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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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Mpox outbreak that is rapidly spreading through Congo may be a new form of the disease

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Mpox outbreak that is rapidly spreading through Congo may be a new form of the disease

Congo is struggling to contain its biggest mpox outbreak, and scientists say a new form of the disease detected in a mining town might more easily spread among people.

Since January, Congo has reported more than 4,500 suspected mpox cases and nearly 300 deaths, numbers that have roughly tripled from the same period last year, according to the World Health Organization. Congo recently declared the outbreak across the country a health emergency.

An analysis of patients hospitalized between October and January in Kamituga, eastern Congo, suggests recent genetic mutations in mpox are the result of its continued transmission in humans; it’s happening in a town where people have little contact with the wild animals thought to naturally carry the disease.

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“We’re in a new phase of mpox,” said Dr. Placide Mbala-Kingebeni, the lead researcher of the study, who said it will soon be submitted to a journal for publication. Mbala-Kingebeni heads a lab at Congo’s National Institute of Biomedical Research, which studies the genetics of diseases.

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The lesions reported by most patients are milder and on the genitals, Mbala-Kingebeni said, making the disease trickier to diagnose. In previous outbreaks in Africa, lesions were mostly seen on the chest, hands and feet. He also said that the new form seems to have a lower death rate.

A patient shows the rash marks on his hands due to the 1996 to 1997 monkeypox outbreak in the Democratic Republic of the Congo. (CDC/Brian W.J. Mahy/Handout via REUTERS)

In a report on the global mpox situation this week, WHO said the new version of the disease might require a new testing strategy to pick up the mutations.

With experts pointing out that fewer than half of people in Congo with mpox are tested, Mbala-Kingebeni said: “The risk is that unless patients themselves come forward, we will have a silent transmission of the disease and nobody will know.”

Mbala-Kingebeni said most people were infected via sex, with about a third of mpox cases found in sex workers. It was not until the 2022 global emergency of mpox that scientists established the disease was spread via sex, with most cases in gay or bisexual men. In November, WHO confirmed sexual transmission of mpox in Congo for the first time.

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There are two kinds, or clades, of mpox, which is related to smallpox and endemic to central and west Africa. Clade 1 is more severe and can kill up to 10% of people infected. Clade 2 triggered the 2022 outbreak; more than 99% of people infected survived.

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Mbala-Kingebeni and colleagues said they have identified a new form of clade 1 that may be responsible for more than 240 cases and at least three deaths in Kamituga, a region with a significant transient population traveling elsewhere in Africa and beyond.

Dr. Boghuma Titanji, an infectious diseases expert at Emory University who is not connected to the research, said the new mutations are concerning.

“This suggests the virus is adapting to spread efficiently in humans and could cause some pretty consequential outbreaks,” she said.

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Although the mpox epidemics in the West were contained with the help of vaccines and treatments, barely any have been available in Congo. Congo’s minister of health has authorized the use of vaccines in high-risk provinces, said Cris Kacita Osako, coordinator of Congo’s Monkeypox Response Committee. He said officials are in talks with donor countries like Japan to help buy the shots.

“Once a sufficient quantity of vaccines is available … vaccination will be implemented as part of the response,” Kacita Osako said.

Dr. Dimie Ogoina, an mpox expert at Niger Delta University, said the new research is an unsettling reminder of an earlier — but different — outbreak.

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“The notable spread among sex workers is reminiscent of the early stages of HIV,” he said, explaining that prejudices attached to treating sexually transmitted infections and the reluctance of people with mpox to come forward were worrying.

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WHO’s emergencies chief, Dr. Michael Ryan, said last week that despite the ongoing spread of mpox in Africa and elsewhere, “there has not been a single donor dollar invested.”

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Cat owners could be at higher risk of schizophrenia, study suggests, but more research needed

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Cat owners could be at higher risk of schizophrenia, study suggests, but more research needed

Cuddling with a cat or kitten might seem therapeutic, but a new study suggests contact with these animals could have adverse mental health effects down the road.

Research published in Schizophrenia Bulletin found that people who are exposed to cats may have more than double the chances of developing schizophrenia and other similar mental disorders later in life.

Australian researchers from the University of Queensland conducted a systematic review of 17 studies performed in 11 countries between Jan. 1, 1980, and May 30, 2023.

