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‘Wild West’ peptide craze surges beyond GLP-1s as FDA faces pressure to ease access
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As GLP-1 weight-loss medications gain traction, the peptide market is experiencing a surge in interest.
A variety of peptides — commonly marketed for weight loss, muscle building, injury recovery and other uses — have emerged as largely unregulated drugs sold through both licensed compounding pharmacies and unverified vendors.
The U.S. Food and Drug Administration is set to evaluate whether to loosen regulations on several peptides during a meeting this summer.
THINKING ABOUT PEPTIDES? DOCTORS REVEAL KEY DOS AND DON’TS AS ‘WILD WEST’ MARKET GROWS
Peptides are short chains of amino acids — the building blocks of proteins — that play key roles in biological functions, according to the National Institutes of Health. Peptide drugs are lab-made versions of natural molecules in the body that are designed to mimic or influence biological signals to treat disease, experts say.
GLP-1s are “incredibly effective at what they do when it comes to changing body composition, benefiting metabolic health, cardiovascular health [and] neurologic health,” the expert said. (iStock)
Though the peptide market has been described as the “Wild West,” demand remains strong, potentially challenging pharmaceutical giants that dominate the GLP-1 market.
Dr. Alex Tatem, an Indiana-based board-certified urologist with expertise in men’s health and peptides, discussed how “life-changing” GLP-1s kicked off the rise of peptides.
“These were all medications that were designed to help people live well and live as healthy as possible.”
“They are incredibly effective at what they do when it comes to changing body composition, benefiting metabolic health, cardiovascular health [and] neurologic health,” he said. “These are truly miracle compounds, and as a result we’ve seen an explosion of interest – not just on the pharmaceutical side or the doctor’s side, but from the general public.”
According to Tatem, the challenge is that nearly all commercial GLP-1 products are administered in a single-dose weekly pen, which works for the “overwhelmingly majority” of patients, but not for everyone.
OZEMPIC ‘MICRODOSING’ IS THE NEW WEIGHT-LOSS TREND: SHOULD YOU TRY IT?
“There are patients I can prescribe tirzepatide to and they can do OK with a once-a-week [dose], but they end up developing nausea with that initial injection – and then by the end of the week, they’re hungry again.”
Because some patients respond better to smaller, more frequent doses — an option not offered by commercial drugs — compounding, or the customization of medications, has grown in popularity, Tatem said.
Several GLP-1 weight loss medications have been approved by the FDA with positive results from consumers. (iStock)
“We’ve had compounding pharmacies that have now developed compounded versions of semaglutide and tirzepatide that allow that sort of dosing flexibility,” he said.
“The reason compounders had to do this was because there was so much demand for GLP-1s that there was actually a national shortage.”
Current legislation allows compounders to step in during widespread national shortages, according to Tatem, prompting the industry to invest millions of dollars into developing and manufacturing these drugs.
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Once commercial pharmaceutical companies could catch back up, compounders continued making these medications in smaller batches for custom doses, allowing for more patient accessibility.
“That creates a huge clash between commercial pharmaceutical companies and compounders, because commercial pharmaceutical companies view that as an infringement of their property,” Tatem noted.
The expert noted a “huge clash” between pharmaceutical companies and compounding pharmacies in peptide production. (iStock)
Tatem raised concerns about the FDA’s regulation of compounding pharmacies, warning that it could limit patients’ access to customized medications.
“That is a real concern for clinicians like me who really care more about patient access, making sure we can get the right medication to the right patients at the right time,” he said.
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Some peptides have been widely administered for more than a decade without major health complications like toxicity or cancer, according to Tatem.
“These are compounds that haven’t gone through the full FDA approval process that you would normally see for a commercial drug, [yet] we didn’t see anything adverse,” he said.
The FDA plans to consider loosening restrictions on several peptides during a summer 2026 meeting. (Issam Ahmed/AFP)
In September 2023, the FDA “quietly” tightened regulation of 19 peptides, making them illegal to manufacture and cutting off patient access.
“They seemed to be working and seemed to be efficacious for patients, and all of a sudden they were banned, which inadvertently ended up contributing to this surge in interest,” Tatem said. “We kind of saw the same thing happen with peptides that we saw with prohibition.”
