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

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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.”

Ruby Smart

“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.

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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.

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“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 in Washington, D.C.

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.”

Alison Smart

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.

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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.

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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.

Insulin injection

“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). 

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“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

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.”

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“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.

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“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.”

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Insulin pump

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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Despite growing concerns over bird flu, many US dairy workers have not received protective equipment

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Despite growing concerns over bird flu, many US dairy workers have not received protective equipment
  • Despite growing concern about bird flu, many U.S. dairy farms have not increased health protections for employees.
  • On May 22, 2024, the U.S. government said a second dairy worker has contracted bird flu since cattle first tested positive in late March.
  • The U.S. Department of Agriculture said it believes unpasteurized milk is the primary vector for transmitting the virus in cows, though officials do not know exactly how it spreads.

Many U.S. dairy farms have not yet increased health protections against bird flu for employees during an outbreak in cows, according to workers, activists and farmers, worrying health experts about the risk for more human infections of a virus with pandemic potential.

Epidemiologists are concerned the virus could potentially spread and cause serious illnesses as farmers downplay the risk to workers while employees are not widely aware of cases in U.S. cattle.

The U.S. government said on Wednesday that a second dairy worker contracted bird flu since cattle first tested positive in late March and that investigators are looking into whether the person was wearing or offered protective equipment.

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Nearly 24,000 farms sell milk around the country, and they offer varying protections to staff. Lobby group the National Milk Producers Federation said it encouraged farms to use protective equipment in line with federal recommendations and heard of increased worker protections.

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Three dairy workers, seven activists and two lawyers who assist farm employees told Reuters that dairy owners have not offered equipment like face shields and goggles to staff who spend 10- to 12-hour days side-by-side with cows. Three large dairy companies with tens of thousands of cows declined to comment on their procedures.

The workers – all based in New York, a major dairy producer – said they heard of the new illness affecting cattle through the media or community organizers, not their employers. One, 39-year-old Luis Jimenez from Mexico, said last week it was business as usual.

A worker using an automated machine helps milk Holstein cows at Airoso Circle A Dairy in Pixley, California, on October 2, 2019. Workers who attach and detach milking equipment to cows get their faces close to unpasteurized milk. The U.S. Department of Agriculture said it believes unpasteurized milk is the primary vector for transmitting the virus in cows. (Reuters/Mike Blake/File Photo)

“They’re not doing anything,” he said.

The U.S. Centers for Disease Control and Prevention in April and May advised workers to use personal protective equipment (PPE) if they may be exposed to sick livestock, after a Texas dairy worker tested positive for bird flu. On May 6, the agency asked states to make equipment available to workers.

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CDC wants “to make sure that farm workers across the country, whether they are at a farm with an affected herd or not, have access to PPE,” said Nirav Shah, principal deputy director, last week.

New York state said it is assessing CDC’s recommendation and has not yet distributed equipment. Texas, New Mexico and Colorado, where cattle were infected, said they distributed equipment to eight dairies combined. Kansas, Idaho and Wisconsin said they have equipment, but no farmers asked for it.

Michigan, where the second dairy worker tested positive, said many farms have protective gear but the state is coordinating a way to make it available for those that need more.

Dairies became more aware of bird flu’s risks in late April after the U.S. government began requiring that cows test negative before crossing state lines, said Emily Yeiser Stepp, who oversees a National Milk Producers Federation program that covers workforce development.

Still, “reaching out into some of our rural networks takes a little longer,” she said when told of workers who said they were not informed of recommendations for protective equipment.

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CLOSE CONTACT WITH COWS

The U.S. confirmed bird flu in dairy cattle in nine states. Scientists have said they believe the outbreak is more widespread based on findings of H5N1 particles in about 20% of retail milk samples.

Bird flu has caused serious or fatal infections globally among people in close contact with wild birds or poultry. In cows, the U.S. Department of Agriculture said it believes unpasteurized milk is the primary vector for transmitting the virus, though officials do not know exactly how it spreads.

Health experts advise dairy workers to wear gloves and disposable coveralls that can block milk splashes on their bodies or clothing.

Jimenez said his coworkers are under pressure to work so quickly that they sometimes do not have time to wash their hands before meals and often drive home in their work clothes.

Workers attach and detach milking equipment on cows, putting their faces close to unpasteurized milk. Most are immigrants and many do not have health insurance.

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“When you’re milking, splashes can’t be avoided. When it splashes in our eyes, we wash it out with water,” said another New York worker, who requested anonymity because he is undocumented.

Lucas Sjostrom, a farmer and executive director of the Minnesota Milk Producers Association, uses robotic machines to attach milking equipment to cows, but said he is being extra conscious that human workers wear gloves while transporting unpasteurized milk. Minnesota has not reported bird flu in cows.

In Indiana, another state without confirmed cases, farmer Steve Obert said he has not increased precautions for workers, though that could change if his herd tests positive. Extra protective equipment is not comfortable to wear, he added.

“We’re rather isolated and I don’t think the risk is really great,” said Obert, executive director of the industry group Indiana Dairy Producers.

BLOOD-RED EYES

The infected Texas worker suffered conjunctivitis and broken blood vessels that turned his eyes scarlet red, according to a photo published in the New England Journal of Medicine. He reported wearing gloves when working with cows but not respiratory or eye protection, the journal said.

