’s a shortage. That information is out,” he said.

Every winter, millions of Americans end the year with tighter waistlines, leading to another annual ritual: the promise of weight loss in the New Year.

Nearly 1 in 4 Americans pledged to live healthier in 2022, making it the #1 New Year’s resolution. One in five said they wanted to lose weight, according to consumer data site Statista.com.

Despite these good intentions, the weight keeps increasing. More than 2 in 5 Americans were classified as obese, with a BMI over 30, between 2017 and 2020, according to the U.S. Centers for Disease Control and Prevention — an increase of more than 10% from 1999-2000 .

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

Three pills approved by the US Food and Drug Administration resulted in 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 designed to treat diabetes to gain 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 makes you feel full pretty much all the time,” says Mitchell of the GLP-1 agonist he’s taking, Ozempic. “You don’t want to eat.”

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

Wegovy became a huge hit, fueled by celebrity mentions and social media posts showing remarkable before-and-after transformations. On Twitter, Elon Musk wegovy credited by your own 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 medications.

But shortly after Novo Nordisk started marketing Wegovy, it ran into shortages when a Brussels-based company hired to fill the syringes was cited by the FDA for quality issues. Manufacturing of the drug has stopped and the shortage that should have been resolved this year has continued.

Wegovy should be taken both to lose weight and to keep it off. Studies show that once people stop using it, the lost pounds can return.

“Several patients who started Wegovy were unable to continue,” said Dr. Kimberly Gudzune, medical director of the American Council on Obesity Medicine.

“And so, as a result of the kind of inability to get Wegovy, a lot of doctors started prescribing Ozempic off-label, which they can, for the treatment of obesity,” she said.

As a result, many of these injectable drugs that mimic GLP-1 are in short supply.

In addition to Ozempic, the FDA lists Eli Lilly’s Mounjaro, or tirzepatide, as being at fault, along with some strengths of the drug Trulicity, or dulaglutide.

“It 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. She used to send prescriptions to pharmacies electronically, which is fast and reduces errors. But she can no longer do that for these injectables.

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

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

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

While acknowledging that some healthcare professionals may be prescribing Ozempic off-label to people who want 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 increase production. It expects to add a second contract manufacturing organization in the first half of 2023. Its current syringe filler has restarted production and it expects to add a second site later in the year.

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

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

Gudzune said it is following that guidance. When people ask about weight loss drugs, she says to wait to start taking them until the tension subsides.

“The excitement about these drugs is, at the moment, a double-edged sword. I’m glad people are excited and feel like they have a treatment option for obesity that would be really meaningful,” she said.

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