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While the rising popularity of GLP-1 drugs has fueled growing public and regulatory interest in peptides, most of the so-called “trendy” peptides still are not available by prescription, according to Tatem.
They may help with injury recovery, skin rejuvenation, sleep improvements and boosting of natural growth hormones, he said.
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“These were all medications that were designed to help people live well and live as healthy as possible,” the doctor told Fox News Digital. “And in reality, that was also their downfall in the American healthcare system, because if you are going to get a drug approved and to market, it has to treat a disease state.”
“These were all medications that were designed to help people live well and live as healthy as possible,” Tatem told Fox News Digital. (iStock)
Tatem confirmed that he’s seen a shift in patients confronting more than just baseline ailments, seeking advice on how to feel their best through new modes like testosterone therapy.
“The desire to function at our highest level is something that we all feel,” he said.
While nothing replaces the fundamentals — getting eight hours of sleep, eating a high-protein diet and maintaining a fitness routine that blends resistance training and cardio — Tatem said individualized treatments such as peptides may help support those healthy habits.
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“If you end up pulling a tendon or pulling a hamstring, and you’re just now starting to get some momentum in the gym, that’s really where peptides start to step in,” he added.
Experts advise consumers to avoid gray-market products, to work only with qualified physicians and reputable pharmacies, and to treat peptides as part of a broader health plan — not a shortcut or risk-free supplement.
Semaglutide (GLP-1) weight-loss drug Wegovy, made by pharmaceutical company Novo Nordisk, is designed to treat type 2 diabetes, but is widely known for its effect on weight loss. Picture date: Wednesday, October 16, 2024. (James Manning/PA Images via Getty Images)
In a statement shared with Fox News Digital, a Novo Nordisk spokesperson said the drugmaker is committed to working with regulators, law enforcement and “other key stakeholders” to ensure “affordable access to safe, effective and FDA-approved GLP-1 obesity medication like Wegovy and to protect patients from unapproved and untested knockoff drugs.”
“The desire to function at our highest level is something that we all feel.”
“Novo Nordisk supports FDA’s recent thorough scientific analysis and conclusion that there is no medical basis or clinical need for the continued mass compounding of unapproved semaglutide and liraglutide drugs,” they went on.
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“The agency’s decision reaffirms that compounding is meant to be a rare and limited exception to FDA’s gold-standard drug approval framework that ensures that medicines in the U.S. are safe and effective.”
Fox News Digital reached out to the FDA and Eli Lilly for comment.
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The leading causes of death have changed dramatically since America’s founding 250 years ago, highlighting how far medicine has come.
Diseases that once devastated communities have largely given way to chronic conditions, data shows, reflecting centuries of breakthroughs in public health, prevention and treatment.
“The amount of changes that have happened over the past 250 years are immeasurable when it comes to life expectancy and disease,” Kenneth J. Perry, M.D., an emergency physician in Charleston, South Carolina, told Fox News Digital.
5 OF AMERICA’S GREATEST MEDICAL BREAKTHROUGHS REVEALED AS THE NATION MARKS 250 YEARS
“Our life expectancy as a country increased from roughly 30 years at the time of the country’s founding to close to 80 years today.”
Check out the following details.
An illustration of an 18th century hospital. The leading causes of death have changed dramatically since America’s founding 250 years ago. (Hulton Archive/Getty Images)
What killed Americans in 1776?
Although there were no official national mortality records in 1776, historians agree that the following illnesses were responsible for the largest number of deaths.
- Smallpox: This viral disease, which causes fever and a blistering rash, had about a 30% fatality rate before the first vaccine became available in 1796. Historians estimate the North American epidemic killed at least 100,000 to 130,000 people over several years.
- Tuberculosis: Also known as consumption, this bacterial infection primarily attacks the lungs. It was one of the leading chronic causes of adult death in the colonies, according to the National Library of Medicine (NLM).
- Pneumonia: A lung infection that fills air sacs with fluid or pus, pneumonia was frequently fatal in 1776 because no antibiotics or effective treatments existed, per the National Institutes of Health (NIH).