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Scientists are watching for changes in the virus that could make it spread more easily among humans. Epidemiologists said it could cause more serious illnesses if it mutates or infects someone with a compromised immune system.

Some dairies with infected cows have resisted allowing federal officials on their farms because of financial concerns, said Gregory Gray, a University of Texas Medical Branch professor studying cattle diseases.

The CDC said it would like to test more farm workers, but it is not required.

New Mexico had anecdotal reports of workers with symptoms similar to conjunctivitis, but most were not tested, according to internal state documents that were dated April 26 and obtained by Reuters under a public records request. The workers were not tested because they did not seek healthcare, the New Mexico Department of Health said.

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Policy changes are needed to encourage workers to seek treatment, such as emergency income assurance for those who test positive, said Brian Castrucci, an epidemiologist and CEO at health policy group the de Beaumont Foundation.

“I don’t want to wait until we have a dead dairy farm worker until we ratchet up what we’re doing,” he said.

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Half of Americans not equipped to provide life-saving treatment in a crisis, poll finds

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Half of Americans not equipped to provide life-saving treatment in a crisis, poll finds

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Only half the people in the U.S. feel they could be helpful in an emergency situation, a new poll found.

The Ohio State University Wexner Medical Center surveyed a national sample of 1,005 Americans, finding that only 51% of them knew how to perform hands-only CPR if needed.

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In cases of serious bleeding, only 49% said they could assist, and 56% said they would be equipped to help someone who was choking.

The data was collected via phone and email from April 5 to April 7 of this year.

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“The key takeaways from our survey are that patient outcomes would improve if the general public learned some basic life-saving measures in the areas of hands-only CPR, choking rescue and bleeding control,” Nicholas Kman, M.D., emergency medicine physician at Ohio State Wexner Medical Center and clinical professor of emergency medicine at The Ohio State University College of Medicine, told Fox News Digital.  

“We can save lives while we wait for first responders to arrive.”

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Only half the people in the U.S. feel they could be helpful in an emergency situation, a new poll has found. (iStock)

“For every minute that passes, the chance of survival drops, and if they do survive, there’s less chance of a good neurologic outcome.”

Data shows that 70% to 80% of cardiac arrests occur in the home and 20% happen in a public place, according to Kman.

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“Outcomes are poor when the arrest is unwitnessed at home,” he told Fox News Digital.  

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“Just think, the person with the medical emergency could be your loved one in your house. You may have to provide life-saving treatment until first responders arrive.”

Heimlich maneuver

Data shows that 70% to 80% of cardiac arrests occur in the home and 20% happen in a public place, a researcher said. (iStock)

Based on the survey findings, Kman advised the public to get trained in life-saving measures — particularly hands-only CPR, choking and serious bleeding.

“Look for training that may be offered through community days at hospitals, schools, libraries, community organizations, religious institutions, volunteer groups, festivals and sporting events,” he suggested.

“We’re responsible for each other.”

Organizations and websites such as the American Red Cross, the American Heart Association and Stop The Bleed may offer these courses for free or low cost, Kman noted.  

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After learning the skills, it’s important to practice them, the doctor said.

“We would love the public to learn how to do hands-only CPR and practice the skill of doing CPR every six weeks,” Kman said.

Performing CPR

Based on the survey findings, researchers advised people to get trained in life-saving measures, particularly hands-only CPR, choking first-aid and serious bleeding assistance. (iStock)

“As with any skill, practice builds confidence. If we don’t practice it, we lose that skill.”

The OSU survey did have some limitations, Kman acknowledged.

“The survey was a convenience sample of a cross-section of Americans,” he told Fox News Digital. 

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“Most demographics were equally represented, but different regions do better at this than others, and their cardiac arrest results and survival reflect that,” he continued. 

“States and countries that prioritize training the public have higher survival rates.”

Emergency room

“When you’re trained in these lifesaving skills, you’ll know how to recognize the signs that someone needs help and buy time until the [first] responders can get there,” a doctor said. (iStock)

Dr. Kenneth Perry, an emergency department physician in South Carolina, was not involved in the survey but said he was surprised that more people don’t feel unprepared.

“Even for medical professionals, having a medical emergency occur without preparation can be a very stressful event,” he told Fox News Digital. 

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“It is very important for people to have basic lifesaving skills.”

“It is very important for people to have basic lifesaving skills.”

The easiest and most helpful skill that people should learn is how to operate an automated external defibrillator (AED). These are located in many public places, such as gyms, malls and even some public walkways, according to Perry.  

“These devices are the best way to save a person who is suffering from cardiac arrest,” he said.

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“If the person has an abnormal heart rhythm that can be brought back to normal with electricity, this device will save that patient.”

This is a very time-sensitive process, however — it must happen as early as possible, the doctor advised. 

“Early defibrillation is directly correlated with the best outcomes for patients who suffer an out-of-hospital cardiac arrest.”

Ultimately, Kwan, said, “we’re responsible for each other.”

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“When you’re trained in these lifesaving skills, you’ll know how to recognize the signs that someone needs help and buy time until the responders can get there.”

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