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FDA panel rejects MDMA-assisted therapies for PTSD despite high hopes from veterans

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FDA panel rejects MDMA-assisted therapies for PTSD despite high hopes from veterans

This story discusses suicide. If you or someone you know is having thoughts of suicide, please contact the Suicide & Crisis Lifeline at 988 or 1-800-273-TALK (8255).

A U.S. Food and Drug Administration (FDA) panel rejected MDMA-based treatments for post-traumatic stress disorder (PTSD) that are often used in veteran care.

On June 4, the advisory committee voted 10-1 against the overall benefits of MDMA when used to treat PTSD, according to the Associated Press.

MARINE VET TOUTS BENEFITS OF PSYCHEDELIC-ASSISTED PTSD DRUGS AS FDA CONSIDERS MDMA APPROVAL

During the nine-hour-long hearing — which was held in Silver Spring, Maryland — the panel addressed some concerns about study flaws, unclear data and potentially damaging side effects, leading to another 9-2 vote against drug efficacy.

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The drug application for psychedelic-assisted therapies was filed by Lykos Therapeutics in California earlier this year. 

“When I heard the verdict, all I could think about was the hopes of those veterans being dashed … and not having a solution for them,” one advocate said. (iStock)

The company expressed its disappointment in the FDA’s decision in a statement on June 4.

“We are disappointed in today’s vote, given the urgent unmet need in PTSD, and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” said Lykos Therapeutics CEO Amy Emerson. 

“We are disappointed in today’s vote, given the urgent unmet need.”

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“We remain committed to working with the FDA to address outstanding questions so that we may find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the health care system, if approved.”

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In a statement sent to Fox News Digital, the FDA echoed the intent for an ongoing review of the drug application.

“The FDA appreciates the input from the Psychopharmacologic Drugs Advisory Committee,” an FDA spokesperson wrote in an email. “Following the meeting, FDA career staff will take the committee’s input into account as they continue their review of the new drug application.”

An FDA panel has rejected MDMA-based treatments for post-traumatic stress disorder (PTSD) that are often used in veteran care. (iStock)

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Juliana Mercer, a 16-year Marine Corps veteran and director of the nonprofit Healing Breakthrough, who is based in San Diego, has been a leading advocate of psychedelic-assisted therapies in treating mental health challenges.

In an interview with Fox News Digital, Mercer said the verdict felt like a “big gut punch.”

She added, “When I heard the verdict, all I could think about was the hopes of those veterans being dashed … and not having a solution for them.”

VET WHO LOST MILITARY ‘BROTHERS’ TO POST-WAR SUICIDE CALLS FOR URGENT CHANGE: ‘WE COULD DO BETTER’

At the hearing, Mercer said there were “quite a few large veteran organizations that shared the great need for a solution to PTSD.” 

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“There were also individual veterans who had undergone the therapy and talked about this life-saving treatment they received,” she added.

U.S. Marine Juliana Mercer is pictured deployed in Helmand Province, Afghanistan, in 2010. The now-veteran also battled PTSD. (Juliana Mercer)

One Marine veteran spoke to the panel about the phone calls he has received from veterans asking, “How do I get this treatment?”

“I get those same calls,” Mercer said. “Veterans have heard that this works. They’ve seen the data and the science, and they’ve been desperately waiting for this approval.”

ON PTSD AWARENESS DAY, IMPORTANT HELP FOR VETERANS, MILITARY SERVICE MEMBERS IN SEARCH OF BETTER SLEEP

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Following the decision, Mercer said, “I just had a pit in my stomach, thinking about those veterans … who shared their testimony. It took me about 48 hours to go from basically grief to recognizing that we had an uphill battle, and I was ready to do everything it took to win this fight.”

Juliana Mercer, pictured, testified on Capitol Hill in November 2023 to advocate for psychedelic-assisted therapies in front of he House Committee for Veterans’ Affairs. (Juliana Mercer)

Mercer noted that the conversation with the advisory committee veered from data and facts into a “conversation about drug abuse, integrity and motivation.”

“They were saying there was not enough data and facts to approve it, basically,” she said. “This is the first time we’ve had something that actually has science and data behind it to actually heal or eliminate a PTSD diagnosis — and they refuse to look at that.”

KETAMINE THERAPY SHOWN EFFECTIVE IN TREATING SEVERE DEPRESSION IN VETERANS, STUDY FINDS

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Mercer said she is “holding out hope” that this decision will be overruled. “We haven’t had a new PTSD drug for over 20 years. And the ones that we have are not as effective as we need them to be.” 