- Dysentery and diarrheal diseases: Intestinal infections, which caused severe diarrhea and dehydration, were common in 1776 because of poor sanitation and contaminated food and water, especially in military camps, per NIH and NLM.
- Malaria: This mosquito-borne parasitic disease causes recurrent fever and chills. It was endemic throughout much of the Southern colonies, the CDC states.
- Yellow fever: A mosquito-borne viral disease, yellow fever can cause liver failure and bleeding. Periodic epidemics struck colonial port cities in the late 1700s, NLM records show.
- Typhoid fever: This bacterial infection spreads through contaminated food and water. Recurring outbreaks were common in places where sanitation was poor, historians confirm.
- Childbirth complications: Maternal deaths from hemorrhage, infection or obstructed labor were common in 1776. This was a major cause of death among women of childbearing age, the NLM states.
- Wound infections: In colonial times, cuts or injuries often led to bacterial infections. These could prove fatal because antisepsis therapies, germ theory and antibiotics did not yet exist.
- Infant mortality: It was extremely common for children to die before age 1, with roughly 10% to 30% of infants not living to their first birthday in many colonial communities, historical records show.
These conditions had much higher fatality rates in 1776 because Americans had no antibiotics, few vaccines, no understanding of germ theory, no sterile surgical techniques and limited access to hospitals, experts note.
Yellow fever epidemic in Philadelphia, 1793. Carriages rumbled through the streets to pick up the dying and the dead. (Getty Images)
There was also a lack of safe drinking water, modern sewage systems and refrigeration — making it more likely for foodborne and waterborne illnesses to spread.
Patients also did not yet have access to blood transfusions, anesthesia and other lifesaving medical advances, according to the CDC, NLM and NIH.
Common causes of death in the 1900s
The first official national mortality statistics were published by the U.S. Census Bureau in 1900.
The data points to the following leading causes of death in the 1900s.
- Influenza & pneumonia: Viral flu and bacterial/viral lung infections were responsible for about 40,000 to 65,000 deaths per year during the period between 1900 and 1910, according to the CDC’s National Center for Health Statistics (NCHS).
- Tuberculosis: The bacteria lung infection claimed about 35,000 to 40,000 lives per year during that same time frame, per the above source.
- Diarrhea/enteritis: Intestinal infections causing severe dehydration led to approximately 25,000 to 35,000 annual deaths between 1900 and 1910.
- Heart disease: Diseases affecting the heart and circulatory system killed between 27,000 and 40,000 Americans per year in this time frame, according to NCHS.
- Stroke: Strokes, which interrupt the flow of blood to the brain, took between 20,000 and 30,000 lives annually.
- Kidney disease: Diseases that impair kidney function (also called nephritis), killed between 17,000 and 25,000 people in the U.S. each year, data shows.
- Accidents: Between 15,000 and 22,000 Americans died each year from unintentional injuries at work, home and in transportation, per NCHS.
- Cancer: Various types of cancer, in which malignant tumors invade surrounding tissues, contributed to between 13,000 and 20,000 deaths annually in this time frame.
- Senility: This was a historical diagnosis for deaths attributed to old age in the early 1900s. It was listed as the cause of death for about 12,000 to 18,000 people per year.
- Diphtheria: The bacterial throat infection, which can block the airway, led to 8,000 to 12,000 deaths per year, mortality data highlights.
Nearly one-third of all deaths were caused by pneumonia, tuberculosis and diarrheal diseases, and about 30% of all deaths occurred in children younger than age 5, records show.
A diphtheria vaccination is administered in the 1900s in this illustration. (Getty Images)
Medical breakthroughs that transformed survival
The introduction of vaccines dramatically reduced certain diseases, including smallpox, polio, diphtheria, measles and whooping cough.
In 1980, smallpox became the first human disease ever eradicated worldwide.
The introduction of vaccines dramatically reduced certain diseases, including smallpox, polio, diphtheria, measles and whooping cough. (iStock)
Improvements in clean water and sanitation also contributed to greater longevity, as cities built sewage systems, water treatment plants and indoor plumbing, according to the CDC. As a result, deaths from cholera, dysentery and typhoid fever fell dramatically.
