Health
Utah mom fights for her daughter’s access to discontinued diabetes medication: ‘Life-saving'
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.
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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.
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“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.”
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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.
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“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.
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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.”
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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.
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.
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A new study suggests that middle-aged men may be more vulnerable to faster biological aging, potentially linked to exposure to “forever chemicals.”
The research, published in the journal Frontiers in Aging, examined how perfluoroalkyl and polyfluoroalkyl substances, more commonly known as PFAS, could impact aging at the cellular level.
PFAS are synthetic chemicals commonly used in nonstick cookware, food packaging, water-resistant fabrics and other consumer products, the study noted.
Their chemical structure makes them highly resistant to breaking down, allowing them to accumulate in water, soil and the human body.
Chinese researchers analyzed blood samples from 326 adults enrolled in the U.S. National Health and Nutrition Examination Survey between 1999 and 2000.
A new study suggests that middle-aged men could face accelerated biological aging at the cellular level due to exposure to PFAS. (iStock)
The researchers measured levels of 11 PFAS compounds in participants’ blood and used DNA-based “epigenetic clocks” — tools that analyze chemical changes to DNA to estimate biological age — to determine how quickly their bodies were aging at the cellular level, the study stated.
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Two compounds, perfluorononanoic acid (PFNA) and perfluorooctanesulfonamide (PFOSA), were detected in 95% of participants.
Higher concentrations of those chemicals were associated with faster biological aging in men of certain age groups, but not in women.
“People should not panic.”
The compounds most strongly linked to accelerated aging were not the PFAS chemicals that typically receive the most public attention, the researchers noted.
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“The associations were strongest in adults aged 50 to 64, particularly in men,” Dr. Xiangwei Li, professor at Shanghai Jiao Tong University School of Medicine and the study’s corresponding author, told Fox News Digital.
“While this does not establish that PFAS cause aging, it suggests that these widely present ‘forever chemicals’ may be linked to molecular changes related to long-term health and aging.”
The study found that two of the compounds were detected in 95% of participants, and higher levels were linked to faster biological aging in men ages 50–64. (iStock)
Midlife may represent a more sensitive biological period, when the body becomes more vulnerable to age-related stressors, according to the researchers.
Lifestyle factors, such as smoking, may influence biological aging markers, potentially increasing vulnerability to environmental pollutants.
While Li said “people should not panic,” she does recommend looking for reasonable ways to reduce exposure.
That might mean checking local drinking water reports, using certified water filters designed to reduce PFAS, and limiting the use of stain- or grease-resistant products when alternatives are available.
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Meaningful reductions in PFAS exposure will likely depend on broader regulatory action and environmental cleanup efforts, Li added.
The researchers noted that midlife could be a particularly sensitive stage, when the body is more susceptible to stressors associated with aging. (iStock)
Study limitations
The researchers outlined several important limitations of the research, including that the findings show an association, but do not prove that PFAS directly causes accelerated aging.
“The study is cross-sectional, meaning exposure and aging markers were measured at the same time, so we cannot determine causality,” Li told Fox News Digital.
The study was also relatively small, limited to 326 adults age 50 or older, which means the findings may not apply to younger people or broader populations.
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Researchers measured PFAS levels using data collected between 1999 and 2000, and today’s exposure patterns may differ.
Li added that while PFAS is known to persist in the environment and the body, these results should be validated through larger, more recent studies that follow participants over time.
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A drug that has long been used to treat seizures has shown promise as a potential means of Alzheimer’s prevention, a new study suggests.
The anti-seizure medication, levetiracetam, was first approved by the FDA in November 1999 under the brand name Keppra as a therapy for partial-onset seizures in adults. The approval has since expanded to include children and other types of seizures.
Northwestern University researchers recently found that levetiracetam prevented the formation of toxic amyloid beta peptides, which are small protein fragments in the brain that are commonly seen in Alzheimer’s patients.
The medication was found to prevent the formation of amyloid-beta 42 in both animal models and cultured human neurons, according to the study findings, which were published in Science Translational Medicine.
The effect was also seen in post-mortem human brain tissue obtained from individuals with Down syndrome, who are at high risk for Alzheimer’s disease.
The medication was found to prevent the formation of amyloid-beta 42 in both animal models and cultured human neurons. (iStock)
“While many of the Alzheimer’s drugs currently on the market, such as lecanemab and donanemab, are approved to clear existing amyloid plaques, we’ve identified this mechanism that prevents the production of the amyloid‑beta 42 peptides and amyloid plaques,” said corresponding author Jeffrey Savas, associate professor of behavioral neurology at Northwestern University Feinberg School of Medicine, in a press release.
“Our new results uncovered new biology while also opening doors for new drug targets.”
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The brain is better able to avoid the pathway that produces toxic amyloid‑beta 42 proteins in younger years, but the aging process gradually weakens that ability, Savas noted.
“This is not a statement of disease; this is just a part of aging. But in brains developing Alzheimer’s, too many neurons go astray, and that’s when you get amyloid-beta 42 production,” he said.
The effect was also seen in post-mortem human brain tissue obtained from individuals with Down syndrome, who are at high risk for Alzheimer’s disease. (iStock)
That then leads to tau (“tangles”) — abnormal clumps of protein inside brain neurons — which can kill brain cells, trigger neuroinflammation and lead to dementia.
In order for levetiracetam to function as an Alzheimer’s blocker, high-risk patients would have to start taking it “very, very early,” Savas said — up to 20 years before elevated amyloid-beta 42 levels would be detected.
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“You couldn’t take this when you already have dementia, because the brain has already undergone a number of irreversible changes and a lot of cell death,” the researcher noted.
The researchers also did a deep dive into previous human clinical data to determine whether Alzheimer’s patients who were taking the anti-seizure drug had slower cognitive decline. They reported that the patients in that category had a “significant delay” in the span from cognitive decline to death compared to those not taking the drug.
“This analysis supports the positive effect of levetiracetam to slow the progression of Alzheimer’s pathology,” the researcher said. (iStock)
“Although the magnitude of change was small (on the scale of a few years), this analysis supports the positive effect of levetiracetam to slow the progression of Alzheimer’s pathology,” Savas said.
Looking ahead, the research team aims to find people who have genetic forms of Alzheimer’s to participate in testing, Savas said.
Limitations and caveats
The study had several limitations, including that it relied on animal models and cultured cells, with no human trials conducted.
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Because the study was observational in nature, it can’t prove that the medication caused the prevention of the toxic brain proteins, the researchers acknowledged.
Savas noted that levetiracetam “is not perfect,” cautioning that it breaks down in the body very quickly.
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The team is currently working to create a “better version” that would last longer in the body and “better target the mechanism that prevents the production of the plaques.”
“You couldn’t take this when you already have dementia, because the brain has already undergone a number of irreversible changes and a lot of cell death.”
The medication’s common documented side effects include drowsiness, weakness, dizziness, irritability, headache, loss of appetite and nasal congestion.
It has also been linked to potential mood and behavior changes, including anxiety, depression, agitation and aggression, according to the prescribing information. In rare cases, it could lead to severe allergic reactions, skin reactions, blood disorders and suicidal ideation.
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Funding for the study was provided by the National Institutes of Health and the Cure Alzheimer’s Fund.
Fox News Digital reached out to the drug manufacturer and the researchers for comment.
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