“There is a huge downside in terms of unregulated recreational uses.”

“We’re losing over 6,000 veterans a year. We’ve lost over 130,000 veterans here on American soil to suicide since 2001, since the global war on terror started.”

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The Department of Veteran Affairs (VA) currently has 13 MDMA-based trials underway, according to Mercer.

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As this decision isn’t the final call, the FDA said it will continue to work with Lykos Therapeutics to address its concerns until the new decision deadline on August 9.

Both MDMA and psilocybin-assisted therapies (also known as ecstasy and magic mushrooms) will be studied by the VA. (iStock)

In a statement sent to Fox News Digital, VA Press Secretary Terrence Hayes said that while the Washington, D.C. agency “closely” monitors the FDA’s decisions, the VA “cannot comment on the recommendations of the FDA advisory committee or the FDA’s pending decision on a new drug application.”

“VA is committed to high-quality research that safely promotes the health of our nation’s veterans,” Hayes wrote. 

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“In line with this goal, as announced in January, VA plans to conduct additional studies under stringent protocols at various facilities to evaluate if psychotherapy in combination with compounds such as MDMA and psilocybin are effective for treating veterans with post-traumatic stress disorder and other mental health conditions.”

“We’re losing over 6,000 veterans a year,” one advocate said. “We’ve lost over 130,000 veterans here on American soil to suicide since 2001, since the global war on terror started.” (iStock)

Hayes added, “VA may provide agency research funding to larger studies investigating these novel therapies, including those that involve novel ways of administering the therapy with the intent of achieving maximum benefit to Veterans, while minimizing risks.”

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, interviewed two of the country’s top researchers on psychedelics. 

He spoke with Dr. Rachel Yehuda, founder and director of the Center for Psychedelic Psychotherapy and Trauma Research at Mt. Sinai in New York, and Dr. Charles Marmar, director of the PTSD research program at NYU Langone, earlier this year.

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“They agree there is therapeutic potential if very carefully studied under very strict medical guidance, but there is a huge downside in terms of unregulated recreational uses,” Siegel told Fox News Digital at the time.

“Both doctors see likely therapeutic value to psychedelics if carefully managed by medical experts.”

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Deaths from one type of cancer are surging among younger adults without college degrees

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Deaths from one type of cancer are surging among younger adults without college degrees

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Colorectal cancer, once considered a disease of older age, is becoming a crisis for younger adults. New research shows one group getting hit the hardest – those without a college degree.

A recent study from the American Cancer Society analyzed data from over 101,000 adults aged 25 to 49 who died from colorectal cancer between 1994 and 2023.

While death rates remained stable for college graduates, they climbed significantly for those without a bachelor’s degree, the findings showed.

WIDESPREAD HABIT MAY RAISE COLORECTAL CANCER RISK MORE THAN YOU THINK

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For young adults with a high school education or less, the mortality rate rose from 4.0 to 5.2 per 100,000 people, while the rate for those with at least a bachelor’s degree stayed flat, at approximately 2.7 per 100,000.

This does not mean that a degree offers some kind of biological protection, researchers cautioned.

Colorectal cancer, once considered a disease of older age, is becoming a crisis for younger adults. (iStock)

The difference is likely driven by the conditions in which people live and work, which often correlate with education levels, the researchers noted.

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The study suggests that the higher death rates are likely driven by differences in the prevalence of risk factors, including obesity, physical inactivity, smoking and diet, which are “known to be elevated among children and young adults with lower [socioeconomic status].”

Because the study relied on death certificates, researchers couldn’t say exactly why college graduates had better outcomes.

Because the researchers didn’t have the patients’ actual medical records, they couldn’t see things like frequency of screenings or treatment options, which would impact survival outcomes. (iStock)

Certificates typically list the cause of death, age, race and education level, but they do not include a person’s full medical history.

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Because the researchers didn’t have the patients’ actual medical records, they couldn’t see things like frequency of screenings or treatment options, which would impact survival outcomes.

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Colorectal cancer is now the leading cause of cancer death for men under 50 and the second leading cause for women in the same age group, according to recent statistics.

While colorectal cancer death rates remained stable for college graduates, they climbed significantly for those without a bachelor’s degree, the findings showed. (iStock)

Because the disease is highly treatable when caught early, the U.S. Preventive Services Task Force (USPSTF) lowered the recommended screening age from 50 to 45 in 2021.

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Common signs and symptoms of colorectal cancer can include a change in bowel habits, such as diarrhea, constipation or narrowing of the stool, that lasts for more than a few days, according to the American Cancer Society.