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The study data was pulled from several databases, including Medline, Embase, CINAHL, Web of Science and other publications.

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All the studies focused on participants who owned cats in their first 25 years of life and experienced schizophrenia-related outcomes, according to the researchers.

A new study suggests that being exposed to cats early in life could have adverse mental health effects down the road. (iStock)

Schizophrenia is a mental illness that affects a person’s thoughts, behaviors and feelings, as defined by the National Institute of Mental Health.

Psychotic symptoms can include hallucinations, delusions and thought disorders. 

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Those with the disorder may also experience cognitive challenges, loss of motivation, withdrawal from social activities, difficulty showing emotions and an overall lack of functioning.

“Based on past studies, there is evidence linking cat ownership and an increased risk of subsequent schizophrenia,” study author Dr. John McGrath, a psychiatrist at Queensland Brain Institute at the University of Queensland, St Lucia, Australia, told Fox News Digital.

“We had an open mind, and we reported the published findings.”

Young girl with cat

Research published in Schizophrenia Bulletin found that people who own cats may have more than double the chance of developing schizophrenia and other similar mental disorders later in life. (iStock)

Previous research linking cat exposure to schizophrenia risk has focused on Toxoplasma gondii (T. gondii), a parasite that can cause a feline disease called toxoplasmosis.

Separate studies have identified a “modest to large association” between toxoplasmosis and schizophrenia.

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The study did have some limitations, McGrath acknowledged.

“While observational epidemiology cannot prove this link, this topic warrants further, more detailed research,” he said.

“I was disappointed that there were not more highly quality — i.e., more rigorous — studies in our review.”

“Schizophrenia is an incredibly complex disorder, and this study identifies one potential risk factor that needs to be understood in a broader context.”

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Schizophrenia is a “poorly understood group of disorders,” McGrath noted.

“We need to invest in more research that looks at potential risk factors. There is much work to be done.”

‘No need to panic’

Dr. Zachary Ginder, a psychological consultant and doctor of clinical psychology at Pine Siskin Consulting, LLC in Riverside, California, was not involved in the study but commented on the findings.

Woman mental disorder

Schizophrenia is a mental illness that affects a person’s thoughts, behaviors and feelings. Psychotic symptoms can include hallucinations, delusions and thought disorders.  (iStock)

“It is important to keep a level head in consideration of these findings, and there is no need to panic if you own a cat and have children or are thinking about starting a family,” Ginder told Fox News Digital.

“Schizophrenia is an incredibly complex disorder, and this study identifies one potential risk factor that needs to be understood in a broader context. It would likely be premature to make strong recommendations about cat ownership solely based on these findings.”

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Although a relationship has been established between early-life cat exposure and schizophrenia, Ginder emphasized that this does not necessarily indicate that exposure causes the disorder. 

cat at the vet

“A lot more research” is needed to better understand these relationships — “accounting for a myriad of potential confounding factors and exploring underlying biological mechanisms,” said one psychological consultant and doctor of clinical psychology. (iStock)

“There is a lot that we still don’t know, and it is important to highlight that not all people who are exposed to cats or infected with the parasite develop mental health issues, and not all people with schizophrenia have had cat exposure,” he told Fox News Digital.

“While this parasite may play a role, it’s likely part of a complex interplay of genetic and environmental factors.” 

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Ginder echoed the researchers’ comments that “a lot more research” is needed to better understand these relationships — “accounting for a myriad of potential confounding factors and exploring underlying biological mechanisms.”

“These findings just give us another piece of an incredibly complex puzzle.”

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High levels of resistant bacteria found in uncooked meats and raw dog food: ‘Red flag’

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High levels of resistant bacteria found in uncooked meats and raw dog food: ‘Red flag’

High levels of E. coli were found in uncooked meats and raw dog food sold in grocery stores in the U.K., according to research presented last week at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress in Barcelona.

Researchers from ​the University of Bristol examined 58 samples of raw beef, chicken, pork and lamb sold at grocery stores in the U.K., along with 15 samples of raw dog food sold at “specialty pet stores,” according to a press release.

Eighty-one percent of the meat samples and 87% of the dog food samples were found to contain E. coli (Escherichia coli) that was resistant to antibiotics.

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The raw chicken had the highest levels of the resistant intestinal bacteria.

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“E. coli is an intestinal bacteria that may propagate in cows and chickens used for meat, especially when they are raised in squalor or close together,” Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, told Fox News Digital.

