Health

Utah mom fights for her daughter’s access to discontinued diabetes medication: ‘Life-saving'

Published

9 months ago

April 19, 2024

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.

Danish pharmaceutical company Novo Nordisk headquarters

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.

For more Health articles, visit www.foxnews.com/health.

Melissa Rudy is health editor and a member of the lifestyle team at Fox News Digital. Story tips can be sent to melissa.rudy@fox.com.

Health

Cancer Remission Like Catherine’s Does Not Always Mean the Illness Is Cured

Published

16 minutes ago

January 15, 2025

Press Room

Cancer Remission Like Catherine’s Does Not Always Mean the Illness Is Cured

Princess Catherine, wife of Prince William, reported on Tuesday that her cancer was in remission. But what does it mean to be in remission from cancer?

Doctors discovered her cancer unexpectedly last March when she had abdominal surgery. She has not revealed the type of cancer she has, nor how advanced it was when it was discovered.

But she did say she had chemotherapy, which she said had been completed in September. She told the British news agency PA Media that she had a port, a small device that is implanted under the skin and attached to a catheter that goes into a large vein. It allows medicines like chemotherapy drugs to be delivered directly to veins in the chest, avoiding needle sticks.

Catherine told PA Media that chemotherapy was “really tough.”

“It is a relief to now be in remission and I remain focused on recovery,” she wrote on Instagram.

Her announcement “certainly is good news and is reassuring,” said Dr. Kimmie Ng, associate chief of the division of gastrointestinal oncology at the Dana-Farber Cancer Institute in Boston.

But cancer experts like Dr. Ng say that the meaning of remission in a patient can vary.

In general, when doctors and patients talk about remission, they mean there is no evidence of cancer in blood tests or scans.

The problem is that a complete remission does not mean the cancer is gone. Even when a cancer is “cured” — defined as no evidence of cancer for five years — it may not be vanquished.

That makes life emotionally difficult for patients, who have to have frequent visits with oncologists for physical exams, blood tests and imaging.

“It’s really scary,” Dr. Ng said. “The amount of uncertainty is very very hard,” she added.

But that ongoing surveillance is necessary, despite the toll it takes on patients.

“Different cancers have different propensities of returning or not returning,” said Dr. Elena Ratner, a gynecologic oncologist at the Yale Cancer Center.

As many as 75 to 80 percent of ovarian cancers, she noted, can come back in an average of 14 to 16 months after a remission, depending on the stage the cancer had reached when it was found and on the cancer’s biology.

“Once the cancer returns, it becomes a chronic disease,” Dr. Ratner said. She tells her patients: “You will live with this cancer. You will be on and off chemotherapy for the rest of your life.”

Dr. Ratner’s gynecological cancer patients have to come back every three months for CT scans to keep an eye out for evidence that the cancer has returned.

“The women live CT scan to CT scan,” she said. “They say that for two and a half months, they have a wonderful life, but then, in time for the next CT scan, the fear returns.”

“It costs them — it costs them a lot,” she said.

“It’s awful, yet I am amazed every day by their strength,” she said of her patients.

Health

Death Toll in Gaza Likely 40 Percent Higher Than Reported, Researchers Say

Published

8 hours ago

January 14, 2025

Press Room

Death Toll in Gaza Likely 40 Percent Higher Than Reported, Researchers Say

Deaths from bombs and other traumatic injuries during the first nine months of the war in Gaza may have been underestimated by more than 40 percent, according to a new analysis published in The Lancet.

The peer-reviewed statistical analysis, led by epidemiologists at the London School of Hygiene and Tropical Medicine, used modeling in an effort to provide an objective third-party estimate of casualties. The United Nations has relied on the figure from the Hamas-led Ministry of Health, which it says has been largely accurate, but which Israel criticizes as inflated.

But the new analysis suggests the Hamas health ministry tally is a significant undercount. The researchers concluded that the death toll from Israel’s aerial bombardment and military ground operation in Gaza between October 2023 and the end of June 2024 was about 64,300, rather than the 37,900 reported by the Palestinian Ministry of Health.