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Other signs that warrant seeing a doctor include blood in the stool or a persistent feeling of needing to go to the bathroom but being unable to go.

The research was published in JAMA Oncology.

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Cancer tied to woman’s vaping habit since age 15 as she’s now given just months to live

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Cancer tied to woman’s vaping habit since age 15 as she’s now given just months to live

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A young woman who started vaping at the age of 15 has been given just 18 months to live — after being diagnosed with lung cancer in her early 20s. 

Kayley Boda, 22, of Manchester, in the United Kingdom, was engaging in heavy vaping on a regular basis when she started coughing up a brown substance with “grainy bits” in it in January 2025, news agency SWNS reported. 

The retail assistant said doctors turned her away eight times, telling her she had a chest infection — until she began coughing up blood.    

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After seven biopsies, Boda was diagnosed with lung cancer. She underwent surgery to remove the lower lobe of her right lung, as well as chemotherapy — and in February 2026, got the all-clear, the same source reported.

Two months later, though, doctors said the cancer had come back in the pleural lining. Now she’s been given 18 months to live.

Kayley Boda, 22, is shown in the hospital. She started coughing up a brown substance with “grainy bits” in January 2025, she said. She had been vaping since the age of 15.  (SWNS)

The young woman has now issued a warning to others to be aware of the dangers of vaping.

Boda said she smoked a bit as a young teenager. She took up vaping after that. 

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Then, “a few months after I switched from reusable vapes to disposable ones, I started coughing up brown, grainy mucus,” as SWNS reported.

TOURISTS MAY FACE STEEP FINES AND JAIL TIME FOR VAPES AT THIS VACATION HOT SPOT

“Doctors turned me away eight times with a chest infection. … Then I started coughing up blood, so they did an X-ray and found a shadow on my lung,” she added.

“They told me they were 99% sure, [since I was] so young, that it wasn’t cancer, so not to worry about it. When I got the results back, and they told me it was lung cancer, it felt so surreal.”

Boda said she was “very naive” before her diagnosis and thought that “something like this would never happen to me.”

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She said that she had surgery to remove half of her right lung.

“After the surgery, I started chemo and I had a terrible reaction to it. I couldn’t lift my head up. I was throwing up blood. I was urinating blood. I couldn’t eat. I couldn’t sleep.”

VACATION HOT SPOT CRACKS DOWN ON VAPING WITH JAIL THREATS AND HEFTY FINES

She said that when she got the “all clear [in Feb. 2026], it felt amazing, but just two months later I was told the cancer had come back, and I have 18 months to live.”

She added, “I’m 22. This isn’t meant to happen to somebody my age.”

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“Stay off the vapes because they will catch up with you.”  

She blames her cancer on vaping, she said.  

“My symptoms started a few months after I started disposable vapes, and there’s no lung cancer in my family,” she said. “I haven’t vaped for three months, I’ve made my partner stop, I’ve made my mom stop, I’m urging all my friends to stop. Stay off the vapes,” she continued, “because they will catch up with you.”  

When doctors did an X-ray, they found a shadow on Boda’s right lung. She was later diagnosed with lung cancer and has undergone surgery to remove the lower lobe of her right lung, as well as chemotherapy. (SWNS)

She said she’d been using reusable vapes since the age of 15 and began using disposable vapes a few months before her cancer symptoms started.

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DISPOSABLE VAPES MORE TOXIC AND CARCINOGENIC THAN CIGARETTES, STUDY SHOWS

In November 2024, when she developed a rash all over her body, doctors said it could have been due to shingles, chicken pox or scabies, she told SWNS.    

‘Nothing worked’

“I got treated for all three, and nothing worked,” Boda said. “It got to the point where I was cutting myself from scratching so hard.” 

A few months after that, she began coughing up a dark brown mucus, with “grainy bits, the consistency of sugar, in it,” she said. When the coughing continued, she visited the doctor’s office, but was told it could be scarring from pneumonia or a chest infection, she also said.    

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It wasn’t until March 2025 that she began coughing up bright red blood. At that point, doctors gave her a chest X-ray and told her they’d found a shadow on her lower right lung.    

Over the next four months, she had seven biopsies as doctors took samples from the “shadow.” In August, when she went to get the results, she was told she had stage one lung cancer.

Boda is shown in the hospital. She was diagnosed with lung cancer and had surgery to remove the lower lobe of her right lung, as well as chemotherapy. (SWNS)

In September 2025, she had surgery to remove the lower lobe of her right lung, and the surrounding lymph nodes. During the surgery, doctors upstaged her cancer from stage one to stage three after finding cancer in six surrounding lymph nodes, she said.  

