Dr. Siegel: Access to insulin is the next supply chain crisis
Fox News' Dr. Marc Siegel discusses a recent study on marijuana users more likely to visit the ER and fears there will be supply chain shortages on insulin.
A Utah mother is fighting for her teenage daughter’s access to diabetes medicine.
Ruby Smart, 15, has been taking Levemir (detemir) insulin since she was diagnosed with type 1 diabetes more than two years ago.
"Levemir is uniquely suited to her situation," Alison Smart, the girl’s mother, told Fox News Digital in an interview.
The family was stunned when Novo Nordisk, the Denmark-based manufacturer of Levemir, announced in November 2023 that the drug was being discontinued.
YOUR DIABETES RISK MAY DOUBLE IF YOU EAT THIS FOOD TWICE A WEEK, SAY HARVARD RESEARCHERS
Smart has now made it her mission to convince Novo Nordisk to continue making Levemir — or to find a pharmaceutical company to create a biosimilar (generic) alternative.
Levemir is a long-acting basal insulin that's injected once or twice a day to control high blood sugar in adults and children with diabetes, according to Novo Nordisk's website.
Utah mother Alison Smart (in green sweater, pictured with Ruby Smart, age 15) is fighting for her teenage daughter’s access to diabetes medicine. (Alison Smart/iStock)
For Smart’s daughter, an active athlete who plays on the tennis team at Woods Cross High School, Levemir has enabled her to continue with her regular activities while controlling her diabetes.
While there are a couple of other types of basal insulin on the market, Smart said Levemir is best suited to her daughter’s needs.
"Levemir is unique in that it is a relatively shorter-acting basal insulin, making it ideal for those with fluctuating basal insulin needs, including teenagers, menstruating women, pregnant women and athletes," she said.
"The two remaining insulins also have side effects we don't worry about when using Levemir."
"She's super active and plays tennis almost every day," Smart said of her daughter, pictured here. "The pump was fine for daily activity, but for tennis tournament days, it didn't work." (Alison Smart)
They did try an insulin pump for a few weeks, which is a wearable device that provides a steady flow of insulin to the body. But Smart said it was not compatible with her daughter’s high activity levels.
"She's super active, and plays tennis almost every day," Smart said. "The pump was fine for daily activity, but for tennis tournament days, it didn't work."
Smart is advocating for people to be able to choose.
"The bottom line is that Levemir works for us," she said. "Our lives are much easier and less complex on a regimen of multiple daily injections using Levemir insulin."
Reasons for discontinuation
Novo Nordisk provided three main reasons for why it's discontinuing Levenir.
"After careful consideration, we made this decision because of global manufacturing issues, decreasing patient coverage, and because we are confident that patients in the U.S. will be able to find alternative treatments," the company said in a press release.
Novo Nordisk announced in Nov. 2023 that Levemir would be discontinued. "During this time, we strongly encourage that health care professionals and patients discuss transitioning to alternative treatment options prior to the discontinuation date," the company said in a statement. (LISELOTTE SABROE/Scanpix Denmark/AFP)
When contacted by Fox News Digital, Novo Nordisk provided the following recommendation to doctors and patients.
"During this time, we strongly encourage that health care professionals and patients discuss transitioning to alternative treatment options prior to the discontinuation date. Novo Nordisk, along with other companies, provides a number of alternative treatment options for people living with diabetes who require basal insulin."
The company suggested that patients switch to other basal insulin options, including but not limited to Basaglar, Insulin Degludec, Insulin Glargine U-300, Lantus, Rezvoglar, Semglee, Toujeo and Tresiba.
"The other options for basal insulin are not equal and are not sufficient — they have different side effects and different qualities."
Many parents, however, say these alternatives are not the same.
"The other options for basal insulin are not equal and are not sufficient — they have different side effects and different qualities," Smart told Fox News Digital.
"They're not as flexible, and not as easy to use with someone who has varying basal insulin needs, like a teenager."
Alison Smart, far right, is pictured with two other parents of teens with type 1 diabetes in Washington, D.C. (Alison Smart)
Other parents are also concerned about being forced to switch medications.
Jaime Losinski, a mother in Tampa, Florida, has a 14-year-old son with type 1 diabetes. He's been taking Levemir for years.
"Levemir is a valuable insulin for children and teens, who have ever-changing insulin needs as they grow," she told Fox News Digital.
OZEMPIC-WEGOVY PILL MAY BE ON THE WAY: TRIAL SHOWS PROMISING RESULTS FOR NEW WEIGHT LOSS TABLET
"Levemir’s action profile makes it perfect for patients who need to make rapid and continual changes," she went on.