The estimate in the analysis corresponds to 2.9 percent of Gaza’s prewar population having been killed by traumatic injury, or one in 35 inhabitants. The analysis did not account for other war-related casualties such as deaths from malnutrition, water-borne illness or the breakdown of the health system as the conflict progressed.

The study found that 59 percent of the dead were women, children and people over the age of 65. It did not establish what share of the reported dead were combatants.

Mike Spagat, an expert on calculating casualties of war who was not involved in this research, said the new analysis convinced him that Gaza casualties were underestimated.

“This is a good piece of evidence that the real number is higher, probably substantially higher, than the Ministry of Health’s official numbers, higher than I had been thinking over the last few months,” said Dr. Spagat, who is a professor at Royal Holloway College at the University of London.

But the presentation of precise figures, such as a 41 percent underreported mortality, is less useful, he said, since the analysis actually shows the real total could be less than, or substantially more. “Quantitatively, it’s a lot more uncertain than I think comes out in the paper,” Dr. Spagat said.

The researchers said their estimate of 64,260 deaths from traumatic injury has a “confidence interval” between 55,298 and 78,525, which means the actual number of casualties is likely in that range.

If the estimated level of underreporting of deaths through June 2024 is extrapolated out to October 2024, the total Gazan casualty figure in the first year of the war would exceed 70,000.

“There is an importance to war injury deaths, because it speaks to the question of whether the campaign is proportional, whether it is, in fact, the case that sufficient provisions are made to to avoid civilian casualties,” said Francesco Checchi, an epidemiologist with an expertise in conflict and humanitarian crises and a professor at the London School of Hygiene and Tropical Medicine who was an author on the study. “I do think memorializing is important. There is inherent value in just trying to come up with the right number.”

The analysis uses a statistical method called capture-recapture analysis, which has been used to estimate casualties in other conflicts, including civil wars in Colombia and Sudan.

For Gaza, the researchers drew on three lists: The first is a register maintained by the Palestinian Ministry of Health, which mainly comprises the dead in hospital morgues and estimates of the number of unrecovered people buried in rubble. The second is deaths reported by family or community members through an online survey form the ministry established on Jan. 1, 2024, when the prewar death registration system had broken down. It asked Palestinians inside and outside Gaza to provide names, ages, national ID number and location of death for casualties. The third source was obituaries of people who died from injuries that were published on social media, which may not include all of the same biographical details and which the researchers compiled by hand.

The researchers analyzed these sources to look for individuals who appear on multiple lists of those killed. A high level of overlap would have suggested that few deaths were uncounted; the low amount they found suggested the opposite. The researchers used models to calculate the probability of each individual appearing on any of the three lists.

“Models enable us to actually estimate the number of people who have not been listed at all,” Dr. Checchi said. That, combined with the listed number, gave the analysts their total.

Patrick Ball, director of research at the Human Rights Data Analysis Group, and a statistician who has conducted similar estimates of violent deaths in conflicts in other regions, said the study was strong and well reasoned. But he cautioned that the authors may have underestimated the amount of uncertainty caused by the ongoing conflict.

The authors used different variations of mathematical models in their calculations, but Dr. Ball said that rather than presenting a single figure — 64,260 deaths — as the estimate, it may have been more appropriate to present the number of deaths as a range from 47,457 to 88,332 deaths, a span that encompasses all of the estimates produced by modeling the overlap among the three lists.

“It’s really hard to do this kind of thing in the middle of a conflict,” Dr. Ball said. “It takes time, and it takes access. I think you could say the range is larger, and that would be plausible.”

While Gaza had a strong death registration process before the war, it now has only limited function after the destruction of much of the health system. Deaths are uncounted when whole families are killed simultaneously, leaving no one to report, or when an unknown number of people die in the collapse of a large building; Gazans are increasingly buried near their homes without passing through a morgue, Dr. Checchi said.

The authors of the study acknowledged that some of those assumed dead may in fact be missing, most likely taken as prisoners in Israel.

Roni Caryn Rabin and Lauren Leatherby contributed reporting.

Health

Dementia risk for people 55 and older has doubled, new study finds

Published

9 hours ago

January 14, 2025

Press Room

Dementia risk for people 55 and older has doubled, new study finds

Dementia cases in the U.S. are expected to double by 2060, with an estimated one million people diagnosed per year, according to a new study led by Johns Hopkins University and other institutions.