Germ theory also emerged in the late 1800s, in which scientists discovered that germs caused disease. This led to vast transformations in surgery, childbirth, handwashing, sterilization and infection control, per NIH and the Science History Institute.
In the 1940s, the widespread use of penicillin allowed for the treatment of diseases that were once fatal.
Routine screening has enabled earlier detection of breast, cervical and colorectal cancers, while improvements in surgery, radiation therapy, chemotherapy, targeted therapies and immunotherapy have helped many patients live longer.
A recent analysis by the National Cancer Institute found that prevention and screening accounted for about 80% of the cancer deaths averted over the past 45 years for five major cancer types.
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In the 1940s, the widespread use of penicillin allowed for the treatment of diseases that were once fatal, including pneumonia, strep infections, wound infections and sepsis.
Advances in childbirth — including prenatal care, Cesarean sections, blood transfusions, antibiotics and neonatal intensive care — also dramatically improved maternal and infant survival compared with colonial America.
The use of CPR, defibrillators, coronary care units, bypass surgery, stents, statins and blood pressure medications helped to reduce cardiovascular deaths. (iStock)
The mid-20th century also ushered in improvements in heart disease treatments. The use of CPR, defibrillators, coronary care units, bypass surgery, stents, statins and blood pressure medications helped to reduce cardiovascular deaths, according to the American Heart Association.
What’s killing Americans today?
In a vast contrast to 1776, chronic diseases now account for most American deaths, because people generally live long enough to develop them.
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Current U.S. health data indicates that the following conditions are now the leading causes of death.
- Heart disease: Disorders affecting the heart and blood vessels, including coronary artery disease and heart attacks, killed more than 638,000 Americans in 2024, according to NCHS data.
- Cancer: Approximately 619,876 people died of cancer in the U.S. in 2024.
- Unintentional injuries: Accidental deaths, including drug overdoses, motor vehicle crashes and falls, were the causes of more than 197,440 deaths that same year, records show.
- Stroke: Interruption of blood flow to the brain, which causes brain damage, claimed 166,852 American lives in 2024, per NCHS.
- Chronic lower respiratory disease: Long-term lung diseases — such as COPD, emphysema and chronic bronchitis — killed 145,643 people in the U.S. that year.
- Alzheimer’s disease: The most common type of dementia, which destroys memory and cognitive function, was responsible for 116,022 deaths in 2024, NCHS data shows.
- Diabetes: The chronic disease, which impairs the body’s ability to properly regulate blood sugar, contributed to 94,445 deaths that year.
- Kidney disease: Diseases that damage the kidneys and impair their ability to filter blood were blamed for 55,081 deaths in 2024.
- Chronic liver disease/cirrhosis: Progressive liver damage caused by conditions such as hepatitis, alcohol misuse or fatty liver disease were responsible for 52,274 deaths that year, per NCHS.
- Suicide: Death caused by intentional self-harm claimed 48,824 lives in 2024. (If you or someone you know is having thoughts of suicide, please contact the National Suicide Prevention Lifeline at 1-800-273-TALK (8255).)
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“The transformation of deaths in the last 250 years, largely from infectious diseases to currently chronic debilitating diseases, represents both success and new challenges Americans will have to face,” Dr. Omer Awan, a physician and professor at the University of Maryland School of Medicine, told Fox News Digital.
“The chronic disease epidemic has been fueled by a lack of exercise, as well as by diets rich in fats, salts and ultraprocessed foods,” a doctor told Fox News Digital. (iStock)
The uptick in chronic diseases is driven not only by an increasingly aging population, but by people’s lifestyle behaviors, according to the doctor.
“The chronic disease epidemic has been fueled by lack of exercise, as well as diets rich in fats, salts and ultraprocessed foods,” he told Fox News Digital. “This has also led to the rise of obesity, which contributes to many of the chronic medical conditions that are among the top killers for Americans in the modern era.”
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Public health advances can change the course of health for millions of Americans, Awan said.
“Just as vaccines and antibiotics prolonged life centuries ago, so can lifestyle changes, exercise and new therapies that target obesity — like GLP-1 drugs and medications that promote better metabolic health.”