"An insulin such as Lantus or Tresiba, which the industry tells us to ‘just switch to,’ lasts far too long in the system for someone like him and would be dangerous overnight," she said. "They also come with side effects, all of which he experienced when we tried them both shortly after his diagnosis seven years ago."
Smart teamed up with other parents to form the Alliance to Protect Insulin Choice. She has also visited Washington, D.C., twice to meet with senators and congressional representatives. (Alison Smart)
Although Levemir is expected to be available until Dec. 2024, Smart said providers have warned her to "expect supply disruption" in the meantime.
Some insurance companies have already stopped coverage of the drug due to the discontinuation.
Smart received a letter from her insurance company in November saying Levemir would not be on her plan any longer. They later agreed to add it back on — but only if she paid a premium.
‘Not as cut and dry as it might seem’
Erin Palinski-Wade, a certified diabetes educator in New Jersey, said the discontinuation of Levemir is "understandably surprising and frustrating" for patients who rely on this brand of insulin.
"Although there are other forms of long-acting insulin on the market, each has its own slight differences, such as peak times, which can have a significant impact on blood glucose management during the day," she told Fox News Digital.
"For children and teens, there may be greater fluctuations in blood sugar."
"Transitioning from one brand of insulin to another is not as cut and dry as it might seem, and can lead to periods of high blood sugar or hypoglycemia episodes (dangerously low blood sugars) as the adjustment occurs," Palinski-Wade added.
For parents who rely on Levemir, the expert recommended working with a physician, endocrinologist and/or dietitian to create the "best transition plan possible" to minimize fluctuations in blood sugar while finding an alternative that works best.
"Levemir is a valuable insulin for children and teens, who have ever-changing insulin needs as they grow," a mother said. (iStock)
When transitioning to a new insulin, increased testing of glucose levels is needed to prevent and correct highs and lows as they occur, Palinski-Wade noted.
"This is especially important for children and teens, as there may be greater fluctuations in blood sugar due to activity, growth and hormone fluctuations," she said.
AI HEALTH CARE PLATFORM PREDICTS DIABETES WITH HIGH ACCURACY BUT 'WON'T REPLACE PATIENT CARE'
Tanya Freirich, a certified diabetes educator in New York City working as The Lupus Dietitian, agreed that the closest replacement in terms of duration of action is Lantus (insulin glargine).
"One of the differences is the peak time," she told Fox News Digital.
"Lantus peaks [or lowers the blood sugar the most] at six hours after administration, while Levemir peaks at eight to 10 hours after administration. This difference would affect the appropriate timing for the medication to prevent dangerous blood sugar lows."
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, said he is also disappointed by the news of the discontinuation. (Fox News)
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, said he is also disappointed by the news of the discontinuation.
"It is based on supply chain and production issues rather than a problem with the product," he told Fox News Digital.
"We definitely need biosimilar versions to replace it," he said. "It can be life-saving."
"It is based on supply chain and production issues rather than a problem with the product."
"Some patients really need a version of insulin and Levemir may be their best option."
Although Levemir is "very similar" to Lantus, Siegel said, it has two important differences: "It causes less weight gain and less hypoglycemia (low glucose)."
Advocating for access
After Novo Nordisk’s November announcement of the discontinuation, Smart sprung into action.
She set up an online petition and began contacting the Food and Drug Administration and the World Health Organization.
"This drug is on the World Health Organization’s list of essential medicines," she said. "I just couldn't wrap my head around the possibility of this happening and people not being as outraged as I was."
CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER
Smart also teamed up with other parents to form the Alliance to Protect Insulin Choice. She has visited Washington, D.C., twice to meet with senators and congressional representatives.
"Our goal is to have Novo Nordisk slow down the discontinuation, and produce Levemir insulin for a few years until a biosimilar is widely available," she said.
"We would like to find a biosimilar manufacturer to make this insulin, so it stays available."
An insulin pump, a wearable device that provides a steady flow of insulin to the body, was not compatible with her daughter’s high activity levels, said Smart of Utah. (iStock)
While Smart recognizes that the medication may not be available "forever," she aims to slow down the discontinuation and keep Levemir available for a few more years — "because it will take that long to get a biosimilar up and running."
Smart’s efforts have also caught the attention of billionaire Mark Cuban, who expressed his willingness to partner with Novo Nordisk to continue producing Levemir.
CLICK HERE TO GET THE FOX NEWS APP
When contacted by Fox News Digital, Cuban said that his pharmaceutical company, CostPlus Drug Company, is "trying to figure out a way to source [Levemir]."
"We aren’t there yet, but we are trying," he said.
Fox News Health
Stay up-to-date on the biggest health and wellness news with our weekly recap.
By entering your email and clicking the Subscribe button, you agree to the Fox News Privacy Policy and Terms of Use, and agree to receive content and promotional communications from Fox News. You understand that you can opt-out at any time.