Researchers found that Americans’ risk of developing dementia after age 55 is 42%, double the risk that has been identified in prior studies, a press release stated.

For those who reach 75 years of age, the lifetime risk exceeds 50%, the study found.

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Women face a 48% average risk and men have a 35% risk, with the discrepancy attributed to women living longer than men.

Dementia cases in the U.S. are expected to double by 2060, with an estimated one million people diagnosed per year. (iStock)

The study, which was published in the journal Nature Medicine on Jan. 13, analyzed data from the Atherosclerosis Risk in Communities Neurocognitive Study (ARIC-NCS), which has tracked the cognitive and vascular health of nearly 16,000 adults since 1987.

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“Our study results forecast a dramatic rise in the burden from dementia in the United States over the coming decades, with one in two Americans expected to experience cognitive difficulties after age 55,” said study senior investigator and epidemiologist Josef Coresh, MD, PhD, who serves as the founding director of the Optimal Aging Institute at NYU Langone, in the release.

Understanding risk factors

“One of the main reasons for the increase is that great medicine and tecnological advances are keeping us alive longer and age is a risk factor for dementia,” Dr. Marc Siegel, clinical professor of medicine at NYU Langone Health and Fox News senior medical analyst, told Fox News Digital.

“Obesity is associated with inflammation, diabetes and high blood pressure, which are all independent risk factors for dementia.”

In addition to aging, other risk factors include genetics, obesity, hypertension, diabetes, unhealthy diets of ultraprocessed foods, sedentary lifestyles and mental health disorders, the release said.

“We have an obesity epidemic with over 45% adults obese in the U.S.,” Siegel noted. “Obesity is associated with inflammation, diabetes and high blood pressure, which are all independent risk factors for dementia.”

“And as an unhealthy population, we also have more heart disease, and atrial fibrillation is a risk factor for cognitive decline,” he added.

Dementia risk was found to be higher among people who have a variant of the APOE4 gene, which has been linked to late-onset Alzheimer’s disease. Black adults also have a higher risk.

virtual volumetric drawing of brain in hand

Researchers found that Americans’ risk of developing dementia after age 55 is 42%, double the risk that has been identified in prior studies. (iStock)

Research has shown that the same interventions used to prevent heart disease risk could also prevent or slow down dementia, the study suggested.

“The pending population boom in dementia cases poses significant challenges for health policymakers in particular, who must refocus their efforts on strategies to minimize the severity of dementia cases, as well as plans to provide more health care services for those with dementia,” said Coresh.

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What needs to change?

Professor Adrian Owen, PhD, neuroscientist and chief scientific officer at Creyos, a Canada-based company that specializes in cognitive assessment and brain health, referred to the increase in dementia cases as a “tidal wave.”

“This new study’s anticipated surge in dementia cases underscores the urgent need for early and accurate detection,” he told Fox News Digital.

“By catching issues early, we give people the power to make lifestyle adjustments, seek available treatments and plan their futures with clarity.”

“By identifying cognitive decline at its earliest stages, we have an opportunity to intervene before patients and families bear the full weight of the disease.”

Owen recommends conducting regular cognitive assessments as part of routine check-ups to proactively identify early signs of cognitive decline.

“By catching issues early, we give people the power to make lifestyle adjustments, seek available treatments and plan their futures with clarity,” he said.

“By identifying cognitive decline at its earliest stages, we have an opportunity to intervene before patients and families bear the full weight of the disease.” (iStock)

Maria C. Carrillo, PhD, chief science officer and medical affairs lead for the Alzheimer’s Association in Chicago, said there is an “urgent need” to address the global crisis of Alzheimer’s disease and dementia.

To help keep the aging brain healthy, the Alzheimer’s Association published its report 10 Healthy Habits for Your Brain. Some of the tips are listed below.

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– Participate in regular physical activity.

– Learn new things throughout your life and engage your brain.

– Get proper nutrition — prioritize vegetables and leaner meats/proteins, along with foods that are less processed and lower in fat.

– Avoid head injury (protect your head).

– Have a healthy heart and cardiovascular system — control blood pressure, avoid diabetes or treat it if you have it, manage your weight and don’t smoke.