High levels of E. coli were found in uncooked meats and raw dog food sold in grocery stores, according to research presented last week at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress in Barcelona. (iStock)

“Since poultry and meat cows are often fed antibiotics to help them grow and to ward off infections, this helps to breed resistant strains, which emerge amid antibiotic overuse.”

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Siegel was not involved in the study.  

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“This study confirms that uncooked meat carries multiple resistant E. coli, commonly including resistance to critically important antibiotics important for human health,” the study authors said in a press release from ESCMID.

E.coli

“E. coli is an intestinal bacteria that may propagate in cows and chickens used for meat, especially when they are raised in squalor or close together.” (iStock)

If ingested, the bacteria could colonize the intestines and cause resistant infections, according to study author Matthew B. Avison, a professor at the School of Cellular & Molecular Medicine, University of Bristol.

“They can sit in your gut for years without causing sickness, and in some cases the bacteria will cause different types of disease later on, including urinary tract infections and bloodstream infections that can kill,” Avison told Fox News Digital. 

“Infections with resistant bacteria are more difficult to treat and so are more likely to get worse.”

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Uncooked meat sold to be eaten by people after cooking is “commonly contaminated” with antibiotic-resistant E. coli, Avison noted.

The study results weren’t surprising, he said, as there have been “numerous reports” of antibiotic-resistant bacteria in uncooked meat and some studies showing this in raw dog food.

“In some cases, the bacteria will cause different types of disease later on, including urinary tract infections and bloodstream infections.”

“People often believe that because raw dog food is sold frozen, the freezing kills the bacteria, but we have shown that it does not,” Avison told Fox News Digital.

“There were just as many samples of chicken-based raw dog food contaminated with resistant E. coli than there were samples of raw chicken meat. If you feed your dog raw meat, therefore, you are likely feeding it antibiotic resistant E. coli.”

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These findings explain why researchers previously found a strong link between feeding dogs raw meat and the dogs excreting resistant E. coli in their feces, Avison noted.

dog with food

“People often believe that because raw dog food is sold frozen, that freezing kills the bacteria on it, but we have shown that it does not,” a researcher told Fox News Digital. (iStock)

Most people are not aware of the risk of these antibiotic-resistant pathogens, the researchers stated in the release.

They emphasized the importance of cooking meat thoroughly before eating, and using “appropriate hygiene practices” while preparing it.

“Cooking the meat properly will kill those bacteria,” Avison advised.

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“Treat all raw meat as if it were contaminated with antibiotic-resistant bacteria and assume dogs fed raw meat will be excreting resistant bacteria,” he went on.

“Use appropriate hand-washing and general hygiene practices to minimize the risk that you and other people will accidentally ingest these bacteria.”

“If you feed your dog raw meat, you are likely feeding it antibiotic resistant E. coli.”

Dog owners who feed raw meat to their pets should dispose of the animals’ waste hygienically, Avison said.

“Don’t let your dog lick your face or share your bed, and wash your hands after petting it,” he recommended. “These are all common sense practices anyway, but even more important if you raw-feed your dog.”

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ground beef

Researchers emphasized the importance of cooking meat thoroughly before eating, and using “appropriate hygiene practices” while preparing it. (iStock)

“And, of course, treat raw dog food as if it were any raw meat, in terms of hygiene and cleaning practices.”

The study raises a “red flag,” Siegel said, underscoring the importance of making sure that poultry and meat is fully cooked prior to human consumption, and that dog food is also cooked. 

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Andre Delattre, chief operating officer of Public Interest Research Groups (PIRG) in Washington, D.C., said the study “underscores the importance of ending the practice of routine use of antibiotics in animal agriculture.”

Wood surface

“Use appropriate hand-washing and general hygiene practices to minimize the risk that you and other people will accidentally ingest these bacteria,” researchers said. (iStock)

“An inevitable byproduct of antibiotic overuse is resistance to these drugs,” he told Fox News Digital. 

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“Studies have also shown that meat raised without antibiotics is less likely to be contaminated with resistant bacteria.”

The University of Bristol study was published on a pre-print server and has not yet been peer-reviewed.

Fox News Digital reached out to the U.K. Food Standards Agency (FSA) and the U.S. Food and Drug Administration (FDA) for comment.

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