Novo Nordisk to slash Wegovy, Ozempic list prices
Board certified rheumatologist Dr. Mahsa Tehrani discusses Novo Nordisk’s decision to dramatically cut the U.S. list prices for its popular diabetes and weight-loss drugs Ozempic and Wegovy on ‘America Reports.’
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Millions of Medicare beneficiaries struggling with obesity could soon see the cost of weight-loss drugs plummet, as a new federal pilot program launching July 1 expands access to GLP-1 medications like Wegovy and Zepbound for eligible seniors.
Through a new trial called Medicare GLP-1 Bridge, the federal government is now offering a selection of the brand-name medications to certain Medicare and Medicare Advantage beneficiaries for $50 a month, The Associated Press reported.
The covered medications include drugmaker Eli Lilly’s Foundayo tablets and Zepbound KwikPens and Novo Nordisk’s Wegovy injections and tablets, all of which have been FDA-approved for weight loss, according to the report.
OZEMPIC USERS MAY BE MAKING A MAJOR WEIGHT-LOSS MISTAKE, NEW STUDY SUGGESTS
The temporary program is set to run until the end of 2027.
This is the first time GLP-1s (glucagon-like peptide-1 receptor agonists) will be covered by insurance when used solely for weight loss.
A new federal pilot program launching July 1 expands access to GLP-1 medications like Wegovy and Zepbound for eligible seniors. (iStock)
Prior to this new Medicare pilot, seniors who wanted to access GLP-1s for obesity alone paid about $1,350-$1,650 per month for Novo Nordisk’s Wegovy (semaglutide) and about $1,086 monthly for Lilly’s Zepbound (tirzepatide). However, both manufacturers offered some cash-pay options that significantly reduced those prices for eligible patients.
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There are some parameters surrounding the coverage — older adults must have had a body mass index (BMI) of 35 or higher when they started GLP-1 therapy, or a BMI of 27 or higher alongside another health condition, such as a past heart attack or stroke or prediabetes.
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Those who already have insurance coverage for other diseases, such as diabetes and sleep apnea, are not eligible for the program.
Through a new trial called Medicare GLP-1 Bridge, the federal government is now offering a selection of the brand-name medications to certain Medicare and Medicare Advantage beneficiaries for $50 a month. (iStock)
There are more than 70 million Americans currently enrolled in Medicare, 10 million of whom are overweight or obese, according to Juliette Cubanski, vice president and director of the program on Medicare policy at the healthcare research nonprofit KFF.
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“For many older Americans living with obesity, this is a moment they and their families have been waiting for,” Jamey Millar, Novo Nordisk’s executive vice president of U.S. operations, said in a press release.
“The Medicare GLP-1 Bridge program offers a new, affordable path to an FDA-approved treatment that was previously not covered.”
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Dr. Mehmet Oz, administrator of the Centers for Medicare & Medicaid Services, said he hopes the program can help his agency collect data to potentially work toward longer-term coverage, while providing immediate relief to cash-strapped older Americans, AP reported.
“The sheer cost of these medications is a huge barrier to access,” he said in a call with reporters. “That ends today.”
Prior to this new Medicare pilot, seniors who wanted to access GLP-1s for obesity alone paid about $1,350-$1,650 per month for Novo Nordisk’s Wegovy (semaglutide) and about $1,086 monthly for Lilly’s Zepbound (tirzepatide). (iStock)
Oz told reporters that CMS plans to “carefully track participation and outcomes” to see whether an extension of the Bridge program or another solution is the best way to move forward. He told AP a federal law permanently allowing the coverage is “not essential right now” but something “for Congress to debate amongst themselves.”
“We can’t decide what’s going to happen long term with Bridge until we see some of the data,” he said, adding that there are ongoing talks with drug companies to lower costs.
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One potential concern is that older patients tend to have more adverse effects to medication in general , according to Dr. Micah Eimer, a clinical assistant professor of cardiology at the Northwestern University Feinberg School of Medicine.
“Specifically, in our research, older patients on blood pressure medications were more likely to experience hypotensive side effects, such as fainting and dizziness, after starting a GLP-1,” he said in a statement.
The Associated Press contributed to this report.
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