Following the surgery, Boda was unable to breathe properly and had to learn to walk all over again.  

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“The oncologist said this is so rare.”

After finishing chemotherapy in February 2026, Kayley was given the all clear, leaving her feeling elated. 

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However, just a month after that, she began experiencing extreme chest pains and was told by doctors she had a pleural effusion — a build-up of fluid in the lungs. She had the fluid removed, but when doctors tested it, they discovered her cancer had returned to the pleural lining of her lungs, giving her 18 months to live.  

“The oncologist said this is so rare, and usually something they see in patients that are 80 years old,” she said, as SWNS reported.  

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Increasingly, vacation hot spots are enforcing strict bans on the use of e-cigarettes in public venues.  (iStock)

Boda claimed that doctors were unable to pin her cancer to a specific cause — but told her that smoking and vaping definitely didn’t help.

Since her diagnosis, she has stopped and is urging others to stop, too.    

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She’s hoping to raise the thousands of dollars needed for treatment to try to prolong her life, she said.  

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Last year, Fox News Digital reported on the case of a Pennsylvania woman, 26, who said she vaped for just one year before her lungs collapsed. She was 22 when she took up the habit, she said in an interview. 

“Everybody warned me about it, but I didn’t listen — I wish that I did,” she said.

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Dr. David Campbell, clinical director and program director at Recover Together Bend in Oregon, told Fox News Digital at that time that signs of collapsed lungs include sharp chest or shoulder pain, shortness of breath and difficulty breathing.

Lung issues are just one of the many health issues linked to vaping, he warned. The habit can also increase the risk of heart disease and stroke, as well as exposure to harmful heavy metals.

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Melissa Rudy of Fox News Digital contributed reporting. 

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Experts reveal why ‘nonnamaxxing’ trend may improve mental, physical health

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Experts reveal why ‘nonnamaxxing’ trend may improve mental, physical health

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The key to feeling better in a fast, overstimulated world might be surprisingly simple: Live a little more like your grandparents.

A growing social media trend, dubbed “nonnamaxxing,” draws inspiration from the slower, more intentional rhythms associated with an Italian grandmother.

The lifestyle is often linked to activities like preparing home-cooked meals, spending time outdoors and making meaningful connections.

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“Nonnamaxxing is a 2026 trend that embraces the slower, more intentional lifestyle of an Italian grandmother (a Nonna). Think cooking from scratch, long family meals, daily walks, gardening and less screen time,” Erin Palinski-Wade, a New Jersey-based registered dietitian, told Fox News Digital.

Nonnamaxxing, derived from the name for an Italian grandmother, is a trend that incorporates lifestyle habits hundreds of years in the making. (iStock)

Stepping away from screens and toward real-world interaction can have measurable benefits, according to California-based psychotherapist Laurie Singer.

“We know that interacting with others in person, rather than spending time on screens, significantly improves mental health,” she told Fox News Digital, adding that social media often fuels comparison and lowers self-esteem.

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Living more like previous generations isn’t purely driven by nostalgia. Cooking meals from scratch, for example, has been linked to better nutrition and more mindful eating patterns.

Adopting traditional mealtime habits can improve diet quality and support both physical and mental health, especially when meals are shared regularly with others, Palinski-Wade noted.

One longevity expert stresses that staying healthy isn’t just about food — it’s also about joy and community. (iStock)

There’s also a psychological benefit to slowing down and focusing on one task at a time. Anxiety often stems from unfinished or avoided tasks, Singer noted, and engaging in hands-on activities can counteract that.

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“Nonnamaxxing encourages us to be present around a task, like gardening, baking or knitting, or just taking a mindful walk, that delivers something ‘real,’” she said.

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Palinski-Wade cautions against turning the trend into another source of pressure, noting that a traditional “nonna” lifestyle often assumes a different pace of life.

The key, she said, is adapting the mindset, not replicating it perfectly.

Nonnamaxxing, derived from the name for an Italian grandmother, is a trend that incorporates lifestyle habits hundreds of years in the making. (iStock)

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The goal is to reintroduce small, intentional moments that make you feel better.

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That might mean prioritizing a few shared meals each week, taking a walk without your phone or setting aside time for a simple hobby, the expert recommended.

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Singer added, “Having a positive place to escape to, through whatever activities speak to us and make us happy, isn’t generational – it’s human.”

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