As the market for new weight loss drugs soars, people with diabetes pay the price | CNN





CNN
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The drug that Jeremy Mitchell takes to manage his diabetes, Ozempic, has become a hot 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 runs in his family. His father, a double amputee, died last month at age 62 after complications from diabetes.

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

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

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

In May, his doctor put him on 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 anything under 5.7%.

When Mitchell recently went to pick up his refill, an automated message told him there would be a delay picking up his standard 1-milligram injector pen because of a nationwide shortage. The three other pharmacies in town all 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 it means he’ll have to double up on injections. It also confused his insurance company, which initially refused to pay for the medication. The pharmacy then said he’d need to shell out $1,000 to pick up a two-week supply. His co-pay is normally $5.

After negotiating with the insurance company, Mitchell was able to get the pen covered, but because he’s doubling up on the shots, they will last him half as long as usual.

He’s not sure what will happen when this pen runs out. He’s worried he’ll have to plead his case to his insurance company all over again.

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

“My goal at 39 years old is to try to delay becoming insulin dependent for as long as possible. I don’t want to suffer the same fate that my father did,” he said.

“I guess I’m just I’m angered by not just the celebrities but anybody that would use this, and especially knowing that there’s a shortage. That information is out,” he said.

Every winter, millions of Americans end the year with tighter waistbands, leading to another annual ritual: the New Year’s pledge to lose weight.

Nearly 1 in 4 Americans vowed to live healthier in 2022, making it the No. 1 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 over 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 slim down could count on only 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 of a class of drugs developed to treat diabetes to get 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 the passage of food through the gut.

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

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

Wegovy has become a runaway hit, fueled by celebrity mentions and social media posts showing off remarkable before-and-after transformations. On Twitter, Elon Musk credited Wegovy for his own recent weight loss.

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

But soon after Novo Nordisk began marketing Wegovy, it went into shortage when a Brussels-based company hired to fill the syringes was cited by the FDA for quality problems. Manufacture of the drug stopped, and shortages that were supposed to have resolved this year have continued.

Wegovy has to be taken both to lose weight and to keep it off. Studies show that once people stop using it, any pounds they dropped can return.

“There were a number of patients who were started on Wegovy who couldn’t continue it,” said Dr. Kimberly Gudzune, medical director of the American Board of Obesity Medicine.

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

As a result, many of these injectable GLP-1 imitating drugs have now gone into shortage.

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

“It really has kind of 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 cuts down on errors. But she can’t do that any more for these injectables.

“We’ve sort of, as a group, have had to revert back to actually giving people paper prescriptions, because then they can actually call around and take it to pharmacy to pharmacy to pharmacy so that they can find places that actually have medication that can be dispensed,” she said.

Gudzune said the shortages are especially hard on lower-income people who don’t necessarily have the means or the 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 dosages of Ozempic “due to the combination of incredible demand coupled with overall global supply constraints.”

Although it recognizes that some health care providers may be prescribing Ozempic off-label to people who want to lose weight, the company “doesn’t promote, suggest, or encourage off-label use of our medicines.”

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 expects to add a second site later in the year.

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

“We are asking healthcare providers to hold off initiating new patients on Wegovy until we confirm more broad availability at the pharmacy level,” Nicole Araujo, senior manager for corporate communications, wrote in an email.

Gudzune said she’s following that guidance. When people ask about the medications for weight loss, she tells them to wait to start taking them until the strain eases.

“The excitement about these medications are, right now, a little bit of a double-edged sword that I’m glad that people are excited and feel like they have a treatment option for their obesity that would really be meaningful,” she said.





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